Guidelines for reporting the methods section of effectiveness-implementation hybrid design study_Chinese Journal of Evidence-Based Medicine

Authors：

YU Xiayan ^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：

ZHU Beibei, Email: a513275541@126.com

Keywords：

Effectiveness-implementation hybrid design; Implementation science; Reporting guideline; Method

DOI：

10.7507/1672-2531.202107115

Video：

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Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.

Citation： YU Xiayan, ZHU Beibei, TAO Fangbiao. Guidelines for reporting the methods section of effectiveness-implementation hybrid design study. Chinese Journal of Evidence-Based Medicine, 2021, 21(10): 1222-1226. doi: 10.7507/1672-2531.202107115 Copy

1.	Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res, 2019, 280: 112513.
2.	胡贵平, 詹思延. PRECIS-2: 基于研究目标的试验设计. 中华流行病学杂志, 2018, 39(2): 222-226.
3.	Miller CJ, Smith SN, Pugatch M. Experimental and quasi-experimental designs in implementation research. Psychiatry Res, 2020, 283: 112452.
4.	Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Stat Med, 2015, 34(2): 181-196.
5.	Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more translation of health promotion research to practice. Rethinking the efficacy-to-effectiveness transition. Am J Public Health, 2003, 93(8): 1261-1267.
6.	Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA, 2003, 290(12): 1624-1632.
7.	Proctor EK, Landsverk J, Aarons G, et al. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health, 2009, 36(1): 24-34.
8.	Stetler CB, Legro MW, Wallace CM, et al. The role of formative evaluation in implementation research and the QUERI experience. J Gen Intern Med, 2006, 21(Suppl 2): S1-S8.
9.	Stetler CB, Mittman BS, Francis J. Overview of the VA quality enhancement research initiative (QUERI) and QUERI theme articles: QUERI series. Implement Sci, 2008, 3: 8.
10.	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.
11.	Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
12.	Eccles MP, Mittman BS. Welcome to implementation science. Implement Sci, 2006, 1(1): 1-3.
13.	Bauer MS, Kirchner J. Implementation science: What is it and why should I care. Psychiatry Res, 2020, 283: 112376.
14.	Peters DH, Adam T, Alonge O, et al. Implementation research: what it is and how to do it. BMJ, 2013, 347: f6753.
15.	Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI) statement. BMJ, 2017, 356: i6795.
16.	Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI): explanation and elaboration document. BMJ Open, 2017, 7(4): e013318.
17.	邢唯杰, 朱政, 胡雁, 等. 实施性研究的报告规范(StaRI)解读. 中国循证医学杂志, 2019, 19(1): 97-101.
18.	Najafzadeh M, Gagne JJ, Schneeweiss S. Synergies from integrating randomized controlled trials and real-world data analyses. Clin Pharmacol Ther, 2017, 102(6): 914-916.
19.	杨祖耀, 詹思延. 阶梯设计在随机对照试验中的应用. 中华流行病学杂志, 2010, 31(1): 92-95.
20.	Grayling MJ, Wason JM, Mander AP. Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features. Trials, 2017, 18(1): 33.
21.	Campbell MK, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.
22.	Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 2018, 363: k1614.
23.	Hamilton AB, Finley EP. Qualitative methods in implementation research: an introduction. Psychiatry Res, 2019, 280: 112516.
24.	褚红玲, 倪凯文, 曾琳, 等. 混合方法研究在真实世界研究中的应用. 中国循证医学杂志, 2018, 18(11): 1203-1206.
25.	Palinkas LA, Aarons GA, Horwitz S, et al. Mixed method designs in implementation research. Adm Policy Ment Health, 2011, 38(1): 44-53.
26.	Bauer MS, Miller CJ, Kim B, et al. Effectiveness of implementing a collaborative chronic care model for clinician teams on patient outcomes and health status in mental health: a randomized clinical trial. JAMA Netw Open, 2019, 2(3): e190230.
27.	Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care, 2007, 19(6): 349-357.
28.	费字彤, 刘建平, 于河, 等. 报告定性研究个体访谈和焦点组访谈统一标准的介绍. 中西医结合学报, 2008, 6(2): 115-118.
29.	刘凡, 段玉婷, 张轩, 等. 中医药领域定性访谈研究报告质量评价与文献分析. 中医杂志, 2020, 61(6): 528-532.
30.	Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health, 2011, 38(2): 65-76.
31.	Damschroder LJ, Aron DC, Keith RE, et al. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci, 2009, 4: 50.
32.	Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci, 2015, 10: 53.
33.	Moore GF, Audrey S, Barker M, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ, 2015, 350: h1258.
34.	Glasgow RE, Harden SM, Gaglio B, et al. RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health, 2019, 7: 64.
35.	De Poli C, Oyebode JR, Binns C, et al. Effectiveness-implementation hybrid type 2 study evaluating an intervention to support 'information work' in dementia care: an implementation study protocol. BMJ Open, 2020, 10(12): e038397.
36.	Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ, 2014, 348: g1687.

1. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res, 2019, 280: 112513.
2. 胡贵平, 詹思延. PRECIS-2: 基于研究目标的试验设计. 中华流行病学杂志, 2018, 39(2): 222-226.
3. Miller CJ, Smith SN, Pugatch M. Experimental and quasi-experimental designs in implementation research. Psychiatry Res, 2020, 283: 112452.
4. Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Stat Med, 2015, 34(2): 181-196.
5. Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more translation of health promotion research to practice. Rethinking the efficacy-to-effectiveness transition. Am J Public Health, 2003, 93(8): 1261-1267.
6. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA, 2003, 290(12): 1624-1632.
7. Proctor EK, Landsverk J, Aarons G, et al. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health, 2009, 36(1): 24-34.
8. Stetler CB, Legro MW, Wallace CM, et al. The role of formative evaluation in implementation research and the QUERI experience. J Gen Intern Med, 2006, 21(Suppl 2): S1-S8.
9. Stetler CB, Mittman BS, Francis J. Overview of the VA quality enhancement research initiative (QUERI) and QUERI theme articles: QUERI series. Implement Sci, 2008, 3: 8.
10. 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.
11. Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
12. Eccles MP, Mittman BS. Welcome to implementation science. Implement Sci, 2006, 1(1): 1-3.
13. Bauer MS, Kirchner J. Implementation science: What is it and why should I care. Psychiatry Res, 2020, 283: 112376.
14. Peters DH, Adam T, Alonge O, et al. Implementation research: what it is and how to do it. BMJ, 2013, 347: f6753.
15. Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI) statement. BMJ, 2017, 356: i6795.
16. Pinnock H, Barwick M, Carpenter CR, et al. Standards for reporting implementation studies (StaRI): explanation and elaboration document. BMJ Open, 2017, 7(4): e013318.
17. 邢唯杰, 朱政, 胡雁, 等. 实施性研究的报告规范(StaRI)解读. 中国循证医学杂志, 2019, 19(1): 97-101.
18. Najafzadeh M, Gagne JJ, Schneeweiss S. Synergies from integrating randomized controlled trials and real-world data analyses. Clin Pharmacol Ther, 2017, 102(6): 914-916.
19. 杨祖耀, 詹思延. 阶梯设计在随机对照试验中的应用. 中华流行病学杂志, 2010, 31(1): 92-95.
20. Grayling MJ, Wason JM, Mander AP. Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features. Trials, 2017, 18(1): 33.
21. Campbell MK, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.
22. Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 2018, 363: k1614.
23. Hamilton AB, Finley EP. Qualitative methods in implementation research: an introduction. Psychiatry Res, 2019, 280: 112516.
24. 褚红玲, 倪凯文, 曾琳, 等. 混合方法研究在真实世界研究中的应用. 中国循证医学杂志, 2018, 18(11): 1203-1206.
25. Palinkas LA, Aarons GA, Horwitz S, et al. Mixed method designs in implementation research. Adm Policy Ment Health, 2011, 38(1): 44-53.
26. Bauer MS, Miller CJ, Kim B, et al. Effectiveness of implementing a collaborative chronic care model for clinician teams on patient outcomes and health status in mental health: a randomized clinical trial. JAMA Netw Open, 2019, 2(3): e190230.
27. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care, 2007, 19(6): 349-357.
28. 费字彤, 刘建平, 于河, 等. 报告定性研究个体访谈和焦点组访谈统一标准的介绍. 中西医结合学报, 2008, 6(2): 115-118.
29. 刘凡, 段玉婷, 张轩, 等. 中医药领域定性访谈研究报告质量评价与文献分析. 中医杂志, 2020, 61(6): 528-532.
30. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health, 2011, 38(2): 65-76.
31. Damschroder LJ, Aron DC, Keith RE, et al. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci, 2009, 4: 50.
32. Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci, 2015, 10: 53.
33. Moore GF, Audrey S, Barker M, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ, 2015, 350: h1258.
34. Glasgow RE, Harden SM, Gaglio B, et al. RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health, 2019, 7: 64.
35. De Poli C, Oyebode JR, Binns C, et al. Effectiveness-implementation hybrid type 2 study evaluating an intervention to support 'information work' in dementia care: an implementation study protocol. BMJ Open, 2020, 10(12): e038397.
36. Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ, 2014, 348: g1687.

Chinese Journal of Evidence-Based Medicine

Guidelines for reporting the methods section of effectiveness-implementation hybrid design study

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