Chris Bojke, Henrietta Konwea, E. Andrea Nelson, Sarah T. Brown, Colin C. Everett, Angela Oates, Michael Backhouse, Howard Collier, Joanna Dennett, Rachael Gilberts, Benjamin A. Lipsky, Michelle M. Lister, Jane E. Nixon, David Russell, Tim Sloan, Fran Game, the CODIFI2 Investigators
{"title":"CODIFI2随机对照试验中拭子与组织取样治疗感染糖尿病足溃疡的成本-效果","authors":"Chris Bojke, Henrietta Konwea, E. Andrea Nelson, Sarah T. Brown, Colin C. Everett, Angela Oates, Michael Backhouse, Howard Collier, Joanna Dennett, Rachael Gilberts, Benjamin A. Lipsky, Michelle M. Lister, Jane E. Nixon, David Russell, Tim Sloan, Fran Game, the CODIFI2 Investigators","doi":"10.1111/dme.15492","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>To compare the cost-effectiveness of wound swabbing versus tissue sampling for infected diabetic foot ulcers.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This multi-centre, Phase III, prospective, unblinded, two-arm parallel group, randomised controlled trial compared clinical (reported elsewhere) and economic outcomes of swab versus tissue sampling over a 52–104 week period.</p>\n \n <p>Resource use was logged using case record forms and patient questionnaire at weeks 4, 12, 26, 39, 52 and 104, costed using laboratory and published sources from the UK NHS perspective, at 2021/2022 price-year. EQ-5D-3L questionnaires issued at these time points were used to derive quality-adjusted life-years (QALYs).</p>\n \n <p>To account for imbalances such as age, a regression-based approach was used to estimate survival, expected costs and QALYs between the sampling arms. Available case analysis (ACA) and multiple imputation methods were applied for self reported missing data, and ACA for researcher-collected data (survival, hospitalisations and antibiotic use). Probabilistic sensitivity analysis was used to assess the uncertainty of economic results.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>We recruited 149 participants (75 swab, 74 tissue) from 21 UK sites, between 07 May 2019 and 28 April 2022 (last follow-up 28 April 2023). Planned sample size was 730 participants, for 90% power to detect 12.5% difference in healing at 52 weeks, but the trial stopped early due to low recruitment.</p>\n \n <p>Expected QALYs in the swab-sampling arm were greater than in the tissue-sampling arm at weeks 26, 52 and 104.</p>\n \n <p>The cost of tissue sampling was greater than of swabbing when including antibiotics and hospitalisation. Swab sampling participants had higher QALYs and lower costs across weeks 26–52, reducing slightly by week 104.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Because of higher costs, lower QALYs and lack of evidence of benefit, potentially due to the trial being underpowered, tissue sampling was dominated by wound swabbing in the cost-effectiveness analysis.</p>\n </section>\n </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 5","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.15492","citationCount":"0","resultStr":"{\"title\":\"Cost-effectiveness of swab versus tissue sampling for infected diabetic foot ulcers from the CODIFI2 randomised controlled trial\",\"authors\":\"Chris Bojke, Henrietta Konwea, E. Andrea Nelson, Sarah T. Brown, Colin C. 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EQ-5D-3L questionnaires issued at these time points were used to derive quality-adjusted life-years (QALYs).</p>\\n \\n <p>To account for imbalances such as age, a regression-based approach was used to estimate survival, expected costs and QALYs between the sampling arms. Available case analysis (ACA) and multiple imputation methods were applied for self reported missing data, and ACA for researcher-collected data (survival, hospitalisations and antibiotic use). Probabilistic sensitivity analysis was used to assess the uncertainty of economic results.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>We recruited 149 participants (75 swab, 74 tissue) from 21 UK sites, between 07 May 2019 and 28 April 2022 (last follow-up 28 April 2023). 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Swab sampling participants had higher QALYs and lower costs across weeks 26–52, reducing slightly by week 104.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Because of higher costs, lower QALYs and lack of evidence of benefit, potentially due to the trial being underpowered, tissue sampling was dominated by wound swabbing in the cost-effectiveness analysis.</p>\\n </section>\\n </div>\",\"PeriodicalId\":11251,\"journal\":{\"name\":\"Diabetic Medicine\",\"volume\":\"42 5\",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-02-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.15492\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetic Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/dme.15492\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetic Medicine","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/dme.15492","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Cost-effectiveness of swab versus tissue sampling for infected diabetic foot ulcers from the CODIFI2 randomised controlled trial
Aims
To compare the cost-effectiveness of wound swabbing versus tissue sampling for infected diabetic foot ulcers.
Methods
This multi-centre, Phase III, prospective, unblinded, two-arm parallel group, randomised controlled trial compared clinical (reported elsewhere) and economic outcomes of swab versus tissue sampling over a 52–104 week period.
Resource use was logged using case record forms and patient questionnaire at weeks 4, 12, 26, 39, 52 and 104, costed using laboratory and published sources from the UK NHS perspective, at 2021/2022 price-year. EQ-5D-3L questionnaires issued at these time points were used to derive quality-adjusted life-years (QALYs).
To account for imbalances such as age, a regression-based approach was used to estimate survival, expected costs and QALYs between the sampling arms. Available case analysis (ACA) and multiple imputation methods were applied for self reported missing data, and ACA for researcher-collected data (survival, hospitalisations and antibiotic use). Probabilistic sensitivity analysis was used to assess the uncertainty of economic results.
Results
We recruited 149 participants (75 swab, 74 tissue) from 21 UK sites, between 07 May 2019 and 28 April 2022 (last follow-up 28 April 2023). Planned sample size was 730 participants, for 90% power to detect 12.5% difference in healing at 52 weeks, but the trial stopped early due to low recruitment.
Expected QALYs in the swab-sampling arm were greater than in the tissue-sampling arm at weeks 26, 52 and 104.
The cost of tissue sampling was greater than of swabbing when including antibiotics and hospitalisation. Swab sampling participants had higher QALYs and lower costs across weeks 26–52, reducing slightly by week 104.
Conclusions
Because of higher costs, lower QALYs and lack of evidence of benefit, potentially due to the trial being underpowered, tissue sampling was dominated by wound swabbing in the cost-effectiveness analysis.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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