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Background and aims Behavioural support increases smoking cessation in clinical settings, but effect sizes differ among providers, due possibly to variations in delivery. This study evaluates a measure (‘fidelity index’) intended to capture fidelity to delivery of content‐ and interaction‐based items of a behavioural support (BS) for smoking cessation and the association of fidelity with quit rates. Methods A fidelity index for scoring the adherence and quality domains of a specific BS intervention, ‘5As for quit’, was developed by classifying the intervention components using the taxonomy of behaviour change techniques. The index was applied to code 154 BS sessions audiotaped among 18 chest clinics in Pakistan to assess their fidelity and explore reliability of coding. The association between intervention fidelity and successful quit achieved by the same providers in a previous study was explored using regression analysis. Results The index represented two domains: adherence to delivery of content‐based activities of 5As (37 items) and quality of interaction‐based activities (eight items). The intercoder reliability was good for content‐based (average Krippendorff's α = 0.80) and moderate for interaction‐based (average Krippendorff's α = 0.66) items. Approximately 70% (intraclass correlation coefficient: adherence scores = 0.72, quality scores = 0.71) of variation in BS delivery was contributed by providers, which increased to 97% (g‐coefficient: adherence scores = 0.973, quality scores = 0.974) after accounting for other sources of variation. Higher quit rates were positively associated with average quality scores [risk ratio = 2.15; 95% confidence interval (CI) = 1.43–3.24], but negatively associated with average adherence scores (risk ratio = 0.55; 95% CI = 0.40–0.77) within services. Conclusions The fidelity index is a reliable measure for quantifying intervention fidelity of delivering smoking cessation behavioural support. Recommended revisions of the fidelity index include incorporation of additional interaction‐based items, such as the relational techniques used in motivational interviewing.

IntroductionAssisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study.Methods and analysisRelevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed.Ethics and disseminationEthical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.