Questions | BMI | Weight | Adverse events (serious adverse events / adverse events causing discontinuation of trial) | Health‐related quality of life | All‐cause mortality | Morbidity | Socioeconomic effects | |
Trial limitations (risk of bias)a | 1. Was random sequence generation used (i.e. no potential for selection bias)? | Yes | Yes | Yes / Yes | N/A | N/A | N/A | N/A |
2. Was allocation concealment used (i.e. no potential for selection bias)? | Yes | Yes | Yes / Yes | |||||
3. Was there blinding of participants and personnel (i.e. no potential for performance bias)? | Yes | Yes | Yes / Yes | |||||
4. Was there blinding of outcome assessment (i.e. no potential for detection bias)? | Yes | Yes | Yes / Yes | |||||
5. Was an objective outcome used? | Yes | Yes | Yes / Yes | |||||
6. Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e | Yes | Yes | Yes / No (↓) | |||||
7. Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? | Yes | Yes | No (↓) / No (↓) | |||||
8. No other biases reported (i.e. no potential of other bias)? | No (↓) | No (↓) | Unclear / Unclear | |||||
9. Did the trials end up as scheduled (i.e. not stopped early)? | Yes | Yes | Yes / Yes | |||||
Inconsistencyb | 1. Point estimates did not vary widely? | Yes | Yes | Yes / Yes | ||||
2. To what extent did confidence intervals overlap (substantial: all confidence intervals overlap at least one of the included studies point estimate; some: confidence intervals overlap but not all overlap at least one point estimate; no: at least one outlier: where the confidence interval of some of the studies do not overlap with those of most included studies)? | Some | Some | Substantial / Substantial | |||||
3. Was the direction of effect consistent? | No (↓) | No (↓) | No (↓) / No (↓) | |||||
4. What was the magnitude of statistical heterogeneity (as measured by I2) ‐ low (I2 < 40%), moderate (I2 = 40% to 60%), high (I2 > 60%)? | High (↓) | High (↓) | Low / Low | |||||
5. Was the test for heterogeneity statistically significant (P < 0.1)? | Statistically significant (↓) | Statistically significant (↓) | Not statistically significant / Not statistically significant | |||||
Indirectnessa | 1. Were the populations in included studies applicable to the decision context? | Applicable | Applicable | Applicable / Applicable | ||||
2. Were the interventions in the included studies applicable to the decision context? | Applicable | Applicable | Applicable / Applicable | |||||
3. Was the included outcome not a surrogate outcome? | Yes | Yes | Yes / Yes | |||||
4. Was the outcome time frame sufficient? | Sufficient | Sufficient | Sufficient / Sufficient | |||||
5. Were the conclusions based on direct comparisons? | Yes | Yes | Yes / Yes | |||||
Imprecisionc | 1. Was the confidence interval for the pooled estimate not consistent with benefit and harm? | Yes | Yes | No (↓) / No (↓) | ||||
2. What is the magnitude of the median sample size (high: > 300 participants, intermediate: 100 to 300 participants, low: < 100 participants)?e | Low (↓) | Low (↓) | Intermediate / Low (↓) | |||||
3. What was the magnitude of the number of included studies (large: > 10 studies, moderate: 5 to 10 studies, small: < 5 studies)?e | Large | Large | Moderate / Moderate | |||||
4. Was the outcome a common event (e.g. occurs more than 1/100)? | N/A | N/A | Yes / Yes | |||||
Publication biasd | 1. Was a comprehensive search conducted? | Yes | Yes | Yes / Yes | ||||
2. Was grey literature searched? | No (↓) | No (↓) | No (↓) / No (↓) | |||||
3. Were no restrictions applied to study selection on the basis of language? | Yes | Yes | Yes / Yes | |||||
4. There was no industry influence on studies included in the review? | No (↓) | No (↓) | No (↓) / No (↓) | |||||
5. There was no evidence of funnel plot asymmetry? | No (↓) | No (↓) | Unclear / Unclear | |||||
6. There was no discrepancy in findings between published and unpublished trials? | Unclear | Unclear | Unclear / Unclear | |||||
aQuestions on risk of bias are answered in relation to most of the aggregated evidence in the meta‐analysis rather than to individual studies.
bQuestions on inconsistency are primarily based on visual assessment of forest plots and the statistical quantification of heterogeneity based on I2 statistic. cWhen judging the width of the confidence interval it is recommended to use a clinical decision threshold to assess whether the imprecision is clinically meaningful. dQuestions address comprehensiveness of the search strategy, industry influence, funnel plot asymmetry and discrepancies between published and unpublished trials. eDepends on the context of the systematic review area. (↓): key item for potential downgrading the certainty of the evidence (GRADE) as shown in the footnotes of the 'Summary of finding' table. BMI: body mass index; N/A: not applicable. |