Application prospects of effectiveness–implementation hybrid designs in acupuncture clinical research_Chinese Journal of Evidence-Based Medicine

Authors：

 DUAN Yuting ^1,2 , ZHANG Mengxi ¹ , SHI Lin ^1,2 , XU Zhirui ^1,2 , ZHU Weifeng ^1,2 , YU Lin ^1,2

1. The Affiliated Guangzhou Hospital of TCM of Guangzhou University of Chinese Medicine, Guangzhou 510000, P. R. China;
2. The Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University, Guangzhou 510000, P. R. China;

Corresponding?author：

DUAN Yuting, Email: 18702009530@163.com

Keywords：

Acupuncture clinical research; Effectiveness-implementation hybrid design; Study design

DOI：

10.7507/1672-2531.202512087

Video：

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Abstract Full text Figures/Tables Video References Cited by

Effectiveness-implementation hybrid design（EIHD）is a research methodology that integrates effectiveness research and implementation science to evaluate the effectiveness of health interventions and implementation strategies. In response to the current challenge of delayed translation of evidence in acupuncture research, this paper analyzes the core underlying reasons in study design, implementation context, and dissemination mechanisms. It systematically demonstrates the profound alignment between implementation science methodologies and clinical acupuncture research. Furthermore, focusing for the first time on the core characteristics of syndrome differentiation and dynamic adjustment in acupuncture treatment, this study clarifies the specific applicable scenarios and classification selection criteria of three types of EIHD for acupuncture research. Integrating theoretical frameworks and reporting guidelines, a full-chain implementation pathway from problem identification, protocol design to outcome dissemination is established, providing operable methodological support for translating high-quality evidence from acupuncture clinical trials into routine clinical practice.

Citation： DUAN Yuting, ZHANG Mengxi, SHI Lin, XU Zhirui, ZHU Weifeng, YU Lin. Application prospects of effectiveness–implementation hybrid designs in acupuncture clinical research. Chinese Journal of Evidence-Based Medicine, 2026, 26(9): 1074-1080. doi: 10.7507/1672-2531.202512087 Copy

