The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale

On behalf of the SCOPE-CLI Academic Research Consortium

doi:10.1016/j.ijcha.2022.100971

The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale

On behalf of the SCOPE-CLI Academic Research Consortium

Surgery

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients’ preferences, or outcomes, as seen from patients’ perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes. ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Original language	English (US)
Article number	100971
Journal	IJC Heart and Vasculature
Volume	39
DOIs	https://doi.org/10.1016/j.ijcha.2022.100971
State	Published - Apr 2022

Bibliographical note

Funding Information:
The SCOPE-CLI research consortium acknowledge the patient and physician expert members, who have advised us throughout the planning, design, and implementation of the study. Dr. Smolderen had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the sponsors. All manuscripts for the SCOPE-CLI study are prepared by independent authors who are not governed by the funding sponsors and are reviewed by an academic publications committee before submission. The funding organizations and sponsors of the study had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the article; and decision to submit the article for publication. SCOPE-CLI is supported by research grants from Abbott Laboratories, W. L. Gore & Associates, Inc. Terumo Corporation, Boston Scientific Corporation, and Janssen Pharmaceutical Companies of Johnson&Johnson. Dr. Smolderen reports unrestricted research grants from Cardiva Medical Inc. W. L. Gore & Associates, Inc. Abbott Laboratories, Merck & Co. Inc. and Janssen Pharmaceutical Companies of Johnson&Johnson. She is a consultant for Optum Labs, Inc. and Abbott Laboratories. Dr. Mena-Hurtado is a consultant for Abbott Laboratories, Boston Scientific Corporation, Cook Medical, Inc. Medtronic, Inc. Cardinal Health, Inc. Optum Labs, Inc. Dr. Shishehbor is a global advisor for Medtronic, Inc. Abbott Laboratories, Terumo Corporation, Boston Scientific Corporation, VentureMed, and Phillips. Dr. Spertus is a consultant to Bayer, Jannsen, Merck, Myokardia, Novartis, Terumo and United Healthcare; he receives grant support from Janssen and Myokadia; he holds the copyright to the PAQ, KCCQ and SAQ and serves on the Board of Blue Cross/Blue Shield of Kansas City. Dr. Humphries is a speaker for Gore, Convatec, and Shockwave. The other authors have no disclosures.

Funding Information:
Dr. Smolderen reports unrestricted research grants from Cardiva Medical Inc., W. L. Gore & Associates, Inc. , Abbott Laboratories, Merck & Co., Inc., and Janssen Pharmaceutical Companies of Johnson&Johnson . She is a consultant for Optum Labs, Inc., and Abbott Laboratories. Dr. Mena-Hurtado is a consultant for Abbott Laboratories, Boston Scientific Corporation, Cook Medical, Inc., Medtronic, Inc., Cardinal Health, Inc., Optum Labs, Inc. Dr. Shishehbor is a global advisor for Medtronic, Inc., Abbott Laboratories, Terumo Corporation, Boston Scientific Corporation, VentureMed, and Phillips. Dr. Spertus is a consultant to Bayer, Jannsen, Merck, Myokardia, Novartis, Terumo and United Healthcare; he receives grant support from Janssen and Myokadia; he holds the copyright to the PAQ, KCCQ and SAQ and serves on the Board of Blue Cross/Blue Shield of Kansas City. Dr. Humphries is a speaker for Gore, Convatec, and Shockwave. The other authors have no disclosures.

Publisher Copyright:
© 2022

Keywords

Critical Limb Ischemia
Health Disparities
Patient-Reported Outcomes
Peripheral Artery Disease
Registries
Study Design

PubMed: MeSH publication types

Journal Article

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ijcha.2022.100971

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@article{c9e3ca4cc79d454f9e09f4be49c87b5d,

title = "The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale",

abstract = "Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients{\textquoteright} preferences, or outcomes, as seen from patients{\textquoteright} perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes. ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.",

keywords = "Critical Limb Ischemia, Health Disparities, Patient-Reported Outcomes, Peripheral Artery Disease, Registries, Study Design",

