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Published by at November 1st, 2023 , Revised On November 1, 2023

Protocol for Systematic Review | Steps with Examples

In academic research, systematic reviews are a gold standard for synthesising existing knowledge and providing valuable insights. These reviews play a crucial role in evidence-based decision-making, and to ensure their rigour and transparency, a well-structured protocol is essential. 

Understanding the Significance of a Protocol For Systematic Review

Before we discuss the nitty-gritty of creating a systematic review protocol, let’s establish why it’s so important.

Why do you Need a Systematic Review Protocol?

A systematic review protocol serves as the blueprint for your research. It outlines the entire process, from defining your research question to conducting the analysis. Here’s why having a protocol is crucial:

  • Transparency: A well-documented protocol ensures transparency in your research, making it easier for others to replicate your study or understand your methodology.
  • Reducing Bias: It helps in reducing bias by pre-specifying criteria for study inclusion and methods for data extraction and analysis. This minimises the risk of cherry-picking data that supports your hypothesis.
  • Efficiency: Protocols save time and resources by streamlining the research process. You have a clear roadmap, making it less likely to deviate from the original plan.
  • Publication: Many journals require or strongly recommend a systematic review protocol before considering your research for publication. This ensures that your study adheres to rigorous standards.

Now that we’ve established the importance of a protocol, let’s move on to the steps involved in creating one.

Steps to Create a Protocol for Systematic Review

1. Define your Research Question

The first step in creating a systematic review protocol is clearly defining your research question. Your question should be specific, relevant, and answerable. For example:

Research Question: “What is the impact of mindfulness meditation on reducing symptoms of anxiety in adults?”

2. Develop Eligibility Criteria

Define the criteria for including or excluding studies in your review. These criteria should be based on your research question and help maintain objectivity. For instance:

Inclusion Criteria:

  • Studies published in the last ten years.
  • Studies with adult participants (aged 18-65).
  • Studies that assess the impact of mindfulness meditation on anxiety symptoms.

Exclusion Criteria:

  • Studies published in languages other than English.
  • Studies with participants outside the specified age range.

3. Conduct a Comprehensive Literature Search

To ensure you don’t miss any relevant studies, conduct a systematic and comprehensive literature search—Utilise academic databases like PubMed, Google Scholar, or specialised databases related to your field.

4. Data Extraction and Management

Outline how you’ll extract data from selected studies, including variables to be collected, data sources, and data management procedures. Consider using software like EndNote or Zotero to manage your references and data.

5. Assess the Risk of Bias

Develop a plan for assessing the risk of bias in the included studies. You can use tools like the Cochrane Risk of Bias tool to evaluate the quality of each study.

6. Data Synthesis

Specify your methods for data synthesis. Will you conduct a meta-analysis or a narrative synthesis? This section should outline your statistical approach if applicable.

7. Publication Bias

Discuss how you will address publication bias, which occurs when studies with positive results are more likely to be published than those with negative results. Methods might include funnel plot analysis or searching for unpublished studies.

8. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P)

Adhere to the PRISMA-P guidelines when drafting your protocol. PRISMA-P provides a structured format for systematic review protocols, ensuring clarity and completeness.

9. Timelines and Resources

Include a timeline outlining key milestones and allocate resources (e.g., personnel, software, access to databases) necessary for completing the review.

10. Review and Approval

Review your protocol carefully and seek input from colleagues or mentors. Once finalised, consider registering your protocol with organisations like PROSPERO or other relevant databases.

Examples of Systematic Review Protocols

To better understand how to create a systematic review protocol, let’s examine two examples:

Example 1: Protocol for a Systematic Review on Diabetes Management

Research Question: “What are the most effective dietary interventions for managing type 2 diabetes?”

Eligibility Criteria:

  • Studies published in the last 15 years.
  • Studies with adult participants diagnosed with type 2 diabetes.
  • Studies assessing the impact of dietary interventions on glycemic control.

Data Extraction and Management: Data will be extracted using a standardised form and managed using EndNote.

Assessment of Risk of Bias: The Cochrane Risk of Bias tool will be employed to assess the quality of included studies.

