Academic Journal
Fragility of cardiovascular outcome trials (CVOTs) examining nutrition interventions among patients with diabetes mellitus: a systematic review of randomized controlled trials
| العنوان: | Fragility of cardiovascular outcome trials (CVOTs) examining nutrition interventions among patients with diabetes mellitus: a systematic review of randomized controlled trials |
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| المؤلفون: | Taouktsi N., Papageorgiou S.T., Tousinas G., Papanikolopoulou S., Grammatikopoulou M.G., Giannakoulas G., Goulis D.G. |
| المصدر: | Hormones ; https://www.scopus.com/inward/record.uri?eid=2-s2.0-85138525323&doi=10.1007%2fs42000-022-00396-5&partnerID=40&md5=dbbe323cede31cdb03495be369e76c68 |
| سنة النشر: | 2022 |
| المجموعة: | University of Thessaly Institutional Repository / Ιδρυματικό Αποθετήριο Πανεπιστημίου Θεσσαλίας |
| مصطلحات موضوعية: | alpha tocopherol, ascorbic acid, beta carotene, coconut oil, cyanocobalamin, docosahexaenoic acid, folic acid, icosapentaenoic acid, nutrition supplement, omega 3 fatty acid, pyridoxine, thioctic acid, vitamin D, Article, cardiovascular disease, cardiovascular outcome trial, diabetes mellitus, diabetic patient, dietary pattern, dietary supplement, Fisher exact test, fragility index, human, intermethod comparison, Mediterranean diet, nut, nutrition, outcome assessment, randomized controlled trial (topic), reverse fragility index |
| الوصف: | Purpose: There is controversy regarding the optimal statistical method to interpret how robust is a statistically significant result. The fragility index (FI) and the reverse fragility index (RFI) are quantitative measures that can facilitate the appraisal of a clinical trial’s robustness. This study was performed to evaluate the FI and RFI of randomized controlled trials (RCTs) examining nutritional interventions in patients with diabetes mellitus, focusing on cardiovascular outcomes. Methods: A systematic search was conducted and relevant RCTs were identified in three databases. RCTs examining nutritional interventions (supplements or dietary patterns) in patients with DM with dichotomous primary endpoints involving cardiovascular outcomes were eligible. Data were extracted to compose 2 × 2 event tables and the FI and RFI were calculated for each comparison, using Fisher’s exact test. Risk of bias (RoB) of the included RCTs was assessed with the Cochrane RoB 2.0 tool. Results: A total of 14,315 records were screened and 10 RCTs were included in the analyses. The median FI of the paired comparisons was 3 (IQR: 2–4) and the median RFI was 8 (IQR: 4.5–17). RoB and heterogeneity were low. Conclusions: RCTs examining nutritional interventions and cardiovascular outcomes among patients with diabetes mellitus appear to be statistically fragile. Τhe FI and the RFI can be reported and interpreted as an additional perspective of a trial’s robustness. Highlights: • In the evidence-healthcare era, assessing how robust statistically significant results are remains a matter of controversy. • Recently, the fragility index (FI) and reverse fragility index (RFI) were proposed to assess the robustness of randomized controlled trials (RCTs) with 2 × 2 comparisons. • When applying the FI and RFI, RCTs examining nutritional interventions and cardiovascular outcomes among patients with diabetes mellitus (DM) appear to be statistically fragile. • Τhe FI and the RFI can be reported and interpreted as an additional perspective of a ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 11093099 |
| Relation: | http://hdl.handle.net/11615/79609 |
| DOI: | 10.1007/s42000-022-00396-5 |
| الاتاحة: | http://hdl.handle.net/11615/79609 https://doi.org/10.1007/s42000-022-00396-5 |
| رقم الانضمام: | edsbas.336129DB |
| قاعدة البيانات: | BASE |
| تدمد: | 11093099 |
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| DOI: | 10.1007/s42000-022-00396-5 |