P1693: patient-reported outcomes in lymphoma trials: a systematic review

Topic: 35. Quality of life and palliative care Background: Treatment for lymphoma may have long-lasting consequences in the form of organ damage, fatigue, and infertility. Clinical trials report extensively on survival outcomes, clinical response and toxicity and often fall short of assessing the treatments impact on the patients’ quality of life and symptoms in the short- and long-term. Aims: To explore the use and frequency of patient-reported outcome (PRO) instruments in randomised controlled trials (RCTs) for lymphoma and assess their consistency of reporting. Methods: We conducted a systematic search of MEDLINE, CENTRAL and trial registries for RCTs investigating Hodgkin lymphoma between January 1st, 2016 until May 31st, 2022, while literature search for non Hodgkin lymphoma is ongoing. Following trial selection, which was conducted by two independent reviewers, we extracted trial- and patient characteristics as well as outcome data, focusing on the use of PRO measures (PROMs) and reporting of PROs using a pre-defined extraction form. To assess consistency of reporting we compared trial registry entries, study protocols and publications, where available. Results: We report results for Hodgkin lymphoma. We identified 4222 records through our search. Following duplication and selection based on title and abstract screening 317 reports were eligible for full-text evaluation. We included 166 reports of 51 ongoing or completed trials in the review. Based on registry entries, 41% of trials were completed, 49% were still ongoing (18% active but not recruiting, 31% recruiting), 8% of trials had an unknown trial status and 2% of trials were terminated. Publications in full-text or abstract form were available for 33 trials. Seventy percent of trials were conducted in the newly diagnosed disease setting, most of which in patients with advanced Hodgkin disease. Across trials with published follow-up data (32 trials), the median follow-up was 5.2 years. Overall, 16 trials, completed or ongoing, mentioned PRO assessment either in their registry entries, protocol, or publications. Except for one trial, PROs were evaluated as a secondary or exploratory outcome. Seven out of 27 trials (25.9%) with full publications available reported on PROs, at least in part. Two trials mentioned PRO assessment in the trial registry or protocol but did not report the outcome. Irrespective of their publication status, the most referenced global patient reported outcome measure was the EORTC-QLQ-C30 (12 studies), followed by EQ-5D (3 studies) and the FACT-Neurotoxicity (2 studies). Notably, none of the trials used the EORTC QLQ-HL27 and FACT-Lymphoma, disease-specific PROMs developed for Hodgkin lymphoma patients’ quality of life assessment. Summary/Conclusion: Our findings show that only a third of RCTs in Hodgkin lymphoma report PROs as an outcome. None of the trials used disease-specific PROMs developed for assessment quality of life in Hodgkin lymphoma patients. Guidance for the assessment of PROs is necessary to inform on comprehensive outcomes important to patients.Keywords: Lymphoma, Systematic review, Patient reported outcomes, Hodgkin’s lymphoma