Data Synthesis: A meta-analysis will be conducted to calculate pooled effect sizes for glycemic control.

Publication Bias: Publication bias will be assessed using funnel plot analysis.

Example 2: Protocol for a Systematic Review on Climate Change Adaptation Strategies

Research Question: “What are the most effective climate change adaptation strategies for coastal communities?”

Eligibility Criteria:

  • Studies published in the last 20 years.
  • Studies related to coastal communities facing climate change impacts.
  • Studies assessing the effectiveness of climate change adaptation strategies.

Data Extraction and Management: Data will be extracted using a standardised form and managed using Zotero.

Assessment of Risk of Bias: A modified risk of bias assessment tool suitable for environmental studies will be used.

Data Synthesis: A narrative synthesis will be conducted due to the heterogeneity of included studies.

Publication Bias: Publication bias will be assessed through a comprehensive search for grey literature and reports.

Good Journals for Systematic Review Protocols

Publishing your systematic review protocols in reputable journals is essential for gaining visibility and recognition in your field. Here are some journals known for accepting systematic review protocols:

  • Systematic Reviews 
  • As the name suggests, this journal specialises in publishing systematic review protocols and full systematic reviews.
  • Journal Of Medical Internet Research (JMIR) Research Protocols 
  • Suitable for protocols related to digital health, medical informatics, and eHealth.
  • Environmental Evidence: Focusing on environmental science, this journal welcomes systematic reviews and protocols related to environmental issues.
  • Cochrane Database Of Systematic Reviews 
  • While primarily known for systematic reviews, Cochrane also publishes protocols for systematic reviews.
  • BMJ Open Science 
  • A multidisciplinary journal that accepts protocols and full reviews across various fields.
  • PLOS ONE
  • This open-access journal covers a wide range of disciplines and often accepts systematic review protocols.

Ethical Considerations in Systematic Reviews

When conducting a systematic review, it’s crucial to adhere to ethical principles and guidelines to ensure the integrity and credibility of your research. Here are some key ethical considerations that should be at the forefront of your review process:

  • Informed Consent 
  • Ensure that studies included in your review obtained proper informed consent from participants.
  • Participant Confidentiality 
  • Protect participant confidentiality by anonymising and aggregating data.
  • Ethical Review 
  • Check if ethical approval is required for your systematic review, especially for studies involving humans or animals.
  • Transparent Reporting 
  • Document your review process to maintain transparency and allow for assessment by others.
  • Conflicts Of Interest 
  • Disclose any potential conflicts of interest among the research team to maintain research integrity.
  • Authorship And Attribution 
  • Properly credit all contributors according to established authorship criteria.
  • Cultural Sensitivities 
  • Be aware of and respect cultural sensitivities when reviewing studies conducted in diverse cultural contexts.
  • Research Integrity 
  • Uphold the highest standards of research integrity and avoid research misconduct.
  • Conflict Resolution 
  • Transparently document and resolve conflicts or disagreements among reviewers.
  • Reporting Ethical Considerations 
  • When publishing your systematic review, report how ethical issues were managed during the research process to maintain transparency and accountability.

Conclusion

In conclusion, creating a protocol for a systematic review is a critical step in conducting rigorous and transparent research. Following the steps outlined in this guide, adhering to guidelines like PRISMA-P, and considering the examples provided will help you develop a robust protocol. Publishing your protocol in reputable journals will further enhance the visibility and credibility of your research in the academic community. Remember that following the right academic research methods, including conducting a scoping review, is essential for producing high-quality systematic reviews that contribute significantly to your field of study.

Frequently Asked Questions

A systematic review protocol is a detailed plan outlining how a systematic review will be conducted, including the research question, inclusion criteria, search strategy, data extraction, and analysis methods. It provides a clear roadmap for the entire review process.

The essential components of a systematic review protocol include the research question, inclusion criteria, search strategy, data extraction methods, risk of bias assessment, data synthesis approach, publication bias considerations, reporting guidelines, resource allocation, and peer review for quality assurance.