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Video roundtable–Endometriosis: Expert perspectives on medical and surgical management
Read the article: Endometriosis: Expert perspectives on medical and surgical management
Read the article: Endometriosis: Expert perspectives on medical and surgical management
Read the article: Endometriosis: Expert perspectives on medical and surgical management
How to avoid and manage complications when placing ports and docking
Should immediate cord clamping be performed for preterm infants?
WHAT DOES THIS MEAN FOR PRACTICE?
- Evaluate carefully between which babies require immediate resuscitation and which babies can have cord clamping delayed
- Evaluation requires patience on the part of the OB, neonatologist, and nurse resuscitating team
- Close collaboration among all team members is required
The beginning of the end of the Pap?
EXPERT COMMENTARY
Realistic prospective performance data are needed to quantify the additional benefit of the cytology component of cotesting on top of what is already known to be highly sensitive molecular HPV testing. While the addition of cytology to HPV testing can add performance, it also can add further costs and the potential for unnecessary colposcopies for what are merely cytomorphologic manifestations of an active HPV infection. Frequent invasive procedures such as colposcopy, which can be costly and lead to anxiety and distress in generally young women and the potential for overtreatment of likely regressive lesions, has been defined as a harm of screening by the US Preventive Services Task Force (USPSTF).
Details of the study
In a cohort from Kaiser Permanente Northern California, 1,208,710 women aged 30 years or older were screened with cotesting from 2003 to 2015. Those who cotested HPV negative and cytology negative were offered triennial screening. Positive cotest results were managed according to Kaiser protocol. Women with cytologic abnormalities were referred for colposcopy. Those with HPV positive/cytology negative results or HPV negative/cytology equivocal results underwent accelerated testing at 1 year. A total of 623 cervical cancers were identified and included in the analyses.
Using multiple analyses, Schiffman and colleagues demonstrated the sensitivity advantage of HPV testing. They clearly showed that the cytology component to cotesting performance over many years is very limited for detecting precancers and early curable cancers. For example, prediagnostic HPV testing (76.7%) was more likely to be positive than cytology (59.1%; P<.001 for paired comparison); 82.6% of all prediagnostic cotests were positive by HPV and/or cytology; and only 5.9% of the cotests were positive by cytology alone (HPV negative.)
Primary HPV testing is recommended as a potential screening strategy by an interim guidance group led by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology, and it is the primary cervical cancer screening recommendation of USPSTF draft guidelines.1 There have been reports that reliance on primary HPV testing would encourage cervical cancer mortality; Schiffman and colleagues point out, however, that according to their study data, such reports are overstated.
Despite these data, practically speaking, shifting away from standard cotesting poses numerous challenges for clinicians and laboratories alike; however, these data clearly show the limited value of cytology and, due to the overtreatment of likely regressive cervical intraepithelial neoplasia grade 2, the possible increased risk of preterm birth and its subsequent harm as well.
Study strengths and weaknesses
The authors examined the long-term relative history of HPV testing and cytology prior to cancer diagnosis in a large, prospectively followed US cohort where hundreds of women in this cohort developed cancer. There will not be a validation study of this size and scale in the near future. Further, the authors showed that the relative value of cytology to cotesting is minimal. Multiple subsequent rounds of cotesting after negative results also can be questioned.
One weakness of the study is that the data were collected from only one health care system and therefore may not be representative of all populations. Additionally, cotesting was performed on 2 separately collected specimens, which may have reduced HPV testing performance.
Excessive cervical cancer screening, including frequent cotesting, could have minimal cancer prevention benefits while increasing the harms of screening. These data confirm guidance showing HPV testing alone is an effective cervical cancer screening strategy.
-- Mark H. Einstein, MD, MS
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.
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337.
EXPERT COMMENTARY
Realistic prospective performance data are needed to quantify the additional benefit of the cytology component of cotesting on top of what is already known to be highly sensitive molecular HPV testing. While the addition of cytology to HPV testing can add performance, it also can add further costs and the potential for unnecessary colposcopies for what are merely cytomorphologic manifestations of an active HPV infection. Frequent invasive procedures such as colposcopy, which can be costly and lead to anxiety and distress in generally young women and the potential for overtreatment of likely regressive lesions, has been defined as a harm of screening by the US Preventive Services Task Force (USPSTF).
Details of the study
In a cohort from Kaiser Permanente Northern California, 1,208,710 women aged 30 years or older were screened with cotesting from 2003 to 2015. Those who cotested HPV negative and cytology negative were offered triennial screening. Positive cotest results were managed according to Kaiser protocol. Women with cytologic abnormalities were referred for colposcopy. Those with HPV positive/cytology negative results or HPV negative/cytology equivocal results underwent accelerated testing at 1 year. A total of 623 cervical cancers were identified and included in the analyses.
