Title PROPOSAL for a NEW COCHRANE INTERVENTION REVIEW

TITLE PROPOSAL FOR A NEW COCHRANE INTERVENTION REVIEW

Please complete this form to outline your proposal for a Cochrane systematic intervention review. Email your completed form to the Group’s Managing Editor, Ann Jones. Please contact Ann Jones for information about qualitative review proposals.

BEFORE COMPLETING THIS PROPOSAL

 Make sure that your proposal falls within the Cochrane Consumers and Communication Group’s (CCCG) scope (see our Topic list titles and reviews.  Read Managing expectations: what does Cochrane expect of authors, and what can authors expect of Cochrane?  Read the relevant author resources.

REVIEW TEAM REQUIREMENTS

 Your review team should include: o someone who is an experienced Cochrane review author; o someone with topic expertise in the title you are registering; o someone with statistical and methodological expertise; and o either someone whose first language is English or someone with a very high standard of written English.  Familiarity with Cochrane methods will be expected at title stage.  All authors must read and follow the Cochrane Handbook for Systematic Reviews of Interventions when preparing their Cochrane review.

EDITORIAL STANDARDS

The CCCG reserves the right to reject a review at any stage of the editorial process, if we have good reason to do so. As an informal rule of thumb, if authors have not appropriately addressed the second set of peer review comments at any stage, such as title, protocol, review or update stage, then the CCCG reserves the right to reject the proposal. This does not mean that authors must follow each and every suggestion made in peer review. Rather, it should be inferred that we expect authors will take peer review and Cochrane standards into account when they complete their work.

Title proposals are assessed by at least two editors. Assessment criteria are presented at page 13.

SECTION A: THE REVIEW

CONTACT AUTHOR NAME

The contact person for the review, see Handbook section 4.2.3

Click here to enter text.

1 CCCG Title Registration Proposal Form PROPOSED TITLE

There is a standard format for Cochrane intervention review titles:

[intervention] FOR [health problem/issue] e.g. Interventions for enhancing medication adherence

[intervention A] VERSUS [intervention B] FOR [health problem/issue] e.g. Written versus oral interventions for enhancing medication adherence

[intervention] FOR [health problem/issue] IN [participant group] e.g. Interventions for enhancing medication adherence in older adults.

(See Handbook section 4.2.1).

QUALITATIVE REVIEWS

If your proposed review is a qualitative synthesis of a social phenomenon, that is experiences or views related to an intervention, please use this form. The Managing Editor will provide advice about fields that must be completed.

REVIEW PROPOSAL AND INCLUSION CRITERIA:

See Handbook chapter 5

(A) PROPOSED REVIEW OBJECTIVE

What is the research question? This would usually be expressed in the form “The objective of this review is to assess the effects of [intervention]...on [list outcomes].”

(B) RATIONALE FOR THE REVIEW

With the growth in systematic reviews, it is important to establish a strong rationale for your review. Address all these questions if possible.

 Why should the effects of this intervention be summarised in a Cochrane review?

 Are there conflicts or uncertainties in the evidence?

 What is the motivation for looking at this intervention?

 What do you think we will learn from this review that we don’t already know?

 Who might be interested in the findings of this review, and why?

(C) TYPES OF STUDY

2 CCCG Title Registration Proposal Form Outline the types of studies that will be included in the review. The inclusion of studies other than randomised controlled trials should be justified explicitly.

See the CCCG’s Study Design Guide and Handbook section 5.5 and Handbook chapter 13.

(D) PARTICIPANTS / POPULATION

Outline the types of populations to be included and excluded. Briefly justify the inclusion/exclusion of particular groups.

See Handbook section 4.5 and Handbook chapter 5.

(E) INTERVENTIONS AND SPECIFIC COMPARISONS TO BE MADE

What is the intervention that your review will consider? Describe it clearly in plain language, and include any different terms that are used for the same intervention (e.g. SMS, text messaging, mobile phone messaging). If your review will assess different interventions that have a common purpose (such as interventions for improving people's involvement in healthcare decision making), outline the range of possible interventions that might be included (such as face-to-face or telephone coaching, written information, question prompt sheets, internet-based resources promoting question asking, etc.) Consider what variations of the intervention (e.g. media, mode of delivery, who delivers it) will be included.

