OBG Management

The age-adjusted prevalence of any sexual problem is 43% among US women. A full 22% of these women experience sexually related personal distress.¹ With publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition² has come a shift in classification and, at times, management approach for reported female sexual dysfunction. When women report to their clinicians decreased sexual desire or arousal or pain at penetration, the management is no longer guided by a linear model of sexual response (excitation, plateau, orgasm, and resolution) but rather by a more nuanced and complex biopsychosocial approach. In this model, diagnosis and management strategies to address bothersome sexual concerns consider the whole woman in the context of her physical and psychosocial health. The patient’s age, medical history, and relationship status are among the factors that could affect management of the problem. In an effort to explore this management approach, I used this Update on Female Sexual Dysfunction as an opportunity to convene a roundtable of several experts, representing varying backgrounds and practice vantage points, to discuss 5 cases of sexual problems that you as a busy clinician may encounter in your practice.

Genital atrophy in a sexually inactive 61-year-old woman

Barbara S. Levy, MD: Two years after her husband's death, which followed several years of illness, your 61-year-old patient mentions at her well woman visit that she anticipates becoming sexually active again. She has not used systemic or vaginal hormone therapy. During pelvic examination, atrophic external genital changes are present, and use of an ultrathin (thinner than a Pederson) speculum reveals vaginal epithelial atrophic changes. A single-digit bimanual exam can be performed with moderate patient discomfort; the patient cannot tolerate a 2-digit bimanual exam. She expresses concern about being able to engage in penile/vaginal sexual intercourse. 

Dr. Kaunitz, what is important for you to ask this patient, and what concerns you most on her physical exam?

Andrew M. Kaunitz, MD: First, it is important to recognize the patient's expectations and desires. As the case suggests, but further questioning could clarify, she would like to be able to comfortably engage in sexual intercourse with a new partner, but penetration may be difficult (and definitely painful for her) unless treatment is pursued. This combination of mucosal and vestibular atrophic changes (genitourinary syndrome of menopause [GSM], or vulvovaginal atrophy [VVA]) plus the absence of penetration for many years can be a double whammy situation for menopausal women. In this case it has led to extensive contracture of the introitus, and if it is not addressed will cause sexual dysfunction.

Dr. Levy: In addition we need to clarify whether or not a history of breast cancer or some other thing may impact the care we provide. How would you approach talking with this patient in order to manage her care?

Dr. Kaunitz: One step is to see how motivated she is to address this, as it is not something that, as gynecologists, we can snap our fingers and the situation will be resolved. If the patient is motivated to treat the atrophic changes with medical treatment, in the form of low-dose vaginal estrogen, and dilation, either on her own if she's highly motivated to do so, or in my practice more commonly with the support of a women's physical therapist, over time she should be able to comfortably engage in sexual intercourse with penetration. If this is what she wants, we can help steer her in the right direction.

Sheryl Kingsberg, PhD: You know that this woman is motivated by virtue of her initiating the topic herself. Patients are often embarrassed talking about sexual issues, or they are not sure that their gynecologist is comfortable with it. After all, they think, if this is the right place to discuss sexual problems, why didn't he or she ask me?  Clinicians must be aware that it is their responsibility to ask about sexual function and not leave it for the patient to open the door.

Dr. Kaunitz: Great point.

Cheryl B. Iglesia, MD: Gratefully, a lot of the atrophic changes this patient demonstrates are reversible. However, other autoimmune diseases (eg, lichen planus, which can affect the vaginal epithelium, or lichen sclerosus, which can affect the clitoris, labia, and vulva) can also cause constriction, and in severe cases, complete obliteration of the vagina and introitus. Women may not be sexually active, and for each annual exam their clinician uses a smaller and smaller speculum--to the point that they cannot even access the cervix anymore--and the vagina can close off. Clinicians may not realize that you need something other than estrogen; with lichen planus you need steroid suppository treatment, and with lichen sclerosus you need topical steroid treatment. So these autoimmune conditions should also be in the differential and, with appropriate treatment, the sexual effects can be reversible.

Michael Krychman, MD: I agree. The vulva can be a great mimicker and, according to the history and physical exam, at some point a vulvoscopy, and even potential biopsies, may be warranted as clinically indicated.

The concept of a comprehensive approach, as Dr. Kingsberg had previously mentioned, involves not only sexual medicine but also evaluating the patient's biopsychosocial variables that may impact her condition.  We also need to set realistic expectations. Some women may benefit from off-label use of medications besides estrogen, including topical testosterone. Informed consent is very important with these treatments. I also have had much clinical success with intravaginal diazepam/lorazepam for pelvic floor hypertonus.

In addition, certainly I agree that pelvic floor physical therapy (PT) is a vital treatment component for this patient and, not to diminish its importance, but many women cannot afford, nor do they have the time or opportunity, to go to pelvic floor PT. As clinicians, we can develop and implement effective programs, even in the office, to educate the patient to help herself as well.

Dr. Kaunitz: Absolutely. Also, if, in a clinical setting consistent with atrophic changes, an ObGyn physician is comfortable that vulvovaginal changes noted on exam represent GSM/atrophic changes, I do not feel vulvoscopy is warranted.

Dr. Levy: In conclusion, we need to be aware that pelvic floor PT may not be available everywhere and that a woman's own digits and her partner can also be incorporated into this treatment.

Something that we have all talked about in other venues, but have not looked at in the larger sphere here, is whether there is value to seeing women annually and performing pelvic exams. As Dr. Kingsberg mentioned, this is a highly motivated patient. We have many patients out there who are silent sufferers. The physical exam is an opportunity for us to recognize and address this problem.

Kimberly Martens for OBG Management

Dyspareunia and low sexual desire in a breast cancer survivor

Dr. Levy: In this case, a 36-year-old woman with BRCA1−positive breast cancer has vaginal dryness, painful intercourse, and lowered sexual interest since her treatment, which included chemotherapy after bilateral mastectomies. She has a bilateral salpingo-oophorectomy(BSO) scheduled for primary prevention of her ovarian cancer risk.

Dr. Kingsberg, what is important for you to know to help guide case management?

Dr. Kingsberg: This woman is actually presenting with 2 sexual problems: dyspareunia, which is probably secondary to VVA or GSM, and low sexual desire. Key questions are: 1) When was symptom onset--acquired after treatment or lifelong? 2) Did she develop the dyspareunia and as a result of having pain during sex lost desire to have sex? Or, did she lose desire and then, without it, had no arousal and therefore pain with penetration developed? It also could be that she has 2 distinct problems, VVA and hypoactive sexual desire disorder (HSDD), in which case you need to think about treating both. Finally, we do not actually know if she is having penetrative intercourse or even if she has a partner.

A vulvovaginal exam would give clues as to whether she has VVA, and hormone levels would indicate if she now has chemo-induced menopause. If she is not in menopause now, she certainly is going to be with her BSO. The hormonal changes due to menopause actually can be primarily responsible for both the dyspareunia and HSDD. Management of both symptoms really needs to be based on shared decision making with the patient--with which treatment for which conditions coming first, based on what is causing her the most distress.

I would encourage this woman to treat her VVA since GSM does have long-term physiologic consequences if untreated. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal treatments as first-line treatments, with vaginal estrogen considered if these therapies fail.³ If lubricants and moisturizers and other nonhormonal options are not sufficient, you could consider local estrogen, even though she is a breast cancer survivor, as well as ospemiphene.

If she is distressed by her loss of sexual desire, you can choose to treat her for HSDD. Flibanserin is the first FDA-approved treatment for HSDD. It is only approved in premenopausal women, so it would be considered off-label use if she is postmenopausal (even though she is quite young). You also could consider exogenous testosterone off-label, after consulting with her oncologist.

In addition to the obvious physiologic etiology of her pain and her low desire, the biopsychosocial aspects to consider are: 1) changes to her body image, as she has had bilateral mastectomies, 2) her anxiety about the cancer diagnosis, and 3) concerns about her relationship if she has one--her partner's reactions to her illness and the quality of the relationship outside the bedroom.

Dr. Iglesia: I am seeing here in our nation's capital a lot of advertisements for laser therapy for GSM. I caution women about this because providers are charging a lot of money for this therapy when we do not have long-term safety and effectiveness data for it.

Our group is currently conducting a randomized controlled trial, looking at vaginal estrogen cream versus laser therapy for GSM here at Medstar Health--one of the first in the country as part of a multisite trial. But the North American Menopause Society (NAMS) has come out with a pretty strong statement,⁴ as has ACOG,⁵ on this therapy, and I caution people about overzealously offering a very costly procedure targeted to a very vulnerable population, especially to women with personal histories of estrogen-sensitive cancers.

Dr. Krychman: I agree. Very often cancer patients are preyed upon by those offering emerging unproven technologies or medications. We have to work as a coordinated comprehensive team, whether it's a sexual medicine expert, psychologist, urogynecologist, gynecologist, or oncologist, and incorporate the patient's needs and expectations and risk tolerance coupled with treatment efficacy and safety.

Dr. Levy: This was a complex case. The biopsychosocial model is critical here. It's important that we are not siloes in our medical management approach and that we try to help this patient embrace the complexity of her situation. It's not only that she has cancer at age 36; there is a possible guilt factor if she has children and passed that gene on.

Another point that we began to talk about is the fact that in this country we tend to be early adopters of new technology. In our discussion with patients, we should focus on what we know and the risk of the unknowns related to some of the treatment options. But let's discuss lasers a little more later on.

Diminished arousal and orgasmic intensity in a patient taking SSRIs

Dr. Levy: In this next case, a 44-year-old woman in a 15-year marriage notices a change in her orgasmic intensity and latency. She has a supportive husband, and they are attentive to each other's sexual needs. However, she notices a change in her arousal and orgasmic intensity, which has diminished over the last year. She reports that the time to orgasm or latency has increased and both she and her partner are frustrated and getting concerned. She has a history of depression that has been managed by selective serotonin reuptake inhibitors for the past 5 years and has no depressive symptoms currently.

Dr. Krychman, what are you considering before beginning to talk with this patient?

Dr. Krychman: My approach really is a comprehensive one, looking not only at the underlying medical issues but also at the psychological and dynamic relationship facets. We of course also want to look at medications: Has she changed her dose or the timing of when she takes it? Is this a new onset? Finally, we want to know why this is coming to the forefront now. Is it because it is getting worse, or is it because there is some significant issue that is going on in the relationship?

Regarding the physical exam, it is important to rule out underlying genital pelvic pathology. Young women can get changes in the integrity of the pelvic floor, in what I would call the orgasmic matrix--the clitoral tissue, the body, the crura (or arms of the clitoris)--we want to examine and be reassured that her genital anatomy is normal and that there is no underlying pathology that could signal an underlying abnormal hormonal profile. Young women certainly can get lowered estrogen effects at the genital/pelvic tissues (including the labia and vulva), and intravaginally as well. Sometimes women will have pelvic floor hypertonus, as we see with other urinary issues. A thorough pelvic exam is quite vital.

Let's not forget the body that is attached to the genitals; we want to rule out chronic medical disease that may impact her: hypertension, diabetes, or hypercholesterolemia. Untreated, these conditions may directly impact the arousal physiologic mechanisms.

Dr. Levy: In doing this patient's physical exam I would be looking for significant weight gain, and even asking about her partner's weight. Body image can be a huge issue. If she has a history of depression, if she is suffering from a body image problem, she can be feeling unattractive. In my experience this can be a common thing to affect women in their mid-40s.

How would you manage this case?

Dr. Krychman: It is important to divide it up in terms of a conservative to aggressive approach. We want to find out about the relationship. For instance, is the sexual dynamic scripted (ie, boring and predictable)? Is she distracted and frustrated or is she getting enough of the type of stimulation that she likes and enjoys? There certainly are a lot of new devices that are available, whether a self-stimulator or vibrator, the Fiera, or other stimulating devices, that may be important to incorporate into the sexual repertoire. If there is underlying pathology, we want to evaluate and treat that. She may need to be primed, so to speak, with systemic hormones. And does she have issues related to other effects of hormonal deprivation, even local effects? Does she have clitoral atrophy?

There are neutraceuticals that are currently available, whether topical arousal gels or ointments, and we as clinicians need to be critical and evaluate their benefit/risk and look at the data concerning these products. In addition, women who have changes in arousal and in orgasmic intensity and latency may be very frustrated. They describe it as climbing up to a peak but never getting over the top, and this frustration may lead to participant spectatoring, so incorporating a certified sex therapist or counselor is sometimes very critical.

Finally, there are a lot of snake oils, charmers, and charlatan unproven procedures--injecting fillers or other substances into the clitoris are a few examples. I would be a critical clinician, examine the evidence, look at the benefit/risk before advocating an intervention that does not have good clinical data to support its use--a comprehensive approach of sexual medicine as well as sexual psychology.

Dr. Kingsberg: Additionally, we know she is in a long-term relationship--15 years; we want to acknowledge the partner. We talked about the partner's weight, but what about his erectile function? Does he have changes in sexual function that are affecting her, and she is the one carrying the "symptom"?

Looking at each piece separately helps a clinician from getting overwhelmed by the patient who comes in reporting distress with orgasmic dysfunction. We have no pharmacologic FDA-approved treatments, so it can feel off-putting for a clinician to try to fix the reported issue. Looking at each component to help her figure out the underlying cause can be helpful.

Dr. Iglesia: With aging, there can be changes in blood flow, not to mention the hormonal and even peripheral nerve changes, that require more stimulation in order to achieve the desired response. I echo concern about expensive procedures being offered with no evidence, such as the "O" or "G" shot, that can cost up to thousands of dollars.

The other procedure that gives me a lot of angst is clitoral unhooding. The 3 parts of the clitoris are sensitive in terms of innervation and blood flow, and cutting around that delicate tissue goes against the surgical principles required for preserving nerves and blood flow.

New onset pain post−prolapse surgery with TOT sling placement

Dr. Levy: For this case, let's consider a 42-year-old woman (P3) who is 6 months post− vaginal hysterectomy. The surgery included ovarian preservation combined with anterior and posterior repair for prolapse as well as apical uterosacral ligament suspension for stage 2 uterovaginal prolapse. A transobturator sling was used.

Extensive preop evaluation was performed, with confirmed symptomatic prolapse. She had no stress incontinence symptoms but did have confirmed occult stress incontinence.

Surgery was uneventful. She resumed intercourse at 8 weeks, but she now has pain with both initial entry and deep penetration. Lubricants and changes in position have not helped. She is in a stable relationship with her husband of 17 years, and she is worried that the sling mesh might be the culprit. On exam, she has no atrophy, pH is 4.5, vaginal length is 8 cm, and there is no prolapse. There is no mesh exposure noted, although she reports slight tenderness with palpation of the right sling arm beneath the right pubic bone.

Dr. Iglesia, what are the patient history questions important to ask here?
 
Dr. Iglesia: This is not an uncommon scenario--elective surgical correction of  occult or latent stress incontinence after surgical correction for pelvic organ prolapse. Now this patient here has no more prolapse complaints; however, she has a new symptom. There are many different causes of dyspareunia; we cannot just assume it is the sling mesh (although with all the legal representation advertisements for those who have had mesh placed, it can certainly be at the top of the patient's mind, causing anxiety and fear).

Multiple trials have looked at prophylactic surgery for incontinence at the time of prolapse repairs. This woman happened to be one of those patients who did not have incontinence symptoms, and they put a sling in. A recent large trial examined women with vaginal prolapse who underwent hysterectomy and suspension.⁶ (They compared 2 different suspensions.) What is interesting is that 25% of women with prolapse do have baseline pain. However, at 24 months, de novo pain can occur in 10% of women--just from the apical suspension. So, here, it could be the prolapse suspension. Or, in terms of the transobturator sling, long-term data do tell us that the de novo dyspareunia rate ranges on the magnitude of 1% to 9%.⁷ What is important here is figuring out the cause of the dyspareunia.

Dr. Levy: One of the important points you raised already was that 25% of these women have preoperative pain. So figuring out what her functioning was before surgery and incorporating that into our assessment postop would be pretty important I would think.

Dr. Iglesia: Yes, you need to understand what her typical encounter was before the surgery and how things have changed now that the prolapse is not in the way. Changes obviously can occur with scar tissue, which over time will improve. If she is perimenopausal and starts to get epithelial changes, we can fix that. The question then becomes, "Is the pain emanating from the mesh?"

When examining this patient, it is not uncommon for me to be able to feel "banjo" strings if the mesh is too tight or close to the surface. It is not exposed but it's palpable, and the patient may feel a ridge during penetration. You can ask the patient if pain occurs with different penetration positions. In addition, explore associated neurologic symptoms (numbness or muscle pain in the thigh).

Dr. Kingsberg: There were 2 different sources of pain--on initial entry and at deep penetration. You want to make sure you address both. Importantly, did one precede the other? For instance, if women have pain with penetration they can then end up with an arousal disorder (the length of the vagina cannot increase as much as it might otherwise) and dystonia secondary to the pain with penetration. The timing of the pain--did it all happen at the same time, or did she start out with pain at one point and did it move to something else--is another critical piece of the history.

Dr. Iglesia: It does take a detailed history and physical exam to identify myofascial trigger points. In this case there seems to be pinpoint tenderness directly on the part of the mesh that is not exposed on the right. There are people who feel you should remove the whole mesh, including the arms. Others feel, okay, we can work on these trigger points, with injections, physical therapy, extra lubrication, and neuromodulatory medications. Only then would they think about potentially excising the sling or a portion thereof.

Dr. Krychman: Keep in mind that, even if you do remove the sling, her pain may not subside, if it is secondary to an underlying issue. Because of media sensationalism, she could be focusing on the sling. It is important to set realistic expectations. I often see vulvar pathology or even provoked vestibulodynia that can present with a deep dyspareunia. The concept of collision dyspareunia or introital discomfort or pain on insertion has far reaching implications. We need to look at the patient in totality, ruling out underlying issues related to the bladder, even the colon.

Patient inquires about the benefits of laser treatment for vaginal health

Dr. Levy: Let's move to this last case: A 47-year-old patient who reports lack of sexual satisfaction and attributes it to a loose vagina says, "I've heard about surgery and laser treatment and radiofrequency devices for vaginal health. What are the benefits and risks of these procedures, and will they correct the issues that I'm experiencing?"

How do you approach this patient?

Dr. Krychman: I want to know why this is of paramount importance to her. Is this her actual complaint or is it society's unrealistic expectation of sexual pleasure and performance placed upon her? Or is this a relationship issue surfacing, compounded by physiologic changes? With good communication techniques, like "ask, tell, ask" or effective use of silence (not interrupting), patients will lead us to the reason and the rationale.

Dr. Levy: I have seen a lot of advertising to women, now showing pictures of genitalia, perhaps creating an expectation that we should look infantile in some way. We are creating a sense of beauty and acceptablevisualization of the vagina and vulva that are completely unrealistic. It's fascinating on one hand but it is also disturbing in that some of the direct-to-consumer marketing going on is creating a sense of unease in women who are otherwise perfectly satisfied. Now they take a look at their sagging skin, maybe after having 2 or 3 children, and although they may not look the same they function not so badly perhaps. I think we are creating a distress and an illness model that is interesting to discuss.

Dr. Iglesia, you are in the midst of a randomized trial, giving an informed consent to participants about the expectations for this potential intervention. How do you explain to women what these laser and radiofrequency devices are expected to do and why they might or might not work?

Dr. Iglesia: We are doing a randomized trial for menopausal women who have GSM. We are comparing estrogen cream with fractional CO2 laser therapy. I also am involved in another randomized trial for lichen sclerosus. I am not involved in the cosmetic use of a laser for people who feel their vaginas are just "loose." Like you, Dr. Levy, I am very concerned about the images that women are seeing of the idealized vulva and vagina, and about the rise of cosmetic gynecology, much of which is being performed by plastic surgeons or dermatologists.

A recent article looked at the number of women who are doing pubic hair grooming; the prevalance is about 80% here in America.⁸ So people have a clear view of what is down there, and then they compare it to what they see in pornographic images on the Internet and want to look like a Barbie doll. That is disturbing because women, particularly young women, do not realize what happens with GSM changes to the vulva and vagina. On the other hand, these laser machines are very expensive, and some doctors are charging thousands of dollars and promising cosmetic and functional results for which we lack long-term, comparative data.

The laser that we are studying is one by Cynosure called Mona Lisa, which works with fractional CO2 and has very low depth of penetration. The concept is that, with microdot therapy (on the order of micrometers), pinpoint destruction will foster regeneration of new collagen and blood flow to the vagina and vulva. We are still in the midst of analyzing this.

Dr. Krychman: I caution people not to lump devices together. There is a significant difference between laser and radiofrequency--especially in the depth of tissue penetration, and level of evidence as well. There are companies performing randomized clinical trials, with well designed sham controls, and have demonstrated clinical efficacy. We need to be cautious of a procedure that is saying it's the best thing since sliced bread, curing interstitial cystitis, dyspareunia, and lichen sclerosus and improving orgasm, lubrication, and arousal. These far reaching, off-label claims are concerning and misleading.

Dr. Levy: I think the important things are 1) shared decision making with the patient and 2) disclosure of what we do not know, which are the long-term results and outcomes and possible downstream negative effects of some of these treatments, since the data we have are so short term.

Dr. Kingsberg: Basics are important. You talked about the pressure for cosmetic appearance, but is that really what is going on for this particular patient? Is she describing a sexual dysfunction when she talks about lack of satisfaction? You need to operationally define that term. Does she have problems with arousal or orgasm or desire and those are what underlie her lack of satisfaction? Is the key to management helping her come to terms with body image issues or to treat a sexual dysfunction? If it truly is a sexual dysfunction, then you can have the shared decision making on preferred treatment approach.

Dr. Levy: This has been an enlightening discussion. Thank all of you for your expertise and clinical acumen.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The age-adjusted prevalence of any sexual problem is 43% among US women. A full 22% of these women experience sexually related personal distress.¹ With publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition² has come a shift in classification and, at times, management approach for reported female sexual dysfunction. When women report to their clinicians decreased sexual desire or arousal or pain at penetration, the management is no longer guided by a linear model of sexual response (excitation, plateau, orgasm, and resolution) but rather by a more nuanced and complex biopsychosocial approach. In this model, diagnosis and management strategies to address bothersome sexual concerns consider the whole woman in the context of her physical and psychosocial health. The patient’s age, medical history, and relationship status are among the factors that could affect management of the problem. In an effort to explore this management approach, I used this Update on Female Sexual Dysfunction as an opportunity to convene a roundtable of several experts, representing varying backgrounds and practice vantage points, to discuss 5 cases of sexual problems that you as a busy clinician may encounter in your practice.

Genital atrophy in a sexually inactive 61-year-old woman

Barbara S. Levy, MD: Two years after her husband's death, which followed several years of illness, your 61-year-old patient mentions at her well woman visit that she anticipates becoming sexually active again. She has not used systemic or vaginal hormone therapy. During pelvic examination, atrophic external genital changes are present, and use of an ultrathin (thinner than a Pederson) speculum reveals vaginal epithelial atrophic changes. A single-digit bimanual exam can be performed with moderate patient discomfort; the patient cannot tolerate a 2-digit bimanual exam. She expresses concern about being able to engage in penile/vaginal sexual intercourse. 

Dr. Kaunitz, what is important for you to ask this patient, and what concerns you most on her physical exam?

Andrew M. Kaunitz, MD: First, it is important to recognize the patient's expectations and desires. As the case suggests, but further questioning could clarify, she would like to be able to comfortably engage in sexual intercourse with a new partner, but penetration may be difficult (and definitely painful for her) unless treatment is pursued. This combination of mucosal and vestibular atrophic changes (genitourinary syndrome of menopause [GSM], or vulvovaginal atrophy [VVA]) plus the absence of penetration for many years can be a double whammy situation for menopausal women. In this case it has led to extensive contracture of the introitus, and if it is not addressed will cause sexual dysfunction.

Dr. Levy: In addition we need to clarify whether or not a history of breast cancer or some other thing may impact the care we provide. How would you approach talking with this patient in order to manage her care?

Dr. Kaunitz: One step is to see how motivated she is to address this, as it is not something that, as gynecologists, we can snap our fingers and the situation will be resolved. If the patient is motivated to treat the atrophic changes with medical treatment, in the form of low-dose vaginal estrogen, and dilation, either on her own if she's highly motivated to do so, or in my practice more commonly with the support of a women's physical therapist, over time she should be able to comfortably engage in sexual intercourse with penetration. If this is what she wants, we can help steer her in the right direction.

Sheryl Kingsberg, PhD: You know that this woman is motivated by virtue of her initiating the topic herself. Patients are often embarrassed talking about sexual issues, or they are not sure that their gynecologist is comfortable with it. After all, they think, if this is the right place to discuss sexual problems, why didn't he or she ask me?  Clinicians must be aware that it is their responsibility to ask about sexual function and not leave it for the patient to open the door.

Dr. Kaunitz: Great point.

Cheryl B. Iglesia, MD: Gratefully, a lot of the atrophic changes this patient demonstrates are reversible. However, other autoimmune diseases (eg, lichen planus, which can affect the vaginal epithelium, or lichen sclerosus, which can affect the clitoris, labia, and vulva) can also cause constriction, and in severe cases, complete obliteration of the vagina and introitus. Women may not be sexually active, and for each annual exam their clinician uses a smaller and smaller speculum--to the point that they cannot even access the cervix anymore--and the vagina can close off. Clinicians may not realize that you need something other than estrogen; with lichen planus you need steroid suppository treatment, and with lichen sclerosus you need topical steroid treatment. So these autoimmune conditions should also be in the differential and, with appropriate treatment, the sexual effects can be reversible.

Michael Krychman, MD: I agree. The vulva can be a great mimicker and, according to the history and physical exam, at some point a vulvoscopy, and even potential biopsies, may be warranted as clinically indicated.

The concept of a comprehensive approach, as Dr. Kingsberg had previously mentioned, involves not only sexual medicine but also evaluating the patient's biopsychosocial variables that may impact her condition.  We also need to set realistic expectations. Some women may benefit from off-label use of medications besides estrogen, including topical testosterone. Informed consent is very important with these treatments. I also have had much clinical success with intravaginal diazepam/lorazepam for pelvic floor hypertonus.

In addition, certainly I agree that pelvic floor physical therapy (PT) is a vital treatment component for this patient and, not to diminish its importance, but many women cannot afford, nor do they have the time or opportunity, to go to pelvic floor PT. As clinicians, we can develop and implement effective programs, even in the office, to educate the patient to help herself as well.

Dr. Kaunitz: Absolutely. Also, if, in a clinical setting consistent with atrophic changes, an ObGyn physician is comfortable that vulvovaginal changes noted on exam represent GSM/atrophic changes, I do not feel vulvoscopy is warranted.

Dr. Levy: In conclusion, we need to be aware that pelvic floor PT may not be available everywhere and that a woman's own digits and her partner can also be incorporated into this treatment.

Something that we have all talked about in other venues, but have not looked at in the larger sphere here, is whether there is value to seeing women annually and performing pelvic exams. As Dr. Kingsberg mentioned, this is a highly motivated patient. We have many patients out there who are silent sufferers. The physical exam is an opportunity for us to recognize and address this problem.

Kimberly Martens for OBG Management

Dyspareunia and low sexual desire in a breast cancer survivor

Dr. Levy: In this case, a 36-year-old woman with BRCA1−positive breast cancer has vaginal dryness, painful intercourse, and lowered sexual interest since her treatment, which included chemotherapy after bilateral mastectomies. She has a bilateral salpingo-oophorectomy(BSO) scheduled for primary prevention of her ovarian cancer risk.

Dr. Kingsberg, what is important for you to know to help guide case management?

Dr. Kingsberg: This woman is actually presenting with 2 sexual problems: dyspareunia, which is probably secondary to VVA or GSM, and low sexual desire. Key questions are: 1) When was symptom onset--acquired after treatment or lifelong? 2) Did she develop the dyspareunia and as a result of having pain during sex lost desire to have sex? Or, did she lose desire and then, without it, had no arousal and therefore pain with penetration developed? It also could be that she has 2 distinct problems, VVA and hypoactive sexual desire disorder (HSDD), in which case you need to think about treating both. Finally, we do not actually know if she is having penetrative intercourse or even if she has a partner.

A vulvovaginal exam would give clues as to whether she has VVA, and hormone levels would indicate if she now has chemo-induced menopause. If she is not in menopause now, she certainly is going to be with her BSO. The hormonal changes due to menopause actually can be primarily responsible for both the dyspareunia and HSDD. Management of both symptoms really needs to be based on shared decision making with the patient--with which treatment for which conditions coming first, based on what is causing her the most distress.

I would encourage this woman to treat her VVA since GSM does have long-term physiologic consequences if untreated. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal treatments as first-line treatments, with vaginal estrogen considered if these therapies fail.³ If lubricants and moisturizers and other nonhormonal options are not sufficient, you could consider local estrogen, even though she is a breast cancer survivor, as well as ospemiphene.

If she is distressed by her loss of sexual desire, you can choose to treat her for HSDD. Flibanserin is the first FDA-approved treatment for HSDD. It is only approved in premenopausal women, so it would be considered off-label use if she is postmenopausal (even though she is quite young). You also could consider exogenous testosterone off-label, after consulting with her oncologist.

In addition to the obvious physiologic etiology of her pain and her low desire, the biopsychosocial aspects to consider are: 1) changes to her body image, as she has had bilateral mastectomies, 2) her anxiety about the cancer diagnosis, and 3) concerns about her relationship if she has one--her partner's reactions to her illness and the quality of the relationship outside the bedroom.

Dr. Iglesia: I am seeing here in our nation's capital a lot of advertisements for laser therapy for GSM. I caution women about this because providers are charging a lot of money for this therapy when we do not have long-term safety and effectiveness data for it.

Our group is currently conducting a randomized controlled trial, looking at vaginal estrogen cream versus laser therapy for GSM here at Medstar Health--one of the first in the country as part of a multisite trial. But the North American Menopause Society (NAMS) has come out with a pretty strong statement,⁴ as has ACOG,⁵ on this therapy, and I caution people about overzealously offering a very costly procedure targeted to a very vulnerable population, especially to women with personal histories of estrogen-sensitive cancers.

Dr. Krychman: I agree. Very often cancer patients are preyed upon by those offering emerging unproven technologies or medications. We have to work as a coordinated comprehensive team, whether it's a sexual medicine expert, psychologist, urogynecologist, gynecologist, or oncologist, and incorporate the patient's needs and expectations and risk tolerance coupled with treatment efficacy and safety.

Dr. Levy: This was a complex case. The biopsychosocial model is critical here. It's important that we are not siloes in our medical management approach and that we try to help this patient embrace the complexity of her situation. It's not only that she has cancer at age 36; there is a possible guilt factor if she has children and passed that gene on.

Another point that we began to talk about is the fact that in this country we tend to be early adopters of new technology. In our discussion with patients, we should focus on what we know and the risk of the unknowns related to some of the treatment options. But let's discuss lasers a little more later on.

Diminished arousal and orgasmic intensity in a patient taking SSRIs

Dr. Levy: In this next case, a 44-year-old woman in a 15-year marriage notices a change in her orgasmic intensity and latency. She has a supportive husband, and they are attentive to each other's sexual needs. However, she notices a change in her arousal and orgasmic intensity, which has diminished over the last year. She reports that the time to orgasm or latency has increased and both she and her partner are frustrated and getting concerned. She has a history of depression that has been managed by selective serotonin reuptake inhibitors for the past 5 years and has no depressive symptoms currently.

Dr. Krychman, what are you considering before beginning to talk with this patient?

Dr. Krychman: My approach really is a comprehensive one, looking not only at the underlying medical issues but also at the psychological and dynamic relationship facets. We of course also want to look at medications: Has she changed her dose or the timing of when she takes it? Is this a new onset? Finally, we want to know why this is coming to the forefront now. Is it because it is getting worse, or is it because there is some significant issue that is going on in the relationship?

Regarding the physical exam, it is important to rule out underlying genital pelvic pathology. Young women can get changes in the integrity of the pelvic floor, in what I would call the orgasmic matrix--the clitoral tissue, the body, the crura (or arms of the clitoris)--we want to examine and be reassured that her genital anatomy is normal and that there is no underlying pathology that could signal an underlying abnormal hormonal profile. Young women certainly can get lowered estrogen effects at the genital/pelvic tissues (including the labia and vulva), and intravaginally as well. Sometimes women will have pelvic floor hypertonus, as we see with other urinary issues. A thorough pelvic exam is quite vital.

Let's not forget the body that is attached to the genitals; we want to rule out chronic medical disease that may impact her: hypertension, diabetes, or hypercholesterolemia. Untreated, these conditions may directly impact the arousal physiologic mechanisms.

Dr. Levy: In doing this patient's physical exam I would be looking for significant weight gain, and even asking about her partner's weight. Body image can be a huge issue. If she has a history of depression, if she is suffering from a body image problem, she can be feeling unattractive. In my experience this can be a common thing to affect women in their mid-40s.

How would you manage this case?

Dr. Krychman: It is important to divide it up in terms of a conservative to aggressive approach. We want to find out about the relationship. For instance, is the sexual dynamic scripted (ie, boring and predictable)? Is she distracted and frustrated or is she getting enough of the type of stimulation that she likes and enjoys? There certainly are a lot of new devices that are available, whether a self-stimulator or vibrator, the Fiera, or other stimulating devices, that may be important to incorporate into the sexual repertoire. If there is underlying pathology, we want to evaluate and treat that. She may need to be primed, so to speak, with systemic hormones. And does she have issues related to other effects of hormonal deprivation, even local effects? Does she have clitoral atrophy?

There are neutraceuticals that are currently available, whether topical arousal gels or ointments, and we as clinicians need to be critical and evaluate their benefit/risk and look at the data concerning these products. In addition, women who have changes in arousal and in orgasmic intensity and latency may be very frustrated. They describe it as climbing up to a peak but never getting over the top, and this frustration may lead to participant spectatoring, so incorporating a certified sex therapist or counselor is sometimes very critical.

Finally, there are a lot of snake oils, charmers, and charlatan unproven procedures--injecting fillers or other substances into the clitoris are a few examples. I would be a critical clinician, examine the evidence, look at the benefit/risk before advocating an intervention that does not have good clinical data to support its use--a comprehensive approach of sexual medicine as well as sexual psychology.

Dr. Kingsberg: Additionally, we know she is in a long-term relationship--15 years; we want to acknowledge the partner. We talked about the partner's weight, but what about his erectile function? Does he have changes in sexual function that are affecting her, and she is the one carrying the "symptom"?

Looking at each piece separately helps a clinician from getting overwhelmed by the patient who comes in reporting distress with orgasmic dysfunction. We have no pharmacologic FDA-approved treatments, so it can feel off-putting for a clinician to try to fix the reported issue. Looking at each component to help her figure out the underlying cause can be helpful.

Dr. Iglesia: With aging, there can be changes in blood flow, not to mention the hormonal and even peripheral nerve changes, that require more stimulation in order to achieve the desired response. I echo concern about expensive procedures being offered with no evidence, such as the "O" or "G" shot, that can cost up to thousands of dollars.

The other procedure that gives me a lot of angst is clitoral unhooding. The 3 parts of the clitoris are sensitive in terms of innervation and blood flow, and cutting around that delicate tissue goes against the surgical principles required for preserving nerves and blood flow.

New onset pain post−prolapse surgery with TOT sling placement

Dr. Levy: For this case, let's consider a 42-year-old woman (P3) who is 6 months post− vaginal hysterectomy. The surgery included ovarian preservation combined with anterior and posterior repair for prolapse as well as apical uterosacral ligament suspension for stage 2 uterovaginal prolapse. A transobturator sling was used.

Extensive preop evaluation was performed, with confirmed symptomatic prolapse. She had no stress incontinence symptoms but did have confirmed occult stress incontinence.

Surgery was uneventful. She resumed intercourse at 8 weeks, but she now has pain with both initial entry and deep penetration. Lubricants and changes in position have not helped. She is in a stable relationship with her husband of 17 years, and she is worried that the sling mesh might be the culprit. On exam, she has no atrophy, pH is 4.5, vaginal length is 8 cm, and there is no prolapse. There is no mesh exposure noted, although she reports slight tenderness with palpation of the right sling arm beneath the right pubic bone.

Dr. Iglesia, what are the patient history questions important to ask here?
 
Dr. Iglesia: This is not an uncommon scenario--elective surgical correction of  occult or latent stress incontinence after surgical correction for pelvic organ prolapse. Now this patient here has no more prolapse complaints; however, she has a new symptom. There are many different causes of dyspareunia; we cannot just assume it is the sling mesh (although with all the legal representation advertisements for those who have had mesh placed, it can certainly be at the top of the patient's mind, causing anxiety and fear).

Multiple trials have looked at prophylactic surgery for incontinence at the time of prolapse repairs. This woman happened to be one of those patients who did not have incontinence symptoms, and they put a sling in. A recent large trial examined women with vaginal prolapse who underwent hysterectomy and suspension.⁶ (They compared 2 different suspensions.) What is interesting is that 25% of women with prolapse do have baseline pain. However, at 24 months, de novo pain can occur in 10% of women--just from the apical suspension. So, here, it could be the prolapse suspension. Or, in terms of the transobturator sling, long-term data do tell us that the de novo dyspareunia rate ranges on the magnitude of 1% to 9%.⁷ What is important here is figuring out the cause of the dyspareunia.

Dr. Levy: One of the important points you raised already was that 25% of these women have preoperative pain. So figuring out what her functioning was before surgery and incorporating that into our assessment postop would be pretty important I would think.

Dr. Iglesia: Yes, you need to understand what her typical encounter was before the surgery and how things have changed now that the prolapse is not in the way. Changes obviously can occur with scar tissue, which over time will improve. If she is perimenopausal and starts to get epithelial changes, we can fix that. The question then becomes, "Is the pain emanating from the mesh?"

When examining this patient, it is not uncommon for me to be able to feel "banjo" strings if the mesh is too tight or close to the surface. It is not exposed but it's palpable, and the patient may feel a ridge during penetration. You can ask the patient if pain occurs with different penetration positions. In addition, explore associated neurologic symptoms (numbness or muscle pain in the thigh).

Dr. Kingsberg: There were 2 different sources of pain--on initial entry and at deep penetration. You want to make sure you address both. Importantly, did one precede the other? For instance, if women have pain with penetration they can then end up with an arousal disorder (the length of the vagina cannot increase as much as it might otherwise) and dystonia secondary to the pain with penetration. The timing of the pain--did it all happen at the same time, or did she start out with pain at one point and did it move to something else--is another critical piece of the history.

Dr. Iglesia: It does take a detailed history and physical exam to identify myofascial trigger points. In this case there seems to be pinpoint tenderness directly on the part of the mesh that is not exposed on the right. There are people who feel you should remove the whole mesh, including the arms. Others feel, okay, we can work on these trigger points, with injections, physical therapy, extra lubrication, and neuromodulatory medications. Only then would they think about potentially excising the sling or a portion thereof.

Dr. Krychman: Keep in mind that, even if you do remove the sling, her pain may not subside, if it is secondary to an underlying issue. Because of media sensationalism, she could be focusing on the sling. It is important to set realistic expectations. I often see vulvar pathology or even provoked vestibulodynia that can present with a deep dyspareunia. The concept of collision dyspareunia or introital discomfort or pain on insertion has far reaching implications. We need to look at the patient in totality, ruling out underlying issues related to the bladder, even the colon.

Patient inquires about the benefits of laser treatment for vaginal health

Dr. Levy: Let's move to this last case: A 47-year-old patient who reports lack of sexual satisfaction and attributes it to a loose vagina says, "I've heard about surgery and laser treatment and radiofrequency devices for vaginal health. What are the benefits and risks of these procedures, and will they correct the issues that I'm experiencing?"

How do you approach this patient?

Dr. Krychman: I want to know why this is of paramount importance to her. Is this her actual complaint or is it society's unrealistic expectation of sexual pleasure and performance placed upon her? Or is this a relationship issue surfacing, compounded by physiologic changes? With good communication techniques, like "ask, tell, ask" or effective use of silence (not interrupting), patients will lead us to the reason and the rationale.

Dr. Levy: I have seen a lot of advertising to women, now showing pictures of genitalia, perhaps creating an expectation that we should look infantile in some way. We are creating a sense of beauty and acceptablevisualization of the vagina and vulva that are completely unrealistic. It's fascinating on one hand but it is also disturbing in that some of the direct-to-consumer marketing going on is creating a sense of unease in women who are otherwise perfectly satisfied. Now they take a look at their sagging skin, maybe after having 2 or 3 children, and although they may not look the same they function not so badly perhaps. I think we are creating a distress and an illness model that is interesting to discuss.

Dr. Iglesia, you are in the midst of a randomized trial, giving an informed consent to participants about the expectations for this potential intervention. How do you explain to women what these laser and radiofrequency devices are expected to do and why they might or might not work?

Dr. Iglesia: We are doing a randomized trial for menopausal women who have GSM. We are comparing estrogen cream with fractional CO2 laser therapy. I also am involved in another randomized trial for lichen sclerosus. I am not involved in the cosmetic use of a laser for people who feel their vaginas are just "loose." Like you, Dr. Levy, I am very concerned about the images that women are seeing of the idealized vulva and vagina, and about the rise of cosmetic gynecology, much of which is being performed by plastic surgeons or dermatologists.

A recent article looked at the number of women who are doing pubic hair grooming; the prevalance is about 80% here in America.⁸ So people have a clear view of what is down there, and then they compare it to what they see in pornographic images on the Internet and want to look like a Barbie doll. That is disturbing because women, particularly young women, do not realize what happens with GSM changes to the vulva and vagina. On the other hand, these laser machines are very expensive, and some doctors are charging thousands of dollars and promising cosmetic and functional results for which we lack long-term, comparative data.

The laser that we are studying is one by Cynosure called Mona Lisa, which works with fractional CO2 and has very low depth of penetration. The concept is that, with microdot therapy (on the order of micrometers), pinpoint destruction will foster regeneration of new collagen and blood flow to the vagina and vulva. We are still in the midst of analyzing this.

Dr. Krychman: I caution people not to lump devices together. There is a significant difference between laser and radiofrequency--especially in the depth of tissue penetration, and level of evidence as well. There are companies performing randomized clinical trials, with well designed sham controls, and have demonstrated clinical efficacy. We need to be cautious of a procedure that is saying it's the best thing since sliced bread, curing interstitial cystitis, dyspareunia, and lichen sclerosus and improving orgasm, lubrication, and arousal. These far reaching, off-label claims are concerning and misleading.

Dr. Levy: I think the important things are 1) shared decision making with the patient and 2) disclosure of what we do not know, which are the long-term results and outcomes and possible downstream negative effects of some of these treatments, since the data we have are so short term.

Dr. Kingsberg: Basics are important. You talked about the pressure for cosmetic appearance, but is that really what is going on for this particular patient? Is she describing a sexual dysfunction when she talks about lack of satisfaction? You need to operationally define that term. Does she have problems with arousal or orgasm or desire and those are what underlie her lack of satisfaction? Is the key to management helping her come to terms with body image issues or to treat a sexual dysfunction? If it truly is a sexual dysfunction, then you can have the shared decision making on preferred treatment approach.

Dr. Levy: This has been an enlightening discussion. Thank all of you for your expertise and clinical acumen.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The age-adjusted prevalence of any sexual problem is 43% among US women. A full 22% of these women experience sexually related personal distress.¹ With publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition² has come a shift in classification and, at times, management approach for reported female sexual dysfunction. When women report to their clinicians decreased sexual desire or arousal or pain at penetration, the management is no longer guided by a linear model of sexual response (excitation, plateau, orgasm, and resolution) but rather by a more nuanced and complex biopsychosocial approach. In this model, diagnosis and management strategies to address bothersome sexual concerns consider the whole woman in the context of her physical and psychosocial health. The patient’s age, medical history, and relationship status are among the factors that could affect management of the problem. In an effort to explore this management approach, I used this Update on Female Sexual Dysfunction as an opportunity to convene a roundtable of several experts, representing varying backgrounds and practice vantage points, to discuss 5 cases of sexual problems that you as a busy clinician may encounter in your practice.

Genital atrophy in a sexually inactive 61-year-old woman

Barbara S. Levy, MD: Two years after her husband's death, which followed several years of illness, your 61-year-old patient mentions at her well woman visit that she anticipates becoming sexually active again. She has not used systemic or vaginal hormone therapy. During pelvic examination, atrophic external genital changes are present, and use of an ultrathin (thinner than a Pederson) speculum reveals vaginal epithelial atrophic changes. A single-digit bimanual exam can be performed with moderate patient discomfort; the patient cannot tolerate a 2-digit bimanual exam. She expresses concern about being able to engage in penile/vaginal sexual intercourse. 

Dr. Kaunitz, what is important for you to ask this patient, and what concerns you most on her physical exam?

Andrew M. Kaunitz, MD: First, it is important to recognize the patient's expectations and desires. As the case suggests, but further questioning could clarify, she would like to be able to comfortably engage in sexual intercourse with a new partner, but penetration may be difficult (and definitely painful for her) unless treatment is pursued. This combination of mucosal and vestibular atrophic changes (genitourinary syndrome of menopause [GSM], or vulvovaginal atrophy [VVA]) plus the absence of penetration for many years can be a double whammy situation for menopausal women. In this case it has led to extensive contracture of the introitus, and if it is not addressed will cause sexual dysfunction.

Dr. Levy: In addition we need to clarify whether or not a history of breast cancer or some other thing may impact the care we provide. How would you approach talking with this patient in order to manage her care?

Dr. Kaunitz: One step is to see how motivated she is to address this, as it is not something that, as gynecologists, we can snap our fingers and the situation will be resolved. If the patient is motivated to treat the atrophic changes with medical treatment, in the form of low-dose vaginal estrogen, and dilation, either on her own if she's highly motivated to do so, or in my practice more commonly with the support of a women's physical therapist, over time she should be able to comfortably engage in sexual intercourse with penetration. If this is what she wants, we can help steer her in the right direction.

Sheryl Kingsberg, PhD: You know that this woman is motivated by virtue of her initiating the topic herself. Patients are often embarrassed talking about sexual issues, or they are not sure that their gynecologist is comfortable with it. After all, they think, if this is the right place to discuss sexual problems, why didn't he or she ask me?  Clinicians must be aware that it is their responsibility to ask about sexual function and not leave it for the patient to open the door.

Dr. Kaunitz: Great point.

Cheryl B. Iglesia, MD: Gratefully, a lot of the atrophic changes this patient demonstrates are reversible. However, other autoimmune diseases (eg, lichen planus, which can affect the vaginal epithelium, or lichen sclerosus, which can affect the clitoris, labia, and vulva) can also cause constriction, and in severe cases, complete obliteration of the vagina and introitus. Women may not be sexually active, and for each annual exam their clinician uses a smaller and smaller speculum--to the point that they cannot even access the cervix anymore--and the vagina can close off. Clinicians may not realize that you need something other than estrogen; with lichen planus you need steroid suppository treatment, and with lichen sclerosus you need topical steroid treatment. So these autoimmune conditions should also be in the differential and, with appropriate treatment, the sexual effects can be reversible.

Michael Krychman, MD: I agree. The vulva can be a great mimicker and, according to the history and physical exam, at some point a vulvoscopy, and even potential biopsies, may be warranted as clinically indicated.

The concept of a comprehensive approach, as Dr. Kingsberg had previously mentioned, involves not only sexual medicine but also evaluating the patient's biopsychosocial variables that may impact her condition.  We also need to set realistic expectations. Some women may benefit from off-label use of medications besides estrogen, including topical testosterone. Informed consent is very important with these treatments. I also have had much clinical success with intravaginal diazepam/lorazepam for pelvic floor hypertonus.

In addition, certainly I agree that pelvic floor physical therapy (PT) is a vital treatment component for this patient and, not to diminish its importance, but many women cannot afford, nor do they have the time or opportunity, to go to pelvic floor PT. As clinicians, we can develop and implement effective programs, even in the office, to educate the patient to help herself as well.

Dr. Kaunitz: Absolutely. Also, if, in a clinical setting consistent with atrophic changes, an ObGyn physician is comfortable that vulvovaginal changes noted on exam represent GSM/atrophic changes, I do not feel vulvoscopy is warranted.

