title: Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting.
abstract: BACKGROUND
  Process evaluations are recommended to open the 'black box' of complex interventions evaluated in trials, but there is limited guidance to help researchers design process evaluations. Much current literature on process evaluations of complex interventions focuses on qualitative methods, with less attention paid to quantitative methods. This discrepancy led us to develop our own framework for designing process evaluations of cluster-randomised controlled trials.
  
  
  METHODS
  We reviewed recent theoretical and methodological literature and selected published process evaluations; these publications identified a need for structure to help design process evaluations. We drew upon this literature to develop a framework through iterative exchanges, and tested this against published evaluations.
  
  
  RESULTS
  The developed framework presents a range of candidate approaches to understanding trial delivery, intervention implementation and the responses of targeted participants. We believe this framework will be useful to others designing process evaluations of complex intervention trials. We also propose key information that process evaluations could report to facilitate their identification and enhance their usefulness.
  
  
  CONCLUSIONS
  There is no single best way to design and carry out a process evaluation. Researchers will be faced with choices about what questions to focus on and which methods to use. The most appropriate design depends on the purpose of the process evaluation; the framework aims to help researchers make explicit their choices of research questions and methods.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01425502.
authors: Quality, Safety and Informatics Research Group, Population Health Sciences, Medical Research Institute, University of Dundee, Mackenzie Building, Dundee DD2 4BF, UK. a.m.grant@dundee.ac.uk
authors: Aileen
authors: A
authors: Grant
authors: Shaun
authors: S
authors: Treweek
authors: Tobias
authors: T
authors: Dreischulte
authors: Robbie
authors: R
authors: Foy
authors: Bruce
authors: B
authors: Guthrie
mesh_terms: D019317:Evidence-Based Medicine / Q000592:standards; D006801:Humans; D033181:Information Dissemination; D010043:Outcome and Process Assessment, Health Care / Q000592:standards; D017410:Practice Guidelines as Topic; D036301:Qualitative Research; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome