Losing the losses

Project Background

Funded by the MRC Methodology Research Panel, the Losing the Losses study is examining  reasons for attrition in randomised trials, with the aim of developing evidence to prevent it.  This study is led by Professor Carrol Gamble at the University of Liverpool, with Dr Athene Lane and Dr Ali Heawood from the School of Social and Community Medicine taking the roles of local lead applicant and qualitative methods lead respectively.

One of the most frequent problems in clinical trials is the failure to achieve the target number of participants with outcome data recorded, leading to a potential waste of resources and unnecessary delays in resolving the uncertainty that prompted the trial. Losing the Losses will seek to redress this by improving understanding of the reasons for the failure to collect complete outcome data on all randomised patients and identifying strategies that might be used to prevent this. It complements and builds on research on improving recruitment to trials, recognising that recruiting and randomising people who are not subsequently retained for the primary outcome measure can actually be worse for the analysis of the trial than not randomising that patient at all. This means that an emphasis on strategies to monitor and boost recruitment alone could be misplaced, if the extra patients recruited are not retained.  Development of retention strategies should be informed by the reasons for attrition, which could potentially be trial or condition specific.

In order to develop effective strategies to reduce the problem of attrition, it is important to understand the interplay of setting and reasons for missing data in trials. Set within a wider mixed methods study that includes a systematic review of trial reports, a survey of trialists, a survey of NIHR registered trials units, and a Delphi study, the qualitative phase of Losing the Losses aims to understand current practice regarding monitoring of missing outcome data in ongoing trials, including strategies to enhance retention. The objectives of the qualitative phase are twofold: (i) to probe beneath the public accounts of practices used by trialists (as documented in published reports) to uncover their private accounts of what they do to maximise retention in clinical trials; (ii) to generate more in-depth and nuanced insights into what trialists do to maximise retention and the reasons why, to elaborate the quantitative data generated within the project. Whereas the survey will provide an overview of methods used by trialists to increase retention, qualitative interviews will provide access to detailed and potentially undocumented knowledge and experiences of trialists, which will aid development of conceptual explanations. Together, the qualitative interview accounts, survey data and published reports of trials will offer opportunities for examination of areas of convergence and divergence regarding reported strategies for increasing retention in clinical trials.