Dr. Levy: In conclusion, we need to be aware that pelvic floor PT may not be available everywhere and that a woman's own digits and her partner can also be incorporated into this treatment.

Something that we have all talked about in other venues, but have not looked at in the larger sphere here, is whether there is value to seeing women annually and performing pelvic exams. As Dr. Kingsberg mentioned, this is a highly motivated patient. We have many patients out there who are silent sufferers. The physical exam is an opportunity for us to recognize and address this problem.

Kimberly Martens for OBG Management

Dyspareunia and low sexual desire in a breast cancer survivor

Dr. Levy: In this case, a 36-year-old woman with BRCA1−positive breast cancer has vaginal dryness, painful intercourse, and lowered sexual interest since her treatment, which included chemotherapy after bilateral mastectomies. She has a bilateral salpingo-oophorectomy(BSO) scheduled for primary prevention of her ovarian cancer risk.

Dr. Kingsberg, what is important for you to know to help guide case management?

Dr. Kingsberg: This woman is actually presenting with 2 sexual problems: dyspareunia, which is probably secondary to VVA or GSM, and low sexual desire. Key questions are: 1) When was symptom onset--acquired after treatment or lifelong? 2) Did she develop the dyspareunia and as a result of having pain during sex lost desire to have sex? Or, did she lose desire and then, without it, had no arousal and therefore pain with penetration developed? It also could be that she has 2 distinct problems, VVA and hypoactive sexual desire disorder (HSDD), in which case you need to think about treating both. Finally, we do not actually know if she is having penetrative intercourse or even if she has a partner.

A vulvovaginal exam would give clues as to whether she has VVA, and hormone levels would indicate if she now has chemo-induced menopause. If she is not in menopause now, she certainly is going to be with her BSO. The hormonal changes due to menopause actually can be primarily responsible for both the dyspareunia and HSDD. Management of both symptoms really needs to be based on shared decision making with the patient--with which treatment for which conditions coming first, based on what is causing her the most distress.

I would encourage this woman to treat her VVA since GSM does have long-term physiologic consequences if untreated. The American College of Obstetricians and Gynecologists (ACOG) recommends nonhormonal treatments as first-line treatments, with vaginal estrogen considered if these therapies fail.³ If lubricants and moisturizers and other nonhormonal options are not sufficient, you could consider local estrogen, even though she is a breast cancer survivor, as well as ospemiphene.

If she is distressed by her loss of sexual desire, you can choose to treat her for HSDD. Flibanserin is the first FDA-approved treatment for HSDD. It is only approved in premenopausal women, so it would be considered off-label use if she is postmenopausal (even though she is quite young). You also could consider exogenous testosterone off-label, after consulting with her oncologist.

In addition to the obvious physiologic etiology of her pain and her low desire, the biopsychosocial aspects to consider are: 1) changes to her body image, as she has had bilateral mastectomies, 2) her anxiety about the cancer diagnosis, and 3) concerns about her relationship if she has one--her partner's reactions to her illness and the quality of the relationship outside the bedroom.

Dr. Iglesia: I am seeing here in our nation's capital a lot of advertisements for laser therapy for GSM. I caution women about this because providers are charging a lot of money for this therapy when we do not have long-term safety and effectiveness data for it.

Our group is currently conducting a randomized controlled trial, looking at vaginal estrogen cream versus laser therapy for GSM here at Medstar Health--one of the first in the country as part of a multisite trial. But the North American Menopause Society (NAMS) has come out with a pretty strong statement,⁴ as has ACOG,⁵ on this therapy, and I caution people about overzealously offering a very costly procedure targeted to a very vulnerable population, especially to women with personal histories of estrogen-sensitive cancers.

Dr. Krychman: I agree. Very often cancer patients are preyed upon by those offering emerging unproven technologies or medications. We have to work as a coordinated comprehensive team, whether it's a sexual medicine expert, psychologist, urogynecologist, gynecologist, or oncologist, and incorporate the patient's needs and expectations and risk tolerance coupled with treatment efficacy and safety.

Dr. Levy: This was a complex case. The biopsychosocial model is critical here. It's important that we are not siloes in our medical management approach and that we try to help this patient embrace the complexity of her situation. It's not only that she has cancer at age 36; there is a possible guilt factor if she has children and passed that gene on.

Another point that we began to talk about is the fact that in this country we tend to be early adopters of new technology. In our discussion with patients, we should focus on what we know and the risk of the unknowns related to some of the treatment options. But let's discuss lasers a little more later on.

Diminished arousal and orgasmic intensity in a patient taking SSRIs

Dr. Levy: In this next case, a 44-year-old woman in a 15-year marriage notices a change in her orgasmic intensity and latency. She has a supportive husband, and they are attentive to each other's sexual needs. However, she notices a change in her arousal and orgasmic intensity, which has diminished over the last year. She reports that the time to orgasm or latency has increased and both she and her partner are frustrated and getting concerned. She has a history of depression that has been managed by selective serotonin reuptake inhibitors for the past 5 years and has no depressive symptoms currently.

Dr. Krychman, what are you considering before beginning to talk with this patient?

Dr. Krychman: My approach really is a comprehensive one, looking not only at the underlying medical issues but also at the psychological and dynamic relationship facets. We of course also want to look at medications: Has she changed her dose or the timing of when she takes it? Is this a new onset? Finally, we want to know why this is coming to the forefront now. Is it because it is getting worse, or is it because there is some significant issue that is going on in the relationship?

Regarding the physical exam, it is important to rule out underlying genital pelvic pathology. Young women can get changes in the integrity of the pelvic floor, in what I would call the orgasmic matrix--the clitoral tissue, the body, the crura (or arms of the clitoris)--we want to examine and be reassured that her genital anatomy is normal and that there is no underlying pathology that could signal an underlying abnormal hormonal profile. Young women certainly can get lowered estrogen effects at the genital/pelvic tissues (including the labia and vulva), and intravaginally as well. Sometimes women will have pelvic floor hypertonus, as we see with other urinary issues. A thorough pelvic exam is quite vital.

Let's not forget the body that is attached to the genitals; we want to rule out chronic medical disease that may impact her: hypertension, diabetes, or hypercholesterolemia. Untreated, these conditions may directly impact the arousal physiologic mechanisms.

Dr. Levy: In doing this patient's physical exam I would be looking for significant weight gain, and even asking about her partner's weight. Body image can be a huge issue. If she has a history of depression, if she is suffering from a body image problem, she can be feeling unattractive. In my experience this can be a common thing to affect women in their mid-40s.

How would you manage this case?

Dr. Krychman: It is important to divide it up in terms of a conservative to aggressive approach. We want to find out about the relationship. For instance, is the sexual dynamic scripted (ie, boring and predictable)? Is she distracted and frustrated or is she getting enough of the type of stimulation that she likes and enjoys? There certainly are a lot of new devices that are available, whether a self-stimulator or vibrator, the Fiera, or other stimulating devices, that may be important to incorporate into the sexual repertoire. If there is underlying pathology, we want to evaluate and treat that. She may need to be primed, so to speak, with systemic hormones. And does she have issues related to other effects of hormonal deprivation, even local effects? Does she have clitoral atrophy?

There are neutraceuticals that are currently available, whether topical arousal gels or ointments, and we as clinicians need to be critical and evaluate their benefit/risk and look at the data concerning these products. In addition, women who have changes in arousal and in orgasmic intensity and latency may be very frustrated. They describe it as climbing up to a peak but never getting over the top, and this frustration may lead to participant spectatoring, so incorporating a certified sex therapist or counselor is sometimes very critical.

Finally, there are a lot of snake oils, charmers, and charlatan unproven procedures--injecting fillers or other substances into the clitoris are a few examples. I would be a critical clinician, examine the evidence, look at the benefit/risk before advocating an intervention that does not have good clinical data to support its use--a comprehensive approach of sexual medicine as well as sexual psychology.

Dr. Kingsberg: Additionally, we know she is in a long-term relationship--15 years; we want to acknowledge the partner. We talked about the partner's weight, but what about his erectile function? Does he have changes in sexual function that are affecting her, and she is the one carrying the "symptom"?

Looking at each piece separately helps a clinician from getting overwhelmed by the patient who comes in reporting distress with orgasmic dysfunction. We have no pharmacologic FDA-approved treatments, so it can feel off-putting for a clinician to try to fix the reported issue. Looking at each component to help her figure out the underlying cause can be helpful.

Dr. Iglesia: With aging, there can be changes in blood flow, not to mention the hormonal and even peripheral nerve changes, that require more stimulation in order to achieve the desired response. I echo concern about expensive procedures being offered with no evidence, such as the "O" or "G" shot, that can cost up to thousands of dollars.

The other procedure that gives me a lot of angst is clitoral unhooding. The 3 parts of the clitoris are sensitive in terms of innervation and blood flow, and cutting around that delicate tissue goes against the surgical principles required for preserving nerves and blood flow.

New onset pain post−prolapse surgery with TOT sling placement

Dr. Levy: For this case, let's consider a 42-year-old woman (P3) who is 6 months post− vaginal hysterectomy. The surgery included ovarian preservation combined with anterior and posterior repair for prolapse as well as apical uterosacral ligament suspension for stage 2 uterovaginal prolapse. A transobturator sling was used.

Extensive preop evaluation was performed, with confirmed symptomatic prolapse. She had no stress incontinence symptoms but did have confirmed occult stress incontinence.

Surgery was uneventful. She resumed intercourse at 8 weeks, but she now has pain with both initial entry and deep penetration. Lubricants and changes in position have not helped. She is in a stable relationship with her husband of 17 years, and she is worried that the sling mesh might be the culprit. On exam, she has no atrophy, pH is 4.5, vaginal length is 8 cm, and there is no prolapse. There is no mesh exposure noted, although she reports slight tenderness with palpation of the right sling arm beneath the right pubic bone.

Dr. Iglesia, what are the patient history questions important to ask here?
 
Dr. Iglesia: This is not an uncommon scenario--elective surgical correction of  occult or latent stress incontinence after surgical correction for pelvic organ prolapse. Now this patient here has no more prolapse complaints; however, she has a new symptom. There are many different causes of dyspareunia; we cannot just assume it is the sling mesh (although with all the legal representation advertisements for those who have had mesh placed, it can certainly be at the top of the patient's mind, causing anxiety and fear).

Multiple trials have looked at prophylactic surgery for incontinence at the time of prolapse repairs. This woman happened to be one of those patients who did not have incontinence symptoms, and they put a sling in. A recent large trial examined women with vaginal prolapse who underwent hysterectomy and suspension.⁶ (They compared 2 different suspensions.) What is interesting is that 25% of women with prolapse do have baseline pain. However, at 24 months, de novo pain can occur in 10% of women--just from the apical suspension. So, here, it could be the prolapse suspension. Or, in terms of the transobturator sling, long-term data do tell us that the de novo dyspareunia rate ranges on the magnitude of 1% to 9%.⁷ What is important here is figuring out the cause of the dyspareunia.

Dr. Levy: One of the important points you raised already was that 25% of these women have preoperative pain. So figuring out what her functioning was before surgery and incorporating that into our assessment postop would be pretty important I would think.

Dr. Iglesia: Yes, you need to understand what her typical encounter was before the surgery and how things have changed now that the prolapse is not in the way. Changes obviously can occur with scar tissue, which over time will improve. If she is perimenopausal and starts to get epithelial changes, we can fix that. The question then becomes, "Is the pain emanating from the mesh?"

When examining this patient, it is not uncommon for me to be able to feel "banjo" strings if the mesh is too tight or close to the surface. It is not exposed but it's palpable, and the patient may feel a ridge during penetration. You can ask the patient if pain occurs with different penetration positions. In addition, explore associated neurologic symptoms (numbness or muscle pain in the thigh).

Dr. Kingsberg: There were 2 different sources of pain--on initial entry and at deep penetration. You want to make sure you address both. Importantly, did one precede the other? For instance, if women have pain with penetration they can then end up with an arousal disorder (the length of the vagina cannot increase as much as it might otherwise) and dystonia secondary to the pain with penetration. The timing of the pain--did it all happen at the same time, or did she start out with pain at one point and did it move to something else--is another critical piece of the history.

Dr. Iglesia: It does take a detailed history and physical exam to identify myofascial trigger points. In this case there seems to be pinpoint tenderness directly on the part of the mesh that is not exposed on the right. There are people who feel you should remove the whole mesh, including the arms. Others feel, okay, we can work on these trigger points, with injections, physical therapy, extra lubrication, and neuromodulatory medications. Only then would they think about potentially excising the sling or a portion thereof.

Dr. Krychman: Keep in mind that, even if you do remove the sling, her pain may not subside, if it is secondary to an underlying issue. Because of media sensationalism, she could be focusing on the sling. It is important to set realistic expectations. I often see vulvar pathology or even provoked vestibulodynia that can present with a deep dyspareunia. The concept of collision dyspareunia or introital discomfort or pain on insertion has far reaching implications. We need to look at the patient in totality, ruling out underlying issues related to the bladder, even the colon.

Patient inquires about the benefits of laser treatment for vaginal health

Dr. Levy: Let's move to this last case: A 47-year-old patient who reports lack of sexual satisfaction and attributes it to a loose vagina says, "I've heard about surgery and laser treatment and radiofrequency devices for vaginal health. What are the benefits and risks of these procedures, and will they correct the issues that I'm experiencing?"

How do you approach this patient?

Dr. Krychman: I want to know why this is of paramount importance to her. Is this her actual complaint or is it society's unrealistic expectation of sexual pleasure and performance placed upon her? Or is this a relationship issue surfacing, compounded by physiologic changes? With good communication techniques, like "ask, tell, ask" or effective use of silence (not interrupting), patients will lead us to the reason and the rationale.

Dr. Levy: I have seen a lot of advertising to women, now showing pictures of genitalia, perhaps creating an expectation that we should look infantile in some way. We are creating a sense of beauty and acceptablevisualization of the vagina and vulva that are completely unrealistic. It's fascinating on one hand but it is also disturbing in that some of the direct-to-consumer marketing going on is creating a sense of unease in women who are otherwise perfectly satisfied. Now they take a look at their sagging skin, maybe after having 2 or 3 children, and although they may not look the same they function not so badly perhaps. I think we are creating a distress and an illness model that is interesting to discuss.

Dr. Iglesia, you are in the midst of a randomized trial, giving an informed consent to participants about the expectations for this potential intervention. How do you explain to women what these laser and radiofrequency devices are expected to do and why they might or might not work?

Dr. Iglesia: We are doing a randomized trial for menopausal women who have GSM. We are comparing estrogen cream with fractional CO2 laser therapy. I also am involved in another randomized trial for lichen sclerosus. I am not involved in the cosmetic use of a laser for people who feel their vaginas are just "loose." Like you, Dr. Levy, I am very concerned about the images that women are seeing of the idealized vulva and vagina, and about the rise of cosmetic gynecology, much of which is being performed by plastic surgeons or dermatologists.

A recent article looked at the number of women who are doing pubic hair grooming; the prevalance is about 80% here in America.⁸ So people have a clear view of what is down there, and then they compare it to what they see in pornographic images on the Internet and want to look like a Barbie doll. That is disturbing because women, particularly young women, do not realize what happens with GSM changes to the vulva and vagina. On the other hand, these laser machines are very expensive, and some doctors are charging thousands of dollars and promising cosmetic and functional results for which we lack long-term, comparative data.

The laser that we are studying is one by Cynosure called Mona Lisa, which works with fractional CO2 and has very low depth of penetration. The concept is that, with microdot therapy (on the order of micrometers), pinpoint destruction will foster regeneration of new collagen and blood flow to the vagina and vulva. We are still in the midst of analyzing this.

Dr. Krychman: I caution people not to lump devices together. There is a significant difference between laser and radiofrequency--especially in the depth of tissue penetration, and level of evidence as well. There are companies performing randomized clinical trials, with well designed sham controls, and have demonstrated clinical efficacy. We need to be cautious of a procedure that is saying it's the best thing since sliced bread, curing interstitial cystitis, dyspareunia, and lichen sclerosus and improving orgasm, lubrication, and arousal. These far reaching, off-label claims are concerning and misleading.

Dr. Levy: I think the important things are 1) shared decision making with the patient and 2) disclosure of what we do not know, which are the long-term results and outcomes and possible downstream negative effects of some of these treatments, since the data we have are so short term.

Dr. Kingsberg: Basics are important. You talked about the pressure for cosmetic appearance, but is that really what is going on for this particular patient? Is she describing a sexual dysfunction when she talks about lack of satisfaction? You need to operationally define that term. Does she have problems with arousal or orgasm or desire and those are what underlie her lack of satisfaction? Is the key to management helping her come to terms with body image issues or to treat a sexual dysfunction? If it truly is a sexual dysfunction, then you can have the shared decision making on preferred treatment approach.

Dr. Levy: This has been an enlightening discussion. Thank all of you for your expertise and clinical acumen.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In her position as Chief Medical Officer, Dr. Patrice Weiss leads efforts not only to assure clinical excellence from the more than 900 clinicians at the Carilion Clinic in Roanoke, Virginia, but also to improve patient experience. She lectures extensively on one of her passions in medicine: medical errors, and the concept of the second victim. OBG Management has discussed with Dr. Weiss her concerns and pointers for those clinicians both involved in and in close proximity to others who have been involved in a medical error, and how this involvement can lead to personal consequences and coping challenges. (Listen to, “Medical errors: Caring for the second victim [you].”) In this current Q&A article, the conversation hones in on unanticipated outcomes with and without medical errors and how best to approach communications with patients in the context of both circumstances.

OBG Management: What is the definition of a medical error?
Patrice M. Weiss, MD: Clinicians may be somewhat surprised to learn that there is no universal definition of a medical error that sets standardized nomenclature. The Institute of Medicine, in its landmark work To Err Is Human, adopted this definition: “failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim.”¹

In general terms, a medical error is an act of commission or omission, meaning that something was done or not done, that has negative consequences for the patient and is judged as wrong by our peers. An unanticipated outcome can be due to a medical error or can occur without a medical error. An unpredicted side effect, for instance—one that may have a low probability of drug–drug interaction or drug reaction occurrence—is an unexpected outcome. If the incidence of a drug reaction is 1 in 1,000 and your patient is that one, it does not necessarily mean that there was a medical error.

Often, if the outcome is unanticipated, patients and their families will assume, rightly or wrongly, that a medical error did occur.

OBG Management: Are physicians required to disclose medical errors?
Dr. Weiss: Yes. The Joint Commission’s standard principle states that the responsible licensed independent practitioner, or his or her designee, clearly explain the outcome of any treatment or procedure to the patient and, when appropriate, the patient’s family, whenever those outcomes differ significantly from the anticipated outcome.²

This can even include unanticipated outcomes that are not due to an error. Specifically speaking about medical errors, however, we do have the responsibility, both from this standard and from a professional and ethical standard to disclose what, why, and how the error occurred and what we are going to do to ensure it does not happen again.

OBG Management: How does a physician best communicate to a patient an unanticipated outcome that was not due to a medical error?
Dr. Weiss: Usually we as health care providers are more comfortable talking about unanticipated outcomes without medical errors. It is important to, when speaking with patients, be clear and concise, describing what you best know at the time, in language that patients can understand. I often jokingly say that, at a minimum, all of us in health care are bilingual: We speak our native language, and we speak “medicine.”

After describing unanticipated outcomes to patients and their families in terms they understand, affirm their understanding with a follow-up open-ended question. “Do you understand what I just said to you?” is ineffective. A better approach is saying, “Mrs. Jones, in your own words, will you describe back to me what your understanding is as to why this happened?” The answer received will allow you to know the patient’s level of understanding. It also will give you the opportunity to clear up points that are not clear or were misinterpreted. Do not leave patients feeling in a “lurch,” left to wonder or with a lack of understanding, or worse yet, with a sense that you are holding something back.

OBG Management: What is the best approach to disclosing an unanticipated outcome that was due to a medical error?
Dr. Weiss: First and foremost, you must be certain that a medical error did actually occur. There can be speculation at first, and that speculation should occur behind the scenes, with peer review or a root cause analysis on the event. Speculation should not enter into your conversation with the patient. Notional language can add to their anxiety, create mistrust on the patient’s part, and perhaps make a patient feel as if you are not giving the answers that he or she needs.

When it is believed that a medical error did occur, there are several things that need to be done:

1. Gather as much information at the event as possible.
2. Notify the hospital (ie, risk management or quality or patient safety). This is important because it is an organizational approach to medical errors when they do occur.
3. Support the patient and the patient’s family through the entire process. Speaking to the patient and the family may be a part of ascertaining what happened and contributing factors. Clinicians have said to me, “Well, I can’t really go talk to the patient or the patient’s family right now because I don’t really know everything that happened.” Keep in mind, however, that the longer you wait to talk to the patient and family, the more time they have to speculate and to ask other people, perhaps those not involved and with no knowledge of, what happened.

OBG Management: What is the best timing and location for the disclosure conversation?
Dr. Weiss: The person who is responsible for the patient who was involved in the medical error needs to have the disclosure conversation. The conversation with the patient, and the family if the patient so desires, should occur as soon as possible. However, take into consideration the patient being awake, coherent, and not under the influence of medications. With those caveats, the best time to speak is when it is convenient for the patient. Do not plug this conversation into a 10-minute opening in your busy schedule. The conversation could take an hour, or it could take 15 minutes. It should not be conducted as a matter of convenience to the clinician.

In addition, often times the recovery room is not the best location—it is not private and confidential, and the patient is still groggy and will be unable to remember most of what is said or ask questions as needed.

OBG Management: You advocate a “TEAM” approach when speaking with the patient. What is TEAM?
Dr. Weiss: Disclosure conversations are not easy to have. The patient and the patient’s family are often upset. Medical errors challenge a physician’s humility and integrity, and they can lead to questioning of one’s own ability. I adopted the helpful pneumonic TEAM after first learning about it at what is now known as the Institute for Healthcare Communication. It refers to what parties need to be notified and who needs to be present with you when having a disclosure conversation. Of course, you want someone there who not only can serve as a witness but also can help facilitate the gathering of answers for questions that will be asked. The best person for this job could be the lead physician involved in the care of the patient, a hospital risk manager, a colleague, or the patient safety officer.

The “T” stands for truthful. When you begin the conversation, tell the patient at that point what you know to be true and what you know may have happened or definitely did not happen that contributed to the outcome. Again, do not speculate in answering the patient’s questions. A good approach is to say, “This is what I know happened. As of right now, this is what I know may have contributed or did contribute. We are going to be looking into this more thoroughly. As I learn more, you will be the first to know.”

These are not one-time conversations. As you do learn more, circle back and talk to the patient and family. This can be a dialogue that goes on for weeks or even months.

“E” equals empathy. Allow the patient and the patient’s family to ventilate. Try to understand what is it that they are most upset about, and try to soothe these upset feelings. For example, do not make the assumption that they are most upset about paying for a surgery in which there was a medical error. In fact, they really may be most upset about staying in the hospital 2 additional days, and they are going to now miss the visit of a relative, their child’s graduation, or something important to them.

Let patients talk. Do not interrupt them. Do not stand over them while they are in the bed; sit down at eye level with them. Talk in a voice and tone that the patient understands and try to soothe and empathetically relate to what is being said.

The “A” is important: Apology. There are 2 things that patients want when a medical error occurs: 1) to hear the clinician say, “I’m sorry”—and you should be sorry if a medical error occurred, and you should say that you are sorry this happened—and 2) what you or your organization is going to do so that this does not happen to the next person. Incorporate these 2 factors into the apology piece.

OBG Management: Can saying, “I’m sorry” expose a clinician unnecessarily to malpractice risk?
Dr. Weiss: Saying “I’m sorry,” of course, has come under a lot of scrutiny. There are various state laws, and you should be aware of your state’s apology laws. In many states an apology, with “I’m sorry,” cannot be used against a provider. However, there is not 100% absolution of the event if an apology occurs. In other words, “I’m sorry” cannot be held against you, but saying “I’m sorry” does not negate the error that occurred.

Even when practicing in a state in which there is not an apology law, however, and a clinician does apologize and that apology comes up in the legal setting of a true medical error, we would need to ask, is it really that bad that an apology was made on behalf of the medical error that was committed? Isn’t that compassion? Isn’t that empathy? Isn’t that showing that I as the physician care for the patient and the medical team cares for the patient?