1.	陳少宗, 張擎宇, 李愛華, 等. 針灸的國際傳播與針灸的實用價值、科學價值[J]. 醫學與哲學, 2024, 45(9): 74-78.
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3.	Rapport F, Clay-Williams R, Churruca K, et al. The struggle of translating science into action: Foundational concepts of implementation science[J]. J Eval Clin Pract, 2018, 24(1): 117-126.
4.	陳文嘉, 徐東, 李慧, 等. 實施科學理論的分類與介紹[J]. 中國循證醫學雜志, 2020, 20(8): 986-992.
5.	Rubin R. It takes an average of 17 years for evidence to change practice-the burgeoning field of implementation science seeks to speed things up[J]. JAMA, 2023, 329(16): 1333-1336.
6.	Lu L, Zhang Y, Tang X, et al. Evidence on acupuncture therapies is underused in clinical practice and health policy[J]. BMJ, 2022, 376: e067475.
7.	Paterson C, Britten N. Acupuncture as a complex intervention: a holistic model[J]. J Altern Complement Med, 2004, 10(5): 791-801.
8.	Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on[J]. Lancet, 2017, 390(10092): 415-423.
9.	陳子雯, 徐韜, 熊堅, 等. 針灸研究的臨床轉化現狀及思考[J]. 針刺研究, 2023, 48(1): 28-31, 43.
10.	Duan Y, Deng Y, Tang B, et al. Exploration of registration and the risk of bias in acupuncture randomised controlled trials: a systematic review protocol[J]. BMJ Open, 2024, 14(5): e083213.
11.	Duan Y, Zhao P, Liu S, et al. Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol[J]. BMJ Open, 2024, 14(2): e079218.
12.	Duan Y, Xu Z, Zhao P, et al. A cross-sectional study of reporting guidelines for clinical studies in traditional Chinese medicine[J]. Euro J Integrat Med, 2023, 64: 102315.
13.	Duan Y, Xu Z, Li X, et al. Reporting and data-sharing level of acupuncture randomised controlled trials: a cross-sectional study protocol[J]. BMJ Open, 2023, 13(6): e070545.
14.	Harrison JD, Reddy S, Liu R, et al. Implementing an inpatient acupuncture service for pain and symptom management: identifying opportunities and challenges[J]. J Altern Complement Med, 2019, 25(5): 503-508.
15.	Eccles MP, Mittman BS. Welcome to implementation science[J]. Implement Sci, 2006, 1(1): 1.
16.	魏緒強, 何麗云, 劉保延. 實施研究對針灸臨床研究的啟示與思考[J]. 中醫雜志, 2020, 61(20): 1783-1789.
17.	Hullender Rubin L, Veleber S. Hospital-based acupuncture integration: access, reimbursement, and implementation[J]. J Altern Complement Med, 2020, 26(5): 356-359.
18.	Efverman A. Implementation of acupuncture in routine oncology care: a comparison of physicians', nurses', physiotherapists' and acupuncturists' practice and beliefs[J]. Integr Cancer Ther, 2022, 21: 15347354221132834.
19.	Li H, Darby JE, Akpotu I, et al. Barriers and facilitators to integrating acupuncture into the u. s. health care system: a scoping review[J]. J Integr Complement Med, 2024, 30(12): 1134-1146.
20.	Miller DW, Roseen EJ, Stone JAM, et al. Incorporating acupuncture into american healthcare: initiating a discussion on implementation science, the status of the field, and stakeholder considerations[J]. Glob Adv Health Med, 2021, 10: 21649561211042574.
21.	Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs[J]. Psychiatry Res, 2019, 280: 112513.
22.	Bauer MS, Kirchner J. Implementation science: what is it and why should I care[J]. Psychiatry Res, 2020, 283: 112376.
23.	Wolfenden L, Williams CM, Wiggers J, et al. Improving the translation of health promotion interventions using effectiveness-implementation hybrid designs in program evaluations[J]. Health Promot J Austr, 2016, 27(3): 204-207.
24.	徐東, 陳江蕓, 蔡毅媛. 實施科學的前世今生(上篇)—起源與發展[J]. 協和醫學雜志, 2024, 15(2): 442-449.
25.	Handley MA, Murphy LD, Sherwin EB, et al. Practical application of hybrid effectiveness-implementation studies for intervention research[J]. Int J Epidemiol, 2025, 54(3): dyaf039.
26.	鄭萍, 劉寧. 實施性研究的方法學綜述[J]. 護理學報, 2022, 29(11): 47-52.
27.	Curran GM, Bauer M, Mittman B, et al. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact[J]. Med Care, 2012, 50(3): 217-226.
28.	Ullman AJ, Beidas RS, Bonafide CP. Methodological progress note: hybrid effectiveness-implementation clinical trials[J]. J Hosp Med, 2022, 17(11): 912-916.
29.	中醫藥振興發展重大工程實施方案[J]. 江蘇中醫藥, 2023, 55(4): 1-8.
30.	Li M, Wang Y, Li K, et al. The efficacy and safety of Jin's three-needle therapy vs. placebo acupuncture on anxiety symptoms in patients with post-stroke anxiety: a study protocol for a randomized controlled trial[J]. Front Psychiatry, 2022, 13: 941566.
31.	Dimitrova A, Murchison C, Oken B. Acupuncture for the treatment of peripheral neuropathy: a systematic review and meta-analysis[J]. J Altern Complement Med, 2017, 23(3): 164-179.
32.	Onan D, Ar?kan H, Ekizo?lu E, et al. The efficacy of physiotherapy approaches in chronic tension-type headache: a systematic review and meta-analysis[J]. J Oral Facial Pain Headache, 2025, 39(1): 34-48.
33.	施蘭君, 崗衛娟, 田紫煜, 等. 保真度及其在針灸臨床研究中的應用與思考[J]. 中國針灸, 2023, 43(7): 813-817.
34.	魯春麗, 徐東, 劉建平. 實施科學在中醫藥與中西醫結合領域應用的設計思路與方法[J]. 中國中西醫結合雜志, 2021, 41(9): 1113-1119.
35.	Birken SA, Powell BJ, Shea CM, et al. Criteria for selecting implementation science theories and frameworks: results from an international survey[J]. Implement Sci, 2017, 12(1): 124.
36.	Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI) statement[J]. BMJ, 2017, 356: i6795.

