Q&A

BACKGROUND: There is concern about the effect of antihistamines in children on alertness and school performance. This study assessed the impact of first- and second-generation antihistamines on school performance.

POPULATION STUDIED: The investigators enrolled 63 children aged 8 to 10 years with antihistamine-treated allergic rhinitis but no current symptoms. Subjects underwent skin testing to prove they were allergic to allergens not currently in season. They had no known learning disabilities or illnesses that might have an impact on the study. In general, the subjects seem similar to patients family physicians see, although no information about the study group composition by weight, sex, ethnicity, specific allergy history, or other medical history was given.

STUDY DESIGN AND VALIDITY: This was a double-blind placebo-controlled study. Participants were randomized to 1 of 3 treatment groups: diphenhdramine (Benadryl, dye-free) 25 mg twice daily, loratadine (Claritin) 10 mg in the morning with placebo in the evening, or placebo twice daily. To simulate an everyday classroom experience, an existing laboratory school was used on 3 consecutive weekends. The medications were administered on study days 1, 2, and 8 at 7:45 AM and 1:45 PM. The subjects were given 1-hour lectures and 1-hour reading assignments on plant biology. After 90 to 120 minutes, they completed computerized testing to assess retention and reaction times. Covariate analysis was performed, with adjustments for sex, age, baseline reading ability, and weight, along with correction for multiple comparisons. The methodology of this study was strong. The major strengths were the randomized design, the use of patients with known allergies, and the realistic laboratory school setting with appropriate and innovative “blinded” testing. The major weaknesses of the study were the relatively small sample size, and—despite the commendable efforts of the investigators—the inherent artificiality of a weekend school that takes place only over a few weekends. Other minor limitations include the short duration of the study and the lack of assessment of baseline medical history. Interpretation was hampered by the lack of information regarding the results of randomization.

OUTCOME MEASURED: Outcomes measured by computer assessment were: (1) retention of material presented orally (average number of errors in 25 questions about teacher presentations); (2) retention of materials presented in a written format (average number of errors in 25 questions from the readings); (3) reaction time for answers (average for all correct computer test questions); and (4) child self report of somnolence.

RESULTS: At the end of the trial, there were no significant differences noted in the verbal instruction score, reading test score, reaction time, or somnolence scale among students in the 3 treatment groups. Female subjects tended to rate somnolence slightly higher than male subjects did; heavier subjects rated somnolence lower.

BACKGROUND: There is concern about the effect of antihistamines in children on alertness and school performance. This study assessed the impact of first- and second-generation antihistamines on school performance.

POPULATION STUDIED: The investigators enrolled 63 children aged 8 to 10 years with antihistamine-treated allergic rhinitis but no current symptoms. Subjects underwent skin testing to prove they were allergic to allergens not currently in season. They had no known learning disabilities or illnesses that might have an impact on the study. In general, the subjects seem similar to patients family physicians see, although no information about the study group composition by weight, sex, ethnicity, specific allergy history, or other medical history was given.

STUDY DESIGN AND VALIDITY: This was a double-blind placebo-controlled study. Participants were randomized to 1 of 3 treatment groups: diphenhdramine (Benadryl, dye-free) 25 mg twice daily, loratadine (Claritin) 10 mg in the morning with placebo in the evening, or placebo twice daily. To simulate an everyday classroom experience, an existing laboratory school was used on 3 consecutive weekends. The medications were administered on study days 1, 2, and 8 at 7:45 AM and 1:45 PM. The subjects were given 1-hour lectures and 1-hour reading assignments on plant biology. After 90 to 120 minutes, they completed computerized testing to assess retention and reaction times. Covariate analysis was performed, with adjustments for sex, age, baseline reading ability, and weight, along with correction for multiple comparisons. The methodology of this study was strong. The major strengths were the randomized design, the use of patients with known allergies, and the realistic laboratory school setting with appropriate and innovative “blinded” testing. The major weaknesses of the study were the relatively small sample size, and—despite the commendable efforts of the investigators—the inherent artificiality of a weekend school that takes place only over a few weekends. Other minor limitations include the short duration of the study and the lack of assessment of baseline medical history. Interpretation was hampered by the lack of information regarding the results of randomization.

OUTCOME MEASURED: Outcomes measured by computer assessment were: (1) retention of material presented orally (average number of errors in 25 questions about teacher presentations); (2) retention of materials presented in a written format (average number of errors in 25 questions from the readings); (3) reaction time for answers (average for all correct computer test questions); and (4) child self report of somnolence.

RESULTS: At the end of the trial, there were no significant differences noted in the verbal instruction score, reading test score, reaction time, or somnolence scale among students in the 3 treatment groups. Female subjects tended to rate somnolence slightly higher than male subjects did; heavier subjects rated somnolence lower.

BACKGROUND: There is concern about the effect of antihistamines in children on alertness and school performance. This study assessed the impact of first- and second-generation antihistamines on school performance.

POPULATION STUDIED: The investigators enrolled 63 children aged 8 to 10 years with antihistamine-treated allergic rhinitis but no current symptoms. Subjects underwent skin testing to prove they were allergic to allergens not currently in season. They had no known learning disabilities or illnesses that might have an impact on the study. In general, the subjects seem similar to patients family physicians see, although no information about the study group composition by weight, sex, ethnicity, specific allergy history, or other medical history was given.

STUDY DESIGN AND VALIDITY: This was a double-blind placebo-controlled study. Participants were randomized to 1 of 3 treatment groups: diphenhdramine (Benadryl, dye-free) 25 mg twice daily, loratadine (Claritin) 10 mg in the morning with placebo in the evening, or placebo twice daily. To simulate an everyday classroom experience, an existing laboratory school was used on 3 consecutive weekends. The medications were administered on study days 1, 2, and 8 at 7:45 AM and 1:45 PM. The subjects were given 1-hour lectures and 1-hour reading assignments on plant biology. After 90 to 120 minutes, they completed computerized testing to assess retention and reaction times. Covariate analysis was performed, with adjustments for sex, age, baseline reading ability, and weight, along with correction for multiple comparisons. The methodology of this study was strong. The major strengths were the randomized design, the use of patients with known allergies, and the realistic laboratory school setting with appropriate and innovative “blinded” testing. The major weaknesses of the study were the relatively small sample size, and—despite the commendable efforts of the investigators—the inherent artificiality of a weekend school that takes place only over a few weekends. Other minor limitations include the short duration of the study and the lack of assessment of baseline medical history. Interpretation was hampered by the lack of information regarding the results of randomization.

OUTCOME MEASURED: Outcomes measured by computer assessment were: (1) retention of material presented orally (average number of errors in 25 questions about teacher presentations); (2) retention of materials presented in a written format (average number of errors in 25 questions from the readings); (3) reaction time for answers (average for all correct computer test questions); and (4) child self report of somnolence.

RESULTS: At the end of the trial, there were no significant differences noted in the verbal instruction score, reading test score, reaction time, or somnolence scale among students in the 3 treatment groups. Female subjects tended to rate somnolence slightly higher than male subjects did; heavier subjects rated somnolence lower.

BACKGROUND: Nausea and vomiting are both common and a source of distress for women in early pregnancy. As the cause is uncertain, numerous treatments are used empirically. Natural products are appealing because of the concern about teratogenic effects of drugs.

POPULATION STUDIED: New obstetric patients with nausea and vomiting of pregnancy were recruited for this study. Women were enrolled at or before 17 weeks’ gestation, during their first visit to an antenatal clinic in Thailand. Patients were not studied if they had other conditions that manifest with nausea or vomiting, reported current use of medications that might cause or relieve nausea or vomiting, had an inability to take medications as prescribed, and if they had mental retardation. The treatment groups did not differ significantly in terms of age (mean = 28 years), parity, gestational age (mean = 10 weeks), education, or baseline assessment of symptoms.

STUDY DESIGN AND VALIDITY: Seventy eligible women received either oral ginger 250 mg before meals and at bedtime (1 g per day) or an identical-appearing placebo for 4 days in this well-designed prospective randomized double-blind trial. Fresh ginger root was chopped, baked, ground into powder, weighed, and packed into capsules by a pharmacist for the study. Women graded nausea severity on a visual analog scale on their first study visit (baseline) and twice daily for the following 4 days, and also recorded the number of vomiting episodes in the 24 hours before treatment and each day afterward. Also, a 5-item Likert scale was used to assess the change in severity of nausea at a follow-up visit 1 week later.The appropriate study design was used for this efficacy trial. Three patients in the placebo group failed to return for follow-up visits; all other subjects completed the study and were included in the analysis. To be certain that excluding the 3 patients from the analysis did not bias the results, an intention-to-treat analysis was performed in which the symptoms of the 3 dropouts in the placebo group were assumed to improve as much as the best response in the ginger group. Concealed allocation of randomized treatment was assured by keeping treatment codes in sequence in sealed black envelopes.

OUTCOMES MEASURED: The primary outcomes were improvement in nausea symptoms (using 2 measurement scales) and decrease in vomiting episodes. Secondary outcomes included side effects and adverse effects on pregnancy outcomes (miscarriage, preterm delivery).

RESULTS: Compared with placebo, the ginger group had significantly lower nausea scores on days 3 (P=.031) and 4 (P=.05), and for the entire treatment period (P=.014). By intention-to-treat analysis (including the 3 dropouts from the placebo group), the ginger group had significantly lower nausea scores only on day 4 of treatment (P=.035). After 4 days of treatment, the proportion of women with vomiting in the ginger group was significantly lower than in the placebo group (37.5% vs 65.7%, P=.021). The number of vomiting episodes decreased significantly over the 4-day treatment period in the ginger group (1.4 ± 1.4) compared with the placebo group (0.3 ± 1.1, P<.001). These results were unchanged using intention-to-treat analysis. Using a Likert scale to assess change in severity of nausea, 87.5% of the ginger-treated women reported improvement compared with 28% in the placebo group (P <.001). Again, results remained statistically significant using intention-to-treat analysis. No important side effects or adverse effects of ginger on pregnancy outcome were noted in this study.

