Reporting treatment fidelity in behavioral tobacco treatment clinical trials: scoping review and measurement recommendations

Abstract

Introduction:

Adoption of rigorous standards for reporting treatment fidelity is essential for advancing discovery, validation, and implementation of behavioral treatments. Whereas the NIH Behavior Change Consortium (BCC) developed an assessment tool to assess quality of reporting and monitoring of treatment fidelity across health behavior change interventions, it has not yet been applied specifically to treatment fidelity in behavioral tobacco treatment trials.

Methods:

We conducted a scoping review of peer-reviewed, clinical trials of behavioral adult tobacco treatment interventions published in English between 2006 and 2018. Using the BCC treatment fidelity checklist, articles were coded for the presence or absence of various treatment fidelity strategies within each of 5 domains: Design,Training, Delivery, Receipt and Enactment. Eligible articles (N=755) were coded by two independent coders.

Results:

The proportion of reporting strategies varied within the fidelity domains, ranging from 5.2%-96.3% in Design, 1.9%-24.9% in Training, 2.6%-32.3% in Delivery, 5.2%-44.3% in Receipt, and 6.7%-43.2% in Enactment. The mean proportion of adherence to treatment fidelity strategies within each domain was: Design (68%), Training (14%), Delivery (15%), Receipt (16%) and Enactment (25%). Only 11 studies achieved ≥80% reporting across >1 fidelity domain. There was no evidence for improvement in fidelity reporting across the 13-year time frame from the initial BCC publication to present.

Conclusions:

These findings illustrate the lack of consistency in fidelity reporting in tobacco treatment trials and underscore the challenges faced in evaluating rigor and reproducibility, as well as interpretation and dissemination of findings. Recommendations are made for improving fidelity reporting in tobacco treatment trials.