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