Pocock SJ. Clinical trials: a practical approach. Chichester: Wiley; 1983.
Google Scholar
Hayes RJ, Moulton LH. Cluster Randomised Trials. Boca Raton: Chapman & Hall; 2009.
Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000
Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999;28(2):319–26.
CAS
PubMed
Google Scholar
Donner A. Some Aspects of the Design and Analysis of Cluster Randomization Trials. J R Stat Soc: Ser C: Appl Stat. 1998;47(1):95–113.
Google Scholar
Wears RL. Advanced statistics: statistical methods for analyzing cluster and cluster-randomized data. Acad Emerg Med. 2002;9(4):330–41.
PubMed
Google Scholar
Murray DM. Design and Analysis of GroupRandomized Trials. New York: Oxford University Press Inc; 1998.
Google Scholar
Campbell MJ, Walters SJ. How to design, analyse and report cluster randomised trials in medicine and health related research. Chichester: Wiley-Blackwell; 2014.
Google Scholar
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006;6:54.
PubMed
PubMed Central
Google Scholar
Mdege ND et al. 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.
PubMed
Google Scholar
Handley MA, Schillinger D, Shiboski S. Quasi-experimental designs in practice-based research settings: design and implementation considerations. J Am Board Fam Med. 2011;24(5):589–96.
PubMed
Google Scholar
Weijer C et al. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346.
PubMed
PubMed Central
Google Scholar
Melis RJ et al. Pseudo cluster randomization performed well when used in practice. J Clin Epidemiol. 2008;61(11):1169–75.
PubMed
Google Scholar
The Gambia Hepatitis Intervention Study. The Gambia Hepatitis Study Group. Cancer Res. 1987;47(21):5782–7.
Google Scholar
Rhoda DA et al. Studies with staggered starts: multiple baseline designs and group-randomized trials. Am J Public Health. 2011;101(11):2164–9.
PubMed
PubMed Central
Google Scholar
Woertman W et al. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–8.
PubMed
Google Scholar
Hemming K et al. 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.
PubMed
Google Scholar
Haines T et al. A novel research design can aid disinvestment from existing health technologies with uncertain effectiveness, cost-effectiveness, and/or safety. J Clin Epidemiol. 2014;67(2):144–51.
PubMed
Google Scholar
Brown C et al. An epistemology of patient safety research: a framework for study design and interpretation. Part 2. Study design. Qual Saf Health Care. 2008;17(3):163–9.
CAS
PubMed
Google Scholar
Beard E et al. Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. Trials. 2015;16:353.
PubMed
PubMed Central
Google Scholar
Austin PC. Estimating multilevel logistic regression models when the number of clusters is low: a comparison of different statistical software procedures. Int J Biostat. 2010;6(1):Article 16.
PubMed
Google Scholar
Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13–22.
Google Scholar
Kauermann G, Carroll RJ. A Note on the Efficiency of Sandwich Covariance Matrix Estimation. J Am Stat Assoc. 2001;96(456):1387–96.
Google Scholar
Hemming K et al. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391.
CAS
PubMed
Google Scholar
Moher D et al. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009;6(7):e1000097.
PubMed
PubMed Central
Google Scholar
Moulton LH 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.
PubMed
Google Scholar
Fok CC, Henry D, Allen J. Research Designs for Intervention Research with Small Samples II: Stepped Wedge and Interrupted Time-Series Designs. Prev Sci. 2015;16(7):967–77.
PubMed
Google Scholar
Gruber JS et al. Estimation of treatment efficacy with complier average causal effects (CACE) in a randomized stepped wedge trial. Am J Epidemiol. 2014;179(9):1134–42.
PubMed
Google Scholar
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91.
PubMed
Google Scholar
Scott JM, et al. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials. Stat Methods Med Res. 2014.
Van den Heuvel, E.R., R.J. Zwanenburg, and C.M. Van Ravenswaaij-Arts, A stepped wedge design for testing an effect of intranasal insulin on cognitive development of children with Phelan-McDermid syndrome: A comparison of different designs. Stat Methods Med Res, 2014.