BACKGROUND: Nausea and vomiting are both common and a source of distress for women in early pregnancy. As the cause is uncertain, numerous treatments are used empirically. Natural products are appealing because of the concern about teratogenic effects of drugs.

POPULATION STUDIED: New obstetric patients with nausea and vomiting of pregnancy were recruited for this study. Women were enrolled at or before 17 weeks’ gestation, during their first visit to an antenatal clinic in Thailand. Patients were not studied if they had other conditions that manifest with nausea or vomiting, reported current use of medications that might cause or relieve nausea or vomiting, had an inability to take medications as prescribed, and if they had mental retardation. The treatment groups did not differ significantly in terms of age (mean = 28 years), parity, gestational age (mean = 10 weeks), education, or baseline assessment of symptoms.

STUDY DESIGN AND VALIDITY: Seventy eligible women received either oral ginger 250 mg before meals and at bedtime (1 g per day) or an identical-appearing placebo for 4 days in this well-designed prospective randomized double-blind trial. Fresh ginger root was chopped, baked, ground into powder, weighed, and packed into capsules by a pharmacist for the study. Women graded nausea severity on a visual analog scale on their first study visit (baseline) and twice daily for the following 4 days, and also recorded the number of vomiting episodes in the 24 hours before treatment and each day afterward. Also, a 5-item Likert scale was used to assess the change in severity of nausea at a follow-up visit 1 week later.The appropriate study design was used for this efficacy trial. Three patients in the placebo group failed to return for follow-up visits; all other subjects completed the study and were included in the analysis. To be certain that excluding the 3 patients from the analysis did not bias the results, an intention-to-treat analysis was performed in which the symptoms of the 3 dropouts in the placebo group were assumed to improve as much as the best response in the ginger group. Concealed allocation of randomized treatment was assured by keeping treatment codes in sequence in sealed black envelopes.

OUTCOMES MEASURED: The primary outcomes were improvement in nausea symptoms (using 2 measurement scales) and decrease in vomiting episodes. Secondary outcomes included side effects and adverse effects on pregnancy outcomes (miscarriage, preterm delivery).

RESULTS: Compared with placebo, the ginger group had significantly lower nausea scores on days 3 (P=.031) and 4 (P=.05), and for the entire treatment period (P=.014). By intention-to-treat analysis (including the 3 dropouts from the placebo group), the ginger group had significantly lower nausea scores only on day 4 of treatment (P=.035). After 4 days of treatment, the proportion of women with vomiting in the ginger group was significantly lower than in the placebo group (37.5% vs 65.7%, P=.021). The number of vomiting episodes decreased significantly over the 4-day treatment period in the ginger group (1.4 ± 1.4) compared with the placebo group (0.3 ± 1.1, P<.001). These results were unchanged using intention-to-treat analysis. Using a Likert scale to assess change in severity of nausea, 87.5% of the ginger-treated women reported improvement compared with 28% in the placebo group (P <.001). Again, results remained statistically significant using intention-to-treat analysis. No important side effects or adverse effects of ginger on pregnancy outcome were noted in this study.

BACKGROUND: Nausea and vomiting are both common and a source of distress for women in early pregnancy. As the cause is uncertain, numerous treatments are used empirically. Natural products are appealing because of the concern about teratogenic effects of drugs.

POPULATION STUDIED: New obstetric patients with nausea and vomiting of pregnancy were recruited for this study. Women were enrolled at or before 17 weeks’ gestation, during their first visit to an antenatal clinic in Thailand. Patients were not studied if they had other conditions that manifest with nausea or vomiting, reported current use of medications that might cause or relieve nausea or vomiting, had an inability to take medications as prescribed, and if they had mental retardation. The treatment groups did not differ significantly in terms of age (mean = 28 years), parity, gestational age (mean = 10 weeks), education, or baseline assessment of symptoms.

STUDY DESIGN AND VALIDITY: Seventy eligible women received either oral ginger 250 mg before meals and at bedtime (1 g per day) or an identical-appearing placebo for 4 days in this well-designed prospective randomized double-blind trial. Fresh ginger root was chopped, baked, ground into powder, weighed, and packed into capsules by a pharmacist for the study. Women graded nausea severity on a visual analog scale on their first study visit (baseline) and twice daily for the following 4 days, and also recorded the number of vomiting episodes in the 24 hours before treatment and each day afterward. Also, a 5-item Likert scale was used to assess the change in severity of nausea at a follow-up visit 1 week later.The appropriate study design was used for this efficacy trial. Three patients in the placebo group failed to return for follow-up visits; all other subjects completed the study and were included in the analysis. To be certain that excluding the 3 patients from the analysis did not bias the results, an intention-to-treat analysis was performed in which the symptoms of the 3 dropouts in the placebo group were assumed to improve as much as the best response in the ginger group. Concealed allocation of randomized treatment was assured by keeping treatment codes in sequence in sealed black envelopes.

OUTCOMES MEASURED: The primary outcomes were improvement in nausea symptoms (using 2 measurement scales) and decrease in vomiting episodes. Secondary outcomes included side effects and adverse effects on pregnancy outcomes (miscarriage, preterm delivery).

RESULTS: Compared with placebo, the ginger group had significantly lower nausea scores on days 3 (P=.031) and 4 (P=.05), and for the entire treatment period (P=.014). By intention-to-treat analysis (including the 3 dropouts from the placebo group), the ginger group had significantly lower nausea scores only on day 4 of treatment (P=.035). After 4 days of treatment, the proportion of women with vomiting in the ginger group was significantly lower than in the placebo group (37.5% vs 65.7%, P=.021). The number of vomiting episodes decreased significantly over the 4-day treatment period in the ginger group (1.4 ± 1.4) compared with the placebo group (0.3 ± 1.1, P<.001). These results were unchanged using intention-to-treat analysis. Using a Likert scale to assess change in severity of nausea, 87.5% of the ginger-treated women reported improvement compared with 28% in the placebo group (P <.001). Again, results remained statistically significant using intention-to-treat analysis. No important side effects or adverse effects of ginger on pregnancy outcome were noted in this study.

BACKGROUND: Anxiety disorders are common psychiatric illnesses in children and may even precede the development of subsequent psychiatric illnesses in adulthood. Data are lacking to guide treatment decisions. Although commonly used for treating anxiety disorders in adults, selective serotonin reuptake inhibitors (SSRIs) are not well studied for anxiety in children, except for obsessive-compulsive disorder. Currently, only fluvoxamine and sertraline are approved by the US Food and Drug Administration for use in children (ages 6-8 years) with obsessive-compulsive disorder.

POPULATION STUDIED: Eligible subjects were aged 6 to 17 years, were recruited from 5 US university-based psychopharmacology department practices, and must have had either social phobia, separation anxiety, or generalized anxiety based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. All patients had clinically important anxiety symptoms according to the Pediatric Anxiety Rating Scale (PARS) and impaired functioning (score <60) on the Children’s Global Assessment (CGA) scale. Each subject agreed to attend weekly visits with a parent. Children could not participate if they were treated with another psychoactive medication or had coexisting psychiatric disorders, conduct disorder, developmental delay, mental retardation, or attention-deficit/hyperactivity disorder. Most children were aged 6 to 12 years (74%) and had both parents at home (72%), but they had variable ethnic and socioeconomic backgrounds.

STUDY DESIGN AND VALIDITY: In this randomized double-blinded controlled trial, subjects received either fluvoxamine (n=63) or placebo (n=65) in conjunction with supportive psychotherapy (that did not include behavioral anxiety treatment) for 8 weeks. The authors did not state that allocation to treatment was concealed before entering patients into the study. The fluvoxamine dose was increased weekly in approximately 50-mg increments to a maximum daily dose of 300 mg in adolescents or 250 mg in children younger than 12 years unless the patient had resolution of symptoms or adverse effects. Intention-to-treat analysis was appropriately used, because the dropout rate approached 19% (24/128). To maintain inter-rater reliability, 16 subjects were rated by each clinician, and differences were resolved by discussion. The study was limited by its short duration (2 months), given that the anxiety disorders studied are commonly chronic. Also, long-term treatment would be necessary to evaluate possible drug-related adverse cognitive effects. This study included a heterogeneous group of patients and did not provide a subgroup analysis of response within the various anxiety disorders. The extensive exclusion criteria limit the external validity in the more complex patients likely encountered in clinical practice.

OUTCOMES MEASURED: The 2 primary outcomes focused on the anxiety symptoms and functional impairment as measured by changes in the weekly PARS and the Clinical Global Impressions-Improvement Scale (CGIS).

RESULTS: From baseline to study completion, the PARS decreased from 18.7+2.9 to 9.0+7.0 in the fluvoxamine group and from 19.0±3.0 to 15.9±5.3 in the placebo group (P <.001). Significant differences were detectable by week 3 and peaked at week 6. Adequate response, as defined as improvement scores less than 4 on the CGIS, was achieved in 48 of 63 children (76%) in the fluvoxamine group and 19 of 65 children (29%) in the placebo group (P <.001). Treatment discontinuation was attributable to adverse events in 5 children (8%) treated with fluvoxamine and 1 child (2%) in the placebo group. Five patients in the placebo group withdrew because of lack of efficacy. Abdominal discomfort was reported more often in the fluvoxamine group (49% vs 28%, P=.02). The greater likelihood of an increase in motor activity in the fluvoxamine group (27% vs 12%) did not quite reach statistical significance (P=.06).