Finally, abide by the disclosure policy and standards of your organization.

OBG Management: What does the “M” in TEAM stand for?
Dr. Weiss: Management. There may be times when a medical error occurs that the patient or the patient’s family are angry and upset to the point that they no longer want you to continue to care for them. Be empathetic and helpful by offering to assist them in finding someone else to continue to provide their care. Also let them know that you are more than happy to continue to care for them and assist them in their healing and restoration to health in any way that you can: “Of course the ongoing management of your care is your decision, and we will do whatever your wishes are.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In her position as Chief Medical Officer, Dr. Patrice Weiss leads efforts not only to assure clinical excellence from the more than 900 clinicians at the Carilion Clinic in Roanoke, Virginia, but also to improve patient experience. She lectures extensively on one of her passions in medicine: medical errors, and the concept of the second victim. OBG Management has discussed with Dr. Weiss her concerns and pointers for those clinicians both involved in and in close proximity to others who have been involved in a medical error, and how this involvement can lead to personal consequences and coping challenges. (Listen to, “Medical errors: Caring for the second victim [you].”) In this current Q&A article, the conversation hones in on unanticipated outcomes with and without medical errors and how best to approach communications with patients in the context of both circumstances.

OBG Management: What is the definition of a medical error?
Patrice M. Weiss, MD: Clinicians may be somewhat surprised to learn that there is no universal definition of a medical error that sets standardized nomenclature. The Institute of Medicine, in its landmark work To Err Is Human, adopted this definition: “failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim.”¹

In general terms, a medical error is an act of commission or omission, meaning that something was done or not done, that has negative consequences for the patient and is judged as wrong by our peers. An unanticipated outcome can be due to a medical error or can occur without a medical error. An unpredicted side effect, for instance—one that may have a low probability of drug–drug interaction or drug reaction occurrence—is an unexpected outcome. If the incidence of a drug reaction is 1 in 1,000 and your patient is that one, it does not necessarily mean that there was a medical error.

Often, if the outcome is unanticipated, patients and their families will assume, rightly or wrongly, that a medical error did occur.

OBG Management: Are physicians required to disclose medical errors?
Dr. Weiss: Yes. The Joint Commission’s standard principle states that the responsible licensed independent practitioner, or his or her designee, clearly explain the outcome of any treatment or procedure to the patient and, when appropriate, the patient’s family, whenever those outcomes differ significantly from the anticipated outcome.²

This can even include unanticipated outcomes that are not due to an error. Specifically speaking about medical errors, however, we do have the responsibility, both from this standard and from a professional and ethical standard to disclose what, why, and how the error occurred and what we are going to do to ensure it does not happen again.

OBG Management: How does a physician best communicate to a patient an unanticipated outcome that was not due to a medical error?
Dr. Weiss: Usually we as health care providers are more comfortable talking about unanticipated outcomes without medical errors. It is important to, when speaking with patients, be clear and concise, describing what you best know at the time, in language that patients can understand. I often jokingly say that, at a minimum, all of us in health care are bilingual: We speak our native language, and we speak “medicine.”

After describing unanticipated outcomes to patients and their families in terms they understand, affirm their understanding with a follow-up open-ended question. “Do you understand what I just said to you?” is ineffective. A better approach is saying, “Mrs. Jones, in your own words, will you describe back to me what your understanding is as to why this happened?” The answer received will allow you to know the patient’s level of understanding. It also will give you the opportunity to clear up points that are not clear or were misinterpreted. Do not leave patients feeling in a “lurch,” left to wonder or with a lack of understanding, or worse yet, with a sense that you are holding something back.

OBG Management: What is the best approach to disclosing an unanticipated outcome that was due to a medical error?
Dr. Weiss: First and foremost, you must be certain that a medical error did actually occur. There can be speculation at first, and that speculation should occur behind the scenes, with peer review or a root cause analysis on the event. Speculation should not enter into your conversation with the patient. Notional language can add to their anxiety, create mistrust on the patient’s part, and perhaps make a patient feel as if you are not giving the answers that he or she needs.

When it is believed that a medical error did occur, there are several things that need to be done:

1. Gather as much information at the event as possible.
2. Notify the hospital (ie, risk management or quality or patient safety). This is important because it is an organizational approach to medical errors when they do occur.
3. Support the patient and the patient’s family through the entire process. Speaking to the patient and the family may be a part of ascertaining what happened and contributing factors. Clinicians have said to me, “Well, I can’t really go talk to the patient or the patient’s family right now because I don’t really know everything that happened.” Keep in mind, however, that the longer you wait to talk to the patient and family, the more time they have to speculate and to ask other people, perhaps those not involved and with no knowledge of, what happened.

OBG Management: What is the best timing and location for the disclosure conversation?
Dr. Weiss: The person who is responsible for the patient who was involved in the medical error needs to have the disclosure conversation. The conversation with the patient, and the family if the patient so desires, should occur as soon as possible. However, take into consideration the patient being awake, coherent, and not under the influence of medications. With those caveats, the best time to speak is when it is convenient for the patient. Do not plug this conversation into a 10-minute opening in your busy schedule. The conversation could take an hour, or it could take 15 minutes. It should not be conducted as a matter of convenience to the clinician.

In addition, often times the recovery room is not the best location—it is not private and confidential, and the patient is still groggy and will be unable to remember most of what is said or ask questions as needed.

OBG Management: You advocate a “TEAM” approach when speaking with the patient. What is TEAM?
Dr. Weiss: Disclosure conversations are not easy to have. The patient and the patient’s family are often upset. Medical errors challenge a physician’s humility and integrity, and they can lead to questioning of one’s own ability. I adopted the helpful pneumonic TEAM after first learning about it at what is now known as the Institute for Healthcare Communication. It refers to what parties need to be notified and who needs to be present with you when having a disclosure conversation. Of course, you want someone there who not only can serve as a witness but also can help facilitate the gathering of answers for questions that will be asked. The best person for this job could be the lead physician involved in the care of the patient, a hospital risk manager, a colleague, or the patient safety officer.

The “T” stands for truthful. When you begin the conversation, tell the patient at that point what you know to be true and what you know may have happened or definitely did not happen that contributed to the outcome. Again, do not speculate in answering the patient’s questions. A good approach is to say, “This is what I know happened. As of right now, this is what I know may have contributed or did contribute. We are going to be looking into this more thoroughly. As I learn more, you will be the first to know.”

These are not one-time conversations. As you do learn more, circle back and talk to the patient and family. This can be a dialogue that goes on for weeks or even months.

“E” equals empathy. Allow the patient and the patient’s family to ventilate. Try to understand what is it that they are most upset about, and try to soothe these upset feelings. For example, do not make the assumption that they are most upset about paying for a surgery in which there was a medical error. In fact, they really may be most upset about staying in the hospital 2 additional days, and they are going to now miss the visit of a relative, their child’s graduation, or something important to them.

Let patients talk. Do not interrupt them. Do not stand over them while they are in the bed; sit down at eye level with them. Talk in a voice and tone that the patient understands and try to soothe and empathetically relate to what is being said.

The “A” is important: Apology. There are 2 things that patients want when a medical error occurs: 1) to hear the clinician say, “I’m sorry”—and you should be sorry if a medical error occurred, and you should say that you are sorry this happened—and 2) what you or your organization is going to do so that this does not happen to the next person. Incorporate these 2 factors into the apology piece.

OBG Management: Can saying, “I’m sorry” expose a clinician unnecessarily to malpractice risk?
Dr. Weiss: Saying “I’m sorry,” of course, has come under a lot of scrutiny. There are various state laws, and you should be aware of your state’s apology laws. In many states an apology, with “I’m sorry,” cannot be used against a provider. However, there is not 100% absolution of the event if an apology occurs. In other words, “I’m sorry” cannot be held against you, but saying “I’m sorry” does not negate the error that occurred.

Even when practicing in a state in which there is not an apology law, however, and a clinician does apologize and that apology comes up in the legal setting of a true medical error, we would need to ask, is it really that bad that an apology was made on behalf of the medical error that was committed? Isn’t that compassion? Isn’t that empathy? Isn’t that showing that I as the physician care for the patient and the medical team cares for the patient?

Finally, abide by the disclosure policy and standards of your organization.

OBG Management: What does the “M” in TEAM stand for?
Dr. Weiss: Management. There may be times when a medical error occurs that the patient or the patient’s family are angry and upset to the point that they no longer want you to continue to care for them. Be empathetic and helpful by offering to assist them in finding someone else to continue to provide their care. Also let them know that you are more than happy to continue to care for them and assist them in their healing and restoration to health in any way that you can: “Of course the ongoing management of your care is your decision, and we will do whatever your wishes are.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In her position as Chief Medical Officer, Dr. Patrice Weiss leads efforts not only to assure clinical excellence from the more than 900 clinicians at the Carilion Clinic in Roanoke, Virginia, but also to improve patient experience. She lectures extensively on one of her passions in medicine: medical errors, and the concept of the second victim. OBG Management has discussed with Dr. Weiss her concerns and pointers for those clinicians both involved in and in close proximity to others who have been involved in a medical error, and how this involvement can lead to personal consequences and coping challenges. (Listen to, “Medical errors: Caring for the second victim [you].”) In this current Q&A article, the conversation hones in on unanticipated outcomes with and without medical errors and how best to approach communications with patients in the context of both circumstances.

OBG Management: What is the definition of a medical error?
Patrice M. Weiss, MD: Clinicians may be somewhat surprised to learn that there is no universal definition of a medical error that sets standardized nomenclature. The Institute of Medicine, in its landmark work To Err Is Human, adopted this definition: “failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim.”¹

In general terms, a medical error is an act of commission or omission, meaning that something was done or not done, that has negative consequences for the patient and is judged as wrong by our peers. An unanticipated outcome can be due to a medical error or can occur without a medical error. An unpredicted side effect, for instance—one that may have a low probability of drug–drug interaction or drug reaction occurrence—is an unexpected outcome. If the incidence of a drug reaction is 1 in 1,000 and your patient is that one, it does not necessarily mean that there was a medical error.

Often, if the outcome is unanticipated, patients and their families will assume, rightly or wrongly, that a medical error did occur.

OBG Management: Are physicians required to disclose medical errors?
Dr. Weiss: Yes. The Joint Commission’s standard principle states that the responsible licensed independent practitioner, or his or her designee, clearly explain the outcome of any treatment or procedure to the patient and, when appropriate, the patient’s family, whenever those outcomes differ significantly from the anticipated outcome.²

This can even include unanticipated outcomes that are not due to an error. Specifically speaking about medical errors, however, we do have the responsibility, both from this standard and from a professional and ethical standard to disclose what, why, and how the error occurred and what we are going to do to ensure it does not happen again.

OBG Management: How does a physician best communicate to a patient an unanticipated outcome that was not due to a medical error?
Dr. Weiss: Usually we as health care providers are more comfortable talking about unanticipated outcomes without medical errors. It is important to, when speaking with patients, be clear and concise, describing what you best know at the time, in language that patients can understand. I often jokingly say that, at a minimum, all of us in health care are bilingual: We speak our native language, and we speak “medicine.”

After describing unanticipated outcomes to patients and their families in terms they understand, affirm their understanding with a follow-up open-ended question. “Do you understand what I just said to you?” is ineffective. A better approach is saying, “Mrs. Jones, in your own words, will you describe back to me what your understanding is as to why this happened?” The answer received will allow you to know the patient’s level of understanding. It also will give you the opportunity to clear up points that are not clear or were misinterpreted. Do not leave patients feeling in a “lurch,” left to wonder or with a lack of understanding, or worse yet, with a sense that you are holding something back.

OBG Management: What is the best approach to disclosing an unanticipated outcome that was due to a medical error?
Dr. Weiss: First and foremost, you must be certain that a medical error did actually occur. There can be speculation at first, and that speculation should occur behind the scenes, with peer review or a root cause analysis on the event. Speculation should not enter into your conversation with the patient. Notional language can add to their anxiety, create mistrust on the patient’s part, and perhaps make a patient feel as if you are not giving the answers that he or she needs.

When it is believed that a medical error did occur, there are several things that need to be done:

1. Gather as much information at the event as possible.
2. Notify the hospital (ie, risk management or quality or patient safety). This is important because it is an organizational approach to medical errors when they do occur.
3. Support the patient and the patient’s family through the entire process. Speaking to the patient and the family may be a part of ascertaining what happened and contributing factors. Clinicians have said to me, “Well, I can’t really go talk to the patient or the patient’s family right now because I don’t really know everything that happened.” Keep in mind, however, that the longer you wait to talk to the patient and family, the more time they have to speculate and to ask other people, perhaps those not involved and with no knowledge of, what happened.

OBG Management: What is the best timing and location for the disclosure conversation?
Dr. Weiss: The person who is responsible for the patient who was involved in the medical error needs to have the disclosure conversation. The conversation with the patient, and the family if the patient so desires, should occur as soon as possible. However, take into consideration the patient being awake, coherent, and not under the influence of medications. With those caveats, the best time to speak is when it is convenient for the patient. Do not plug this conversation into a 10-minute opening in your busy schedule. The conversation could take an hour, or it could take 15 minutes. It should not be conducted as a matter of convenience to the clinician.

In addition, often times the recovery room is not the best location—it is not private and confidential, and the patient is still groggy and will be unable to remember most of what is said or ask questions as needed.

OBG Management: You advocate a “TEAM” approach when speaking with the patient. What is TEAM?
Dr. Weiss: Disclosure conversations are not easy to have. The patient and the patient’s family are often upset. Medical errors challenge a physician’s humility and integrity, and they can lead to questioning of one’s own ability. I adopted the helpful pneumonic TEAM after first learning about it at what is now known as the Institute for Healthcare Communication. It refers to what parties need to be notified and who needs to be present with you when having a disclosure conversation. Of course, you want someone there who not only can serve as a witness but also can help facilitate the gathering of answers for questions that will be asked. The best person for this job could be the lead physician involved in the care of the patient, a hospital risk manager, a colleague, or the patient safety officer.

The “T” stands for truthful. When you begin the conversation, tell the patient at that point what you know to be true and what you know may have happened or definitely did not happen that contributed to the outcome. Again, do not speculate in answering the patient’s questions. A good approach is to say, “This is what I know happened. As of right now, this is what I know may have contributed or did contribute. We are going to be looking into this more thoroughly. As I learn more, you will be the first to know.”

These are not one-time conversations. As you do learn more, circle back and talk to the patient and family. This can be a dialogue that goes on for weeks or even months.

“E” equals empathy. Allow the patient and the patient’s family to ventilate. Try to understand what is it that they are most upset about, and try to soothe these upset feelings. For example, do not make the assumption that they are most upset about paying for a surgery in which there was a medical error. In fact, they really may be most upset about staying in the hospital 2 additional days, and they are going to now miss the visit of a relative, their child’s graduation, or something important to them.

Let patients talk. Do not interrupt them. Do not stand over them while they are in the bed; sit down at eye level with them. Talk in a voice and tone that the patient understands and try to soothe and empathetically relate to what is being said.

The “A” is important: Apology. There are 2 things that patients want when a medical error occurs: 1) to hear the clinician say, “I’m sorry”—and you should be sorry if a medical error occurred, and you should say that you are sorry this happened—and 2) what you or your organization is going to do so that this does not happen to the next person. Incorporate these 2 factors into the apology piece.

OBG Management: Can saying, “I’m sorry” expose a clinician unnecessarily to malpractice risk?
Dr. Weiss: Saying “I’m sorry,” of course, has come under a lot of scrutiny. There are various state laws, and you should be aware of your state’s apology laws. In many states an apology, with “I’m sorry,” cannot be used against a provider. However, there is not 100% absolution of the event if an apology occurs. In other words, “I’m sorry” cannot be held against you, but saying “I’m sorry” does not negate the error that occurred.

Even when practicing in a state in which there is not an apology law, however, and a clinician does apologize and that apology comes up in the legal setting of a true medical error, we would need to ask, is it really that bad that an apology was made on behalf of the medical error that was committed? Isn’t that compassion? Isn’t that empathy? Isn’t that showing that I as the physician care for the patient and the medical team cares for the patient?

Finally, abide by the disclosure policy and standards of your organization.

OBG Management: What does the “M” in TEAM stand for?
Dr. Weiss: Management. There may be times when a medical error occurs that the patient or the patient’s family are angry and upset to the point that they no longer want you to continue to care for them. Be empathetic and helpful by offering to assist them in finding someone else to continue to provide their care. Also let them know that you are more than happy to continue to care for them and assist them in their healing and restoration to health in any way that you can: “Of course the ongoing management of your care is your decision, and we will do whatever your wishes are.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Physician burnout is a serious issue, especially in the often high-pressure world of obstetrics and gynecology. In the July 2016 issue of OBG Management, we briefly looked at studies showing that 1) ObGyns experience high rates of burnout, 2) rates of burnout are increasing over time, and 3) women, the majority gender in ObGyn, experience higher rates of burnout than their male counterparts. Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ In 2016, 51% of ObGyns reported experiencing burnout, with women reporting a rate of 55% compared with 46% for men.²

Numerous studies show that burnout is associated with increased likelihood of physician suicide, decisions to leave the practice of medicine, and poorer health, including obesity. These statistics ring alarm bells that we cannot ignore, especially as they may signal real concern for patient care.

The top causes of physician burnout, according to a Medscape survey, are²:

• too many bureaucratic tasks
• spending too many hours at work
• increasing computerization of practice
• income not high enough.

Physician burnout is not a one-size-fits-all condition. Not everyone experiences it similarly. Likewise, there are many strategies you can use to prevent and overcome burnout.

Experts offer guidance on preventing burnout

The 3 ObGyn leaders profiled in this article offer insight, inspiration, and opportunities to help you regain the joy of practice. The American Medical Association (AMA) also offers an online practice-based initiative that includes strategies to help improve professional satisfaction.

Take burnout by the horns
As Assistant Dean for Graduate Medical Education and Professor of Clinical Biologic Sciences, Charles E. Schmidt College of Medicine, at Florida Atlantic University in Boca Raton, Florida, Roger P. Smith, MD, has developed an authoritative focus on the symptoms and effects of physician burnout. Recently, Dr. Smith taught a clinical seminar titled “Burnout: A constant threat” at the American College of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical and Scientific Meeting in Washington, DC, where he reviewed the causes and symptoms of burnout as well as strategies to minimize and avoid it. His work shows that burnout is pervasive and is becoming more so. Dr. Smith indicates that burnout is not any more common to one part of the country or one type of ObGyn care than any other, although it is becoming more commonly recognized among younger physicians.

As with other nonphysical ailments, symptoms of burnout may have affected ObGyns over many generations—symptoms that people did not discuss with their families or colleagues or that were easily dismissed.

Dr. Smith is opening the door for unreserved conversations about burnout in the physician community. He suggests ways for practices to focus on physician wellness and for individual ObGyns to recognize and take steps to overcome burnout signs. To hear Dr. Smith’s expert discussion on burnout, tune in to his audio interview, “Is burnout on the rise and what are the signs ObGyns should be on the lookout for?”

Develop a passion outside of medicine
Jeffrey M. Rothenberg, MD, MS, experienced serious burnout in 1997 after 3 infants in his high-risk obstetrical unit died in the same week. Like many ObGyns, he tries to not bring work-related issues home, but that week Dr. Rothenberg’s wife Joani, an accomplished art therapist, recognized her husband’s anguish. Soon, she enrolled him in a glass-blowing class to give him a needed break from the pressures of his practice. Dr. Rothenberg’s life was transformed. “Initially it was an escape,” he says about his venture into the art world. “Unlike the OR or in labor and delivery, no one could get hurt but me; it wasn’t life and death—it was something outside of what I do for a living and allowed me to disconnect from my chosen profession—if even for a little bit.”

Still a practicing ObGyn and currently the Designated Institutional Official at St. Vincent in Indianapolis, Dr. Rothenberg is now an accomplished glass artist with his work in public and private collections around the world. Because he feels so passionately that physicians should have a creative outlet, he helps medical students discover their own forms of self-expression through the Creative Arts Therapy Student Interest Group in the Office of Medical Student Service-Learning at Indiana University, where he serves as a mentor. There, he teaches medical students the importance of taking care of themselves as well as their patients. Dr. Rothenberg has made integrating the arts and humanities an integral part of the Indiana University School of Medicine curricula, and he helped establish the Visual Thinking Strategy program, which teaches nursing and medical students better communication skills using the power of observation gained through the arts. In honor of this work, Dr. Rothenberg received a 2015 Arnold P. Gold Foundation Humanism in Medicine Award.

For Dr. Rothenberg, glass has been the perfect medium. “It’s a very tactile art form, and I like doing things with my hands, as a surgeon—there’s a real affinity there—taking materials that are dangerous to touch and coaxing them into forms and shapes that are either artistic or functional is a challenge—but definitely stress reducing,” he says. He also found striking similarities between the operating room and the glass studio, which both involve teamwork, good communication skills, and repetition.

“I think that every healer needs an avocation in addition to his or her chosen vocation. Especially in medicine, both for patients and healers, we all deal with some amazingly complex and difficult situations—often at the intersection of life and death—that go beyond verbalizing and may have no right or wrong answer—just a bad and a worse choice. Given that backdrop, having another way to express yourself or an avenue for a kind of emotional catharsis... is very, very helpful. I think it’s important for our learners, in particular, to embrace the humanistic side of medicine. After all, medicine is so much more than just a science. It’s more of an art, and I think they can really bond with both patients and other providers alike if they have something else in common—something that they can talk about that is outside of medicine. We have very stressful jobs and we need to model to our trainees and to each other that it is important to take care of ourselves. It’s important for a healer to have a passion, a creative outlet,” he explains.

Be part of the solution
ACOG President Thomas Gellhaus, MD, has dedicated his life to advocating for his specialty and for patient care. His presidential initiatives hold great potential for preventing and overcoming burnout in ObGyns throughout the nation.

Join a mentoring program. Dr. Gellhaus encourages greater participation in mentoring—both as a mentor and a mentee—through an innovative mentor matching program created by Thomas Arnold, MD, and Tamara Helfer, MD, MBA, in ACOG District VI. This program allows physicians to share new ideas and aspirations, connect colleagues, and build lifelong bonds. Young ObGyns find an experienced and trusted advisor; more experienced ObGyns find satisfaction in helping others grow. Helping ObGyns avoid burnout is a key goal of this mentoring program, and Dr. Gellhaus is expanding the program to ACOG Fellows in all Districts.

The District VI mentoring program includes these goals:

• sharing skills, knowledge, and expertise
• demonstrating optimism and enthusiasm about the mentor-mentee relationship and the field of obstetrics and gynecology
• promoting ongoing learning and growth
• providing guidance and constructive feedback
• setting personal and professional goals
• celebrating accomplishments.

Dr. Arnold and Dr. Helfer point out that mentoring opportunities are also critical to help align practice with the future, especially working in collaborative groups, focusing on population health, and incorporating integrated learning. Learn more about bringing this mentorship program to your practice or ACOG section at http://www.acog.org/mentorshipprogram.

Consider going on a global health mission. Dr. Gellhaus and his family have participated in and led many medical missions over the years, braving oppressive heat and discomfort for the opportunity to bring health care to those who have none. He points out, “In areas where health care is out of reach, these missions help people return to economic productivity and retain their dignity.”

Under Dr. Gellhaus’ leadership, ACOG will help connect interested ObGyns with care needs across the globe through the organizations that need physician volunteers for short-term stays.

Already, ACOG is developing an ObGyn educational curriculum for Health Volunteers Overseas, a nonprofit organization that for 30 years has helped educate local health providers in villages in developing nations.

These short-term experiences not only can help physicians break out of their burnout ruts but also transform women’s lives and help build long-term relationships with physicians across the globe.

Become an advocate. Also under the leadership of Dr. Gellhaus, ACOG is investing in the imperative to help members thrive and lead health care into the next generation. Advocacy means getting politicians out of our exam rooms, reducing red tape, and improving payments and participation experiences for practicing ObGyns.

Dr. Gellhaus’ All-in for Advocacy program is designed to increase ACOG’s legislative power while expanding advocacy opportunities throughout the membership. Dr. Gellhaus said in his inaugural presidential address, “I’d like everyone to realize that caring for your patients does not end in the exam room or the surgical suite and everyone is affected by our legislative fights.”

