Quality assessment scale
1. Was the assignment to the treatment groups really random? 2. Was the treatment allocation concealed?
3. Were the groups similar at baseline in terms of prognostic factors? 4. Were the eligibility criteria specified?
5. Were the point estimates and measure of variability presented for the primary outcome measure? 6. Did the analyses include an intention-to-treat analysis?
7. Were withdrawals and dropouts completely described?
Some instructions for using a checklist for RCTs
Quality item Coding Explanation
1. Was the assignment to the treatment groups really random?
Random sequence generation Adequate Adequate: random numbers table or computer
Partial and central office or coded packages
Inadequate Partial: (sealed) envelopes without further
Unknown description or serially numbered opaque, sealed envelopes
Inadequate: alternation, case record number, birth date or similar procedures
Unknown: just the term ‘randomised’ or ‘randomly allocated’ etc.
2. Was the treatment allocation concealed?
Concealment of randomisation Adequate Adequate: when a paper convinces you that The person(s) who decide on eligibility should Inadequate allocation cannot be predicted [separate persons, not be able to know or be able to predict with Unknown placebo really indistinguishable, clever use of block reasonable accuracy to which treatment group sizes (large or variable)]. Adequate approaches might a patient will be allocated. In trials that use include centralised or pharmacy-controlled
good placebos this should normally be the case; randomisation, serially numbered identical however, different modes or timing of drug containers, on-site computer-based system with a administration in combination with the use of randomisation sequence that is not readable until small block sizes of known size may present allocation and other approaches with robust opportunities for clinicians who are also involved methods to prevent foreknowledge of the allocation in the inclusion procedure to make accurate sequence to clinicians and patients
guesses and selectively exclude eligible patients Inadequate: this option is often difficult. You have to in the light of their most likely treatment visualise the procedure and think how people might allocation; in centres with very low inclusion be able to circumvent it. Inadequate approaches frequencies combined with very brief follow-up might include use of alternation, case record times this may also present a potential problem numbers, birth dates or week days, open random because the outcome of the previous patient numbers lists, serially numbered envelopes (even may serve as a predictor of the next likely sealed opaque envelopes can be subject to allocation manipulation) and any other measures that cannot
prevent foreknowledge of group allocation
Unknown: no details in text. Disagreements or lack of clarity should be discussed in the review team
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Quality item Coding Explanation
3. Were the groups similar at baseline regarding the prognostic factors?
Baseline characteristics Reported Consult the list of prognostic factors or baseline Main aim is to enable the reviewer to see Unknown characteristics (not included in this Appendix). which patients were actually recruited. It Reviewer decides
enables one to get a rough idea on prognostic comparability. A real check on comparability requires multivariable stratification (seldom shown)
4. Were the eligibility criteria specified?
Adequate Partial Inadequate Unknown
5. Were the point estimates and measure of variability presented for the primary outcome measure?
Results for the primary outcome measure Adequate Adequate: mean outcome in each group together
Partial with mean difference and its standard error (SE) or
Inadequate standard deviation (SD) or any CI around it or the
Unknown possibility to calculate those from the paper. Survival curve with log-rank test and patient numbers at later time points
Partial: partially reported
Inadequate: no SE or SD, or SD without N(SE = SD/N)
Unknown: very unlikely
6. Did the analysis include an intention to treat analysis?
Intention-to-treat analysis (ITT) Adequate Reviewers should not just look for the term ITT but Early dropout can make this very difficult. Inadequate assure themselves that the calculations were Strictest requirement is sensitivity analysis according to the ITT principle
including early dropouts
7. Loss to follow-up
This item examines both numbers and reasons; Adequate Adequate: number randomised must be stated. typically an item that needs checking in the Partial Number(s) lost to follow-up (dropped out) stated or methods section and the marginal totals in the Inadequate deducible (from tables) for each group and reasons tables. Note that it may differ for different Unknown summarised for each group
outcome phenomena or time points. Some Partial: numbers, but not the reasons (or vice versa) reasons may be reasons given by the patient Inadequate: numbers randomised not stated or not when asked and may not be the true reason. specified for each group
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