Registering a review of animal studies on PROSPERO

PROSPERO for animal studies is an international database of prospectively registered systematic reviews of animal studies relevant to human health. Key features from the review protocol are recorded and maintained as a permanent record in PROSPERO. The aim is to provide a comprehensive listing of systematic reviews registered at inception, to help avoid unplanned duplication. By promoting transparency in the process and enabling comparison of reported review findings with what was planned in the protocol PROSPERO also aims to minimise the risk of bias in systematic review.

PROSPERO for animal studies has been developed and is managed by the SYRCLE-CAMARADES team and the Centre for Reviews and Dissemination (CRD) at the University of York. It is  funded by the UK’s National Institute for Health Research (NIHR).

What does registration on PROSPERO involve?

Registration in PROSPERO involves the prospective submission and publication of key information about the design and conduct of a systematic review.

Registration on PROSPERO is free of charge. In return, registrants are accountable for the accuracy and updating of information submitted.

Inclusion criteria

PROSPERO includes details of any planned or on-going systematic review that has a health related outcome.

PROSPERO accepts:

Systematic review protocols assessing:

• Interventions (Including qualitative and individual participant data reviews)
• Diagnostic accuracy
• Prognostic factors
• Prevention
• Epidemiological reviews relevant to health and social care
• Public health
• Service delivery in health and social care
• Methodological

Further information on protocol development specific to review types is accessible below.

Requirements for registration

• A full protocol should be ready before registering with PROSPERO
• Submissions must be made before data extraction commences (from October 2019)
• Registration forms must be complete.
• Submissions must be in English (search strategies and protocols attached to a record may be in any language).

PROSPERO does not accept:

• Systematic reviews without an outcome of clear relevance to the health of humans
• Scoping reviews
• Literature reviews that use a systematic search
• Systematic reviews assessing sports performance as an outcome
• Methodological reviews that assess ONLY the quality of reporting
• Systematic critical appraisals

Other considerations

• Cochrane protocols are automatically uploaded- To avoid duplication of records, Cochrane protocols should not be registered separately with PROSPERO.
• Systematic reviews of human studies only are not eligible for registration in the section of PROSPERO dedicated to reviews of animal studies. These should be registered in the section of PROSPERO for human studies.
• Systematic reviews of in-vitro studies only are not eligible for registration on PROSPERO. We recommend registering such protocols elsewhere, for instance on Open Science Framework.

If you are in any doubt about the eligibility of your review, including the stage of progress please contact us by email using the details on the contact page for advice.

When to register your review

Do not register too early. Your systematic review protocol should be complete before you submit your registration request  

Registering reviews that are never performed is unhelpful to the research community and may discredit the research team.
You should therefore have the necessary resources in place to complete the review before you register your protocol (notification of award of research funding or firm commitment that author time is available for unfunded projects).

Accessing and navigating the registration form

Obtain a username and password by following the ‘Join’ link in the top right hand corner of the PROSPERO website.

Once you have joined, you can ‘Sign in’ and then you will be able to select ‘Register a review’ in the left hand column. This opens a page that encourages you to check that your review will meet the inclusion criteria and that the review is not already registered. If you are happy to continue, open the registration form by clicking on the "Register a systematic review of animal research studies (study subjects are animals) that is of direct relevance to human health" link. This opens a page where you are asked to confirm your review is eligible for inclusion and sufficiently different from any other review registered. If you are happy to confirm the information you may proceed to the registration form by clicking on the "Register a review" link. This will take you to the electronic registration form which has 26 required fields and 14 optional fields. All subfields of required fields, marked with a red asterisk, must be completed before the protocol can be submitted. You may save and exit the form at any time, and return at a later date changes are also automatically saved when a field is exited. You are able to add or edit information at a later time by signing in at the main page and going to ‘My PROSPERO records’.

Providing access to a protocol is not a substitute for entering data into the required fields.

Most registrants complete the form in 60 minutes or less.

Brief guidance about the information required in each field is given in the form by clicking the icon or by clicking ‘show help’ at the top of the page and more detailed information, with examples, is given below for each section..
When you are ready, the form can be sent to the PROSPERO administrators by clicking on "Submit".

