Developing a Methodological Framework and a Dissemination Plan for Herb-drug Interactions-related Clinical Practice Guidelines

NCT07248826 | Recruiting

• 1 other identifier: SBRE-25-0100
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to develop a methodological framework for clinical practice guidelines (CPGs) related to herb-drug interactions (HDIs). It will also learn barriers and facilitators of disseminating HDI-related CPGs and formulate a dissemination plan. The main questions it aims to answer are:

• Participants in the Delphi survey will engage in a consensus development to determine the framework of HDI-related CPGs, including key characteristics and components of this framework.
• Participants in the semi-structured interviews will be interviewed on the following topics: their experiences in searching for evidence and CPGs related to HDIs; barriers and facilitators encountered when obtaining information from existing CPGs; their views on the ideal platform for disseminating HDI-related CPGs.

Conditions

Herb-drug Interactions

Keywords

herb-drug interactions; methodological framework; evidence-based approach; Delphi method; dissemination plan; semi-structured interview

Outcome Measures

Primary Outcomes (2)

• Degree of consensus

  The level of agreement for all statements achieving consensus among the expert panel. This study sets the consistency threshold at 75%. Namely, if more than 75% of participants select either "Relevant" or "Highly relevant", the item will be considered to have reached consensus for inclusion in the final framework. Conversely, if more than 75% of participants select either "Highly irrelevant" or "Irrelevant", the item will be considered to have reached consensus for exclusion. Items that do not meet either criterion will be considered as failing to reach consensus and be carried forward to the next round.

  Through study completion, an average of 6 months

• Experiences in searching for clinical practice guidelines (CPGs) related to herb-drug interactions (HDIs); barriers and facilitators encountered during retrieving process; views on the ideal platform for disseminating HDI-related CPGs and the framework

  The primary outcome will be assessed by asking participants about the sources they refer to for recommendations on HDIs; what barriers or facilitators they encountered when retrieving HDI-related CPGs; what factors will promote or hinder the development of HDI-related CPGs or the CPG dissemination platform; what anticipated benefits or potential traps the development of the CPG dissemination platform might bring; and the target audience, ideal dissemination channels, etc.

  Through study completion, an average of 6 months

Study Arms (2)

Delphi Panel

The expert panel with the following backgrounds will be invited to participate in the Delphi survey: a. registered Chinese medicine practitioners, herbalists, or researchers in the field of integrated Chinese and Western medicine; b. physicians providing care in integrated Chinese and Western medicine settings; c. healthcare administrators or policymakers from clinics/hospitals directly involved in developing or reviewing clinical practice guidelines related to integrated Chinese and Western medicine.

Other: Delphi method survey

Participants of semi-structured interview

Experts with the following backgrounds will be invited to participate in the semi-structured interview: a. registered Chinese medicine practitioners, herbalists, or researchers in the field of integrated Chinese and Western medicine; b. physicians providing care in integrated Chinese and Western medicine settings; c. healthcare administrators or policymakers from clinics/hospitals directly involved in developing or reviewing clinical practice guidelines related to integrated Chinese and Western medicine.

Other: Semi-structured interview

Interventions

Delphi method survey OTHER

The Delphi survey intervention will comprise two rounds of structured questionnaire surveys to gather stakeholder consensus on the factors and components to consider when translating herb-drug interactions' evidence into recommendations. Following the first round of surveys, we will calculate the median score and interquartile range for each consideration factor, expressing participant consensus on these factors as percentages. Consideration factors achieving consensus in the first round will be considered for inclusion in the clinical practice guideline development framework. For factors where consensus was not reached, we will summarize relevant opinions and further evaluate them in the second round of the Delphi survey. Finally, descriptive statistics (frequencies and proportions) will be used to summarize the quantitative results of the Delphi survey.

Delphi Panel

Semi-structured interview OTHER

A face-to-face semi-structured interview with participants will be conducted. Interview questions will be developed based on the Theoretical Domains Framework (TDF). The interview will cover three main aspects: a. participants' experiences in searching for evidence and clinical practice guidelines (CPGs) related to herb-drug interactions (HDIs); b. barriers and facilitators encountered when retrieving HDI-related CPGs or obtaining information from existing CPGs; c. their views on the ideal platform for disseminating HDI-related CPGs.

Participants of semi-structured interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population encompass a diverse group of experts, including registered Chinese medicine practitioners, herbalists, or researchers; clinicians; and healthcare administrators or policymakers in the field of integrated Chinese and Western medicine. This expert panel aims to gather a broad range of perspectives to ensure the establishment of a comprehensive and standardized framework for developing guidelines on herb-drug interactions.

You may qualify if:

• Registered Chinese medicine practitioners, herbalists, or researchers in the field of integrated Chinese and Western medicine;
• or physicians providing care in integrated Chinese and Western medicine settings;
• or healthcare administrators or policymakers from clinics/hospitals directly involved in developing or reviewing clinical practice guidelines related to integrated Chinese and Western medicine.

You may not qualify if:

• Panelists who are unable to commit to participating in all rounds of the Delphi process;
• or panelists who are unable to complete the online questionnaire in either Chinese or English;
• or panelists who are unable to conduct the interview in either English or Cantonese.

Sponsors & Collaborators

• Chinese Medicine Hospital, Hong Kong Baptist University: collaborator
• Hong Kong Poison Control Center, Hospital Authority: collaborator
• Chinese Medicine Development Fund: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Chinese University of Hong Kong: lead

Study Sites (1)

School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• Lam CS, Koon HK, Ma CT, Au KY, Zuo Z, Chung VC, Cheung YT. Real-world data on herb-drug interactions in oncology: A scoping review of pharmacoepidemiological studies. Phytomedicine. 2022 Aug;103:154247. doi: 10.1016/j.phymed.2022.154247. Epub 2022 Jun 7.

  PMID: 35716539 BACKGROUND

• Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8;355(9198):134-8. doi: 10.1016/S0140-6736(99)06457-0.

  PMID: 10675182 BACKGROUND

• Wong CHL, Wu IXY, Adams J, Steel A, Wardle J, Wu JCY, Leung TH, Chung VCH. Development of Evidence-Based Chinese Medicine Clinical Service Recommendations for Cancer Palliative Care Using Delphi Approach Based on the Evidence to Decision Framework. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420940418. doi: 10.1177/1534735420940418.

  PMID: 32646246 BACKGROUND

• Zuo Z, Huang M, Kanfer I, Chow MS, Cho WC. Herb-drug interactions: systematic review, mechanisms, and therapies. Evid Based Complement Alternat Med. 2015;2015:239150. doi: 10.1155/2015/239150. Epub 2015 Feb 22. No abstract available.

  PMID: 25792995 BACKGROUND

• Bush TM, Rayburn KS, Holloway SW, Sanchez-Yamamoto DS, Allen BL, Lam T, So BK, Tran de H, Greyber ER, Kantor S, Roth LW. Adverse interactions between herbal and dietary substances and prescription medications: a clinical survey. Altern Ther Health Med. 2007 Mar-Apr;13(2):30-5.

  PMID: 17405676 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-08

Locations

HK (1)