Development and adaptation of patient-reported outcome measures for patients who experience itch associated with primary biliary cholangitis

Journal of Patient-Reported Outcomes

Table 1 Participant demographic and disease characteristics

Characteristic	N = 20
Age, y
Mean (SD)	57.4 (11.2)
Range	32–74
Female, n (%)	18 (90)
Race, n (%)
White	18 (90)
Hispanic	2 (10)
Highest level of education completed, n (%)
High school	1 (5)
Some college	7 (35)
Bachelor’s degree	6 (30)
Graduate or professional school	6 (30)
Current employment status, n (%)
Full time	11 (55)
Part time	1 (5)
Unemployed for > 1 year	1 (5)
Retired	6 (30)
Unable to work because of PBC, CPS/fibromyalgia	1 (5)
Household income, US $, n (%)
$15,000–$24,999	2 (10)
$25,000–$34,999	1 (5)
$35,000–$49,999	2 (10)
$50,000–$74,999	6 (30)
$75,000–$99,999	2 (10)
$100,000–$124,999	1 (5)
≥$125,000	5 (25)
Declined to answer	1 (5)
Comorbidities, n (%)^a
Allergies (hay fever, chronic sinus trouble, other)	10 (50)
Arthritis or rheumatism	10 (50)
Asthma or other severe lung problems^b	4 (20)
Back problems (including disc or spine)	7 (35)
Depression	2 (10)
Diabetes or high blood sugar	3 (15)
Headache or migraine	3 (15)
Heart trouble^c	1 (5)
High blood pressure or hypertension	7 (35)
Nervousness or anxiety disorder	2 (10)
Thyroid problems	1 (5)
Trouble seeing (even with glasses or contact lenses)	4 (20)
Itch NRS (scale 0–100)^d
Severity of worst itch, mean (SD)	89.3 (14.1)
Severity of usual amount of itch, mean (SD)	50.5 (24.5)

CPS, chronic pain syndromes; NRS numerical response scale; PBC primary biliary cholangitis; SD, standard deviation; US, United States
^aOne participant each (5%) reported celiac disease, chronic reflux, fibromyalgia, hepatitis C, mixed nonspecific autoimmune disease, osteoarthritis, osteoporosis, polyps, Raynaud’s disease, Sjogren’s syndrome, or sphincter of Oddi dysfunction
^bChronic bronchitis, chronic obstructive pulmonary disorder, or emphysema
^cAngina, congestive heart failure, coronary artery disease, use of cardiac pacemaker
^dDuring the concept elicitation portion of the interview, participants were asked to complete a series of rating exercises using a NRS, with the 0 end of the scale representing “NO Itching at All,” and 100 representing “Worst Itching You Can Imagine”