Q&A

BACKGROUND: One avenue to reduce the overprescribing of antibiotics for common respiratory symptoms is to use back-up antibiotic prescriptions with instructions to have them filled only if the condition does not improve or gets worse. This study investigated the level of patient satisfaction with medical care and the 7-day fill rate with the use of back-up antibiotic prescriptions for common respiratory symptoms.

POPULATION STUDIED: The authors of study evaluated patients with common respiratory symptoms presenting to 1 of 3 family practice clinics during the first 4 months of 1999. The prescribing clinicians included 19 family medicine physicians, 9 family medicine residents, and 2 physician extenders. Patients were enrolled in the study if they had chest, sinus, or head congestion; fever; headache; sore throat; or cough. Patients presenting with only one dominant symptom or physical finding were excluded. The average age or other usual demographics of the patients were not provided. Patients were enrolled from a primary care outpatient population, and therefore the results are likely to be applicable to the family practice setting. Of the 947 patients enrolled, 441 (46.6%) did not receive a prescription for an antibiotic, 220 (23.2%) received an immediate-fill prescription, and 286 (30.2%) received a back-up prescription.

STUDY DESIGN AND VALIDITY: The authors performed a prospective observational study on the use of back-up antibiotic prescriptions for patients presenting with or desiring treatment for common respiratory symptoms. The decision to provide an immediate versus back-up prescription was left to the discretion of the treating clinician. A survey was completed by each clinician to assess demographics, clinical need for antibiotics, and the type of prescription if one was provided (immediate fill or back up). Patients were instructed to fill the back-up prescription only if their condition did not improve or got worse. Those given a back-up prescription were provided a survey to be completed and mailed back 7 days after their visit. Those not completing the survey were contacted by phone. The patient survey assessed satisfaction with care, their perceived need for antibiotic therapy before the visit, whether the back-up prescription had been filled, and if additional medical care was sought for the same complaint. The time frame for filling the back-up prescription was left to the discretion of the prescriber and patient. The study is limited by the method of verifying prescription-filling (self-report by the patients). Also, the decision to use a back-up prescription was left to the treating clinician rather than randomly assigning patients.

OUTCOMES MEASURED: The authors evaluated patient satisfaction and prescription fill rates associated with the use of back-up antibiotic prescriptions.

RESULTS: Of the 255 patients completing the survey, 245 (96.1%) were satisfied with their medical care. Most patients (76.1%) receiving a back-up prescription believed they would need an antibiotic for their symptoms. The 7-day fill rate of the back-up prescriptions provided was 50.2%. Absolute reduction in antibiotic usage, assuming that all patients getting back-up prescriptions would have received an immediate-fill prescription, was 15%. Twenty-three patients (9%) required additional medical care; 74% of these patients (n=17) had their back-up prescription filled.

BACKGROUND: One avenue to reduce the overprescribing of antibiotics for common respiratory symptoms is to use back-up antibiotic prescriptions with instructions to have them filled only if the condition does not improve or gets worse. This study investigated the level of patient satisfaction with medical care and the 7-day fill rate with the use of back-up antibiotic prescriptions for common respiratory symptoms.

POPULATION STUDIED: The authors of study evaluated patients with common respiratory symptoms presenting to 1 of 3 family practice clinics during the first 4 months of 1999. The prescribing clinicians included 19 family medicine physicians, 9 family medicine residents, and 2 physician extenders. Patients were enrolled in the study if they had chest, sinus, or head congestion; fever; headache; sore throat; or cough. Patients presenting with only one dominant symptom or physical finding were excluded. The average age or other usual demographics of the patients were not provided. Patients were enrolled from a primary care outpatient population, and therefore the results are likely to be applicable to the family practice setting. Of the 947 patients enrolled, 441 (46.6%) did not receive a prescription for an antibiotic, 220 (23.2%) received an immediate-fill prescription, and 286 (30.2%) received a back-up prescription.

STUDY DESIGN AND VALIDITY: The authors performed a prospective observational study on the use of back-up antibiotic prescriptions for patients presenting with or desiring treatment for common respiratory symptoms. The decision to provide an immediate versus back-up prescription was left to the discretion of the treating clinician. A survey was completed by each clinician to assess demographics, clinical need for antibiotics, and the type of prescription if one was provided (immediate fill or back up). Patients were instructed to fill the back-up prescription only if their condition did not improve or got worse. Those given a back-up prescription were provided a survey to be completed and mailed back 7 days after their visit. Those not completing the survey were contacted by phone. The patient survey assessed satisfaction with care, their perceived need for antibiotic therapy before the visit, whether the back-up prescription had been filled, and if additional medical care was sought for the same complaint. The time frame for filling the back-up prescription was left to the discretion of the prescriber and patient. The study is limited by the method of verifying prescription-filling (self-report by the patients). Also, the decision to use a back-up prescription was left to the treating clinician rather than randomly assigning patients.

OUTCOMES MEASURED: The authors evaluated patient satisfaction and prescription fill rates associated with the use of back-up antibiotic prescriptions.

RESULTS: Of the 255 patients completing the survey, 245 (96.1%) were satisfied with their medical care. Most patients (76.1%) receiving a back-up prescription believed they would need an antibiotic for their symptoms. The 7-day fill rate of the back-up prescriptions provided was 50.2%. Absolute reduction in antibiotic usage, assuming that all patients getting back-up prescriptions would have received an immediate-fill prescription, was 15%. Twenty-three patients (9%) required additional medical care; 74% of these patients (n=17) had their back-up prescription filled.

BACKGROUND: One avenue to reduce the overprescribing of antibiotics for common respiratory symptoms is to use back-up antibiotic prescriptions with instructions to have them filled only if the condition does not improve or gets worse. This study investigated the level of patient satisfaction with medical care and the 7-day fill rate with the use of back-up antibiotic prescriptions for common respiratory symptoms.

POPULATION STUDIED: The authors of study evaluated patients with common respiratory symptoms presenting to 1 of 3 family practice clinics during the first 4 months of 1999. The prescribing clinicians included 19 family medicine physicians, 9 family medicine residents, and 2 physician extenders. Patients were enrolled in the study if they had chest, sinus, or head congestion; fever; headache; sore throat; or cough. Patients presenting with only one dominant symptom or physical finding were excluded. The average age or other usual demographics of the patients were not provided. Patients were enrolled from a primary care outpatient population, and therefore the results are likely to be applicable to the family practice setting. Of the 947 patients enrolled, 441 (46.6%) did not receive a prescription for an antibiotic, 220 (23.2%) received an immediate-fill prescription, and 286 (30.2%) received a back-up prescription.

STUDY DESIGN AND VALIDITY: The authors performed a prospective observational study on the use of back-up antibiotic prescriptions for patients presenting with or desiring treatment for common respiratory symptoms. The decision to provide an immediate versus back-up prescription was left to the discretion of the treating clinician. A survey was completed by each clinician to assess demographics, clinical need for antibiotics, and the type of prescription if one was provided (immediate fill or back up). Patients were instructed to fill the back-up prescription only if their condition did not improve or got worse. Those given a back-up prescription were provided a survey to be completed and mailed back 7 days after their visit. Those not completing the survey were contacted by phone. The patient survey assessed satisfaction with care, their perceived need for antibiotic therapy before the visit, whether the back-up prescription had been filled, and if additional medical care was sought for the same complaint. The time frame for filling the back-up prescription was left to the discretion of the prescriber and patient. The study is limited by the method of verifying prescription-filling (self-report by the patients). Also, the decision to use a back-up prescription was left to the treating clinician rather than randomly assigning patients.

OUTCOMES MEASURED: The authors evaluated patient satisfaction and prescription fill rates associated with the use of back-up antibiotic prescriptions.

RESULTS: Of the 255 patients completing the survey, 245 (96.1%) were satisfied with their medical care. Most patients (76.1%) receiving a back-up prescription believed they would need an antibiotic for their symptoms. The 7-day fill rate of the back-up prescriptions provided was 50.2%. Absolute reduction in antibiotic usage, assuming that all patients getting back-up prescriptions would have received an immediate-fill prescription, was 15%. Twenty-three patients (9%) required additional medical care; 74% of these patients (n=17) had their back-up prescription filled.

BACKGROUND: Acute migraine headache treatment may be approached in 3 ways. Stratified care implies treatment selection based on headache severity and associated disability. Step care either across a number of attacks or within an attack suggests choosing a common initial remedy that collectively optimizes efficacy, tolerability, and cost. Alternative regimens that may be higher in toxicity or cost are then progressively picked as necessary for treatment failure. Although commonly advocated for migraine management, these strategies have not yet been systematically compared to determine the best approach.

POPULATION STUDIED: Patients were eligible if they were aged 18 to 65 years and diagnosed with a migraine headache according to International Headache Society criteria. Subjects were recruited from 88 sites in 13 countries, but only those with a Migraine Disability Assessment Scale (MIDAS) of grade II, III, or IV were studied. Additional criteria included age at onset younger than 50 years, 1 to 8 attacks per month for the preceding 3 months, fewer than 10 nonmigraine headache days per month, and no change in preventive therapy during the trial. Participants were mostly women (83.2%), young (mean=37 years), and described their baseline disability as grade III or IV (mean=55%).

STUDY DESIGN AND VALIDITY: The study was conducted in an unblinded randomized parallel group design. During the 15-month period patients treated up to 6 moderate to severe migraines. The stratified group received care based on headache severity: Grade II was treated with aspirin 800 to 1000 mg plus metoclopramide 10 mg and grades III and IV with zolmitriptan 2.5 mg. The step care across attacks group all administered aspirin plus metoclopramide 10 mg as initial treatment. Therapy was escalated to zolmitriptan 2.5 mg in those that failed to respond in 2 of the first 3 attacks. Lack of response was defined as failure to reduce headache severity from moderate-severe to none-mild. All subjects in the step care within attacks group received the aspirin/metoclopramide combination as initial therapy but could add zolmitriptan if a response was not achieved within 2 hours. Efficacy and adverse effect data were self-reported on diary cards. Overall, the study was well conducted. Although the lack of treatment blinding is a potentially significant limitation, it may more closely approximate clinical practice. More importantly, the results may be different if other study drugs were chosen, and other agents are more commonly used in the United States. Finally, the results were not analyzed according to intention to treat and the dropout rate for the efficacy analysis was approximately 20%.

