OTA 2013 Posters

Scientific Poster #24 Geriatric OTA 2013

The Inclusion of Patients With Cognitive Impairment in Hip Fracture Trials: A Missed Opportunity--Systematic Review

Simran Mundi, BHSc (cand); Harman Chaudhry, MD; Mohit Bhandari, MD, PhD, FRCSC;
Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada

Background/Purpose: Over 320,000 hip fractures occur annually in North America and the incidence continues to rise with the graying of the “baby boomer” cohort. Because hip fracture is predominantly a condition of the elderly, comanifestation with cognitive impairment or dementia—a condition prevalent among the elderly as well—is not uncommon. By some estimates, 30% of the hip fracture population suffers from cognitive impairment or dementia. Furthermore, there is evidence to suggest that these patients may have poorer outcomes than those without such impairment. We performed a systematic review to determine the extent to which patients with cognitive impairment and/or dementia were included in randomized controlled trials (RCTs) assessing operative hip fracture management.

Methods: Two investigators conducted a search of three electronic journal databases (MEDLINE, Embase, PubMed) using comprehensive search terminology. All titles and abstracts were reviewed in duplicate, assessing eligibility based on the following criteria: (1) RCT study design; (2) trial assessed an operative intervention for femoral head, femoral neck, or intertrochanteric fractures; (3) publication of the manuscript in the English language; (4) original publication; and (5) published between January 2000 and June 2010. All articles that met the aforementioned inclusion criteria, and those with equivocal eligibility, were retrieved for full text review. We systematically collected descriptive data on trial characteristics, inclusion of patients with cognitive impairment, and use of cognitive assessment tools. We reported descriptive statistics and used the χ2 statistical test for comparison between groups as appropriate.

Results: We screened a total of 1201 abstracts, and 92 were collected for full text review. 12 were excluded because they did not meet our inclusion criteria, and 8 articles could not be accessed, leaving 72 studies for inclusion. The large majority of studies were European (n = 57, 79%), single-center trials (n = 47, 65%), and compared two methods of internal fixation (n = 38, 53%). Femoral neck and intertrochanteric fractures were equally represented. 33 studies (46%) did not report the inclusion or exclusion of patients with cognitive impairment in their trials. 19 studies (26%) explicitly included patients with cognitive impairment and 20 (28%) explicitly excluded this cohort. Only two trials reported outcomes specific to cognitively impaired patients: the first was a study specific to this population; the second performed a subgroup analysis. 14 trials (19%) reported the use of a validated cognitive assessment tool. None of the RCTs that reported inclusion of cognitively impaired patients were from North American centers. There were no significant differences between RCTs that included and excluded these patients in terms of patient age, number of centers, or operative procedures compared.

Conclusion: One in three patients with hip fracture have concomitant cognitive impairment, yet eight of ten hip fracture trials exclude or ignore this population in their conduct. The ambiguity and/or exclusion of these patients misses an opportunity to study outcomes and identify factors associated with improved prognosis.

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant.