Development and validation of an evidence-based auricular acupressure intervention for managing chemotherapy-induced nausea and vomiting in breast cancer patients

Abstract

BackgroundAuricular therapy (AT) has been utilized as a promising complementary health approach to alleviating chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients. However, current evidence on AT for CINV management has been inconclusive, and relevant AT treatment protocols have varied considerably in the intervention dosage and acupoint formula without an evidence-informed intervention protocol tailored to CINV symptoms. This study aimed to develop an evidence-based AT intervention protocol for CINV management in breast cancer patients receiving chemotherapy. MethodsThis study adopted the Medical Research Council Framework for Developing and Evaluating Complex Interventions (the MRC framework) to guide the AT intervention development process. The process consists of four steps: identification of the evidence base, identification of theories and practice standards, identification of cancer symptom characteristics, and modelling and validation. The preliminary AT intervention was then evaluated through a content validity study to identify its theoretical and practical appropriateness. The content validity index (CVI) was used to determine the consensus level of the panel. ResultsA preliminary AT intervention protocol, including a true AT intervention and a sham AT intervention, was developed based on research evidence identified from five systematic reviews, the homuncular reflex theory, the zang-fu organs and meridian theory, relevant AT practice standards, and the natural symptom progress of CINV. The true AT was designed as a daily manual acupressure for five consecutive days. While the sham AT was designed with the same intervention duration and acupoint formula as the true AT without manual acupressure. The content validity study demonstrated excellent consensus among the expert panel to support the AT intervention as a theoretically and practically feasible program with the item-level CVI ranging from 0.83 to 1.0 and the scale-level CVI reaching 1.0. ConclusionThis study followed the MRC framework to develop an evidence-based AT intervention for CINV management which is well supported by systematic review research evidence, AT theories and practice standards, CINV symptom characteristics, and expert panel consensus. The AT intervention would be further evaluated in a pilot randomised controlled trial to confirm its utility, feasibility and acceptability in clinical settings.