Prospective Psychometric Validation of the Swahili Translated and Adapted Pediatric Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE).

Background: High quality clinical research is necessary in order to address the significant disparities in pediatric cancer outcomes seen in low- and middle-income countries (LMICs). Patient reported outcomes are now recognized as a critical part of many clinical trials, however, use of patient reported outcomes (PROs) in LMICs is limited by the lack of thoroughly translated and validated PRO surveys. To address this gap in Tanzania, we subsequently undertook the prospective psychometric validation of a recently translated Swahili Ped-PRO-CTCAE survey in order to support its use in Swahili speaking settings. Methodology: Between June and September, 2023, 41 patients seen in the pediatric oncology clinic at Bugando Medical Centre, in Mwanza, Tanzania, were enrolled. Patients or their parents, as age appropriate, were administered the Swahili Ped-PRO-CTCAE. Simultaneously, a CTCAE provider assessment was completed. Descriptive statistical and psychometric analysis of survey results was performed using R. Results: 49 surveys were collected, with 8 participants repeating surveys at later clinic visits. Internal consistency within symptom domains was supported by polychoric correlation coefficients all ≥0.5 with most ≥0.7. Principle component analysis of all evaluable symptom domains demonstrated one component explained >70% of the cumulative variance for most symptoms. Concurrent validity was supported as nearly all Spearman correlation coefficients between Ped-PRO-CTCAE questions and relevant provider assessment questions were all ≥0.5. Conclusions: Administration of the Swahili translated and adapted Ped-PRO-CTCAE in a representative Swahili speaking pediatric cancer patient population proved feasible and psychometric evaluation of survey results support the validity of the translation.