Q&A

BACKGROUND: Population-based screening for fecal occult blood has been shown to reduce mortality from colorectal cancer. Unfortunately, low fecal occult blood testing (FOBT) participation rates limit the potential impact of this screening intervention. One reason that patients choose not to complete and return their FOBT cards may be that they have difficulty following the recommended pretesting dietary restrictions. Substances that patients are often instructed to avoid before FOBT include red meat, fresh fruits and vegetables, vitamin C, iron, and nonsteroidal anti-inflammatory drugs.

POPULATION STUDIED: Participants in the studies included American Association of Retired Persons members (n=3783), patients of 32 Canadian Family Physicians (n=5003), patients in a single British general practice (n=153), patients aged 40 to 74 years not otherwise specified (n=634), and Veterans Affairs hospital patients (n=786).

STUDY DESIGN AND VALIDITY: Five randomized controlled trials were included in the meta-analysis. These trials were identified by a structured MEDLINE search augmented by hand searching and by contacting experts. All 5 studies randomized participants to either a dietary restrictions or no dietary restrictions arm before FOBT and reported screening completion rates for each arm. The authors do not specifically mention searching for unpublished trials, an important consideration in meta-analytic studies. Published studies are more likely to have positive results and this publication bias makes it more likely that the meta-analysis results will show a positive effect.

OUTCOMES MEASURED: The primary outcome was the difference between the completion rates of FOBT in the dietary restriction arm and the no dietary restriction arm. As a secondary outcome the investigators looked at positivity rates or the percentage of positive FOBT results among completed tests in each arm. Positivity rates are used here as a proxy for test specificity, which we would expect to be improved by dietary restriction.

RESULTS: When patients were counseled to avoid certain foods before obtaining a fecal sample, completion rates of FOBT across the studies ranged from 18.1% to 80.4%. This wide range of completion rates suggests heterogeneity in the interventions. It also suggests that factors other than dietary restriction may account for most of the difference in completion rates. Only one study showed a significant difference between the dietary restriction arm and the no dietary restriction arm. This study was the smallest of the 5 trials, and it had relatively complex dietary restrictions. There was no significant difference between positivity rates in any of the individual trials or in the pooled difference.

BACKGROUND: Population-based screening for fecal occult blood has been shown to reduce mortality from colorectal cancer. Unfortunately, low fecal occult blood testing (FOBT) participation rates limit the potential impact of this screening intervention. One reason that patients choose not to complete and return their FOBT cards may be that they have difficulty following the recommended pretesting dietary restrictions. Substances that patients are often instructed to avoid before FOBT include red meat, fresh fruits and vegetables, vitamin C, iron, and nonsteroidal anti-inflammatory drugs.

POPULATION STUDIED: Participants in the studies included American Association of Retired Persons members (n=3783), patients of 32 Canadian Family Physicians (n=5003), patients in a single British general practice (n=153), patients aged 40 to 74 years not otherwise specified (n=634), and Veterans Affairs hospital patients (n=786).

STUDY DESIGN AND VALIDITY: Five randomized controlled trials were included in the meta-analysis. These trials were identified by a structured MEDLINE search augmented by hand searching and by contacting experts. All 5 studies randomized participants to either a dietary restrictions or no dietary restrictions arm before FOBT and reported screening completion rates for each arm. The authors do not specifically mention searching for unpublished trials, an important consideration in meta-analytic studies. Published studies are more likely to have positive results and this publication bias makes it more likely that the meta-analysis results will show a positive effect.

OUTCOMES MEASURED: The primary outcome was the difference between the completion rates of FOBT in the dietary restriction arm and the no dietary restriction arm. As a secondary outcome the investigators looked at positivity rates or the percentage of positive FOBT results among completed tests in each arm. Positivity rates are used here as a proxy for test specificity, which we would expect to be improved by dietary restriction.

RESULTS: When patients were counseled to avoid certain foods before obtaining a fecal sample, completion rates of FOBT across the studies ranged from 18.1% to 80.4%. This wide range of completion rates suggests heterogeneity in the interventions. It also suggests that factors other than dietary restriction may account for most of the difference in completion rates. Only one study showed a significant difference between the dietary restriction arm and the no dietary restriction arm. This study was the smallest of the 5 trials, and it had relatively complex dietary restrictions. There was no significant difference between positivity rates in any of the individual trials or in the pooled difference.

BACKGROUND: Population-based screening for fecal occult blood has been shown to reduce mortality from colorectal cancer. Unfortunately, low fecal occult blood testing (FOBT) participation rates limit the potential impact of this screening intervention. One reason that patients choose not to complete and return their FOBT cards may be that they have difficulty following the recommended pretesting dietary restrictions. Substances that patients are often instructed to avoid before FOBT include red meat, fresh fruits and vegetables, vitamin C, iron, and nonsteroidal anti-inflammatory drugs.

POPULATION STUDIED: Participants in the studies included American Association of Retired Persons members (n=3783), patients of 32 Canadian Family Physicians (n=5003), patients in a single British general practice (n=153), patients aged 40 to 74 years not otherwise specified (n=634), and Veterans Affairs hospital patients (n=786).

STUDY DESIGN AND VALIDITY: Five randomized controlled trials were included in the meta-analysis. These trials were identified by a structured MEDLINE search augmented by hand searching and by contacting experts. All 5 studies randomized participants to either a dietary restrictions or no dietary restrictions arm before FOBT and reported screening completion rates for each arm. The authors do not specifically mention searching for unpublished trials, an important consideration in meta-analytic studies. Published studies are more likely to have positive results and this publication bias makes it more likely that the meta-analysis results will show a positive effect.

