PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.
Competing Interests: Disclosures CSL reports grants or contracts from NIH and QED Medical Research Foundation; JS reports grants from Natera; BR, PCORI, UCSD) and consulting fees from LAA, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis; JS reports from Medtronic; JL reports from Abbott, AstraZeneca, Alleviant, Boston Scientific, Merck, CVRx, VWave, and Edwards; EDA reports from Abiomed, Novartis, Abbott, Ionis Pharmaceuticals, Sana Biotechnology, Medtronic, Lexeo Pharmaceuticals, and Cytokinetics; KLG reports payment or honoraria from Amgen; JJT reports CareDx, Medtronic, and Paragonix; MSK reports from Medtronic; BR reports TEACH faculty development program; KLG reports AHA, payment for expert testimony (EDA: Astra Zeneca), meeting/travel support; MSK reports Abbott; KLG: ISHLT, AHA); Data Safety Monitoring Board or Advisory Board; JJT reports from CareDx, Medtronic, Abiomed, Takeda, Abbott; MSK reports Medtronic; JKK reports Carmat and Xeltis clinical trials), leadership or fiduciary role (EDA Papillon Therapeutics, ResQ Pharmaceuticals); JKK reports ISHLT Research Foundation, International Society for Heart & Lung Transplantation; KLG reports ISHLT; LAA reports being associate editor of Circulation: Heart Failure; DC reports being President-elect, PROMIS Health Organization; JKK reports being Director of the Data Center for STS-Intermacs Registry for Mechanical Circulatory Support.
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