Showing papers in "Controlled Clinical Trials in 2003"
TL;DR: The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information.
846 citations
TL;DR: The Look AHEAD clinical trial is to assess the long-term effects of an intensive weight loss program delivered over 4 years in overweight and obese individuals with type 2 diabetes and is designed to provide a 0.90 probability of detecting an 18% difference in major CVD event rates between the two groups.
681 citations
TL;DR: Loads of the randomization in clinical trials theory and practice book catalogues in this site are found as the choice of you visiting this page.
275 citations
TL;DR: The aim of this paper is to examine the use and utility of the Weibull model in the analysis of survival data from clinical trials and illustrate the practical benefits of a WeIBull-based analysis.
222 citations
TL;DR: Patients' perceptions of randomization and reasons for consent or refusal to participate in the ProtecT study (a randomized trial of surgery, radiotherapy, and monitoring for localized prostate cancer) were explored, and belief in clinical equipoise was key to participants' consent to randomization.
131 citations
TL;DR: Whether a standardized modified Burch colposuspension, when added to planned abdominal sacrocolpopexy for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects without preoperative symptoms of stress urinary incontinence is evaluated.
97 citations
TL;DR: The loss to follow-up rate is successfully minimized in this ongoing multicenter, randomized controlled trial comparing reamed and nonreamed intramedullary nailing of tibial shaft fractures by incorporating innovative prevention and retention strategies into its design and conduct.
95 citations
TL;DR: This trial is unique because the cancer diagnosis is used not only as a marker of risk for functional decline, but also as a "teachable moment" - an opportune time when elders may be more receptive to making beneficial lifestyle changes.
92 citations
TL;DR: Local approval of two multicenter clinical trials was time-consuming and resulted in many changes in centrally approved consent forms, which frequently decreased readability and introduced errors.
89 citations
TL;DR: The design of the MTOPS trial, the concept of BPH progression, the definition and methods of determining the primary outcome events and the proposed statistical analysis methods are described.
82 citations
TL;DR: The Arthritis, Diet, and Activity Promotion Trial (ADAPT) as mentioned in this paper was developed to test the efficacy of lifestyle behavioral changes on physical function, pain, and disability in obese, sedentary older adults with knee OA.
TL;DR: It is concluded that responsive adaptive designs may be useful for some purposes, particularly in the presence of large treatment effects, although allowing early stopping minimizes the benefits.
TL;DR: For example, the preliminary results of the twelfth Medical Research Council acute myeloid leukemia trial show no evidence of a survival advantage for five courses of therapy compared to four courses in a randomized comparison involving 1078 patients (hazard ratio 1.09, 95% confidence interval [CI] 0.87-1.4) as mentioned in this paper.
TL;DR: This is the first randomized controlled trial of a six-way factorial design for the prevention of postoperative nausea and vomiting (PONV) and may serve as an example for numerous other medical specialties.
TL;DR: Well-designed monitoring plans for all studies that are appropriate to their scope and risk, more centralized review of large multisite studies and closer local scrutiny of single-institution studies are recommended.
TL;DR: The results suggest that in detecting errors of single data entry, the RA method is inferior to the DDE method, while its time cost is lower.
TL;DR: This work points out the difficulty in accurately estimating the treatment effect midway through a trial, and encourages the use of a simple, conservative approach whereby sample size can be increased but not decreased from what was originally planned.
TL;DR: The results indicate that if an RCT is to be designed to detect small effects, it is inadvisable to use very short instruments analyzed using IRT, and the SF-36, SF-12, and SF-8 instruments were considered.
TL;DR: The potential for selecting patients based on response during a run-in period to jeopardize validity directly is addressed, through its intended effect of overrepresenting some segments in the randomized portion of the trial and underrepresenting others.
TL;DR: The OPAL study is one of the first large randomized studies to determine the effects of continuous combined estrogen-progestin therapy on carotid atherosclerosis in healthy postmenopausal women, and results are expected to complement other studies on Atherosclerosis progression inhealthy post menopausal women.
TL;DR: The BErgamo NEphrologic DIabetes Complications Trial (BENEDICT) is a prospective, randomized, double-blind parallel-group study primarily aimed at evaluating the possibility of preventing the progression to microalbuminuria and exploring whether primary prevention of diabetic nephropathy is an achievable goal.
TL;DR: The elicitation of the pretrial opinions of the investigators involved in the new trial and the construction of appropriate clinical and skeptical prior distributions based on their responses are described.
TL;DR: The Digitalis Investigation Group (DIG) trial was a randomized, double-blind placebo-controlled trial whose primary objective was to determine whether digoxin had beneficial, harmful, or no effect on total mortality in patients with heart failure who were in sinus rhythm and whose ejection fraction was
TL;DR: The evaluation provides guidance as to what percentage of the control effect needs to be preserved so that through noninferiority testing of effect retention one can assert the treatment efficacy within a desired level of the error rate.
TL;DR: This is the first large-scale, multicenter, randomized controlled trial to compare the relative efficacy of these different therapeutic strategies and the rationale behind the OPTIMA Trial design is discussed.
TL;DR: The rationale behind various aspects of the design, including ethical issues and practical challenges of conducting a randomized trial in schools, data linkage for key outcomes to reduce bias, and integrating process and outcome measures to improve the interpretation of findings are discussed.
TL;DR: The decision process used to apply the stopping rules and the activities engaged in by CARET participants and staff to implement the decision were described, leading to smooth closure of active intervention.
TL;DR: The issues involved in the decision to terminate the study are presented, including a troublesome age by vasectomy technique interaction became apparent in the analysis, and trial enrollment was terminated.
TL;DR: It was discovered that it was easier and more informative to request computerized data files and merge them ourselves than to ask the investigators to abstract partial data from their files, and analyses based on individual patient data are extremely informative.