A systematic review of patient-reported outcome measures patients with chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for the measurement of clinical effectiveness and cost effectiveness and for shared decision-making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, and other PROMs exist for patients with pain, and still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps that need to be addressed to develop a unifying PROM instrument for CLTI.

The Impact of Work Status and Age in Choosing Type of Abdominal Aortic Aneurysm Repair.

INTRODUCTION: The PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) trial aimed to determine the efficacy of a validated decision aid to enable better alignment between patient preference and their ultimate repair. We sought to determine the key factors influencing the decision-making of veterans for endovascular repair of abdominal aortic aneurysm (EVAR) or open surgical repair (OSR). METHODS: A total of 235 veterans in the PROVE-AAA trial were asked their information sources regarding repairs, employment status, and preferred intervention. Answers were coded and analyzed using conventional content analysis to generate nonoverlapping themes, then stratified by employment status. RESULTS: Forty-two patients (17.8% of enrollees) provided their source of information for OSR prior to using a decision aid. 81% of retired veterans were greater than 70 y old, while 58% of nonretired veterans were greater than 70 (P = 0.003). The most common information source was from a vascular surgeon/professional or unspecified MD/other health professionals (51.4%), while sources from outside this group made up the remaining 48.5%. The most preferred procedure was EVAR. However, nonretired individuals were more likely to prefer OSR. These data on information source and preferred procedure were similar in patients who provided their source for EVAR. CONCLUSIONS: Veterans in the PROVE-AAA study were more likely to be retired and more likely to rely on information from an unspecified MD/other health professionals for EVAR. Although both retired and nonretired veterans preferred EVAR the most, nonretired veterans were more likely to prefer OSR despite being younger.

Short-Term Concerns Primarily Determine Patient Preference for Abdominal Aortic Aneurysm Repair.

INTRODUCTION: Abdominal aortic aneurysm (AAA) repair may be performed through open or endovascular approaches, but the factors influencing a patient's repair-type preference are not well characterized. Here we performed a qualitative analysis to better understand factors influencing patient preference within the Preference for Open Versus Endovascular Repair of AAA Trial. METHODS: Open-ended responses regarding primary (n = 21) and secondary (n = 47) factors influencing patient preference underwent qualitative analysis using the constant comparative method with iterative reviews. Codes were used to generate themes and themes grouped into categories, with each step conducted via consensus agreement between three researchers. Relative prevalence of themes were compared to ascertain trends in patient preference. RESULTS: Patient responses regarding both primary and secondary factors fell into four categories: Short-term concerns, long-term concerns, advice & experience, and other. Patients most frequently described short-term concerns (23) as their primary influence, with themes including post-op complications, hospitalization & recovery, and intraoperative concerns. Long-term concerns were more prevalent (20) as secondary factors, which included themes such as survival, and chronic management. The average age of patients voicing only long-term concerns as a primary factor was 11 years younger than those listing only short-term concerns. CONCLUSION: Short-term concerns relating to the procedure and recovery are more often the primary factor influencing patient preference, while long term concerns play a more secondary role. Long-term concerns are more often a primary factor in younger patients. Vascular surgeons should consider this information in shared decision making to reach an optimal outcome.

Adapting Disease Prevention Protocols for Human Spaceflight During COVID-19.

BACKGROUND: The National Aeronautics and Space Administration (NASA) Flight Crew Health Stabilization Program (HSP) was historically implemented to minimize infectious disease transmission to astronauts in the immediate prelaunch period. The first ever commercial application and adaptation of the NASA HSP was implemented during the Crew Demo-2 mission in the time of the Coronavirus disease 2019 (COVID-19) pandemic. This article details and discusses the first commercial implementation and adaptation of the HSP prior to the Crew Demo-2 launch.METHODS: This is a retrospective descriptive analysis of the application of NASA disease prevention protocols for human spaceflight during the COVID-19 pandemic. In the context of the pandemic, extra precautions added to the HSP included daily symptom surveys completed by Primary Contacts of the crew, COVID-19 RT-PCR testing, and improved quarantine protocols.RESULTS: Of the 91 SpaceX Primary Contacts who completed a total of 2720 daily symptom surveys prior to launch, 22 individuals (24.2) and 198 surveys (7.3) returned positive for potential symptoms of COVID-19. Two individuals were removed due to symptoms indistinguishable from COVID-19. Through this survey, systematic quarantine, and PCR testing, the Crew Demo-2 mission was successful with no known infectious diseases transmitted.CONCLUSIONS: Overall, the commercial implementation of the NASA Health Stabilization Program by SpaceX with adjustments required during the COVID-19 pandemic was a success, with protocols allowing identification and removal of potentially infectious persons from the program. The principles of the HSP may provide an adequate infectious disease playbook for commercial spaceflight operations going forward.Petersen E, Pattarini JM, Mulcahy RA, Beger SB, Mitchell MR, Hu YD, Middleton KN, Frazier W, Mormann B, Esparza H, Asadi A, Musk ER, Alter G, Nilles E, Menon AS. Adapting disease prevention protocols for human spaceflight during COVID-19. Aerosp Med Hum Perform. 2021; 92(7):597602.

ALX1-related frontonasal dysplasia results from defective neural crest cell development and migration.

A pedigree of subjects presented with frontonasal dysplasia (FND). Genome sequencing and analysis identified a p.L165F missense variant in the homeodomain of the transcription factor ALX1 which was imputed to be pathogenic. Induced pluripotent stem cells (iPSC) were derived from the subjects and differentiated to neural crest cells (NCC). NCC derived from ALX1L165F/L165F iPSC were more sensitive to apoptosis, showed an elevated expression of several neural crest progenitor state markers, and exhibited impaired migration compared to wild-type controls. NCC migration was evaluated in vivo using lineage tracing in a zebrafish model, which revealed defective migration of the anterior NCC stream that contributes to the median portion of the anterior neurocranium, phenocopying the clinical presentation. Analysis of human NCC culture media revealed a change in the level of bone morphogenic proteins (BMP), with a low level of BMP2 and a high level of BMP9. Soluble BMP2 and BMP9 antagonist treatments were able to rescue the defective migration phenotype. Taken together, these results demonstrate a mechanistic requirement of ALX1 in NCC development and migration.