Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?

Jana S Jensen,1,* Stella Reiter-Theil,2,* Diana A Celio,3 Marcel Jakob,1 Werner Vach,1 Franziska J Saxer1 1Department of Orthopaedic and Trauma Surgery, University Hospital Basel, Basel 4031, Switzerland; 2Department of Clinical Ethics, University Hospital Basel/Psychiatric Hospitals of the Univers...

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Autores principales: Jensen JS, Reiter-Theil S, Celio DA, Jakob M, Vach W, Saxer FJ
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Lenguaje:EN
Publicado: Dove Medical Press 2019
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Acceso en línea:https://doaj.org/article/2b5f977d2cdd4a7c8b23e737e9a9611e
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spelling oai:doaj.org-article:2b5f977d2cdd4a7c8b23e737e9a9611e2021-12-02T07:10:20ZHandling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?1178-1998https://doaj.org/article/2b5f977d2cdd4a7c8b23e737e9a9611e2019-02-01T00:00:00Zhttps://www.dovepress.com/handling-of-informed-consent-and-patient-inclusion-in-research-with-ge-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Jana S Jensen,1,* Stella Reiter-Theil,2,* Diana A Celio,3 Marcel Jakob,1 Werner Vach,1 Franziska J Saxer1 1Department of Orthopaedic and Trauma Surgery, University Hospital Basel, Basel 4031, Switzerland; 2Department of Clinical Ethics, University Hospital Basel/Psychiatric Hospitals of the University Basel, Basel 4012, Switzerland; 3Department for Visceral, Thoracic and Vascular Surgery, Triemli Hospital, Zürich 8063, Switzerland *These authors contributed equally to this work Background: Despite the aging of numerous societies and future health care challenges, clinical research in the elderly is underrepresented. The aim of this review was to analyze the current practice exemplary in gerontotraumatology and to discuss potential improvements. Materials and methods: A literature review was performed in 2016 based on a PubMed search for gerontotraumatologic studies published between 2005 and 2015. Trials were evaluated for methodology and ethical and age-related aspects. Results: The search revealed 649 articles, 183 of which met the inclusion criteria. The age range for inclusion was heterogeneous; one-third of trials included patients Conclusion: Many trials in gerontotraumatology exclude relevant subgroups of patients, and thus risk presenting biased estimates of the relevant treatment effects. Exclusion based on age, cognitive impairment, or other exhaustive exclusion criteria impedes specific scientific progress in the treatment of elderly patients. Meaningful trials could profit from a staged, transparent approach that fosters shared decision making. Rethinking current policies is indispensable to improve treatment and care of elderly trauma patients and to protect study participants and researchers alike. Keywords: systematic review, orthogeriatric, gerontotraumatology, informed consent, clinical research ethics, decisional capacityJensen JSReiter-Theil SCelio DAJakob MVach WSaxer FJDove Medical PressarticleSystematic revieworthogeriatricgerontotraumatologyinformed consentclinical research ethicsdecisional capacityGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 14, Pp 321-334 (2019)
institution DOAJ
collection DOAJ
language EN
topic Systematic review
orthogeriatric
gerontotraumatology
informed consent
clinical research ethics
decisional capacity
Geriatrics
RC952-954.6
spellingShingle Systematic review
orthogeriatric
gerontotraumatology
informed consent
clinical research ethics
decisional capacity
Geriatrics
RC952-954.6
Jensen JS
Reiter-Theil S
Celio DA
Jakob M
Vach W
Saxer FJ
Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
description Jana S Jensen,1,* Stella Reiter-Theil,2,* Diana A Celio,3 Marcel Jakob,1 Werner Vach,1 Franziska J Saxer1 1Department of Orthopaedic and Trauma Surgery, University Hospital Basel, Basel 4031, Switzerland; 2Department of Clinical Ethics, University Hospital Basel/Psychiatric Hospitals of the University Basel, Basel 4012, Switzerland; 3Department for Visceral, Thoracic and Vascular Surgery, Triemli Hospital, Zürich 8063, Switzerland *These authors contributed equally to this work Background: Despite the aging of numerous societies and future health care challenges, clinical research in the elderly is underrepresented. The aim of this review was to analyze the current practice exemplary in gerontotraumatology and to discuss potential improvements. Materials and methods: A literature review was performed in 2016 based on a PubMed search for gerontotraumatologic studies published between 2005 and 2015. Trials were evaluated for methodology and ethical and age-related aspects. Results: The search revealed 649 articles, 183 of which met the inclusion criteria. The age range for inclusion was heterogeneous; one-third of trials included patients Conclusion: Many trials in gerontotraumatology exclude relevant subgroups of patients, and thus risk presenting biased estimates of the relevant treatment effects. Exclusion based on age, cognitive impairment, or other exhaustive exclusion criteria impedes specific scientific progress in the treatment of elderly patients. Meaningful trials could profit from a staged, transparent approach that fosters shared decision making. Rethinking current policies is indispensable to improve treatment and care of elderly trauma patients and to protect study participants and researchers alike. Keywords: systematic review, orthogeriatric, gerontotraumatology, informed consent, clinical research ethics, decisional capacity
format article
author Jensen JS
Reiter-Theil S
Celio DA
Jakob M
Vach W
Saxer FJ
author_facet Jensen JS
Reiter-Theil S
Celio DA
Jakob M
Vach W
Saxer FJ
author_sort Jensen JS
title Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
title_short Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
title_full Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
title_fullStr Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
title_full_unstemmed Handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
title_sort handling of informed consent and patient inclusion in research with geriatric trauma patients – a matter of protection or disrespect?
publisher Dove Medical Press
publishDate 2019
url https://doaj.org/article/2b5f977d2cdd4a7c8b23e737e9a9611e
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