| Items |
Scores |
| A. Was the assigned treatment adequately concealed prior to allocation? |
2 = (Cochrane code A) yes; method did not allow disclosure of assignment
1 = (Cochrane code B) not sure; small but possible chance of disclosure of assignment or unclear
0 = (Cochrane code C) clearly no; quasi‐randomized or open list/tables |
| B. Were the outcomes of participants who withdrew described and included in the analysis (intention‐to‐treat)? |
2 = intention‐to‐treat analysis based on all cases randomized possible or carried out
1 = states number and reasons for withdrawal but intention‐to‐treat analysis not possible
0 = not mentioned, or states number of withdrawals only |
| 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 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 |
| F. 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 |
| G. Were the inclusion and exclusion criteria clearly defined? |
2 = clearly defined
1 = inadequately defined
0 = not defined |
| H. 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 |
| I. Were the outcome measures used clearly defined? |
2 = clearly defined
1 = inadequately defined
0 = not defined |
| J. Were diagnostic tests used in outcome assessment clinically useful? (by outcome) |
2 = optimal
1 = adequate
0 = not defined, not adequate |
| K. Was the surveillance active, and of clinically appropriate duration? |
2 = active surveillance and appropriate duration (set visits up to six months or longer)
1 = active surveillance, but inadequate duration (set visits for three months)
0 = surveillance not active or not defined (no set visits or time of follow up not detailed). |
