Reporting randomized controlled trials.
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Publishing↗
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Results for “Randomized controlled trials”
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Reporting of power and sample size in randomized controlled trials.
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Publishing↗
Prospective, randomized controlled trial of interferon-alpha in children with chronic hepatitis B.
Thirty-six children with chronic hepatitis B were entered into a randomized controlled trial of recombinant human interferon-alpha. All patients had hepatitis B virus DNA and increased levels of aminotransferases in serum for at least 1 yr. Twelve children received 10 MU of interferon-alpha 2b/m2 body surface area three times a week (group I); 12 children received 5 MU/m2 under the same conditions (group II); and 12 children served as controls (group III). During 6 mo of therapy, 12 of 24 (50%) treated patients (7 from group I, 58%, and 5 from group II, 42%) and 2 of 12 (17%) controls lost hepatitis B virus DNA from serum and subsequently remained negative. Comparison of the rate of response in group I vs. controls showed a statistically significant difference (p less than 0.05). Eleven of 12 (92%) treated patients who cleared hepatitis B virus DNA from serum lost HBeAg, seroconverted to anti-HBe and had improvement in liver histological findings with loss of hepatitis B virus DNA from liver. In 10, serum ALT levels became normal. Interferon-alpha was well tolerated and all children finished therapy. These findings indicate that a 6-mo course of interferon-alpha is effective in inducing a serological, biochemical and histological remission of disease in approximately 50% of children with chronic hepatitis B.
Biopsy↗
The cost implications of academic group practice. A randomized controlled trial.
We evaluated the reorganization of a general medical clinic into several group practices, using equivalent groups of patients and physicians in a randomized controlled trial. The group practice, unlike the traditional clinic, provided decentralized registration, clinic coverage five days a week, and telephone coverage at night and on weekends. Residents worked in small groups with an attending physician, nurse practitioner, and receptionist. All financial activity involving a sample of 2299 patients was followed during the 11-month intervention. The total hospital charges per patient were 26 percent lower for the patients seen in the group practice than for those seen in the traditional clinic (P = 0.003). This difference was primarily attributable to inpatient charges, which were 27 percent lower per patient hospitalized (P = 0.004). The mean length of stay was 8.3 days among group-practice patients and 10.5 days among traditional-clinic patients (P = 0.011). We conclude that organizational changes to improve outpatient access and to integrate inpatient and outpatient services can decrease medical charges.
Academic Medical Centers↗
Is rectal misoprostol really effective in the treatment of third stage of labor? A randomized controlled trial.
OBJECTIVE: The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor. STUDY DESIGN: In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery. RESULTS: The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy. CONCLUSION: Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage.
Administration, Rectal↗
Delivery of preventive health services for breast cancer control: a longitudinal view of a randomized controlled trial.
OBJECTIVE: To develop a longitudinal model to characterize the delivery of mammography services using repeated observations of mammography referral rates during a randomized controlled trial (RCT) of physician mammography reminders. DATA SOURCES/STUDY SETTING: Administrative records of a health department and observational data on mammography appointment scheduling. STUDY DESIGN: The design was a longitudinal study of month-specific referral rates during a 1-year RCT. A retrospective case-control study was used to investigate differences between women with timely and delayed (or absent) mammography referral assessed at the end of the intervention year. DATA COLLECTION/EXTRACTION METHODS: Month-specific indicators for referrals and missed clinical opportunities, that is, months when clinic visitors were due for a mammogram and not referred, were constructed using administrative and observational data. FINDINGS: In the unadjusted analysis, the effectiveness of the reminder declined over time. However, in a multivariate analysis that controlled for the number of missed opportunities, the effectiveness was constant over time. On a monthly basis, physician reminders were significantly associated with higher referral rates among clinic visitors newly due for mammography (adjusted OR = 2.8, 95 percent CI = 1.3, 5.8) or who had one previously missed clinical opportunity (adjusted OR = 3.0, 95 percent CI = 1.6, 5.3) but were not for those with two or more missed clinical opportunities (adjusted OR = 1.2, 95 percent CI = 0.7, 2.3). Factors independently associated with delayed referral were age over 65, presence of more than one chronic illness, and the absence of a physician mammography reminder. CONCLUSIONS: Longitudinal models that examine rates of referral over time and include information about outcomes on previous visits can enhance our understanding of how intervention strategies work in practice.
