A clinical outcome assessment (COA) measures how a patient feels, functions or survives. There are four types, defined by who provides the information: the patient, a clinician, an observer, or the patient's performance on a task.
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Patient-reported
Participant, own phone
Observer-reported
Caregiver
Clinician-reported
Site staff, clinic tablet
Performance outcome
Site-run test, e.g. chair rise
The four types
| Type | Who reports | Examples |
|---|---|---|
| PRO: patient-reported outcome | The patient, without interpretation by anyone else | PHQ-9, EQ-5D, DLQI, PRO-CTCAE |
| ClinRO: clinician-reported outcome | A trained clinician using judgement | C-SSRS, ADAS-Cog, rating scales |
| ObsRO: observer-reported outcome | Someone who observes the patient, such as a parent or caregiver | Caregiver-reported behaviours, infant symptoms |
| PerfO: performance outcome | The patient performs a standardised task | Six-minute walk test, timed up and go |
In short
In Capture
In Capture each assessment on the schedule is set to be completed by the participant (PRO), a caregiver (ObsRO) or site staff (ClinRO, and PerfO tests built as site forms). The same form works on a participant's phone, a home tablet or a clinic device, and licensed instruments carry their licence details.
How much pain do you feel right now?
How much pain do you feel right now?
NoneMildModerateSevereA measure of how a patient feels, functions or survives, reported by the patient, a clinician, an observer, or through task performance.
A PRO comes from the patient. An ObsRO comes from someone who observes the patient, such as a caregiver, and covers observable behaviours rather than feelings.
No. It is a performance outcome (PerfO): the patient performs a standardised task.
Electronic collection of clinical outcome assessments. ePRO is its patient-reported subset.