Wyman PA et al. Designs for Testing Group-Based Interventions with Limited Numbers of Social Units: The Dynamic Wait-Listed and Regression Point Displacement Designs. Prev Sci. 2015;16(7):956–66.
PubMed
PubMed Central
Google Scholar
Lipsitz SR, Laird NM, Harrington DP. Using the jackknife to estimate the variance of regression estimators from repeated measures studies. Commun Stat Theory Methods. 1990;19(3):821–45.
Google Scholar
Golden MR et al. Uptake and Population-Level Impact of Expedited Partner Therapy (EPT) on Chlamydia trachomatis and Neisseria gonorrhoeae: The Washington State Community-Level Randomized Trial of EPT. PLoS Med. 2015;12(1):1–22.
Google Scholar
Davey C et al. Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014. Trials. 2015;16:358.
PubMed
PubMed Central
Google Scholar
Brown CH et al. Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide. Clin Trials. 2006;3(3):259–71.
PubMed
Google Scholar
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):181–96.
PubMed
Google Scholar
Baio G et al. Sample size calculation for a stepped wedge trial. Trials. 2015;16(1):1–15.
Google Scholar
StataCorp. Stata 13 Base Reference Manual. College Station, TX: Stata Press; 2013.
Google Scholar
Hemming K, Girling A. A menu-driven facility for power and detectable-difference calculations in stepped-wedge cluster-randomized trials. Stata J. 2014;14(2):363–80.
Google Scholar
de Hoop E, Woertman W, Teerenstra S. The stepped wedge cluster randomized trial always requires fewer clusters but not always fewer measurements, that is, participants than a parallel cluster randomized trial in a cross-sectional design In reply. J Clin Epidemiol. 2013;66(12):1428.
PubMed
Google Scholar
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.
PubMed
Google Scholar
Copas AJ et al. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials. 2015;16:352.
PubMed
PubMed Central
Google Scholar
Kotz D et al. The stepped wedge design does not inherently have more power than a cluster randomized controlled trial. J Clin Epidemiol. 2013;66(9):1059–60.
PubMed
Google Scholar
Davis MP, Mitchell GK. Topics in research: structuring studies in palliative care. Curr Opin Support Palliat Care. 2012;6(4):483–9.
PubMed
Google Scholar
Larsen DA et al. Population-wide malaria testing and treatment with rapid diagnostic tests and artemether-lumefantrine in southern zambia: a community randomized step-wedge control trial design. Am J Trop Med Hyg. 2015;92(5):913–21.
PubMed
PubMed Central
Google Scholar
Bacchieri G et al. A community intervention to prevent traffic accidents among bicycle commuters. Rev Saude Publica. 2010;44(5):867–75.
PubMed
Google Scholar
Hill AM et al. Fall rates in hospital rehabilitation units after individualised patient and staff education programmes: a pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet. 2015;385(9987):2592–9.
PubMed
Google Scholar
Durovni B 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.
CAS
PubMed
PubMed Central
Google Scholar
Golub JE et al. Long-term protection from isoniazid preventive therapy for tuberculosis in HIV-infected patients in a medium-burden tuberculosis setting: the TB/HIV in Rio (THRio) study. Clin Infect Dis. 2015;60(4):639–45.
CAS
PubMed
Google Scholar
Bouwsma EV et al. The cost effectiveness of a tailored, web-based care program to enhance postoperative recovery in gynecologic patients in comparison with usual care: protocol of a stepped wedge cluster randomized controlled trial. JMIR Res Protoc. 2014;3(2):e30.
PubMed
PubMed Central
Google Scholar
Pearse R. 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. Lancet. 2015.
Due TD et al. The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial. BMC Fam Pract. 2014;15:65.
PubMed
PubMed Central
Google Scholar
Grunewaldt KH et al. Working memory training improves cognitive function in VLBW preschoolers. Pediatrics. 2013;131(3):e747–54.
PubMed
Google Scholar
Doherty S et al. National project seeking to improve pain management in the emergency department setting: findings from the NHMRC-NICS National Pain Management Initiative. Emerg Med Australas. 2013;25(2):120–6.
