Qualitative modification and development of patient- and caregiver-reported outcome measures for iron chelation therapy

Table 4 PRO and ObsRO Palatability instruments

#	Item Stem^a	Response Scale
PRO
Inst	The following questions are about the medicine you take for iron overload (too much iron in your body). Please read each one and answer by yourself. There are no right or wrong answers. All of your answers will remain confidential. Please answer each question about your medicine for iron overload TODAY:	N/A
1	How did your medicine for iron overload taste today?	5-point scale: Very good, Good, Not good or bad, Bad, Very bad
2	Some medicines have an aftertaste (taste left in your mouth after you swallow). How was the aftertaste of your medicine for iron overload today?
3	Using the answers listed below, which answer best describes what happened after you took your medicine for iron overload today?	4-point scale: Swallowed ALL of the medicine, Spat out SOME of the medicine, Spat out ALL of the medicine and swallowed none of it, Vomited within 30 min after swallowing the medicine
4	How would you describe the amount of liquid that you took with your medicine for iron overload today?	3-point scale: Not enough liquid, Just enough liquid, Too much liquid
ObsRO^b
1	Please choose the face that best describes your child’s reaction to the taste of the medicine for iron overload immediately after putting it in his/her mouth today.	5-point scale: Faces scale 1–5
2	Please choose the face that best describes your child’s reaction to the aftertaste of the medicine after swallowing his/her medicine for iron overload today.	5-point scale: Faces scale 1–5

Abbreviations: Inst, instructions; N/A, not applicable; ObsRO, observer-reported outcome; PRO, patient-reported outcome
^aInstructions, items, and response options reflect exact wording used in the PRO measure, unless otherwise specified. The ObsRO measure instructions were identical, with the exception of replacing “the medicine you take”/“your medicine” with “the medicine your child takes”/“the medicine your child took”. The ObsRO items 3 and 4 stem and response scale were identical to the PRO, with the exception of replacing “you took your” with “your child took his/her” in item 3, and “you took with your” with “your child took with his/her” in item 4
^bItems 1 and 2 item stems and response scale for the ObsRO were different from the PRO

ISSN: 1477-7525