What happens after submitting a form

Access to your record to make further changes or updates is suspended during the administrative process. Receipt of submission is acknowledged in an automated email sent to the named contact.

Registration forms are checked against the eligibility criteria for PROSPERO. If they meet the inclusion criteria, they are checked for clarity of content before either being approved and published on the register, returned for clarification, or rejected. We endeavour to provide an update within five working days. If you wish to enquire on the progress of your submission please contact the administration team by email using the details on the contact page.

Once published on the register, the record will again become accessible for future editing. However, the original document submitted will remain in the register to provide a permanent record for the audit trail and for reference.

Should your submission be rejected for registration, the record will be locked and no further edits can be made. Further access to the record for editing is not possible without contacting us by email using the details on the contact page.

Please do not create a new record to substitute a rejected record without contacting us.

Making changes, amendments and updating a published record

Changes, amendments and updates can be made to a published record by signing in, going to “My PROSPERO records” and opening the saved record. Once the changes have been made,  click the “Submit” button. You will then be asked to give brief details of the changes made. The information entered here will appear in the public record and should inform users of the database of the nature of the changes made (e.g. removed one of the outcome measures; changed the anticipated completion date).

Full guidance notes are available here.

All submitted edits and changes to a PROSPERO record will be recorded, dated, and made available within the public record audit trail. The most recent version will appear with previous versions accessible from dated links on the right-hand side of the screen, with the revision notes.

What to do after completing a review and after publishing the findings

Records remain permanently on PROSPERO. Once the review is completed this information should be updated in the record together with the anticipated publication date. The bibliographic reference and electronic links to publications should be added to the record by the authors. In the absence of a publication, details of availability of the review’s unpublished results, or reasons for the discontinuation of the review, should be documented. Reminder emails with detailed instructions on what to do, are sent on the anticipated completion and publication dates.

Registering an update of a completed review

If you decide to update the registration of a review you have already completed, you can access the record by signing in and going to “My PROSPERO records”. You can make changes to the protocol and submit it as an update and it will be processed as for a new review. It is important to decide if you are updating a review, or in fact are doing a new review because of changes to the protocol. The following definitions have been provided to help you decide.

What is an update of a review?

Updating a systematic review is a discrete event during which efforts are made to identify and incorporate new evidence into a previously completed systematic review
An ‘update’ may be any modified version of a review that includes the findings of a more recent search than the previously completed version of the review. It can still be considered an update even if the new search reveals no additional studies. Any newly identified studies should be assessed and, if appropriate, incorporated into the updated review. An update might also be an opportunity to conduct new analyses or add additional information to the review.

What constitutes a new review rather than an update?

It can be difficult to decide whether an update to a review is in fact a new review. There is little published guidance on this. PROSPERO adopts a pragmatic approach. If changes to the review questions or methods are so substantial that they require major changes to the original protocol, this should be regarded as a new review rather than an update. Examples that would constitute a new review:

• addition of new treatment comparisons e.g. direct comparison of different drugs, when the old review included only comparisons of drug with placebo;
• substantial changes to the population being studied e.g. adding non-rodents to a review that was previously restricted to rodents;
• exclusion criteria in the old review become inclusion criteria in the new review;
• introduction of new analysis techniques e.g. a switch from aggregate data meta-analyses to individual participant meta-analyses.

If in doubt, a new record for a new review should be created. This will minimise the complexity of the editing to the original record in PROSPERO and make it easier for users to distinguish between the original review and the later version. Links between the new and original review can be added in field #37 in the registration form.

Guide to completing the registration fields

The following guidance notes follow the format of the registration form. The guidance includes a description and example of what is required for each of the fields within each section.

PROSPERO records need to be fully searchable. We can therefore not accept submissions in which only a link to a protocol registered elsewhere is provided, without providing the basic information in the fields.

SPECIAL NOTES:
We accept information in good faith and rely upon the integrity of researchers to ensure the validity of all the data presented in PROSPERO records. Action will be taken if inaccuracies in data, particularly stage of review and anticipated completion date, are identified at any time.