A 64-year-old woman came into our emergency department (ED) complaining of constipation and worsening rectal pain. In an attempt to promote her overall health, the patient had recently begun experimenting with healthy alternatives to her regular diet. Three days before her visit, she had ceased having stools and was experiencing intermittent abdominal cramping. She self-administered 2 bisacodyl suppositories, 2 sodium biphosphate enemas, one 10-ounce bottle of magnesium citrate, and 15 senna-containing laxative tablets without improvement.

She sought care at an urgent care clinic where she received 2 additional enemas and a trial of manual disimpaction—without results. She was sent home to rest and asked to return the next morning for another trial of disimpaction. When the patient’s efforts to manually disimpact herself at home were unsuccessful, she contacted her primary care physician, who arranged a house call. When his own protracted disimpaction procedure was unsuccessful, he referred her to our ED.

On presentation, the patient had lower abdominal and rectal discomfort. Her vital signs were normal except for a temperature of 38.8° C. Her abdomen was soft and nontender. Inspection of her perianal area revealed erythema and excoriations. On digital rectal exam (which was poorly tolerated because of pain), we noted a moderate amount of soft, clay-like feces in the rectal vault, with overflow liquid stool expulsion.

Computed tomography (CT) imaging of the abdomen was obtained to rule out rectal injury or colonic perforation (FIGURE 1).

FIGURE 1
CT scan reveals a speckled intraluminal mass

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Fecal impaction caused by a proctophytobezoar

CT imaging revealed a proctophytobezoar. On follow-up questioning, the patient recalled consuming approximately 10 ounces of cooked quinoa, a nutritious, gluten-free, high-protein seed, just prior to the onset of her constipation.

Constipation disproportionately affects the elderly and the young.¹ Fecal impaction is a sequelae of constipation. Most commonly defined as hard, compacted feces in the rectum, fecal impaction can also include more proximal impactions due to fecal loading or retention.²

Causes of constipation and fecal impaction are similar and include low intake of dietary fiber, dehydration, immobility, alcohol ingestion, laxative abuse, medication adverse effects, depression, dementia, spinal cord dysfunction, diabetes, metabolic imbalances, and hypothyroidism.^2,3 Insufficient hydration with consumption of a high-fiber food, as in this case, or with a bulk-forming laxative such as psyllium seed can result in fecal impaction.³

The many causes of a bezoar
A bezoar is a mass of poorly digested material that forms within the gastrointestinal tract—usually in the stomach—and less commonly in the small or large intestine.⁴ Trichobezoars (hair), lactobezoars (milk curd), phytobezoars (plant fiber), medication bezoars, and lithobezoars (small stones, pebbles, or gravel) are named after their contents. In keeping with this naming tradition, a gummi bear bezoar⁵ has also been described. Fecal impaction due to phytobezoars primarily composed of seeds has been associated with prickly pears, watermelons, sunflowers, pumpkins, pomegranates,^6,7 and sesame seeds.⁴ Our patient’s experience adds quinoa seeds to this list.

Patients will complain of nausea and rectal urgency
Patients with fecal impaction may complain of nausea, rectal urgency, and rectalgia. A ball-valve effect of the fecal mass may allow paradoxical fecal incontinence and diarrhea.³ Digital rectal exam may demonstrate stool of any consistency, from rock hard pellets to soft clay-like stool.³ Absence of stool in the rectal vault does not rule out fecal impaction, and more proximal impactions may be revealed on plain abdominal radiography as bubbly, speckled masses of stool with associated signs of obstruction, such as colonic dilatation.

Fever, increased leukocyte count, and abdominal tenderness may indicate colonic perforation or ulceration. Signs of generalized peritonitis and free air on abdominal radiography warrant an immediate surgical consult.³

Complications from fecal impaction include bowel obstruction, sigmoid volvulus, and rectal prolapse.² Stercoral ulceration and perforation due to pressure necrosis from a hard, inspissated fecal mass is an uncommon but life-threatening complication requiring resection of the affected colonic segment.⁸

What to look for on the CT. When the diagnosis is unclear or signs of complications are present, an abdominal CT is indicated. Concerning CT findings include ulceration, bowel wall enhancement and thickening (FIGURE 2), discontinuity of the bowel wall, presence of fecal material either protruding through the colonic wall or lying free within the intra-abdominal cavity, and extraluminal air.⁸

FIGURE 2
CT scan shows bowel wall thickening

Treatment begins with a pharmacologic approach

By the time a patient with a fecal impaction gets to your office, it’s likely that he or she will have already tried over-the-counter laxatives, stool softeners, and perhaps an enema.

When such pharmacologic management has failed, you’ll need to perform a manual fragmentation and extraction of the fecal mass. Apply topical 2% lidocaine jelly for analgesia and lubrication, and then gently and progressively dilate the anal sphincter with one and then 2 fingers. A scissoring action will fragment the impaction.³

Once fragmentation and partial expulsion has been achieved, you may want to try a lubricating mineral oil enema, bisacodyl suppository, or rectal lavage. If the impaction extends beyond the reach of the fingers, sigmoidoscopic visualization and lavage are indicated.

Adding water-soluble contrast material (Gastrografin) in 20% to 50% solutions directed by fluoroscopy draws water into the lumen, thus lubricating the fecal mass^3,9 and helping it to pass spontaneously.

Our patient’s case resolved with a trip to the OR
Since conservative and comprehensive management to improve our patient’s condition failed, she was taken to the operating room for a proctosigmoidoscopic disimpaction. A beveled metal proctoscope was used to disimpact the distal-most 10 cm and then a rigid sigmoidoscope was used to clear the colon of quinoa-laden fecal material to a total distance of 18 cm. Bowel walls were ecchymotic, yet viable and without laceration. She made an uneventful recovery and was discharged on hospital Day 3.

CORRESPONDENCE George L. Higgins, III, MD, Maine Medical Center, Department of Emergency Medicine, 47 Bramhall Street, Portland, ME 04102; higgig@mmc.org

A 64-year-old woman came into our emergency department (ED) complaining of constipation and worsening rectal pain. In an attempt to promote her overall health, the patient had recently begun experimenting with healthy alternatives to her regular diet. Three days before her visit, she had ceased having stools and was experiencing intermittent abdominal cramping. She self-administered 2 bisacodyl suppositories, 2 sodium biphosphate enemas, one 10-ounce bottle of magnesium citrate, and 15 senna-containing laxative tablets without improvement.

She sought care at an urgent care clinic where she received 2 additional enemas and a trial of manual disimpaction—without results. She was sent home to rest and asked to return the next morning for another trial of disimpaction. When the patient’s efforts to manually disimpact herself at home were unsuccessful, she contacted her primary care physician, who arranged a house call. When his own protracted disimpaction procedure was unsuccessful, he referred her to our ED.

On presentation, the patient had lower abdominal and rectal discomfort. Her vital signs were normal except for a temperature of 38.8° C. Her abdomen was soft and nontender. Inspection of her perianal area revealed erythema and excoriations. On digital rectal exam (which was poorly tolerated because of pain), we noted a moderate amount of soft, clay-like feces in the rectal vault, with overflow liquid stool expulsion.

Computed tomography (CT) imaging of the abdomen was obtained to rule out rectal injury or colonic perforation (FIGURE 1).

FIGURE 1
CT scan reveals a speckled intraluminal mass

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Fecal impaction caused by a proctophytobezoar

CT imaging revealed a proctophytobezoar. On follow-up questioning, the patient recalled consuming approximately 10 ounces of cooked quinoa, a nutritious, gluten-free, high-protein seed, just prior to the onset of her constipation.

Constipation disproportionately affects the elderly and the young.¹ Fecal impaction is a sequelae of constipation. Most commonly defined as hard, compacted feces in the rectum, fecal impaction can also include more proximal impactions due to fecal loading or retention.²

Causes of constipation and fecal impaction are similar and include low intake of dietary fiber, dehydration, immobility, alcohol ingestion, laxative abuse, medication adverse effects, depression, dementia, spinal cord dysfunction, diabetes, metabolic imbalances, and hypothyroidism.^2,3 Insufficient hydration with consumption of a high-fiber food, as in this case, or with a bulk-forming laxative such as psyllium seed can result in fecal impaction.³

The many causes of a bezoar
A bezoar is a mass of poorly digested material that forms within the gastrointestinal tract—usually in the stomach—and less commonly in the small or large intestine.⁴ Trichobezoars (hair), lactobezoars (milk curd), phytobezoars (plant fiber), medication bezoars, and lithobezoars (small stones, pebbles, or gravel) are named after their contents. In keeping with this naming tradition, a gummi bear bezoar⁵ has also been described. Fecal impaction due to phytobezoars primarily composed of seeds has been associated with prickly pears, watermelons, sunflowers, pumpkins, pomegranates,^6,7 and sesame seeds.⁴ Our patient’s experience adds quinoa seeds to this list.

Patients will complain of nausea and rectal urgency
Patients with fecal impaction may complain of nausea, rectal urgency, and rectalgia. A ball-valve effect of the fecal mass may allow paradoxical fecal incontinence and diarrhea.³ Digital rectal exam may demonstrate stool of any consistency, from rock hard pellets to soft clay-like stool.³ Absence of stool in the rectal vault does not rule out fecal impaction, and more proximal impactions may be revealed on plain abdominal radiography as bubbly, speckled masses of stool with associated signs of obstruction, such as colonic dilatation.

Fever, increased leukocyte count, and abdominal tenderness may indicate colonic perforation or ulceration. Signs of generalized peritonitis and free air on abdominal radiography warrant an immediate surgical consult.³

Complications from fecal impaction include bowel obstruction, sigmoid volvulus, and rectal prolapse.² Stercoral ulceration and perforation due to pressure necrosis from a hard, inspissated fecal mass is an uncommon but life-threatening complication requiring resection of the affected colonic segment.⁸

What to look for on the CT. When the diagnosis is unclear or signs of complications are present, an abdominal CT is indicated. Concerning CT findings include ulceration, bowel wall enhancement and thickening (FIGURE 2), discontinuity of the bowel wall, presence of fecal material either protruding through the colonic wall or lying free within the intra-abdominal cavity, and extraluminal air.⁸

FIGURE 2
CT scan shows bowel wall thickening

Treatment begins with a pharmacologic approach

By the time a patient with a fecal impaction gets to your office, it’s likely that he or she will have already tried over-the-counter laxatives, stool softeners, and perhaps an enema.

When such pharmacologic management has failed, you’ll need to perform a manual fragmentation and extraction of the fecal mass. Apply topical 2% lidocaine jelly for analgesia and lubrication, and then gently and progressively dilate the anal sphincter with one and then 2 fingers. A scissoring action will fragment the impaction.³

Once fragmentation and partial expulsion has been achieved, you may want to try a lubricating mineral oil enema, bisacodyl suppository, or rectal lavage. If the impaction extends beyond the reach of the fingers, sigmoidoscopic visualization and lavage are indicated.

Adding water-soluble contrast material (Gastrografin) in 20% to 50% solutions directed by fluoroscopy draws water into the lumen, thus lubricating the fecal mass^3,9 and helping it to pass spontaneously.

Our patient’s case resolved with a trip to the OR
Since conservative and comprehensive management to improve our patient’s condition failed, she was taken to the operating room for a proctosigmoidoscopic disimpaction. A beveled metal proctoscope was used to disimpact the distal-most 10 cm and then a rigid sigmoidoscope was used to clear the colon of quinoa-laden fecal material to a total distance of 18 cm. Bowel walls were ecchymotic, yet viable and without laceration. She made an uneventful recovery and was discharged on hospital Day 3.

CORRESPONDENCE George L. Higgins, III, MD, Maine Medical Center, Department of Emergency Medicine, 47 Bramhall Street, Portland, ME 04102; higgig@mmc.org

A 64-year-old woman came into our emergency department (ED) complaining of constipation and worsening rectal pain. In an attempt to promote her overall health, the patient had recently begun experimenting with healthy alternatives to her regular diet. Three days before her visit, she had ceased having stools and was experiencing intermittent abdominal cramping. She self-administered 2 bisacodyl suppositories, 2 sodium biphosphate enemas, one 10-ounce bottle of magnesium citrate, and 15 senna-containing laxative tablets without improvement.

She sought care at an urgent care clinic where she received 2 additional enemas and a trial of manual disimpaction—without results. She was sent home to rest and asked to return the next morning for another trial of disimpaction. When the patient’s efforts to manually disimpact herself at home were unsuccessful, she contacted her primary care physician, who arranged a house call. When his own protracted disimpaction procedure was unsuccessful, he referred her to our ED.

On presentation, the patient had lower abdominal and rectal discomfort. Her vital signs were normal except for a temperature of 38.8° C. Her abdomen was soft and nontender. Inspection of her perianal area revealed erythema and excoriations. On digital rectal exam (which was poorly tolerated because of pain), we noted a moderate amount of soft, clay-like feces in the rectal vault, with overflow liquid stool expulsion.

Computed tomography (CT) imaging of the abdomen was obtained to rule out rectal injury or colonic perforation (FIGURE 1).

FIGURE 1
CT scan reveals a speckled intraluminal mass

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Diagnosis: Fecal impaction caused by a proctophytobezoar

CT imaging revealed a proctophytobezoar. On follow-up questioning, the patient recalled consuming approximately 10 ounces of cooked quinoa, a nutritious, gluten-free, high-protein seed, just prior to the onset of her constipation.

Constipation disproportionately affects the elderly and the young.¹ Fecal impaction is a sequelae of constipation. Most commonly defined as hard, compacted feces in the rectum, fecal impaction can also include more proximal impactions due to fecal loading or retention.²

Causes of constipation and fecal impaction are similar and include low intake of dietary fiber, dehydration, immobility, alcohol ingestion, laxative abuse, medication adverse effects, depression, dementia, spinal cord dysfunction, diabetes, metabolic imbalances, and hypothyroidism.^2,3 Insufficient hydration with consumption of a high-fiber food, as in this case, or with a bulk-forming laxative such as psyllium seed can result in fecal impaction.³

The many causes of a bezoar
A bezoar is a mass of poorly digested material that forms within the gastrointestinal tract—usually in the stomach—and less commonly in the small or large intestine.⁴ Trichobezoars (hair), lactobezoars (milk curd), phytobezoars (plant fiber), medication bezoars, and lithobezoars (small stones, pebbles, or gravel) are named after their contents. In keeping with this naming tradition, a gummi bear bezoar⁵ has also been described. Fecal impaction due to phytobezoars primarily composed of seeds has been associated with prickly pears, watermelons, sunflowers, pumpkins, pomegranates,^6,7 and sesame seeds.⁴ Our patient’s experience adds quinoa seeds to this list.

Patients will complain of nausea and rectal urgency
Patients with fecal impaction may complain of nausea, rectal urgency, and rectalgia. A ball-valve effect of the fecal mass may allow paradoxical fecal incontinence and diarrhea.³ Digital rectal exam may demonstrate stool of any consistency, from rock hard pellets to soft clay-like stool.³ Absence of stool in the rectal vault does not rule out fecal impaction, and more proximal impactions may be revealed on plain abdominal radiography as bubbly, speckled masses of stool with associated signs of obstruction, such as colonic dilatation.

Fever, increased leukocyte count, and abdominal tenderness may indicate colonic perforation or ulceration. Signs of generalized peritonitis and free air on abdominal radiography warrant an immediate surgical consult.³

Complications from fecal impaction include bowel obstruction, sigmoid volvulus, and rectal prolapse.² Stercoral ulceration and perforation due to pressure necrosis from a hard, inspissated fecal mass is an uncommon but life-threatening complication requiring resection of the affected colonic segment.⁸

What to look for on the CT. When the diagnosis is unclear or signs of complications are present, an abdominal CT is indicated. Concerning CT findings include ulceration, bowel wall enhancement and thickening (FIGURE 2), discontinuity of the bowel wall, presence of fecal material either protruding through the colonic wall or lying free within the intra-abdominal cavity, and extraluminal air.⁸

FIGURE 2
CT scan shows bowel wall thickening

Treatment begins with a pharmacologic approach

By the time a patient with a fecal impaction gets to your office, it’s likely that he or she will have already tried over-the-counter laxatives, stool softeners, and perhaps an enema.

When such pharmacologic management has failed, you’ll need to perform a manual fragmentation and extraction of the fecal mass. Apply topical 2% lidocaine jelly for analgesia and lubrication, and then gently and progressively dilate the anal sphincter with one and then 2 fingers. A scissoring action will fragment the impaction.³

Once fragmentation and partial expulsion has been achieved, you may want to try a lubricating mineral oil enema, bisacodyl suppository, or rectal lavage. If the impaction extends beyond the reach of the fingers, sigmoidoscopic visualization and lavage are indicated.

Adding water-soluble contrast material (Gastrografin) in 20% to 50% solutions directed by fluoroscopy draws water into the lumen, thus lubricating the fecal mass^3,9 and helping it to pass spontaneously.

Our patient’s case resolved with a trip to the OR
Since conservative and comprehensive management to improve our patient’s condition failed, she was taken to the operating room for a proctosigmoidoscopic disimpaction. A beveled metal proctoscope was used to disimpact the distal-most 10 cm and then a rigid sigmoidoscope was used to clear the colon of quinoa-laden fecal material to a total distance of 18 cm. Bowel walls were ecchymotic, yet viable and without laceration. She made an uneventful recovery and was discharged on hospital Day 3.

CORRESPONDENCE George L. Higgins, III, MD, Maine Medical Center, Department of Emergency Medicine, 47 Bramhall Street, Portland, ME 04102; higgig@mmc.org

Most acute respiratory tract infections (ARTIs) are caused by viruses, do not require antibiotics, and resolve spontaneously.^1,2 And yet, unnecessary prescribing of antibiotics for ARTIs continues—accounting for approximately half of all such prescriptions²—despite its well-known contribution to antimicrobial resistance, a public health threat as declared by the Institute of Medicine, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).^3-5

Even though the CDC has widely disseminated clinical guidelines for ARTI^6-10 and annually publicizes recommendations for ARTI management during “Get Smart About Antibiotics Week,”¹¹ it appears that providers have difficulty implementing the guidelines.^12-14 Granted, antibiotic prescription rates in general have declined somewhat, but the use of broad-spectrum antibiotics (macrolides and fluoroquinolones) and antibiotics for older Americans has increased.¹²

There are several plausible reasons for overprescribing. Patients have expectations for treatment based on prior experience or on a false assumption that their illness is bacterial in origin.¹⁴ Providers may be concerned that certain individuals are at risk of complications if not treated. Patient race, health maintenance organization membership, and insurance status have all been implicated as factors related to antimicrobial overutilization.^12-16 It can be perceived as time consuming to educate patients about the likely viral nature of their illness and the lack of utility and increased risks in taking unneeded antibiotics.¹⁷ Furthermore, attempts at patient and physician education (eg, physician performance feedback) do not always reduce antibiotic overuse.^18-20

We wanted to know the state of ARTI antibiotic use in our practice and whether we could identify goals for improvement through quality interventions. We sought to determine the distribution of ARTI final diagnoses in our practice, the frequency and types of antibiotics prescribed, and factors associated with antibiotic prescribing.

