Review proposal form: intervention reviews

Email the completed form to Denise Atherton (), or send to Cochrane Pregnancy and Childbirth, Women’s and Children’s Health, Institute of Translational Medicine, University of Liverpool, First Floor, Liverpool Women’s NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UK. Tel: +44 151 7959570.

Before completing this form:

·  Make sure your proposal falls within the scope of Cochrane Pregnancy and Childbirth.
·  Ensure that your proposed review is not already covered in another Cochrane review published in The Cochrane Library (http://www.thecochranelibrary.com/view/0/index.html). Also, check existing registered titles at http://pregnancy.cochrane.org/whats-new.
·  Note that all authors must follow the Cochrane Handbook for Systematic Reviews of Interventions (see http://handbook.cochrane.org/).
·  Be aware that preparing a Cochrane review requires a significant, long-term commitment. At least two authors are required before a title can be registered and the review team must include at least one experienced Cochrane review author who has hands-on experience of preparing a Cochrane review with Cochrane Pregnancy and Childbirth.
·  Plagiarism - A Cochrane proposal, protocol and review should be an original piece of work produced by the team of review authors. Where review authors report other sources, this should include an appropriate citation and be paraphrased in the review authors’ own words rather than copied word-for-word from the original source. Where more than a few words of the original text is used this should be placed within quotation marks and a citation provided to demonstrate where the text has been taken from. Cochrane Pregnancy and Childbirth now use formal plagiarism software to detect plagiarism at all stages of a Cochrane review. The Cochrane Collaboration has a policy relating to plagiarism, how to avoid it, and what happens when plagiarism is suspected – for more information, see http://community.cochrane.org/editorial-and-publishing-policy-resource/plagiarism.
·  (To activate a yes/no check boxes in this form double click the box and change the default value to ‘checked’)

Proposed title (using standard format)

(Include the word ‘for’ in the title; for example, [intervention] FOR [health problem]; ‘[Intervention A] versus [intervention B] FOR [health problem]’ (see section 4.2.1 of the Cochrane Handbook))

Contact person

This person will be responsible for communicating with the Review Group on behalf of the author team and for co-ordinating the development of the proposal, the protocol and review (see section 4.2.3 of the Cochrane Handbook).
Name:

Reason for writing this review

Why are you proposing to undertake this review? For example, is this review going to be part of a Masters or Doctorate; is it part of a larger project; is it particularly topical at the present time; is it needed to inform a local or national clinical or practice guideline?

Objectives of the proposed review

Give a short statement of the primary aim of the review (see section 4.5 of the Cochrane Handbook).

Background

(See section 4.5 of the Cochrane Handbook for more information)

Well-formulated review questions occur in the context of an already-formed body of knowledge. The background should address this context, help set the rationale for the review, and explain why the questions being asked are important. It should be concise (about half a page for each of the four sections) and be understandable to the users of the intervention under investigation. All sources of information should be supported by an appropriate citation and all citations should be listed in the ‘Supporting references’ section below.
1.  Description of the condition (no more than half a page text)
2.  Description of the intervention (no more than half a page text)
3.  How the intervention might work (no more than half a page text)
4.  Why it is important to do this review (no more than half a page text)
Supporting references
(references should follow the Cochrane Style Guide – see http://community.cochrane.org/sites/default/files/uploads/Cochrane-Style-Guide_4-1-edition.pdf )

