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Results for “Randomized controlled trials”

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PubMed1988

Bumetanide, spironolactone and a combination of the two, in the treatment of ascites due to liver disease. A prospective, controlled, randomized trial.

There are few studies available comparing the efficacy of loop and distal diuretics and a combination of the two groups, in the treatment of ascites due to liver disease. Thirty-seven nonazotemic cirrhotic patients with ascites were randomly allocated to receive for 2 weeks bumetanide (group A, n = 13), spironolactone (group B, n = 12) or a combination of the two drugs (group C, n = 12) after a 5-day stabilization period. The response to the treatment was 69, 42 and 83% in groups A, B and C, respectively; the difference was not significant. Hypokalemia was seen in 4 patients of group A and mild hyperkalemia in 2 patients of group B. Electrolyte disturbances were minimal in patients of group C. The response to diuretic treatment was prompt in groups A and C. It can be concluded that a combination of loop and distal diuretics is superior to a one-drug regimen in achieving a rapid and better diuretic response with fewer side effects.

Administration, Oral↗

PubMed1992

A prospective, placebo-controlled, randomized trial of intravenous streptokinase and angioplasty versus lone angioplasty therapy of acute myocardial infarction.

BACKGROUND: The value of routine administration of intravenous thrombolytic agents during percutaneous transluminal coronary angioplasty (PTCA) therapy of acute myocardial infarction (MI) has not been determined. Therefore, we prospectively randomized 122 patients with evolving MI to PTCA therapy with or without adjunctive intravenous streptokinase therapy. METHODS AND RESULTS: Patients with ECG ST segment elevation who presented within 4 hours of symptom onset, had no contraindication to thrombolytic therapy, and were not in cardiogenic shock were enrolled. They were treated immediately with intravenous heparin (10,000 units) and oral aspirin (325 mg) and randomized to treatment with placebo or streptokinase (1.5 M units) administered intravenously over 30 minutes. Patients then were taken immediately to the catheterization laboratory, and those with suitable coronary anatomy underwent immediate PTCA. Subsequent clinical course, serial radionuclide ventriculography, and 6-month repeat angiography were analyzed. A total of 106 patients were treated with PTCA. Use of PTCA was similar for placebo (92%) and streptokinase (83%) groups. Angioplasty was successful in 95% of patients, with no difference in placebo (93%) and streptokinase (98%) groups. Serial radionuclide ventriculography demonstrated no difference in 24-hour (52 +/- 12% versus 50 +/- 12%) or 6-week (51 +/- 12% versus 51 +/- 13%) ejection fraction values for placebo and streptokinase groups, respectively. Contrast ventriculography demonstrated improvement in immediate (54 +/- 12%) versus 6-month (60 +/- 15%, p < 0.05) values for the overall group. No differences in 6-month values were present (58 +/- 15% versus 62 +/- 15%, p = NS) for placebo and streptokinase groups, respectively. Coronary angiography was performed in 75% of the 90 patients eligible for restudy. Arterial patency was 87% at 6 months, and coronary restenosis was present in 38% of patients. No differences in chronic patency or restenosis were detected for the two treatment groups. Although adjunctive intravenous streptokinase therapy did not improve outcome, it did complicate the hospital course. Hospitalization was longer (9.3 +/- 5.0 versus 7.7 +/- 4.4 days, p = 0.046) and more costly ($25,191 +/- 15,368 versus $19,643 +/- 7,250, p < 0.02). Transfusion rate was higher (39% versus 8%, p = 0.0001) and need for emergency coronary bypass surgery was greater (10.3% versus 1.6%, p = 0.03) for the streptokinase-treated patients. CONCLUSIONS: Adjunctive intravenous streptokinase therapy does not enhance early preservation of ventricular function, improve arterial patency rates, or lower restenosis rates after PTCA therapy of acute MI. Hospital course is longer, more expensive, and more complicated. For these reasons, PTCA therapy of acute MI should not be routinely performed with adjunctive intravenous streptokinase therapy.

