TY - JOUR
T1 - Intervention fidelity
T2 - Aspects of complementary and alternative medicine research
AU - Wyatt, Gwen
AU - Sikorskii, Alla
AU - Rahbar, Mohammad Hossein
AU - Victorson, David
AU - Adams, Lora
PY - 2010/9
Y1 - 2010/9
N2 - 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.
AB - 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.
KW - Complementary and alternative medicine
KW - Dosing
KW - Intervention delivery
KW - Intervention fidelity
KW - Interventionists consistency
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U2 - 10.1097/NCC.0b013e3181d0b4b7
DO - 10.1097/NCC.0b013e3181d0b4b7
M3 - Article
C2 - 20467309
AN - SCOPUS:77955230815
SN - 0162-220X
VL - 33
SP - 331
EP - 342
JO - Cancer Nursing
JF - Cancer Nursing
IS - 5
ER -