Data harmonization framework for neonatal hypoxic-ischemic encephalopathy studies

“The definition of the metadata and the data dictionary of the framework is maintained as spreadsheets and REDCap format and can be found in Supplementary Material S1, S2, and S4 . With the separation of Datasets, Software, and Results, the Results, including the definition of the metadata and the data dictionary of the framework, and the statistical analysis results, are licensed under CC BY 4.0 and can be found at the public repository https://github.com/i3-research/COMBINE-harmonizer/tree/v1.1.0/results . The LH dataset and the OC dataset have been released to the public.”— not found in the paper; verdict downgraded

The statement points to the article's supplementary material and a GitHub repository link, not to a repository record with an accession or DOI; this maps to Colavizza category 2 (data in article/supplement) and a link, so partial. [downgraded to 'no' — no verifiable quote from the paper] [majority verdict 'no' (2/5 passes agreed)]

Colavizza, Hrynaszkiewicz, Staden, Whitaker & McGillivray (2020), 'The citation advantage of li · Springer Nature research data policy — Data Availability Statements: standard statement templat · RDA-F3-01M — metadata clearly and explicitly includes the identifier of the data it describes

“Table 2. Excerpts of the data dictionary.”

The paper includes a table (Table 2) that itemises variables from the data dictionary, constituting an itemised inventory of the dataset.

RDA-F2-01M — 'Rich metadata is provided to allow discovery' (priority Essential) · FsF-F2-01M — F-UJI: 'Metadata includes descriptive core elements to support data findability' · FsF-R1-01MD — F-UJI: 'Metadata specifies the content of the data'

“the Results, including the definition of the metadata and the data dictionary of the framework, and the statistical analysis results, are licensed under CC BY 4.0 and can be found at the public repository https://github.com/i3-research/COMBINE-harmonizer/tree/v1.1.0/results”

The paper applies the access-level label 'public repository' and the open licence CC BY 4.0 to its own data. [majority verdict 'yes' (3/5 passes agreed)]

FsF-A1-01M — F-UJI: 'Metadata contains access level and access conditions of the data' · RDA-A1-01M — metadata contains information to enable the user to get access to the data · COAR Controlled Vocabularies — Access Rights v1.0 (open / embargoed / restricted / metadata-onl

The paper's own data (harmonized dictionary and results) are not sensitive and are publicly available; no gatekeeper of any kind is named for this study's data.

NIH Genomic Data Sharing Policy (NOT-OD-14-124) — controlled-access via a Data Access Committee · RDA-A1.2-01D — 'Data is accessible through an access protocol that supports authentication and · NIH DMS Policy Element 5 (NOT-OD-21-014) — Access, Distribution, or Reuse Considerations (conse

The paper does not mention how long the data will be retained or any persistence commitment; it only states the data are available now. [majority verdict 'no' (4/5 passes agreed)]

NIH DMS Plan Element 4 (NOT-OD-21-014) — Data Preservation, Access, and Associated Timelines · NSTC Desirable Characteristics (2022), Organizational Infrastructure: 'Retention Policy' · RDA-A2-01M — 'Metadata is guaranteed to remain available after data is no longer available'

No data or metadata community standard (e.g., MIAME, ISA-Tab, an ontology) is named as applied to the paper's own data; the discussion of OMOP and CDE is for future work or other datasets. [majority verdict 'no' (3/5 passes agreed)]

RDA-R1.3-01M — 'Metadata complies with a community standard' (priority Essential) · RDA-R1.3-01D — 'Data complies with a community standard' · RDA-I2-01M — '(Meta)data use vocabularies that follow FAIR principles'

“NCT00614744”

The paper includes the trial registration number NCT00614744, which is an identifier for a resource other than the paper's own dataset. [majority verdict 'yes' (3/5 passes agreed)]

RDA-I3-01M — '(meta)data include references to other (meta)data' · RDA-I3-03M — 'metadata includes qualified references to other metadata' · FsF-I3-01M — F-UJI: 'Metadata includes links between the data and its related entities'

“Variables were first categorized by chronological stages and then by medical topics. We created a dictionary to harmonize variable names and value coding.”

The production of the harmonized data is described in generic terms without naming specific instruments or software versions. [majority verdict 'partial' (2/5 passes agreed)]

RDA-R1.2-01M — 'Metadata includes provenance information according to community- specific standa · FsF-R1.2-01M — F-UJI: 'Metadata includes provenance information about data creation or generati · W3C PROV-O (W3C Recommendation, 2013) — the entity/activity/agent model of provenance

“The definition of the metadata and the data dictionary of the framework is maintained as spreadsheets and REDCap format and can be found in Supplementary Material S1, S2, and S4 .”

The variable definitions are provided inside the article's supplementary material, not as a separate documentation object shipped with the data; this is partial (inside the article). [majority verdict 'partial' (4/5 passes agreed)]

RDA-R1-01M — '(Meta)data are richly described with a plurality of accurate and relevant attribu · FsF-R1-01MD — F-UJI: 'Metadata specifies the content of the data' · NIH DMS Policy Element 3 (NOT-OD-21-014) — Standards (documentation and metadata to accompany t