Research methods for implementation science in health care_Chinese Journal of Evidence-Based Medicine

Authors：

XIE Runsheng ^1,2 , XU Dong ³ ,  LI Hui ^1,2 , CHEN Yaolong ⁴ , DU Liang ⁵ , ZHOU Yingfeng ⁶ , JIN Yinghui ⁷

1. Key Research Department of Standardization of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine (The Second Affiliated Hospital of Guangzhou University of Chinese Medicine), Guangzhou 510120, P.R.China;
2. Engineering and Technology Research Center of Standardization of Traditional Chinese Medicine, Guangzhou 510120, P.R.China;
3. Sun Yat-sen Global Health Institute, School of Public Health, Sun Yat-sen University, Guangzhou 510275, P.R.China;
4. WHO Collaborating Center for Guideline Implementation and Knowledge Translation, Lanzhou University, Lanzhou 730000, P.R.China;
5. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P.R.China;
6. Fudan University Centre for Evidence-based Nursing: A Joanna Briggs Institute Centre of Excellence, Shanghai 200032, P.R.China;
7. Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, P.R.China;

Corresponding author：

LI Hui, Email: lihuitcm@126.com

Keywords：

Implementation science; Implementation research; Research methods; Outcomes variables; Reporting guideline

DOI：

10.7507/1672-2531.202003234

Video：

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Implementation science is a relatively emergent and growing research area. Implementation research can assist to transform what is possible in theory to reality in practice and address the challenge of implementing proven interventions in the real world. Implementation research has a wide range of usages and complex research problems, so appropriate research methods, designs, and outcomes variables are required to address different research objectives. To better conduct implementation research, this paper systematically introduces the research designs, outcome variables, and reporting guideline of the implementation research in health care, based on the purposes and research questions of implementation research.

Citation： XIE Runsheng, XU Dong, LI Hui, CHEN Yaolong, DU Liang, ZHOU Yingfeng, JIN Yinghui. Research methods for implementation science in health care. Chinese Journal of Evidence-Based Medicine, 2020, 20(9): 1104-1110. doi: 10.7507/1672-2531.202003234 Copy

