Skip to main content
. 2019 Dec 3;2019(12):CD008558. doi: 10.1002/14651858.CD008558.pub2
Items (1) All‐cause mortality (2) Incidence of type 2 diabetes mellitus (3) Serious adverse events (4) Cardiovascular mortality (5) Non‐fatal myocardial infarction/stroke (6) Health‐related quality of life (7) Socioeconomic effects
Trial limitations
 (risk of bias)a Was random sequence generation used (i.e. no potential for selection bias)? Unclear Unclear Unclear Unclear Unclear Yes Unclear
Was allocation concealment used (i.e. no potential for selection bias)? Unclear Unclear Unclear Unclear Unclear Yes Unclear
Was there blinding of participants and personnel (i.e. no potential for performance bias) or outcome not likely to be influenced by lack of blinding? Yes Yes Yes Yes Yes No (↓) Yes
Was there blinding of outcome assessment (i.e. no potential for detection bias) or was outcome measurement not likely to be influenced by lack of blinding? Yes Yes Yes Yes Yes No (↓) Yes
Was an objective outcome used? Yes Yes Yes Yes Yes No (↓) Yes
Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e Yes Yes Unclear Yes Yes Yes Yes
Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? Unclear Unclear No (↓) Unclear Unclear Unclear Yes
No other biases reported (i.e. no potential of other bias)? Yes Yes Yes Yes Yes Yes Yes
Did the trials end up as scheduled (i.e. not stopped early)? No (↓) No (↓) No (↓) No (↓) No (↓) No (↓) No (↓)
Inconsistencyb Point estimates did not vary widely? Yes Yes Not applicable Not applicable Not applicable Not applicable Not applicable
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)? Substantial Substantial
Was the direction of effect consistent? No (↓) Yes
What was the magnitude of statistical heterogeneity (as measured by I²) ‐ low (I²< 40%), moderate (I² 40% to 60%), high I² > 60%)? Low Moderate
Was the test for heterogeneity statistically significant (P < 0.1)? Not statistically significant Statistically significant (↓)
Indirectness Were the populations in included studies applicable to the decision context? Highly applicable Highly applicable Highly applicable Highly applicable Highly applicable Highly applicable Highly applicable
Were the interventions in the included studies applicable to the decision context? Highly applicable Highly applicable Highly applicable Highly applicable Highly applicable Highly applicable Highly applicable
Was the included outcome not a surrogate outcome? Yes Yes Yes Yes Yes Yes Yes
Was the outcome timeframe sufficient? Sufficient Sufficient Sufficient Sufficient Sufficient Sufficient Sufficient
Were the conclusions based on direct comparisons? Yes Yes Yes Yes Yes Yes Yes
Imprecisionc Was the confidence interval for the pooled estimate not consistent with benefit and harm? No (↓) Yes Not applicable Not applicable Not applicable N/A N/A
What is the magnitude of the median sample size (high: 300 participants, intermediate: 100 to 300 participants, low: < 100 participants)?e High High High High
What was the magnitude of the number of included studies (large: >10 studies, moderate: 5 to 10 studies, small: < 5 studies)?e Moderate Large Small (↓) Small (↓)
Was the outcome a common event (e.g. occurs more than 1/100)? No (↓) Yes Not applicable Not applicable
Publication biasd Was a comprehensive search conducted? Yes Yes Yes Yes Yes Yes Yes
Was grey literature searched? Yes Yes Yes Yes Yes Yes Yes
Were no restrictions applied to study selection on the basis of language? Yes Yes Yes Yes Yes Yes Yes
There was no industry influence on studies included in the review? Yes Yes Yes Yes Yes Yes Yes
There was no evidence of funnel plot asymmetry? Not applicable Unclear Not applicable Not applicable Not applicable Not applicable Not applicable
There was no discrepancy in findings between published and unpublished trials? Unclear Unclear Unclear Unclear Unclear Unclear Unclear
aQuestions on risk of bias are answered in relation to the majority of the aggregated evidence in the meta‐analysis rather than to individual trials
 bQuestions on inconsistency are primarily based on visual assessment of forest plots and the statistical quantification of heterogeneity based on I²
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 quality of the evidence (GRADE) as shown in the footnotes of the 'Summary of finding' table(s); GRADE: Grading of Recommendations Assessment, Development and Evaluation.