TABLE 2.
Number of Times a PRO Concept Was Mentioned in the PBC and PSC Literature (n = 926)
| Variable | Frequency n (%) | ||
|---|---|---|---|
| PBC (n = 642) | PSC (n = 177) | Both (n = 107) | |
| Concept category | |||
| Quality of life/functioning | 105 (16.4) | 38 (21.5) | 32 (29.9) |
| Symptoms | 421 (65.6) | 120 (67.8) | 51 (47.7) |
| Treatment AEs/side effects | 90 (14.0) | 18 (10.2) | 22 (20.5) |
| Other | 26 (4.0) | 1 (0.5) | 2 (1.9) |
| Descriptive vs. outcome | |||
| Descriptive only | 174 (27.1) | 48 (27.1) | 25 (23.4) |
| Outcome only | 468 (72.9) | 129 (72.9) | 82 (76.6) |
| Specific concepts | |||
| Quality of life/functioning | |||
| Broad HRQOL | 82 (12.8) | 34 (19.2) | 30 (28.0) |
| Cognitive functioning | 4 (0.6) | 0 (0) | 0 (0) |
| Emotional functioning | 3 (0.5) | 1 (0.6) | 2 (1.9) |
| Physical functioning | 8 (1.3) | 1 (0.6) | 1 (0.9) |
| Social functioning | 4 (0.6) | 0 (0) | 1 (0.9) |
| Symptoms | |||
| Abdominal distension | 2 (0.3) | 0 (0) | 0 (0) |
| Abdominal pain | 14 (2.2) | 23 (13) | 0 (0) |
| Anorexia | 6 (0.9) | 2 (1.1) | 0 (0) |
| Anxiety | 15 (2.3) | 0 (0) | 0 (0) |
| Arthralgia | 6 (0.9) | 1 (0.6) | 0 (0) |
| Autonomic dysfunction | 8 (1.3) | 1 (0.6) | 2 (1.9) |
| Back pain | 1 (0.2) | 0 (0) | 0 (0) |
| Blood in stool | 1 (0.2) | 1 (0.6) | 0 (0) |
| Bone pain | 2 (0.3) | 0 (0) | 0 (0) |
| Depression | 25 (3.9) | 4 (2.3) | 5 (4.7) |
| Diarrhea | 3 (0.5) | 5 (2.8) | 0 (0) |
| Edema | 1 (0.2) | 0 (0) | 0 (0) |
| Fatigue | 130 (20.3) | 28 (15.8) | 14 (13.1) |
| Fever | 0 (0) | 2 (1.1) | 0 (0) |
| Malaise | 2 (0.3) | 2 (1.1) | 0 (0) |
| Muscle aches | 2 (0.3) | 0 (0) | 0 (0) |
| Nausea/vomiting | 4 (0.6) | 5 (2.8) | 0 (0) |
| Other gastrointestinal symptoms (multiple) | 1 (0.2) | 1 (0.6) | 0 (0) |
| Poor sleep quality | 1 (0.2) | 0 (0) | 2 (1.9) |
| Pruritus/itch | 166 (25.9) | 39 (22.0) | 26 (24.3) |
| Sexual dysfunction | 1 (0.2) | 2 (1.1) | 0 (0) |
| Sicca symptoms | 1 (0.2) | 0 (0) | 0 (0) |
| Sleep disturbance | 12 (1.9) | 1 (0.6) | 0 (0) |
| Sleepiness/daytime somnolence | 17 (2.7) | 1 (0.6) | 0 (0) |
| Weight loss | 0 (0) | 3 (1.7) | 0 (0) |
| Xerophthalmia | 4 (0.6) | 0 (0) | 0 (0) |
| Xerostomia | 3 (0.5) | 0 (0) | 0 (0) |
| Treatment AEs/side effects | |||
| Cognitive AEs | 6 (0.9) | 0 (0) | 2 (1.9) |
| Emotional AEs | 2 (0.3) | 1 (0.9) | 0 (0) |
| Gastrointestinal AEs | 41 (6.4) | 10 (5.7) | 8 (7.5) |
| Opioid withdrawal symptoms | 2 (0.3) | 0 (0) | 2 (1.9) |
| Physical AEs | 34 (5.3) | 8 (4.5) | 9 (8.4) |
| Other | |||
| Coping strategies | 2 (0.3) | 0 (0) | 0 (0) |
| Dissatisfaction with health care delivery or information | 1 (0.2) | 0 (0) | 0 (0) |
| Health behaviors (e.g., smoking, exercise) | 1 (0.2) | 0 (0) | 1 (0.9) |
| Health perception | 2 (0.3) | 0 (0) | 1 (0.9) |
| Identity/role change | 1 (0.2) | 0 (0) | 0 (0) |
| Illness perceptions | 2 (0.3) | 0 (0) | 0 (0) |
| Loneliness/social isolation | 2 (0.3) | 0 (0) | 0 (0) |
| Psychological distress | 4 (0.6) | 1 (0.6) | 0 (0) |
| Self‐efficacy | 3 (0.5) | 0 (0) | 0 (0) |
| Social support | 1 (0.2) | 0 (0) | 0 (0) |
| Stigma | 6 (0.9) | 0 (0) | 0 (0) |
| Uncertainty | 3 (0.5) | 1 (0.6) | 0 (0) |