OUTCOMES MEASURED: The primary outcome was the difference between the completion rates of FOBT in the dietary restriction arm and the no dietary restriction arm. As a secondary outcome the investigators looked at positivity rates or the percentage of positive FOBT results among completed tests in each arm. Positivity rates are used here as a proxy for test specificity, which we would expect to be improved by dietary restriction.

RESULTS: When patients were counseled to avoid certain foods before obtaining a fecal sample, completion rates of FOBT across the studies ranged from 18.1% to 80.4%. This wide range of completion rates suggests heterogeneity in the interventions. It also suggests that factors other than dietary restriction may account for most of the difference in completion rates. Only one study showed a significant difference between the dietary restriction arm and the no dietary restriction arm. This study was the smallest of the 5 trials, and it had relatively complex dietary restrictions. There was no significant difference between positivity rates in any of the individual trials or in the pooled difference.

BACKGROUND: Syncope is a very common complaint in primary care and is often very difficult to diagnose. Most previous studies have focused only on high-risk patients and on selected diagnostic tests.

POPULATION STUDIED: All patients were eligible for inclusion who were 18 years or older and who presented to the emergency department (ED) of a large primary and tertiary care teaching hospital with a chief complaint of syncope. Syncope was defined as a sudden transient loss of consciousness with an inability to maintain postural tone, with spontaneous recovery. Patients with a seizure disorder, vertigo, dizziness, coma, or shock were excluded. Of 788 eligible patients, 115 did not complete the standardized evaluation, and 23 refused to participate. The remaining 650 patients ranged in age from 18 to 93 years (mean age = 60 years) and represented both men and women equally.

STUDY DESIGN AND VALIDITY: Patients underwent a standard evaluation including a complete history and physical examination, laboratory evaluation (hematocrit, serum creatine kinase and glucose), electrocardiogram (EKG), testing for orthostatic hypotension, and bilateral carotid massage unless contraindicated. If this approach did not lead to a diagnosis, a second series of tests was conducted: 24-hour Holter monitoring, ambulatory loop monitoring or electrophysiologic studies as guided by an abnormal EKG, or a tilt-table test to identify neurocardiogenic or orthostatic syncope. A committee of 2 internists and a cardiologist reviewed the findings of each case, and explicit and reproducible criteria were used to verify the etiology of the syncope. Some of the diagnoses relied on clinical judgment, since no gold standard reference was available.

OUTCOMES MEASURED: The cause of syncope for each patient based on the sequential evaluation. Follow-up information about mortality and recurrent syncope was obtained at 3 6-month intervals from primary physicians, patients, or their families.

RESULTS: A diagnosis was made in 69% of patients following the initial round of examination. In this group, vasovagal disorders accounted for 53% of the diagnoses, along with orthostatic hypotension (35%), arrhythmia (5%), and other causes (5%). Targeted testing was performed in 67 patients, and the suspected diagnosis was confirmed in an additional 49 patients (8%). Extensive cardiovascular testing of 122 of the remaining 155 patients established a diagnosis in 30 of them through the use of Holter or ambulatory loop monitoring, tilt-table, or electrophysiologic testing. No etiology was found in 92 patients (14%). Overall mortality (9% over 18 months) and sudden death were more common among patients with cardiac causes of syncope compared with other causes of syncope.

BACKGROUND: Syncope is a very common complaint in primary care and is often very difficult to diagnose. Most previous studies have focused only on high-risk patients and on selected diagnostic tests.

POPULATION STUDIED: All patients were eligible for inclusion who were 18 years or older and who presented to the emergency department (ED) of a large primary and tertiary care teaching hospital with a chief complaint of syncope. Syncope was defined as a sudden transient loss of consciousness with an inability to maintain postural tone, with spontaneous recovery. Patients with a seizure disorder, vertigo, dizziness, coma, or shock were excluded. Of 788 eligible patients, 115 did not complete the standardized evaluation, and 23 refused to participate. The remaining 650 patients ranged in age from 18 to 93 years (mean age = 60 years) and represented both men and women equally.

STUDY DESIGN AND VALIDITY: Patients underwent a standard evaluation including a complete history and physical examination, laboratory evaluation (hematocrit, serum creatine kinase and glucose), electrocardiogram (EKG), testing for orthostatic hypotension, and bilateral carotid massage unless contraindicated. If this approach did not lead to a diagnosis, a second series of tests was conducted: 24-hour Holter monitoring, ambulatory loop monitoring or electrophysiologic studies as guided by an abnormal EKG, or a tilt-table test to identify neurocardiogenic or orthostatic syncope. A committee of 2 internists and a cardiologist reviewed the findings of each case, and explicit and reproducible criteria were used to verify the etiology of the syncope. Some of the diagnoses relied on clinical judgment, since no gold standard reference was available.

OUTCOMES MEASURED: The cause of syncope for each patient based on the sequential evaluation. Follow-up information about mortality and recurrent syncope was obtained at 3 6-month intervals from primary physicians, patients, or their families.

RESULTS: A diagnosis was made in 69% of patients following the initial round of examination. In this group, vasovagal disorders accounted for 53% of the diagnoses, along with orthostatic hypotension (35%), arrhythmia (5%), and other causes (5%). Targeted testing was performed in 67 patients, and the suspected diagnosis was confirmed in an additional 49 patients (8%). Extensive cardiovascular testing of 122 of the remaining 155 patients established a diagnosis in 30 of them through the use of Holter or ambulatory loop monitoring, tilt-table, or electrophysiologic testing. No etiology was found in 92 patients (14%). Overall mortality (9% over 18 months) and sudden death were more common among patients with cardiac causes of syncope compared with other causes of syncope.

BACKGROUND: Syncope is a very common complaint in primary care and is often very difficult to diagnose. Most previous studies have focused only on high-risk patients and on selected diagnostic tests.

