This document is a quality assessment tool used to evaluate a study. It contains 10 criteria rated on a scale from 0 to 2: whether treatment was concealed, outcomes of withdrawn patients were reported, outcome assessors were blinded, treatment/control groups were comparable, subjects/providers were blinded, care programs were identical, inclusion/exclusion and intervention definitions, outcome measures were clearly defined, diagnostic tests were clinically useful, and surveillance duration was appropriate. Each criterion is rated and possible scores noted to determine study quality.
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Quality Assessment Tool
This document is a quality assessment tool used to evaluate a study. It contains 10 criteria rated on a scale from 0 to 2: whether treatment was concealed, outcomes of withdrawn patients were reported, outcome assessors were blinded, treatment/control groups were comparable, subjects/providers were blinded, care programs were identical, inclusion/exclusion and intervention definitions, outcome measures were clearly defined, diagnostic tests were clinically useful, and surveillance duration was appropriate. Each criterion is rated and possible scores noted to determine study quality.
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Quality Assessment Tool
Study ID:........................................................ Raters initials: ........... Date:..............
Score Query A/B/C
A Was the assigned treatment adequately concealed prior to allocation? 2 = method did not allow disclosure of assignment Clearly yes = A 1 = small but possible chance of disclosure of assignment or unclear Not sure = B 0 = quasirandomized or open list/tables Clearly no = C B Were the outcomes of patients 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 subjects blind to assignment status after allocation? 2 = Effective action taken to blind subjects 1 = Small or moderate chance of unblinding of subjects 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? 2 = Clearly defined 1 = inadequately defined 0 = not defined Outcome 1: Outcome 2: Outcome 3: Outcome 4: Outcome 5: K Were diagnostic tests used in outcome assessment clinically useful? 2 = optimal 1 = adequate 0 = not defined, not adequate Outcome 1: Outcome 2: Outcome 3: Outcome 4: Outcome 5: L Was the surveillance active, and of clinically appropriate duration? 2 = optimal 1 = adequate 0 = not defined, not adequate Outcome 1: Outcome 2: Outcome 3: Outcome 4: Outcome 5:
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