Total cholesterol change | ||
Study limitations (risk of bias) | 1. Was random sequence generation used (i.e. no potential for selection bias)? | Yes |
2. Was allocation concealment used (i.e. no potential for selection bias)? | Unclear (half of the studies low risk and the other half unclear) | |
3. Was there blinding of participants and personnel (i.e. no potential for performance bias)? | N/A (not applicable in lifestyle interventions) | |
4. Was there blinding of outcome assessment (i.e. no potential for detection bias)? | No (does not affect objective outcomes) | |
5. Was an objective outcome used? | Yes | |
6. Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?a | Yes | |
7. Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? | Unclear | |
8. No other biases reported (i.e. no potential of other bias)? | Possible risk of attrition bias | |
9. Did the trials end up as scheduled (i.e. not stopped early)? | Yes | |
Inconsistency | 1. Point estimates did not vary widely? | No (some variability) (↓) |
2. To what extent did confidence intervals overlap (substantial: all confidence intervals overlap at least 1 of the included studies point estimate; some: confidence intervals overlap but not all overlap at least 1 point estimate; no: at least 1 outlier, where the confidence intervals of some of the studies do not overlap with those of most included studies)? | Some | |
3. Was the direction of effect consistent? | No (↓) | |
4. What was the magnitude of statistical heterogeneity (as measured by I2) ‐ low (I2 < 40%), moderate (I2 40% to 60%), high (I2 > 60%)? | Low | |
5. Was the test for heterogeneity statistically significant (P < 0.1)? | No | |
Indirectness | 1. Were the populations in included studies applicable to the decision context? | Yes |
2. Were the interventions in the included studies applicable to the decision context? | Yes | |
3. Was the included outcome not a surrogate outcome? | No (however relevant risk factors) | |
4. Was the outcome timeframe sufficient? | Yes | |
5. Were the conclusions based on direct comparisons? | Yes | |
Imprecision | 1. Was the confidence interval for the pooled estimate not consistent with benefit and harm? | No (↓) |
2. What is the magnitude of the median sample size (high: 300 participants, intermediate: 100‐300 participants, low: <100 participants)?a | Intermediate (103 participants) | |
3. What was the magnitude of the number of included studies (large: > 10 studies, moderate: 5 to 10 studies, small: < 5 studies)?a | Moderate | |
4. Was the outcome a common event (e.g. occurs more than 1/100)? | N/A | |
Publication bias | 1. Was a comprehensive search conducted? | Yes |
2. Was grey literature searched? | No | |
3. Were no restrictions applied to study selection on the basis of language? | No | |
4. There was no industry influence on studies included in the review? | Some industry support but all declared | |
5. There was no evidence of funnel plot asymmetry? | N/A | |
6. There was no discrepancy in findings between published and unpublished trials? | N/A | |
aDepends 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 findings' table(s); N/A: not applicable |