Classification and application of effectiveness-implementation hybrid designs_Chinese Journal of Evidence-Based Medicine

Authors：

GU Yue ^1,2,3 , ZHU Beibei ^1,2,3 ,  TAO Fangbiao ^1,2,3

1. Department of Maternal, Child and Adolescent Health, School of Public Health, Anhui Medical University, Hefei 230032, P.R.China;
2. Key Laboratory of Population Health Across Life Cycle (Anhui Medical University), Ministry of Education of the People’s Republic of China, Hefei 230032, P.R.China;
3. Anhui Provincial Key Laboratory of Population Health and Aristogenics, Hefei 230032, P.R.China;

Corresponding author：

TAO Fangbiao, Email: fbtao@ahmu.edu.cn

Keywords：

Effectiveness-implementation hybrid design; Implementation science; Clinical intervention

DOI：

10.7507/1672-2531.202107116

Video：

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Evidence-based evidence translated into health care services requires three conversion processes, preclinical research-clinical research-implementation research, which might take a very long time. In order to speed up the process of research results translated into daily medical practice and health policy, an effectiveness-implementation hybrid design combining the effectiveness research of clinical and implementation research was emerging. This paper introduced the concept, classification and application of effectiveness-implementation hybrid design, to provide references for researchers in this area.

Citation： GU Yue, ZHU Beibei, TAO Fangbiao. Classification and application of effectiveness-implementation hybrid designs. Chinese Journal of Evidence-Based Medicine, 2022, 22(1): 120-124. doi: 10.7507/1672-2531.202107116 Copy