Adolescent↗

PubMed2002

HR (Venoruton1000, Paroven, 0-[beta-hydroxyethyl]-rutosides) vs. Daflon 500 in chronic venous disease and microangiopathy: an independent prospective, controlled, randomized trial.

OBJECTIVES: The aim of this study was to demonstrate whether and how HR (Venoruton(1000), Paroven, 0-[beta-hydroxyethyl]-rutosides) and Daflon (diosmin, 500 mg) were comparatively effective in improving the microcirculation in venous hypertension and microangiopathy. METHODS: A group of 90 patients with severe venous hypertension due to chronic venous insufficiency, ankle swelling, and lipodermatosclerosis were included. After informed consent, patients were randomized into a Venoruton and a Daflon (DF) group: patients in the Venoruton group received oral HR (2 g/day for 8 weeks); those in the Daflon group received three 500-mg tablets daily every 8 hours. The two groups were comparable for age and sex distribution. The mean age was 41 years (SD +/- 11) in the Venoruton group (46 patients) and 41.3 (SD +/- 12) in the DF group (44 patients). RESULTS: There were no differences in microcirculatory parameters between the Venoruton and DF treatment groups at inclusion. There was no significant change between inclusion and measurements at 8 weeks in the DF group. In comparison, a significant decrease (P < .05) in RF (resting skin flux) and RAS (rate of ankle swelling) was observed in the Venoruton group (P < .001). The decrease in capillary filtration was associated with improvement in signs and symptoms (measured by an analogue scale line) (P < .05). Symptomatic improvement was clinically and statistically significant and important only in the Venoruton group. No side effects and no drop-outs were observed. CONCLUSION: Venous microangiopathy was improved by the treatment with Venoruton. The comparison with Daflon indicates that HR is comparatively more effective both on microcirculatory parameters and on signs and symptoms.

Adult↗

PubMed1999

Is prophylactic pelvic drainage useful after elective rectal or anal anastomosis? A multicenter controlled randomized trial. French Association for Surgical Research.

OBJECTIVE: We investigated the role of drainage in the prevention of complications after elective rectal or anal anastomosis in the pelvis. Anastomotic leakage after colorectal resection is more prevalent when the anastomosis is in the distal or infraperitoneal pelvis than in the abdomen. The benefit of pelvic drains versus their potential harm has been questioned. Drain-related complications include (1) those possibly benefiting from drainage (leakage, intra-abdominal infection, bleeding) and (2) those possibly caused by drainage (wound infection or hernia, intestinal obstruction, fistula). METHODS: Between September 1990 and June 1995, 494 patients (249 men and 245 women), mean age 66 +/- 15 (range 15 to 101) years, with either carcinoma, benign tumor, colonic Crohn's disease, diverticular disease of the sigmoid colon, or another disorder located anywhere from the right colon to the midrectum undergoing resection followed by rectal or anal anastomosis were randomized to undergo either drainage (n = 248) with 2 multiperforated 14F suction drains or no drainage (n = 246). The primary end point was the number of patients with one or more postoperative drain-related complications. Secondary end points included severity of these complications as assessed by the rate of related repeat operations and associated deaths as well as extra-abdominally related morbidity and mortality. RESULTS: After withdrawal of 2 patients (1 in each group) both groups were comparable with regard to preoperative characteristics and intraoperative findings. The overall leakage rate was 6.3% with no significant difference between those with or without drainage. There were 18 deaths (3.6%), 8 (3.2%) in those with drainage and 10 (4%) in those without drainage. Five patients with anastomotic leakage died (1%), 3 of whom had drainage. There were 32 repeat operations (6.5%) for anastomotic leakage 11 in the group with drainage and 4 in the group with no drainage. The rate of these and the other intra-abdominal and extra-abdominal complications did not differ significantly between the 2 groups. CONCLUSION: Prophylactic drainage of the pelvic space does not improve outcome or influence the severity of complications.

