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Published in: Trials 1/2023

Open Access 01-12-2023 | Commentary

What is the role of randomised trials in implementation science?

Authors: Robbie Foy, Noah M. Ivers, Jeremy M. Grimshaw, Paul M. Wilson

Published in: Trials | Issue 1/2023

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Abstract

Background

There is a consistent demand for implementation science to inform global efforts to close the gap between evidence and practice. Key evaluation questions for any given implementation strategy concern the assessment and understanding of effects. Randomised trials are generally accepted as offering the most trustworthy design for establishing effectiveness but may be underused in implementation science.

Main body

There is a continuing debate about the primacy of the place of randomised trials in evaluating implementation strategies, especially given the evolution of more rigorous quasi-experimental designs. Further critiques of trials for implementation science highlight that they cannot provide ‘real world’ evidence, address urgent and important questions, explain complex interventions nor understand contextual influences. We respond to these critiques of trials and highlight opportunities to enhance their timeliness and relevance through innovative designs, embedding within large-scale improvement programmes and harnessing routine data.
Our suggestions for optimising the conditions for randomised trials of implementation strategies include strengthening partnerships with policy-makers and clinical leaders to realise the long-term value of rigorous evaluation and accelerating ethical approvals and decluttering governance procedures for lower risk studies.

Conclusion

Policy-makers and researchers should avoid prematurely discarding trial designs when evaluating implementation strategies and work to enhance the conditions for their conduct.
Literature
1.
go back to reference Seddon ME, Marshall MN, Campbell SM, Roland MO. Systematic review of studies of quality of clinical care in general practice in the UK, Australia and New Zealand. Qual Health Care. 2001;10:152–8.PubMedPubMedCentralCrossRef Seddon ME, Marshall MN, Campbell SM, Roland MO. Systematic review of studies of quality of clinical care in general practice in the UK, Australia and New Zealand. Qual Health Care. 2001;10:152–8.PubMedPubMedCentralCrossRef
2.
go back to reference Steel N, Bachmann M, Maisey S, Shekelle P, Breeze E, Marmot M, Melzer D. Self reported receipt of care consistent with 32 quality indicators: national population survey of adults aged 50 or more in England. Bmj. 2008;337:a957.PubMedPubMedCentralCrossRef Steel N, Bachmann M, Maisey S, Shekelle P, Breeze E, Marmot M, Melzer D. Self reported receipt of care consistent with 32 quality indicators: national population survey of adults aged 50 or more in England. Bmj. 2008;337:a957.PubMedPubMedCentralCrossRef
3.
go back to reference Zeitlin J, Manktelow BN, Piedvache A, Cuttini M, Boyle E, van Heijst A, Gadzinowski J, Van Reempts P, Huusom L, Weber T, et al. Use of evidence based practices to improve survival without severe morbidity for very preterm infants: results from the EPICE population based cohort. Bmj. 2016;354:i2976.PubMedPubMedCentralCrossRef Zeitlin J, Manktelow BN, Piedvache A, Cuttini M, Boyle E, van Heijst A, Gadzinowski J, Van Reempts P, Huusom L, Weber T, et al. Use of evidence based practices to improve survival without severe morbidity for very preterm infants: results from the EPICE population based cohort. Bmj. 2016;354:i2976.PubMedPubMedCentralCrossRef
4.
go back to reference Wright AA, Cronin A, Milne DE, Bookman MA, Burger RA, Cohn DE, Cristea MC, Griggs JJ, Keating NL, Levenback CF, et al. Use and effectiveness of intraperitoneal chemotherapy for treatment of ovarian cancer. J Clin Oncol. 2015;33(26):2841–7.PubMedPubMedCentralCrossRef Wright AA, Cronin A, Milne DE, Bookman MA, Burger RA, Cohn DE, Cristea MC, Griggs JJ, Keating NL, Levenback CF, et al. Use and effectiveness of intraperitoneal chemotherapy for treatment of ovarian cancer. J Clin Oncol. 2015;33(26):2841–7.PubMedPubMedCentralCrossRef
5.
go back to reference Chung SC, Sundstrom J, Gale CP, James S, Deanfield J, Wallentin L, Timmis A, Jernberg T, Hemingway H. Comparison of hospital variation in acute myocardial infarction care and outcome between Sweden and United Kingdom: population based cohort study using nationwide clinical registries. BMJ. 2015;351:h3913.PubMedPubMedCentralCrossRef Chung SC, Sundstrom J, Gale CP, James S, Deanfield J, Wallentin L, Timmis A, Jernberg T, Hemingway H. Comparison of hospital variation in acute myocardial infarction care and outcome between Sweden and United Kingdom: population based cohort study using nationwide clinical registries. BMJ. 2015;351:h3913.PubMedPubMedCentralCrossRef
6.
go back to reference Levine DM, Linder JA, Landon BE. The quality of outpatient care delivered to adults in the United States, 2002 to 2013. JAMA Intern Med. 2016;176(12):1778–90. Levine DM, Linder JA, Landon BE. The quality of outpatient care delivered to adults in the United States, 2002 to 2013. JAMA Intern Med. 2016;176(12):1778–90.
