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The Cochrane

Public Health Group



Guide for developing a Cochrane protocol

This Guide has been produced by the Cochrane Public Health Group (CPHG) to
make the process of preparing a protocol for a public health review in Cochrane
format as clear as possible. The editorial base has developed guidelines that detail
each section of the protocol and what should be included. These guidelines are a
distillation of the Cochrane Handbook for Systematic Reviews of Interventions,
review group policies, recommendations from the CPHG Editorial Team and also
incorporate the Methodological Standards for the Conduct of Cochrane
Intervention Reviews, released in November 2011.

Please refer to The Cochrane Collaboration Training website at
http://training.cochrane.org/ to access online training modules for Cochrane
review authors.

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Table of contents
TABLE OF CONTENTS ............................................................................................................................................. - 2 -
GETTING STARTED................................................................................................................................................. - 3 -
FILLING OUT THE PROTOCOL TEMPLATE ............................................................................................................... - 4 -
BACKGROUND ....................................................................................................................................................... - 4 -
Description of the condition .......................................................................................................................... - 4 -
Description of the intervention ...................................................................................................................... - 4 -
How the intervention might work .................................................................................................................. - 4 -
Why it is important to do this review ............................................................................................................. - 5 -
OBJECTIVES .......................................................................................................................................................... - 6 -
Resources ..................................................................................................................................................... - 6 -
METHODS ............................................................................................................................................................ - 6 -
Criteria for considering studies for this review ............................................................................................... - 6 -
Types of studies ............................................................................................................................................ - 6 -
Types of participants..................................................................................................................................... - 7 -
Types of interventions ................................................................................................................................... - 7 -
Types of outcome measures .......................................................................................................................... - 7 -
SEARCH METHODS ................................................................................................................................................. - 9 -
DATA COLLECTION AND ANALYSIS ............................................................................................................................. - 10 -
Selection of studies ..................................................................................................................................... - 10 -
Data extraction and management .............................................................................................................. - 10 -
Assessment of risk of bias in included studies .............................................................................................. - 12 -
Measures of treatment effect ..................................................................................................................... - 13 -
Unit of analysis issues ................................................................................................................................. - 14 -
Dealing with missing data ........................................................................................................................... - 14 -
Assessment of heterogeneity ...................................................................................................................... - 15 -
Assessment of reporting biases ................................................................................................................... - 15 -
Data synthesis ............................................................................................................................................ - 16 -
Subgroup analysis and investigation of heterogeneity ................................................................................. - 17 -
Sensitivity analysis ...................................................................................................................................... - 17 -
ACKNOWLEDGEMENTS .......................................................................................................................................... - 17 -
CONTRIBUTIONS OF AUTHORS ................................................................................................................................. - 18 -
POTENTIAL CONFLICT OF INTEREST ............................................................................................................................ - 18 -
REFERENCES - OTHER REFERENCES ........................................................................................................................... - 18 -
Additional references .................................................................................................................................. - 18 -
Other published versions of the review ........................................................................................................ - 19 -
REFERENCES ....................................................................................................................................................... - 20 -
APPENDIX 1 GUIDANCE FOR ESTABLISHING A REVIEW ADVISORY GROUP ....................................................... - 21 -
APPENDIX 2 - PUBLIC HEALTH GROUP EDITORIAL PROCESS ................................................................................ - 24 -
APPENDIX 3 RISK OF BIAS ASSESSMENT ........................................................................................................... - 26 -
APPENDIX 4 DATA EXTRACTION AND ASSESSMENT FORM ............................................................................... - 29 -
APPENDIX 5 CHECKLIST FOR SUBMISSION ........................................................................................................ - 48 -


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Getting started
Now that your title has been registered there are several resources you will need to help you to
complete your protocol. These are listed below and we have provided relevant links throughout
these documents. All are available at www.cochrane.org and www.ims.cochrane.org. If you have
problems downloading these files please contact the Review Group Coordinator. You should also
have received an email notifying you that a user account has now been set up for you in Archie.
Once you have activated this account you will be able to check out your review.

1) Cochrane Handbook for Systematic Reviews of Interventions
The Cochrane Handbook explains the Review process (parts have been summarised in this
document but you will need to refer to The Cochrane Handbook for more complete guidance)
(Higgins and Green 2008). The handbook is incorporated in the RevMan 5.1 software and also
available at http://www.cochrane-handbook.org. This document includes a chapter specific to
public health reviews (Chapter 21).

2) RevMan 5.1
This is the program which you must use to write your protocol and later your review. It is free
software that you can download easily to your computer. A tutorial is accessible from the help
menu in RevMan.

ALL AUTHORS ARE ASKED TO WORK THROUGH THE REVMAN TUTORIAL BEFORE WORKING ON
YOUR PROTOCOL.

3) RevMan user guide
This guide can be accessed as a PDF from the help menu in RevMan and provides a detailed
description about how to use RevMan. You should continue to refer to this user guide throughout
the review production process.

4) Cochrane style guide
This guide explains the style conventions for a Cochrane review.
www.cochrane.org/training/authors-mes/cochrane-style-guide

5) Other resources
There are a number of other resources available to support you. Many are listed on the Cochrane
Public Health Group website (http://ph.cochrane.org/resources-and-guidance)

6) Advisory group
The CPHG recommends that all review teams establish a Review Advisory Group (RAG) to advise
them on the scope of their review and its relevance to end-users. One author, usually the lead
author, should take responsibility for establishing the RAG prior to commencing work on the
protocol. The CPHG can provide you with assistance in identifying relevant RAG members but
ultimately it is the author teams responsibility. Appendix 1 outlines guidance for establishing and
working with a RAG
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Filling out the protocol template
This document provides advice on what to include in each of the sections presented to review
authors in a RevMan protocol template. The headings described below will align with the set
headings of the protocol template. The advice reflects CPHG editorial policy and following these
guiding principles should ensure fewer modifications are requested at editorial revision stage.
See Appendix 2 for an overview of the stages each review goes through prior to publication. You
should also refer to Chapter 4 of the Cochrane Handbook as you complete the protocol. This
document does not repeat information in the Cochrane Handbook but rather provides
supplementary material specific to CPHG requirements.
Background
Description of the condition
This section should describe the condition or issue that the intervention/s under review are
aiming to address, including information on the historical, (and perhaps political), social,
economic, geographical and biological perspectives of the problem or issue so as to set a context
for the review. This will help to establish the rationale for the review and explain the importance
of the questions being asked. It may be appropriate to change this heading to Description of the
Issue.
Description of the intervention
Define all terms and interventions clearly and try to set a tone that does not pre-judge the value
of the intervention (i.e. the likely effectiveness of the intervention/s). Provision of examples of
interventions and their components here will help the reader gain a better understanding of the
interventions the authors refer to thereafter in the Types of Interventions of the Methods
section. The complexity of the intervention in seeking to address the problem or issue (especially
if it is delivered in many different contexts, using different methods and tools or includes many
interventions to meet the desired outcome/s) needs to be acknowledged, even if the review is
only looking at a component of the problem or issue. Areas of uncertainty about the intervention
and issues that may be controversial or the subject of public concern should be highlighted. While
this section may require you to cover technicalities of the intervention, it is important to write
this clearly and in plain language to aid reader comprehension. We recommend including
definitions of key concepts in this section.

How the intervention might work
In this section identify the theoretical underpinnings and refer to literature that identifies a
potential pathway of effect between intervention and outcomes. You might like to include a logic
model here which shows the connections between determinants of health, interventions and
outcomes. Logic models can also help to identify the interventions of interest and important
outcomes, or provide a logical rationale for why only a component of an intervention is being
reviewed (and point to where other reviews may need to be carried out to complete the
evidence picture). The following diagram from the published protocol for Community-based
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interventions for enhancing access to and/or consumption of fruits and vegetable access among
5-18 year olds (Ganann et al 2010) is an example of how a logic model might be constructed.


Why it is important to do this review
Clearly describe the justification for doing this review. Cochrane reviews should include a focus
on exploring uncertainty about effects and/or uncertainty about effects within particular
subgroups. You should include supporting references to existing and ongoing primary research
and reviews (including non-Cochrane reviews) of the research topic, to highlight what has been
learned from past efforts as well as to point out any inconsistencies, methodological strengths
and weaknesses, and evidence gaps that still remain. The contribution of your planned review
should be emphasised by clearly stating the unresolved questions and controversies that will be
addressed. To instruct the end-user on the potential application of review findings, include a brief
statement on how this could inform practice or policy decisions.

This section should be comprehensive but concise (1-2 paragraphs per subsection).

Resources
Cochrane Handbook - Chapters 4 and 5
The Cochrane Public Health Group Training Handbook (http://ph.cochrane.org/resources-
and-guidance) see How to Ask an Answerable Question
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Objectives
The objective/s of the review should be clear and specific with a precise statement that covers
both intervention/s or exposure/s to be reviewed, the population of interest (e.g. whole
population or particular sub-group/s) and the types of outcome measures of interest. One
sentence may be enough; however, for some review questions it may be more appropriate to
break it down into primary and secondary objectives. The intention to identify and report on
adverse consequences or effects of the intervention/s in the review also should be included in
this section.

The objectives should be consistent with the review title.
Resources
Cochrane Handbook Chapter 4
Methods
The purpose of the methods sections of a protocol is to describe how the review will be
conducted and to theoretically allow for the review to be replicated by others.

Please refer to the Cochrane-Campbell Methods Group Equity Checklist
(http://equity.cochrane.org/sites/equity.cochrane.org/files/uploads/equitychecklist2011.pdf)
throughout the development of your protocol. This highlights methodological aspects to consider
at both the protocol and the review stage to help you identify the impact of interventions on
equity in your review.

