STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT...

Area of Science:

• Integrative and Complementary Medicine
• Clinical Trial Methodology
• Evidence-Based Practice

Background:

• Massage, particularly Tuina (Chinese massage), is a prevalent nonpharmacological therapy.
• Standardized reporting of Tuina/Massage interventions is crucial for research evaluation and replication.
• Existing reporting guidelines like CONSORT need extension for specific nonpharmacological therapies.

Purpose of the Study:

• To develop an extension for the CONSORT statement tailored for reporting Tuina/Massage interventions in clinical trials.
• To introduce "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)" checklist.

Main Methods:

• A multidisciplinary expert group developed STRICTOTM using a rigorous methodology recommended by the EQUATOR Network.
• Methods included prospective registration, literature review, item drafting, Delphi surveys, a consensus meeting, and pilot testing.

Main Results:

• A comprehensive checklist comprising seven main items and 16 subitems for reporting Tuina/Massage interventions was created.
• The checklist covers rationale, intervention details, regimen, provider background, comparators, and precautions.
• Explanations and examples (E&E) were developed to guide the application of each item.

Conclusions:

• The STRICTOTM checklist is expected to enhance the quality and transparency of clinical research reporting for Tuina/Massage.
• It serves as a valuable tool when used alongside the CONSORT statement and its extensions for nonpharmacological treatments.