Evidence Synthesis: Step 2: Protocol

A protocol is an outline of your project methodologies and plans. It is completed before you start searching for literature. It may be published as a full article in a journal or it can be shared on a protocol registry site.

It is okay if your final review deviates from what was outlined in your protocol. If there are deviations, you can state what they are in your final review.

Reasons to make a protocol before you start your review:

• Create a plan to keep your team on track
• Keep your team accountable 
• Reduce bias and increase transparency
• Inform other research teams that you are working on this topic (to reduce duplication of effort)

Key pieces of a protocol can include:

• Definitions of key pieces of your research question

• Objectives of and justification for the review. Why is this research question important? What do you hope to answer?
• Key team members who will contribute to the review, and their roles
• Inclusion/exclusion criteria for your research question
  • Criteria can include population demographics, geographic region, date range of publication, publication type, study type, and more
• Search methods
  • What databases will you search? 
  • Where will you search for grey literature (if relevant)? 
  • What key words and phrases will you use? How will they be combined into a cohesive and reproducible search query?
• Software you plan to use
  • Consider what will be used for managing citations, screening, data extraction, quality analysis (if relevant)
• Plans for data extraction
  • What data will be extracted?
  • How will it be extracted? What tool will be used?
• Plans for quality analysis (if relevant)
  • What tool will be used for QA?
• Potential conflicts of interest

There are several options for registering a protocol. Some research teams choose to publish their protocol in a peer-reviewed journal, but most teams opt for a free protocol registry instead. Listed below are three places to consider registering your protocol.

Open Science Framework (OSF) Registries

Open Science Framework is free for anyone to use and accepts protocols for all types of reviews and all subject areas. To register a protocol, you'll need to create a free account. OSF will provide a DOI for your registration.

If you have a preferred protocol template already, you will need to write your protocol in Word or Google Docs and upload that file into OSF. After clicking Add New, select the option "Open-Ended Registration." In addition to attaching your protocol document file, you will want to write a summary abstract to make your protocol more findable. This summary can include the background/rationale for your review, your review questions, and any other important pieces of information. 

If you do not have a preferred protocol template, you can use the OSF template "Generalized Systematic Review Registration." This template is built into OSF and will provide fillable fields. You do not need to upload any files. If a field is required but not relevant to the review you are doing, write "N/A" in the field. 

Carolina Digital Repository (CDR)

The Carolina Digital Repository is managed by the UNC Chapel Hill Libraries. Students, faculty, staff, and other UNC affiliates can deposit scholarly work free of charge so that it is publicly available. Items in the CDR will appear in Google Scholar searches. When you choose this option for a protocol, you can select any template you prefer and write your protocol in Word or Google Docs. In addition to your document, you will need an abstract and keywords to make your protocol more findable. Materials in the CDR are assigned DOIs if they do not have one already. 

PROSPERO

PROSPERO only accepts protocols for systematic reviews that are measuring health-related outcomes. It does not accept other types of evidence syntheses (such as scoping reviews), reviews that measure health outcomes directly, or reviews on sporting performance. The full list of criteria for inclusion is available on its website. PROSPERO requires use of its own template for registrations.

Some specialized protocol registries have preferred templates. If you are uploading your protocol to a general registry or repository (like OSF Registries and the Carolina Digital Repository, respectively), you can use any template that fits your needs. 

• Evidence Synthesis Protocol Template
• PROSPERO: Conduct a search in the PROSPERO registry to see what information is included.
• OSF Generalized Systematic Review Registration Form: See an example.
• UNC Health Sciences Protocol Template: A downloadable Word document

These instructions will walk you through the steps of submitting a protocol on Open Science Framework Registries using either the Generalized Systematic Review Registration template or the Open-Ended Registration template.

1. Navigate to https://osf.io/ and log in or create an account. You can create an account using your email, ORCiD, or the institutional affiliation login (which requires your ONYEN). 

2. On the left menu bar, click on "Registries" -> "Discover". Click the "Add a Registration" button.

3.  Ignore Step 1 (unless you are linking the registration to an existing project). Under Step 2, select the template you would like to use and click Create Draft. Creating a draft does NOT make it publicly available. Only contributors who are added by the project creator can view the protocol draft. 

• Select Generalized Systematic Review Registration for a detailed template that can be filled out online
• Select Open-Ended Registration if you would like to attach your protocol as a supplemental document

4. Fill out the following boxes on the Registration Metadata page:

• Title: Add the protocol title. This can be changed later before publishing the protocol.
  • Tip: Include the type of review you are doing and the word "protocol" in the title. This makes your protocol findable and will differentiate it from your final manuscript, which will likely have the same title.
• Description: A short description will suffice (e.g. "Scoping review protocol"). 
• Contributors: Click "Add Contributor by Search". Type in the name of the team member you want to add. 
  • If you are adding a team member who already has an OSF account, their name should be listed.
  • If you are adding a team member who doesn't have an account yet, scroll down and click "Add Unregistered Contributor". Type in their name and email address and click Add. 
  • Anyone you add to the registration will receive an email.
  • Contributors listed as Administrators can change permissions for each contributor.
  • A checked box under "Bibliographic Contributor" means the person's name will appear in the protocol citation. 
    • To add someone to the protocol draft so they can view it before it's live: Add them as a contributor and uncheck the Bibliographic Contributor box.
• Affiliated Institutions: The UNC logo will appear when a contributor is affiliated with UNC.
• License: Select a copyright license for the protocol. 
  • Not sure which license to choose? View this OSF copyright list or contact a librarian for help.
• Subjects: Select at least 1 subject. Click on the ">" buttons next to each subject to view subheadings. Note that if you select a subheading, the larger subject it is nested under will also be selected.
• Tags: Add your own keywords to make your registration more findable.

5. After filling out the basic metadata, you will continue filling out more details.

For the Open-Ended template:

• Paste details from your working document into the Summary box. Include any key information you want to be easily findable on your protocol landing page.
• After your working document is finalized, attach it as a supplemental file.

For the Generalized template:

• Fill out as much information as you can on each page. For any boxes that are required but not relevant, type N/A. 

6. Submitting your work: The registration will not go live until you submit it. Only submit your protocol when it has been finalized.

Tips:

• OSF will automatically save your work. 
• Make sure only 1 team member is editing the registration at a time. Work might be deleted/overwritten if multiple team members are working in the same template fields. 
• All contributors listed as administrators will receive an email when a draft registration has been submitted. There is a 48 hour period where admin contributors can cancel the submission. After 48 hours, the submission will go live.