Minimal Clinically Important Difference (MCID) for the Short Musculoskeletal Function Assessment (SMFA) in Severe Lower Extremity Trauma: Pooled Data from 7 Multicenter, Prospective Clinical Trials.

BACKGROUND: The Short Musculoskeletal Function Assessment (SMFA) is a well validated, widely used patient-reported outcome (PRO) measure for orthopaedic patients. Despite its widespread use and acceptance, this measure does not have an agreed upon minimal clinically important difference (MCID). The purpose of the present study was to create distributional MCIDs with use of a large cohort of research participants with severe lower extremity fractures. METHODS: Three distributional approaches were used to calculate MCIDs for the Dysfunction and Bother Indices of the SMFA as well as all its domains: (1) half of the standard deviation (one-half SD), (2) twice the standard error of measurement (2SEM), and (3) minimal detectable change (MDC). In addition to evaluating by patient characteristics and the timing of assessment, we reviewed these calculations across several injury groups likely to affect functional outcomes. RESULTS: A total of 4,298 SMFA assessments were collected from 3,185 patients who had undergone surgical treatment of traumatic injuries of the lower extremity at 60 Level-I trauma centers across 7 multicenter, prospective clinical studies. Depending on the statistical approach used, the MCID associated with the overall sample ranged from 7.7 to 10.7 for the SMFA Dysfunction Index and from 11.0 to 16.8 for the SMFA Bother Index. For the Dysfunction Index, the variability across the scores was small (<5%) within the sex and age subgroups but was modest (12% to 18%) across subgroups related to assessment timing. CONCLUSIONS: A defensible MCID can be found between 7 and 11 points for the Dysfunction Index and between 11 and 17 points for the Bother Index. The precise choice of MCID may depend on the preferred statistical approach and the population under study. While differences exist between MCID values based on the calculation method, values were consistent across the categories of the various subgroups presented. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials.

BACKGROUND: Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. METHODS: This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. RESULTS: No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. CONCLUSIONS: Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. TRIAL REGISTRATION: Please see Table 1 for individual trial registration numbers and dates of registration.

Cost of U.S emergency department and inpatient visits for fall injuries in older adults.

BACKGROUND: Falls are a leading cause of injury and hospital readmissions in older adults. Understanding the distribution of acute treatment costs across inpatient and emergency department settings is critical for informed investment and evaluation of fall prevention efforts. METHODS: This study used the 2016-2018 National Inpatient Sample and National Emergency Department Sample. Annual treatment cost of fall injury among adults 65 years and older was estimated from charges, applying cost-to-charge and professional fee ratios. Weighted multivariable generalized linear models were used to separately estimate cost for inpatient and emergency department (ED) setting by injury type and individual demographic and health characteristics after adjusting for payer and hospital level characteristics. RESULTS: Older adults incurred an estimated 922,428 inpatient and 2.3 million ED visits annually due to falls with combined annual costs of $19.8 billion. Over half of inpatient visits for fall injury were for fracture. Notably, 23% of inpatient visits were for fractures other than hip fracture and 14% of inpatient visits were for multiple fractures with costs totaling $3.4 billion and $2.5 billion, respectively. Annual ED costs were driven by superficial injury totaling $1.5 billion. Cost of ED visits were higher for adults 85 years and older (adjusted cost ratio (aCR): 1.11, 95% Confidence Interval (CI)I: 1.11-1.12) and those with dementia (aCR: 1.14, 95% CI: 1.13-1.15). Higher inpatient and ED visit cost was also associated with high-energy falls and discharge to post-acute care. CONCLUSION: The study found that more than 3 million older adults in the United States seek hospital care for fall injuries annually, a major concern given increasing capacity strain on hospitals and EDs. The $20 billion in annual acute treatment costs attributed to fall injury indicate an urgent need to implement evidence-based fall prevention interventions and underscores the importance of newly launched ED-based fall prevention efforts and investments in geriatric emergency departments.

Associations of Days Spent at Home Before Hip Fracture With Postfracture Days at Home and 1-Year Mortality Among Medicare Beneficiaries Living With Alzheimer's Disease or Related Dementias.

