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ArticleNeurosurgical review2025

Exclusion criteria in randomized clinical trials of subarachnoid hemorrhage.

Adnan I Qureshi, Kamran Zahoor, Ibrahim A Bhatti, Rameez Merchant, Jonathan Beall, Christy N Cassarly, Byron Gajewski, Renee L Martin, Jose I Suarez

Abstract read
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In one paragraph

Article in Neurosurgical review, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Observational
  2. Article
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

9 authors.

Adnan I QureshiZeenat Qureshi Stroke Institute, Columbia, MO, USA.
Kamran ZahoorZeenat Qureshi Stroke Institute, Columbia, MO, USA. Kzwyc@health.missouri.edu.
Ibrahim A BhattiZeenat Qureshi Stroke Institute, Columbia, MO, USA.
Rameez MerchantDepartment of Neurology, University of Missouri, Columbia, MO, USA.
Jonathan BeallDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Christy N CassarlyDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Byron GajewskiDepartment of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, USA.
Renee L MartinDivision of Biostatistics, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Jose I SuarezDivision of Neurosciences Critical Care, Departments of Anesthesiology and Critical Care, Neurology, and Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionExclusion criteria are designed to optimize the scientific yield and safety of clinical trials. However, periodic analysis is necessary to understand the impact on trial complexity, enrollment, generalizability, and costs. We analyzed the types of exclusion criteria used among clinical trials performed in subarachnoid hemorrhage (SAH) patients and impact upon exclusion of patients.

methodsWe identified trials involving SAH patients that provided a list of exclusion criteria and determined the number and proportion of those trials which used various exclusion criteria, proportion of excluded patients for each of the exclusion criteria and whether Consolidated Standards of Reporting Trials (CONSORT) was used. We also used target trial emulation approach and applied arbitrary trial exclusion criteria to a single center cohort of SAH patients to determine proportions of patients excluded for each of the reasons for exclusion.

resultsA total of 109 trials involving SAH patients were identified, of which 68(62.3%) provided a list of the exclusion criteria. The median number of exclusion criteria was 6 (range 2-9). The most common exclusion criteria were pregnancy (n = 31 trials), SAH due to other causes (trauma, fusiform or mycotic aneurysm, n = 26 trials) and significant liver disease/hepatic insufficiency (n = 19 trials). CONSORT was used in 16(23.5%) trials and 18 (16.5%) trials provided the proportion of patients excluded according to each of the exclusion criteria. In a single center cohort, the highest proportion of patients were excluded because no aneurysm was identified on imaging (23%) followed by withdrawal of care (9.6%) and need for dual anti-platelet treatment (8.6%). The in-hospital mortality was higher in patients who were excluded as compared with those who were included in the hypothetical trial (22 [30.1%] of 73 and 0 [0%] of 31 patients).

conclusionsOur analysis on exclusion criteria used and proportion of patients excluded in clinical trials involving SAH patients will assist in future trial enrollment, completion, and generalizability. Standardized reporting using CONSORT in clinical trials involving SAH patients is strongly recommended.

Indexed as

Patient SelectionRandomized Controlled Trials as TopicSubarachnoid HemorrhageFemaleHumansClinical trialsEligibilityGeneralizabilityRandomized controlled trialsSubarachnoid hemorrhage

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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.