Malone, Daniel C.

Background To evaluate the short-term clinical performance of Symvess (acellular tissue engineered vessel-tyod), formerly known as human acellular vessel, or HAV, compared with autologous vein for the treatment of extremity arterial injury. Methods Subjects treated with acellular tissue engineered vessel (ATEV) from two clinical trials were propensity score-matched on a 1:2 basis to PROspective Observational Vascular Injury Trial (PROOVIT) registry subjects with the same injured artery and treated with autologous vein. Matching characteristics included age, sex, trauma type (penetrating vs blunt), injury severity score, mangled extremity severity score, concomitant fracture, shunt use, and ischemia duration>6 hours. Incidence of outcomes (primary/secondary patency, amputation, conduit infection, reintervention for thrombosis/stenosis, pseudoaneurysm, and death) was assessed by a generalized linear model. Outcomes were assessed at Day 30 (ATEV group) or during initial hospitalization (autologous group). Results ATEV subjects lacking suitable autologous vein (n=67) and PROOVIT subjects treated with autologous vein (n=134) suffered injuries to axillary, brachial, femoral, popliteal, and posterior tibial arteries. Subgroups were clinically similar; Injury Severity Score, Mangled Extremity Severity Score, and duration of follow-up (16 vs 30 days) were higher for the ATEV subgroup. Primary patency for the ATEV versus autologous group was 86.6% versus 91.8%, secondary patency: 91.0% versus 97.7%; amputation: 7.5% versus 8.2%; conduit infection: 1.5% versus 0%; reintervention for thrombosis or stenosis: 6.0% versus 8.2%; and death 4.5% versus 4.5%, respectively. No cases of pseudoaneurysm, true aneurysm, or significant differences between the ATEV and autologous groups for any outcome were observed. Conclusions Short-term outcomes were similar between ATEV subjects without feasible autologous vein, and propensity score-matched autologous vein recipients from the PROOVIT registry. The ATEV may provide effective and safe revascularization in subjects with extremity arterial injury without feasible autologous vein. Level of evidence Level 3, Therapeutic/Care Management

Background There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.