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. 2016 Jan 21;2016(1):CD011281. doi: 10.1002/14651858.CD011281.pub2
'Summary of findings' tables outcome measures (for both insulin lispro and insulin aspart) All‐cause mortality Hypoglycaemic episodes Morbidity Adverse events other than hypoglycaemic episodes Time to resolution of diabetic ketoacidosis Patient satisfaction Socioeconomic effects (length of hospital stay)
Trial limitations
 (risk of bias)a Was random sequence generation used (i.e. no potential for selection bias)? Unclear Yes/unclear N/A N/I Unclear N/I Yes/unclear
Was allocation concealment used (i.e. no potential for selection bias)? Unclear Unclear Unclear Unclear
Was there blinding of participants and personnel (i.e. no potential for performance bias)? No No (↓) No (↓) No (↓)
Was there blinding of outcome assessment (i.e. no potential for detection bias)? Unclear Unclear Unclear No (↓)
Was an objective outcome used? Yes Yes Yes Yes
Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e Yes Yes Yes Yes
Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? Yes Yes Unclear Yes
No other biases reported (i.e. no potential for other bias)? Yes Yes Yes Yes
Did the trials end as scheduled (i.e. not stopped early)? Yes No Yes Yes
Inconsistencyb Point estimates did not vary widely? N/A Yesf Yesf Yesf
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 interval of some of the studies does not overlap with those of most included studies)? N/A Substantialf Substantialf Substantialf
Was the direction of effect consistent? Yes Yesf No (↓)f Yesf
What was the magnitude of statistical heterogeneity (as measured by I²): low (I² < 40%), moderate (I² 40% ‐ 60%), high (I² > 60%)? N/A Lowf High (↓)f Lowf
Was the test for heterogeneity statistically significant (P < 0.1)? N/A Not statistically significantf Not statistically significantf Not statistically significantf
Indirectnessa Were the populations in the included studies applicable to the decision context? 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
Was the included outcome not a surrogate outcome? Yes Yes Yes Yes
Was the outcome time frame sufficient? Sufficient Sufficient Sufficient Sufficient
Were the conclusions based on direct comparisons? Yes Yes Yes Yes
Imprecisionc Was the confidence interval for the pooled estimate not consistent with benefit and harm? N/A No (↓)f No (↓)f No (↓)f
What is the magnitude of the median sample size (high: 300 participants, intermediate: 100‐300 participants, low: < 100 participants)?e Intermediateg Intermediateg Low (↓) Low (↓)
What was the magnitude of the number of included studies (large: > 10 studies, moderate: 5‐10 studies, small: < 5 studies)?e Small (↓) Small (↓) Small (↓) Small (↓)
Was the outcome a common event (e.g. occurs more than 1/100)? N/A Yes N/A N/A
Publication biasd Was a comprehensive search conducted? Yes Yes Yes Yes
Was grey literature searched? No (↓) No (↓) No (↓) No (↓)
Were no restrictions applied to study selection on the basis of language? Yes Yes Yes Yes
There was no industry influence on studies included in the review? No (↓) No (↓) No (↓) No (↓)
There was no evidence of funnel plot asymmetry? N/A Unclear Unclear Unclear
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 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
fN/A for insulin aspart
gLow for insulin aspart
(↓): key item for possible downgrading the quality of the evidence (GRADE) as shown in the footnotes of the 'Summary of findings' table(s)
 GRADE: Grading of Recommendations Assessment, Development and Evaluation; N/A: not applicable; N/I: not investigated