Further Refinement is Required for Patient-Reported Outcome Scales for Respiratory Diseases Based on Traditional Chinese Medicine Theory for Applicability

Figures & data

Figure 1 Literature screening flow chart.

Table 1 Characteristics of the Included Studies

Reference	Instrument	Population	Disease Stage	Sample Size (% Female)	Age	Country	Number of Locations	Completion Rate
Ren et al, 2011^Citation23	TCMPRO-COPD	COPD	AECOPD	210^a	18–70^b	China	NR	100%
Zhou et al, 2016^Citation24	PRO-COPD	COPD	Stable COPD	60^a	18–80^b	China	1	100%
Li et al, 2011^Citation25	COPD-PRO	COPD	Stable COPD	215 (30.0)	63.9 ± 9.2^c	China	1	93.48%
Li et al, 2020^Citation26	mcopd-PRO	COPD	Stable COPD	366 (23.77)	66.0	China	6	99.5%
Zhu et al, 2011^Citation27	scopd-PRO	COPD	Stable COPD	319 (28.21)	62.78 ± 9.42^c	China	6	98.46%
Wei et al, 2021^Citation28	CFS-COPD-PRO	COPD	Cold and fluid syndrome (TCM syndrome)	300^a	≥30^b	China	1	92.31%
Zang et al, 2016^Citation29	IPF-TQ32	IPF	—	50^a	30–70^b	China	1	NR
Liang et al, 2016^Citation30	QOL-IPF	IPF	—	34 (38.24)	61 ± 14^c	China	1	NR
Li et al, 2016^Citation31	CAP-PRO	CAP	—	240^a	68.99 ± 11.48^c	China	4	98.3%
Diao et al, 2007^Citation32	QOL-AL	Lung cancer	Advanced Lung cancer	100 (51.00)	63.89 ± 9.95^c	China	1	NR
Yang et al, 2011^Citation33	QLASTCM-Lu	Lung cancer	—	240 (65)	60.3 ± 10.2^c	China	NR	NR
Wang et al, 2019^Citation34	QLASTCM-Lu (modified)	Lung cancer	—	100 (45)	61.2 ± 10.1^c	China	5	92%
Guan et al, 2022^Citation35	BE-PRO	Bronchiectasis	—	160 (61.3)	53.42 ± 13.4^c	China	6	100%

Notes: ^aNumber of males or females in the sample not reported; ^bOnly the age range was reported; ^cMean ± standard deviation; NR, Not reported.

Abbreviations: TCMPRO-COPD, Self-reported scale for patients with chronic obstructive pulmonary disease in TCM; PRO-COPD, PRO instrument for chronic obstructive pulmonary disease with characters of TCM; COPD-PRO, PRO instrument for chronic obstructive pulmonary diseases; mCOPD-PRO, Modified PRO scale for chronic obstructive pulmonary disease; sCOPD-PRO, PRO scale for patients with stable chronic obstructive pulmonary disease; CFS-COPD-PRO, Cold and fluid syndrome-COPD-PRO; IPF-TQ32, Health-related QOL of TCM scale for patients with idiopathic pulmonary fibrosis; QOL-IPF, QOL scale for patients with idiopathic pulmonary fibrosis; CAP-PRO, PRO instrument for community-acquired pneumonia; QOL-AL, QOL scale in patients with advanced lung cancer; QLASTCM-Lu, QOL assessment instrument for lung cancer patients based on TCM; QLASTCM-Lu (modified), Modified version of QOL assessment instrument for lung cancer patients based on TCM; BE-PRO, the scale combination of disease and syndrome of PRO with bronchiectasis; COPD, Chronic obstructive pulmonary disease; AECOPD, Acute exacerbation of chronic obstructive pulmonary disease; TCM, Traditional Chinese medicine; IPF, Idiopathic pulmonary fibrosis; CAP, Community-acquired pneumonia.

