The reporting of safety among drug systematic reviews was poor before the implementation of the PRISMA harms checklist

Ling Li; Chang Xu; Ke Deng; Xu Zhou; Zhibin Liu; Jason W Busse; Yan Ren; Kang Zou; Xin Sun

doi:10.1016/j.jclinepi.2018.09.014

The reporting of safety among drug systematic reviews was poor before the implementation of the PRISMA harms checklist

J Clin Epidemiol. 2019 Jan:105:125-135. doi: 10.1016/j.jclinepi.2018.09.014. Epub 2018 Sep 29.

Authors

Ling Li¹, Chang Xu¹, Ke Deng¹, Xu Zhou², Zhibin Liu¹, Jason W Busse³, Yan Ren¹, Kang Zou¹, Xin Sun⁴

Affiliations

¹ Chinese Evidence-based Medicine Center and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University and Collaborative Innovation Center, Chengdu, Sichuan 610041, China.
² Evidence-based Medicine Research Center, School of Basic Science, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi 330004, China.
³ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada; Department of Anesthesia, McMaster University, Hamilton, ON L8S 4K1, Canada; The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON L8S 4K1, Canada; The Michael G. DeGroote Centre for Medicinal Cannabis Research, McMaster University, Hamilton, ON L8S 4K1, Canada.
⁴ Chinese Evidence-based Medicine Center and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University and Collaborative Innovation Center, Chengdu, Sichuan 610041, China; Evidence-based Medicine Research Center, School of Basic Science, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi 330004, China. Electronic address: sunx26@gmail.com.

PMID: 30278212
DOI: 10.1016/j.jclinepi.2018.09.014

Abstract

Objectives: To examine, through a cross-sectional survey, how well safety information was reported among drug systematic reviews predating PRISMA harms checklist and explore factors associated with better reporting.

Study design and setting: We searched PubMed to identify all systematic reviews published in the Cochrane Database of Systematic Review or the core clinical journals in 2015, one year before the PRISMA harms checklist was published. We randomly selected, in a 1:1 ratio, Cochrane and non-Cochrane systematic reviews assessing drug effects (including both efficacy and safety). We used the PRISMA harms checklist published in 2016 to assess the quality of reporting of drug safety information. Multivariable linear regression analyses were used to explore the association of six prespecified variables with more complete reporting of PRISMA harms items.

Results: We included 120 systematic reviews, including 60 Cochrane and 60 non-Cochrane reviews. Scores on the PRISMA harms checklist (23 items) were low (median 4, [first, third quartile: 2, 6]), with no difference between Cochrane and non-Cochrane reviews (4.5 [2, 7] vs. 4 [2.5, 5]; P = 0.29). Among all eligible reviews, only one item (i.e., state conclusions in coherence with the review findings) was reported adequately (proportion of adherence 81.6%); proportion of reporting for other items ranged from 1.7% to 68.3%. The four essential reporting items from PRISMA harms checklist were also poorly complied (proportion of adherence ranged from 1.7% to 9.2%). Multivariable linear regression analyses found no significant associations between any study characteristic and reporting on the PRISMA harms, likely because of limited variability in scores across studies.

Conclusions: The reporting of safety information was poor both for Cochrane and non-Cochrane drug systematic reviews predating PRISMA harms checklist. The findings suggested a strong need to use the PRISMA harms checklist for reporting safety among drug systematic reviews.

Keywords: Cross-sectional survey; Drug systematic review; PRISMA harms checklist; Poor; Reporting quality; Safety information.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Checklist / methods
Cross-Sectional Studies
Data Accuracy
Humans
Medication Therapy Management*
Outcome Assessment, Health Care* / methods
Outcome Assessment, Health Care* / standards
Patient Safety*
Research Design / standards*
Systematic Reviews as Topic*