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Applying the PRECIS-2 tool for self-declared 'pragmatic' acupuncture trials: protocol for a systematic review
Jinwoong Lim1, Hyeonhoon Lee1, Yong-Suk Kim2
1Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Korea (the Republic of).
BMJ Open
|April 13, 2022
Summary
This systematic review assesses the pragmatism of acupuncture clinical trials using the PRECIS-2 tool. It aims to evaluate how well these trials reflect real-world practice, offering insights for future research design.
Area of Science:
- Clinical Research Methodology
- Integrative and Complementary Medicine
- Evidence-Based Practice
Background:
- Pragmatic trial designs are crucial for acupuncture research due to limited understanding of specific treatment effects.
- However, the extent to which acupuncture trials are truly pragmatic has not been thoroughly examined.
- The PRECIS-2 tool offers a standardized method for assessing trial pragmatism.
Purpose of the Study:
- To systematically review and assess the pragmatism of self-declared pragmatic acupuncture randomized clinical trials (RCTs).
- To apply the PRECIS-2 tool to evaluate the degree of pragmatism across nine domains and an additional control domain.
- To identify the extent to which acupuncture RCTs align with pragmatic principles.
Main Methods:
- Systematic search of multiple databases (MEDLINE, EMBASE, Cochrane, AMED, etc.) and ClinicalTrials.gov for pragmatic acupuncture RCTs from inception to March 2022.
- Exclusion of trial protocols and secondary analyses.
- Independent data extraction and assessment of pragmatism using the nine domains of the PRECIS-2 tool plus a control domain by two authors.
- Statistical analysis using descriptive statistics and one-sample t-tests to compare scores against a midpoint of 3.
- Visualization of pragmatism using PRECIS-2 wheel diagrams.
Main Results:
- Descriptive statistics will be reported for each PRECIS-2 domain and the overall score.
- A one-sample t-test will determine if the average pragmatism score is significantly greater than 3 (indicating a balance between pragmatic and explanatory approaches).
- Wheel diagrams will visually represent the pragmatism profile of the included acupuncture trials.
Conclusions:
- The study will provide a comprehensive assessment of the pragmatism of acupuncture clinical trials.
- Findings will inform the design of future acupuncture research to enhance real-world applicability.
- This evaluation contributes to the understanding of how pragmatic principles are implemented in acupuncture research.