Table 2 Characteristics of the Included Scales

Instrument	Domain	Number of Items	Response Options	Scoring Direction	Scoring Algorithm	Recall Period	Completion Time
TCMPRO-COPD	5 domains: disease characters, syndrome elements, seven modes of emotions of TCM, limitation of activity and social activities	27	NR	W–B	NR	NR	8.85 min ^a
PRO-COPD	5 domains:TCM syndrome, physical domain, mental domain, individual life domain, remedial satisfaction	35	5-point (1–5)	(W–B) R	NR	AECOPD: 3 days; Stable COPD: 1 week	14.48 ± 5.26 min ^c
COPD-PRO	3 domains: amelioration of clinical symptom, satisfaction of health conditions, satisfaction of treatment effect	17	5-point (0–4)	B–W	Sum score (range, 0–68)	NR	6.7 ± 1.9 min ^c
mcopd-PRO	3 domains: physiological domain, psychological domain and environmental domain	27	5-point (0–4)	(B–W) R	Average score of items (range, 0–4)	2 weeks	5 min (4–11 min) ^b
scopd-PRO	4 domains: lung and kidney deficiency symptom, spleen deficiency symptom, functional activities and emotional impact	23	5-point (1–5)	B–W	Proportional score (range, 0–100)	NR	13.55 ± 6.32 min ^c
CFS-COPD-PRO	2 domains: external cold pattern and phlegm-drink pattern	27	5-point (0–4)	B–W	NA	NR	9.7 min ^a
IPF-TQ32	4 domains: symptoms of integration of TCM and western medicine, physiological function, mental function and social adaptability	32	5-point (1–5)	(W–B) R	Sum score (range, 32–160)	NR	NR
QOL-IPF	3 domains: clinical symptom, activity ability, influence of diseases on daily life	38	2-point (0–1); 3-point (0–2); 4-point (0–3); 5-point (0–4)	B–W	Proportional score (range, 0–100)	3 months	NR
CAP-PRO	3 domains: symptom, health satisfaction and efficacy satisfaction	17	5-point (1–5)	B–W	Sum score (range, 17–85)	3 days	9.85 ± 1.32 min ^c
QOL - AL	5 domains: physiological status, social and family status, emotional status, functional status, and other related issues	37	4-point	(W–B) R	Proportional score (range, 0–100)	NR	NR
QLASTCM-Lu	3 domains: correspondence between nature and man, integration of body and spirit, specific module	46	5-point	(B–W) R	Proportional score (range, 0–100)	NR	NR
QLASTCM-Lu (modified)	5 domains: physical status, mental condition, social function, unity of man and nature, and symptoms	49	5-point	(W–B) R	Sum score	NR	NR
BE-PRO	5 domains: physiology, psychology, environment, society, and satisfaction.	16	5-point (0–4)	B–W	Sum score (0–64)	2 weeks	9.07 ± 4.35 min ^c

Notes: W–B, As the scale score increases, the better the level of health; B–W, As the scale score increases, the health level deteriorates; R, The scale contains reverse scoring items; ^aStandard deviation not reported; ^bMedian (Interquartile Range, IQR); ^cMean ± standard deviation; NR, Not reported.

Abbreviations: TCMPRO-COPD, Self-reported scale for patients with chronic obstructive pulmonary disease in TCM; PRO-COPD, PRO instrument for chronic obstructive pulmonary disease with characters of TCM; COPD-PRO, PRO instrument for chronic obstructive pulmonary diseases; mCOPD-PRO, Modified PRO scale for chronic obstructive pulmonary disease; sCOPD-PRO, PRO scale for patients with stable chronic obstructive pulmonary disease; CFS-COPD-PRO, Cold and fluid syndrome-COPD-PRO; IPF-TQ32, Health-related QOL of TCM scale for patients with idiopathic pulmonary fibrosis; QOL-IPF, QOL scale for patients with idiopathic pulmonary fibrosis; CAP-PRO, PRO instrument for community-acquired pneumonia; QOL-AL, QOL scale in patients with advanced lung cancer; QLASTCM-Lu, QOL assessment instrument for lung cancer patients based on TCM; QLASTCM-Lu (modified), Modified version of QOL assessment instrument for lung cancer patients based on TCM; BE-PRO, the scale combination of disease and syndrome of PRO with bronchiectasis; COPD, Chronic obstructive pulmonary disease; AECOPD, Acute exacerbation of chronic obstructive pulmonary disease.

