Understanding pathways from implementation to sustainment: a longitudinal, mixed methods analysis of promising practices implemented in the Veterans Health Administration.

BACKGROUND: The Veterans Health Administration (VHA) is the United States largest learning health system. The Diffusion of Excellence (DoE) program is a large-scale model of diffusion that identifies and diffuses evidence-informed practices across VHA. During the period of 2016-2021, 57 evidence-informed practices were implemented across 82 VHA facilities. This setting provides a unique opportunity to understand sustainment determinants and pathways. Our objective was to characterize the longitudinal pathways of practices as they transition from initial implementation to long-term sustainment at each facility. METHODS: A longitudinal, mixed-methods evaluation of 82 VHA facilities. Eighty-two facility representatives, chosen by leadership as points-of-contact for 57 DoE practices, were eligible for post-implementation interviews and annual sustainment surveys. Primary outcomes (implementation, sustainment), and secondary outcomes (institutionalization, effectiveness, anticipated sustainment) at four time-points were collected. We performed descriptive statistics and directed content analysis using Hailemariam et al.'s factors influencing sustainment. RESULTS: After approximately five years post-implementation (e.g., 2021 sustainment outcomes), of the 82 facilities, about one-third fully sustained their practice compared to one-third that did not fully sustain their practice because it was in a "liminal" stage (neither sustained nor discontinued) or permanently discontinued. The remaining one-third of facilities had missing 2021 sustainment outcomes. A higher percentage of facilities (70%) had inconsistent primary outcomes (changing over time) compared to facilities (30%) with consistent primary outcomes (same over time). Thirty-four percent of facilities with sustained practices reported resilience since they overcame implementation and sustainment barriers. Facilities with sustained practices reported more positive secondary outcomes compared to those that did not sustain their practice. Key factors facilitating practice sustainment included: demonstrating practice effectiveness/benefit, sufficient organizational leadership, sufficient workforce, and adaptation/alignment with local context. Key factors hindering practice sustainment included: insufficient workforce, not able to maintain practice fidelity/integrity, critical incidents related to the COVID-19 pandemic, organizational leadership did not support sustainment of practice, and no ongoing support. CONCLUSIONS: We identified diverse pathways from implementation to sustainment, and our data underscore that initial implementation outcomes may not determine long-term sustainment outcomes. This longitudinal evaluation contributes to understanding impacts of the DoE program, including return on investment, achieving learning health system goals, and insights into achieving high-quality healthcare in VHA.

Reported Outcome Measures in Complex Fracture Elbow Dislocations: A Systematic Review.

BACKGROUND: Complex elbow fracture dislocations, dislocation with fracture of one or several surrounding bony stabilizers, are difficult to manage and associated with poor outcomes. While many studies have explored treatment strategies but a lack of standardization of patient-reported outcome measures (PROMs) makes cross-study comparison difficult. In this systematic review, we aim to describe what injury patterns, measured outcomes, and associated complications are reported in the complex elbow fracture dislocation literature to provide outcome reporting recommendations that will facilitate improved future cross-study comparison. METHODS: A systematic review was performed per PRISMA guidelines. We queried PubMed/MEDLINE, Embase, Web of Science, and Cochrane databases to identify articles published between 2010 and 2022 reporting on adult patients who had a complex elbow fracture dislocation. Pathologic fractures were excluded. A bias assessment using the methodological index for non-randomized studies criteria was conducted. For each article, patient demographics, injury pattern, outcome measures, and complications were recorded. RESULTS: Ninety-one studies reporting on 3664 elbows (3654 patients) with an elbow fracture and dislocation (weighted mean age 44 years, follow-up of 30 months, 41% female) were evaluated. Of these, the injury pattern was described in 3378 elbows and included 2951 (87%) terrible triad injuries and 72 (2%) transolecranon fracture-dislocations. The three most commonly reported classification systems were: Mason classification for radial head fractures, Regan and Morrey coronoid classification for coronoid fractures, and O'Driscoll classification for coronoid fractures. Range of motion was reported in 87 (96%) studies with most reporting flexion (n=70), extension (n=62), pronation (n=68), or supination (n=67). Strength was reported in 11 (12%) studies. PROMs were reported in 83 (91%) studies with an average of 2.6 outcomes per study. There were 14 outcome scores including the Mayo Elbow Performance Score (MEPS) (n=69 [83%]), the Disabilities of Arm, Shoulder and Hand (DASH) score (n=28 [34%]), the visual analog scale for pain (VAS) (n=27 [33%]), QuickDASH score (n=13 [15.7%]), and Oxford Elbow score (n=5 [6.0%]). No significance was found between the number of PROMs used per article and the year of publication (P=.313), study type (P=.689), complex fracture pattern (P=.211), or number of elbows included (P=.152). CONCLUSION: There is great heterogeneity in reported PROMs in the complex elbow fracture dislocation literature. Although there is no gold standard PROM for assessing complex elbow fracture dislocations, we recommend the use of at least the MEPS and DASH outcomes measures as well as VAS pain rating scale in future studies to facilitate cross-study comparisons.

