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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.
Showing the technology this term belongs to: Electronic patient-reported outcome (ePRO) symptom monitoring.
The QLQ-C30 made patient-reported quality of life a standard trial endpoint and is the instrument behind many of the quality of life claims on drug labels and in health technology assessments. Cancer-specific modules were later added on top of the core questionnaire.
FACT-G and the EORTC QLQ-C30 are the two instruments behind most patient-reported quality of life results in cancer trials and regulatory submissions. Knowing which was used matters when comparing quality of life claims between trials.
Shares PROSELICA, AFFIRM, TAX 327, TheraP (ANZUP 1603).
Shares PIVOT (Prostate Cancer Intervention Versus Observation Trial), GETUG-AFU 17, Choosing treatment for localised prostate cancer: what each option costs, RADICALS-RT.
Shares SWOG 9346 (intermittent androgen deprivation), EORTC 22961, PATCH (Prostate Adenocarcinoma Transcutaneous Hormone), What androgen deprivation costs: the side of hormone therapy the survival curves do not show.
Shares NICE technology appraisal methods (2022), EU HTA Regulation (EU) 2021/2282: joint clinical assessments, Health technology assessment (HTA), reimbursement and QALYs.
Shares PROSELICA, AFFIRM, TAX 327, TheraP (ANZUP 1603).
Shares N-of-1 trial, Absolute versus relative benefit (number needed to treat), Decentralised trial, Quality-adjusted survival (QALYs and Q-TWiST).
Shares NICE technology appraisal methods (2022), Cancer Drugs Fund (England), Health technology assessment (HTA), reimbursement and QALYs.
Shares Time to progression (TTP) and time to next treatment (TTNT), Atrasentan, PROSELICA, AFFIRM.