Using multiple analyses, Schiffman and colleagues demonstrated the sensitivity advantage of HPV testing. They clearly showed that the cytology component to cotesting performance over many years is very limited for detecting precancers and early curable cancers. For example, prediagnostic HPV testing (76.7%) was more likely to be positive than cytology (59.1%; P<.001 for paired comparison); 82.6% of all prediagnostic cotests were positive by HPV and/or cytology; and only 5.9% of the cotests were positive by cytology alone (HPV negative.)
Primary HPV testing is recommended as a potential screening strategy by an interim guidance group led by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology, and it is the primary cervical cancer screening recommendation of USPSTF draft guidelines.1 There have been reports that reliance on primary HPV testing would encourage cervical cancer mortality; Schiffman and colleagues point out, however, that according to their study data, such reports are overstated.
Despite these data, practically speaking, shifting away from standard cotesting poses numerous challenges for clinicians and laboratories alike; however, these data clearly show the limited value of cytology and, due to the overtreatment of likely regressive cervical intraepithelial neoplasia grade 2, the possible increased risk of preterm birth and its subsequent harm as well.
Study strengths and weaknesses
The authors examined the long-term relative history of HPV testing and cytology prior to cancer diagnosis in a large, prospectively followed US cohort where hundreds of women in this cohort developed cancer. There will not be a validation study of this size and scale in the near future. Further, the authors showed that the relative value of cytology to cotesting is minimal. Multiple subsequent rounds of cotesting after negative results also can be questioned.
One weakness of the study is that the data were collected from only one health care system and therefore may not be representative of all populations. Additionally, cotesting was performed on 2 separately collected specimens, which may have reduced HPV testing performance.
Excessive cervical cancer screening, including frequent cotesting, could have minimal cancer prevention benefits while increasing the harms of screening. These data confirm guidance showing HPV testing alone is an effective cervical cancer screening strategy.
-- Mark H. Einstein, MD, MS
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
Realistic prospective performance data are needed to quantify the additional benefit of the cytology component of cotesting on top of what is already known to be highly sensitive molecular HPV testing. While the addition of cytology to HPV testing can add performance, it also can add further costs and the potential for unnecessary colposcopies for what are merely cytomorphologic manifestations of an active HPV infection. Frequent invasive procedures such as colposcopy, which can be costly and lead to anxiety and distress in generally young women and the potential for overtreatment of likely regressive lesions, has been defined as a harm of screening by the US Preventive Services Task Force (USPSTF).
Details of the study
In a cohort from Kaiser Permanente Northern California, 1,208,710 women aged 30 years or older were screened with cotesting from 2003 to 2015. Those who cotested HPV negative and cytology negative were offered triennial screening. Positive cotest results were managed according to Kaiser protocol. Women with cytologic abnormalities were referred for colposcopy. Those with HPV positive/cytology negative results or HPV negative/cytology equivocal results underwent accelerated testing at 1 year. A total of 623 cervical cancers were identified and included in the analyses.
Using multiple analyses, Schiffman and colleagues demonstrated the sensitivity advantage of HPV testing. They clearly showed that the cytology component to cotesting performance over many years is very limited for detecting precancers and early curable cancers. For example, prediagnostic HPV testing (76.7%) was more likely to be positive than cytology (59.1%; P<.001 for paired comparison); 82.6% of all prediagnostic cotests were positive by HPV and/or cytology; and only 5.9% of the cotests were positive by cytology alone (HPV negative.)
Primary HPV testing is recommended as a potential screening strategy by an interim guidance group led by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology, and it is the primary cervical cancer screening recommendation of USPSTF draft guidelines.1 There have been reports that reliance on primary HPV testing would encourage cervical cancer mortality; Schiffman and colleagues point out, however, that according to their study data, such reports are overstated.
Despite these data, practically speaking, shifting away from standard cotesting poses numerous challenges for clinicians and laboratories alike; however, these data clearly show the limited value of cytology and, due to the overtreatment of likely regressive cervical intraepithelial neoplasia grade 2, the possible increased risk of preterm birth and its subsequent harm as well.
Study strengths and weaknesses
The authors examined the long-term relative history of HPV testing and cytology prior to cancer diagnosis in a large, prospectively followed US cohort where hundreds of women in this cohort developed cancer. There will not be a validation study of this size and scale in the near future. Further, the authors showed that the relative value of cytology to cotesting is minimal. Multiple subsequent rounds of cotesting after negative results also can be questioned.
One weakness of the study is that the data were collected from only one health care system and therefore may not be representative of all populations. Additionally, cotesting was performed on 2 separately collected specimens, which may have reduced HPV testing performance.
Excessive cervical cancer screening, including frequent cotesting, could have minimal cancer prevention benefits while increasing the harms of screening. These data confirm guidance showing HPV testing alone is an effective cervical cancer screening strategy.
-- Mark H. Einstein, MD, MS
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.
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337.
- Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337.
Does hormonal contraception increase the risk of breast cancer?