Veteran Caretaker Perspectives of the Need for Childcare Assistance During Health Care Appointments.

PURPOSE: In 2020, Congress passed legislation to establish the national Veterans Child Care Assistance Program (VCAP) targeting eligible veterans receiving care through the Veterans Health Administration (VA). This needs assessment describes the childcare needs of veteran caretakers of young children and explores the implications of inadequate childcare on health care engagement. METHODS: Survey data were collected from 2,000 VA users with dependent children; data were analyzed using standard descriptive statistics. Qualitative data were collected from 19 veterans through focus groups and analyzed using rapid thematic analysis. FINDINGS: More than 75% of veterans surveyed indicated that they required childcare assistance during health care appointments and 73% reported barriers to finding childcare. Prominent barriers included the high cost of childcare and not having a trusted source of childcare. Nearly 58% of survey respondents reported missed or canceled VA health care appointments due to childcare challenges. Furthermore, 35% of surveyed veterans reported that their children had accompanied them to an appointment in the past year. Among these veterans, 59% brought their children into the exam room. Focus group participants discussed how having children present during their health care appointments hampered communication with health care providers. CONCLUSIONS: Veterans report that lack of childcare keeps them from attending and remaining focused on the provider during their health care visits, which could compromise quality of care. As one of the only health systems in the United States that will offer childcare assistance, VCAP presents an opportunity to improve health care access and quality by reducing missed appointments and suboptimal care.

Nivolumab/Relatlimab-rmbw: A Novel Dual Combination Therapy to Treat Adult and Pediatric Patients With Unresectable or Metastatic Melanoma.

BACKGROUND: Immune checkpoint inhibitors control effector mechanisms and work to restore downregulated T-cells in patients with melanoma. Examples of such include programmed death-1 inhibitors and lymphocyte-activating gene 3 inhibitors. The combination of nivolumab, a programmed death-1 inhibitor, and relatlimab-rmbw, a lymphocyte-activating gene 3 inhibitor, has shown antitumor activity and improved progression-free survival in patients with unresectable or metastatic melanoma. MECHANISM OF ACTION PHARMACOKINETICS/PHARMACODYNAMICS: The fixed-dose combination of nivolumab and relatlimab immunotherapy is approved for adults and pediatrics 12 years of age or older with metastatic or unresectable melanoma. Volume of distribution is 6.6 L for relatlimab and nivolumab, and half-life is 27 and 26 days, respectively. Clearance at steady state is 7.6 mL/h for nivolumab and 5.5 mL/h for relatlimab. Sex, age, race, and mild hepatic/renal impairment had no clinical effect on clearance. The exposure-response relationship and pharmacodynamic response for the safety and effectiveness of nivolumab/relatlimab-rmbw have not been fully characterized. Safety concerns include severe and fatal immune-mediated adverse reactions, infusion-related reactions, and complications of allogeneic hematopoietic stem cell transplantation, and fetal toxicity. Dosing is determined by patient's age and weight. Solution is infused over a 30-minute timeframe. CLINICAL TRIALS: In the RELATIVITY-047 trial, patients received nivolumab or nivolumab/relatlimab-rmbw. Results showed superiority of dual therapy over monotherapy with a progression-free survival of 10.1 months (95% CI, 6.4-15.7) compared with 4.6 months (95% CI, 3.4-5.6) and hazard ratio of 0.75 (95% CI, 0.62-0.92); P = 0.006, respectively. No safety concerns were observed compared with monotherapy with treatment-related adverse events occurring in 18.9% of patients on combination therapy compared with 9.7% on nivolumab alone. THERAPEUTIC ADVANCE: The novel mechanism and improvement in progression-free survival compared with standard of care highlight the therapeutic advancement of nivolumab/relatlimab-rmbw in the treatment of unresectable and metastatic melanoma.

