Development of Core Outcome Set for Integrative Traditional Chinese and Western Medicine Clinical Research in Spinal...

To develop a core outcome set (COS) specifically tailored for integrative medicine clinical research in spinal metastases (SM), aiming to standardize efficacy evaluation and enhance consistency in outcome reporting across clinical trials.

This study adhered to the methodological standards outlined in the COMET Handbook 1.0, the Core Outcome Set-Standards for Development (COS-STAD), and the T/CACM 1339-2020 guidelines for the development of core outcome sets in Chinese medicine (CM) clinical trials. Candidate outcomes were initially identified through a systematic literature review and semi-structured stakeholder interviews. These outcomes were subsequently refined through a 2-round Delphi survey process, followed by final consensus at an online meeting. The development of a COS for the integration of traditional Chinese medicine and Western medicine clinical research in SM (COS-TCM-SM).

Following 2 rounds of the Delphi survey involving 62 and 61 stakeholders respectively, 10 outcomes met the inclusion criteria. A final online consensus meeting involving 25 stakeholders finalized the selection and refined 1 outcome domain. The finalized COS-TCM-SM comprises 11 outcomes categorized into 7 domains: survival (overall survival, progression-free survival), neurological function (spinal cord function), pain (pain relief rate), health-related quality of life (self-care ability, activity status, psychological state), radiological outcomes (spinal stability, local tumor control), CM-specific outcome (syndrome differentiation score), and safety events (adverse events and complications).

The COS-TCM-SM provides a consensus-based framework that standardizes outcome measurement for integrative medicine clinical research in SM. By integrating key indicators from both CM (syndrome differentiation) and Western medicine (survival, radiological outcomes), it directly addresses the critical issue of outcome heterogeneity.