posted on 2018-04-27, 11:32authored byCaroline Kristunas, Karla Hemming, Helen C. Eborall, Laura J. Gray
Background
The stepped-wedge cluster randomised trial (SW-CRT) is a complex
design for which many decisions must be made during the design
stage, such as the required number and length of steps. Feasibility
studies might help to inform these decisions and increase the likelihood
of the main trial’s success. However, there is currently no guidance
on how feasibility studies for SW-CRTs should be conducted.
This review, the first in a series of related projects, aims to establish
how often feasibility studies are being conducted for SW- CRTs and
determine which feasibility issues are currently being investigated.
Ultimately this work will lead to guidance on how feasibility studies
in SW- CRTs should be conducted.
Methods and analysis
Searches for feasibility studies for SW- CRTs were conducted in Ovid
MEDLINE, Scopus, and psycinfo. Relevant studies were identified via
titles, abstracts and full-text retrievals according to pre-defined study
inclusion criteria. Data were abstracted on the aims of these studies
and how these studies were able to inform the main trial. In order to
also identify unpublished feasibility studies for SW- CRTs, fully published
SW- CRTs were identified from the most recent systematic reviews.
The authors of these studies were contacted with the aim of
determining whether any unpublished feasibility work was conducted
prior to the main trial. In addition, the lead statisticians for
registered UK clinical trials units were contacted to acquire information
on feasibility work that is being undertaken by these units to inform
SW- CRTs.
Conclusion
This review, which is pending final results, will determine how often
feasibility studies are being used to inform SW- CRTs and identify
which feasibility issues are being investigated. Any information that
is gained on how these feasibility studies have informed the main trials,
will allow us to gain an insight into how feasibility studies can
benefit SW- CRTs. Future qualitative work will determine which aspects
of feasibility studies are considered most useful and what barriers
are commonly encountered when conducting a SW-CRT.
History
Citation
Trials, 2017, 18(Suppl 1):P139
Author affiliation
/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Health Sciences
Source
4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials, Liverpool, UK