A new framework for developing and evaluating complex interventions: interpretation of the 2021 update of Medical Research Council framework_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHAO Yanli ¹ , LI Yingying ² , LI Qiufang ¹ , WANG Xiaokai ¹ , LIU Lamei ¹

1. School of Nursing and Health, Zhengzhou University, Zhengzhou 450001, P. R. China;
2. Department of Hematology, Henan Provincial People’s Hospital, Zhengzhou 450003, P. R. China;

Corresponding author：

ZHAO Yanli, Email: zhaoyanli86@126.com

Keywords：

Complex intervention; Development; Evaluation

DOI：

10.7507/1672-2531.202207029

Video：

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Complex interventions are commonly used in health and social care services, public health practice, and other areas of social and economic policy that have consequences for health. Due to the multiple components of interventions, the complicated mechanisms of change, the diversity of the population involved, and the interaction between the intervention and the context in which it is implemented, the appropriate development and evaluation of complex interventions has become increasingly critical. The UK Medical Research Council published a framework for developing and evaluating complex interventions. The aim of this article is to introduce and interpret the framework to provide guidance on the development and evaluation of complex interventions for domestic researchers.

Citation： ZHAO Yanli, LI Yingying, LI Qiufang, WANG Xiaokai, LIU Lamei. A new framework for developing and evaluating complex interventions: interpretation of the 2021 update of Medical Research Council framework. Chinese Journal of Evidence-Based Medicine, 2023, 23(2): 125-132. doi: 10.7507/1672-2531.202207029 Copy

1.	Campbell M, Fitzpatrick R, Haines A, et al. Framework for design and evaluation of complex interventions to improve health. BMJ, 2000, 321(7262): 694-696.
2.	Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ, 2008, 337: a1655.
3.	Skivington K, Matthews L, Simpson SA, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ, 2021, 374: n2061.
4.	Guise JM, Chang C, Butler M, et al. AHRQ series on complex intervention systematic reviews-paper 1: an introduction to a series of articles that provide guidance and tools for reviews of complex interventions. J Clin Epidemiol, 2017, 90: 6-10.
5.	Hardeman W, Sutton S, Griffin S, et al. A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation. Health Educ Res, 2005, 20(6): 676-687.
6.	Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to improve health care. BMJ, 2007, 334(7591): 455-459.
7.	Oakley A, Strange V, Bonell C, et al. Process evaluation in randomised controlled trials of complex interventions. BMJ, 2006, 332(7538): 413-416.
8.	Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med, 2007, 26(1): 2-19.
9.	Shiell A, Hawe P, Gold L. Complex interventions or complex systems. Implications for health economic evaluation. BMJ, 2008, 336(7656): 1281-1283.
10.	刘淼, 洪志恒, 詹思延. 复杂干预的设计和评价. 中华流行病学杂志, 2010, 31(12): 1410-1413.
11.	Moore GF, Audrey S, Barker M, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ, 2015, 350: h1258.
12.	褚红玲, 曾琳, 赵一鸣, 等. 复杂干预研究的过程评价指南解读. 中国循证医学杂志, 2020, 20(11): 1353-1358.
13.	Skivington K, Matthews L, Simpson SA, et al. Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update. Health Technol Assess, 2021, 25(57): 1-132.
14.	Philliber S, Kaye JW, Herrling S, et al. Preventing pregnancy and improving health care access among teenagers: an evaluation of the children's aid society-carrera program. Perspect Sex Reprod Health, 2002, 34(5): 244-251.
15.	Wiggins M, Bonell C, Sawtell M, et al. Health outcomes of youth development programme in England: prospective matched comparison study. BMJ, 2009, 339: b2534.
16.	Hoddinott P, Britten J, Pill R. Why do interventions work in some places and not others: a breastfeeding support group trial. Soc Sci Med, 2010, 70(5): 769-778.
17.	Yardley L, Ainsworth B, Arden-Close E, et al. The person-based approach to enhancing the acceptability and feasibility of interventions. Pilot Feasibility Stud, 2015, 1: 37.
18.	O'Cathain A, Croot L, Duncan E, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open, 2019, 9(8): e029954.
19.	Hawkes RE, Miles LM, French DP. The theoretical basis of a nationally implemented type 2 diabetes prevention programme: how is the programme expected to produce changes in behaviour. Int J Behav Nutr Phys Act, 2021, 18(1): 64.
20.	Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud, 2016, 2: 64.
21.	Thabane L, Hopewell S, Lancaster GA, et al. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud, 2016, 2: 25.
22.	Burnett T, Mozgunov P, Pallmann P, et al. Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs. BMC Med, 2020, 18(1): 352.
23.	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): S112-118.
24.	McDonald S, Quinn F, Vieira R, et al. The state of the art and future opportunities for using longitudinal n-of-1 methods in health behaviour research: a systematic literature overview. Health Psychol Rev, 2017, 11(4): 307-323.
25.	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.
26.	Tugwell P, Knottnerus JA, McGowan J, et al. Big-5 Quasi-Experimental designs. J Clin Epidemiol, 2017, 89: 1-3.
27.	Craig P, Cooper C, Gunnell D, et al. Using natural experiments to evaluate population health interventions: new Medical Research Council guidance. J Epidemiol Community Health, 2012, 66(12): 1182-1186.
28.	Egan M, McGill E, Penney T, et al. Guidance on systems approaches to local public health evaluation. Part 1: introducing systems thinking. NIHR School for Public Health Research, 2019. Available at: https://sphr.nihr.ac.uk/wp-content/uploads/2018/08/NIHR-SPHR-SYSTEM-GUIDANCE-PART-1-FINAL_SBnavy.pdf.
29.	Bicket M, Christie I, Gilbert N, et al. Magenta book 2020 supplementary guide: handling complexity in policy evaluation. Lond HM Treas, 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/879437/Magenta_Book_supplementary_guide._Handling_Complexity_in_policy_evaluation.pdf.
30.	Campbell R, Starkey F, Holliday J, et al. An informal school-based peer-led intervention for smoking prevention in adolescence (ASSIST): a cluster randomised trial. Lancet, 2008, 371(9624): 1595-1602.
31.	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.
32.	Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res, 2019, 280: 112513.