Adult↗
Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group.
This randomized, double-masked, placebo-controlled trial evaluated the safety, tolerability and effects on bone mineral density (BMD) of alendronate in a large, multinational population of postmenopausal women with low bone mass. At 153 centers in 34 countries, 1908 otherwise healthy, postmenopausal women with lumbar spine BMD 2 standard deviations or more below the premenopausal adult mean were randomly assigned to receive oral alendronate 10 mg (n = 950) or placebo (n = 958) once daily for 1 year. All patients received 500 mg elemental calcium daily. Baseline characteristics of patients in the two treatment groups were similar. At 12 months, mean increases in BMD were significantly (p</=0.001) greater in the alendronate than the placebo group by 4.9% (95% confidence interval 4.6% to 5.2%) at the lumbar spine, 2.4% (2.0% to 2.8%) at the femoral neck, 3.6% (3.2% to 4.1%) at the trochanter and 3.0% (2.6% to 3.4%) for the total hip. The incidence of nonvertebral fractures was significantly lower in the alendronate than the placebo group (19 vs 37 patients with fractures), representing a 47% risk reduction for nonvertebral fracture for alendronate-treated patients (95% confidence interval 10% to 70%; p = 0.021). Incidences of adverse events, including upper gastrointestinal adverse events, were similar in the two groups. Therefore, for postmenopausal women with low bone mass, alendronate is well tolerated and produces significant, progressive increases in BMD at the lumbar spine and hip in addition to significant reduction in the risk of nonvertebral fracture.
Adult↗
The effects of perioperative beta-blockade: results of the Metoprolol after Vascular Surgery (MaVS) study, a randomized controlled trial.
BACKGROUND: Patients undergoing vascular surgery comprise the highest risk group for perioperative cardiac mortality and morbidity after noncardiac procedures. Many current guidelines recommend the use of beta-blockers in all patients undergoing vascular surgery. We report a trial of the perioperative administration of metoprolol and its effects on the incidence of cardiac complications at 30 days and 6 months after vascular surgery. METHODS: Patients undergoing abdominal aortic surgery and infrainguinal or axillofemoral revascularizations were recruited to a double-blind randomized controlled trial of perioperative metoprolol versus placebo. Patients were randomized to receive study medication, starting 2 hours preoperatively until hospital discharge or maximum of 5 days postoperatively. Primary outcome were postoperative 30-day composite incidence of nonfatal myocardial infarction, unstable angina, new congestive heart failure, new atrial or ventricular dysrhythmia requiring treatment, or cardiac death. RESULTS: Patients were randomized to receive either metoprolol (n = 246) or placebo (n = 250). Primary outcome events at 30 days postoperative occurred in 25 (10.2%) versus 30 (12.0%) (P = .57) in metoprolol and placebo groups, respectively (relative risk reduction 15.3%, 95% CI -38.3% to 48.2%). Observed effects at 6 months were not significantly different (P = .81) (relative risk reduction 6.2%, 95% CI% -58.4% to 43.8%). Intraoperative bradycardia requiring treatment was more frequent in the metoprolol group (53/246 vs 19/250, P = .00001), as was intraoperative hypotension requiring treatment (114/246 vs 84/250, P = .0045). CONCLUSION: Our results showed metoprolol was not effective in reducing the 30-day and 6-month postoperative cardiac event rates. Prophylactic use of perioperative beta-blockers in all vascular patients is not indicated.
Adrenergic beta-Antagonists↗
Randomized controlled trial of a treatment for anorexia and bulimia nervosa.