7.
go back to reference Turner GM, Calvert M, Feltham MG, Ryan R, Fitzmaurice D, Cheng KK, Marshall T. Under-prescribing of prevention drugs and primary prevention of stroke and transient ischaemic attack in UK general practice: a retrospective analysis. PLoS Med. 2016;13(11): e1002169. Turner GM, Calvert M, Feltham MG, Ryan R, Fitzmaurice D, Cheng KK, Marshall T. Under-prescribing of prevention drugs and primary prevention of stroke and transient ischaemic attack in UK general practice: a retrospective analysis. PLoS Med. 2016;13(11): e1002169.
8.
go back to reference Bucholz EM, Butala NM, Normand SL, Wang Y, Krumholz HM. Association of guideline-based admission treatments and life expectancy after myocardial infarction in elderly medicare beneficiaries. J Am Coll Cardiol. 2016;67(20):2378–91.PubMedPubMedCentralCrossRef Bucholz EM, Butala NM, Normand SL, Wang Y, Krumholz HM. Association of guideline-based admission treatments and life expectancy after myocardial infarction in elderly medicare beneficiaries. J Am Coll Cardiol. 2016;67(20):2378–91.PubMedPubMedCentralCrossRef
9.
go back to reference Serumaga B, Ross-Degnan D, Avery A, Elliott R, Majumdar SR, Zhang F, Soumerai SB. Effect of pay for performance on the management and outcomes of hypertension in the United Kingdom: interrupted time series study. BMJ. 2011;342:d108.PubMedPubMedCentralCrossRef Serumaga B, Ross-Degnan D, Avery A, Elliott R, Majumdar SR, Zhang F, Soumerai SB. Effect of pay for performance on the management and outcomes of hypertension in the United Kingdom: interrupted time series study. BMJ. 2011;342:d108.PubMedPubMedCentralCrossRef
10.
go back to reference Campbell SM, Roland MO, Middleton E, Reeves D. Improvements in quality of clinical care in English general practice 1998–2003: longitudinal observational study. BMJ. 2005;331(7525):1121.PubMedPubMedCentralCrossRef Campbell SM, Roland MO, Middleton E, Reeves D. Improvements in quality of clinical care in English general practice 1998–2003: longitudinal observational study. BMJ. 2005;331(7525):1121.PubMedPubMedCentralCrossRef
11.
go back to reference Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010–2011. JAMA. 2016;315(17):1864–73.PubMedCrossRef Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010–2011. JAMA. 2016;315(17):1864–73.PubMedCrossRef
12.
go back to reference Foy R, Leaman B, McCrorie C, Petty D, House A, Bennett M, Carder P, Faulkner S, Glidewell L, West R. Prescribed opioids in primary care: cross-sectional and longitudinal analyses of influence of patient and practice characteristics. BMJ Open. 2016;6(5):e010276.PubMedPubMedCentralCrossRef Foy R, Leaman B, McCrorie C, Petty D, House A, Bennett M, Carder P, Faulkner S, Glidewell L, West R. Prescribed opioids in primary care: cross-sectional and longitudinal analyses of influence of patient and practice characteristics. BMJ Open. 2016;6(5):e010276.PubMedPubMedCentralCrossRef
13.
go back to reference Yamey G, Garcia P, Hassan F, Mao W, McDade KK, Pai M, Saha S, Schellekens P, Taylor A, Udayakumar K. It is not too late to achieve global covid-19 vaccine equity. BMJ. 2022;376:e070650.PubMedPubMedCentralCrossRef Yamey G, Garcia P, Hassan F, Mao W, McDade KK, Pai M, Saha S, Schellekens P, Taylor A, Udayakumar K. It is not too late to achieve global covid-19 vaccine equity. BMJ. 2022;376:e070650.PubMedPubMedCentralCrossRef
14.
go back to reference Cooksey R. A review of UK health research funding. Norwich: HMSO; 2006. Accessed 4 Sept 2022. Cooksey R. A review of UK health research funding. Norwich: HMSO; 2006. Accessed 4 Sept 2022.
15.
go back to reference Roland M. Linking physicians’ pay to the quality of care – a major experiment in the United Kingdom. N Engl J Med. 2004;351:1448–54.PubMedCrossRef Roland M. Linking physicians’ pay to the quality of care – a major experiment in the United Kingdom. N Engl J Med. 2004;351:1448–54.PubMedCrossRef
16.
go back to reference Ryan AM, Krinsky S, Kontopantelis E, Doran T. Long-term evidence for the effect of pay-for-performance in primary care on mortality in the UK: a population study. Lancet. 2016;388(10041):268–74. Ryan AM, Krinsky S, Kontopantelis E, Doran T. Long-term evidence for the effect of pay-for-performance in primary care on mortality in the UK: a population study. Lancet. 2016;388(10041):268–74.
