Facial reconstruction

Search LJMU Research Online

Browse Repository | Browse E-Theses

Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews

Saini, P, Loke, YK, Gamble, C, Altman, DG, Williamson, PR and Kirkham, JJ (2014) Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ Open, 349. ISSN 2044-6055

Full text not available from this repository. Please see publisher or open access link below:
Open Access URL: http://www.bmj.com/content/349/bmj.g6501 (Published version)

Abstract

Objective To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews.
Design Cohort study of systematic reviews from two databases.
Setting Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events.
Participants 92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort).
Methods A 13 point classification system for missing outcome data on harm was developed and applied to the studies.
Results 86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393).
Conclusions The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews.

Item Type: Article
Subjects: H Social Sciences > HA Statistics
R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
Divisions: Natural Sciences and Psychology
Publisher: BMJ Publishing
Date Deposited: 09 Mar 2018 12:06
Last Modified: 09 Mar 2018 12:06
DOI or Identification number: 10.1136/bmj.g6501
URI: http://researchonline.ljmu.ac.uk/id/eprint/8249

Actions (login required)

View Item View Item