OUTCOMES MEASURED: The 2 primary outcomes were headache response at 2 hours and disability time per treated attack at 4 hours. Secondary end points included 1- and 4-hour responses, 2-hour pain-free response, and the occurrence of adverse events.

RESULTS: Headache response at 2 hours was significantly greater for stratified care than for either step care across attacks (odds ratio [OR]=1.67; 95% confidence interval [CI], 1.31-2.12) or within attacks (OR=2.14; 95% CI, 1.66-2.77). These differences were mostly accounted for by the lack of response during the first 3 headaches (OR=2.91; 95% CI, 2.18-3.87) or within the first 2 hours of an attack, respectively. Disability time (from 0-4 hours) was also lower in the stratified care group than the step care across attacks group or the step care within attacks group. Again, there were no differences following treatment escalation in the step care groups. Adverse events were reported in approximately 14% of the attacks. They were more common in patients randomized to the stratified care group (19.5% vs 9.7% vs 13.1%). Those occurring less than 2% (asthenia, nausea, dizziness, paresthesias, and somnolence) were mild to moderate in severity and likely associated with zolmitriptan use. There was no difference in study withdrawal between treatment groups.

BACKGROUND: Acute migraine headache treatment may be approached in 3 ways. Stratified care implies treatment selection based on headache severity and associated disability. Step care either across a number of attacks or within an attack suggests choosing a common initial remedy that collectively optimizes efficacy, tolerability, and cost. Alternative regimens that may be higher in toxicity or cost are then progressively picked as necessary for treatment failure. Although commonly advocated for migraine management, these strategies have not yet been systematically compared to determine the best approach.

POPULATION STUDIED: Patients were eligible if they were aged 18 to 65 years and diagnosed with a migraine headache according to International Headache Society criteria. Subjects were recruited from 88 sites in 13 countries, but only those with a Migraine Disability Assessment Scale (MIDAS) of grade II, III, or IV were studied. Additional criteria included age at onset younger than 50 years, 1 to 8 attacks per month for the preceding 3 months, fewer than 10 nonmigraine headache days per month, and no change in preventive therapy during the trial. Participants were mostly women (83.2%), young (mean=37 years), and described their baseline disability as grade III or IV (mean=55%).

STUDY DESIGN AND VALIDITY: The study was conducted in an unblinded randomized parallel group design. During the 15-month period patients treated up to 6 moderate to severe migraines. The stratified group received care based on headache severity: Grade II was treated with aspirin 800 to 1000 mg plus metoclopramide 10 mg and grades III and IV with zolmitriptan 2.5 mg. The step care across attacks group all administered aspirin plus metoclopramide 10 mg as initial treatment. Therapy was escalated to zolmitriptan 2.5 mg in those that failed to respond in 2 of the first 3 attacks. Lack of response was defined as failure to reduce headache severity from moderate-severe to none-mild. All subjects in the step care within attacks group received the aspirin/metoclopramide combination as initial therapy but could add zolmitriptan if a response was not achieved within 2 hours. Efficacy and adverse effect data were self-reported on diary cards. Overall, the study was well conducted. Although the lack of treatment blinding is a potentially significant limitation, it may more closely approximate clinical practice. More importantly, the results may be different if other study drugs were chosen, and other agents are more commonly used in the United States. Finally, the results were not analyzed according to intention to treat and the dropout rate for the efficacy analysis was approximately 20%.

OUTCOMES MEASURED: The 2 primary outcomes were headache response at 2 hours and disability time per treated attack at 4 hours. Secondary end points included 1- and 4-hour responses, 2-hour pain-free response, and the occurrence of adverse events.

RESULTS: Headache response at 2 hours was significantly greater for stratified care than for either step care across attacks (odds ratio [OR]=1.67; 95% confidence interval [CI], 1.31-2.12) or within attacks (OR=2.14; 95% CI, 1.66-2.77). These differences were mostly accounted for by the lack of response during the first 3 headaches (OR=2.91; 95% CI, 2.18-3.87) or within the first 2 hours of an attack, respectively. Disability time (from 0-4 hours) was also lower in the stratified care group than the step care across attacks group or the step care within attacks group. Again, there were no differences following treatment escalation in the step care groups. Adverse events were reported in approximately 14% of the attacks. They were more common in patients randomized to the stratified care group (19.5% vs 9.7% vs 13.1%). Those occurring less than 2% (asthenia, nausea, dizziness, paresthesias, and somnolence) were mild to moderate in severity and likely associated with zolmitriptan use. There was no difference in study withdrawal between treatment groups.

BACKGROUND: Acute migraine headache treatment may be approached in 3 ways. Stratified care implies treatment selection based on headache severity and associated disability. Step care either across a number of attacks or within an attack suggests choosing a common initial remedy that collectively optimizes efficacy, tolerability, and cost. Alternative regimens that may be higher in toxicity or cost are then progressively picked as necessary for treatment failure. Although commonly advocated for migraine management, these strategies have not yet been systematically compared to determine the best approach.

POPULATION STUDIED: Patients were eligible if they were aged 18 to 65 years and diagnosed with a migraine headache according to International Headache Society criteria. Subjects were recruited from 88 sites in 13 countries, but only those with a Migraine Disability Assessment Scale (MIDAS) of grade II, III, or IV were studied. Additional criteria included age at onset younger than 50 years, 1 to 8 attacks per month for the preceding 3 months, fewer than 10 nonmigraine headache days per month, and no change in preventive therapy during the trial. Participants were mostly women (83.2%), young (mean=37 years), and described their baseline disability as grade III or IV (mean=55%).

STUDY DESIGN AND VALIDITY: The study was conducted in an unblinded randomized parallel group design. During the 15-month period patients treated up to 6 moderate to severe migraines. The stratified group received care based on headache severity: Grade II was treated with aspirin 800 to 1000 mg plus metoclopramide 10 mg and grades III and IV with zolmitriptan 2.5 mg. The step care across attacks group all administered aspirin plus metoclopramide 10 mg as initial treatment. Therapy was escalated to zolmitriptan 2.5 mg in those that failed to respond in 2 of the first 3 attacks. Lack of response was defined as failure to reduce headache severity from moderate-severe to none-mild. All subjects in the step care within attacks group received the aspirin/metoclopramide combination as initial therapy but could add zolmitriptan if a response was not achieved within 2 hours. Efficacy and adverse effect data were self-reported on diary cards. Overall, the study was well conducted. Although the lack of treatment blinding is a potentially significant limitation, it may more closely approximate clinical practice. More importantly, the results may be different if other study drugs were chosen, and other agents are more commonly used in the United States. Finally, the results were not analyzed according to intention to treat and the dropout rate for the efficacy analysis was approximately 20%.

OUTCOMES MEASURED: The 2 primary outcomes were headache response at 2 hours and disability time per treated attack at 4 hours. Secondary end points included 1- and 4-hour responses, 2-hour pain-free response, and the occurrence of adverse events.

RESULTS: Headache response at 2 hours was significantly greater for stratified care than for either step care across attacks (odds ratio [OR]=1.67; 95% confidence interval [CI], 1.31-2.12) or within attacks (OR=2.14; 95% CI, 1.66-2.77). These differences were mostly accounted for by the lack of response during the first 3 headaches (OR=2.91; 95% CI, 2.18-3.87) or within the first 2 hours of an attack, respectively. Disability time (from 0-4 hours) was also lower in the stratified care group than the step care across attacks group or the step care within attacks group. Again, there were no differences following treatment escalation in the step care groups. Adverse events were reported in approximately 14% of the attacks. They were more common in patients randomized to the stratified care group (19.5% vs 9.7% vs 13.1%). Those occurring less than 2% (asthenia, nausea, dizziness, paresthesias, and somnolence) were mild to moderate in severity and likely associated with zolmitriptan use. There was no difference in study withdrawal between treatment groups.

BACKGROUND: The sensitivity of the conventional Pap test is estimated at 51% with a specificity of 98%. Newer technologies including thin-layer cytology (Thin-Prep), computerized re-screening (Papnet), and algorithmic classification (AutoPap) of slides can increase the sensitivity of cervical cancer screening by up to 30% at an increased cost of $5 to $10 per slide. The specificity of the new technologies is not reported. The impact of these tests on cost-effectiveness has not been clearly described. In general, a screening test is cost-effective (less cost and more benefit) when the incidence of the disease is common enough to warrant screening, the disease has a long asymptomatic period during which the disease can be identified, or the specificity of the test is high, resulting in less false-positive tests. An additional way to improve cost-effectiveness is if the cost of the screening test and subsequent treatments can be decreased through better identification or definitive treatment of clinically progressive disease.

POPULATION STUDIED: This theoretical model used data based on American women aged 15 to 85 years who were at average risk for cervical cancer.

STUDY DESIGN AND VALIDITY: This study is a cost-effectiveness analysis designed to estimate the cost of screening assuming several different scenarios. Cost is defined as direct medical costs, including inpatient and outpatient costs associated with the diagnosis and treatment of cervical dysplasia and cancer. Cost-benefit was estimated using several scenarios including varying the screening interval (1-, 2-, 3-, and 5-year intervals), altering the specificity of the test from 80% to 99% with sensitivity constant at 51%, and altering the sensitivity of the initial screening test from 51% to 99% using a constant specificity of 97%. Costs and years of life were discounted at 3% annually and varied 0% to 5% in sensitivity analysis. Overall this was a well-done analysis. The authors focused only on direct costs and did not estimate the effect of screening on other costs such as time lost from work and child care expense. Also, the impact of screening on quality of life was not factored into the analysis. Treatment options for atypical squamous cells of uncertain significance, low- through high-grade squamous intraepithelial lesions, and carcinoma are clearly described for determination of costs. Sensitivity analysis included the pertinent variables of sensitivity and specificity of the screening test, and screening intervals. Discount for costs and benefit was included in this analysis

OUTCOMES MEASURED: Effectiveness as measured is the incremental cost per life-year saved.

