Development of the Core Outcome Set for Herbal Medicine Treatment of Lumbar Disc Herniation (COS-HM-LDH)

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.

Contributors

Soo-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

Further Study Information

Current Stage: Ongoing
Date: September 2023 - June 2025
Funding source(s): This study was funded by the Korea Institute of Oriental Medicine (KSN1823211).


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Lumbar disc herniation

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Complementary and alternative medicine (CAM) therapy

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- 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.

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