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Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014.

Beard E, Lewis JJ, Copas A, Davey C, Osrin D, Baio G, Thompson JA, Fielding KL, Omar RZ, Ononge S, Hargreaves J, Prost A - Trials (2015)

Bottom Line: Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25).The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. e.beard@ucl.ac.uk.

ABSTRACT

Background: In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design's perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design.

Methods: We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.

Results: Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.

Conclusions: The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.

No MeSH data available.


Flowchart describing the selection of studies included in the systematic review
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Fig1: Flowchart describing the selection of studies included in the systematic review

Mentions: Figure 1 describes the selection of studies included in this systematic review. Of the 2,948 records retrieved from the database search, we reviewed 47 full texts, and 36 studies were eligible for this review. In addition, the authors of this paper identified one more paper not found in the database search (as it is an SWT, but also refers to ‘stepped expansion’ in the abstract). Four of the published papers had previously been included as published protocols in the Mdege et al. review [5].Fig. 1


Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014.

Beard E, Lewis JJ, Copas A, Davey C, Osrin D, Baio G, Thompson JA, Fielding KL, Omar RZ, Ononge S, Hargreaves J, Prost A - Trials (2015)

Flowchart describing the selection of studies included in the systematic review
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4538902&req=5

Fig1: Flowchart describing the selection of studies included in the systematic review
Mentions: Figure 1 describes the selection of studies included in this systematic review. Of the 2,948 records retrieved from the database search, we reviewed 47 full texts, and 36 studies were eligible for this review. In addition, the authors of this paper identified one more paper not found in the database search (as it is an SWT, but also refers to ‘stepped expansion’ in the abstract). Four of the published papers had previously been included as published protocols in the Mdege et al. review [5].Fig. 1

Bottom Line: Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25).The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. e.beard@ucl.ac.uk.

ABSTRACT

Background: In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design's perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design.

Methods: We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.

Results: Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.

Conclusions: The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.

No MeSH data available.