Guide for Developing a Cochrane Protocol - Cochrane Public Health ...

design due to ethical or other reasons the review needs to be explicit about which study designs
are appropriate to include and why. It may be appropriate to include more than one study design,
even if it is likely that RCTs are available, to increase external validity of the review findings.
Studies should be included irrespective of their publication status, unless explicitly justified in
your protocol.
The CPHG accepts the following study designs as appropriate to the review question: RCTs,
cluster RCTs, non-randomised controlled studies (including controlled before and after studies
and interrupted time series studies (with three time points before and after the intervention).
Whilst there are challenges associated with using study labels, authors are encouraged to refer to
Box 13.1.a of the Cochrane Handbook to ensure they are clear about the types of study design
descriptors they might find in the literature. You could consider including a list of definitions of
your chosen study designs. The focus for eligibility must be on the features of a study’s design,
rather than the design labels used. You should state in this section if you will be collecting and
extracting information from qualitative studies emanating from included intervention studies.
Qualitative research studies can be used in the review to help contextualize the major findings,
rather than provide causative understandings. The extent to which you search for and include
qualitative studies will depend on the questions you wish to answer in your review.
Types of participants
Clearly describe the population for which the intervention under review is targeted at or likely to
have an effect on, and clearly specify inclusion and exclusion criteria for your review. These may
be based on individuals or communities. Examples of defining characteristics may be geographic
(e.g. where they live or work), demographic (e.g. age, sex) and/or social factors (e.g. education
level, ‘at-risk’ groups (as specified by the authors). Any restrictions with respect to specific
population characteristics, settings or factors needs to be justified and reflect information
presented in the Background section. Many reviews published within the remit of the CPHG will
have community as their participants. Reviews should provide a definition for community that is
appropriate for the intervention. It is important to distinguish between ‘community-wide’ and
‘community-based’ interventions, if these terms are used in your review.
Types of interventions
List the intervention/s that will be included in the review, and specify clear inclusion and
exclusion criteria (e.g. any essential components, minimum duration of the intervention, etc.).
This section should not describe or define interventions - this detail should be included in the
Background section (Description of the intervention). This section should therefore be brief and
outline the types or groups of included interventions, as referred to in the Background section.
Authors should also include a list of the interventions that will be excluded from the review.
Include specific examples of relevant interventions/programs of both included and excluded
studies when possible. If relevant to the inclusion criteria, identify any specific intervention/s
your intervention/s of interest should be compared against (i.e. what the control group will be).
Types of outcome measures
The outcomes you plan to report for your review should be pre-specified in your review to avoid
bias in reporting your findings. If possible, you should also define in advance the details of what
will be considered acceptable outcome measures for your review and also how outcome
Last updated: 24 November 2011 - 7 -