RESULTS: When a screening Pap test is used at a constant screening interval, increased sensitivity or decreased specificity of the test increases the incremental cost per life-year saved. In this analysis, the diagnosis and treatment of low-grade lesions had the greatest effect on cost-effectiveness estimates. If a new test with increased sensitivity does not cost more than the conventional test, it is only cost-effective if the screening interval is 3 years and the cost of diagnosing and treating low-grade lesions is $550 (which is lower than 75% of the cases in this data). The diagnosis, workup, and treatment of low-grade lesions that may regress contributes to increased cost without benefit. For any screening interval a new screening test with increased sensitivity that costs more than $3 per slide over the conventional test will not be cost-effective.

BACKGROUND: The sensitivity of the conventional Pap test is estimated at 51% with a specificity of 98%. Newer technologies including thin-layer cytology (Thin-Prep), computerized re-screening (Papnet), and algorithmic classification (AutoPap) of slides can increase the sensitivity of cervical cancer screening by up to 30% at an increased cost of $5 to $10 per slide. The specificity of the new technologies is not reported. The impact of these tests on cost-effectiveness has not been clearly described. In general, a screening test is cost-effective (less cost and more benefit) when the incidence of the disease is common enough to warrant screening, the disease has a long asymptomatic period during which the disease can be identified, or the specificity of the test is high, resulting in less false-positive tests. An additional way to improve cost-effectiveness is if the cost of the screening test and subsequent treatments can be decreased through better identification or definitive treatment of clinically progressive disease.

POPULATION STUDIED: This theoretical model used data based on American women aged 15 to 85 years who were at average risk for cervical cancer.

STUDY DESIGN AND VALIDITY: This study is a cost-effectiveness analysis designed to estimate the cost of screening assuming several different scenarios. Cost is defined as direct medical costs, including inpatient and outpatient costs associated with the diagnosis and treatment of cervical dysplasia and cancer. Cost-benefit was estimated using several scenarios including varying the screening interval (1-, 2-, 3-, and 5-year intervals), altering the specificity of the test from 80% to 99% with sensitivity constant at 51%, and altering the sensitivity of the initial screening test from 51% to 99% using a constant specificity of 97%. Costs and years of life were discounted at 3% annually and varied 0% to 5% in sensitivity analysis. Overall this was a well-done analysis. The authors focused only on direct costs and did not estimate the effect of screening on other costs such as time lost from work and child care expense. Also, the impact of screening on quality of life was not factored into the analysis. Treatment options for atypical squamous cells of uncertain significance, low- through high-grade squamous intraepithelial lesions, and carcinoma are clearly described for determination of costs. Sensitivity analysis included the pertinent variables of sensitivity and specificity of the screening test, and screening intervals. Discount for costs and benefit was included in this analysis

OUTCOMES MEASURED: Effectiveness as measured is the incremental cost per life-year saved.

RESULTS: When a screening Pap test is used at a constant screening interval, increased sensitivity or decreased specificity of the test increases the incremental cost per life-year saved. In this analysis, the diagnosis and treatment of low-grade lesions had the greatest effect on cost-effectiveness estimates. If a new test with increased sensitivity does not cost more than the conventional test, it is only cost-effective if the screening interval is 3 years and the cost of diagnosing and treating low-grade lesions is $550 (which is lower than 75% of the cases in this data). The diagnosis, workup, and treatment of low-grade lesions that may regress contributes to increased cost without benefit. For any screening interval a new screening test with increased sensitivity that costs more than $3 per slide over the conventional test will not be cost-effective.

BACKGROUND: The sensitivity of the conventional Pap test is estimated at 51% with a specificity of 98%. Newer technologies including thin-layer cytology (Thin-Prep), computerized re-screening (Papnet), and algorithmic classification (AutoPap) of slides can increase the sensitivity of cervical cancer screening by up to 30% at an increased cost of $5 to $10 per slide. The specificity of the new technologies is not reported. The impact of these tests on cost-effectiveness has not been clearly described. In general, a screening test is cost-effective (less cost and more benefit) when the incidence of the disease is common enough to warrant screening, the disease has a long asymptomatic period during which the disease can be identified, or the specificity of the test is high, resulting in less false-positive tests. An additional way to improve cost-effectiveness is if the cost of the screening test and subsequent treatments can be decreased through better identification or definitive treatment of clinically progressive disease.

POPULATION STUDIED: This theoretical model used data based on American women aged 15 to 85 years who were at average risk for cervical cancer.

STUDY DESIGN AND VALIDITY: This study is a cost-effectiveness analysis designed to estimate the cost of screening assuming several different scenarios. Cost is defined as direct medical costs, including inpatient and outpatient costs associated with the diagnosis and treatment of cervical dysplasia and cancer. Cost-benefit was estimated using several scenarios including varying the screening interval (1-, 2-, 3-, and 5-year intervals), altering the specificity of the test from 80% to 99% with sensitivity constant at 51%, and altering the sensitivity of the initial screening test from 51% to 99% using a constant specificity of 97%. Costs and years of life were discounted at 3% annually and varied 0% to 5% in sensitivity analysis. Overall this was a well-done analysis. The authors focused only on direct costs and did not estimate the effect of screening on other costs such as time lost from work and child care expense. Also, the impact of screening on quality of life was not factored into the analysis. Treatment options for atypical squamous cells of uncertain significance, low- through high-grade squamous intraepithelial lesions, and carcinoma are clearly described for determination of costs. Sensitivity analysis included the pertinent variables of sensitivity and specificity of the screening test, and screening intervals. Discount for costs and benefit was included in this analysis

OUTCOMES MEASURED: Effectiveness as measured is the incremental cost per life-year saved.

RESULTS: When a screening Pap test is used at a constant screening interval, increased sensitivity or decreased specificity of the test increases the incremental cost per life-year saved. In this analysis, the diagnosis and treatment of low-grade lesions had the greatest effect on cost-effectiveness estimates. If a new test with increased sensitivity does not cost more than the conventional test, it is only cost-effective if the screening interval is 3 years and the cost of diagnosing and treating low-grade lesions is $550 (which is lower than 75% of the cases in this data). The diagnosis, workup, and treatment of low-grade lesions that may regress contributes to increased cost without benefit. For any screening interval a new screening test with increased sensitivity that costs more than $3 per slide over the conventional test will not be cost-effective.

BACKGROUND: In 1995, 3 independent studies found that OCs containing the progestogens desogestrel or gestodene (third-generation OCs) doubled the risk of VTE over OCs containing levonorgestrel. A subsequent warning issued by the Committee on Safety of Medicines of England altered prescribing and use patterns accordingly, but no reduction of VTE incidence occurred, suggesting that the original research was flawed.

POPULATION STUDIED: Subjects were selected from more than 3 million patient records contained in the United Kingdom General Practice Research Database, which includes personal characteristics, drugs prescribed, and clinical diagnoses. The investigators identified women aged 15 to 39 years who were users of either third-generation OCs (n=361,724) or OCs containing levonorgestrel (n=979,052) and whose records had been contained within the database for at least 1 year. A total of 106 cases of idiopathic VTE occurred within this cohort. These cases were matched with 569 controls for the case-control analysis. Patients were excluded if their VTE was due to an apparent proximate cause, such as pregnancy, recent surgery or lower limb injury, cancer, or recent severe trauma.

STUDY DESIGN AND VALIDITY: Two study designs were employed, a cohort design and a nested case-control design. Data for both were analyzed separately for 2 time periods from January 1993 to October 1995 (before the safety warning) and from January 1996 to December 1999 (following the warning). For the cohort study, person-time at risk was estimated from the date of first prescription of oral contraceptive until either the OC was stopped; a different study OC was prescribed; the woman died, left the practice, or became a case; or the study period ended. Summary incidence rates for the 2 periods were adjusted for age and compared between the 2 types of OC users. Each patient with idiopathic VTE (case group) was then matched with up to 6 patients without VTE (control group) by age, practice, and index date (both using OCs on the date of the diagnosis of the case). Odds ratios were calculated for both study periods individually and combined, with adjustments for body mass index, smoking history, duration of use of OCs, and whether a change in OC had occurred. The authors describe significant measures to assure the quality of the General Practice Database and made blinded assessments of outcome. By excluding women with predisposing risk factors for VTE they appropriately limited the study results to average risk individuals. Since 1,340,776 women contributed only 361,300 person-years of observation over 7 years of observation, significant variation in length of OC use must have occurred. In fact, though more women took third-generation OCs, these contributed fewer person-years to the analysis. Several known confounders (smoking, obesity, duration of OC use) were controlled for in the case-control analysis.

OUTCOMES MEASURED: The first case of idiopathic VTE as measured by careful chart review was the outcome of interest. The chart review was conducted by blinded investigators.

RESULTS: Both the cohort and matched case-control analyses of these data demonstrated an approximately two-fold increase in risk of VTE among users of third-generation OCs compared with OCs containing levonorgestrel (age-adjusted relative risk [RR]=1.9; 95% confidence interval [CI], 1.3-2.8 and odds ratio [OR] =2.3, 95% CI, 1.3-3.9). No difference in the age-adjusted incidence of VTE was apparent between the 2 study periods, though the proportion of users of third-generation OCs dropped significantly after the warning notice was issued. VTE was also independently associated with higher body mass index and smoking.

