title: Examining the use of process evaluations of randomised controlled trials of complex interventions addressing chronic disease in primary health care-a systematic review protocol.
abstract: Randomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery.
  
  
  
  Systematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented.
  
  
  
  Process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond the research setting.
  
  
  
  PROSPERO CRD42016035572.
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia. hliu@georgeinstitute.org.au.
authors.forename: Hueiming
authors.initials: H
authors.lastname: Liu
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia.
authors.forename: Janini
authors.initials: J
authors.lastname: Muhunthan
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia.
authors.forename: Adina
authors.initials: A
authors.lastname: Hayek
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia.
authors.forename: Maree
authors.initials: M
authors.lastname: Hackett
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia.
authors.forename: Tracey-Lea
authors.initials: TL
authors.lastname: Laba
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Peiris
authors.affiliation: The George Institute for Global Health, University of Sydney, Level 10, King George V Building, 83-117 Missenden Rd, PO Box M201, Camperdown, NSW, 2050, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
mesh_terms: D002908:Chronic Disease / Q000628:therapy; D055317:Evidence-Based Practice; D006801:Humans; D011320:Primary Health Care; D017064:Process Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D000078202:Systematic Reviews as Topic
keywords: Chronic disease; Complex interventions; Primary health care; Process evaluations; Qualitative; Systematic review