Methods

Setting and subjects
Subjects were adult patients seen at Mayo Clinic Family Medicine offices in Arizona between December 14, 2009, and March 4, 2010. We created a convenience sample from visits scheduled for patients with ARTI symptoms. We encouraged, but did not require, clinic staff to use a standardized data collection form to document symptoms, physical examination findings, diagnostic impressions, and prescription decisions that were then entered into an Excel spreadsheet. At one of our 2 sites, clinicians (attending physicians, nurse practitioners, and resident physicians) used the form at the point of care to enroll a portion of the sample population. A retrospective chart audit (with or without use of the form) was the means of selecting the remainder of the sample at this site and the entire sample at our second site. We obtained informed consent from all patients enrolled with the data collection form. The Mayo Foundation Institutional Review Board approved the project.

We defined an ARTI as a new illness occurring within the previous 3 weeks, associated with cough, sinus pain, nasal congestion or rhinorrhea, sore throat, or fever. We excluded patients who had a longer duration of symptoms, a previous evaluation, or a noninfectious diagnosis. We included ARTI patients with concomitant asthma or chronic obstructive pulmonary disease (COPD).

We enrolled 438 patients. Two hundred thirty-one (53%) consented prospectively to data collection with our standardized form; 207 (47%) were reviewed by retrospective chart audit. The mean age of subjects was 54 years (range 18-94, intraquartile range 45-69). Cough was the most frequent chief complaint (58%).

Statistical analysis
We calculated the frequency of each ARTI final diagnosis and its associated antibiotic prescription rate. We also tested for associations between clinical features and the provision of antibiotics. We hypothesized that our providers would be more likely to prescribe antibiotics for patients of advanced age and in the presence of other risk factors for complications.

Results

We determined patient risks for ARTI complication in the prospective data collection group only. Of the 231 patients, 147 (64%) had at least one risk for complication, the most common being age ≥65 (37%). Other risks were employment as a health care worker (12%), asthma (11%), atherosclerotic heart disease (8%), COPD (7%), and tobacco use (5%).

Final diagnoses for all patients appear in TABLE 1. We allowed clinicians to report more than one diagnosis, resulting in 501 final diagnoses reported for 438 patients (63 received 2 final diagnoses). Sinusitis was diagnosed most frequently (32%). Other common diagnoses were viral upper respiratory infection (URI) and acute bronchitis (29% and 24%, respectively).

Antibiotics most often prescribed. Three hundred four ARTI patients (69%) received antibiotic prescriptions. Macrolides were most commonly prescribed (167/304 [55%]). Two hundred eight ARTI patients (68%) received broad-spectrum antibiotics (macrolides or fluoroquinolones); 96 (32%) received narrow-spectrum agents (penicillin, cephalosporin, sulfa, or tetracycline derivatives). TABLE 2 lists the frequency of antibiotic prescription and the antibiotic class most frequently prescribed for each ARTI diagnosis.

Factors associated with increased prescribing included specific history and physical exam findings (TABLE 3). A major determinant of treatment was duration of illness. Those who received antibiotics had a mean duration of illness of 8.3 days, compared with 7.0 days for those not receiving antibiotic therapy (P = .03).

The rate of antibiotic prescribing varied by provider type (TABLE 4). Four resident physicians (all of whom were investigators) prescribed least often, followed by attending physicians, then nurse practitioners. Investigators were significantly less likely to prescribe antimicrobials than noninvestigators (P<.001). We assessed whether use of our standardized data collection form affected prescribing rates. When we excluded patients whose data were entered with this form, no difference in rates was seen.

We also noted wide ranges of prescribing rates between individual providers. While all providers enrolled patients, numbers ranged from one to 51, with a mean of 18. For those who enrolled ≥10 subjects, prescribing rates ranged from a low of 29% (8/28) for a resident physician investigator to 93% (63/68) for 4 noninvestigator attending physicians.

Factors not associated with increased prescribing. We had hypothesized that specific patient characteristics (age and medical complication) would be associated with provision of antimicrobials. However, there was no correlation between patient age and rate of prescribing. The 304 patients who received an antibiotic had a mean age of 54 years (standard deviation [SD]=18), as did the 134 who did not receive one (mean age, 54; SD=20; P=.95). There was a nonsignificant trend for a reduced rate of prescribing for patients younger than age 30. For patients 18 to 29 years old, the rate was 60% (31/52); for those ≥30 years, it was 71% (273/386; odds ratio [OR]=1.64; 95% confidence interval, 0.90-2.97).

Similarly, presence of medical complication did not significantly affect antibiotic prescribing rates. Patients with any risk factor for complication (age >65, diabetes, atherosclerotic heart disease, heart failure, COPD, asthma, tobacco smoking, or active cancer treatment) had a 62% prescription rate (91/147), which was the same as that of patients without such risks (52/84 [62%]; P=1.0).

TABLE 1
Final diagnoses for 438 patients with ARTI

TABLE 2
Antibiotic use and type prescribed for ARTI varied by diagnosis

TABLE 3
Historical features, exam findings associated with antibiotic prescribing

TABLE 4
Antibiotic prescription rates for ARTI varied by provider type, investigator status

Discussion

Providers in our practice had surprisingly high rates of antibiotic prescribing for ARTIs (69% overall). By comparison, the overall antibiotic use rate for ARTIs in the most recent National Ambulatory Medical Care Survey (NAMCS) analysis (1995-2006) was 58%.¹² The prescribing rate for office settings alone was just 52%. Steinman’s analysis of NAMCS data from 1997-1999 revealed an overall rate of 63%.¹³

Data analyzed from >4200 Medicare enrollees seen for ARTI visits revealed great variation in prescribing rates by office site: 21% to 88%, with a median rate of 54%.²⁰ The rate varied by final diagnoses: sinusitis, 69%; bronchitis, 59%; pharyngitis, 50%; and URI, 26%. A rate of 77% was recently reported in a Veterans Administration office setting.²¹ Those with sinusitis and bronchitis similarly received more prescriptions than those with acute pharyngitis and URI.

In addition to our high overall rate, we also diagnosed patients with sinusitis and bronchitis frequently (32% and 24% of all patients, respectively), perhaps as false justification for prescribing antibiotics (provided for 99% and 91%, respectively). Also noteworthy is that more than one-third of URI patients in our practice received antibiotics.

We had expected, but did not see, differences in prescribing rates between older and younger patients, as well as those with and without risk factors for complications. Our expectations were based on NAMCS data, which have demonstrated increasing use of antibiotics in older patients.²

Treatment for those with bronchitis was surprisingly frequent; 91% received antibiotics. A Cochrane systematic review attributes slight symptom benefit to antibiotic use (improvement in cough by about one day).²² This benefit, however, is rarely seen in patients who have been ill for <1 week. The magnitude of this benefit must be weighed against the cost and adverse effects of antibiotics and the potential for promoting antimicrobial resistance. Most patients’ symptoms are mild and self-limited, and risks may exceed benefits.

Guidelines state, “The widespread use of antibiotics for the treatment of acute bronchitis is not justified and vigorous efforts to curtail their use should be encouraged.”²³ The CDC agrees, noting that “routine antibiotic treatment of uncomplicated acute bronchitis is not recommended, regardless of duration of cough.”¹⁰

As observed in another study,¹⁴ a clinical factor associated with prescribing decisions at our practice was the duration of illness. Patients in our practice had been ill, on average, 8 days before presenting to the office. Over time, our encounters with regular patients may have taught them to wait until their symptoms are prolonged or progressive before seeking evaluation.

We saw large differences in prescribing rates between providers, and hope this means there is room for improvement by addressing reasons for variability. Education about individual prescribing behaviors may motivate those with the highest rates of use to improve.

We noted high rates of broad-spectrum antibiotic use. This is consistent with other research findings of a shift away from narrow-spectrum agents.¹² We did not determine the frequency of allergies to narrow-spectrum agents. Anecdotally, the opinion of some patients was that narrow-spectrum medicines “just don’t work,” given their experience of persistent cold symptoms when using such agents.

Quality-improvement processes such as DMAIC (Define, Measure, Analyze, Improve, Control) or PDSA (Plan, Do, Study, Act) require collection of baseline data so that interventions can be tailored to meet the root causes identified.²⁴ This project determined preintervention practice behaviors and allowed us to create quality metrics that could define our future success.

Study limitations. One obvious reason for the prescribing variability noted above is that those who helped plan and implement the project knew their practice behaviors were being reviewed and had studied the relevant practice guidelines. Whether non-investigator providers were up to date with recommendations and could carefully select appropriate treatment candidates is unclear.

This study was of our practice alone, and findings may not be generalizable to other practices. We encourage physicians to similarly examine their own prescribing habits in order to set practice-improvement goals.

CORRESPONDENCE Michael L. Grover, DO, Department of Family Medicine, Mayo Clinic, 13737 N 92nd Street, Scottsdale, AZ 85260; grover.michael@mayo.edu

Most acute respiratory tract infections (ARTIs) are caused by viruses, do not require antibiotics, and resolve spontaneously.^1,2 And yet, unnecessary prescribing of antibiotics for ARTIs continues—accounting for approximately half of all such prescriptions²—despite its well-known contribution to antimicrobial resistance, a public health threat as declared by the Institute of Medicine, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).^3-5

Even though the CDC has widely disseminated clinical guidelines for ARTI^6-10 and annually publicizes recommendations for ARTI management during “Get Smart About Antibiotics Week,”¹¹ it appears that providers have difficulty implementing the guidelines.^12-14 Granted, antibiotic prescription rates in general have declined somewhat, but the use of broad-spectrum antibiotics (macrolides and fluoroquinolones) and antibiotics for older Americans has increased.¹²

There are several plausible reasons for overprescribing. Patients have expectations for treatment based on prior experience or on a false assumption that their illness is bacterial in origin.¹⁴ Providers may be concerned that certain individuals are at risk of complications if not treated. Patient race, health maintenance organization membership, and insurance status have all been implicated as factors related to antimicrobial overutilization.^12-16 It can be perceived as time consuming to educate patients about the likely viral nature of their illness and the lack of utility and increased risks in taking unneeded antibiotics.¹⁷ Furthermore, attempts at patient and physician education (eg, physician performance feedback) do not always reduce antibiotic overuse.^18-20

We wanted to know the state of ARTI antibiotic use in our practice and whether we could identify goals for improvement through quality interventions. We sought to determine the distribution of ARTI final diagnoses in our practice, the frequency and types of antibiotics prescribed, and factors associated with antibiotic prescribing.

Methods

Setting and subjects
Subjects were adult patients seen at Mayo Clinic Family Medicine offices in Arizona between December 14, 2009, and March 4, 2010. We created a convenience sample from visits scheduled for patients with ARTI symptoms. We encouraged, but did not require, clinic staff to use a standardized data collection form to document symptoms, physical examination findings, diagnostic impressions, and prescription decisions that were then entered into an Excel spreadsheet. At one of our 2 sites, clinicians (attending physicians, nurse practitioners, and resident physicians) used the form at the point of care to enroll a portion of the sample population. A retrospective chart audit (with or without use of the form) was the means of selecting the remainder of the sample at this site and the entire sample at our second site. We obtained informed consent from all patients enrolled with the data collection form. The Mayo Foundation Institutional Review Board approved the project.

We defined an ARTI as a new illness occurring within the previous 3 weeks, associated with cough, sinus pain, nasal congestion or rhinorrhea, sore throat, or fever. We excluded patients who had a longer duration of symptoms, a previous evaluation, or a noninfectious diagnosis. We included ARTI patients with concomitant asthma or chronic obstructive pulmonary disease (COPD).

We enrolled 438 patients. Two hundred thirty-one (53%) consented prospectively to data collection with our standardized form; 207 (47%) were reviewed by retrospective chart audit. The mean age of subjects was 54 years (range 18-94, intraquartile range 45-69). Cough was the most frequent chief complaint (58%).

Statistical analysis
We calculated the frequency of each ARTI final diagnosis and its associated antibiotic prescription rate. We also tested for associations between clinical features and the provision of antibiotics. We hypothesized that our providers would be more likely to prescribe antibiotics for patients of advanced age and in the presence of other risk factors for complications.

Results

We determined patient risks for ARTI complication in the prospective data collection group only. Of the 231 patients, 147 (64%) had at least one risk for complication, the most common being age ≥65 (37%). Other risks were employment as a health care worker (12%), asthma (11%), atherosclerotic heart disease (8%), COPD (7%), and tobacco use (5%).

Final diagnoses for all patients appear in TABLE 1. We allowed clinicians to report more than one diagnosis, resulting in 501 final diagnoses reported for 438 patients (63 received 2 final diagnoses). Sinusitis was diagnosed most frequently (32%). Other common diagnoses were viral upper respiratory infection (URI) and acute bronchitis (29% and 24%, respectively).

Antibiotics most often prescribed. Three hundred four ARTI patients (69%) received antibiotic prescriptions. Macrolides were most commonly prescribed (167/304 [55%]). Two hundred eight ARTI patients (68%) received broad-spectrum antibiotics (macrolides or fluoroquinolones); 96 (32%) received narrow-spectrum agents (penicillin, cephalosporin, sulfa, or tetracycline derivatives). TABLE 2 lists the frequency of antibiotic prescription and the antibiotic class most frequently prescribed for each ARTI diagnosis.

Factors associated with increased prescribing included specific history and physical exam findings (TABLE 3). A major determinant of treatment was duration of illness. Those who received antibiotics had a mean duration of illness of 8.3 days, compared with 7.0 days for those not receiving antibiotic therapy (P = .03).

The rate of antibiotic prescribing varied by provider type (TABLE 4). Four resident physicians (all of whom were investigators) prescribed least often, followed by attending physicians, then nurse practitioners. Investigators were significantly less likely to prescribe antimicrobials than noninvestigators (P<.001). We assessed whether use of our standardized data collection form affected prescribing rates. When we excluded patients whose data were entered with this form, no difference in rates was seen.

We also noted wide ranges of prescribing rates between individual providers. While all providers enrolled patients, numbers ranged from one to 51, with a mean of 18. For those who enrolled ≥10 subjects, prescribing rates ranged from a low of 29% (8/28) for a resident physician investigator to 93% (63/68) for 4 noninvestigator attending physicians.

Factors not associated with increased prescribing. We had hypothesized that specific patient characteristics (age and medical complication) would be associated with provision of antimicrobials. However, there was no correlation between patient age and rate of prescribing. The 304 patients who received an antibiotic had a mean age of 54 years (standard deviation [SD]=18), as did the 134 who did not receive one (mean age, 54; SD=20; P=.95). There was a nonsignificant trend for a reduced rate of prescribing for patients younger than age 30. For patients 18 to 29 years old, the rate was 60% (31/52); for those ≥30 years, it was 71% (273/386; odds ratio [OR]=1.64; 95% confidence interval, 0.90-2.97).

Similarly, presence of medical complication did not significantly affect antibiotic prescribing rates. Patients with any risk factor for complication (age >65, diabetes, atherosclerotic heart disease, heart failure, COPD, asthma, tobacco smoking, or active cancer treatment) had a 62% prescription rate (91/147), which was the same as that of patients without such risks (52/84 [62%]; P=1.0).

TABLE 1
Final diagnoses for 438 patients with ARTI

TABLE 2
Antibiotic use and type prescribed for ARTI varied by diagnosis

TABLE 3
Historical features, exam findings associated with antibiotic prescribing

TABLE 4
Antibiotic prescription rates for ARTI varied by provider type, investigator status

Discussion

Providers in our practice had surprisingly high rates of antibiotic prescribing for ARTIs (69% overall). By comparison, the overall antibiotic use rate for ARTIs in the most recent National Ambulatory Medical Care Survey (NAMCS) analysis (1995-2006) was 58%.¹² The prescribing rate for office settings alone was just 52%. Steinman’s analysis of NAMCS data from 1997-1999 revealed an overall rate of 63%.¹³

Data analyzed from >4200 Medicare enrollees seen for ARTI visits revealed great variation in prescribing rates by office site: 21% to 88%, with a median rate of 54%.²⁰ The rate varied by final diagnoses: sinusitis, 69%; bronchitis, 59%; pharyngitis, 50%; and URI, 26%. A rate of 77% was recently reported in a Veterans Administration office setting.²¹ Those with sinusitis and bronchitis similarly received more prescriptions than those with acute pharyngitis and URI.

In addition to our high overall rate, we also diagnosed patients with sinusitis and bronchitis frequently (32% and 24% of all patients, respectively), perhaps as false justification for prescribing antibiotics (provided for 99% and 91%, respectively). Also noteworthy is that more than one-third of URI patients in our practice received antibiotics.

We had expected, but did not see, differences in prescribing rates between older and younger patients, as well as those with and without risk factors for complications. Our expectations were based on NAMCS data, which have demonstrated increasing use of antibiotics in older patients.²

Treatment for those with bronchitis was surprisingly frequent; 91% received antibiotics. A Cochrane systematic review attributes slight symptom benefit to antibiotic use (improvement in cough by about one day).²² This benefit, however, is rarely seen in patients who have been ill for <1 week. The magnitude of this benefit must be weighed against the cost and adverse effects of antibiotics and the potential for promoting antimicrobial resistance. Most patients’ symptoms are mild and self-limited, and risks may exceed benefits.

Guidelines state, “The widespread use of antibiotics for the treatment of acute bronchitis is not justified and vigorous efforts to curtail their use should be encouraged.”²³ The CDC agrees, noting that “routine antibiotic treatment of uncomplicated acute bronchitis is not recommended, regardless of duration of cough.”¹⁰

As observed in another study,¹⁴ a clinical factor associated with prescribing decisions at our practice was the duration of illness. Patients in our practice had been ill, on average, 8 days before presenting to the office. Over time, our encounters with regular patients may have taught them to wait until their symptoms are prolonged or progressive before seeking evaluation.

We saw large differences in prescribing rates between providers, and hope this means there is room for improvement by addressing reasons for variability. Education about individual prescribing behaviors may motivate those with the highest rates of use to improve.

We noted high rates of broad-spectrum antibiotic use. This is consistent with other research findings of a shift away from narrow-spectrum agents.¹² We did not determine the frequency of allergies to narrow-spectrum agents. Anecdotally, the opinion of some patients was that narrow-spectrum medicines “just don’t work,” given their experience of persistent cold symptoms when using such agents.

Quality-improvement processes such as DMAIC (Define, Measure, Analyze, Improve, Control) or PDSA (Plan, Do, Study, Act) require collection of baseline data so that interventions can be tailored to meet the root causes identified.²⁴ This project determined preintervention practice behaviors and allowed us to create quality metrics that could define our future success.

Study limitations. One obvious reason for the prescribing variability noted above is that those who helped plan and implement the project knew their practice behaviors were being reviewed and had studied the relevant practice guidelines. Whether non-investigator providers were up to date with recommendations and could carefully select appropriate treatment candidates is unclear.

This study was of our practice alone, and findings may not be generalizable to other practices. We encourage physicians to similarly examine their own prescribing habits in order to set practice-improvement goals.

CORRESPONDENCE Michael L. Grover, DO, Department of Family Medicine, Mayo Clinic, 13737 N 92nd Street, Scottsdale, AZ 85260; grover.michael@mayo.edu

Most acute respiratory tract infections (ARTIs) are caused by viruses, do not require antibiotics, and resolve spontaneously.^1,2 And yet, unnecessary prescribing of antibiotics for ARTIs continues—accounting for approximately half of all such prescriptions²—despite its well-known contribution to antimicrobial resistance, a public health threat as declared by the Institute of Medicine, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).^3-5

Even though the CDC has widely disseminated clinical guidelines for ARTI^6-10 and annually publicizes recommendations for ARTI management during “Get Smart About Antibiotics Week,”¹¹ it appears that providers have difficulty implementing the guidelines.^12-14 Granted, antibiotic prescription rates in general have declined somewhat, but the use of broad-spectrum antibiotics (macrolides and fluoroquinolones) and antibiotics for older Americans has increased.¹²

There are several plausible reasons for overprescribing. Patients have expectations for treatment based on prior experience or on a false assumption that their illness is bacterial in origin.¹⁴ Providers may be concerned that certain individuals are at risk of complications if not treated. Patient race, health maintenance organization membership, and insurance status have all been implicated as factors related to antimicrobial overutilization.^12-16 It can be perceived as time consuming to educate patients about the likely viral nature of their illness and the lack of utility and increased risks in taking unneeded antibiotics.¹⁷ Furthermore, attempts at patient and physician education (eg, physician performance feedback) do not always reduce antibiotic overuse.^18-20

We wanted to know the state of ARTI antibiotic use in our practice and whether we could identify goals for improvement through quality interventions. We sought to determine the distribution of ARTI final diagnoses in our practice, the frequency and types of antibiotics prescribed, and factors associated with antibiotic prescribing.

Methods

Setting and subjects
Subjects were adult patients seen at Mayo Clinic Family Medicine offices in Arizona between December 14, 2009, and March 4, 2010. We created a convenience sample from visits scheduled for patients with ARTI symptoms. We encouraged, but did not require, clinic staff to use a standardized data collection form to document symptoms, physical examination findings, diagnostic impressions, and prescription decisions that were then entered into an Excel spreadsheet. At one of our 2 sites, clinicians (attending physicians, nurse practitioners, and resident physicians) used the form at the point of care to enroll a portion of the sample population. A retrospective chart audit (with or without use of the form) was the means of selecting the remainder of the sample at this site and the entire sample at our second site. We obtained informed consent from all patients enrolled with the data collection form. The Mayo Foundation Institutional Review Board approved the project.

We defined an ARTI as a new illness occurring within the previous 3 weeks, associated with cough, sinus pain, nasal congestion or rhinorrhea, sore throat, or fever. We excluded patients who had a longer duration of symptoms, a previous evaluation, or a noninfectious diagnosis. We included ARTI patients with concomitant asthma or chronic obstructive pulmonary disease (COPD).

We enrolled 438 patients. Two hundred thirty-one (53%) consented prospectively to data collection with our standardized form; 207 (47%) were reviewed by retrospective chart audit. The mean age of subjects was 54 years (range 18-94, intraquartile range 45-69). Cough was the most frequent chief complaint (58%).

Statistical analysis
We calculated the frequency of each ARTI final diagnosis and its associated antibiotic prescription rate. We also tested for associations between clinical features and the provision of antibiotics. We hypothesized that our providers would be more likely to prescribe antibiotics for patients of advanced age and in the presence of other risk factors for complications.

Results

We determined patient risks for ARTI complication in the prospective data collection group only. Of the 231 patients, 147 (64%) had at least one risk for complication, the most common being age ≥65 (37%). Other risks were employment as a health care worker (12%), asthma (11%), atherosclerotic heart disease (8%), COPD (7%), and tobacco use (5%).

Final diagnoses for all patients appear in TABLE 1. We allowed clinicians to report more than one diagnosis, resulting in 501 final diagnoses reported for 438 patients (63 received 2 final diagnoses). Sinusitis was diagnosed most frequently (32%). Other common diagnoses were viral upper respiratory infection (URI) and acute bronchitis (29% and 24%, respectively).

Antibiotics most often prescribed. Three hundred four ARTI patients (69%) received antibiotic prescriptions. Macrolides were most commonly prescribed (167/304 [55%]). Two hundred eight ARTI patients (68%) received broad-spectrum antibiotics (macrolides or fluoroquinolones); 96 (32%) received narrow-spectrum agents (penicillin, cephalosporin, sulfa, or tetracycline derivatives). TABLE 2 lists the frequency of antibiotic prescription and the antibiotic class most frequently prescribed for each ARTI diagnosis.

Factors associated with increased prescribing included specific history and physical exam findings (TABLE 3). A major determinant of treatment was duration of illness. Those who received antibiotics had a mean duration of illness of 8.3 days, compared with 7.0 days for those not receiving antibiotic therapy (P = .03).

The rate of antibiotic prescribing varied by provider type (TABLE 4). Four resident physicians (all of whom were investigators) prescribed least often, followed by attending physicians, then nurse practitioners. Investigators were significantly less likely to prescribe antimicrobials than noninvestigators (P<.001). We assessed whether use of our standardized data collection form affected prescribing rates. When we excluded patients whose data were entered with this form, no difference in rates was seen.

We also noted wide ranges of prescribing rates between individual providers. While all providers enrolled patients, numbers ranged from one to 51, with a mean of 18. For those who enrolled ≥10 subjects, prescribing rates ranged from a low of 29% (8/28) for a resident physician investigator to 93% (63/68) for 4 noninvestigator attending physicians.

Factors not associated with increased prescribing. We had hypothesized that specific patient characteristics (age and medical complication) would be associated with provision of antimicrobials. However, there was no correlation between patient age and rate of prescribing. The 304 patients who received an antibiotic had a mean age of 54 years (standard deviation [SD]=18), as did the 134 who did not receive one (mean age, 54; SD=20; P=.95). There was a nonsignificant trend for a reduced rate of prescribing for patients younger than age 30. For patients 18 to 29 years old, the rate was 60% (31/52); for those ≥30 years, it was 71% (273/386; odds ratio [OR]=1.64; 95% confidence interval, 0.90-2.97).

Similarly, presence of medical complication did not significantly affect antibiotic prescribing rates. Patients with any risk factor for complication (age >65, diabetes, atherosclerotic heart disease, heart failure, COPD, asthma, tobacco smoking, or active cancer treatment) had a 62% prescription rate (91/147), which was the same as that of patients without such risks (52/84 [62%]; P=1.0).

TABLE 1
Final diagnoses for 438 patients with ARTI

TABLE 2
Antibiotic use and type prescribed for ARTI varied by diagnosis

TABLE 3
Historical features, exam findings associated with antibiotic prescribing

TABLE 4
Antibiotic prescription rates for ARTI varied by provider type, investigator status

Discussion

Providers in our practice had surprisingly high rates of antibiotic prescribing for ARTIs (69% overall). By comparison, the overall antibiotic use rate for ARTIs in the most recent National Ambulatory Medical Care Survey (NAMCS) analysis (1995-2006) was 58%.¹² The prescribing rate for office settings alone was just 52%. Steinman’s analysis of NAMCS data from 1997-1999 revealed an overall rate of 63%.¹³

Data analyzed from >4200 Medicare enrollees seen for ARTI visits revealed great variation in prescribing rates by office site: 21% to 88%, with a median rate of 54%.²⁰ The rate varied by final diagnoses: sinusitis, 69%; bronchitis, 59%; pharyngitis, 50%; and URI, 26%. A rate of 77% was recently reported in a Veterans Administration office setting.²¹ Those with sinusitis and bronchitis similarly received more prescriptions than those with acute pharyngitis and URI.

In addition to our high overall rate, we also diagnosed patients with sinusitis and bronchitis frequently (32% and 24% of all patients, respectively), perhaps as false justification for prescribing antibiotics (provided for 99% and 91%, respectively). Also noteworthy is that more than one-third of URI patients in our practice received antibiotics.

We had expected, but did not see, differences in prescribing rates between older and younger patients, as well as those with and without risk factors for complications. Our expectations were based on NAMCS data, which have demonstrated increasing use of antibiotics in older patients.²

Treatment for those with bronchitis was surprisingly frequent; 91% received antibiotics. A Cochrane systematic review attributes slight symptom benefit to antibiotic use (improvement in cough by about one day).²² This benefit, however, is rarely seen in patients who have been ill for <1 week. The magnitude of this benefit must be weighed against the cost and adverse effects of antibiotics and the potential for promoting antimicrobial resistance. Most patients’ symptoms are mild and self-limited, and risks may exceed benefits.

Guidelines state, “The widespread use of antibiotics for the treatment of acute bronchitis is not justified and vigorous efforts to curtail their use should be encouraged.”²³ The CDC agrees, noting that “routine antibiotic treatment of uncomplicated acute bronchitis is not recommended, regardless of duration of cough.”¹⁰

As observed in another study,¹⁴ a clinical factor associated with prescribing decisions at our practice was the duration of illness. Patients in our practice had been ill, on average, 8 days before presenting to the office. Over time, our encounters with regular patients may have taught them to wait until their symptoms are prolonged or progressive before seeking evaluation.

We saw large differences in prescribing rates between providers, and hope this means there is room for improvement by addressing reasons for variability. Education about individual prescribing behaviors may motivate those with the highest rates of use to improve.

We noted high rates of broad-spectrum antibiotic use. This is consistent with other research findings of a shift away from narrow-spectrum agents.¹² We did not determine the frequency of allergies to narrow-spectrum agents. Anecdotally, the opinion of some patients was that narrow-spectrum medicines “just don’t work,” given their experience of persistent cold symptoms when using such agents.

Quality-improvement processes such as DMAIC (Define, Measure, Analyze, Improve, Control) or PDSA (Plan, Do, Study, Act) require collection of baseline data so that interventions can be tailored to meet the root causes identified.²⁴ This project determined preintervention practice behaviors and allowed us to create quality metrics that could define our future success.

Study limitations. One obvious reason for the prescribing variability noted above is that those who helped plan and implement the project knew their practice behaviors were being reviewed and had studied the relevant practice guidelines. Whether non-investigator providers were up to date with recommendations and could carefully select appropriate treatment candidates is unclear.

This study was of our practice alone, and findings may not be generalizable to other practices. We encourage physicians to similarly examine their own prescribing habits in order to set practice-improvement goals.

CORRESPONDENCE Michael L. Grover, DO, Department of Family Medicine, Mayo Clinic, 13737 N 92nd Street, Scottsdale, AZ 85260; grover.michael@mayo.edu

Undiluted acid used for vulvar surgery

WIDE LOCAL EXCISION was performed on a 42-year-old woman with vulvar intraepithelial neoplasm, VIN II, with moderate dysplasia. Her ObGyn performed the surgery.

Instead of applying a diluted solution of acetic acid wash to delineate the borders of the dysplastic area, a highly concentrated acetic acid or trichloroacetic acid was used. The patient suffered severe chemical burns of the vulva that took several months to heal. She has permanent scarring of the vulvar area, severe tenderness, discoloration, and atrophy of the vaginal opening, with a band of thick scar tissue at the posterior fourchette. The perineum, extending to the anal area, is scarred, including a 2-mm plaque layer.

PATIENT’S CLAIM Sexual intercourse is extremely painful, and therefore impossible. She suffers discomfort at all times. Additional surgery has been recommended to alleviate her condition.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $600,000 Ohio settlement was reached.

Large baby with cervical spine injury

A WOMAN WAS IN LABOR with her third child. Her first baby was born by cesarean delivery. During the vaginal birth of her second child, shoulder dystocia was encountered; this child weighed 8 lb 4 oz at birth.

Using ultrasonography, the ObGyn determined vaginal birth was appropriate. Shoulder dystocia was encountered and the infant suffered injuries to the cervical spine and right arm. The newborn weighed 9 lb 13 oz.

PATIENT’S CLAIM The baby’s weight was grossly underestimated prior to delivery; ultrasonography was not properly performed or evaluated. The mother’s history, large fundal height, estimated fetal weight, and the mother’s request for a cesarean delivery should have resulted in the performance of a cesarean delivery.

PHYSICIAN’S DEFENSE Shoulder dystocia was not reasonably foreseeable. Injuries to the baby were due to the forces of labor.

VERDICT A confidential Texas settlement was reached.

Suture causes nerve damage

PELVIC PROLAPSE RECONSTRUCTION was performed; surgery included a pubovaginal sling procedure with graft, and repairs of Grade 2 cystocele and Grade 3 rectocele. The gynecologist used transvaginal sutures to attach the mesh to the sacrospinous ligament.

The patient immediately reported pain, tingling, and weakness in her buttocks and legs. The gynecologist diagnosed a hematoma and continued conservative treatment while waiting for the hematoma to resorb.

After 10 days, the patient terminated the gynecologist’s services and left the hospital. She saw a neurologist, who diagnosed proximal sciatic nerve irritation secondary to suturing. When a suture was removed from the sacral spinous ligament plexus, many of the patient’s neurologic symptoms immediately resolved. She still has pain and walks with a noticeable limp using a cane.

PATIENT’S CLAIM The gynecologist failed to determine that a suture was causing nerve damage. Removal of the suture within the first 3 days would have avoided neurologic injury.

PHYSICIAN’S DEFENSE Postsurgical care was proper. A neurologist was consulted, and a sonogram had ruled out deep vein thrombosis.

VERDICT A $1.58 million Illinois verdict was returned.

Colon damage after embolization

UTERINE FIBROID EMBOLIZATION was performed on a 51-year-old woman. The next day, she reported severe abdominal pain and was readmitted. A uterine infection was suspected, and she underwent a hysterectomy. Necrosis of the colon was found; a surgeon removed one-third of the colon and performed a colostomy. She underwent several operations, including rectal-vaginal fistula repair, before the colostomy was corrected.

PATIENT’S CLAIM Misdirected embolization injured an artery supplying the colon. She continues to suffer ongoing fecal urgency and frequency.

PHYSICIAN’S DEFENSE An anomalous connection between the patient’s uterine artery and mesenteric artery was impossible for the physician to have known prior to the embolization procedure.

VERDICT A California defense verdict was returned.

$1.18 M verdict set aside because of Facebook   postings

SEVERAL HOURS AFTER A WOMAN’S LABOR BEGAN, fetal bradycardia developed precipitously. The on-call ObGyn arrived after 10 minutes and ordered an immediate cesarean delivery, which occurred 22 minutes later. The child suffered a catastrophic, irreversible brain injury. He lived for 39 days before life support was removed and he died.

ESTATE’S CLAIM The nurses did not report decelerations to the ObGyn, and they were slow to notify him of the fetal bradycardia. The child would not have been injured if the nursing staff had reacted appropriately.

DEFENDANTS’ DEFENSE Isolated heart-rate decelerations during labor are not troubling. A cord accident occurred, which could not be predicted nor avoided. The ObGyn was called promptly; the emergency cesarean delivery was performed quickly. However, the injury already had occurred and was irreparable.

VERDICT A $1.18 million Kentucky verdict was returned. The hospital sought a mistrial because Facebook postings by a juror proved the case had been discussed and prejudged. The court found in favor of the hospital on its post-trial motion.

Bilateral mastectomy: nipples not spared

A 46-YEAR-OLD WOMAN UNDERWENT prophylactic bilateral mastectomy. A plastic surgeon drew presurgical markings on the day of surgery; the breast surgeon removed the nipples.

PATIENT’S CLAIM All parties had agreed the nipples would be spared. The plastic surgeon drew improper markings and failed to remind the breast surgeon prior to surgery that the nipples would be preserved.

PHYSICIAN’S DEFENSE The breast surgeon was at fault for misinterpreting the markings.

VERDICT The patient reached a pretrial settlement with the breast surgeon. The case proceeded against the plastic surgeon. A Maryland defense verdict was returned for the plastic surgeon.

Signs of intrauterine growth restriction; stillborn child

AT 24 WEEKS’ GESTATION, a 17-year-old woman who smoked reported spotting. An ultrasound demonstrated significant fetal growth restriction. The mother was hospitalized to assess the spotting; no testing was ordered to assess fetal growth. When blood was not found in the birth canal, she was discharged. During the next month, she saw the ObGyn three times; testing indicated that the fetus was at least 3 weeks behind the stage of pregnancy. The ObGyn did not order additional testing nor consult a specialist. At 31 weeks’ gestation, ultrasonography found no fetal heart tones. The stillborn was delivered by cesarean section.

ESTATE’S CLAIM A wrongful death suit was filed by the parents, who also claimed lack of informed consent concerning the risk of stillbirth in the presence of intrauterine growth restriction.

PHYSICIANS’ DEFENSE The mother’s smoking was mentioned at trial as a possible explanation of why fetal development was delayed. The ObGyn denied negligence.

VERDICT A $800,000 Maryland verdict was awarded to the parents.

Three BrCa patients share $72.6 M

THREE MENOPAUSAL WOMEN took Premarin (conjugated estrogens) plus Provera (medroxyprogesterone), and/or Prempro (conjugated estrogens/medroxyprogesterone acetate). Each discontinued hormone therapy after being diagnosed with hormone-positive breast cancer.

PATIENTS’ CLAIM The only source of hormonal stimulation for their cancer was the use of estrogen plus progestin.

DEFENDANTS’ DEFENSE Science is currently unable to determine precisely what causes breast cancer. Each plaintiff had risk factors.

VERDICT The three cases were consolidated to a reverse-bifurcated trial, with causation and damages assessed first. The Pennsylvania jury found the Wyeth Pharmaceutical products to be factual causes of the patients’ cancer, and awarded a total of $72.6 million in compensatory damages. The parties settled for confidential amounts before the liability phase began.

Undiluted acid used for vulvar surgery

WIDE LOCAL EXCISION was performed on a 42-year-old woman with vulvar intraepithelial neoplasm, VIN II, with moderate dysplasia. Her ObGyn performed the surgery.

Instead of applying a diluted solution of acetic acid wash to delineate the borders of the dysplastic area, a highly concentrated acetic acid or trichloroacetic acid was used. The patient suffered severe chemical burns of the vulva that took several months to heal. She has permanent scarring of the vulvar area, severe tenderness, discoloration, and atrophy of the vaginal opening, with a band of thick scar tissue at the posterior fourchette. The perineum, extending to the anal area, is scarred, including a 2-mm plaque layer.

PATIENT’S CLAIM Sexual intercourse is extremely painful, and therefore impossible. She suffers discomfort at all times. Additional surgery has been recommended to alleviate her condition.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $600,000 Ohio settlement was reached.

Large baby with cervical spine injury

A WOMAN WAS IN LABOR with her third child. Her first baby was born by cesarean delivery. During the vaginal birth of her second child, shoulder dystocia was encountered; this child weighed 8 lb 4 oz at birth.

Using ultrasonography, the ObGyn determined vaginal birth was appropriate. Shoulder dystocia was encountered and the infant suffered injuries to the cervical spine and right arm. The newborn weighed 9 lb 13 oz.

PATIENT’S CLAIM The baby’s weight was grossly underestimated prior to delivery; ultrasonography was not properly performed or evaluated. The mother’s history, large fundal height, estimated fetal weight, and the mother’s request for a cesarean delivery should have resulted in the performance of a cesarean delivery.

PHYSICIAN’S DEFENSE Shoulder dystocia was not reasonably foreseeable. Injuries to the baby were due to the forces of labor.

VERDICT A confidential Texas settlement was reached.

Suture causes nerve damage

PELVIC PROLAPSE RECONSTRUCTION was performed; surgery included a pubovaginal sling procedure with graft, and repairs of Grade 2 cystocele and Grade 3 rectocele. The gynecologist used transvaginal sutures to attach the mesh to the sacrospinous ligament.

The patient immediately reported pain, tingling, and weakness in her buttocks and legs. The gynecologist diagnosed a hematoma and continued conservative treatment while waiting for the hematoma to resorb.

After 10 days, the patient terminated the gynecologist’s services and left the hospital. She saw a neurologist, who diagnosed proximal sciatic nerve irritation secondary to suturing. When a suture was removed from the sacral spinous ligament plexus, many of the patient’s neurologic symptoms immediately resolved. She still has pain and walks with a noticeable limp using a cane.

PATIENT’S CLAIM The gynecologist failed to determine that a suture was causing nerve damage. Removal of the suture within the first 3 days would have avoided neurologic injury.

PHYSICIAN’S DEFENSE Postsurgical care was proper. A neurologist was consulted, and a sonogram had ruled out deep vein thrombosis.

VERDICT A $1.58 million Illinois verdict was returned.

Colon damage after embolization

UTERINE FIBROID EMBOLIZATION was performed on a 51-year-old woman. The next day, she reported severe abdominal pain and was readmitted. A uterine infection was suspected, and she underwent a hysterectomy. Necrosis of the colon was found; a surgeon removed one-third of the colon and performed a colostomy. She underwent several operations, including rectal-vaginal fistula repair, before the colostomy was corrected.

PATIENT’S CLAIM Misdirected embolization injured an artery supplying the colon. She continues to suffer ongoing fecal urgency and frequency.

PHYSICIAN’S DEFENSE An anomalous connection between the patient’s uterine artery and mesenteric artery was impossible for the physician to have known prior to the embolization procedure.

VERDICT A California defense verdict was returned.

$1.18 M verdict set aside because of Facebook   postings

SEVERAL HOURS AFTER A WOMAN’S LABOR BEGAN, fetal bradycardia developed precipitously. The on-call ObGyn arrived after 10 minutes and ordered an immediate cesarean delivery, which occurred 22 minutes later. The child suffered a catastrophic, irreversible brain injury. He lived for 39 days before life support was removed and he died.

ESTATE’S CLAIM The nurses did not report decelerations to the ObGyn, and they were slow to notify him of the fetal bradycardia. The child would not have been injured if the nursing staff had reacted appropriately.

DEFENDANTS’ DEFENSE Isolated heart-rate decelerations during labor are not troubling. A cord accident occurred, which could not be predicted nor avoided. The ObGyn was called promptly; the emergency cesarean delivery was performed quickly. However, the injury already had occurred and was irreparable.

VERDICT A $1.18 million Kentucky verdict was returned. The hospital sought a mistrial because Facebook postings by a juror proved the case had been discussed and prejudged. The court found in favor of the hospital on its post-trial motion.

Bilateral mastectomy: nipples not spared

A 46-YEAR-OLD WOMAN UNDERWENT prophylactic bilateral mastectomy. A plastic surgeon drew presurgical markings on the day of surgery; the breast surgeon removed the nipples.

PATIENT’S CLAIM All parties had agreed the nipples would be spared. The plastic surgeon drew improper markings and failed to remind the breast surgeon prior to surgery that the nipples would be preserved.

PHYSICIAN’S DEFENSE The breast surgeon was at fault for misinterpreting the markings.

VERDICT The patient reached a pretrial settlement with the breast surgeon. The case proceeded against the plastic surgeon. A Maryland defense verdict was returned for the plastic surgeon.

Signs of intrauterine growth restriction; stillborn child

AT 24 WEEKS’ GESTATION, a 17-year-old woman who smoked reported spotting. An ultrasound demonstrated significant fetal growth restriction. The mother was hospitalized to assess the spotting; no testing was ordered to assess fetal growth. When blood was not found in the birth canal, she was discharged. During the next month, she saw the ObGyn three times; testing indicated that the fetus was at least 3 weeks behind the stage of pregnancy. The ObGyn did not order additional testing nor consult a specialist. At 31 weeks’ gestation, ultrasonography found no fetal heart tones. The stillborn was delivered by cesarean section.

ESTATE’S CLAIM A wrongful death suit was filed by the parents, who also claimed lack of informed consent concerning the risk of stillbirth in the presence of intrauterine growth restriction.

PHYSICIANS’ DEFENSE The mother’s smoking was mentioned at trial as a possible explanation of why fetal development was delayed. The ObGyn denied negligence.

VERDICT A $800,000 Maryland verdict was awarded to the parents.

Three BrCa patients share $72.6 M

THREE MENOPAUSAL WOMEN took Premarin (conjugated estrogens) plus Provera (medroxyprogesterone), and/or Prempro (conjugated estrogens/medroxyprogesterone acetate). Each discontinued hormone therapy after being diagnosed with hormone-positive breast cancer.

PATIENTS’ CLAIM The only source of hormonal stimulation for their cancer was the use of estrogen plus progestin.

DEFENDANTS’ DEFENSE Science is currently unable to determine precisely what causes breast cancer. Each plaintiff had risk factors.

VERDICT The three cases were consolidated to a reverse-bifurcated trial, with causation and damages assessed first. The Pennsylvania jury found the Wyeth Pharmaceutical products to be factual causes of the patients’ cancer, and awarded a total of $72.6 million in compensatory damages. The parties settled for confidential amounts before the liability phase began.

Undiluted acid used for vulvar surgery

WIDE LOCAL EXCISION was performed on a 42-year-old woman with vulvar intraepithelial neoplasm, VIN II, with moderate dysplasia. Her ObGyn performed the surgery.

Instead of applying a diluted solution of acetic acid wash to delineate the borders of the dysplastic area, a highly concentrated acetic acid or trichloroacetic acid was used. The patient suffered severe chemical burns of the vulva that took several months to heal. She has permanent scarring of the vulvar area, severe tenderness, discoloration, and atrophy of the vaginal opening, with a band of thick scar tissue at the posterior fourchette. The perineum, extending to the anal area, is scarred, including a 2-mm plaque layer.

PATIENT’S CLAIM Sexual intercourse is extremely painful, and therefore impossible. She suffers discomfort at all times. Additional surgery has been recommended to alleviate her condition.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $600,000 Ohio settlement was reached.

Large baby with cervical spine injury

A WOMAN WAS IN LABOR with her third child. Her first baby was born by cesarean delivery. During the vaginal birth of her second child, shoulder dystocia was encountered; this child weighed 8 lb 4 oz at birth.

Using ultrasonography, the ObGyn determined vaginal birth was appropriate. Shoulder dystocia was encountered and the infant suffered injuries to the cervical spine and right arm. The newborn weighed 9 lb 13 oz.

PATIENT’S CLAIM The baby’s weight was grossly underestimated prior to delivery; ultrasonography was not properly performed or evaluated. The mother’s history, large fundal height, estimated fetal weight, and the mother’s request for a cesarean delivery should have resulted in the performance of a cesarean delivery.

PHYSICIAN’S DEFENSE Shoulder dystocia was not reasonably foreseeable. Injuries to the baby were due to the forces of labor.

VERDICT A confidential Texas settlement was reached.

Suture causes nerve damage

PELVIC PROLAPSE RECONSTRUCTION was performed; surgery included a pubovaginal sling procedure with graft, and repairs of Grade 2 cystocele and Grade 3 rectocele. The gynecologist used transvaginal sutures to attach the mesh to the sacrospinous ligament.

The patient immediately reported pain, tingling, and weakness in her buttocks and legs. The gynecologist diagnosed a hematoma and continued conservative treatment while waiting for the hematoma to resorb.

After 10 days, the patient terminated the gynecologist’s services and left the hospital. She saw a neurologist, who diagnosed proximal sciatic nerve irritation secondary to suturing. When a suture was removed from the sacral spinous ligament plexus, many of the patient’s neurologic symptoms immediately resolved. She still has pain and walks with a noticeable limp using a cane.

PATIENT’S CLAIM The gynecologist failed to determine that a suture was causing nerve damage. Removal of the suture within the first 3 days would have avoided neurologic injury.

PHYSICIAN’S DEFENSE Postsurgical care was proper. A neurologist was consulted, and a sonogram had ruled out deep vein thrombosis.

VERDICT A $1.58 million Illinois verdict was returned.

Colon damage after embolization

UTERINE FIBROID EMBOLIZATION was performed on a 51-year-old woman. The next day, she reported severe abdominal pain and was readmitted. A uterine infection was suspected, and she underwent a hysterectomy. Necrosis of the colon was found; a surgeon removed one-third of the colon and performed a colostomy. She underwent several operations, including rectal-vaginal fistula repair, before the colostomy was corrected.

PATIENT’S CLAIM Misdirected embolization injured an artery supplying the colon. She continues to suffer ongoing fecal urgency and frequency.

PHYSICIAN’S DEFENSE An anomalous connection between the patient’s uterine artery and mesenteric artery was impossible for the physician to have known prior to the embolization procedure.

VERDICT A California defense verdict was returned.

$1.18 M verdict set aside because of Facebook   postings

SEVERAL HOURS AFTER A WOMAN’S LABOR BEGAN, fetal bradycardia developed precipitously. The on-call ObGyn arrived after 10 minutes and ordered an immediate cesarean delivery, which occurred 22 minutes later. The child suffered a catastrophic, irreversible brain injury. He lived for 39 days before life support was removed and he died.

ESTATE’S CLAIM The nurses did not report decelerations to the ObGyn, and they were slow to notify him of the fetal bradycardia. The child would not have been injured if the nursing staff had reacted appropriately.

DEFENDANTS’ DEFENSE Isolated heart-rate decelerations during labor are not troubling. A cord accident occurred, which could not be predicted nor avoided. The ObGyn was called promptly; the emergency cesarean delivery was performed quickly. However, the injury already had occurred and was irreparable.

VERDICT A $1.18 million Kentucky verdict was returned. The hospital sought a mistrial because Facebook postings by a juror proved the case had been discussed and prejudged. The court found in favor of the hospital on its post-trial motion.

Bilateral mastectomy: nipples not spared

A 46-YEAR-OLD WOMAN UNDERWENT prophylactic bilateral mastectomy. A plastic surgeon drew presurgical markings on the day of surgery; the breast surgeon removed the nipples.

PATIENT’S CLAIM All parties had agreed the nipples would be spared. The plastic surgeon drew improper markings and failed to remind the breast surgeon prior to surgery that the nipples would be preserved.

PHYSICIAN’S DEFENSE The breast surgeon was at fault for misinterpreting the markings.

VERDICT The patient reached a pretrial settlement with the breast surgeon. The case proceeded against the plastic surgeon. A Maryland defense verdict was returned for the plastic surgeon.

Signs of intrauterine growth restriction; stillborn child

AT 24 WEEKS’ GESTATION, a 17-year-old woman who smoked reported spotting. An ultrasound demonstrated significant fetal growth restriction. The mother was hospitalized to assess the spotting; no testing was ordered to assess fetal growth. When blood was not found in the birth canal, she was discharged. During the next month, she saw the ObGyn three times; testing indicated that the fetus was at least 3 weeks behind the stage of pregnancy. The ObGyn did not order additional testing nor consult a specialist. At 31 weeks’ gestation, ultrasonography found no fetal heart tones. The stillborn was delivered by cesarean section.

ESTATE’S CLAIM A wrongful death suit was filed by the parents, who also claimed lack of informed consent concerning the risk of stillbirth in the presence of intrauterine growth restriction.

PHYSICIANS’ DEFENSE The mother’s smoking was mentioned at trial as a possible explanation of why fetal development was delayed. The ObGyn denied negligence.

VERDICT A $800,000 Maryland verdict was awarded to the parents.

Three BrCa patients share $72.6 M

THREE MENOPAUSAL WOMEN took Premarin (conjugated estrogens) plus Provera (medroxyprogesterone), and/or Prempro (conjugated estrogens/medroxyprogesterone acetate). Each discontinued hormone therapy after being diagnosed with hormone-positive breast cancer.

PATIENTS’ CLAIM The only source of hormonal stimulation for their cancer was the use of estrogen plus progestin.

DEFENDANTS’ DEFENSE Science is currently unable to determine precisely what causes breast cancer. Each plaintiff had risk factors.

VERDICT The three cases were consolidated to a reverse-bifurcated trial, with causation and damages assessed first. The Pennsylvania jury found the Wyeth Pharmaceutical products to be factual causes of the patients’ cancer, and awarded a total of $72.6 million in compensatory damages. The parties settled for confidential amounts before the liability phase began.

Placement of a suture around an incompetent cervix to prevent premature pregnancy loss was first described more than 50 years ago^1,2—but the few randomized studies that have been published (all of them in the past decade) devote very little attention to technique.^3-7

Are we to assume, then, that over more than 50 years, no modifications to technique have been devised?

Are we to assume as well that in the two largest randomized studies to date, which involved 266 cerclages inserted in 27 different medical centers over more than 4 years,^5,7 all cerclages were inserted in an identical manner using the same technique originated more than half a century ago?

In this article, we lay out five principles to achieve effective cerclage and describe a stepwise approach to technique. This technique is based on our experience with approximately 2,000 cerclages performed in a single medical center. We emphasize anatomic landmarks and surgical principles that are based on the published literature as well as our personal experience.

Five principles of effective cerclage

Place the cerclage as high as possible

In the original paper on cerclage, McDonald emphasized the need to place the suture as high as possible to be as close as possible to the level of the internal cervical os.²

Zilianti and colleagues elegantly described how—in the absence of cerclage—cervical tissue begins to change at the level of the internal os, forming a funnel that advances downward in the shape of the letters “Y,” “V,” and “U.”⁸ If we accept this notion, then the only way to prevent further shortening from the top down is by placing a high cerclage.

Studies have demonstrated improved pregnancy outcomes after placement of a high cervico-isthmic cerclage following failure of a “conventional” low cerclage.^9,10

Place the cerclage adjacent to the cervical stroma

Macroscopic and microscopic visualization of the cervix reveals the following main layers:

• epithelium/mucosa, which covers the deeper connective tissue known as cervical stroma
• cervical stroma, which may be divided into two zones: 1) a superficial, subepithelial zone that appears histologically as loose stromal bands and 2) a deeper, dense collagen layer.

It is the dense collagen layer of the cervical stroma that affords most of the resistance to forces of deformation, whereas the loose stromal layer and the epithelium above it slide easily over the deeper stroma. Including too great a proportion of these “slippery” components within the cerclage could increase the risk of displacement and failure.^11,12

Shirodkar was the first to suggest that the mucosa and submucosa be excluded from cerclage,¹ and a detailed submucosal cerclage insertion was described by Fahmy more than 30 years ago.¹³ We support his recommendation that cerclage placement be as close to the inner cervical stroma as possible and that it include as little as possible of the surrounding tissue.

Take three encircling cervical “bites”

In his original publication, McDonald described “five or six bites with the needle” to encircle the cervix.² Later authors usually described four encircling steps, but no reliable study has challenged the original dogma.

Although we lack science to favor one approach over another, common sense suggests that three bites (versus four or five) offer the following advantages. They:

• produce less penetrating injury
• require less manipulation of the cervix
• are simpler and quicker to perform
• offer less opportunity for the cerclage tape to get twisted (a flat tape provides for better distribution of the load)
• permit a small gap between the two final exit points of the tape (at 5 o’clock and 7 o’clock), which allows for easier cinching and tightening of the cerclage (FIGURE 1).

FIGURE 1 A small gap between the ends of the cerclage tape, which exit at 5 o’clock and 7 o’clock, allows for easier cinching and tightening.

Place the knot at 6 o’clock

Both Shirodkar¹ and McDonald² described placement of the knot (or approximation of the “ends”) at 12 o’clock, anteriorly. However, this approach can complicate removal if strong pressure is applied to the cerclage or if it is covered by tissue. Attempts to remove the cerclage can result in bladder injury.

For these reasons, we prefer the approach described by Caspi and colleagues, who placed the knot in the back of the cervix at 6 o’clock.¹⁴ In that location, the surgeon can reach as high as desired, and there is no risk of organ injury during removal.

That said, it should be noted that removal of a cerclage with a knot at 6 o’clock is more difficult than removal of one with a knot at 12 o’clock—but the convenience of the operator should be secondary to safety and efficacy of the cerclage.

Place a figure of 8 around the cerclage knot

Because of the proximity of the bladder anteriorly, there is a limit to how high one can place the cerclage anteriorly. However, in the back of the cervix, one can place the cerclage much higher without risk of injury. This approach sometimes will result in downward forces on the posterior part (where the knot is) and occasionally may cover the knot with tissue from the posterior vaginal fornix.

For these reasons, we propose securing the knot of the cerclage tape to the posterior surface of the cervical “core” by placing a figure of 8 using bright blue Prolene #1 (Ethicon) to prevent slippage and help call attention to the knot when the time for removal comes.

Stepwise surgical technique

1. Use a weighted speculum to retract the posterior-inferior vaginal wall. Have an assistant hold one or two right-angle retractors to retract the other aspects of the vaginal wall, including the bladder anteriorly, as needed.

2. Clamp the anterior and posterior lips of the cervix and tug them lightly—at all times—in an outward direction (FIGURE 2).

FIGURE 2 Clamping of the cervix
Clamp the anterior and posterior lips of the cervix and tug them lightly and steadily in an outward direction.

3. Retract and release the bladder several times using a right-angle retractor for more accurate identification of the cervico-vesical fold (FIGURE 3 and FIGURE 4). Note the distance from the external os to the cervico-vesical fold; it should be 2 cm or farther. (If it is less than 2 cm, another type of cerclage may be preferable.)

FIGURE 3 Anatomic landmarks
Cerclage is facilitated by orientation to the following landmarks; A. cervico-vesical fold; B. posterior fornix; C. cervical stroma; D. cervical mucosa.

FIGURE 4 Cervico-vesical fold
The black line indicates the location of the fold.

4. Identify the roof of the posterior fornix (FIGURE 3 and FIGURE 5).

FIGURE 5 Roof of the posterior fornix
This landmark is delineated in black.

5. Using Allis clamps bilaterally, clamp the soft tissue covering the cervical core (stroma), between the cervico-vesical junction anteriorly and the superior point of the posterior fornix posteriorly. This is a cardinal step because it separates the core from the mucosal/ submucosal elements (FIGURE 6). (Helpful hint: To achieve optimal placement of the lateral Allis clamps, place the open clamp ever so slightly to one side of the middle of the cervix. As you close the instrument, let the clamp slide off the cervical core until it is locked adjacent to it. This takes the soft tissue and supporting blood vessels out of the operative field.)

FIGURE 6 Anterolateral view
The pericervical mucosa (black arrow) after application of an Allis clamp.

6. Take three bites, 1 mm in depth, through the cervical core using a 5-mm Mersilene tape and a blunt-tipped needle (RS21; Ethicon). One bite should encompass 12:30 to 11:30 anteriorly. Another bite should go in at 3 o’clock and out at 5 o’clock, and another bite should go in at 9 o’clock and out at 7 o’clock (FIGURE 1). (Helpful hint: Ensure that the direction of the pull always is a direct extension of the passage through tissue in small steps and not an outward direction toward the operator. An instrument such as a curved Mayo clamp should be placed at the point of the needle’s exit to reduce the risk of injury. At the conclusion of the three bites, the Mersilene tape should be the same length on each side, exiting at 5 o’clock and 7 o’clock, as stated earlier [FIGURE 7].)

