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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Research

Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014

Authors: Emma Beard, James J. Lewis, Andrew Copas, Calum Davey, David Osrin, Gianluca Baio, Jennifer A. Thompson, Katherine L. Fielding, Rumana Z. Omar, Sam Ononge, James Hargreaves, Audrey Prost

Published in: Trials | Issue 1/2015

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Abstract

Background

In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design’s perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design.

Methods

We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.

Results

Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being ‘instruction on how to perform a behaviour’ (n = 32) and ‘persuasive source’ (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.

Conclusions

The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.
Appendix
Available only for authorised users
Literature
1.
Hayes R, Moulton L. Cluster randomised trials. Pharmaceut Statist. 2009;11:88.
2.
3.
Grant AD, Charalambous S, Fielding KL, Day JH, Corbett EL, Chaisson RE, et al. Effect of routine isoniazid preventive therapy on tuberculosis incidence among HIV-infected men in South Africa: a novel randomized incremental recruitment study. JAMA. 2005;293(22):2719–25.CrossRefPubMed
4.
5.
Mdege ND, Man M-S, Taylor CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011;64(9):936–48.CrossRefPubMed
6.
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91.CrossRefPubMed
7.
Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, et al. Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Clin Trials. 2007;4(2):190–9.CrossRefPubMed
8.
Ivers N, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, et al. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000–8. BMJ. 2011;343:d5886.CrossRefPubMedPubMedCentral
9.
Hemming K, Girling A, Haines T, Lilford R. Protocol: Consort extension to stepped wedge cluster randomised controlled trial. BMJ. 2014. doi:10.​1136/​bmj.​h391.
10.
Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–8.CrossRefPubMed
11.
Dimairo M, Bradburn M, Walters SJ. Sample size determination through power simulation; practical lessons from a stepped wedge cluster randomised trial (SW CRT). Trials. 2011;12(1):1.CrossRef
12.
Scott JM, Juraska M, Fay MP, Gilbert PB. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials. Stat Methods Med Res. 2014. doi:10.​1177/​0962280214552092​.
13.
Kotz D, Spigt M, Arts IC, Crutzen R, Viechtbauer W. Use of the stepped wedge design cannot be recommended: a critical appraisal and comparison with the classic cluster randomized controlled trial design. J Clin Epidemiol. 2012;65(12):1249–52.CrossRefPubMed
14.
Hemming K, Girling A, Martin J, Bond SJ. Stepped wedge cluster randomized trials are efficient and provide a method of evaluation without which some interventions would not be evaluated. J Clin Epidemiol. 2013;66(9):1058–9.CrossRefPubMed
15.
Hemming K, Girling A. The efficiency of stepped wedge vs. cluster randomized trials: stepped wedge studies do not always require a smaller sample size. J Clin Epidemiol. 2013;66(12):1427–8.CrossRefPubMed
16.
Mdege ND, Man M-S, Taylor CA, Torgerson DJ. There are some circumstances where the stepped-wedge cluster randomized trial is preferable to the alternative: no randomized trial at all. Response to the commentary by Kotz and colleagues. J Clin Epidemiol. 2012;65(12):1253–4.CrossRefPubMed
17.
Baio G, Copas A, Ambler G, King M, Beard E, RZ O. Sample size calculation for a stepped wedge trial. Trials.
18.
Copas AJ, Lewis JJ, Thompson, JA, Davey C, Baio G, Hargreaves J. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials.
19.
Davey C, Hargreaves J, Thompson JA, Copas AJ, Beard E, Lewis JJ, et al. Analysis and reporting of stepped-wedge randomised-controlled trials: synthesis and critical appraisal of published studies. Trials.
20.
Michie S, Atkins L, West R. The behaviour change wheel: a guide to designing interventions. London: Silverback Publishing; 2014.
21.
Dolan P, Hallsworth M, Halpern D, King D, Vlaev D. MINDSPACE: Influencing behaviour through public policy. London: Cabinet Office and Institute for Government; 2010.
22.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95.CrossRefPubMed
23.
Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008;27(3):379.CrossRefPubMed
24.
Bacchieri G, Barros AJ, dos Santos JV, Gonçalves H, Gigante DP. A community intervention to prevent traffic accidents among bicycle commuters. Rev Saude Publica. 2010;44(5):867–75.CrossRefPubMed
25.
