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Handling of informed consent and patient inclusion in research with geriatric trauma patients - a matter of protection or disrespect?
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
ID 4526918
Author(s) Jensen, Jana S.; Reiter-Theil, Stella; Celio, Diana A.; Jakob, Marcel; Vach, Werner; Saxer, Franziska J.
Author(s) at UniBasel Reiter-Theil, Stella
Jensen, Jana Sabrina
Jakob, Marcel
Vach, Werner
Saxer, Franziska
Year 2019
Title Handling of informed consent and patient inclusion in research with geriatric trauma patients - a matter of protection or disrespect?
Journal Clinical Interventions in Aging
Volume 14
Number 14
Pages / Article-Number 321-334
Keywords clinical research ethics; decisional capacity; gerontotraumatology; informed consent; orthogeriatric; systematic review
Mesh terms Aged; Aged, 80 and over; Clinical Trials as Topic, methods; Humans; Informed Consent; Mental Competency; Middle Aged; Patient Selection; Proxy; Wounds and Injuries, therapy
Abstract 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.; 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.; 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 <65 years and only 11% excluded very elderly. Seventy-four trials excluded patients with typical comorbidities, with 55% of these without stating scientific reasons. Frailty was assessed in 94 trials and defined as the exclusion criterion in 66 of them. Informed consent (IC) was reportedly obtained in 144 trials; descriptions of the IC process mostly remained vague. Substitute decision making was described in 19 trials; the consenting party remained unclear in 45 articles. Diagnosed dementia was a primary exclusion criterion in 31% of the trials. Seventeen trials assessed decisional capacity before inclusion, with six using specific assessments.; 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.
Publisher Dove Medical Press
ISSN/ISBN 1176-9092 ; 1178-1998
Full Text on edoc No
Digital Object Identifier DOI 10.2147/CIA.S191751
PubMed ID
ISI-Number WOS:000458898800001
Document type (ISI) Journal Article, Review

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