All these initiatives offer alternatives to the pressure of day-to-day practice, and participation can bring back the joy of collegiality and making a difference.

AMA’s initiative to battle burnout

The AMA, too, has responded to physicians’ needs by developing its STEPS Forward interactive practice transformation series (www.stepsforward.org). A 2013 Rand study commissioned by the AMA found that “the satisfaction physicians derive from their work is eroding as they spend more time on grueling administrative rules, regulations and paperwork than caring for patients. The report noted that many physicians say that the bureaucratic obstacles to providing patients with high-quality care are major contributors to symptoms of burnout, including emotional fatigue, depersonalization, loss of enthusiasm and early retirement.”^3,4

The STEPS Forward module Preventing Physician Burnout (www.stepsforward.org/modules/physician-burnout) can help identify if you are at risk for burnout and offers examples of how to implement changes that may restore your work satisfaction and work-life balance (TABLE).⁵ It details practice changes that can improve workflow and reduce administrative barriers, improving both patient and physician satisfaction.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Physician burnout is a serious issue, especially in the often high-pressure world of obstetrics and gynecology. In the July 2016 issue of OBG Management, we briefly looked at studies showing that 1) ObGyns experience high rates of burnout, 2) rates of burnout are increasing over time, and 3) women, the majority gender in ObGyn, experience higher rates of burnout than their male counterparts. Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ In 2016, 51% of ObGyns reported experiencing burnout, with women reporting a rate of 55% compared with 46% for men.²

Numerous studies show that burnout is associated with increased likelihood of physician suicide, decisions to leave the practice of medicine, and poorer health, including obesity. These statistics ring alarm bells that we cannot ignore, especially as they may signal real concern for patient care.

The top causes of physician burnout, according to a Medscape survey, are²:

• too many bureaucratic tasks
• spending too many hours at work
• increasing computerization of practice
• income not high enough.

Physician burnout is not a one-size-fits-all condition. Not everyone experiences it similarly. Likewise, there are many strategies you can use to prevent and overcome burnout.

Experts offer guidance on preventing burnout

The 3 ObGyn leaders profiled in this article offer insight, inspiration, and opportunities to help you regain the joy of practice. The American Medical Association (AMA) also offers an online practice-based initiative that includes strategies to help improve professional satisfaction.

Take burnout by the horns
As Assistant Dean for Graduate Medical Education and Professor of Clinical Biologic Sciences, Charles E. Schmidt College of Medicine, at Florida Atlantic University in Boca Raton, Florida, Roger P. Smith, MD, has developed an authoritative focus on the symptoms and effects of physician burnout. Recently, Dr. Smith taught a clinical seminar titled “Burnout: A constant threat” at the American College of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical and Scientific Meeting in Washington, DC, where he reviewed the causes and symptoms of burnout as well as strategies to minimize and avoid it. His work shows that burnout is pervasive and is becoming more so. Dr. Smith indicates that burnout is not any more common to one part of the country or one type of ObGyn care than any other, although it is becoming more commonly recognized among younger physicians.

As with other nonphysical ailments, symptoms of burnout may have affected ObGyns over many generations—symptoms that people did not discuss with their families or colleagues or that were easily dismissed.

Dr. Smith is opening the door for unreserved conversations about burnout in the physician community. He suggests ways for practices to focus on physician wellness and for individual ObGyns to recognize and take steps to overcome burnout signs. To hear Dr. Smith’s expert discussion on burnout, tune in to his audio interview, “Is burnout on the rise and what are the signs ObGyns should be on the lookout for?”

Develop a passion outside of medicine
Jeffrey M. Rothenberg, MD, MS, experienced serious burnout in 1997 after 3 infants in his high-risk obstetrical unit died in the same week. Like many ObGyns, he tries to not bring work-related issues home, but that week Dr. Rothenberg’s wife Joani, an accomplished art therapist, recognized her husband’s anguish. Soon, she enrolled him in a glass-blowing class to give him a needed break from the pressures of his practice. Dr. Rothenberg’s life was transformed. “Initially it was an escape,” he says about his venture into the art world. “Unlike the OR or in labor and delivery, no one could get hurt but me; it wasn’t life and death—it was something outside of what I do for a living and allowed me to disconnect from my chosen profession—if even for a little bit.”

Still a practicing ObGyn and currently the Designated Institutional Official at St. Vincent in Indianapolis, Dr. Rothenberg is now an accomplished glass artist with his work in public and private collections around the world. Because he feels so passionately that physicians should have a creative outlet, he helps medical students discover their own forms of self-expression through the Creative Arts Therapy Student Interest Group in the Office of Medical Student Service-Learning at Indiana University, where he serves as a mentor. There, he teaches medical students the importance of taking care of themselves as well as their patients. Dr. Rothenberg has made integrating the arts and humanities an integral part of the Indiana University School of Medicine curricula, and he helped establish the Visual Thinking Strategy program, which teaches nursing and medical students better communication skills using the power of observation gained through the arts. In honor of this work, Dr. Rothenberg received a 2015 Arnold P. Gold Foundation Humanism in Medicine Award.

For Dr. Rothenberg, glass has been the perfect medium. “It’s a very tactile art form, and I like doing things with my hands, as a surgeon—there’s a real affinity there—taking materials that are dangerous to touch and coaxing them into forms and shapes that are either artistic or functional is a challenge—but definitely stress reducing,” he says. He also found striking similarities between the operating room and the glass studio, which both involve teamwork, good communication skills, and repetition.

“I think that every healer needs an avocation in addition to his or her chosen vocation. Especially in medicine, both for patients and healers, we all deal with some amazingly complex and difficult situations—often at the intersection of life and death—that go beyond verbalizing and may have no right or wrong answer—just a bad and a worse choice. Given that backdrop, having another way to express yourself or an avenue for a kind of emotional catharsis... is very, very helpful. I think it’s important for our learners, in particular, to embrace the humanistic side of medicine. After all, medicine is so much more than just a science. It’s more of an art, and I think they can really bond with both patients and other providers alike if they have something else in common—something that they can talk about that is outside of medicine. We have very stressful jobs and we need to model to our trainees and to each other that it is important to take care of ourselves. It’s important for a healer to have a passion, a creative outlet,” he explains.

Be part of the solution
ACOG President Thomas Gellhaus, MD, has dedicated his life to advocating for his specialty and for patient care. His presidential initiatives hold great potential for preventing and overcoming burnout in ObGyns throughout the nation.

Join a mentoring program. Dr. Gellhaus encourages greater participation in mentoring—both as a mentor and a mentee—through an innovative mentor matching program created by Thomas Arnold, MD, and Tamara Helfer, MD, MBA, in ACOG District VI. This program allows physicians to share new ideas and aspirations, connect colleagues, and build lifelong bonds. Young ObGyns find an experienced and trusted advisor; more experienced ObGyns find satisfaction in helping others grow. Helping ObGyns avoid burnout is a key goal of this mentoring program, and Dr. Gellhaus is expanding the program to ACOG Fellows in all Districts.

The District VI mentoring program includes these goals:

• sharing skills, knowledge, and expertise
• demonstrating optimism and enthusiasm about the mentor-mentee relationship and the field of obstetrics and gynecology
• promoting ongoing learning and growth
• providing guidance and constructive feedback
• setting personal and professional goals
• celebrating accomplishments.

Dr. Arnold and Dr. Helfer point out that mentoring opportunities are also critical to help align practice with the future, especially working in collaborative groups, focusing on population health, and incorporating integrated learning. Learn more about bringing this mentorship program to your practice or ACOG section at http://www.acog.org/mentorshipprogram.

Consider going on a global health mission. Dr. Gellhaus and his family have participated in and led many medical missions over the years, braving oppressive heat and discomfort for the opportunity to bring health care to those who have none. He points out, “In areas where health care is out of reach, these missions help people return to economic productivity and retain their dignity.”

Under Dr. Gellhaus’ leadership, ACOG will help connect interested ObGyns with care needs across the globe through the organizations that need physician volunteers for short-term stays.

Already, ACOG is developing an ObGyn educational curriculum for Health Volunteers Overseas, a nonprofit organization that for 30 years has helped educate local health providers in villages in developing nations.

These short-term experiences not only can help physicians break out of their burnout ruts but also transform women’s lives and help build long-term relationships with physicians across the globe.

Become an advocate. Also under the leadership of Dr. Gellhaus, ACOG is investing in the imperative to help members thrive and lead health care into the next generation. Advocacy means getting politicians out of our exam rooms, reducing red tape, and improving payments and participation experiences for practicing ObGyns.

Dr. Gellhaus’ All-in for Advocacy program is designed to increase ACOG’s legislative power while expanding advocacy opportunities throughout the membership. Dr. Gellhaus said in his inaugural presidential address, “I’d like everyone to realize that caring for your patients does not end in the exam room or the surgical suite and everyone is affected by our legislative fights.”

All these initiatives offer alternatives to the pressure of day-to-day practice, and participation can bring back the joy of collegiality and making a difference.

AMA’s initiative to battle burnout

The AMA, too, has responded to physicians’ needs by developing its STEPS Forward interactive practice transformation series (www.stepsforward.org). A 2013 Rand study commissioned by the AMA found that “the satisfaction physicians derive from their work is eroding as they spend more time on grueling administrative rules, regulations and paperwork than caring for patients. The report noted that many physicians say that the bureaucratic obstacles to providing patients with high-quality care are major contributors to symptoms of burnout, including emotional fatigue, depersonalization, loss of enthusiasm and early retirement.”^3,4

The STEPS Forward module Preventing Physician Burnout (www.stepsforward.org/modules/physician-burnout) can help identify if you are at risk for burnout and offers examples of how to implement changes that may restore your work satisfaction and work-life balance (TABLE).⁵ It details practice changes that can improve workflow and reduce administrative barriers, improving both patient and physician satisfaction.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Physician burnout is a serious issue, especially in the often high-pressure world of obstetrics and gynecology. In the July 2016 issue of OBG Management, we briefly looked at studies showing that 1) ObGyns experience high rates of burnout, 2) rates of burnout are increasing over time, and 3) women, the majority gender in ObGyn, experience higher rates of burnout than their male counterparts. Between 2011 and 2014, rates of physician burnout increased from 45.5% to 54.4%.¹ In 2016, 51% of ObGyns reported experiencing burnout, with women reporting a rate of 55% compared with 46% for men.²

Numerous studies show that burnout is associated with increased likelihood of physician suicide, decisions to leave the practice of medicine, and poorer health, including obesity. These statistics ring alarm bells that we cannot ignore, especially as they may signal real concern for patient care.

The top causes of physician burnout, according to a Medscape survey, are²:

• too many bureaucratic tasks
• spending too many hours at work
• increasing computerization of practice
• income not high enough.

Physician burnout is not a one-size-fits-all condition. Not everyone experiences it similarly. Likewise, there are many strategies you can use to prevent and overcome burnout.

Experts offer guidance on preventing burnout

The 3 ObGyn leaders profiled in this article offer insight, inspiration, and opportunities to help you regain the joy of practice. The American Medical Association (AMA) also offers an online practice-based initiative that includes strategies to help improve professional satisfaction.

Take burnout by the horns
As Assistant Dean for Graduate Medical Education and Professor of Clinical Biologic Sciences, Charles E. Schmidt College of Medicine, at Florida Atlantic University in Boca Raton, Florida, Roger P. Smith, MD, has developed an authoritative focus on the symptoms and effects of physician burnout. Recently, Dr. Smith taught a clinical seminar titled “Burnout: A constant threat” at the American College of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical and Scientific Meeting in Washington, DC, where he reviewed the causes and symptoms of burnout as well as strategies to minimize and avoid it. His work shows that burnout is pervasive and is becoming more so. Dr. Smith indicates that burnout is not any more common to one part of the country or one type of ObGyn care than any other, although it is becoming more commonly recognized among younger physicians.

As with other nonphysical ailments, symptoms of burnout may have affected ObGyns over many generations—symptoms that people did not discuss with their families or colleagues or that were easily dismissed.

Dr. Smith is opening the door for unreserved conversations about burnout in the physician community. He suggests ways for practices to focus on physician wellness and for individual ObGyns to recognize and take steps to overcome burnout signs. To hear Dr. Smith’s expert discussion on burnout, tune in to his audio interview, “Is burnout on the rise and what are the signs ObGyns should be on the lookout for?”

Develop a passion outside of medicine
Jeffrey M. Rothenberg, MD, MS, experienced serious burnout in 1997 after 3 infants in his high-risk obstetrical unit died in the same week. Like many ObGyns, he tries to not bring work-related issues home, but that week Dr. Rothenberg’s wife Joani, an accomplished art therapist, recognized her husband’s anguish. Soon, she enrolled him in a glass-blowing class to give him a needed break from the pressures of his practice. Dr. Rothenberg’s life was transformed. “Initially it was an escape,” he says about his venture into the art world. “Unlike the OR or in labor and delivery, no one could get hurt but me; it wasn’t life and death—it was something outside of what I do for a living and allowed me to disconnect from my chosen profession—if even for a little bit.”

Still a practicing ObGyn and currently the Designated Institutional Official at St. Vincent in Indianapolis, Dr. Rothenberg is now an accomplished glass artist with his work in public and private collections around the world. Because he feels so passionately that physicians should have a creative outlet, he helps medical students discover their own forms of self-expression through the Creative Arts Therapy Student Interest Group in the Office of Medical Student Service-Learning at Indiana University, where he serves as a mentor. There, he teaches medical students the importance of taking care of themselves as well as their patients. Dr. Rothenberg has made integrating the arts and humanities an integral part of the Indiana University School of Medicine curricula, and he helped establish the Visual Thinking Strategy program, which teaches nursing and medical students better communication skills using the power of observation gained through the arts. In honor of this work, Dr. Rothenberg received a 2015 Arnold P. Gold Foundation Humanism in Medicine Award.

For Dr. Rothenberg, glass has been the perfect medium. “It’s a very tactile art form, and I like doing things with my hands, as a surgeon—there’s a real affinity there—taking materials that are dangerous to touch and coaxing them into forms and shapes that are either artistic or functional is a challenge—but definitely stress reducing,” he says. He also found striking similarities between the operating room and the glass studio, which both involve teamwork, good communication skills, and repetition.

“I think that every healer needs an avocation in addition to his or her chosen vocation. Especially in medicine, both for patients and healers, we all deal with some amazingly complex and difficult situations—often at the intersection of life and death—that go beyond verbalizing and may have no right or wrong answer—just a bad and a worse choice. Given that backdrop, having another way to express yourself or an avenue for a kind of emotional catharsis... is very, very helpful. I think it’s important for our learners, in particular, to embrace the humanistic side of medicine. After all, medicine is so much more than just a science. It’s more of an art, and I think they can really bond with both patients and other providers alike if they have something else in common—something that they can talk about that is outside of medicine. We have very stressful jobs and we need to model to our trainees and to each other that it is important to take care of ourselves. It’s important for a healer to have a passion, a creative outlet,” he explains.

Be part of the solution
ACOG President Thomas Gellhaus, MD, has dedicated his life to advocating for his specialty and for patient care. His presidential initiatives hold great potential for preventing and overcoming burnout in ObGyns throughout the nation.

Join a mentoring program. Dr. Gellhaus encourages greater participation in mentoring—both as a mentor and a mentee—through an innovative mentor matching program created by Thomas Arnold, MD, and Tamara Helfer, MD, MBA, in ACOG District VI. This program allows physicians to share new ideas and aspirations, connect colleagues, and build lifelong bonds. Young ObGyns find an experienced and trusted advisor; more experienced ObGyns find satisfaction in helping others grow. Helping ObGyns avoid burnout is a key goal of this mentoring program, and Dr. Gellhaus is expanding the program to ACOG Fellows in all Districts.

The District VI mentoring program includes these goals:

• sharing skills, knowledge, and expertise
• demonstrating optimism and enthusiasm about the mentor-mentee relationship and the field of obstetrics and gynecology
• promoting ongoing learning and growth
• providing guidance and constructive feedback
• setting personal and professional goals
• celebrating accomplishments.

Dr. Arnold and Dr. Helfer point out that mentoring opportunities are also critical to help align practice with the future, especially working in collaborative groups, focusing on population health, and incorporating integrated learning. Learn more about bringing this mentorship program to your practice or ACOG section at http://www.acog.org/mentorshipprogram.

Consider going on a global health mission. Dr. Gellhaus and his family have participated in and led many medical missions over the years, braving oppressive heat and discomfort for the opportunity to bring health care to those who have none. He points out, “In areas where health care is out of reach, these missions help people return to economic productivity and retain their dignity.”

Under Dr. Gellhaus’ leadership, ACOG will help connect interested ObGyns with care needs across the globe through the organizations that need physician volunteers for short-term stays.

Already, ACOG is developing an ObGyn educational curriculum for Health Volunteers Overseas, a nonprofit organization that for 30 years has helped educate local health providers in villages in developing nations.

These short-term experiences not only can help physicians break out of their burnout ruts but also transform women’s lives and help build long-term relationships with physicians across the globe.

Become an advocate. Also under the leadership of Dr. Gellhaus, ACOG is investing in the imperative to help members thrive and lead health care into the next generation. Advocacy means getting politicians out of our exam rooms, reducing red tape, and improving payments and participation experiences for practicing ObGyns.

Dr. Gellhaus’ All-in for Advocacy program is designed to increase ACOG’s legislative power while expanding advocacy opportunities throughout the membership. Dr. Gellhaus said in his inaugural presidential address, “I’d like everyone to realize that caring for your patients does not end in the exam room or the surgical suite and everyone is affected by our legislative fights.”

All these initiatives offer alternatives to the pressure of day-to-day practice, and participation can bring back the joy of collegiality and making a difference.

AMA’s initiative to battle burnout

The AMA, too, has responded to physicians’ needs by developing its STEPS Forward interactive practice transformation series (www.stepsforward.org). A 2013 Rand study commissioned by the AMA found that “the satisfaction physicians derive from their work is eroding as they spend more time on grueling administrative rules, regulations and paperwork than caring for patients. The report noted that many physicians say that the bureaucratic obstacles to providing patients with high-quality care are major contributors to symptoms of burnout, including emotional fatigue, depersonalization, loss of enthusiasm and early retirement.”^3,4

The STEPS Forward module Preventing Physician Burnout (www.stepsforward.org/modules/physician-burnout) can help identify if you are at risk for burnout and offers examples of how to implement changes that may restore your work satisfaction and work-life balance (TABLE).⁵ It details practice changes that can improve workflow and reduce administrative barriers, improving both patient and physician satisfaction.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In the first part of this article series (“Preparation: Tips that lead to a solid, engaging presentation,” OBG Manag. 2016;28[7]:31–36.), we offered tips on preparing for a group presentation. In this article, part 2, we discuss the presentation itself and what you can do to capture and hold your audience’s attention.

Paul Zwolak for OBG Management

How to connect with the audience

Let’s assume the meeting host has just introduced you to the audience using, as we suggested in the previous article, an autobiographical profile you provided. You now have the audience’s undivided attention. What you do and say in the next 30 to 60 seconds will set the stage for your program. Following the requisite “thank you” to the host and meeting sponsor, use this time to establish your expertise as a spokesperson on the chosen topic. Or, if the introductory remarks made your expertise plain, you may choose to connect with the audience on an informal, personal level. If you are from out of town, for instance, you could remark on an interesting aspect of the city or region you are visiting that you learned on the Internet before arriving.

Underscore the topic’s importance. On the other hand, you might want to begin with an insightful statistic germane to your talk. For example, a talk on breast cancer might begin with, “According to the American Cancer Society, there are nearly 250,000 new cases of breast cancer each year, and breast cancer accounts for more than 40,000 deaths per year. That means more women die from breast cancer than die in auto accidents each year. So this emphasizes the importance of appropriately screening women for breast cancer annually after age 40.”

An opening story about a patient can be powerful. Better yet, a personal experience reflecting your topic is a great way to connect with your audience members and get their attention. For example, one of us (NHB) gives talks on practice management and practice efficiency. I might talk about when I was called from an exam room 3 times to answer “emergency” phone calls from a patient who wanted only to request her medical records. To ensure that this embarrassment would never happen again, I put in place a system that I then describe for the audience.

Alternatively, an opening that addresses the audience’s unspoken question, “What’s in this for me?” is sure to grab their attention. For instance, a talk on office productivity might begin by promising to share a way to increase annual collections by $250,000 per physician through scheduling adjustments that can increase the number of examined patients by one per hour.

Steer clear of these openings. In general, avoid “I’m delighted to be here” and other clichés. One exception would be if you can make that cliché humorous. For example, if a speaker from the deep South is visiting the northern part of the country in summer, she might say, “Most speakers say they’re delighted to be here, and you may well question their sincerity. However, I’m from New Orleans where the temperature is approaching 105 degrees with 95% humidity. You know I’m really delighted to be here!”

Importantly, avoid starting with an apology. Do not mention problems with the audiovisual equipment or why you arrived late. The audience does not care, and you will immediately lose their attention. They want to be educated and entertained. There is no better way to do this than by offering a compelling and captivating opening that begins the moment after you are introduced.

Finally, avoid use of the “royal I,” as in “I am here to talk about XYZ.” It places you in a position superior to the audience, and that is a turnoff. Instead, you could say to the audience, “The reason you are here is to learn about XYZ.” This places the audience on an equal level with you, and they know there will be something in the presentation for them.

Housekeeping notes

The audience will appreciate knowing how long you plan to speak and whether you will take questions during or after the presentation. Based on our experience, if there are fewer than 20 attendees, we often encourage questions during the program instead of waiting until the end. This makes the program more conversational and usually generates more questions. With a dinner presentation, we prefer to speak while the audience is eating. We usually start after the waiters have taken the orders and the attendees have had their appetizers. We might say we will finish the program by the time they are ready for dessert. We also mention that we will distribute a handout after the presentation so they do not have to worry about following the handout, taking notes, and watching the speaker while trying to eat.

The main body of the program

As for structuring your talk, we suggest you follow this time-honored advice often attributed to Aristotle: Tell the audience what you are going to say, say it, and tell them what you said.

So we begin a presentation by stating the objectives of our program, usually limited to 3 and no more than 4. For example, a talk on hormone therapy (HT) for treating vasomotor symptoms of menopause might mention 1) the history of HT use, 2) which women are appropriate candidates for HT, and 3) how to monitor women who receive HT.

Enhance the talk’s relevance. We like to begin a clinical program with a case scenario wherein we describe how one of our patients had the specific problem and how we used a particular drug, treatment, or device to manage the case. We try to select a patient similar to ones who would be seen by members of the audience.

Simplify as much as possible. We then present the slides exactly as they have been provided by the pharmaceutical company. Most company slides contain too many words as well as diagrams that are too complex for the audience to grasp easily. We try to find one salient point on each slide and focus attention on that single word, phrase, or sentence. We can do this in a small audience by walking over to the screen and pointing it out, or we can use the laser pointer from a distance.

Change things up to keep the message fresh. Let’s be honest, most medical talks are dry and boring. Try to inject some energy and enthusiasm in the middle of the presentation. Every few minutes we tell a story or ask the audience a question. For example, during a program on practice management, one of us (NHB) will relate a story about an unhappy patient and then ask a physician in the audience how he or she might handle the disgruntled patient. This is a nice break from the main content of the presentation, re-engaging the audience in an interactive exchange.

Should you use humor?

Although many physicians attempt to use humor during a presentation, few are talented at stand-up comedy. However, used judiciously humor, like seasoning in fine cuisine, can do great things for a presentation. It can break the ice, drive home a point, and enhance your likeability. It can, though, also backfire. One of us (NHB) once gave a talk to a large audience of pharmaceutical representatives. As part of my wrap-up I displayed a slide from the cover of Economics that showed 2 camels in the mating position. My closing line was that reps need to “hump to it” and get involved with their physicians and be value-added in their product detailing. Afterward, the meeting planner told me that he would never hire me again. He said I had a great program, great material, and a good connection with the audience. But my closing was over the top. I learned my lesson. Never use material that has the potential to offend. If you want to use humor, the self-deprecatingkind is always safest.

Try using visual aids

Our observation is that few physician speakers use visual aids other than their slides. We have learned that audience attention will stay focused on you if you make use of visual aids. For example, if we are speaking to a lay audience about urinary incontinence, we might use a balloon to demonstrate the bladder and the urethra.

