Table 4.
Validation parameters of PROMs considered for SSc-ILD organized by content, responsiveness and utility.
| Instruments |
Dyspnea |
SHAQ Breathing VAS | UCSD SOBQ | MTDI generic | Cough | HRQoL |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Physical function | SHAQ SSc | ||||||||||||
| D-12 generic | MRC generic | LCQ generic | SF-36 generic | EQ-5D generic | SGRQ respiratory | Pt-GA a generic | HAQ-DI generic | ||||||
| Content | Face validity | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
| Content validity | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
| Construct validity | Y | Y | Y | Y | ? | Y | Y | Y | Y | NT | Y | Y | |
| Criterion validity | NT | NT | NT | NT | NT | NT | NT | NT | NT | NT | NT | NT | |
| Response | Discriminatory | Y | Y | Y | Y | UC | Y | Y | UC b | Y | NT | Y | Y |
| Reliable | Y | Y | Y | NT | UC | Y | Y | Y | NT | NT | Y | Y | |
| Reproducible | NT | NT | Y | NT | Y | NT | NT | Y | NT | NT | Y | Y | |
| Sensitive to change | Y | Y | Y | Y | Y | Y | Y | UC b | NT | NT | Y | Y | |
| Utility | Cost effective | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
| Interpretability | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
| Readily available | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
| Safety | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
| Time efficient | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | |
| Discrete components | Physical mental vitality | SSc Sx Pt-GA | |||||||||||
| Developed for ILD | N | N | Y c | N | N | N | N | N | N | N | N | Y | |
| Patient-derived content | Y | No | No | No | No | No | No | No | No | No | No | No | |
PROM: patient-reported outcome measures; SSc-ILD: systemic sclerosis–related interstitial lung disease; D-12: Dyspnea-12; MRC: Medical Research Council Dyspnea Scale; SHAQ: Scleroderma Health Assessment Questionnaire; VAS: Visual Analogue Scale; UCSD SOBQ: University of San Diego Shortness of Breath Questionnaire; MTDI: Mahler Transitional Dyspnea Index; LCQ: Leicester Cough Questionnaire; HRQoL: health-related quality of life; SF-36: short form-36; EQ-5D: EurQoL 5 Dimensions; SGRQ: St. George’s Respiratory Questionnaire; Pt-GA: Patient Global Assessment; HAQ-DI: Health Assessment Questionnaire-Disability Index; SSc: systemic sclerosis; Y: yes; NT: not yet tested; UC: unclear; ILD: interstitial lung disease.
Pt-GA is an independent instrument categorized under HRQoL.
EQ-5D has variable performance depending on condition. 64
SHAQ VAS.