Characteristic and properties of patient-reported outcome measures (PROMs) used in idiopathic pulmonary fibrosis (IPF)/interstitial lung disease (ILD) clinical trials

Domain of PROMSource populationFDA/EMA guidance concordant developmentCross-sectional validationLongitudinal validation
MCIDNumber of items
Response time
SGRQHRQoL 3 domains:
symptoms (frequency and severity);
activity (effects of breathlessness on mobility and activity);
impact (psychosocial impact of disease)
COPD, asthmaNoYes (at least in CTD-ILDs)YesTotal 7 (4–8)Paper or electronic
50 items, 10 min
[48, 50, 5254]
Recall periods: symptoms: past 4 weeks
YesSymptoms 8
Activity 5
Impact 7
SGRQ-IHRQoL 3 domains:
symptoms (frequency and severity);
activity (effects of breathlessness on mobility and activity);
impact (psychosocial impact of disease)
total 3.9/4.9
symptoms 9.0/8.1
activities 9.8/10.4
impact 5.4/5.4
Paper or electronic 34 items 10–15 min
Recall periods: symptoms: past 4 weeks
[51, 55, 56]
EQ-5DHRQoL 5 domains: assesses impact of disease on mobility, self-care, usual activities, pain/discomfort and anxiety/depressionCOPDNoNoNo0.028 (range 0.017–0.033)Paper or electronic
3 levels: 15 items
5 levels: 25 items
8 min
Recall period: immediate situation
CRQHRQoL 4 domains: assesses dyspnoea “individualised” (impact on 5 activities chosen by patients including chores and social function); fatigue (severity and frequency); emotional functioning (satisfaction with life and frequency of impairment); and mastery (frequency of pain versus confidence in self-care)COPDNoNoNoNot availablePaper or electronic 20 items 15–25 min (administered) 8–10 min (self)
Recall period: past 4 weeks
K-BILDHRQoL 3 domains: psychological (frequency of impairment); breathlessness and activities (frequency of impact on activities); and chest symptoms (frequency of air hunger, wheezing and tightness)ILD, some IPFYesYesYesImprovement/decline
Total score 4.7/2.7
Breathlessness and activities 3.6/3.6
Chest symptoms 7/6
Psychological 4.8/3.5
Paper or electronic 15 items 5–7 minutes
Recall period: past 2 weeks
[51, 55, 6163]
SF-36HRQoL 8 domains: physical functioning (frequency of limitation); physical role limitations (degree of limitation); bodily pain; general health perceptions; energy/vitality (loss of energy or presence of fatigue); social functioning (limitations); emotional role limitations (difficulties with work and daily activities); mental health (presence of depression/nervousness)NoYesYesPCS 5; MCS 7; MID range 7–14Paper or electronic 36 items <10 min
Recall period: past 1 week
[64, 65]
L-IPFHRQoL 2 modules: symptoms (3 domains- shortness of breath, cough, energy) and impactIPFYesYesNoNot availableNot available 35 items
Recall periods:
symptoms: past 24 h
impact: past 1 week
IPF-PROMHRQoL 4 domains:
physical experience of breathlessness; psychological experience of breathlessness; emotional wellbeing; and energy level
IPFYesYesNoNot availableNot available 12 items[67, 68]
UCSD-SOBQDyspnoea: assesses dyspnoea severity with activities (21 items) and limitations from dyspnoea and related fear and harm (3 items)COPDNoYesYes5 unitsPaper or electronic 24 items 5–10 min
Recall period: immediate situation
Dyspnoea-12Dyspnoea 2 domains: physical (breathlessness severity) and affective, incorporating both physical and affective aspects, and does not depend on activity limitationCOPD, ILDNoYesNoNot availablePaper 12 items 5–10 min
Recall period: immediate situation
[72, 73]
LCQCough 3 domains:
physical, psychological and social (frequency of impairment ranging from all to none of the time)
COPD and chronic coughNoNoNoNot availablePaper or electronic 19 items <5 min
Recall period: past 2 weeks
[74, 75]
CASA-QCough 4 domains: cough symptoms; cough impact; sputum symptoms; and sputum impact (assesses frequency ranging from never to a lot)COPDNoYesNoNot availablePaper 20 items
Recall period: past 1 week
[76, 77]

FDA: US Food and Drug Administration; EMA: European Medicines Agency; MCID: minimal clinically important difference; SGRQ: St George's Respiratory Questionnaire; SGRQ-I: SGRQ IPF-specific version; EQ-5D: EuroQol five dimensions; CRQ: Chronic Respiratory Disease Questionnaire; K-BILD: King's Brief Interstitial Lung Disease Questionnaire; SF-36: 36-item short form; L-IPF: Living with Idiopathic Pulmonary Fibrosis; UCSD-SOBQ: University of California San Diego Shortness of Breath Questionnaire; LCQ: Leicester Cough Questionnaire; CASA-Q: Cough and Sputum Assessment Questionnaire; HRQoL: health-related quality of life; CTD-ILD: connective tissue disease-associated ILD; PCS: physical component summary; MCS: mental health component summary; MID: minimally important difference.