Quality of life and patient-reported outcomes (QoL, PRO)
Measures of how patients themselves feel and function during treatment (pain, fatigue, nausea, daily activities), collected by questionnaire rather than by the doctor. Regulators and payers now expect them alongside survival, and clinician grading is known to under-report symptoms.
Standard instruments include EORTC QLQ-C30 and disease modules, FACT scales, EQ-5D for health economics and PRO-CTCAE for symptomatic adverse events; endpoints are mean change, time to deterioration and proportion improved. PROs revealed that clinician-graded toxicity misses much of what patients experience, showed that some 'well-tolerated' drugs are not, and supported approvals and HTA decisions where survival gains were modest. Weekly electronic PRO symptom monitoring during chemotherapy improved survival in a randomised trial (Basch 2017) and is now guideline-recommended. Missing data (sicker patients stop filling forms) is the main analytic problem; FDA core PRO guidance (2021-24) standardises collection.
Pages like this
not linked directly; found by shared links- TermOncology drug pricing and price transparency
Shares Health technology assessment (HTA), reimbursement and QALYs, Financial toxicity.
- Key paperBasch: asking patients to report symptoms online during chemotherapy improved survival
Shares Electronic patient-reported outcomes and remote monitoring, Electronic patient-reported outcome (ePRO) symptom monitoring.