Studies have shown that there are more nerve endings from the eye to the brain than from the ear to the brain. Humans purportedly receive 25 times as much stimulus from visual cues than from auditory ones. To paraphrase an old proverb, “One seeing is better than 100 times hearing about”!

A few suggestions regarding the use of visual aids:

1. Keep the visual aid out of sight until you are ready to use it. You do not want the audience staring at it when they should be focusing on you or your slide material. We usually keep our visual aids under the table that supports the computer and projector.
2. Make certain the visual aid is large enough to be seen by everyone in the audience.
3. Do not hand out the aid to the audience during your program. Doing so will divert their attention from you and your material.
4. When you have finished using the aid, put it away.

Closing out the program

After we have covered the program’s 3 objectives, we let the audience know we are approaching the end of the presentation. For a dinner program, we try to time the ending just as plates are being cleared and before dessert is served. We then restate the 3 objectives as they might pertain to the attendees’ patients and practices. At this time, we take questions from the audience, even if some were asked during the presentation. We repeat each question when it is asked so that everyone can hear it. (This also gives us a few seconds to think about it and frame our answer.) If it appears that many questions will be asked, we assure everyone that we plan to finish on time and will remain after the program is over to answer additional questions.

Tips on fielding questions. When responding to a question, direct your attention initially to the person who asked it. After that, spend about 20% of the time focused on that person and 80% of the time on the rest of the audience. If you focus only on the questioner, it becomes a one-on-one conversation. You want to end your response with your eyes on the group and not on the questioner. Looking at the group will also act as a bridge to the next question. Although we used to reply to an inquiry with, “That’s a great question,” we now suggest avoiding this comment. Why? Because it is unlikely that you’ll keep using that line, and the next questioner who does not receive the same compliment might feel slighted.

Wrap up. When you announce, “I would like to conclude my program with…,” this is the magical time when you hold the complete attention of the audience. Often, the speaker’s last words are the ones the audience remembers the longest. So this is the time to offer your take-home message. For example, a talk on how to motivate your staff might conclude, “Remember, your staff members are the people that patients encounter first and the ones they see last as they leave the office. Every patient can have a positive experience with you and your practice if you ensure that your personnel are highly motivated. This happens in part by your effort to recognize their accomplishments.” Then hold up your hands and spread out your arms as you end with “Thank you.” The audience likely will applaud and, if your speech is truly exceptional, you might receive a gratifying standing ovation!

Be seated

Renowned for his speeches, Franklin Delano Roosevelt summarized the art of effective speaking when he said, “Be sincere. Be brief. Be seated.” When your time is up, turn the program back over to the meeting host and take a seat.

In the final article in this public speaking series, we will discuss the follow-up steps to take once the program is over, including the call to action or what you want the audience to do after you have left the podium or the speaking venue.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In the first part of this article series (“Preparation: Tips that lead to a solid, engaging presentation,” OBG Manag. 2016;28[7]:31–36.), we offered tips on preparing for a group presentation. In this article, part 2, we discuss the presentation itself and what you can do to capture and hold your audience’s attention.

Paul Zwolak for OBG Management

How to connect with the audience

Let’s assume the meeting host has just introduced you to the audience using, as we suggested in the previous article, an autobiographical profile you provided. You now have the audience’s undivided attention. What you do and say in the next 30 to 60 seconds will set the stage for your program. Following the requisite “thank you” to the host and meeting sponsor, use this time to establish your expertise as a spokesperson on the chosen topic. Or, if the introductory remarks made your expertise plain, you may choose to connect with the audience on an informal, personal level. If you are from out of town, for instance, you could remark on an interesting aspect of the city or region you are visiting that you learned on the Internet before arriving.

Underscore the topic’s importance. On the other hand, you might want to begin with an insightful statistic germane to your talk. For example, a talk on breast cancer might begin with, “According to the American Cancer Society, there are nearly 250,000 new cases of breast cancer each year, and breast cancer accounts for more than 40,000 deaths per year. That means more women die from breast cancer than die in auto accidents each year. So this emphasizes the importance of appropriately screening women for breast cancer annually after age 40.”

An opening story about a patient can be powerful. Better yet, a personal experience reflecting your topic is a great way to connect with your audience members and get their attention. For example, one of us (NHB) gives talks on practice management and practice efficiency. I might talk about when I was called from an exam room 3 times to answer “emergency” phone calls from a patient who wanted only to request her medical records. To ensure that this embarrassment would never happen again, I put in place a system that I then describe for the audience.

Alternatively, an opening that addresses the audience’s unspoken question, “What’s in this for me?” is sure to grab their attention. For instance, a talk on office productivity might begin by promising to share a way to increase annual collections by $250,000 per physician through scheduling adjustments that can increase the number of examined patients by one per hour.

Steer clear of these openings. In general, avoid “I’m delighted to be here” and other clichés. One exception would be if you can make that cliché humorous. For example, if a speaker from the deep South is visiting the northern part of the country in summer, she might say, “Most speakers say they’re delighted to be here, and you may well question their sincerity. However, I’m from New Orleans where the temperature is approaching 105 degrees with 95% humidity. You know I’m really delighted to be here!”

Importantly, avoid starting with an apology. Do not mention problems with the audiovisual equipment or why you arrived late. The audience does not care, and you will immediately lose their attention. They want to be educated and entertained. There is no better way to do this than by offering a compelling and captivating opening that begins the moment after you are introduced.

Finally, avoid use of the “royal I,” as in “I am here to talk about XYZ.” It places you in a position superior to the audience, and that is a turnoff. Instead, you could say to the audience, “The reason you are here is to learn about XYZ.” This places the audience on an equal level with you, and they know there will be something in the presentation for them.

Housekeeping notes

The audience will appreciate knowing how long you plan to speak and whether you will take questions during or after the presentation. Based on our experience, if there are fewer than 20 attendees, we often encourage questions during the program instead of waiting until the end. This makes the program more conversational and usually generates more questions. With a dinner presentation, we prefer to speak while the audience is eating. We usually start after the waiters have taken the orders and the attendees have had their appetizers. We might say we will finish the program by the time they are ready for dessert. We also mention that we will distribute a handout after the presentation so they do not have to worry about following the handout, taking notes, and watching the speaker while trying to eat.

The main body of the program

As for structuring your talk, we suggest you follow this time-honored advice often attributed to Aristotle: Tell the audience what you are going to say, say it, and tell them what you said.

So we begin a presentation by stating the objectives of our program, usually limited to 3 and no more than 4. For example, a talk on hormone therapy (HT) for treating vasomotor symptoms of menopause might mention 1) the history of HT use, 2) which women are appropriate candidates for HT, and 3) how to monitor women who receive HT.

Enhance the talk’s relevance. We like to begin a clinical program with a case scenario wherein we describe how one of our patients had the specific problem and how we used a particular drug, treatment, or device to manage the case. We try to select a patient similar to ones who would be seen by members of the audience.

Simplify as much as possible. We then present the slides exactly as they have been provided by the pharmaceutical company. Most company slides contain too many words as well as diagrams that are too complex for the audience to grasp easily. We try to find one salient point on each slide and focus attention on that single word, phrase, or sentence. We can do this in a small audience by walking over to the screen and pointing it out, or we can use the laser pointer from a distance.

Change things up to keep the message fresh. Let’s be honest, most medical talks are dry and boring. Try to inject some energy and enthusiasm in the middle of the presentation. Every few minutes we tell a story or ask the audience a question. For example, during a program on practice management, one of us (NHB) will relate a story about an unhappy patient and then ask a physician in the audience how he or she might handle the disgruntled patient. This is a nice break from the main content of the presentation, re-engaging the audience in an interactive exchange.

Should you use humor?

Although many physicians attempt to use humor during a presentation, few are talented at stand-up comedy. However, used judiciously humor, like seasoning in fine cuisine, can do great things for a presentation. It can break the ice, drive home a point, and enhance your likeability. It can, though, also backfire. One of us (NHB) once gave a talk to a large audience of pharmaceutical representatives. As part of my wrap-up I displayed a slide from the cover of Economics that showed 2 camels in the mating position. My closing line was that reps need to “hump to it” and get involved with their physicians and be value-added in their product detailing. Afterward, the meeting planner told me that he would never hire me again. He said I had a great program, great material, and a good connection with the audience. But my closing was over the top. I learned my lesson. Never use material that has the potential to offend. If you want to use humor, the self-deprecatingkind is always safest.

Try using visual aids

Our observation is that few physician speakers use visual aids other than their slides. We have learned that audience attention will stay focused on you if you make use of visual aids. For example, if we are speaking to a lay audience about urinary incontinence, we might use a balloon to demonstrate the bladder and the urethra.

Studies have shown that there are more nerve endings from the eye to the brain than from the ear to the brain. Humans purportedly receive 25 times as much stimulus from visual cues than from auditory ones. To paraphrase an old proverb, “One seeing is better than 100 times hearing about”!

A few suggestions regarding the use of visual aids:

1. Keep the visual aid out of sight until you are ready to use it. You do not want the audience staring at it when they should be focusing on you or your slide material. We usually keep our visual aids under the table that supports the computer and projector.
2. Make certain the visual aid is large enough to be seen by everyone in the audience.
3. Do not hand out the aid to the audience during your program. Doing so will divert their attention from you and your material.
4. When you have finished using the aid, put it away.

Closing out the program

After we have covered the program’s 3 objectives, we let the audience know we are approaching the end of the presentation. For a dinner program, we try to time the ending just as plates are being cleared and before dessert is served. We then restate the 3 objectives as they might pertain to the attendees’ patients and practices. At this time, we take questions from the audience, even if some were asked during the presentation. We repeat each question when it is asked so that everyone can hear it. (This also gives us a few seconds to think about it and frame our answer.) If it appears that many questions will be asked, we assure everyone that we plan to finish on time and will remain after the program is over to answer additional questions.

Tips on fielding questions. When responding to a question, direct your attention initially to the person who asked it. After that, spend about 20% of the time focused on that person and 80% of the time on the rest of the audience. If you focus only on the questioner, it becomes a one-on-one conversation. You want to end your response with your eyes on the group and not on the questioner. Looking at the group will also act as a bridge to the next question. Although we used to reply to an inquiry with, “That’s a great question,” we now suggest avoiding this comment. Why? Because it is unlikely that you’ll keep using that line, and the next questioner who does not receive the same compliment might feel slighted.

Wrap up. When you announce, “I would like to conclude my program with…,” this is the magical time when you hold the complete attention of the audience. Often, the speaker’s last words are the ones the audience remembers the longest. So this is the time to offer your take-home message. For example, a talk on how to motivate your staff might conclude, “Remember, your staff members are the people that patients encounter first and the ones they see last as they leave the office. Every patient can have a positive experience with you and your practice if you ensure that your personnel are highly motivated. This happens in part by your effort to recognize their accomplishments.” Then hold up your hands and spread out your arms as you end with “Thank you.” The audience likely will applaud and, if your speech is truly exceptional, you might receive a gratifying standing ovation!

Be seated

Renowned for his speeches, Franklin Delano Roosevelt summarized the art of effective speaking when he said, “Be sincere. Be brief. Be seated.” When your time is up, turn the program back over to the meeting host and take a seat.

In the final article in this public speaking series, we will discuss the follow-up steps to take once the program is over, including the call to action or what you want the audience to do after you have left the podium or the speaking venue.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In the first part of this article series (“Preparation: Tips that lead to a solid, engaging presentation,” OBG Manag. 2016;28[7]:31–36.), we offered tips on preparing for a group presentation. In this article, part 2, we discuss the presentation itself and what you can do to capture and hold your audience’s attention.

Paul Zwolak for OBG Management

How to connect with the audience

Let’s assume the meeting host has just introduced you to the audience using, as we suggested in the previous article, an autobiographical profile you provided. You now have the audience’s undivided attention. What you do and say in the next 30 to 60 seconds will set the stage for your program. Following the requisite “thank you” to the host and meeting sponsor, use this time to establish your expertise as a spokesperson on the chosen topic. Or, if the introductory remarks made your expertise plain, you may choose to connect with the audience on an informal, personal level. If you are from out of town, for instance, you could remark on an interesting aspect of the city or region you are visiting that you learned on the Internet before arriving.

Underscore the topic’s importance. On the other hand, you might want to begin with an insightful statistic germane to your talk. For example, a talk on breast cancer might begin with, “According to the American Cancer Society, there are nearly 250,000 new cases of breast cancer each year, and breast cancer accounts for more than 40,000 deaths per year. That means more women die from breast cancer than die in auto accidents each year. So this emphasizes the importance of appropriately screening women for breast cancer annually after age 40.”

An opening story about a patient can be powerful. Better yet, a personal experience reflecting your topic is a great way to connect with your audience members and get their attention. For example, one of us (NHB) gives talks on practice management and practice efficiency. I might talk about when I was called from an exam room 3 times to answer “emergency” phone calls from a patient who wanted only to request her medical records. To ensure that this embarrassment would never happen again, I put in place a system that I then describe for the audience.

Alternatively, an opening that addresses the audience’s unspoken question, “What’s in this for me?” is sure to grab their attention. For instance, a talk on office productivity might begin by promising to share a way to increase annual collections by $250,000 per physician through scheduling adjustments that can increase the number of examined patients by one per hour.

Steer clear of these openings. In general, avoid “I’m delighted to be here” and other clichés. One exception would be if you can make that cliché humorous. For example, if a speaker from the deep South is visiting the northern part of the country in summer, she might say, “Most speakers say they’re delighted to be here, and you may well question their sincerity. However, I’m from New Orleans where the temperature is approaching 105 degrees with 95% humidity. You know I’m really delighted to be here!”

Importantly, avoid starting with an apology. Do not mention problems with the audiovisual equipment or why you arrived late. The audience does not care, and you will immediately lose their attention. They want to be educated and entertained. There is no better way to do this than by offering a compelling and captivating opening that begins the moment after you are introduced.

Finally, avoid use of the “royal I,” as in “I am here to talk about XYZ.” It places you in a position superior to the audience, and that is a turnoff. Instead, you could say to the audience, “The reason you are here is to learn about XYZ.” This places the audience on an equal level with you, and they know there will be something in the presentation for them.

Housekeeping notes

The audience will appreciate knowing how long you plan to speak and whether you will take questions during or after the presentation. Based on our experience, if there are fewer than 20 attendees, we often encourage questions during the program instead of waiting until the end. This makes the program more conversational and usually generates more questions. With a dinner presentation, we prefer to speak while the audience is eating. We usually start after the waiters have taken the orders and the attendees have had their appetizers. We might say we will finish the program by the time they are ready for dessert. We also mention that we will distribute a handout after the presentation so they do not have to worry about following the handout, taking notes, and watching the speaker while trying to eat.

The main body of the program

As for structuring your talk, we suggest you follow this time-honored advice often attributed to Aristotle: Tell the audience what you are going to say, say it, and tell them what you said.

So we begin a presentation by stating the objectives of our program, usually limited to 3 and no more than 4. For example, a talk on hormone therapy (HT) for treating vasomotor symptoms of menopause might mention 1) the history of HT use, 2) which women are appropriate candidates for HT, and 3) how to monitor women who receive HT.

Enhance the talk’s relevance. We like to begin a clinical program with a case scenario wherein we describe how one of our patients had the specific problem and how we used a particular drug, treatment, or device to manage the case. We try to select a patient similar to ones who would be seen by members of the audience.

Simplify as much as possible. We then present the slides exactly as they have been provided by the pharmaceutical company. Most company slides contain too many words as well as diagrams that are too complex for the audience to grasp easily. We try to find one salient point on each slide and focus attention on that single word, phrase, or sentence. We can do this in a small audience by walking over to the screen and pointing it out, or we can use the laser pointer from a distance.

Change things up to keep the message fresh. Let’s be honest, most medical talks are dry and boring. Try to inject some energy and enthusiasm in the middle of the presentation. Every few minutes we tell a story or ask the audience a question. For example, during a program on practice management, one of us (NHB) will relate a story about an unhappy patient and then ask a physician in the audience how he or she might handle the disgruntled patient. This is a nice break from the main content of the presentation, re-engaging the audience in an interactive exchange.

Should you use humor?

Although many physicians attempt to use humor during a presentation, few are talented at stand-up comedy. However, used judiciously humor, like seasoning in fine cuisine, can do great things for a presentation. It can break the ice, drive home a point, and enhance your likeability. It can, though, also backfire. One of us (NHB) once gave a talk to a large audience of pharmaceutical representatives. As part of my wrap-up I displayed a slide from the cover of Economics that showed 2 camels in the mating position. My closing line was that reps need to “hump to it” and get involved with their physicians and be value-added in their product detailing. Afterward, the meeting planner told me that he would never hire me again. He said I had a great program, great material, and a good connection with the audience. But my closing was over the top. I learned my lesson. Never use material that has the potential to offend. If you want to use humor, the self-deprecatingkind is always safest.

Try using visual aids

Our observation is that few physician speakers use visual aids other than their slides. We have learned that audience attention will stay focused on you if you make use of visual aids. For example, if we are speaking to a lay audience about urinary incontinence, we might use a balloon to demonstrate the bladder and the urethra.

Studies have shown that there are more nerve endings from the eye to the brain than from the ear to the brain. Humans purportedly receive 25 times as much stimulus from visual cues than from auditory ones. To paraphrase an old proverb, “One seeing is better than 100 times hearing about”!

A few suggestions regarding the use of visual aids:

1. Keep the visual aid out of sight until you are ready to use it. You do not want the audience staring at it when they should be focusing on you or your slide material. We usually keep our visual aids under the table that supports the computer and projector.
2. Make certain the visual aid is large enough to be seen by everyone in the audience.
3. Do not hand out the aid to the audience during your program. Doing so will divert their attention from you and your material.
4. When you have finished using the aid, put it away.

Closing out the program

After we have covered the program’s 3 objectives, we let the audience know we are approaching the end of the presentation. For a dinner program, we try to time the ending just as plates are being cleared and before dessert is served. We then restate the 3 objectives as they might pertain to the attendees’ patients and practices. At this time, we take questions from the audience, even if some were asked during the presentation. We repeat each question when it is asked so that everyone can hear it. (This also gives us a few seconds to think about it and frame our answer.) If it appears that many questions will be asked, we assure everyone that we plan to finish on time and will remain after the program is over to answer additional questions.

Tips on fielding questions. When responding to a question, direct your attention initially to the person who asked it. After that, spend about 20% of the time focused on that person and 80% of the time on the rest of the audience. If you focus only on the questioner, it becomes a one-on-one conversation. You want to end your response with your eyes on the group and not on the questioner. Looking at the group will also act as a bridge to the next question. Although we used to reply to an inquiry with, “That’s a great question,” we now suggest avoiding this comment. Why? Because it is unlikely that you’ll keep using that line, and the next questioner who does not receive the same compliment might feel slighted.

Wrap up. When you announce, “I would like to conclude my program with…,” this is the magical time when you hold the complete attention of the audience. Often, the speaker’s last words are the ones the audience remembers the longest. So this is the time to offer your take-home message. For example, a talk on how to motivate your staff might conclude, “Remember, your staff members are the people that patients encounter first and the ones they see last as they leave the office. Every patient can have a positive experience with you and your practice if you ensure that your personnel are highly motivated. This happens in part by your effort to recognize their accomplishments.” Then hold up your hands and spread out your arms as you end with “Thank you.” The audience likely will applaud and, if your speech is truly exceptional, you might receive a gratifying standing ovation!

Be seated

Renowned for his speeches, Franklin Delano Roosevelt summarized the art of effective speaking when he said, “Be sincere. Be brief. Be seated.” When your time is up, turn the program back over to the meeting host and take a seat.

In the final article in this public speaking series, we will discuss the follow-up steps to take once the program is over, including the call to action or what you want the audience to do after you have left the podium or the speaking venue.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

After having a previous cesarean delivery (CD), women who subsequently become pregnant inevitably face the decision to undergo a repeat CD or attempt a trial of labor after cesarean (TOLAC). Currently in the United States, 83% of women with a prior uterine scar are delivered by repeat CD.¹ According to the Consortium on Safe Labor, more than half of all CD indications are attributed to having a prior uterine scar.¹ Furthermore, only 28% of women attempt a TOLAC, with a successful vaginal birth after cesarean (VBAC) rate of approximately 57%.¹

The reason for the low TOLAC rate is multifactorial, but a primary concern may be the safety risk of a TOLAC as it relates to uterine rupture, a rare but potentially catastrophic complication. In a large, multicenter prospective observational trial of more than 17,800 women attempting a TOLAC, the symptomatic uterine rupture rate was 0.7%.² As such, efforts to identify women at highest risk for uterine rupture and those with characteristics predictive of a successful VBAC have remained ongoing. Jastrow and colleagues have expanded this body of knowledge with their prospective cohort study.

Details of the study

The researchers assessed lower uterine segment thickness via vaginal and abdominal ultrasound at 34 to 38 weeks’ gestation in more than 1,850 women with a previous CD. Women enrolled in the trial were classified into 3 risk categories based on lower uterine segment thickness: high risk (<2.0 mm), intermediate risk (2.0 to 2.4 mm), and low risk (≥2.5 mm). The investigators’ objective was to estimate the occurrence of uterine rupture when this measurement was included in the decision-making process on mode of delivery.

An important aspect of this study involved how the provider discussed the mode of delivery with the patient after the lower uterine segment measurement was obtained. Both the provider and the patient were informed of the risk category, and further counseling included the following:

• average overall uterine rupture risk, 0.5% to 1%
• if <2.0 mm, uterine rupture risk likely >1%
• if ≥2.5 mm, uterine rupture risk likely <0.5%
• uterine rupture risks (including perinatal asphyxia and death)
• maternal and neonatal complications of cesarean
• estimation of likelihood for successful VBAC.

How did risk-stratified women fare?

In approximately 1,000 cases, the authors reported no symptomatic uterine ruptures. Of particular interest, however, is the rate of women attempting a TOLAC in each category:

• 194 women with high risk
  • 9% underwent a TOLAC
  • 82% had a successful vaginal birth
• 217 women with intermediate risk
  • 42% underwent a TOLAC
  • 78% had a successful vaginal birth
• 1,438 women with low risk
  • 61% underwent a TOLAC
  • 66% had a successful vaginal birth.

Considering cesarean scar defect

Finally, uterine scar defects at CD in those who underwent a TOLAC were 0/3 (0%), 5/21 (25%), and 20/276 (7%) in the high-, intermediate-, and low-risk groups, respectively. Given the observational nature of the study, the authors suggest that uterine scar dehiscence may be predictive of labor dystocia, but it remains unclear if it predicts or is a prerequisite for subsequent uterine rupture if labor occurs.
 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

After having a previous cesarean delivery (CD), women who subsequently become pregnant inevitably face the decision to undergo a repeat CD or attempt a trial of labor after cesarean (TOLAC). Currently in the United States, 83% of women with a prior uterine scar are delivered by repeat CD.¹ According to the Consortium on Safe Labor, more than half of all CD indications are attributed to having a prior uterine scar.¹ Furthermore, only 28% of women attempt a TOLAC, with a successful vaginal birth after cesarean (VBAC) rate of approximately 57%.¹

The reason for the low TOLAC rate is multifactorial, but a primary concern may be the safety risk of a TOLAC as it relates to uterine rupture, a rare but potentially catastrophic complication. In a large, multicenter prospective observational trial of more than 17,800 women attempting a TOLAC, the symptomatic uterine rupture rate was 0.7%.² As such, efforts to identify women at highest risk for uterine rupture and those with characteristics predictive of a successful VBAC have remained ongoing. Jastrow and colleagues have expanded this body of knowledge with their prospective cohort study.

Details of the study

The researchers assessed lower uterine segment thickness via vaginal and abdominal ultrasound at 34 to 38 weeks’ gestation in more than 1,850 women with a previous CD. Women enrolled in the trial were classified into 3 risk categories based on lower uterine segment thickness: high risk (<2.0 mm), intermediate risk (2.0 to 2.4 mm), and low risk (≥2.5 mm). The investigators’ objective was to estimate the occurrence of uterine rupture when this measurement was included in the decision-making process on mode of delivery.