BACKGROUND: In 1995, 3 independent studies found that OCs containing the progestogens desogestrel or gestodene (third-generation OCs) doubled the risk of VTE over OCs containing levonorgestrel. A subsequent warning issued by the Committee on Safety of Medicines of England altered prescribing and use patterns accordingly, but no reduction of VTE incidence occurred, suggesting that the original research was flawed.

POPULATION STUDIED: Subjects were selected from more than 3 million patient records contained in the United Kingdom General Practice Research Database, which includes personal characteristics, drugs prescribed, and clinical diagnoses. The investigators identified women aged 15 to 39 years who were users of either third-generation OCs (n=361,724) or OCs containing levonorgestrel (n=979,052) and whose records had been contained within the database for at least 1 year. A total of 106 cases of idiopathic VTE occurred within this cohort. These cases were matched with 569 controls for the case-control analysis. Patients were excluded if their VTE was due to an apparent proximate cause, such as pregnancy, recent surgery or lower limb injury, cancer, or recent severe trauma.

STUDY DESIGN AND VALIDITY: Two study designs were employed, a cohort design and a nested case-control design. Data for both were analyzed separately for 2 time periods from January 1993 to October 1995 (before the safety warning) and from January 1996 to December 1999 (following the warning). For the cohort study, person-time at risk was estimated from the date of first prescription of oral contraceptive until either the OC was stopped; a different study OC was prescribed; the woman died, left the practice, or became a case; or the study period ended. Summary incidence rates for the 2 periods were adjusted for age and compared between the 2 types of OC users. Each patient with idiopathic VTE (case group) was then matched with up to 6 patients without VTE (control group) by age, practice, and index date (both using OCs on the date of the diagnosis of the case). Odds ratios were calculated for both study periods individually and combined, with adjustments for body mass index, smoking history, duration of use of OCs, and whether a change in OC had occurred. The authors describe significant measures to assure the quality of the General Practice Database and made blinded assessments of outcome. By excluding women with predisposing risk factors for VTE they appropriately limited the study results to average risk individuals. Since 1,340,776 women contributed only 361,300 person-years of observation over 7 years of observation, significant variation in length of OC use must have occurred. In fact, though more women took third-generation OCs, these contributed fewer person-years to the analysis. Several known confounders (smoking, obesity, duration of OC use) were controlled for in the case-control analysis.

OUTCOMES MEASURED: The first case of idiopathic VTE as measured by careful chart review was the outcome of interest. The chart review was conducted by blinded investigators.

RESULTS: Both the cohort and matched case-control analyses of these data demonstrated an approximately two-fold increase in risk of VTE among users of third-generation OCs compared with OCs containing levonorgestrel (age-adjusted relative risk [RR]=1.9; 95% confidence interval [CI], 1.3-2.8 and odds ratio [OR] =2.3, 95% CI, 1.3-3.9). No difference in the age-adjusted incidence of VTE was apparent between the 2 study periods, though the proportion of users of third-generation OCs dropped significantly after the warning notice was issued. VTE was also independently associated with higher body mass index and smoking.

BACKGROUND: In 1995, 3 independent studies found that OCs containing the progestogens desogestrel or gestodene (third-generation OCs) doubled the risk of VTE over OCs containing levonorgestrel. A subsequent warning issued by the Committee on Safety of Medicines of England altered prescribing and use patterns accordingly, but no reduction of VTE incidence occurred, suggesting that the original research was flawed.

POPULATION STUDIED: Subjects were selected from more than 3 million patient records contained in the United Kingdom General Practice Research Database, which includes personal characteristics, drugs prescribed, and clinical diagnoses. The investigators identified women aged 15 to 39 years who were users of either third-generation OCs (n=361,724) or OCs containing levonorgestrel (n=979,052) and whose records had been contained within the database for at least 1 year. A total of 106 cases of idiopathic VTE occurred within this cohort. These cases were matched with 569 controls for the case-control analysis. Patients were excluded if their VTE was due to an apparent proximate cause, such as pregnancy, recent surgery or lower limb injury, cancer, or recent severe trauma.

STUDY DESIGN AND VALIDITY: Two study designs were employed, a cohort design and a nested case-control design. Data for both were analyzed separately for 2 time periods from January 1993 to October 1995 (before the safety warning) and from January 1996 to December 1999 (following the warning). For the cohort study, person-time at risk was estimated from the date of first prescription of oral contraceptive until either the OC was stopped; a different study OC was prescribed; the woman died, left the practice, or became a case; or the study period ended. Summary incidence rates for the 2 periods were adjusted for age and compared between the 2 types of OC users. Each patient with idiopathic VTE (case group) was then matched with up to 6 patients without VTE (control group) by age, practice, and index date (both using OCs on the date of the diagnosis of the case). Odds ratios were calculated for both study periods individually and combined, with adjustments for body mass index, smoking history, duration of use of OCs, and whether a change in OC had occurred. The authors describe significant measures to assure the quality of the General Practice Database and made blinded assessments of outcome. By excluding women with predisposing risk factors for VTE they appropriately limited the study results to average risk individuals. Since 1,340,776 women contributed only 361,300 person-years of observation over 7 years of observation, significant variation in length of OC use must have occurred. In fact, though more women took third-generation OCs, these contributed fewer person-years to the analysis. Several known confounders (smoking, obesity, duration of OC use) were controlled for in the case-control analysis.

OUTCOMES MEASURED: The first case of idiopathic VTE as measured by careful chart review was the outcome of interest. The chart review was conducted by blinded investigators.

RESULTS: Both the cohort and matched case-control analyses of these data demonstrated an approximately two-fold increase in risk of VTE among users of third-generation OCs compared with OCs containing levonorgestrel (age-adjusted relative risk [RR]=1.9; 95% confidence interval [CI], 1.3-2.8 and odds ratio [OR] =2.3, 95% CI, 1.3-3.9). No difference in the age-adjusted incidence of VTE was apparent between the 2 study periods, though the proportion of users of third-generation OCs dropped significantly after the warning notice was issued. VTE was also independently associated with higher body mass index and smoking.

BACKGROUND: Published guidelines recommend using intranasal corticosteroids as an adjunctive measure to reduce inflammation in the treatment of sinusitis,¹ yet insufficient data exist to support these recommendations.

POPULATION STUDIED: The authors of this study included 407 patients aged older than 12 years with symptoms that characterized acute sinusitis and who had at least a 2-year history of acute recurrent sinusitis (at least 2 sinus infections requiring antibiotic treatment per year separated by symptom-free periods). Patients were included if they met a minimum symptom score based on a severity rating of 6 symptoms (purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, cough). Sinusitis was confirmed by computed tomography. Patients were excluded if they used nasal steroids in the previous 2 weeks or oral steroids in the previous 4 weeks or had anatomic abnormalities (nasal polyps, sinus surgery), cystic fibrosis, or steroid-related conditions, such as cataracts. Patients were also excluded if they had active seasonal allergic rhinitis and viral upper respiratory infections. Both groups were similar in age (40 years), men to women ratio, smoking history (40%), history of allergic rhinitis (40%), and sinusitis symptom scores

STUDY DESIGN AND VALIDITY: Patients were randomized to receive 21 days of treatment with amoxacillin clavulanate potassium (ACP) 875 mg twice daily combined with either MFNS 400 (g twice daily (divided between both nostrils) or matching placebo. Patients kept symptom diaries and rated the severity of the 6 symptoms twice daily. On day 21 the investigators evaluated patient symptoms using the same severity scale, and each patient evaluated their overall therapeutic response to treatment. Data were analyzed using an intention-to-treat approach. This was a well-done study that was multicentered and double blinded. Although allocation concealment is unclear, the design of this study minimizes systematic bias. It focused on patients with recurrent acute sinusitis, so the results may not be as positive in patients with a first episode of acute sinusitis.

OUTCOMES MEASURED: The outcomes measured were the presence of purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, and cough. The patients evaluated overall response to treatment on a 5-point scale.

RESULTS: At the end of 2 weeks mean total symptom scores decreased more in the steroid group compared with the placebo-treated patients (50.5% vs 44%; P=.01). For days 16 through 21 mean total symptom scores decreased 68% and 56.5%, respectively (P <.01). Inflammatory symptoms (congestion, facial pain, headache) showed significant improvement in patients using a nasal steroid (P≤.05), while secretory symptoms (purulent rhinorrhea, postnasal drip, cough) were not significantly improved. There were no differences in symptom response between smokers and nonsmokers or between those with or without atopy. Physician evaluations at the end of treatment showed a 68% reduction in total symptoms in the nasal steroid group and a 61% reduction in the placebo group (P <.01). At the conclusion of 21 days of treatment, 62% of the patients treated with MFNS and an antibiotic reported complete or marked relief compared with the 49% treated with antibiotic alone (P <.05; number needed to treat=8). Only 12% of the treatment group reported no or slight improvement of symptoms (treatment failure) compared with 23% in the placebo group. Adverse events were relatively uncommon, with 12% of the treatment group and 12% of the placebo group reporting such adverse events as headaches, nasal irritation, epistaxis, and diarrhea. Dropout rates were 4% in the nasal steroid group and 3% in the placebo group.

BACKGROUND: Published guidelines recommend using intranasal corticosteroids as an adjunctive measure to reduce inflammation in the treatment of sinusitis,¹ yet insufficient data exist to support these recommendations.

