TY - JOUR
T1 - A systematic review of patient-reported outcome measures patients with chronic limb-threatening ischemia
AU - Goodney, Philip
AU - Shah, Samir
AU - Hu, Yiyuan David
AU - Suckow, Bjoern
AU - Kinlay, Scott
AU - Armstrong, David G.
AU - Geraghty, Patrick
AU - Patterson, Megan
AU - Menard, Matthew
AU - Patel, Manesh R.
AU - Conte, Michael S.
N1 - Funding Information:
Author conflict of interest: D.G.A. was partially supported by National Institutes of Health , National Institute of Diabetes and Digestive and Kidney Diseases Award Number 1R01124789-01A1 .” P.G. was partially supported by a Strategically Focused Research Network Grant from the American Heart Association ( 18SFRN33900085 ). M.M. reports a role on the Advisory Board for Janssen, Inc., and Anges. M.R.P. reports conflicts from Bayer, Janssen, Amgen, and Heartflow, and Research Grants from the NHLBI and Medtronic. M.S.C. reports conflicts from an Advisory Board role from Abbott Vascular, and Anges. P.G. reports conflicts from Bard, Boston Scientific, and equity shares in Pulse Therapeutics and MedAlliance.
Funding Information:
Vascular Cures Foundation provided funding for a meeting where the concept of the article was developed.Author conflict of interest: D.G.A. was partially supported by National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases Award Number 1R01124789-01A1.” P.G. was partially supported by a Strategically Focused Research Network Grant from the American Heart Association (18SFRN33900085). M.M. reports a role on the Advisory Board for Janssen, Inc., and Anges. M.R.P. reports conflicts from Bayer, Janssen, Amgen, and Heartflow, and Research Grants from the NHLBI and Medtronic. M.S.C. reports conflicts from an Advisory Board role from Abbott Vascular, and Anges. P.G. reports conflicts from Bard, Boston Scientific, and equity shares in Pulse Therapeutics and MedAlliance.
Funding Information:
Choosing these pilot projects will be an effort undertaken by VascularCures and other stakeholders convened for this forum. Broader support from specialty societies and national funding agencies such as the Agency for Healthcare Research and Quality and the National Institutes of Health is sorely needed. By collaborating with experts from vascular surgery, vascular medicine, podiatry, wound care, endocrinology, qualitative science, survey design, and clinical research, investigators will have a broad range of critique and insight to develop the best possible measures.
Publisher Copyright:
© 2021 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
KW - Amputation
KW - Chronic limb-threatening ischemia
KW - Critical limb ischemia
KW - Decision aid
KW - Decision tool
KW - Patient reported outcome
KW - Peripheral artery disease
KW - Shared decision-making
KW - Surgical decision
KW - Surgical decision-making
UR - http://www.scopus.com/inward/record.url?scp=85128291061&partnerID=8YFLogxK
U2 - 10.1016/j.jvs.2021.11.057
DO - 10.1016/j.jvs.2021.11.057
M3 - Review article
C2 - 35085747
AN - SCOPUS:85128291061
VL - 75
SP - 1762
EP - 1775
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
SN - 0741-5214
IS - 5
ER -