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.

A Multifaceted Intervention to Improve Treatment of Depression in Primary Care

Abstract: Background: This research study evaluates the effectiveness of a multifaceted intervention program to improve the management of depression in primary care. Methods: One hundred fifty-three primary care patients with current depression were entered into a randomized controlled trial. Intervention patients received a structured depression treatment program in the primary care setting that included both behavioral treatment to increase use of adaptive coping strategies and counseling to improve medication adherence. Control patients received "usual" care by their primary care physicians. Outcome measures included adherence to antidepressant medication, satisfaction with care of depression and with antidepressant treatment, and reduction of depressive symptoms over time. Results: At 4-month follow-up, significantly more intervention patients with major and minor depression than usual care patients adhered to antidepressant medication and rated the quality of care they received for depression as good to excellent. Intervention patients with major depression demonstrated a significantly greater decrease in depression severity over time compared with usual care patients on all 4 outcome analyses. Intervention patients with minor depression were found to have a significant decrease over time in depression severity on only 1 of 4 study outcome analyses compared with usual care patients. Conclusion: A multifaceted primary care intervention improved adherence to antidepressant regimens and satisfaction with care in patients with major and minor depression. The intervention consistently resulted in more favorable depression outcomes among patients with major depression, while outcome effects were ambiguous among patients with minor depression.

OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial

Abstract: Objectives: This is the first of a pair of studies designed to assess efficacy, safety and tolerability of onabotulinumtoxinA (BOTOX®) as headache prophylaxis in adults with chronic migraine.Methods: The Phase III REsearch Evaluating Migraine Prophylaxis Therapy 1 (PREEMPT 1) is a phase 3 study, with a 24-week, double-blind, parallel-group, placebo-controlled phase followed by a 32-week, open-label phase. Subjects were randomized (1:1) to injections every 12 weeks of onabotulinumtoxinA (155 U–195 U; n = 341) or placebo (n = 338) (two cycles). The primary endpoint was mean change from baseline in headache episode frequency at week 24.Results: No significant between-group difference for onabotulinumtoxinA versus placebo was observed for the primary endpoint, headache episodes (−5.2 vs. −5.3; p = 0.344). Large within-group decreases from baseline were observed for all efficacy variables. Significant between-group differences for onabotulinumtoxinA were observed for the secondary endpoints, headache days (p =...

Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial.

Abstract: OBJECTIVE Persistent or recurrent radicular pain after lumbosacral spine surgery is often associated with nerve root compression and is treated by repeated operation or, as a last resort, by spinal cord stimulation (SCS). We conducted a prospective, randomized, controlled trial to test our hypothesis that SCS is more likely than reoperation to result in a successful outcome by standard measures of pain relief and treatment outcome, including subsequent use of health care resources. METHODS For an average of 3 years postoperatively, disinterested third-party interviewers followed 50 patients selected for reoperation by standard criteria and randomized to SCS or reoperation. If the results of the randomized treatment were unsatisfactory, patients could cross over to the alternative. Success was based on self-reported pain relief and patient satisfaction. Crossover to the alternative procedure was an outcome measure. Use of analgesics, activities of daily living, and work status were self-reported. RESULTS Among 45 patients (90%) available for follow-up, SCS was more successful than reoperation (9 of 19 patients versus 3 of 26 patients, P <0.01). Patients initially randomized to SCS were significantly less likely to cross over than were those randomized to reoperation (5 of 24 patients versus 14 of 26 patients, P=0.02). Patients randomized to reoperation required increased opiate analgesics significantly more often than those randomized to SCS (P <0.025). Other measures of activities of daily living and work status did not differ significantly. CONCLUSION SCS is more effective than reoperation as a treatment for persistent radicular pain after lumbosacral spine surgery, and in the great majority of patients, it obviates the need for reoperation.

Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomised controlled trial.