17.
go back to reference Auerbach A, Landefeld C, Shojania K. The tension between needing to improve care and knowing how to do it. N Engl J Med. 2007;357:608–13.PubMedCrossRef Auerbach A, Landefeld C, Shojania K. The tension between needing to improve care and knowing how to do it. N Engl J Med. 2007;357:608–13.PubMedCrossRef
18.
go back to reference Foy R, Eccles M, Grimshaw J. Why does primary care need more implementation research? Family Practice. 2001;18:353–5.PubMedCrossRef Foy R, Eccles M, Grimshaw J. Why does primary care need more implementation research? Family Practice. 2001;18:353–5.PubMedCrossRef
20.
go back to reference Furler J, O’Neal D, Speight J, Manski-Nankervis J-A, Gorelik A, Holmes-Truscott E, Ginnivan L, Young D, Best J, Patterson E, et al. Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial. BMJ. 2017;356:j783.PubMedPubMedCentralCrossRef Furler J, O’Neal D, Speight J, Manski-Nankervis J-A, Gorelik A, Holmes-Truscott E, Ginnivan L, Young D, Best J, Patterson E, et al. Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial. BMJ. 2017;356:j783.PubMedPubMedCentralCrossRef
21.
go back to reference Eccles M, Steen N, Grimshaw J, Thomas L, McNamee P, Soutter J, Wilsdon J, Matowe L, Needham G, Gilbert F, et al. Effect of audit and feedback, and reminder messages on primary-care radiology referrals: a randomised trial. Lancet. 2001;357:1406–9.PubMedCrossRef Eccles M, Steen N, Grimshaw J, Thomas L, McNamee P, Soutter J, Wilsdon J, Matowe L, Needham G, Gilbert F, et al. Effect of audit and feedback, and reminder messages on primary-care radiology referrals: a randomised trial. Lancet. 2001;357:1406–9.PubMedCrossRef
22.
go back to reference Eccles M, Grimshaw JM, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and quality improvement strategies. Qual Saf Health Care. 2003;12:47–52.PubMedPubMedCentralCrossRef Eccles M, Grimshaw JM, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and quality improvement strategies. Qual Saf Health Care. 2003;12:47–52.PubMedPubMedCentralCrossRef
23.
go back to reference Wolfenden L, Foy R, Presseau J, Grimshaw JM, Ivers NM, Powell BJ, Taljaard M, Wiggers J, Sutherland R, Nathan N, et al. Designing and undertaking randomised implementation trials: guide for researchers. BMJ. 2021;372:m3721.PubMedPubMedCentralCrossRef Wolfenden L, Foy R, Presseau J, Grimshaw JM, Ivers NM, Powell BJ, Taljaard M, Wiggers J, Sutherland R, Nathan N, et al. Designing and undertaking randomised implementation trials: guide for researchers. BMJ. 2021;372:m3721.PubMedPubMedCentralCrossRef
24.
go back to reference Davies HTO (ed), Nutley S (ed), Smith PC (ed). What works? Evidence-based policy and practice in public services. Bristol: Policy Press; 2000. Davies HTO (ed), Nutley S (ed), Smith PC (ed). What works? Evidence-based policy and practice in public services. Bristol: Policy Press; 2000.
25.
go back to reference Berwick DM. The science of improvement. JAMA. 2008;283:2275–80. Berwick DM. The science of improvement. JAMA. 2008;283:2275–80.
26.
go back to reference Oliver D. Should practical quality improvement have parity of esteem with evidence based medicine? BMJ. 2017;357:j2582.PubMedCrossRef Oliver D. Should practical quality improvement have parity of esteem with evidence based medicine? BMJ. 2017;357:j2582.PubMedCrossRef
27.
go back to reference Lamont T, Barber N, de Pury J, Fulop N, Garfield-Birkbeck S, Lilford R, Mear L, Raine R, Fitzpatrick R. New approaches to evaluating complex health and care systems. BMJ. 2016;352:i154.PubMedCrossRef Lamont T, Barber N, de Pury J, Fulop N, Garfield-Birkbeck S, Lilford R, Mear L, Raine R, Fitzpatrick R. New approaches to evaluating complex health and care systems. BMJ. 2016;352:i154.PubMedCrossRef
29.
go back to reference Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.PubMedPubMedCentralCrossRef Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.PubMedPubMedCentralCrossRef
30.
go back to reference Soumerai SB, McLaughlin TJ, Avorn J. Improving drug prescribing in primary care: a critical analysis of the experimental literature. Milbank Q. 1989;67:268–317.PubMedCrossRef Soumerai SB, McLaughlin TJ, Avorn J. Improving drug prescribing in primary care: a critical analysis of the experimental literature. Milbank Q. 1989;67:268–317.PubMedCrossRef
31.
go back to reference Foy R, Hempel S, Rubenstein L, Suttorp M, Seelig M, Shanman R, Shekelle P. Meta-analysis: effect of interactive communication between collaborating primary care physicians and specialists. Ann Intern Med. 2010;152:247–58.PubMedCrossRef Foy R, Hempel S, Rubenstein L, Suttorp M, Seelig M, Shanman R, Shekelle P. Meta-analysis: effect of interactive communication between collaborating primary care physicians and specialists. Ann Intern Med. 2010;152:247–58.PubMedCrossRef
32.
go back to reference Kontopantelis E, Doran T, Springate DA, Buchan I, Reeves D. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ. 2015;350:h2750.PubMedPubMedCentralCrossRef Kontopantelis E, Doran T, Springate DA, Buchan I, Reeves D. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ. 2015;350:h2750.PubMedPubMedCentralCrossRef
34.
