ePRO
ePRO Backend on FHIR
Electronic patient-reported outcomes (ePRO) collect symptom, function, and quality-of-life data directly from the patient. The natural shape is FHIR's Questionnaire and QuestionnaireResponse; the natural scheduling is CarePlan-driven Tasks; the clinician view sits on top of the same data.
What you can build
- PROs land in typed, validated FHIR resources
Each response item links back to a Questionnaire item with its value type, allowing units, and validation rules.
- Scheduled prompts come from the CarePlan
Weekly, daily, or event-triggered prompts materialize as Tasks the patient sees in their app.
- Clinician review is a search
Severe responses are a QuestionnaireResponse search filtered by item value. No separate alerting pipeline.
What you get out of the box
Who this is for
Clinical research teams, oncology and rheumatology programs, and product teams building patient-facing data collection flows.
Clinical applicability
An oncology clinic collects PRO-CTCAE responses weekly during treatment. Each response triggers a clinician review for severe symptoms. The same data feeds the trial outcome dataset.
Why Questionnaire over a custom form table
A custom form table looks simpler initially but loses the link between the question and the answer's metadata. PRO instruments (PROMIS, PRO-CTCAE, EQ-5D) have item codes, value sets, and scoring algorithms that the FHIR Questionnaire captures.
A QuestionnaireResponse referencing a published Questionnaire keeps the instrument identity intact. Scoring runs against a known instrument; outcome reports cite the instrument by name; the responses are portable to other systems that recognize the instrument.
Scheduling and reminders
The schedule for prompts (weekly, daily, before each visit) lives in the CarePlan or PlanDefinition. The activities materialize as Tasks the patient sees in their app. Completed Tasks point to the QuestionnaireResponse that fulfilled them.
Reminder logic (push notifications for incomplete Tasks) sits in the patient app or a notification service that subscribes to Task creation and tracks completion. The state of record is the Task, not a separate reminder log.
Severe-response handling
FHIR Subscription with FHIRPath criteria fires when a submitted QuestionnaireResponse contains an answer above a configured severity. The downstream handler creates a Task for the clinician to review the response.
The audit log records the response, the Subscription that matched, and the resulting Task creation. The clinician's review is recorded as the next state on the Task.
Related docs
FAQ
Can I use validated PRO instruments out of the box?
PROMIS, PRO-CTCAE, EQ-5D, and other validated instruments can be loaded as Questionnaire resources. Many are published as FHIR Questionnaires already; others are converted from their reference specifications.
How do I score the responses?
Scoring runs as derived Observations or as a separate scoring service that reads the QuestionnaireResponses and writes computed scores back. The choice tracks how often the scoring algorithm changes and where the algorithm is owned.
What about offline patient devices?
Patient apps can collect responses offline and submit when connectivity returns. The submission is the same write the online flow uses; the offline cache is the app's responsibility.
Can the response data feed an EDC system?
Yes. Bulk Data export produces the QuestionnaireResponses in standard FHIR format; the EDC system or its loader consumes from there.
