Ao Li, Siteng Chen, Stuart F Quan, Graciela E Silva, Charlotte Ackerman, Linda S Powers, Janet M Roveda, Michelle M Perfect
Sleep patterns and sleep deprivation recorded by actigraphy in 4th-grade and 5th-grade students
Sleep medicine
response evaluation criteria solid tumors recist commonly used assess therapeutic response clinical trials routine care thus recistbased end points difficult include observational studies cliniciananchored approaches measuring clinical response validated widely compared clinical trial data limiting use evidence clinical decisionmaking compare response progressionbased end points clinical trial observational cohorts patients nonsmall cell lung cancer nsclc retrospective cohort study used patientlevel data impower132 trial conducted april 7 2016 may 31 2017 nationwide electronic health record ehrderived deidentified database data collected january 1 2011 march 31 2022 patients observational cohort selected according inclusion exclusion criteria impower132 trial patients observational cohort stage iv nsclc patients randomized received firstline carboplatin cisplatin plus pemetrexed end points included response rates duration response progressionfree survival compared trial observational cohorts weighting response rates observational cohort derived ehr total 769 patients met inclusion criteria 494 observational cohort median iqr age 67 6074 years 228 462 female 45 91 black african american 352 713 white 53 107 american indian alaska native asian hawaiian pacific islander multiracial 275 trial cohort median iqr age 63 5668 years 90 327 female 4 15 black african american 194 705 white 65 236 american indian alaska native asian hawaiian pacific islander multiracial 3 end points comparable study cohorts trial patients higher number response assessments compared patients weighted observational cohort ehrderived response rate numerically higher objective response rate weighting 1003 2493 402 vs 105 275 382 due higher rates observed partial response recistbased partial response among patients least 1 response assessment ehrderived response rate remained higher objective response rate 1003 1934 519 vs 105 256 410 due higher proportion patients observational cohort response assessment study response progressionbased end points similar clinical trial weighted observational cohorts increases confidence reliability observational end points inform interpretation relation trial end points additionally difference observed response rates including vs excluding patients response assessment highlights importance future research adopting 2way approach evaluating relationship ehrderived objective response rates