WSO - February 2023 - 161

Godolphin et al.
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Table 3. Suggestions on when to adjudicate in future stroke trials.
Outcome
Primary outcome: stroke or a composite
including stroke
Primary outcome: functional outcome
measured on the mRS
Subjective key safety or secondary outcome
Objective key safety or secondary outcome
Other outcome
SI: site investigator; mRS: modified Rankin Scale.
and is most important for studies where outcome assessors
cannot be blinded. Table 3 summarizes our suggestions for
future stroke trials based on their outcome and blinding of
site investigators. Our suggestions provided here are general,
and we appreciate that the decision to adjudicate may
vary substantially based on the trial budget, trial sponsor
(e.g. academic/industry), the number of sites, and the experience
of the site investigators. However, these suggestions
provide a general guide from which to base a decision on
whether adjudication is important for a specific trial and
outcome.
Limitations
This systematic review has several limitations. First, half
of the included studies were from the present authors, and
it is possible that our research methods and beliefs have
unduly influenced the findings. However, the findings
from our studies are broadly in agreement from the other
articles that we identified. Second, in our previous systematic
review,2 which provides a large amount of the evidence,
we only managed to obtain results from 15 trials.
There were a further 74 that were potentially eligible, but
did not provide sufficient information to include, even
after efforts to contact the authors.33 However, without
this additional evidence, we have presented the most thorough
assessment of adjudication in stroke trials to date.
Furthermore, while we did not assess the quality of the
randomized trials that were involved in the methodological
articles identified in this review, they represent predominantly
high-quality prevention stroke trials with
commonly used objective outcomes and may not be representative
of all stroke trials that adjudicate. Finally, the
only assessment of the cost-benefit of adjudication was
from a retrospective study.23 These costs are only approximate,
and a prospective study to properly measure the cost
of adjudication is warranted to fully understand the cost
and time implications.
Conclusion
Central adjudication may be of little importance for stroke
trials where site investigators are already masked to treatment
allocation. However, adjudication may be more
important in determining unbiased outcomes for stroke trials
without sufficient blinding for site investigators. Given
that adjudication comes with non-trivial expense, it is
important to have a clear rationale for its inclusion before
implementing such a process in future stroke trials.
Nevertheless, it is ultimately up to the trialists, funder, and
governance teams (sponsor, ethics committee, and regulator)
to decide on what degree of adjudication is carried out
in any individual trial.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.
Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article: No
specific funding was received for this review. P.J.G. is part supported
by the National Institute for Health Research's
Development and Skills Enhancement Award (NIHR301653) and
the Medical Research Council (grant no. MC_UU_00004/06).
P.M.B.'s research is funded by the British Heart Foundation and
NIHR Health Technology Assessment. He is Stroke Association
Professor of Stroke Medicine and an Emeritus NIHR Senior
Investigator.
ORCID iDs
Peter J Godolphin
Philip M Bath
https://orcid.org/0000-0003-0648-0992
https://orcid.org/0000-0003-2734-5132
Supplemental material
Supplemental material for this article is available online.
International Journal of Stroke, 18(2)
SI blind to treatment allocation when
assessing outcome
Adjudication is less important
Adjudication is less important
Adjudication is less important
Adjudication is not important
Adjudication is not important
SI not blind to treatment allocation
when assessing outcome
Adjudication is more important
Adjudication is more important
Adjudication is more important
Adjudication is more important
Adjudication is not important
https://www.orcid.org/0000-0003-0648-0992 https://www.orcid.org/0000-0003-2734-5132
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