Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) pilot study: A cluster randomized trial

Abstract The stepped-wedge cluster randomized trial (SW-CRT) involves the sequential transition of clusters (such as hospitals, public health units or communities) from control to intervention conditions in a randomized order. The use of the SW-CRT is growing rapidly. Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT). For this reason, the CONSORT extension for SW-CRTs requires that investigators provide a clear justification for the choice of study design. In this paper, we argue that all other things being equal, the SW-CRT is at greater risk of bias due to misspecification of the secular trends at the analysis stage. This is particularly problematic for studies randomizing a small number of heterogeneous clusters. We outline the potential conditions under which an SW-CRT might be an appropriate choice. Potentially appropriate and often overlapping justifications for conducting an SW-CRT include: (i) the SW-CRT provides a means to conduct a randomized evaluation which otherwise would not be possible; (ii) the SW-CRT facilitates cluster recruitment as it enhances the acceptability of a randomized evaluation either to cluster gatekeepers or other stakeholders; (iii) the SW-CRT is the only feasible design due to pragmatic and logistical constraints (for example the roll-out of a scare resource); and (iv) the SW-CRT has increased statistical power over other study designs (which will include situations with a limited number of clusters). As the number of arguments in favour of an SW-CRT increases, the likelihood that the benefits of using the SW-CRT, as opposed to a parallel-CRT, outweigh its risks also increases. We argue that the mere popularity and novelty of the SW-CRT should not be a factor in its adoption. In situations when a conventional parallel-CRT is feasible, it is likely to be the preferred design.

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A Pilot Study to Assess the Feasibility of a Multicenter Cluster Randomized Trial for the Management of Asymptomatic Persons with a Thrombophilia

Journal of Genetic Counseling ◽

10.1007/s10897-009-9239-7 ◽

2009 ◽

Vol 18 (5) ◽

pp. 475-482 ◽

Cited By ~ 4

Author(s):

Philip S. Wells ◽

Martha L. Louzada ◽

Monica Taljaard ◽

David R. Anderson ◽

Susan R. Kahn ◽

...

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Cluster Randomized

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Improving Care of Patients With Diabetes and CKD: A Pilot Study for a Cluster-Randomized Trial

American Journal of Kidney Diseases ◽

10.1053/j.ajkd.2007.12.039 ◽

2008 ◽

Vol 51 (5) ◽

pp. 777-788 ◽

Cited By ~ 37

Author(s):

Laura Cortés-Sanabria ◽

Carlos E. Cabrera-Pivaral ◽

Alfonso M. Cueto-Manzano ◽

Enrique Rojas-Campos ◽

Graciela Barragán ◽

...

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Patients With Diabetes ◽

Cluster Randomized

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An mHealth intervention to improve vaccination uptake and other health outcomes among rural Indian children: pilot study for a cluster-randomized trial

http://isrctn.com/ ◽

10.1186/isrctn44840759 ◽

2018 ◽

Cited By ~ 1

Author(s):

Mira Johri

Keyword(s):

Pilot Study ◽

Health Outcomes ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Indian Children ◽

Vaccination Uptake ◽

Mhealth Intervention ◽

Cluster Randomized

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The Acute Kidney Outreach to Prevent Deterioration and Death trial: a large pilot study for a cluster-randomized trial

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfz246 ◽

2019 ◽

Author(s):

Mark E Thomas ◽

Tarek S Abdelaziz ◽

Gavin D Perkins ◽

Alice J Sitch ◽

Jyoti Baharani ◽

...

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Primary Outcome ◽

Cluster Randomized Trial ◽

Teaching Hospitals ◽

Specialist Care ◽

Outreach Service ◽

Intervention Hospital ◽

Catchment Areas ◽

Cluster Randomized

Abstract Background and Objectives The Acute Kidney Outreach to Reduce Deterioration and Death trial was a large pilot study for a cluster-randomized trial of acute kidney injury (AKI) outreach. Methods An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas. In the intervention (after) phase, a working-hours AKI outreach service operated for the intervention hospital/area for 20 weeks, with the other site acting as a control. All AKI alerts in both hospital and community patients were screened for inclusion. Major exclusion criteria were patients who were at the end of life, unlikely to benefit from outreach, lacking mental capacity or already referred to the renal team. The intervention arm included a model of escalation of renal care to AKI patients, depending on AKI stage. The 30-day primary outcome was a combination of death, or deterioration, as shown by any need for dialysis or progression in AKI stage. A total of 1762 adult patients were recruited; 744 at the intervention site during the after phase. Results A median of 3.0 non-medication recommendations and 0.5 medication-related recommendations per patient were made by the outreach team a median of 15.7 h after the AKI alert. Relatively low rates of the primary outcomes of death within 30 days (11–15%) or requirement for dialysis (0.4–3.7%) were seen across all four groups. In an exploratory analysis, at the intervention hospital during the after phase, there was an odds ratio for the combined primary outcome of 0.73 (95% confidence interval 0.42–1.26; P = 0.26). Conclusions An AKI outreach service can provide standardized specialist care to those with AKI across a healthcare economy. Trials assessing AKI outreach may benefit from focusing on those patients with ‘mid-range’ prognosis, where nephrological intervention could have the most impact.

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