Items and 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‐randomized or open list/tables.

B. Were the outcomes of patients/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 groups 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 interventions are applied with a standardized protocol. 1 = clearly defined interventions are applied but the application protocol is not standardized. 0 = intervention and/or application protocol are poorly or 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 = active surveillance and appropriate duration. 1 = active surveillance, but inadequate duration. 0 = surveillance not active or not defined.