title: Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials.
abstract: BACKGROUND
  Surgical interventions are complex, with multiple components that require consideration in trial reporting. This review examines the reporting of details of surgical interventions in randomized clinical trials (RCTs) within the context of explanatory and pragmatic study designs.
  
  
  METHODS
  Systematic searches identified RCTs of surgical interventions published in 2010 and 2011. Included studies were categorized as predominantly explanatory or pragmatic. The extent of intervention details in the reports were compared with the CONSORT statement for reporting trials of non-pharmacological treatments (CONSORT-NPT). CONSORT-NPT recommends reporting the descriptions of surgical interventions, whether they were standardized and adhered to (items 4a, 4b and 4c). Reporting of the context of intervention delivery (items 3 and 15) and operator expertise (item 15) were assessed.
  
  
  RESULTS
  Of 4541 abstracts and 131 full-text articles, 80 were included (of which 39 were classified as predominantly pragmatic), reporting 160 interventions. Descriptions of 129 interventions (80.6 per cent) were provided. Standardization was mentioned for 47 (29.4 per cent) of the 160 interventions, and 22 articles (28 per cent) reported measurement of adherence to at least one aspect of the intervention. Seventy-one papers (89 per cent) provided some information about context. For one-third of interventions (55, 34.4 per cent), some data were provided regarding the expertise of personnel involved. Reporting standards were similar in trials classified as pragmatic or explanatory.
  
  
  CONCLUSIONS
  The lack of detail in trial reports about surgical interventions creates difficulties in understanding which operations were actually evaluated. Methods for designing and reporting surgical interventions in RCTs, contributing to the quality of the overall study design, are required. This should allow better implementation of trial results into practice.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK.
authors.forename: N S
authors.initials: NS
authors.lastname: Blencowe
authors.affiliation: Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary, Leicester, UK.
authors.forename: A P
authors.identifier: http://orcid.org/0000-0001-7243-0155
authors.initials: AP
authors.lastname: Boddy
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Harris
authors.affiliation: National Institute for Health Research Pancreas Biomedical Research Unit, Royal Liverpool and Broadgreen University Hospital and University of Liverpool, Liverpool, UK.
authors.forename: T
authors.initials: T
authors.lastname: Hanna
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: P
authors.initials: P
authors.lastname: Whiting
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: J A
authors.initials: JA
authors.lastname: Cook
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D064792:Pragmatic Clinical Trials as Topic / Q000379:methods / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards*; D058028:Research Report / Q000592:standards*; D013514:Surgical Procedures, Operative