Criteria for considering studies for this review
This section should make it clear how studies will be selected for inclusion in the analysis. All
inclusion/exclusion criteria must be explicitly stated within this section, even if mentioned again
elsewhere throughout your protocol. The protocol needs to reflect your intention to include
information that will allow the review author, and hence the reader, to judge what factors may
increase or decrease effectiveness, and under what circumstances/contexts. You do not need to
provide any text under this heading. Rather complete each of the sections below. Review authors
should note that if non-randomised studies are to be included detailed descriptions of your
approach will be needed throughout your protocol. Suggestions are provided throughout this
guidance document. Note that any changes to eligibility criteria or outcomes studies will need to
be justified in the review.
Types of studies
In this section you need to list the study designs you will include in your review. Whilst you do not
need to document your study selection in detail, study design/s chosen should be determined by,
and appropriate for, the intervention and the research question. You should consider the risk of
bias of each study design and value added to the review. Clear justification for choice of eligible
study designs must be included. Randomised controlled trials should be included if they are
feasible for the interventions and outcomes of interest. If an RCT is not able to be used as a study
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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 studys 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
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measures will be selected when there are several possible measures (e.g. multiple definitions,
assessors or scales).

You should include all important outcomes in the protocol, even if you believe there will be
insufficient data present in the existing research to include in the synthesis. As well as potential
benefits, you must consider any potential adverse consequences of the intervention and ensure
that these are addressed in your review. Public health questions often have a large number of
outcomes of interest we encourage authors to think carefully about what the main outcomes of
interest are likely to be for end-users. Once you have a complete list of the outcomes of interest,
you should identify a short list of main outcomes. The Cochrane Handbook suggests no more
than seven main outcomes should be chosen, however this should be examined on an individual
review basis. These outcomes will be used to summarise the key findings of your completed
review, for example in the abstract and Summary of Findings tables (if you include this in your
review). For some review questions, it may be appropriate to summarise findings for groups of
similar outcomes.

From among the main outcomes, select a small number of primary outcomes (usually 3 or less).
A primary outcome is of core interest to your review i.e. the outcome that best answers your
effectiveness question. You should include at least one undesirable outcome (adverse effect),
known or hypothesised, with a rationale for why you think these may arise and why they are
important to include in the review.

All other main outcomes become secondary outcomes, along with any other additional outcomes
the review intends to address. These may include unintended outcomes that occur as a result of
the intervention. These are considered helpful in explaining intervention effects or the integrity
of the intervention. If you have a large number of secondary outcomes you should consider the
most appropriate ways of categorising these. If you are planning to include a Summary of
Findings table in your review (not compulsory but strongly recommended in The Cochrane
Handbook), you should state the outcomes you will be prioritising for this here.

For public health reviews, it may often be appropriate to include measures of changes in social
and environmental determinants of population health, as opposed to or in addition to direct
health outcomes. For example, changes in childrens purchasing habits (as a result of new
canteen policies in a school), and reduction in violent behaviour (as a result of adoption of
responsible drinking policies at a sports club).

You must clarify in advance whether any outcomes will be used as criteria for including studies
(rather than as a list of the outcomes of interest within included studies). Outcome measure
often do not necessarily form part of the criteria for including studies in a review, however some
reviews do legitimately restrict eligibility to specific outcomes. Furthermore, if relevant to your
topic, you may wish to specify requirements for the timing of outcome measurement, such as a
minimum period after the intervention before which an effect would not be detectable (e.g. the
effect of an intervention in pregnant women on the rate of babies born with low birth weight
could not be observable for several months after the intervention).

Resources
Cochrane Handbook Chapters 4, 5, 13 and 21
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Chapter 21 in Cochrane Handbook on Reviews in Health Promotion and Public Health
(www.cochrane-handbook.org)
The Cochrane Non-Randomised Studies Methods Group has provided information on how
non-randomised studies should be dealt with in Cochrane reviews (see Chapter 13 in
Cochrane Handbook (www.cochrane-handbook.org).
Cochrane Consumers and Communication Group have useful information on study
designs at :
www.latrobe.edu.au/cochrane/assets/downloads/StudyQualityGuide050307.pdf )
Refer to Cochrane Health Equity website for information on assessing issues relevant to
equity, along with a checklist for authors that can be used and submitted along with the
draft protocol (http://equity.cochrane.org)
Search methods
Include a description of the search strategy to be used to retrieve studies. You should list the
sources to be searched (e.g. reference databases, personal contacts, hand searches of journals).
At a minimum you should search Medline, Embase and CENTRAL. Include a rationale for the
choice of literature sources (e.g. ERIC for reviews of educational interventions) if possible and the
years to be covered. It may be useful to refer to your logic model to justify your approach.
Consider including databases relevant for health equity. Relevant trial/study registers and
repositories of results must also be included in your search to reduce the risk of publication bias
and identify ongoing studies. Reference lists of included studies and any relevant systematic
reviews identified must also be searched and this should be noted in your protocol.

You should also describe the mechanisms you intend to use or resources that you have available
to enable you to retrieve potentially relevant documents, especially ones that are unpublished
and/or written in languages other than English. For example, you may plan to contact relevant
individuals and organisations for information about unpublished or ongoing studies. You should
not apply inclusion restrictions based on publication status or language. The CPHG can assist
authors in identifying potential options for translations if they are required. You should consider
mechanisms for searching grey literature, for example using databases such as OpenSIGLE. If
searching restrictions are necessary, a rationale must be provided.

You should at least make a first attempt at a search strategy (ideally utilising an information
specialist available to the review author team). The CPHG Trials Search Coordinator, Ruth Turley
(TurleyRL@cardiff.ac.uk) will provide feedback once you have submitted your protocol for
editorial review. Your protocol should include (as an appendix) a complete electronic search
strategy for one database (usually Medline). Consider including terms or concepts in your search
strategy that are relevant for health equity. Note that generally CPHG review authors will need to
conduct their own searches. We therefore recommend that an information specialist be recruited
to the author team. You should outline in your protocol who will conduct the searches.

Resources
Cochrane Handbook Chapters 6 and 21
Chapter 21 in Cochrane Handbook on Reviews in Health Promotion and Public Health
(www.cochrane-handbook.org)
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Data collection and analysis
Selection of studies
This section should outline how results of the various searches will be assessed for inclusion, by
whom and what you will do if more information is required to determine eligibility (e.g.
contacting the authors for additional information or finding a process paper associated with the
study which outlines further information). Specify how many review authors will independently
review all abstracts and titles and how disputes regarding inclusion will be resolved (there must
be at least two, and we recommend a third being available to resolve disputes). Specify that all
irrelevant titles should be excluded and that full-text papers will be obtained where titles are
deemed to be relevant or where eligibility is unclear. Again, state how many review authors will
assess these full text papers and how disagreement will be resolved. You should note that you
will keep a record of reasons for excluding studies. Documentation regarding inclusion decisions
must be sufficient to complete a PRISMA flow chart and a table of Characteristics of excluded
studies. If any statistics will be used to determine inter-rater agreement (e.g. using Cohen's
kappa) include these details. Please indicate if articles in a language other than English will be
translated. The reference management software you will be using to manage the records
retrieved from searches of electronic databases should be named. The most commonly used
software programs are Endnote and Reference Manager.
It is common for included studies to refer to a process evaluation or other methodological detail
that is published elsewhere in a separate paper. These additional papers must be obtained (when
referred to in the primary paper) and considered as part of the included study. They are likely to
contain important information needed to understand the implementation of the intervention and
adequately assess the risk of bias of the study. Multiple reports of the same study must be
collated, so that each study (rather than each paper) is the unit of interest in the review.
Data extraction and management
This section should provide an adequate description of methods used to collect data from
included studies. You should mention how many people will conduct data extraction and how any
disagreements will be resolved. It is highly desirable that that study characteristics are extracted
in duplicate (i.e two review authors extract data and a third review author be consulted where
there is disagreement), but not essential. It is essential that outcome data is extracted in
duplicate.
You also need to identify the data extraction form/methods you will be using. Appendix 4
provides a sample data extraction form that you can modify to meet the needs of your review. It
is recommended that you pilot your data extraction form, to ensure that all participating authors
are retrieving comparable results, and this should be noted in the protocol. Inclusion of the data
extraction form that your author team has developed would be useful to include as additional
information in a figure or additional table.
In the text of the protocol you should include a brief description of the categories of data you
intend to collect. In order to provide essential detail for decision makers, information about
context, implementation factors, equity, cost and sustainability must be collected from included
studies where available (in addition to data on effectiveness). As mentioned in the above section,
included studies may refer to a process evaluation or other methodological detail that is
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published elsewhere. These additional papers must be obtained and relevant information
extracted, as a minimum requirement. In this section of the protocol you should state that you
will collect this information (i.e. context, implementation, cost, sustainability etc) and what you
will do with it thereafter. i.e. at a minimum, this information should be reported in the
Characteristics of included studies table. If you plan to use this information to help synthesise
your findings (for example, grouping studies by measure of intensity or level of implementation),
you should state this in your protocol (with the caveat that this would only be done if adequate
data was available). You may also choose to conduct additional searches for contextual
information, such as implementation factors, cost and sustainability, beyond that linked with
included studies. Any plans to do this should be noted in your protocol.
Within your data extraction form, you should identify studies that report on socio-demographic
characteristics known to be important from an equity perspective. For this process, use the
PROGRESS (Place, Race, Occupation, Gender, Religion, Education, Socioeconomic status, Social
status) framework and, at a minimum, report for each included study which of the eight
PROGRESS factors were reported for participants at baseline and which were reported at
endpoint. In addition to the PROGRESS framework, also collect whether or not interventions
included particular strategies to address diversity or disadvantage.

We strongly recommend that you incorporate the Cochrane-Campbell Methods Group Equity
Checklist in your data extraction form and you should note this in your protocol
(http://equity.cochrane.org/sites/equity.cochrane.org/files/uploads/equitychecklist2011.pdf).
This may help you to identify the impact of interventions on equity later on in your analysis, if this
is an important consideration for your review.

In this section you should state that all potential moderators/confounders of study outcomes will
be included in the extraction form (even if some of these characteristics are not expected to be
formally tested or discussed in the final review). Consider potential confounders and adjustment
processes. When extracting data, include this information.

It can be helpful to refer to The Quality Assessment Tool for Quantitative Studies
(www.myhamilton.ca/nr/rdonlyres/6b3670ac-8134-4f76-a64c-9c39dbc0f768/0/qatool.pdf),
developed by The Effective Public Health Practice Project (EPHPP), to be used in conjunction with
their Quality Assessment Tool for Quantitative Studies Dictionary
(www.myhamilton.ca/nr/rdonlyres/f5944f3b-15a9-46e7-8afd-1cd67628e33d/0/qadictionary.pdf)
to check for items that you may wish to consider including as part of your data extraction form. If
you use items from this tool, you need to state this in your protocol.

Document how you intend to handle instances in which a single study of effectiveness provides
data on multiple measures of the same or similar outcomes and you may need to choose what to
report (e.g. when several variations on an outcome are measured (e.g. weight and BMI) or when
the same outcome is measured at multiple points in time). An explanation of the criteria used to
determine whether multiple outcomes from the same or related studies are independent data
points should be included.

Authors of primary studies should be contacted where information is missing or clarification is
needed. You should note this in the later section on Dealing with missing data. You should outline
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how you will attempt to avoid duplicate publication bias and state how multiple reports and if
publications of the same study will be assembled and compared for duplication, completeness
and possible contradictions.

Please note in this section if you will use RevMan to manage data storage and analysis. If you
intend to use alternative software you must discuss this with the CPHG, and note your intention
in the protocol.

Resources
Cochrane Handbook Chapter 7
Chapter 21 in Cochrane Handbook on Reviews in Health Promotion and Public Health
(www.cochrane-handbook.org)
Refer to Cochrane Health Equity website for information on assessing issues relevant to
equity, along with a checklist for authors that can be used and submitted along with the
draft protocol (http://equity.cochrane.org)

Assessment of risk of bias in included studies
In this section, you should provide an adequate description of the tool(s) you will use to assess
the risk of bias of included studies. You should also describe how the tool(s) will be implemented
and the criteria used to assign studies, for example, to judgements of low risk, high risk and
unclear risk of bias. The risk of bias assessment must be conducted in duplicate with a clear
process for resolving disagreements. Supporting information to justify all risk of bias judgements
must be included in the risk of bias tables. You can consider including the source of the
information, for example, direct quotes from the study paper. If you are only including
randomised controlled trials, we recommend that you use the Cochrane Collaborations Risk of
Bias (RoB) tool. This includes selection bias, performance bias, attrition bias, detection bias and
reporting bias. With regard to the assessment of blinding, we recommend that you consider
separately the risk of bias due to lack of blinding for (i) participants and study personnel
(performance bias) and (ii) outcome assessment (detection bias). It is also often appropriate to
consider the risk of bias due to lack of blinding separately for different types of outcomes. When
assessing attrition bias, it is recommended to consider the impact of missing data separately for
different outcomes.

If you are including non-randomised studies we recommend you use the Effective Practice and
Organisation of Care (EPOC) RoB Tool for studies with a separate control group instead. This can
be used for randomised controlled trials as well as controlled before and after studies and other
nonrandomised designs that include a control group (with the exception of interrupted time
series studies). This tool includes the standard Cochrane RoB tool items as well as an additional
item to consider the likelihood of contamination. Importantly for nonrandomised studies, it also
includes additional items to assess the risk of selection bias and subsequent confounding (were
baseline outcome measurements similar? and were baseline characteristics similar?). We
recommend supplementing this with another additional item, did the study authors
appropriately adjust for important confounders in their analysis?.

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If you are including ITS studies we recommend that you assess the risk of bias of these studies
using the EPOC RoB tool for ITS study designs which includes four items from the Cochrane 'Risk
of bias' tool to assess performance, attrition, detection and reporting bias as well as the following
additional items relevant for ITS studies: was the intervention independent of other changes?,
was the shape of the intervention effect pre-specified? and was the intervention unlikely to
affect data collection?.

Both of the EPOC RoB tools mentioned above can be found on the EPOC website:
http://epocoslo.cochrane.org/sites/epocoslo.cochrane.org/files/uploads/Suggested%20risk%20o
f%20bias%20criteria%20for%20EPOC%20reviews.doc as well as guidance for how to prepare a
RoB table:
http://epocoslo.cochrane.org/sites/epocoslo.cochrane.org/files/uploads/How%20to%20prepare
%20a%20risk%20of%20bias%20table%20for%20reviews%20that%20include%20more%20than%2
0one%20study%20design.doc. Note that for some items in the RoB tool, for example blinding, it
may make sense to provide a different assessment for different outcomes (for example outcome
assessors may be blinded for some outcome measures and not others, or some measures may be
more objective/subjective than others). Where appropriate, add additional items into the RoB
table to allow for this.

Alternative approaches should be discussed and agreed with your contact editor. See Appendix 3
for general information on Risk of bias tables (referenced from the Cochrane Handbook). This is
an area of methodological development and any new tools will be available on the CPHG website.

In this section you also need to describe the method by which you will summarise the risk of bias
assessments. Rather than at the study level, it is recommended that you do this at the outcome
level. This is due to the fact that the risk of bias may be different for different outcomes within
the same study. To do this you can provide an overall risk of bias assessment for the main
outcomes within each study, then provide an overall risk of bias assessment for relevant
outcomes across studies, so that outcomes will be judged overall as Low, Medium or High risk
of bias given overall considerations of the study designs, and the potential impact of the
identified risks noted in the table for each study that contributed results for that outcome. Also,
consider how you will address risk of bias in the synthesis of your results, considering how
potential study biases might affect your conclusions.

Measures of treatment effect
In this section you should state how outcomes will be reported (e.g. dichotomous data) and how
you will analyse and compare them (e.g. using Risk Ratios). It is likely that a number of
quantitative outcome measures may be identified. You need to firstly identity the types of data
you will obtain from your included study designs. For controlled studies, with continuous data,
we recommend reporting means or changes in mean scores. Weighted mean difference can also
be reported for continuous outcomes. Standardised mean differences should be reported when
different studies use different scales to report the same outcome (e.g. quality of life scales).
Where a number of outcome measures are identified, authors should use the ratio of means
method (Friedrich 2008). Dichotomous (or binary) outcomes can expressed as relative risks (RR),
odds ratio (OR) or risk difference (RD), however the CPHG recommends using RR (Deeks 2002).
We also recommend using RR for categorical data (e.g. outcomes reported on a short Likert
Last updated: 24 November 2011 - 14 -
scale).
Unit of analysis issues
It can be difficult to identify the unit of analysis issues that may emerge from your included
studies. However, it is important to consider and document in this section what these might be,
based on your included study designs.

Special issues in the analysis of studies with non-standard designs, such as cross-over trials and
cluster-randomised trials, should be described here. Where these studies are not analysed
appropriately this may result in unit of analysis error, for example where cluster-randomised
trials are analysed at the individual participant level without taking into account the effect of
clustering. Effects can be recalculated using the approximately correct analysis or by inflating
standard errors which is equivalent to calculating new sample sizes. If you plan to include these
studies you should consult a statistician to identify how unit of analysis errors will be treated, and
note this in the protocol.

If you find studies with multiple intervention groups, you will need to consider and document
how you will deal with multiple groups in your analysis. Report outcomes for all groups of interest
in your review, however only include groups that meet the eligibility criteria. If you identify more
than one intervention group of interest, you may need to divide your analysis into pair-wise
comparisons (e.g. Group A vs control, Group B vs control, Group A vs Group B) and conduct a
meta-analysis for each comparison, if appropriate to do so. Be careful not to include a group of
participants twice in the same meta-analysis. One way to include two pair-wise comparisons
against the same control group in one meta-analysis is to simply halve the number of participants
in the control group. Document your intentions regarding these issues in this section.

Resources
Cochrane Handbook - Chapter 7 and 9 (data extraction and methods of analysis by type
of outcome)
Chapter 21 in Cochrane Handbook on Reviews in Health Promotion and Public Health
(www.cochrane-handbook.org)
Non-standard designs are discussed in detail in Chapters 9 and 16 of the Cochrane
Handbook for Systematic Reviews of Interventions, including cluster-randomised trials
(Section 16.3), cross-over trials (Section 16.4), and studies with multiple intervention
groups (Section 16.5)
Dealing with missing data
Strategies for dealing with missing data should be described in this section. This will principally
include missing information on the methods used in included studies, missing participants due to
drop-out (and whether an intention-to-treat analysis will be conducted), and missing statistics
(such as standard deviations or correlation coefficients or where data is reported at baseline but
is not reported at outcome). It may be necessary for you to contact authors where data are
missing. Your strategy for contacting authors (e.g. using email addresses on the studys
publication or accessing phone directories from authors documented affiliated organisation)
should be outlined in the protocol. Section 16.1.2 of the Cochrane Handbook outlines the options
available to review authors if missing data is not found. Refer to Section 16.1.2 of The Cochrane
Last updated: 24 November 2011 - 15 -
Handbook which outlines the options available to review authors if missing data is not found and
state in your protocol which option you will use. The option chosen will depend on what is
practical and whether or not it can be assumed that the data is missing at random.

Resources
Cochrane Handbook - Chapter 16 (Sections 16.1 and 16.2)
Assessment of heterogeneity
This section should outline how you plan to assess the heterogeneity (or differences) between
your included studies. It is helpful to consider and refer in this section to methodological
heterogeneity (e.g. how similar or different your included studies are in terms of study design,
types of participants, interventions and outcomes), as well as statistical heterogeneity (i.e
variability in the intervention effects being evaluated in the different studies) which is a
consequence of methodological heterogeneity.