Establishing a mentorship program for prospective genetic counseling graduate students: Two cycles of program experience.

Mentorship has been a long-standing and important piece of healthcare training, but few formal, structured mentorship programs exist in the genetic counseling field. Our report describes the creation and evaluation of the Genetic Counseling Assistant Mentorship Program (GCAMP) after two cycles of the program. Genetic counseling assistant (GCA) mentees were paired with genetic counselor mentors for support and advice primarily surrounding graduate school applications and professional development. Pairs were encouraged to meet at regular intervals, but the specific meeting patterns were determined by the pair based on the needs of the mentee. The GCAMP also involved electronic and interactive resources for mentees, which were continually developed. Many of the electronic resources were created and maintained by past and current GCAs, such as a list of local shadowing and advocacy opportunities and a list of factors to consider when evaluating graduate programs. Interactive resources included workshops, mock graduate school interviews, reviews of graduate school application materials, and social events. Mentors were also provided with resources about mentorship. Surveys were conducted to evaluate the program. Overall satisfaction with the program and the mentoring relationship was high among both mentees and mentors. In aggregate, results revealed that mentees felt strongly supported by the mentorship program and were highly satisfied with their mentorship experience. Results also showed that mentors enjoyed a high level of fulfillment and professional development themselves by participating in the program.

Quantifying success after first revision reverse total shoulder arthroplasty: the minimal clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state.

BACKGROUND: When patients require revision of primary shoulder arthroplasty, revision reverse total shoulder arthroplasty (rTSA) is most commonly performed. However, defining clinically important improvement in these patients is challenging because benchmarks have not been previously defined. Our purpose was to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for outcome scores and range of motion (ROM) after revision rTSA and to quantify the proportion of patients achieving clinically relevant success. METHODS: This retrospective cohort study used a prospectively collected single-institution database of patients undergoing first revision rTSA between August 2015 and December 2019. Patients with a diagnosis of periprosthetic fracture or infection were excluded. Outcomes scores included the ASES, raw and normalized Constant, SPADI, SST, and University of California, Los Angeles (UCLA) scores. ROM measures included abduction, forward elevation (FE), external rotation (ER), and internal rotation (IR) score. Anchor-based and distribution-based methods were used to calculate the MCID, SCB, and PASS. The proportions of patients achieving each threshold were assessed. RESULTS: Ninety-three revision rTSAs with minimum 2-year follow-up were evaluated. Mean age was 67 years, 56% were female, and average follow-up was 54 months. Revision rTSA was performed most commonly for failed anatomic TSA (n = 47), followed by hemiarthroplasty (n = 21), rTSA (n = 15), and resurfacing (n = 10). The indication for revision rTSA was most commonly glenoid loosening (n = 24), followed by rotator cuff failure (n = 23), subluxation and unexplained pain (n = 11 for both). The anchor-based MCID thresholds (% of patients achieving) were as follows: ASES, 20.1 (42%); normalized Constant, 12.6 (80%); UCLA, 10.2 (54%); SST, 0.9 (78%); SPADI, -18.4 (58%); abduction, 13° (83%); FE, 18° (82%); ER, 4° (49%); and IR, 0.8 (34%). The SCB thresholds (% of patients achieving) were as follows: ASES, 34.1 (25%); normalized Constant, 26.6 (43%); UCLA, 14.1 (28%); SST, 3.9 (48%); SPADI, -36.4 (33%); abduction, 20° (77%); FE, 28° (71%); ER, 15° (15%); and IR, 1.0 (29%). The PASS thresholds (% of patients achieving) were as follows: ASES, 63.5 (53%); normalized Constant, 59.1 (61%); UCLA, 25.4 (48%); SST, 7.0 (55%); SPADI, 42.4 (59%); abduction, 98° (61%); FE, 110° (56%); ER, 19° (73%); and IR, 3.3 (59%). CONCLUSIONS: This study establishes thresholds for the MCID, SCB, and PASS at minimum 2-years after revision rTSA, providing physicians an evidence-based method to counsel patients and assess patient outcomes postoperatively.