Hormonal contraception (HC) has long been utilized safely in this country for a variety of indications, including pregnancy prevention, timing pregnancy appropriately, management of symptoms (dysmenorrhea, irregular menstrual cycles, heavy menstrual bleeding), and to prevent serious diseases (such as ovarian cancer, uterine cancer, osteoporosis in women with premature menopause). Like most prescription medications, there are potential adverse effects. With HC, side effects such as venous thromboembolism, a slight increase in liver cancer, and a possible increase in breast cancer risk have long been recognized.
Danish study compared HC use with breast cancer risk
In the December 7, 2017, issue of New England Journal of Medicine,1 investigators in Denmark published a study of women using HC (oral, transdermal, intravaginal routes, and levonorgestrel intrauterine device [LNG-IUD]) and breast cancer risk compared with women who did not use HC. This retrospective observational country-wide study was very large (1.8 million women followed over an average of 10.9 years), which allowed for the detection of even small changes in breast cancer risk.
Putting results in perspective
It is important to point out that this is an observational study, and small effect sizes (1 in 7,600) should be interpreted with caution. Observational studies can introduce many different types of bias (prescribing bias, confounding bias, etc). Of note, while the LNG-IUD was associated with a small increased risk of breast cancer (relative risk [RR], 1.21; 95% confidence interval [CI], 1.11-1.33]), the higher dose continuous progestin administration (medroxyprogesterone) was not (RR, 0.95; 95% CI, 0.40-2.29).1
Nonetheless, providing patients with a balanced summary of this new study along with other published and reliable information about HC that conveys both benefits and risks is important to assure that each woman makes a decision regarding HC that achieves her health and life goals. See "Counseling talking points" below.
Bottom line
This recent study demonstrated that in Denmark, a woman's risk of developing breast cancer is very slightly elevated on HC1:
- 1 in 7,690 users overall
- 1 in 50,000 women older than age 35 years.
By comparison, the risk of maternal mortality in the United States is 1 in 3,788.2 A substantial reduction in HC use would likely increase unintended and mistimed pregnancies with a potential substantial negative impact on quality of life and personal/societal cost.
The best available data indicate that a woman's risk of developing any cancer is slightly less on HC than not on HC, even with this incremental breast cancer increase.3,4
Breast cancer risk relative to benefits of pregnancy prevention
There was a very slight increase in breast cancer in women using HC in the Danish study.1
Risk of breast cancer
- Overall, the number needed to harm (NNH) was approximately 1 in 7,690, which equates to 13 incremental breast cancers for every 100,000 women using HC (0.013%).
- Breast cancer risk was not evenly distributed across the different age groups. In women younger than 35 years, the risk was 1 extra case for every 50,000 women using HC (0.002%).
Risk of pregnancy prevention failure: Maternal mortality
- By comparison, the rate of maternal mortality is considerably higher than either of these risks in the United States. Specifically, the most recently available rate of maternal mortality (2015) in the United States was 26.4 for every 100,000 women, essentially double that of developing breast cancer on HC.2
-- Most women who develop breast cancer while on HC will survive their cancer long-term.5 And most would agree that while neither is desirable, death is a worse outcome than the development of breast cancer.
Risk of pregnancy prevention failure other than maternal mortality
- Other than the copper IUD and sterilization methods, all other nonhormonal contraceptive methods are by far inferior in terms of the ability to prevent unintended pregnancy.
- Unintended pregnancy has substantial health, social, and economic consequences to women and infants, and contraception use is a well-accepted proximate determinant of unintended pregnancy.6
- Unintended pregnancy is a serious maternal-child health problem with potentially long-term burdens not only for women and families7-10 but also for society.11-13
- Unintended pregnancies generate an estimated $21 billion direct and indirect costs for the US health care system per year,14 and approximately 42% of these pregnancies end in abortion.15
HC cancer risk and HC cancer prevention
- HC use increases risk of breast and liver cancer but reduces risk of ovarian, endometrial, and colorectal cancer; the net effect is a modest reduction in total cancer.3,4
- In addition, there appears to be additional cervical cancer prevention benefit from IUD use.16
- In a recent meta-analysis, IUDs (including LNG-IUD) have been associated with a 33% reduction in cervical cancer.16
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.
- Mørch, LS, Skovlund CW, Hannaford PC, et al. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228-2239.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775-1812.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193-200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276-2277.
- American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta, Georgia: American Cancer Society, Inc; 2015.
- Sonfield A. What the Agency for Healthcare Research and Quality forgets to tell Americans about how to protect their sexual and reproductive health. Womens Health Issues. 2015;25(1):1-2.
- Brown SS, Eisenberg L. The best intentions: Unintended pregnancy and the wellbeing of children and families. Washington, DC: National Academy Press; 1995:50-90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281-286.
- Logan C, Holcombe E, Manlove J, Ryan S. The consequences of unintended childbearing. The National Campaign to Prevent Teen Pregnancy and Child Trends. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf. Published May 2007. Accessed January 11, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126-127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161.
