TABLE 3.
PRO Instruments Used to Measure PRO Concepts in the PBC and PSC Literature
| Variable | Frequency n (%) | |||
|---|---|---|---|---|
| PBC (n = 642) | PSC (n = 177) | Both (n = 107) | Total (n = 926) | |
| Use of PRO Instrument | ||||
| Yes | 381 (59.3) | 93 (52.5) | 84 (78.5) | 558 (60.2) |
| No | 242 (37.7) | 68 (38.4) | 23 (21.5) | 333 (36.0) |
| Unclear | 19 (3.0) | 16 (9.1) | 0 (0) | 35 (3.8) |
| Mention of PRO instrument validity in PBC/PSC | ||||
| Yes | 87 (13.6) | 14 (7.9) | 14 (13.1) | 115 (12.4) |
| No | 294 (45.8) | 79 (44.6) | 70 (65.4) | 443 (47.8) |
| Not applicable (no instrument) | 261 (40.6) | 84 (47.5) | 23 (21.5) | 368 (39.4) |
| TOP 20 most commonly used PRO instruments | ||||
| Likert/Numeric Grading Scale NOS | 63 (9.8) | 18 (10.2) | 3 (2.8) | 84 (9.1) |
| PBC‐40 | 58 (9.0)* | 6 (3.4) † | 4 (3.7) | 67 (7.2) |
| Itch Visual Analog Scale | 35 (5.5) | 6 (3.4) | 18 (16.8) | 59 (6.4) |
| Fatigue Impact Scale | 36 (5.6) † | 6 (3.4) | 4 (3.7) | 46 (5.0) |
| SF‐36 | 20 (3.1) | 11 (6.2) | 13 (12.2) | 44 (4.8) |
| Visual Analog Scale NOS | 9 (1.4) | 12 (6.8) | 9 (8.4) | 30 (3.2) |
| Hospital Anxiety and Depression Scale | 23 (3.6) | 2 (1.1) | 1 (0.9) | 26 (2.8) |
| Epworth Sleepiness Scale | 15 (2.3) | 1 (0.6) | 0 (0) | 16 (1.7) |
| Chronic Liver Disease Questionnaire | 5 (0.8)* | 4 (2.3)* | 3 (2.8) | 12 (1.3) |
| 5‐D Itch Scale | 9 (1.4) | 2 (1.1) | 0 (0) | 11 (1.2) |
| Diary NOS | 7 (1.1) | 4 (2.3) | 0 (0) | 11 (1.2) |
| Orthostatic Grading Scale–Autonomic Events | 7 (1.1) | 0 (0) | 2 (1.9) | 9 (1.0) |
| PBC‐27 | 4 (0.6)* | 3 (1.7) † | 2 (1.9) | 9 (1.0) |
| Fisk Fatigue Severity Scale | 5 (0.8) † | 0 (0) | 3 (2.8) | 8 (0.9) |
| Beck Depression Inventory | 4 (0.6) | 1 (0.6) | 1 (0.9) | 6 (0.7) |
| Pittsburgh Sleep Quality Index | 6 (0.9) | 0 (0) | 0 (0) | 6 (0.7) |
| Pruritus Numeric Rating Scale (0‐10) | 2 (0.3) | 2 (1.1) | 1 (0.9) | 5 (0.5) |
| Gastrointestinal Symptom Rating Scale | 3 (0.5) | 1 (0.6) | 0 (0) | 4 (0.4) |
| Hamilton Depression Rating Scale | 3 (0.5) | 0 (0) | 1 (0.9) | 4 (0.4) |
| Krupp’s Fatigue Severity Scale | 4 (0.6) | 0 (0) | 0 (0) | 4 (0.4) |
Bolded instruments denote instruments that were either developed in the target population or subsequently underwent psychometric testing in the target population.
*
Instrument was developed with input from the target population.
†
Instrument was not developed with input from the target population but later underwent psychometric testing in the target population.
Abbreviation: NOS, not otherwise specified.