Summary of findings for the main comparison. Lifestyle intervention versus usual care compared to placebo for weight reduction in obesity to improve survival in women with endometrial cancer.
| Lifestyle intervention versus usual care compared to placebo for weight reduction in obesity to improve survival in women with endometrial cancer | ||||||
| Patient or population: weight reduction in obesity to improve survival in women with endometrial cancer Setting: university hospitals in the USA Intervention: Lifestyle intervention versus. usual care Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with Lifestyle intervention versus. usual care | |||||
| Overall survival (24 months) (Number of deaths from any cause) |
100 per 1000 | 23 per 1000 (1 to 455) | RR 0.23 (0.01 to 4.55) | 37 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 3 4 | Risk ratio for mortality calculated |
| Adverse events‐musculoskeletal (Number of musculoskeletal adverse events reported) |
0 per 1000 | 0 per 1000 (0 to 0) | RR 19.03 (1.17 to 310.52) | 91 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 5 6 7 | Unable to calculate assumed and corresponding risk as no events in control groups |
| Recurrence‐free survival (24 months) (Number of cases of disease recurrence or death) |
See comment | See comment | ‐ | ‐ | ‐ | No RCTs reported this outcome |
| Cancer‐specific survival (24 months) (Number of cancer‐related deaths) |
See comment | See comment | not estimable | 37 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 3 8 | Unable to calculate risk ratio for mortality as no cancer related deaths reported in either arm of the study |
| Weight loss (12 months) (Change in weight from baseline in kg; positive values = weight gain, negative values = weight lost) |
The mean weight loss (12 months) was + 1.5kg12 | MD 8.98 lower (19.88 lower to 1.92 higher) | ‐ | 91 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 2 9 10 | |
| Cardiovascular and metabolic event frequency (12 months) (Number of strokes, myocardial infarctions and hospitalisations for heart failure) |
See comment | See comment | ‐ | 93 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 1 2 8 9 | Unable to perform meta‐analysis as no events recorded in any study |
| Quality of life FACT‐G (12 months) (Change in QOL on FACT‐G questionnaire from baseline; positive values = improved QOL, negative values = worsening QOL) |
The mean quality of life FACT‐G (12 months) ranged from 0 to + 2 units13 | MD 2.77 units higher (0.65 lower to 6.20 higher) | ‐ | 89 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 9 11 | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; RR: Risk ratio; | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Although participants, personnel and outcome assessors were not blinded to treatment group allocation this is unlikely to affect this specific outcome measure
2 Downgraded by one point as included study at high risk of attrition bias due to incomplete outcome reporting
3 Downgraded by one point due to indirect results (included study contained two patients who, in addition to receiving the intervention, underwent gastric bypass during follow‐up and were included in the final analysis)
4 Downgraded by one point due to imprecision as low event number in included study and wide confidence intervals
5 Downgraded by one point as two of the included studies were at high risk of attrition bias due to incomplete outcome reporting
6 Downgraded by one point due to imprecision as no events in control arms of included studies and wide confidence intervals
7 One of the included studies contained two patients who, in addition to receiving the intervention, had undergone gastric bypass during follow‐up. This was not felt to impact on the number of adverse musculoskeletal events experienced and, therefore, the study was not downgraded for this reason.
8 Downgraded by one point due to imprecision as no events in any study
9 Downgraded by one point due to indirect results (one of the included studies contained one patient, who by this time, had undergone a gastric bypass in addition to receiving the specific study intervention and was included in the final analysis)
10 Downgraded by one point due to imprecision as wide confidence intervals in all included studies, which cross the line of unity
11 Downgraded by one point due to high risk of performance and detection bias in all included studies. Participants, personnel and outcome assessors were unblinded to treatment group allocation, which may have affected the subjective results
12The assumed (control) risk is the median weight change from baseline among the control groups in the included studies
13The assumed (control) risk is the range of scores for change in QOL from baseline at 12 months in the control groups from the included studies, presented in preference to the median change score due to significant variation