BACKGROUND: Hip fracture is a disabling event experienced disproportionately by older adults with Alzheimer's disease or related dementias (ADRD). Claims information recorded prior to a hip fracture could provide valuable insights into recovery potential for these patients. Thus, our objective was to identify distinct trajectories of claims-based days at home (DAH) before a hip fracture among older adults with ADRD and evaluate associations with postfracture DAH and 1-year mortality. METHODS: We conducted a cohort study of 16 576 Medicare beneficiaries living with ADRD who experienced hip fracture between 2010 and 2017. Growth mixture modeling was used to estimate trajectories of DAH assessed from 180 days prior to fracture until index fracture admission, and their joint associations with postfracture DAH trajectories and 1-year mortality. RESULTS: Before a hip fracture, a model with 3 distinct latent DAH trajectories was the best fit. Trajectories were characterized based on their temporal patterns as Consistently High (n = 14 980, 90.3%), Low but Increasing (n = 809, 5.3%), or Low and Decreasing (n = 787, 4.7%). Membership in the Low and Decreasing prefracture DAH trajectory was associated with less favorable postfracture DAH trajectories, and a 65% higher 1-year mortality rate (hazard ratio 1.65, 95% confidence interval 1.45-1.87) as compared to those in the Consistently High trajectory. Similar albeit weaker associations with these outcomes were observed for hip fracture survivors in the Low but Improving prefracture DAH trajectory. CONCLUSIONS: Distinct prefracture DAH trajectories among hip fracture survivors with ADRD are strongly linked to postfracture DAH and 1-year mortality, which could guide development of tailored interventions.

Radiographic Assessment of Ankle Fracture Displacement: A Validation Study.

BACKGROUND: Ankle fracture displacement is an important outcome in clinical research examining the effectiveness of surgical and rehabilitation interventions. However, the assessment of displacement remains subjective without well-described or validated measurement methods. The aim of this study was to assess inter- and intrarater reliability of ankle fracture displacement radiographic measures and select measurement thresholds that differentiate displaced and acceptably reduced fractures. METHODS: Eight fellowship-trained orthopaedic surgeons evaluated a set of 26 postoperative ankle fracture radiographs on 2 occasions. Surgeons followed standardized instructions for making 5 measurements: coronal displacement (3) talar tilt (1), and sagittal displacement (1). Inter- and intraobserver interclass correlations were determined by random effects regression models. Logistic regression was used to determine the optimal sensitivity and specificity for the measurements with the highest correlation. RESULTS: Three of the 5 measures had excellent interobserver reliability (correlation coefficient > 0.75): (1) coronal plane distance between the lateral border of tibia and lateral border of talus, (2) coronal plane talar tilt, and (3) sagittal plane displacement. The threshold that best discriminated displaced from well-aligned fractures was 2 mm for coronal plane distance (sensitivity 82.1%, specificity 85.4%), 3 degrees for talar tilt (sensitivity 80.4%, specificity 82.2%), and 5 mm for sagittal plane distance (sensitivity 83.9%, specificity 84.9%). CONCLUSION: This study identified 3 reliable measures of ankle fracture displacement and determined optimal thresholds for discriminating between displaced and acceptably reduced fractures. These measurement criteria can be used for the design and conduct of clinical research studying the impact of surgical treatment and rehabilitation interventions.

The 1-Year Economic Impact of Work Productivity Loss Following Severe Lower Extremity Trauma.

BACKGROUND: Severe lower extremity trauma among working-age adults is highly consequential for returning to work; however, the economic impact attributed to injury has not been fully quantified. The purpose of this study was to examine work and productivity loss during the year following lower extremity trauma and to calculate the economic losses associated with lost employment, lost work time (absenteeism), and productivity loss while at work (presenteeism). METHODS: This is an analysis of data collected prospectively across 3 multicenter studies of lower extremity trauma outcomes in the United States. Data were used to construct a Markov model that accumulated hours lost over time due to lost employment, absenteeism, and presenteeism among patients from 18 to 64 years old who were working prior to their injury. Average U.S. wages were used to calculate economic loss overall and by sociodemographic and injury subgroups. RESULTS: Of 857 patients working prior to injury, 47.2% had returned to work at 1 year. The average number of productive hours of work lost was 1,758.8/person, representing 84.6% of expected annual productive hours. Of the hours lost, 1,542.3 (87.7%) were due to working no hours or lost employment, 71.1 (4.0%) were due to missed hours after having returned, and 145.4 (8.3%) were due to decreased productivity while working. The 1-year economic loss due to injury totaled $64,427/patient (95% confidence interval [CI], $63,183 to $65,680). Of the 1,758.8 lost hours, approximately 88% were due to not being employed (working zero hours), 4% were due to absenteeism, and 8% were due to presenteeism. Total productivity loss was higher among older adults (≥40 years), men, those with a physically demanding job, and the most severe injuries (i.e., those leading to amputation as well as Gustilo type-IIIB tibial fractures and type-III pilon/ankle fractures). CONCLUSIONS: Patients with severe lower extremity trauma carry a substantial economic burden. The costs of lost productivity should be considered when evaluating outcomes.

