Research Design for the Development and Evaluation of Complex Technologies: An Empirical Example and Critical Discussion
Abstract
This article offers for wider discussion a description of the approach used in a situation where the gold standard of a randomized controlled trial (RCT) was not immediately feasible. It explains how the methods and research design of a developmental project known as `WRAP' (Woundcare Research for Appropriate Products) evolved, and discusses their implications for complex wound care evaluations.The project was guided by the UK Medical Research Council (MRC) framework for the development and evaluation of RCTs (MRC and Board, 2000).
It is proposed that dressing performance in chronic wound care may best be evaluated by a focus on the first two phases of the framework, theorizing and modelling, to design interventions and measurement tools, before proceeding to the third phase, exploratory trials.When the data generated in such trials are deemed valid and reliable, using specified criteria, alternative forms of evaluation to the randomized controlled trial, such as post-market surveillance studies, can follow.
It is also proposed that these adaptations of the MRC framework may apply to complex evaluations more generally.