Adult↗

PubMedDate not supplied

Devascularization procedure and DSRS: a controlled randomized trial on selected haemodynamic portal flow pattern in schistosomal portal hypertension with variceal bleeding.

OBJECTIVES: The use of duplex studies for the portal tree has revolutionized the concepts of haemodynamic pathophysiology in the case of portal hypertensive bleeders. The identification of possible haemodynamic patterns in schistosomal bleeders, and the effects of devascularization procedure and distal lienorenal shunts on a selected haemodynamic pattern, are the aim of this work. PATIENTS AND METHODS: Patients (219) with schistosomal hepatic fibrosis and history of bleeding oesophageal varices were studied. The patency, diameter, velocity and flow volume/min in the portal and splenic veins were followed by coloured Duplex. Two matched groups (30 patients each) with the most commonly found haemodynamic pattern (splenic vein flow exceeding portal vein flow) were operated upon. Devascularization procedure was done for the first group (A) and distal splenorenal shunt for the second group (B). RESULTS: Coloured duplex assessment of portal circulation in schistosomal patients identified four haemodynamic patterns. Pattern I (approximately 59%); splenic vein flow exceeds the portal vein flow. Pattern II (approximately 28%); portal vein flow exceeds splenic vein flow. In both patterns, the portal flow was hepatopedal. Patterns III and IV (8% and 5%, respectively) were associated with hepatofugal flow. Splenic vein flow exceeds portal vein flow in pattern III and the reverse in pattern IV. Distal lienorenal shunts done for patients with haemodynamic pattern I was followed by a rebleeding rate of 3.3% while devascularization done for patients with the same pattern was followed by a rebleeding rate of 26.6%. Mild encephalopathy was detected in 10% of patients with distal lienorenal shunts and responded to dietary regulations. CONCLUSIONS: DSRS proved to be ideal for schistosomal patients with hepatopedal flow and splenic vein flow exceeding portal vein flow; since in addition to eliminating the high splenic flow out of portal circulation, it decreased the pressure in the gastroesophageal region. Other patterns with their frequencies and the suggested surgical procedures were also presented.

Adult↗

PubMed2002

A placebo-controlled, randomized trial of droperidol versus metoclopramide for outpatients undergoing gynecological laparoscopy under conscious sedation.

This study compared the prophylactic antiemetic efficacy and the adverse effects of 0.5 mg droperidol, 5.0 mg metoclopramide, and placebo for outpatients undergoing gynecological laparoscopy under conscious sedation. One hundred and fifty outpatients were randomly allocated, in a randomized double-blind manner, into three groups to receive intravenous normal saline, 0.5 mg droperidol, and 5.0 mg metoclopramide before operation. Conscious sedation using intravenous pethidine, midazolam and local infiltration were given to each patient during the operation. Emetic symptoms were graded twice by the patients, at discharge time and the 24th post-operative hour. The difference of antiemetic effect of both study drugs failed to reach statistical significance. There was also no statistical difference of intra-operative hypoxemia, sedation score, and discharge time among the groups. Therefore, using 0.5 mg droperidol or 5.0 mg metoclopramide is not effective in providing antiemetic prophylaxis for outpatients undergoing gynecological laparoscopy under conscious sedation.

Adolescent↗

PubMed1985

Prophylactic antibiotics in amputation of the lower extremity for ischemia. A placebo-controlled, randomized trial of cefoxitin.

Of 152 patients who were scheduled for an amputation for ischemia, seventy-seven were randomly assigned to perioperative prophylaxis with cefoxitin (Mefoxin) and seventy-five patients, to injections of a placebo. The patients were followed for twenty-one days or, in the case of wound complications, to the end of treatment. An infected wound occurred in 38.7 per cent of the patients in the placebo group and 16.9 per cent of those in the antibiotic group (p less than 0.005). Clostridial infection occurred in eight patients in the placebo group and in none in the antibiotic group (p = 0.003). Three of the patients with clostridial infection died of gas gangrene. A multivariate analysis showed that the absence of antibiotic prophylaxis increased the risk of infection by a factor of 3.3 (p = 0.004) and increased the need for reamputation by a factor of 4.5 (p = 0.003). We concluded that amputation patients should have prophylaxis with a broad-spectrum antibiotic given perioperatively.