PubMed
Google Scholar
Viera AJ, Garrett JM. Preliminary study of a school-based program to improve hypertension awareness in the community. Fam Med. 2008;40(4):264–70.
PubMed
Google Scholar
Skrovseth SO et al. Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial. Diabetes Technol Ther. 2015;17(7):482–9.
PubMed
PubMed Central
Google Scholar
Somerville M et al. From local concern to randomized trial: the Watcombe Housing Project. Health Expect. 2002;5(2):127–35.
PubMed
PubMed Central
Google Scholar
Barton A et al. The Watcombe Housing Study: the short term effect of improving housing conditions on the health of residents. J Epidemiol Community Health. 2007;61:771–7.
PubMed
PubMed Central
Google Scholar
Schnelle JF et al. Reducing and managing restraints in long-term-care facilities. J Am Geriatr Soc. 1992;40(4):381–5.
CAS
PubMed
Google Scholar
Dilworth S et al. Examining clinical supervision as a mechanism for changes in practice: a research protocol. J Adv Nurs. 2014;70(2):421–30.
PubMed
Google Scholar
Mouchoux C et al. Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol. BMC Geriatr. 2011;11:25.
PubMed
PubMed Central
Google Scholar
van den Broek IV et al. Evaluation design of a systematic, selective, internet-based, Chlamydia screening implementation in the Netherlands, 2008-2010: implications of first results for the analysis. BMC Infect Dis. 2010;10:89.
PubMed
PubMed Central
Google Scholar
van den Broek IV et al. Effectiveness of yearly, register based screening for chlamydia in the Netherlands: controlled trial with randomised stepped wedge implementation. BMJ. 2012;345:e4316.
PubMed
PubMed Central
Google Scholar
Cowan JF et al. Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach. Implement Sci. 2015;10(1):61.
PubMed
PubMed Central
Google Scholar
Craine N et al. A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons. Eur J Public Health. 2015;25(2):351–7.
PubMed
Google Scholar
Groshaus H et al. Use of clinical decision support to improve the quality of care provided to older hospitalized patients. Appl Clin Inform. 2012;3(1):94–102.
CAS
PubMed
PubMed Central
Google Scholar
Kelly PJ et al. Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment. BMC Public Health. 2015;15(1):465.
PubMed
PubMed Central
Google Scholar
Weiner M et al. A web-based generalist-specialist system to improve scheduling of outpatient specialty consultations in an academic center. J Gen Intern Med. 2009;24(6):710–5.
PubMed
PubMed Central
Google Scholar
Williamson A et al. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)-protocol for a stepped wedge trial. BMJ Open. 2014;4(7):e005293.
Google Scholar
Ciliberto MA et al. Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial. Am J Clin Nutr. 2005;81(4):864–70.
CAS
PubMed
Google Scholar
Mosha F et al. Evaluation of the effectiveness of a clean delivery kit intervention in preventing cord infection and puerperal sepsis among neonates and their mothers in rural Mwanza Region. Tanzania Tanzan Health Res Bull. 2005;7(3):185–8.
CAS
PubMed
Google Scholar
Patel MP et al. Supplemental feeding with ready-to-use therapeutic food in Malawian children at risk of malnutrition. J Health Popul Nutr. 2005;23(4):351–7.
PubMed
Google Scholar
Haugen AS et al. Effect of the World Health Organization checklist on patient outcomes: a stepped wedge cluster randomized controlled trial. Ann Surg. 2015;261(5):821–8.
PubMed
Google Scholar
Ononge S, Campbell O, Mirembe F. Haemoglobin status and predictors of anaemia among pregnant women in Mpigi, Uganda. BMC Res Notes. 2014;7:712.
PubMed
PubMed Central
Google Scholar
Badenbroek IF et al. Design of the INTEGRATE study: effectiveness and cost-effectiveness of a cardiometabolic risk assessment and treatment program integrated in primary care. BMC Fam Pract. 2014;15:90.
PubMed
PubMed Central
Google Scholar
Bailey IW, Archer L. The impact of the introduction of treated water on aspects of community health in a rural community in Kwazulu-Natal, South Africa. Water Sci Technol. 2004;50(1):105–10.