If you plan to conduct a meta-analysis you should consider and document how you will assess
statistical heterogeneity. You should state that this analysis will be used to determine whether it
is suitable to conduct a meta-analysis or to analyse your studies qualitatively. The CPHG
recommend that you should use the I
2
statistic to quantify the level of heterogeneity present.
Review authors may also consider using the Chi square test for heterogeneity (p<0.10). RevMan
will calculate these statistics for you. If there is a high level of heterogeneity between studies, it
may be inappropriate to conduct a meta-analysis. Meta-analysis should only be considered when
a group of studies is sufficiently similar in terms of participants, interventions and outcomes to
provide a meaningful summary. If the studies are comparable in these respects, but there
remains a very high level of heterogeneity, you may decide not to conduct a meta-analysis, and
to present your results in a qualitative analysis. If you plan to use a heterogeneity threshold
above which you will not conduct a meta-analysis, you should note this in the protocol. A rough
guide to interpretation of the I
2
statistic is given in the Cochrane Handbook, however note that
thresholds for the interpretation of I
2
can be misleading, due to the range of factors that may
contribute to heterogeneity. For this reason, statistical assessment of heterogeneity is not a
substitute method for exploring the causes of variation between your studies. You should outline
the statistical methods you will use for conducting subgroup analyses and investigation of
heterogeneity in the section below.

Resources
Cochrane Handbook Chapter 9
Assessment of reporting biases
Assessment of reporting bias is often difficult in public health reviews where the numbers of
studies can be small. If you have a small number of studies (<10) you should follow methods
described in the Cochrane Handbook. If, however, a larger number of studies (>10) are available
for review, it may be useful to investigate reporting bias using a funnel plot. You should identify
both approaches in your protocol as you will not know how many included studies you will find at
protocol stage.

Resources
Last updated: 24 November 2011 - 16 -
Cochrane Handbook Chapter 10
Data synthesis
The protocol should outline the procedures you intend to use to analyse and summarise the
study results, including whether or not you intend to carry out meta-analyses. This section should
contain a clear rationale for any choices, considering the potential impact of each choice on the
outcomes of the review. Meta-analyses should only be undertaken if participants, interventions
and comparisons are judged to be sufficiently similar to ensure an answer that is meaningful. It
may be useful to organise this section by study type and/or by type of outcome data (e.g.
continuous or binary).

More specifically, if the intention is to carry out a quantitative analysis of results, you should
outline in the protocol:
the software package that will be used to conduct the analyses (this should
be RevMan and alternatives should be discussed with the CPHG);
how statistics describing the overall literature will be presented;
why a particular effect size metric is to be used;
if adjustments to effect sizes will be made for any reason;
techniques to be used to combine results of separate tests;
techniques to be used to assess and then analyse variability in findings
across tests.

As a default option, the CPHG recommend using the random-effects model to incorporate
heterogeneity into your meta-analyses (as opposed to the fixed-effect model). The random-
effects model allows for a greater level of natural heterogeneity between studies, assuming that
each study is estimating a unique true effect applicable to the time, population and context in
which the study was conducted. Fixed effects meta-analysis may be included in subsequent
sensitivity analysis or when significant justification is provided in the protocol.

For qualitative syntheses (with or without a meta analysis), you need to provide a rationale for
how you intend to organise studies/findings to arrive at reasonable conclusions and present
information in a useful way for end-users of the review. For example, you may like to synthesise
studies grouped by the type of intervention, the length of the intervention, the type of outcome,
or by study design. It may be difficult to identify what is most appropriate at protocol stage but
we encourage you to report your anticipated approach or to identify the options for analysis and
how the decision on synthesis structure will be reached.

You must include information about how you will summarise the findings of the review. Use the
five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and
publication bias) to assess the quality of the body of evidence for each outcome, and to draw
conclusions about the quality of the body of evidence within the text of the review. Note that this
does not mean you have to provide a GRADE rating for the quality of the body of evidence (high,
moderate, low, very low), however you must consider the five factors mentioned above in your
review. Be sure to justify and document all assessments so that they can be included in your
review. These factors must be addressed irrespective of whether your review will include a
Summary of Findings Table (SoFT). If you plan to include a formal SoFT in your review, you
should include this information in this section of your protocol. It is good practice to list the
Last updated: 24 November 2011 - 17 -
outcomes (up to seven) that you plan to include within the SoFT, as well as which comparisons
and subgroups will be covered, if appropriate. A SoFT should include the number of participants
and studies for each outcome, summarise the intervention effect and include a measure of the
quality of the body of evidence addressing the considerations listed above.
Subgroup analysis and investigation of heterogeneity
In this section you should list your proposed sub-group analyses, selecting key factors that may
differ between or within your included studies, and that you anticipate will be associated with
differences in the effect observed, such as differences in the population, intervention or context
of the studies. These should be restricted in number with a rationale provided for each. Issues of
equity may be a key consideration. Include information about any formal statistical tests that will
be used to compare subgroups, in the event that there are sufficient studies for this to be
meaningful. It may be possible to undertake a meta-regression. Please note if this is an option for
your review.

Resources
Cochrane Handbook Chapter 9
Campbell and Cochrane Equity Methods Group Equity Checklist:
http://equity.cochrane.org/sites/equity.cochrane.org/files/uploads/equitychecklist.pdf

Sensitivity analysis
You should document in this section under what circumstances a sensitivity analysis will be
undertaken. Sensitivity analysis is often confused with subgroup analysis although they are
different. Sensitivity analysis is undertaken to identify whether review findings are dependent on
the decisions made during the review process, such as about study inclusion/exclusion, the
selection of data to analyse, the analysis methods used, imputed data, and the impact of studies
at high risk of bias. Some examples of decisions that may indicate a need for sensitivity analysis
are listed in The Cochrane Handbook (Chapter 9, section 9.7). Where it is known in advance that
decisions have been made that may affect the results of the review, sensitivity analysis should be
planned and noted in the protocol. During the course of the review, other study characteristics
may also be identified for inclusion in the sensitivity analysis. This is acceptable and should be
stated as a possibility in the protocol.

Resources
Cochrane Handbook Chapter 9
Acknowledgements
Acknowledge any individuals or organisations who may have made a sufficient contribution to
developing the protocol, (e.g. secretarial support, protocol referees, review advisory group
members) but are not included in the Contributions of Authors section. Please ensure you have
obtained permission to name these people in the protocol, otherwise a general acknowledgment
based on roles (our advisory group members, external peer referees of the protocol). It is not
necessary to acknowledge the support of specific people within the CPHG team who have helped
Last updated: 24 November 2011 - 18 -
you in developing the protocol. A broad acknowledgement of the CPHG team is quite adequate if
you wish to acknowledge the group.
Contributions of authors
Identify who has or will perform each of the following tasks (authors initials only):
Draft the protocol
Study selection
Extract data from studies
Enter data into RevMan
Carry out the analysis
Interpret the analysis
Draft the final review
Disagreement resolution
Update the review
Potential conflict of interest
You should report any conflict of interest of any of the authors, which may influence their
judgments in conducting the review, at protocol stage (refer to the summary of the
Collaborations policy on conflicts of interest in Chapter 2 (Section 2.6) of the Cochrane Handbook
for Systematic Reviews of Interventions for more information). This will include any present or
past affiliations or other involvement in any organisation or entity with an interest in the review
that might lead to a real or perceived conflict of interest. Areas of uncertainty should always be
discussed with the CPHG. Situations that might be perceived by others as being capable of
influencing a review authors judgements include personal, political, academic and other possible
conflicts, as well as financial conflicts. Authors must state if they have been involved in a study
that may be included in the review.

This section should reflect the information contained in authors Declarations of interest
statement within the Disclosure of Potential Conflicts of Interest Forms. You can access these
forms from within your Revman file by clicking File -> Reports -> Declaration of Interest (you will
receive a reminder from the editorial office to fill out electronically during the course of
completing your protocol if you have not done so already).

If there are no known conflicts of interest, this should be stated explicitly, for example, by writing
None known.
References - Other references
Additional references
References cited in the text should be listed here. Other reference categories (such as Included
Studies) are generally not used in a protocol, but will be used in the completed review.
References are referred to throughout the review using a Reference ID, usually comprising the
first authors surname and year of publication (e.g. Smith 2001), and all references must be linked
Last updated: 24 November 2011 - 19 -
from the text of the protocol using this ID. You can enter the references individually, or import
them from reference management software.

Instructions on entering, importing and linked references are available from the Help menu in
RevMan.

Please run the Citation wizard in Revman, to help identify other Cochrane reviews of potential
relevance to your review, to cite where appropriate in the protocol (and review thereafter).
Other published versions of the review
If the review has previously been published (e.g. in a journal or textbook) it should be listed here.

Completing our Checklist

Appendix 5 is a checklist we would like the author team to complete and send back when
submitting their protocol for editorial review. This will help ensure you have followed our
guidance and ensure speedier progress through this editorial stage.