Home and Neighborhood Context of Falls Among Black and White Older Americans.

Objectives: To examine social and physical environmental fall-risk factors in a nationally representative sample of community-living older adults overall and by racial group. Methods: We used data from the 2015 and 2016 rounds of the National Health and Aging Trends Study (n = 5581) linked to census tract measures from the American Community Survey. Recurrent falls are defined as 2+ self-reported falls over 12 months. Results: Older adults with recurrent falls were more likely to have lower education, lower income, financial hardship, live in homes with disorder and disrepair and in neighborhoods without sidewalks, with high social deprivation, and in nonmetropolitan counties. Home disrepair, lack of sidewalks, and residence in a nonmetropolitan county were important fall-risk factors among White older adults only. Financial hardship was an important risk factor among Black older adults. Discussion: Environmental factors are associated with recurrent falls among older Americans and should be incorporated into fall-risk profiles and prevention efforts.

Outpatient Physical Therapy Use Following Tibial Fractures: A Retrospective Commercial Claims Analysis.

OBJECTIVE: The purpose of this study was to characterize outpatient physical therapy (OPT) use following tibial fractures and examine the variability of OPT attendance, time of initiation, number of visits, and length of care by patient, injury, and treatment factors. In the absence of clinical guidelines, results will guide future efforts to optimize OPT following tibial fractures. METHODS: This study used 2016 to 2017 claims from the IBM MarketScan Commercial Claims Research Database. The cohort included 9079 patients with International Classification of Diseases: Tenth Revision (ICD-10) diagnosis codes for tibial fractures. Use in the year following initial fracture management was determined using Current Procedural Terminology codes. Differences in use were examined using χ2 tests, t tests, and Kruskal-Wallace tests. RESULTS: Sixty-seven percent of patients received OPT the year following fracture. OPT attendance was higher in female patients, in patients with 1 or no major comorbidity, and in the western United States. Attendance was higher in patients with upper tibial fractures, moderate-severity injuries, and treatment with external fixation and in patients discharged to an inpatient rehabilitation facility. Patients started OPT on average [SD] 50 [52.6] days after fracture and attended 18 [16.1] visits over the course of 101 [86.4] days. The timing of OPT, the number of visits attended, and the length of OPT care varied by patient, injury, and treatment-level factors. CONCLUSIONS: One-third of insured patients do not receive OPT following tibial fracture. The timing of OPT initiation, the length of OPT care, and the number of visits attended by patients with tibial fractures were highly variable. Further research is needed to standardize referral and prescription practices for OPT following tibial fractures. IMPACT: OPT use varies based on patient, injury, and treatment-level factors following tibial fractures. Results from this study can be used to inform future efforts to optimize rehabilitation care for patients with tibial fractures.

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Healthcare task difficulty among older adults with multimorbidity.

BACKGROUND: Applying disease-specific guidelines to people with multimorbidity may result in complex regimens that impose treatment burden. OBJECTIVES: To describe and validate a measure of healthcare task difficulty (HCTD) in a sample of older adults with multimorbidity. RESEARCH DESIGN: Cross-sectional and longitudinal secondary data analysis. SUBJECTS: Multimorbid adults aged 65 years or older from primary care clinics. MEASURES: We generated a scale (0-16) of self-reported difficulty with 8 HCTD and conducted factor analysis to assess its dimensionality and internal consistency. To assess predictive ability, cross-sectional associations of HCTD and number of chronic diseases, and conditions that add to health status complexity (falls, visual, and hearing impairment), patient activation, patient-reported quality of chronic illness care (Patient Assessment of Chronic Illness Care), mental and physical health (SF-36) were tested using statistical tests for trend (n=904). Longitudinal analyses of the effects of change in HCTD on changes in the outcomes were conducted among a subset (n=370) with ≥1 follow-up at 6 and/or 18 months. All models were adjusted for age, education, sex, race, and time. RESULTS: Greater HCTD was associated with worse mental and physical health [Cuzick test for trend (P<0.05)], and patient-reported quality of chronic illness care (P<0.05). In longitudinal analysis, increasing patient activation was associated with declining HCTD over time (P<0.01). Increasing HCTD over time was associated with declining mental (P<0.001) and physical health (P=0.001) and patient-reported quality of chronic illness care (P<0.05). CONCLUSIONS: The findings of this study establish the construct validity of the HCTD scale.

A matched-pair cluster-randomized trial of guided care for high-risk older patients.