- Sonfield A, Kost K. Public costs from unintended pregnancy and the role of public insurance program in paying for pregnancy and infant care: Estimates for 2008. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP.pdf. Published October 2013. Accessed January 15, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6-15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: National and state estimates for 2010. Guttmacher Institute; 2015. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Accessed January 29, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843-852.
- Cortessis VK, Barrett M, Brown Wade N, et al. Intrauterine device use and cervical cancer risk: A systematic review and meta-analysis. Obstet Gynecol. 2017;130(6):1226-1236.
Hormonal contraception (HC) has long been utilized safely in this country for a variety of indications, including pregnancy prevention, timing pregnancy appropriately, management of symptoms (dysmenorrhea, irregular menstrual cycles, heavy menstrual bleeding), and to prevent serious diseases (such as ovarian cancer, uterine cancer, osteoporosis in women with premature menopause). Like most prescription medications, there are potential adverse effects. With HC, side effects such as venous thromboembolism, a slight increase in liver cancer, and a possible increase in breast cancer risk have long been recognized.
Danish study compared HC use with breast cancer risk
In the December 7, 2017, issue of New England Journal of Medicine,1 investigators in Denmark published a study of women using HC (oral, transdermal, intravaginal routes, and levonorgestrel intrauterine device [LNG-IUD]) and breast cancer risk compared with women who did not use HC. This retrospective observational country-wide study was very large (1.8 million women followed over an average of 10.9 years), which allowed for the detection of even small changes in breast cancer risk.
Putting results in perspective
It is important to point out that this is an observational study, and small effect sizes (1 in 7,600) should be interpreted with caution. Observational studies can introduce many different types of bias (prescribing bias, confounding bias, etc). Of note, while the LNG-IUD was associated with a small increased risk of breast cancer (relative risk [RR], 1.21; 95% confidence interval [CI], 1.11-1.33]), the higher dose continuous progestin administration (medroxyprogesterone) was not (RR, 0.95; 95% CI, 0.40-2.29).1
Nonetheless, providing patients with a balanced summary of this new study along with other published and reliable information about HC that conveys both benefits and risks is important to assure that each woman makes a decision regarding HC that achieves her health and life goals. See "Counseling talking points" below.
Bottom line
This recent study demonstrated that in Denmark, a woman's risk of developing breast cancer is very slightly elevated on HC1:
- 1 in 7,690 users overall
- 1 in 50,000 women older than age 35 years.
By comparison, the risk of maternal mortality in the United States is 1 in 3,788.2 A substantial reduction in HC use would likely increase unintended and mistimed pregnancies with a potential substantial negative impact on quality of life and personal/societal cost.
The best available data indicate that a woman's risk of developing any cancer is slightly less on HC than not on HC, even with this incremental breast cancer increase.3,4
Breast cancer risk relative to benefits of pregnancy prevention
There was a very slight increase in breast cancer in women using HC in the Danish study.1
Risk of breast cancer
- Overall, the number needed to harm (NNH) was approximately 1 in 7,690, which equates to 13 incremental breast cancers for every 100,000 women using HC (0.013%).
- Breast cancer risk was not evenly distributed across the different age groups. In women younger than 35 years, the risk was 1 extra case for every 50,000 women using HC (0.002%).
Risk of pregnancy prevention failure: Maternal mortality
- By comparison, the rate of maternal mortality is considerably higher than either of these risks in the United States. Specifically, the most recently available rate of maternal mortality (2015) in the United States was 26.4 for every 100,000 women, essentially double that of developing breast cancer on HC.2
-- Most women who develop breast cancer while on HC will survive their cancer long-term.5 And most would agree that while neither is desirable, death is a worse outcome than the development of breast cancer.
Risk of pregnancy prevention failure other than maternal mortality
- Other than the copper IUD and sterilization methods, all other nonhormonal contraceptive methods are by far inferior in terms of the ability to prevent unintended pregnancy.
- Unintended pregnancy has substantial health, social, and economic consequences to women and infants, and contraception use is a well-accepted proximate determinant of unintended pregnancy.6
- Unintended pregnancy is a serious maternal-child health problem with potentially long-term burdens not only for women and families7-10 but also for society.11-13
- Unintended pregnancies generate an estimated $21 billion direct and indirect costs for the US health care system per year,14 and approximately 42% of these pregnancies end in abortion.15
HC cancer risk and HC cancer prevention
- HC use increases risk of breast and liver cancer but reduces risk of ovarian, endometrial, and colorectal cancer; the net effect is a modest reduction in total cancer.3,4
- In addition, there appears to be additional cervical cancer prevention benefit from IUD use.16
- In a recent meta-analysis, IUDs (including LNG-IUD) have been associated with a 33% reduction in cervical cancer.16
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.
