Module 19 · Part 6 · Using Your Data
Publications
Turn your registry data into peer reviewed publications that establish your organization as a scientific leader and advance the field.
Patient Registries 101 · Dr. Danielle Boyce · EpilepsyLive
Why publish?
- Publications are how science moves.
- Strategic reasons to publish
- Establish scientific credibility for your organization
- Demonstrate registry data quality and utility
- Attract academic collaborators and industry partners
- Support regulatory submissions with published natural history data
Why publish? (cont.)
- Fulfill obligations to participants ("we will use your data to advance science")
- Build the evidence base for clinical trial endpoints
Registry description / methods paper
- Describes the registry's design, governance, data elements, and enrolled population.
- Target journals: Rare diseases journals, clinical informatics journals, disease specific specialty journals When to publish: After first 50 to 100 participants are enrolled and baseline data qualit…
Natural history paper
- Describes the disease course, symptom prevalence, progression, and outcomes in your participant population.
- Value: This paper becomes a reference for every clinical trial in your disease space.
Genotype phenotype paper
- Links specific genetic variants to clinical features.
- Requires: Genetic data (verified molecular diagnoses) + HPO coded phenotype data
Patient-reported outcomes paper
- Describes participant burden, quality of life, and unmet needs from the participant perspective.
Treatment patterns / real world evidence paper
- Describes which treatments participants are receiving and their outcomes in real world practice.
Reporting standards
- Use established reporting guidelines, reviewers and editors expect them
- STROBE , Strengthening the Reporting of Observational Studies in Epidemiology strobe-statement.org
- RECORD , Reporting of Studies Conducted Using Observational Routinely-Collected Data (extension of STROBE for registry/EHR-based studies) record-statement.org
- CONSORT , For any controlled component consort-statement.org
Reporting standards (cont.)
- CONSORT , For any controlled component consort-statement.org
- GRIPS , Genetic Risk Prediction Studies grips-statement.org
Participant authorship and acknowledgment
- Every publication from your registry should
- Acknowledge participants , "The authors gratefully acknowledge the participants and families who contributed data to the [registry name]."
- Include participant coauthors where possible, participants who contributed meaningfully to study design, questionnaire development, or interpretation of findings should be considered for co-authors…
- Disclose funding sources including industry partnerships
- Disclose conflicts of interest for all authors
- ICMJE authorship criteria: icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
Open access
- Make your publications open access whenever possible.
- NIH PubMed Central deposit: Required within 12 months for NIH funded research publicaccess.nih.gov
- Plan S / cOAlition S: International open access mandate increasingly adopted by funders coalition-s.org
Key resources
- STROBE Statement
- RECORD Statement
- ICMJE Authorship Guidelines
- NIH Public Access Policy
- Orphanet Journal of Rare Diseases
- EQUATOR Network, Reporting guidelines
Key resources (cont.)
- ← Module 18 | Reference Card →