go back to reference Barnighausen T, Tugwell P, Rottingen JA, Shemilt I, Rockers P, Geldsetzer P, Lavis J, Grimshaw J, Daniels K, Brown A, et al. Quasi-experimental study designs series-paper 4: uses and value. J Clin Epidemiol. 2017;89:21–9.PubMedCrossRef Barnighausen T, Tugwell P, Rottingen JA, Shemilt I, Rockers P, Geldsetzer P, Lavis J, Grimshaw J, Daniels K, Brown A, et al. Quasi-experimental study designs series-paper 4: uses and value. J Clin Epidemiol. 2017;89:21–9.PubMedCrossRef
35.
go back to reference Barr B, Zhang X, Green M, Buchan I. A blueprint for synthetic control methodology: a causal inference tool for evaluating natural experiments in population health. BMJ. 2022;379:o2712.PubMedCrossRef Barr B, Zhang X, Green M, Buchan I. A blueprint for synthetic control methodology: a causal inference tool for evaluating natural experiments in population health. BMJ. 2022;379:o2712.PubMedCrossRef
36.
go back to reference Fretheim A, Zhang F, Ross-Degnan D, Oxman AD, Cheyne H, Foy R, Goodacre S, Herrin J, Kerse N, McKinlay RJ, et al. A reanalysis of cluster randomized trials showed interrupted time-series studies were valuable in health system evaluation. J Clin Epidemiol. 2015;68(3):324–33.PubMedCrossRef Fretheim A, Zhang F, Ross-Degnan D, Oxman AD, Cheyne H, Foy R, Goodacre S, Herrin J, Kerse N, McKinlay RJ, et al. A reanalysis of cluster randomized trials showed interrupted time-series studies were valuable in health system evaluation. J Clin Epidemiol. 2015;68(3):324–33.PubMedCrossRef
37.
go back to reference Morales DR, Minchin M, Kontopantelis E, Roland M, Sutton M, Guthrie B. Estimated impact from the withdrawal of primary care financial incentives on selected indicators of quality of care in Scotland: controlled interrupted time series analysis. BMJ. 2023;380:e072098.PubMedPubMedCentralCrossRef Morales DR, Minchin M, Kontopantelis E, Roland M, Sutton M, Guthrie B. Estimated impact from the withdrawal of primary care financial incentives on selected indicators of quality of care in Scotland: controlled interrupted time series analysis. BMJ. 2023;380:e072098.PubMedPubMedCentralCrossRef
39.
go back to reference Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.PubMedPubMedCentralCrossRef Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.PubMedPubMedCentralCrossRef
40.
go back to reference Willis TA, Collinson M, Glidewell L, Farrin AJ, Holland M, Meads D, Hulme C, Petty D, Alderson S, Hartley S, et al. An adaptable implementation package targeting evidence-based indicators in primary care: a pragmatic cluster-randomised evaluation. PLOS Med. 2020;17(2):e1003045.PubMedPubMedCentralCrossRef Willis TA, Collinson M, Glidewell L, Farrin AJ, Holland M, Meads D, Hulme C, Petty D, Alderson S, Hartley S, et al. An adaptable implementation package targeting evidence-based indicators in primary care: a pragmatic cluster-randomised evaluation. PLOS Med. 2020;17(2):e1003045.PubMedPubMedCentralCrossRef
42.
go back to reference Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.PubMedCrossRef Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.PubMedCrossRef
43.
go back to reference Elouafkaoui P, Young L, Newlands R, Duncan EM, Elders A, Clarkson JE. An audit and feedback intervention for reducing antibiotic prescribing in general dental practice: the RAPiD cluster randomised controlled trial. PLoS Med. 2016;13(8):e1002115. Elouafkaoui P, Young L, Newlands R, Duncan EM, Elders A, Clarkson JE. An audit and feedback intervention for reducing antibiotic prescribing in general dental practice: the RAPiD cluster randomised controlled trial. PLoS Med. 2016;13(8):e1002115.
44.
go back to reference Shadish WR, Cook TD, Campbell DT. Experimental and quasi-experimental designs for generalised causal inference. Boston: Houghton Mifflin Company; 2002. Shadish WR, Cook TD, Campbell DT. Experimental and quasi-experimental designs for generalised causal inference. Boston: Houghton Mifflin Company; 2002.
45.
go back to reference Fleming PJ, Gilbert R, Azaz Y, Berry PJ, Rudd PT, Stewart A, Hall E. Interaction between bedding and sleeping position in the sudden infant death syndrome: a population based case-control study. BMJ. 1990;301(6743):85–9.PubMedPubMedCentralCrossRef Fleming PJ, Gilbert R, Azaz Y, Berry PJ, Rudd PT, Stewart A, Hall E. Interaction between bedding and sleeping position in the sudden infant death syndrome: a population based case-control study. BMJ. 1990;301(6743):85–9.PubMedPubMedCentralCrossRef
46.
go back to reference Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust; 1972. Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust; 1972.