Methods

(see section 4.5 of the Cochrane Handbook for more information -

Types of study:
(section 5.5) / Randomised controlled trials (RCTs) Yes
Quasi-RCTs? Yes/No?
Cluster-RCTs? Yes/No?
Studies published in abstract form only? Yes/No?
Cross-over studies? Yes/No (not recommended)
NOTE: it is our group’s policy to restrict our reviews to RCTs although information from other study designs can be included in the background and discussion but must not inform the results, conclusions or recommendations of the review.
Participants/ population: / Outline the types of populations to be included and excluded, with thought given to aspects such as demographic factors, the type/stage of disease/condition, or their setting. See Handbook section 5.2.
Intervention: / Outline the details of the intervention you wish to investigate. Consider the dose, intensity, mode of delivery, and combinations of interventions. Are there variations you wish to exclude? See Handbook section 5.3.
Comparison: / What will the intervention be compared to, e.g. placebo, no intervention, standard care? See Handbook section 5.3.
Outcomes and adverse effects: (section 5.4) / List the primary and secondary outcomes you wish to measure, including outcomes important to those experiencing the disease/condition as well as those treating them. Give thought to the inclusion of adverse effects as a primary outcome. Also consider how your outcomes may be measured, e.g. the type of scale or count likely to be used, and the timing of the measurement. See Handbook section 5.4.
Primary outcomes: / Note:
a)  No more than seven outcomes main outcomes should be selected for use in a Summary of Findings table.
b)  Are there any core outcomes available for this topic?
Secondary outcomes:
Subgroup analyses: (section 9.6) / Outline any subgroups you plan to investigate for their influence on the size of the treatment effect, e.g. subgroups of the population, variations of the intervention, etc. (see Handbook section 9.6). NOTE: subgroup analyses are usually restricted in number and only carried out for the review’s primary outcomes.
______versus ______
______versus ______

Use of GRADE and preparing a Summary of Findings (SoF) table

You will be required to demonstrate a thorough understanding of GRADE and be able to produce a SoF table in your review (that you have first created using GRADEProGDT software (http://www.guidelinedevelopment.org/)).
Before submitting this proposal please ensure that at least one member of your team visits the Cochrane Training webpage and watches all of the slidecast presentations/webinars surrounding this topic, see http://training.cochrane.org/authors/grade-and-sof-tables.
Declaration statement: the following team members have read the PCG GRADE/SoF information sheet and completed the online training slidecasts/webinars.
Name: Date completed:
Name: Date completed:
Other information: / Outline any other factors you plan to consider in your review, or other information you would like to provide, e.g. relevance to consumers, how this review complements other published Cochrane reviews.
Cross referencing other Cochrane reviews
Proposals for new Cochrane reviews should not overlap with current publications or work underway. Cochrane reviews should cite other relevant Cochrane reviews (for example, when describing alternative interventions and any effects of the interventions when used for other health conditions or in relation to how the findings of the review compare and contrast with other Cochrane reviews). Please cite here other Cochrane reviews, in progress or published that are relevant to your proposal.

Authors' responsibilities

By completing this form, you accept responsibility for preparing, maintaining and updating the review in accordance with Cochrane Collaboration policy.
A draft protocol and full review must be submitted to Cochrane Pregnancy and Childbirth within the timescales agreed with the PCG editorial base. If the drafts are not submitted by the agreed deadlines, or if we are unable to contact you for an extended period, Pregnancy and Childbirth has the right to de-register the title or transfer the title to another review team.
Cochrane Pregnancy and Childbirth has the right to de-register or transfer the title if the draft protocol or review does not meet the standards of the Group and/or Cochrane or if the draft contains text that has been plagiarised from another source*.
By completing this form, you accept responsibility for maintaining the review in the light of new evidence, comments and criticisms and other developments, and updating the review at least once every two years or, if requested, transferring responsibility for maintaining the review to others as agreed with Cochrane Pregnancy and Childbirth.

Publication in the Cochrane Database of Systematic Reviews

The support of the CRG in preparing your review is conditional upon your agreement to publish the protocol, finished review and subsequent updates the Cochrane Database of Systematic Reviews. By completing this form you undertake to publish this review in the Cochrane Database of Systematic Reviews before publishing elsewhere (concurrent publication in other journals may be allowed in certain circumstances with prior permission from the CRG).
I understand the commitment required to undertake a Cochrane Review, and agree to publish first in the Cochrane Database of Systematic Reviews.
Signed on behalf of the authors:
Form completed by: Date:

Do any of the authors have any potential conflict of interest in this topic?

Cochrane's general policy states: "Cochrane Reviews must be free of any real or perceived bias introduced by any financial relationships or other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing the Cochrane Protocol or Review." (see Cochrane Editorial and Publishing Policy Resource: Conflicts of interest and Cochrane Reviews).
Do the authors have any potential conflict of interest in this topic? Yes No
If yes, please give details

Review context

Is the review subject to any specific funding?
Is there a deadline for completing the review?
Has the review already been completed or published elsewhere?