Last updated: 24 November 2011 - 20 -
References
Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with
binary outcomes. Stat.Med. 21 (11):1575-1600, 2002.
Evans T, Brown H. Road traffic crashes: operationalizing equity in the context of health sector
reform. Inj Control Saf Promot. 2003 Mar-Jun;10(1-2):11-2.
Friedrich JO, Adhikari NKJ, Beyene J. The ratio of means method as an alternative to mean
differences for analyzing continuous outcome variables in meta-analysis: A simulation study. BMC
Medical Research Methodology 2008;8(32).
Ganann R, Fitzpatrick-Lewis D, Ciliska D, Dobbins M, Krishnaratne S, Beyers J, Fieldhouse P,
Delgado Noguera MF, Gauvin FP, Tort S, Hams SP, Martinez-Zapata MJ, Wolfenden L, Bonfill Cosp
X, Clay F. Community-based interventions for enhancing access to or consumption of fruit and
vegetables (or both) among five to 18-year olds (Protocol). Cochrane Database of Systematic
Reviews 2010, Issue 8. Art. No.: CD008644. DOI: 10.1002/14651858.CD008644.
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ
2003; 327(7414):557-60.
Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions
Version 5.0.0 [updated February 2008]. The Cochrane Collaboration. 2008. Available from
www.cochrane-handbook.org.
Kavanagh J, Oliver S, Caird J, Tucker H, Greaves A, Harden A, et al. Inequalities and the mental
health of young people: a systematic review of secondary school-based cognitive behavioural
interventions. London: EPPI-Centre, Social Science Research Unit, Institute of Education,
University of London.; 2009.
National Health Service: Centre for Reviews and Dissemination. Undertaking systematic reviews
of research on effectiveness. CRD's guidance for those carrying out or commissioning reviews.
CRD Report Number 4 (2nd Edition). 2001 [cited 2007 19 September]; Available from:
http://www.york.ac.uk/inst/crd/report4.htm.

Rees R, Oliver S, Harden A, Shepherd J, Kavanagh J, Burchett H, et al. Use of an advisory group to
ensure relevance: reflections on participation of stakeholders in a review of sexual health
promotion for men who have sex with men (MSM), in XII Cochrane Colloquium. 2004: Ottawa,
Canada.

Thomas BH, Ciliska D, Dobbins M, Micucci S. A process for systematically reviewing the literature:
providing the research evidence for public health nursing interventions. Worldviews Evid Based
Nurs, 2004. 1(3): p. 176-84.

Thompson SG and Pocock SJ. Can meta-analysis be trusted. Lancet 1991 Nov 2;338(8775):1127-
30.

Last updated: 24 November 2011 - 21 -
Appendix 1 Guidance for establishing a Review Advisory
Group
The Cochrane Handbook suggests the establishment of Review Advisory Groups to help reviewers
outline the parameters of their review. The establishment and management of an advisory group
can be difficult and potentially time-consuming but it is an important component in the initial
stages of review development and it can help establish appropriate review parameters so that
the end product reflects the needs of end users.

Systematic reviews are likely to be more relevant to the end user and of higher quality if they are
informed by advice from people with a range of experiences, in terms of both the topic and the
methodology (Rees 2004, Thomas 2004, NHS CRD 2001).

This guidance has been developed by the Cochrane Health Promotion and Public Health Field.

What is the role of a review advisory group?
Review Advisory Groups are established to help reviewers outline the parameters of their
proposed review to ensure that the end product reflects the needs of its potential readers and
users. Systematic reviews are likely to be more relevant to the end user and of higher quality if
they are informed by advice from people with a range of experiences.

Examples of opinions sought from the review advisory group:
Does the review question seem to capture the essence of the topic under review (will it
sound interesting and useful to its target audience)?
What interventions should be included in the review?
Which populations should be included in the review and which should be excluded?
What types of outcomes should the review include?
How should equity issues be highlighted in the review?
Are the needs of developing countries considered in the review?

How do I establish an advisory group?
The Cochrane entities with whom you are involved, especially Fields
(www.cochrane.org/contact/entities.htm#FIELDLIST), may be a useful source of advisory group
members. Many entities keep a database of members tagged with skills, special interests and
expertise. You should email relevant entity contacts and request for them to contact relevant
members.

Alternately, it may be appropriate for you to make contact directly with potential members with
known interest or expertise in the topic under review. It is important that you have set up tasks
or terms of reference for your advisory group prior to making contact with potential members.
This will ensure that roles and responsibilities are known from the outset.

Who should the members of the advisory group be?
Advisory groups are not intended to be another layer of peer-review. Nor are they intended to
assist with technical review support (e.g. statistical expertise). If you require this level of
assistance you should contact your review group or consider recruiting an additional reviewer
Last updated: 24 November 2011 - 22 -
with these skills to assist you. Advisory Group members should only be used to provide content-
related support, highlighting what end users of the review will want to have included in the
review. They may be able to direct you to additional studies and/or to provide background
information on the topic, particularly within the context of their local situation. This latter point
is a good reason why membership of the advisory group should be inclusive of people from
different parts of the world, to ensure the end review has relevance globally. . Experience by
Effective Public Health Practice Project in Canada suggests 6 members is an appropriate size for
the advisory group.

The members of your advisory group will vary depending on your review question. However, it
may be useful to consider members in the following categories:
Consumers (those with whom the intervention/s under review are targeted)
Content experts
Policy-makers
Practitioners (those implementing the intervention/s under review)

Who is responsible for coordinating the advisory group?
The lead author should take primary responsibility for coordinating the advisory group and
establishing a communication strategy that is acceptable to all (and reflective of the resources
available to the review team) . Contact should be made via the lead author in the first instance.
Lead authors should cc all authors into correspondence with advisory group members. It may also
be appropriate to cc others in (e.g. any Cochrane entities with whom you are involved).

What information does the lead author need to provide prospective advisory group members
with?
Potential members should be provided with adequate details about the review (title, authors
etc), preferably before the title is registered with a CRG.
They also may need information about the Cochrane Collaboration as all members may not be
familiar with Cochrane and the review process. Call for advisory group members should include a
clearly defined role, remits and boundaries (potentially a terms of reference document) and
timeline of tasks.

What processes need to be established for the advisory group to work effectively?
To ensure that your advisory group works effectively it is important that you establish roles and
responsibilities (You may want to formalise this in a terms of reference document). This will
ensure that authors and advisory group members are clear about the role of the advisory group.
Again, processes may differ although you should consider the following:

What is the role of each advisory group member (for example, will each answer concerns
about their area of expertise or experience only or the whole review)?
What tasks do you want them to complete?
What method of communication will be used and how frequently will the advisory group
members be consulted?
What workload is involved?
Are there timelines that need to be considered?
When does the work of the advisory group end (once the parameters for the protocol
have been accepted by the registering CRG?)
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How will advice be managed and what will happen if conflicting advice (or that quite
contrary to the reviewers beliefs) is offered?
Last updated: 24 November 2011 - 24 -
Appendix 2 - Public Health Group editorial process
The overall process of review development can be seen below:

On completion of the draft protocol it should be submitted to the Managing Editor who then
organises for an internal review of the protocol by your assigned Contact editor, methods
advisor, statistical editor, the trial search coordinator and, if appropriate, the CPHGs developing
countries editorial consultant. All the comments are compiled and sent to the author. Prompt
reply and amendment will ensure timely progression to the next stage external review.
Generally 3-4 external referees are recruited (composing of content experts,potential end users
and if appropriate and possible, a consumer). Once these referees have agreed to referee the
protocol the relevant documents are sent and there is an understanding that the comments
should be returned to the CPHG within two weeks.

All the comments are compiled by the Contact editor (with guiding comments added) and sent to
the author. Again, prompt reply and amendment will ensure quicker inclusion into The Cochrane
Library. On resubmission, the Contact editor and the Coordinating Editor will then review the
changes. Once the changes have been approved, the protocol will be sent to Wiley Publishes for
copy editing and thereafter the protocol marked by the Managing Editor for publication.
Thereafter all authors will be sent a Permission to Publish Form, along with the final version of
the protocol for approval, to sign. The protocol can NOT be published until this form is signed
(electronically) by ALL authors (therefore all authors need to be available to do so before
publication deadline).
Registration of title
Submission of
Protocol
(editorial
base)
Integration into
Public Health Group module
Publication in
Cochrane Library
Submission of
completed
review
(editorial base)
Review andcomments
6-12
months
3-6
months
4 weeks
6-8 weeks
Review and comments
Note:
Protocol/review
may undergo 2-3
drafts/reviews
before
acceptance for
publication
Last updated: 24 November 2011 - 25 -

The same editorial processes apply for review development and publication.
Last updated: 24 November 2011 - 26 -
Appendix 3 Risk of bias assessment
See Table 8.5.c (Criteria for judging risk of bias in the Risk of bias assessment tool) in Cochrane Handbook
for Systematic Reviews of Interventions.
Extract from Cochrane EPOC Data Collection Checklist for assessing risk of bias in controlled studies and
ITS

Source:
http://epocoslo.cochrane.org/sites/epocoslo.cochrane.org/files/uploads/Suggested%20risk%20o
f%20bias%20criteria%20for%20EPOC%20reviews.doc


6.4.1 Risk of bias for studies with a separate control group (RCTs, CCTs, CBAs)

Nine standard criteria are used for all RCTs, CCTs and CBAs. Further information can be obtained from the Cochrane
handbook section on Risk of Bias and from the draft methods paper on risk of bias under the EPOC specific resources
section of the EPOC website.

Was the allocation sequence adequately generated?
Score Yes if a random component in the sequence generation process is described (eg Referring to a random number table).
Score No when a nonrandom method is used (eg performed by date of admission). CCTs and CBAs should be scored No. Score
unclear if not specified in the paper.

Was the allocation adequately concealed?
Score Yes if the unit of allocation was by institution, team or professional and allocation was performed on all units at the start
of the study; or if the unit of allocation was by patient or episode of care and there was some form of centralised randomisation
scheme, an on-site computer system or sealed opaque envelopes were used. CBAs should be scored No. Score unclear if not
specified in the paper.

Were baseline outcome measurements similar?*
Score Yes if performance or patient outcomes were measured prior to the intervention, and no important differences were
present across study groups. In RCTs, score Yes if imbalanced but appropriate adjusted analysis was performed (e.g. Analysi s of
covariance). Score No if important differences were present and not adjusted for in analysis.** If RCTs have no baseline
measure of outcome, score Unclear.**

Were baseline characteristics similar?
Score Yes if baseline characteristics of the study and control providers are reported and similar. Score Unclear if it is not
clear in the paper (e.g. characteristics are mentioned in text but no data were presented). Score No if there is no report of
characteristics in text or tables or if there are differences between control and intervention providers. Note that in some cases
imbalance in patient characteristics may be due to recruitment bias whereby the provider was responsible for recruiting patients
into the trial.

