Does study simply replicate others or offer something new?
Method
Is study design appropriate?
qualitative/quantitative
observational/experimental
retrospective/prospective
longitudinal/cross-sectional
Instruments
Are they appropriate to concepts?
Have they been validated in practice?
Subjects
Recruitment
Are study and control groups equally matched?
Age/sex/class
Were they recruited in the same way?
Sensible inclusions, clear criteria?
Do exclusions influence applicability?
Subjects studied in “real life” circumstances?
Design
Are the intervention and comparison clear?
Are outcome criteria defined?
What was actually measured or done? (Beware surrogate markers)
Is sample size sufficient? (To indicate clinical and statistical significance) was “power” calculated? b-error = no effect seen when one exists -due to small sample size a-error = significant effect due to sampling error
Is randomsation/allocation described? Is it concealed?
Was assessment blind?
Remember biases
selection/inclusion
performance
exclusion
detection
Follow up – were completeness and duration OK?
Results
Consider drop outs/exclusions (analysis by intention to treat?)
Are tables and graphs honest?
Are statistics appropriate? – CI’s, p-values.
Is clinical significance achieved?
Were all subjects accounted for at the conclusion of the study?
Discussion
Aware of methodological/design limitations?
Conclusions justified?
Compare with previous work?
Are speculations appropriate and realistic?
Application of findings
Are the patients comparable to your own?
Is the setting comparable?
Are the results clinically significant?
Is the intervention feasible in your own practice setting?