Hormonal contraception (HC) has long been utilized safely in this country for a variety of indications, including pregnancy prevention, timing pregnancy appropriately, management of symptoms (dysmenorrhea, irregular menstrual cycles, heavy menstrual bleeding), and to prevent serious diseases (such as ovarian cancer, uterine cancer, osteoporosis in women with premature menopause). Like most prescription medications, there are potential adverse effects. With HC, side effects such as venous thromboembolism, a slight increase in liver cancer, and a possible increase in breast cancer risk have long been recognized.
Danish study compared HC use with breast cancer risk
In the December 7, 2017, issue of New England Journal of Medicine,1 investigators in Denmark published a study of women using HC (oral, transdermal, intravaginal routes, and levonorgestrel intrauterine device [LNG-IUD]) and breast cancer risk compared with women who did not use HC. This retrospective observational country-wide study was very large (1.8 million women followed over an average of 10.9 years), which allowed for the detection of even small changes in breast cancer risk.
Putting results in perspective
It is important to point out that this is an observational study, and small effect sizes (1 in 7,600) should be interpreted with caution. Observational studies can introduce many different types of bias (prescribing bias, confounding bias, etc). Of note, while the LNG-IUD was associated with a small increased risk of breast cancer (relative risk [RR], 1.21; 95% confidence interval [CI], 1.11-1.33]), the higher dose continuous progestin administration (medroxyprogesterone) was not (RR, 0.95; 95% CI, 0.40-2.29).1
Nonetheless, providing patients with a balanced summary of this new study along with other published and reliable information about HC that conveys both benefits and risks is important to assure that each woman makes a decision regarding HC that achieves her health and life goals. See "Counseling talking points" below.
Bottom line
This recent study demonstrated that in Denmark, a woman's risk of developing breast cancer is very slightly elevated on HC1:
- 1 in 7,690 users overall
- 1 in 50,000 women older than age 35 years.
By comparison, the risk of maternal mortality in the United States is 1 in 3,788.2 A substantial reduction in HC use would likely increase unintended and mistimed pregnancies with a potential substantial negative impact on quality of life and personal/societal cost.
The best available data indicate that a woman's risk of developing any cancer is slightly less on HC than not on HC, even with this incremental breast cancer increase.3,4
Breast cancer risk relative to benefits of pregnancy prevention
There was a very slight increase in breast cancer in women using HC in the Danish study.1
Risk of breast cancer
- Overall, the number needed to harm (NNH) was approximately 1 in 7,690, which equates to 13 incremental breast cancers for every 100,000 women using HC (0.013%).
- Breast cancer risk was not evenly distributed across the different age groups. In women younger than 35 years, the risk was 1 extra case for every 50,000 women using HC (0.002%).
Risk of pregnancy prevention failure: Maternal mortality
- By comparison, the rate of maternal mortality is considerably higher than either of these risks in the United States. Specifically, the most recently available rate of maternal mortality (2015) in the United States was 26.4 for every 100,000 women, essentially double that of developing breast cancer on HC.2
-- Most women who develop breast cancer while on HC will survive their cancer long-term.5 And most would agree that while neither is desirable, death is a worse outcome than the development of breast cancer.
Risk of pregnancy prevention failure other than maternal mortality
- Other than the copper IUD and sterilization methods, all other nonhormonal contraceptive methods are by far inferior in terms of the ability to prevent unintended pregnancy.
- Unintended pregnancy has substantial health, social, and economic consequences to women and infants, and contraception use is a well-accepted proximate determinant of unintended pregnancy.6
- Unintended pregnancy is a serious maternal-child health problem with potentially long-term burdens not only for women and families7-10 but also for society.11-13
- Unintended pregnancies generate an estimated $21 billion direct and indirect costs for the US health care system per year,14 and approximately 42% of these pregnancies end in abortion.15
HC cancer risk and HC cancer prevention
- HC use increases risk of breast and liver cancer but reduces risk of ovarian, endometrial, and colorectal cancer; the net effect is a modest reduction in total cancer.3,4
- In addition, there appears to be additional cervical cancer prevention benefit from IUD use.16
- In a recent meta-analysis, IUDs (including LNG-IUD) have been associated with a 33% reduction in cervical cancer.16
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.
- Mørch, LS, Skovlund CW, Hannaford PC, et al. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228-2239.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775-1812.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193-200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276-2277.
- American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta, Georgia: American Cancer Society, Inc; 2015.
- Sonfield A. What the Agency for Healthcare Research and Quality forgets to tell Americans about how to protect their sexual and reproductive health. Womens Health Issues. 2015;25(1):1-2.
- Brown SS, Eisenberg L. The best intentions: Unintended pregnancy and the wellbeing of children and families. Washington, DC: National Academy Press; 1995:50-90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281-286.
- Logan C, Holcombe E, Manlove J, Ryan S. The consequences of unintended childbearing. The National Campaign to Prevent Teen Pregnancy and Child Trends. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf. Published May 2007. Accessed January 11, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126-127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161.
