Table 1

 Evaluation form A, adapted from Chalmers et al,28 showing the 15 items scored to evaluate the study design of a clinical trial

ItemsPossible points
The total possible score is 60.
Description of selection of subject was adequate0–3
Description of patients screened was provided0–3
Inclusion criteria for study included0–2
Exclusion criteria for study included0–2
Withdrawals and reason for withdrawal were described0–3
Therapeutic regimen definition0–3
Control appearance0–2
Randomisation was blinded0–10
Patients were blinded to treatment group0–8
Investigators were blinded to treatment group0–8
Power calculations (sample size requirements)0–4
Adequacy of randomisation was evaluated0–4
Adequacy of blinding was evaluated0–3
Compliance with treatment was assessed0–3
Measure of outcome of active therapy was made0–2