Stepped wedge cluster randomised trials: a review of the statistical methodology used and available

被引:110
作者
Barker, D. [1 ]
McElduff, P. [1 ]
D'Este, C. [1 ,2 ]
Campbell, M. J. [3 ]
机构
[1] Univ Newcastle, Sch Med & Publ Hlth, Fac Hlth, CCEB, HMRI Bldg,Level 4 West,Univ Dr, Callaghan, NSW 2308, Australia
[2] Australian Natl Univ, Res Sch Populat Hlth, Natl Ctr Epidemiol & Populat Hlth, GPO Box 4, Canberra, ACT 0200, Australia
[3] Univ Sheffield, Med Stat Grp, ScHARR, Sheffield, S Yorkshire, England
关键词
Stepped wedge; Cluster randomised; Statistical methodology; MULTIFACETED IMPLEMENTATION STRATEGY; PHYSICAL-ACTIVITY INTERVENTION; ISONIAZID PREVENTIVE THERAPY; SCHOOL BREAKFAST PROGRAM; NURSING-HOME RESIDENTS; EVALUATION DAVE TRIAL; QUALITY-OF-CARE; LOW-BACK-PAIN; COST-EFFECTIVENESS; CHALLENGING BEHAVIOR;
D O I
10.1186/s12874-016-0176-5
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background: Previous reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used. This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials. Methods: Literature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design. Results: This review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used. Conclusions: Many studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.
引用
收藏
页数:19
相关论文
共 191 条
  • [41] Designing and Implementing Research on a Statewide Quality Improvement Initiative The DIAMOND Study and Initiative
    Crain, A. Lauren
    Solberg, Leif I.
    Unuetzer, Juergen
    Ohnsorg, Kris A.
    Maciosek, Michael V.
    Whitebird, Robin R.
    Beck, Arne
    Molitor, Beth A.
    [J]. MEDICAL CARE, 2013, 51 (09) : e58 - e66
  • [42] A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons
    Craine, Noel
    Whitaker, Rhiannon
    Perrett, Stephanie
    Zou, Lu
    Hickman, Matthew
    Lyons, Marion
    [J]. EUROPEAN JOURNAL OF PUBLIC HEALTH, 2015, 25 (02) : 351 - 357
  • [43] A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial
    Dainty, Katie N.
    Scales, Damon C.
    Brooks, Steve C.
    Needham, Dale M.
    Dorian, Paul
    Ferguson, Niall
    Rubenfeld, Gordon
    Wax, Randy
    Zwarenstein, Merrick
    Thorpe, Kevin
    Morrison, Laurie J.
    [J]. IMPLEMENTATION SCIENCE, 2011, 6
  • [44] Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014
    Davey, Calum
    Hargreaves, James
    Thompson, Jennifer A.
    Copas, Andrew J.
    Beard, Emma
    Lewis, James J.
    Fielding, Katherine L.
    [J]. TRIALS, 2015, 16
  • [45] Topics in research: structuring studies in palliative care
    Davis, Mellar P.
    Mitchell, Geoffrey K.
    [J]. CURRENT OPINION IN SUPPORTIVE AND PALLIATIVE CARE, 2012, 6 (04) : 483 - 489
  • [46] Step-wedge cluster-randomised community-based trials: An application to the study of the impact of community health insurance
    De Allegri M.
    Pokhrel S.
    Becher H.
    Dong H.
    Mansmann U.
    Kouyaté B.
    Kynast-Wolf G.
    Gbangou A.
    Sanon M.
    Bridges J.
    Sauerborn R.
    [J]. Health Research Policy and Systems, 6 (1)
  • [47] 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 Reply
    de Hoop, Esther
    Woertman, Willem
    Teerenstra, Steven
    [J]. JOURNAL OF CLINICAL EPIDEMIOLOGY, 2013, 66 (12) : 1428 - 1428
  • [48] Examining clinical supervision as a mechanism for changes in practice: a research protocol
    Dilworth, Sophie
    Higgins, Isabel
    Parker, Vicki
    Kelly, Brian
    Turner, Jane
    [J]. JOURNAL OF ADVANCED NURSING, 2014, 70 (02) : 421 - 430
  • [49] National project seeking to improve pain management in the emergency department setting: Findings from the NHMRC-NICS National Pain Management Initiative
    Doherty, Steven
    Knott, Jonathan
    Bennetts, Scott
    Jazayeri, Mitra
    Huckson, Sue
    [J]. EMERGENCY MEDICINE AUSTRALASIA, 2013, 25 (02) : 120 - 126
  • [50] Some aspects of the design and analysis of cluster randomization trials
    Donner, A
    [J]. JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS, 1998, 47 : 95 - 113