Objective
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.
Methods
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).
Results
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).
Conclusions
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.
The advancement of medical technology has significantly extended the survival period of patients diagnosed with malignant tumors. However, the incidence of spinal metastases (SM) is escalating annually. In response to this grave public health concern, scholars have proposed or enhanced a variety of efficacious treatment approaches, including traditional Chinese medicine decoction, acupuncture, surgical interventions, radiotherapy, radiofrequency ablation, among others. Nonetheless, the actual efficacy of these methods remains contentious. On the one hand, the complexity of the disease and the limited survival time render it challenging to conduct effective clinical trials. On the other hand, there is considerable heterogeneity in the efficacy indicators of spinal metastases across various clinical trials, coupled with the lack of uniform measurement standards for trial data, making it difficult for researchers to appraise the merits and demerits of different methods. Consequently, it is of paramount importance to establish a core outcome set (COS-SM) for evaluating the efficacy of clinical research on integrated traditional Chinese and western medicine on spinal metastases. This study consists of four main stages: systematic review, stakeholder interviews, Delphi survey, and consensus meeting. The initial step involves systematically reviewing clinical studies on the treatment of spinal metastases utilizing either traditional Chinese or Western medicine, and extracting the relevant effective outcome indices. Subsequently, a questionnaire survey was administered to patients with spinal metastases and their caregivers from multiple medical centers, to supplement and compile a pool of outcome indicators. A three-stage Delphi survey will follow, inviting a broad range of participants to rate the outcome indicators, including an initial online pre-survey and two offline meetings. Ultimately, a face-to-face consensus meeting will review, score, and approve the Delphi survey's screening results, culminating in the establishment of the COS-SM and the recommendation of appropriate measures.
ContributorsWen-long Yu, Lin Zhou, Yue-li Sun, Yin-jie Yan, Yan-ping Yang, Quan Huang, Shu-qiang Wang, Jian-ru Xiao and Meng-chen Yin
Disease Category: Orthopaedics & trauma
Disease Name: Spinal metastases
Age Range: 14 - 99
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Procedure, Surgery, Traditional Chinese Medicine
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Epidemiologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus conference
- Delphi process
- Interview
- Systematic review
This study consists of four main stages: systematic review, stakeholder interviews, Delphi survey, and consensus meeting. The checklists of core outcomes and measurements will be formed from the systematic review and stakeholder interviews. The COS-SM and CMS-SM will be established based on the checklists through the Delphi method and consensus meeting. After the establishment, the recommended measurements will be tested and optimized with the clinical practice data.