Specify all of the comparisons to be made, such as intervention compared with usual care, compared with no intervention, or with other interventions.

(F) OUTCOMES INCLUDING ADVERSE EFFECTS

List primary outcomes (the main conclusions will be based on the primary outcomes) and secondary outcomes to be included in the review, giving thought to those likely to be important to those experiencing the problem, and their family/caregivers, as well as those treating them. Adverse effects must be one of the outcomes.

Refer to Handbook section 4.5, Handbook chapter 5 and Handbook chapter 17 and the Taxonomy of relevant outcomes.

Primary: Click here to enter text.

Secondary: Click here to enter text.

(G) CONSUMER INVOLVEMENT IN THE REVIEW

Please identify how you will involve consumers:

 As co-authors?

 As referees?

3 CCCG Title Registration Proposal Form  As part of a consumer panel?

Additional help for completing this section can be found in Ideas for improving the relevance of your review to consumer issues.

(H) SCOPING THE SIZE OF THIS REVIEW

We strongly encourage you conduct a preliminary search of CENTRAL, to ensure that there are at least some relevant studies and to give you a sense of the potential scope of your review. On some topics, a broad review might require sifting tens of thousands of citations to identify trials.

Provide citations for two or three trials which would be included studies in this review.

Citations: Click here to enter text.

Provide a rough estimate of how many citations you might need to screen.

Magnitude of literature: Click here to enter text.

(I) OVERLAP

Identify and address any issues of overlap with other Cochrane reviews, completed or in progress.

(J) RESEARCH PRIORITY

Can you provide evidence that the proposed topic is a priority issue for at least one health system?

OPTIONAL: SUGGESTED EXTERNAL PEER REFEREES

Please provide contact details (at least an email address) for any suggested external peer referees for your review.

PROVISIONAL DATES FOR SUBMISSION OF DRAFTS TO EDITORIAL BASE

Anticipated submission date of draft protocol (within 6 months of title registration) Click here to enter text.

Anticipated submission date of draft review (within 18 months of protocol acceptance) Click here to enter text.

TIMEFRAME OF REVIEW

Is this review the subject of specific funding and/or does it need to be finished within a specific 4 CCCG Title Registration Proposal Form timeframe?

Yes ☐ No ☐

If yes, please give details.

5 CCCG Title Registration Proposal Form SECTION B: THE AUTHORS

REVIEW AUTHOR TEAM

See Handbook section 4.2.2

The team must include at least two people. It is important to discuss at an early stage how each co-author will contribute.

The Contact Author is the person who develops and co-ordinates the review team, discusses and assigns roles for individual members of the review team, liaises with the editorial base and takes responsibility for the on-going updates of the review.

Your team must possess, or have access to, the statistical skills required to extract, manipulate and interpret data from the included studies.

A detailed task list is available from the Authors Resources section of the Group’s website for your use when preparing your review. You will find this helpful in completing the protocol section on ‘Contributions of authors’ if your title is registered.

Please note that Cochrane reviews are unique in that most important reviews are updated approximately every two to three years. Each update is a new citation. Authors are expected to ensure that their review is kept up to date, or to negotiate with the editorial base for the responsibility for maintaining the review to be handed over to a new team.

Please list names of all members of the team and their area of expertise. This list may change over the course of the review.

Name Area of expertise

Contact author:

Co author(s)

6 CCCG Title Registration Proposal Form

CONTACT PERSON/AUTHOR 1

See Handbook section 4.2.3

Is the contact person an author of the review? Yes ☐ No ☐

Prefix (e.g. Ms, Dr): Click here to enter Given name (名字 Click here to enter text. text. míngzi):

Middle initial(s): Click here to enter Family name (姓 xìng): Click here to enter text. text.

Suffix (e.g. MD, PhD): Click here to enter Web address: Click here to enter text. text.

