The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting

Hemming, Karla; Haines, Terrence Peter; Chilton, Peter J; Girling, Alan; Lilford, Richard

doi:10.1136/bmj.h391

Cited by 1,026 publications

(960 citation statements)

References 28 publications

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“…What are the pros and cons of a stepped wedge design vs a randomized clinical trial? 2,3 • To what degree can the findings be accounted for by: …”

Section: Discussion Questionsmentioning

confidence: 99%

Implementation Science is Challenging: When RCT Evidence Doesn't Translate into Practice

2015

The Annals of Family Medicine

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“…What are the pros and cons of a stepped wedge design vs a randomized clinical trial? 2,3 • To what degree can the findings be accounted for by: …”

Section: Discussion Questionsmentioning

confidence: 99%

Implementation Science is Challenging: When RCT Evidence Doesn't Translate into Practice

2015

The Annals of Family Medicine

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“…We will test our hypothesis with a logistic regression model with a random effect for cluster and a fixed effect for each step of implementation of the intervention to adjust for possible effects of calendar time [33,34].…”

Section: Statistical Analysis and Sample Sizementioning

confidence: 99%

A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial (Preprint)

Kwegyir-Afful¹,

Verbeek²,

Aziato³

et al. 2018

Preprint

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Background: Preterm birth (PTB) is a leading cause of infant morbidity and mortality in the world. Every year 20 million babies are born with low birthweight (LBW) and about 96% occurring in low-income countries. Despite their associated dangers, in about 40-50% of PTB and LBW cases, the causes are unexplained. Existing evidence is inconclusive as to whether occupational physical activities such as heavy lifting are implicated. African women bear the transport burden of accessing basic needs for their families. Ghana's preterm birth rate is 14.5% as compared to the global average of 9.6%. The proposed lift-less intervention aims to decrease lifting exposure during pregnancy among Ghanaian women. Our hypothesis is, a reduction in heavy lifting among pregnant women in Ghana will increase gestational age and birthweight.Method: A cohort stepped-wedge cluster randomized controlled trial in 10 antenatal clinics will be carried out in Ghana. A total of 1,000 participants will be recruited for 60 weeks period. To be eligible participant's pregnancy should be singleton between 12 to 16 weeks gestation, attending any of the 10 antenatal clinics and exposed to heavy lifting. All participants will receive standard antenatal care within the control phase and by random allocation; two clusters will transit into the intervention phase. The midwife-led 3-components lift-less intervention consists of health education, a take-home reminder card mimicking the colours of traffic light and a shopping voucher. The primary outcome will be gestational age at <28, 28-32 and 33-37 weeks. Secondary outcomes are LBW (preterm LBW, term but LBW and post term), compliance, prevalence of low back and pelvic pains and premature uterine contractions.Objective: To investigate the effects of the lift-less intervention on the incidence of prematurity and low birthweight among Ghanaian pregnant women. Results:The results of the trial will be published in a peer reviewed journal. It will increase knowledge in the prevention of PTB and low birth weight worldwide. Conclusion:To the best of our knowledge, there has been no randomized trial of this nature in Ghana. Minimizing heavy lifting among African pregnant women can reduce the soaring numbers of preterm and LBW.

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“…[33] Further studies on the implementation and outcomes of the SSC would require a stepped-wedge cluster design, as it would no longer be deemed ethical to withhold the use of an SSC in a control group. [31,34] The rationale for a trial on the implementation of an SSC in SA is twofold, as the trial: (i) effects the implementation of a mandated, essential public health intervention provision; while (ii) simultaneously providing additional high-level evidence to aid universal uptake of the SSC.…”

Section: Priority 6 a Stepped-wedge Trial Of A Surgical Safety Checkmentioning

confidence: 99%

National priorities for perioperative research in South Africa

et al. 2016

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Perioperative research is currently unco-ordinated in South Africa (SA). A large group of investigators and interested individuals collaborated under the auspices of the South African Perioperative Research Group (SAPORG), the members of which are listed in Appendix 1, to address this limitation. This initiative was undertaken because the group believed that: (i) collaborative research is necessary to address the clinical challenges encountered in perioperative care and outcomes, both in SA and globally; (ii) we have the capacity to conduct national and international collaborative research in SA; [1] (iii) collaborative research conserves the limited research resources in SA and globally; [2] (iv) there are urgent public health issues in perioperative medicine that need to be addressed to improve the health of the SA and/or global surgical populations; [1] and (v) a national research priority-setting process [3] is necessary to prioritise research in an environment of limited research resources. ObjectiveTo determine the top ten national research priorities for perioperative research in SA, using a national research prioritysetting process. MethodsA Delphi technique [4] was followed for this national research priority-setting project. It was conducted in four rounds. In the first round, an open email invitation was sent to approximately 600 individuals across SA, based predominantly on South African Surgical Outcomes Study (SASOS) participation [1] together with other perioperative and critical care research leaders who were identified to the group. Furthermore, the recipients were encouraged to forward the email to other individuals who might be interested in the research-setting process. In the first round respondents were asked to submit potential research questions or research priority areas. The responses were collated, and where appropriate research questions were amalgamated by BMB. This resulted in 116 potential research priority questions, covering a broad range of questions and including proposals within the following fields: national pragmatic trials, perioperative outcomes, cardiovascular, critical care, education, obstetrics, paediatrics, trauma and resuscitation, perioperative ultrasonography, burns and perioperative airway management.In the second round, these 116 potential research priority questions were circulated to all the respondents. They were asked to rank the top ten research questions, and where possible to provide justifications for inclusion or exclusion of priorities. In the third round, the same 116 questions were presented in rank order based on the responses from round two, with all submitted justifications attached. In this round the respondents were asked to consider re-ranking their previous submission from round two, based on the priorities ranking and justifications of the group. If the respondents preferred not to change their previous rankings, Background. Perioperative research is currently unco-ordinated in South Africa (SA), with no clear research agenda. Objective. To de...

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The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting

Cited by 1,026 publications

References 28 publications

Implementation Science is Challenging: When RCT Evidence Doesn't Translate into Practice

Implementation Science is Challenging: When RCT Evidence Doesn't Translate into Practice

A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial (Preprint)

National priorities for perioperative research in South Africa

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