دورية أكاديمية
أعرض في EDS

Application of a decision analytic framework for adoption of clinical trial results: are the data regarding TARGIT-A IORT ready for prime time?

التفاصيل البيبلوغرافية
العنوان: Application of a decision analytic framework for adoption of clinical trial results: are the data regarding TARGIT-A IORT ready for prime time?
المؤلفون: Esserman LJ; University of California, 1600 Divisadero, 2nd Floor, Box1710, San Francisco, CA, 94115, USA, Linda.esserman@ucsfmedctr.org., Alvarado MD, Howe RJ, Mohan AJ, Harrison B, Park C, O'Donoghue C, Ozanne EM
المصدر: Breast cancer research and treatment [Breast Cancer Res Treat] 2014 Apr; Vol. 144 (2), pp. 371-8. Date of Electronic Publication: 2014 Mar 02.
نوع المنشور: Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Kluwer Academic Country of Publication: Netherlands NLM ID: 8111104 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-7217 (Electronic) Linking ISSN: 01676806 NLM ISO Abbreviation: Breast Cancer Res Treat Subsets: MEDLINE
أسماء مطبوعة: Publication: Dordrecht : Kluwer Academic
Original Publication: The Hague ; Boston : M. Nijhoff, c1981-
مواضيع طبية MeSH: Decision Support Techniques*, Breast Neoplasms/*therapy , Randomized Controlled Trials as Topic/*methods, Aged ; Aged, 80 and over ; Animals ; Breast Neoplasms/economics ; Female ; Humans ; Intraoperative Care/economics ; Intraoperative Care/methods ; Markov Chains ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy ; Postmenopause ; Quality of Life ; Radiotherapy, Adjuvant/economics ; Radiotherapy, Adjuvant/methods ; United States
مستخلص: The results from randomized clinical trials are often adopted slowly. This practice potentially prevents many people from benefiting from more effective care. Provide a framework for analyzing clinical trial results to determine whether and when early adoption of novel interventions is appropriate. The framework includes the evaluation of three components: confidence in trial results, impact of early, and late adoption if trial results are reversed or sustained. The adverse impact of early adoption, and the opportunity cost of late adoption are determined using Markov modeling to simulate the impact of early and late adoption in terms of quality of life years and resources gained or lost. We applied the framework to the TARGIT-A randomized clinical trial comparing intraoperative radiation (IORT) to standard external beam radiation (EBRT) and considered these results in the context of trials comparing endocrine therapy with and without radiation therapy in postmenopausal women. Confidence in the TARGIT-A trial 4 year results is high because the peak hazard for local recurrence in the trial is between 2 and 3 years. This is consistent with most trials, and no second peak has been observed in similar patient populations, suggesting that the TARGIT-A trial results are stable. The interventions offer approximately equivalent life expectancy. If IORT local recurrences rate were as high as 10 % at 10 years (which is higher than expected), we would project only 0.002 fewer expected life years (less than 1 day) compared to EBRT if IORT is adopted early. However, there is a $1.7 billion opportunity cost of waiting an additional 5 years to adopt IORT in low risk, hormone-receptor-positive, postmenopausal women. EBRT costs an additional $1467 in indirect costs per patient. Applying an evaluative framework for the adoption of clinical trial results to the TARGIT-A IORT therapy trial results in the assessment that the trial results are stable, early adoption would lead to minimal adverse impact, and substantially less resource use. Both IORT and no radiation are reasonable strategies to adopt.
التعليقات: Comment in: Breast Cancer Res Treat. 2014 Aug;147(1):221-2. (PMID: 25048466)
Comment in: Breast Cancer Res Treat. 2014 Aug;147(1):223-4. (PMID: 25062705)
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معلومات مُعتمدة: 07/60/49 United Kingdom DH_ Department of Health
تواريخ الأحداث: Date Created: 20140304 Date Completed: 20141203 Latest Revision: 20220129
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC3949013
DOI: 10.1007/s10549-014-2881-2
PMID: 24584875
قاعدة البيانات: MEDLINE
الوصف
تدمد:1573-7217
DOI:10.1007/s10549-014-2881-2