Cover; Title Page; Colophon ; Summary ; Introduction to Patient Reported Outcomes; Definitions; Application; Taxonomy; Format; Applications of PRO data; Clinical trials; Regulatory approvals; Real world evidence studies; Clinical practice; Health technology assessment; Prescribers and patients; Collecting PRO data to support product evaluation; Develop a PRO strategy considering issues important to patients, the target product profile and stakeholder requirements; Select validated PRO instruments; Ensure the trial or study design is appropriate for PRO collection; Linguistic Validation
The Need for Linguistically Validated PROsMethodology; Same Language Different Country; Measurement Equivalence; Regulators; ePRO Technology Overview; Introduction; Technologies; Patient & Site Staff Acceptance; Regulatory Perspective; Migration & Validation; Analysing and reporting PRO data; Statistical analysis plan; Reporting PRO results; References; Authors