Adult↗

PubMed1977

Mepacrine hydrochloride in the treatment of malignant pleural effusion. A controlled randomized trial.

The effect of local instillation of mepacrine hydrochloride (quinacrine hydrochloride U.S.P., Atabrine) was compared with triethylenethiophosphoramide (Thiotepa) applied locally and with pleurocentesis alone. Twentyfive patients with disseminated malignant disease were allocated at random to one of these three treatments. A finding of more than 500 ml effusion within 3 months of instituting treatment was regarded as a failure, and subsequently one of the other treatments was used at random. Sixty-four per cent of the patients treated with mepacrine responded, compared with 27% treated with triethylenethiophosphoramide, and 11% treated with pleurocentesis alone.

Adult↗

PubMed1983

Short-term treatment with sucralfate or cimetidine in gastric ulcer: preliminary results of a controlled randomized trial.

The aim of this study was to compare the healing capacities of sucralfate and cimetidine in gastric ulcer. Twenty-nine patients were randomly assigned to active sucralfate (1 g qid) and cimetidine placebo, or to cimetidine (300 mg qid) and sucralfate placebo. The patients were endoscoped before entry into the study, after 4 wk, and after 8 wk if complete healing was not found at 4 wk. Twenty-five patients completed the study. After 4 wk, 50% (6/12) of the sucralfate patients had healed in comparison to 54% (7/13) of cimetidine patients. After 8 wk, the cumulative healing rates were 75% and 77%, respectively. The results indicate that sucralfate is as effective as cimetidine in the short-term treatment of gastric ulcer.

Adult↗

PubMed1999

Elevated systolic blood pressure and risk of cardiovascular and renal disease: overview of evidence from observational epidemiologic studies and randomized controlled trials.

The effect of elevated blood pressure on risk of cardiovascular and renal disease has been documented in both observational epidemiologic studies and clinical trials. However, these studies have traditionally concentrated on diastolic blood pressure to characterize the risk associated with hypertension. We reviewed evidence from prospective studies and randomized controlled trials to quantify the risk associated with systolic blood pressure. Prospective studies and randomized controlled clinical trials that were published in English-language journals were retrieved using MEDLINE, bibliographies, and the authors' reference files. All retrieved publications were reviewed and information on sample size, duration, study design, antihypertensive medication, participant characteristics, and outcomes was abstracted for randomized controlled trials that reported systolic blood pressure reduction during intervention. Several prospective studies indicate that the association between systolic blood pressure and risk of coronary heart disease, stroke, and end-stage renal disease is continuous, graded, and independent. Furthermore, they suggest that the association of systolic blood pressure with these outcomes is stronger than that of diastolic blood pressure. Pooling of the data available from randomized controlled trials indicates that an average reduction of 12 to 13 mm Hg in systolic blood pressure over 4 years of follow-up is associated with a 21% reduction in coronary heart disease, 37% reduction in stroke, 25% reduction in total cardiovascular mortality, and 13% reduction in all-cause mortality rates. These data indicate that systolic blood pressure is an independent and strong predictor for risk of cardiovascular and renal disease.

Blood Pressure↗

PubMedDate not supplied

Evaluating the quality of reporting occupational therapy randomized controlled trials by expanding the CONSORT criteria.

