cochrane纳入的RCT文献质量评价英文原版

Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment.
Performance bias.
Blinding of participants and personnelAssessments should be made for each main outcome (or class of outcomes).
Using an open random allocation schedule . a list of random numbers);
Allocation by availability of the intervention.
Criteria for the judgement of ‘Unclear risk’ of bias.
Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’.
cochrane纳入的RCT文献质量评价英文原版
Domain
Support for judgement
Review authors’ judgement
Selection bias.
Random sequence generation.
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation:
RANDOM SEQUENCE GENERATION
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.
Criteria for a judgement of ‘Low risk’ of bias.
Central allocation (including telephone, web-based and pharmacy-controlled randomization);
Sequentially numbered drug containers of identical appearance;
Reporting bias due to selective outcome reporting.
Other bias.
Other sources of bias.
State any important concerns about bias not addressed in the other domains in the tool.
Detection bias due to knowledge of the allocated interventions by outcome assessors.
Attrition bias.
Incomplete outcome dataAssessments should be made for each main outcome (or class ofoutcomes).
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each interventiongroup (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence.
Allocation concealment.
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study.
Detection bias.
Blinding of outcome a each main outcome (or class of outcomes).
ALLOCATION CONCEALMENT
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment.
Criteria for a judgement of ‘Low risk’ of bias.
If particular questions/entries were pre-specified in the review’s protocol, responses should be provided for each question/entry.
Bias due to problems not covered elsewhere in the table.
Sequentially numbered, opaque, sealed envelopes.
Criteria for the judgement of ‘High risk’ of bias.
Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on:
Attrition bias due to amount, nature or handling of incomplete outcome data.
Reporting bias.
Selective reporting.
State how the possibility of selective outcome reporting was examined by the review authors, and what was found.
Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Coin tossing;
Shuffling cards or envelopes;
Throwing dice;
Drawing of lots;
Minimization*.
*Minimization may be implemented without a random element, and this is considered to be equivalent to being random.
Criteria for the judgement of ‘High risk’ of bias.
The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: