ABSTRACT
Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.
Subject(s)
Patient Reported Outcome Measures , Quality of Life , Renal Insufficiency, Chronic/therapy , Renal Replacement Therapy/adverse effects , Renal Replacement Therapy/instrumentation , User-Centered Design , Clinical Trials as Topic , Employment , Fatigue/etiology , Humans , Interpersonal Relations , Inventions , Leisure Activities , Medical Device Legislation , Social ParticipationABSTRACT
The American Society of Plastic Surgeons commissioned the Breast Reconstruction Performance Measure Development Work Group to identify and draft quality measures for the care of patients undergoing breast reconstruction surgery. Two outcome measures were identified. The first desired outcome was to reduce the number of returns to the operating room following reconstruction within 60 days of the initial reconstructive procedure. The second desired outcome was to reduce flap loss within 30 days of the initial reconstructive procedure. All measures in this report were approved by the American Society of Plastic Surgeons Breast Reconstruction Performance Measures Work Group and the American Society of Plastic Surgeons Executive Committee. The Work Group recommends the use of these measures for quality initiatives, Continuing Medical Education, Maintenance of Certification, American Society of Plastic Surgeons' Qualified Clinical Data Registry reporting, and national quality reporting programs.