Evidence for the effectiveness of existing treatments of patients with eating disorders is weak. Here we describe and evaluate a method of treatment in a randomized controlled trial. Sixteen patients, randomly selected out of a group composed of 19 patients with anorexia nervosa and 13 with bulimia nervosa, were trained to eat and recognize satiety by using computer support. They rested in a warm room after eating, and their physical activity was restricted. The patients in the control group (n = 16) received no treatment. Remission was defined by normal body weight (anorexia), cessation of binge eating and purging (bulimia), a normal psychiatric profile, normal laboratory test values, normal eating behavior, and resumption of social activities. Fourteen patients went into remission after a median of 14.4 months (range 4.9-26.5) of treatment, but only one patient went into remission while waiting for treatment (P = 0.0057). Relapse is considered a major problem in patients who have been treated to remission. We therefore report results on a total of 168 patients who have entered our treatment program. The estimated rate of remission was 75%, and estimated time to remission was 14.7 months (quartile range 9.6 > or = 32). Six patients (7%) of 83 who were treated to remission relapsed, but the others (93%) have remained in remission for 12 months (quartile range 6-36). Because the risk of relapse is maximal in the first year after remission, we suggest that most patients treated with this method recover.
Adolescent↗
Effect of preventive home visits by a nurse on the outcomes of frail elderly people in the community: a randomized controlled trial.
BACKGROUND: Timely recognition and prevention of health problems among elderly people have been shown to improve their health. In this randomized controlled trial the authors examined the impact of preventive home visits by a nurse compared with usual care on the outcomes of frail elderly people living in the community. METHODS: A screening questionnaire identified eligible participants (those aged 70 years or more at risk of sudden deterioration in health). Those randomly assigned to the visiting nurse group were assessed and followed up in their homes for 14 months. The primary outcome measure was the combined rate of deaths and admissions to an institution, and the secondary outcome measure the rate of health services utilization, during the 14 months; these rates were determined through a medical chart audit by a research nurse who was blind to group allocation. RESULTS: The questionnaire was mailed to 415 elderly people, of whom 369 (88.9%) responded. Of these, 198 (53.7%) were eligible, and 142 consented to participate and were randomly assigned to either the visiting nurse group (73) or the usual care group (69). The combined rate of deaths and admissions to an institution was 10.0% in the visiting nurse group and 5.8% in the usual care group (p = 0.52). The rate of health services utilization did not differ significantly between the 2 groups. Influenza and pneumonia vaccination rates were significantly higher in the visiting nurse group (90.1% and 81.9%) than in the usual care group (53.0% and 0%) (p < 0.001). INTERPRETATION: The trial failed to show any effect of a visiting nurse other than vastly improved vaccination coverage.
Aged↗
Efforts to improve compliance with the National Cholesterol Education Program guidelines. Results of a randomized controlled trial.
STUDY OBJECTIVE: We compared three approaches for improving compliance with the practice guidelines of the National Cholesterol Education Program (NCEP). DESIGN: A randomized controlled trial. SETTING: Academic group practices of a major urban teaching hospital. PARTICIPANTS: Study physicians were three equivalent groups of PG-2 and PG-3 residents (N = 33) seeing patients in equivalent outpatient clinics. Continuity patients of these residents were included (N = 240) if they were younger than 66 years, saw their primary physician during the intervention period, were not pregnant, and had no serious life-shortening noncardiac illnesses. INTERVENTIONS: Three interventions were implemented over a 5-week period. Control group physicians (group 1) were offered only a standard lecture provided through the Physician Cholesterol Education Program (PCEP). Group 2 physicians were offered the PCEP lecture and also received generic chart reminders of the NCEP guidelines on each eligible patient's chart. Group 3 physicians were offered the PCEP lecture and also received timely patient-specific feedback, including acknowledgement of recent lipid values and management, and explicit recommendations for further action. Knowledge of lipid disorders was tested before and after the PCEP lecture, and physicians' attitudes were surveyed following the intervention period. MEASUREMENTS AND MAIN RESULTS: The three groups were similar in baseline (preintervention) compliance with NCEP recommendations (average, 39%) and physicians' knowledge. Patients were similar across groups in number of coronary artery disease risk factors and cholesterol values. Significant within-group improvements in compliance were noted for groups 2 and 3 (7.6% and 10.6%, respectively), but not for group 1 (4.5%). Importantly, there were no differences observed in improvements across groups. In exploratory analyses, however, there was a significant correlation between improved compliance and the number of patients seen by each provider in group 3 that was not observed in groups 1 or 2. Notably, changes in compliance were unrelated to PCEP lecture attendance (8.6% vs 8.1% for attenders vs nonattenders, respectively), level of postgraduate training, baseline or later tests of knowledge, or patient factors. The postintervention survey revealed marked overestimation by physicians of their personal compliance with NCEP guidelines, although there was strong support for clinic efforts that would screen patients for lipid disorders independent of physician initiative. CONCLUSIONS: This study raises questions about the effectiveness of education alone for improving compliance with NCEP guidelines. The effectiveness and efficiency of timely, individualized feedback should be explored in studies over a longer period. Innovative alternative approaches are suggested by the responses to our survey and other research in preventive practices.