Preferred full name e.g. John Smith = Smith JB; Chen Ming Yu = Chen MY for review byline: Click here to enter text.

Do you already have a user account and password for the Archie database? Yes ☐ No ☐

Email address(es): 1. Click here to enter text.

2. Click here to enter text.

Job Title/Position: Click here to enter text.

Department: Click here to enter text.

Organisation: Click here to enter text.

Street/Address: Click here to enter text.

City: Click here to enter text. Post/Zip code: Click here to enter text.

State/Province: Click here to enter text. Country: Click here to enter text.

Telephone number: Click here to enter text. Fax number: Click here to enter text.

Mobile/cell number: Click here to enter text.

7 CCCG Title Registration Proposal Form 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 members. Please see our privacy policy. Within Archie, would you like to:

Hide your address and phone numbers: ☐ Hide your email address: ☐

Country of origin: Click here to enter text. Gender: Female☐ Male ☐

Have you prepared a systematic review before? Yes ☐ No ☐

If it is a Cochrane review, provide citations for all Cochrane reviews and protocols.

Are you already a member of another Cochrane Review Group? Which one(s)? Yes ☐ No ☐

At what level are you able to speak and write English? First language ☐ Fluent ☐ Not fluent ☐

Translating trials published in languages other than English I would be willing to assist with translation of is a vital role in Cochrane. If you speak any other languages clinical trials published in the following and would be willing to do partial translations on behalf of language(s): Click here to enter text. other author teams, please let us know.

8 CCCG Title Registration Proposal Form

AUTHOR 2

You must have at least two authors to register a title. Copy this table for each additional author.

Prefix (e.g. Ms, Dr): Click here to enter text. Given name (名字 Click here to enter text. míngzi):

Middle initial(s): Click here to enter text. Family name (姓 xìng): Click here to enter text.

Suffix (e.g. MD, PhD): Click here to enter text. Web address: Click here to enter text.

Preferred full name e.g. John Smith = Smith JB; Chen Ming Yu = Chen MY for review byline: Click here to enter text.

Do you already have a user account and password for the Archie database? Yes ☐ No ☐

Email address(es): 1. Click here to enter text.

2. Click here to enter text.

Job Title/Position: Click here to enter text.

Department: Click here to enter text.

Organisation: Click here to enter text.

Street/Address: Click here to enter text.

City: Click here to enter text. Post/Zip code: Click here to enter text.

State/Province: Click here to enter text. Country: Click here to enter text.

Telephone number: Click here to enter text. Fax number: Click here to enter text.

Mobile/cell number: Click here to enter text.

Privacy: Your details will be stored on our central database, known as ‘Archie’, and may be accessed by Cochrane members. Please see our privacy policy. Within Archie, would you like to:

Hide your address and phone numbers: ☐ Hide your email address: ☐

Country of origin: Click here to enter text. Gender: Female ☐ Male ☐

Have you prepared a systematic review before? Yes ☐ No ☐

If it is a Cochrane review, please provide citations of all Cochrane reviews.

Are you already a member of another Cochrane Review Group? Which one(s)? Yes ☐ No ☐ 9 CCCG Title Registration Proposal Form Click here to enter text.

At what level are you able to speak and write English? First language ☐ Fluent ☐ Not fluent ☐

Translating trials published in languages other than English is a I would be willing to assist with vital role in Cochrane. If you speak any other languages and translation of clinical trials published in would be willing to do partial translations on behalf of other the following language(s): author teams, please let us know.

CONFLICT OF INTEREST

Cochrane’s policy statement on Conflict of Interest states: ‘The performance of the review must be free of any real or perceived bias introduced by receipt of any benefit in cash or kind, any hospitality, or any subsidy derived from any source that may have or be perceived to have an interest in the outcome of the review.’ As such, authors should declare and describe any present or past affiliations or other involvement in any organisation or entity with an interest in the outcome of the review that might lead to a real or perceived conflict of interest. This includes acting as an investigator of a study that might be included in this review.