FIGURE 7 Ensure equal distribution of the tape
After taking three bites of tissue, ensure that the ends of the Mersilene tape are of equal length on each side.

7. Once the tape is of equal length on both sides, closely encircling three sides of the cervical core, empty the bladder with a catheter to ensure the presence of clear urine. Bloody urine could be an indication for cystoscopy to rule out bladder injury.

8. Cut the needles off of the tape and tie the cerclage in three ties, the first one being a surgical tie. After tying the first tie, ensure proper tension by pressing gently with the index finger up and down on the knot; if it is properly tensioned, it will not be displaced by this movement. (Helpful hint: There is no clear indication of how tight a cerclage should be tied. We suggest making the first tie as close as possible to the cervical core to create a visible, and palpable, depression in the soft tissue at the area of the knot [FIGURE 8]).

FIGURE 8 Tying the cerclage
Make the first tie as close as possible to the cervical core so that it creates a visible, and palpable, depression in the soft tissue at the area of the knot. Inset: Cerclage tie secured by a figure of 8.

9. Trim the ends of the tape to 3 cm to facilitate easy identification and manipulation at the time of removal. Place a figure of 8, using bright blue Prolene #1 (Ethicon), around the knot, securing it to the posterior surface of the cervical core (FIGURE 9). The tape should encircle the firm part of the cervix near the internal os, as shown by transvaginal ultrasonography in FIGURE 10. (Helpful hint: Place surgical gauze under pressure around the cervix to support hemostasis after removal of the clamps. Remove the gauze approximately 30 minutes after the procedure.)

FIGURE 9 Mark the cerclage
Place a figure of 8, using bright blue Prolene #1, around the knot of the cerclage, securing it to the posterior surface of the cervical core.

FIGURE 10 Final placement
The cerclage tape should encircle the firm part of the cervix near the internal os, as shown by transvaginal ultrasonography.

Technique is applicable to most cerclage procedures

One potential limitation of this technique is the fact that it is based on surgical experience in a single center, although it includes more than 2,000 operations performed at that center. Therefore, we lack data on the ease of teaching and reproducing this technique. Nevertheless, our approach incorporates various elements that previously were proposed to enhance the effectiveness of cerclage. It likely will be applicable to most cerclage procedures, with the exception of a few unique cases. These unique cases—most of them involving the failure of conventional cerclage—may require more elaborate technique.

As for data on the location of biomechanical stresses on cervical tissue during pregnancy, the literature indicates that the forces of maximum deformation begin internally at the level of the cervico-uterine junction.¹² If not successfully resisted, these forces will proceed down along the cervical canal and could lead to premature pregnancy loss.

Although the superiority of a high cerclage has not yet been proven clinically, it appears to be more effective than low placement because it is more likely to provide support at the right location.

As pregnancy progresses, the challenge to the cervix increases—not only because of increasing uterine volume but also because of greater uterine activity. Both raise the risk of cerclage slippage and displacement.¹⁵ To address these issues, several investigators proposed an approach that excludes the slippery mucosal layer.^1,13,14

The original Shirodkar cerclage and its modifications—but not the McDonald cerclage and its subsequent modifications—included an “anchor” suture attaching the cerclage band to the firm cervical stromal layer as a means to prevent downward slippage and displacement.¹ It remains to be seen whether this addition of a figure of 8 using nonabsorbable suture, as proposed here, is indeed effective.

We believe that, if a standardized way to perform effective cerclage can be agreed upon, we also might devise a better way to compare results based on proper patient selection.

We want to hear from you! Tell us what you think.

Placement of a suture around an incompetent cervix to prevent premature pregnancy loss was first described more than 50 years ago^1,2—but the few randomized studies that have been published (all of them in the past decade) devote very little attention to technique.^3-7

Are we to assume, then, that over more than 50 years, no modifications to technique have been devised?

Are we to assume as well that in the two largest randomized studies to date, which involved 266 cerclages inserted in 27 different medical centers over more than 4 years,^5,7 all cerclages were inserted in an identical manner using the same technique originated more than half a century ago?

In this article, we lay out five principles to achieve effective cerclage and describe a stepwise approach to technique. This technique is based on our experience with approximately 2,000 cerclages performed in a single medical center. We emphasize anatomic landmarks and surgical principles that are based on the published literature as well as our personal experience.

Five principles of effective cerclage

Place the cerclage as high as possible

In the original paper on cerclage, McDonald emphasized the need to place the suture as high as possible to be as close as possible to the level of the internal cervical os.²

Zilianti and colleagues elegantly described how—in the absence of cerclage—cervical tissue begins to change at the level of the internal os, forming a funnel that advances downward in the shape of the letters “Y,” “V,” and “U.”⁸ If we accept this notion, then the only way to prevent further shortening from the top down is by placing a high cerclage.

Studies have demonstrated improved pregnancy outcomes after placement of a high cervico-isthmic cerclage following failure of a “conventional” low cerclage.^9,10

Place the cerclage adjacent to the cervical stroma

Macroscopic and microscopic visualization of the cervix reveals the following main layers:

• epithelium/mucosa, which covers the deeper connective tissue known as cervical stroma
• cervical stroma, which may be divided into two zones: 1) a superficial, subepithelial zone that appears histologically as loose stromal bands and 2) a deeper, dense collagen layer.

It is the dense collagen layer of the cervical stroma that affords most of the resistance to forces of deformation, whereas the loose stromal layer and the epithelium above it slide easily over the deeper stroma. Including too great a proportion of these “slippery” components within the cerclage could increase the risk of displacement and failure.^11,12

Shirodkar was the first to suggest that the mucosa and submucosa be excluded from cerclage,¹ and a detailed submucosal cerclage insertion was described by Fahmy more than 30 years ago.¹³ We support his recommendation that cerclage placement be as close to the inner cervical stroma as possible and that it include as little as possible of the surrounding tissue.

Take three encircling cervical “bites”

In his original publication, McDonald described “five or six bites with the needle” to encircle the cervix.² Later authors usually described four encircling steps, but no reliable study has challenged the original dogma.

Although we lack science to favor one approach over another, common sense suggests that three bites (versus four or five) offer the following advantages. They:

• produce less penetrating injury
• require less manipulation of the cervix
• are simpler and quicker to perform
• offer less opportunity for the cerclage tape to get twisted (a flat tape provides for better distribution of the load)
• permit a small gap between the two final exit points of the tape (at 5 o’clock and 7 o’clock), which allows for easier cinching and tightening of the cerclage (FIGURE 1).

FIGURE 1 A small gap between the ends of the cerclage tape, which exit at 5 o’clock and 7 o’clock, allows for easier cinching and tightening.

Place the knot at 6 o’clock

Both Shirodkar¹ and McDonald² described placement of the knot (or approximation of the “ends”) at 12 o’clock, anteriorly. However, this approach can complicate removal if strong pressure is applied to the cerclage or if it is covered by tissue. Attempts to remove the cerclage can result in bladder injury.

For these reasons, we prefer the approach described by Caspi and colleagues, who placed the knot in the back of the cervix at 6 o’clock.¹⁴ In that location, the surgeon can reach as high as desired, and there is no risk of organ injury during removal.

That said, it should be noted that removal of a cerclage with a knot at 6 o’clock is more difficult than removal of one with a knot at 12 o’clock—but the convenience of the operator should be secondary to safety and efficacy of the cerclage.

Place a figure of 8 around the cerclage knot

Because of the proximity of the bladder anteriorly, there is a limit to how high one can place the cerclage anteriorly. However, in the back of the cervix, one can place the cerclage much higher without risk of injury. This approach sometimes will result in downward forces on the posterior part (where the knot is) and occasionally may cover the knot with tissue from the posterior vaginal fornix.

For these reasons, we propose securing the knot of the cerclage tape to the posterior surface of the cervical “core” by placing a figure of 8 using bright blue Prolene #1 (Ethicon) to prevent slippage and help call attention to the knot when the time for removal comes.

Stepwise surgical technique

1. Use a weighted speculum to retract the posterior-inferior vaginal wall. Have an assistant hold one or two right-angle retractors to retract the other aspects of the vaginal wall, including the bladder anteriorly, as needed.

2. Clamp the anterior and posterior lips of the cervix and tug them lightly—at all times—in an outward direction (FIGURE 2).

FIGURE 2 Clamping of the cervix
Clamp the anterior and posterior lips of the cervix and tug them lightly and steadily in an outward direction.

3. Retract and release the bladder several times using a right-angle retractor for more accurate identification of the cervico-vesical fold (FIGURE 3 and FIGURE 4). Note the distance from the external os to the cervico-vesical fold; it should be 2 cm or farther. (If it is less than 2 cm, another type of cerclage may be preferable.)

FIGURE 3 Anatomic landmarks
Cerclage is facilitated by orientation to the following landmarks; A. cervico-vesical fold; B. posterior fornix; C. cervical stroma; D. cervical mucosa.

FIGURE 4 Cervico-vesical fold
The black line indicates the location of the fold.

4. Identify the roof of the posterior fornix (FIGURE 3 and FIGURE 5).

FIGURE 5 Roof of the posterior fornix
This landmark is delineated in black.

5. Using Allis clamps bilaterally, clamp the soft tissue covering the cervical core (stroma), between the cervico-vesical junction anteriorly and the superior point of the posterior fornix posteriorly. This is a cardinal step because it separates the core from the mucosal/ submucosal elements (FIGURE 6). (Helpful hint: To achieve optimal placement of the lateral Allis clamps, place the open clamp ever so slightly to one side of the middle of the cervix. As you close the instrument, let the clamp slide off the cervical core until it is locked adjacent to it. This takes the soft tissue and supporting blood vessels out of the operative field.)

FIGURE 6 Anterolateral view
The pericervical mucosa (black arrow) after application of an Allis clamp.

6. Take three bites, 1 mm in depth, through the cervical core using a 5-mm Mersilene tape and a blunt-tipped needle (RS21; Ethicon). One bite should encompass 12:30 to 11:30 anteriorly. Another bite should go in at 3 o’clock and out at 5 o’clock, and another bite should go in at 9 o’clock and out at 7 o’clock (FIGURE 1). (Helpful hint: Ensure that the direction of the pull always is a direct extension of the passage through tissue in small steps and not an outward direction toward the operator. An instrument such as a curved Mayo clamp should be placed at the point of the needle’s exit to reduce the risk of injury. At the conclusion of the three bites, the Mersilene tape should be the same length on each side, exiting at 5 o’clock and 7 o’clock, as stated earlier [FIGURE 7].)

FIGURE 7 Ensure equal distribution of the tape
After taking three bites of tissue, ensure that the ends of the Mersilene tape are of equal length on each side.

7. Once the tape is of equal length on both sides, closely encircling three sides of the cervical core, empty the bladder with a catheter to ensure the presence of clear urine. Bloody urine could be an indication for cystoscopy to rule out bladder injury.

8. Cut the needles off of the tape and tie the cerclage in three ties, the first one being a surgical tie. After tying the first tie, ensure proper tension by pressing gently with the index finger up and down on the knot; if it is properly tensioned, it will not be displaced by this movement. (Helpful hint: There is no clear indication of how tight a cerclage should be tied. We suggest making the first tie as close as possible to the cervical core to create a visible, and palpable, depression in the soft tissue at the area of the knot [FIGURE 8]).

FIGURE 8 Tying the cerclage
Make the first tie as close as possible to the cervical core so that it creates a visible, and palpable, depression in the soft tissue at the area of the knot. Inset: Cerclage tie secured by a figure of 8.

9. Trim the ends of the tape to 3 cm to facilitate easy identification and manipulation at the time of removal. Place a figure of 8, using bright blue Prolene #1 (Ethicon), around the knot, securing it to the posterior surface of the cervical core (FIGURE 9). The tape should encircle the firm part of the cervix near the internal os, as shown by transvaginal ultrasonography in FIGURE 10. (Helpful hint: Place surgical gauze under pressure around the cervix to support hemostasis after removal of the clamps. Remove the gauze approximately 30 minutes after the procedure.)

FIGURE 9 Mark the cerclage
Place a figure of 8, using bright blue Prolene #1, around the knot of the cerclage, securing it to the posterior surface of the cervical core.

FIGURE 10 Final placement
The cerclage tape should encircle the firm part of the cervix near the internal os, as shown by transvaginal ultrasonography.

Technique is applicable to most cerclage procedures

One potential limitation of this technique is the fact that it is based on surgical experience in a single center, although it includes more than 2,000 operations performed at that center. Therefore, we lack data on the ease of teaching and reproducing this technique. Nevertheless, our approach incorporates various elements that previously were proposed to enhance the effectiveness of cerclage. It likely will be applicable to most cerclage procedures, with the exception of a few unique cases. These unique cases—most of them involving the failure of conventional cerclage—may require more elaborate technique.

As for data on the location of biomechanical stresses on cervical tissue during pregnancy, the literature indicates that the forces of maximum deformation begin internally at the level of the cervico-uterine junction.¹² If not successfully resisted, these forces will proceed down along the cervical canal and could lead to premature pregnancy loss.

Although the superiority of a high cerclage has not yet been proven clinically, it appears to be more effective than low placement because it is more likely to provide support at the right location.

As pregnancy progresses, the challenge to the cervix increases—not only because of increasing uterine volume but also because of greater uterine activity. Both raise the risk of cerclage slippage and displacement.¹⁵ To address these issues, several investigators proposed an approach that excludes the slippery mucosal layer.^1,13,14

The original Shirodkar cerclage and its modifications—but not the McDonald cerclage and its subsequent modifications—included an “anchor” suture attaching the cerclage band to the firm cervical stromal layer as a means to prevent downward slippage and displacement.¹ It remains to be seen whether this addition of a figure of 8 using nonabsorbable suture, as proposed here, is indeed effective.

We believe that, if a standardized way to perform effective cerclage can be agreed upon, we also might devise a better way to compare results based on proper patient selection.

We want to hear from you! Tell us what you think.

Placement of a suture around an incompetent cervix to prevent premature pregnancy loss was first described more than 50 years ago^1,2—but the few randomized studies that have been published (all of them in the past decade) devote very little attention to technique.^3-7

Are we to assume, then, that over more than 50 years, no modifications to technique have been devised?

Are we to assume as well that in the two largest randomized studies to date, which involved 266 cerclages inserted in 27 different medical centers over more than 4 years,^5,7 all cerclages were inserted in an identical manner using the same technique originated more than half a century ago?

In this article, we lay out five principles to achieve effective cerclage and describe a stepwise approach to technique. This technique is based on our experience with approximately 2,000 cerclages performed in a single medical center. We emphasize anatomic landmarks and surgical principles that are based on the published literature as well as our personal experience.

Five principles of effective cerclage

Place the cerclage as high as possible

In the original paper on cerclage, McDonald emphasized the need to place the suture as high as possible to be as close as possible to the level of the internal cervical os.²

Zilianti and colleagues elegantly described how—in the absence of cerclage—cervical tissue begins to change at the level of the internal os, forming a funnel that advances downward in the shape of the letters “Y,” “V,” and “U.”⁸ If we accept this notion, then the only way to prevent further shortening from the top down is by placing a high cerclage.

Studies have demonstrated improved pregnancy outcomes after placement of a high cervico-isthmic cerclage following failure of a “conventional” low cerclage.^9,10

Place the cerclage adjacent to the cervical stroma

Macroscopic and microscopic visualization of the cervix reveals the following main layers:

• epithelium/mucosa, which covers the deeper connective tissue known as cervical stroma
• cervical stroma, which may be divided into two zones: 1) a superficial, subepithelial zone that appears histologically as loose stromal bands and 2) a deeper, dense collagen layer.

It is the dense collagen layer of the cervical stroma that affords most of the resistance to forces of deformation, whereas the loose stromal layer and the epithelium above it slide easily over the deeper stroma. Including too great a proportion of these “slippery” components within the cerclage could increase the risk of displacement and failure.^11,12

Shirodkar was the first to suggest that the mucosa and submucosa be excluded from cerclage,¹ and a detailed submucosal cerclage insertion was described by Fahmy more than 30 years ago.¹³ We support his recommendation that cerclage placement be as close to the inner cervical stroma as possible and that it include as little as possible of the surrounding tissue.

Take three encircling cervical “bites”

In his original publication, McDonald described “five or six bites with the needle” to encircle the cervix.² Later authors usually described four encircling steps, but no reliable study has challenged the original dogma.

Although we lack science to favor one approach over another, common sense suggests that three bites (versus four or five) offer the following advantages. They:

• produce less penetrating injury
• require less manipulation of the cervix
• are simpler and quicker to perform
• offer less opportunity for the cerclage tape to get twisted (a flat tape provides for better distribution of the load)
• permit a small gap between the two final exit points of the tape (at 5 o’clock and 7 o’clock), which allows for easier cinching and tightening of the cerclage (FIGURE 1).

FIGURE 1 A small gap between the ends of the cerclage tape, which exit at 5 o’clock and 7 o’clock, allows for easier cinching and tightening.

Place the knot at 6 o’clock

Both Shirodkar¹ and McDonald² described placement of the knot (or approximation of the “ends”) at 12 o’clock, anteriorly. However, this approach can complicate removal if strong pressure is applied to the cerclage or if it is covered by tissue. Attempts to remove the cerclage can result in bladder injury.

For these reasons, we prefer the approach described by Caspi and colleagues, who placed the knot in the back of the cervix at 6 o’clock.¹⁴ In that location, the surgeon can reach as high as desired, and there is no risk of organ injury during removal.

That said, it should be noted that removal of a cerclage with a knot at 6 o’clock is more difficult than removal of one with a knot at 12 o’clock—but the convenience of the operator should be secondary to safety and efficacy of the cerclage.

Place a figure of 8 around the cerclage knot

Because of the proximity of the bladder anteriorly, there is a limit to how high one can place the cerclage anteriorly. However, in the back of the cervix, one can place the cerclage much higher without risk of injury. This approach sometimes will result in downward forces on the posterior part (where the knot is) and occasionally may cover the knot with tissue from the posterior vaginal fornix.

For these reasons, we propose securing the knot of the cerclage tape to the posterior surface of the cervical “core” by placing a figure of 8 using bright blue Prolene #1 (Ethicon) to prevent slippage and help call attention to the knot when the time for removal comes.

Stepwise surgical technique

1. Use a weighted speculum to retract the posterior-inferior vaginal wall. Have an assistant hold one or two right-angle retractors to retract the other aspects of the vaginal wall, including the bladder anteriorly, as needed.

2. Clamp the anterior and posterior lips of the cervix and tug them lightly—at all times—in an outward direction (FIGURE 2).

FIGURE 2 Clamping of the cervix
Clamp the anterior and posterior lips of the cervix and tug them lightly and steadily in an outward direction.

3. Retract and release the bladder several times using a right-angle retractor for more accurate identification of the cervico-vesical fold (FIGURE 3 and FIGURE 4). Note the distance from the external os to the cervico-vesical fold; it should be 2 cm or farther. (If it is less than 2 cm, another type of cerclage may be preferable.)