47.
go back to reference Edwards P, Arango M, Balica L, Cottingham R, El-Sayed H, Farrell B, Fernandes J, Gogichaisvili T, Golden N, Hartzenberg B, et al. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet. 2005;365(9475):1957–9.PubMedCrossRef Edwards P, Arango M, Balica L, Cottingham R, El-Sayed H, Farrell B, Fernandes J, Gogichaisvili T, Golden N, Hartzenberg B, et al. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet. 2005;365(9475):1957–9.PubMedCrossRef
48.
go back to reference The AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015;386(9988):46–55. The AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015;386(9988):46–55.
49.
go back to reference Elshaug AG, Watt AM, Mundy L, Willis CD. Over 150 potentially low-value health care practices: an Australian study. Med J Aust. 2012;197(10):556–60.PubMedCrossRef Elshaug AG, Watt AM, Mundy L, Willis CD. Over 150 potentially low-value health care practices: an Australian study. Med J Aust. 2012;197(10):556–60.PubMedCrossRef
51.
go back to reference Wilson PM, Boaden R, Harvey G. Plans to accelerate innovation in health systems are less than IDEAL. BMJ Qual Saf. 2016;25(8):572–6.PubMedCrossRef Wilson PM, Boaden R, Harvey G. Plans to accelerate innovation in health systems are less than IDEAL. BMJ Qual Saf. 2016;25(8):572–6.PubMedCrossRef
52.
go back to reference Westlake D, Tierney S, Wong G, Mahtani KR. Social prescribing in the NHS—is it too soon to judge its value? BMJ. 2023;380: p699.CrossRef Westlake D, Tierney S, Wong G, Mahtani KR. Social prescribing in the NHS—is it too soon to judge its value? BMJ. 2023;380: p699.CrossRef
53.
go back to reference Klein R. The new politics of the National Health Service. London: Longman Publishing Group; 1995. Klein R. The new politics of the National Health Service. London: Longman Publishing Group; 1995.
54.
go back to reference Al-Shahi Salman R, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, Macleod M, Wisely J, Chalmers I. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383(9912):176–85.PubMedCrossRef Al-Shahi Salman R, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, Macleod M, Wisely J, Chalmers I. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383(9912):176–85.PubMedCrossRef
55.
go back to reference Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, et al. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet. 2011;378(9804):1699–706.PubMedCrossRef Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, et al. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet. 2011;378(9804):1699–706.PubMedCrossRef
56.
go back to reference Middleton S, Coughlan K, Mnatzaganian G, Low Choy N, Dale S, Jammali-Blasi A, Levi C, Grimshaw JM, Ward J, Cadilhac DA, et al. Mortality reduction for fever, hyperglycemia, and swallowing nurse-initiated stroke intervention: QASC Trial (Quality in Acute Stroke Care) follow-up. Stroke. 2017;48(5):1331–6.PubMedCrossRef Middleton S, Coughlan K, Mnatzaganian G, Low Choy N, Dale S, Jammali-Blasi A, Levi C, Grimshaw JM, Ward J, Cadilhac DA, et al. Mortality reduction for fever, hyperglycemia, and swallowing nurse-initiated stroke intervention: QASC Trial (Quality in Acute Stroke Care) follow-up. Stroke. 2017;48(5):1331–6.PubMedCrossRef
57.
go back to reference Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.PubMedPubMedCentralCrossRef Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.PubMedPubMedCentralCrossRef
58.
go back to reference Morris S, Hunter RM, Ramsay AI, Boaden R, McKevitt C, Perry C, Pursani N, Rudd AG, Schwamm LH, Turner SJ, et al. Impact of centralising acute stroke services in English metropolitan areas on mortality and length of hospital stay: difference-in-differences analysis. BMJ. 2014;349:g4757.PubMedPubMedCentralCrossRef Morris S, Hunter RM, Ramsay AI, Boaden R, McKevitt C, Perry C, Pursani N, Rudd AG, Schwamm LH, Turner SJ, et al. Impact of centralising acute stroke services in English metropolitan areas on mortality and length of hospital stay: difference-in-differences analysis. BMJ. 2014;349:g4757.PubMedPubMedCentralCrossRef
59.
go back to reference Shojania KG. Conventional evaluations of improvement interventions: more trials or just more tribulations? BMJ Qual Saf. 2013;22(11):881–4.PubMedCrossRef Shojania KG. Conventional evaluations of improvement interventions: more trials or just more tribulations? BMJ Qual Saf. 2013;22(11):881–4.PubMedCrossRef
60.
go back to reference Pawson R, Tilley N. Realistic evaluation. London: Sage; 1997. Pawson R, Tilley N. Realistic evaluation. London: Sage; 1997.
