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

Abstract

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

Keywords

• Systematic review
• orthogeriatric
• gerontotraumatology
• informed consent
• clinical research ethics
• decisional capacity