{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T09:32:17Z","timestamp":1773826337561,"version":"3.50.1"},"reference-count":30,"publisher":"American Diabetes Association","issue":"11","license":[{"start":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T00:00:00Z","timestamp":1725580800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/journals\/pages\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,11,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>Diabetes affects 537 million people globally, with 34% expected to develop foot ulceration in their lifetime. Diabetes-related foot ulceration causes strain on health care systems worldwide, necessitating provision of high-quality evidence to guide their management. Given heterogeneity of reported outcomes, a core outcome set (COS) was developed to standardize outcome measures in studies assessing treatments for diabetes-related foot ulceration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>The COS was developed using Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and patient interviews generated a long list of outcomes that were rated by patients and experts using a nine-point Likert scale (from 1 [not important] to 9 [critical]) in the first round of the Delphi survey. Based on predefined criteria, outcomes without consensus were reprioritized in a second Delphi round. Critical outcomes and those without consensus after two Delphi rounds were discussed in the consensus meeting where the COS was ratified.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>The systematic review and patient interviews generated 103 candidate outcomes. The two consecutive Delphi rounds were completed by 336 and 176 respondents, resulting in an overall second round response rate of 52%. Of 37 outcomes discussed in the consensus meeting (22 critical and 15 without consensus after the second round), 8 formed the COS: wound healing, time to healing, new\/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, and mortality.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>The proposed COS for studies assessing treatments for diabetes-related foot ulceration was developed using COMET methodology. Its adoption by the research community will facilitate assessment of comparative effectiveness of current and evolving interventions.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc24-1112","type":"journal-article","created":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T17:11:31Z","timestamp":1725642691000},"page":"1958-1968","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":21,"title":["Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration"],"prefix":"10.2337","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8917-1281","authenticated-orcid":false,"given":"Aleksandra","family":"Staniszewska","sequence":"first","affiliation":[{"name":"1Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K."},{"name":"2North Bristol NHS Trust, Bristol, U.K."}]},{"given":"Frances","family":"Game","sequence":"additional","affiliation":[{"name":"3University Hospitals of Derby and Burton NHS Foundation Trust, Derby, U.K."}]},{"given":"Jane","family":"Nixon","sequence":"additional","affiliation":[{"name":"4Leeds Institute of Health Sciences, University of Leeds, Leeds, U.K."}]},{"given":"David","family":"Russell","sequence":"additional","affiliation":[{"name":"5Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, U.K."}]},{"given":"David G.","family":"Armstrong","sequence":"additional","affiliation":[{"name":"6Southwestern Academic Limb Salvage Alliance, Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA"}]},{"given":"Christopher","family":"Ashmore","sequence":"additional","affiliation":[{"name":"7Faculty of Medicine and Health, University of Leeds, Leeds, U.K."}]},{"given":"Sicco A.","family":"Bus","sequence":"additional","affiliation":[{"name":"8Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Center and University of Amsterdam, Amsterdam, the Netherlands"}]},{"given":"Jayer","family":"Chung","sequence":"additional","affiliation":[{"name":"9Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX"}]},{"given":"Vivienne","family":"Chuter","sequence":"additional","affiliation":[{"name":"10School of Health Sciences, Western Sydney University, Campbelltown, Australia"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3619-9579","authenticated-orcid":false,"given":"Ketan","family":"Dhatariya","sequence":"additional","affiliation":[{"name":"11Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K."},{"name":"12Norwich Medical School, University of East Anglia, Norwich, U.K."}]},{"given":"George","family":"Dovell","sequence":"additional","affiliation":[{"name":"1Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8931-0069","authenticated-orcid":false,"given":"Michael","family":"Edmonds","sequence":"additional","affiliation":[{"name":"13Diabetic Foot Clinic, King\u2019s College Hospital NHS Foundation Trust, London, U.K."}]},{"given":"Robert","family":"Fitridge","sequence":"additional","affiliation":[{"name":"14Discipline of Surgery, The University of Adelaide, Adelaide, Australia"},{"name":"15Vascular and Endovascular Surgery Service, Royal Adelaide Hospital, Adelaide, Australia"}]},{"given":"Catherine","family":"Gooday","sequence":"additional","affiliation":[{"name":"16Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K."}]},{"given":"Emma J.","family":"Hamilton","sequence":"additional","affiliation":[{"name":"17Medical School, University of Western Australia, Murdoch, Australia"},{"name":"18Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Murdoch, Australia"}]},{"given":"Amy","family":"Jones","sequence":"additional","affiliation":[{"name":"2North Bristol NHS Trust, Bristol, U.K."}]},{"given":"Venu","family":"Kavarthapu","sequence":"additional","affiliation":[{"name":"19Department of Trauma and Orthopaedics, King's College Hospital, London, U.K."}]},{"given":"Lawrence A.","family":"Lavery","sequence":"additional","affiliation":[{"name":"20Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX"}]},{"given":"Joseph L.","family":"Mills","sequence":"additional","affiliation":[{"name":"9Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX"}]},{"given":"Matilde","family":"Monteiro-Soares","sequence":"additional","affiliation":[{"name":"21Portuguese Red Cross Health School Lisbon, Lisbon, Portugal"},{"name":"22Cross Investiga\u00e7\u00e3o e Desenvolvimento, Lisbon, Portugal"},{"name":"23Departamento de Medicina da Comunidade Informa\u00e7\u00e3o e Decis\u00e3o em Sa\u00fade, Faculty of Medicine, University of Porto, Porto, Portugal"},{"name":"24Center for Health Technology and Services Research, Faculty of Medicine, University of Porto, Porto, Portugal"}]},{"given":"Maia","family":"Osborne-Grinter","sequence":"additional","affiliation":[{"name":"1Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K."}]},{"given":"Edgar J.G.","family":"Peters","sequence":"additional","affiliation":[{"name":"25Amsterdam Infection & Immunity, Infectious Diseases and Amsterdam Movement Sciences, Rehabilitation and Development, Amsterdam University Medical Center, Amsterdam, the Netherlands"}]},{"given":"Joseph","family":"Shalhoub","sequence":"additional","affiliation":[{"name":"26Imperial Vascular Unit and Department of Surgery & Cancer, Imperial College Healthcare NHS Trust, London, U.K."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6420-6046","authenticated-orcid":false,"given":"Jaap","family":"van Netten","sequence":"additional","affiliation":[{"name":"8Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam University Medical Center and University of Amsterdam, Amsterdam, the Netherlands"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3637-6208","authenticated-orcid":false,"given":"Dane K.","family":"Wukich","sequence":"additional","affiliation":[{"name":"27Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, TX"}]},{"given":"Robert J.","family":"Hinchliffe","sequence":"additional","affiliation":[{"name":"1Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K."},{"name":"2North Bristol NHS Trust, Bristol, U.K."}]}],"member":"1167","published-online":{"date-parts":[[2024,9,6]]},"reference":[{"key":"2024102118512770600_B1","unstructured":"International Diabetes Association\n          . 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