author = "{On behalf of the SCOPE-CLI Academic Research Consortium} and Scierka, {Lindsey E.} and Carlos Mena-Hurtado and Shishehbor, {Mehdi H.} and Spertus, {John A.} and Sameer Nagpal and Trissa Babrowski and Bunte, {Matthew C.} and Amani Politano and Misty Humphries and Jayer Chung and Lee Kirksey and Olamide Alabi and Peter Soukas and Sahil Parikh and Rumi Faizer and Robert Fitridge and Jeremy Provance and Ga{\"e}lle Romain and Neil McMillan and Nancy Stone and Kate Scott and Christine Fuss and Pacheco, {Christina M.} and Kensey Gosch and Avis Harper-Brooks and Smolderen, {Kim G.}",

note = "Funding Information: The SCOPE-CLI research consortium acknowledge the patient and physician expert members, who have advised us throughout the planning, design, and implementation of the study. Dr. Smolderen had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the sponsors. All manuscripts for the SCOPE-CLI study are prepared by independent authors who are not governed by the funding sponsors and are reviewed by an academic publications committee before submission. The funding organizations and sponsors of the study had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the article; and decision to submit the article for publication. SCOPE-CLI is supported by research grants from Abbott Laboratories, W. L. Gore & Associates, Inc. Terumo Corporation, Boston Scientific Corporation, and Janssen Pharmaceutical Companies of Johnson&Johnson. Dr. Smolderen reports unrestricted research grants from Cardiva Medical Inc. W. L. Gore & Associates, Inc. Abbott Laboratories, Merck & Co. Inc. and Janssen Pharmaceutical Companies of Johnson&Johnson. She is a consultant for Optum Labs, Inc. and Abbott Laboratories. Dr. Mena-Hurtado is a consultant for Abbott Laboratories, Boston Scientific Corporation, Cook Medical, Inc. Medtronic, Inc. Cardinal Health, Inc. Optum Labs, Inc. Dr. Shishehbor is a global advisor for Medtronic, Inc. Abbott Laboratories, Terumo Corporation, Boston Scientific Corporation, VentureMed, and Phillips. Dr. Spertus is a consultant to Bayer, Jannsen, Merck, Myokardia, Novartis, Terumo and United Healthcare; he receives grant support from Janssen and Myokadia; he holds the copyright to the PAQ, KCCQ and SAQ and serves on the Board of Blue Cross/Blue Shield of Kansas City. Dr. Humphries is a speaker for Gore, Convatec, and Shockwave. The other authors have no disclosures. Funding Information: Dr. Smolderen reports unrestricted research grants from Cardiva Medical Inc., W. L. Gore & Associates, Inc. , Abbott Laboratories, Merck & Co., Inc., and Janssen Pharmaceutical Companies of Johnson&Johnson . She is a consultant for Optum Labs, Inc., and Abbott Laboratories. Dr. Mena-Hurtado is a consultant for Abbott Laboratories, Boston Scientific Corporation, Cook Medical, Inc., Medtronic, Inc., Cardinal Health, Inc., Optum Labs, Inc. Dr. Shishehbor is a global advisor for Medtronic, Inc., Abbott Laboratories, Terumo Corporation, Boston Scientific Corporation, VentureMed, and Phillips. Dr. Spertus is a consultant to Bayer, Jannsen, Merck, Myokardia, Novartis, Terumo and United Healthcare; he receives grant support from Janssen and Myokadia; he holds the copyright to the PAQ, KCCQ and SAQ and serves on the Board of Blue Cross/Blue Shield of Kansas City. Dr. Humphries is a speaker for Gore, Convatec, and Shockwave. The other authors have no disclosures. Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = apr,

doi = "10.1016/j.ijcha.2022.100971",

language = "English (US)",

volume = "39",

journal = "IJC Heart and Vasculature",

issn = "2352-9067",

publisher = "Elsevier Ireland Ltd",

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TY - JOUR

T1 - The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale

AU - On behalf of the SCOPE-CLI Academic Research Consortium

AU - Scierka, Lindsey E.

AU - Mena-Hurtado, Carlos

AU - Shishehbor, Mehdi H.

AU - Spertus, John A.

AU - Nagpal, Sameer

AU - Babrowski, Trissa

AU - Bunte, Matthew C.