Diffusion of excellence: evaluating a system to identify, replicate, and spread promising innovative practices across the Veterans health administration.

Introduction: The Veterans Health Administration (VHA) Diffusion of Excellence (DoE) program provides a system to identify, replicate, and spread promising practices across the largest integrated healthcare system in the United States. DoE identifies innovations that have been successfully implemented in the VHA through a Shark Tank style competition. VHA facility and regional directors bid resources needed to replicate promising practices. Winning facilities/regions receive external facilitation to aid in replication/implementation over the course of a year. DoE staff then support diffusion of successful practices across the nationwide VHA. Methods: Organized around the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework, we summarize results of an ongoing long-term mixed-methods implementation evaluation of DoE. Data sources include: Shark Tank application and bid details, tracking practice adoptions through a Diffusion Marketplace, characteristics of VHA facilities, focus groups with Shark Tank bidders, structured observations of DoE events, surveys of DoE program participants, and semi-structured interviews of national VHA program office leaders, VHA healthcare system/facility executives, practice developers, implementation teams and facilitators. Results: In the first eight Shark Tanks (2016-2022), 3,280 Shark Tank applications were submitted; 88 were designated DoE Promising Practices (i.e., practices receive facilitated replication). DoE has effectively spread practices across the VHA, with 1,440 documented instances of adoption/replication of practices across the VHA. This includes 180 adoptions/replications in facilities located in rural areas. Leadership decisions to adopt innovations are often based on big picture considerations such as constituency support and linkage to organizational goals. DoE Promising Practices that have the greatest national spread have been successfully replicated at new sites during the facilitated replication process, have close partnerships with VHA national program offices, and tend to be less expensive to implement. Two indicators of sustainment indicate that 56 of the 88 Promising Practices are still being diffused across the VHA; 56% of facilities originally replicating the practices have sustained them, even up to 6 years after the first Shark Tank. Conclusion: DoE has developed a sustainable process for the identification, replication, and spread of promising practices as part of a learning health system committed to providing equitable access to high quality care.

Characterization of Bacillus anthracis replication and persistence on environmental substrates associated with wildlife anthrax outbreaks.

Anthrax is a zoonosis caused by the environmentally maintained, spore-forming bacterium Bacillus anthracis, affecting humans, livestock, and wildlife nearly worldwide. Bacterial spores are ingested, inhaled, and may be mechanically transmitted by biting insects or injection as occurs during heroin-associated human cases. Herbivorous hoofstock are very susceptible to anthrax. When these hosts die of anthrax, a localized infectious zone (LIZ) forms in the area surrounding the carcass as it is scavenged and decomposes, where viable populations of vegetative B. anthracis and spores contaminate the environment. In many settings, necrophagous flies contaminate the outer carcass, surrounding soils, and vegetation with viable pathogen while scavenging. Field observations in Texas have confirmed this process and identified primary browse species (e.g., persimmon) are contaminated. However, there are limited data available on B. anthracis survival on environmental substrates immediately following host death at a LIZ. Toward this, we simulated fly contamination by inoculating live-attenuated, fully virulent laboratory-adapted, and fully virulent wild B. anthracis strains on untreated leaves and rocks for 2, 5, and 7 days. At each time point after inoculation, the number of vegetative cells and spores were determined. Sporulation rates were extracted from these different time points to enable comparison of sporulation speeds between B. anthracis strains with different natural histories. We found all B. anthracis strains used in this study could multiply for 2 or more days post inoculation and persist on leaves and rocks for at least seven days with variation by strain. We found differences in sporulation rates between laboratory-adapted strains and wild isolates, with the live-attenuated strain sporulating fastest, followed by the wild isolates, then laboratory-adapted virulent strains. Extrapolating our wild strain lab results to potential contamination, a single blow fly may contaminate leaves with up to 8.62 x 105 spores per day and a single carcass may host thousands of flies. Replication outside of the carcass and rapid sporulation confirms the LIZ extends beyond the carcass for several days after formation and supports the necrophagous fly transmission pathway for amplifying cases during an outbreak. We note caution must be taken when extrapolating replication and sporulation rates from live-attenuated and laboratory-adapted strains of B. anthracis.