1. Campbell M, Fitzpatrick R, Haines A, et al. Framework for design and evaluation of complex interventions to improve health. BMJ, 2000, 321(7262): 694-696.
2. Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ, 2008, 337: a1655.
3. Skivington K, Matthews L, Simpson SA, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ, 2021, 374: n2061.
4. Guise JM, Chang C, Butler M, et al. AHRQ series on complex intervention systematic reviews-paper 1: an introduction to a series of articles that provide guidance and tools for reviews of complex interventions. J Clin Epidemiol, 2017, 90: 6-10.
5. Hardeman W, Sutton S, Griffin S, et al. A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation. Health Educ Res, 2005, 20(6): 676-687.
6. Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to improve health care. BMJ, 2007, 334(7591): 455-459.
7. Oakley A, Strange V, Bonell C, et al. Process evaluation in randomised controlled trials of complex interventions. BMJ, 2006, 332(7538): 413-416.
8. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med, 2007, 26(1): 2-19.
9. Shiell A, Hawe P, Gold L. Complex interventions or complex systems. Implications for health economic evaluation. BMJ, 2008, 336(7656): 1281-1283.
10. 刘淼, 洪志恒, 詹思延. 复杂干预的设计和评价. 中华流行病学杂志, 2010, 31(12): 1410-1413.
11. Moore GF, Audrey S, Barker M, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ, 2015, 350: h1258.
12. 褚红玲, 曾琳, 赵一鸣, 等. 复杂干预研究的过程评价指南解读. 中国循证医学杂志, 2020, 20(11): 1353-1358.
13. Skivington K, Matthews L, Simpson SA, et al. Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update. Health Technol Assess, 2021, 25(57): 1-132.
14. Philliber S, Kaye JW, Herrling S, et al. Preventing pregnancy and improving health care access among teenagers: an evaluation of the children's aid society-carrera program. Perspect Sex Reprod Health, 2002, 34(5): 244-251.
15. Wiggins M, Bonell C, Sawtell M, et al. Health outcomes of youth development programme in England: prospective matched comparison study. BMJ, 2009, 339: b2534.
16. Hoddinott P, Britten J, Pill R. Why do interventions work in some places and not others: a breastfeeding support group trial. Soc Sci Med, 2010, 70(5): 769-778.
17. Yardley L, Ainsworth B, Arden-Close E, et al. The person-based approach to enhancing the acceptability and feasibility of interventions. Pilot Feasibility Stud, 2015, 1: 37.
18. O'Cathain A, Croot L, Duncan E, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open, 2019, 9(8): e029954.
19. Hawkes RE, Miles LM, French DP. The theoretical basis of a nationally implemented type 2 diabetes prevention programme: how is the programme expected to produce changes in behaviour. Int J Behav Nutr Phys Act, 2021, 18(1): 64.
20. Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud, 2016, 2: 64.
21. Thabane L, Hopewell S, Lancaster GA, et al. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud, 2016, 2: 25.
22. Burnett T, Mozgunov P, Pallmann P, et al. Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs. BMC Med, 2020, 18(1): 352.
23. 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): S112-118.
24. McDonald S, Quinn F, Vieira R, et al. The state of the art and future opportunities for using longitudinal n-of-1 methods in health behaviour research: a systematic literature overview. Health Psychol Rev, 2017, 11(4): 307-323.
25. 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.
26. Tugwell P, Knottnerus JA, McGowan J, et al. Big-5 Quasi-Experimental designs. J Clin Epidemiol, 2017, 89: 1-3.
27. Craig P, Cooper C, Gunnell D, et al. Using natural experiments to evaluate population health interventions: new Medical Research Council guidance. J Epidemiol Community Health, 2012, 66(12): 1182-1186.
28. Egan M, McGill E, Penney T, et al. Guidance on systems approaches to local public health evaluation. Part 1: introducing systems thinking. NIHR School for Public Health Research, 2019. Available at: https://sphr.nihr.ac.uk/wp-content/uploads/2018/08/NIHR-SPHR-SYSTEM-GUIDANCE-PART-1-FINAL_SBnavy.pdf.
29. Bicket M, Christie I, Gilbert N, et al. Magenta book 2020 supplementary guide: handling complexity in policy evaluation. Lond HM Treas, 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/879437/Magenta_Book_supplementary_guide._Handling_Complexity_in_policy_evaluation.pdf.
30. Campbell R, Starkey F, Holliday J, et al. An informal school-based peer-led intervention for smoking prevention in adolescence (ASSIST): a cluster randomised trial. Lancet, 2008, 371(9624): 1595-1602.
31. 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.
32. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res, 2019, 280: 112513.

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