title: Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care.
abstract: BACKGROUND
  Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors.
  
  
  METHODS
  This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention.
  
  
  CONCLUSIONS
  We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.
authors.affiliation: Quality, Safety and Informatics Research Group, Population Health Sciences, University of Dundee, Mackenzie Building, Dundee DD2 4BF, UK. a.m.grant@dundee.ac.uk
authors.forename: Aileen
authors.initials: A
authors.lastname: Grant
authors.forename: Tobias
authors.initials: T
authors.lastname: Dreischulte
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
authors.forename: Bruce
authors.initials: B
authors.lastname: Guthrie
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D016000:Cluster Analysis; D017144:Focus Groups; D006801:Humans; D008508:Medication Errors / Q000517:prevention & control*; D061214:Patient Safety; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D010818:Practice Patterns, Physicians'; D011320:Primary Health Care; D036301:Qualitative Research; D058996:Quality Improvement; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D006113:United Kingdom
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010975:Platelet Aggregation Inhibitors