The effect of the CONSORT statement on the amount of 'unclear' Risk of Bias reporting in Cochrane Systematic Reviews

Autor: Geerte G. J. Ramakers, Lotty Hooft, Adriana L. Smit, Maaike M. Rademaker, Inge Stegeman
Rok vydání: 2020
Předmět:
Logistic regression
law.invention
Mathematical and Statistical Techniques
0302 clinical medicine
Randomized controlled trial
law
Medicine and Health Sciences
030212 general & internal medicine
Randomized Controlled Trials as Topic
Multidisciplinary
Statistics
Research Assessment
Reference Standards
Systematic review
Research Design
030220 oncology & carcinogenesis
Physical Sciences
Research Reporting Guidelines
Regression Analysis
Medicine
Research Article
medicine.medical_specialty
Drug Research and Development
Systematic Reviews
Science
education
Replication Studies
MEDLINE
Research and Analysis Methods
Odds
03 medical and health sciences
Bias
medicine
Clinical Trials
Statistical Methods
Scientific Publishing
Pharmacology
business.industry
Consolidated Standards of Reporting Trials
Odds ratio
Randomized Controlled Trials
Confidence interval
Otorhinolaryngology
Family medicine
Clinical Medicine
business
Mathematics
Systematic Reviews as Topic
Zdroj: PLoS ONE, Vol 15, Iss 7, p e0235535 (2020)
PLoS ONE
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0235535
Popis: BackgroundThe Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear".ObjectiveIn this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews.MethodsAll Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (≤1995, 1996-2000, 2001-2009 and ≥2010) based on the release- and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression.ResultsData was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published ≥2010, compared to ≤1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)).ConclusionA slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.
Databáze: OpenAIRE
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