Critical appraisal of clinical trials

Question 1

Levels of evidence

Answer 1

1. Systematic reviews and meta-analyses (cochrane)
2. RCT w/ definite results
3. RCT w/ non-definite results
4. Cohort studies
5. Case-control studies
6. Cross-sectional studies
7. Case series/reports, personal opinions

Question 2

Source and authorship of a published paper

Answer 2

Peer-reviewed
Indexed
Impact factor

Authors- qualification and affiliation

Question 3

Components of a published RCT

Answer 3

Title
Authors and affiliations
Abstract
Intro and background
Methods
Results
Discussion
Conclusion

Question 4

STEP

Answer 4

S- safety
T-tolerability
E- efficacy
P- price

Question 5

Holistic approach of evaluating paper

Answer 5

Is study valid?
Are results important?
Are patients similar to study?
Is trial realistic in setting?

Question 6

Checklist for critical evaluation of studies

Answer 6

Patient-reported outcome measures (PROMs)
CONSORT
PRISMA
AGREE
NHMRC

Question 7

Critical evaluation of cohort studies

Answer 7

Prospective or retrospective
Cohort representative of a defined group/population?
Factors identified?
Follow up for sufficient time?

Question 8

Critical evaluation of case-control studies

Answer 8

Clearly defined cases?
Cases represent defined population?
How were controls selected?
Study measures identical to cases and controls?
Objective or subjective study measures?
Bias?

Question 9

Critical evaluation of cross-sectional study

Answer 9

Study sample clearly defined?
Representative sample achieved? (high response rate?)
Factors and outcomes measured accurately?

Question 10

Critical evaluation of a case series/case report

Answer 10

Were cases identified prospectively or retrospectively?
Represent sample similar to patients?
Exposures, factors, and outcomes measured accordingly?