Review authors

(see Handbook section 4.2.2)
Provide contact details for everyone who you expect to be an author of the review. For more information on authorship, see Handbook section 4.2.2. Each person named as an author must make a substantial contribution to the conception and design, or analysis and interpretation of the data in the review. Please attach a brief CV for each author.
Your team should have at least two authors, and should include someone with relevant content area expertise and someone with hands-on experience in preparing a Cochrane systematic review with Cochrane Pregnancy and Childbirth.
Your team must possess, or have access to, the statistical skills required to extract, manipulate and interpret data from the included studies. Incorporating the perspectives of those affected by the intervention is highly recommended. Authors are responsible for ensuring the review will be updated in future.

Contact person/Author 1

(see Handbook section 4.2.3)
(To activate a yes/no check boxes in this form double click the box and change the default value to ‘checked’)
Contact details for this person will be published with the completed protocol or review.
Prefix (e.g. Ms, Dr): / First name (名字 míngzi):
Middle initial(s): / Family name (姓 xìng):
Suffix (e.g. MD, PhD): / Web address:
Preferred full name for review byline: / e.g. John Smith = Smith JB; Chen Ming Yu = Chen MY
Do you already have a user account and password for the Archie database? / Yes No
Email address(es): / 1)
2)
Job Title/Position:
Department:
Organisation:
Street/Address:
City: / Post/Zip code:
State/Province: / Country:
Telephone number: / Fax number:
Mobile/cell number:
Privacy: / As the contact person, your address and email will be published with the completed protocol or review. Your details will be stored on our central database, known as 'Archie', and may be accessed by Cochrane contributors. See Archie Privacy Policy. Within Archie, would you like to:
Hide your address and phone numbers: Hide your email address:
Country of origin: / Gender: / Female Male
What expertise do you bring to the review? (e.g. clinical, review methods, statistics)
Have you prepared a systematic review before? / Yes No
If yes, have you prepared a Cochrane Review?
If yes, please state most recent title: / Yes No
Are you already a member of another Cochrane Review Group?
If yes, which one(s)? / Yes No
At what level are you able to speak and write English?
Translating trials published in languages other than English is a vital role in Cochrane. If you speak any other languages and would be willing to do partial translations on behalf of other author teams, please let us know. / Yes, I would be willing to assist with translation of clinical trials published in the following language(s):
Note: if your proposal is accepted, we will automatically subscribe you to PCG-info, our Group’s email information/discussion list.

Author 2

You must have at least two authors to register a title.
You can copy this table (as many times as required) for additional authors. All authors must be listed within your proposal.
Prefix (e.g. Ms, Dr): / First name (名字 míngzi):
Middle initial(s): / Family name (姓 xìng):
Suffix (e.g. MD, PhD): / Web address:
Preferred full name for review byline: / e.g. John Smith = Smith JB; Chen Ming Yu = Chen MY
Do you already have a user account and password for the Archie database? / Yes No
Email address(es): / 1)
2)
Job Title/Position:
Department:
Organisation:
Street/Address:
City: / Post/Zip code:
State/Province: / Country:
Telephone number: / Fax number:
Mobile/cell number:
Privacy: / As the contact person, your address and email will be published with the completed protocol or review. Your details will be stored on our central database, known as 'Archie', and may be accessed by Cochrane contributors. See Archie Privacy Policy. Within Archie, would you like to:
Hide your address and phone numbers: Hide your email address:
Country of origin: / Gender: / Female Male
What expertise do you bring to the review? (e.g. clinical, review methods, statistics)
Have you prepared a systematic review before? / Yes No
If yes, have you prepared a Cochrane Review?
If yes, please state most recent title: / Yes No
Are you already a member of another Cochrane Review Group?
If yes, which one(s)? / Yes No
At what level are you able to speak and write English?
Translating trials published in languages other than English is a vital role in Cochrane. If you speak any other languages and would be willing to do partial translations on behalf of other author teams, please let us know. / Yes, I would be willing to assist with translation of clinical trials published in the following language(s):
Note: if your proposal is accepted, we will automatically subscribe you to PCG-info, our Group’s email information/discussion list.

Roles and responsibilities