POPULATION STUDIED: The authors of this study included 407 patients aged older than 12 years with symptoms that characterized acute sinusitis and who had at least a 2-year history of acute recurrent sinusitis (at least 2 sinus infections requiring antibiotic treatment per year separated by symptom-free periods). Patients were included if they met a minimum symptom score based on a severity rating of 6 symptoms (purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, cough). Sinusitis was confirmed by computed tomography. Patients were excluded if they used nasal steroids in the previous 2 weeks or oral steroids in the previous 4 weeks or had anatomic abnormalities (nasal polyps, sinus surgery), cystic fibrosis, or steroid-related conditions, such as cataracts. Patients were also excluded if they had active seasonal allergic rhinitis and viral upper respiratory infections. Both groups were similar in age (40 years), men to women ratio, smoking history (40%), history of allergic rhinitis (40%), and sinusitis symptom scores

STUDY DESIGN AND VALIDITY: Patients were randomized to receive 21 days of treatment with amoxacillin clavulanate potassium (ACP) 875 mg twice daily combined with either MFNS 400 (g twice daily (divided between both nostrils) or matching placebo. Patients kept symptom diaries and rated the severity of the 6 symptoms twice daily. On day 21 the investigators evaluated patient symptoms using the same severity scale, and each patient evaluated their overall therapeutic response to treatment. Data were analyzed using an intention-to-treat approach. This was a well-done study that was multicentered and double blinded. Although allocation concealment is unclear, the design of this study minimizes systematic bias. It focused on patients with recurrent acute sinusitis, so the results may not be as positive in patients with a first episode of acute sinusitis.

OUTCOMES MEASURED: The outcomes measured were the presence of purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, and cough. The patients evaluated overall response to treatment on a 5-point scale.

RESULTS: At the end of 2 weeks mean total symptom scores decreased more in the steroid group compared with the placebo-treated patients (50.5% vs 44%; P=.01). For days 16 through 21 mean total symptom scores decreased 68% and 56.5%, respectively (P <.01). Inflammatory symptoms (congestion, facial pain, headache) showed significant improvement in patients using a nasal steroid (P≤.05), while secretory symptoms (purulent rhinorrhea, postnasal drip, cough) were not significantly improved. There were no differences in symptom response between smokers and nonsmokers or between those with or without atopy. Physician evaluations at the end of treatment showed a 68% reduction in total symptoms in the nasal steroid group and a 61% reduction in the placebo group (P <.01). At the conclusion of 21 days of treatment, 62% of the patients treated with MFNS and an antibiotic reported complete or marked relief compared with the 49% treated with antibiotic alone (P <.05; number needed to treat=8). Only 12% of the treatment group reported no or slight improvement of symptoms (treatment failure) compared with 23% in the placebo group. Adverse events were relatively uncommon, with 12% of the treatment group and 12% of the placebo group reporting such adverse events as headaches, nasal irritation, epistaxis, and diarrhea. Dropout rates were 4% in the nasal steroid group and 3% in the placebo group.

BACKGROUND: Published guidelines recommend using intranasal corticosteroids as an adjunctive measure to reduce inflammation in the treatment of sinusitis,¹ yet insufficient data exist to support these recommendations.

POPULATION STUDIED: The authors of this study included 407 patients aged older than 12 years with symptoms that characterized acute sinusitis and who had at least a 2-year history of acute recurrent sinusitis (at least 2 sinus infections requiring antibiotic treatment per year separated by symptom-free periods). Patients were included if they met a minimum symptom score based on a severity rating of 6 symptoms (purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, cough). Sinusitis was confirmed by computed tomography. Patients were excluded if they used nasal steroids in the previous 2 weeks or oral steroids in the previous 4 weeks or had anatomic abnormalities (nasal polyps, sinus surgery), cystic fibrosis, or steroid-related conditions, such as cataracts. Patients were also excluded if they had active seasonal allergic rhinitis and viral upper respiratory infections. Both groups were similar in age (40 years), men to women ratio, smoking history (40%), history of allergic rhinitis (40%), and sinusitis symptom scores

STUDY DESIGN AND VALIDITY: Patients were randomized to receive 21 days of treatment with amoxacillin clavulanate potassium (ACP) 875 mg twice daily combined with either MFNS 400 (g twice daily (divided between both nostrils) or matching placebo. Patients kept symptom diaries and rated the severity of the 6 symptoms twice daily. On day 21 the investigators evaluated patient symptoms using the same severity scale, and each patient evaluated their overall therapeutic response to treatment. Data were analyzed using an intention-to-treat approach. This was a well-done study that was multicentered and double blinded. Although allocation concealment is unclear, the design of this study minimizes systematic bias. It focused on patients with recurrent acute sinusitis, so the results may not be as positive in patients with a first episode of acute sinusitis.

OUTCOMES MEASURED: The outcomes measured were the presence of purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, and cough. The patients evaluated overall response to treatment on a 5-point scale.

RESULTS: At the end of 2 weeks mean total symptom scores decreased more in the steroid group compared with the placebo-treated patients (50.5% vs 44%; P=.01). For days 16 through 21 mean total symptom scores decreased 68% and 56.5%, respectively (P <.01). Inflammatory symptoms (congestion, facial pain, headache) showed significant improvement in patients using a nasal steroid (P≤.05), while secretory symptoms (purulent rhinorrhea, postnasal drip, cough) were not significantly improved. There were no differences in symptom response between smokers and nonsmokers or between those with or without atopy. Physician evaluations at the end of treatment showed a 68% reduction in total symptoms in the nasal steroid group and a 61% reduction in the placebo group (P <.01). At the conclusion of 21 days of treatment, 62% of the patients treated with MFNS and an antibiotic reported complete or marked relief compared with the 49% treated with antibiotic alone (P <.05; number needed to treat=8). Only 12% of the treatment group reported no or slight improvement of symptoms (treatment failure) compared with 23% in the placebo group. Adverse events were relatively uncommon, with 12% of the treatment group and 12% of the placebo group reporting such adverse events as headaches, nasal irritation, epistaxis, and diarrhea. Dropout rates were 4% in the nasal steroid group and 3% in the placebo group.

BACKGROUND: Elective inductions without a clear medical or obstetric indication are increasingly common. There are multiple studies suggesting that elective induction increases the risk of cesarean and instrumental delivery. However, the data are inconsistent, and many of the studies were performed before the introduction of cervical ripening agents. Therefore, it is unclear whether elective inductions without a medical or obstetric indication increase the risk of adverse outcomes under current practice guidelines.

POPULATION STUDIED: A sample of 2886 low-risk obstetric patients who underwent induction of labor without a medical or obstetric indication were compared with 9648 women with spontaneous labor. Eligibility criteria included women with single fetuses in a vertex position who delivered in the hospital between 37 and 41 weeks’ gestation. Women were excluded if an indication for induction was present according to the 1996 American College of Obstetrics and Gynecology (ACOG) guidelines. Of note, women who underwent induction for suspected macrosomia or post-term pregnancy before 42 weeks were not excluded from the study. The 2 populations of women were similar in most characteristics; however, those in the induction group were more likely to have a gestational age of 41 weeks or more (30% vs 18%), to have an infant with a birth weight of 4000 g or more (21.7% vs 13.3%), and to have medical insurance.

STUDY DESIGN AND VALIDITY: A sample of births in Washington State from 1989 to 1993 was obtained using birth certificates and linked hospital discharge data. Procedure codes and International Classification of Diseases—ninth revision codes used during the birth hospitalization were analyzed to determine whether a medical or obstetric indication for induction of labor was present. A random sample of women who underwent induction was compared with a random sample of women with spontaneous onset of labor. The retrospective cohort model was an appropriate design for this study. However, birth certificates and discharge data are often not complete with reference to the full hospitalization record. Because the charts from the birth hospitalization were not reviewed, a misclassification bias may have occurred. In addition, there are often unmeasured characteristics that influence the decision to induce labor that are not recorded on birth certificates or discharge data.

OUTCOMES MEASURED: The primary outcomes measured were the risk of cesarean or instrumental delivery (forceps or vacuum extraction) associated with elective induction of labor compared with spontaneous onset of labor. Other outcomes measured were risk of birth injury, 5-minute APGAR score less than 7, presence of meconium, and meconium aspiration.

RESULTS: Among women meeting the study eligibility criteria, the proportion of births by induction nearly doubled during the study period (10.2% in 1989 to 19.7% in 1993). Nulliparous women who were induced were more likely to have a cesarean delivery than those women with spontaneous onset of labor (19.4% vs 9.9%; relative risk [RR, adjusted for birth weight]=1.77; 95% confidence interval [CI], 1.50-2.08; number needed to harm [NNH]=11). For multiparous women there was no difference in cesarean delivery rate (4% in each group). The risk of instrumental vaginal delivery was slightly increased for women with induced labor (18.6% vs 15.5%; RR=1.20; 95% CI, 1.09-1.36; NNH=32). There was also an increase in the incidence of shoulder dystocia in the induction group (3% vs 1.7%; RR=1.32; 95% CI, 1.02-1.69). Of the other outcomes, the only difference between the groups was a decreased risk of moderate to heavy meconium present at birth in the induction group (4.4% vs 5.7%; RR=0.78; 95% CI, 0.65-0.95). However, this was not associated with a decreased risk of meconium aspiration. As these differences could potentially be confounded by a post-term gestation of 41 weeks or more, the authors repeated a data analysis including only women who delivered between 37 and 41 weeks. All outcomes were unchanged.

BACKGROUND: Elective inductions without a clear medical or obstetric indication are increasingly common. There are multiple studies suggesting that elective induction increases the risk of cesarean and instrumental delivery. However, the data are inconsistent, and many of the studies were performed before the introduction of cervical ripening agents. Therefore, it is unclear whether elective inductions without a medical or obstetric indication increase the risk of adverse outcomes under current practice guidelines.

POPULATION STUDIED: A sample of 2886 low-risk obstetric patients who underwent induction of labor without a medical or obstetric indication were compared with 9648 women with spontaneous labor. Eligibility criteria included women with single fetuses in a vertex position who delivered in the hospital between 37 and 41 weeks’ gestation. Women were excluded if an indication for induction was present according to the 1996 American College of Obstetrics and Gynecology (ACOG) guidelines. Of note, women who underwent induction for suspected macrosomia or post-term pregnancy before 42 weeks were not excluded from the study. The 2 populations of women were similar in most characteristics; however, those in the induction group were more likely to have a gestational age of 41 weeks or more (30% vs 18%), to have an infant with a birth weight of 4000 g or more (21.7% vs 13.3%), and to have medical insurance.

