Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies
Introduction The aim of the study was to develop and validate a clinical prediction rule (CPR) for foot ulceration in people with diabetes.Research design and methods Development of a CPR using individual participant data from four international cohort studies identified by systematic review, with v...
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2021-03-01
|
| Series: | BMJ Open Diabetes Research & Care |
| Online Access: | https://drc.bmj.com/content/9/1/e002150.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850123738290323456 |
|---|---|
| author | David Weller Francesca M Chappell Richard D Riley Angela Martin Matilde Monteiro-Soares Margaret Horne Graham P Leese Fay Crawford Andrew J M Boulton Caroline Abbott Aristidis Veves |
| author_facet | David Weller Francesca M Chappell Richard D Riley Angela Martin Matilde Monteiro-Soares Margaret Horne Graham P Leese Fay Crawford Andrew J M Boulton Caroline Abbott Aristidis Veves |
| author_sort | David Weller |
| collection | DOAJ |
| description | Introduction The aim of the study was to develop and validate a clinical prediction rule (CPR) for foot ulceration in people with diabetes.Research design and methods Development of a CPR using individual participant data from four international cohort studies identified by systematic review, with validation in a fifth study. Development cohorts were from primary and secondary care foot clinics in Europe and the USA (n=8255, adults over 18 years old, with diabetes, ulcer free at recruitment). Using data from monofilament testing, presence/absence of pulses, and participant history of previous ulcer and/or amputation, we developed a simple CPR to predict who will develop a foot ulcer within 2 years of initial assessment and validated it in a fifth study (n=3324). The CPR’s performance was assessed with C-statistics, calibration slopes, calibration-in-the-large, and a net benefit analysis.Results CPR scores of 0, 1, 2, 3, and 4 had a risk of ulcer within 2 years of 2.4% (95% CI 1.5% to 3.9%), 6.0% (95% CI 3.5% to 9.5%), 14.0% (95% CI 8.5% to 21.3%), 29.2% (95% CI 19.2% to 41.0%), and 51.1% (95% CI 37.9% to 64.1%), respectively. In the validation dataset, calibration-in-the-large was −0.374 (95% CI −0.561 to −0.187) and calibration slope 1.139 (95% CI 0.994 to 1.283). The C-statistic was 0.829 (95% CI 0.790 to 0.868). The net benefit analysis suggested that people with a CPR score of 1 or more (risk of ulceration 6.0% or more) should be referred for treatment.Conclusion The clinical prediction rule is simple, using routinely obtained data, and could help prevent foot ulcers by redirecting care to patients with scores of 1 or above. It has been validated in a community setting, and requires further validation in secondary care settings. |
| format | Article |
| id | doaj-art-1265fe7426da4b6384496e5944f04df2 |
| institution | OA Journals |
| issn | 2052-4897 |
| language | English |
| publishDate | 2021-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Diabetes Research & Care |
| spelling | doaj-art-1265fe7426da4b6384496e5944f04df22025-08-20T02:34:32ZengBMJ Publishing GroupBMJ Open Diabetes Research & Care2052-48972021-03-019110.1136/bmjdrc-2021-002150Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studiesDavid Weller0Francesca M Chappell1Richard D Riley2Angela Martin3Matilde Monteiro-Soares4Margaret Horne5Graham P Leese6Fay Crawford7Andrew J M Boulton8Caroline Abbott9Aristidis Veves10Usher Institute, The University of Edinburgh, Edinburgh, UKUK Dementia Research Institute at the University of Edinburgh, Edinburgh, UKsenior lecturer in medical statistics6 Victoria Hospital, NHS Fife, Kirkcaldy, UK4 Escola Superior de Saúde da Cruz Vermelha Portuguesa, Cruz Vermelha Portuguesa, Lisbon, Portugal4 Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK9 Department of Medicine, Ninewells Hospital and Medical School, Dundee, UK2 The School of Medicine, University of St Andrews, St Andrews, Fife, UK8 Division of Diabetes, Endocrinology and Gastroenterology, University of Manchester & Manchester Royal Infirmary, Manchester, UK10 Manchester Metropolitan University, Manchester, Greater Manchester, UK12 Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USAIntroduction The aim of the study was to develop and validate a clinical prediction rule (CPR) for foot ulceration in people with diabetes.Research design and methods Development of a CPR using individual participant data from four international cohort studies identified by systematic review, with validation in a fifth study. Development cohorts were from primary and secondary care foot clinics in Europe and the USA (n=8255, adults over 18 years old, with diabetes, ulcer free at recruitment). Using data from monofilament testing, presence/absence of pulses, and participant history of previous ulcer and/or amputation, we developed a simple CPR to predict who will develop a foot ulcer within 2 years of initial assessment and validated it in a fifth study (n=3324). The CPR’s performance was assessed with C-statistics, calibration slopes, calibration-in-the-large, and a net benefit analysis.Results CPR scores of 0, 1, 2, 3, and 4 had a risk of ulcer within 2 years of 2.4% (95% CI 1.5% to 3.9%), 6.0% (95% CI 3.5% to 9.5%), 14.0% (95% CI 8.5% to 21.3%), 29.2% (95% CI 19.2% to 41.0%), and 51.1% (95% CI 37.9% to 64.1%), respectively. In the validation dataset, calibration-in-the-large was −0.374 (95% CI −0.561 to −0.187) and calibration slope 1.139 (95% CI 0.994 to 1.283). The C-statistic was 0.829 (95% CI 0.790 to 0.868). The net benefit analysis suggested that people with a CPR score of 1 or more (risk of ulceration 6.0% or more) should be referred for treatment.Conclusion The clinical prediction rule is simple, using routinely obtained data, and could help prevent foot ulcers by redirecting care to patients with scores of 1 or above. It has been validated in a community setting, and requires further validation in secondary care settings.https://drc.bmj.com/content/9/1/e002150.full |
| spellingShingle | David Weller Francesca M Chappell Richard D Riley Angela Martin Matilde Monteiro-Soares Margaret Horne Graham P Leese Fay Crawford Andrew J M Boulton Caroline Abbott Aristidis Veves Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies BMJ Open Diabetes Research & Care |
| title | Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies |
| title_full | Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies |
| title_fullStr | Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies |
| title_full_unstemmed | Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies |
| title_short | Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies |
| title_sort | development and validation of a clinical prediction rule for development of diabetic foot ulceration an analysis of data from five cohort studies |
| url | https://drc.bmj.com/content/9/1/e002150.full |
| work_keys_str_mv | AT davidweller developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT francescamchappell developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT richarddriley developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT angelamartin developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT matildemonteirosoares developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT margarethorne developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT grahampleese developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT faycrawford developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT andrewjmboulton developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT carolineabbott developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies AT aristidisveves developmentandvalidationofaclinicalpredictionrulefordevelopmentofdiabeticfootulcerationananalysisofdatafromfivecohortstudies |