Although in recent years there has been a strong increase in published research on theories (e.g. realist evaluation, normalization process theory) driving and guiding process evaluations of complex interventions, there is limited guidance to help rehabilitation researchers design and carry out process evaluations. This can lead to the risk of process evaluations being unsystematic. This paper reports on the development of new consensus guidelines that address the specific challenges of conducting process evaluations alongside clinical trials of rehabilitation interventions.
A formal consensus process was carried out based on a modified nominal group technique, which comprised two phases. Phase I was informed by the findings of a systematic review, and included a nominal group meeting with an expert panel of participants to rate and discuss the proposed statements. Phase II was an in depth semi-structured telephone interviews with expert panel participants in order to further discuss the structure and contents of the revised guidelines. Frequency of rating responses to each statement was calculated and thematic analysis was carried out on all qualitative data.
The guidelines for carrying out process evaluations within complex intervention rehabilitation research were produced by combining findings from Phase I and Phase II. The consensus guidelines include recommendations that are grouped in seven sections. These sections are theoretical work, design and methods, context, recruitment and retention, intervention staff, delivery of the intervention and results. These sections represent different aspects or stages of the evaluation process.
The consensus guidelines here presented can play a role at assisting rehabilitation researchers at the time of designing and conducting process evaluations alongside trials of complex interventions. The guidelines break new ground in terms of concepts and theory and works towards a consensus in regards to how rehabilitation researchers should go about carrying out process evaluations and how this evaluation should be linked into the proposed trials. These guidelines may be used, adapted and tested by rehabilitation researchers depending on the research stage or study design (e.g. feasibility trial, pilot trial, etc.).