POPULATION STUDIED: All patients were eligible for inclusion who were 18 years or older and who presented to the emergency department (ED) of a large primary and tertiary care teaching hospital with a chief complaint of syncope. Syncope was defined as a sudden transient loss of consciousness with an inability to maintain postural tone, with spontaneous recovery. Patients with a seizure disorder, vertigo, dizziness, coma, or shock were excluded. Of 788 eligible patients, 115 did not complete the standardized evaluation, and 23 refused to participate. The remaining 650 patients ranged in age from 18 to 93 years (mean age = 60 years) and represented both men and women equally.

STUDY DESIGN AND VALIDITY: Patients underwent a standard evaluation including a complete history and physical examination, laboratory evaluation (hematocrit, serum creatine kinase and glucose), electrocardiogram (EKG), testing for orthostatic hypotension, and bilateral carotid massage unless contraindicated. If this approach did not lead to a diagnosis, a second series of tests was conducted: 24-hour Holter monitoring, ambulatory loop monitoring or electrophysiologic studies as guided by an abnormal EKG, or a tilt-table test to identify neurocardiogenic or orthostatic syncope. A committee of 2 internists and a cardiologist reviewed the findings of each case, and explicit and reproducible criteria were used to verify the etiology of the syncope. Some of the diagnoses relied on clinical judgment, since no gold standard reference was available.

OUTCOMES MEASURED: The cause of syncope for each patient based on the sequential evaluation. Follow-up information about mortality and recurrent syncope was obtained at 3 6-month intervals from primary physicians, patients, or their families.

RESULTS: A diagnosis was made in 69% of patients following the initial round of examination. In this group, vasovagal disorders accounted for 53% of the diagnoses, along with orthostatic hypotension (35%), arrhythmia (5%), and other causes (5%). Targeted testing was performed in 67 patients, and the suspected diagnosis was confirmed in an additional 49 patients (8%). Extensive cardiovascular testing of 122 of the remaining 155 patients established a diagnosis in 30 of them through the use of Holter or ambulatory loop monitoring, tilt-table, or electrophysiologic testing. No etiology was found in 92 patients (14%). Overall mortality (9% over 18 months) and sudden death were more common among patients with cardiac causes of syncope compared with other causes of syncope.

BACKGROUND: Many people come to physicians with acute chest pain, and it is difficult to sort out those who have potentially dangerous AMI and unstable angina from the many with more benign conditions that do not require hospital admission. Traditionally, this “rule out” process has required a hospital stay with numerous measurements of cardiac enzymes often taking more than 24 hours and includes electrocardiogram (EKG) monitoring.

POPULATION STUDIED: The researchers of this study enrolled 383 consecutive patients presenting over a 12-month period to an inner-city emergency department in Manchester, England, with chest pain of low to moderate risk of AMI (the end prevalence of AMI in study participants was 18%). Patients were eligible if they were older than 25 years, had chest pain for less than 12 hours, had no history of trauma or other medical causes, no EKG evidence of AMI or ischemia, and no hypotension or arrhythmia.

STUDY DESIGN AND VALIDITY: This is a cohort study that entered consecutive patients in a 6-hour study protocol. This rule-out protocol consisted of continuous 12-lead ST segment monitoring and serial measurement of creatine kinase, myocardial bound (CK-MB) mass. CK-MB was measured 3 hours and 6 hours after the onset of pain, and after 6 hours of monitoring in patients with chest pain of less than 3 hours’ duration. If chest pain had lasted 3 to 12 hours the CK-MB was measured on arrival and 3 hours later. Patients were ruled in if any of the CK-MB test results were positive or if an important change in the ST segment occurred, and ruled out if no changes occurred. Patients with a positive result were admitted, and discharged patients returned 2 days later for measurement of troponin T, which was used as the gold standard. A level of 0.1 μg per mL indicated myocardial damage. Patients were also asked to return to the clinic at 1 month for a history, examination, and EKG.

OUTCOMES MEASURED: The primary outcome was to determine the number of patients with an elevated 2-day troponin T level given a diagnosis of AMI. Patients also followed up at 1 month with examination and EKG, but it is unclear how many did so.

RESULTS: Of the 383 patients who began the study protocol, 368 completed the initial 6-hour assessment. Fifty-three were protocol positive with either elevated CK-MB levels or ST segment changes; by the gold standard tests 18 patients had false-positive results. Only 292 had the follow-up 2-day troponin T value measured, with 11 people withdrawing from follow-up and the 65 others not returning for the 2-day blood test, making study results available for 76% of the original participants. Of the 239 people who had no initial CK-MB or ST segment changes, 238 had negative troponin T values, and one had a borderline increase in troponin T of 1.1 μg per L. The sensitivity of the diagnostic test was 97.2% (95% confidence interval [CI], 95%-99%), and specificity was 93% (95% CI, 90%-96%). At a prevalence of 18%, which may be higher than some primary care populations, the protocol will correctly rule out patients without MI 99.6% of the time and correctly rule in patients 66% of the time (positive likelihood ratio = 13.9; negative likelihood ratio = 0.03).

BACKGROUND: Many people come to physicians with acute chest pain, and it is difficult to sort out those who have potentially dangerous AMI and unstable angina from the many with more benign conditions that do not require hospital admission. Traditionally, this “rule out” process has required a hospital stay with numerous measurements of cardiac enzymes often taking more than 24 hours and includes electrocardiogram (EKG) monitoring.

POPULATION STUDIED: The researchers of this study enrolled 383 consecutive patients presenting over a 12-month period to an inner-city emergency department in Manchester, England, with chest pain of low to moderate risk of AMI (the end prevalence of AMI in study participants was 18%). Patients were eligible if they were older than 25 years, had chest pain for less than 12 hours, had no history of trauma or other medical causes, no EKG evidence of AMI or ischemia, and no hypotension or arrhythmia.