Ambulatory Care↗
Randomized controlled trial of music during kangaroo care on maternal state anxiety and preterm infants' responses.
The purpose of this randomized controlled trial was to investigate the influences of music during kangaroo care (KC) on maternal anxiety and preterm infants' responses. There are no experimental studies that explore the influences of combination of music and KC on psychophysiological responses in mother-infant dyads. Purposive sampling was used to recruit 30 hospitalized preterm infants body weight 1500 gm and over, gestational age 37 weeks and lower from two NICUs. Mother-infant dyads were randomly assigned to the treatment and the control group using permuted block randomization stratified on gender. There were 15 mother-infant dyads in each group. Subjects in the treatment dyads listened to their choice of a lullaby music during KC for 60 min/section/day for three consecutive days. Control dyads received routine incubator care. Using a repeated measures design with a pretest and three posttests, the responses of treatment dyads including maternal anxiety and infants' physiologic responses (heart rate, respiratory rate, and O2 saturation) as well as behavioural state were measured. The results revealed that there were no significant differences between the two groups on infants' physiologic responses and the values were all in the normal range. However, infants in the treatment group had more occurrence of quiet sleep states and less crying (p<0.05-0.01). Music during KC also resulted in significantly lower maternal anxiety in the treatment group (p<0.01). Maternal state anxiety improved daily, indicating a cumulative dose effect. The findings provide evidence for the use of music during KC as an empirically-based intervention for bahavioural state stability and maternal anxiety in mother-infant dyads.
Adult↗
Clinical effectiveness of a combination of bromhexine and amoxicillin in lower respiratory tract infection. A randomized controlled trial.
A multicenter double-blind randomized trial was performed in 22 teaching hospitals to compare the clinical effectiveness of the combination of amoxicillin (CAS 26787-78-0) plus bromhexine (CAS 3572-43-8) versus amoxicillin alone given 4 times a day for 5 to 7 days in the treatment of clinically diagnosed community-acquired bacterial lower respiratory tract infections. 392 adult patients diagnosed clinically to have acute bronchitis or pneumonia of bacterial etiology were recruited for the study with 192 subjects given amoxicillin (250 mg) plus bromhexine (8 mg) (Drug AB) and 200 receiving amoxicillin (250 mg) (Drug AA) alone 4 times a day for 5 to 7 days. Clinical response, improvement in symptom scores using a visual analogue scale, and bacteriologic response were monitored at Days 3, 5 and 7 of treatment. Results showed that although 180/192 (94%) given Drug AB and 185/200 (93%) given Drug AA had favorable clinical response at the end of treatment, the infection was completely resolved for 89/192 (46%) among the Drug AB group and in 67/200 (34%) of patients on Drug AA (p = 0.022). Also, patients given Drug AB had significantly greater reduction of their symptom scores at Day 3 for symptoms of cough discomfort, cough frequency, ease of expectoration and sputum volume. Among the subset of patients with pneumonia, the cure rates for Drug AB and Drug AA were 24/50 (47%) and 11/50 (22%), respectively (p = 0.008). A respiratory pathogen was cultured in only 72/392 (18%) of subjects.(ABSTRACT TRUNCATED AT 250 WORDS)
Adolescent↗
Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial.