BACKGROUND: Anxiety disorders are common psychiatric illnesses in children and may even precede the development of subsequent psychiatric illnesses in adulthood. Data are lacking to guide treatment decisions. Although commonly used for treating anxiety disorders in adults, selective serotonin reuptake inhibitors (SSRIs) are not well studied for anxiety in children, except for obsessive-compulsive disorder. Currently, only fluvoxamine and sertraline are approved by the US Food and Drug Administration for use in children (ages 6-8 years) with obsessive-compulsive disorder.

POPULATION STUDIED: Eligible subjects were aged 6 to 17 years, were recruited from 5 US university-based psychopharmacology department practices, and must have had either social phobia, separation anxiety, or generalized anxiety based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. All patients had clinically important anxiety symptoms according to the Pediatric Anxiety Rating Scale (PARS) and impaired functioning (score <60) on the Children’s Global Assessment (CGA) scale. Each subject agreed to attend weekly visits with a parent. Children could not participate if they were treated with another psychoactive medication or had coexisting psychiatric disorders, conduct disorder, developmental delay, mental retardation, or attention-deficit/hyperactivity disorder. Most children were aged 6 to 12 years (74%) and had both parents at home (72%), but they had variable ethnic and socioeconomic backgrounds.

STUDY DESIGN AND VALIDITY: In this randomized double-blinded controlled trial, subjects received either fluvoxamine (n=63) or placebo (n=65) in conjunction with supportive psychotherapy (that did not include behavioral anxiety treatment) for 8 weeks. The authors did not state that allocation to treatment was concealed before entering patients into the study. The fluvoxamine dose was increased weekly in approximately 50-mg increments to a maximum daily dose of 300 mg in adolescents or 250 mg in children younger than 12 years unless the patient had resolution of symptoms or adverse effects. Intention-to-treat analysis was appropriately used, because the dropout rate approached 19% (24/128). To maintain inter-rater reliability, 16 subjects were rated by each clinician, and differences were resolved by discussion. The study was limited by its short duration (2 months), given that the anxiety disorders studied are commonly chronic. Also, long-term treatment would be necessary to evaluate possible drug-related adverse cognitive effects. This study included a heterogeneous group of patients and did not provide a subgroup analysis of response within the various anxiety disorders. The extensive exclusion criteria limit the external validity in the more complex patients likely encountered in clinical practice.

OUTCOMES MEASURED: The 2 primary outcomes focused on the anxiety symptoms and functional impairment as measured by changes in the weekly PARS and the Clinical Global Impressions-Improvement Scale (CGIS).

RESULTS: From baseline to study completion, the PARS decreased from 18.7+2.9 to 9.0+7.0 in the fluvoxamine group and from 19.0±3.0 to 15.9±5.3 in the placebo group (P <.001). Significant differences were detectable by week 3 and peaked at week 6. Adequate response, as defined as improvement scores less than 4 on the CGIS, was achieved in 48 of 63 children (76%) in the fluvoxamine group and 19 of 65 children (29%) in the placebo group (P <.001). Treatment discontinuation was attributable to adverse events in 5 children (8%) treated with fluvoxamine and 1 child (2%) in the placebo group. Five patients in the placebo group withdrew because of lack of efficacy. Abdominal discomfort was reported more often in the fluvoxamine group (49% vs 28%, P=.02). The greater likelihood of an increase in motor activity in the fluvoxamine group (27% vs 12%) did not quite reach statistical significance (P=.06).

BACKGROUND: Anxiety disorders are common psychiatric illnesses in children and may even precede the development of subsequent psychiatric illnesses in adulthood. Data are lacking to guide treatment decisions. Although commonly used for treating anxiety disorders in adults, selective serotonin reuptake inhibitors (SSRIs) are not well studied for anxiety in children, except for obsessive-compulsive disorder. Currently, only fluvoxamine and sertraline are approved by the US Food and Drug Administration for use in children (ages 6-8 years) with obsessive-compulsive disorder.

POPULATION STUDIED: Eligible subjects were aged 6 to 17 years, were recruited from 5 US university-based psychopharmacology department practices, and must have had either social phobia, separation anxiety, or generalized anxiety based on the criteria from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. All patients had clinically important anxiety symptoms according to the Pediatric Anxiety Rating Scale (PARS) and impaired functioning (score <60) on the Children’s Global Assessment (CGA) scale. Each subject agreed to attend weekly visits with a parent. Children could not participate if they were treated with another psychoactive medication or had coexisting psychiatric disorders, conduct disorder, developmental delay, mental retardation, or attention-deficit/hyperactivity disorder. Most children were aged 6 to 12 years (74%) and had both parents at home (72%), but they had variable ethnic and socioeconomic backgrounds.

STUDY DESIGN AND VALIDITY: In this randomized double-blinded controlled trial, subjects received either fluvoxamine (n=63) or placebo (n=65) in conjunction with supportive psychotherapy (that did not include behavioral anxiety treatment) for 8 weeks. The authors did not state that allocation to treatment was concealed before entering patients into the study. The fluvoxamine dose was increased weekly in approximately 50-mg increments to a maximum daily dose of 300 mg in adolescents or 250 mg in children younger than 12 years unless the patient had resolution of symptoms or adverse effects. Intention-to-treat analysis was appropriately used, because the dropout rate approached 19% (24/128). To maintain inter-rater reliability, 16 subjects were rated by each clinician, and differences were resolved by discussion. The study was limited by its short duration (2 months), given that the anxiety disorders studied are commonly chronic. Also, long-term treatment would be necessary to evaluate possible drug-related adverse cognitive effects. This study included a heterogeneous group of patients and did not provide a subgroup analysis of response within the various anxiety disorders. The extensive exclusion criteria limit the external validity in the more complex patients likely encountered in clinical practice.

OUTCOMES MEASURED: The 2 primary outcomes focused on the anxiety symptoms and functional impairment as measured by changes in the weekly PARS and the Clinical Global Impressions-Improvement Scale (CGIS).

RESULTS: From baseline to study completion, the PARS decreased from 18.7+2.9 to 9.0+7.0 in the fluvoxamine group and from 19.0±3.0 to 15.9±5.3 in the placebo group (P <.001). Significant differences were detectable by week 3 and peaked at week 6. Adequate response, as defined as improvement scores less than 4 on the CGIS, was achieved in 48 of 63 children (76%) in the fluvoxamine group and 19 of 65 children (29%) in the placebo group (P <.001). Treatment discontinuation was attributable to adverse events in 5 children (8%) treated with fluvoxamine and 1 child (2%) in the placebo group. Five patients in the placebo group withdrew because of lack of efficacy. Abdominal discomfort was reported more often in the fluvoxamine group (49% vs 28%, P=.02). The greater likelihood of an increase in motor activity in the fluvoxamine group (27% vs 12%) did not quite reach statistical significance (P=.06).

BACKGROUND: The American Academy of Pediatrics recommends that pediatric sinusitis be a clinical diagnosis, based on persistent rhinosinusitis and cough for more than 10 to 14 days. Limited-spectrum antibiotics are recommended when antibiotic treatment is felt necessary. However, these recommendations are based on limited clinical research. Recent European studies have suggested that antibiotics may only be minimally effective for children with otitis media and adults with sinusitis.

POPULATION STUDIED: The authors enrolled 188 patients between the ages of 1 and 18 years from 3 primary care pediatric practices in suburban St. Louis, Missouri. The children had persistent cough and rhinosinusitis symptoms for 10 to 28 days, the criteria for clinical diagnosis of acute sinusitis. Patients were excluded if they had fulminant sinusitis including a fever of 39° C or higher, facial swelling, and headache/facial pain. The study also excluded patients with minimal symptoms, chronic sinusitis (>28 days), cystic fibrosis, and other valid reasons.

STUDY DESIGN AND VALIDITY: Patients were stratified by age (older or younger than 7 years) and symptom severity. They were randomly assigned to either a 14-day treatment course of amoxicillin (40 mg/kg up to 500 mg 3 times daily), amoxicillin-clavulanate (45 mg/kg/day of amoxicillin component up to 875 mg twice daily), or placebo. Nineteen patients were later excluded because they failed to meet eligibility criteria. However, 97% of all follow-up interviews were completed. Physicians could recommend ancillary nonantimicrobial therapies (such as decongestants) to any patient. There were no major differences in these treatments in the 3 groups. This study was well designed, used concealed allocation, had good follow-up, and the analysis appeared appropriate.

OUTCOMES MEASURED: The main outcome was a severity of symptom score, assessed by using the S5 score (a validated combination score of 5 items, including nasal obstruction, nighttime coughing, daytime coughing, headache/facial pain, and colored nasal mucous) with symptom score ranging from 0 to 3. Outcomes were assessed by telephone interview at 3, 7, 10, 14, 21, 28, and 60 days. Secondary outcomes included patient/parent satisfaction, adverse drug effects, illness days, and functional status.

RESULTS: Patient outcomes did not differ in any of the groups at any date. The 2-week improvement rate was 79% for the placebo and amoxicillin groups and 81% for the amoxicillin-clavulanate group (P=.97). Average symptom scores dropped from around 2.0 to 0.6 (of a possible 3.0). Secondary outcomes such as patient satisfaction and side effects did not differ significantly in the groups except for a higher incidence of side effects in the amoxicillin group (19% in the amoxicillin group vs 11% in the amoxicillin-clavulanate group and 10% in the placebo group, P=.017).

BACKGROUND: The American Academy of Pediatrics recommends that pediatric sinusitis be a clinical diagnosis, based on persistent rhinosinusitis and cough for more than 10 to 14 days. Limited-spectrum antibiotics are recommended when antibiotic treatment is felt necessary. However, these recommendations are based on limited clinical research. Recent European studies have suggested that antibiotics may only be minimally effective for children with otitis media and adults with sinusitis.

