Evidence map›Paper›PMID 41347705›Full record

ReviewInternational journal of stroke : official journal of the International Stroke Society2026

A methodological review of pragmatic designs in acute stroke trials.

Ayooluwanimi P Okikiolu, Sucharita Ray, Kamalesh Chakravarty, Olayinka Arimoro, Riley Martens, Nishita Singh, Aravind Ganesh, Mohammed Almekhlafi, Michael D Hill, Bijoy K Menon and 1 more

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Review in International journal of stroke : official journal of the International Stroke Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ayooluwanimi P OkikioluDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.ORCID 0009-0003-2300-7301
Sucharita RayDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
Kamalesh ChakravartyDepartment of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Olayinka ArimoroCommunity Health Sciences, University of Calgary, Calgary, AB, Canada.
Riley MartensCommunity Health Sciences, University of Calgary, Calgary, AB, Canada.
Nishita SinghDepartment of Neurology, University of Manitoba, Winnipeg, MB, Canada.
Aravind GaneshDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.ORCID 0000-0003-4914-4737
Mohammed AlmekhlafiDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
Michael D HillDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-6269-1543
Bijoy K MenonDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
Tolulope T SajobiDepartment of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-5696-5552

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomized controlled trials (RCTs) have traditionally been designed with an explanatory approach, in contrast to incorporating real-world, pragmatic considerations.

aimsThis methodological review assesses the uptake of pragmatic designs in Phase III acute stroke RCTs.

methodsWe conducted a comprehensive literature search of the MEDLINE, Embase, and Cochrane Library databases from inception to 1 July 2024. Eligible articles included English-language published Phase III RCTs of acute ischemic stroke and intracerebral hemorrhage interventions. Using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) tool, each trial was rated on nine key domains, and relevant study characteristics were extracted. Trials with an average rating of 3 or higher, or a total score (sum of ratings) of 27 or higher (given that all domains were assessed), were considered to adopt an overall pragmatic approach to their design. Risk of bias was evaluated using the Cochrane risk of bias tool.

resultsOf the 5663 unique articles obtained after deduplication, 136 trials were included, and 71 (52%) trials were classified as pragmatic using the PRECIS-2 tool. A majority had a low risk of bias (63.2%). Pragmatic trials were more likely to be large sample, multicenter, multinational trials with broad inclusion criteria that cover multiple types of strokes.

conclusionThere has been an increased uptake of pragmatic designs in acute stroke over the last decade, reflecting improvements in acute stroke care and a greater consideration of real-world applicability by trialists.

Indexed as

Pragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignStrokeClinical Trials, Phase III as TopicHumansacute strokeclinical trialshemorrhagic strokeischemic strokemethodologypatient-centered carephase III trialspragmatismPRECIS 2RCTreal worldreviewStroke

Identifiers

PMID41347705
PMCPMC13197612

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.