Registration and Outcome-Reporting Bias in Randomized Controlled Trials of Distal Radial Fracture Treatment

Abstract

Background:The purpose of the present study was to systematically evaluate the completeness of trial registration and the extent of outcome-reporting bias in modern randomized controlled trials (RCTs) relating to the treatment of distal radial fracture.Methods:With use of 4 databases (PubMed, Cochrane CENTRAL, Embase, and PEDro), this systematic review identified all RCTs of distal radial fracture treatment published from January 1, 2010, to December 31, 2015. We independently determined the registration status of these trials in a public trial registry and compared the characteristics of registered and non-registered trials. We assessed the quality and consistency of primary outcome measure (POM) reporting between the registration data and the final published studies.Results:Ninety studies met the inclusion criteria. Of those, only 28 (31%) were registered, and only 3 (3%) were “appropriately registered” (i.e., prospectively registered and identifying and fully describing the POM). Registered trials had larger sample sizes and were more likely to be multicenter, to report funding sources, and to be published in higher-impact-factor journals. Sixteen (18%) of the 90 registered RCTs named a POM in the registry; 7 (44%) of those 16 registered RCTs stated a different POM, an additional POM, or no POM at all in the final publication than was stated in the registry data. Additionally, 13 (81%) of those 16 registered RCTs had discrepancies in the time point reported for the POM.Conclusions:In an attempt to address publication and outcome-reporting bias, prospective trial registration in a public registry has been deemed a condition for publication by the International Committee of Medical Journal Editors (ICMJE) since 2005. This study shows poor registration rates as well as inconsistencies in the reporting of POMs of recent trials relating to the treatment of distal radial fracture, one of the most common and most investigated injuries in orthopaedic practice.Clinical Relevance:The problems of registration and outcome-reporting bias in RCTs are important to highlight and address, and to find a solution will require the cooperation of researchers, reviewers, and journal editors. Increasing the transparency and consistency of reporting will help to increase the quality of research, which can impact patient care through evidence-based guidelines.

Treatment interventions for hand fractures and joint injuries: a scoping review of randomized controlled trials

“…The review identified 78 trials published over a period of 35 years, which is a surprisingly small number. To put this number into context, a systematic review on the treatment of distal radial fractures identified 90 RCTs published over 5 years from 2010 to 2015 (Lee et al., 2018). The trials identified in the present review covered only seven anatomical areas of the hand.…”

Outcome reporting bias in nephrology randomized clinical trials: Examining outcomes represented by graphical illustrations

“…Previous research has shown a similar high prevalence of ORB in RCTs, but no previous study has focused on the contribution of graphical illustrations to ORB [ [6] , [7] , [8] , [18] , [19] , [20] ]. This is very surprising, given the key role that data visualization has assumed in the medical literature since the first principles were historically presented by authors such as Tufte and Cleveland, and particularly with the advent and growth of social media and electronic publishing [ 21 , 22 ].…”

“…This has been further supported by design guidelines such as SPIRIT and PRISMA-P [ 34 , 35 ]. However, these measures have not proven to be the intended panacea, with non-registration of published trials and ORB remaining commonplace [ 6 , 7 , [36] , [37] , [38] , [39] , [40] ]. This inertia has been attributed to a lack of researcher awareness, but stricter enforcement by editorial teams is required, particularly moving away from the publication of un-registered trials or trials registered after outcome collection [ [41] , [42] , [43] ].…”

“…Several studies of ORB have focused on mapping the outcomes in the published manuscript text to those pre-specified at trial registration [ [6] , [7] , [8] ]. The extent to which the choice of graphical illustrations (figures and graphs) might represent ORB has not been previously reported.…”

Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review

“…The updated Consolidated Standards of Reporting Trials statement (CONSORT) in 2010 contains clear recommendations for registration and outcome reporting (Schulz et al, 2010). Despite these standards being set, Lee et al (2018) found that only 31% (28/90) of RCTs on DRFs were registered. Only 16 trials specified a primary outcome measure at registration, and seven of these ended up reporting either a different/additional primary outcome or none at all.…”