Geriatric traumatology is a rapidly growing subspecialty of orthopedic trauma surgery, but there are challenges to including older patients in clinical trials.
Researchers at Brigham and Women’s Hospital recently conducted a scoping review to evaluate the characteristics of papers published in this field. In the Journal of Orthopaedic Trauma, they say the overall quality of the existing literature is poor. Most studies were retrospective, many were small, relatively few investigated patient-reported outcomes, and patients with cognitive impairment are commonly excluded.
The authors are Henk Jan Schuijt, MD, PhD, a fellow in the Harvard Medical School Orthopedic Trauma Initiative at the Brigham, Michael J. Weaver, MD, chief of the Orthopaedic Trauma Service at the Brigham, and colleagues.
The authors first chose 154 journals to include in their review:
- 118 core clinical journals from Abridged Index Medicus (e.g., JAMA, NEJM, Lancet)
- 18 orthopedics and emergency medicine journals were selected by reviewing those categories in Web of Science
- 18 journals were added by reviewing references from the initial papers identified
In February 2020, they searched PubMed for all studies published in the selected journals between January 1, 2017, and January 1, 2020, that concerned fracture patients with a median or mean age of 65 and older. Patients with skull or spine fractures were excluded.
The reviewers included 723 papers reporting on 16,690,375 older fracture patients. The median age was 79, and the median proportion of female participants was 71%. The median sample size was 203 (IQR, 72-825).
Most papers were retrospective cohort studies (n=505; 70%). 130 were prospective cohort studies (18%), and 57 were randomized, controlled trials (8%).
Most studies used traditional outcomes measures, mortality (52%), and complications (63%). Less frequently studied were functional outcomes (37%), patient-reported outcome measures (22%), length of stay (21%), radiological outcomes (20%), union rates (11%), and quality of life (9%).
Cognitively Impaired Patients
About half of the studies included cognitively impaired patients: 51% of prospective cohort studies and 50% of randomized control trials. Studies that included patients with cognitive impairment measured patient-reported outcomes less often than studies that excluded them.
25% of studies reported a method to determine cognitive impairment. The most frequent (52%) was the consultation of medical records.
A Three-Step Plan
The results of this review give reason for serious concern. Patients with cognitive impairments may benefit most from clinical research, and their selective exclusion leads to bias across the field of geriatric trauma research.
The inclusion of these patients can be improved by using the following:
- Less restrictive eligibility criteria—If patients with cognitive impairment are excluded, an evidence-based justification should be explicitly stated
- Validated cognition screening tools—Subjective clinical judgments and past history are unreliable for determining cognitive impairment. The scientific community should reach consensus on which cognitive screeners are useful for determining cognitive impairment for geriatric trauma research (the Mini-Mental State Examination, Montreal Cognitive Assessment, etc.)
- Appropriate outcome measures—Future research should investigate how to effectively measure outcomes such as quality of life in cognitively impaired patients, such as through proxies. A review of pediatric literature, whose population also has trouble judging or vocalizing outcomes, might be worthwhile for researchers in this field.