Linking the region-specific tissue microstructure to the biaxial mechanical properties of the porcine left anterior descending artery.

Coronary atherosclerosis is the main cause of death worldwide. Advancing the understanding of coronary microstructure-based mechanics is fundamental for the development of therapeutic tools and surgical procedures. Although the passive biaxial properties of the coronary arteries have been extensively explored, their regional differences and the relationship between tissue microstructure and mechanics have not been fully characterized. In this study, we characterized the passive biaxial mechanical properties and microstructural properties of the proximal, medial, and distal regions of the porcine left anterior descending artery (LADA). We also attempted to relate the biaxial stress-stretch response of the LADA and its respective birefringent responses to the polarized light for obtaining information about the load-dependent microstructural variations. We found that the LADA extensibility is reduced in the proximal-to-distal direction and that the medial region exhibits more heterogeneous mechanical behavior than the other two regions. We have also observed highly dynamic microstructural behavior where fiber families realign themselves depending on loading. In addition, we found that the microstructure of the distal region exhibited highly aligned fibers along the longitudinal axis of the artery. To verify this microstructural feature, we imaged the LADA specimens with multi-photon microscopy and observed that the adventitia microstructure transitioned from a random fiber network in the proximal region to highly aligned fibers in the distal region. Our findings could offer new perspectives for understanding coronary mechanics and aid in the development of tissue-engineered vascular grafts, which are currently limited due to their mismatch with native tissue in terms of mechanical properties and microstructural features. STATEMENT OF SIGNIFICANCE: The tissue biomechanics of coronary arteries is fundamental for the development of revascularization techniques such as coronary artery bypass. These therapeutics require a deep understanding of arterial mechanics, microstructure, and mechanobiology to prevent graft failure and reoperation. The present study characterizes the unique regional mechanical and microstructural properties of the porcine left anterior descending artery using biaxial testing, polarized-light imaging, and confocal microscopy. This comprehensive characterization provides an improved understanding of the collagen/elastin architecture in response to mechanical loads using a region-specific approach. The unique tissue properties obtained from this study will provide guidance for the selection of anastomotic sites in coronary artery bypass grafting and for the design of tissue-engineered vascular grafts.

Preparation Technique Affects Recipient Immune Targeting of Autologous Mesenchymal Stem Cells.

Fetal bovine serum (FBS) is used for MSC preparation in pre-clinical animal models and veterinary applications, recently in US clinical trials, and for MSC products with current foreign market authorizations. The effect of anti-bovine titers, which are common in animals and humans, has not been investigated. In the equine model, where anti-bovine titers are universally high due to routine vaccination, we evaluated the recipient immune response to autologous MSCs prepared with and without FBS. Preparation of MSCs with FBS resulted in post injection inflammation and antibody mediated cytotoxicity of MSCs when compared to MSCs prepared without FBS. Importantly, synovial MSC concentrations were reduced and LPS induced pain was higher, when FBS was used to prepare MSCs, demonstrating reduced efficacy of FBS prepared MSCs. Fetal bovine serum should no longer be utilized for MSC preparation in pre-clinical study, clinical study, or veterinary applications. The use of FBS in previously reported studies, and in MSC therapeutics with current foreign market authorization, should be considered when interpreting results.