STUDY DESIGN AND VALIDITY: A sample of births in Washington State from 1989 to 1993 was obtained using birth certificates and linked hospital discharge data. Procedure codes and International Classification of Diseases—ninth revision codes used during the birth hospitalization were analyzed to determine whether a medical or obstetric indication for induction of labor was present. A random sample of women who underwent induction was compared with a random sample of women with spontaneous onset of labor. The retrospective cohort model was an appropriate design for this study. However, birth certificates and discharge data are often not complete with reference to the full hospitalization record. Because the charts from the birth hospitalization were not reviewed, a misclassification bias may have occurred. In addition, there are often unmeasured characteristics that influence the decision to induce labor that are not recorded on birth certificates or discharge data.

OUTCOMES MEASURED: The primary outcomes measured were the risk of cesarean or instrumental delivery (forceps or vacuum extraction) associated with elective induction of labor compared with spontaneous onset of labor. Other outcomes measured were risk of birth injury, 5-minute APGAR score less than 7, presence of meconium, and meconium aspiration.

RESULTS: Among women meeting the study eligibility criteria, the proportion of births by induction nearly doubled during the study period (10.2% in 1989 to 19.7% in 1993). Nulliparous women who were induced were more likely to have a cesarean delivery than those women with spontaneous onset of labor (19.4% vs 9.9%; relative risk [RR, adjusted for birth weight]=1.77; 95% confidence interval [CI], 1.50-2.08; number needed to harm [NNH]=11). For multiparous women there was no difference in cesarean delivery rate (4% in each group). The risk of instrumental vaginal delivery was slightly increased for women with induced labor (18.6% vs 15.5%; RR=1.20; 95% CI, 1.09-1.36; NNH=32). There was also an increase in the incidence of shoulder dystocia in the induction group (3% vs 1.7%; RR=1.32; 95% CI, 1.02-1.69). Of the other outcomes, the only difference between the groups was a decreased risk of moderate to heavy meconium present at birth in the induction group (4.4% vs 5.7%; RR=0.78; 95% CI, 0.65-0.95). However, this was not associated with a decreased risk of meconium aspiration. As these differences could potentially be confounded by a post-term gestation of 41 weeks or more, the authors repeated a data analysis including only women who delivered between 37 and 41 weeks. All outcomes were unchanged.

BACKGROUND: Elective inductions without a clear medical or obstetric indication are increasingly common. There are multiple studies suggesting that elective induction increases the risk of cesarean and instrumental delivery. However, the data are inconsistent, and many of the studies were performed before the introduction of cervical ripening agents. Therefore, it is unclear whether elective inductions without a medical or obstetric indication increase the risk of adverse outcomes under current practice guidelines.

POPULATION STUDIED: A sample of 2886 low-risk obstetric patients who underwent induction of labor without a medical or obstetric indication were compared with 9648 women with spontaneous labor. Eligibility criteria included women with single fetuses in a vertex position who delivered in the hospital between 37 and 41 weeks’ gestation. Women were excluded if an indication for induction was present according to the 1996 American College of Obstetrics and Gynecology (ACOG) guidelines. Of note, women who underwent induction for suspected macrosomia or post-term pregnancy before 42 weeks were not excluded from the study. The 2 populations of women were similar in most characteristics; however, those in the induction group were more likely to have a gestational age of 41 weeks or more (30% vs 18%), to have an infant with a birth weight of 4000 g or more (21.7% vs 13.3%), and to have medical insurance.

STUDY DESIGN AND VALIDITY: A sample of births in Washington State from 1989 to 1993 was obtained using birth certificates and linked hospital discharge data. Procedure codes and International Classification of Diseases—ninth revision codes used during the birth hospitalization were analyzed to determine whether a medical or obstetric indication for induction of labor was present. A random sample of women who underwent induction was compared with a random sample of women with spontaneous onset of labor. The retrospective cohort model was an appropriate design for this study. However, birth certificates and discharge data are often not complete with reference to the full hospitalization record. Because the charts from the birth hospitalization were not reviewed, a misclassification bias may have occurred. In addition, there are often unmeasured characteristics that influence the decision to induce labor that are not recorded on birth certificates or discharge data.

OUTCOMES MEASURED: The primary outcomes measured were the risk of cesarean or instrumental delivery (forceps or vacuum extraction) associated with elective induction of labor compared with spontaneous onset of labor. Other outcomes measured were risk of birth injury, 5-minute APGAR score less than 7, presence of meconium, and meconium aspiration.

RESULTS: Among women meeting the study eligibility criteria, the proportion of births by induction nearly doubled during the study period (10.2% in 1989 to 19.7% in 1993). Nulliparous women who were induced were more likely to have a cesarean delivery than those women with spontaneous onset of labor (19.4% vs 9.9%; relative risk [RR, adjusted for birth weight]=1.77; 95% confidence interval [CI], 1.50-2.08; number needed to harm [NNH]=11). For multiparous women there was no difference in cesarean delivery rate (4% in each group). The risk of instrumental vaginal delivery was slightly increased for women with induced labor (18.6% vs 15.5%; RR=1.20; 95% CI, 1.09-1.36; NNH=32). There was also an increase in the incidence of shoulder dystocia in the induction group (3% vs 1.7%; RR=1.32; 95% CI, 1.02-1.69). Of the other outcomes, the only difference between the groups was a decreased risk of moderate to heavy meconium present at birth in the induction group (4.4% vs 5.7%; RR=0.78; 95% CI, 0.65-0.95). However, this was not associated with a decreased risk of meconium aspiration. As these differences could potentially be confounded by a post-term gestation of 41 weeks or more, the authors repeated a data analysis including only women who delivered between 37 and 41 weeks. All outcomes were unchanged.

BACKGROUND: Some clinicians recommend cesarean delivery for all babies with breech presentation, while others encourage a trial of vaginal delivery for selected women. This randomized trial compared planned cesarean delivery (PCD) with planned vaginal delivery (PVD) for term breech babies.

POPULATION STUDIED: A total of 2088 women from 121 centers in 26 different countries were enrolled. Each woman had an uncomplicated complete or frank breech at more than 37 weeks’ gestation. Most of the women were aged younger than 30 years; approximately 50% were primiparous. Ultrasound sizing was performed on 40%, and external cephalic version was attempted in 20%. Fifty percent of the countries had a low perinatal mortality rate. Thus, the clinical setting is probably similar to that of family physicians in the United States.

STUDY DESIGN AND VALIDITY: This was a well-designed study. Participating subjects were randomly assigned (masked allocation) to either PCD (n=1043) or to PVD by an accoucheur experienced in breech delivery (n=1045). The accoucheur’s experience was confirmed by the department head, and approximately 60% had more than 10 years’ vaginal breech delivery experience. For those women assigned to vaginal delivery, a standardized labor protocol was used and was comparable with practice in the United States. The method of delivery was by assisted or spontaneous breech delivery with control of the after-coming head either by use of a forceps or the Mauriceau-Smellie-Veit maneuver. Cesarean deliveries were scheduled for women with gestation greater than 38 weeks. The follow-up rate was 99.8%. Analysis was by intention to treat, with lethal congenital anomalies excluded. Multiple logistic regression was used to assess for interaction; the Fisher exact test and the Wilcoxon rank-sum test were used to test outcomes, with a one-sided P value used for neonatal outcomes and a two-sided P value for maternal outcomes.

OUTCOMES MEASURED: The main outcome was perinatal or neonatal mortality and serious neonatal morbidity, including birth injury, seizures, and an APGAR score less than 4 at 5 minutes. A secondary outcome was maternal mortality or serious maternal morbidity in the first 6 weeks; cesarean delivery itself was not included as maternal morbidity.

RESULTS: At enrollment the groups were similar. Because of early results showing an important difference in outcomes, the trial was stopped early. In the PCD group, 10% delivered vaginally compared with 57% of the PVD group. Perinatal and neonatal mortality was lower in the PCD group than in the PVD group (0.3% vs 1.3%; relative risk [RR]=0.23; 95% confidence interval [CI], 0.07-0.81; number needed to treat [NNT]=100) as was serious neonatal morbidity (1.4% vs 3.8%; RR=0.36; 95% CI, 0.19-0.65; NNT=42). The benefit of PCD was greater in countries with low mortality rates (combined mortality and morbidity, 0.4% vs 5.7%; P <.005; NNT=19). There was no difference in maternal mortality or morbidity.

BACKGROUND: Some clinicians recommend cesarean delivery for all babies with breech presentation, while others encourage a trial of vaginal delivery for selected women. This randomized trial compared planned cesarean delivery (PCD) with planned vaginal delivery (PVD) for term breech babies.

POPULATION STUDIED: A total of 2088 women from 121 centers in 26 different countries were enrolled. Each woman had an uncomplicated complete or frank breech at more than 37 weeks’ gestation. Most of the women were aged younger than 30 years; approximately 50% were primiparous. Ultrasound sizing was performed on 40%, and external cephalic version was attempted in 20%. Fifty percent of the countries had a low perinatal mortality rate. Thus, the clinical setting is probably similar to that of family physicians in the United States.

STUDY DESIGN AND VALIDITY: This was a well-designed study. Participating subjects were randomly assigned (masked allocation) to either PCD (n=1043) or to PVD by an accoucheur experienced in breech delivery (n=1045). The accoucheur’s experience was confirmed by the department head, and approximately 60% had more than 10 years’ vaginal breech delivery experience. For those women assigned to vaginal delivery, a standardized labor protocol was used and was comparable with practice in the United States. The method of delivery was by assisted or spontaneous breech delivery with control of the after-coming head either by use of a forceps or the Mauriceau-Smellie-Veit maneuver. Cesarean deliveries were scheduled for women with gestation greater than 38 weeks. The follow-up rate was 99.8%. Analysis was by intention to treat, with lethal congenital anomalies excluded. Multiple logistic regression was used to assess for interaction; the Fisher exact test and the Wilcoxon rank-sum test were used to test outcomes, with a one-sided P value used for neonatal outcomes and a two-sided P value for maternal outcomes.

