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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: Early intensive lowering of elevated blood pressure (BP) after acute intracerebral haemorrhage (ICH) was evaluated in this article, as a run-in phase to a larger trial.
Abstract: Summary Background There is much uncertainty about the effects of early lowering of elevated blood pressure (BP) after acute intracerebral haemorrhage (ICH). Our aim was to assess the safety and efficiency of this treatment, as a run-in phase to a larger trial. Methods Patients who had acute spontaneous ICH diagnosed by CT within 6 h of onset, elevated systolic BP (150–220 mm Hg), and no definite indication or contraindication to treatment were randomly assigned to early intensive lowering of BP (target systolic BP 140 mm Hg; n=203) or standard guideline-based management of BP (target systolic BP 180 mm Hg; n=201). The primary efficacy endpoint was proportional change in haematoma volume at 24 h; secondary efficacy outcomes included other measurements of haematoma volume. Safety and clinical outcomes were assessed for up to 90 days. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00226096. Findings Baseline characteristics of patients were similar between groups, but mean haematoma volumes were smaller in the guideline group (12·7 mL, SD 11·6) than in the intensive group (14·2 mL, SD 14·5). From randomisation to 1 h, mean systolic BP was 153 mm Hg in the intensive group and 167 mm Hg in the guideline group (difference 13·3 mm Hg, 95% CI 8·9–17·6 mm Hg; p Interpretation Early intensive BP-lowering treatment is clinically feasible, well tolerated, and seems to reduce haematoma growth in ICH. A large randomised trial is needed to define the effects on clinical outcomes across a broad range of patients with ICH. Funding National Health and Medical Research Council of Australia.

640 citations

Journal ArticleDOI
TL;DR: It appears that nonpublication was primarily a result of failure to write up and submit the trial results rather than rejection of submitted manuscripts, implying the existence of a publication bias of importance both to meta-analysis and the interpretation of statistically significant positive trials.

638 citations

Journal ArticleDOI
TL;DR: Self-monitoring and appointment reminders may be useful adjuncts to the above strategies to improve blood pressure control but require further evaluation.
Abstract: Background Patients with high blood pressure (hypertension) in the community frequently fail to meet treatment goals - a condition labelled as "uncontrolled" hypertension. The optimal way to organize and deliver care to hypertensive patients has not been clearly identified. Objectives To determine the effectiveness of interventions to improve control of blood pressure in patients with hypertension. To evaluate the effectiveness of reminders on improving the follow-up of patients with hypertension. Search methods All-language search of all articles (any year) in the Cochrane Controlled Trials Register (CCTR) and Medline; and Embase from January 1980. Selection criteria Randomized controlled trials (RCTs) of patients with hypertension that evaluated the following interventions: (1) self-monitoring (2) educational interventions directed to the patient (3) educational interventions directed to the health professional (4) health professional (nurse or pharmacist) led care (5) organisational interventions that aimed to improve the delivery of care (6) appointment reminder systems Outcomes assessed were: (1) mean systolic and diastolic blood pressure (2) control of blood pressure (3) proportion of patients followed up at clinic Data collection and analysis Two authors extracted data independently and in duplicate and assessed each study according to the criteria outlined by the Cochrane Handbook. Main results 72 RCTs met our inclusion criteria. The methodological quality of included studies varied. An organized system of regular review allied to vigorous antihypertensive drug therapy was shown to reduce systolic blood pressure (weighted mean difference (WMD) -8.0 mmHg, 95% CI: -8.8 to -7.2 mmHg) and diastolic blood pressure (WMD -4.3 mmHg, 95% CI: -4.7 to -3.9 mmHg) for three strata of entry blood pressure, and all-cause mortality at five years follow-up (6.4% versus 7.8%, difference 1.4%) in a single large RCT- the Hypertension Detection and Follow-Up study. Other interventions had variable effects. Self-monitoring was associated with moderate net reduction in systolic blood pressure (WMD -2.5 mmHg, 95% CI: -3.7 to -1.3 mmHg) and diastolic blood pressure (WMD -1.8 mmHg, 95% CI: -2.4 to -1.2 mmHg). RCTs of educational interventions directed at patients or health professionals were heterogeneous but appeared unlikely to be associated with large net reductions in blood pressure by themselves. Nurse or pharmacist led care may be a promising way forward, with the majority of RCTs being associated with improved blood pressure control and mean SBP and DBP but these interventions require further evaluation. Appointment reminder systems also require further evaluation due to heterogeneity and small trial numbers, but the majority of trials increased the proportion of individuals who attended for follow-up (odds ratio 0.41, 95% CI 0.32 to 0.51) and in two small trials also led to improved blood pressure control, odds ratio favouring intervention 0.54 (95% CI 0.41 to 0.73). Authors' conclusions Family practices and community-based clinics need to have an organized system of regular follow-up and review of their hypertensive patients. Antihypertensive drug therapy should be implemented by means of a vigorous stepped care approach when patients do not reach target blood pressure levels. Self-monitoring and appointment reminders may be useful adjuncts to the above strategies to improve blood pressure control but require further evaluation.

638 citations

Journal ArticleDOI
TL;DR: This study aims to investigate the effectiveness of an exercise program in improving ability to perform activities of daily living, physical performance, and nutritional status and decreasing behavioral disturbance and depression in patients with Alzheimer's disease.
Abstract: OBJECTIVES: To investigate the effectiveness of an exercise program in improving ability to perform activities of daily living (ADLs), physical performance, and nutritional status and decreasing behavioral disturbance and depression in patients with Alzheimer's disease (AD). DESIGN: Randomized, controlled trial. SETTING: Five nursing homes. PARTICIPANTS: One hundred thirty-four ambulatory patients with mild to severe AD. INTERVENTION: Collective exercise program (1 hour, twice weekly of walk, strength, balance, and flexibility training) or routine medical care for 12 months. MEASUREMENTS: ADLs were assessed using the Katz Index of ADLs. Physical performance was evaluated using 6-meter walking speed, the get-up-and-go test, and the one-leg-balance test. Behavioral disturbance, depression, and nutritional status were evaluated using the Neuropsychiatric Inventory, the Montgomery and Asberg Depression Rating Scale, and the Mini-Nutritional Assessment. For each outcome measure, the mean change from baseline to 12 months was calculated using intention-to-treat analysis. RESULTS: ADL mean change from baseline score for exercise program patients showed a slower decline than in patients receiving routine medical care (12-month mean treatment differences: ADL=0.39, P=.02). A significant difference between the groups in favor of the exercise program was observed for 6-meter walking speed at 12 months. No effect was observed for behavioral disturbance, depression, or nutritional assessment scores. In the intervention group, adherence to the program sessions in exploratory analysis predicted change in ability to perform ADLs. No adverse effects of exercise occurred. CONCLUSION: A simple exercise program, 1 hour twice a week, led to significantly slower decline in ADL score in patients with AD living in a nursing home than routine medical care.

638 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