The criteria for assessment of such an article include:
• Is the trials design valid and powered to achieve a result? It seems doubtful in this case but a large effect in a specific group may be detected.
• Was the hypothesis based on valid evidence?
• Were all the entered patients accounted for?
• Were the groups equivalent after randomisation?
• Was there proper blinding of study personnel?
• Apart from the experimental intervention were the groups treated equivalently?
• Was the statistical analysis appropriate?
• How large was the treatment affect?
• Can the results be applied to my patients?
Though not owrd-for-word identical, this question closely resembles Question 8 from the second paper of 2012, as well as Question 8 from the first paper of 2004. It discusses the assessment of the validity of a randomised controlled trial, which is discussed in greater detail elsewhere.
The answer is reproduced below, to simplify revision and damage SEO:
Is the premise sound?
- Is the primary hypothesis biologically plausible?
- Is the research ethical?
- If the results are valid, are there any disastrous logistical ethical or financial emplications to a change in practice?
Is the methodology of high quality?
- Were the inclusion/exclusion criteria appropriate?
- Was the assignment of patients to treatments randomised? If yes, then was it truly random?
- Were the study groups homogenous?
- Were the groups treated equally?
- Are there any missing patients? Is every enrolled patient accounted for?
- Was follow-up complete? Is the drop-out rate explained? Do we know what happened to the dropouts?
Is the reporting of an appropriate quality?
- Methods describtion should be complete: the trial should be reproduceable
- Do the results have confidence intervals?
- Results should present relative and absolute effect sizes
- Is a CONSORT-style flow diagram of patient selection available?
- Discussion should contain limitation, bias and imprecision
- Funding sources and the full trial protocol should be disclosed
Are the results of the study valid?
- Was there blinding? Was blinding even possible? Was it double-blind? If not, at least were the data interpreters and statisticians blinded?
- Was there allocation concealment?
- Was there intention-to-treat analysis?
- If there were sub-groups, were they identified a priori?
What were the results?
- How large was the treatment effect?
- How precisely was the effect estimated? (i.e. what was the 95% confidence interval)
Is this study helpful for me?
- Is this applicable to my patient? i.e. would my patient have been enrolled in this study?
- Does the population studied correspond with the population to which my patient belongs?
- Were all the clinically meaningful outcomes considered?
- Does the benefit outweigh the cost and risk?