title: A multidimensional approach to assessing intervention fidelity in a process evaluation of audit and feedback interventions to reduce unnecessary blood transfusions: a study protocol.
abstract: In England, NHS Blood and Transplant conducts national audits of transfusion and provides feedback to hospitals to promote evidence-based practice. Audits demonstrate 20% of transfusions fall outside guidelines. The AFFINITIE programme (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) involves two linked, 2×2 factorial, cluster-randomised trials, each evaluating two theoretically-enhanced audit and feedback interventions to reduce unnecessary blood transfusions in UK hospitals. The first intervention concerns the content/format of feedback reports. The second aims to support hospital transfusion staff to plan their response to feedback and includes a web-based toolkit and telephone support. Interpretation of trials is enhanced by comprehensively assessing intervention fidelity. However, reviews demonstrate fidelity evaluations are often limited, typically only assessing whether interventions were delivered as intended. This protocol presents methods for assessing fidelity across five dimensions proposed by the Behaviour Change Consortium fidelity framework, including intervention designer-, provider- and recipient-levels.
  
  
  
  (1) Design: Intervention content will be specified in intervention manuals in terms of component behaviour change techniques (BCTs). Treatment differentiation will be examined by comparing BCTs across intervention/standard practice, noting the proportion of unique/convergent BCTs. (2) Training: draft feedback reports and audio-recorded role-play telephone support scenarios will be content analysed to assess intervention providers' competence to deliver manual-specified BCTs. (3) Delivery: intervention materials (feedback reports, toolkit) and audio-recorded telephone support session transcripts will be content analysed to assess actual delivery of manual-specified BCTs during the intervention period. (4) Receipt and (5) enactment: questionnaires, semi-structured interviews based on the Theoretical Domains Framework, and objective web-analytics data (report downloads, toolkit usage patterns) will be analysed to assess hospital transfusion staff exposure to, understanding and enactment of the interventions, and to identify contextual barriers/enablers to implementation. Associations between observed fidelity and trial outcomes (% unnecessary transfusions) will be examined using mediation analyses.
  
  
  
  If the interventions have acceptable fidelity, then results of the AFFINITIE trials can be attributed to effectiveness, or lack of effectiveness, of the interventions. Hence, this comprehensive assessment of fidelity will be used to interpret trial findings. These methods may inform fidelity assessments in future trials.
  
  
  
  ISRCTN 15490813 . Registered 11/03/2015.
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City, University of London, London, EC1V 0HB, UK. Fabiana.lorencatto.2@city.ac.uk.
authors.forename: Fabiana
authors.initials: F
authors.lastname: Lorencatto
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City, University of London, London, EC1V 0HB, UK.
authors.forename: Natalie J
authors.initials: NJ
authors.lastname: Gould
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City, University of London, London, EC1V 0HB, UK.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: McIntyre
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City, University of London, London, EC1V 0HB, UK.
authors.forename: Camilla
authors.initials: C
authors.lastname: During
authors.affiliation: School of Mathematics, Computer Science, Engineering, City, University of London, London, UK.
authors.forename: Jon
authors.initials: J
authors.lastname: Bird
authors.affiliation: Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Walwyn
authors.affiliation: Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Cicero
authors.affiliation: Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Liz
authors.initials: L
authors.lastname: Glidewell
authors.affiliation: Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hartley
authors.affiliation: National Health Service Blood & Transplant, Oxford Radcliffe Hospitals, University of Oxford, Oxford, UK.
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Stanworth
authors.affiliation: Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Robbie
authors.initials: R
authors.lastname: Foy
authors.affiliation: Department of Medicine & Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Grimshaw
authors.affiliation: Centre for Outcomes Research and Effectiveness, University College London, London, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Michie
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City, University of London, London, EC1V 0HB, UK.
authors.forename: Jill J
authors.initials: JJ
authors.lastname: Francis
mesh_terms: D001803:Blood Transfusion; D006801:Humans; D008485:Medical Audit / Q000379:methods*; D012107:Research Design; D058028:Research Report; D006113:United Kingdom; D019564:Unnecessary Procedures
keywords: Audit and feedback; Blood transfusion; Fidelity; Implementation; Process evaluation; Randomised controlled trial; Research protocol