Quality assessment of trials

appropriate and clearly focused questionyesYesyes
method of randomisationnot describednot describeddescribed, adequate
allocation concealednot reportednot reportedunclear
participants blindednonot reportedno
outcome assessors blindednonot reportedno
all relevant outcomes measured in standard, valid, reliable wayyesnot reportedyes
proportion of participants excluded / lost to follow-up4 patients withdrew consent after randomisation and received no study medication; 1 received medication but provided no outcome measures; 49 were excluded for major protocol violations; no further detailsnot reported18, 16 and 17 in morning detemir, evening detemir and evening NPH groups, reasons listed, no significant difference between groups
handling of missing datanot reportednot reportedlast observation carried forward
intention-to-treat analysis performedyesnot reportedyes
statistical analysis appropriateyesnot reportedyes, non-inferiority analysis
only difference between groups is treatment under investigationyesYesyes
results in multi-centre studies comparable for all sitesnot reportednot reportednot reported
groups comparable at baselineyesYesyes
How well was study done to minimise bias: (++ / + / −)(−)unclear, abstract only(+)
What is the likely direction in which bias might affect study results?positive effects of study drug exaggerated
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?probablyyes
Are the results of this study directly applicable to the patient group targeted by this guideline?no (Asian patients only)yes

From: 6.3 Appendix 3, Evidence tables for included studies

Cover of Type 2 Diabetes
Type 2 Diabetes: Newer Agents for Blood Glucose Control in Type 2 Diabetes.
NICE Clinical Guidelines, No. 87.
Centre for Clinical Practice at NICE (UK).
Copyright © 2009, National Institute for Health and Clinical Excellence.

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