Health outcomes research is a science which has emerged as the measuring and interpreting of treatment benefits to patients. Experience with regulatory guidance addressing the development, use and collection of outcomes data from patients (PRO), clinicians(ClinRO) and/or caregivers(ObsRO) continues to accumulate. In response, efforts to develop novel instruments will likely yield tools which are electronic from conception. Clinical research will eventually shift to a more personalized approach to treating patients in the future, making it imperative that outcomes data collection technologies be flexible enough to adapt to the personal renderings of a study subject’s outcomes.
PRO – Patient Reported Outcomes – A measurement based on a report that comes directly from the patient (i.e. study subject) about the status of particular aspects of a patient’s health condition. PROs are recoded without amendment or interpretation of the patient’s response by a clinician or other observer. A PRO measurement can be recorded by the patients directly, or recorded by an interviewer provided that the interviewer records exactly the patient’s response. ePRO (electronic patient reported outcomes) represents an electronic method to collect the same patient reported data using a variety of devices and/or modalities.
ObsRO – Observer-Reported Outcomes – An Assessment that is determined by an observer who does not have a background of professional training that is relevant to the measurement being made, i.e. a non-clinician observer such as a caregiver. This type of assessment is often used when the patient is unable to self-report (e.g., infants, young children). An ObsRO should only be used in the reporting of observable concepts (e.g., signs or behaviors); ObsROs cannot be validly used to directly assess symptoms (e.g. pain) or other unobservable concepts
ClinRO – Clinician-Reported Outcomes – An assessment that is determined by an observer with some recognized professional training that is relevant to the measurement being made.