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.

Predictors of participation in online self-management programs: A longitudinal observational study.

PURPOSE/OBJECTIVE: Lack of patient participation and engagement remains a barrier to implementing effective online self-management and behavioral health interventions. Identifying patient characteristics associated with engagement rates may lead to interventions that improve engagement in traditional and online self-management programs. In this study, two online self-management and recovery programs were evaluated to identify factors that predict patient engagement. RESEARCH METHOD/DESIGN: Predictors were collected in a questionnaire at baseline before 435 participants started either of the two interventions. One or two online lessons were completed per week with seven or eight total lessons to complete in each program, and each lesson took about 20-30 min to finish. Full patient engagement was defined as completing all lessons and assessments in the program and partial engagement as attempting at least one lesson or assessment. RESULTS: Predictors of full patient engagement were self-rated confidence in completing the program or being over 60 years of age. Predictors of at least partial patient engagement were experienced ordering online or being over 50 years of age. CONCLUSIONS/IMPLICATIONS: Identifying profiles of individuals who predict poor engagement may improve implementation and the health outcomes of intervention programs. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Long-Term Consequences of Major Extremity Trauma: A Pilot Study.

SUMMARY: Limited data are available on the longer-term physical and psychosocial consequences after major extremity trauma apart from literature on the consequences after major limb amputation. The existing literature suggests that although variations in outcome exist, a significant proportion of service members and civilians sustaining major limb trauma will have less than optimal outcomes or health and rehabilitation needs over their life course. The proposed pilot study will address this gap in current research by locating and consenting METRC participants with the period of 5-7 years postinjury, identifying potential participation barriers and appropriate use of incentives, and conducting the follow-up examination at several data collection sites. The resulting data will inform the primary objective of refining and developing specific hypotheses to determine the design, scope, and feasibility of the main long-term consequences of major extremity trauma. Three METRC enrollment centers will contact past participants to achieve the goal of completing an interview, select patient-reported outcomes, perform a medical record review, and conduct an in-person clinic visit that will consist of a physical examination, blood draw, and x-ray of the study injury area. If successful, it will be possible to design studies to further examine these effects and develop future therapeutic interventions.

Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox Within an Orthopaedic Trauma Clinical Trials Consortium.

LEVEL OF EVIDENCE: Prognostic Level II.

The impact of statewide school closures on COVID-19 infection rates.

Daily COVID-19 infection rates were examined before and after statewide school closure orders. Regression techniques were used to model changes in the number of confirmed cases and data was combined across states using meta analyses. School closures were found to have a significant impact on infection rates, and thus, may be considered a viable intervention to lower COVID-19 infection rates.

Barriers and Facilitators to the Implementation of Injury Prevention Programs: A Qualitative Exploration and Model Development.

BACKGROUND: In 2006, the American College of Surgeons Committee on Trauma mandated implementation of injury prevention programs as a requirement for Level I and II trauma center designation. Little is known about the factors that facilitate or create barriers to establishing evidence-based injury prevention program implementation. The purpose of this research is to generate hypotheses regarding processes used to implement injury prevention programs at trauma centers, identify the factors that facilitate and serve as a barrier to implementation, and develop a model reflecting these factors and relationships. METHODS: This is a qualitative study of injury prevention programs at trauma centers. Study participants were chosen from 24 sites representing trauma centers of different patient volumes, geographic regions, and settings in the United States. Subjects participated in phone interviews based on guides developed from pilot interviews with prevention coordinators. Transcribed interviews from eight subjects were analyzed using a system of member checking to code; analysis informed the identification of factors that influence the establishment of evidence-based injury prevention programs. RESULTS: Five themes emerged from the data analysis: external factors, internal organizational factors, program capacity, program selection, and program success. Analysis revealed that successful program implementation was related to supportive leaders and collaborative, interdepartmental relationships. Additional themes indicated that while organizations were motivated primarily by verification requirements (external factor), strong institutional leadership (internal factor) was lacking. Employee readiness (program capacity) was hindered by limited training opportunities, and programs were often chosen (selection) based on implementation ease rather than evidence base or local data. CONCLUSIONS: Data analysis reveals five emerging themes of program implementation; using these data, we suggest an initial model of barriers and facilitators for implementing evidence-based injury prevention programs that could serve as the springboard for additional research involving a larger representative sample.

The Impact of Adherence to Clinical Practice Guidelines on Medical Costs.

OBJECTIVE: To examine the association between non-adherence to clinical practice guidelines (CPGs) and medical and indemnity spending among back and shoulder injury patients. METHODS: Workers compensation claims data was used from a large, US insurer (1999 to 2010). Least square regression models were created to examine the association between spending and guideline-discordant care. RESULTS: Non-adherence to CPGs was associated with higher medical and indemnity spending for 11 of the 28 CPG indicators. Failure to adhere to the other CPGs did not increase medical or total spending. After covariate adjustment, non-adherence to these 11 CPGs was associated with spending increases that ranged from $16,000 for physical therapy (PT) to $114,000 for surgery. CONCLUSIONS: Our results demonstrate that failure to adhere to a subset of CPG indicators significantly predicts increased medical and indemnity spending for two important occupational injuries.

The effect of state-level stay-at-home orders on COVID-19 infection rates.

State-level stay-at-home orders were monitored to determine their effect on the rate of confirmed COVID-19 diagnoses. Confirmed cases were tracked before and after state-level stay-at-home orders were put in place. Linear regression techniques were used to determine slopes for log case count data, and meta analyses were conducted to combine data across states. The results were remarkably consistent across states and support the usefulness of stay-at-home orders in reducing COVID-19 infection rates.

Real-time imaging of yeast cells reveals several distinct mechanisms of curing of the [URE3] prion.

The [URE3] yeast prion is the self-propagating amyloid form of the Ure2 protein. [URE3] is cured by overexpression of several yeast proteins, including Ydj1, Btn2, Cur1, Hsp42, and human DnaJB6. To better understand [URE3] curing, we used real-time imaging with a yeast strain expressing a GFP-labeled full-length Ure2 construct to monitor the curing of [URE3] over time. [URE3] yeast cells exhibited numerous fluorescent foci, and expression of the GFP-labeled Ure2 affected neither mitotic stability of [URE3] nor the rate of [URE3] curing by the curing proteins. Using guanidine to cure [URE3] via Hsp104 inactivation, we found that the fluorescent foci are progressively lost as the cells divide until they are cured; the fraction of cells that retained the foci was equivalent to the [URE3] cell fraction measured by a plating assay, indicating that the foci were the prion seeds. During the curing of [URE3] by Btn2, Cur1, Hsp42, or Ydj1 overexpression, the foci formed aggregates, many of which were 0.5 µm or greater in size, and [URE3] was cured by asymmetric segregation of the aggregated seeds. In contrast, DnaJB6 overexpression first caused a loss of detectable foci in cells that were still [URE3] before there was complete dissolution of the seeds, and the cells were cured. We conclude that GFP labeling of full-length Ure2 enables differentiation among the different [URE3]-curing mechanisms, including inhibition of severing followed by seed dilution, seed clumping followed by asymmetric segregation between mother and daughter cells, and seed dissolution.