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.

Weight-bearing Guidelines for Common Geriatric Upper and Lower Extremity Fractures.

PURPOSE OF REVIEW: The purpose of this review paper is to summarize current weight-bearing guidelines for common geriatric fractures, around weight-bearing joints, of the upper and lower extremities. RECENT FINDINGS: There is an increasing amount of literature investigating the safety and efficacy of early weight-bearing in geriatric fractures, particularly of the lower extremity. Many recent studies, although limited, suggest that early weight-bearing may be safe for geriatric distal femur and ankle fractures. Given the limited data pertaining to early weight-bearing in geriatric fractures, it is difficult to establish concrete weight-bearing guidelines in this population. However, in the literature available, early weight-bearing appears to be safe and effective across most injuries. The degree and time to weight-bearing vary significantly based on fracture type and treatment method. Future studies investigating postoperative weight-bearing protocols should focus on the growing geriatric population and identify methods to address specific barriers to early weight-bearing in these patients such as cognitive impairment, dependence on caregivers, and variations in post-acute disposition.

Time to Completion of Pediatric PROMIS Computerized Adaptive Testing Measures and the SRS-22r in an Adolescent Idiopathic Scoliosis Population.

BACKGROUND: Patient-reported outcome measures are useful tools to quantify patients' pre-treatment and post-treatment symptoms. Historically used "legacy measures", such as the Scoliosis Research Society-22 revised questionnaire (SRS-22r), are often disease-specific and can be time-intensive. Recently developed Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive testing (CAT) measures may reduce administrative burdens and permit more efficient outcome collection within clinic workflows. In an era of medicine where payments are becoming tied to outcomes, we sought to assess the time to completion (TTC) of 8 pediatric PROMIS CAT measures and the SRS-22r in adolescents with idiopathic scoliosis. MATERIALS AND METHODS: Patients presenting to a large, urban tertiary referral hospital were prospectively enrolled into the study. Subjects were first-time survey respondents in various phases and types of treatment for adolescent idiopathic scoliosis. In total, 200 patients ranging from 10 to 17 years old completed 8 Pediatric PROMIS CATs and the SRS-22r. PROMIS CATs administered include Physical Activity, Mobility, Anxiety, Depressive symptoms, Peer Relationships, Physical Stress Experiences, Pain Behavior and Pain Interference. TTC was calculated using start and stop timestamps in the REDCap software. RESULTS: The mean (±SD) TTC for each PROMIS CAT was 1.1 (±0.9) minutes with physical activity, mobility, anxiety, depressive symptoms, peer relationships, physical stress experiences, pain behavior, and pain interference taking 1.2, 1.4, 1.0, 0.9, 1.2, 1.0, 1.0, and 1.2 minutes on average to complete, respectively. Mean TTC for the SRS-22r was 5.2 (±3.0) minutes. CONCLUSIONS: In this pediatric orthopaedic cohort, completion of 8 PROMIS CATs demonstrated minimal test-taker burden and time required for completion. These findings support rapid and easily integrable PROMIS CATs in clinical practice to aid in increased delivery of efficient, patient-centered care. LEVEL OF EVIDENCE: III, cross-sectional study.

Construct Validity of Pediatric PROMIS Computerized Adaptive Testing Measures in Children With Adolescent Idiopathic Scoliosis.

BACKGROUND: The use of patient-reported outcome measures, especially Patient-Reported Outcomes Measurement Information System (PROMIS) measures, has increased in recent years. Given this growth, it is imperative to ensure that the measures being used are validated for the intended population(s)/disease(s). Our objective was to assess the construct validity of 8 PROMIS computer adaptive testing (CAT) measures among children with adolescent idiopathic scoliosis (AIS). METHODS: We prospectively enrolled 200 children (aged 10 to 17 y) with AIS, who completed 8 PROMIS CATs (Anxiety, Depressive Symptoms, Mobility, Pain Behavior, Pain Interference, Peer Relationships, Physical Activity, Physical Stress Experiences) and the Scoliosis Research Society-22r questionnaire (SRS-22r) electronically. Treatment categories were observation, bracing, indicated for surgery, or postoperative from posterior spinal fusion. Construct validity was evaluated using known group analysis and convergent and discriminant validity analyses. Analysis of variance was used to identify differences in PROMIS T -scores by treatment category (known groups). The Spearman rank correlation coefficient ( rs ) was calculated between corresponding PROMIS and SRS-22r domains (convergent) and between unrelated PROMIS domains (discriminant). Floor/ceiling effects were calculated. RESULTS: Among treatment categories, significant differences were found in PROMIS Mobility, Pain Behavior, Pain Interference, and Physical Stress Experiences and in all SRS-22r domains ( P <0.05) except Mental Health ( P =0.15). SRS-22r Pain was strongly correlated with PROMIS Pain Interference ( rs =-0.72) and Pain Behavior ( rs =-0.71) and moderately correlated with Physical Stress Experiences ( rs =-0.57). SRS-22r Mental Health was strongly correlated with PROMIS Depressive Symptoms ( rs =-0.72) and moderately correlated with Anxiety ( rs =-0.62). SRS-22r Function was moderately correlated with PROMIS Mobility ( rs =0.64) and weakly correlated with Physical Activity ( rs =0.34). SRS-22r Self-Image was weakly correlated with PROMIS Peer Relationships ( rs =0.33). All unrelated PROMIS CATs were weakly correlated (| rs |<0.40). PROMIS Anxiety, Mobility, Pain Behavior, and Pain Interference and SRS-22r Function, Pain, and Satisfaction displayed ceiling effects. CONCLUSIONS: Evidence supports the construct validity of 6 PROMIS CATs in evaluating AIS patients. Ceiling effects should be considered when using specific PROMIS CATs. LEVEL OF EVIDENCE: Level II, prognostic.

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.