Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
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Karla Hemming | Mary Dixon-Woods | Andrew Copas | Jeremy M Grimshaw | Marion K Campbell | Sandra Eldridge | Monica Taljaard | Richard Hooper | Alan Girling | Michael Grayling | Andrew B Forbes | Joanne E McKenzie | Charles Weijer | Jennifer A Thompson | Adrian Aldcroft | Adelaide Doussau | Caroline Kristunas | Cory E Goldstein | Mike J Campbell | Richard J Lilford | M. Dixon-Woods | J. Grimshaw | M. Taljaard | C. Weijer | J. McKenzie | A. Copas | A. Girling | R. Lilford | K. Hemming | S. Eldridge | Martin Campbell | A. Forbes | Jennifer A Thompson | M. Campbell | R. Hooper | M. Grayling | A. Doussau | Cory E. Goldstein | C. Kristunas | Adrian Aldcroft
[1] J. Hughes,et al. Design and analysis of stepped wedge cluster randomized trials. , 2007, Contemporary clinical trials.
[2] D. Heisey,et al. The Abuse of Power , 2001 .
[3] W. Shadish,et al. Experimental and Quasi-Experimental Designs for Generalized Causal Inference , 2001 .
[4] Steven Teerenstra,et al. Substantial risks associated with few clusters in cluster randomized and stepped wedge designs , 2016, Clinical trials.
[5] Andre Charlett,et al. The Feedback Intervention Trial (FIT) — Improving Hand-Hygiene Compliance in UK Healthcare Workers: A Stepped Wedge Cluster Randomised Controlled Trial , 2012, PloS one.
[6] M. Campbell,et al. Stepped wedge cluster randomised trials: a review of the statistical methodology used and available , 2016, BMC Medical Research Methodology.
[7] J. Grimshaw,et al. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review , 2017, Clinical trials.
[8] D. Moher,et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement , 2008, BMJ : British Medical Journal.
[9] M. Kerin,et al. Effect of the World Health Organization Checklist on Patient Outcomes: A Stepped Wedge Cluster Randomized Controlled Trial. , 2016, Annals of surgery.
[10] V. Rodríguez,et al. International Covenant on Civil and Political Rights. , 1988, Annual review of population law.
[11] I. Olkin,et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. , 1996, JAMA.
[12] P. Heagerty,et al. Current issues in the design and analysis of stepped wedge trials. , 2015, Contemporary clinical trials.
[13] M. Taljaard,et al. Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials , 2016, BMJ Open.
[14] Valérie Buthion,et al. ColoNav: patient navigation for colorectal cancer screening in deprived areas – Study protocol , 1999, BMC Cancer.
[15] I. Olkin,et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. , 1996, JAMA.
[16] Zhuozhao Zhan,et al. Statistical methods for unidirectional switch designs: Past, present, and future , 2018, Statistical methods in medical research.
[17] Deborah Ashby,et al. Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care , 2005, Clinical trials.
[18] M. Taljaard,et al. Sample size calculations for stepped wedge and cluster randomised trials: a unified approach , 2016, Journal of clinical epidemiology.
[19] Richard J Hayes,et al. Bias and inference from misspecified mixed‐effect models in stepped wedge trial analysis , 2017, Statistics in medicine.
[20] B. Giraudeau,et al. Timeline cluster: a graphical tool to identify risk of bias in cluster randomised trials , 2016, British Medical Journal.
[21] Aart Hendriks,et al. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. , 2000, The Journal of medicine and philosophy.
[22] M. Hillsdon,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 , 2012, BMC Public Health.
[23] Icmje admin,et al. International Committee of Medical Journal Editors Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals , 2017 .
[24] Gianluca Baio,et al. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches , 2015, Trials.
[25] John B. Carlin,et al. The Intra‐Cluster Correlation Coefficient in Cluster Randomized Trials: A Review of Definitions , 2009 .
[26] T. Wachs,et al. CONSORT for reporting randomised trials in journal and conference abstracts , 2008 .
[27] D. Osrin,et al. Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies , 2015, Trials.
[28] Steven Teerenstra,et al. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial , 2013, The Lancet.
[29] Allan Donner,et al. Group sequential methods for cluster randomization trials with binary outcomes , 2005, Clinical trials.
[30] J. Grimshaw,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 , 2011, BMJ : British Medical Journal.
[31] J. Hartley,et al. Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals , 2014, Annals of surgery.
[32] T. Haines,et al. Stepped-wedge cluster-randomised trials: level of evidence, feasibility and reporting. , 2018, Journal of physiotherapy.
[33] A. Hall,et al. Population-Based Interventions to Reduce the Public Health Burden Related with Hepatitis B Virus Infection in The Gambia, West Africa , 2014, Tropical medicine and health.
[34] M. Campbell,et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials , 2016, British Medical Journal.
[35] S. Senn. Testing for baseline balance in clinical trials. , 1994, Statistics in medicine.
[36] D. Rennie. CONSORT revised--improving the reporting of randomized trials. , 2001, JAMA.
[37] L. Hooft,et al. Trial Registration Numbers Are Underreported in Biomedical Publications , 2012, PloS one.
[38] C. Grady,et al. Deciphering assumptions about stepped wedge designs: the case of Ebola vaccine research , 2016, Journal of Medical Ethics.
[39] E. Søfteland,et al. Effect of the World Health Organization checklist on patient outcomes: a stepped wedge cluster randomized controlled trial. , 2015, Annals of surgery.
