Skip to main content

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