Were incomplete outcome data adequately addressed?*
Score Yes if missing outcome measures were unlikely to bias the results (e.g. the proportion of missing data was similar in the
intervention and control groups or the proportion of missing data was less than the effect size i.e. unlikely to overturn the study
result). Score No if missing outcome data was likely to bias the results. Score Unclear if not specified in the paper (Do not
assume 100% follow up unless stated explicitly).

Was knowledge of the allocated interventions adequately prevented during the study? *
Score Yes if the authors state explicitly that the primary outcome variables were assessed blindly, or the outcomes are
objective, e.g. length of hospital stay. Primary outcomes are those variables that correspond to the primary hypothesis or
question as defined by the authors. Score No if the outcomes were not assessed blindly. Score unclear if not specified in the
paper.
Last updated: 24 November 2011 - 27 -

Was the study adequately protected against contamination?
Score Yes if allocation was by community, institution or practice and it is unlikely that the control group received the
intervention. Score No if it is likely that the control group received the intervention (e.g. if patients rather than professional s
were randomised). Score unclear if professionals were allocated within a clinic or practice and it is possible that communication
between intervention and control professionals could have occurred (e.g. physicians within practices were allocated to
intervention or control)

Was the study free from selective outcome reporting?
Score Yes if there is no evidence that outcomes were selectively reported (e.g. all relevant outcomes in the methods section are
reported in the results section). Score No if some important outcomes are subsequently omitted from the results. Score
unclear if not specified in the paper.

Was the study free from other risks of bias?
Score Yes if there is no evidence of other risk of biases


* If some primary outcomes were imbalanced at baseline, assessed blindly or affected by missing data and others were not, each
primary outcome can be scored separately.

**If UNCLEAR or No, but there is sufficient data in the paper to do an adjusted analysis (e.g. Baseline adjustment analysis or
Intention to treat analysis) the criteria should be re scored to Yes.


6.4.2 Risk of bias for interrupted time series studies

Seven standard criteria are used for all ITS studies. Further information can be obtained from the Cochrane
handbook section on Risk of Bias and from the draft methods paper on risk of bias under the EPOC specific resources
section of the EPOC website.

Note: If the ITS study has ignored secular (trend) changes and performed a simple t-test of the pre versus post
intervention periods without further justification, the study should not be included in the review unless reanalysis is
possible.

Was the intervention independent of other changes?
Score Yes if there are compelling arguments that the intervention occurred independently of other changes over time and the
outcome was not influenced by other confounding variables/historic events during study period. If Events/variables identified,
note what they are. Score NO if reported that intervention was not independent of other changes in time.

Was the shape of the intervention effect pre-specified?
Score Yes if point of analysis is the point of intervention OR a rational explanation for the shape of intervention effect was given
by the author(s). Where appropriate, this should include an explanation if the point of analysis is NOT the point of
intervention;Score No if it is clear that the condition above is not met

Was the intervention unlikely to affect data collection?
Score Yes if reported that intervention itself was unlikely to affect data collection (for example, sources and methods of data
collection were the same before and after the intervention); Score No if the intervention itself was likely to affect data
collection (for example, any change in source or method of data collection reported).

Was knowledge of the allocated interventions adequately prevented during the study?***
Score Yes if the authors state explicitly that the primary outcome variables were assessed blindly, or the outcomes are
objective, e.g. length of hospital stay. Primary outcomes are those variables that correspond to the primary hypothesis or
question as defined by the authors. Score No if the outcomes were not assessed blindly. Score unclear if not specified in the
paper.

Were incomplete outcome data adequately addressed?***
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Score Yes if missing outcome measures were unlikely to bias the results (e.g. the proportion of missing data was similar in the
pre- and post-intervention periods or the proportion of missing data was less than the effect size i.e. unlikely to overturn the
study result). Score No if missing outcome data was likely to bias the results. Score Unclear if not specified in the paper (Do
not assume 100% follow up unless stated explicitly).
Was the study free from selective outcome reporting?
Score Yes if there is no evidence that outcomes were selectively reported (e.g. all relevant outcomes in the methods section are
reported in the results section). Score No if some important outcomes are subsequently omitted from the results. Score
unclear if not specified in the paper.

Was the study free from other risks of bias?
Score Yes if there is no evidence of other risk of biases.
e.g. should consider if seasonality is an issue (i.e. if January to June comprises the pre-intervention period and july to December
the post, could the seasons have caused a spurious effect).

*** If some primary outcomes were assessed blindly or affected by missing data and others were not, each primary outcome can
be scored separately.

Last updated: 24 November 2011 - 29 -
Appendix 4 Data Extraction and Assessment Form


This form is to be modified in keeping with the following instructions. Some questions may be
changed from open-ended questions to specific data items where appropriate. Refer to the
Cochrane Handbook when undertaking modifications to this form.

Sections can be expanded and irrelevant sections can be removed. It is difficult to design a single
form that meets the needs of all reviews. It is therefore important that you consider your needs
carefully prior to data extraction and pilot your process. Elements within the template are not
intended for use as a scoring system, but rather suggests elements which should be addressed in
the Table of Included Studies and Comparisons and Data in RevMan. The components of the Risk
of Bias Table have been incorporated into this form. If you are using an additional quality
assessment tool you will need to add appropriate questions to reflect the additional components.

Notes on using a data extraction form:

Pilot the Data Extraction Form you plan on using (and note in your protocol that it will, or has,
been piloted)

Be consistent in the order and style you use to describe the information. This will make it
easier to complete the Table of Included Studies, prevent you from overlooking information
and make reading of the review easier.

Highlight any missing information as unclear or not described, to make it clear to the reader
of your review that the information was not included in the description of the study, not that
you forgot to extract it.

You should include instructions and decision rules on the data collection form. It is crucial that
you practice using the form and receive, or give, training if the form was designed by
someone other than the person using it.

Assessment of Risk of Bias has been adapted from Cochrane Handbook Table 8.5.a: The
Cochrane Collaborations tool for assessing risk of bias.
http://epocoslo.cochrane.org/sites/epocoslo.cochrane.org/files/uploads/How%20to%20prepare
%20a%20risk%20of%20bias%20table%20for%20reviews%20that%20include%20more%20than%2
0one%20study%20design.doc. Criteria for judging risk of bias as well as examples of appropriate
methods of addressing each form of bias are provided in Chapter 8 of the Cochrane Handbook,
particularly Table 8.5.c. For tips on how to enter data into RevMan 5, see Risk of Bias tables in
the RevMan User Guide.



Last updated: 24 November 2011 - 30 -




Data Extraction and Assessment Form template (cut and paste and modify to suit your
review)

Study ID: Report ID : Date form completed:
First author: Year of study: Data extractor:
Citation:


1. General Information
Publication type Journal Article Abstract Other (specify e.g. book chapter)___________________
Country of study:
Funding source of study: Potential conflict of interest from funding? Y / N / unclear

2. Study Eligibility
Study Characteristics Page/
Para/
Figure #
Type of study
(Review authors
to add/remove
designs based on
criteria specified
in protocol)
Randomised Controlled Trial (RCT)
Cluster Randomised Controlled Trial
(cluster RCT)

Controlled Before and After (CBA) study
Contemporaneous data collection
Comparable control site
At least 2 x intervention and 2 x
control clusters

Interrupted Time Series (ITS)
At least 1 time point before
and 1 after the intervention
Clearly defined intervention
point
Other design (specify):



A process evaluation of an included
study design
Does the study design meet the criteria for
inclusion?
Yes No Exclude Unclear

Description in text:





Last updated: 24 November 2011 - 31 -
Participants
(Review authors
insert inclusion
criteria as
defined in
Protocol)
Describe the participants included:


Are participants defined as a group
having specific social or cultural
characteristics?
Yes No Unclear
Details:

How is the geographic boundary
defined?
Details:
Specific location (e.g. state / country):

Do the participants meet the criteria
for inclusion?
Yes No Exclude Unclear

Types of
intervention
(Review authors
insert inclusion
criteria as
defined in
Protocol)
Strategies included in the
intervention

Focus of the intervention
Does the intervention meet the
criteria for inclusion?
Yes No Exclude Unclear
Duration of
intervention
Start date: Stop date: Intervention duration:
Is the duration of intervention
adequate for inclusion?
Yes No Exclude Unclear
Types of
outcome
measures
(Review authors
insert inclusion
criteria as
defined in
Protocol)
List outcomes:
Outcome measured at a population
level or individual level?
Details:
Do the outcome measures meet the
criteria for inclusion?
Yes No Exclude Unclear

Last updated: 24 November 2011 - 32 -
Summary of Assessment for Inclusion
Include in review Exclude from review
Independently assessed, and then compared? Yes
No
Differences resolved Yes No
Request further details? Yes No Contact details of authors:

Notes:



DO NOT PROCEED IF PAPER EXCLUDED FROM REVIEW

3. Study details
Study intention Descriptions as stated in the report/paper Page/
Para/
Figure #
Aim of intervention

What was the problem that this intervention was designed to address?



Aim of study

What was the study designed to assess? Are these clearly stated?



Equity pointer:
Social context of
the study
e.g. was study conducted in a particular setting that might target/exclude specific
population s? See also Inclusion/exclusion criteria under Methods, below.

Start and end date
of the study
Identify which elements of planning of the intervention should be included
Total study
duration


Methods

Descriptions as stated in the report/paper

Page/
Para/
Figure #
Method/s of recruitment of participants
(How were potential participants approached and
invited to participate? Where were participants
recruited from? Does this differ from the intervention
setting?)

