Categorisation of the Fragility and Reverse Fragility Index according to randomised controlled trial design, sample size, compliance assessment method and primary outcomes (n, median and IQR)
| N | Fragility Index | P-value | Reverse Fragility Index | P-value | |
| Masking | |||||
| Single blind | 21 | 4.0 (2.5–10.5) | 0.38* | 7.0 (3.3–15.3) | 0.68* |
| Open label | 24 | 7.0 (4.0–12.0) | 7.0 (6.0–10.5) | ||
| Not reported | 2 | CNC | 10.5 (0.3–11.8) | ||
| Outcome categorisation | |||||
| Perinatal outcomes | 4 | 4.0 (3.0–21.5) | 0.34* | 7.0 (7.0–7.0) | 0.98* |
| Outcomes related to the MetS and DM | 15 | 11.5 (7.8–17.0) | 6.0 (2.5–7.5) | ||
| Cardiovascular outcomes | 16 | 5.0 (3.8–8.3) | 10.5 (7.0–17.3) | ||
| Outcomes related to NAFLD | 3 | 1.0 (1.0–1.0) | 4.0 (2.5–5.5) | ||
| Other† | 9 | 5.0 (4.3–7.0) | 16.0 (13.0–28.0) | ||
| Composite outcome | |||||
| Yes‡ | 15 | 6.0 (4.0–16.8) | 0.29§ | 7.0 (7.0–7.0) | 0.85§ |
| No¶ | 32 | 5.0 (3.3–8.5) | 7.0 (3.3–13.8) | ||
| Sample size | |||||
| <1000 patients | 20 | 5.0 (4.0–7.0) | 0.64§ | 7.0 (2.0–13.0) | 0.57§ |
| ≥1000 patients | 27 | 7.0 (3.5–12.5) | 7.0 (6.0–14.8) | ||
| Dietary compliance assessment methods | |||||
| Questionnaires (FFQs, diet scores)/diet history | 22 | 5.0 (2.3–10.8) | 0.59* | 7.0 (6.3–13.0) | 0.035* |
| Diet recalls or records | 7 | 4.5 (3.3–11.8) | 2.0 (1.5–2.5) | ||
| Biomarkers | 18 | 6.0 (4.0–11.0) | 11.0 (6.0–27.3) |
*Based on the Kruskal-Wallis test.
†First incidence of breast cancer, cataract surgery, osteoporotic fractures, return to robustness, depression.
‡Maternal/offspring composite outcome, incidence of metabolic syndrome (MetS), cardiovascular (CV) mortality, composite CV events, optimal CV risk factor control, total cardiac events, total outcome endpoints.
§Based on the Mann-Whitney U test.
¶incidence of gestational diabetes mellitus (GDM), atrial fibrillation, heart failure, type 2 diabetes mellitus (T2DM), depression, first invasive breast cancer, steatosis, non-fatal myocardial infarction, cataract surgery, diabetic retinopathy, osteoporotic fractures, need for T2DM medication, reversion to robustness, weight loss, non-alcoholic fatty liver disease (NAFLD) resolution, new symptomatic periphery artery disease cases, reversion of MetS.
CNC, could not be calculated; DM, diabetes mellitus; FFQ, food frequency questionnaire; ;IQR, interquartile range.