How do trial teams plan for retention during the design stage of the trial? A scoping review protocol

Murphy, Ellen K.; Gillies, Katie; Shiely, Frances

doi:10.1186/s13063-022-06866-w

Cited by 2 publications

References 19 publications

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The financial impact of participant attrition from randomised trials: a case‐study from the Occupational Therapist Intervention Study (OTIS)

Gkekas,

Ronaldson,

Parker

et al. 2024

Evaluation Clinical Practice

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RationaleLoss to follow‐up of participants can compromise the statistical validity of randomised trials. Moreover, it can have financial consequences for trial teams and funders. This study explores the Occupational Therapist Intervention Study (OTIS) where, despite a withdrawal rate of less than 10%, the trial team incurred opportunity costs related to participants who were initially recruited but subsequently decided to withdraw from the trial.Aims and ObjectivesTo estimate the cost of participant losses to follow‐up in the OTIS trial and thus introduce a costing framework to research teams on how they could estimate the opportunity costs of participant withdrawal from their randomised trials.MethodsThe participants lost to follow‐up are differentiated by (1) the time point at which they were lost to follow‐up; (2) the treatment group they were allocated to; (3) their response patters to follow‐up questionnaires; these elements were considered to identify the relevant types of attrition. Protocol‐driven costs of trial materials, including administration, print, and shipping, were gathered. We calculated unit costs for each type of attrition by multiplying protocol‐driven and intervention costs with the relevant number of participants. Summing up unit costs by type of loss to follow‐up yields aggregate figures, enabling the estimation of aggregate and average opportunity costs of attrition.ResultsThe average cost per participant loss to follow‐up in the OTIS trial is £98.41. The aggregate cost of participant loss to follow‐up is £10,234.90 from the economic perspective of the trial team. Therefore, 1.42% of the allocated funding has been misallocated because of participant loss to follow‐up.ConclusionDespite the low attrition rate of the OTIS trial, loss to follow‐up has still generated considerable opportunity costs. It is recommended that decision makers focus on identifying strategies which could improve participant retention in randomised trials to optimise their budget.

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The financial impact of participant attrition from randomised trials: a case‐study from the Occupational Therapist Intervention Study (OTIS)

Gkekas,

Ronaldson,

Parker

et al. 2024

Evaluation Clinical Practice

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Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol; an analysis of patient information leaflets and their corresponding protocols.

Murphy,

Gillies,

Shiely

2023

Preprint

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Background Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are planned at the design stage of a trial, but some protocols include plans to use strategies to promote participant retention. It is yet unknown if these plans are communicated in the corresponding PILs. The purpose of our study was to determine if Patient Information Leaflets (PILs) communicate plans to promote participant retention and if so, are these outlined in the corresponding trial protocol. Methods 157 PILs and their 121 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) qualitative content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate. Results Plans to promote participant retention were communicated in 81.5% (n = 75) of PILs. Fifty-six percent (n = 42) of PILs communicated plans to use ‘combined strategies’ to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12 PILs). The importance of retention and the impact that missing, or deleted, data has on the trial were explained in 6.5% (n = 6) and 5.4% (n = 5) of PILs respectively. Out of the 59 PILs and 58 matching protocols that communicated plans to use strategies to promote participant retention, 18.6% (n = 11) communicated the same information, the remaining 81.4% (n = 48) of PILs either only partially communicated the same information or did not communicate the same information. Conclusion Retention strategies are frequently communicated to potential trial participants in PILs however the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the design phase of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.

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How do trial teams plan for retention during the design stage of the trial? A scoping review protocol

Cited by 2 publications

References 19 publications

The financial impact of participant attrition from randomised trials: a case‐study from the Occupational Therapist Intervention Study (OTIS)

The financial impact of participant attrition from randomised trials: a case‐study from the Occupational Therapist Intervention Study (OTIS)

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol; an analysis of patient information leaflets and their corresponding protocols.

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