Trial reportBMC neurology2017
Selection bias in clinical stroke trials depending on ability to consent.
Trial report in BMC neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.
What it found
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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.
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.
Stroke Adverse Outcome is Associated With Nosocomial Infections: PCTus- Guided Antibacterial Therapy in Severe Ischemic Stroke Patients
Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke) (Stroke-CORE)
Who cites it
14 citing papers in PubMed.
- The effect of repeated remote ischemic postconditioning after an ischemic stroke (REPOST): A randomized controlled trial.International journal of stroke : official journal of the International Stroke Society · 2023Trial
- Clinical equipoise and ethical challenges in expanding endovascular stroke thrombectomy practice.Frontiers in surgery · 2026Review
- Article
- Recruiting patients into a healthcare services trial: lessons learned from a feasibility study to investigate a patient-oriented navigation intervention for age-associated diseases.BMC health services research · 2025Article
- Early Complications After Mild to Moderate Ischemic Stroke and Impact on 3-Month Outcome: The Multicenter Prospective Stroke Unit Plus Cohort Study.Journal of the American Heart Association · 2025Article
- Comprehensive Symptom Prediction in Inpatients With Acute Psychiatric Disorders Using Wearable-Based Deep Learning Models: Development and Validation Study.Journal of medical Internet research · 2024Article
- Article
- A scoping review of the use of visual tools and adapted easy-read approaches in Quality-of-Life instruments for adults.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Cardiac dysfunction and high-sensitive C-reactive protein are associated with troponin T elevation in ischemic stroke: insights from the SICFAIL study.BMC neurology · 2022Article
- Development of a patient-oriented navigation model for patients with lung cancer and stroke in Germany.BMC health services research · 2022Article
- Advancing brain network models to reconcile functional neuroimaging and clinical research.NeuroImage. Clinical · 2022Review
- Guideline adherence in speech and language therapy in stroke aftercare. A health insurance claims data analysis.PloS one · 2022Article
- Translational Block in Stroke: A Constructive and "Out-of-the-Box" Reappraisal.Frontiers in neuroscience · 2021Article
- Ethics and Bias in Clinical Trial Enrollment in Stroke.Current cardiology reports · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundClinical trials are the hallmark of evidence-based medicine, but recruitment is often challenging, especially in stroke trials investigating patients not being able to give informed consent. In some nations, ethics committees will not approve of inclusion in a clinical study via consent of a legal representative. The ethical dilemma of including or excluding those patients has not been properly addressed, as there is little data on the effect of stroke characteristics on the ability to give informed consent.
methodsTo examine differences between patients able and unable to consent at inclusion to an acute stroke trial, we conducted a post-hoc analysis of monitoring records from a multicentric interventional trial. These records listed patients who gave informed consent by themselves and those who needed a legal representative to do so. This exemplary STRAWINSKI trial aimed at improving stroke outcome by biomarker-guided antibiotic treatment of stroke associated pneumonia and included patients within 40 h after stroke onset, suffering from MCA infarctions with an NIHSS score > 9 at admission. Standard descriptive and associative statistics were calculated to compare baseline characteristics and outcome measures between patients who were able to consent and those who were not.
resultsWe identified the person giving consent in 228 out of 229 subjects. Patients with inability to consent were older (p < 0.01), suffered from more left-hemispheric (p < 0.01) and more severe strokes (NIHSS, p < 0.01), were more likely to die during hospitalisation (p < 0.01) or have unfavourable outcome at discharge (mRS, p < 0.01), to develop fever (p < 0.01) and tended to be more susceptible to infections (p = 0.06) during the acute course of the disorder.
conclusionsDemographics, stroke characteristics and outcomes significantly affect stroke patients in their ability to consent. Where selection criteria and primary outcome measures of a trial are significantly affected by ability to consent, excluding patients unable to consent might be unethical.
trial registrationURL http://www.clinicaltrials.gov . Unique identifier: NCT01264549 .
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Registered trials
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.