Table 3 Methodological Quality of the Included Studies

Instrument	Content Validity			Structural Validity	Internal Consistency	Reliability	Criterion Validity	Responsiveness
	Relevance	Comprehensiveness	Comprehensibility
TCMPRO-COPD	D^a,b	NR	NR	A	V	D	NR	D
PRO-COPD	D^a	NR	D^b	I	V	NR	I	V
COPD-PRO	D^b	NR	NR	A	V	D	NR	D
mCOPD-PRO	D^a,b	NR	D^b	V	V	NR	D	V
sCOPD-PRO23	NR	NR	D^b	A	V	NR	V	V
CFS-COPD-PRO	NR	NR	NR	A	V	D	NR	D
IPF-TQ32	D^a,b	NR	NR	NR	D	NR	D	NR
IPF-PRO	D^a,b	NR	NR	I	I	NR	V	NR
CAP-PRO	D^b	NR	NR	A	V	NR	NR	D
QOL - AL	D^b	NR	NR	I	V	NR	V	V
QLASTCM-Lu	D^a	NR	D^b	A	V	D	I	D
QLASTCM-Lu (modified)	NR	NR	NR	I	V	NR	I	D
BE-PRO	D^a	NR	NR	V	V	NR	V	D

Notes: V, very good; A, adequate; D, doubtful; I, inadequate; ^aconsulting experts; ^bconsulting patients; NR, Not reported.

Abbreviations: TCMPRO-COPD, Self-reported scale for patients with chronic obstructive pulmonary disease in TCM; PRO-COPD, Patient-reported outcome instrument for chronic obstructive pulmonary disease with characters of TCM; COPD-PRO, Patient-reported outcome instrument for chronic obstructive pulmonary diseases; mCOPD-PRO, Modified patient-reported outcome scale for chronic obstructive pulmonary disease; sCOPD-PRO, Patient-reported outcome scale for patients with stable chronic obstructive pulmonary disease; CFS-COPD-PRO, Cold and fluid syndrome-COPD-patient report outcome; IPF-TQ32, Health-related quality of life of traditional Chinese medicine scale for patients with idiopathic pulmonary fibrosis; QOL-IPF, Quality of life scale for patients with idiopathic pulmonary fibrosis; CAP-PRO, Patient-reported outcome instrument for community-acquired pneumonia; QOL-AL, Quality of life scale in patients with advanced lung cancer; QLASTCM-Lu, Quality of life assessment instrument for lung cancer patients based on traditional Chinese medicine; QLASTCM-Lu (modified), Modified version of quality of life assessment instrument for lung cancer patients based on traditional Chinese medicine; BE-PRO, the scale combination of disease and syndrome of patient-reported outcomes with bronchiectasis.

Table 4 The Measurement Properties, Quality of Evidence, and Recommendation of the Scales

PROM	Content Validity		Structural Validity		Internal Consistency		Reliability		Criterion Validity		Responsiveness		Recommendation
	M	E	M	E	M	E	M	E	M	E	M	E
TCMPRO-COPD	–	Low	?	Moderate	–	Moderate	?	Low	NR	NR	?	Low	B
PRO-COPD	?	Moderate	?	Moderate	+	Moderate	NR	NR	?	Low	?	Moderate	B
COPD-PRO	–	Moderate	?	High	+	High	+	Moderate	NR	NR	?	Moderate	B
mCOPD-PRO	?	Moderate	+	High	+	High	NR	NR	+	Moderate	?	High	B
sCOPD-PRO23	–	Moderate	?	High	+	High	NR	NR	+	High	?	High	B
CFS-COPD-PRO	NR	NR	?	Moderate	+	Moderate	+	Moderate	NR	NR	?	Low	B
IPF-TQ32	–	Moderate	NR	NR	+	Moderate	NR	NR	+	Low	NR	NR	B
IPF-PRO	–	Moderate	?	Moderate	?	Very low	NR	NR	+	Low	NR	NR	B
CAP-PRO	–	Moderate	?	High	+	High	NR	NR	NR	NR	?	Moderate	B
QOL - AL	–	Moderate	?	Moderate	+	High	NR	NR	+	High	?	Moderate	B
QLASTCM-Lu	?	Moderate	?	High	+	High	+	Moderate	?	Moderate	?	Moderate	B
QLASTCM-Lu (modified)	NR	NR	?	Moderate	+	Moderate	NR	NR	+	Low	?	Low	B
BE-PRO	?	Moderate	+	High	+	High	NR	NR	+	High	?	Moderate	B

Notes: M, Rating the measurement properties; E, Level of evidence; +, sufficient; –, insufficient; ?, indeterminate; B, the level of recommendation is B; C, the level of recommendation is C; NR, Not reported.