Bashour HN, Kanaan M, Kharouf MH, Abdulsalam AA, Tabbaa MA, Cheikha SA. The effect of training doctors in communication skills on women’s satisfaction with doctor–woman relationship during labour and delivery: a stepped wedge cluster randomised trial in Damascus. BMJ Open. 2013;3(8):e002674.CrossRefPubMedPubMedCentral
26.
Durovni B, Saraceni V, Moulton LH, Pacheco AG, Cavalcante SC, King BS, et al. Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial. Lancet Infect Dis. 2013;13(10):852–8.CrossRefPubMedPubMedCentral
27.
Fuller C, Michie S, Savage J, McAteer J, Besser S, Charlett A, et al. The Feedback Intervention Trial (FIT)—improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial. PLoS One. 2012;7(10):e41617.CrossRefPubMedPubMedCentral
28.
Gruber JS, Reygadas F, Arnold BF, Ray I, Nelson K, Colford JM. A stepped wedge, cluster-randomized trial of a household UV-disinfection and safe storage drinking water intervention in rural Baja California Sur, Mexico. Am J Trop Med Hyg. 2013;89(2):238–45.CrossRefPubMedPubMedCentral
29.
Horner C, Wilcox M, Barr B, Hall D, Hodgson G, Parnell P, et al. The longitudinal prevalence of MRSA in care home residents and the effectiveness of improving infection prevention knowledge and practice on colonisation using a stepped wedge study design. BMJ Open. 2012;2(1):e000423.CrossRefPubMedPubMedCentral
30.
Mhurchu CN, Gorton D, Turley M, Jiang Y, Michie J, Maddison R, et al. Effects of a free school breakfast programme on children’s attendance, academic achievement and short-term hunger: results from a stepped-wedge, cluster randomised controlled trial. J Epidemiol Community Health. 2013;67(3):257–64.CrossRefPubMed
31.
Kitson AL, Schultz TJ, Long L, Shanks A, Wiechula R, Chapman I, et al. The prevention and reduction of weight loss in an acute tertiary care setting: protocol for a pragmatic stepped wedge randomised cluster trial (the PRoWL project). BMC Health Serv Res. 2013;13(1):299.CrossRefPubMedPubMedCentral
32.
Schultz TJ, Kitson AL, Soenen S, Long L, Shanks A, Wiechula R, et al. Does a multidisciplinary nutritional intervention prevent nutritional decline in hospital patients? A stepped wedge randomised cluster trial. Clin Nutr ESPEN. 2014;9(2):e84–90.
33.
Roy A, Anaraki S, Hardelid P, Catchpole M, Rodrigues LC, Lipman M, et al. Universal HIV testing in London tuberculosis clinics: a cluster randomised controlled trial. Eur Respir J. 2013;41(3):627–34.CrossRefPubMed
34.
Stern A, Mitsakakis N, Paulden M, Alibhai S, Wong J, Tomlinson G, et al. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care. BMC Health Serv Res. 2014;14(1):83.CrossRefPubMedPubMedCentral
35.
Fearon P, Quinn T, Wright F, Fraser P, McAlpine C, Stott D, editors. Evaluation of a telephone hotline to enhance rapid outpatient assessment of minor stroke or TIA: a stepped wedge cluster randomised control trial, International Journal of Stroke. NJ: Wiley-Blackwell; 2013.
36.
Bennett PN, Daly RM, Fraser SF, Haines T, Barnard R, Ockerby C, et al. The impact of an exercise physiologist coordinated resistance exercise program on the physical function of people receiving hemodialysis: a stepped wedge randomised control study. BMC Nephrol. 2013;14(1):204.CrossRefPubMedPubMedCentral
37.
Bernabe-Ortiz A, Diez-Canseco F, Gilman RH, Cárdenas MK, Sacksteder KA, Miranda JJ. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru. Trials. 2014;15(1):93.CrossRefPubMedPubMedCentral
38.
Brimblecombe J, Ferguson M, Liberato SC, Ball K, Moodie ML, Magnus A, et al. Stores Healthy Options Project in Remote Indigenous Communities (SHOP@ RIC): a protocol of a randomised trial promoting healthy food and beverage purchases through price discounts and in-store nutrition education. BMC Public Health. 2013;13(1):744.CrossRefPubMedPubMedCentral
39.
Dainty KN, Scales DC, Brooks SC, Needham DM, Dorian P, Ferguson N, et al. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial. Implement Sci. 2011;6:4.CrossRefPubMedPubMedCentral
40.
Dreischulte T, Grant A, Donnan P, McCowan C, Davey P, Petrie D, et al. A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: the DQIP study protocol. Implement Sci. 2012;7:24.CrossRefPubMedPubMedCentral
41.
Gerritsen DL, Smalbrugge M, Teerenstra S, Leontjevas R, Adang EM, Vernooij-Dassen MJ, et al. Act In case of Depression: the evaluation of a care program to improve the detection and treatment of depression in nursing homes, Study Protocol. BMC Psychiatry. 2011;11(1):91.CrossRefPubMedPubMedCentral
42.
Gucciardi E, Fortugno M, Horodezny S, Lou W, Sidani S, Espin S, et al. Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial. Trials. 2012;13(1):165.CrossRefPubMedPubMedCentral
43.
Keriel-Gascou M, Buchet-Poyau K, Duclos A, Rabilloud M, Figon S, Dubois J-P, et al. Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial. Implement Sci. 2013;8(1):69.CrossRefPubMedPubMedCentral