CONTEXT: Well-reported randomized controlled trials (RCTs) are necessary for evidenced-based practice in the field of occupational therapy. OBJECTIVE: The primary purpose of this study was to analyze the quality of reporting in selected RCTs relevant to occupational therapy by using the Nelson-Moberg Expanded CONSORT Instrument (NMECI). The interrater reliability of the NMECI was also tested. METHOD: The 201-sub-item NMECI was developed by the authors to clarify the 22-item CONSORT Statement, each item of which raises several issues. Fourteen RCTs obtained through the OTseeker database were analyzed independently by the authors. RESULTS: The 14 articles complied with slightly more than half of the sub-items of the NMECI (M = 104.2, SD = 32.9 for the main rater). The only area of full compliance involved reporting of objectives and hypotheses; areas of frequent noncompliance included reporting of adverse events, randomization, and blinding. The intraclass correlation coefficient assessing level of interrater agreement on the total NMECI score was .95, indicating strong agreement overall. For the 176 kappas that could be computed on individual sub-items, the median kappa was .85, with an inter-quartile range from .58 to 1, indicating high levels of agreement for most items. However, 29 kappas fell below the moderate level of agreement (.40). CONCLUSIONS: The field of occupational therapy needs increased sophistication in conducting and reporting RCTs. The NMECI shows promise in evaluating the quality of RCTs, given refinements to some items.

Evidence-Based Medicine↗

PubMed1998

Nutritional interventions to prevent intrauterine growth retardation: evidence from randomized controlled trials.

This report summarizes the evidence from systematic reviews of randomized controlled trials on the effectiveness of nutritional interventions aimed at reducing intrauterine growth retardation (IUGR). There were 12 interventions including protein-energy, vitamin, mineral, and fish oil supplementation, as well as the prevention and treatment of anemia and hypertensive disorders. A primary concern is the limited data supporting the effectiveness of recommended nutritional interventions during pregnancy, some of which are widely used even in women without nutritional deficiencies. Overall, with the exception of perhaps balanced protein/energy supplementation (typical odds ratio: 0.77; 95 per cent confidence interval: 0.58 to 1.01), no effective nutritional interventions for reducing the risk of IUGR have been demonstrated. Other interventions, such as zinc, folate and magnesium supplementation during gestation, merit further research which should be conducted among populations at risk of IUGR, using larger sample sizes, and addressing coexisting factors limiting fetal growth. Appropriate combinations of interventions should be a priority for evaluation as it is unlikely that a single factor will reduce a multicausal outcome like IUGR that is so dependent on socioeconomic disparities.

Dietary Proteins↗

PubMed2005

Saponins from Chinese Buckeye Seed reduce cerebral edema: metaanalysis of randomized controlled trials.

To evaluate the effects of saponins from Chinese Buckeye Seed in the treatment of cerebral edema in patients with stroke or cerebral trauma, a metaanalysis of randomized controlled trials was conducted. Randomized trials that compare the effects of treatment with saponins from Chinese Buckeye Seed to placebo treatment, to lack of treatment, to non-specific treatment, or to mannitol treatment for cerebral edema were identified with electronic and manual searches. No blinding and language limitations were applied. The methodological quality of trials was assessed with the Jadad scale plus allocation concealment. The metaanalysis was performed where data were available. Forty-one randomized controlled trials involving 4066 patients were identified. The methodological quality of the trials was generally low. The combined results showed that intravenous administration of saponins from Chinese Buckeye Seed increased the total effective rate, reduced the mortality and the incidence of renal function impairment in comparison to control treatment. No serious adverse event was reported. Based on the metaanalysis, saponins from Chinese Buckeye Seed can reduce cerebral edema in patients with stroke or cerebral trauma. However, the evidence is not sufficient due to the generally low methodological quality of the studies. Further trials are needed with sufficiently numerous group size and rigorous design.

Aesculus↗

PubMed2003

How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies.