- Sonfield A, Kost K. Public costs from unintended pregnancy and the role of public insurance program in paying for pregnancy and infant care: Estimates for 2008. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP.pdf. Published October 2013. Accessed January 15, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6-15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: National and state estimates for 2010. Guttmacher Institute; 2015. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Accessed January 29, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843-852.
- Cortessis VK, Barrett M, Brown Wade N, et al. Intrauterine device use and cervical cancer risk: A systematic review and meta-analysis. Obstet Gynecol. 2017;130(6):1226-1236.
- Mørch, LS, Skovlund CW, Hannaford PC, et al. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228-2239.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775-1812.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193-200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276-2277.
- American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta, Georgia: American Cancer Society, Inc; 2015.
- Sonfield A. What the Agency for Healthcare Research and Quality forgets to tell Americans about how to protect their sexual and reproductive health. Womens Health Issues. 2015;25(1):1-2.
- Brown SS, Eisenberg L. The best intentions: Unintended pregnancy and the wellbeing of children and families. Washington, DC: National Academy Press; 1995:50-90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281-286.
- Logan C, Holcombe E, Manlove J, Ryan S. The consequences of unintended childbearing. The National Campaign to Prevent Teen Pregnancy and Child Trends. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf. Published May 2007. Accessed January 11, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126-127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161.
- Sonfield A, Kost K. Public costs from unintended pregnancy and the role of public insurance program in paying for pregnancy and infant care: Estimates for 2008. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP.pdf. Published October 2013. Accessed January 15, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6-15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: National and state estimates for 2010. Guttmacher Institute; 2015. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Accessed January 29, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med. 2016;374(9):843-852.
- Cortessis VK, Barrett M, Brown Wade N, et al. Intrauterine device use and cervical cancer risk: A systematic review and meta-analysis. Obstet Gynecol. 2017;130(6):1226-1236.
Does maternal sleep position affect risk of stillbirth?
WHAT DOES THIS MEAN FOR PRACTICE?
Encourage pregnant patients to not go to sleep in the supine position, especially those who:
- are obese
- have medical complications of pregnancy
- have a history of prior stillbirth
- smoke
- are of advanced maternal age
Is mannitol a good alternative agent for evaluating ureteral patency after gynecologic surgery?
EXPERT COMMENTARY
Although the incidence of lower urinary tract and ureteral injury following gynecologic surgery is low, intraoperative identification of ureteral patency can prevent serious long-term sequelae. Since the indigo carmine shortage in 2014, US surgeons have searched for multiple alternative agents. Intravenous methylene blue is suboptimal due to its systemic adverse effects and the length of time for dye excretion in the urine.
Grimes and colleagues conducted a study to determine if there was any significant difference in surgeon satisfaction among 4 different alternatives to indigo carmine for intraoperative ureteral patency evaluation.
Related article:
Farewell to indigo carmine
Details of the study
The investigators conducted a randomized clinical trial of 130 women undergoing benign gynecologic or pelvic reconstructive surgery. Four different regimens were used for intraoperative ureteral evaluation: 1) oral phenazopyridine 200 mg, 2) intravenous sodium fluorescein 25 mg, 3) mannitol bladder distention, and 4) normal saline bladder distention.
Study outcomes. The primary outcome was surgeon satisfaction based on a 0 to 100 point visual analog scale rating (with 0 indicating strong agreement, 100 indicating disagreement). Secondary outcomes included ease of ureteral jet visualization, time to surgeon confidence of ureteral patency, and occurrence of adverse events over 6 weeks.
Surgeon satisfaction rating. The investigators found statistically significant physician satisfaction with the use of mannitol as a bladder distention medium over oral phenazopyridine, and slightly better satisfaction compared with the use of intravenous sodium fluorescein or normal saline distention. The median (range) visual analog scores for ureteral patency were phenazopyridine, 48 (0–83); sodium fluorescein 20 (0–82); mannitol, 0 (0–44); and normal saline, 23 (3–96) (P<.001).
There was no difference across the 4 groups in the timing to surgeon confidence of ureteral patency, length of cystoscopy (on average, 3 minutes), and development of postoperative urinary tract infections (UTIs).
Most dissatisfaction related to phenazopyridine is the fact that the resulting orange-stained urine can obscure the bladder mucosa.
One significant adverse event was a protocol deviation in which 1 patient received an incorrect dose of IV sodium fluorescein (500 mg) instead of the recommended 25-mg dose.
Related article:
Alternative options for visualizing ureteral patency during intraoperative cystoscopy
Study strengths and weaknesses
The strength of this study is in its randomized design and power. Its major weakness is surgeon bias, since the surgeons could not possibly be blinded to the method used.
The study confirms the problem that phenazopyridine makes the urine so orange that bladder mucosal lesions and de novo hematuria could be difficult to detect. Recommending mannitol as a hypertonic distending medium (as it is used in hysteroscopy procedures), however, may be premature. Prior studies have shown increased postoperative UTIs when 50% and 10% dextrose was used versus normal saline for cystoscopy.1,2 Since the Grimes study protocol did not include postoperative urine collection for cultures, more research on UTIs after mannitol use would be needed before surgeons confidently could use it routinely.
In our practice, surgeons prefer that intravenous sodium fluorescein be administered just prior to cystoscopy and oral phenazopyridine en route to the operating room. I agree that a major disadvantage to phenazopyridine is the heavy orange staining that obscures visualization.
Finally, this study did not account for cost of the various methods; standard normal saline would be cheapest, followed by phenazopyridine.
This study showed that surgeon satisfaction was greatest with the use of mannitol as a distending medium for intraoperative evaluation of ureteral patency compared with oral phenazopyridine, intravenous sodium fluorescein, and normal saline distention. However, time to surgeon confidence of ureteral patency was similar with all 4 methods. More data are needed related to UTIs and the cost of mannitol compared with the other 3 methods.
-- Cheryl B. Iglesia, MD
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.
- Narasimhulu DM, Prabakar C, Tang N, Bral P. 50% dextrose versus normal saline as distention media during cystoscopy for assessment of ureteric patency. Eur J Obstet Gynecol Reprod Biol. 2016;199:38–41.
- Siff LN, Unger CA, Jelovsek JE, Paraiso MF, Ridgeway BM, Barber MD. Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates. Am J Obstet Gynecol. 2016;215(1):74.e1–e6.
EXPERT COMMENTARY
Although the incidence of lower urinary tract and ureteral injury following gynecologic surgery is low, intraoperative identification of ureteral patency can prevent serious long-term sequelae. Since the indigo carmine shortage in 2014, US surgeons have searched for multiple alternative agents. Intravenous methylene blue is suboptimal due to its systemic adverse effects and the length of time for dye excretion in the urine.
Grimes and colleagues conducted a study to determine if there was any significant difference in surgeon satisfaction among 4 different alternatives to indigo carmine for intraoperative ureteral patency evaluation.
Related article:
Farewell to indigo carmine
Details of the study
The investigators conducted a randomized clinical trial of 130 women undergoing benign gynecologic or pelvic reconstructive surgery. Four different regimens were used for intraoperative ureteral evaluation: 1) oral phenazopyridine 200 mg, 2) intravenous sodium fluorescein 25 mg, 3) mannitol bladder distention, and 4) normal saline bladder distention.
Study outcomes. The primary outcome was surgeon satisfaction based on a 0 to 100 point visual analog scale rating (with 0 indicating strong agreement, 100 indicating disagreement). Secondary outcomes included ease of ureteral jet visualization, time to surgeon confidence of ureteral patency, and occurrence of adverse events over 6 weeks.
Surgeon satisfaction rating. The investigators found statistically significant physician satisfaction with the use of mannitol as a bladder distention medium over oral phenazopyridine, and slightly better satisfaction compared with the use of intravenous sodium fluorescein or normal saline distention. The median (range) visual analog scores for ureteral patency were phenazopyridine, 48 (0–83); sodium fluorescein 20 (0–82); mannitol, 0 (0–44); and normal saline, 23 (3–96) (P<.001).
There was no difference across the 4 groups in the timing to surgeon confidence of ureteral patency, length of cystoscopy (on average, 3 minutes), and development of postoperative urinary tract infections (UTIs).
Most dissatisfaction related to phenazopyridine is the fact that the resulting orange-stained urine can obscure the bladder mucosa.
One significant adverse event was a protocol deviation in which 1 patient received an incorrect dose of IV sodium fluorescein (500 mg) instead of the recommended 25-mg dose.
Related article:
Alternative options for visualizing ureteral patency during intraoperative cystoscopy
Study strengths and weaknesses
The strength of this study is in its randomized design and power. Its major weakness is surgeon bias, since the surgeons could not possibly be blinded to the method used.
The study confirms the problem that phenazopyridine makes the urine so orange that bladder mucosal lesions and de novo hematuria could be difficult to detect. Recommending mannitol as a hypertonic distending medium (as it is used in hysteroscopy procedures), however, may be premature. Prior studies have shown increased postoperative UTIs when 50% and 10% dextrose was used versus normal saline for cystoscopy.1,2 Since the Grimes study protocol did not include postoperative urine collection for cultures, more research on UTIs after mannitol use would be needed before surgeons confidently could use it routinely.
In our practice, surgeons prefer that intravenous sodium fluorescein be administered just prior to cystoscopy and oral phenazopyridine en route to the operating room. I agree that a major disadvantage to phenazopyridine is the heavy orange staining that obscures visualization.
Finally, this study did not account for cost of the various methods; standard normal saline would be cheapest, followed by phenazopyridine.