[40] D. Moher,et al. Guidance for Developers of Health Research Reporting Guidelines , 2010, PLoS medicine.
[41] J. Carlin,et al. Comparison of the risk difference, risk ratio and odds ratio scales for quantifying the unadjusted intervention effect in cluster randomized trials , 2008, Statistics in medicine.
[42] R. Emsley,et al. Choosing the target difference (‘effect size’) for a randomised controlled trial - DELTA2 guidance protocol , 2017, Trials.
[43] S. Pocock,et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. , 2006, JAMA.
[44] M. Hillsdon,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 , 2014, International Journal of Behavioral Nutrition and Physical Activity.
[45] J. Hattie,et al. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial , 2010, BMC public health.
[46] A. Garg,et al. Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry , 2017, Trials.
[47] M. Taljaard,et al. Analysis of cluster randomised stepped wedge trials with repeated cross-sectional samples , 2017, Trials.
[48] Arash Rashidian,et al. Introducing Critical Care Outreach: a ward-randomised trial of phased introduction in a general hospital , 2004, Intensive Care Medicine.
[49] Isabelle Boutron,et al. A revised tool for assessing risk of bias in randomized trials , 2016 .
[50] Steven Teerenstra,et al. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials , 2016, Statistics in medicine.
[51] K Hemming,et al. Impact of non-uniform correlation structure on sample size and power in multiple-period cluster randomised trials , 2019, Statistical methods in medical research.
[52] D. Moher,et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, BMC medicine.
[53] L. Thabane,et al. The reporting quality of abstracts of stepped wedge randomized trials is suboptimal: A systematic survey of the literature , 2017, Contemporary clinical trials communications.
[54] Richard J Lilford,et al. Ethical issues in the design and conduct of cluster randomised controlled trials , 1999, BMJ.
[55] J. Whitty,et al. Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial , 2017, BMJ Open.
[56] M. Sinclair,et al. Protocol for a cluster randomised stepped wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India , 2017, BMJ Open.
[57] Andrew J Copas,et al. Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014 , 2015, Trials.
[58] S. Iliffe,et al. Bmc Medical Research Methodology Open Access the Hawthorne Effect: a Randomised, Controlled Trial , 2022 .
[59] J. Hattie,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 , 2012, Journal of Epidemiology & Community Health.
[60] C. Pedroza,et al. Performance of models for estimating absolute risk difference in multicenter trials with binary outcome , 2016, BMC Medical Research Methodology.
[61] R. Lilford,et al. Bmc Medical Research Methodology Open Access the Stepped Wedge Trial Design: a Systematic Review , 2022 .
[62] D. Moher,et al. CONSORT for reporting randomised trials in journal and conference abstracts , 2008, The Lancet.
[63] P. Gill,et al. Targeted case finding in the prevention of cardiovascular disease: a stepped wedge cluster randomised controlled trial. , 2016, The British journal of general practice : the journal of the Royal College of General Practitioners.
[64] M. Halek,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 , 2014, Trials.
[65] Karla Hemming,et al. A Menu-Driven Facility for Power and Detectable-Difference Calculations in Stepped-Wedge Cluster-Randomized Trials , 2014 .
[66] A. Girling,et al. Intra-cluster and inter-period correlation coefficients for cross-sectional cluster randomised controlled trials for type-2 diabetes in UK primary care , 2016, Trials.
[67] Karla Hemming,et al. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs , 2014, Statistics in medicine.
[68] M. Taljaard,et al. Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: a review. , 2015, Journal of clinical epidemiology.
[69] J. Wason,et al. Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features , 2017, Trials.
[70] L. Gray,et al. The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope. , 2017 .
[71] R J Lilford,et al. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting , 2015, BMJ : British Medical Journal.
[72] P. Tugwell,et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials , 2016, British Medical Journal.
[73] J. Wyatt,et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide , 2014, BMJ : British Medical Journal.
[74] R. Hayes,et al. Simple sample size calculation for cluster-randomized trials. , 1999, International journal of epidemiology.
[75] Celia A Taylor nee Brown,et al. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. , 2011, Journal of clinical epidemiology.
[76] G. Piaggio,et al. Consort 2010 statement: extension to cluster randomised trials , 2012, BMJ : British Medical Journal.
[77] R. Chaisson,et al. Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention , 2007, Clinical trials.
[78] A. Girling,et al. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models , 2016, Statistics in medicine.
[79] Karen Tu,et al. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review , 2012, Trials.
[80] D. Altman,et al. CONSORT statement: extension to cluster randomised trials , 2004, BMJ : British Medical Journal.
[81] B. Thombs,et al. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology , 2015, PloS one.
[82] L. Bourke,et al. Cluster randomised trials with repeated cross sections: alternatives to parallel group designs , 2015, BMJ : British Medical Journal.
[83] Rik Crutzen,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. , 2012, Journal of clinical epidemiology.
[84] J. Carlin,et al. Optimal stepped wedge designs , 2015 .
[85] B. Cissé,et al. Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial , 2016, PloS one.
[86] Gianluca Baio,et al. Sample size calculation for a stepped wedge trial , 2015, Trials.
[87] J. Grimshaw,et al. The Ottawa Statement on the ethical design and conduct of cluster randomised trials: précis for researchers and research ethics committees , 2013, BMJ.
[88] G. Baio,et al. Five questions to consider before conducting a stepped wedge trial , 2015, Trials.