title: Assessing the fidelity of delivery of an intervention to increase attendance at the English Stop Smoking Services.
abstract: Implementation fidelity refers to the extent to which a proposed intervention is enacted as designed and is necessary to determine how much the intervention in question is the primary mechanism in any changes observed. Start2quit was a randomised controlled trial that aimed to improve attendance at the English Stop Smoking Service (SSS). The complex intervention combining computer-tailored personal risk letters and no-commitment ("taster") sessions aimed at encouraging attendance at the SSS doubled attendance at the SSS and significantly increased abstinence rates, although attendance and abstinence varied between participating SSSs. Assessment of the fidelity of the delivery of the taster sessions to the protocol was embedded into the trial and is the focus of this study.
  
  
  
  Eighteen SSSs participated in the study. Taster sessions were delivered by SSS advisors in the area. Of the 131 sessions delivered, 93 (71 %) were recorded and 41 (31.3 %) were selected for transcription and analysis. The taster session protocol contained 73 specified behaviours, which were independently classified into component behaviour change techniques (BCTs) using an established taxonomy for smoking cessation. All transcripts were coded by two authors with 25 % additionally coded by a third. The fidelity of each taster session was expressed as the percentage of overall protocol-specified behaviours that were delivered. Adherence to each BCT was measured as the number of behaviours applied by the advisors within each BCT divided by the total number classified within each.
  
  
  
  Adherence of protocol-specified behaviours was relatively high (median 71.23 %), though there was considerable variation (28.76 to 95.89 %) in individual sessions. Median fidelity to specific BCTs across sessions also varied from 50 to 100 %. Shorter sessions, sessions run jointly by two advisors, by female advisors, or by advisors aged 45 to 54 were associated with higher levels of adherence. There was no association between adherence and subsequent attendance at the SSS.
  
  
  
  These results suggest that the delivery of the intervention of this study is not likely to have been impacted by issues of fidelity. As such, we can have greater confidence that variability in the main outcome is not due to variability in SSS advisor adherence to the protocol of the taster sessions.
  
  
  
  Current Controlled Trials ISRCTN76561916.
authors.affiliation: Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.
authors.forename: Molly
authors.initials: M
authors.lastname: Sweeney-Magee
authors.affiliation: Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.
authors.forename: Dimitra
authors.initials: D
authors.lastname: Kale
authors.affiliation: Smokefree Camden (Public Health), NHS Camden, London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Galton
authors.affiliation: Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.
authors.forename: Andrea
authors.initials: A
authors.lastname: Hamill
authors.affiliation: Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK. hazel.gilbert@ucl.ac.uk.
authors.forename: Hazel
authors.identifier: 0000-0002-1254-6874
authors.initials: H
authors.lastname: Gilbert
mesh_terms: D004739:England; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000628:therapy*
keywords: Behaviour change techniques; Implementation; Stop smoking clinics; Treatment fidelity