POPULATION STUDIED: The authors enrolled 188 patients between the ages of 1 and 18 years from 3 primary care pediatric practices in suburban St. Louis, Missouri. The children had persistent cough and rhinosinusitis symptoms for 10 to 28 days, the criteria for clinical diagnosis of acute sinusitis. Patients were excluded if they had fulminant sinusitis including a fever of 39° C or higher, facial swelling, and headache/facial pain. The study also excluded patients with minimal symptoms, chronic sinusitis (>28 days), cystic fibrosis, and other valid reasons.

STUDY DESIGN AND VALIDITY: Patients were stratified by age (older or younger than 7 years) and symptom severity. They were randomly assigned to either a 14-day treatment course of amoxicillin (40 mg/kg up to 500 mg 3 times daily), amoxicillin-clavulanate (45 mg/kg/day of amoxicillin component up to 875 mg twice daily), or placebo. Nineteen patients were later excluded because they failed to meet eligibility criteria. However, 97% of all follow-up interviews were completed. Physicians could recommend ancillary nonantimicrobial therapies (such as decongestants) to any patient. There were no major differences in these treatments in the 3 groups. This study was well designed, used concealed allocation, had good follow-up, and the analysis appeared appropriate.

OUTCOMES MEASURED: The main outcome was a severity of symptom score, assessed by using the S5 score (a validated combination score of 5 items, including nasal obstruction, nighttime coughing, daytime coughing, headache/facial pain, and colored nasal mucous) with symptom score ranging from 0 to 3. Outcomes were assessed by telephone interview at 3, 7, 10, 14, 21, 28, and 60 days. Secondary outcomes included patient/parent satisfaction, adverse drug effects, illness days, and functional status.

RESULTS: Patient outcomes did not differ in any of the groups at any date. The 2-week improvement rate was 79% for the placebo and amoxicillin groups and 81% for the amoxicillin-clavulanate group (P=.97). Average symptom scores dropped from around 2.0 to 0.6 (of a possible 3.0). Secondary outcomes such as patient satisfaction and side effects did not differ significantly in the groups except for a higher incidence of side effects in the amoxicillin group (19% in the amoxicillin group vs 11% in the amoxicillin-clavulanate group and 10% in the placebo group, P=.017).

BACKGROUND: The American Academy of Pediatrics recommends that pediatric sinusitis be a clinical diagnosis, based on persistent rhinosinusitis and cough for more than 10 to 14 days. Limited-spectrum antibiotics are recommended when antibiotic treatment is felt necessary. However, these recommendations are based on limited clinical research. Recent European studies have suggested that antibiotics may only be minimally effective for children with otitis media and adults with sinusitis.

POPULATION STUDIED: The authors enrolled 188 patients between the ages of 1 and 18 years from 3 primary care pediatric practices in suburban St. Louis, Missouri. The children had persistent cough and rhinosinusitis symptoms for 10 to 28 days, the criteria for clinical diagnosis of acute sinusitis. Patients were excluded if they had fulminant sinusitis including a fever of 39° C or higher, facial swelling, and headache/facial pain. The study also excluded patients with minimal symptoms, chronic sinusitis (>28 days), cystic fibrosis, and other valid reasons.

STUDY DESIGN AND VALIDITY: Patients were stratified by age (older or younger than 7 years) and symptom severity. They were randomly assigned to either a 14-day treatment course of amoxicillin (40 mg/kg up to 500 mg 3 times daily), amoxicillin-clavulanate (45 mg/kg/day of amoxicillin component up to 875 mg twice daily), or placebo. Nineteen patients were later excluded because they failed to meet eligibility criteria. However, 97% of all follow-up interviews were completed. Physicians could recommend ancillary nonantimicrobial therapies (such as decongestants) to any patient. There were no major differences in these treatments in the 3 groups. This study was well designed, used concealed allocation, had good follow-up, and the analysis appeared appropriate.

OUTCOMES MEASURED: The main outcome was a severity of symptom score, assessed by using the S5 score (a validated combination score of 5 items, including nasal obstruction, nighttime coughing, daytime coughing, headache/facial pain, and colored nasal mucous) with symptom score ranging from 0 to 3. Outcomes were assessed by telephone interview at 3, 7, 10, 14, 21, 28, and 60 days. Secondary outcomes included patient/parent satisfaction, adverse drug effects, illness days, and functional status.

RESULTS: Patient outcomes did not differ in any of the groups at any date. The 2-week improvement rate was 79% for the placebo and amoxicillin groups and 81% for the amoxicillin-clavulanate group (P=.97). Average symptom scores dropped from around 2.0 to 0.6 (of a possible 3.0). Secondary outcomes such as patient satisfaction and side effects did not differ significantly in the groups except for a higher incidence of side effects in the amoxicillin group (19% in the amoxicillin group vs 11% in the amoxicillin-clavulanate group and 10% in the placebo group, P=.017).

BACKGROUND: GERD is common in US adults, and its sequela, Barrett esophagus, is a risk factor for esophageal carcinoma. Modern medical and surgical (laparoscopic fundoplication) therapies are highly effective in controlling GERD symptoms, but there are few data regarding long-term outcomes.

POPULATION STUDIED: The patients studied were part of a Veterans Affairs cooperative study comparing medical and surgical therapy from 1986 to 1988. The enrolled subjects had complicated GERD as determined by GERD Activity Index score and presence of esophagitis, esophageal ulcer, esophageal stricture, or Barrett esophagus.

STUDY DESIGN AND VALIDITY: This study provides the longest follow-up (approximately 10 years) and most complete comparison of outcomes of medical and surgical therapy for severe GERD. In the original trial, patients had been randomized (allocation assignment concealed) to medical treatment with ranitidine and other drugs given continuously or intermittently for symptoms, or to surgery (open Nissen fundoplication). For this follow-up report, the researchers identified the cause of death of those who had died since the original study and re-evaluated those still living. The evaluation consisted of GERD activity scores, endoscopy, 24-hour esophageal pH monitoring, and completion of the 36-item Medical Outcomes Study short form (SF-36) and a questionnaire regarding GERD treatments. Patients discontinued antireflux medications for 1 week before the endoscopy and recording their symptoms. In the original study, baseline characteristics were similar between treatment groups, including frequency of complications such as ulcers and Barrett esophagus. Almost all the patients were men, with a mean age of 67 years. This might limit generalizability, although men have a higher risk of esophageal cancer. Possible limitations included lack of blinding of the investigators to the original treatment assignment, self-reporting of symptoms using a diary (probably similar reliability for both groups), and inability to document if patients stopped use of all antireflux medications in the second week (antacids were allowed).

OUTCOMES MEASURED: The outcomes measured included antireflux medication usage, GERD activity index score off medication, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of additional antireflux operations, SF-36 survey scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma.

RESULTS: In the original study, 165 patients received medical therapy, and 82 had surgery (n=247). In the follow-up study, 239 subjects were located; of these, 79 had died. Of the remaining 160 subjects, 129 participated in the follow-up study. Thus, outcomes were determined for 84% of the original participants (129 survivors and 79 deaths). More medically treated than surgically treated patients reported regular use of antireflux medications (92% vs 62%; P <.001; number needed to treat = 3). Symptom scores were also significantly lower in the surgical group during the week off medication. No significant differences were found between the groups in the endoscopic grade of esophagitis, frequency of treatment of esophageal stricture, subsequent antireflux operations, health survey scores, overall satisfaction with antireflux therapy, or the incidence of esophageal cancer. Mortality was significantly higher in the surgical group during the follow-up period (40% vs 28%; P=.047; number needed to harm = 8). The majority of these deaths were attributed to heart disease. Patients with Barrett esophagus developed esophageal cancer at an annual rate of 0.4%, while the rate was 0.07% in patients with severe GERD but without Barrett esophagus. Esophageal cancer was an uncommon cause of death.

BACKGROUND: GERD is common in US adults, and its sequela, Barrett esophagus, is a risk factor for esophageal carcinoma. Modern medical and surgical (laparoscopic fundoplication) therapies are highly effective in controlling GERD symptoms, but there are few data regarding long-term outcomes.

POPULATION STUDIED: The patients studied were part of a Veterans Affairs cooperative study comparing medical and surgical therapy from 1986 to 1988. The enrolled subjects had complicated GERD as determined by GERD Activity Index score and presence of esophagitis, esophageal ulcer, esophageal stricture, or Barrett esophagus.

STUDY DESIGN AND VALIDITY: This study provides the longest follow-up (approximately 10 years) and most complete comparison of outcomes of medical and surgical therapy for severe GERD. In the original trial, patients had been randomized (allocation assignment concealed) to medical treatment with ranitidine and other drugs given continuously or intermittently for symptoms, or to surgery (open Nissen fundoplication). For this follow-up report, the researchers identified the cause of death of those who had died since the original study and re-evaluated those still living. The evaluation consisted of GERD activity scores, endoscopy, 24-hour esophageal pH monitoring, and completion of the 36-item Medical Outcomes Study short form (SF-36) and a questionnaire regarding GERD treatments. Patients discontinued antireflux medications for 1 week before the endoscopy and recording their symptoms. In the original study, baseline characteristics were similar between treatment groups, including frequency of complications such as ulcers and Barrett esophagus. Almost all the patients were men, with a mean age of 67 years. This might limit generalizability, although men have a higher risk of esophageal cancer. Possible limitations included lack of blinding of the investigators to the original treatment assignment, self-reporting of symptoms using a diary (probably similar reliability for both groups), and inability to document if patients stopped use of all antireflux medications in the second week (antacids were allowed).

OUTCOMES MEASURED: The outcomes measured included antireflux medication usage, GERD activity index score off medication, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of additional antireflux operations, SF-36 survey scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma.

