RCT Triage/CONSORT

Question 1

Participants

Answer 1

1. Clear description of participants and conclusions aimed at a population similar to participants in the study
   - reveals whether results apply to target population
2. Baseline Data Table
   - reveals whether groups were similar at start of trial

Question 2

Outcome description

Answer 2

Single primary outcome should be identified; conclusions about efficacy should be based on that outcome
- risk of false positive is either alpha (0.05) or alpha times # of outcomes

Question 3

Outcome reporting

Answer 3

1. See if all outcomes have been reported
   - undesired findings may be hidden from reader
2. Results should be presented as absolute numbers, not only percentage
   - percentage can exaggerate impression of efficacy
3. See if confidence intervals have been provided
   - CI indicates medical importance
4. Means in different groups should be compared to each other, not only to baseline within the same group
   - risk of false positive = 50% or higher (results are meaningless)

Question 4

Sample size calculation

Answer 4

1. If they said a calculation was done, look for the four variables as evidence
   - calculation needed for false positive risk (alpha) & false negative risk (beta)
2. Groups used in trial should be at least as large as the calculation
   - tells if the trial is adequately powered or underpowered

Question 5

Randomization

Answer 5

Was the randomization method to produce random sequence truly random? Samples less than 100, did they use restricted randomization?
- helps to distribute confounding variables evenly between groups

Question 6

Allocation Concealment

Answer 6

Third party used to allocate participants into groups or if they used
SNOSE
- prevents visual indicators of health to
place healthier participants in one group

Question 7

Blinding

Answer 7

1. See if the treatments were similar
   - if participants and researchers figure out who received which treatment, hopes and expectations can bias the study
2. See if they said who was blinded, or if they only used vague ‘double-blinded’ terminology
   - participants and primary outcome assessors are most important to blind to reduce chance of hopes and expectations distorting results
3. If blinding was not done, primary outcome should be objective
   - hopes and expectations render results worthless if the primary outcome is subjective

Question 8

Participant flow and losses

Answer 8

Flow chart showing losses from each group, with reasons; losses should be included in intention-to-treat analysis
- reveals any ignored adverse effects
- reveals risk of non-random losses in non-random groups
- reveals if losses have resulted in underpowered trial

Question 9

Interpretation

Answer 9

1. Conclusions should match the data
   - identify and reject exaggerated conclusions
2. See if limitations have been discussed, and if serious limitations have been ignored
   - if a limitation means conclusions about efficacy cannot be justified, then the conclusion should be rejected

Question 10

Harms

Answer 10

Table comparing adverse effects to see if serious adverse effects (if any) have been taken into account in the conclusions
- reduces the risk that important adverse effects have been missed/downplayed/ignored

Question 11

Funding

Answer 11

1. See if funding is for-profit or non-profit
   - for-profit is 4 times more likely to draw exaggerated conclusions; compare conclusions with data carefully
2. Do authors stand to gain financially from intervention being studied? Check affiliations, disclosure/conflict of interest statement, employee status, fees received
   - helps to identify studies with high-risk of exaggeration due to COI