1.	钟婕, 周英凤. 实施性研究的方法学及应用进展. 中华护理杂志, 2018, 53(7): 862-866.
2.	Streiner DL. The 2 "Es" of research: efficacy and effectiveness trials. Can J Psychiatry, 2002, 47(6): 552-556.
3.	Eccles MP, Mittman BS. Welcome to implementation science. Implement Sci, 2006, 1(1): 1-3.
4.	全球慢性病联盟中-加抑郁研究团队. 推进实施性研究在中国公共卫生领域的应用. 中华预防医学杂志, 2020, 54(1): 8-12.
5.	刘雅莉, 谢琪, 刘保延, 等. 临床试验百年历程概述. 中国循证医学杂志, 2016, 16(11): 1241-1249.
6.	Bauer MS, Kirchner J. Implementation science: What is it and why should I care. Psychiatry Res, 2020, 283: 112376.
7.	Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med, 2011, 104(12): 510-520.
8.	Bernet AC, Willens DE, Bauer MS. Effectiveness-implementation hybrid designs: implications for quality improvement science. Implement Sci, 2013, 8(1): 2-3.
9.	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. Med Care, 2012, 50(3): 217-226.
10.	Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res, 2019, 280: 112513.
11.	Brown CH, Curran G, Palinkas LA, et al. An overview of research and evaluation designs for dissemination and implementation. Annu Rev Public Health, 2017, 38: 1-22.
12.	David HP, Nhan TT, Taghreed A. Implementation research in health: a practical guide. Alliance for Health Policy and Systems Research, World Health Organization, 2013: 46-47.
13.	Green BB, Coronado GD, Schwartz M, et al. Using a continuum of hybrid effectiveness-implementation studies to put research-tested colorectal screening interventions into practice. Implement Sci, 2019, 14(1): 53.
14.	Milaneschi Y, Simmons WK, van Rossum EFC, et al. Depression and obesity: evidence of shared biological mechanisms. Mol Psychiatry, 2019, 24(1): 18-33.
15.	Fang S, Wang M, Zheng Y, et al. Acupuncture and lifestyle modification treatment for obesity: a meta-analysis. Am J Chin Med, 2017, 45(2): 239-254.
16.	Kamenov K, Twomey C, Cabello M, et al. The efficacy of psychotherapy, pharmacotherapy and their combination on functioning and quality of life in depression: a meta-analysis. Psychol Med, 2017, 47(3): 414-425.
17.	Ma J, Yank V, Lv N, et al. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials, 2015, 43: 260-278.
18.	Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health, 1999, 89(9): 1322-1327.
19.	Dehar MA, Casswell S, Duignan P. Formative and process evaluation of health promotion and disease prevention programs. Eval Rev, 1993, 17(2): 204-220.
20.	Palinkas LA, Mendon SJ, Hamilton AB. Innovations in mixed methods evaluations. Annu Rev Public Health, 2019, 40: 423-442.
21.	翁瑛丽, 赵博伦, 周璇, 等. 实施性研究中保真度测评的研究进展. 护理学报, 2020, 27(19): 23-28.
22.	Powell BJ, Waltz TJ, Chinman MJ, et al. A refined compilation of implementation strategies: results from the expert recommendations for implementing change (ERIC) project. Implement Sci, 2015, 10: 21.
23.	Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI): explanation and elaboration document. BMJ Open, 2017, 7(4): e013318.
24.	Leung LB, Rubenstein LV, Yoon J, et al. Veterans health administration investments in primary care and mental health integration improved care access. Health Aff (Millwood), 2019, 38(8): 1281-1288.
25.	Owen RR, Woodward EN, Drummond KL, et al. Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design. Implement Sci, 2019, 14(1): 33.
26.	Kirchner JE, Smith JL, Powell BJ, et al. Getting a clinical innovation into practice: an introduction to implementation strategies. Psychiatry Res, 2020, 283: 112467.
27.	Kitson AL, Harvey G. Methods to succeed in effective knowledge translation in clinical practice. J Nurs Scholarsh, 2016, 48(3): 294-302.
28.	张立华, 顾莺. 临床实践变革的概念框架: 从PARIHS到i-PARIHS. 中国循证医学杂志, 2019, 19(6): 741-747.
29.	Kadota JL, Musinguzi A, Nabunje J, et al. Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda. Implement Sci, 2020, 15(1): 65.
30.	Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterizing and designing behaviour change interventions. Implement Sci, 2011, 6: 42.
31.	陈文嘉, 徐东, 李慧, 等. 实施科学理论的分类与介绍. 中国循证医学杂志, 2020, 20(8): 986-992.
32.	Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol, 2009, 62(5): 464-475.
33.	Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
34.	谢润生, 徐东, 李慧, 等. 医疗卫生领域中实施科学的研究方法. 中国循证医学杂志, 2020, 20(9): 1104-1110.
35.	Rudd BN, Davis M, Beidas RS. Integrating implementation science in clinical research to maximize public health impact: a call for the reporting and alignment of implementation strategy use with implementation outcomes in clinical research. Implement Sci, 2020, 15(1): 103.
36.	Pfadenhauer LM, Gerhardus A, Mozygemba K, et al. Making sense of complexity in context and implementation: the context and implementation of complex interventions (CICI) framework. Implement Sci, 2017, 12(1): 21.
37.	Kemp CG, Wagenaar BH, Haroz EE. Expanding hybrid studies for implementation research: intervention, implementation strategy, and context. Front Public Health, 2019, 7: 325.