AU - Politano, Amani

AU - Humphries, Misty

AU - Chung, Jayer

AU - Kirksey, Lee

AU - Alabi, Olamide

AU - Soukas, Peter

AU - Parikh, Sahil

AU - Faizer, Rumi

AU - Fitridge, Robert

AU - Provance, Jeremy

AU - Romain, Gaëlle

AU - McMillan, Neil

AU - Stone, Nancy

AU - Scott, Kate

AU - Fuss, Christine

AU - Pacheco, Christina M.

AU - Gosch, Kensey

AU - Harper-Brooks, Avis

AU - Smolderen, Kim G.

N1 - Funding Information: The SCOPE-CLI research consortium acknowledge the patient and physician expert members, who have advised us throughout the planning, design, and implementation of the study. Dr. Smolderen had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the sponsors. All manuscripts for the SCOPE-CLI study are prepared by independent authors who are not governed by the funding sponsors and are reviewed by an academic publications committee before submission. The funding organizations and sponsors of the study had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the article; and decision to submit the article for publication. SCOPE-CLI is supported by research grants from Abbott Laboratories, W. L. Gore & Associates, Inc. Terumo Corporation, Boston Scientific Corporation, and Janssen Pharmaceutical Companies of Johnson&Johnson. Dr. Smolderen reports unrestricted research grants from Cardiva Medical Inc. W. L. Gore & Associates, Inc. Abbott Laboratories, Merck & Co. Inc. and Janssen Pharmaceutical Companies of Johnson&Johnson. She is a consultant for Optum Labs, Inc. and Abbott Laboratories. Dr. Mena-Hurtado is a consultant for Abbott Laboratories, Boston Scientific Corporation, Cook Medical, Inc. Medtronic, Inc. Cardinal Health, Inc. Optum Labs, Inc. Dr. Shishehbor is a global advisor for Medtronic, Inc. Abbott Laboratories, Terumo Corporation, Boston Scientific Corporation, VentureMed, and Phillips. Dr. Spertus is a consultant to Bayer, Jannsen, Merck, Myokardia, Novartis, Terumo and United Healthcare; he receives grant support from Janssen and Myokadia; he holds the copyright to the PAQ, KCCQ and SAQ and serves on the Board of Blue Cross/Blue Shield of Kansas City. Dr. Humphries is a speaker for Gore, Convatec, and Shockwave. The other authors have no disclosures. Funding Information: Dr. Smolderen reports unrestricted research grants from Cardiva Medical Inc., W. L. Gore & Associates, Inc. , Abbott Laboratories, Merck & Co., Inc., and Janssen Pharmaceutical Companies of Johnson&Johnson . She is a consultant for Optum Labs, Inc., and Abbott Laboratories. Dr. Mena-Hurtado is a consultant for Abbott Laboratories, Boston Scientific Corporation, Cook Medical, Inc., Medtronic, Inc., Cardinal Health, Inc., Optum Labs, Inc. Dr. Shishehbor is a global advisor for Medtronic, Inc., Abbott Laboratories, Terumo Corporation, Boston Scientific Corporation, VentureMed, and Phillips. Dr. Spertus is a consultant to Bayer, Jannsen, Merck, Myokardia, Novartis, Terumo and United Healthcare; he receives grant support from Janssen and Myokadia; he holds the copyright to the PAQ, KCCQ and SAQ and serves on the Board of Blue Cross/Blue Shield of Kansas City. Dr. Humphries is a speaker for Gore, Convatec, and Shockwave. The other authors have no disclosures. Publisher Copyright: © 2022

PY - 2022/4

Y1 - 2022/4

N2 - Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients’ preferences, or outcomes, as seen from patients’ perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes. ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

AB - Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients’ preferences, or outcomes, as seen from patients’ perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes. ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

KW - Critical Limb Ischemia

KW - Health Disparities

KW - Patient-Reported Outcomes

KW - Peripheral Artery Disease

KW - Registries

KW - Study Design

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UR - http://www.scopus.com/inward/citedby.url?scp=85124397223&partnerID=8YFLogxK

U2 - 10.1016/j.ijcha.2022.100971

DO - 10.1016/j.ijcha.2022.100971

M3 - Article

C2 - 35198727

AN - SCOPUS:85124397223

SN - 2352-9067

VL - 39

JO - IJC Heart and Vasculature

JF - IJC Heart and Vasculature

M1 - 100971

ER -

The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

Publisher link

Find It

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