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This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access. [ABSTRACT FROM AUTHOR]

IMPORTANCE A persistent dilemma when performing meta-analyses is whether all available trials should be included in the meta-analysis. OBJECTIVES To compare treatment outcomes estimated by meta-analysis of all trials and several alternative analytic strategies: single most precise trial (ie, trial with the narrowest confidence interval), meta-analysis restricted to the 25%largest trials, limit meta-analysis (a meta-analysis model adjusted for small-study effect), and meta-analysis restricted to trials at low overall risk of bias. DATA SOURCES One hundred sixty-three meta-analyses published between 2008 and 2010 in high-impact-factor journals and between 2011 and 2013 in the Cochrane Database of Systematic Reviews: 92 (705 randomized clinical trials [RCTs]) with subjective outcomes and 71 (535 RCTs) with objective outcomes. DATA SYNTHESIS For each meta-analysis, the difference in treatment outcomes between meta-analysis of all trials and each alternative strategy, expressed as a ratio of odds ratios (ROR), was assessed considering the dependency between strategies. A difference greater than 30% was considered substantial. RORs were combined by random-effects meta-analysis models to obtain an average difference across the sample. An ROR greater than 1 indicates larger treatment outcomes with meta-analysis of all trials. Subjective and objective outcomes were analyzed separately. RESULTS Treatment outcomes were larger in the meta-analysis of all trials than in the single most precise trial (combined ROR, 1.13 [95% CI, 1.07-1.19]) for subjective outcomes and 1.03 (95% CI, 1.01-1.05) for objective outcomes). The difference in treatment outcomes between these strategies was substantial in 47 of 92 (51%) meta-analyses of subjective outcomes (meta-analysis of all trials showing larger outcomes in 40/47) and in 28 of 71 (39%) meta-analyses of objective outcomes (meta-analysis of all trials showing larger outcomes in 21/28). The combined ROR for subjective and objective outcomes was, respectively, 1.08 (95% CI, 1.04-1.13) and 1.03 (95% CI, 1.00-1.06) when comparing meta-analysis of all trials and meta-analysis of the 25%largest trials, 1.17 (95% CI, 1.11-1.22) and 1.13 (95% CI, 0.82-1.55) when comparing meta-analysis of all trials and limit meta-analysis, and 0.94 (95% CI, 0.86-1.04) and 1.03 (95% CI, 1.00-1.06) when comparing meta-analysis of all trials and meta-analysis restricted to trials at low risk of bias. CONCLUSIONS AND RELEVANCE Estimation of treatment outcomes in meta-analyses differs depending on the strategy used. This instability in findings can result in major alterations in the conclusions derived from the analysis and underlines the need for systematic sensitivity analyses. [ABSTRACT FROM AUTHOR]

The article discusses a study which identified the nature and frequency of distorted presentation in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes. The researchers analyzed data from MEDLINE through PubMed using the Cochrane Highly Sensitive Search Strategy to determine RCTs published in December 2006. It was concluded by the researchers that the reporting and interpretation of findings was inconsistent with the results in the representative sample of RCTs.

The article discusses a study which compared the registered and published primary outcome of randomized controlled trials (RCT). Study authors reviewed MEDLINE via PubMed to search for RCT reports in cardiology, rheumatology and gastroenterology that were indexed in 2008 in 10 general medical and specialty journals. They found that 45.5 percent of the trials were adequately registered, while 27.6 percent published reports lack trial registration. They also noted that 31 percent of trials with adequate registration showed some discrepancies between the outcomes registered and outcomes published. Study authors concluded that selective outcome reporting is prevalent in RCT.

Context: Randomized controlled trials have been developed essentially in the context of pharmacological treatments (ie, oral drugs; intra-articular injection; and topical, intramuscular, and intravenous treatments), but assessment of the effectiveness of nonpharmacological treatments (ie, surgery, arthroscopy, joint lavage, rehabilitation, acupuncture, and education) presents specific issues.Objectives: To compare the quality of articles of nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific methodological issues related to assessment of nonpharmacological treatments.Design and Setting: We searched MEDLINE and the Cochrane Central Register of Controlled Trials for articles of randomized controlled trials published between January 1, 1992, and February 28, 2002, in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis.Main Outcome Measures: The quality of the methods reported in the selected articles was assessed by 2 independent reviewers using the Jadad scale, the Delphi list, and guidelines found in the Users' Guides to the Medical Literature. Investigators also used a checklist of items developed by the authors to analyze study characteristics.Results: A total of 110 articles were included in the analysis; 50 (45.5%) assessed nonpharmacological treatments and 60 (54.5%) assessed pharmacological treatments. Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale (mean [SD] score, 1.4 [1.3] vs 3.0 [1.3]) and the Delphi list (mean [SD] score, 5.2 [1.5] vs 7.5 [1.1]). Lack of reporting adequate random sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles. Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments (28.0% of articles vs 71.7%). Compared with pharmacological articles, nonpharmacological articles less often described blinding of patients (26.0% vs 96.7%), care providers (6.0% vs 81.7%), and outcome assessors (68.0% vs 98.3%). Care providers' skill levels could influence treatment effect in 84.0% of nonpharmacological articles vs 23.3% of pharmacological articles.Conclusions: In this analysis of reports of hip and knee osteoarthritis therapy, nonpharmacological articles scored lower than pharmacological articles in terms of quality. Assessments of nonpharmacological treatments must take into consideration additional methodological issues. [ABSTRACT FROM AUTHOR]

The article presents a study which examined the completeness of data sharing on the Clinical Study Data Request (CSDR) website as of late June 2016. In the study, all data from the ClinicalTrials.gov and CSDR databases were merged by trial registry number. Based on the data, the studies were sponsored by such pharmaceutical firms as Roche, Lilly, and GlaxoSmithKline (GSK).

Two letters to the editor are presented concerning the article "Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials," by S. Mathieu and colleagues, published in the 2009 issue, including a comment on the citation of the journal "Arthritis & Rheumatism/Arthritis Care & Research" in the study and a reply from the authors.

A letter and a response to a letter to the editor is presented which discussed the inappropriate use of statistically nonsignificant results in public reports of randomized controlled trials.

Presents a letter to the editor in response to the article "Effect of awareness of a randomized controlled trial on use of experimental therapy," by W. F. Clark et al. in a previous issue.