Inclusion/exclusion criteria for participation in study


Representativeness of sample: Are participants in the
study likely to be representative of the target
population?

Total number of intervention groups
Assumed risk estimate
(e. .baseline or population risk noted in Background)
References:
Sample size calculation:
What assumptions were made?
Were these assumptions appropriate?


(Yes/No/Unclear)

Last updated: 24 November 2011 - 33 -
What was the unit of randomisation?
Allocation by individuals or cluster/groups

What was the unit of analysis?
Is this the same as the unit of randomisation?


(Yes/No/Unclear)

Statistical methods used and appropriateness of
these methods
(Check with your statistician if unsure about
appropriateness)





Results
Participants
Include if relevant
Include information for each group (i.e. intervention and controls)
under study


Page/
Para/
Figure #
What percentage of selected
individuals agreed to
participate?

Total number randomised (or
total pop. at start of study for
NRCTs)

Number allocated to each
intervention group (no. of
individuals)

For cluster trials, number of
clusters, number of people per
cluster

Where there any significant
baseline imbalances?
Yes No Unclear
Details:

Number and reason for (and
sociodemographic differences
of) withdrawals and exclusions
for each intervention group

Were patients who entered the
study adequately accounted
for?


What percentage of patients
completed the study?


What percentage of participants
received the allocated
intervention or exposure of
interest?

Is the analysis performed by
intervention allocation status
(intention to treat) rather than
the actual intervention
received? Have any attempts
been made to impute missing
data?

Age (median, mean and range if
possible)

Sex
Last updated: 24 November 2011 - 34 -
Race/Ethnicity


Principal health problem (incl.
stage of illness)


Diagnostic criteria


Co-morbidity




Other sociodemographics (eg.
Educational level, literacy level,
soci-economic status, first
language. Also consider possible
proxies for these e.g. low
baseline nutritional status )

PROGRESS categories reported
at baseline (indicate letters of
those reported: Place of
residence, race, occupation,
gender, religion, education, SES,
social capital)


Subgroups Enter a description of any participant subgroups from this paper to
be analysed in the review.





Intervention Group 1
(copy and paste table for each Intervention group)
Group name: (State brief name for this intervention group.) Page/
Para/
Figure #
Details of intervention or control condition (Include if relevant in sufficient detail for replication)
Setting eg multicentre, university
teaching hospitals, rural,
metropolitan, school, workplace,
community, GP clinic, etc.


Theoretical basis (include key
references)


Content (list the strategies
intended and delivered)


Did the intervention include
strategies to address
diversity/disadvantage?
Enter a description of any relevant strategies
Delivery (eg. Stages (sequential
or simultaneous), timing,
frequency, duration, intensity,

Last updated: 24 November 2011 - 35 -
fidelity process indicators)

Providers (who, number,
education/training in
intervention delivery, ethnicity
etc. if potentially relevant to
acceptance and uptake by
participants



Co-interventions


Duration of intervention
Duration of follow-up


Was sustainability discussed by the
authors? Was is a consideration in
study development?

Economic variables
ie costs of the intervention, and
changes in other (eg health care)
costs as result of intervention
Yes List in Outcome section if appropriate
No Unclear
Details:

Other economic information (from a
societal, non-healthcare view e.g.
lost wages, time)
Yes
No
Details:

Resource requirements to replicate
intervention (e.g. staff numbers,
hours of implementation,
equipment?)

Subgroups Enter a description of any intervention subgroups from this report to
be analysed in the review.

What are the moderators/mediators
of changes stated in the study?

Do the authors describe any political
or organisational context?
List relevant dot points
Were any partnerships referred to? List these as dot points
Was a process evaluation
conducted?
What components were included in the process evaluation? (eg.
dose, frequency, consistency, implemented as intended etc)

Control/comparison (what
information is provided about what
the control or comparison group
received?)
Enter a description of what was provided for the control group, if
applicable



Outcomes
(This table is set up for 2 outcome measure to save spaces, copy and paste table as often as required)

Costs associated with the intervention can be linked with provider or participant outcomes in an
economic evaluation (depends on the type of economic evaluation)
Last updated: 24 November 2011 - 36 -
Question Outcome 1 Page/
Para/
Figure #
Outcome 2 Page/
Para/
Figure #
Is there an analytic
framework applied (e.g.
logic model, conceptual
framework)?

Outcome definition
(with diagnostic criteria
if relevant)

Type of outcome: Is this
a modifiable variable
(Community level,
neighbourhood level,
individual level) or
desired health outcome


Time points measured


Time points reported
Is there adequate
latency for the outcome
to be observed?

Is the measure repeated
on the same individuals
or redrawn from the
population / community
for each time point?

Unit of measurement (if
relevant)

For scales upper and
lower limits and indicate
whether high or low
score is good


How is the measure
applied? Telephone
survey, mail survey, in
person by trained
assessor, routinely
collected data, other

How is the outcome
reported? Self or study
assessor

Is this outcome/tool
validated?

And has it been used
as validated?

Is it a reliable outcome
measure?

Is there adequate power
for this outcome?


Last updated: 24 November 2011 - 37 -
Were PROGRESS
categories analysed by
outcome? Indicate the
letters of those that
outcomes were
analysed by (place of
residence, race,
occupation, gender,
religion, education, SES,
social capital)



Last updated: 24 November 2011 - 38 -
Results
Copy and paste the appropriate table for each outcome and subgroup at each timepoint,
including baseline

For RCT/CCT
Dichotomous outcome
page/para/fig
Comparison

Outcome

Subgroup

Timepoint

Results Intervention Comparison

Events No. participants Events No. participants


No. of missing
participants
and reasons





Any other
results
reported

Reanalysis
required?
(specify -
(e.g. correlation
adjustment)


Reanalysis
possible?
yes/no/unclear

Reanalysed
results



For RCT/CCT
Continuous outcome page/para/fig
Comparison

Outcome

Subgroup

Timepoint

Post-
intervention
or change
from
baseline?

Results Intervention Comparison

Mean SD (or
other
variance)
No.
participants
Mean SD (or
other
variance)
No. participants


No. missing
participants
and reasons

Any other
results

Last updated: 24 November 2011 - 39 -
reported
Reanalysis
required?
(specify)


Reanalysis
possible?
yes/no/unclear

Reanalysed
results



For RCT/CCT
Generic inverse variance method
Page/para/figure
Comparison

Outcome

Subgroup

Timepoint

Results Effect estimate SE (or other variance) Intervention no. Control no.


No. missing
participants
and reasons

Any other
results
reported

Reanalysis
required?
(specify)


Reanalysis
possible?
yes/no/unclear

Reanalysed
results



For CBA
Page/para/fig
Comparison

Assignment How were control and treatment groups selected?? Is there likely to be an
effect if these were the opposite way?


Contemporaneous data collection?


Outcome

Subgroup

Timepoint

Post-
intervention or
change from
baseline?


Intervention Comparison
No.
participants
measured

Last updated: 24 November 2011 - 40 -
No. missing
participants
and reasons

Baseline result
(with variance
measure)

Post-
intervention
results (with
variance
measure)

Change (Post
baseline) (with
variance
measure)

Difference in
change
(intervention
control) (with
variance
measure)

Any other
results
reported

Reanalysis
required?
(specify)


Reanalysis
possible?
yes/no/unclear

Reanalysed
results



For ITS
Generic inverse variance method
Page/para/fig
Comparison

Outcome

Subgroup

Length of
timepoints
measured

Snapshot or
interval
measured


No.
participants
measured

No. missing
participants
and reasons


Pre-intervention Post-intervention
No. of
timepoints
measured

Last updated: 24 November 2011 - 41 -
Mean value
(with variance
measure)

Difference in
means (post
pre)

Percent
relative
change

Result
reported by
authors (with
variance
measure)

Reanalysis
required?
(specify)


Reanalysis
possible?
yes/no/unclear

Individual time
point results


Read from
figure?
yes/no

Reanalysed
results
Change in level SE Change in slope SE


Last updated: 24 November 2011 - 42 -
Other relevant information

Were outcomes relating to harms/unintended
effects of the intervention described? Include any
data for these in the outcomes tables above

Potential for author conflict ie. evidence that
author or data collectors would benefit if results
favoured the intervention under study or the
control

Key conclusions of the study authors



Could the inclusion of this study potentially bias
the generalisability of the review? Equity pointer:
Remember to consider whether disadvantaged
populations may have been excluded from the
study.

Is there potential for differences in relative effects
between advantaged and disadvantaged
populations? (e.g. are children from lower income
families less likely to wear bicycle helmets)

Are interventions likely to be aimed at the
disadvantaged? (e.g. school meals aimed at poor
children).

Issues affecting directness
(Note any aspects of population, intervention, etc.
that affect this studys direct applicability to the
review question)

References to other relevant studies
Additional notes by review authors


Correspondence required for further study
information (from whom, what and when)




Last updated: 24 November 2011 - 43 -
Risk of bias assessment
Please refer to Chapter 8 - Table 8.5.c: Criteria for judging risk of bias in the Risk of bias
assessment tool and to the Cochrane EPOC Groups guidance for assessing Risk of bias for studies
with a separate control group (RCTs, CCTs, CBAs) and Risk of bias for interrupted time series
studies (Appendix 3) for additional guidance for scoring Yes/No/Unclear. Note that the table
below includes items from both EPOC tools. The ITS tool has been incorporated into the bottom
of the table and all items for ITS studies are denoted by ITS preceding the risk of bias question.
Domain Review
authors
judgement*
Description Page/
Para/
Figure #
Was the allocation
sequence
adequately
generated?
Yes / No /
Unclear
Describe the method used to generate the allocation sequence in
sufficient detail to allow an assessment of whether it should
produce comparable groups.


