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Randomised controlled trials are the gold standard of health research evidence. In this design, participants are randomised to receive either the intervention being assessed, or a control condition (which may be the standard of care). Tension often exists between people wanting to use a new intervention, and the scientists who are generating evidence through a controlled evaluation study.
One way that has emerged to balance this is the stepped wedge randomised controlled trial design. In this approach, the participants are divided into groups or clusters, all of which will eventually get the intervention under study but this is done in a staggered or stepped way in which the order in which, and the time point at which, each cluster or group gets the intervention is randomised.
This type of design is growing in popularity, and there have been recent calls to standardise the way in which these trials are designed and reported. To this end, the Trials journal has recently published a series of papers that deals with this research design specifically. You can access this series here.
This series includes the following topics:
- Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies. 2010 to 2014 Calum Davey, James Hargreaves, Jennifer A Thompson, Andrew J Copas, Emma Beard, James J Lewis, Katherine L Fielding. Trials 2015, 16:358 (17 August 2015)
- Sample size calculation for a stepped wedge trial. Gianluca Baio, Andrew Copas, Gareth Ambler, James Hargreaves, Emma Beard, Rumana Z Omar. Trials 2015, 16:354 (17 August 2015)
- Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. Emma Beard, James Lewis, Andrew Copas, Calum Davey, David Osrin, Gianluca Baio, Jennifer Thompson, Katherine Fielding, Rumana Omar, Sam Ononge, James Hargreaves, Audrey Prost, Trials 2015, 16:353 (17 August 2015)
- Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Andrew Copas, James Lewis, Jennifer Thompson, Calum Davey, Gianluca Baio, James Hargreaves. Trials 2015, 16:352 (17 August 2015
- Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies. Audrey Prost, Ariella Binik, Ibrahim Abubakar, Anjana Roy, Manuela De Allegri, Christelle Mouchoux, Tobias Dreischulte, Helen Ayles, James Lewis, David Osrin. Trials 2015, 16:351 (17 August 2015)
- Five questions to consider before conducting a stepped wedge trial. James R Hargreaves, Andrew J Copas, Emma Beard, David Osrin, James J Lewis, Calum Davey, Jennifer A Thompson, Gianluca Baio, Katherine L Fielding, Audrey Prost. Trials 2015, 16:350 (17 August 2015).
What are your thoughts? Is this a valuable and useful research design? Do you have examples of interventions that are best suited to this approach? Have you been involved in a stepped wedge randomised trial? We would love to hear from you, and share your experience.