Table 1.

Quality assessment items and possible scores

A. Was the assigned treatment adequately concealed prior to allocation?

2 = Method did not allow disclosure of assignment

1 = Small but possible chance of disclosure of assignment or unclear

0 = Quasi-randomised or open list/tables

B. Were the outcomes of participants who withdrew described and included in the analysis (intention to treat)?

2 = Withdrawals well described and accounted for in analysis

1 = Withdrawals described and analysis not possible

0 = No mention, inadequate mention, or obvious differences and no adjustment

C. Were the outcome assessors blinded to treatment status?

2 = Effective action taken to blind assessors

1 = Small or moderate chance of unblinding of assessors

0 = Not mentioned or not possible

D. Were the treatment and control group comparable at entry?

2 = Good comparability of groups, or confounding adjusted for in analysis

1 = Confounding small; mentioned but not adjusted for

0 = Large potential for confounding, or not discussed

E. Were the participants blind to assignment status after allocation?

2 = Effective action taken to blind participants

1 = Small or moderate chance of unblinding of participants

0 = Not possible, or not mentioned (unless double-blind), or possible but not done

F. Were the treatment providers blind to assignment status?

2 = Effective action taken to blind treatment providers

1 = Small or moderate chance of unblinding of treatment providers

0 = Not possible, or not mentioned (unless double-blind), or possible but not done

G. Were care programmes, other than the trial options, identical?

2 = Care programmes clearly identical

1 = Clear but trivial differences

0 = Not mentioned or clear and important differences in care programmes

H. Were the inclusion and exclusion criteria clearly defined?

2 = Clearly defined, 1 = inadequately defined, 0 = not defined

I. Were the interventions clearly defined?

2 = Clearly defined, 1 = inadequately defined, 0 = not defined

J. Were the outcome measures used clearly defined? (by outcome)

2 = Clearly defined, 1 = inadequately defined, 0 = not defined

K. Were diagnostic tests used in outcome assessment clinically useful? (by outcome)

2 = Optimal, 1 = adequate, 0 = not defined, not adequate

L. Was the surveillance active, and of clinically appropriate duration? (by outcome)

2 = Optimal, 1 = adequate, 0 = not defined, not adequate