SPIRIT‐A: An Extension of SPIRIT 2025 for Acupuncture Clinical Trial Protocols

BACKGROUND: Protocols for acupuncture randomized controlled trials (RCTs) often lack adequate reporting of acupuncture-specific features. This study developed the Standard Protocol Items: Recommendations for Interventional Trials-Acupuncture (SPIRIT-A) extension to provide tailored reporting guidance for acupuncture clinical trial protocols. METHODS: The study followed EQUATOR Network guidance for developing health research reporting guidelines. A Development Group, Advisory Group, and international Delphi expert panel were established. The initial checklist was informed by two reviews assessing reporting quality using SPIRIT and Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine (SPIRIT-TCM) extension respectively, and refined with reference to SPIRIT 2025, STandards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), and the SPIRIT-TCM extension. A modified Delphi survey was conducted according to a predefined consensus criterion (≥80% agreement), followed by final expert endorsement. RESULTS: Thirty-four experts from 10 countries participated in the Delphi survey, and all candidate items reached the predefined consensus threshold. The final checklist includes 34 items (57 subitems) that supplement SPIRIT 2025 with acupuncture-specific recommendations covering syndrome differentiation and treatment, procedural details, blinding and control design, acupuncturist qualifications, and safety monitoring. CONCLUSIONS: SPIRIT-A provides structured reporting recommendations addressing key methodological considerations in acupuncture clinical trial protocols. Its development followed internationally recognized methodological standards and is expected to enhance the completeness and reproducibility of acupuncture RCT protocols and facilitate their broader dissemination and use.