This study showed that surgeon satisfaction was greatest with the use of mannitol as a distending medium for intraoperative evaluation of ureteral patency compared with oral phenazopyridine, intravenous sodium fluorescein, and normal saline distention. However, time to surgeon confidence of ureteral patency was similar with all 4 methods. More data are needed related to UTIs and the cost of mannitol compared with the other 3 methods.
-- Cheryl B. Iglesia, MD
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
Although the incidence of lower urinary tract and ureteral injury following gynecologic surgery is low, intraoperative identification of ureteral patency can prevent serious long-term sequelae. Since the indigo carmine shortage in 2014, US surgeons have searched for multiple alternative agents. Intravenous methylene blue is suboptimal due to its systemic adverse effects and the length of time for dye excretion in the urine.
Grimes and colleagues conducted a study to determine if there was any significant difference in surgeon satisfaction among 4 different alternatives to indigo carmine for intraoperative ureteral patency evaluation.
Related article:
Farewell to indigo carmine
Details of the study
The investigators conducted a randomized clinical trial of 130 women undergoing benign gynecologic or pelvic reconstructive surgery. Four different regimens were used for intraoperative ureteral evaluation: 1) oral phenazopyridine 200 mg, 2) intravenous sodium fluorescein 25 mg, 3) mannitol bladder distention, and 4) normal saline bladder distention.
Study outcomes. The primary outcome was surgeon satisfaction based on a 0 to 100 point visual analog scale rating (with 0 indicating strong agreement, 100 indicating disagreement). Secondary outcomes included ease of ureteral jet visualization, time to surgeon confidence of ureteral patency, and occurrence of adverse events over 6 weeks.
Surgeon satisfaction rating. The investigators found statistically significant physician satisfaction with the use of mannitol as a bladder distention medium over oral phenazopyridine, and slightly better satisfaction compared with the use of intravenous sodium fluorescein or normal saline distention. The median (range) visual analog scores for ureteral patency were phenazopyridine, 48 (0–83); sodium fluorescein 20 (0–82); mannitol, 0 (0–44); and normal saline, 23 (3–96) (P<.001).
There was no difference across the 4 groups in the timing to surgeon confidence of ureteral patency, length of cystoscopy (on average, 3 minutes), and development of postoperative urinary tract infections (UTIs).
Most dissatisfaction related to phenazopyridine is the fact that the resulting orange-stained urine can obscure the bladder mucosa.
One significant adverse event was a protocol deviation in which 1 patient received an incorrect dose of IV sodium fluorescein (500 mg) instead of the recommended 25-mg dose.
Related article:
Alternative options for visualizing ureteral patency during intraoperative cystoscopy
Study strengths and weaknesses
The strength of this study is in its randomized design and power. Its major weakness is surgeon bias, since the surgeons could not possibly be blinded to the method used.
The study confirms the problem that phenazopyridine makes the urine so orange that bladder mucosal lesions and de novo hematuria could be difficult to detect. Recommending mannitol as a hypertonic distending medium (as it is used in hysteroscopy procedures), however, may be premature. Prior studies have shown increased postoperative UTIs when 50% and 10% dextrose was used versus normal saline for cystoscopy.1,2 Since the Grimes study protocol did not include postoperative urine collection for cultures, more research on UTIs after mannitol use would be needed before surgeons confidently could use it routinely.
In our practice, surgeons prefer that intravenous sodium fluorescein be administered just prior to cystoscopy and oral phenazopyridine en route to the operating room. I agree that a major disadvantage to phenazopyridine is the heavy orange staining that obscures visualization.
Finally, this study did not account for cost of the various methods; standard normal saline would be cheapest, followed by phenazopyridine.
This study showed that surgeon satisfaction was greatest with the use of mannitol as a distending medium for intraoperative evaluation of ureteral patency compared with oral phenazopyridine, intravenous sodium fluorescein, and normal saline distention. However, time to surgeon confidence of ureteral patency was similar with all 4 methods. More data are needed related to UTIs and the cost of mannitol compared with the other 3 methods.
-- Cheryl B. Iglesia, MD
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.
- Narasimhulu DM, Prabakar C, Tang N, Bral P. 50% dextrose versus normal saline as distention media during cystoscopy for assessment of ureteric patency. Eur J Obstet Gynecol Reprod Biol. 2016;199:38–41.
- Siff LN, Unger CA, Jelovsek JE, Paraiso MF, Ridgeway BM, Barber MD. Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates. Am J Obstet Gynecol. 2016;215(1):74.e1–e6.
- Narasimhulu DM, Prabakar C, Tang N, Bral P. 50% dextrose versus normal saline as distention media during cystoscopy for assessment of ureteric patency. Eur J Obstet Gynecol Reprod Biol. 2016;199:38–41.
- Siff LN, Unger CA, Jelovsek JE, Paraiso MF, Ridgeway BM, Barber MD. Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates. Am J Obstet Gynecol. 2016;215(1):74.e1–e6.