CAS
PubMed
Google Scholar
Banga FR et al. The impact of transmural multiprofessional simulation-based obstetric team training on perinatal outcome and quality of care in the Netherlands. BMC Med Educ. 2014;14:175.
PubMed
PubMed Central
Google Scholar
Proeschold-Bell RJ et al. Use of a randomized multiple baseline design: rationale and design of the spirited life holistic health intervention study. Contemp Clin Trials. 2013;35(2):138–52.
PubMed
Google Scholar
Brimblecombe J 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;13:744.
PubMed
PubMed Central
Google Scholar
Fuller C 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.
CAS
PubMed
PubMed Central
Google Scholar
Bailey FA et al. Intervention to improve care at life’s end in inpatient settings: The BEACON trial. J Gen Intern Med. 2014;29(6):836–43.
PubMed
PubMed Central
Google Scholar
Palmer VJ et al. The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting. BMJ Open. 2015;5(3):e006688.
PubMed
PubMed Central
Google Scholar
Stern A et al. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care. BMC Health Serv Res. 2014;14:83.
PubMed
PubMed Central
Google Scholar
Tielsch JM et al. Designs of two randomized, community-based trials to assess the impact of alternative cookstove installation on respiratory illness among young children and reproductive outcomes in rural Nepal. BMC Public Health. 2014;14:1271.
PubMed
PubMed Central
Google Scholar
van Daalen FV et al. A cluster randomized trial for the implementation of an antibiotic checklist based on validated quality indicators: the AB-checklist. BMC Infect Dis. 2015;15(1):134.
PubMed
PubMed Central
Google Scholar
Lilly CM et al. Hospital mortality, length of stay, and preventable complications among critically ill patients before and after tele-ICU reengineering of critical care processes. JAMA. 2011;305(21):2175–83.
CAS
PubMed
Google Scholar
Priestley G et al. Introducing Critical Care Outreach: a ward-randomised trial of phased introduction in a general hospital. Intensive Care Med. 2004;30(7):1398–404.
PubMed
Google Scholar
Strijbos MJ et al. Design and methods of the Hospital Elder Life Program (HELP), a multicomponent targeted intervention to prevent delirium in hospitalized older patients: efficacy and cost-effectiveness in Dutch health care. BMC Geriatr. 2013;13:78.
PubMed
PubMed Central
Google Scholar
Kotz D et al. 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.
PubMed
Google Scholar
Mancl LA, DeRouen TA. A covariance estimator for GEE with improved small-sample properties. Biometrics. 2001;57(1):126–34.
CAS
PubMed
Google Scholar
Snijders TAB, Bosker RJ. Multilevel Analysis: An Introduction to Basic and Advanced Multilevel Modeling. 2nd ed. Sage Publications Ltd; 1999.
Bellan SE et al. Statistical power and validity of Ebola vaccine trials in Sierra Leone: a simulation study of trial design and analysis. Lancet Infect Dis. 2015;15(6):703–10.
PubMed
PubMed Central
Google Scholar
Beard E et al. Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. Trials. 2015;16(1):1–14.
Google Scholar
Fatemi Y, Jacobson RM. The stepped wedge cluster randomized trial and its potential for child health services research: a narrative review. Acad Pediatr. 2015;15(2):128–33.
PubMed
Google Scholar
Hargreaves JR et al. Five questions to consider before conducting a stepped wedge trial. Trials. 2015;16:350.
PubMed
PubMed Central
Google Scholar
Hargreaves JR et al. How important is randomisation in a stepped wedge trial? Trials. 2015;16:359.
PubMed
PubMed Central
Google Scholar
Keriel-Gascou M et al. A stepped wedge cluster randomized trial is preferable for assessing complex health interventions. J Clin Epidemiol. 2014;67(7):831–3.
PubMed
Google Scholar
Kotz D et al. Researchers should convince policy makers to perform a classic cluster randomized controlled trial instead of a stepped wedge design when an intervention is rolled out. J Clin Epidemiol. 2012;65(12):1255–6.
PubMed
Google Scholar
Mdege ND et al. 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.