We evaluated the short- and long-term efficacy of a brief cognitive-behavioral therapy (CBT) for chronic temporomandibular disorder (TMD) pain in a randomized controlled trial. TMD clinic patients were assigned randomly to four sessions of either CBT (n=79) or an education/attention control condition (n=79). Participants completed outcome (pain, activity interference, jaw function, and depression) and process (pain beliefs, catastrophizing, and coping) measures before randomization, and 3 (post-treatment), 6, and 12 months later. As compared with the control group, the CBT group showed significantly greater improvement across the follow-ups on each outcome, belief, and catastrophizing measure (intent-to-treat analyses). The CBT group also showed a greater increase in use of relaxation techniques to cope with pain, but not in use of other coping strategies assessed. On the primary outcome measure, activity interference, the proportion of patients who reported no interference at 12 months was nearly three times higher in the CBT group (35%) than in the control group (13%) (P=0.004). In addition, more CBT than control group patients had clinically meaningful improvement in pain intensity (50% versus 29% showed > or =50% decrease, P=0.01), masticatory jaw function (P<0.001), and depression (P=0.016) at 12 months (intent-to-treat analyses). The two groups improved equivalently on a measure of TMD knowledge. A brief CBT intervention improves one-year clinical outcomes of TMD clinic patients and these effects appear to result from specific ingredients of the CBT.
Activities of Daily Living↗
Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer--pooled analysis from three multicenter, randomized, controlled trials using individual patient data.
PURPOSE: To identify baseline prognostic factors and assess whether pretreatment quality of life (QoL) predicts survival in patients with locally advanced or metastatic esophago-gastric cancer. PATIENTS AND METHODS: Between 1992 and 2001, 1,080 patients were enrolled into three randomized, controlled trials assessing fluorouracil-based combination chemotherapy. All patients were required to complete the European Organization for Research and Treatment of Cancer core QoL questionnaire before random assignment. RESULTS: Of the 1080 patients randomly assigned, 979 (91%) died. Four independent poor prognostic factors were identified by multivariate analysis: performance status >or= 2 (hazard ratio [HR], 1.58; 99% CI, 1.25 to 1.98), liver metastases (HR, 1.41; 99%CI, 1.14 to 1.74), peritoneal metastases (HR, 1.33; 99%CI, 1.01 to 1.74) and alkaline phosphatase >or= 100 U/L (HR, 1.41; 99% CI, 1.14 to 1.76). A prognostic index was constructed dividing patients into good (no risk factor), moderate (one or two risk factors) or poor (three or four risk factors) risk groups. One-year survival for good, moderate, and poor risk groups were 48.5%, 25.7%, and 11%, respectively, and the survival differences among these groups were highly significant (P <.00001). Compared with the good risk group, the moderate risk group had nearly twice the risk of death, and the poor risk group had 3.5-fold increased risk of death. Pretreatment physical (P =.003), role functioning (P <.001), and global QoL (P <.001) predicted survival. CONCLUSION: Four poor prognostic factors were identified and a simple prognostic index was devised. Information from this analysis can be used to aid clinical decision-making, help individual patient risk stratification, and serve as benchmark for the planning for future phase III trials.
Adult↗
Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial.
Chronic pain in persons with spinal cord injury (SCI) is a difficult problem for which there is no simple method of treatment. Few randomized controlled trials of medications for pain in persons with SCI have been conducted. This study was designed to determine whether amitriptyline, a tricyclic antidepressant, is efficacious in relieving chronic pain and improving pain-related physical and psychosocial dysfunction in persons with SCI. Eighty-four participants with SCI and chronic pain were randomized to a 6-week trial of amitriptyline or an active placebo, benztropine mesylate. All pre- and post-treatment assessments were conducted by evaluators blind to the allocation. Regression analyses were conducted to examine whether there was a medication group effect on the primary (average pain intensity) and secondary outcome measures. No significant differences were found between the groups in pain intensity or pain-related disability post-treatment, in either intent-to-treat analyses or analyses of study completers. These findings do not support the use of amitriptyline in the treatment of chronic pain in this population, but we cannot rule out the possibility that certain subgroups may benefit.
