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Medicine Subject Guides: Create & register protocol

Create & register protocol

What is a protocol?

A protocol in a systematic literature review is a predefined plan that outlines the methods and procedures to be followed, ensuring transparency and consistency in the review process. It minimizes bias in the process, thereby enhancing the reliability and validity of the review's findings.

Why registering a protocol is important?

There are more than 2500 systematic reviews indexed in MEDLINE annually but not all of the are being published. Registering protocols for systematic reviews aids reviewers and editors in identifying potential bias in outcome reporting.

Registering a protocol

The list below are the main sources of registered protocols.

PROSPERO

PROSPERO serves as a global database for registering systematic reviews in various fields including health and social care, welfare, public health, education, crime, justice, and international development, as long as there is a health-related outcome. It ensures that key details from the review protocol are documented and preserved as a permanent record. Notably, PROSPERO does not provide a DOI (Digital Object Identifier).

Inplasy

Inplasy is a global platform designed for the registration of systematic review and meta-analysis protocols. Registering a protocol on this platform requires a nominal fee, and the processing time is guaranteed to be within 48 hours. Additionally, registered protocols on Inplasy are assigned a DOI (Digital Object Identifier) for easy identification and referencing.

Open Science Framework

The Open Science Framework (OSF) is a project management tool that is freely available and open-source, providing comprehensive support to researchers at every stage of their project. Developed by the Center for Open Science, the OSF is dedicated to promoting research openness, integrity, and reproducibility.

One of its notable features is the option for preregistration, where researchers can outline their research plan prior to conducting their study and submit it to a registry. This initiative enables researchers to establish and document their research plans in advance, enhancing transparency and facilitating the replication of studies.

Research Registry 

The Research Registry provides registration services for various types of research studies, encompassing case reports, observational and interventional studies, systematic reviews, and meta-analyses.

Historically, the emphasis has been on registering randomized controlled trials (RCTs). However, there has been a significant increase in the number of observational studies (such as case series, cohort studies, case-control studies, and cross-sectional studies) that remain unregistered. Although certain trial registries do permit the registration of observational studies, only a small portion of them are actually registered.

Cochrane Library 

Before initiating and registering a new review, it is recommended to search the Cochrane Library, a comprehensive database housing a variety of reliable, independent evidence for informed healthcare decision-making. By exploring the Cochrane Library, you can identify any existing published protocols or reviews relevant to your area of interest. This step ensures that you are aware of the current evidence and can avoid duplicating efforts by proposing a review that has already been conducted or is in progress.

JBI 

JBI is a global leader in evidence-based healthcare, promoting the synthesis and utilization of evidence to improve healthcare outcomes worldwide. The JBI EBP database consists of over 3,000 records across seven publication types, providing comprehensive resources such as Evidence Summaries, Systematic Reviews, and Consumer Information Sheets.

Items included in protocol

A systematic review protocol should include several essential components to ensure clarity, transparency, and reproducibility. Here are the key elements typically included in a systematic review protocol (Cochrane Library):

Citation
Review question
Searches
Types of study to be included
Condition or domain being studied 
Participants/population 
Intervention(s), exposure(s)
Comparator(s)/control
Context
Main outcome(s)
Data extraction (selection and coding)

Risk of bias (quality) assessment 
Strategy for data synthesis
Analysis of subgroups or subsets
Contact details for further information
Organisational affiliation of the review
Review team members
Type and method of review 
Anticipated or actual start date
Anticipated completion date 
Language
Country

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