The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.

Patient-reported outcome (PRO) measures provide an important perspective on how patients feel and function that cannot be adequately captured by clinical measures. A PRO is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient's response by a clinician or anyone else.

Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial.

As part of the Optic Neuritis Treatment Trial, vision-specific quality-of-life data were collected on the patients at their 6-month visits. The purpose of this study was to determine the types of visual tasks in day-to-day living in which patients have difficulty and to compare the patients' subjective assessment of visual impairment with measurements of visual acuity, contrast sensitivity, mean deviation, and color vision. The questionnaire was completed by 382 (87%) of the 438 patients who had 6-month study visits. Associations between ophthalmic test scores and self-reported vision were examined using both a summary problem index and selected individual items. Although a substantial percentage of the patients (63%) indicated that vision had not recovered to normal in the affected eye, the reported visual deficits generally were mild. For most of the visual tasks of daily living, patients reported little or no problem. Among the 215 patients who perceived their vision at 6 months to be somewhat or much worse than it was before optic neuritis, 20% had normal results on none of the four visual function tests, 14% had normal results on one of the four tests, 23% had two of four, 23% had three of four, and 20% had normal results on all four. Reported visual symptoms 6 months after optic neuritis generally were mild. When patients were symptomatic, the four visual function tests often did not detect abnormality. This finding supports previous reports that visual deficits are frequently perceived even when vision testing is normal.