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

IF 4.7 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Journal of Evidence‐Based Medicine Pub Date : 2026-09-25 Epub Date: 2026-07-15 DOI:10.1111/jebm.70169
Soo-Dam Kim, Changsop Yang, Kyung-Min Shin, Mi Mi Ko, Sungha Kim, Myeong Soo Lee
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引用次数: 0

Abstract

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.

韩国医学实践中草药治疗腰椎间盘突出症(COS-HM-LDH)核心结局集的发展。
背景:腰椎间盘突出症(LDH)是引起腰痛和残疾的常见原因。在韩国医学(KM)实践中,越来越多地使用草药(HM)治疗LDH,但由于结果选择和报告不一致,证据合成受到限制。我们的目标是制定一个核心结果集(COS),以标准化在KM实践中LDH的HM研究报告。方法:研究遵循核心结局集-发展标准(COS-STAD),报告以核心结局集-报告标准(COS-STAR)为指导。候选结果是通过对韩国(OASIS, ScienceON)和国际(PubMed, CENTRAL)数据库从建立到2024年12月的系统评价确定的,并辅以临床实践指南和教科书。结果被细化到预定义的领域,并确定潜在的效果修饰因子(EMs)。对专家进行了两轮德尔菲调查,随后对KM临床医生进行了德尔菲调查,以评估实践中的可行性。举行了一次有组织的协商一致意见会议,以最后确定COS。结果:1426份记录中,纳入122份研究。96个结果在6个领域中被细化为75个不同的结果,以及15个新兴市场。参与德尔菲调查的专家包括第1轮的25名专家,第2轮的23名专家,以及临床医生德尔菲调查的10名KM临床医生。中草药治疗腰椎间盘突出症的最终核心结局集(COS-HM-LDH)包括13个结局和10个主要结局。结论:COS-HM-LDH为HM试验和KM实践中的现实世界研究提供了一套标准化的临床重要LDH结果和EMs的最小集合,提高了研究之间的一致性和可比性。
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来源期刊
Journal of Evidence‐Based Medicine
Journal of Evidence‐Based Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
11.20
自引率
1.40%
发文量
42
期刊介绍: The Journal of Evidence-Based Medicine (EMB) is an esteemed international healthcare and medical decision-making journal, dedicated to publishing groundbreaking research outcomes in evidence-based decision-making, research, practice, and education. Serving as the official English-language journal of the Cochrane China Centre and West China Hospital of Sichuan University, we eagerly welcome editorials, commentaries, and systematic reviews encompassing various topics such as clinical trials, policy, drug and patient safety, education, and knowledge translation.
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