Background and aims: Patient reported outcomes(PROs)are used in clinical trials to evaluate toxicity,effectiveness, and quality of life.A program to assess PROs was started at our hospital in2020.Here we present preliminary results about its utility in reporting symptoms and reducing visits toEmergencies and hospitalization.Patients complete a questionnaire at every cycle of treatment.
Methods: Patients(pts)with diagnosis of any type of lymphoma in need of starting therapy in our hospital between 1st Jan 2019 and 31st Dec 2021 were included in our study. Pts who started treatment in 2019 and those who refused to participate in 2020 and 2021 were considered the control arm of our study. Principal endpoint was to compare physician and patient-reported adverse events through a standardized questionnaire (PRO-CTCAE). Secondary endpoints included association between inclusion in PROMs program and reduction of hospital admissions and Emergencies visits. Here, we present the preliminary results from answers given at the beginning of treatment (as it is considered the period were most toxicity is expected). A subgroup analysis to study patients with Hodgkin lymphoma(HL)was performed.
Results: Two-hundred and eight patients were included.Thirty-six(17,3%)were HL.Patients with HL were significantly younger (49.3vs.63.5 y.o.;p=0,029).No differences were found in terms of adherence to PROMs program between HL and NHL(52.8%vs.56.4%; p=0,69).Figure 1 shows most commonly adverse events (AEs) reported by clinicians and patients among those with diagnosis of HL and NHL. Differences were found in both groups.Differences between patients with HL and NHL were found at sexual symptoms reported by physicians(10.5%among HL and 1%among NHL; p=0,02)and tendency to statistically significant difference at oral symptoms reported by patients(36.1% among NHL and 15.1% among HL;p=0.085). Patients included in the PROMprogram would visit Emergencies less than those in the control arm. Difference was statistically significant in the whole group(n=208)and showed tendency to significancy in the smaller group of HL(31.6%vs.58.8%;p=0,1).The same happened with unscheduled hospitalization.
Conclusions: Integration of PROs is essential to evaluate the effect of treatment. Incorporation of patients’ perspective makes personalized medicine more concrete. Physicians and patients report different symptoms and intensity and those included in the program tend to use fewer unscheduled resources.