Study Design and Procedures
We previously reported Chichewa translation and validation of the Pediatric PROMIS-25 survey.20 The Chichewa Pediatric PROMIS-25 short form was administered at diagnosis (at the time of study enrollment prior to initiation of chemotherapy), during active treatment (within 30 days of last receiving chemotherapy, typically on day 0 of the next scheduled chemotherapy) and at follow-up (patients returning for a scheduled follow-up clinic visit between 6 months and 2 years after treatment completion). If patients progressed or relapsed and were receiving second line chemotherapy at the time of the PROMIS-25 administration, then this was categorized as active treatment. If they progressed or relapsed, but were on palliative care and not receiving chemotherapy, then this was categorized as follow-up.
For children ≥8 years old, the Chichewa Pediatric PROMIS-25 was administered directly to the child. The parent-proxy version was used for children 5-7 years old, cognitively impaired, or too ill to complete the questionnaire themselves.20,25–27 Questionnaires were read aloud to the child/parent via a non-provider research assistant trained in survey methodology and recorded on a paper form. This modification was deemed necessary in our setting due to low literacy in the target population. The parent/child had an answer choice sheet in front of them so they could point to choose their answers, a method previously used by our team in Malawi and validated for other PRO-HRQoL instruments targeting young children.20,28
After treatment completion, some patients were lost to follow-up (LTFU) from clinic but reachable by phone. We encouraged these patients to return to clinic in person, and when unsuccessful we administered the PROMIS-25 survey via phone. Prior work has demonstrated that in person and telephone administration of English Pediatric PROMIS measure does not affect validity, although this has not been demonstrated for the Chichewa version.29,30