How would you describe your patients?
How is the disease/condition defined?
What are the most important characteristics that describe these people (participants)?
Are there any relevant demographic factors (e.g. age, sex, ethnicity)?
What is the setting (e.g. hospital, community etc)?
Who should make the diagnosis?
Are there other types of people who should be excluded from the review (because they are likely to react to the intervention in a different way)?
How will studies involving only a subset of relevant participants be handled?
Source: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from http://handbook.cochrane.org.
What are the experimental and control (comparator) interventions of interest
Does the intervention have variations (e.g. dosage/intensity, mode of delivery, personnel who deliver it, frequency of delivery, duration of delivery, timing of delivery)?
Are all variations to be included (for example is there a critical dose below which the intervention may not be clinically appropriate)?
How will trials including only part of the intervention be handled?
How will trials including the intervention of interest combined with another intervention (co-intervention) be handled?
Main outcomes, for inclusion in the ‘Summary of findings’ table, are those that are essential for decision-making, and should usually have an emphasis on patient-important outcomes.
Primary outcomes are the two or three outcomes from among the main outcomes that the review would be likely to be able to address if sufficient studies are identified, in order to reach a conclusion about the effects (beneficial and adverse) of the intervention(s).
Secondary outcomes include the remaining main outcomes (other than primary outcomes) plus additional outcomes useful for explaining effects.
Ensure that outcomes cover potential as well as actual adverse effects.
Consider outcomes relevant to all potential decision makers, including economic data.
Consider the type and timing of outcome measurements.