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Table 2 List of COAs included in cognitive debriefing interviews

From: Qualitative research with patients and caregivers of patients with PIK3CA related overgrowth spectrum: content validity of clinical outcome assessments

Concept of interest COA by report
Adult self-report Pediatric self-report Observer-report
Global impression of symptom severity Single item on the overall severity of PROSa
Pain intensity Brief pain inventory, items 2-6d Brief Pain Inventory,
items 2-6d
Wong-Baker FACES
Physical function PROMIS-29 + 2 Profile v2.1 PROMIS Pediatric-25 Profile v2.0 PROMIS-Parent-Proxy-25 Profile v2.0
Fatigue
Ability to participate in social roles and activities/Peer relationshipsb
Pain interference
Pain intensity
Anxiety
Depression
Sleep disturbancec PROMIS Pediatric Short Form
v1.0 – Sleep Disturbance 4a
PROMIS Parent Proxy Short Form
v1.0 – Sleep Disturbance 4a
Dyspnea PROMIS Dyspnea Severity, three items from item bank
  1. aWhile the overall content of these items were identical across the adult, child, and observer-reported measures, minor changes to item wording were made to make it relevant for the intended group (e.g., modifying ‘how would you rate your overall symptoms’ to ‘how would you rate your child’s overall symptoms)
  2. b ‘Ability to participate in social roles and activities’ was assessed for adults, while ‘peer relationships’ was assessed for children/observer-report
  3. cSleep disturbance was assessed in the PROMIS-29 + 2 Profile v2.1 using the PROMIS Sleep Disturbance Short Form 6a. Sleep disturbance was not assessed on the PROMIS Pediatric or Parent Proxy Profile, and thus a separate short form assessment was needed
  4. dBrief Pain Inventory Items 2–6 were as follows: (2) On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most; (3) Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 h; (4) Please rate your pain by circling the one number that best describes your pain at its least in the last 24 h; (5) Please rate your pain by circling the one number that best describes your pain on the average; and (6) Please rate your pain by circling the one number that tells how much pain you have right now