RESULTS: In the original study, 165 patients received medical therapy, and 82 had surgery (n=247). In the follow-up study, 239 subjects were located; of these, 79 had died. Of the remaining 160 subjects, 129 participated in the follow-up study. Thus, outcomes were determined for 84% of the original participants (129 survivors and 79 deaths). More medically treated than surgically treated patients reported regular use of antireflux medications (92% vs 62%; P <.001; number needed to treat = 3). Symptom scores were also significantly lower in the surgical group during the week off medication. No significant differences were found between the groups in the endoscopic grade of esophagitis, frequency of treatment of esophageal stricture, subsequent antireflux operations, health survey scores, overall satisfaction with antireflux therapy, or the incidence of esophageal cancer. Mortality was significantly higher in the surgical group during the follow-up period (40% vs 28%; P=.047; number needed to harm = 8). The majority of these deaths were attributed to heart disease. Patients with Barrett esophagus developed esophageal cancer at an annual rate of 0.4%, while the rate was 0.07% in patients with severe GERD but without Barrett esophagus. Esophageal cancer was an uncommon cause of death.

BACKGROUND: GERD is common in US adults, and its sequela, Barrett esophagus, is a risk factor for esophageal carcinoma. Modern medical and surgical (laparoscopic fundoplication) therapies are highly effective in controlling GERD symptoms, but there are few data regarding long-term outcomes.

POPULATION STUDIED: The patients studied were part of a Veterans Affairs cooperative study comparing medical and surgical therapy from 1986 to 1988. The enrolled subjects had complicated GERD as determined by GERD Activity Index score and presence of esophagitis, esophageal ulcer, esophageal stricture, or Barrett esophagus.

STUDY DESIGN AND VALIDITY: This study provides the longest follow-up (approximately 10 years) and most complete comparison of outcomes of medical and surgical therapy for severe GERD. In the original trial, patients had been randomized (allocation assignment concealed) to medical treatment with ranitidine and other drugs given continuously or intermittently for symptoms, or to surgery (open Nissen fundoplication). For this follow-up report, the researchers identified the cause of death of those who had died since the original study and re-evaluated those still living. The evaluation consisted of GERD activity scores, endoscopy, 24-hour esophageal pH monitoring, and completion of the 36-item Medical Outcomes Study short form (SF-36) and a questionnaire regarding GERD treatments. Patients discontinued antireflux medications for 1 week before the endoscopy and recording their symptoms. In the original study, baseline characteristics were similar between treatment groups, including frequency of complications such as ulcers and Barrett esophagus. Almost all the patients were men, with a mean age of 67 years. This might limit generalizability, although men have a higher risk of esophageal cancer. Possible limitations included lack of blinding of the investigators to the original treatment assignment, self-reporting of symptoms using a diary (probably similar reliability for both groups), and inability to document if patients stopped use of all antireflux medications in the second week (antacids were allowed).

OUTCOMES MEASURED: The outcomes measured included antireflux medication usage, GERD activity index score off medication, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of additional antireflux operations, SF-36 survey scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma.

RESULTS: In the original study, 165 patients received medical therapy, and 82 had surgery (n=247). In the follow-up study, 239 subjects were located; of these, 79 had died. Of the remaining 160 subjects, 129 participated in the follow-up study. Thus, outcomes were determined for 84% of the original participants (129 survivors and 79 deaths). More medically treated than surgically treated patients reported regular use of antireflux medications (92% vs 62%; P <.001; number needed to treat = 3). Symptom scores were also significantly lower in the surgical group during the week off medication. No significant differences were found between the groups in the endoscopic grade of esophagitis, frequency of treatment of esophageal stricture, subsequent antireflux operations, health survey scores, overall satisfaction with antireflux therapy, or the incidence of esophageal cancer. Mortality was significantly higher in the surgical group during the follow-up period (40% vs 28%; P=.047; number needed to harm = 8). The majority of these deaths were attributed to heart disease. Patients with Barrett esophagus developed esophageal cancer at an annual rate of 0.4%, while the rate was 0.07% in patients with severe GERD but without Barrett esophagus. Esophageal cancer was an uncommon cause of death.

BACKGROUND: Pharmacologic methods of cervical ripening are associated with uterine contractile abnormalities. This randomized trial compares intravaginal misoprostol to transcervical Foley catheters for preinduction cervical ripening.

POPULATION STUDIED: A total of 111 pregnant women were admitted to a tertiary hospital for induction. Subjects had singleton vertex pregnancies at more than 28 weeks’ gestation and a Bishop score of less than 6; indications for induction included preeclampsia, oligohydramnios, postdates, and growth restriction. Exclusion criteria included previous uterine surgeries, rupture of membranes, previous induction, or use of a pre-induction agent during the pregnancy. Mean age was 26 years; 70% were nulliparous. Labor was managed actively with rupture of membranes as soon as possible, use of oxytocin, and an epidural rate of almost 90%. Although the study population included premature infants and the setting was different from that in which most family physicians deliver babies, the results probably apply to patients cared for by family physicians.

STUDY DESIGN AND VALIDITY: The participants were randomized with concealed allocation to placement of a transcervical Foley catheter or 50 mg intravaginal misoprostol. A 16F Foley catheter was inserted under direct visualization during a sterile speculum examination without an obturator, tenaculum, or cervical cleansing. Once past the internal os, the balloon was filled with 30 cc of sterile water, and gentle traction was applied (the end of the catheter was taped to the patient’s medial knee or thigh). Every 6 hours the catheter was adjusted to continue traction. In the misoprostol group, 50 μg was placed in the posterior fornix of the vagina every 4 hours up to 6 times. Oxytocin was begun after extrusion of the catheter or 4 hours after the last dose of misoprostol if no labor ensued or if all 6 doses had been given. Bishop scores were assigned before randomization and at the time of Foley catheter extrusion or last dose of misoprostol. The Student t test, Fisher exact test, Mann-Whitney U, and chi square were used to compare groups; no information was given about whether testing was by intention to treat. The methodologic strength of this study was adequate. Its major strengths were randomization with concealed allocation and adequate power. Major weaknesses included the lack of attention to potential confounding factors, such as labor support, that are known to influence the course of labor and the inability to mask the physician assessing the Bishop scores. Other minor weaknesses included the intrinsic lack of intra- and inter-observer reliability of the Bishop score, the possible variation in the timing of giving the Bishop score for the misoprostol group, and the lack of power for assessment of outcomes other than the primary ones.

OUTCOMES MEASURED: The primary outcome measure was change in Bishop score. Secondary outcome measures included length of time for preinduction cervical ripening, total time for induction, delivery route, uterine tachysystole, side effects, subject comfort, and other fetal heart rate disturbances. Cost, patient satisfaction, and neonatal outcomes were not addressed.

RESULTS: The groups were similar at baseline. There was no difference between the groups in change of Bishop score, preinduction cervical ripening times, total induction times, or mode of delivery. However, misoprostol-treated women were statistically more likely to have uterine contractile abnormalities (P <.001; number needed to harm [NNH]=5) and meconium passage (P=.01; NNH=6). Two women in the misoprostol group had hyperstimulation and required cesarean deliveries, but the infants did well. The most frequent complaint in the Foley group was mild discomfort at insertion, but there was no difference between the groups in overall maternal discomfort.

BACKGROUND: Pharmacologic methods of cervical ripening are associated with uterine contractile abnormalities. This randomized trial compares intravaginal misoprostol to transcervical Foley catheters for preinduction cervical ripening.

POPULATION STUDIED: A total of 111 pregnant women were admitted to a tertiary hospital for induction. Subjects had singleton vertex pregnancies at more than 28 weeks’ gestation and a Bishop score of less than 6; indications for induction included preeclampsia, oligohydramnios, postdates, and growth restriction. Exclusion criteria included previous uterine surgeries, rupture of membranes, previous induction, or use of a pre-induction agent during the pregnancy. Mean age was 26 years; 70% were nulliparous. Labor was managed actively with rupture of membranes as soon as possible, use of oxytocin, and an epidural rate of almost 90%. Although the study population included premature infants and the setting was different from that in which most family physicians deliver babies, the results probably apply to patients cared for by family physicians.

STUDY DESIGN AND VALIDITY: The participants were randomized with concealed allocation to placement of a transcervical Foley catheter or 50 mg intravaginal misoprostol. A 16F Foley catheter was inserted under direct visualization during a sterile speculum examination without an obturator, tenaculum, or cervical cleansing. Once past the internal os, the balloon was filled with 30 cc of sterile water, and gentle traction was applied (the end of the catheter was taped to the patient’s medial knee or thigh). Every 6 hours the catheter was adjusted to continue traction. In the misoprostol group, 50 μg was placed in the posterior fornix of the vagina every 4 hours up to 6 times. Oxytocin was begun after extrusion of the catheter or 4 hours after the last dose of misoprostol if no labor ensued or if all 6 doses had been given. Bishop scores were assigned before randomization and at the time of Foley catheter extrusion or last dose of misoprostol. The Student t test, Fisher exact test, Mann-Whitney U, and chi square were used to compare groups; no information was given about whether testing was by intention to treat. The methodologic strength of this study was adequate. Its major strengths were randomization with concealed allocation and adequate power. Major weaknesses included the lack of attention to potential confounding factors, such as labor support, that are known to influence the course of labor and the inability to mask the physician assessing the Bishop scores. Other minor weaknesses included the intrinsic lack of intra- and inter-observer reliability of the Bishop score, the possible variation in the timing of giving the Bishop score for the misoprostol group, and the lack of power for assessment of outcomes other than the primary ones.

OUTCOMES MEASURED: The primary outcome measure was change in Bishop score. Secondary outcome measures included length of time for preinduction cervical ripening, total time for induction, delivery route, uterine tachysystole, side effects, subject comfort, and other fetal heart rate disturbances. Cost, patient satisfaction, and neonatal outcomes were not addressed.

RESULTS: The groups were similar at baseline. There was no difference between the groups in change of Bishop score, preinduction cervical ripening times, total induction times, or mode of delivery. However, misoprostol-treated women were statistically more likely to have uterine contractile abnormalities (P <.001; number needed to harm [NNH]=5) and meconium passage (P=.01; NNH=6). Two women in the misoprostol group had hyperstimulation and required cesarean deliveries, but the infants did well. The most frequent complaint in the Foley group was mild discomfort at insertion, but there was no difference between the groups in overall maternal discomfort.

BACKGROUND: Pharmacologic methods of cervical ripening are associated with uterine contractile abnormalities. This randomized trial compares intravaginal misoprostol to transcervical Foley catheters for preinduction cervical ripening.

POPULATION STUDIED: A total of 111 pregnant women were admitted to a tertiary hospital for induction. Subjects had singleton vertex pregnancies at more than 28 weeks’ gestation and a Bishop score of less than 6; indications for induction included preeclampsia, oligohydramnios, postdates, and growth restriction. Exclusion criteria included previous uterine surgeries, rupture of membranes, previous induction, or use of a pre-induction agent during the pregnancy. Mean age was 26 years; 70% were nulliparous. Labor was managed actively with rupture of membranes as soon as possible, use of oxytocin, and an epidural rate of almost 90%. Although the study population included premature infants and the setting was different from that in which most family physicians deliver babies, the results probably apply to patients cared for by family physicians.

STUDY DESIGN AND VALIDITY: The participants were randomized with concealed allocation to placement of a transcervical Foley catheter or 50 mg intravaginal misoprostol. A 16F Foley catheter was inserted under direct visualization during a sterile speculum examination without an obturator, tenaculum, or cervical cleansing. Once past the internal os, the balloon was filled with 30 cc of sterile water, and gentle traction was applied (the end of the catheter was taped to the patient’s medial knee or thigh). Every 6 hours the catheter was adjusted to continue traction. In the misoprostol group, 50 μg was placed in the posterior fornix of the vagina every 4 hours up to 6 times. Oxytocin was begun after extrusion of the catheter or 4 hours after the last dose of misoprostol if no labor ensued or if all 6 doses had been given. Bishop scores were assigned before randomization and at the time of Foley catheter extrusion or last dose of misoprostol. The Student t test, Fisher exact test, Mann-Whitney U, and chi square were used to compare groups; no information was given about whether testing was by intention to treat. The methodologic strength of this study was adequate. Its major strengths were randomization with concealed allocation and adequate power. Major weaknesses included the lack of attention to potential confounding factors, such as labor support, that are known to influence the course of labor and the inability to mask the physician assessing the Bishop scores. Other minor weaknesses included the intrinsic lack of intra- and inter-observer reliability of the Bishop score, the possible variation in the timing of giving the Bishop score for the misoprostol group, and the lack of power for assessment of outcomes other than the primary ones.

OUTCOMES MEASURED: The primary outcome measure was change in Bishop score. Secondary outcome measures included length of time for preinduction cervical ripening, total time for induction, delivery route, uterine tachysystole, side effects, subject comfort, and other fetal heart rate disturbances. Cost, patient satisfaction, and neonatal outcomes were not addressed.

RESULTS: The groups were similar at baseline. There was no difference between the groups in change of Bishop score, preinduction cervical ripening times, total induction times, or mode of delivery. However, misoprostol-treated women were statistically more likely to have uterine contractile abnormalities (P <.001; number needed to harm [NNH]=5) and meconium passage (P=.01; NNH=6). Two women in the misoprostol group had hyperstimulation and required cesarean deliveries, but the infants did well. The most frequent complaint in the Foley group was mild discomfort at insertion, but there was no difference between the groups in overall maternal discomfort.

BACKGROUND: The impact of b-blockers on survival after AMI has been well demonstrated in multiple randomized controlled trials. However, differences among specific b-blockers have not been evaluated. Because b-blockers differ in b-receptor selectivity and lipophilicity, researchers and clinicians have postulated variations in efficacy due to these properties. Also, clinicians are often hesitant to use b-blockers in certain patient populations with comorbid conditions, despite the known benefit after AMI. This study was designed to compare the effectiveness of 3 b-blockers (atenolol, metoprolol, and propranolol) on survival after AMI. Atenolol and metoprolol are cardioselective b-blockers; metoprolol and propranolol are lipophilic agents.

POPULATION STUDIED: Data were obtained from the Cooperative Cardiovascular Project (CCP), a database of acute care hospital claims for Medicare patients with AMI from 1994 to 1995 (n=201,752). Of this group, 69,338 patients (34%) were prescribed b-blockers, and they comprise the population for this study. Patients were elderly (mean age = approximately 73 years), 45% men, primarily white, and had comorbidities, including illness (ie, diabetes mellitus and chronic obstructive pulmonary disease) for which b-blocker use is often considered a relative contraindication. The mean systolic blood pressure was 146 mm Hg; heart rate was 81 to 83 beats per minute; and ejection fraction was 46% to 48%.

STUDY DESIGN AND VALIDITY: This study was a retrospective chart review of hospital claims data submitted to Medicare. Survival data were based on Social Security records and were reported to be 99% accurate at 60 days. Outcomes of patients prescribed different b-blockers were compared on the basis of demographic and clinical variables. The investigators emphasized comparing the magnitude of difference between groups, given that the enormous size of the database could allow for statistical but inconsequential differences among b-blockers. Obvious limitations to this study are the lack of randomization and the use of data collected from medical records, although the authors stated that the data were very complete. Also, b-blockers prescribed in the hospital may have been changed after discharge, and these data were not collected.

OUTCOMES MEASURED: Outcomes included 1- and 2-year mortality adjusted for age, race, sex, length of hospital stay, severity of illness, type of AMI, cardiovascular interventions (ie, angioplasty, bypass surgery, thrombolytics), various comorbidities (ie, diabetes, congestive heart failure, chronic obstructive pulmonary disease, asthma), and medication use (ie, angiotensin-converting enzyme inhibitors, calcium channel blockers).

RESULTS: Sixty-five percent (n=44,865) of the CCP patients were given metoprolol; 25% (n=17,411) received atenolol; and 6% (n=4236) were given propranolol in the CCP. No other b-blocker was prescribed for more than 1% of the patients. Adjusted 1-year mortality was similar among the patient groups (8.3% for metoprolol, 8.2% for atenolol, 9.6% for propranolol, and 9.2% for other b-blockers). In comparison, adjusted 2-year mortality was similar for the cardioselective b-blockers, metoprolol and atenolol (13.52% vs 13.41%, respectively). Patients discharged while taking propranolol had a slightly increased mortality rate (15.91%), which may have been related to undetected differences in severity of illness at baseline in this group. Compared with metoprolol, patients discharged while taking propranolol had a 15% increased mortality rate at 1 year and an 18% increased mortality rate at 2 years. Overall, survival with all b-blockers was superior to the 23.2% 2-year mortality rate documented in patients not receiving therapy (number needed to treat = 10-14 over 2 years).

BACKGROUND: The impact of b-blockers on survival after AMI has been well demonstrated in multiple randomized controlled trials. However, differences among specific b-blockers have not been evaluated. Because b-blockers differ in b-receptor selectivity and lipophilicity, researchers and clinicians have postulated variations in efficacy due to these properties. Also, clinicians are often hesitant to use b-blockers in certain patient populations with comorbid conditions, despite the known benefit after AMI. This study was designed to compare the effectiveness of 3 b-blockers (atenolol, metoprolol, and propranolol) on survival after AMI. Atenolol and metoprolol are cardioselective b-blockers; metoprolol and propranolol are lipophilic agents.

POPULATION STUDIED: Data were obtained from the Cooperative Cardiovascular Project (CCP), a database of acute care hospital claims for Medicare patients with AMI from 1994 to 1995 (n=201,752). Of this group, 69,338 patients (34%) were prescribed b-blockers, and they comprise the population for this study. Patients were elderly (mean age = approximately 73 years), 45% men, primarily white, and had comorbidities, including illness (ie, diabetes mellitus and chronic obstructive pulmonary disease) for which b-blocker use is often considered a relative contraindication. The mean systolic blood pressure was 146 mm Hg; heart rate was 81 to 83 beats per minute; and ejection fraction was 46% to 48%.

STUDY DESIGN AND VALIDITY: This study was a retrospective chart review of hospital claims data submitted to Medicare. Survival data were based on Social Security records and were reported to be 99% accurate at 60 days. Outcomes of patients prescribed different b-blockers were compared on the basis of demographic and clinical variables. The investigators emphasized comparing the magnitude of difference between groups, given that the enormous size of the database could allow for statistical but inconsequential differences among b-blockers. Obvious limitations to this study are the lack of randomization and the use of data collected from medical records, although the authors stated that the data were very complete. Also, b-blockers prescribed in the hospital may have been changed after discharge, and these data were not collected.

OUTCOMES MEASURED: Outcomes included 1- and 2-year mortality adjusted for age, race, sex, length of hospital stay, severity of illness, type of AMI, cardiovascular interventions (ie, angioplasty, bypass surgery, thrombolytics), various comorbidities (ie, diabetes, congestive heart failure, chronic obstructive pulmonary disease, asthma), and medication use (ie, angiotensin-converting enzyme inhibitors, calcium channel blockers).

RESULTS: Sixty-five percent (n=44,865) of the CCP patients were given metoprolol; 25% (n=17,411) received atenolol; and 6% (n=4236) were given propranolol in the CCP. No other b-blocker was prescribed for more than 1% of the patients. Adjusted 1-year mortality was similar among the patient groups (8.3% for metoprolol, 8.2% for atenolol, 9.6% for propranolol, and 9.2% for other b-blockers). In comparison, adjusted 2-year mortality was similar for the cardioselective b-blockers, metoprolol and atenolol (13.52% vs 13.41%, respectively). Patients discharged while taking propranolol had a slightly increased mortality rate (15.91%), which may have been related to undetected differences in severity of illness at baseline in this group. Compared with metoprolol, patients discharged while taking propranolol had a 15% increased mortality rate at 1 year and an 18% increased mortality rate at 2 years. Overall, survival with all b-blockers was superior to the 23.2% 2-year mortality rate documented in patients not receiving therapy (number needed to treat = 10-14 over 2 years).

