Abstract
Background: The Treatment Fidelity Workgroup (TFW) established by the National Institutes of Health provides a 5-point structure for intervention fidelity: dosing, interventionists' consistency, intervention delivery, receipt, and enactment of the intervention. Using our reflexology trial, we apply the first 3 points.
Objectives: Study objectives were to (1) evaluate key dosage dimensions associated with complementary and alternative medicine (CAM) research, (2) evaluate approaches to interventionists' consistency of delivery of CAM protocols, and (3) evaluate and discuss data that reflect CAM intervention fidelity.
Methods: Women with late-stage breast cancer (N = 318) were randomly assigned to either 4 weeks of reflexology, placebo, or standard care.
Results: Dosing consists of 3 dimensions: frequency (4 sessions), duration (30 minutes), and interval between sessions (5-9 days). Interventionist consistency revealed more than a 90% accuracy rate in following the protocol; 84% and 89% completion rate of the 4 sessions in the reflexology and placebo groups, respectively; and no differences in attrition after randomization between reflexology and placebo groups (17% and 15%, respectively). Intervention delivery, examined through debriefing data, indicated a significantly higher rate of correct guesses on group assignment in the reflexology group as compared with the placebo (82% vs 46%, P = .0002).
Conclusion: This study points out the relevance of dosing, interventionists' consistency, and delivery data within a CAM clinical trial, as well as the challenges of blinding.
Implications for Practice: Monitoring intervention fidelity by using the key areas identified by the TFW ensures that findings from a clinical trial are meaningful and have the potential to be translated to clinical practice.