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? (Likely confounders may be age, partial or total rupture, activity level, acute or chronic injury) 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 standardised protocol 1 = clearly defined interventions are applied but the application protocol is not standardised 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? 2 = active surveillance and appropriate duration 1 = active surveillance, but inadequate duration 0 = surveillance not active or not defined