STUDY DESIGN AND VALIDITY: This is a cohort study that entered consecutive patients in a 6-hour study protocol. This rule-out protocol consisted of continuous 12-lead ST segment monitoring and serial measurement of creatine kinase, myocardial bound (CK-MB) mass. CK-MB was measured 3 hours and 6 hours after the onset of pain, and after 6 hours of monitoring in patients with chest pain of less than 3 hours’ duration. If chest pain had lasted 3 to 12 hours the CK-MB was measured on arrival and 3 hours later. Patients were ruled in if any of the CK-MB test results were positive or if an important change in the ST segment occurred, and ruled out if no changes occurred. Patients with a positive result were admitted, and discharged patients returned 2 days later for measurement of troponin T, which was used as the gold standard. A level of 0.1 μg per mL indicated myocardial damage. Patients were also asked to return to the clinic at 1 month for a history, examination, and EKG.

OUTCOMES MEASURED: The primary outcome was to determine the number of patients with an elevated 2-day troponin T level given a diagnosis of AMI. Patients also followed up at 1 month with examination and EKG, but it is unclear how many did so.

RESULTS: Of the 383 patients who began the study protocol, 368 completed the initial 6-hour assessment. Fifty-three were protocol positive with either elevated CK-MB levels or ST segment changes; by the gold standard tests 18 patients had false-positive results. Only 292 had the follow-up 2-day troponin T value measured, with 11 people withdrawing from follow-up and the 65 others not returning for the 2-day blood test, making study results available for 76% of the original participants. Of the 239 people who had no initial CK-MB or ST segment changes, 238 had negative troponin T values, and one had a borderline increase in troponin T of 1.1 μg per L. The sensitivity of the diagnostic test was 97.2% (95% confidence interval [CI], 95%-99%), and specificity was 93% (95% CI, 90%-96%). At a prevalence of 18%, which may be higher than some primary care populations, the protocol will correctly rule out patients without MI 99.6% of the time and correctly rule in patients 66% of the time (positive likelihood ratio = 13.9; negative likelihood ratio = 0.03).

BACKGROUND: Many people come to physicians with acute chest pain, and it is difficult to sort out those who have potentially dangerous AMI and unstable angina from the many with more benign conditions that do not require hospital admission. Traditionally, this “rule out” process has required a hospital stay with numerous measurements of cardiac enzymes often taking more than 24 hours and includes electrocardiogram (EKG) monitoring.

POPULATION STUDIED: The researchers of this study enrolled 383 consecutive patients presenting over a 12-month period to an inner-city emergency department in Manchester, England, with chest pain of low to moderate risk of AMI (the end prevalence of AMI in study participants was 18%). Patients were eligible if they were older than 25 years, had chest pain for less than 12 hours, had no history of trauma or other medical causes, no EKG evidence of AMI or ischemia, and no hypotension or arrhythmia.

STUDY DESIGN AND VALIDITY: This is a cohort study that entered consecutive patients in a 6-hour study protocol. This rule-out protocol consisted of continuous 12-lead ST segment monitoring and serial measurement of creatine kinase, myocardial bound (CK-MB) mass. CK-MB was measured 3 hours and 6 hours after the onset of pain, and after 6 hours of monitoring in patients with chest pain of less than 3 hours’ duration. If chest pain had lasted 3 to 12 hours the CK-MB was measured on arrival and 3 hours later. Patients were ruled in if any of the CK-MB test results were positive or if an important change in the ST segment occurred, and ruled out if no changes occurred. Patients with a positive result were admitted, and discharged patients returned 2 days later for measurement of troponin T, which was used as the gold standard. A level of 0.1 μg per mL indicated myocardial damage. Patients were also asked to return to the clinic at 1 month for a history, examination, and EKG.

OUTCOMES MEASURED: The primary outcome was to determine the number of patients with an elevated 2-day troponin T level given a diagnosis of AMI. Patients also followed up at 1 month with examination and EKG, but it is unclear how many did so.

RESULTS: Of the 383 patients who began the study protocol, 368 completed the initial 6-hour assessment. Fifty-three were protocol positive with either elevated CK-MB levels or ST segment changes; by the gold standard tests 18 patients had false-positive results. Only 292 had the follow-up 2-day troponin T value measured, with 11 people withdrawing from follow-up and the 65 others not returning for the 2-day blood test, making study results available for 76% of the original participants. Of the 239 people who had no initial CK-MB or ST segment changes, 238 had negative troponin T values, and one had a borderline increase in troponin T of 1.1 μg per L. The sensitivity of the diagnostic test was 97.2% (95% confidence interval [CI], 95%-99%), and specificity was 93% (95% CI, 90%-96%). At a prevalence of 18%, which may be higher than some primary care populations, the protocol will correctly rule out patients without MI 99.6% of the time and correctly rule in patients 66% of the time (positive likelihood ratio = 13.9; negative likelihood ratio = 0.03).

BACKGROUND: Episiotomy was initially used based on theoretical benefit, with little evidence supporting claims that it prevented severe perineal lacerations or pelvic floor dysfunction. As principles of evidence-based medicine have begun to influence obstetrical practice, the utility of routine episiotomy has been called into question. Several observational studies have suggested that episiotomy increases the risk of third- and fourth-degree lacerations. A recent Cochrane review of 6 randomized controlled clinical trials comparing routine versus restricted use of episiotomy showed that episiotomy was associated with more second-degree perineal trauma, without significant differences in dyspareunia, severe perineal trauma, or severe pain. Although all but one of the trials included in the review used mediolateral episiotomy, the one randomized trial conducted in North America (which used midline episiotomy) showed similar results. Despite these data, episiotomy remains a common practice performed in more than 40% of deliveries in the United States.

POPULATION STUDIED: The authors of this study enrolled 80 pregnant women at term who had not had previous vaginal deliveries. The 62 who went on to have vaginal deliveries were included in the analysis. The participants’ mean age was 26.3 years. The majority (92%) had prenatal care, and most (88%) had epidural analgesia during labor. Approximately one fourth of the women (28%) had forceps or vacuum-assisted delivery. A few had malpresentations, with 6% in the occiput posterior position.

STUDY DESIGN AND VALIDITY: This small observational study looked at a range of variables hypothesized to be related to perineal laceration length, including maternal demographics, size of genital hiatus and perineal body, fetal size and presentation, duration of second stage of labor, level of experience of birth attendant, operative vaginal delivery, and episiotomy. After delivery, one of the study authors measured perineal laceration length, and for 10 patients 3 additional observers measured laceration length to assess inter-rater reliability. Observers were blinded to one another’s measurements but not to the other variables included in the analysis. The authors used logistic regression and Mann-Whitney U test to determine which variables were associated with laceration length.

OUTCOMES MEASURED: Perineal laceration length was the primary outcome measured in this study. The authors also assessed laceration severity. The study did not include variables relevant to quality of life, such as healing complications, severity of pain, duration of symptoms, dyspareunia, or incontinence.

RESULTS: Of the 62 patients in the final analysis, 76% had a perineal laceration, with a median length of 4 cm. Five patients (8%) had a third-degree laceration, and one patient (2%) had a fourth-degree laceration. Approximately half (44%) had an episiotomy. The mean laceration length was 3 cm longer for patients who had an episiotomy (4.9 cm vs 1.9 cm; P < 001). Patients who had a forceps- or vacuum-assisted delivery had a longer average length of laceration, but this association was not independent of episiotomy. When assisted deliveries were excluded from the analysis, the association between episiotomy and laceration length remained significant.

BACKGROUND: Episiotomy was initially used based on theoretical benefit, with little evidence supporting claims that it prevented severe perineal lacerations or pelvic floor dysfunction. As principles of evidence-based medicine have begun to influence obstetrical practice, the utility of routine episiotomy has been called into question. Several observational studies have suggested that episiotomy increases the risk of third- and fourth-degree lacerations. A recent Cochrane review of 6 randomized controlled clinical trials comparing routine versus restricted use of episiotomy showed that episiotomy was associated with more second-degree perineal trauma, without significant differences in dyspareunia, severe perineal trauma, or severe pain. Although all but one of the trials included in the review used mediolateral episiotomy, the one randomized trial conducted in North America (which used midline episiotomy) showed similar results. Despite these data, episiotomy remains a common practice performed in more than 40% of deliveries in the United States.

POPULATION STUDIED: The authors of this study enrolled 80 pregnant women at term who had not had previous vaginal deliveries. The 62 who went on to have vaginal deliveries were included in the analysis. The participants’ mean age was 26.3 years. The majority (92%) had prenatal care, and most (88%) had epidural analgesia during labor. Approximately one fourth of the women (28%) had forceps or vacuum-assisted delivery. A few had malpresentations, with 6% in the occiput posterior position.

STUDY DESIGN AND VALIDITY: This small observational study looked at a range of variables hypothesized to be related to perineal laceration length, including maternal demographics, size of genital hiatus and perineal body, fetal size and presentation, duration of second stage of labor, level of experience of birth attendant, operative vaginal delivery, and episiotomy. After delivery, one of the study authors measured perineal laceration length, and for 10 patients 3 additional observers measured laceration length to assess inter-rater reliability. Observers were blinded to one another’s measurements but not to the other variables included in the analysis. The authors used logistic regression and Mann-Whitney U test to determine which variables were associated with laceration length.

OUTCOMES MEASURED: Perineal laceration length was the primary outcome measured in this study. The authors also assessed laceration severity. The study did not include variables relevant to quality of life, such as healing complications, severity of pain, duration of symptoms, dyspareunia, or incontinence.

RESULTS: Of the 62 patients in the final analysis, 76% had a perineal laceration, with a median length of 4 cm. Five patients (8%) had a third-degree laceration, and one patient (2%) had a fourth-degree laceration. Approximately half (44%) had an episiotomy. The mean laceration length was 3 cm longer for patients who had an episiotomy (4.9 cm vs 1.9 cm; P < 001). Patients who had a forceps- or vacuum-assisted delivery had a longer average length of laceration, but this association was not independent of episiotomy. When assisted deliveries were excluded from the analysis, the association between episiotomy and laceration length remained significant.

BACKGROUND: Episiotomy was initially used based on theoretical benefit, with little evidence supporting claims that it prevented severe perineal lacerations or pelvic floor dysfunction. As principles of evidence-based medicine have begun to influence obstetrical practice, the utility of routine episiotomy has been called into question. Several observational studies have suggested that episiotomy increases the risk of third- and fourth-degree lacerations. A recent Cochrane review of 6 randomized controlled clinical trials comparing routine versus restricted use of episiotomy showed that episiotomy was associated with more second-degree perineal trauma, without significant differences in dyspareunia, severe perineal trauma, or severe pain. Although all but one of the trials included in the review used mediolateral episiotomy, the one randomized trial conducted in North America (which used midline episiotomy) showed similar results. Despite these data, episiotomy remains a common practice performed in more than 40% of deliveries in the United States.

POPULATION STUDIED: The authors of this study enrolled 80 pregnant women at term who had not had previous vaginal deliveries. The 62 who went on to have vaginal deliveries were included in the analysis. The participants’ mean age was 26.3 years. The majority (92%) had prenatal care, and most (88%) had epidural analgesia during labor. Approximately one fourth of the women (28%) had forceps or vacuum-assisted delivery. A few had malpresentations, with 6% in the occiput posterior position.

