{"entity":{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","aka":["QoL","QOL","quality of life","quality-of-life","health-related quality of life","HRQoL","HRQL","PRO","PROs","patient-reported outcome","patient-reported outcomes","patient-reported","patient reported","PRO-CTCAE","EORTC QLQ-C30","QLQ-C30","FACT-G","EQ-5D","symptom burden","symptom scores","functional status","time to deterioration","TTD","global health status","tolerability endpoints","patient experience","financial toxicity questionnaire","symptom score"],"tldr":"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.","summary":"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.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Patient-reported_outcome","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Patient-reported_outcome"},{"label":"FDA guidance: patient-reported outcome measures in medical product development","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims"}],"tags":[],"related":["ctcae-grading","hta","ttp","financial-toxicity","quality-adjusted-survival","decentralised-trial","n-of-1-trial","absolute-benefit"],"cancers":[],"sections":["supportive-care","drug-discovery"],"technologies":["epro-symptom-monitoring","remote-patient-monitoring"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-9er","cctg-ce6","quartz","mars-2","therap"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Trials"},"route":"/terms/qol-pro/","neighbours":{"term":[{"id":"absolute-benefit","kind":"term","name":"Absolute versus relative benefit (number needed to treat)","route":"/terms/absolute-benefit/"},{"id":"cancer-drugs-fund","kind":"term","name":"Cancer Drugs Fund (England)","route":"/terms/cancer-drugs-fund/"},{"id":"prostate-treatment-choice-localised","kind":"term","name":"Choosing treatment for localised prostate cancer: what each option costs","route":"/terms/prostate-treatment-choice-localised/"},{"id":"ctcae-grading","kind":"term","name":"CTCAE toxicity grading (grade 3-4 adverse events)","route":"/terms/ctcae-grading/"},{"id":"decentralised-trial","kind":"term","name":"Decentralised trial","route":"/terms/decentralised-trial/"},{"id":"dose-modification","kind":"term","name":"Dose reduction, interruption and discontinuation","route":"/terms/dose-modification/"},{"id":"endpoint","kind":"term","name":"Endpoint","route":"/terms/endpoint/"},{"id":"eu-hta-regulation","kind":"term","name":"EU HTA Regulation (EU) 2021/2282: joint clinical assessments","route":"/terms/eu-hta-regulation/"},{"id":"financial-toxicity","kind":"term","name":"Financial toxicity","route":"/terms/financial-toxicity/"},{"id":"prostate-focal-therapy","kind":"term","name":"Focal and tissue-preserving treatment of prostate cancer","route":"/terms/prostate-focal-therapy/"},{"id":"hta","kind":"term","name":"Health technology assessment (HTA), reimbursement and QALYs","route":"/terms/hta/"},{"id":"prostate-radiotherapy-fractionation","kind":"term","name":"How many radiotherapy visits: the prostate fractionation trials","route":"/terms/prostate-radiotherapy-fractionation/"},{"id":"n-of-1-trial","kind":"term","name":"N-of-1 trial","route":"/terms/n-of-1-trial/"},{"id":"nice-methods","kind":"term","name":"NICE technology appraisal methods (2022)","route":"/terms/nice-methods/"},{"id":"project-optimus","kind":"term","name":"Project Optimus","route":"/terms/project-optimus/"},{"id":"quality-adjusted-survival","kind":"term","name":"Quality-adjusted survival (QALYs and Q-TWiST)","route":"/terms/quality-adjusted-survival/"},{"id":"ttp","kind":"term","name":"Time to progression (TTP) and time to next treatment (TTNT)","route":"/terms/ttp/"},{"id":"prostate-adt-burden","kind":"term","name":"What androgen deprivation costs: the side of hormone therapy the survival curves do not show","route":"/terms/prostate-adt-burden/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"epro-symptom-monitoring","kind":"technology","name":"Electronic patient-reported outcome (ePRO) symptom monitoring","route":"/technologies/epro-symptom-monitoring/"},{"id":"remote-patient-monitoring","kind":"technology","name":"Electronic patient-reported outcomes and remote monitoring","route":"/technologies/remote-patient-monitoring/"}],"trial":[{"id":"affirm","kind":"trial","name":"AFFIRM","route":"/trials/affirm/"},{"id":"cctg-ce6","kind":"trial","name":"CCTG CE.6 / EORTC 26062-22061 (Perry trial)","route":"/trials/cctg-ce6/"},{"id":"checkmate-9er","kind":"trial","name":"CheckMate 9ER","route":"/trials/checkmate-9er/"},{"id":"eortc-22961","kind":"trial","name":"EORTC 22961","route":"/trials/eortc-22961/"},{"id":"getug-afu-17","kind":"trial","name":"GETUG-AFU 17","route":"/trials/getug-afu-17/"},{"id":"keynote-921","kind":"trial","name":"KEYNOTE-921","route":"/trials/keynote-921/"},{"id":"mars-2","kind":"trial","name":"MARS 2","route":"/trials/mars-2/"},{"id":"patch-transdermal-oestradiol","kind":"trial","name":"PATCH (Prostate Adenocarcinoma Transcutaneous Hormone)","route":"/trials/patch-transdermal-oestradiol/"},{"id":"pivot","kind":"trial","name":"PIVOT (Prostate Cancer Intervention Versus Observation 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