Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

On 28 August 2020 the FDA announced the availability of the draft guidance for industry and FDA staff, and other stakeholders.

The U.S. FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices. Patients’ perspectives on living with their health condition and its treatment or management are most useful in medical device evaluation when they are relevant to the regulatory decision and reliably measured. Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel, function, and survive as valid scientific evidence to support the regulatory and healthcare decision-making process. By integrating patients’ voices throughout the total product lifecycle, concepts important to patients can be considered in the evaluation and surveillance of medical devices.

PRO instruments allow for collection of certain data as valid scientific evidence of safety and/or effectiveness which is complementary to other evidence of clinical outcomes and/or biomarkers. Use of PRO instruments is generally voluntary but may be specifically recommended in certain standards and guidances. PRO instruments can include patient diaries, visual analog scale (such as measures of pain severity), symptom measures, as well as multi-item, multidomain questionnaires measuring aspects of health-related quality of life (HRQOL). A PRO can be measured by self-report or by an interview, provided that the interviewer records only the patient’s response. Symptoms and unobservable concepts known only to the patient (e.g., pain

intensity and anxiety level) can be measured using PRO instruments. A PRO instrument can be used in clinical studies to measure the effects of a medical intervention or changes in the health status of a patient.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /