Background
Lumbar disc herniation (LDH) is a common cause of low back pain and disability. Herbal medicine (HM) is increasingly used for LDH in Korean medicine (KM) practice, but evidence synthesis is limited by inconsistent outcome selection and reporting. We aimed to develop a core outcome set (COS) to standardize reporting in HM studies of LDH in KM practice.
Methods
The study followed the Core Outcome Set-STAndards for Development (COS-STAD), with reporting guided by the Core Outcome Set-STAndards for Reporting (COS-STAR). Candidate outcomes were identified through a systematic review of Korean (OASIS, ScienceON) and international (PubMed, CENTRAL) databases from inception to December 2024, supplemented by clinical practice guidelines and textbooks. Outcomes were refined into predefined domains and potential effect modifiers (EMs) were identified. A two-round Delphi survey with experts was conducted, followed by a Delphi survey with KM clinicians to assess feasibility in practice. A structured consensus meeting was held to finalize the COS.
Results
Of 1426 records, 122 studies were included. Ninety-six outcomes were refined to 75 distinct outcomes across six domains, alongside 15 EMs. Delphi participation included 25 experts in Round 1, 23 experts in Round 2, and 10 KM clinicians in the clinician Delphi survey. The final Core Outcome Set for Herbal Medicine Treatment of Lumbar Disc Herniation (COS-HM-LDH) comprised 13 outcomes and 10 EMs.
Conclusion
COS-HM-LDH provides a standardized minimum set of clinically important LDH outcomes and EMs for HM trials and real-world studies in KM practice, improving consistency and comparability across studies.
Lumbar Disc Herniation (LDH) is a common global musculoskeletal disorder that causes a significant socioeconomic burden. Nonsurgical interventions are the primary treatment; however, herbal medicines (HM) are gaining traction for their efficacy in managing LDH. Conversely, their integration into clinical settings is limited owing to inconsistencies in clinical trial methodologies, mainly stemming from a lack of standardized outcome measures. Our research, highlighting this gap, sought to develop a Core Outcome Set (COS) to consistently assess HM treatments for LDH in Korean medicine (KM) clinics using a consensus-driven, multi-phased approach.
ContributorsSoo-Dam Kim (principal investigator), Korea Institute of Oriental Medicine
Changsop Yang, Korea Institute of Oriental Medicine
Kyung-Min Shin, Korea Institute of Oriental Medicine
Mi Mi Ko, Korea Institute of Oriental Medicine
Sungha Kim (supervisor), Korea Institute of Oriental Medicine
Myeong Soo Lee (supervisor), Korea Institute of Oriental Medicine
Disease Category: Orthopaedics & trauma
Disease Name: Lumbar disc herniation
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy
- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Systematic review
The development of the COS-HM-LDH involves four main phases: (1) a project management group (PMG) will conduct a systematic review to curate an initial list of outcomes; (2) Several Delphi survey rounds will be administered to a selected panel of experts to validate and refine these outcomes; (3) primary clinicians will be involved in a subsequent Delphi survey to further refine the outcomes; and (4) a final consensus meeting will finalize the COS.