Item | Judgmenta | Description (quote from paper, or describe key information) | |
---|---|---|---|
1. Sequence generation | |||
2. Allocation concealment | |||
3a. Confoundingb | Outcome 1 | ||
3b. Confoundingb | Outcome 2 | ||
4a. Blinding? | Outcome 1 | ||
4b. Blinding? | Outcome 2 | ||
5a. Incompl. outcome data addressed? | Outcome 1 | ||
5b. Incompl. outcome data addressed? | Outcome 2 | ||
6a. Free of selective reporting? | Outcome 1 | ||
6b. Free of selective reporting? | Outcome 2 | ||
7. Free of other bias? | |||
8. A priori protocol?c | |||
9. A priori analysis plan?d |
Some items on low/high risk/unclear scale (items 1–2), some on 5-point scale/unclear (items 3–7), some on yes/no/unclear scale (items 8–9). For all items, record ’unclear’ if inadequate reporting prevents a judgment being made.
Based on list of confounders considered important at the outset and defined in the protocol for the review (and 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? N.B. May be outcome specific.
Did the researchers have an analysis plan defining the primary and other outcomes, statistical methods, subgroup analyses, etc. in advance of starting the study?