OUTCOMES MEASURED: The main outcome was perinatal or neonatal mortality and serious neonatal morbidity, including birth injury, seizures, and an APGAR score less than 4 at 5 minutes. A secondary outcome was maternal mortality or serious maternal morbidity in the first 6 weeks; cesarean delivery itself was not included as maternal morbidity.

RESULTS: At enrollment the groups were similar. Because of early results showing an important difference in outcomes, the trial was stopped early. In the PCD group, 10% delivered vaginally compared with 57% of the PVD group. Perinatal and neonatal mortality was lower in the PCD group than in the PVD group (0.3% vs 1.3%; relative risk [RR]=0.23; 95% confidence interval [CI], 0.07-0.81; number needed to treat [NNT]=100) as was serious neonatal morbidity (1.4% vs 3.8%; RR=0.36; 95% CI, 0.19-0.65; NNT=42). The benefit of PCD was greater in countries with low mortality rates (combined mortality and morbidity, 0.4% vs 5.7%; P <.005; NNT=19). There was no difference in maternal mortality or morbidity.

BACKGROUND: Some clinicians recommend cesarean delivery for all babies with breech presentation, while others encourage a trial of vaginal delivery for selected women. This randomized trial compared planned cesarean delivery (PCD) with planned vaginal delivery (PVD) for term breech babies.

POPULATION STUDIED: A total of 2088 women from 121 centers in 26 different countries were enrolled. Each woman had an uncomplicated complete or frank breech at more than 37 weeks’ gestation. Most of the women were aged younger than 30 years; approximately 50% were primiparous. Ultrasound sizing was performed on 40%, and external cephalic version was attempted in 20%. Fifty percent of the countries had a low perinatal mortality rate. Thus, the clinical setting is probably similar to that of family physicians in the United States.

STUDY DESIGN AND VALIDITY: This was a well-designed study. Participating subjects were randomly assigned (masked allocation) to either PCD (n=1043) or to PVD by an accoucheur experienced in breech delivery (n=1045). The accoucheur’s experience was confirmed by the department head, and approximately 60% had more than 10 years’ vaginal breech delivery experience. For those women assigned to vaginal delivery, a standardized labor protocol was used and was comparable with practice in the United States. The method of delivery was by assisted or spontaneous breech delivery with control of the after-coming head either by use of a forceps or the Mauriceau-Smellie-Veit maneuver. Cesarean deliveries were scheduled for women with gestation greater than 38 weeks. The follow-up rate was 99.8%. Analysis was by intention to treat, with lethal congenital anomalies excluded. Multiple logistic regression was used to assess for interaction; the Fisher exact test and the Wilcoxon rank-sum test were used to test outcomes, with a one-sided P value used for neonatal outcomes and a two-sided P value for maternal outcomes.

OUTCOMES MEASURED: The main outcome was perinatal or neonatal mortality and serious neonatal morbidity, including birth injury, seizures, and an APGAR score less than 4 at 5 minutes. A secondary outcome was maternal mortality or serious maternal morbidity in the first 6 weeks; cesarean delivery itself was not included as maternal morbidity.

RESULTS: At enrollment the groups were similar. Because of early results showing an important difference in outcomes, the trial was stopped early. In the PCD group, 10% delivered vaginally compared with 57% of the PVD group. Perinatal and neonatal mortality was lower in the PCD group than in the PVD group (0.3% vs 1.3%; relative risk [RR]=0.23; 95% confidence interval [CI], 0.07-0.81; number needed to treat [NNT]=100) as was serious neonatal morbidity (1.4% vs 3.8%; RR=0.36; 95% CI, 0.19-0.65; NNT=42). The benefit of PCD was greater in countries with low mortality rates (combined mortality and morbidity, 0.4% vs 5.7%; P <.005; NNT=19). There was no difference in maternal mortality or morbidity.

BACKGROUND: Injudicious use of antibiotics in the management of sore throat contributes to the proliferation of resistant organisms and exposes patients to adverse effects of unnecessary medication. A clinical decision-making tool that better identifies patients with streptococcal infection would decrease unnecessary testing and antibiotic therapy. The authors of this study evaluated the validity of such a clinical rule in a primary care setting.

POPULATION STUDIED: Family physicians in Ontario, Canada, enrolled 621 patients, all of whom presented with a sore throat and an upper respiratory infection. Of these, two thirds were women and one fourth were aged younger than 15 years. Exclusion criteria included age younger than 3 years, recent treatment with antibiotics, or an alternate diagnosis that explains the symptoms (eg, otitis media, pneumonia).

STUDY DESIGN AND VALIDITY: The authors compared the results of a clinical rule with the independent clinical decisions of the treating physician. Physicians evaluated and treated patients per their usual routine and recorded their findings and interventions on an assessment form. Throat cultures were obtained for all patients. The physicians also recorded the “strep” score for each patient. This rule assigns 1 point for each of the following symptoms: temperature greater than 38°C, absence of cough, tender anterior cervical adenopathy, tonsillar swelling or exudate, and age younger than 15 years. One point is subtracted for age older than 45 years. A score of 1 or less was considered negative, and neither throat culture nor antibiotic therapy was recommended. A score of 2 or 3 was considered indeterminate, and a throat culture was recommended with antibiotic therapy based on culture results. A score of 4 or greater was considered positive, and antibiotic therapy or throat culture was recommended. Comparison of the number of antibiotic prescriptions and throat cultures was made between the physicians’ plan and the clinical rule.

OUTCOMES MEASURED: The primary outcomes were the sensitivity and specificity of the clinical rule. Concordance of antibiotic treatment and throat culture results was evaluated.

RESULTS: Physicians prescribed antibiotics to 27.9% of patients. Of these, only 37% had group A streptococcus (GAS) on culture. Cultures were positive for GAS in 17% of all patients. The clinical rule was 85% sensitive for identifying GAS infection (95% confidence interval [CI], 76.5%-91.4%) and 92.1% specific (95% CI, 89.3%-94.3%). Few patients with a clinical rule score of 1 or less had GAS pharyngitis (4.7%). The prevalence of GAS was 17% for a score of 2, 35% for a score of 3, and 51% for a score of 4 or more. Use of the clinical rule would have reduced antibiotic use by 52.3% and throat culture by 35.8% in all patients. Although this effect was more notable in adult patients, even in children the score was more sensitive than the clinical assessment and would have reduced unnecessary testing.

BACKGROUND: Injudicious use of antibiotics in the management of sore throat contributes to the proliferation of resistant organisms and exposes patients to adverse effects of unnecessary medication. A clinical decision-making tool that better identifies patients with streptococcal infection would decrease unnecessary testing and antibiotic therapy. The authors of this study evaluated the validity of such a clinical rule in a primary care setting.

POPULATION STUDIED: Family physicians in Ontario, Canada, enrolled 621 patients, all of whom presented with a sore throat and an upper respiratory infection. Of these, two thirds were women and one fourth were aged younger than 15 years. Exclusion criteria included age younger than 3 years, recent treatment with antibiotics, or an alternate diagnosis that explains the symptoms (eg, otitis media, pneumonia).

STUDY DESIGN AND VALIDITY: The authors compared the results of a clinical rule with the independent clinical decisions of the treating physician. Physicians evaluated and treated patients per their usual routine and recorded their findings and interventions on an assessment form. Throat cultures were obtained for all patients. The physicians also recorded the “strep” score for each patient. This rule assigns 1 point for each of the following symptoms: temperature greater than 38°C, absence of cough, tender anterior cervical adenopathy, tonsillar swelling or exudate, and age younger than 15 years. One point is subtracted for age older than 45 years. A score of 1 or less was considered negative, and neither throat culture nor antibiotic therapy was recommended. A score of 2 or 3 was considered indeterminate, and a throat culture was recommended with antibiotic therapy based on culture results. A score of 4 or greater was considered positive, and antibiotic therapy or throat culture was recommended. Comparison of the number of antibiotic prescriptions and throat cultures was made between the physicians’ plan and the clinical rule.

OUTCOMES MEASURED: The primary outcomes were the sensitivity and specificity of the clinical rule. Concordance of antibiotic treatment and throat culture results was evaluated.

RESULTS: Physicians prescribed antibiotics to 27.9% of patients. Of these, only 37% had group A streptococcus (GAS) on culture. Cultures were positive for GAS in 17% of all patients. The clinical rule was 85% sensitive for identifying GAS infection (95% confidence interval [CI], 76.5%-91.4%) and 92.1% specific (95% CI, 89.3%-94.3%). Few patients with a clinical rule score of 1 or less had GAS pharyngitis (4.7%). The prevalence of GAS was 17% for a score of 2, 35% for a score of 3, and 51% for a score of 4 or more. Use of the clinical rule would have reduced antibiotic use by 52.3% and throat culture by 35.8% in all patients. Although this effect was more notable in adult patients, even in children the score was more sensitive than the clinical assessment and would have reduced unnecessary testing.

BACKGROUND: Injudicious use of antibiotics in the management of sore throat contributes to the proliferation of resistant organisms and exposes patients to adverse effects of unnecessary medication. A clinical decision-making tool that better identifies patients with streptococcal infection would decrease unnecessary testing and antibiotic therapy. The authors of this study evaluated the validity of such a clinical rule in a primary care setting.

POPULATION STUDIED: Family physicians in Ontario, Canada, enrolled 621 patients, all of whom presented with a sore throat and an upper respiratory infection. Of these, two thirds were women and one fourth were aged younger than 15 years. Exclusion criteria included age younger than 3 years, recent treatment with antibiotics, or an alternate diagnosis that explains the symptoms (eg, otitis media, pneumonia).