Abbreviations: TCMPRO-COPD, Self-reported scale for patients with chronic obstructive pulmonary disease in traditional Chinese medicine; PRO-COPD, Patient-reported outcome instrument for chronic obstructive pulmonary disease with characters of TCM; COPD-PRO, Patient-reported outcome instrument for chronic obstructive pulmonary diseases; mCOPD-PRO, Modified patient-reported outcome scale for chronic obstructive pulmonary disease; sCOPD-PRO, Patient-reported outcome scale for patients with stable chronic obstructive pulmonary disease; CFS-COPD-PRO, Cold and fluid syndrome-COPD-patient report outcome; IPF-TQ32, Health-related quality of life of traditional Chinese medicine scale for patients with idiopathic pulmonary fibrosis; QOL-IPF, Quality of life scale for patients with idiopathic pulmonary fibrosis; CAP-PRO, Patient-reported outcome instrument for community-acquired pneumonia; QOL-AL, Quality of life scale in patients with advanced lung cancer; QLASTCM-Lu, Quality of life assessment instrument for lung cancer patients based on traditional Chinese medicine; QLASTCM-Lu (modified), Modified version of quality of life assessment instrument for lung cancer patients based on traditional Chinese medicine; BE-PRO, the scale combination of disease and syndrome of patient-reported outcomes with bronchiectasis.

Ren M, Sun ZT, Feng JH, et al. Evaluating of self-reported scale for patients with chronic obstruction pulmonary disease in TCM. Tianjin J Tradit Chin Med. 2011;28(02):101–103.

 Google Scholar

Zhou D. Application and Evaluation of the “Patient Reported Outcome” Traditional Chinese Medicine Evaluation Scale for Chronic Obstructive Pulmonary Disease. Hunan: Hunan University of Chinese Medicine; 2016.

 Google Scholar

Li JS, Wang MH, Yu XQ, Li SY, Xie Y. Development and validation of a patient reported outcome instrument for chronic obstructive pulmonary diseases. Chin J Integr Med. 2015;21(9):667–675. doi:10.1007/s11655-014-1982-4

 PubMed Web of Science ®Google Scholar

Li J, Wang J, Xie Y, Feng Z. Development and validation of the modified patient-reported outcome scale for Chronic Obstructive Pulmonary Disease (mCOPD-PRO). Int J Chron Obstruct Pulmon Dis. 2020;15:661–669. doi:10.2147/COPD.S240842

 PubMed Web of Science ®Google Scholar

Zhu YB, Li YL, Wang W, Jiang FC. Development of a patient-reported outcome scale for stable chronic obstructive pulmonary disease and its clinical applicability. J Integr Med. 2011;9(08):857–865.

 Google Scholar

Wei R, You LN, Xia J, Lei L, Wu ZY, Pan X. Evaluation of reliability and validity of CFS-COPD-PRO for COPD patients of “cold and fluid” pattern. West J Tradit Chin Med. 2021;34(02):80–84.

 Google Scholar

Zang NZ, Pang LJ, Li P, et al. Establishment and evaluation of IPF-TCM-HRQOL32: a health-related quality of life of TCM scale for patients with idiopathic pulmonary fibrosis. China J Tradit Chin Med Pharm. 2016;31(05):1638–1642.

 Google Scholar

Liang LJ, Liang LR, Dai HP. Research on life quality scale for patients with idiopathic pulmonary fibrosis. Chin J Integr Tradit West Med. 2016;36(06):668–673.

 Google Scholar

Li JS, Wang MH, Yu XQ, Xie Y, Li SY. Development and assessment of efficacy measurement instruments for community-acquired pneumonia. China J Chin Med. 2016;31(11):1654–1661.

 Google Scholar

Diao J. Study on Quality of Life Scale in Patient with Advance Lung Cancer. Nanjing: Nanjing University of Chinese Medicine; 2007.

 Google Scholar

Yang Z, Lu JG, You SF, et al. Development of quality of life assessment system for cancer based on traditional Chinese medicine-lung cancer (QLASTCM-LU). Mod Prev Med. 2011;38(18):3636–3639+3645.

 Google Scholar

Wang TT, He LY, Zhang M, et al. Development of improved version of Quality of Life Assessment Instrument for Lung Cancer Patients Based on Traditional Chinese Medicine (QLASTCM-Lu). Chin J Integr Med. 2019;25(11):831–836. doi:10.1007/s11655-018-2991-5

 PubMed Web of Science ®Google Scholar

Guan JR. Development of the Scale Combination of Disease and Syndrome of Patient-Reported Outcomes with Bronchiectasis Based on Modern Testing Theory. Henan: Henan University of Chinese Medicine; 2022.

 Google Scholar