FIGURE 3 Anatomic landmarks
Cerclage is facilitated by orientation to the following landmarks; A. cervico-vesical fold; B. posterior fornix; C. cervical stroma; D. cervical mucosa.

FIGURE 4 Cervico-vesical fold
The black line indicates the location of the fold.

4. Identify the roof of the posterior fornix (FIGURE 3 and FIGURE 5).

FIGURE 5 Roof of the posterior fornix
This landmark is delineated in black.

5. Using Allis clamps bilaterally, clamp the soft tissue covering the cervical core (stroma), between the cervico-vesical junction anteriorly and the superior point of the posterior fornix posteriorly. This is a cardinal step because it separates the core from the mucosal/ submucosal elements (FIGURE 6). (Helpful hint: To achieve optimal placement of the lateral Allis clamps, place the open clamp ever so slightly to one side of the middle of the cervix. As you close the instrument, let the clamp slide off the cervical core until it is locked adjacent to it. This takes the soft tissue and supporting blood vessels out of the operative field.)

FIGURE 6 Anterolateral view
The pericervical mucosa (black arrow) after application of an Allis clamp.

6. Take three bites, 1 mm in depth, through the cervical core using a 5-mm Mersilene tape and a blunt-tipped needle (RS21; Ethicon). One bite should encompass 12:30 to 11:30 anteriorly. Another bite should go in at 3 o’clock and out at 5 o’clock, and another bite should go in at 9 o’clock and out at 7 o’clock (FIGURE 1). (Helpful hint: Ensure that the direction of the pull always is a direct extension of the passage through tissue in small steps and not an outward direction toward the operator. An instrument such as a curved Mayo clamp should be placed at the point of the needle’s exit to reduce the risk of injury. At the conclusion of the three bites, the Mersilene tape should be the same length on each side, exiting at 5 o’clock and 7 o’clock, as stated earlier [FIGURE 7].)

FIGURE 7 Ensure equal distribution of the tape
After taking three bites of tissue, ensure that the ends of the Mersilene tape are of equal length on each side.

7. Once the tape is of equal length on both sides, closely encircling three sides of the cervical core, empty the bladder with a catheter to ensure the presence of clear urine. Bloody urine could be an indication for cystoscopy to rule out bladder injury.

8. Cut the needles off of the tape and tie the cerclage in three ties, the first one being a surgical tie. After tying the first tie, ensure proper tension by pressing gently with the index finger up and down on the knot; if it is properly tensioned, it will not be displaced by this movement. (Helpful hint: There is no clear indication of how tight a cerclage should be tied. We suggest making the first tie as close as possible to the cervical core to create a visible, and palpable, depression in the soft tissue at the area of the knot [FIGURE 8]).

FIGURE 8 Tying the cerclage
Make the first tie as close as possible to the cervical core so that it creates a visible, and palpable, depression in the soft tissue at the area of the knot. Inset: Cerclage tie secured by a figure of 8.

9. Trim the ends of the tape to 3 cm to facilitate easy identification and manipulation at the time of removal. Place a figure of 8, using bright blue Prolene #1 (Ethicon), around the knot, securing it to the posterior surface of the cervical core (FIGURE 9). The tape should encircle the firm part of the cervix near the internal os, as shown by transvaginal ultrasonography in FIGURE 10. (Helpful hint: Place surgical gauze under pressure around the cervix to support hemostasis after removal of the clamps. Remove the gauze approximately 30 minutes after the procedure.)

FIGURE 9 Mark the cerclage
Place a figure of 8, using bright blue Prolene #1, around the knot of the cerclage, securing it to the posterior surface of the cervical core.

FIGURE 10 Final placement
The cerclage tape should encircle the firm part of the cervix near the internal os, as shown by transvaginal ultrasonography.

Technique is applicable to most cerclage procedures

One potential limitation of this technique is the fact that it is based on surgical experience in a single center, although it includes more than 2,000 operations performed at that center. Therefore, we lack data on the ease of teaching and reproducing this technique. Nevertheless, our approach incorporates various elements that previously were proposed to enhance the effectiveness of cerclage. It likely will be applicable to most cerclage procedures, with the exception of a few unique cases. These unique cases—most of them involving the failure of conventional cerclage—may require more elaborate technique.

As for data on the location of biomechanical stresses on cervical tissue during pregnancy, the literature indicates that the forces of maximum deformation begin internally at the level of the cervico-uterine junction.¹² If not successfully resisted, these forces will proceed down along the cervical canal and could lead to premature pregnancy loss.

Although the superiority of a high cerclage has not yet been proven clinically, it appears to be more effective than low placement because it is more likely to provide support at the right location.

As pregnancy progresses, the challenge to the cervix increases—not only because of increasing uterine volume but also because of greater uterine activity. Both raise the risk of cerclage slippage and displacement.¹⁵ To address these issues, several investigators proposed an approach that excludes the slippery mucosal layer.^1,13,14

The original Shirodkar cerclage and its modifications—but not the McDonald cerclage and its subsequent modifications—included an “anchor” suture attaching the cerclage band to the firm cervical stromal layer as a means to prevent downward slippage and displacement.¹ It remains to be seen whether this addition of a figure of 8 using nonabsorbable suture, as proposed here, is indeed effective.

We believe that, if a standardized way to perform effective cerclage can be agreed upon, we also might devise a better way to compare results based on proper patient selection.

We want to hear from you! Tell us what you think.

RELATED ARTICLE WITH VIDEOS

• Which sling for which SUI patient?
  Mark D. Walters, MD, and Anne M. Weber, MD (Surgical Techniques, May 2012)

3 video clips illustrating midurethral sling procedures

These videos were selected by Dr. Walters and presented courtesy of the International Academy of Pelvic Surgery (IAPS)

When ISD is present, the urethra cannot coaptate and loses its ability to maintain a watertight seal. Women who have this condition often are severely incontinent, leaking urine at low volumes and pressures and with minimal exertion.

In this randomized trial, Schierlitz and colleagues hypothesized that TOT would produce higher objective and subjective failure rates than the TVT. This was confirmed by 6-month data published in 2008.

Details of the trial

Women who had SUI were included in the trial if they had ISD based on urodynamic findings (i.e., maximum urethral closure pressure ≤20 cm H₂O or Valsalva leak-point pressure ≤60 cm H₂O, or both) and were randomly assigned to TVT or TOT. The primary endpoint was symptomatic SUI (confirmed by repeat urodynamic testing) that required a second procedure upon patient request.

Participants were followed for 3 years. If a patient reported symptoms, urodynamic testing was repeated. In addition, the patient was offered another surgery, usually involving placement of a TVT sling.

Schierlitz and colleagues concluded that, if TVT were used in all patients, repeat surgery would be avoided in one in every six patients. The risk of repeat surgery was 15 times greater for TOT, compared with the TVT sling. The median time to failure was 15.6 months for the TOT sling, compared with 43.7 months for the TVT.

Of the 16 patients who underwent repeat surgery, 56% were cured, 25% reported minimal leakage, and 19% remained unchanged.

Quality-of-life scores were similar between groups at the 6-month follow-up.

Why did the TVT outperform the TOT in this population?

Investigators theorized that there is a difference in sling axis, with the TVT placed at a more acute angle than the TOT sling. In addition, the location of the TOT sling is more distal than that of the TVT, based on ultrasonographic imaging. As a result, more effective urethral kinking and support are likely with the TVT sling, improving continence rates.

Strengths and limitations of the trial

The randomization of participants and long-term follow-up bolster the trial’s credibility.

Weaknesses include unblinded participation and postoperative surgical assessment.

Although the sample size was underpowered, there was a significant difference in the primary outcome between the two groups.

We want to hear from you! Tell us what you think.

RELATED ARTICLE WITH VIDEOS

• Which sling for which SUI patient?
  Mark D. Walters, MD, and Anne M. Weber, MD (Surgical Techniques, May 2012)

3 video clips illustrating midurethral sling procedures

These videos were selected by Dr. Walters and presented courtesy of the International Academy of Pelvic Surgery (IAPS)

When ISD is present, the urethra cannot coaptate and loses its ability to maintain a watertight seal. Women who have this condition often are severely incontinent, leaking urine at low volumes and pressures and with minimal exertion.

In this randomized trial, Schierlitz and colleagues hypothesized that TOT would produce higher objective and subjective failure rates than the TVT. This was confirmed by 6-month data published in 2008.

Details of the trial

Women who had SUI were included in the trial if they had ISD based on urodynamic findings (i.e., maximum urethral closure pressure ≤20 cm H₂O or Valsalva leak-point pressure ≤60 cm H₂O, or both) and were randomly assigned to TVT or TOT. The primary endpoint was symptomatic SUI (confirmed by repeat urodynamic testing) that required a second procedure upon patient request.

Participants were followed for 3 years. If a patient reported symptoms, urodynamic testing was repeated. In addition, the patient was offered another surgery, usually involving placement of a TVT sling.

Schierlitz and colleagues concluded that, if TVT were used in all patients, repeat surgery would be avoided in one in every six patients. The risk of repeat surgery was 15 times greater for TOT, compared with the TVT sling. The median time to failure was 15.6 months for the TOT sling, compared with 43.7 months for the TVT.

Of the 16 patients who underwent repeat surgery, 56% were cured, 25% reported minimal leakage, and 19% remained unchanged.

Quality-of-life scores were similar between groups at the 6-month follow-up.

Why did the TVT outperform the TOT in this population?

Investigators theorized that there is a difference in sling axis, with the TVT placed at a more acute angle than the TOT sling. In addition, the location of the TOT sling is more distal than that of the TVT, based on ultrasonographic imaging. As a result, more effective urethral kinking and support are likely with the TVT sling, improving continence rates.

Strengths and limitations of the trial

The randomization of participants and long-term follow-up bolster the trial’s credibility.

Weaknesses include unblinded participation and postoperative surgical assessment.

Although the sample size was underpowered, there was a significant difference in the primary outcome between the two groups.

We want to hear from you! Tell us what you think.

RELATED ARTICLE WITH VIDEOS

• Which sling for which SUI patient?
  Mark D. Walters, MD, and Anne M. Weber, MD (Surgical Techniques, May 2012)

3 video clips illustrating midurethral sling procedures

These videos were selected by Dr. Walters and presented courtesy of the International Academy of Pelvic Surgery (IAPS)

When ISD is present, the urethra cannot coaptate and loses its ability to maintain a watertight seal. Women who have this condition often are severely incontinent, leaking urine at low volumes and pressures and with minimal exertion.

In this randomized trial, Schierlitz and colleagues hypothesized that TOT would produce higher objective and subjective failure rates than the TVT. This was confirmed by 6-month data published in 2008.

Details of the trial

Women who had SUI were included in the trial if they had ISD based on urodynamic findings (i.e., maximum urethral closure pressure ≤20 cm H₂O or Valsalva leak-point pressure ≤60 cm H₂O, or both) and were randomly assigned to TVT or TOT. The primary endpoint was symptomatic SUI (confirmed by repeat urodynamic testing) that required a second procedure upon patient request.

Participants were followed for 3 years. If a patient reported symptoms, urodynamic testing was repeated. In addition, the patient was offered another surgery, usually involving placement of a TVT sling.

Schierlitz and colleagues concluded that, if TVT were used in all patients, repeat surgery would be avoided in one in every six patients. The risk of repeat surgery was 15 times greater for TOT, compared with the TVT sling. The median time to failure was 15.6 months for the TOT sling, compared with 43.7 months for the TVT.

Of the 16 patients who underwent repeat surgery, 56% were cured, 25% reported minimal leakage, and 19% remained unchanged.

Quality-of-life scores were similar between groups at the 6-month follow-up.

Why did the TVT outperform the TOT in this population?

Investigators theorized that there is a difference in sling axis, with the TVT placed at a more acute angle than the TOT sling. In addition, the location of the TOT sling is more distal than that of the TVT, based on ultrasonographic imaging. As a result, more effective urethral kinking and support are likely with the TVT sling, improving continence rates.

Strengths and limitations of the trial

The randomization of participants and long-term follow-up bolster the trial’s credibility.

Weaknesses include unblinded participation and postoperative surgical assessment.

Although the sample size was underpowered, there was a significant difference in the primary outcome between the two groups.

We want to hear from you! Tell us what you think.

Mr. S, a 45-year-old veteran, was diagnosed with posttraumatic stress disorder (PTSD) 18 years ago after a tour of duty in the Persian Gulf. He had combat-related flashbacks triggered by the smell of gasoline or smoke from a fire, was easily startled, and began to isolate himself socially. However, his symptoms improved when he started volunteering at his local Veterans Affairs Medical Center. After he lost his job 3 years ago, Mr. S started experiencing flashbacks. He was irritable, easily startled, and avoided things that reminded him of his time in the Persian Gulf. His psychiatrist prescribed sertraline, titrated to 200 mg/d. The drug reduced the severity of his avoidance and hyperarousal symptoms and improved his mood.

During a clinic visit, Mr. S says he is doing well and can fall asleep at night but is having recurring nightmares about traumatic events that occurred during combat. These nightmares wake him up and have become more frequent, occurring once per night for the past month. Mr. S says he has been watching more news programs about conflicts in Afghanistan and Iraq since the nightmares began. His psychiatrist starts quetiapine, 50 mg at bedtime for 7 nights then 100 mg at bedtime, but after 6 weeks Mr. S says his nightmares continue.

PTSD occurs in approximately 19% of Vietnam war combat veterans¹ and 14% of service members returning from Iraq and Afghanistan.² PTSD symptoms are classified into clusters: intrusive/re-experiencing; avoidant/numbing; and hyperarousal.³ Nightmares are part of the intrusive/re-experiencing cluster, which is Criterion B in DSM-IV-TR. See Table 1 for a description of DSM-IV-TR PTSD criteria. Among PTSD patients, 50% to 70% report PTSD-associated nightmares.⁴ Despite adequate treatment targeted to improve PTSD’s core symptoms, symptoms such as sleep disturbances or nightmares often persist.

Table 1

DSM-IV-TR diagnostic criteria for posttraumatic stress disorder

Nightmares and other sleep disturbances are associated with significant distress and daytime impairment and can interfere with PTSD recovery^4-8 by disrupting sleep-dependent processing of emotional experiences and causing repeated resensitization to trauma cues (Table 2).⁸

Table 2

Psychosocial consequences of sleep disruption in PTSD

Few randomized controlled medication trials specifically address PTSD-related nightmares. Most PTSD studies do not examine sleep outcomes as a primary measure, and comprehensive literature reviews could not offer evidence-based recommendations.^9,10 The American Academy of Sleep Medicine (AASM) also noted a paucity of PTSD studies that identified nightmares as a primary outcome measure.¹¹ See Table 3 for a list of recommended medication options for PTSD-associated nightmares.

Table 3

Recommended medication treatments for PTSD-associated nightmares

CASE CONTINUED: Medication change, improvement

After reviewing AASM’s treatment recommendations, we prescribe prazosin, 1 mg at bedtime for 7 nights, then increase by 1 mg at bedtime each week until Mr. S’s nightmares improve. He reports a substantial improvement in nightmare severity and frequency after a few weeks of treatment with prazosin, 5 mg at bedtime.

Prazosin

Prazosin is an α1-adrenergic receptor antagonist with good CNS penetrability. The rationale for reducing adrenergic activity to address intrusive PTSD symptoms has been well documented.^12,13 In open-label trials,^14-18 a chart review,¹⁹ and placebo-controlled trials,^20-22prazosin reduced trauma nightmares and improved sleep quality and global clinical status more than placebo (Table 4). In these studies, prazosin doses ranged from 1 to 20 mg/d, with an average of 3 mg at bedtime and a starting dose of 1 mg. Prazosin is the only agent recommended in the AASM’s Best Practice Guide for treating PTSD-related nightmares.¹¹

Table 4

RCTs of prazosin for trauma-related nightmares

Atypical antipsychotics

Atypical antipsychotics have been used to reduce nightmares in PTSD; however, most of the evidence from studies evaluated in the AASM’s Best Practice Guide were considered to be low quality.¹¹ Quetiapine and ziprasidone were not included in the AASM review. See (Table 5) for a review of the evidence for atypical antipsychotics for treating PTSD nightmares.

Table 5

Combat-related nightmares: Evidence for atypical antipsychotics

Comparing prazosin and quetiapine. A historical prospective cohort study of 237 veterans with PTSD receiving prazosin or quetiapine for nighttime PTSD symptoms demonstrated that although the 2 drugs have similar efficacy (defined as symptomatic improvement) for short-term, 6-month treatment (61% vs 62%; P=.54), a higher percentage of patients continued prazosin long-term (3 to 6 years) than those taking quetiapine (48% vs 24%; P < .001).²³ Twenty-five percent of patients taking quetiapine switched to prazosin during the study, and approximately one-half of these patients remained on prazosin until the study’s end. Only 8% of prazosin patients switched to quetiapine, and none continued this therapy until study end.²³ Patients in the quetiapine group were more likely to discontinue the drug because of lack of efficacy (13% vs 3%; P=.03) and adverse effects (35% vs 18%; P=.008), specifically sedation (21% vs 2%; P < .001) and metabolic effects (9% vs 0%; P=.014), compared with prazosin. Although this trial may be the only published comparison study of prazosin and quetiapine, its methodological quality has been questioned, which makes it difficult to draw definitive conclusions.

Metabolic syndrome—elevated diastolic blood pressure, increased waist circumference, and low high-density lipoprotein cholesterol—is common among PTSD patients treated with antipsychotics.²⁴ This syndrome may be caused by medications, lifestyle factors, or long-term overactivation of stress-response pathways. A retrospective chart review at a community mental health center revealed that patients taking even low doses of quetiapine for insomnia gained an average of 5 lbs (P=.037).²⁵ Another retrospective chart review at 2 military hospitals reported that patients receiving low-dose quetiapine (≤100 mg/d) gained an average of slightly less than 1 lb per month, which adds up to approximately 10 lbs per year (P < .001).²⁶ The benefit of using atypical antipsychotics may be outweighed by metabolic risks such as obesity, new-onset diabetes, and dyslipidemia.²⁷

Prazosin is considered a first-line treatment for sleep disturbances and nightmares in PTSD because of its superior long-term efficacy and decreased adverse effects compared with quetiapine.

Related Resources

• American Psychiatric Association. Practice guidelines for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Arlington, VA: American Psychiatric Publishing, Inc.; 2004.
• Veterans Affairs/Department of Defense clinical practice guidelines. Management of traumatic stress disorder and acute stress reaction. www.healthquality.va.gov/Post_Traumatic_Stress_Disorder_PTSD.asp.

Drug Brand Names

• Prazosin • Minipress
• Quetiapine • Seroquel
• Sertraline • Zoloft
• Ziprasidone • Geodon

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Mr. S, a 45-year-old veteran, was diagnosed with posttraumatic stress disorder (PTSD) 18 years ago after a tour of duty in the Persian Gulf. He had combat-related flashbacks triggered by the smell of gasoline or smoke from a fire, was easily startled, and began to isolate himself socially. However, his symptoms improved when he started volunteering at his local Veterans Affairs Medical Center. After he lost his job 3 years ago, Mr. S started experiencing flashbacks. He was irritable, easily startled, and avoided things that reminded him of his time in the Persian Gulf. His psychiatrist prescribed sertraline, titrated to 200 mg/d. The drug reduced the severity of his avoidance and hyperarousal symptoms and improved his mood.

