Gerardo Lazaro
When Positive is Negative: Health Literacy Barriers to Patient Access to Clinical Laboratory Test Results
The journal of applied laboratory medicine
oncology trials healthrelated quality life hrqol specifically patientreported symptom burden functional status support interpretation survival endpoints progressionfree survival however applying timetoevent endpoints patientreported outcomes pro data challenging example timetodeterioration analyses clinical events disease progression common many settings often handled censoring patient time occurrence however disease progression hrqol often related leading informative censoring special consideration definition events intercurrent events ices necessary work demonstrate timetodeterioration pro estimands sensitivity analyses answer research questions using composite hypothetical treatment policy strategies applied single endpoint diseaserelated symptoms multiple imputation methods missingatrandom missingnotatrandom assumptions used sensitivity analyses primary estimands hazard ratios ranged 052 066 estimands sensitivity analyses modeling robust treatment effect favoring treatment time disease symptom deterioration death differences estimands include people experience disease progression discontinue randomized treatment due aes accounted analysis use estimand framework define interpretable principled approaches different timetodeterioration research questions provide practical recommendations reporting proportions patient events patient censoring reason helps understand mechanisms drive results allowing optimal interpretation