Table 1 Characteristics of the included PROMs
PROM* | First Author (year) | (Sub)scale (s) (number of items) | Response options | Scoring; M (SD) | Recall period | Mode of administration | Psychometric proprieties reported |
|---|---|---|---|---|---|---|---|
SF-36 | Gomide MA et al. (2013) [26] | 36 items 8 dimensions: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH) | The response scales and the number of response options range from 3-points (PF) to 6-points (VT, MH) Likert scale. Scores for each domain can range from 0 to 100, higher scores indicating better health state | PF = 75.57 (22.61) RP = 60.57 (22.02) BP = 58.10 (30.15) GH = 59.26 (18.71) VT = 51.03 (12.42) SF = 54.29 (13.87) RE = 75.95 (25.14) MH = 65.20 (16.85) | 4 weeks | Self-administered | Internal Consistency |
SF-36v2 | Jindal et al. (2017) [27] | 36 items 8 dimensions: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH) | The response scales and the number of response options range from 3-points (PF) to 6-points (VT, MH) Likert scale. Scores for each domain can range from 0 to 100, higher scores indicating better health state | PF = 87.86 (16.25) RP = 84.23 (23.19) BP = 67.90 (21.79) GH = 61.05 (23.39) VT = 57.74 (18.32) SF = 85.12 (27.28) RE = 88.89 (24.49) MH = 76.19 (16.95) | 4 weeks | Self-administered | Internal Consistency, Floor/Ceiling effects |
Palao‑Ocharan et al. (2022) [28] | 36 items 8 dimensions: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH) | The response scales and the number of response options range from 3-points (PF) to 6-points (VT, MH) Likert scale. Higher scores indicating better health state | PF = 26.53 (4.15) RP = 15.66 (4.22) BP = 8.01 (3.03) GH = 15.79 (4.86) VT = 12.94 (3.25) SF = 7.91 (2.00) RE = 12.32 (3.01) MH = 18.23 (4.18) | 4 weeks | Self-administered | Construct validity (Convergent validity, H-test, Discriminative validity), Internal Consistency, Test–retest reliability, Measurement error (SEM), Minimal clinically important difference (MCID), Floor/Ceiling effects | |
HAE-QoL | Prior et al. (2012) [29] | 44 items 10 dimensions: health conditions, physical functioning, social role, emotional role, physical role, general health, aesthetics, mental health and treatment | 5- or 6-point Likert scale depending on the item. Total score ranges from 25–135 (range of scores differs between the various dimensions); higher scores indicate lower impairment | NR | 6 months | Self-administered | Face validity, Content validity (PATIENTS), |
Prior et al. (2016) [30] | 25 items 7 dimensions: treatment difficulties, physical functioning and health, disease-related stigma, motional role and social functioning, concern about offspring, perceived control over illness, and mental health | 5- or 6-point Likert scale depending on the item. Total score ranges from 25–135 (range of scores differs between the various dimensions); higher scores indicate lower impairment | NR | 6 months | Self-administered | Structural Validity (EFA), Cross-cultural adaptation, Content validity (EXPERTS), Construct validity (Convergent validity, H-test, Discriminative validity), Criterion validity, Internal consistency, test–retest reliability, Floor/Ceiling effects | |
HAEA- QoL | Busse et al. (2019) [31] | 27 items 2 dimensions: emotional and social well-being “feelings” domain, and an HAE-specific “concerns” domain | 4-point Likert scale: 1 = not at all; 2 = a little; 3 = medium; 4 = a lot/severe Higher scores indicated worse outcomes | NR | NR | Self-administered | Face validity, Content validity, Structural validity (EFA), Construct validity (known-groups validity) |
AE-QoL | Vanya et al. (2023) [32] | 17 items 4 dimensions: functioning, fatigue/mood, fears/shame, and food | 5-point Likert scales: never, rarely, sometimes, often, and very often. Total score range from 0 to 100, with higher scores indicating greater impairment | Total = 46.60 (20.89) | 4 weeks | Self-administered | Content validity, Construct validity (Convergent validity, H-test, Discriminant validity), Criterion validity, Internal consistency, Test–retest reliability, Measurement error (SEM), Sensitivity to change |