1.	Bauer MS, Damschroder L, Hagedorn H, <italic>et al</italic>. An introduction to implementation science for the non-specialist. BMC Psychol, 2015, 3: 32.
2.	Ferlie EB, Shortell SM. Improving the quality of health care in the United Kingdom and the United States: a framework for change. Milbank Q, 2001, 79(2): 281-315.
3.	Burnes B. Emergent change and planned change-competitors or allies? The case of XYZ construction. Int J Oper Pro Man, 2004, 24(9): 886-902.
4.	Peters DH, Adam T, Alonge O, <italic>et al</italic>. Republished research: implementation research: what it is and how to do it. Br J Sports Med, 2014, 48(8): 731-736.
5.	Peters DH, Tran N, Adam T, et al. Implementation research in health: a practical guide. World Health Organization: Alliance for Health Policy and Systems Research, 2013.
6.	Hamilton AB, Finley EP. Qualitative methods in implementation research: An introduction. Psychiatry Res, 2019, 280: 112516.
7.	Southam-Gerow MA, Dorsey S. Qualitative and mixed methods research in dissemination and implementation science: introduction to the special issue. J Clin Child Adolesc Psychol, 2014, 43(6): 845-850.
8.	Gale RC, Wu J, Erhardt T, <italic>et al</italic>. Comparison of rapid <italic>vs</italic>. in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans’ Health Administration. Implement Sci, 2019, 14(1): 11.
9.	Brown CH, Curran G, Palinkas LA, <italic>et al</italic>. An overview of research and evaluation designs for dissemination and implementation. Annu Rev Public Health, 2017, 38: 1-22.
10.	Miller CJ, Smith SN, Pugatch M. Experimental and quasi-experimental designs in implementation research. Psychiatry Res, 2020, 283: 112452.
11.	Palinkas LA, Aarons GA, Horwitz S, <italic>et al</italic>. Mixed method designs in implementation research. Adm Policy Ment Health, 2011, 38(1): 44-53.
12.	Collins KMT, Onwuegbuzie AJ, Sutton IL. A model incorporating the rationale and purpose for conducting mixed methods research in special education and beyond. Contemp J, 2006, 4(1): 67-100.
13.	Leech NL, Onwuegbuzie AJ. Guidelines for conducting and reporting mixed research in the field of counseling and beyond. J Coun Dev, 2010, 88: 61-69.
14.	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.
15.	Copas AJ, Lewis JJ, Thompson JA, <italic>et al</italic>. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials, 2015, 16: 352.
16.	Curran GM, Bauer M, Mittman B, <italic>et al</italic>. Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care, 2012, 50(3): 217-226.
17.	Thorpe KE, Zwarenstein M, Oxman AD, <italic>et al</italic>. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol, 2009, 62(5): 464-475.
18.	Loudon K, Treweek S, Sullivan F, <italic>et al</italic>. The PRECIS-2 tool: Designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
19.	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.
20.	Handley MA, Lyles CR, McCulloch C, <italic>et al</italic>. Selecting and improving quasi-experimental designs in effectiveness and implementation research. Annu Rev Public Health, 2018, 39: 5-25.
21.	窦亚兰, 戴江红, 黄爱龙. 准试验研究. 中华流行病学杂志, 2015, 36(9): 1018-1019.
22.	Venkataramani AS, Bor J, Jena AB. Regression discontinuity designs in healthcare research. BMJ, 2016, 352: i1216.
23.	Linden A, Trochim WM, Adams JL. Evaluating program effectiveness using the regression point displacement design. Eval Health Prof, 2006, 29(4): 407-423.
24.	Cruz M, Bender M, Ombao H. A robust interrupted time series model for analyzing complex health care intervention data. Stat Med, 2017, 36(29): 4660-4676.
25.	Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol, 2017, 46(1): 348-355.
26.	Collins LM, Murphy SA, Nair VN, <italic>et al</italic>. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med, 2005, 30(1): 65-73.
27.	Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med, 2007, 32(5 Suppl): S112-S118.
28.	王婧婷, 袁长蓉. 多阶段优化策略在多因素干预研究中的应用现状与前景分析. 中华护理杂志, 2016, 51(12): 1521-1524.
29.	Murphy SA. An experimental design for the development of adaptive treatment strategies. Stat Med, 2005, 24(10): 1455-1481.
30.	Liu Y, Zeng D, Wang Y. Use of personalized dynamic treatment regimens (DTRs) and sequential multiple assignment randomized trials (SMARTs) in mental health studies. Shanghai Arch Psychiatry, 2014, 26(6): 376-383.
31.	Nahum-Shani I, Qian M, Almirall D, <italic>et al</italic>. Experimental design and primary data analysis methods for comparing adaptive interventions. Psychol Methods, 2012, 17(4): 457-477.
32.	Proctor EK, Landsverk J, Aarons G, <italic>et al</italic>. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health, 2009, 36(1): 24-34.
33.	Proctor E, Silmere H, Raghavan R, <italic>et al</italic>. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health, 2011, 38(2): 65-76.
34.	Jensen C, McKerrow NH, Wills G. Acceptability and uptake of an electronic decision-making tool to support the implementation of IMCI in primary healthcare facilities in KwaZulu-Natal, South Africa. Paediatr Int Child Health, 2019, (11): 1-12.
35.	Haug NA, Shopshire M, Tajima B, <italic>et al</italic>. Adoption of evidence-based practices among substance abuse treatment providers. J Drug Educ, 2008, 38(2): 181-192.
36.	Henggeler SW, Chapman JE, Rowland MD, <italic>et al</italic>. Statewide adoption and initial implementation of contingency management for substance-abusing adolescents. J Consult Clin Psychol, 2008, 76(4): 556-567.
37.	Smith JA, Baker-Henningham H, Brentani A, <italic>et al</italic>. Implementation of reach up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Ann N Y Acad Sci, 2018, 1419(1): 120-140.
38.	Richesson RL, Staes CJ, Douthit BJ, <italic>et al</italic>. Measuring implementation feasibility of clinical decision support alerts for clinical practice recommendations. J Am Med Inform Assoc, 2020, 27(4): 514-521.
39.	唐金陵, 杨祖耀. 观察与实验效力与效果. 中华流行病学杂志, 2014, 35(3): 221-227.
40.	Sari N, Rotter T, Goodridge D, <italic>et al</italic>. An economic analysis of a system wide lean approach: cost estimations for the implementation of Lean in the Saskatchewan healthcare system for 2012-2014. BMC Health Serv Res, 2017, 17(1): 523.
41.	McHugh RK, Otto MW, Barlow DH, <italic>et al</italic>. Cost-efficacy of individual and combined treatments for panic disorder. J Clin Psychiatry, 2007, 68(7): 1038-1044.
42.	Harter M, Lilje J, Mosler HJ. Role of implementation factors for the success of community-led total sanitation on latrine coverage. A case study from rural Ghana. Environ Sci Technol, 2019, 53(9): 5466-5472.
43.	Prusaczyk B, Mixon AS, Kripalani S. Implementation and sustainability of a pharmacy-led, hospital-wide bedside medication delivery program: a qualitative process evaluation using RE-AIM. Front Public Health, 2020, 7: 419.
44.	Pinnock H, Barwick M, Carpenter CR, <italic>et al</italic>. Standards for reporting implementation studies (StaRI) statement. BMJ, 2017, 356: i6795.
45.	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.

