<p>Handling of informed consent and patient inclusion in research with geriatric trauma patients &ndash; a matter of protection or disrespect?</p>

Abstract

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 <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. 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.

Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review

“…This complexity leads to misunderstanding and misinterpretation of the legislation by researchers who design trials involving adults who lack capacity [ 35 ], RECs who review these trials [ 36 ] and healthcare professionals caring for these populations [ 37 ]. Current ethical guidelines fail to support the inclusion of participants unable to consent through the lack of specific and appropriate advice, which is in itself ethically problematic [ 14 ]. Further guidance is urgently needed for RECs/IRBs, the trials community, and healthcare professionals in order to improve confidence and reduce inconsistencies that act as barriers to conducting trials involving adults lacking capacity to consent.…”

“…Approximately 58% of the total US population are typically excluded from research studies [ 9 ], and a third of randomized controlled trials are at high risk of bias, most commonly because the clinical population used is not appropriate for the trial [ 8 ]. Exclusions of people with cognitive impairment are seen in areas such as geriatrics research [ 10 ], rehabilitation interventions after hip fracture [ 11 ], learning disabilities [ 12 ], peri-operative medicine [ 13 ], trauma [ 14 ] and neurological research [ 15 ]. Clinical trials in other areas such as emergency research also encounter significant ethical challenges around informed consent which impacts on the populations included in trials [ 16 ].…”

“…Even in trials that are designed to include adults who lack capacity to consent, the proportion and numbers of participants lacking capacity actually recruited are worryingly small [ 17 ]. This recruitment bias leads to underpowered or abandoned studies [ 15 ] and trials which are not representative of the clinical population [ 14 , 16 , 18 ], resulting in evidence ‘biased’ medicine for these populations [ 19 ].…”

“…These regulations were originally designed to protect ‘vulnerable’ research participants. However this exclusionary ethics puts vulnerable populations at risk, while trying to protect them from exploitation [ 14 ]. More recent changes in the attitudes of research communities' are starting to recognise that these groups should be protected through research, rather than from research [ 9 ].…”

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

“…A recent review of studies on the NIHR portfolio found that 60% of the studies excluded learning disability groups, none of the studies investigating pneumonia or sepsis included learning disability groups despite being a key contributor to premature deaths, and only 1.4% of all studies were specifically related to learning disabilities [18]. Similar exclusions of people with cognitive impairment are seen in other areas of research such as geriatrics [7], rehabilitation interventions following hip fracture [19], perioperative medicine [20], trauma [21] and neurological research [22]. Under-recruitment to research into conditions such as dementia is one of the key challenges to advancing understanding of these conditions and improving the care and treatment of those who live with these conditions [23].…”