Selection bias in clinical stroke trials depending on ability to consent View Full Text


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Article Info

DATE

2017-12

AUTHORS

Benjamin Hotter, Lena Ulm, Sarah Hoffmann, Mira Katan, Joan Montaner, Alejandro Bustamante, Andreas Meisel

ABSTRACT

BACKGROUND: Clinical 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. METHODS: To 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. RESULTS: We 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. CONCLUSIONS: Demographics, 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 REGISTRATION: URL http://www.clinicaltrials.gov . Unique identifier: NCT01264549 . More... »

PAGES

206

References to SciGraph publications

  • 2012-07. The immunology of acute stroke in NATURE REVIEWS NEUROLOGY
  • 2006-11. Ethics and research in critical care in INTENSIVE CARE MEDICINE
  • 2005-10. Central nervous system injury-induced immune deficiency syndrome in NATURE REVIEWS NEUROSCIENCE
  • 2010-12. IMproving PArticipation of patients in Clinical Trials - rationale and design of IMPACT in BMC MEDICAL RESEARCH METHODOLOGY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s12883-017-0989-9

    DOI

    http://dx.doi.org/10.1186/s12883-017-0989-9

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1093162712

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29202730


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        "description": "BACKGROUND: Clinical 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.\nMETHODS: To 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\u00a0h after stroke onset, suffering from MCA infarctions with an NIHSS score\u2009>\u20099 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.\nRESULTS: We identified the person giving consent in 228 out of 229 subjects. Patients with inability to consent were older (p\u2009<\u20090.01), suffered from more left-hemispheric (p\u2009<\u20090.01) and more severe strokes (NIHSS, p\u2009<\u20090.01), were more likely to die during hospitalisation (p\u2009<\u20090.01) or have unfavourable outcome at discharge (mRS, p\u2009<\u20090.01), to develop fever (p\u2009<\u20090.01) and tended to be more susceptible to infections (p\u2009=\u20090.06) during the acute course of the disorder.\nCONCLUSIONS: Demographics, 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.\nTRIAL REGISTRATION: URL http://www.clinicaltrials.gov . Unique identifier: NCT01264549 .", 
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    37 schema:description BACKGROUND: Clinical 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. METHODS: To 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. RESULTS: We 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. CONCLUSIONS: Demographics, 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 REGISTRATION: URL http://www.clinicaltrials.gov . Unique identifier: NCT01264549 .
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