PubMed
Google Scholar
Mdege ND, Kanaan M. Response to Keriel-Gascou et al. Addressing assumptions on the stepped wedge randomized trial design. J Clin Epidemiol. 2014;67(7):833–4.
PubMed
Google Scholar
Pater J et al. Future research and methodological approaches. Ann Oncol. 2011;22 Suppl 7:vii57–61.
CAS
PubMed
Google Scholar
Prost A et al. Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies. Trials. 2015;16:351.
PubMed
PubMed Central
Google Scholar
Sanson-Fisher RW et al. Evaluation of systems-oriented public health interventions: alternative research designs. Annu Rev Public Health. 2014;35:9–27.
PubMed
Google Scholar
Schelvis RM et al. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs. Scand J Work Environ Health. 2015;41(5):491–503.
PubMed
Google Scholar
van der Tweel I, van der Graaf R. Issues in the use of stepped wedge cluster and alternative designs in the case of pandemics. Am J Bioeth. 2013;13(9):23–4.
PubMed
Google Scholar
Viechtbauer W et al. Response to Keriel-Gascou et al.: higher efficiency and other alleged advantages are not inherent to the stepped wedge design. J Clin Epidemiol. 2014;67(7):834–6.
PubMed
Google Scholar
Wolkewitz M et al. Interventions to control nosocomial infections: study designs and statistical issues. J Hosp Infect. 2014;86(2):77–82.
CAS
PubMed
Google Scholar
Zhan Z et al. Strengths and weaknesses of a stepped wedge cluster randomized design: Its application in a colorectal cancer follow-up study. J Clin Epidemiol. 2014;67(4):454–61.
PubMed
Google Scholar
Aoun S et al. Supporting family caregivers to identify their own needs in end-of-life care: Qualitative findings from a stepped wedge cluster trial. Palliat Med. 2015;29(6):508–17.
PubMed
Google Scholar
Aoun S et al. Enabling a family caregiver-led assessment of support needs in home-based palliative care: Potential translation into practice. Palliat Med. 2015;29(10):929–38.
PubMed
Google Scholar
Aoun S et al. Implementing and evaluating the impact of the carer support needs assessment tool (CSNAT) in community palliative care in Australia. Palliat Med. 2014;28(6):606.
Google Scholar
Aoun SM et al. The Impact of the Carer Support Needs Assessment Tool (CSNAT) in Community Palliative Care Using a Stepped Wedge Cluster Trial. PLoS One. 2015;10(4):e0123012.
PubMed
PubMed Central
Google Scholar
Austin L, Ewing G, Grande G. Facilitating a shift to comprehensive carer-led assessment in palliative home care: The CSNAT approach. Palliat Med. 2014;4(1):612–3.
Google Scholar
GrandeG.E, et al. Assessing the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in palliative home care: a stepped wedge cluster trial. BMJ Support Palliat Care, 2015.
Lo AC et al. Prevalence of molecular markers of drug resistance in an area of seasonal malaria chemoprevention in children in Senegal. Malar J. 2013;12:137–7.
Bailet LL et al. Emergent literacy intervention for prekindergarteners at risk for reading failure. J Learn Disabil. 2009;42(4):336–55.
PubMed
Google Scholar
Bashour HN, et al. 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).
Bennett PN 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.
PubMed
PubMed Central
Google Scholar
Bernabe-Ortiz A et al. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru. Trials. 2014;15:93.
PubMed
PubMed Central
Google Scholar
Brown BB et al. Clinician-led improvement in cancer care (CLICC)--testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial--study protocol. Implement Sci. 2014;9:64.
PubMed
Google Scholar
Brownell MD et al. Long-term benefits of full-day kindergarten: a longitudinal population-based study. Early Child Dev Care. 2015;185(2):291–316.
CAS
PubMed
Google Scholar
Chavane L et al. Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol. BMC Health Serv Res. 2014;14:228.
PubMed
PubMed Central
Google Scholar
Chinbuah MA et al. Impact of community management of fever (using antimalarials with or without antibiotics) on childhood mortality: a cluster-randomized controlled trial in Ghana. Am J Trop Med Hyg. 2012;87(5 Suppl):11–20.