BACKGROUND: The impact of b-blockers on survival after AMI has been well demonstrated in multiple randomized controlled trials. However, differences among specific b-blockers have not been evaluated. Because b-blockers differ in b-receptor selectivity and lipophilicity, researchers and clinicians have postulated variations in efficacy due to these properties. Also, clinicians are often hesitant to use b-blockers in certain patient populations with comorbid conditions, despite the known benefit after AMI. This study was designed to compare the effectiveness of 3 b-blockers (atenolol, metoprolol, and propranolol) on survival after AMI. Atenolol and metoprolol are cardioselective b-blockers; metoprolol and propranolol are lipophilic agents.

POPULATION STUDIED: Data were obtained from the Cooperative Cardiovascular Project (CCP), a database of acute care hospital claims for Medicare patients with AMI from 1994 to 1995 (n=201,752). Of this group, 69,338 patients (34%) were prescribed b-blockers, and they comprise the population for this study. Patients were elderly (mean age = approximately 73 years), 45% men, primarily white, and had comorbidities, including illness (ie, diabetes mellitus and chronic obstructive pulmonary disease) for which b-blocker use is often considered a relative contraindication. The mean systolic blood pressure was 146 mm Hg; heart rate was 81 to 83 beats per minute; and ejection fraction was 46% to 48%.

STUDY DESIGN AND VALIDITY: This study was a retrospective chart review of hospital claims data submitted to Medicare. Survival data were based on Social Security records and were reported to be 99% accurate at 60 days. Outcomes of patients prescribed different b-blockers were compared on the basis of demographic and clinical variables. The investigators emphasized comparing the magnitude of difference between groups, given that the enormous size of the database could allow for statistical but inconsequential differences among b-blockers. Obvious limitations to this study are the lack of randomization and the use of data collected from medical records, although the authors stated that the data were very complete. Also, b-blockers prescribed in the hospital may have been changed after discharge, and these data were not collected.

OUTCOMES MEASURED: Outcomes included 1- and 2-year mortality adjusted for age, race, sex, length of hospital stay, severity of illness, type of AMI, cardiovascular interventions (ie, angioplasty, bypass surgery, thrombolytics), various comorbidities (ie, diabetes, congestive heart failure, chronic obstructive pulmonary disease, asthma), and medication use (ie, angiotensin-converting enzyme inhibitors, calcium channel blockers).

RESULTS: Sixty-five percent (n=44,865) of the CCP patients were given metoprolol; 25% (n=17,411) received atenolol; and 6% (n=4236) were given propranolol in the CCP. No other b-blocker was prescribed for more than 1% of the patients. Adjusted 1-year mortality was similar among the patient groups (8.3% for metoprolol, 8.2% for atenolol, 9.6% for propranolol, and 9.2% for other b-blockers). In comparison, adjusted 2-year mortality was similar for the cardioselective b-blockers, metoprolol and atenolol (13.52% vs 13.41%, respectively). Patients discharged while taking propranolol had a slightly increased mortality rate (15.91%), which may have been related to undetected differences in severity of illness at baseline in this group. Compared with metoprolol, patients discharged while taking propranolol had a 15% increased mortality rate at 1 year and an 18% increased mortality rate at 2 years. Overall, survival with all b-blockers was superior to the 23.2% 2-year mortality rate documented in patients not receiving therapy (number needed to treat = 10-14 over 2 years).

BACKGROUND: Fluid in the middle ear creates a conductive hearing loss. This has historically raised concern for potential delays in child development. Persistent otitis media with effusion (OME) is, therefore, the primary indication for tympanostomy tube placement. This study re-examines the link between middle ear effusions, developmental outcomes, and the ability of this surgical intervention to affect these outcomes.

POPULATION STUDIED: Healthy newborns were recruited to participate from a variety of practice settings in the greater Pittsburgh area. Exclusion criteria included: birth weight less than 2270 g, congenital malformation or significant neonatal illness, multiple birth, maternal illness, maternal drug abuse, and several social limitations (foster care, inability to give informed consent, younger than 18 years, English as a second language).

STUDY DESIGN AND VALIDITY: This was a nonblinded randomized clinical trial. Of 6350 patients screened between the ages of 2 days and 2 months, 588 met eligibility criteria, and 429 ultimately participated. The subjects were examined monthly to assess for the presence of OME from age 2 months until 3 years. Children with significant effusions (defined either as bilateral effusions persisting 90 or more days or unilateral effusions persisting for more than 135 days) were randomized to an early intervention group (n=216) or a delayed treatment group (n=213). Children in the early treatment group received tympanostomy tubes as soon as possible. Children in the delayed treatment group had tubes placed either 6 months (for persistent bilateral OME) or 9 months (for persistent unilateral OME) after the initial diagnosis. Ninety-four percent of the subjects (402 of 429) successfully completed developmental testing at the age of 3 years. One of the particular strengths of this study is its methodologic attention to detail. The study groups are well defined and well described, and relevant outcomes are reported. Questions that were not adequately addressed, however, include: (1) Is 3 years an adequate length for follow-up in terms of reliable developmental outcomes?¹ and (2) Could tympanostomy tube placement be delayed even longer than 9 months (or perhaps avoided completely)?

OUTCOMES MEASURED: Three sets of primary developmental outcomes were measured up to 3 years after randomization: formal norm-referenced tests to assess cognition and receptive language skills, conversational sampling to assess expressive language skills, and parental questionnaires to assess parental distress and child behavior.

RESULTS: By age 3 years, 82% of the early intervention group (n=169) and 34% of the delayed treatment group (n=66) had undergone tympanostomy tube placement. There were no significant differences between groups for receptive or expressive language skills, cognition, parental distress, or child behaviors.

BACKGROUND: Fluid in the middle ear creates a conductive hearing loss. This has historically raised concern for potential delays in child development. Persistent otitis media with effusion (OME) is, therefore, the primary indication for tympanostomy tube placement. This study re-examines the link between middle ear effusions, developmental outcomes, and the ability of this surgical intervention to affect these outcomes.

POPULATION STUDIED: Healthy newborns were recruited to participate from a variety of practice settings in the greater Pittsburgh area. Exclusion criteria included: birth weight less than 2270 g, congenital malformation or significant neonatal illness, multiple birth, maternal illness, maternal drug abuse, and several social limitations (foster care, inability to give informed consent, younger than 18 years, English as a second language).

STUDY DESIGN AND VALIDITY: This was a nonblinded randomized clinical trial. Of 6350 patients screened between the ages of 2 days and 2 months, 588 met eligibility criteria, and 429 ultimately participated. The subjects were examined monthly to assess for the presence of OME from age 2 months until 3 years. Children with significant effusions (defined either as bilateral effusions persisting 90 or more days or unilateral effusions persisting for more than 135 days) were randomized to an early intervention group (n=216) or a delayed treatment group (n=213). Children in the early treatment group received tympanostomy tubes as soon as possible. Children in the delayed treatment group had tubes placed either 6 months (for persistent bilateral OME) or 9 months (for persistent unilateral OME) after the initial diagnosis. Ninety-four percent of the subjects (402 of 429) successfully completed developmental testing at the age of 3 years. One of the particular strengths of this study is its methodologic attention to detail. The study groups are well defined and well described, and relevant outcomes are reported. Questions that were not adequately addressed, however, include: (1) Is 3 years an adequate length for follow-up in terms of reliable developmental outcomes?¹ and (2) Could tympanostomy tube placement be delayed even longer than 9 months (or perhaps avoided completely)?

OUTCOMES MEASURED: Three sets of primary developmental outcomes were measured up to 3 years after randomization: formal norm-referenced tests to assess cognition and receptive language skills, conversational sampling to assess expressive language skills, and parental questionnaires to assess parental distress and child behavior.

RESULTS: By age 3 years, 82% of the early intervention group (n=169) and 34% of the delayed treatment group (n=66) had undergone tympanostomy tube placement. There were no significant differences between groups for receptive or expressive language skills, cognition, parental distress, or child behaviors.

BACKGROUND: Fluid in the middle ear creates a conductive hearing loss. This has historically raised concern for potential delays in child development. Persistent otitis media with effusion (OME) is, therefore, the primary indication for tympanostomy tube placement. This study re-examines the link between middle ear effusions, developmental outcomes, and the ability of this surgical intervention to affect these outcomes.

POPULATION STUDIED: Healthy newborns were recruited to participate from a variety of practice settings in the greater Pittsburgh area. Exclusion criteria included: birth weight less than 2270 g, congenital malformation or significant neonatal illness, multiple birth, maternal illness, maternal drug abuse, and several social limitations (foster care, inability to give informed consent, younger than 18 years, English as a second language).

STUDY DESIGN AND VALIDITY: This was a nonblinded randomized clinical trial. Of 6350 patients screened between the ages of 2 days and 2 months, 588 met eligibility criteria, and 429 ultimately participated. The subjects were examined monthly to assess for the presence of OME from age 2 months until 3 years. Children with significant effusions (defined either as bilateral effusions persisting 90 or more days or unilateral effusions persisting for more than 135 days) were randomized to an early intervention group (n=216) or a delayed treatment group (n=213). Children in the early treatment group received tympanostomy tubes as soon as possible. Children in the delayed treatment group had tubes placed either 6 months (for persistent bilateral OME) or 9 months (for persistent unilateral OME) after the initial diagnosis. Ninety-four percent of the subjects (402 of 429) successfully completed developmental testing at the age of 3 years. One of the particular strengths of this study is its methodologic attention to detail. The study groups are well defined and well described, and relevant outcomes are reported. Questions that were not adequately addressed, however, include: (1) Is 3 years an adequate length for follow-up in terms of reliable developmental outcomes?¹ and (2) Could tympanostomy tube placement be delayed even longer than 9 months (or perhaps avoided completely)?