During a clinic visit, Mr. S says he is doing well and can fall asleep at night but is having recurring nightmares about traumatic events that occurred during combat. These nightmares wake him up and have become more frequent, occurring once per night for the past month. Mr. S says he has been watching more news programs about conflicts in Afghanistan and Iraq since the nightmares began. His psychiatrist starts quetiapine, 50 mg at bedtime for 7 nights then 100 mg at bedtime, but after 6 weeks Mr. S says his nightmares continue.

PTSD occurs in approximately 19% of Vietnam war combat veterans¹ and 14% of service members returning from Iraq and Afghanistan.² PTSD symptoms are classified into clusters: intrusive/re-experiencing; avoidant/numbing; and hyperarousal.³ Nightmares are part of the intrusive/re-experiencing cluster, which is Criterion B in DSM-IV-TR. See Table 1 for a description of DSM-IV-TR PTSD criteria. Among PTSD patients, 50% to 70% report PTSD-associated nightmares.⁴ Despite adequate treatment targeted to improve PTSD’s core symptoms, symptoms such as sleep disturbances or nightmares often persist.

Table 1

DSM-IV-TR diagnostic criteria for posttraumatic stress disorder

Nightmares and other sleep disturbances are associated with significant distress and daytime impairment and can interfere with PTSD recovery^4-8 by disrupting sleep-dependent processing of emotional experiences and causing repeated resensitization to trauma cues (Table 2).⁸

Table 2

Psychosocial consequences of sleep disruption in PTSD

Few randomized controlled medication trials specifically address PTSD-related nightmares. Most PTSD studies do not examine sleep outcomes as a primary measure, and comprehensive literature reviews could not offer evidence-based recommendations.^9,10 The American Academy of Sleep Medicine (AASM) also noted a paucity of PTSD studies that identified nightmares as a primary outcome measure.¹¹ See Table 3 for a list of recommended medication options for PTSD-associated nightmares.

Table 3

Recommended medication treatments for PTSD-associated nightmares

CASE CONTINUED: Medication change, improvement

After reviewing AASM’s treatment recommendations, we prescribe prazosin, 1 mg at bedtime for 7 nights, then increase by 1 mg at bedtime each week until Mr. S’s nightmares improve. He reports a substantial improvement in nightmare severity and frequency after a few weeks of treatment with prazosin, 5 mg at bedtime.

Prazosin

Prazosin is an α1-adrenergic receptor antagonist with good CNS penetrability. The rationale for reducing adrenergic activity to address intrusive PTSD symptoms has been well documented.^12,13 In open-label trials,^14-18 a chart review,¹⁹ and placebo-controlled trials,^20-22prazosin reduced trauma nightmares and improved sleep quality and global clinical status more than placebo (Table 4). In these studies, prazosin doses ranged from 1 to 20 mg/d, with an average of 3 mg at bedtime and a starting dose of 1 mg. Prazosin is the only agent recommended in the AASM’s Best Practice Guide for treating PTSD-related nightmares.¹¹

Table 4

RCTs of prazosin for trauma-related nightmares

Atypical antipsychotics

Atypical antipsychotics have been used to reduce nightmares in PTSD; however, most of the evidence from studies evaluated in the AASM’s Best Practice Guide were considered to be low quality.¹¹ Quetiapine and ziprasidone were not included in the AASM review. See (Table 5) for a review of the evidence for atypical antipsychotics for treating PTSD nightmares.

Table 5

Combat-related nightmares: Evidence for atypical antipsychotics

Comparing prazosin and quetiapine. A historical prospective cohort study of 237 veterans with PTSD receiving prazosin or quetiapine for nighttime PTSD symptoms demonstrated that although the 2 drugs have similar efficacy (defined as symptomatic improvement) for short-term, 6-month treatment (61% vs 62%; P=.54), a higher percentage of patients continued prazosin long-term (3 to 6 years) than those taking quetiapine (48% vs 24%; P < .001).²³ Twenty-five percent of patients taking quetiapine switched to prazosin during the study, and approximately one-half of these patients remained on prazosin until the study’s end. Only 8% of prazosin patients switched to quetiapine, and none continued this therapy until study end.²³ Patients in the quetiapine group were more likely to discontinue the drug because of lack of efficacy (13% vs 3%; P=.03) and adverse effects (35% vs 18%; P=.008), specifically sedation (21% vs 2%; P < .001) and metabolic effects (9% vs 0%; P=.014), compared with prazosin. Although this trial may be the only published comparison study of prazosin and quetiapine, its methodological quality has been questioned, which makes it difficult to draw definitive conclusions.

Metabolic syndrome—elevated diastolic blood pressure, increased waist circumference, and low high-density lipoprotein cholesterol—is common among PTSD patients treated with antipsychotics.²⁴ This syndrome may be caused by medications, lifestyle factors, or long-term overactivation of stress-response pathways. A retrospective chart review at a community mental health center revealed that patients taking even low doses of quetiapine for insomnia gained an average of 5 lbs (P=.037).²⁵ Another retrospective chart review at 2 military hospitals reported that patients receiving low-dose quetiapine (≤100 mg/d) gained an average of slightly less than 1 lb per month, which adds up to approximately 10 lbs per year (P < .001).²⁶ The benefit of using atypical antipsychotics may be outweighed by metabolic risks such as obesity, new-onset diabetes, and dyslipidemia.²⁷

Prazosin is considered a first-line treatment for sleep disturbances and nightmares in PTSD because of its superior long-term efficacy and decreased adverse effects compared with quetiapine.

Related Resources

• American Psychiatric Association. Practice guidelines for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Arlington, VA: American Psychiatric Publishing, Inc.; 2004.
• Veterans Affairs/Department of Defense clinical practice guidelines. Management of traumatic stress disorder and acute stress reaction. www.healthquality.va.gov/Post_Traumatic_Stress_Disorder_PTSD.asp.

Drug Brand Names

• Prazosin • Minipress
• Quetiapine • Seroquel
• Sertraline • Zoloft
• Ziprasidone • Geodon

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Mr. S, a 45-year-old veteran, was diagnosed with posttraumatic stress disorder (PTSD) 18 years ago after a tour of duty in the Persian Gulf. He had combat-related flashbacks triggered by the smell of gasoline or smoke from a fire, was easily startled, and began to isolate himself socially. However, his symptoms improved when he started volunteering at his local Veterans Affairs Medical Center. After he lost his job 3 years ago, Mr. S started experiencing flashbacks. He was irritable, easily startled, and avoided things that reminded him of his time in the Persian Gulf. His psychiatrist prescribed sertraline, titrated to 200 mg/d. The drug reduced the severity of his avoidance and hyperarousal symptoms and improved his mood.

During a clinic visit, Mr. S says he is doing well and can fall asleep at night but is having recurring nightmares about traumatic events that occurred during combat. These nightmares wake him up and have become more frequent, occurring once per night for the past month. Mr. S says he has been watching more news programs about conflicts in Afghanistan and Iraq since the nightmares began. His psychiatrist starts quetiapine, 50 mg at bedtime for 7 nights then 100 mg at bedtime, but after 6 weeks Mr. S says his nightmares continue.

PTSD occurs in approximately 19% of Vietnam war combat veterans¹ and 14% of service members returning from Iraq and Afghanistan.² PTSD symptoms are classified into clusters: intrusive/re-experiencing; avoidant/numbing; and hyperarousal.³ Nightmares are part of the intrusive/re-experiencing cluster, which is Criterion B in DSM-IV-TR. See Table 1 for a description of DSM-IV-TR PTSD criteria. Among PTSD patients, 50% to 70% report PTSD-associated nightmares.⁴ Despite adequate treatment targeted to improve PTSD’s core symptoms, symptoms such as sleep disturbances or nightmares often persist.

Table 1

DSM-IV-TR diagnostic criteria for posttraumatic stress disorder

Nightmares and other sleep disturbances are associated with significant distress and daytime impairment and can interfere with PTSD recovery^4-8 by disrupting sleep-dependent processing of emotional experiences and causing repeated resensitization to trauma cues (Table 2).⁸

Table 2

Psychosocial consequences of sleep disruption in PTSD

Few randomized controlled medication trials specifically address PTSD-related nightmares. Most PTSD studies do not examine sleep outcomes as a primary measure, and comprehensive literature reviews could not offer evidence-based recommendations.^9,10 The American Academy of Sleep Medicine (AASM) also noted a paucity of PTSD studies that identified nightmares as a primary outcome measure.¹¹ See Table 3 for a list of recommended medication options for PTSD-associated nightmares.

Table 3

Recommended medication treatments for PTSD-associated nightmares

CASE CONTINUED: Medication change, improvement

After reviewing AASM’s treatment recommendations, we prescribe prazosin, 1 mg at bedtime for 7 nights, then increase by 1 mg at bedtime each week until Mr. S’s nightmares improve. He reports a substantial improvement in nightmare severity and frequency after a few weeks of treatment with prazosin, 5 mg at bedtime.

Prazosin

Prazosin is an α1-adrenergic receptor antagonist with good CNS penetrability. The rationale for reducing adrenergic activity to address intrusive PTSD symptoms has been well documented.^12,13 In open-label trials,^14-18 a chart review,¹⁹ and placebo-controlled trials,^20-22prazosin reduced trauma nightmares and improved sleep quality and global clinical status more than placebo (Table 4). In these studies, prazosin doses ranged from 1 to 20 mg/d, with an average of 3 mg at bedtime and a starting dose of 1 mg. Prazosin is the only agent recommended in the AASM’s Best Practice Guide for treating PTSD-related nightmares.¹¹

Table 4

RCTs of prazosin for trauma-related nightmares

Atypical antipsychotics

Atypical antipsychotics have been used to reduce nightmares in PTSD; however, most of the evidence from studies evaluated in the AASM’s Best Practice Guide were considered to be low quality.¹¹ Quetiapine and ziprasidone were not included in the AASM review. See (Table 5) for a review of the evidence for atypical antipsychotics for treating PTSD nightmares.

Table 5

Combat-related nightmares: Evidence for atypical antipsychotics

Comparing prazosin and quetiapine. A historical prospective cohort study of 237 veterans with PTSD receiving prazosin or quetiapine for nighttime PTSD symptoms demonstrated that although the 2 drugs have similar efficacy (defined as symptomatic improvement) for short-term, 6-month treatment (61% vs 62%; P=.54), a higher percentage of patients continued prazosin long-term (3 to 6 years) than those taking quetiapine (48% vs 24%; P < .001).²³ Twenty-five percent of patients taking quetiapine switched to prazosin during the study, and approximately one-half of these patients remained on prazosin until the study’s end. Only 8% of prazosin patients switched to quetiapine, and none continued this therapy until study end.²³ Patients in the quetiapine group were more likely to discontinue the drug because of lack of efficacy (13% vs 3%; P=.03) and adverse effects (35% vs 18%; P=.008), specifically sedation (21% vs 2%; P < .001) and metabolic effects (9% vs 0%; P=.014), compared with prazosin. Although this trial may be the only published comparison study of prazosin and quetiapine, its methodological quality has been questioned, which makes it difficult to draw definitive conclusions.

Metabolic syndrome—elevated diastolic blood pressure, increased waist circumference, and low high-density lipoprotein cholesterol—is common among PTSD patients treated with antipsychotics.²⁴ This syndrome may be caused by medications, lifestyle factors, or long-term overactivation of stress-response pathways. A retrospective chart review at a community mental health center revealed that patients taking even low doses of quetiapine for insomnia gained an average of 5 lbs (P=.037).²⁵ Another retrospective chart review at 2 military hospitals reported that patients receiving low-dose quetiapine (≤100 mg/d) gained an average of slightly less than 1 lb per month, which adds up to approximately 10 lbs per year (P < .001).²⁶ The benefit of using atypical antipsychotics may be outweighed by metabolic risks such as obesity, new-onset diabetes, and dyslipidemia.²⁷

Prazosin is considered a first-line treatment for sleep disturbances and nightmares in PTSD because of its superior long-term efficacy and decreased adverse effects compared with quetiapine.

Related Resources

• American Psychiatric Association. Practice guidelines for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Arlington, VA: American Psychiatric Publishing, Inc.; 2004.
• Veterans Affairs/Department of Defense clinical practice guidelines. Management of traumatic stress disorder and acute stress reaction. www.healthquality.va.gov/Post_Traumatic_Stress_Disorder_PTSD.asp.

Drug Brand Names

• Prazosin • Minipress
• Quetiapine • Seroquel
• Sertraline • Zoloft
• Ziprasidone • Geodon

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Dear Dr. Mossman:
Could providing a “curbside” consultation to a colleague leave me medico legally vulnerable if an adverse event leads to a malpractice lawsuit? If so, what can I do to address this risk?—Submitted by “Dr. W”

Medicine is a collaborative profession. Surgeons often combine skills to perform complex operations together, and specialists pool their expertise when they collectively manage patients with several medical problems. Doctors share their knowledge when they give lectures to medical audiences, write reports to referring physicians, or respond verbally to colleagues’ requests for information or advice.¹

Doctors use the phrase “curbside consult” to refer (with humor and self-deprecation) to informal conversations with colleagues about patients’ medical management—advice-seeking that falls short of asking a colleague to make recommendations based on a formal, personal examination. Many physicians seek or provide curbside advice several times a month.² Curbside consults transmit knowledge and cement professional bonds among physicians, making them “an integral part of our medical culture.”³

More than a dozen legal decisions mention curbside consultations. Judges think informal information-sharing improves medical practice and don’t want doctors to stop soliciting ideas or offering suggestions because they fear lawsuits.^4,5 However, courts have found that, under certain conditions, giving advice can create liability for a bad outcome, even though the doctor never met the patient who was harmed.

In this article, we’ll look at:

• when such liability might occur, and
• what you can do to minimize it.

A doctor-patient relationship?

Legally, doctors are obligated to provide competent care for just 1 group of people: their patients. Therefore, to decide if plaintiffs could pursue malpractice claims in cases where doctors offered comments about patients they did not personally examine, courts have asked whether the circumstances, actions undertaken, or nature of information that was exchanged created a professional relationship.

Reynolds v Decatur Memorial Hospital⁴ describes an informal consultation that did not create a physician-patient relationship. In this case, a boy was admitted to a hospital after he had fallen. The treating pediatrician telephoned a neurosurgeon, who asked whether the boy’s neck was stiff, discussed diagnostic possibilities with the pediatrician, and suggested doing a lumbar puncture. The neurosurgeon offered to see the boy if requested, but he never did, and he did not bill for the telephone consultation. Guillain-Barré syndrome was first suspected, but a spinal cord injury was discovered after the boy—who developed quadriplegia—was transferred to another hospital.

In a subsequent lawsuit, the boy’s mother claimed her son’s paralysis resulted from negligence by the first hospital and its doctors, but the trial court dismissed the case against the neurosurgeon. Affirming the trial court’s ruling, an Illinois appeals court explained that the neurosurgeon had not been asked to provide medical services, conduct tests, or interpret test results. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed,” the Reynolds court said.

Campbell v Haber⁶ describes circumstances that differed slightly from those described in the Reynolds decision but appeared to create a doctor-patient relationship. Campbell concerned a patient who came to an emergency room (ER) complaining of chest pain. The ER physician’s findings indicated possible heart muscle damage, so he telephoned a cardiologist (whom the ER doctor believed was “on call”) and described the patient’s symptoms and test results. The cardiologist thought the test results were not consistent with a cardiac event. The ER physician told the patient and his wife about the cardiologist’s opinion and, relying on what the cardiologist said, discharged the patient. Shortly after, the patient had a heart attack.

The patient sued not just the ER physician, but the cardiologist, who sought dismissal from the suit because he never saw the patient, had no treatment relationship with him, and never billed for services. However, the trial judge ruled that the patient could sue the cardiologist and the appellate court agreed, saying that a jury had to decide whether the cardiologist had incurred a doctor-patient relationship and might be liable. “An implied physician-patient relationship may arise when a physician gives advice to a patient,” the appeals court said, “even if that advice is communicated through another health care professional.”

Telling the difference

So what differentiates a no-liability curbside consult from a medical discussion that creates a doctor-patient duty and potential for liability for adverse results?

You create a physician-patient relationship when you assume responsibility to diagnose or treat someone.⁷ Although typically this requires an in-person encounter with a patient, it can happen indirectly—electronically (through e-mail), by telephone, or through a family member or another professional. But if you do nothing that implies consent to act for the patient’s benefit, you should have no actual malpractice liability if something goes wrong.^3,8 As a Kansas Supreme Court decision explains, you “cannot be liable for medical malpractice” if you “merely consult with a treating physician and [do] nothing more.”⁵

Several legal cases discuss doctors’ efforts to extricate themselves from lawsuits arising from clinical encounters that the doctors mistakenly thought were just curbside consults. Table 1^8-12 lists situations in which talking about patients goes beyond just being “curbsided.”

Table 1

When it’s not a ‘curbside consultation’

How to respond

Should you decline to provide curbside consultations to keep yourself out of lawsuits? Some authors think so, pointing out that informally transmitted clinical data may be faulty, which means you may give bad advice based on incomplete information or a verbal misunderstanding.^13-16 These authors suggest that if you’re curbsided you should ask to see the patient for a formal consultation, decline to give informal advice, or provide a response that lacks specifics.

Other authors feel that these approaches are needlessly cautious and would harm patients by impeding doctors’ ability to help and learn from each other.^3,17 These authors think the risk of incurring liability from a curbside consult is low. Also, getting advice from a colleague is a valuable risk management strategy; it helps you make sure you’re on the right track, and it shows you are a thoughtful clinician whose patients benefit from your own and your colleagues’ medical expertise.

Even if you’re comfortable soliciting and providing curbside advice, sometimes circumstances make it wise to follow-up an informal initial inquiry with a formal consultation. Table 2^3,17 lists examples of when you should follow-up with a formal consultation.

Table 2

Considerations that favor formal consultation

Documentation

Experts disagree about whether the requesting or receiving physician should document a curbside consultation, and if so, how. On one hand, making a notation in a patient’s record documents the treating doctor’s diligence and may provide a measure of liability protection in a malpractice action. Doing this, however, exposes the identity of the consultant, who might be named among the defendants in a lawsuit.

One commonly recommended strategy is to request the consultant’s permission before identifying him or her in the record,^13,16,17 a position that is defensible on grounds of courtesy alone. But omitting a consultant’s name from record does not guarantee that the consultant’s involvement won’t be discovered in the course of litigation.³ For example, treating doctors who get sued often are asked during their depositions about whether they talked with anyone about the case, and they have to answer honestly.

If a consulted doctor makes written notes, it might suggest that the consultation was more than the sort of informal information-sharing implied by the term “curbside.” However, in the unlikely event that a lawsuit arose and included the consultant as a defendant, documentation of advice given would help the consultant recall and defend what was said.

Related Resources

• Grant-Kels JM, Kels BD. The curbside consultation: legal, moral, and ethical considerations. J Am Acad Dermatol. 2012;66(5):827-829.
• Kreichelt R, Hilbert ML, Shinn D. Minimizing the legal risk with ‘curbside’ consultation. J Healthc Risk Manag. 2008;28(1):27-29.
• Atkinson L. Curbside consults: what is your liability risk? Iowa Med. 2003;93(4):15.

