TABLE 2

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

	Domain of PROM	Source population	FDA/EMA guidance concordant development	Cross-sectional validation	Longitudinal validation MCID	MCID	Number of items Response time	References
SGRQ	HRQoL 3 domains: symptoms (frequency and severity); activity (effects of breathlessness on mobility and activity); impact (psychosocial impact of disease)	COPD, asthma	No	Yes (at least in CTD-ILDs)	Yes	Total 7 (4–8)	Paper or electronic 50 items, 10 min	[48, 50, 52–54]
					Yes	Total 7 (4–8)	Recall periods: symptoms: past 4 weeks
					Yes	Symptoms 8
						Activity 5
						Impact 7
SGRQ-I	HRQoL 3 domains: symptoms (frequency and severity); activity (effects of breathlessness on mobility and activity); impact (psychosocial impact of disease)	COPD	No	Yes	Yes	Improvement/decline 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-5D	HRQoL 5 domains: assesses impact of disease on mobility, self-care, usual activities, pain/discomfort and anxiety/depression	COPD	No	No	No	0.028 (range 0.017–0.033)	Paper or electronic 3 levels: 15 items 5 levels: 25 items 8 min Recall period: immediate situation	[57–59]
EQ-5D		COPD	No	No	Yes	0.028 (range 0.017–0.033)		[57–59]
CRQ	HRQoL 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)	COPD	No	No	No	Not available	Paper or electronic 20 items 15–25 min (administered) 8–10 min (self) Recall period: past 4 weeks	[60]
CRQ		COPD	No	No	No	Not available		[60]
K-BILD	HRQoL 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 IPF	Yes	Yes	Yes	Improvement/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, 61–63]
K-BILD		ILD, some IPF	Yes	Yes	Yes			[51, 55, 61–63]
SF-36	HRQoL 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)		No	Yes	Yes	PCS 5; MCS 7; MID range 7–14	Paper or electronic 36 items <10 min Recall period: past 1 week	[64, 65]
SF-36			No	Yes	Yes	PCS 5; MCS 7; MID range 7–14		[64, 65]
L-IPF	HRQoL 2 modules: symptoms (3 domains- shortness of breath, cough, energy) and impact	IPF	Yes	Yes	No	Not available	Not available 35 items Recall periods: symptoms: past 24 h impact: past 1 week	[66]
L-IPF		IPF	Yes	Yes	No	Not available		[66]
IPF-PROM	HRQoL 4 domains: physical experience of breathlessness; psychological experience of breathlessness; emotional wellbeing; and energy level	IPF	Yes	Yes	No	Not available	Not available 12 items	[67, 68]
IPF-PROM		IPF	Yes	Yes	No	Not available	Not available 12 items	[67, 68]
UCSD-SOBQ	Dyspnoea: assesses dyspnoea severity with activities (21 items) and limitations from dyspnoea and related fear and harm (3 items)	COPD	No	Yes	Yes	5 units	Paper or electronic 24 items 5–10 min Recall period: immediate situation	[69–71]
UCSD-SOBQ		COPD	No	Yes	No	5 units		[69–71]
Dyspnoea-12	Dyspnoea 2 domains: physical (breathlessness severity) and affective, incorporating both physical and affective aspects, and does not depend on activity limitation	COPD, ILD	No	Yes	No	Not available	Paper 12 items 5–10 min Recall period: immediate situation	[72, 73]
Dyspnoea-12		COPD, ILD	No	Yes	No	Not available	Paper 12 items 5–10 min Recall period: immediate situation	[72, 73]
LCQ	Cough 3 domains: physical, psychological and social (frequency of impairment ranging from all to none of the time)	COPD and chronic cough	No	No	No	Not available	Paper or electronic 19 items <5 min Recall period: past 2 weeks	[74, 75]
LCQ		COPD and chronic cough	No	No	No	Not available		[74, 75]
CASA-Q	Cough 4 domains: cough symptoms; cough impact; sputum symptoms; and sputum impact (assesses frequency ranging from never to a lot)	COPD	No	Yes	No	Not available	Paper 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.