1. 钟婕, 周英凤. 实施性研究的方法学及应用进展. 中华护理杂志, 2018, 53(7): 862-866.
2. Streiner DL. The 2 "Es" of research: efficacy and effectiveness trials. Can J Psychiatry, 2002, 47(6): 552-556.
3. Eccles MP, Mittman BS. Welcome to implementation science. Implement Sci, 2006, 1(1): 1-3.
4. 全球慢性病联盟中-加抑郁研究团队. 推进实施性研究在中国公共卫生领域的应用. 中华预防医学杂志, 2020, 54(1): 8-12.
5. 刘雅莉, 谢琪, 刘保延, 等. 临床试验百年历程概述. 中国循证医学杂志, 2016, 16(11): 1241-1249.
6. Bauer MS, Kirchner J. Implementation science: What is it and why should I care. Psychiatry Res, 2020, 283: 112376.
7. Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med, 2011, 104(12): 510-520.
8. Bernet AC, Willens DE, Bauer MS. Effectiveness-implementation hybrid designs: implications for quality improvement science. Implement Sci, 2013, 8(1): 2-3.
9. 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. Med Care, 2012, 50(3): 217-226.
10. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res, 2019, 280: 112513.
11. Brown CH, Curran G, Palinkas LA, et al. An overview of research and evaluation designs for dissemination and implementation. Annu Rev Public Health, 2017, 38: 1-22.
12. David HP, Nhan TT, Taghreed A. Implementation research in health: a practical guide. Alliance for Health Policy and Systems Research, World Health Organization, 2013: 46-47.
13. Green BB, Coronado GD, Schwartz M, et al. Using a continuum of hybrid effectiveness-implementation studies to put research-tested colorectal screening interventions into practice. Implement Sci, 2019, 14(1): 53.
14. Milaneschi Y, Simmons WK, van Rossum EFC, et al. Depression and obesity: evidence of shared biological mechanisms. Mol Psychiatry, 2019, 24(1): 18-33.
15. Fang S, Wang M, Zheng Y, et al. Acupuncture and lifestyle modification treatment for obesity: a meta-analysis. Am J Chin Med, 2017, 45(2): 239-254.
16. Kamenov K, Twomey C, Cabello M, et al. The efficacy of psychotherapy, pharmacotherapy and their combination on functioning and quality of life in depression: a meta-analysis. Psychol Med, 2017, 47(3): 414-425.
17. Ma J, Yank V, Lv N, et al. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials, 2015, 43: 260-278.
18. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health, 1999, 89(9): 1322-1327.
19. Dehar MA, Casswell S, Duignan P. Formative and process evaluation of health promotion and disease prevention programs. Eval Rev, 1993, 17(2): 204-220.
20. Palinkas LA, Mendon SJ, Hamilton AB. Innovations in mixed methods evaluations. Annu Rev Public Health, 2019, 40: 423-442.
21. 翁瑛丽, 赵博伦, 周璇, 等. 实施性研究中保真度测评的研究进展. 护理学报, 2020, 27(19): 23-28.
22. Powell BJ, Waltz TJ, Chinman MJ, et al. A refined compilation of implementation strategies: results from the expert recommendations for implementing change (ERIC) project. Implement Sci, 2015, 10: 21.
23. Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI): explanation and elaboration document. BMJ Open, 2017, 7(4): e013318.
24. Leung LB, Rubenstein LV, Yoon J, et al. Veterans health administration investments in primary care and mental health integration improved care access. Health Aff (Millwood), 2019, 38(8): 1281-1288.
25. Owen RR, Woodward EN, Drummond KL, et al. Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design. Implement Sci, 2019, 14(1): 33.
26. Kirchner JE, Smith JL, Powell BJ, et al. Getting a clinical innovation into practice: an introduction to implementation strategies. Psychiatry Res, 2020, 283: 112467.
27. Kitson AL, Harvey G. Methods to succeed in effective knowledge translation in clinical practice. J Nurs Scholarsh, 2016, 48(3): 294-302.
28. 张立华, 顾莺. 临床实践变革的概念框架: 从PARIHS到i-PARIHS. 中国循证医学杂志, 2019, 19(6): 741-747.
29. Kadota JL, Musinguzi A, Nabunje J, et al. Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda. Implement Sci, 2020, 15(1): 65.
30. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterizing and designing behaviour change interventions. Implement Sci, 2011, 6: 42.
31. 陈文嘉, 徐东, 李慧, 等. 实施科学理论的分类与介绍. 中国循证医学杂志, 2020, 20(8): 986-992.
32. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol, 2009, 62(5): 464-475.
33. Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
34. 谢润生, 徐东, 李慧, 等. 医疗卫生领域中实施科学的研究方法. 中国循证医学杂志, 2020, 20(9): 1104-1110.
35. Rudd BN, Davis M, Beidas RS. Integrating implementation science in clinical research to maximize public health impact: a call for the reporting and alignment of implementation strategy use with implementation outcomes in clinical research. Implement Sci, 2020, 15(1): 103.
36. Pfadenhauer LM, Gerhardus A, Mozygemba K, et al. Making sense of complexity in context and implementation: the context and implementation of complex interventions (CICI) framework. Implement Sci, 2017, 12(1): 21.
37. Kemp CG, Wagenaar BH, Haroz EE. Expanding hybrid studies for implementation research: intervention, implementation strategy, and context. Front Public Health, 2019, 7: 325.

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Classification and application of effectiveness-implementation hybrid designs

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