Disclosure

Dr. Mossman reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Dear Dr. Mossman:
Could providing a “curbside” consultation to a colleague leave me medico legally vulnerable if an adverse event leads to a malpractice lawsuit? If so, what can I do to address this risk?—Submitted by “Dr. W”

Medicine is a collaborative profession. Surgeons often combine skills to perform complex operations together, and specialists pool their expertise when they collectively manage patients with several medical problems. Doctors share their knowledge when they give lectures to medical audiences, write reports to referring physicians, or respond verbally to colleagues’ requests for information or advice.¹

Doctors use the phrase “curbside consult” to refer (with humor and self-deprecation) to informal conversations with colleagues about patients’ medical management—advice-seeking that falls short of asking a colleague to make recommendations based on a formal, personal examination. Many physicians seek or provide curbside advice several times a month.² Curbside consults transmit knowledge and cement professional bonds among physicians, making them “an integral part of our medical culture.”³

More than a dozen legal decisions mention curbside consultations. Judges think informal information-sharing improves medical practice and don’t want doctors to stop soliciting ideas or offering suggestions because they fear lawsuits.^4,5 However, courts have found that, under certain conditions, giving advice can create liability for a bad outcome, even though the doctor never met the patient who was harmed.

In this article, we’ll look at:

• when such liability might occur, and
• what you can do to minimize it.

A doctor-patient relationship?

Legally, doctors are obligated to provide competent care for just 1 group of people: their patients. Therefore, to decide if plaintiffs could pursue malpractice claims in cases where doctors offered comments about patients they did not personally examine, courts have asked whether the circumstances, actions undertaken, or nature of information that was exchanged created a professional relationship.

Reynolds v Decatur Memorial Hospital⁴ describes an informal consultation that did not create a physician-patient relationship. In this case, a boy was admitted to a hospital after he had fallen. The treating pediatrician telephoned a neurosurgeon, who asked whether the boy’s neck was stiff, discussed diagnostic possibilities with the pediatrician, and suggested doing a lumbar puncture. The neurosurgeon offered to see the boy if requested, but he never did, and he did not bill for the telephone consultation. Guillain-Barré syndrome was first suspected, but a spinal cord injury was discovered after the boy—who developed quadriplegia—was transferred to another hospital.

In a subsequent lawsuit, the boy’s mother claimed her son’s paralysis resulted from negligence by the first hospital and its doctors, but the trial court dismissed the case against the neurosurgeon. Affirming the trial court’s ruling, an Illinois appeals court explained that the neurosurgeon had not been asked to provide medical services, conduct tests, or interpret test results. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed,” the Reynolds court said.

Campbell v Haber⁶ describes circumstances that differed slightly from those described in the Reynolds decision but appeared to create a doctor-patient relationship. Campbell concerned a patient who came to an emergency room (ER) complaining of chest pain. The ER physician’s findings indicated possible heart muscle damage, so he telephoned a cardiologist (whom the ER doctor believed was “on call”) and described the patient’s symptoms and test results. The cardiologist thought the test results were not consistent with a cardiac event. The ER physician told the patient and his wife about the cardiologist’s opinion and, relying on what the cardiologist said, discharged the patient. Shortly after, the patient had a heart attack.

The patient sued not just the ER physician, but the cardiologist, who sought dismissal from the suit because he never saw the patient, had no treatment relationship with him, and never billed for services. However, the trial judge ruled that the patient could sue the cardiologist and the appellate court agreed, saying that a jury had to decide whether the cardiologist had incurred a doctor-patient relationship and might be liable. “An implied physician-patient relationship may arise when a physician gives advice to a patient,” the appeals court said, “even if that advice is communicated through another health care professional.”

Telling the difference

So what differentiates a no-liability curbside consult from a medical discussion that creates a doctor-patient duty and potential for liability for adverse results?

You create a physician-patient relationship when you assume responsibility to diagnose or treat someone.⁷ Although typically this requires an in-person encounter with a patient, it can happen indirectly—electronically (through e-mail), by telephone, or through a family member or another professional. But if you do nothing that implies consent to act for the patient’s benefit, you should have no actual malpractice liability if something goes wrong.^3,8 As a Kansas Supreme Court decision explains, you “cannot be liable for medical malpractice” if you “merely consult with a treating physician and [do] nothing more.”⁵

Several legal cases discuss doctors’ efforts to extricate themselves from lawsuits arising from clinical encounters that the doctors mistakenly thought were just curbside consults. Table 1^8-12 lists situations in which talking about patients goes beyond just being “curbsided.”

Table 1

When it’s not a ‘curbside consultation’

How to respond

Should you decline to provide curbside consultations to keep yourself out of lawsuits? Some authors think so, pointing out that informally transmitted clinical data may be faulty, which means you may give bad advice based on incomplete information or a verbal misunderstanding.^13-16 These authors suggest that if you’re curbsided you should ask to see the patient for a formal consultation, decline to give informal advice, or provide a response that lacks specifics.

Other authors feel that these approaches are needlessly cautious and would harm patients by impeding doctors’ ability to help and learn from each other.^3,17 These authors think the risk of incurring liability from a curbside consult is low. Also, getting advice from a colleague is a valuable risk management strategy; it helps you make sure you’re on the right track, and it shows you are a thoughtful clinician whose patients benefit from your own and your colleagues’ medical expertise.

Even if you’re comfortable soliciting and providing curbside advice, sometimes circumstances make it wise to follow-up an informal initial inquiry with a formal consultation. Table 2^3,17 lists examples of when you should follow-up with a formal consultation.

Table 2

Considerations that favor formal consultation

Documentation

Experts disagree about whether the requesting or receiving physician should document a curbside consultation, and if so, how. On one hand, making a notation in a patient’s record documents the treating doctor’s diligence and may provide a measure of liability protection in a malpractice action. Doing this, however, exposes the identity of the consultant, who might be named among the defendants in a lawsuit.

One commonly recommended strategy is to request the consultant’s permission before identifying him or her in the record,^13,16,17 a position that is defensible on grounds of courtesy alone. But omitting a consultant’s name from record does not guarantee that the consultant’s involvement won’t be discovered in the course of litigation.³ For example, treating doctors who get sued often are asked during their depositions about whether they talked with anyone about the case, and they have to answer honestly.

If a consulted doctor makes written notes, it might suggest that the consultation was more than the sort of informal information-sharing implied by the term “curbside.” However, in the unlikely event that a lawsuit arose and included the consultant as a defendant, documentation of advice given would help the consultant recall and defend what was said.

Related Resources

• Grant-Kels JM, Kels BD. The curbside consultation: legal, moral, and ethical considerations. J Am Acad Dermatol. 2012;66(5):827-829.
• Kreichelt R, Hilbert ML, Shinn D. Minimizing the legal risk with ‘curbside’ consultation. J Healthc Risk Manag. 2008;28(1):27-29.
• Atkinson L. Curbside consults: what is your liability risk? Iowa Med. 2003;93(4):15.

Disclosure

Dr. Mossman reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Dear Dr. Mossman:
Could providing a “curbside” consultation to a colleague leave me medico legally vulnerable if an adverse event leads to a malpractice lawsuit? If so, what can I do to address this risk?—Submitted by “Dr. W”

Medicine is a collaborative profession. Surgeons often combine skills to perform complex operations together, and specialists pool their expertise when they collectively manage patients with several medical problems. Doctors share their knowledge when they give lectures to medical audiences, write reports to referring physicians, or respond verbally to colleagues’ requests for information or advice.¹

Doctors use the phrase “curbside consult” to refer (with humor and self-deprecation) to informal conversations with colleagues about patients’ medical management—advice-seeking that falls short of asking a colleague to make recommendations based on a formal, personal examination. Many physicians seek or provide curbside advice several times a month.² Curbside consults transmit knowledge and cement professional bonds among physicians, making them “an integral part of our medical culture.”³

More than a dozen legal decisions mention curbside consultations. Judges think informal information-sharing improves medical practice and don’t want doctors to stop soliciting ideas or offering suggestions because they fear lawsuits.^4,5 However, courts have found that, under certain conditions, giving advice can create liability for a bad outcome, even though the doctor never met the patient who was harmed.

In this article, we’ll look at:

• when such liability might occur, and
• what you can do to minimize it.

A doctor-patient relationship?

Legally, doctors are obligated to provide competent care for just 1 group of people: their patients. Therefore, to decide if plaintiffs could pursue malpractice claims in cases where doctors offered comments about patients they did not personally examine, courts have asked whether the circumstances, actions undertaken, or nature of information that was exchanged created a professional relationship.

Reynolds v Decatur Memorial Hospital⁴ describes an informal consultation that did not create a physician-patient relationship. In this case, a boy was admitted to a hospital after he had fallen. The treating pediatrician telephoned a neurosurgeon, who asked whether the boy’s neck was stiff, discussed diagnostic possibilities with the pediatrician, and suggested doing a lumbar puncture. The neurosurgeon offered to see the boy if requested, but he never did, and he did not bill for the telephone consultation. Guillain-Barré syndrome was first suspected, but a spinal cord injury was discovered after the boy—who developed quadriplegia—was transferred to another hospital.

In a subsequent lawsuit, the boy’s mother claimed her son’s paralysis resulted from negligence by the first hospital and its doctors, but the trial court dismissed the case against the neurosurgeon. Affirming the trial court’s ruling, an Illinois appeals court explained that the neurosurgeon had not been asked to provide medical services, conduct tests, or interpret test results. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed,” the Reynolds court said.

Campbell v Haber⁶ describes circumstances that differed slightly from those described in the Reynolds decision but appeared to create a doctor-patient relationship. Campbell concerned a patient who came to an emergency room (ER) complaining of chest pain. The ER physician’s findings indicated possible heart muscle damage, so he telephoned a cardiologist (whom the ER doctor believed was “on call”) and described the patient’s symptoms and test results. The cardiologist thought the test results were not consistent with a cardiac event. The ER physician told the patient and his wife about the cardiologist’s opinion and, relying on what the cardiologist said, discharged the patient. Shortly after, the patient had a heart attack.

The patient sued not just the ER physician, but the cardiologist, who sought dismissal from the suit because he never saw the patient, had no treatment relationship with him, and never billed for services. However, the trial judge ruled that the patient could sue the cardiologist and the appellate court agreed, saying that a jury had to decide whether the cardiologist had incurred a doctor-patient relationship and might be liable. “An implied physician-patient relationship may arise when a physician gives advice to a patient,” the appeals court said, “even if that advice is communicated through another health care professional.”

Telling the difference

So what differentiates a no-liability curbside consult from a medical discussion that creates a doctor-patient duty and potential for liability for adverse results?

You create a physician-patient relationship when you assume responsibility to diagnose or treat someone.⁷ Although typically this requires an in-person encounter with a patient, it can happen indirectly—electronically (through e-mail), by telephone, or through a family member or another professional. But if you do nothing that implies consent to act for the patient’s benefit, you should have no actual malpractice liability if something goes wrong.^3,8 As a Kansas Supreme Court decision explains, you “cannot be liable for medical malpractice” if you “merely consult with a treating physician and [do] nothing more.”⁵

Several legal cases discuss doctors’ efforts to extricate themselves from lawsuits arising from clinical encounters that the doctors mistakenly thought were just curbside consults. Table 1^8-12 lists situations in which talking about patients goes beyond just being “curbsided.”

Table 1

When it’s not a ‘curbside consultation’

How to respond

Should you decline to provide curbside consultations to keep yourself out of lawsuits? Some authors think so, pointing out that informally transmitted clinical data may be faulty, which means you may give bad advice based on incomplete information or a verbal misunderstanding.^13-16 These authors suggest that if you’re curbsided you should ask to see the patient for a formal consultation, decline to give informal advice, or provide a response that lacks specifics.

Other authors feel that these approaches are needlessly cautious and would harm patients by impeding doctors’ ability to help and learn from each other.^3,17 These authors think the risk of incurring liability from a curbside consult is low. Also, getting advice from a colleague is a valuable risk management strategy; it helps you make sure you’re on the right track, and it shows you are a thoughtful clinician whose patients benefit from your own and your colleagues’ medical expertise.

Even if you’re comfortable soliciting and providing curbside advice, sometimes circumstances make it wise to follow-up an informal initial inquiry with a formal consultation. Table 2^3,17 lists examples of when you should follow-up with a formal consultation.

Table 2

Considerations that favor formal consultation

Documentation

Experts disagree about whether the requesting or receiving physician should document a curbside consultation, and if so, how. On one hand, making a notation in a patient’s record documents the treating doctor’s diligence and may provide a measure of liability protection in a malpractice action. Doing this, however, exposes the identity of the consultant, who might be named among the defendants in a lawsuit.

One commonly recommended strategy is to request the consultant’s permission before identifying him or her in the record,^13,16,17 a position that is defensible on grounds of courtesy alone. But omitting a consultant’s name from record does not guarantee that the consultant’s involvement won’t be discovered in the course of litigation.³ For example, treating doctors who get sued often are asked during their depositions about whether they talked with anyone about the case, and they have to answer honestly.

If a consulted doctor makes written notes, it might suggest that the consultation was more than the sort of informal information-sharing implied by the term “curbside.” However, in the unlikely event that a lawsuit arose and included the consultant as a defendant, documentation of advice given would help the consultant recall and defend what was said.

Related Resources

• Grant-Kels JM, Kels BD. The curbside consultation: legal, moral, and ethical considerations. J Am Acad Dermatol. 2012;66(5):827-829.
• Kreichelt R, Hilbert ML, Shinn D. Minimizing the legal risk with ‘curbside’ consultation. J Healthc Risk Manag. 2008;28(1):27-29.
• Atkinson L. Curbside consults: what is your liability risk? Iowa Med. 2003;93(4):15.

Disclosure

Dr. Mossman reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Although cholinesterase inhibitors (ChEIs) and memantine at standard doses may slow the progression of Alzheimer’s disease (AD) as assessed by cognitive, functional, and global measures, this effect is relatively modest. For the estimated 5.4 million Americans with AD¹—more than one-half of whom have moderate to severe disease²—there is a great need for new approaches to slow AD progression.

High doses of donepezil or memantine may be the next step in achieving better results than standard pharmacologic treatments for AD. This article presents the possible benefits and indications for high doses of donepezil (23 mg/d) and memantine (28 mg/d) for managing moderate to severe AD and their safety and tolerability profiles.

Current treatments offer modest benefits

AD treatments comprise 2 categories: ChEIs (donepezil, rivastigmine, and galantamine) and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine (Table 1).^3,4 All ChEIs are FDA-approved for mild to moderate AD; donepezil also is approved for severe AD. Memantine is approved for moderate to severe AD, either alone or in combination with ChEIs. Until recently, the maximum FDA-approved doses were donepezil, 10 mg/d, and memantine, 20 mg/d. However, these dosages are associated with only modest beneficial effects in managing cognitive deterioration in patients with moderate to severe dementia.^5,6 Studies have reported that combining a ChEI, such as donepezil, and memantine is well tolerated and may result in synergistic benefits by affecting different neurotransmitters in patients with moderate to severe AD.^7,8

Recently, the FDA approved higher daily doses of donepezil (23 mg) and memantine (28 mg) for moderate to severe AD on the basis of positive phase III trial results.^9-11 Donepezil, 23 mg/d, currently is marketed in the United States; the availability date for memantine, 28 mg/d, was undetermined at press time.

Table 1

FDA-approved treatments for Alzheimer’s disease

High-dose donepezil (23 mg/d)

Cognitive decline with AD has been associated with increasing loss of cholinergic neurons and cholinergic activities, particularly in areas associated with memory/cognition and learning, including cortical areas involving the temporal lobe, hippocampus, and nucleus basalis of Meynert.^12-14 In addition, evidence suggests that increasing levels of acetylcholine by using ChEIs can enhance cognitive function.^13,15

Donepezil is a selective, reversible ChEI believed to enhance central cholinergic function.¹⁵ Randomized clinical trials assessing dose-response with donepezil, 5 mg/d and 10 mg/d, have demonstrated more benefit in cognition with either dose than placebo. The 10 mg/d dose was more effective than 5 mg/d in patients with mild to moderate and severe AD.^16-18 In patients with advanced AD who are stable on 5 mg/d, increasing to 10 mg/d could slow the progression of cognitive decline.¹⁸

Rationale for higher doses. Positron emission tomography studies have shown that at stable doses of donepezil, 5 mg/d or 10 mg/d, average cortical acetylcholinesterase (AChE) inhibition was <30%.^19,20 Based on these findings, researchers thought that cortical AChE inhibition may be suboptimal with donepezil, 10 mg/d, and that higher doses of ChEI may be required in patients with more advanced AD—and therefore more cholinergic loss—for adequate cholinesterase inhibition. In a pilot study of patients with mild to moderate AD, higher doses of donepezil (15 mg/d and 20 mg/d) were reported to be safe and well tolerated.²¹

The 23-mg/d donepezil formulation was developed to provide a higher dose administered once daily without a sharp rise in peak concentration. The FDA approved donepezil, 23 mg/d, for patients with moderate to severe AD on the basis of phase III trial results.^9,22 In a randomized, double-blind, multicenter, head-to-head clinical trial, >1,400 patients with moderate to severe AD (Mini-Mental State Exam [MMSE]: 0 to 20) on a stable dose of donepezil, 10 mg/d, for ≥3 months were randomly assigned to receive high-dose donepezil (23 mg/d) or standard-dose donepezil (10 mg/d) for 24 weeks.^9,22 Patients in the 23-mg/d group showed a statistically significant improvement in cognition compared with the 10-mg/d group. The difference between groups on a measure of global improvement was not significant.^9,22 However, in a post-hoc analysis, it was demonstrated that a subgroup of patients with more severe cognitive impairment (baseline MMSE: 0 to 16), showed significant improvement in cognition as well as global functioning.⁹

Overall, treatment-emergent adverse events (TEAEs) during the study were higher in patients receiving 23 mg/d (74%) than those receiving 10 mg/d (64%). The most common TEAEs in the 23-mg/d and 10-mg/d groups were nausea (12% vs 3%, respectively), vomiting (9% vs 3%), and diarrhea (8% vs 5%) (Table 2).²² These gastrointestinal adverse effects were more frequent during the first month of treatment and were relatively infrequent beyond 1 month. Serious TEAEs, such as falls, urinary tract infection, pneumonia, syncope, aggression, and confusional state, were noted in a similar proportion of patients in the 23-mg/d and 10-mg/d groups; most of these were considered unrelated to treatment. No drug-related deaths occurred during the study. High-dose (23 mg/d) donepezil generally was well tolerated, with a typical ChEI safety profile but superior efficacy.

A recent commentary discussed the issue of effect size and whether a 2.2-point difference on a 100-point scale (the Severe Impairment Battery [SIB]) is clinically meaningful.²³ As with all anti-dementia therapies, in any cohort some patients will gain considerably more than 2.2 points on the SIB, which is clinically significant. A 6-month trial is recommended to identify these optimal responders.

Table 2

High-dose vs standard-dose donepezil: Treatment-emergent adverse events