OUTCOMES MEASURED: Three sets of primary developmental outcomes were measured up to 3 years after randomization: formal norm-referenced tests to assess cognition and receptive language skills, conversational sampling to assess expressive language skills, and parental questionnaires to assess parental distress and child behavior.

RESULTS: By age 3 years, 82% of the early intervention group (n=169) and 34% of the delayed treatment group (n=66) had undergone tympanostomy tube placement. There were no significant differences between groups for receptive or expressive language skills, cognition, parental distress, or child behaviors.

BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.

POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).

STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.

OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.

RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.

BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.

POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).

STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.

OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.

RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.

BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.

POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).

STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.

OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.

RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.

BACKGROUND: Antibiotics are generally ineffective for patients with acute cough,¹ yet they continue to be prescribed frequently by primary care physicians. A recent observational study showed that delayed prescribing can reduce antibiotic use for such patients without leading to patient dissatisfaction, but symptom outcomes were not reported.²

POPULATION STUDIED: This study enrolled 191 patients older than 16 years who presented to 1 of 22 Scottish general practices with a primary complaint of acute cough with or without coryza, shortness of breath, sputum, fever, sore throat, or chest tightness. The researchers excluded 2 groups: patients expressing a strong preference for antibiotics or for whom the general practitioner (GP) would not have considered antibiotics.

STUDY DESIGN AND VALIDITY: This was an unblinded randomized controlled trial. The patients were assigned to 1 of 2 groups; the immediate group received an antibiotic prescription at the visit, and the delayed group had their prescription held at the reception desk for 2 weeks and were invited to pick it up at any time, if required. Outcomes were measured by patient questionnaires (78% return rate), physician questionnaires (98% return rate), and a chart review (88% of charts). The strengths of this study were a proper randomization procedure, adequate allocation concealment, an intention-to-treat analysis, and baseline similarity between groups in terms of symptoms and belief in antibiotics. Weaknesses included an unblinded study design and possible selection bias in both physician and patient recruitment (a minority of eligible practices participated, and the GPs taking part enrolled between 1 and 25 patients each). The study only recruited half the target number of patients, so the power to detect clinical differences between groups was less than anticipated.

OUTCOMES MEASURED: The number and timing of collected prescriptions in the delayed group were recorded. The patient questionnaire included daily presence of cough and other symptoms, satisfaction with the visit, and the patient’s intention of consulting for future similar illnesses. The physician questionnaire asked for impressions of the utility of and frequency with which patients subsequently used delayed prescribing. Chart reviews noted the number of return visits for similar illnesses in the subsequent 6 or more months.

RESULTS: Almost half (45%) of the patients in the delayed group picked up their prescriptions after an average of 6 days and were more likely to do so if they had persistent symptoms or were more worried about their cough. Beginning with day 4 following the visit, there was a nonstatistically significant trend in the persistence of cough between groups that widened on day 7 (75% in the delayed group still coughing compared with 55% in the immediate group) and narrowed on day 10. By day 14, a similar number of patients were still coughing (35% in the delayed group vs 30% in the immediate group). The authors state there were no differences in other symptoms (data not provided). Fewer patients in the delayed group were very satisfied with the visit (54% vs 73%; P=.03; number needed to harm [NNH]=5), and more were dissatisfied with the treatment (13% vs 0%; P=.001; NNH=8). Patients of the GPs who recruited fewer patients were more likely to be very satisfied than those of GPs who recruited more patients. Chart reviews did not reveal a difference in return visits between groups. Eighty-seven percent of the physicians described delayed prescription as a useful strategy, and 68% used this method at least monthly.

BACKGROUND: Antibiotics are generally ineffective for patients with acute cough,¹ yet they continue to be prescribed frequently by primary care physicians. A recent observational study showed that delayed prescribing can reduce antibiotic use for such patients without leading to patient dissatisfaction, but symptom outcomes were not reported.²

POPULATION STUDIED: This study enrolled 191 patients older than 16 years who presented to 1 of 22 Scottish general practices with a primary complaint of acute cough with or without coryza, shortness of breath, sputum, fever, sore throat, or chest tightness. The researchers excluded 2 groups: patients expressing a strong preference for antibiotics or for whom the general practitioner (GP) would not have considered antibiotics.

STUDY DESIGN AND VALIDITY: This was an unblinded randomized controlled trial. The patients were assigned to 1 of 2 groups; the immediate group received an antibiotic prescription at the visit, and the delayed group had their prescription held at the reception desk for 2 weeks and were invited to pick it up at any time, if required. Outcomes were measured by patient questionnaires (78% return rate), physician questionnaires (98% return rate), and a chart review (88% of charts). The strengths of this study were a proper randomization procedure, adequate allocation concealment, an intention-to-treat analysis, and baseline similarity between groups in terms of symptoms and belief in antibiotics. Weaknesses included an unblinded study design and possible selection bias in both physician and patient recruitment (a minority of eligible practices participated, and the GPs taking part enrolled between 1 and 25 patients each). The study only recruited half the target number of patients, so the power to detect clinical differences between groups was less than anticipated.

OUTCOMES MEASURED: The number and timing of collected prescriptions in the delayed group were recorded. The patient questionnaire included daily presence of cough and other symptoms, satisfaction with the visit, and the patient’s intention of consulting for future similar illnesses. The physician questionnaire asked for impressions of the utility of and frequency with which patients subsequently used delayed prescribing. Chart reviews noted the number of return visits for similar illnesses in the subsequent 6 or more months.

RESULTS: Almost half (45%) of the patients in the delayed group picked up their prescriptions after an average of 6 days and were more likely to do so if they had persistent symptoms or were more worried about their cough. Beginning with day 4 following the visit, there was a nonstatistically significant trend in the persistence of cough between groups that widened on day 7 (75% in the delayed group still coughing compared with 55% in the immediate group) and narrowed on day 10. By day 14, a similar number of patients were still coughing (35% in the delayed group vs 30% in the immediate group). The authors state there were no differences in other symptoms (data not provided). Fewer patients in the delayed group were very satisfied with the visit (54% vs 73%; P=.03; number needed to harm [NNH]=5), and more were dissatisfied with the treatment (13% vs 0%; P=.001; NNH=8). Patients of the GPs who recruited fewer patients were more likely to be very satisfied than those of GPs who recruited more patients. Chart reviews did not reveal a difference in return visits between groups. Eighty-seven percent of the physicians described delayed prescription as a useful strategy, and 68% used this method at least monthly.

BACKGROUND: Antibiotics are generally ineffective for patients with acute cough,¹ yet they continue to be prescribed frequently by primary care physicians. A recent observational study showed that delayed prescribing can reduce antibiotic use for such patients without leading to patient dissatisfaction, but symptom outcomes were not reported.²

POPULATION STUDIED: This study enrolled 191 patients older than 16 years who presented to 1 of 22 Scottish general practices with a primary complaint of acute cough with or without coryza, shortness of breath, sputum, fever, sore throat, or chest tightness. The researchers excluded 2 groups: patients expressing a strong preference for antibiotics or for whom the general practitioner (GP) would not have considered antibiotics.

STUDY DESIGN AND VALIDITY: This was an unblinded randomized controlled trial. The patients were assigned to 1 of 2 groups; the immediate group received an antibiotic prescription at the visit, and the delayed group had their prescription held at the reception desk for 2 weeks and were invited to pick it up at any time, if required. Outcomes were measured by patient questionnaires (78% return rate), physician questionnaires (98% return rate), and a chart review (88% of charts). The strengths of this study were a proper randomization procedure, adequate allocation concealment, an intention-to-treat analysis, and baseline similarity between groups in terms of symptoms and belief in antibiotics. Weaknesses included an unblinded study design and possible selection bias in both physician and patient recruitment (a minority of eligible practices participated, and the GPs taking part enrolled between 1 and 25 patients each). The study only recruited half the target number of patients, so the power to detect clinical differences between groups was less than anticipated.

OUTCOMES MEASURED: The number and timing of collected prescriptions in the delayed group were recorded. The patient questionnaire included daily presence of cough and other symptoms, satisfaction with the visit, and the patient’s intention of consulting for future similar illnesses. The physician questionnaire asked for impressions of the utility of and frequency with which patients subsequently used delayed prescribing. Chart reviews noted the number of return visits for similar illnesses in the subsequent 6 or more months.

RESULTS: Almost half (45%) of the patients in the delayed group picked up their prescriptions after an average of 6 days and were more likely to do so if they had persistent symptoms or were more worried about their cough. Beginning with day 4 following the visit, there was a nonstatistically significant trend in the persistence of cough between groups that widened on day 7 (75% in the delayed group still coughing compared with 55% in the immediate group) and narrowed on day 10. By day 14, a similar number of patients were still coughing (35% in the delayed group vs 30% in the immediate group). The authors state there were no differences in other symptoms (data not provided). Fewer patients in the delayed group were very satisfied with the visit (54% vs 73%; P=.03; number needed to harm [NNH]=5), and more were dissatisfied with the treatment (13% vs 0%; P=.001; NNH=8). Patients of the GPs who recruited fewer patients were more likely to be very satisfied than those of GPs who recruited more patients. Chart reviews did not reveal a difference in return visits between groups. Eighty-seven percent of the physicians described delayed prescription as a useful strategy, and 68% used this method at least monthly.