Adult↗
Exercise training and blood lipids in hyperlipidemic and normolipidemic adults: a meta-analysis of randomized, controlled trials.
OBJECTIVE: To determine the effectiveness of exercise training (aerobic and resistance) in modifying blood lipids, and to determine the most effective training programme with regard to duration, intensity and frequency for optimizing the blood lipid profile. DESIGN: Trials were identified by a systematic search of Medline, Embase, Science Citation Index (SCI), published reviews and the references of relevant trials. The inclusion criteria were limited to randomized, controlled trials of aerobic and resistance exercise training which were conducted over a minimum of four weeks and involved measurement of one or more of the following: total cholesterol (TC), high density lipoprotein (HIDL-C), low density lipoprotein (LDL-C) and triglycerides (TG). SUBJECTS: A total of 31 trials ( 1833 hyperlipidemic and normolipidemic participants) were included. RESULTS: Aerobic exercise training resulted in small but statistically significant decreases of 0.10 mmol/L (95% CI: 0.02, 0.18). 0.10 (95% CI: 0.02, 0.19), 0.08 mmol/L (95% CI: 0.02, 0.14), for TC, LDL-C, and TG, respectively, with an increase in HDL-C of 0.05 mmol/L (95% CI: 0.02, 0.08). Comparisons between the intensities of the aerobic exercise programmes produced inconsistent results; but more frequent exercise did not appear to result in greater improvements to the lipid profile than exercise three times per week. The evidence for the effect of resistance exercise training was inconclusive. CONCLUSIONS: Caution is required when drawing firm conclusions from this study given the significant heterogeneity with comparisons. However, the results appear to indicate that aerobic exercise training produced small but favourable modifications to blood lipids in previously sedentary adults.
Adult↗
Topical anesthetics for dermal instrumentation: a systematic review of randomized, controlled trials.
STUDY OBJECTIVE: We compare the analgesic efficacy of topical anesthetics for dermal instrumentation with conventional infiltrated local anesthesia and also compare topically available amide and ester agents with a eutectic mixture of local anesthetics (EMLA). METHODS: We conducted a systematic review of randomized, controlled trials. Relevant literature was identified through searches of MEDLINE, Cochrane Central Register of Controlled Trials, and the Excerpta Medica Database Drugs and Pharmacology. We limited the type of procedures to puncture of intact skin with a needle. The primary outcome was analgesic efficacy, reflected in the patient's self-report of pain intensity during dermal instrumentation. Where possible, quantitative methods were used to summarize the results. RESULTS: We identified 25 randomized controlled trials including 2,096 subjects. The results of the trials comparing the efficacy of EMLA with infiltrated local anesthetic were inconsistent. Qualitative analysis demonstrated comparable analgesic efficacy between liposome-encapsulated lidocaine and EMLA. The weighted mean difference in 100-mm visual analogue scale pain scores favored topical tetracaine over EMLA (-8.1 mm; 95% confidence interval -15.6 mm to -0.6 mm). Liposome-encapsulated tetracaine provided greater analgesia than EMLA according to the weighted mean difference in 100-mm visual analogue scale scores (-10.9 mm; 95% confidence interval -15.9 mm to -5.9 mm). CONCLUSION: EMLA may be an effective, noninvasive means of analgesia before dermal procedures. However, we identified 3 topical anesthetics that are at least as efficacious as EMLA: tetracaine, liposome-encapsulated tetracaine, and liposome-encapsulated lidocaine. Liposomal lidocaine is commercially available in the United States and offers a more rapid onset and less expensive alternative to EMLA.
Administration, Cutaneous↗