Detailed Methodology Outline

The steps shared in this detailed living guideline methods document outline the protocols in place to ensure that the development of the Living Guideline for Pediatric Concussion provides all stakeholders have access to the most current, evidence-based recommendations for managing and preventing concussions in children and adolescents. This project integrates comprehensive evidence synthesis, expert consensus, and active patient, community, and stakeholder engagement to create dynamic, user-friendly guidelines that are regularly updated as new research emerges. PedsConcussion has committed to supporting the real-time update of this guideline and any derivative products. Updated: May 2024

  1. Preparation and Planning (Conceptual Development)
  • Define the objective and scope of the living guideline.
  • Identify the target audience, including clinicians, healthcare providers, patients, caregivers, policymakers, and schools.
  • Formulate key questions and outcomes, grouping them into relevant themes.
  • Follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol (PRISMA-P) guidelines for transparency and rigor.
  1. Team Formation: Assemble a Multidisciplinary Team
  • Gather experts from various clinical disciplines to ensure comprehensive coverage.
  • Ensure team members possess expertise relevant to the guideline topics.
  • Include community stakeholders and patients/caregivers with lived experience to provide diverse perspectives.
  • Conduct conflict of interest declarations to maintain transparency and trust.
  1. Search Strategy Development

The Pediatric Concussion Guideline literature search strategy (a peer-reviewed template) will be used as part of this process. Search outputs will undergo preliminary filtering by expert reviewers to eliminate irrelevant articles.

  • Search Strategy: Develop and peer-review the search strategy following the PRESS guideline to ensure accuracy.
  • Database Selection: Select relevant databases, including MEDLINE and PsycInfo, to ensure comprehensive literature coverage. Re-assess every 12 months in collaboration with a PhD librarian.
  • Link to search strategy.
  1. Screening and Selection
  • Import search results into EPPIreviewer for duplicate removal to ensure data integrity.
  • Conduct title and abstract screening to identify relevant studies.
  • Perform full-text screening for a thorough evaluation of the selected studies.
  • Inclusion Criteria:
    • Level 1: Themes specific to pediatrics; ages 0-18 years old; concussions and mTBI.
    • Level 2: mTBI articles related to concussion.
    • Level 3: Articles related to treatment and assessment, aligning with themes (level 1).
  • A dedicated coordinator with knowledge and expertise in this area will conduct screening. A higher-level screening will be completed to ensure that the mTBIs are indeed concussions and that the articles relate to treatment, assessment, and relevant domains.
  • The level of evidence for individual research papers will be assigned using the Oxford Centre for Evidence-Based Medicine 2011 Level of Evidence Criteria.
  • Transparency Steps: Use EPPIreviewer to view the sorting and screening of each paper. This is archived. Reviewers will complete EPPIreviewer and GRADE training. Detailed instructions and site monitoring ensure adequate screening.
  • Link to Living Guideline PRISMA diagrams that are available for download.
  1. Data Management
  • Data Extraction and Strength of Evidence: Use EPPIreviewer for data extraction and assessment of evidence strength to maintain consistency.
  • Data Extraction Form (coded in EPPIreviewer): Document details such as ID, authors, year of publication, title, country, aim, study design, outcome measures, PICO, findings, and bias.
  • Conduct regular consensus meetings to ensure reliability and consistency in data extraction.
  1. Data Synthesis
  • Use a modified GRADE approach to assess the quality of evidence and the strength of recommendations.
  • Upload findings into the Living Evidence Gap Map via EPPIvis for easy access and visualization.
  1. Expert Panel Review
  • Critical articles will be forwarded to the appropriate team of expert reviewers specializing in that specific theme/domain. A minimum quorum of 75% of the expert panel team is required to proceed with modifying recommendations.
  • Included critical papers reviewed by the expert panel will be included in the EPPIvis Evidence Gap Map and these results can be visualized by level of evidence, domain, and year of publication. All included evidence can be downloaded by RIS or an excel document.
  • In addition to the critical research papers, other international consensus documents/projects/protcols are also considered and aligned with the proposed updates presented to the experts in order to harmonize internationally where relevant.
  • Domain Assignment: Assign experts to specific guideline sections based on their expertise.
  • Review and Voting: Experts review evidence, discuss in virtual meetings, and vote on recommendations. Use a structured approach for guideline updates to ensure consistency. Formulate new or revised recommendations based on evidence review, expert opinion, and stakeholder guidance.\
  1. Modification of Recommendations
  • Modification will be based on the quality of the evidence. Expert reviewers will vote via REDCap. Changes will be made as follows:
    • No change to the guideline recommendations or the level of evidence.
    • Modify the level of evidence (up or down) with a minimum of 75% endorsement.
    • Modify the wording of the recommendation(s) with a minimum of 75% endorsement.
    • Delete the recommendation(s) entirely with a minimum of 75% endorsement.
    • Add a new recommendation or clinical tool with a minimum of 75% endorsement.
  • In case of disparity, a teleconference will be arranged to discuss and reach a consensus. The Living Guideline website and downloadable PDF version will be updated with summaries of improvements and specific changes.
  • Once consensus is reached, the Living Guideline website and downloadable pdf version of the recommendations will both be updated. The Living Guideline Updates will be shared on the website under the “Living Guideline Updates” tab, which includes a summary of the improvements and a chart sharing specific minor and major changes made to the recommendations.
  1. External Review by Independent Panel and External Endorsement
  • Conduct an external peer review using the AGREE II tool to ensure the guideline’s quality and applicability.
  • Seek endorsement from guideline clearinghouses and external partners to enhance credibility.
  1. Dissemination and Knowledge Mobilization
  • Publishing and Engagement: Publish results in peer-reviewed journals and on the guideline website for widespread access.
  • Present at conferences, community events, and other relevant venues.
  • Engage patients and the public in drafting knowledge-translated recommendations and reviewing resources to ensure relevance.
  • Collaborate with partners to ensure their educational resources are accurate, including organizations like Parachute, CATT, SIRC, CDC, and the Coaching Association of Canada.
  1. Continuous Monitoring and Updates
  • Schedule and conduct regular literature searches every six months to capture new evidence.
  • Update the guideline via the expert panel review methodology with new evidence as it becomes available.
  • Maintain transparency and documentation of all updates and changes to ensure the guideline’s integrity.

Methodology References: 1. OCEBM Levels of Evidence Working Group*. “The Oxford Levels of Evidence 2”. Oxford Centre for Evidence-Based Medicine. * OCEBM Levels of Evidence Working Group = Jeremy Howick, Iain Chalmers (James Lind Library), Paul Glasziou, Trish Greenhalgh, Carl Heneghan, Alessandro Liberati, Ivan Moschetti, Bob Phillips, Hazel Thornton, Olive Goddard and Mary Hodgkinson

Archive: 2019 Living Guideline Methods pdf  2019 Guideline Update Methods (2014-2018 update)

Methods Flow Chart by CHEO-RI