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Literature DB >> 26247569

Current issues in the design and analysis of stepped wedge trials.

James P Hughes¹, Tanya S Granston², Patrick J Heagerty².

Abstract

The use of stepped wedge designs in cluster-randomized trials and implementation studies has increased rapidly in recent years but there remains considerable debate regarding the merits of the design. We discuss three key issues in the design and analysis of stepped wedge trials - time-on-treatment effects, treatment effect heterogeneity and cohort studies.

Entities: Chemical Disease Gene Species

Keywords: Cluster randomized trial; Implementation research; Stepped wedge design

Mesh：

Year: 2015 PMID： 26247569 PMCID： PMC4639463 DOI： 10.1016/j.cct.2015.07.006

Source DB: PubMed Journal: Contemp Clin Trials ISSN： 1551-7144 Impact factor: 2.226

23 in total

Review 1. Studies with staggered starts: multiple baseline designs and group-randomized trials.

Authors: Dale A Rhoda; David M Murray; Rebecca R Andridge; Michael L Pennell; Erinn M Hade
Journal: Am J Public Health Date: 2011-09-22 Impact factor: 9.308

2. The stepped wedge design does not inherently have more power than a cluster randomized controlled trial.

Authors: Daniel Kotz; Mark Spigt; Ilja C W Arts; Rik Crutzen; Wolfgang Viechtbauer
Journal: J Clin Epidemiol Date: 2013-09 Impact factor: 6.437

3. 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.

Authors: Esther de Hoop; Willem Woertman; Steven Teerenstra
Journal: J Clin Epidemiol Date: 2013-09-08 Impact factor: 6.437

4. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials.

Authors: JoAnna M Scott; Allan deCamp; Michal Juraska; Michael P Fay; Peter B Gilbert
Journal: Stat Methods Med Res Date: 2014-09-29 Impact factor: 3.021

5. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial.

Authors: Ronald H Gray; Godfrey Kigozi; David Serwadda; Frederick Makumbi; Stephen Watya; Fred Nalugoda; Noah Kiwanuka; Lawrence H Moulton; Mohammad A Chaudhary; Michael Z Chen; Nelson K Sewankambo; Fred Wabwire-Mangen; Melanie C Bacon; Carolyn F M Williams; Pius Opendi; Steven J Reynolds; Oliver Laeyendecker; Thomas C Quinn; Maria J Wawer
Journal: Lancet Date: 2007-02-24 Impact factor: 79.321

6. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial.

Authors: Robert C Bailey; Stephen Moses; Corette B Parker; Kawango Agot; Ian Maclean; John N Krieger; Carolyn F M Williams; Richard T Campbell; Jeckoniah O Ndinya-Achola
Journal: Lancet Date: 2007-02-24 Impact factor: 79.321

7. Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention.

Authors: Lawrence H Moulton; Jonathan E Golub; Betina Durovni; Solange C Cavalcante; Antonio G Pacheco; Valeria Saraceni; Bonnie King; Richard E Chaisson
Journal: Clin Trials Date: 2007 Impact factor: 2.486

8. Antiretroviral therapy in antenatal care to increase treatment initiation in HIV-infected pregnant women: a stepped-wedge evaluation.

Authors: William P Killam; Bushimbwa C Tambatamba; Namwinga Chintu; Dwight Rouse; Elizabeth Stringer; Maximillian Bweupe; Yong Yu; Jeffrey Sa Stringer
Journal: AIDS Date: 2010-01-02 Impact factor: 4.177

Review 9. The stepped wedge trial design: a systematic review.

Authors: Celia A Brown; Richard J Lilford
Journal: BMC Med Res Methodol Date: 2006-11-08 Impact factor: 4.615

10. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs.

Authors: Karla Hemming; Richard Lilford; Alan J Girling
Journal: Stat Med Date: 2014-10-24 Impact factor: 2.373

43 in total

1. Planning and Analysis of Trials Using a Stepped Wedge Design.

Authors: Stefan Wellek; Norbert Donner-Banzhoff; Jochem König; Philipp Mildenberger; Maria Blettner
Journal: Dtsch Arztebl Int Date: 2019-06-28 Impact factor: 5.594

2. The Importance of Evaluating Health Disparities Research.

Authors: Bruce A Dye; Deborah G Duran; David M Murray; John W Creswell; Patrick Richard; Tilda Farhat; Nancy Breen; Michael M Engelgau
Journal: Am J Public Health Date: 2019-01 Impact factor: 9.308

3. Multilevel Interventions Targeting Obesity: Research Recommendations for Vulnerable Populations.

Authors: June Stevens; Charlotte Pratt; Josephine Boyington; Cheryl Nelson; Kimberly P Truesdale; Dianne S Ward; Leslie Lytle; Nancy E Sherwood; Thomas N Robinson; Shirley Moore; Shari Barkin; Ying Kuen Cheung; David M Murray
Journal: Am J Prev Med Date: 2016-10-26 Impact factor: 5.043

4. Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.

Authors: Stephen K Williams; Brent A Johnson; Jonathan N Tobin; Amneris Esther Luque; Mechelle Sanders; Jennifer K Carroll; Andrea Cassells; Tameir Holder; Kevin Fiscella
Journal: Prog Cardiovasc Dis Date: 2020-02-05 Impact factor: 8.194

5. A Cluster Randomized Evaluation of a Health Department Data to Care Intervention Designed to Increase Engagement in HIV Care and Antiretroviral Use.

Authors: Julia C Dombrowski; James P Hughes; Susan E Buskin; Amy Bennett; David Katz; Mark Fleming; Angela Nunez; Matthew R Golden
Journal: Sex Transm Dis Date: 2018-06 Impact factor: 2.830

10. Extending the I-squared statistic to describe treatment effect heterogeneity in cluster, multi-centre randomized trials and individual patient data meta-analysis.

Authors: Karla Hemming; James P Hughes; Joanne E McKenzie; Andrew B Forbes
Journal: Stat Methods Med Res Date: 2020-09-21 Impact factor: 3.021