Clinical course next to the measurements, with its history

A step count or heart rate series from a wearable is often not enough on its own. To study recovery after surgery, you need to know when the surgery took place, how many days the patient stayed in hospital and whether there were complications. EnaResearch records this information separately for each participation, so measurements and clinical events can be read on the same timeline.

These are research records. EnaResearch does not replace the hospital information system or the electronic health record; treatment and care records stay in the organization’s own systems.

In the participant panel, hospital stays are entered with admission and discharge dates, and clinical events with their type, start and end. Events include surgery, intra-operative procedures and complications; complications can be graded with the Clavien–Dindo classification and linked to the event they relate to.

Records belong to the participation. If the same person also takes part in another study, the records do not mix.

When a hospital stay or event is corrected, the earlier version is not lost. Creation, every correction and every entered-in-error mark keep a full copy of the record. A reason is required for each correction; the panel shows who changed what, when and why for every record.

A record entered by mistake is not deleted; it is marked as entered in error with a reason. Exports and variables read records as they were at the data cut-off, so a correction made after the cut-off does not change a file regenerated with the earlier cut-off.

Measurements that are not collected by a device are entered by hand in the participant panel: pain and fatigue (NRS 0–10), the Borg rating of perceived exertion (6–20), hemoglobin, CRP, leukocytes, creatinine and albumin. The value must be within the catalog range and inside the participation period.

Manual values join the standardized data with the source “manual” and can be used in variables, the data quality report and analyses. A correction creates a new version, a deleted value stays in the history, and the person who entered the value is recorded.

The study’s inclusion and exclusion criteria are defined as a list in the protocol. In the eligibility section of the participant panel, each criterion is marked as met or not met. The outcome, a copy of the criteria at that moment, and who recorded it and when are saved and written to the audit log.

The eligibility record is for documentation; it does not block enrollment on its own. The research team makes the decision.

Clinical records can be brought in from a CSV file or a FHIR R4 Bundle. In FHIR, Encounter resources become hospital stays and Procedure resources become clinical events; the Patient resource is skipped and identity fields are not read.

Every import starts with a dry run. Invalid rows are listed with their row number and the reason, and nothing is saved at this stage. Valid rows are then added under the same rules as the panel, with revisions and audit entries.