Item | Judgement a | Description (quote from paper, or describe key information) |
1. Sequence generation | ||
2. Allocation concealment | ||
3. Confoundingb, c | ||
4. Blinding?b | ||
5. Incomplete outcome data addressed?b | ||
6. Free of selective reporting?b | ||
7. Free of other bias? | ||
8. A priori protocol?d | ||
9. A priori analysis plan?e |
Some items on low/high risk/unclear scale (double‐line border), some on 5 point scale/unclear (single line border), some on yes/no/unclear scale (dashed border). For all items, record “unclear” if inadequate reporting prevents a judgement being made.
For each outcome in the study.
This item is only used for NRCTs and NRSs. It is based on list of confounders considered important at the outset and defined in the protocol for the review (assessment against worksheet).
Did the researchers write a protocol defining the study population, intervention and comparator, primary and other outcomes, data collection methods, etc. in advance of starting the study?
Did the researchers have an analysis plan defining the primary and other outcomes, statistical methods, subgroup analyses, etc. in advance of starting the study?