STUDY DESIGN AND VALIDITY: This small observational study looked at a range of variables hypothesized to be related to perineal laceration length, including maternal demographics, size of genital hiatus and perineal body, fetal size and presentation, duration of second stage of labor, level of experience of birth attendant, operative vaginal delivery, and episiotomy. After delivery, one of the study authors measured perineal laceration length, and for 10 patients 3 additional observers measured laceration length to assess inter-rater reliability. Observers were blinded to one another’s measurements but not to the other variables included in the analysis. The authors used logistic regression and Mann-Whitney U test to determine which variables were associated with laceration length.

OUTCOMES MEASURED: Perineal laceration length was the primary outcome measured in this study. The authors also assessed laceration severity. The study did not include variables relevant to quality of life, such as healing complications, severity of pain, duration of symptoms, dyspareunia, or incontinence.

RESULTS: Of the 62 patients in the final analysis, 76% had a perineal laceration, with a median length of 4 cm. Five patients (8%) had a third-degree laceration, and one patient (2%) had a fourth-degree laceration. Approximately half (44%) had an episiotomy. The mean laceration length was 3 cm longer for patients who had an episiotomy (4.9 cm vs 1.9 cm; P < 001). Patients who had a forceps- or vacuum-assisted delivery had a longer average length of laceration, but this association was not independent of episiotomy. When assisted deliveries were excluded from the analysis, the association between episiotomy and laceration length remained significant.

BACKGROUND: Medical professionals routinely teach women breast self-examination (BSE) as a screen for detecting breast cancer, yet there are conflicting recommendations regarding BSE from different professional organizations. One study has shown that only 7.6% of women with breast tumors who were practicing regular BSE actually detected the tumor by means of self-examination. Different studies have estimated the sensitivity of BSE as between 26% and 89% and the specificity between 66% and 81%. The US Preventive Services Task Force found insufficient evidence to recommend for or against teaching BSE. The purpose of this review was to evaluate the evidence relating to the effectiveness of BSE in preventing death of breast cancer to make recommendations for the Canadian Task Force on Preventive Health Care.

POPULATION STUDIED: The studies’ populations included women between ages 31 and 64 years in one study and from 40 to 69 years in the other studies. These women were from multiple areas of the world, including Shanghai, Russia, the United Kingdom, Canada, the United States, and Finland.

STUDY DESIGN AND VALIDITY: his is a systematic review of articles found using an electronic database search of abstracts and reports published from 1966 to October 2000. The author identified 2 randomized controlled trials, one quasi-randomized controlled trial, 2 large cohort studies, and several case-control studies that evaluated the effects of BSE on breast cancer outcomes. The 2 randomized-controlled trials and the quasi-randomized controlled trial were large studies enrolling more than 625,000 women with at least 5 years of follow-up and confirmation that women in the BSE group actually learned how to perform the maneuver. One of the cohort studies appeared to have a significant selection bias, rendering its results difficult to interpret. Since different designs were used in the review, the studies could not be combined using meta-analysis.

OUTCOMES MEASURED: The prevention of death resulting from breast cancer was viewed as the most important outcome. Other outcomes examined included the rate of benign biopsy results, the number of patient visits for breast complaints, the stage of cancer detected, and psychological benefits and harms.

RESULTS: Of the 8 studies included in this review, 7 studies, including the 2 randomized controlled trials and the quasi-randomized controlled trial, found no difference between groups taught BSE and the control groups with regard to rates of breast cancer diagnosis, breast cancer death, or in tumor stage or size. In the 2 randomized controlled trials and the quasi-randomized controlled trial, there were higher rates of benign biopsy results in the BSE groups, approximately 1 additional biopsy for every 200 women performing BSE. Women in the BSE groups also presented to the physician’s office more frequently for breast complaints.

BACKGROUND: Medical professionals routinely teach women breast self-examination (BSE) as a screen for detecting breast cancer, yet there are conflicting recommendations regarding BSE from different professional organizations. One study has shown that only 7.6% of women with breast tumors who were practicing regular BSE actually detected the tumor by means of self-examination. Different studies have estimated the sensitivity of BSE as between 26% and 89% and the specificity between 66% and 81%. The US Preventive Services Task Force found insufficient evidence to recommend for or against teaching BSE. The purpose of this review was to evaluate the evidence relating to the effectiveness of BSE in preventing death of breast cancer to make recommendations for the Canadian Task Force on Preventive Health Care.

POPULATION STUDIED: The studies’ populations included women between ages 31 and 64 years in one study and from 40 to 69 years in the other studies. These women were from multiple areas of the world, including Shanghai, Russia, the United Kingdom, Canada, the United States, and Finland.

STUDY DESIGN AND VALIDITY: his is a systematic review of articles found using an electronic database search of abstracts and reports published from 1966 to October 2000. The author identified 2 randomized controlled trials, one quasi-randomized controlled trial, 2 large cohort studies, and several case-control studies that evaluated the effects of BSE on breast cancer outcomes. The 2 randomized-controlled trials and the quasi-randomized controlled trial were large studies enrolling more than 625,000 women with at least 5 years of follow-up and confirmation that women in the BSE group actually learned how to perform the maneuver. One of the cohort studies appeared to have a significant selection bias, rendering its results difficult to interpret. Since different designs were used in the review, the studies could not be combined using meta-analysis.

OUTCOMES MEASURED: The prevention of death resulting from breast cancer was viewed as the most important outcome. Other outcomes examined included the rate of benign biopsy results, the number of patient visits for breast complaints, the stage of cancer detected, and psychological benefits and harms.

RESULTS: Of the 8 studies included in this review, 7 studies, including the 2 randomized controlled trials and the quasi-randomized controlled trial, found no difference between groups taught BSE and the control groups with regard to rates of breast cancer diagnosis, breast cancer death, or in tumor stage or size. In the 2 randomized controlled trials and the quasi-randomized controlled trial, there were higher rates of benign biopsy results in the BSE groups, approximately 1 additional biopsy for every 200 women performing BSE. Women in the BSE groups also presented to the physician’s office more frequently for breast complaints.

BACKGROUND: Medical professionals routinely teach women breast self-examination (BSE) as a screen for detecting breast cancer, yet there are conflicting recommendations regarding BSE from different professional organizations. One study has shown that only 7.6% of women with breast tumors who were practicing regular BSE actually detected the tumor by means of self-examination. Different studies have estimated the sensitivity of BSE as between 26% and 89% and the specificity between 66% and 81%. The US Preventive Services Task Force found insufficient evidence to recommend for or against teaching BSE. The purpose of this review was to evaluate the evidence relating to the effectiveness of BSE in preventing death of breast cancer to make recommendations for the Canadian Task Force on Preventive Health Care.

POPULATION STUDIED: The studies’ populations included women between ages 31 and 64 years in one study and from 40 to 69 years in the other studies. These women were from multiple areas of the world, including Shanghai, Russia, the United Kingdom, Canada, the United States, and Finland.

STUDY DESIGN AND VALIDITY: his is a systematic review of articles found using an electronic database search of abstracts and reports published from 1966 to October 2000. The author identified 2 randomized controlled trials, one quasi-randomized controlled trial, 2 large cohort studies, and several case-control studies that evaluated the effects of BSE on breast cancer outcomes. The 2 randomized-controlled trials and the quasi-randomized controlled trial were large studies enrolling more than 625,000 women with at least 5 years of follow-up and confirmation that women in the BSE group actually learned how to perform the maneuver. One of the cohort studies appeared to have a significant selection bias, rendering its results difficult to interpret. Since different designs were used in the review, the studies could not be combined using meta-analysis.

OUTCOMES MEASURED: The prevention of death resulting from breast cancer was viewed as the most important outcome. Other outcomes examined included the rate of benign biopsy results, the number of patient visits for breast complaints, the stage of cancer detected, and psychological benefits and harms.

RESULTS: Of the 8 studies included in this review, 7 studies, including the 2 randomized controlled trials and the quasi-randomized controlled trial, found no difference between groups taught BSE and the control groups with regard to rates of breast cancer diagnosis, breast cancer death, or in tumor stage or size. In the 2 randomized controlled trials and the quasi-randomized controlled trial, there were higher rates of benign biopsy results in the BSE groups, approximately 1 additional biopsy for every 200 women performing BSE. Women in the BSE groups also presented to the physician’s office more frequently for breast complaints.

BACKGROUND: Long-acting anti-angina agents have theoretical advantages over short-acting options. They offer more consistent blood levels, which could result in fewer side effects, as well as more sustained control of symptoms. This randomized controlled trial addressed the effectiveness of a strategy of converting to long-acting antianginal medication.

POPULATION STUDIED: The investigators enrolled 100 male outpatients at a Veterans Administration (VA) Health Systems Clinic who had known coronary disease or angina and who were taking at least 2 antianginal drugs. They were identified by clinician or a pharmacy database. Patients were excluded from the study if they had a recent hospitalization, aortic stenosis, an ejection fraction of less than 40%, significant conduction defects, or limited life expectancy. Most of the men (81%) were white and the average age was 65 years. The men had several concomitant diseases: 39% had diabetes, 28% congestive heart failure, and 68% had a prior myocardial infarction. These patients seem similar to the sicker patients in a typical family practice, but caution should be exercised in generalizing the results to women and to settings different from the VA.

STUDY DESIGN AND VALIDITY: The study was a single-blind, prospective randomized trial using concealed allocation. A nurse practitioner evaluated all patients weekly for 4 weeks and then monthly for 2 months. In the “once a day” group, all previous antianginal medications were withdrawn and then restarted one at a time in this order: long-acting diltiazem (up to 360 mg/day), nitroglycerin patches (up to 0.8 mg/hour) and atenolol (up to 100 mg/day). Doses were maximized prior to the addition of the next drug. In contrast, no drugs were stopped in “usual care”; instead, baseline medications were increased on the basis of symptoms to maximum doses following alphabetical order. For both groups, an algorithm was used to adjust medications. Data were analyzed according to intention-to-treat using t tests, with logistic regression to control for baseline frequency of angina. The methodology of this study was pragmatic and appropriate. Strengths included randomization, concealed allocation and complete follow-up. A major limitation of the design was that the intervention was complex, involving frequent visits along with a specific care algorithm, complete withdrawal of medication at the beginning and a specified order of medication re-introduction. The consequence is that it is difficult to determine which component of the intervention led to the results. Other important limitations include short duration (3 months); inattention to important confounding variables such as diabetes, congestive heart failure, or which specific drugs the patients were taking; lack of statistical power to assess confounding; and lack of attention to multiple comparisons.

OUTCOMES MEASURED: Primary outcomes were functional status, treatment satisfaction, and quality of life, measured by the Seattle Angina Questionnaire, a validated disease-specific measure for patients with coronary artery disease. The study did not address cost, side-effects, morbidity/mortality, or any long-term outcomes.

RESULTS: At the end of the trial, the once-a-day group had fewer symptoms than the usual care group (difference of averages: 12.3 points, P <.002; 5-8 points is considered clinically significant). Controlling for baseline frequency of angina did not change this result. There was no significant difference between groups in treatment satisfaction or quality of life. By the end of the trial, the patients in the once-a-day group were taking fewer medications (average 1.55 vs 2.14, P <.001).

BACKGROUND: Long-acting anti-angina agents have theoretical advantages over short-acting options. They offer more consistent blood levels, which could result in fewer side effects, as well as more sustained control of symptoms. This randomized controlled trial addressed the effectiveness of a strategy of converting to long-acting antianginal medication.