BACKGROUND: Patients at risk for generating high health care expenditures often receive fragmented, low-quality, inefficient health care. Guided Care is designed to provide proactive, coordinated, comprehensive care for such patients. OBJECTIVE: We hypothesized that Guided Care, compared to usual care, produces better functional health and quality of care, while reducing the use of expensive health services. DESIGN: 32-month, single-blind, matched-pair, cluster-randomized controlled trial of Guided Care, conducted in eight community-based primary care practices. PATIENTS: The "Hierarchical Condition Category" (HCC) predictive model was used to identify high-risk older patients who were insured by fee-for-service Medicare, a Medicare Advantage plan or Tricare. Patients with HCC scores in the highest quartile (at risk for generating high health care expenditures during the coming year) were eligible to participate. INTERVENTION: A registered nurse collaborated with two to five primary care physicians in providing eight services to participants: comprehensive assessment, evidence-based care planning, proactive monitoring, care coordination, transitional care, coaching for self-management, caregiver support, and access to community-based services. MAIN MEASURES: Functional health was measured using the Short Form-36. Quality of care and health services utilization were measured using the Patient Assessment of Chronic Illness Care and health insurance claims, respectively. KEY RESULTS: Of the eligible patients, 904 (37.8 %) gave written consent to participate; of these, 477 (52.8 %) completed the final interview, and 848 (93.8 %) provided complete claims data. In intention-to-treat analyses, Guided Care did not significantly improve participants' functional health, but it was associated with significantly higher participant ratings of the quality of care (difference = 0.27, 95 % CI = 0.08-0.45) and 29 % lower use of home care (95 % CI = 3-48 %). CONCLUSIONS: Guided Care improves high-risk older patients' ratings of the quality of their care, and it reduces their use of home care, but it does not appear to improve their functional health.

The effect of guided care teams on the use of health services: results from a cluster-randomized controlled trial.

BACKGROUND: The effect of interdisciplinary primary care teams on the use of health services by patients with multiple chronic conditions is uncertain. This study aimed to measure the effect of guided care teams on multimorbid older patients' use of health services. METHODS: Eligible patients from 3 health care systems in the Baltimore, Maryland-Washington, DC, area were cluster-randomized to receive guided care or usual care for 20 months between November 1, 2006, and June 30, 2008. Eight services of a guided care nurse working in partnership with patients' primary care physicians were provided: comprehensive assessment, evidence-based care planning, monthly monitoring of symptoms and adherence, transitional care, coordination of health care professionals, support for self-management, support for family caregivers, and enhanced access to community services. Outcome measures were frequency of use of emergency departments, hospitals, skilled nursing facilities, home health agencies, primary care physician services, and specialty physician services. RESULTS: The study included 850 older patients at high risk for using health care heavily in the future. The only statistically significant overall effect of guided care in the whole sample was a reduction in episodes of home health care (odds ratio, 0.70; 95% confidence interval, 0.53-0.93). In a preplanned analysis, guided care also reduced skilled nursing facility admissions (odds ratio, 0.53; 95% confidence interval, 0.31-0.89) and days (0.48; 0.28-0.84) among Kaiser-Permanente patients. CONCLUSIONS: Guided care reduces the use of home health care but has little effect on the use of other health services in the short run. Its positive effect on Kaiser-Permanente patients' use of skilled nursing facilities and other health services is intriguing. Trial Registration clinicaltrials.gov Identifier: NCT00121940.

Guided care and the cost of complex healthcare: a preliminary report.

OBJECTIVE: Guided Care (GC) is a model of proactive, evidence-based comprehensive healthcare provided by physician-nurse teams for people with several chronic health conditions. Our objective was to evaluate the preliminary effects of GC on health service utilization and costs. STUDY DESIGN: Cluster-randomized controlled trial of GC involving 14 primary care teams (49 physicians) and 904 of their chronically ill patients age 65 years or older. METHODS: Using insurance claims, we compared the health services used by patients who received GC with the health services used by patients who received usual care during the first 8 months of the study. RESULTS: After adjustment for baseline characteristics, GC patients experienced, on average, 24% fewer hospital days (95% confidence interval [CI]: 49% fewer, 13% more), 37% fewer skilled nursing facility days (95% CI: 65% fewer, 5% more), 15% fewer emergency department visits (95% CI: 38% fewer, 18% more), and 29% fewer home healthcare episodes (95% CI: 53% fewer, 8% more), as well as 9% more specialist visits (95% CI: 8% fewer, 29% more). Based on current Medicare payment rates and GC costs, these differences in utilization represent an annual net savings of $75,000 (95% CI: -$244,000, $150,900) per nurse, or $1364 per patient. CONCLUSIONS: Initial introduction of GC into primary care practices may be associated with less use of expensive health services and a net savings in healthcare costs among older patients with several chronic health conditions. Final results from the remaining 2 years of this ongoing study will be published in 2011.