PubMed
PubMed Central
Google Scholar
Chinbuah MA et al. Impact of treating young children with antimalarials with or without antibiotics on morbidity: a cluster-randomized controlled trial in Ghana. Int Health. 2013;5(3):228–35.
PubMed
Google Scholar
Crain AL et al. Designing and implementing research on a statewide quality improvement initiative: the DIAMOND study and initiative. Med Care. 2013;51(9):e58–66.
PubMed
PubMed Central
Google Scholar
Solberg LI et al. Partnership research: a practical trial design for evaluation of a natural experiment to improve depression care. Med Care. 2010;48(7):576–82.
PubMed
PubMed Central
Google Scholar
Dainty KN 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.
PubMed
PubMed Central
Google Scholar
Morrison LJ et al. Improving Use of Targeted Temperature Management After Out-of-Hospital Cardiac Arrest: A Stepped Wedge Cluster Randomized Controlled Trial. Crit Care Med. 2015;43(5):954–64.
PubMed
Google Scholar
De Allegri M et al. Step-wedge cluster-randomised community-based trials: an application to the study of the impact of community health insurance. Health Res Policy Syst. 2008;6:10.
PubMed
PubMed Central
Google Scholar
Gnawali DP et al. The effect of community-based health insurance on the utilization of modern health care services: evidence from Burkina Faso. Health Policy. 2009;90(2-3):214–22.
PubMed
Google Scholar
Turner J 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;11:48.
PubMed
PubMed Central
Google Scholar
Dreischulte T 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.
PubMed
PubMed Central
Google Scholar
Dryden-Peterson S et al. An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: A cluster randomized trial. PLoS One. 2015;10(2):e0117181.
PubMed
PubMed Central
Google Scholar
Duijster D et al. Associations between oral health-related impacts and rate of weight gain after extraction of pulpally involved teeth in underweight preschool Filipino children. BMC Public Health. 2013;13:533.
PubMed
PubMed Central
Google Scholar
Monse B et al. The effects of extraction of pulpally involved primary teeth on weight, height and BMI in underweight Filipino children. A cluster randomized clinical trial. BMC Public Health. 2012;12:725.
PubMed
PubMed Central
Google Scholar
Durovni B et al. Impact of Replacing Smear Microscopy with Xpert MTB/RIF for Diagnosing Tuberculosis in Brazil: A Stepped-Wedge Cluster-Randomized Trial. PLoS Med. 2014;11(12):e1001766.
PubMed
PubMed Central
Google Scholar
Trajman A et al. Impact on Patients’ Treatment Outcomes of XpertMTB/RIF Implementation for the Diagnosis of Tuberculosis: Follow-Up of a Stepped-Wedge Randomized Clinical Trial. PLoS One. 2015;10(4):e0123252.
PubMed
PubMed Central
Google Scholar
Emond YE et al. Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial. Implement Sci. 2015;10(1):3.
PubMed
PubMed Central
Google Scholar
Enns E et al. A controlled quality improvement trial to reduce the use of physical restraints in older hospitalized adults. J Am Geriatr Soc. 2014;62(3):541–5.
PubMed
Google Scholar
Etchells E et al. Real-time automated paging and decision support for critical laboratory abnormalities. BMJ Qual Saf. 2011;20(11):924–30.
PubMed
Google Scholar
Fernald LCH, Gertler PJ, Neufeld LM. Role of cash in conditional cash transfer programmes for child health, growth, and development: an analysis of Mexico’s Oportunidades. Lancet. 2008;371(9615):828–37.
PubMed
PubMed Central
Google Scholar
Franklin BD et al. The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: A naturalistic stepped wedge study. BMJ Qual Saf. 2014;23(8):629–38.
PubMed
PubMed Central
Google Scholar
Gerritsen DL 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;11:91.
PubMed
Google Scholar
Leontjevas R et al. Process evaluation to explore internal and external validity of the “Act in Case of Depression” care program in nursing homes. J Am Med Dir Assoc. 2012;13(5):488 e1–8.
Google Scholar
Leontjevas R et al. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial. Lancet. 2013;381(9885):2255–64.
PubMed
Google Scholar
Leontjevas R et al. More insight into the concept of apathy: a multidisciplinary depression management program has different effects on depressive symptoms and apathy in nursing homes. Int Psychogeriatr. 2013;25(12):1941–52.
PubMed
Google Scholar
Gruber JS et al. 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.
PubMed
PubMed Central
Google Scholar
Gucciardi E 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;13:165.
PubMed
PubMed Central
Google Scholar
Haines TP et al. Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services. Trials. 2015;16(1):133.
PubMed
PubMed Central
Google Scholar
Haukka E et al. Efficacy of temporary work modifications on disability related to musculoskeletal pain or depressive symptoms-study protocol for a controlled trial. BMJ Open. 2015;5(5):e008300.
PubMed
PubMed Central
Google Scholar
Hayden MK et al. Prevention of colonization and infection by klebsiella pneumoniae carbapenemase-producing enterobacteriaceae in long-term acute-care hospitals. Clin Infect Dis. 2015;60(8):1154–61.
Google Scholar
Hill AM et al. A stepped-wedge cluster randomised controlled trial for evaluating rates of falls among inpatients in aged care rehabilitation units receiving tailored multimedia education in addition to usual care: A trial protocol. BMJ Open. 2014;4(1):e004195.
PubMed
PubMed Central
Google Scholar
Horner C 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.
CAS
PubMed
PubMed Central
Google Scholar
Howlin P et al. The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial. J Child Psychol Psychiatry. 2007;48(5):473–81.
PubMed
Google Scholar
Hunter SB et al. Continuous quality improvement (CQI) in addiction treatment settings: design and intervention protocol of a group randomized pilot study. Addict Sci Clin Pract. 2014;9(1):1–11.
Google Scholar
Husaini BA et al. A church-based program on prostate cancer screening for African American men: reducing health disparities. Ethn Dis. 2008;18(2 Suppl 2):S2-179-84.
PubMed
Google Scholar
Killam WP et al. Antiretroviral therapy in antenatal care to increase treatment initiation in HIV-infected pregnant women: a stepped-wedge evaluation. AIDS. 2010;24(1):85–91.
PubMed
Google Scholar
Kitson AL 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;13:299.
PubMed
PubMed Central
Google Scholar
Schultz TJ et al. Does a multidisciplinary nutritional intervention prevent nutritional decline in hospital patients? A stepped wedge randomised cluster trial. e-SPEN J. 2014;9(2):e84–90.
Google Scholar
Kjeken I 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;15:153.
PubMed
PubMed Central
Google Scholar
Li S et al. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China. Am Heart J. 2015;169(3):349–55.
PubMed
Google Scholar
Liddy C et al. Improved delivery of cardiovascular care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care. Implement Sci. 2011;6:110.
PubMed
PubMed Central
Google Scholar
Maheu-Giroux M, Castro MC. Do malaria vector control measures impact disease-related behaviour and knowledge? Evidence from a large-scale larviciding intervention in Tanzania. Malar J. 2013;12(1):422.
PubMed
PubMed Central
Google Scholar
Marrin K et al. Option Grids to facilitate shared decision making for patients with Osteoarthritis of the knee: protocol for a single site, efficacy trial. BMC Health Serv Res. 2014;14:160.
PubMed
PubMed Central
Google Scholar
Marshall T et al. Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT. BMC Public Health. 2012;12:908.
PubMed
PubMed Central
Google Scholar
Mhurchu CN 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.
PubMed
Google Scholar
Ni Mhurchu C et al. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial. BMC Public Health. 2010;10:738.
PubMed
PubMed Central
Google Scholar
Muntinga ME et al. Implementing the chronic care model for frail older adults in the Netherlands: study protocol of ACT (frail older adults: care in transition). BMC Geriatr. 2012;12:19.
PubMed
PubMed Central
Google Scholar
Palmay L et al. Hospital-wide rollout of antimicrobial stewardship: A stepped-wedge randomized trial. Clin Infect Dis. 2014;59(6):867–74.