1. Bauer MS, Damschroder L, Hagedorn H, <italic>et al</italic>. An introduction to implementation science for the non-specialist. BMC Psychol, 2015, 3: 32.
2. Ferlie EB, Shortell SM. Improving the quality of health care in the United Kingdom and the United States: a framework for change. Milbank Q, 2001, 79(2): 281-315.
3. Burnes B. Emergent change and planned change-competitors or allies? The case of XYZ construction. Int J Oper Pro Man, 2004, 24(9): 886-902.
4. Peters DH, Adam T, Alonge O, <italic>et al</italic>. Republished research: implementation research: what it is and how to do it. Br J Sports Med, 2014, 48(8): 731-736.
5. Peters DH, Tran N, Adam T, et al. Implementation research in health: a practical guide. World Health Organization: Alliance for Health Policy and Systems Research, 2013.
6. Hamilton AB, Finley EP. Qualitative methods in implementation research: An introduction. Psychiatry Res, 2019, 280: 112516.
7. Southam-Gerow MA, Dorsey S. Qualitative and mixed methods research in dissemination and implementation science: introduction to the special issue. J Clin Child Adolesc Psychol, 2014, 43(6): 845-850.
8. Gale RC, Wu J, Erhardt T, <italic>et al</italic>. Comparison of rapid <italic>vs</italic>. in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans’ Health Administration. Implement Sci, 2019, 14(1): 11.
9. Brown CH, Curran G, Palinkas LA, <italic>et al</italic>. An overview of research and evaluation designs for dissemination and implementation. Annu Rev Public Health, 2017, 38: 1-22.
10. Miller CJ, Smith SN, Pugatch M. Experimental and quasi-experimental designs in implementation research. Psychiatry Res, 2020, 283: 112452.
11. Palinkas LA, Aarons GA, Horwitz S, <italic>et al</italic>. Mixed method designs in implementation research. Adm Policy Ment Health, 2011, 38(1): 44-53.
12. Collins KMT, Onwuegbuzie AJ, Sutton IL. A model incorporating the rationale and purpose for conducting mixed methods research in special education and beyond. Contemp J, 2006, 4(1): 67-100.
13. Leech NL, Onwuegbuzie AJ. Guidelines for conducting and reporting mixed research in the field of counseling and beyond. J Coun Dev, 2010, 88: 61-69.
14. 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.
15. Copas AJ, Lewis JJ, Thompson JA, <italic>et al</italic>. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials, 2015, 16: 352.
16. Curran GM, Bauer M, Mittman B, <italic>et al</italic>. Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care, 2012, 50(3): 217-226.
17. Thorpe KE, Zwarenstein M, Oxman AD, <italic>et al</italic>. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol, 2009, 62(5): 464-475.
18. Loudon K, Treweek S, Sullivan F, <italic>et al</italic>. The PRECIS-2 tool: Designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
19. 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.
20. Handley MA, Lyles CR, McCulloch C, <italic>et al</italic>. Selecting and improving quasi-experimental designs in effectiveness and implementation research. Annu Rev Public Health, 2018, 39: 5-25.
21. 窦亚兰, 戴江红, 黄爱龙. 准试验研究. 中华流行病学杂志, 2015, 36(9): 1018-1019.
22. Venkataramani AS, Bor J, Jena AB. Regression discontinuity designs in healthcare research. BMJ, 2016, 352: i1216.
23. Linden A, Trochim WM, Adams JL. Evaluating program effectiveness using the regression point displacement design. Eval Health Prof, 2006, 29(4): 407-423.
24. Cruz M, Bender M, Ombao H. A robust interrupted time series model for analyzing complex health care intervention data. Stat Med, 2017, 36(29): 4660-4676.
25. Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol, 2017, 46(1): 348-355.
26. Collins LM, Murphy SA, Nair VN, <italic>et al</italic>. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med, 2005, 30(1): 65-73.
27. Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med, 2007, 32(5 Suppl): S112-S118.
28. 王婧婷, 袁长蓉. 多阶段优化策略在多因素干预研究中的应用现状与前景分析. 中华护理杂志, 2016, 51(12): 1521-1524.
29. Murphy SA. An experimental design for the development of adaptive treatment strategies. Stat Med, 2005, 24(10): 1455-1481.
30. Liu Y, Zeng D, Wang Y. Use of personalized dynamic treatment regimens (DTRs) and sequential multiple assignment randomized trials (SMARTs) in mental health studies. Shanghai Arch Psychiatry, 2014, 26(6): 376-383.
31. Nahum-Shani I, Qian M, Almirall D, <italic>et al</italic>. Experimental design and primary data analysis methods for comparing adaptive interventions. Psychol Methods, 2012, 17(4): 457-477.
32. Proctor EK, Landsverk J, Aarons G, <italic>et al</italic>. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health, 2009, 36(1): 24-34.
33. Proctor E, Silmere H, Raghavan R, <italic>et al</italic>. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health, 2011, 38(2): 65-76.
34. Jensen C, McKerrow NH, Wills G. Acceptability and uptake of an electronic decision-making tool to support the implementation of IMCI in primary healthcare facilities in KwaZulu-Natal, South Africa. Paediatr Int Child Health, 2019, (11): 1-12.
35. Haug NA, Shopshire M, Tajima B, <italic>et al</italic>. Adoption of evidence-based practices among substance abuse treatment providers. J Drug Educ, 2008, 38(2): 181-192.
36. Henggeler SW, Chapman JE, Rowland MD, <italic>et al</italic>. Statewide adoption and initial implementation of contingency management for substance-abusing adolescents. J Consult Clin Psychol, 2008, 76(4): 556-567.
37. Smith JA, Baker-Henningham H, Brentani A, <italic>et al</italic>. Implementation of reach up early childhood parenting program: acceptability, appropriateness, and feasibility in Brazil and Zimbabwe. Ann N Y Acad Sci, 2018, 1419(1): 120-140.
38. Richesson RL, Staes CJ, Douthit BJ, <italic>et al</italic>. Measuring implementation feasibility of clinical decision support alerts for clinical practice recommendations. J Am Med Inform Assoc, 2020, 27(4): 514-521.
39. 唐金陵, 杨祖耀. 观察与实验效力与效果. 中华流行病学杂志, 2014, 35(3): 221-227.
40. Sari N, Rotter T, Goodridge D, <italic>et al</italic>. An economic analysis of a system wide lean approach: cost estimations for the implementation of Lean in the Saskatchewan healthcare system for 2012-2014. BMC Health Serv Res, 2017, 17(1): 523.
41. McHugh RK, Otto MW, Barlow DH, <italic>et al</italic>. Cost-efficacy of individual and combined treatments for panic disorder. J Clin Psychiatry, 2007, 68(7): 1038-1044.
42. Harter M, Lilje J, Mosler HJ. Role of implementation factors for the success of community-led total sanitation on latrine coverage. A case study from rural Ghana. Environ Sci Technol, 2019, 53(9): 5466-5472.
43. Prusaczyk B, Mixon AS, Kripalani S. Implementation and sustainability of a pharmacy-led, hospital-wide bedside medication delivery program: a qualitative process evaluation using RE-AIM. Front Public Health, 2020, 7: 419.
44. Pinnock H, Barwick M, Carpenter CR, <italic>et al</italic>. Standards for reporting implementation studies (StaRI) statement. BMJ, 2017, 356: i6795.
45. 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.

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