Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals.

OBJECTIVE: To evaluate the reporting quality of key methodological items of randomized control trials (RCTs) in 55 of the highest ranked journals. STUDY DESIGN AND SETTING: A list of the highest top ranked journals was identified, and a search for detecting RCTs in those journals was made. Two hundred sixty four journals were screened and 55 of them were identified having at least one RCT. Three RCTs were randomly selected a priori from each journal; 148 RCTs were finally included. RCTs were assessed by two reviewers using the Consolidated Standards of Reporting Trials (CONSORT) statement. RESULTS: Only 11 (8%) RCTs had all items adequately reported. In addition, 36% of RCTs reported that the study was registered in any trial registry. We found a significant difference in the quality of reporting for baseline characteristics, recruitment, participant's flow, and randomization implementation between those studies having reported the registration of their RCT in a trial registry and those that have not. Adherence to key methodological items of the CONSORT statement was as follows: sample size determination (60%), sequence generation (49%), allocation concealment (40%), and blinding (25%). CONCLUSIONS: Reporting of varied CONSORT items remains suboptimal. Registration in a trial registry was associated with improved reporting. Further efforts to enhance RCT registration could contribute to this improvement.

The responsiveness of generic quality of life instruments in rheumatic diseases. A systematic review of randomized controlled trials.

To review the available evidence that has used generic instruments alone or in comparison with disease specific instruments. A systematic review was carried out using the methods recommended by the Cochrane Collaboration. We used MEDLINE and EMBASE searches and we performed a hand search of the abstracts listed under "quality of life" at American College of Rheumatology (ACR) meetings. Selection was limited to randomized controlled trials (RCT) using generic instruments in populations older than 18 years with any of the following diseases: rheumatoid arthritis, fibromyalgia, osteoporosis, osteoarthritis, systemic lupus erythematosus, and ankylosing spondylitis. Language was restricted to English papers. Studies using only disease-specific instruments were excluded. From 488 articles retrieved, 13 reports of 10 randomized controlled trials were selected. There were 101 abstracts on quality of life in ACR abstract books; 78 abstracts contained data on generic instruments, and of these, 9 described their use in RCT. Despite a substantial increase in the number of papers and abstracts addressing different aspects of generic questionnaires, the majority of the papers were descriptive. The evidence is not yet available to document that any of the generic instruments pass the requirements of the OMERACT Filter.