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Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.


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Journal ArticleDOI
TL;DR: Categorical individual change analyses show that remission is normative, and they suggest that participants receiving the brief intervention are more likely to improve and less likely to worsen regarding negative drinking consequences.
Abstract: Objectives. This study examined long-term response to an individual preventive intervention for high-risk college drinkers relative to the natural history of college drinking.Methods. A single-session, individualized preventive intervention was evaluated within a randomized controlled trial with college freshmen who reported drinking heavily while in high school. An additional group randomly selected from the entire screening pool provided a normative comparison. Participant self-report was assessed annually for 4 years.Results. High-risk controls showed secular trends for reduced drinking quantity and negative consequences without changes in drinking frequency. Those receiving the brief preventive intervention reported significant additional reductions, particularly with respect to negative consequences. Categorical individual change analyses show that remission is normative, and they suggest that participants receiving the brief intervention are more likely to improve and less likely to worsen regarding...

517 citations

Journal ArticleDOI
TL;DR: Improvements in exercise tolerance and quality of life can be achieved and sustained for 6 months in patients undergoing respiratory rehabilitation compared with those receiving conventional care.

517 citations

Journal ArticleDOI
16 Sep 1992-JAMA
TL;DR: To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women, a systematic search of the English-language literature was conducted.
Abstract: Objective —To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women Data Sources —We conducted a systematic search of the English-language literature from January 1960 through September 1991 to identify all relevant studies of specific pharmacotherapies employed in the treatment of acute myocardial infarction To accomplish this, we searched MEDLINE, major cardiology textbooks, meta-analyses, reviews, editorials, and the bibliographies of all identified articles Study Selection —Only trials in which patients were randomly allocated to receive a specific therapeutic regimen or a placebo or nonplacebo control regimen were included for review Data Extraction —Studies were abstracted for year of publication, source of support, performance location, drug therapies to which patients were randomized, use of invasive diagnostic tests or therapeutic procedures, exclusion criteria, size and demographic characteristics of the randomized study population, and principal outcome measures Data Synthesis —A total of 214 trials met inclusion criteria, involving 150920 study subjects Over 60% of trials excluded persons over the age of 75 years Studies published after 1980 were more likely to have age-based exclusions compared with studies published before 1980 (adjusted odds ratio, 492; 95% confidence interval, 233 to 1054) Trials of thrombolytic therapy involving an invasive procedure were more likely to exclude elderly patients compared with other studies (adjusted odds ratio, 245; 95% confidence interval, 110 to 547) Studies with age-based exclusions had a smaller percentage of women compared with those without such exclusions (18% vs 23%; P =0002), with the mean age of the study population significantly associated with the proportion of women participants ( P =0001, R 2 =29) Conclusions —Age-based exclusions are frequently used in clinical trials of medications used in the treatment of acute myocardial infarction Such exclusions limit the ability to generalize study findings to the patient population that experiences the most morbidity and mortality from acute myocardial infarction ( JAMA 1992;268:1417-1422)

517 citations

Journal ArticleDOI
22 May 1996-JAMA
TL;DR: In this article, the authors conducted a systematic search of human studies with Medical Subject Heading (MHE) terms to ascertain whether restriction of dietary sodium lowers blood pressure in hypertensive and normotensive individuals.
Abstract: Objective. —To ascertain whether restriction of dietary sodium lowers blood pressure in hypertensive and normotensive individuals. Data Sources. —An English-language computerized literature search, restricted to human studies with Medical Subject Heading terms, "hypertension," "blood pressure," "vascular resistance," "sodium and dietary," "diet and sodium restricted," "sodium chloride," "clinical trial," "randomized controlled trial," and "prospective studies," was conducted. Bibliographies of review articles and personal files were also searched. Trial Selection. —Trials that had randomized allocation to control and dietary sodium intervention groups, monitored by timed sodium excretion, with outcome measures of both systolic and diastolic blood pressure were selected by blinded review of the methods section. Data Extraction. —Two observers extracted data independently, using purposedesigned forms, and discrepancies were resolved by discussion. Data Synthesis. —The 56 trials that met our inclusion criteria showed significant heterogeneity. Publication bias was also evident. The mean reduction (95% confidence interval) in daily urinary sodium excretion, a proxy measure of dietary sodium intake, was 95 mmol/d (71-119 mmol/d) in 28 trials with 1131 hypertensive subjects and 125 mmol/d (95-156 mmol/d) in 28 trials with 2374 normotensive subjects. After adjustment for measurement error of urinary sodium excretion, the decrease in blood pressure for a 100-mmol/d reduction in daily sodium excretion was 3.7 mm Hg (2.35-5.05 mm Hg) for systolic ( P P =.09) in the hypertensive trials, and 1.0 mm Hg (0.51-1.56 mm Hg) for systolic ( P P =.64) in the normotensive trials. Decreases in blood pressure were larger in trials of older hypertensive individuals and small and nonsignificant in trials of normotensive individuals whose meals were prepared and who lived outside the institution setting. Conclusion. —Dietary sodium restriction for older hypertensive individuals might be considered, but the evidence in the normotensive population does not support current recommendations for universal dietary sodium restriction. ( JAMA . 1996;275:1590-1597)

517 citations

Journal ArticleDOI
20 Sep 2016-JAMA
TL;DR: Among young adults with a BMI between 25 and less than 40, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months, suggesting devices that monitor and provide feedback on physical activity may not offer an advantage over standard behavioral weight loss approaches.
Abstract: Importance Effective long-term treatments are needed to address the obesity epidemic. Numerous wearable technologies specific to physical activity and diet are available, but it is unclear if these are effective at improving weight loss. Objective To test the hypothesis that, compared with a standard behavioral weight loss intervention (standard intervention), a technology-enhanced weight loss intervention (enhanced intervention) would result in greater weight loss. Design, Setting, Participants Randomized clinical trial conducted at the University of Pittsburgh and enrolling 471 adult participants between October 2010 and October 2012, with data collection completed by December 2014. Interventions Participants were placed on a low-calorie diet, prescribed increases in physical activity, and had group counseling sessions. At 6 months, the interventions added telephone counseling sessions, text message prompts, and access to study materials on a website. At 6 months, participants randomized to the standard intervention group initiated self-monitoring of diet and physical activity using a website, and those randomized to the enhanced intervention group were provided with a wearable device and accompanying web interface to monitor diet and physical activity. Main Outcomes and Measures The primary outcome of weight was measured over 24 months at 6-month intervals, and the primary hypothesis tested the change in weight between 2 groups at 24 months. Secondary outcomes included body composition, fitness, physical activity, and dietary intake. Results Among the 471 participants randomized (body mass index [BMI], 25 to P = .002). Both groups had significant improvements in body composition, fitness, physical activity, and diet, with no significant difference between groups. Conclusions and Relevance Among young adults with a BMI between 25 and less than 40, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months. Devices that monitor and provide feedback on physical activity may not offer an advantage over standard behavioral weight loss approaches. Trial Registration clinicaltrials.gov Identifier:NCT01131871

517 citations


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Performance
Metrics
No. of papers in the topic in previous years
YearPapers
20241
202317,032
202234,327
202112,220
202010,774
20199,017