61.
go back to reference Gulliford MC, Prevost AT, Charlton J, Juszczyk D, Soames J, McDermott L, Sultana K, Wright M, Fox R, Hay AD, et al. Effectiveness and safety of electronically delivered prescribing feedback and decision support on antibiotic use for respiratory illness in primary care: REDUCE cluster randomised trial. BMJ. 2019;364:l236.PubMedPubMedCentralCrossRef Gulliford MC, Prevost AT, Charlton J, Juszczyk D, Soames J, McDermott L, Sultana K, Wright M, Fox R, Hay AD, et al. Effectiveness and safety of electronically delivered prescribing feedback and decision support on antibiotic use for respiratory illness in primary care: REDUCE cluster randomised trial. BMJ. 2019;364:l236.PubMedPubMedCentralCrossRef
62.
go back to reference Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O’Cathain A, Tinati T, Wight D, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350: h1258.PubMedPubMedCentralCrossRef Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O’Cathain A, Tinati T, Wight D, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350: h1258.PubMedPubMedCentralCrossRef
63.
go back to reference Foy R, Walker A, Ramsay C, Penney G, Grimshaw J, Francis JJ. Theory-based identification of barriers to quality improvement: induced abortion care. Int J Qual Health Care. 2005;17:147–55.PubMedCrossRef Foy R, Walker A, Ramsay C, Penney G, Grimshaw J, Francis JJ. Theory-based identification of barriers to quality improvement: induced abortion care. Int J Qual Health Care. 2005;17:147–55.PubMedCrossRef
64.
go back to reference Kwan JL, Lo L, Ferguson J, Goldberg H, Diaz-Martinez JP, Tomlinson G, Grimshaw JM, Shojania KG. Computerised clinical decision support systems and absolute improvements in care: meta-analysis of controlled clinical trials. BMJ. 2020;370:m3216. Kwan JL, Lo L, Ferguson J, Goldberg H, Diaz-Martinez JP, Tomlinson G, Grimshaw JM, Shojania KG. Computerised clinical decision support systems and absolute improvements in care: meta-analysis of controlled clinical trials. BMJ. 2020;370:m3216.
65.
go back to reference The Improved Clinical Effectiveness through Behavioural Research Group. Designing theoretically-informed implementation interventions. Implement Sci. 2006;1:4.CrossRef The Improved Clinical Effectiveness through Behavioural Research Group. Designing theoretically-informed implementation interventions. Implement Sci. 2006;1:4.CrossRef
66.
go back to reference 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.PubMedPubMedCentralCrossRef 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.PubMedPubMedCentralCrossRef
67.
go back to reference Eccles MP, Francis J, Foy R, Johnston M, Bamford C, Grimshaw JM, Hughes J, Lecouturier J, Steen N, Whitty PM. Improving professional practice in the disclosure of a diagnosis of dementia: a modeling experiment to evaluate a theory-based intervention. Int J Behav Med. 2009;16(4):377–87.PubMedCrossRef Eccles MP, Francis J, Foy R, Johnston M, Bamford C, Grimshaw JM, Hughes J, Lecouturier J, Steen N, Whitty PM. Improving professional practice in the disclosure of a diagnosis of dementia: a modeling experiment to evaluate a theory-based intervention. Int J Behav Med. 2009;16(4):377–87.PubMedCrossRef
68.
go back to reference Gude WT, van Engen-Verheul MM, van der Veer SN, de Keizer NF, Peek N. How does audit and feedback influence intentions of health professionals to improve practice? A laboratory experiment and field study in cardiac rehabilitation. BMJ Qual Saf. 2017;26(4):279–87.PubMedCrossRef Gude WT, van Engen-Verheul MM, van der Veer SN, de Keizer NF, Peek N. How does audit and feedback influence intentions of health professionals to improve practice? A laboratory experiment and field study in cardiac rehabilitation. BMJ Qual Saf. 2017;26(4):279–87.PubMedCrossRef
69.
go back to reference Kilbourne AM, Almirall D, Goodrich DE, Lai Z, Abraham KM, Nord KM, Bowersox NW. Enhancing outreach for persons with serious mental illness: 12-month results from a cluster randomized trial of an adaptive implementation strategy. Implement Sci. 2014;9:163.PubMedPubMedCentralCrossRef Kilbourne AM, Almirall D, Goodrich DE, Lai Z, Abraham KM, Nord KM, Bowersox NW. Enhancing outreach for persons with serious mental illness: 12-month results from a cluster randomized trial of an adaptive implementation strategy. Implement Sci. 2014;9:163.PubMedPubMedCentralCrossRef
70.
go back to reference Dreischulte T, Donnan P, Grant A, Hapca A, McCowan C, Guthrie B. Safer prescribing–a trial of education, informatics, and financial incentives. N Engl J Med. 2016;374(11):1053–64.PubMedCrossRef Dreischulte T, Donnan P, Grant A, Hapca A, McCowan C, Guthrie B. Safer prescribing–a trial of education, informatics, and financial incentives. N Engl J Med. 2016;374(11):1053–64.PubMedCrossRef
71.
go back to reference Hargreaves JR, Copas AJ, Beard E, Osrin D, Lewis JJ, Davey C, Thompson JA, Baio G, Fielding KL, Prost A. Five questions to consider before conducting a stepped wedge trial. Trials. 2015;16:350.PubMedPubMedCentralCrossRef Hargreaves JR, Copas AJ, Beard E, Osrin D, Lewis JJ, Davey C, Thompson JA, Baio G, Fielding KL, Prost A. Five questions to consider before conducting a stepped wedge trial. Trials. 2015;16:350.PubMedPubMedCentralCrossRef
73.
go back to reference Davey C, Hargreaves J, Thompson JA, Copas AJ, Beard E, Lewis JJ, Fielding KL. Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014. Trials. 2015;16:358.PubMedPubMedCentralCrossRef Davey C, Hargreaves J, Thompson JA, Copas AJ, Beard E, Lewis JJ, Fielding KL. Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014. Trials. 2015;16:358.PubMedPubMedCentralCrossRef
74.
