Thursday 16 October 2014

Feasibility/Pilot studies in the design, conduct and evaluation of complex interventions

Gill Lancaster - Senior Lecturer, Department of Mathematics and Statistics, University of Lancaster, Lancaster [Presentation]

Feasibility/Pilot studies in the design, conduct and evaluation of complex interventions

Pilot/feasibility studies can be an essential part of trial preparation, particularly in planning complex interventions. The Medical Research Council's guidance document on complex interventions emphasises the importance of thorough groundwork in designing and evaluating complex interventions. However several studies have shown that there is a dearth of pilot studies in the literature that state they are specifically in preparation for a randomised controlled trial, and that give a clear list of key objectives relating to the pilot phase. This talk will provide an overview of the objectives of feasibility and pilot studies, consider statistical issues in the study design, and provide useful examples and references.

Duncan Wilson - Clinical Trials Research Unit, University of Leeds [Presentation]

Assessing efficacy in pilot or feasibility trials of complex interventions: an extension from phase II designs

Early phase trials in the development of complex interventions currently focus on assessing the feasibility of a large RCT and on conducting pilot work. Assessing the efficacy of the proposed intervention in these trials is generally discouraged, due to concerns of underpowered testing. In contrast, early assessment of efficacy is common for drug therapies, where phase II trials are often used as a screening mechanism to identify promising treatments. In this talk I will discuss to what extent the ideas developed in the phase II trial design literature may be applied to the complex intervention setting in order to allow efficacy to be assessed in the context of feasibility or pilot studies. In particular, the barriers presented by the prevalence of both multiple endpoints and of clustering of outcome data will be reviewed.

Alex Wright-Hughes and Rebecca Walwyn - Clinical Trials Research Unit, University of Leeds [Presentation]

Formally assessing proof of concept in a feasibility trial: A case study

OK-DIABETES is an ongoing HTA-funded feasibility study for a definitive trial of a manualised supported self-management intervention in adults with Type 2 diabetes and learning disabilities. The feasibility trial was designed to assess feasibility in terms of recruitment and retention, data collection and intervention delivery. At an annual visit with the funders, it was requested that proof of concept, in relation to potential efficacy of the intervention, was also assessed. We will give a brief overview of the trial, its original design and the changes made since, highlighting the challenges encountered and areas for discussion.

Presentations to then be followed by a 20 minute discussion.

Room: Upper Chapel LR (1.04a), Main Building. Fairbairn House, University of Leeds, Leeds. Starting 3pm until 5pm with Teas/Coffees available from 2:30pm. See campus map (Building 6)