TY - JOUR
T1 - The effect of the CONSORT statement on the amount of "unclear" Risk of Bias reporting in Cochrane Systematic Reviews
AU - Rademaker, Maaike M
AU - Ramakers, Geerte G J
AU - Smit, Adriana L
AU - Hooft, Lotty
AU - Stegeman, Inge
N1 - Publisher Copyright:
© 2020 Rademaker et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/7
Y1 - 2020/7
N2 - BACKGROUND: The 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".OBJECTIVE: In 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.METHODS: All 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.RESULTS: Data 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)).CONCLUSION: A slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.
AB - BACKGROUND: The 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".OBJECTIVE: In 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.METHODS: All 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.RESULTS: Data 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)).CONCLUSION: A slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.
KW - Bias
KW - Randomized Controlled Trials as Topic
KW - Reference Standards
KW - Research Design/standards
KW - Systematic Reviews as Topic
UR - http://www.scopus.com/inward/record.url?scp=85088205736&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0235535
DO - 10.1371/journal.pone.0235535
M3 - Article
C2 - 32650340
SN - 1932-6203
VL - 15
SP - 1
EP - 9
JO - PLoS ONE
JF - PLoS ONE
IS - 7
M1 - e0235535
ER -