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

Table 5 PRO and ObsRO GI Symptom Diary instruments

#	Item Stem^a	Response Scale^b
Inst PRO	Please read each symptom carefully. For each symptom, choose the number between 0 and 10 to rate how severe the symptom was over the past 24 h (for example, from 8:00 AM yesterday to 8:00 AM today). Zero ‘0’ means you did not have this symptom and ‘10’ means it is the worst level of the symptom you can have. Please answer all of the following questions after taking your daily dose of medicine for iron overload.	N/A
Inst ObsRO	Please read each symptom carefully. Indicate how often your child had each symptom over the past 24 h (for example, from 8:00 AM yesterday to 8:00 AM today). Please answer all of the following questions after your child has taken his/her daily dose of medicine for iron overload.	N/A
1	Pain in your belly	11-point horizontal scale: 0 to 10 (0 = No Pain; 10 = Worst Pain)
2	Nausea (feeling like you might throw up)	11-point horizontal scale: 0 to 10 (0 = No Nausea; 10 = Worst Nausea)
3	Vomiting (throwing up)	11-point horizontal scale: 0 to 10 (0 = No Vomiting; 10 = Worst Vomiting)
4	Constipation	11-point horizontal scale: 0 to 10 (0 = No Constipation; 10 = Worst Constipation)
5	Diarrhea	11-point horizontal scale: 0 to 10 (0 = No Diarrhea; 10 = Worst Diarrhea)
6	How many bowel movements did you have in the past 24 h?	0 (none), 1, 2, 3, 4, 5–10, 11 or more

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 and response options differed from that of the PRO, while item stems were identical, with the exception of replacing “your” with “his//her” in item 1, “you” with “he/she” in item 2, and “you” with “your child” in item 6
^bIn the ObsRO measure, the response scale for items 1–5 consisted of 5-point scale (Always, Most of the time, Sometimes, Rarely, Never) instead of the 11-point scale used in the PRO

ISSN: 1477-7525