go back to reference Snooks H, Bailey-Jones K, Burge-Jones D, Dale J, Davies J, Evans B, Farr A, Fitzsimmons D, Harrison J, Heaven M, et al. Fitzsimmons D, Harrison J, Heaven M et al: Health services and delivery research. In: Predictive risk stratification model: a randomised stepped-wedge trial in primary care (PRISMATIC). Southampton: NIHR Journals Library; 2018. Snooks H, Bailey-Jones K, Burge-Jones D, Dale J, Davies J, Evans B, Farr A, Fitzsimmons D, Harrison J, Heaven M, et al. Fitzsimmons D, Harrison J, Heaven M et al: Health services and delivery research. In: Predictive risk stratification model: a randomised stepped-wedge trial in primary care (PRISMATIC). Southampton: NIHR Journals Library; 2018.
75.
go back to reference Park JJH, Siden E, Zoratti MJ, Dron L, Harari O, Singer J, Lester RT, Thorlund K, Mills EJ. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. Trials. 2019;20(1):572.PubMedPubMedCentralCrossRef Park JJH, Siden E, Zoratti MJ, Dron L, Harari O, Singer J, Lester RT, Thorlund K, Mills EJ. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. Trials. 2019;20(1):572.PubMedPubMedCentralCrossRef
76.
go back to reference Edwards H, Redaniel MT, Opmeer B, Peters T, Margelyte R, Sillero Rejon C, Hollingworth W, Craggs P, Hill E, Redwood S, et al. Evaluating an enhanced quality improvement intervention in maternity units: PReCePT trial protocol. BMJ Open Quality. 2021;10(2):e001204.PubMedPubMedCentralCrossRef Edwards H, Redaniel MT, Opmeer B, Peters T, Margelyte R, Sillero Rejon C, Hollingworth W, Craggs P, Hill E, Redwood S, et al. Evaluating an enhanced quality improvement intervention in maternity units: PReCePT trial protocol. BMJ Open Quality. 2021;10(2):e001204.PubMedPubMedCentralCrossRef
77.
78.
go back to reference Haynes L, Service O, Goldacre B, Torgerson D. Test, learn, adapt: developing public policy with randomised controlled trials. London: Cabinet Office Behavioural Insights Team; 2012. Haynes L, Service O, Goldacre B, Torgerson D. Test, learn, adapt: developing public policy with randomised controlled trials. London: Cabinet Office Behavioural Insights Team; 2012.
79.
go back to reference Ivers NM, Grimshaw JM. Reducing research waste with implementation laboratories. Lancet. 2016;388(10044):547–8.PubMedCrossRef Ivers NM, Grimshaw JM. Reducing research waste with implementation laboratories. Lancet. 2016;388(10044):547–8.PubMedCrossRef
80.
go back to reference Grimshaw JM, Ivers N, Linklater S, Foy R, Francis JJ, Gude WT. Reinvigorating stagnant science: implementation laboratories and a meta-laboratory to efficiently advance the science of audit and feedback. BMJ Qual Saf. 2019;28(5):416–23. Grimshaw JM, Ivers N, Linklater S, Foy R, Francis JJ, Gude WT. Reinvigorating stagnant science: implementation laboratories and a meta-laboratory to efficiently advance the science of audit and feedback. BMJ Qual Saf. 2019;28(5):416–23.
81.
go back to reference Stanworth SJ, Walwyn R, Grant-Casey J, Hartley S, Moreau L, Lorencatto F, Francis J, Gould N, Swart N, Rowley M, et al. Effectiveness of enhanced performance feedback on appropriate use of blood transfusions: a comparison of 2 cluster randomized trials. JAMA Network Open. 2022;5(2):e220364–e220364.PubMedPubMedCentralCrossRef Stanworth SJ, Walwyn R, Grant-Casey J, Hartley S, Moreau L, Lorencatto F, Francis J, Gould N, Swart N, Rowley M, et al. Effectiveness of enhanced performance feedback on appropriate use of blood transfusions: a comparison of 2 cluster randomized trials. JAMA Network Open. 2022;5(2):e220364–e220364.PubMedPubMedCentralCrossRef
82.
go back to reference Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374:86–9.PubMedCrossRef Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374:86–9.PubMedCrossRef
83.
go back to reference Ivers NM, Grimshaw JM, Jamtvedt G, Flottorp S, O’Brien MA, French SD, Young J, Odgaard-Jensen J. Growing literature, stagnant science? Systematic review, meta-regression and cumulative analysis of audit and feedback interventions in health care. J Gen Intern Med. 2014;29(11):1534–41.PubMedPubMedCentralCrossRef Ivers NM, Grimshaw JM, Jamtvedt G, Flottorp S, O’Brien MA, French SD, Young J, Odgaard-Jensen J. Growing literature, stagnant science? Systematic review, meta-regression and cumulative analysis of audit and feedback interventions in health care. J Gen Intern Med. 2014;29(11):1534–41.PubMedPubMedCentralCrossRef
84.
