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.

Reduction of Hospital Utilization in Patients With Chronic Obstructive Pulmonary Disease: A Disease-Specific Self-management Intervention

Abstract: Background Self-management interventions improve various outcomes for many chronic diseases. The definite place of self-management in the care of chronic obstructive pulmonary disease (COPD) has not been established. We evaluated the effect of a continuum of self-management, specific to COPD, on the use of hospital services and health status among patients with moderate to severe disease. Methods A multicenter, randomized clinical trial was carried out in 7 hospitals from February 1998 to July 1999. All patients had advanced COPD with at least 1 hospitalization for exacerbation in the previous year. Patients were assigned to a self-management program or to usual care. The intervention consisted of a comprehensive patient education program administered through weekly visits by trained health professionals over a 2-month period with monthly telephone follow-up. Over 12 months, data were collected regarding the primary outcome and number of hospitalizations; secondary outcomes included emergency visits and patient health status. Results Hospital admissions for exacerbation of COPD were reduced by 39.8% in the intervention group compared with the usual care group ( P = .01), and admissions for other health problems were reduced by 57.1% ( P = .01). Emergency department visits were reduced by 41.0% ( P = .02) and unscheduled physician visits by 58.9% ( P = .003). Greater improvements in the impact subscale and total quality-of-life scores were observed in the intervention group at 4 months, although some of the benefits were maintained only for the impact score at 12 months. Conclusions A continuum of self-management for COPD patients provided by a trained health professional can significantly reduce the utilization of health care services and improve health status. This approach of care can be implemented within normal practice.

Effect of estrogen plus progestin on global cognitive function in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial.

Abstract: ContextObservational studies have suggested that postmenopausal hormone treatment may improve cognitive function, but data from randomized clinical trials have been sparse and inconclusive The Women's Health Initiative Memory Study (WHIMS) is an ancillary study of the Women's Health Initiative (WHI) hormone therapy trials On July 8, 2002, the estrogen plus progestin therapy in the WHI trial was discontinued because of certain increased health risks for womenObjectiveTo determine whether estrogen plus progestin therapy protects global cognitive function in older postmenopausal womenDesign, Setting, and ParticipantsA randomized, double-blind, placebo-controlled clinical trial, WHIMS is an ancillary study of geographically diverse, community-dwelling women aged 65 years or older from 39 of 40 clinical centers within the WHI estrogen plus progestin trial that started in June 1995 Of 4894 eligible postmenopausal women aged 65 years or older and free of probable dementia at baseline, 4532 (926%) were enrolled in the estrogen plus progestin component of WHIMS A total of 4381 participants (967%) provided at least 1 valid cognitive function score between June 1995 and July 8, 2002InterventionsParticipants received either 1 daily tablet containing 0625 mg of conjugated equine estrogen with 25 mg of medroxyprogesterone acetate (n = 2145) or matching placebo (n = 2236)Main Outcome MeasureGlobal cognitive function measured annually with the Modified Mini-Mental State ExaminationResultsThe Modified Mini-Mental State Examination mean total scores in both groups increased slightly over time (mean follow-up of 42 years) Women in the estrogen plus progestin group had smaller average increases in total scores compared with women receiving placebo (P = 03), but these differences were not clinically important Removing women by censoring them after adjudicated dementia, mild cognitive impairment, or stroke, and nonadherence to study protocol, did not alter the findings Prior hormone therapy use and duration of prior use did not affect the interpretation of the results, nor did timing of prior hormone therapy initiation with respect to the final menstrual period More women in the estrogen plus progestin group had a substantial and clinically important decline (≥2 SDs) in Modified Mini-Mental State Examination total score (67%) compared with the placebo group (48%) (P = 008)ConclusionsAmong postmenopausal women aged 65 years or older, estrogen plus progestin did not improve cognitive function when compared with placebo While most women receiving estrogen plus progestin did not experience clinically relevant adverse effects on cognition compared with placebo, a small increased risk of clinically meaningful cognitive decline occurred in the estrogen plus progestin group

A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients.

Abstract: Background Adjuvant chemotherapy is standard treatment for patients with resected colon cancer who are at high risk for recurrence, but the efficacy and toxicity of such treatment in patients more than 70 years of age are controversial Methods We performed a pooled analysis, based on the intention to treat, of individual patient data from seven phase 3 randomized trials (involving 3351 patients) in which the effects of postoperative fluorouracil plus leucovorin (five trials) or fluorouracil plus levamisole (two trials) were compared with the effects of surgery alone in patients with stage II or III colon cancer The patients were grouped into four age categories of equal size, and analyses were repeated with 10-year age ranges (≤50, 51 to 60, 61 to 70, and >70 years), with the same conclusions The toxic effects measured in all trials were nausea or vomiting, diarrhea, stomatitis, and leukopenia Patients in the fluorouracil-plus-leucovorin and fluorouracil-plus-levamisole groups were combined for the ef