Note in particular:

Individuals who are employed by a company that has a real or potential financial interest in the outcome of the Cochrane Review (including but not limited to drug companies or medical device manufacturers), or who hold or have applied for a patent related to the Cochrane Review are prohibited from being Cochrane Review authors. In most cases, employment would be characterised by the affiliation statement made by the author at the title registration, protocol, or review stage of the Cochrane Review. Any questions about what constitutes “employment by a company with a financial interest” should be referred to the Funding Arbiter.

Authors who in the last three years have received financial support from commercial sponsors or sources who have a real or potential financial interest in the findings of the Cochrane Review, but who are not covered by the restriction above may need review by the Funding Arbiter panel. Such financial support may include remuneration from a consultancy, grants, fees, fellowships, support for sabbaticals, royalties, stocks from pharmaceutical companies, advisory board membership, or otherwise. In such cases, at the Funding Arbiter’s discretion, and only where a majority of the review authors and lead author have no relevant conflicts of interests, it may be possible for an author who has a declared interest as listed in the previous sentence to be a Cochrane Review author.

Authors should declare potential conflicts even if they are confident that their judgement is not influenced (see Handbook section 2.6).

Do you or your co-authors have any interests in this topic that could be perceived as conflicts of interest, as outlined in Cochrane’s policy statement?

Yes ☐ No ☐

10 CCCG Title Registration Proposal Form If yes, please give details. Click here to enter text.

The Managing Editor will seek further information so that a decision can be made by the Cochrane Funding Arbiter.

If the perceived conflict of interest of any author alters after signing this declaration, please contact the Cochrane Consumers and Communication Group for advice and to notify us of the change

11 CCCG Title Registration Proposal Form AGREEMENT TO EDITORIAL REVIEW AND PUBLICATION IN THE COCHRANE LIBRARY

By completing this form, you accept responsibility for preparing the review in accordance with Cochrane policy.

The Cochrane Consumers and Communication Group will support you in various ways to complete your review, including: development of search strategies, advice and assistance with RevMan software as needed, peer review of your protocol and review (and updates), and checking of your extracted data and analysis methods at review stage. We provide a range of written and electronic resources including resource packs, a data extraction template, and a study design and study quality guide.

A draft protocol must be submitted to the Review Group within six months of title registration. The review must be completed within a reasonable period. If drafts are not submitted before the agreed deadlines, or if we are unable to contact you for an extended period, the Review Group has the right to de-register the title or transfer the title to alternative authors. The Review Group also has the right to de-register or transfer the title if the submissions do not meet the standards of the Review Group and/or Cochrane.

The support of the Review Group in preparing your review is conditional upon your agreement to publish the protocol, finished review or subsequent updates in the Cochrane Library. By completing this form you undertake to publish this review in the Cochrane Library before publishing elsewhere (concurrent publication in other journals may be allowed in certain circumstances with prior permission from the Review Group).

I understand the work required to undertake a Cochrane Review, and agree to publish first in the Cochrane Library.

Title submitted: Click here to enter text.

Contact author: Click here to enter text.

Signed on behalf of all authors: ……………………………………………… Date: Click here to enter text.

12 CCCG Title Registration Proposal Form ASSESSMENT CRITERIA

Your form will be assessed against these criteria:

1. Have the authors presented a well-argued case for why this should be Cochrane systematic review of the effects of interventions, or a Cochrane synthesis of qualitative studies about the social phenomenon (that is, experiences, views) regarding an intervention?

2. Does the review address conflicts or uncertainties in the evidence?

3. Have the authors considered potential overlap, and identified the unique contribution that this review will make?

4. Is the review appropriately conceived as a systematic review and are the inclusion criteria carefully and thoroughly defined?

5. Does the team have the knowledge, skills and resources to complete the review, taking into account equity issues relating to authors in resource poor settings?

6. Are there any concerns that the lead author has too many Cochrane review commitments?

7. Is the proposal too broad or too narrow and have the authors considered the implications of this?

The proposal will be rejected if the answer to criterion 1 is ‘No’.

The title proposal may be sent back to the authors for revision, with accompanying editorial feedback.

Last updated: March 2016