go back to reference Karanatsios B, Prang K-H, Verbunt E, Yeung JM, Kelaher M, Gibbs P. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials. 2020;21(1):552.PubMedPubMedCentralCrossRef Karanatsios B, Prang K-H, Verbunt E, Yeung JM, Kelaher M, Gibbs P. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials. 2020;21(1):552.PubMedPubMedCentralCrossRef
85.
go back to reference Rushforth B, Stokes T, Andrews E, Willis TA, McEachan R, Faulkner S, Foy R. Developing ‘high impact’ guideline-based quality indicators for UK primary care: a multi-stage consensus process. BMC Fam Pract. 2015;16(1):156.PubMedPubMedCentralCrossRef Rushforth B, Stokes T, Andrews E, Willis TA, McEachan R, Faulkner S, Foy R. Developing ‘high impact’ guideline-based quality indicators for UK primary care: a multi-stage consensus process. BMC Fam Pract. 2015;16(1):156.PubMedPubMedCentralCrossRef
86.
go back to reference Foy R, Eccles MP, Hrisos S, Hawthorne G, Steen N, Gibb I, Croal B, Grimshaw J. A cluster randomised trial of educational messages to improve the primary care of diabetes. Implement Sci. 2011;6:129.PubMedPubMedCentralCrossRef Foy R, Eccles MP, Hrisos S, Hawthorne G, Steen N, Gibb I, Croal B, Grimshaw J. A cluster randomised trial of educational messages to improve the primary care of diabetes. Implement Sci. 2011;6:129.PubMedPubMedCentralCrossRef
87.
go back to reference McLintock K, Russell AM, Alderson SL, West R, House A, Westerman K, Foy R. The effects of financial incentives for case finding for depression in patients with diabetes and coronary heart disease: interrupted time series analysis. BMJ Open. 2014;4(8):e005178.PubMedPubMedCentralCrossRef McLintock K, Russell AM, Alderson SL, West R, House A, Westerman K, Foy R. The effects of financial incentives for case finding for depression in patients with diabetes and coronary heart disease: interrupted time series analysis. BMJ Open. 2014;4(8):e005178.PubMedPubMedCentralCrossRef
88.
go back to reference Ivers N: Supporting audit and feedback to encourage vaccine uptake (NCT05099497). ClinicalTrialsgov 2021. Ivers N: Supporting audit and feedback to encourage vaccine uptake (NCT05099497). ClinicalTrialsgov 2021.
89.
go back to reference Yu LM, Bafadhel M, Dorward J, Hayward G, Saville BR, Gbinigie O, Van Hecke O, Ogburn E, Evans PH, Thomas NPB, et al. Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet. 2021;398(10303):843–55.PubMedPubMedCentralCrossRef Yu LM, Bafadhel M, Dorward J, Hayward G, Saville BR, Gbinigie O, Van Hecke O, Ogburn E, Evans PH, Thomas NPB, et al. Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet. 2021;398(10303):843–55.PubMedPubMedCentralCrossRef
90.
go back to reference Foy R, Skrypak M, Alderson S, Ivers NM, McInerney B, Stoddart J, Ingham J, Keenan D. Revitalising audit and feedback to improve patient care. BMJ. 2020;368:m213.PubMedPubMedCentralCrossRef Foy R, Skrypak M, Alderson S, Ivers NM, McInerney B, Stoddart J, Ingham J, Keenan D. Revitalising audit and feedback to improve patient care. BMJ. 2020;368:m213.PubMedPubMedCentralCrossRef
91.
go back to reference Ruppertsberg AI, Ward V, Ridout A, Foy R. The development and application of audit criteria for assessing knowledge exchange plans in health research grant applications. Implement Sci. 2014;9:93.PubMedPubMedCentralCrossRef Ruppertsberg AI, Ward V, Ridout A, Foy R. The development and application of audit criteria for assessing knowledge exchange plans in health research grant applications. Implement Sci. 2014;9:93.PubMedPubMedCentralCrossRef
92.
go back to reference Wilkinson E. RECOVERY trial: the UK covid-19 study resetting expectations for clinical trials. BMJ. 2020;369:m1626.PubMedCrossRef Wilkinson E. RECOVERY trial: the UK covid-19 study resetting expectations for clinical trials. BMJ. 2020;369:m1626.PubMedCrossRef
93.
go back to reference James M, Ford GA, Robinson T, Al-Shahi Salman R. Rapid mobilisation of research in response to covid-19: a paradigm for the future. BMJ. 2020;369:m2155.PubMedCrossRef James M, Ford GA, Robinson T, Al-Shahi Salman R. Rapid mobilisation of research in response to covid-19: a paradigm for the future. BMJ. 2020;369:m2155.PubMedCrossRef
94.
go back to reference Wieseler B, Neyt M, Kaiser T, Hulstaert F, Windeler J. Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy? BMJ. 2023;380:e073100.PubMedCrossRef Wieseler B, Neyt M, Kaiser T, Hulstaert F, Windeler J. Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy? BMJ. 2023;380:e073100.PubMedCrossRef
Metadata
Title
What is the role of randomised trials in implementation science?
Authors
Robbie Foy
Noah M. Ivers
Jeremy M. Grimshaw
Paul M. Wilson
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07578-5

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