Author: Litrownik D1, Gilliam E1, Berkowitz D1, Yeh GY1, Wayne PM2,3
Affiliation: <sup>1</sup>1 Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
<sup>2</sup>2 Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
<sup>3</sup>3 Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Conference/Journal: J Altern Complement Med.
Date published: 2019 Mar 5
Other:
Special Notes: doi: 10.1089/acm.2018.0389. [Epub ahead of print] , Word Count: 315
BACKGROUND: Mind-body exercise interventions are typically multimodal, complex, and pluralistic, and few have been developed with the goal of therapeutically targeting a specific medical population. It is thus important that clinical trials evaluating mind-body interventions provide some justification for the use of the specific protocol being evaluated.
OBJECTIVES: This article reports the results of a systematic review of the quality of reporting of protocol rationale and content validity for using a specific t'ai chi protocol in a randomized controlled trial (RCT).
METHODS: Electronic literature searches were conducted using PubMed/MEDLINE, EBSCOhost, and the Cochrane Library from inception through June 2015. Search terms were Tai Chi, Taiji, Tai Chi Chuan; searches were limited to English-language RCTs. Inclusion and exclusion of trials were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors assessed the level of reporting with respect to t'ai chi protocol validation using a 5-point grading system based on whether (1) a specific protocol was mentioned, (2) rationale for the specific protocol was stated and supported, and (3) formal evaluation for content validity was conducted.
RESULTS: There was significant heterogeneity in the quality of reporting related to protocol rationale and content validity. A total of 171 publications were identified. Studies met between 0 and 4 validity criteria (of possible 5, more indicating better quality), with a mean of 2.52 (±SD 1.2) and median of 3. Twenty (12%) trials did not mention a specific t'ai chi protocol, 10 (6%) trials met 0 of 5 criteria, and 47 (31%) studies met 4 of 5 criteria. Formal validity assessments were employed in only one trial.
CONCLUSIONS: The poor quality of protocol rationale and content validity reporting limits our ability to accurately evaluate the evidence of t'ai chi as a therapeutic intervention. The development of formal guidelines for developing and reporting intervention validity for multimodal mind-body exercises like t'ai chi may improve the quality and interpretability of research.
KEYWORDS: ; content validity; methodology; mind–body; nonpharmacological intervention; protocol rationale
PMID: 30835135 DOI: 10.1089/acm.2018.0389