BACKGROUND: Failure to recruit adequate numbers of participants represents a major barrier to the completion of randomized controlled trials in primary care and is associated with substantial opportunity costs. However, uncertainty exists regarding the relative effectiveness of different methods to promote recruitment. OBJECTIVES: The purpose of this study was to estimate the proportion of strategies used to promote patient recruitment to randomized controlled trials in primary care that are evidence based. METHODS: Investigators from seven primary care-based clinical trials of dyspepsia management aiming to recruit a total of 6070 patients participated. Following a survey of trial organization, a Delphi technique was used to reach consensus on levels of evidence on the effectiveness of interventions or organizational characteristics in influencing recruitment. The main outcome measures were the proportions of interventions or organizational characteristics for influencing patient recruitment that are based upon randomized controlled trials, on convincing non-experimental evidence or meeting neither of these criteria. RESULTS: Out of a total of 56 interventions used across the trials, 35 (63%) were judged as evidence based. Out of a total of 29 organizational characteristics possessed by the trials, five (17%) were judged as evidence based. Across the seven dyspepsia trials, the presence of 'favourable' organizational characteristics appeared to be important contributors towards successful recruitment. CONCLUSIONS: A wide range of interventions and organizational characteristics with the potential to promote recruitment were used or possessed by seven primary care trials. Many were not evidence based. Our experience suggests that organizational characteristics could be more influential in trial recruitment than the use of specific interventions. Given the costs of primary care-based trials, researchers need more rigorous evidence to inform recruitment strategies.

Dyspepsia↗

PubMed1999

Capture-recapture method for estimating misclassification errors: application to the measurement of vaccine efficacy in randomized controlled trials.

BACKGROUND: The measure of efficacy is optimally performed by randomized controlled trials. However, low specificity of the judgement criteria is known to bias toward lower estimation, while low sensitivity increases the required sample size. A common technique for ensuring good specificity without a drop in sensitivity is to use several diagnostic tests in parallel, with each of them being specific. This approach is similar to the more general situation of case-counting from multiple data sources, and this paper explores the application of the capture-recapture method for the analysis of the estimates of efficacy. METHOD: An illustration of this application is derived from a study on the efficacy of pertussis vaccines where the outcome was based on > or =21 days of cough confirmed by at least one of three criteria performed independently for each subject: bacteriology, serology, or epidemiological link. Log-linear methods were applied to these data considered as three sources of information. RESULTS: The best model considered the three simple effects and an interaction term between bacteriology and epidemiological linkage. Among the 801 children experiencing > or =21 days of cough, it was estimated that 93 cases were missed, leading to a corrected total of 413 confirmed cases. The relative vaccine efficacy estimated from the same model was 1.50 (95% confidence interval: 1.24-1.82), similar to the crude estimate of 1.59 and confirming better protection afforded by one of the two vaccines. CONCLUSION: This method allows supporting analysis to interpret primary estimates of vaccine efficacy.

Adolescent↗

PubMed2004

Short-term interferon-alfa therapy for acute hepatitis C: a randomized controlled trial.

Acute hepatitis C often progresses to chronic infection. We undertook a randomized controlled trial to determine whether short-term therapy with interferon (IFN) during acute hepatitis C is effective in preventing the development of chronic hepatitis. Thirty patients with acute hepatitis C were randomized into 1 of 2 treatment groups. IFN therapy was initiated 8 weeks after the onset of acute hepatitis in the early-intervention group and after 1 year of observation in the late-intervention group. Short-term therapy consisted of natural IFN-alfa (6 million units) administered on consecutive days for a period of 4 weeks. Any signs of recrudescence of disease were immediately followed by interval IFN therapy (3 times weekly for 20 weeks). In the early-intervention group, short-term therapy was associated with a sustained virological response in 13 of 15 patients (87%). Follow-up treatment was associated with a sustained virological response in both of the remaining 2 patients (100%). The sustained virological response rate was significantly higher in the early-intervention group (87%, 13 of 15 patients after short-term therapy alone, and 100%, 15 of 15 patients after short-term with or without follow-up therapy) than in the late-intervention group (40%, 6 of 15 patients after short-term therapy alone, and 53%, 8 of 15 patients after short-term therapy with or without follow-up therapy, P =.021 and P =.006, respectively). In conclusion, short-term (4 weeks) IFN treatment of patients with acute hepatitis C may be associated with satisfactory results, if initiated at an early stage of the disease.