STUDY DESIGN AND VALIDITY: The authors compared the results of a clinical rule with the independent clinical decisions of the treating physician. Physicians evaluated and treated patients per their usual routine and recorded their findings and interventions on an assessment form. Throat cultures were obtained for all patients. The physicians also recorded the “strep” score for each patient. This rule assigns 1 point for each of the following symptoms: temperature greater than 38°C, absence of cough, tender anterior cervical adenopathy, tonsillar swelling or exudate, and age younger than 15 years. One point is subtracted for age older than 45 years. A score of 1 or less was considered negative, and neither throat culture nor antibiotic therapy was recommended. A score of 2 or 3 was considered indeterminate, and a throat culture was recommended with antibiotic therapy based on culture results. A score of 4 or greater was considered positive, and antibiotic therapy or throat culture was recommended. Comparison of the number of antibiotic prescriptions and throat cultures was made between the physicians’ plan and the clinical rule.

OUTCOMES MEASURED: The primary outcomes were the sensitivity and specificity of the clinical rule. Concordance of antibiotic treatment and throat culture results was evaluated.

RESULTS: Physicians prescribed antibiotics to 27.9% of patients. Of these, only 37% had group A streptococcus (GAS) on culture. Cultures were positive for GAS in 17% of all patients. The clinical rule was 85% sensitive for identifying GAS infection (95% confidence interval [CI], 76.5%-91.4%) and 92.1% specific (95% CI, 89.3%-94.3%). Few patients with a clinical rule score of 1 or less had GAS pharyngitis (4.7%). The prevalence of GAS was 17% for a score of 2, 35% for a score of 3, and 51% for a score of 4 or more. Use of the clinical rule would have reduced antibiotic use by 52.3% and throat culture by 35.8% in all patients. Although this effect was more notable in adult patients, even in children the score was more sensitive than the clinical assessment and would have reduced unnecessary testing.

BACKGROUND: Routine sweeping or “stripping” of the membranes beginning at 38 to 40 weeks’ gestation is an effective method of reducing the risk of a postdate and post-term pregnancy, as well as the need for more formal induction of labor. However, sweeping has not been shown to decrease the rate of cesarean delivery. This study is the first clinical trial of the effectiveness of membrane sweeping in conjunction with formal induction of labor.

POPULATION STUDIED: Nulliparous (N=130) and multiparous (N=118) women at term (38 to 42 weeks) were recruited into the study if they were admitted for induction of labor and had not had pre-admission sweeping performed. Indications for induction of labor included hypertension, intrauterine growth restriction, post-term, gestational diabetes, and oligohydramnios.

STUDY DESIGN AND VALIDITY: Pairs of eligible women were matched for parity and method of induction, and each was assigned to membrane sweeping or gentle cervical examination to determine Bishop score before induction. Sweeping involved separating the membranes from the lower uterine segment as far as possible with a finger inserted into the internal os. Induction protocols included the use of 3 mg vaginal prostaglandin (PGE2) pessary for women with unfavorable cervices (Bishop score <5) and rupture of membranes at any point when the cervix was favorable. PGE2 was repeated every 6 hours if needed. Oxytocin was started if there were insufficient uterine contractions within 3 hours after rupture of membranes. The oxytocin protocol called for increases of 2.5 mU per minute every half hour to a maximum of 40 mU per minute to achieve 4 to 5 contractions every 10 minutes. Vaginal examinations were routinely done every 3 hours.

OUTCOMES MEASURED: Induction-to-delivery interval, total duration of labor, maximum dose of oxytocin used during induction, and mode of delivery were the primary maternal outcomes reported. The authors also reported meconium-stained amniotic fluid and admission to the neonatal unit but did not report any other patient-based outcomes, such as pain or satisfaction.

RESULTS: No differences in any outcome measures were found for multiparous women. Nulliparous women assigned to the membrane sweeping group who required cervical ripening with prostaglandins had shorter induction-to-delivery intervals (13.6 vs 17.3 hours, P=.043), required less oxytocin, were more likely to have a spontaneous vaginal delivery (83.3% vs 58.2%, P=.01; number needed to treat [NNT]=4) and were less likely to require a cesarean delivery (6.3% vs 21.8%, P=.01; NNT=7). Nulliparas who had induction with artificial rupture of the membranes plus oxytocin also appeared to have shorter induction-to-delivery intervals and to require lower maximum doses of oxytocin. When these results were analyzed according to Bishop score, however, significant differences persisted only for nulliparous women who had scores of less than 5. There were no significant differences in other outcome measures.

BACKGROUND: Routine sweeping or “stripping” of the membranes beginning at 38 to 40 weeks’ gestation is an effective method of reducing the risk of a postdate and post-term pregnancy, as well as the need for more formal induction of labor. However, sweeping has not been shown to decrease the rate of cesarean delivery. This study is the first clinical trial of the effectiveness of membrane sweeping in conjunction with formal induction of labor.

POPULATION STUDIED: Nulliparous (N=130) and multiparous (N=118) women at term (38 to 42 weeks) were recruited into the study if they were admitted for induction of labor and had not had pre-admission sweeping performed. Indications for induction of labor included hypertension, intrauterine growth restriction, post-term, gestational diabetes, and oligohydramnios.

STUDY DESIGN AND VALIDITY: Pairs of eligible women were matched for parity and method of induction, and each was assigned to membrane sweeping or gentle cervical examination to determine Bishop score before induction. Sweeping involved separating the membranes from the lower uterine segment as far as possible with a finger inserted into the internal os. Induction protocols included the use of 3 mg vaginal prostaglandin (PGE2) pessary for women with unfavorable cervices (Bishop score <5) and rupture of membranes at any point when the cervix was favorable. PGE2 was repeated every 6 hours if needed. Oxytocin was started if there were insufficient uterine contractions within 3 hours after rupture of membranes. The oxytocin protocol called for increases of 2.5 mU per minute every half hour to a maximum of 40 mU per minute to achieve 4 to 5 contractions every 10 minutes. Vaginal examinations were routinely done every 3 hours.

OUTCOMES MEASURED: Induction-to-delivery interval, total duration of labor, maximum dose of oxytocin used during induction, and mode of delivery were the primary maternal outcomes reported. The authors also reported meconium-stained amniotic fluid and admission to the neonatal unit but did not report any other patient-based outcomes, such as pain or satisfaction.

RESULTS: No differences in any outcome measures were found for multiparous women. Nulliparous women assigned to the membrane sweeping group who required cervical ripening with prostaglandins had shorter induction-to-delivery intervals (13.6 vs 17.3 hours, P=.043), required less oxytocin, were more likely to have a spontaneous vaginal delivery (83.3% vs 58.2%, P=.01; number needed to treat [NNT]=4) and were less likely to require a cesarean delivery (6.3% vs 21.8%, P=.01; NNT=7). Nulliparas who had induction with artificial rupture of the membranes plus oxytocin also appeared to have shorter induction-to-delivery intervals and to require lower maximum doses of oxytocin. When these results were analyzed according to Bishop score, however, significant differences persisted only for nulliparous women who had scores of less than 5. There were no significant differences in other outcome measures.

BACKGROUND: Routine sweeping or “stripping” of the membranes beginning at 38 to 40 weeks’ gestation is an effective method of reducing the risk of a postdate and post-term pregnancy, as well as the need for more formal induction of labor. However, sweeping has not been shown to decrease the rate of cesarean delivery. This study is the first clinical trial of the effectiveness of membrane sweeping in conjunction with formal induction of labor.

POPULATION STUDIED: Nulliparous (N=130) and multiparous (N=118) women at term (38 to 42 weeks) were recruited into the study if they were admitted for induction of labor and had not had pre-admission sweeping performed. Indications for induction of labor included hypertension, intrauterine growth restriction, post-term, gestational diabetes, and oligohydramnios.

STUDY DESIGN AND VALIDITY: Pairs of eligible women were matched for parity and method of induction, and each was assigned to membrane sweeping or gentle cervical examination to determine Bishop score before induction. Sweeping involved separating the membranes from the lower uterine segment as far as possible with a finger inserted into the internal os. Induction protocols included the use of 3 mg vaginal prostaglandin (PGE2) pessary for women with unfavorable cervices (Bishop score <5) and rupture of membranes at any point when the cervix was favorable. PGE2 was repeated every 6 hours if needed. Oxytocin was started if there were insufficient uterine contractions within 3 hours after rupture of membranes. The oxytocin protocol called for increases of 2.5 mU per minute every half hour to a maximum of 40 mU per minute to achieve 4 to 5 contractions every 10 minutes. Vaginal examinations were routinely done every 3 hours.

OUTCOMES MEASURED: Induction-to-delivery interval, total duration of labor, maximum dose of oxytocin used during induction, and mode of delivery were the primary maternal outcomes reported. The authors also reported meconium-stained amniotic fluid and admission to the neonatal unit but did not report any other patient-based outcomes, such as pain or satisfaction.

RESULTS: No differences in any outcome measures were found for multiparous women. Nulliparous women assigned to the membrane sweeping group who required cervical ripening with prostaglandins had shorter induction-to-delivery intervals (13.6 vs 17.3 hours, P=.043), required less oxytocin, were more likely to have a spontaneous vaginal delivery (83.3% vs 58.2%, P=.01; number needed to treat [NNT]=4) and were less likely to require a cesarean delivery (6.3% vs 21.8%, P=.01; NNT=7). Nulliparas who had induction with artificial rupture of the membranes plus oxytocin also appeared to have shorter induction-to-delivery intervals and to require lower maximum doses of oxytocin. When these results were analyzed according to Bishop score, however, significant differences persisted only for nulliparous women who had scores of less than 5. There were no significant differences in other outcome measures.