An important aspect of this study involved how the provider discussed the mode of delivery with the patient after the lower uterine segment measurement was obtained. Both the provider and the patient were informed of the risk category, and further counseling included the following:

• average overall uterine rupture risk, 0.5% to 1%
• if <2.0 mm, uterine rupture risk likely >1%
• if ≥2.5 mm, uterine rupture risk likely <0.5%
• uterine rupture risks (including perinatal asphyxia and death)
• maternal and neonatal complications of cesarean
• estimation of likelihood for successful VBAC.

How did risk-stratified women fare?

In approximately 1,000 cases, the authors reported no symptomatic uterine ruptures. Of particular interest, however, is the rate of women attempting a TOLAC in each category:

• 194 women with high risk
  • 9% underwent a TOLAC
  • 82% had a successful vaginal birth
• 217 women with intermediate risk
  • 42% underwent a TOLAC
  • 78% had a successful vaginal birth
• 1,438 women with low risk
  • 61% underwent a TOLAC
  • 66% had a successful vaginal birth.

Considering cesarean scar defect

Finally, uterine scar defects at CD in those who underwent a TOLAC were 0/3 (0%), 5/21 (25%), and 20/276 (7%) in the high-, intermediate-, and low-risk groups, respectively. Given the observational nature of the study, the authors suggest that uterine scar dehiscence may be predictive of labor dystocia, but it remains unclear if it predicts or is a prerequisite for subsequent uterine rupture if labor occurs.
 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

After having a previous cesarean delivery (CD), women who subsequently become pregnant inevitably face the decision to undergo a repeat CD or attempt a trial of labor after cesarean (TOLAC). Currently in the United States, 83% of women with a prior uterine scar are delivered by repeat CD.¹ According to the Consortium on Safe Labor, more than half of all CD indications are attributed to having a prior uterine scar.¹ Furthermore, only 28% of women attempt a TOLAC, with a successful vaginal birth after cesarean (VBAC) rate of approximately 57%.¹

The reason for the low TOLAC rate is multifactorial, but a primary concern may be the safety risk of a TOLAC as it relates to uterine rupture, a rare but potentially catastrophic complication. In a large, multicenter prospective observational trial of more than 17,800 women attempting a TOLAC, the symptomatic uterine rupture rate was 0.7%.² As such, efforts to identify women at highest risk for uterine rupture and those with characteristics predictive of a successful VBAC have remained ongoing. Jastrow and colleagues have expanded this body of knowledge with their prospective cohort study.

Details of the study

The researchers assessed lower uterine segment thickness via vaginal and abdominal ultrasound at 34 to 38 weeks’ gestation in more than 1,850 women with a previous CD. Women enrolled in the trial were classified into 3 risk categories based on lower uterine segment thickness: high risk (<2.0 mm), intermediate risk (2.0 to 2.4 mm), and low risk (≥2.5 mm). The investigators’ objective was to estimate the occurrence of uterine rupture when this measurement was included in the decision-making process on mode of delivery.

An important aspect of this study involved how the provider discussed the mode of delivery with the patient after the lower uterine segment measurement was obtained. Both the provider and the patient were informed of the risk category, and further counseling included the following:

• average overall uterine rupture risk, 0.5% to 1%
• if <2.0 mm, uterine rupture risk likely >1%
• if ≥2.5 mm, uterine rupture risk likely <0.5%
• uterine rupture risks (including perinatal asphyxia and death)
• maternal and neonatal complications of cesarean
• estimation of likelihood for successful VBAC.

How did risk-stratified women fare?

In approximately 1,000 cases, the authors reported no symptomatic uterine ruptures. Of particular interest, however, is the rate of women attempting a TOLAC in each category:

• 194 women with high risk
  • 9% underwent a TOLAC
  • 82% had a successful vaginal birth
• 217 women with intermediate risk
  • 42% underwent a TOLAC
  • 78% had a successful vaginal birth
• 1,438 women with low risk
  • 61% underwent a TOLAC
  • 66% had a successful vaginal birth.

Considering cesarean scar defect

Finally, uterine scar defects at CD in those who underwent a TOLAC were 0/3 (0%), 5/21 (25%), and 20/276 (7%) in the high-, intermediate-, and low-risk groups, respectively. Given the observational nature of the study, the authors suggest that uterine scar dehiscence may be predictive of labor dystocia, but it remains unclear if it predicts or is a prerequisite for subsequent uterine rupture if labor occurs.
 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

One of the most important medical interventions to improve maternal-child health is providing effective contraception to men and women of reproductive age. The 52-mg levonorgestrel-intrauterine device (LNG-IUD; Mirena) is one of the most effective forms of reversible contraception available to women, with a failure rate of 1.1% over 5 years of use.¹ The TCu380A copper-IUD (ParaGard), another highly effective reversible contraceptive, is reported to have failure rates of approximately 1.4% and 2.2%, over 5 and 10 years of use.²

An interesting question is whether—in certain clinical situations—a single IUD can be used for longer than the currently recommended 5 and 10 years for a Mirena IUD and a ParaGard IUD, respectively.

The LNG-IUD containing 52 mg LNG may be effective up to 7 years

The US Food and Drug Administration (FDA) package insert for the Mirena 52-mg LNG-IUD states that the device is “indicated for contraception for up to 5 years. Thereafter if continued contraception is desired, the system should be replaced.”¹ The FDA package insert for the levonorgestrel-releasing intrauterine system, Liletta 52-mg LNG-IUD, states that it is “indicated for prevention of pregnancy up to 3 years.”³ The FDA guidance is based on data submitted to the agency by the manufacturers to support the approval process. Completing large-scale clinical trials that extend past 5 years or more is challenging, because of the cost and the loss of study participants to follow-up. Hence, few clinical trials of contraceptive IUDs continue for more than 5 to 10 years.

Although the FDA-approved indication for Mirena and Liletta is 5 and 3 years, respectively, evidence suggests that the 52-mg LNG-IUD is an effective contraceptive beyond 5 years. In fact, multiple studies report that this IUD is an effective contraceptive for at least 6 or 7 years (TABLE 1).^4–9 Among 895 women using the 52-mg LNG-IUD for 6 to 7 years, only 1 pregnancy was reported in the last year of use. In that case, the IUD was in the cervix and partially expelled from the uterus.⁸ These data indicate that the 52-mg LNG-IUD is likely an effective contraceptive for up to 7 years, with pregnancy rates below 1% in the last year of use.

The TCu380A copper-IUD is effective up to 12 years

The currently available TCu380A copper-IUD (ParaGard) is FDA approved for 10 years.² Studies evaluating the efficacy of this copper-IUD are limited, but those that have been published reported that it is effective for at least 12 years and possibly up to 20 years (TABLE 2).¹⁰⁻¹³

Recently I saw a patient who had a copper-IUD (ParaGard, TCu380A) inserted as a teen after a birth, and had successfully used the same device for 17 years. She presented for removal of the IUD so that she could attempt conception. After removal of the IUD, copper wire was visible on the device. Long-term studies of the TCu220 copper-IUD, which contains less copper than the ParaGard, report pregnancies with the use of the device beyond 10 years.¹² These devices, which are not available in the United States, should not be used past their recommended interval.

Plastic devices without copper or levonorgestrel are effective intrauterine contraceptives

---

In 1962, the plastic, double S-IUD (Lippes loop) was marketed for use in the United States.^1,2 Developed by the New York ObGyn Dr. Jack Lippes, the Lippes loop was thought to prevent pregnancy by inducing a local inflammatory response that disrupts endometrial, tubal, and sperm function.³ No longer marketed, the Lippes loop came in 4 sizes, with size A the smallest and size D the largest. The Lippes loop contains no copper and no progestin, demonstrating that plastic devices are highly effective intrauterine contraceptives. However, the smallest Lippes loop (size A), with less surface area, was associated with a higher pregnancy rate than the largest Lippes loop (size D), at 4.8 versus 1.0 per 100 women-years, respectively.¹ This finding suggests that the surface area of the plastic device may influence contraceptive efficacy.

The shape of the device also may be important. The double S shape of the Lippes loop maximized the area of contact between the device and the endometrium. For plastic devices that contain copper (ParaGard) or LNG (Mirena) the relative contribution of the plastic device and the active agent to contraceptive efficacy is not well characterized.

References

1. Lippes J. Contraception with intrauterine plastic loops. Am J Obstet Gynecol. 1965;93(7):1024–1030.
2. Wright EA, Aisien OA. Comparison of copper T-200 with Lippes loop as a contraceptive device. Int J Gynaecol Obstet. 1989;29(2):173–177.
3. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception. 1987;36(1):37–53.

Patient age is important in deciding to extend use of an IUD

A woman’s age is an important determinant of fecundity. Younger women are at a higher risk of pregnancy while using a contraceptive than older women. Hence, the age of the woman may be an important factor in identifying patients who are the best candidates for extending the time interval before replacing an IUD.

For women who are younger than 35 years and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, most authorities recommend replacing the device at the FDA-recommended time.

For women who are 35 to 45 years of age and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, the woman can be offered the option of extending use of the device for 1 to 2 additional years. The patient should be made aware of the FDA recommendation to exchange the device and proceed to extended use only after being informed that such use is off-label.

For women who are older than 45 years and have completed 10 years of use of the ParaGard IUD, the device will probably remain effective throughout the perimenopause and does not need to be removed until menses cease and the postmenopause begins. For women who are older than 45 years, have completed 5 years of use of the Mirena, and had the Mirena placed to control abnormal uterine bleeding, maintenance of amenorrhea is a sign that the device continues to release sufficient quantities of LNG or that the patient has transitioned into the postmenopause. Use of the device likely can be safely extended in these women.

For women who are using the Mirena IUD to control heavy uterine bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the return of bothersome symptoms between years 4 and 7 may be an indication that insufficient quantities of LNG are being released and the device should be replaced. Alternatively, the increase in symptoms may be due to a change in underlying disease activity.

 

 

Emergency contraception with immediate placement of an IUD

---

For women who need emergency contraception and would like to initiate long-term contraception with an IUD, the copper device is an optimal choice. Recently, a novel use of combined oral levonorgestrel emergency contraception (1.5-mg dose) with immediate placement of a 52-mg LNG-IUD was reported to be an effective alternative to the placement of a copper-IUD for women who need both emergency and long-term contraception.¹

References

1. Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016;93(6):526–532.

ParaGard and Mirena: Two highly effective contraceptives

For women with contraceptive needs and gynecologic issues such as heavy menstrual bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the LNG-IUD may be an optimal choice. For women who desire to have monthly uterine bleeding and for women who prefer to avoid “hormones,” the copper-IUD may be the preferred option.

The IUD is one of the most effective forms of reversible contraception available. Yet IUDs are underutilized in the United States compared with Europe and Asia. Optimizing use of these devices is an important goal for ObGyns. The FDA does recommend that a single LNG-IUD (Mirena) or copper-IUD (ParaGard) not be used beyond 5 and 10 years, respectively. However, in certain clinical situations it may be appropriate to extend device use for a greater length of time.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

One of the most important medical interventions to improve maternal-child health is providing effective contraception to men and women of reproductive age. The 52-mg levonorgestrel-intrauterine device (LNG-IUD; Mirena) is one of the most effective forms of reversible contraception available to women, with a failure rate of 1.1% over 5 years of use.¹ The TCu380A copper-IUD (ParaGard), another highly effective reversible contraceptive, is reported to have failure rates of approximately 1.4% and 2.2%, over 5 and 10 years of use.²

An interesting question is whether—in certain clinical situations—a single IUD can be used for longer than the currently recommended 5 and 10 years for a Mirena IUD and a ParaGard IUD, respectively.

The LNG-IUD containing 52 mg LNG may be effective up to 7 years

The US Food and Drug Administration (FDA) package insert for the Mirena 52-mg LNG-IUD states that the device is “indicated for contraception for up to 5 years. Thereafter if continued contraception is desired, the system should be replaced.”¹ The FDA package insert for the levonorgestrel-releasing intrauterine system, Liletta 52-mg LNG-IUD, states that it is “indicated for prevention of pregnancy up to 3 years.”³ The FDA guidance is based on data submitted to the agency by the manufacturers to support the approval process. Completing large-scale clinical trials that extend past 5 years or more is challenging, because of the cost and the loss of study participants to follow-up. Hence, few clinical trials of contraceptive IUDs continue for more than 5 to 10 years.

Although the FDA-approved indication for Mirena and Liletta is 5 and 3 years, respectively, evidence suggests that the 52-mg LNG-IUD is an effective contraceptive beyond 5 years. In fact, multiple studies report that this IUD is an effective contraceptive for at least 6 or 7 years (TABLE 1).^4–9 Among 895 women using the 52-mg LNG-IUD for 6 to 7 years, only 1 pregnancy was reported in the last year of use. In that case, the IUD was in the cervix and partially expelled from the uterus.⁸ These data indicate that the 52-mg LNG-IUD is likely an effective contraceptive for up to 7 years, with pregnancy rates below 1% in the last year of use.

The TCu380A copper-IUD is effective up to 12 years

The currently available TCu380A copper-IUD (ParaGard) is FDA approved for 10 years.² Studies evaluating the efficacy of this copper-IUD are limited, but those that have been published reported that it is effective for at least 12 years and possibly up to 20 years (TABLE 2).¹⁰⁻¹³

Recently I saw a patient who had a copper-IUD (ParaGard, TCu380A) inserted as a teen after a birth, and had successfully used the same device for 17 years. She presented for removal of the IUD so that she could attempt conception. After removal of the IUD, copper wire was visible on the device. Long-term studies of the TCu220 copper-IUD, which contains less copper than the ParaGard, report pregnancies with the use of the device beyond 10 years.¹² These devices, which are not available in the United States, should not be used past their recommended interval.

Plastic devices without copper or levonorgestrel are effective intrauterine contraceptives

---

In 1962, the plastic, double S-IUD (Lippes loop) was marketed for use in the United States.^1,2 Developed by the New York ObGyn Dr. Jack Lippes, the Lippes loop was thought to prevent pregnancy by inducing a local inflammatory response that disrupts endometrial, tubal, and sperm function.³ No longer marketed, the Lippes loop came in 4 sizes, with size A the smallest and size D the largest. The Lippes loop contains no copper and no progestin, demonstrating that plastic devices are highly effective intrauterine contraceptives. However, the smallest Lippes loop (size A), with less surface area, was associated with a higher pregnancy rate than the largest Lippes loop (size D), at 4.8 versus 1.0 per 100 women-years, respectively.¹ This finding suggests that the surface area of the plastic device may influence contraceptive efficacy.

The shape of the device also may be important. The double S shape of the Lippes loop maximized the area of contact between the device and the endometrium. For plastic devices that contain copper (ParaGard) or LNG (Mirena) the relative contribution of the plastic device and the active agent to contraceptive efficacy is not well characterized.

References

1. Lippes J. Contraception with intrauterine plastic loops. Am J Obstet Gynecol. 1965;93(7):1024–1030.
2. Wright EA, Aisien OA. Comparison of copper T-200 with Lippes loop as a contraceptive device. Int J Gynaecol Obstet. 1989;29(2):173–177.
3. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception. 1987;36(1):37–53.

Patient age is important in deciding to extend use of an IUD

A woman’s age is an important determinant of fecundity. Younger women are at a higher risk of pregnancy while using a contraceptive than older women. Hence, the age of the woman may be an important factor in identifying patients who are the best candidates for extending the time interval before replacing an IUD.

For women who are younger than 35 years and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, most authorities recommend replacing the device at the FDA-recommended time.

For women who are 35 to 45 years of age and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, the woman can be offered the option of extending use of the device for 1 to 2 additional years. The patient should be made aware of the FDA recommendation to exchange the device and proceed to extended use only after being informed that such use is off-label.

For women who are older than 45 years and have completed 10 years of use of the ParaGard IUD, the device will probably remain effective throughout the perimenopause and does not need to be removed until menses cease and the postmenopause begins. For women who are older than 45 years, have completed 5 years of use of the Mirena, and had the Mirena placed to control abnormal uterine bleeding, maintenance of amenorrhea is a sign that the device continues to release sufficient quantities of LNG or that the patient has transitioned into the postmenopause. Use of the device likely can be safely extended in these women.

For women who are using the Mirena IUD to control heavy uterine bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the return of bothersome symptoms between years 4 and 7 may be an indication that insufficient quantities of LNG are being released and the device should be replaced. Alternatively, the increase in symptoms may be due to a change in underlying disease activity.

 

 

Emergency contraception with immediate placement of an IUD

---

For women who need emergency contraception and would like to initiate long-term contraception with an IUD, the copper device is an optimal choice. Recently, a novel use of combined oral levonorgestrel emergency contraception (1.5-mg dose) with immediate placement of a 52-mg LNG-IUD was reported to be an effective alternative to the placement of a copper-IUD for women who need both emergency and long-term contraception.¹

References

1. Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016;93(6):526–532.

ParaGard and Mirena: Two highly effective contraceptives

For women with contraceptive needs and gynecologic issues such as heavy menstrual bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the LNG-IUD may be an optimal choice. For women who desire to have monthly uterine bleeding and for women who prefer to avoid “hormones,” the copper-IUD may be the preferred option.

The IUD is one of the most effective forms of reversible contraception available. Yet IUDs are underutilized in the United States compared with Europe and Asia. Optimizing use of these devices is an important goal for ObGyns. The FDA does recommend that a single LNG-IUD (Mirena) or copper-IUD (ParaGard) not be used beyond 5 and 10 years, respectively. However, in certain clinical situations it may be appropriate to extend device use for a greater length of time.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

One of the most important medical interventions to improve maternal-child health is providing effective contraception to men and women of reproductive age. The 52-mg levonorgestrel-intrauterine device (LNG-IUD; Mirena) is one of the most effective forms of reversible contraception available to women, with a failure rate of 1.1% over 5 years of use.¹ The TCu380A copper-IUD (ParaGard), another highly effective reversible contraceptive, is reported to have failure rates of approximately 1.4% and 2.2%, over 5 and 10 years of use.²

An interesting question is whether—in certain clinical situations—a single IUD can be used for longer than the currently recommended 5 and 10 years for a Mirena IUD and a ParaGard IUD, respectively.

The LNG-IUD containing 52 mg LNG may be effective up to 7 years

The US Food and Drug Administration (FDA) package insert for the Mirena 52-mg LNG-IUD states that the device is “indicated for contraception for up to 5 years. Thereafter if continued contraception is desired, the system should be replaced.”¹ The FDA package insert for the levonorgestrel-releasing intrauterine system, Liletta 52-mg LNG-IUD, states that it is “indicated for prevention of pregnancy up to 3 years.”³ The FDA guidance is based on data submitted to the agency by the manufacturers to support the approval process. Completing large-scale clinical trials that extend past 5 years or more is challenging, because of the cost and the loss of study participants to follow-up. Hence, few clinical trials of contraceptive IUDs continue for more than 5 to 10 years.

Although the FDA-approved indication for Mirena and Liletta is 5 and 3 years, respectively, evidence suggests that the 52-mg LNG-IUD is an effective contraceptive beyond 5 years. In fact, multiple studies report that this IUD is an effective contraceptive for at least 6 or 7 years (TABLE 1).^4–9 Among 895 women using the 52-mg LNG-IUD for 6 to 7 years, only 1 pregnancy was reported in the last year of use. In that case, the IUD was in the cervix and partially expelled from the uterus.⁸ These data indicate that the 52-mg LNG-IUD is likely an effective contraceptive for up to 7 years, with pregnancy rates below 1% in the last year of use.

The TCu380A copper-IUD is effective up to 12 years

The currently available TCu380A copper-IUD (ParaGard) is FDA approved for 10 years.² Studies evaluating the efficacy of this copper-IUD are limited, but those that have been published reported that it is effective for at least 12 years and possibly up to 20 years (TABLE 2).¹⁰⁻¹³

Recently I saw a patient who had a copper-IUD (ParaGard, TCu380A) inserted as a teen after a birth, and had successfully used the same device for 17 years. She presented for removal of the IUD so that she could attempt conception. After removal of the IUD, copper wire was visible on the device. Long-term studies of the TCu220 copper-IUD, which contains less copper than the ParaGard, report pregnancies with the use of the device beyond 10 years.¹² These devices, which are not available in the United States, should not be used past their recommended interval.

Plastic devices without copper or levonorgestrel are effective intrauterine contraceptives

---

In 1962, the plastic, double S-IUD (Lippes loop) was marketed for use in the United States.^1,2 Developed by the New York ObGyn Dr. Jack Lippes, the Lippes loop was thought to prevent pregnancy by inducing a local inflammatory response that disrupts endometrial, tubal, and sperm function.³ No longer marketed, the Lippes loop came in 4 sizes, with size A the smallest and size D the largest. The Lippes loop contains no copper and no progestin, demonstrating that plastic devices are highly effective intrauterine contraceptives. However, the smallest Lippes loop (size A), with less surface area, was associated with a higher pregnancy rate than the largest Lippes loop (size D), at 4.8 versus 1.0 per 100 women-years, respectively.¹ This finding suggests that the surface area of the plastic device may influence contraceptive efficacy.

The shape of the device also may be important. The double S shape of the Lippes loop maximized the area of contact between the device and the endometrium. For plastic devices that contain copper (ParaGard) or LNG (Mirena) the relative contribution of the plastic device and the active agent to contraceptive efficacy is not well characterized.

References

1. Lippes J. Contraception with intrauterine plastic loops. Am J Obstet Gynecol. 1965;93(7):1024–1030.
2. Wright EA, Aisien OA. Comparison of copper T-200 with Lippes loop as a contraceptive device. Int J Gynaecol Obstet. 1989;29(2):173–177.
3. Ortiz ME, Croxatto HB. The mode of action of IUDs. Contraception. 1987;36(1):37–53.

Patient age is important in deciding to extend use of an IUD

A woman’s age is an important determinant of fecundity. Younger women are at a higher risk of pregnancy while using a contraceptive than older women. Hence, the age of the woman may be an important factor in identifying patients who are the best candidates for extending the time interval before replacing an IUD.

For women who are younger than 35 years and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, most authorities recommend replacing the device at the FDA-recommended time.

For women who are 35 to 45 years of age and have completed 5 and 10 years of use of the Mirena and ParaGard, respectively, the woman can be offered the option of extending use of the device for 1 to 2 additional years. The patient should be made aware of the FDA recommendation to exchange the device and proceed to extended use only after being informed that such use is off-label.

For women who are older than 45 years and have completed 10 years of use of the ParaGard IUD, the device will probably remain effective throughout the perimenopause and does not need to be removed until menses cease and the postmenopause begins. For women who are older than 45 years, have completed 5 years of use of the Mirena, and had the Mirena placed to control abnormal uterine bleeding, maintenance of amenorrhea is a sign that the device continues to release sufficient quantities of LNG or that the patient has transitioned into the postmenopause. Use of the device likely can be safely extended in these women.

For women who are using the Mirena IUD to control heavy uterine bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the return of bothersome symptoms between years 4 and 7 may be an indication that insufficient quantities of LNG are being released and the device should be replaced. Alternatively, the increase in symptoms may be due to a change in underlying disease activity.

 

 

Emergency contraception with immediate placement of an IUD

---

For women who need emergency contraception and would like to initiate long-term contraception with an IUD, the copper device is an optimal choice. Recently, a novel use of combined oral levonorgestrel emergency contraception (1.5-mg dose) with immediate placement of a 52-mg LNG-IUD was reported to be an effective alternative to the placement of a copper-IUD for women who need both emergency and long-term contraception.¹

References

1. Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016;93(6):526–532.

ParaGard and Mirena: Two highly effective contraceptives

For women with contraceptive needs and gynecologic issues such as heavy menstrual bleeding, dysmenorrhea, or endometriosis-related pelvic pain, the LNG-IUD may be an optimal choice. For women who desire to have monthly uterine bleeding and for women who prefer to avoid “hormones,” the copper-IUD may be the preferred option.

The IUD is one of the most effective forms of reversible contraception available. Yet IUDs are underutilized in the United States compared with Europe and Asia. Optimizing use of these devices is an important goal for ObGyns. The FDA does recommend that a single LNG-IUD (Mirena) or copper-IUD (ParaGard) not be used beyond 5 and 10 years, respectively. However, in certain clinical situations it may be appropriate to extend device use for a greater length of time.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“STOP USING RECTAL MISOPROSTOL FOR THE TREATMENT OF POSTPARTUM HEMORRHAGE CAUSED BY UTERINE ATONY”Robert L. Barbieri, MD (Editorial; July 2016)

The BEPCOP strategy for uterine atony

I appreciated Dr. Barbieri’s editorial about oxytocics for postpartum uterine atony and have personally noted the poor effectiveness of rectal misoprostol. I was reminded of his previous editorial that recommended administering intravenous (IV) oxytocin to postcesarean delivery patients for about 6 to 8 hours to reduce the risk of postoperative hemorrhage.