POPULATION STUDIED: The investigators enrolled 100 male outpatients at a Veterans Administration (VA) Health Systems Clinic who had known coronary disease or angina and who were taking at least 2 antianginal drugs. They were identified by clinician or a pharmacy database. Patients were excluded from the study if they had a recent hospitalization, aortic stenosis, an ejection fraction of less than 40%, significant conduction defects, or limited life expectancy. Most of the men (81%) were white and the average age was 65 years. The men had several concomitant diseases: 39% had diabetes, 28% congestive heart failure, and 68% had a prior myocardial infarction. These patients seem similar to the sicker patients in a typical family practice, but caution should be exercised in generalizing the results to women and to settings different from the VA.

STUDY DESIGN AND VALIDITY: The study was a single-blind, prospective randomized trial using concealed allocation. A nurse practitioner evaluated all patients weekly for 4 weeks and then monthly for 2 months. In the “once a day” group, all previous antianginal medications were withdrawn and then restarted one at a time in this order: long-acting diltiazem (up to 360 mg/day), nitroglycerin patches (up to 0.8 mg/hour) and atenolol (up to 100 mg/day). Doses were maximized prior to the addition of the next drug. In contrast, no drugs were stopped in “usual care”; instead, baseline medications were increased on the basis of symptoms to maximum doses following alphabetical order. For both groups, an algorithm was used to adjust medications. Data were analyzed according to intention-to-treat using t tests, with logistic regression to control for baseline frequency of angina. The methodology of this study was pragmatic and appropriate. Strengths included randomization, concealed allocation and complete follow-up. A major limitation of the design was that the intervention was complex, involving frequent visits along with a specific care algorithm, complete withdrawal of medication at the beginning and a specified order of medication re-introduction. The consequence is that it is difficult to determine which component of the intervention led to the results. Other important limitations include short duration (3 months); inattention to important confounding variables such as diabetes, congestive heart failure, or which specific drugs the patients were taking; lack of statistical power to assess confounding; and lack of attention to multiple comparisons.

OUTCOMES MEASURED: Primary outcomes were functional status, treatment satisfaction, and quality of life, measured by the Seattle Angina Questionnaire, a validated disease-specific measure for patients with coronary artery disease. The study did not address cost, side-effects, morbidity/mortality, or any long-term outcomes.

RESULTS: At the end of the trial, the once-a-day group had fewer symptoms than the usual care group (difference of averages: 12.3 points, P <.002; 5-8 points is considered clinically significant). Controlling for baseline frequency of angina did not change this result. There was no significant difference between groups in treatment satisfaction or quality of life. By the end of the trial, the patients in the once-a-day group were taking fewer medications (average 1.55 vs 2.14, P <.001).

BACKGROUND: Long-acting anti-angina agents have theoretical advantages over short-acting options. They offer more consistent blood levels, which could result in fewer side effects, as well as more sustained control of symptoms. This randomized controlled trial addressed the effectiveness of a strategy of converting to long-acting antianginal medication.

POPULATION STUDIED: The investigators enrolled 100 male outpatients at a Veterans Administration (VA) Health Systems Clinic who had known coronary disease or angina and who were taking at least 2 antianginal drugs. They were identified by clinician or a pharmacy database. Patients were excluded from the study if they had a recent hospitalization, aortic stenosis, an ejection fraction of less than 40%, significant conduction defects, or limited life expectancy. Most of the men (81%) were white and the average age was 65 years. The men had several concomitant diseases: 39% had diabetes, 28% congestive heart failure, and 68% had a prior myocardial infarction. These patients seem similar to the sicker patients in a typical family practice, but caution should be exercised in generalizing the results to women and to settings different from the VA.

STUDY DESIGN AND VALIDITY: The study was a single-blind, prospective randomized trial using concealed allocation. A nurse practitioner evaluated all patients weekly for 4 weeks and then monthly for 2 months. In the “once a day” group, all previous antianginal medications were withdrawn and then restarted one at a time in this order: long-acting diltiazem (up to 360 mg/day), nitroglycerin patches (up to 0.8 mg/hour) and atenolol (up to 100 mg/day). Doses were maximized prior to the addition of the next drug. In contrast, no drugs were stopped in “usual care”; instead, baseline medications were increased on the basis of symptoms to maximum doses following alphabetical order. For both groups, an algorithm was used to adjust medications. Data were analyzed according to intention-to-treat using t tests, with logistic regression to control for baseline frequency of angina. The methodology of this study was pragmatic and appropriate. Strengths included randomization, concealed allocation and complete follow-up. A major limitation of the design was that the intervention was complex, involving frequent visits along with a specific care algorithm, complete withdrawal of medication at the beginning and a specified order of medication re-introduction. The consequence is that it is difficult to determine which component of the intervention led to the results. Other important limitations include short duration (3 months); inattention to important confounding variables such as diabetes, congestive heart failure, or which specific drugs the patients were taking; lack of statistical power to assess confounding; and lack of attention to multiple comparisons.

OUTCOMES MEASURED: Primary outcomes were functional status, treatment satisfaction, and quality of life, measured by the Seattle Angina Questionnaire, a validated disease-specific measure for patients with coronary artery disease. The study did not address cost, side-effects, morbidity/mortality, or any long-term outcomes.

RESULTS: At the end of the trial, the once-a-day group had fewer symptoms than the usual care group (difference of averages: 12.3 points, P <.002; 5-8 points is considered clinically significant). Controlling for baseline frequency of angina did not change this result. There was no significant difference between groups in treatment satisfaction or quality of life. By the end of the trial, the patients in the once-a-day group were taking fewer medications (average 1.55 vs 2.14, P <.001).