PubMed
Google Scholar
Pickering BW et al. The implementation of clinician designed, human-centered electronic medical record viewer in the intensive care unit: a pilot step-wedge cluster randomized trial. Int J Med Inform. 2015;84(5):299–307.
PubMed
Google Scholar
Poldervaart JM 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.
PubMed
PubMed Central
Google Scholar
Rasmussen CD et al. 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;13:1088.
PubMed
PubMed Central
Google Scholar
Reuther S et al. Effect evaluation of two types of dementia-specific case conferences in German nursing homes (FallDem) using a stepped-wedge design: study protocol for a randomized controlled trial. Trials. 2014;15:319.
PubMed
PubMed Central
Google Scholar
Roy A et al. Universal HIV testing in London tuberculosis clinics: a cluster randomised controlled trial. Eur Respir J. 2013;41(3):627–34.
PubMed
Google Scholar
Solomon E et al. 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;12:581.
PubMed
PubMed Central
Google Scholar
Solomon E et al. The Devon Active Villages Evaluation (DAVE) trial of a community-level physical activity intervention in rural south-west England: a stepped wedge cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2014;11:94.
PubMed
PubMed Central
Google Scholar
Suman A et al. Cost-effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for nonspecific low back pain: design of a stepped-wedge cluster randomised controlled trial. BMC Public Health. 2015;15:522.
PubMed
PubMed Central
Google Scholar
Tiono AB et al. The AvecNet Trial to assess whether addition of pyriproxyfen, an insect juvenile hormone mimic, to long-lasting insecticidal mosquito nets provides additional protection against clinical malaria over current best practice in an area with pyrethroid-resistant vectors in rural Burkina Faso: study protocol for a randomised controlled trial. Trials. 2015;16(1):1–12.
CAS
Google Scholar
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;2:683.
PubMed
PubMed Central
Google Scholar
Tirlea L, Truby H, Haines TP. Pragmatic, Randomized Controlled Trials of the Girls on the Go! Program to Improve Self-Esteem in Girls. Am J Health Promot, 2015.
Toftegaard BS, Bro F, Vedsted P. A geographical cluster randomised stepped wedge study of continuing medical education and cancer diagnosis in general practice. Implement Sci. 2014;9:159.
PubMed
PubMed Central
Google Scholar
Ward J et al. STI in remote communities: improved and enhanced primary health care (STRIVE) study protocol: a cluster randomised controlled trial comparing ‘usual practice’ STI care to enhanced care in remote primary health care services in Australia. BMC Infect Dis. 2013;13(1):1–9.
Google Scholar
Williams AL et al. The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial. Trials. 2014;15:409.
PubMed
PubMed Central
Google Scholar
Wilrycx GK et al. Mental health recovery: evaluation of a recovery-oriented training program. Sci World J. 2012;2012:820846.
CAS
Google Scholar
Zwijsen SA et al. Grip on challenging behaviour: a multidisciplinary care programme for managing behavioural problems in nursing home residents with dementia. Study protocol. BMC Health Serv Res. 2011;11:41.
PubMed
PubMed Central
Google Scholar
Zwijsen SA et al. Coming to grips with challenging behavior: A cluster randomized controlled trial on the effects of a multidisciplinary care program for challenging behavior in Dementia. J Am Med Dir Assoc. 2014;15(7):531.e1–531.e10.
Google Scholar
Zwijsen SA et al. Grip on challenging behavior: Process evaluation of the implementation of a care program. Trials. 2014;15(1):302.
PubMed
PubMed Central
Google Scholar
Zwijsen SA et al. Coming to grips with challenging behaviour: a cluster randomised controlled trial on the effects of a new care programme for challenging behaviour on burnout, job satisfaction and job demands of care staff on dementia special care units. Int J Nurs Stud. 2015;52(1):68–74.
CAS
PubMed
Google Scholar
Van de Steeg L et al. 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.
PubMed
PubMed Central
Google Scholar
van de Steeg L et al. Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial. BMC Geriatr. 2014;14:69.
PubMed
PubMed Central
Google Scholar
van Holland BJ et al. 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;12:1003.
PubMed
PubMed Central
Google Scholar