Structural tissue damage and 24-month progression of semi-quantitative MRI biomarkers of knee osteoarthritis in the IMI-APPROACH cohort

“The data that support the findings of this study are available from the APPROACH Steering Committee but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from Frank W. Roemer, M.D. (corresponding author), upon reasonable request and with permission of the APPROACH Steering Committee.”

The statement points to a person (corresponding author) and a committee, not to a repository record, which matches Colavizza category 1 (data available on request).

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

The paper does not contain an itemised inventory of the dataset (e.g., a 'Data Records' section, table, or list of files/variables). It only describes methods and results in prose. [majority verdict 'no' (3/5 passes agreed)]

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'

“Data are however available from Frank W. Roemer, M.D. (corresponding author), upon reasonable request and with permission of the APPROACH Steering Committee.”

The paper does not label the access level of the data; it describes an action sentence for obtaining the data. [majority verdict 'partial' (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

“Data are however available from Frank W. Roemer, M.D. (corresponding author), upon reasonable request and with permission of the APPROACH Steering Committee.”

The APPROACH Steering Committee is a named institutional gatekeeper that controls access to the human-subject data, qualifying as a Data Access Committee.

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 any retention period, availability timing, or persistence commitment for the data.

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., minimum information checklist, ontology) is named; the MOAKS scoring instrument is not a standard in the FAIRsharing sense. [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'

“Trial Registration: Clinicaltrials.gov identification: NCT03883568.”

The paper provides an identifier for the trial (NCT03883568), which is a resource other than the study'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'

“two of the centers using 1.5 T systems (A Coruña: Ingenia CX, Philips Medical Systems, Netherlands; Oslo: Aera, Siemens Healthcare, Germany), and the other centers using 3 T systems (Utrecht: Ingenia or Achieva, Philips Medical Systems, Netherlands; Leiden: Ingenia, Philips Medical Systems, Netherlands; Paris: Skyra, Siemens Healthcare, Germany).”— not found in the paper; verdict downgraded

The paper names specific MRI instruments and models used for data acquisition, providing provenance information. [downgraded to 'partial' — no verifiable quote from the paper] [majority verdict 'partial' (4/5 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

“MOAKS uses a two-digit score for cartilage assessment (each 0–3) that incorporates both area size per subregion (i.e. in the following referred to as "area extent"-dimension) and percentage of subregion that is affected by full-thickness cartilage loss (i.e. in this analysis referred to as "full-thickness"-dimension).”— not found in the paper; verdict downgraded

Variable definitions are provided inside the article in prose, not as a separate documentation object shipped with the data. [downgraded to 'no' — no verifiable quote from the paper] [majority verdict 'no' (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