At my current hospital we usually use postpartum oxytocin, 30 units in 500 mL of 5% dextrose in water (D5W) for vaginal deliveries, and that infusion typically is administered for only 1 to 2 hours. Cesarean delivery patients receive oxytocin, 20 units in 1,000 mL of Ringer’s lactate, over the first 1 to 2 hours postoperatively. As an OB hospitalist I have been summoned occasionally to the bedside of patients who have uterine atony and hemorrhage, which usually occurs several hours after their oxytocin infusion has finished.

With this in mind I developed a proactive protocol that I call BEPCOP, an acronym for “Barnes’ Excellent Post Cesarean Oxytocin Protocol.” This involves simply running a 500-mL bag of oxytocin (30 units in 500 mL of D5W) at a constant rate of 50 mL/hour, which provides 50 mU/min oxytocin over the first 10 hours postdelivery.

I recommend BEPCOP for every cesarean delivery patient, as well as for any vaginally delivered patients who are at increased risk for atony, such as those with prolonged labor, large babies, polyhydramnios, multifetal gestation, chorioamnio‑nitis, and history of hemorrhage after a previous delivery, and for patients who are Jehovah’s Witnesses. It is important to reduce the rate of the mainline IV bag while the oxytocin is infusing to reduce the risk of fluid overload.

Since starting this routine I have seen a noticeable decrease in postpartum and postcesarean uterine atony.

E. Darryl Barnes, MD
Mechanicsville, Virginia
 

Nondissolving misoprostol is ineffective

There is something about misoprostol that is not mentioned in Dr. Barbieri’s editorial. There are 2 types of misoprostol: the proprietary formulation (Cytotec, Pfizer) and the generic form (probably the one used in most hospitals, and possibly also the one used in the randomized studies alluded to).

The generic form, manufactured overseas, is literally insoluble. In my experience, these undissolved tabletsare expelled intact from the rectum5 hours after insertion and they therefore do nothing. The proprietary brand of misoprostol dissolves instantly in the rectum, and the results are dramatic to say the least.

Helio Zapata, MD
Skokie, Illinois

Bundles of care protocols useful in critical events

We often assume the etiology of the postpartum hemorrhage (PPH) is purely and exclusively uterine atony. A frequent clinical scenario is as follows: A hospital birth is conducted by a trained attendant, in a US learning hospital, on a parturient assessed as being at low risk; the single circulating nurse is busy at the keyboard complying with the data entry requirements; the just-delivered patient is enjoying skin-to-skin contact as recommended; and the new father is obtaining all the appropriate pictorial material when a massive vaginal bleed ensues, diagnosed as due to uterine atony. There is little time to remember the results of the randomized controlled trials condemning the use of misoprostol, or the effectiveness of the individual components of the AMTSL (active management of the third stage of labor). The IV oxytocin at the prescribed dose is running wide open, extra personnel are summoned to help, the first doses of methylergonovine are given, and the misoprostol tablets are stored in the nearby drawer as prescribed by the institution’s protocol.

Currently, a multi-state, multi-institutional initiative spearheaded by the American College of Obstetricians and Gynecologists and known as AIM (Alliance for Innovation in Maternity Care) supports the use of “bundles of care” to standardize obstetric care as recommended by the Joint Commission and the Society for Maternal-Fetal Medicine. One of the “bundles” addresses PPH. It is understood that each institution may adjust the steps in accord with its individual capabilities. Included in the algorithm is the use of rectal misoprostol 800 to 1,000 μg.¹⁻⁵

The International Federation of Gynecology and Obstetrics, in referencing the Blum trial,⁶ states that the results indicated misoprostol was noninferior to oxytocin at controlling bleeding (90% vs 89%) and preventing additional blood loss (31% vs 34%).⁷ Misoprostol’s contraindications and side effects are recognized by all investigators. In the field of obstetrics, changes are slow in permeating into daily practice.⁸ Dr. Barbieri’s recommendation, originating from an influential academic institution, opens the door to continue the dialog on a critical clinical event.

Federico G. Mariona, MD
Dearborn, Michigan

References

1. Shields LE, Wiesner S, Fulton J, Pelletreau B. Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety. Am J Obstet Gynecol. 2015;212(3):272–280.
2. Obstetric hemorrhage checklist. Beaumont Health, Michigan. October 2015.
3. California Maternal Quality Care Collaborative, California Department of Public Health. OB hemorrhage toolkit, Version 2.0. https://www.cmqcc.org/resources-tool-kits/toolkits/ob-hemorrhage-toolkit. Published March 24, 2015. Accessed August 24, 2015.
4. Main EK, Goffman D, Scavone BM, et al; National Partnership for Maternal Safety Council on Patient Safety in Women’s Health Care. Consensus bundle on obstetric hemorrhage. Obstet Gynecol. 2015;126(1):155–162.
5. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 76: postpartum hemorrhage. Obstet Gynecol. 2006;108(4):1039–1047.
6. Blum J, Winikoff B, Raghavan S, et al. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double blind randomised, non-inferiority trial. Lancet. 2010;375(9710):217–223.
7. International Federation of Gynecology and Obstetrics. Treatment of post-partum haemorrhage with misoprostol. FIGO guideline, annotated version. http://www.figo.org/sites/default/files/uploads/project-publications/Miso/PPH%20treatment/Annotated%20versions/Treatment%20of%20PPH%20with%20Misoprostol_Annotated_2012_English.pdf. Published May 2012. Accessed August 24, 2015.
8. Mariona FG, Roura LC. The role of placental alpha macroglobulin-1 amnisure in determining the status of the fetal membranes; its associations with preterm birth. Traditions, traditions. J Matern Fetal Neonatal Med. 2016;29(6):1016–1020.

Rectal misoprostol has merit

It is well established in medicine that IV medications have a rapid onset of action. Therefore, IV uterotonics would be the first choice to control PPH. Most likely they will control the majority of uterine atony.

However, the causes of uterine atony are numerous, and they most commonly include prolonged labor and/or infection. Like any fatigued muscle, there is rebound relaxation. Intravenous uterotonics have a very short half-life and have a maximum total dose. Repeating oxytocin 40 U in a 1,000-mL infusion over 15 minutes carries the risk of water intoxication due to the antidiuretic effect.

Misoprostol 800 to 1,000 mg when used rectally will have a longer effect—up to 4 hours—and fewer side effects. It should be used in combination with other parenteral uterotonics to act in synergistic way. This way the more serious cases of PPH can be reduced or even prevented.

Raymond Michael, MD
Marshall, Minnesota

Dr. Barbieri responds

I deeply appreciate the perspectives provided by Drs. Barnes, Zapata, Mariona, and Michael. The obstetricians and gynecologists who read OBG Management have vast clinical experience, expertise, and exceptional insights. By sharing our knowledge with each other we best advance the care provided to women and their families.

As a hospitalist, Dr. Barnes is privileged to care for women at the highest-risk time of their pregnancy. I think his BEPCOP proactive protocol to reduce the rate of PPH is superb and urge him to publish his experience. I appreciate Dr. Zapata’s insight that misoprostol tablets from different manufacturers have markedly different rates of dissolution. I agree with him that I have seen entire, undissolved misoprostol tablets expelled from the rectum many hours after they were administered for the treatment of PPH. If the tablet does not dissolve, it certainly cannot work. Dr. Mariona’s guidance to adhere to protocol bundles and continuously improve and update the bundles is absolutely critical to advancing health care for pregnant women. Dr. Michael rightly points out that one advantage of misoprostol is that it has a longer half-life than many parenteral uterotonics. However, in my practice I prefer Dr. Barnes’ BEPCOP protocol involving the multi-hour administration of oxytocin to prevent and treat a PPH.

“STOP USING RECTAL MISOPROSTOL FOR THE TREATMENT OF POSTPARTUM HEMORRHAGE CAUSED BY UTERINE ATONY”Robert L. Barbieri, MD (Editorial; July 2016)

The BEPCOP strategy for uterine atony

I appreciated Dr. Barbieri’s editorial about oxytocics for postpartum uterine atony and have personally noted the poor effectiveness of rectal misoprostol. I was reminded of his previous editorial that recommended administering intravenous (IV) oxytocin to postcesarean delivery patients for about 6 to 8 hours to reduce the risk of postoperative hemorrhage.

At my current hospital we usually use postpartum oxytocin, 30 units in 500 mL of 5% dextrose in water (D5W) for vaginal deliveries, and that infusion typically is administered for only 1 to 2 hours. Cesarean delivery patients receive oxytocin, 20 units in 1,000 mL of Ringer’s lactate, over the first 1 to 2 hours postoperatively. As an OB hospitalist I have been summoned occasionally to the bedside of patients who have uterine atony and hemorrhage, which usually occurs several hours after their oxytocin infusion has finished.

With this in mind I developed a proactive protocol that I call BEPCOP, an acronym for “Barnes’ Excellent Post Cesarean Oxytocin Protocol.” This involves simply running a 500-mL bag of oxytocin (30 units in 500 mL of D5W) at a constant rate of 50 mL/hour, which provides 50 mU/min oxytocin over the first 10 hours postdelivery.

I recommend BEPCOP for every cesarean delivery patient, as well as for any vaginally delivered patients who are at increased risk for atony, such as those with prolonged labor, large babies, polyhydramnios, multifetal gestation, chorioamnio‑nitis, and history of hemorrhage after a previous delivery, and for patients who are Jehovah’s Witnesses. It is important to reduce the rate of the mainline IV bag while the oxytocin is infusing to reduce the risk of fluid overload.

Since starting this routine I have seen a noticeable decrease in postpartum and postcesarean uterine atony.

E. Darryl Barnes, MD
Mechanicsville, Virginia
 

Nondissolving misoprostol is ineffective

There is something about misoprostol that is not mentioned in Dr. Barbieri’s editorial. There are 2 types of misoprostol: the proprietary formulation (Cytotec, Pfizer) and the generic form (probably the one used in most hospitals, and possibly also the one used in the randomized studies alluded to).

The generic form, manufactured overseas, is literally insoluble. In my experience, these undissolved tabletsare expelled intact from the rectum5 hours after insertion and they therefore do nothing. The proprietary brand of misoprostol dissolves instantly in the rectum, and the results are dramatic to say the least.

Helio Zapata, MD
Skokie, Illinois

Bundles of care protocols useful in critical events

We often assume the etiology of the postpartum hemorrhage (PPH) is purely and exclusively uterine atony. A frequent clinical scenario is as follows: A hospital birth is conducted by a trained attendant, in a US learning hospital, on a parturient assessed as being at low risk; the single circulating nurse is busy at the keyboard complying with the data entry requirements; the just-delivered patient is enjoying skin-to-skin contact as recommended; and the new father is obtaining all the appropriate pictorial material when a massive vaginal bleed ensues, diagnosed as due to uterine atony. There is little time to remember the results of the randomized controlled trials condemning the use of misoprostol, or the effectiveness of the individual components of the AMTSL (active management of the third stage of labor). The IV oxytocin at the prescribed dose is running wide open, extra personnel are summoned to help, the first doses of methylergonovine are given, and the misoprostol tablets are stored in the nearby drawer as prescribed by the institution’s protocol.

Currently, a multi-state, multi-institutional initiative spearheaded by the American College of Obstetricians and Gynecologists and known as AIM (Alliance for Innovation in Maternity Care) supports the use of “bundles of care” to standardize obstetric care as recommended by the Joint Commission and the Society for Maternal-Fetal Medicine. One of the “bundles” addresses PPH. It is understood that each institution may adjust the steps in accord with its individual capabilities. Included in the algorithm is the use of rectal misoprostol 800 to 1,000 μg.¹⁻⁵

The International Federation of Gynecology and Obstetrics, in referencing the Blum trial,⁶ states that the results indicated misoprostol was noninferior to oxytocin at controlling bleeding (90% vs 89%) and preventing additional blood loss (31% vs 34%).⁷ Misoprostol’s contraindications and side effects are recognized by all investigators. In the field of obstetrics, changes are slow in permeating into daily practice.⁸ Dr. Barbieri’s recommendation, originating from an influential academic institution, opens the door to continue the dialog on a critical clinical event.

Federico G. Mariona, MD
Dearborn, Michigan

References

1. Shields LE, Wiesner S, Fulton J, Pelletreau B. Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety. Am J Obstet Gynecol. 2015;212(3):272–280.
2. Obstetric hemorrhage checklist. Beaumont Health, Michigan. October 2015.
3. California Maternal Quality Care Collaborative, California Department of Public Health. OB hemorrhage toolkit, Version 2.0. https://www.cmqcc.org/resources-tool-kits/toolkits/ob-hemorrhage-toolkit. Published March 24, 2015. Accessed August 24, 2015.
4. Main EK, Goffman D, Scavone BM, et al; National Partnership for Maternal Safety Council on Patient Safety in Women’s Health Care. Consensus bundle on obstetric hemorrhage. Obstet Gynecol. 2015;126(1):155–162.
5. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 76: postpartum hemorrhage. Obstet Gynecol. 2006;108(4):1039–1047.
6. Blum J, Winikoff B, Raghavan S, et al. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double blind randomised, non-inferiority trial. Lancet. 2010;375(9710):217–223.
7. International Federation of Gynecology and Obstetrics. Treatment of post-partum haemorrhage with misoprostol. FIGO guideline, annotated version. http://www.figo.org/sites/default/files/uploads/project-publications/Miso/PPH%20treatment/Annotated%20versions/Treatment%20of%20PPH%20with%20Misoprostol_Annotated_2012_English.pdf. Published May 2012. Accessed August 24, 2015.
8. Mariona FG, Roura LC. The role of placental alpha macroglobulin-1 amnisure in determining the status of the fetal membranes; its associations with preterm birth. Traditions, traditions. J Matern Fetal Neonatal Med. 2016;29(6):1016–1020.

Rectal misoprostol has merit

It is well established in medicine that IV medications have a rapid onset of action. Therefore, IV uterotonics would be the first choice to control PPH. Most likely they will control the majority of uterine atony.

However, the causes of uterine atony are numerous, and they most commonly include prolonged labor and/or infection. Like any fatigued muscle, there is rebound relaxation. Intravenous uterotonics have a very short half-life and have a maximum total dose. Repeating oxytocin 40 U in a 1,000-mL infusion over 15 minutes carries the risk of water intoxication due to the antidiuretic effect.

Misoprostol 800 to 1,000 mg when used rectally will have a longer effect—up to 4 hours—and fewer side effects. It should be used in combination with other parenteral uterotonics to act in synergistic way. This way the more serious cases of PPH can be reduced or even prevented.

Raymond Michael, MD
Marshall, Minnesota

Dr. Barbieri responds

I deeply appreciate the perspectives provided by Drs. Barnes, Zapata, Mariona, and Michael. The obstetricians and gynecologists who read OBG Management have vast clinical experience, expertise, and exceptional insights. By sharing our knowledge with each other we best advance the care provided to women and their families.

As a hospitalist, Dr. Barnes is privileged to care for women at the highest-risk time of their pregnancy. I think his BEPCOP proactive protocol to reduce the rate of PPH is superb and urge him to publish his experience. I appreciate Dr. Zapata’s insight that misoprostol tablets from different manufacturers have markedly different rates of dissolution. I agree with him that I have seen entire, undissolved misoprostol tablets expelled from the rectum many hours after they were administered for the treatment of PPH. If the tablet does not dissolve, it certainly cannot work. Dr. Mariona’s guidance to adhere to protocol bundles and continuously improve and update the bundles is absolutely critical to advancing health care for pregnant women. Dr. Michael rightly points out that one advantage of misoprostol is that it has a longer half-life than many parenteral uterotonics. However, in my practice I prefer Dr. Barnes’ BEPCOP protocol involving the multi-hour administration of oxytocin to prevent and treat a PPH.

“STOP USING RECTAL MISOPROSTOL FOR THE TREATMENT OF POSTPARTUM HEMORRHAGE CAUSED BY UTERINE ATONY”Robert L. Barbieri, MD (Editorial; July 2016)

The BEPCOP strategy for uterine atony

I appreciated Dr. Barbieri’s editorial about oxytocics for postpartum uterine atony and have personally noted the poor effectiveness of rectal misoprostol. I was reminded of his previous editorial that recommended administering intravenous (IV) oxytocin to postcesarean delivery patients for about 6 to 8 hours to reduce the risk of postoperative hemorrhage.

At my current hospital we usually use postpartum oxytocin, 30 units in 500 mL of 5% dextrose in water (D5W) for vaginal deliveries, and that infusion typically is administered for only 1 to 2 hours. Cesarean delivery patients receive oxytocin, 20 units in 1,000 mL of Ringer’s lactate, over the first 1 to 2 hours postoperatively. As an OB hospitalist I have been summoned occasionally to the bedside of patients who have uterine atony and hemorrhage, which usually occurs several hours after their oxytocin infusion has finished.

With this in mind I developed a proactive protocol that I call BEPCOP, an acronym for “Barnes’ Excellent Post Cesarean Oxytocin Protocol.” This involves simply running a 500-mL bag of oxytocin (30 units in 500 mL of D5W) at a constant rate of 50 mL/hour, which provides 50 mU/min oxytocin over the first 10 hours postdelivery.

I recommend BEPCOP for every cesarean delivery patient, as well as for any vaginally delivered patients who are at increased risk for atony, such as those with prolonged labor, large babies, polyhydramnios, multifetal gestation, chorioamnio‑nitis, and history of hemorrhage after a previous delivery, and for patients who are Jehovah’s Witnesses. It is important to reduce the rate of the mainline IV bag while the oxytocin is infusing to reduce the risk of fluid overload.

Since starting this routine I have seen a noticeable decrease in postpartum and postcesarean uterine atony.

E. Darryl Barnes, MD
Mechanicsville, Virginia
 

Nondissolving misoprostol is ineffective

There is something about misoprostol that is not mentioned in Dr. Barbieri’s editorial. There are 2 types of misoprostol: the proprietary formulation (Cytotec, Pfizer) and the generic form (probably the one used in most hospitals, and possibly also the one used in the randomized studies alluded to).

The generic form, manufactured overseas, is literally insoluble. In my experience, these undissolved tabletsare expelled intact from the rectum5 hours after insertion and they therefore do nothing. The proprietary brand of misoprostol dissolves instantly in the rectum, and the results are dramatic to say the least.

Helio Zapata, MD
Skokie, Illinois

Bundles of care protocols useful in critical events

We often assume the etiology of the postpartum hemorrhage (PPH) is purely and exclusively uterine atony. A frequent clinical scenario is as follows: A hospital birth is conducted by a trained attendant, in a US learning hospital, on a parturient assessed as being at low risk; the single circulating nurse is busy at the keyboard complying with the data entry requirements; the just-delivered patient is enjoying skin-to-skin contact as recommended; and the new father is obtaining all the appropriate pictorial material when a massive vaginal bleed ensues, diagnosed as due to uterine atony. There is little time to remember the results of the randomized controlled trials condemning the use of misoprostol, or the effectiveness of the individual components of the AMTSL (active management of the third stage of labor). The IV oxytocin at the prescribed dose is running wide open, extra personnel are summoned to help, the first doses of methylergonovine are given, and the misoprostol tablets are stored in the nearby drawer as prescribed by the institution’s protocol.

Currently, a multi-state, multi-institutional initiative spearheaded by the American College of Obstetricians and Gynecologists and known as AIM (Alliance for Innovation in Maternity Care) supports the use of “bundles of care” to standardize obstetric care as recommended by the Joint Commission and the Society for Maternal-Fetal Medicine. One of the “bundles” addresses PPH. It is understood that each institution may adjust the steps in accord with its individual capabilities. Included in the algorithm is the use of rectal misoprostol 800 to 1,000 μg.¹⁻⁵

The International Federation of Gynecology and Obstetrics, in referencing the Blum trial,⁶ states that the results indicated misoprostol was noninferior to oxytocin at controlling bleeding (90% vs 89%) and preventing additional blood loss (31% vs 34%).⁷ Misoprostol’s contraindications and side effects are recognized by all investigators. In the field of obstetrics, changes are slow in permeating into daily practice.⁸ Dr. Barbieri’s recommendation, originating from an influential academic institution, opens the door to continue the dialog on a critical clinical event.

Federico G. Mariona, MD
Dearborn, Michigan

References

1. Shields LE, Wiesner S, Fulton J, Pelletreau B. Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety. Am J Obstet Gynecol. 2015;212(3):272–280.
2. Obstetric hemorrhage checklist. Beaumont Health, Michigan. October 2015.
3. California Maternal Quality Care Collaborative, California Department of Public Health. OB hemorrhage toolkit, Version 2.0. https://www.cmqcc.org/resources-tool-kits/toolkits/ob-hemorrhage-toolkit. Published March 24, 2015. Accessed August 24, 2015.
4. Main EK, Goffman D, Scavone BM, et al; National Partnership for Maternal Safety Council on Patient Safety in Women’s Health Care. Consensus bundle on obstetric hemorrhage. Obstet Gynecol. 2015;126(1):155–162.
5. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 76: postpartum hemorrhage. Obstet Gynecol. 2006;108(4):1039–1047.
6. Blum J, Winikoff B, Raghavan S, et al. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double blind randomised, non-inferiority trial. Lancet. 2010;375(9710):217–223.
7. International Federation of Gynecology and Obstetrics. Treatment of post-partum haemorrhage with misoprostol. FIGO guideline, annotated version. http://www.figo.org/sites/default/files/uploads/project-publications/Miso/PPH%20treatment/Annotated%20versions/Treatment%20of%20PPH%20with%20Misoprostol_Annotated_2012_English.pdf. Published May 2012. Accessed August 24, 2015.
8. Mariona FG, Roura LC. The role of placental alpha macroglobulin-1 amnisure in determining the status of the fetal membranes; its associations with preterm birth. Traditions, traditions. J Matern Fetal Neonatal Med. 2016;29(6):1016–1020.

Rectal misoprostol has merit

It is well established in medicine that IV medications have a rapid onset of action. Therefore, IV uterotonics would be the first choice to control PPH. Most likely they will control the majority of uterine atony.

However, the causes of uterine atony are numerous, and they most commonly include prolonged labor and/or infection. Like any fatigued muscle, there is rebound relaxation. Intravenous uterotonics have a very short half-life and have a maximum total dose. Repeating oxytocin 40 U in a 1,000-mL infusion over 15 minutes carries the risk of water intoxication due to the antidiuretic effect.

Misoprostol 800 to 1,000 mg when used rectally will have a longer effect—up to 4 hours—and fewer side effects. It should be used in combination with other parenteral uterotonics to act in synergistic way. This way the more serious cases of PPH can be reduced or even prevented.

Raymond Michael, MD
Marshall, Minnesota

Dr. Barbieri responds

I deeply appreciate the perspectives provided by Drs. Barnes, Zapata, Mariona, and Michael. The obstetricians and gynecologists who read OBG Management have vast clinical experience, expertise, and exceptional insights. By sharing our knowledge with each other we best advance the care provided to women and their families.

As a hospitalist, Dr. Barnes is privileged to care for women at the highest-risk time of their pregnancy. I think his BEPCOP proactive protocol to reduce the rate of PPH is superb and urge him to publish his experience. I appreciate Dr. Zapata’s insight that misoprostol tablets from different manufacturers have markedly different rates of dissolution. I agree with him that I have seen entire, undissolved misoprostol tablets expelled from the rectum many hours after they were administered for the treatment of PPH. If the tablet does not dissolve, it certainly cannot work. Dr. Mariona’s guidance to adhere to protocol bundles and continuously improve and update the bundles is absolutely critical to advancing health care for pregnant women. Dr. Michael rightly points out that one advantage of misoprostol is that it has a longer half-life than many parenteral uterotonics. However, in my practice I prefer Dr. Barnes’ BEPCOP protocol involving the multi-hour administration of oxytocin to prevent and treat a PPH.

TREATING GRAM-NEGATIVE BACTERIAL INFECTIONS