Development of the Korean Medicine Core Outcome Set for Primary Dysmenorrhea (COS-PD-KM) for Herbal Medicine Treatment of Primary Dysmenorrhea in Primary Clinics

Pyung-Wha Kim; Sungha Kim; Dong-Il Kim; Jiyun Cha; He-Sol Lee; Mi Mi Ko; Soobin Jang; Changsop Yang; Myeong Soo Lee

doi:10.3390/ijerph192215321

Development of the Korean Medicine Core Outcome Set for Primary Dysmenorrhea (COS-PD-KM) for Herbal Medicine Treatment of Primary Dysmenorrhea in Primary Clinics

Int J Environ Res Public Health. 2022 Nov 19;19(22):15321. doi: 10.3390/ijerph192215321.

Authors

Pyung-Wha Kim¹, Sungha Kim², Dong-Il Kim³, Jiyun Cha⁴, He-Sol Lee¹, Mi Mi Ko², Soobin Jang⁵, Changsop Yang², Myeong Soo Lee²

Affiliations

¹ R&D Strategy Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
² KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
³ Department of Obstetrics & Gynecology, College of Korean Medicine, Dongguk University, Goyang 10326, Republic of Korea.
⁴ Digital Health Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
⁵ Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University, Gyeongsan 38610, Republic of Korea.

Abstract

The aim of this study was to develop a Korean medicine (KM) core outcome set (COS) for primary dysmenorrhea to evaluate the effectiveness of herbal medicine (HM) in treating primary dysmenorrhea in patients visiting KM primary clinics. Previously reported outcomes were identified through a literature review to define outcomes and effect modifiers (EMs) for the questionnaire. Experts were invited to conduct modified Delphi consensus exercises, and primary care clinicians were invited to conduct Delphi consensus exercises to evaluate suitability and feasibility. Finally, an additional round of a modified Delphi exercise was conducted with experts to obtain a final agreement on the COS. Seventeen outcomes and 15 EMs were included from a literature review, and one effect modifier was suggested by the experts (Phase 1). In Phase 2, after the modified Delphi consensus exercises by experts, 10 outcomes and 11 EMs were included in the COS. The clinicians all agreed on the feasibility of COS (Phase 3). Finally, 10 outcomes and 6 EMs were included in the COS-PD-KM after the final modified Delphi consensus exercise (Phase 4). The effectiveness of HM used in primary clinics could be evaluated with this COS in patients with primary dysmenorrhea. Further studies that involve more relevant stakeholder groups, such as patient representatives and gynecological experts, are needed.

Keywords: Korean medicine; core outcome set; herbal medicine; primary care; primary dysmenorrhea.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Delphi Technique
Dysmenorrhea / drug therapy
Female
Herbal Medicine*
Humans
Outcome Assessment, Health Care
Plants, Medicinal*
Republic of Korea
Research Design

Grants and funding

This study was funded by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (HF22C0087), the Ministry of Health and Welfare of South Korea (ERT2111030) and the Korea Institute of Oriental Medicine (KSN2022210). The funders had no role in the design or conduct of the study, in the analysis and interpretation of the data, or in the preparation or approval of the manuscript.