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. Author manuscript; available in PMC: 2015 Jan 15.
Published in final edited form as: Cochrane Database Syst Rev. 2014 Jan 15;1:CD010235. doi: 10.1002/14651858.CD010235.pub2
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
a

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.

b

Based on list of confounders considered important at the outset and defined in the protocol for the review (and assessment against worksheet)

c

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.

d

Did the researchers have an analysis plan defining the primary and other outcomes, statistical methods, subgroup analyses, etc. in advance of starting the study?