Abstract: Objectives: To assess the effects of rivastigmine on the core domains of Alzheimer9s disease. Design: Prospective, randomised, multicentre, double blind, placebo controlled, parallel group trial. Patients received either placebo, 1-4 mg/day (lower dose) rivastigmine, or 6-12 mg/day (higher dose) rivastigmine. Doses were increased in one of two fixed dose ranges (1-4 mg/day or 6-12 mg/day) over the first 12 weeks with a subsequent assessment period of 14 weeks. Setting: 45 centres in Europe and North America. Participants: 725 patients with mild to moderately severe probable Alzheimer9s disease diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders , fourth edition, and the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer9s Disease and Related Disorders Association. Outcome measures: Cognitive subscale of the Alzheimer9s disease assessment scale, rating on the clinician interview based impression of change incorporating caregiver information scale, and the progressive deterioration scale. Results: At the end of the study cognitive function had deteriorated among those in the placebo group. Scores on the Alzheimer9s disease assessment scale improved in patients in the higher dose group when compared with patients taking placebo (P v 16% (39/238)). Global function as rated by the clinician interview scale had significantly improved among those in the higher dose group compared with those taking placebo (P v 20% (46/230)). Mean scores on the progressive deterioration scale improved from baseline in patients in the higher dose group but fell in the placebo group. Adverse events were predominantly gastrointestinal, of mild to moderate severity, transient, and occurred mainly during escalation of the dose. 23% (55/242) of those in the higher dose group, 7% (18/242) of those in the lower dose group, and 7% (16/239) of those in the placebo group discontinued treatment because of adverse events. Conclusions: Rivastigmine is well tolerated and effective. It improves cognition, participation in activities of daily living, and global evaluation ratings in patients with mild to moderately severe Alzheimer9s disease. This is the first treatment to show compelling evidence of efficacy in a predominantly European population. Key messages In a 6 month trial rivastigmine was effective in treating the core cognitive and functional symptoms of patients with mild to moderate Alzheimer9s disease Rivastigmine at doses of 6-12 mg/day produces clinically relevant and statistically significant improvements in cognitive and global assessments, and in activities of daily living The effects of rivastigmine are dose dependent Rivastigmine was well tolerated in this population of elderly patients

Comprehensive Discharge Planning With Postdischarge Support for Older Patients With Congestive Heart Failure: A Meta-analysis

Abstract: ContextComprehensive discharge planning plus postdischarge support may reduce readmission rates for older patients with congestive heart failure (CHF).ObjectiveTo evaluate the effect of comprehensive discharge planning plus postdischarge support on the rate of readmission in patients with CHF, all-cause mortality, length of stay (LOS), quality of life (QOL), and medical costs.Data SourcesWe searched MEDLINE (1966 to October 2003), the Cochrane Clinical Trials Register (all years), Social Science Citation Index (1992 to October 2003), and other databases for studies that described such an intervention and evaluated its effect in patients with CHF. Where possible we also contacted lead investigators and experts in the field.Study SelectionWe selected English-language publications of randomized clinical trials that described interventions to modify hospital discharge for older patients with CHF (mean age ≥55 years), delineated clearly defined inpatient and outpatient components, compared efficacy with usual care, and reported readmission as the primary outcome.Data ExtractionTwo authors independently reviewed each report, assigned quality scores, and extracted data for primary and secondary outcomes in an unblinded standardized manner.Data SynthesisEighteen studies representing data from 8 countries randomized 3304 older inpatients with CHF to comprehensive discharge planning plus postdischarge support or usual care. During a pooled mean observation period of 8 months (range, 3-12 months), fewer intervention patients were readmitted compared with controls (555/1590 vs 741/1714, number needed to treat = 12; relative risk [RR], 0.75; 95% confidence interval [CI], 0.64-0.88). Analysis of studies reporting secondary outcomes found a trend toward lower all-cause mortality for patients assigned to an intervention compared with usual care (RR, 0.87; 95% CI, 0.73-1.03; n = 14 studies), similar initial LOS (mean [SE]: 8.4 [2.5] vs 8.5 [2.2] days, P = .60; n = 10), greater percentage improvement in QOL scores compared with baseline scores (25.7% [95% CI, 11.0%-40.4%] vs 13.5% [95% CI, 5.1%-22.0%]; n = 6, P = .01), and similar or lower charges for medical care per patient per month for the initial hospital stay, administering the intervention, outpatient care, and readmission (−$359 [95% CI, −$763 to $45]; n = 4, P = .10 for non-US trials and −$536 [95% CI, −$956 to −$115]; n = 4, P = .03, for US trials).ConclusionComprehensive discharge planning plus postdischarge support for older patients with CHF significantly reduced readmission rates and may improve health outcomes such as survival and QOL without increasing costs.