Acute Disease↗

PubMed2002

Primary prophylaxis of variceal hemorrhage: a randomized controlled trial comparing band ligation, propranolol, and isosorbide mononitrate.

BACKGROUND & AIMS: This randomized controlled trial compared variceal band ligation (VBL), propranolol (PPL), and isosorbide-5-mononitrate (ISMN) in the prevention of first esophageal variceal bleed. METHODS: Over a 6-year period, 172 patients with cirrhosis, grade II or III esophageal varices that had never bled, were recruited; 44 into VBL, 66 into PPL, and 62 into ISMN. Baseline patient characteristics: age, 55 +/- 11 years; Child-Pugh score, 8 +/- 2; 65% alcohol-induced cirrhosis; follow-up period, 19.7 +/- 17.6 months (range, 0.13-72.1 months), were comparable in the 3 groups. RESULTS: On intention-to-treat analysis, variceal bleeding occurred in 7% of patients randomized to VBL, 14% to PPL, and 23% to ISMN. The 2-year actuarial risks for first variceal bleed were 6.2% (95% confidence interval [CI], 0.0%-15.0%) for VBL, 19.4% (95% CI, 0.1%-32.4%) for PPL, and 27.7% (95% CI, 14.2%-41.2%) for ISMN. A significant number of patients reported side effects with drug treatment (45% PPL and 42% ISMN vs. 2% VBL; P = 0.00), resulting in withdrawal from treatment in 30% of PPL and 21% of ISMN patients. There were no statistically significant differences in mortality rates in the 3 groups. In as-treated analysis, there was a statistically significant difference in actuarial risk for bleeding at 2 years between VBL and ISMN (7.5%, 95% CI, 2.5%-10.6% vs. 33.0%, 95% CI, 15%-49%, respectively, log rank test P = 0.03) but not between VBL and PPL. CONCLUSIONS: VBL was equivalent to PPL and superior to ISMN in preventing first variceal bleed. The side-effect profile for pharmacotherapy was considerable.

Antihypertensive Agents↗

PubMed2001

Value of flow diagrams in reports of randomized controlled trials.

CONTEXT: Diagrams of the flow of participants through a clinical trial are recommended in the Consolidated Standards for Reporting of Trials (CONSORT) statement, but it is unclear whether such flow diagrams improve the quality of trial reports. OBJECTIVE: To examine the information contributed by flow diagrams and the completeness of reporting overall in reports of randomized controlled trials (RCTs) published in 5 general and internal medicine journals. DESIGN AND SETTING: Analysis of 270 reports of RCTs published in 1998 in the Annals of Internal Medicine (AIM; n = 19), BMJ (n = 42), JAMA (n = 45), The Lancet (n = 81), and The New England Journal of Medicine (NEJM; n = 83). MAIN OUTCOME MEASURES: Proportion of reports that included a flow diagram, information provided in flow diagrams, and completeness of reporting about flow of participants overall in flow diagrams or text. RESULTS: A total of 139 reports (51.5%) of RCTs included a flow diagram, but this varied widely among journals (AIM, 21.0%; BMJ, 38.1%; JAMA, 80.0%; The Lancet, 93.8%; and NEJM, 8.4%). Diagrams generally provided useful information, but only 73 (52.5%) included the number of participants who received allocated interventions and only 32 (23.0%) included the number of participants included in the analysis. In logistic regression analysis, overall completeness of reporting about flow of study participants was associated with publication of a flow diagram. CONCLUSIONS: Flow diagrams are associated with improved quality of reporting of randomized controlled trials. However, the structure of current flow diagrams is less than ideal. We propose a revised flow diagram that includes all important counts through the stages of parallel group trials.

Algorithms↗