Was allocation
adequately
concealed?
Yes / No /
Unclear
Describe the method used to conceal the allocation sequence in
sufficient detail to determine whether intervention allocations
could have been foreseen in advance of, or during, enrolment.

Were baseline
outcome
measurements
similar?
Yes/No/Uncl
ear
Note whether baseline outcome measurements were reported and
whether there were any important differences between groups. If
there were important differences between groups, note whether
appropriate adjusted analysis was performed to account for this.

Were baseline
characteristics
similar?
Yes/No/Uncl
ear
Note whether baseline characteristics were reported and whether
there were any important differences between groups.

Were incomplete
outcome data
adequately
addressed?
Assessments should
be made for each
main outcome (or
class of outcomes).
Yes / No /
Unclear

Describe the completeness of outcome data for each main
outcome, including attrition and exclusions from the analysis. State
whether attrition and exclusions were reported, the numbers in
each intervention group (compared with total randomized
participants), reasons for attrition/exclusions where reported, and
any re-inclusions in analyses performed by the review authors.


Was knowledge of
the allocated
intervention
adequately
prevented during
the study?

Separate
assessments should
be made for
relevant groups of
Yes / No /
Unclear

Describe all measures used, if any, to blind study participants and
personnel from knowledge of which intervention a participant
received. Provide any information relating to whether the intended
blinding was effective, or whether blinding was appropriate.
Participants yes, no, unclear [record supporting statement
from study].

Investigators yes, no, unclear [record supporting statement
from study].

Outcomes assessors yes, no, unclear [record supporting

Last updated: 24 November 2011 - 44 -
people involved in
the study i.e
participants,
outcome assessors,
investigators, data
assessors etc
statement from study].

Data assessors yes, no, unclear [record supporting statement from
study].
Was the study
adequately
protected against
contamination?
Yes/No/Uncl
ear
State whether and how the possibility of contamination was
minimised by the study design/implementation.

Are reports of the
study free of
suggestion of
selective outcome
reporting?
Assessments should
be made for each
main outcome (or
class of outcomes).
Yes / No /
Unclear

State how the possibility of selective outcome reporting was
examined by the review authors, and what was found.

Other sources of
bias

Yes / No /
Unclear



State any important concerns about bias not addressed in the
other domains in the tool.


ITS: Was the
intervention
independent of
other changes?
Yes/No/Uncl
ear
Describe whether or not the intervention occurred independently
of other changes over time and whether or not the outcomes may
have been influenced by other confounding variables/historic
events during the study period.

Last updated: 24 November 2011 - 45 -
ITS: Was the shape
of the intervention
effect pre-specified?
Yes/No/Uncl
ear
State whether or not the point of analysis was the point of
intervention. If not, describe whether a rationale for the shape of
the intervention effect was given by the study authors.

ITS: Was the
intervention
unlikely to affect
data collection?
Yes/No/Uncl
ear
Describe whether or not the intervention was likely to affect data
collection and what the potential impact might have been.

ITS: Was knowledge
of the allocated
interventions
adequately
prevented during
the study?

Separate
assessments should
be made for
relevant groups of
people involved in
the study i.e
participants,
outcome assessors,
investigators, data
assessors etc
Yes/No/Uncl
ear
Describe all measures used, if any, to blind study participants and
personnel from knowledge of which intervention a participant
received. Provide any information relating to whether the intended
blinding was effective, or whether blinding was appropriate.
Participants yes, no, unclear [record supporting statement
from study].

Investigators yes, no, unclear [record supporting statement
from study].

Outcomes assessors yes, no, unclear [record supporting
statement from study].

Data assessors yes, no, unclear [record supporting statement from
study].

ITS: Was incomplete
outcome data
adequately
addressed?

Assessments should
be made for each
main outcome (or
class of outcomes).
Yes/No/Uncl
ear
Describe the completeness of outcome data for each main
outcome, including attrition and exclusions from the analysis. State
whether attrition and exclusions were reported, the numbers in
each intervention group (compared with total randomized
participants), reasons for attrition/exclusions where reported, and
any re-inclusions in analyses performed by the review authors.


ITS: Was the study
free from selective
reporting?
Yes/No/Uncl
ear
State how the possibility of selective outcome reporting was
examined by the review authors, and what was found.

Last updated: 24 November 2011 - 46 -
ITS: Was the study
free from other
risks of bias?
Yes/No/Uncl
ear
State any important concerns about bias not addressed in the
other domains in the tool.


* Note: For each section above Yes indicates a low risk of bias; No indicates a high risk of bias; Unclear
indicates an uncertain risk of bias. When entering the data into RevMan, the options to choose from will be Low,
High and Unclear


Last updated: 24 November 2011 - 47 -
Results

Comparison:
Outcome:
Subcategory:

Treatment group: Control group:
Observed (n) total (N) observed (n) total (N)


Treatment group: Control group:
Total randomised
excluded*
Observed
lost to follow up*

*Reasons for loss/exclusion:



Subcategory:

Treatment group: Control group:
Observed (n) total (N) observed (n) total (N)


Treatment group: Control group:
Total randomised
excluded*
Observed
lost to follow up*

*Reasons for loss/exclusion



Last updated: 24 November 2011 - 48 -
Appendix 5 Checklist for submission
This checklist should be cut and pasted, completed and sent with your protocol to the referees. Please ensure all
sections have been addressed by your protocol. This will speed up the process and ensure your protocol is quickly
included on the Cochrane Library. Please remove this section and use to check your protocol before submitting to
the Coordinator.
Title
Is the title consistent with the one originally approved by the CPHG?
Background
Does the background support the need for a systematic review by providing sufficient
information on the frequency and severity of the problem/public health issue and the
uncertainties in its management?
Objective/s
Is the main objective of the review specified in terms of intervention(s), issue being addressed,
population and outcomes (both beneficial and harmful)?
To evaluate the benefits and harms of various initiatives that aim to ensure adequate access for all to food in
communities within developed countries.
Selection criteria
Types of studies
Have you adequately identified which study designs will be included?
Is there a rationale provided for why the study designs have been included/excluded?
Types of participants
Are the characteristics of the issue being addressed and the population with whom the
intervention is targeted described adequately?

Have the population groups to be excluded been specified?

Have the appropriate population groups been excluded?
Types of interventions
Have the study interventions been described?
Have the control interventions been described?
Have all relevant interventions for the issue being addressed and question asked been
identified?
Have the interventions to be excluded been described?
Last updated: 24 November 2011 - 49 -
Are the interventions to be excluded appropriate?
Types of outcome measures
Are the outcome measures for benefits and harms of the intervention(s) clearly defined in
nature and in timing?
Are the outcome measures used important to the population with whom the intervention is
targeted?
Have all relevant outcomes (both beneficial and harmful) been included?
If specific outcomes have not been included, does this conform to the question asked?
Search methods for identification of studies
Has the search strategy been included and are the search terms appropriate?
Are the dates that each source will be searched indicated?
Does the search strategy include contacting experts in the field?
Have the appropriate subject headings, key words and text words for the clinical problem and
population been used?
Has the Cochrane Collaboration search strategy to identify RCTs been used?
Has the Trials Search Coordinator been contacted?
Are studies in languages other than English to be included?
Has the team considered how duplicate publications of the same study will be identified and
dealt with?
Will the following data sources be searched?
The Cochrane Public Health Group specialised register
Cochrane Central Register of Controlled Trials (CENTRAL) (most recent)
MEDLINE (from 1950 - )
EMBASE (from 1980 - )
Other databases relevant to the review topic
Reference lists of textbooks, reviews (including previous systematic reviews), and previous
trials
Conference proceedings
Assessment of risk of bias
Have the criteria to be used to assess the individual studies risk of bias been reported?
Does the criteria to be used to assess study bias include:-
Sequence generation
Last updated: 24 November 2011 - 50 -
Allocation concealment
Blinding
o Participants
o Investigators
o Outcome assessment
o Data assessors
Incomplete outcome data
Selective outcome reporting
Other potential biases
Methods of the Review
Will at least two authors of the review:-
Perform the literature search?
Determine study eligibility?
Assess study quality?
Extract data?
Enter data in RevMan?
Will authors work independently?
Will consensus and/or liaison with a third author be used to resolve disagreement between
the primary authors?
Will authors of primary studies be contacted for clarification of unclear data or to obtain
missing information?
Will you attempt to analyse for possible publication bias using funnel plots or other methods?
Will plausible explanations for variations in treatment effect be explored using subgroup
analysis based on study quality, population and interventions?
Statistical analysis
Will the results of primary studies be reported with 95% confidence intervals using relative risk
(RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes?
Have the methods used to pool the results of the primary studies been reported?
Are these methods relevant?
Will RR and MD summary statistics be calculated using a random effects model?
Example of text: Statistical analysis will be performed using RevMan. For dichotomous outcomes (relapse or no
relapse) results will be expressed as relative risks with 95% confidence intervals. Data will be pooled using the
random effects model. Where continuous scales of measurement are used to assess the effects of treatment (e.g.
time to relapse), the weighted mean difference will be used, or the standardised mean difference if different scales
have been used
Have you stated how you will test for heterogeneity?
Example of text: Heterogeneity will be analysed using the Cochran Q test on N-1 degrees of freedom, with an of
0.1 used for statistical significance.
Last updated: 24 November 2011 - 51 -

Have you specified how you will determine the applicability of the results to individuals?
Example of text: Calculation of absolute risk reductions with intervention in relation to different baseline risk of
the event with no intervention or a different intervention.
Acknowledgements
Have you acknowledged all the relevant people and/or organizations?
Declarations of interest
Have you and your coauthors declared any potential conflicts of interest?
References
Have you checked your references?
Sources of support
Have you listed your internal sources of support (e.g. hospital, university)?
Have you listed your external sources of support (e.g. scholarship, bursaries)?

OTHER
Have you completed and are including with your protocol submission, the Health Equity
Checklist?