44.
Kjeken I, Berdal G, Bø I, Dager T, Dingsør A, Hagfors J, et al. Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial. BMC Musculoskelet Disord. 2014;15(1):153.CrossRefPubMedPubMedCentral
45.
Marshall T, Caley M, Hemming K, Gill P, Gale N, Jolly K. Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT. BMC Public Health. 2012;12(1):908.CrossRefPubMedPubMedCentral
46.
Mouchoux C, Rippert P, Duclos A, Fassier T, Bonnefoy M, Comte B, et al. Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol. BMC Geriatr. 2011;11(1):25.CrossRefPubMedPubMedCentral
47.
Poldervaart JM, Reitsma JB, Koffijberg H, Backus BE, Six AJ, Doevendans PA, et al. The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial. BMC Cardiovasc Disord. 2013;13(1):77.CrossRefPubMedPubMedCentral
48.
Praveen D, Patel A, McMahon S, Prabhakaran D, Clifford GD, Maulik PK, et al. A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial. Communities. 2013;5:6.
49.
Rasmussen CD, Holtermann A, Mortensen OS, Søgaard K, Jørgensen MB. Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial. BMC Public Health. 2013;13(1):1088.CrossRefPubMedPubMedCentral
50.
Ratanawongsa N, Handley MA, Quan J, Sarkar U, Pfeifer K, Soria C, et al. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol. BMC Health Serv Res. 2012;12(1):22.CrossRefPubMedPubMedCentral
51.
Solomon E, Rees T, Ukoumunne OC, Hillsdon M. The Devon Active Villages Evaluation (DAVE) trial: study protocol of a stepped wedge cluster randomised trial of a community-level physical activity intervention in rural southwest England. BMC Public Health. 2012;12(1):581.CrossRefPubMedPubMedCentral
52.
Stringer JS, Chisembele-Taylor A, Chibwesha CJ, Chi HF, Ayles H, Manda H, et al. Protocol-driven primary care and community linkages to improve population health in rural Zambia: the Better Health Outcomes through Mentoring and Assessment (BHOMA) project. BMC Health Serv Res. 2013;13 Suppl 2:S7.CrossRefPubMedPubMedCentral
53.
Tirlea L, Truby H, Haines TP. Investigation of the effectiveness of the “Girls on the Go!” program for building self-esteem in young women: trial protocol. SpringerPlus. 2013;2(1):683.CrossRefPubMedPubMedCentral
54.
Turner J, Kelly B, Clarke D, Yates P, Aranda S, Jolley D, et al. A randomised trial of a psychosocial intervention for cancer patients integrated into routine care: the PROMPT study (promoting optimal outcomes in mood through tailored psychosocial therapies). BMC Cancer. 2011;11(1):48.CrossRefPubMedPubMedCentral
55.
Van de Steeg L, Langelaan M, Ijkema R, Wagner C. The effect of a complementary e-learning course on implementation of a quality improvement project regarding care for elderly patients: a stepped wedge trial. Implement Sci. 2012;7:13.CrossRefPubMedPubMedCentral
56.
van Holland BJ, de Boer MR, Brouwer S, Soer R, Reneman MF. Sustained employability of workers in a production environment: design of a stepped wedge trial to evaluate effectiveness and cost-benefit of the POSE program. BMC Public Health. 2012;12(1):1003.CrossRefPubMedPubMedCentral
57.
58.
Everingham K. Enhanced Peri-Operative Care for High-risk patients (EPOCH) Trial: A stepped wedge cluster randomised trial of a quality improvement intervention for patients undergoing emergency laparotomy. 2014. http://​www.​isrctn.​com/​ISRCTN80682973.
59.
60.
Koeberlein-Neu J. Prospective, cluster-randomized, controlled trial of effectiveness and costs of a cross-professional and cross-organisational medication therapy management in multimorbid patients with polypharmacy. 2013. http://​www.​isrctn.​com/​ISRCTN41595373.
61.
Viikari-Juntura E. Efficacy of temporary work modifications on disability related to musculoskeletal pain and depressive symptoms: a non-randomised controlled trial. 2013. ISRCTN74743666.
62.
63.
Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McDonald S, McKenzie JE. The use of the cluster randomized crossover design in clinical trials: protocol for a systematic. Syst Rev. 2014;3:86.CrossRefPubMedPubMedCentral
64.
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):S112–8.CrossRefPubMedPubMedCentral
65.
66.
Prost A, Binik A, Abubakar I, Roy A, de Allegri M, Mouchoux C, et al. Uncertainty on a background of optimism: logistic, ethical and political dimensions of stepped wedge designs. Trials.
Metadata
Title
Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014
Authors
Emma Beard
James J. Lewis
Andrew Copas
Calum Davey
David Osrin
Gianluca Baio
Jennifer A. Thompson
Katherine L. Fielding
Rumana Z. Omar
Sam Ononge
James Hargreaves
Audrey Prost
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0839-2

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