1. 陳少宗, 張擎宇, 李愛華, 等. 針灸的國際傳播與針灸的實用價值、科學價值[J]. 醫學與哲學, 2024, 45(9): 74-78.
2. 世界針灸學會聯合會科技工作委員會. 針灸臨床研究證據藍皮書(2015-2024)[M]. 倫敦: 世界針灸學會聯合會, 2024.
3. Rapport F, Clay-Williams R, Churruca K, et al. The struggle of translating science into action: Foundational concepts of implementation science[J]. J Eval Clin Pract, 2018, 24(1): 117-126.
4. 陳文嘉, 徐東, 李慧, 等. 實施科學理論的分類與介紹[J]. 中國循證醫學雜志, 2020, 20(8): 986-992.
5. Rubin R. It takes an average of 17 years for evidence to change practice-the burgeoning field of implementation science seeks to speed things up[J]. JAMA, 2023, 329(16): 1333-1336.
6. Lu L, Zhang Y, Tang X, et al. Evidence on acupuncture therapies is underused in clinical practice and health policy[J]. BMJ, 2022, 376: e067475.
7. Paterson C, Britten N. Acupuncture as a complex intervention: a holistic model[J]. J Altern Complement Med, 2004, 10(5): 791-801.
8. Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on[J]. Lancet, 2017, 390(10092): 415-423.
9. 陳子雯, 徐韜, 熊堅, 等. 針灸研究的臨床轉化現狀及思考[J]. 針刺研究, 2023, 48(1): 28-31, 43.
10. Duan Y, Deng Y, Tang B, et al. Exploration of registration and the risk of bias in acupuncture randomised controlled trials: a systematic review protocol[J]. BMJ Open, 2024, 14(5): e083213.
11. Duan Y, Zhao P, Liu S, et al. Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol[J]. BMJ Open, 2024, 14(2): e079218.
12. Duan Y, Xu Z, Zhao P, et al. A cross-sectional study of reporting guidelines for clinical studies in traditional Chinese medicine[J]. Euro J Integrat Med, 2023, 64: 102315.
13. Duan Y, Xu Z, Li X, et al. Reporting and data-sharing level of acupuncture randomised controlled trials: a cross-sectional study protocol[J]. BMJ Open, 2023, 13(6): e070545.
14. Harrison JD, Reddy S, Liu R, et al. Implementing an inpatient acupuncture service for pain and symptom management: identifying opportunities and challenges[J]. J Altern Complement Med, 2019, 25(5): 503-508.
15. Eccles MP, Mittman BS. Welcome to implementation science[J]. Implement Sci, 2006, 1(1): 1.
16. 魏緒強, 何麗云, 劉保延. 實施研究對針灸臨床研究的啟示與思考[J]. 中醫雜志, 2020, 61(20): 1783-1789.
17. Hullender Rubin L, Veleber S. Hospital-based acupuncture integration: access, reimbursement, and implementation[J]. J Altern Complement Med, 2020, 26(5): 356-359.
18. Efverman A. Implementation of acupuncture in routine oncology care: a comparison of physicians', nurses', physiotherapists' and acupuncturists' practice and beliefs[J]. Integr Cancer Ther, 2022, 21: 15347354221132834.
19. Li H, Darby JE, Akpotu I, et al. Barriers and facilitators to integrating acupuncture into the u. s. health care system: a scoping review[J]. J Integr Complement Med, 2024, 30(12): 1134-1146.
20. Miller DW, Roseen EJ, Stone JAM, et al. Incorporating acupuncture into american healthcare: initiating a discussion on implementation science, the status of the field, and stakeholder considerations[J]. Glob Adv Health Med, 2021, 10: 21649561211042574.
21. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs[J]. Psychiatry Res, 2019, 280: 112513.
22. Bauer MS, Kirchner J. Implementation science: what is it and why should I care[J]. Psychiatry Res, 2020, 283: 112376.
23. Wolfenden L, Williams CM, Wiggers J, et al. Improving the translation of health promotion interventions using effectiveness-implementation hybrid designs in program evaluations[J]. Health Promot J Austr, 2016, 27(3): 204-207.
24. 徐東, 陳江蕓, 蔡毅媛. 實施科學的前世今生(上篇)—起源與發展[J]. 協和醫學雜志, 2024, 15(2): 442-449.
25. Handley MA, Murphy LD, Sherwin EB, et al. Practical application of hybrid effectiveness-implementation studies for intervention research[J]. Int J Epidemiol, 2025, 54(3): dyaf039.
26. 鄭萍, 劉寧. 實施性研究的方法學綜述[J]. 護理學報, 2022, 29(11): 47-52.
27. Curran GM, Bauer M, Mittman B, et al. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact[J]. Med Care, 2012, 50(3): 217-226.
28. Ullman AJ, Beidas RS, Bonafide CP. Methodological progress note: hybrid effectiveness-implementation clinical trials[J]. J Hosp Med, 2022, 17(11): 912-916.
29. 中醫藥振興發展重大工程實施方案[J]. 江蘇中醫藥, 2023, 55(4): 1-8.
30. Li M, Wang Y, Li K, et al. The efficacy and safety of Jin's three-needle therapy vs. placebo acupuncture on anxiety symptoms in patients with post-stroke anxiety: a study protocol for a randomized controlled trial[J]. Front Psychiatry, 2022, 13: 941566.
31. Dimitrova A, Murchison C, Oken B. Acupuncture for the treatment of peripheral neuropathy: a systematic review and meta-analysis[J]. J Altern Complement Med, 2017, 23(3): 164-179.
32. Onan D, Ar?kan H, Ekizo?lu E, et al. The efficacy of physiotherapy approaches in chronic tension-type headache: a systematic review and meta-analysis[J]. J Oral Facial Pain Headache, 2025, 39(1): 34-48.
33. 施蘭君, 崗衛娟, 田紫煜, 等. 保真度及其在針灸臨床研究中的應用與思考[J]. 中國針灸, 2023, 43(7): 813-817.
34. 魯春麗, 徐東, 劉建平. 實施科學在中醫藥與中西醫結合領域應用的設計思路與方法[J]. 中國中西醫結合雜志, 2021, 41(9): 1113-1119.
35. Birken SA, Powell BJ, Shea CM, et al. Criteria for selecting implementation science theories and frameworks: results from an international survey[J]. Implement Sci, 2017, 12(1): 124.
36. Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI) statement[J]. BMJ, 2017, 356: i6795.

Chinese Journal of Evidence-Based Medicine

Application prospects of effectiveness–implementation hybrid designs in acupuncture clinical research

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