Review proposal form for existing review teams

Email the completed form to Frances Kellie (f.kellie@liverpool.ac.uk), 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: 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 review can proceed 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 – Cochrane evidence 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. Text from other sources should not be copied word-for-word from the original source (this is plagiarism). 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 (including the review proposal stage). 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 is the person who is will be responsible for communicating with Cochrane Pregnancy and Childbirth on behalf of the author team and for co-ordinating the development of the review (see section 4.2.3 of the Cochrane Handbook).

Name:

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Reason for writing this reviewWhy are you proposing to undertake this review now? Is it particularly topical at the present time? Is it needed to inform a local or national clinical or practice guideline? Is there a reason to incorporate new methods? Is there evidence of ongoing uncertainty and the potential that new evidence will change practice? Are there new studies available with sufficient power to change the conclusions of your existing Cochrane review?

What is the review question?Give a short statement of the primary aims and objectives 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 an A4 page text)

2. Description of the intervention (no more than half an A4 page text)

3. How the intervention might work (no more than half an A4 page text)

4. Why it is important to do this review (no more than half an A4 page text)

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Supporting references (please format all supporting references in line with the Cochrane Style Manual – see http://community.cochrane.org/style-manual)

Cross referencing other Cochrane reviewsCochrane 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 this proposal.

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

Types of study:

(section 5.5)

Randomised controlled trials (RCTs) Yes

Will you include:

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.

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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 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 one of your main outcomes. 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.

Are there any core outcomes available for this topic? If so, please consider using these or state why you have chosen not to use them. Please check the COMET database (see http://www.comet-initiative.org/ )

Outcomes for use in GRADE and SoF:

Note: Select up to seven main outcomes. These outcomes will be used in your Summary of Findings table (SoF).

For some reviews it might be appropriate to include two separate SoF tables (one for the mother and another for the baby)

Other important outcomes:

Planned analyses: Please tell us your approach to setting up the analysis in your proposed review. Please include all comparisons (including subgroups).

For example:

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Comparison x versus y

Comparison a versus b

Subgroup i)

Subgroup ii)

You are encouraged to provide this information as a separate word document to accompany this proposal.

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/path/grade-approach-evaluating-quality-evidence-pathway.

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.

Authors' responsibilities

By completing this proposal, if approved, you accept responsibility for preparing the review in

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accordance with Cochrane policy.

All drafts 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, Cochrane Pregnancy and Childbirth has the right to withdraw, de-register or transfer the review title to another review team.

All drafts should meet Cochrane’s MECIR standards, and adhere to the Cochrane Style Manual. Cochrane Pregnancy and Childbirth has the right to withdraw, de-register or transfer the review where drafts do not meet minimum standards (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, as required, 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 review and subsequent versions in 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 this 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

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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 maintained in the future, as required.

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:

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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 (if you are not already subscribed).

Author 2 Please 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

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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 (if you are not already subscribed).

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Roles and responsibilitiesPlease advise who has agreed to undertake each of the following tasks.

Develop the search strategy for searches (if relevant) in addition to those developed by the Cochrane Pregnancy and Childbirth’s Information Specialist.

Obtain copies of the trial reports

Select which studies to include (2 people)

Extract data from studies (2 people)

GRADE the evidence and prepare a summary of findings table (2 people)

Enter data into RevMan

Carry out the analysis

Interpret the analysis

Draft the final review

Experience in systematic reviewing and other information

Have you attended a Cochrane Review training workshop?

If yes, which one did you attend?

If no, which one are you planning to attend?(see http://uk.cochrane.org/review-author-RA-training)

Yes No

Have you seen the Cochrane Pregnancy and Childbirth website? Yes No

Do you have access to these databases:

The Cochrane Library

MEDLINE

PubMed

EMBASE

Yes No

Yes No

Yes No

Yes No

Do you have access to a medical library?

If yes, can you order journal articles not held in the library?

Do you have access to advice from a medical librarian?

Yes No

Yes No

Yes No

Do you have access to reference management software (e.g. Endnote)?

If yes, which software, and what version?

Yes No

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Do you have access to a statistician (strongly recommended)?

If yes, whom?

Yes No

Do you have contact with consumer groups relevant to this review?

If yes, which one(s)?

Yes No

Have you identified appropriate time and resources to complete the review? Yes No

It is the Cochrane Pregnancy and Childbirth’s policy that all Cochrane review teams must include an experienced Cochrane author who has direct experience of preparing a full Cochrane review with Cochrane Pregnancy and Childbirth.

Does your team include an experienced Cochrane review author who has prepared a full Cochrane review with Cochrane Pregnancy and Childbirth?

If yes, please state who:

Have they agreed to provide the team with hands-on mentorship and supportIn preparing the proposed review?

Please list team members with direct experience of Cochrane review preparation and describe the extent and nature of their experience below.

Yes No

Yes No

Name Experience (e.g. extracting data)

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For office use only

1. Approved title:

2. Approved by:

(a) Name:

Role: Contact Editor Date approved:

(b) Name: Zarko Alfirevic

Role: Co-ordinating Editor Date approved:

(c) Name:

Role: Date approved:

(c) Name:

Role: Date approved:

3. Date registered in Archie: Registered by:

4. Notes:

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