Validation of COPDPredict™: Unique Combination of Remote Monitoring and Exacerbation Prediction to Support Preventative Management of COPD Exacerbations

Figures & data

Figure 1 Study flowchart total number of patients screened and included/excluded for the study. This image is the property of the author.

Figure 2 (A) Screenshot of the COPDPredict™ Wellbeing self-assessment opening screen. (B) Screenshot of the first page of the Wellbeing self-assessment Both images are the property of the author.

Table 1 Patient Characteristics at Enrolment (n = 90)

Demographics	(n = 90)	I (n = 8)	II (n = 37)	III (n = 33)	IV (n = 12)
Age ^a(years)	69 ± 8	70 ± 6	66 ± 8	71 ± 8	68 ± 7
Gender, Male (Female)	45 (45)	2 (5)	13 (11)	10 (9)	2 (3)
Duration of COPD ^a(years)	9 ± 7	11 ± 10	7 ± 4	9 ± 8	7 ± 3
*Stable FEV1 ^a(% predicted)	50 ± 20	86 ± 7	60 ± 9	41 ± 4	26 ± 8
BMI, ^a(kg/m^2)	27 ± 6	29 ± 5	28 ± 6	25 ± 5	26 ± 5
MRC Score ^b(n)	3.0, 2.0	3.0, 0.5	3.0, 1.5	3.0, 1.0	3.0, 2.8
Exacerbations in the previous 1year ^a(n)	4.0 ± 2.2	4.9 ± 3.3	4.3 ± 1.1	4.2 ± 3.6	4.2 ± 1.3
Hospitalisations for AECOPD in the previous 6 months ^a(n)	1.0 ± 0.0	1.0 ± 0.0	1.0 ± 0.0	1.0 ± 0.0	1.0 ± 0.0
Co-morbidities
None	20	3	7	6	4
Cardiovascular	38	3	21	13	1
Type 2 Diabetes Mellitus	14	2	6	3	3
Other	24	3	10	9	2
COPD Medications
β2-Agonists, Short Acting, (Long Acting)	88, (79)	8, (6)	37, (37)	33, (33)	10, (3)
Anticholinergic, Short Acting, (Long Acting)	7, (67)	0, (5)	2, (27)	3, (26)	2, (9)
Inhaled Steroid	78	6	29	31	12
Oral Theophylline	17	1	7	5	4

Notes: Data presented as ^aMean ± standard deviation and ^bMedian, inter-quartile range. Roman numerals represent GOLD categorization of airflow limitation severity: I = mild, II = moderate, III = severe, IV = very severe. *Statistically significant difference between FEV₁ across the four (I, II, III, IV) groups (p<0.001).

Abbreviations: COPD, chronic obstructive pulmonary disease; n, number; FEV_1, forced expiratory volume in 1 second; BMI, body mass index; kg, kilogram; m, meter; MRC, medical research council; AECOPD, acute exacerbation of chronic obstructive pulmonary disease.

Table 2 Characteristics of the Different Patient Cohorts: Non-Exacerbators and Exacerbators (n = 90)

Demographics	COPD Patients
	Non-Exacerbators (n = 10)	Exacerbators Steroids + Antibiotics (n = 62)	Exacerbators Nebulised Bronchodilators+ Steroids + Antibiotics (n = 14)	Exacerbators Steroids + Antibiotics Attended Hospital (n = 4)
Age, ^ayears	69 ± 8	68 ± 16	69 ± 8	69 ± 8
Gender, Male (Female)	5 (5)	31, (31)	5, (9)	4, (0)
Duration of COPD, ^ayears	8 ± 7	8 ± 6	14 ± 8	14 ± 11
MRC Score, ^bn	3.0, 0.75	3.0, 2.0	3.0, 2.0	4.0, 0.5
Exacerbations in previous 1 year, ^an	2.5 ± 1.0	4.3 ± 2.4	3.9 ± 2.1	3.8 ± 2.4
Exacerbations in the study, ^an	0	1.4 ± 0.6	1.7 ± 0.8	2.0 ± 0.0
Smoking Status, Current, (Ex)	2, (8)	6, (56)	2, (12)	3, (1)
Co-morbidities
None	2	16	2	0
Cardiovascular	4	24	8	2
Type 2 Diabetes Mellitus	0	11	2	1
Other	6	5	9	4
COPD Medications
β2 Agonists, Short Acting, (Long Acting)	10, (7)	60, (55)	14, (13)	4, (4)
Anticholinergic, Short Acting, (Long Acting)	2, (7)	4, (45)	0, (12)	1, (3)
Inhaled Steroid	5	56	13	4
Oral Theophylline	1	14	0	2
Assessment Data
Wellbeing Score, ^bn – Stable	14, (6–19)	16, (7–24)	13, (8–28)	19, (17–21)
Wellbeing Score, ^bn – Exacerbation	n/a	20, (10–31)	23, (15–31)	25, (20–26)
FEV1, ^a(% predicted) – Stable	54 ± 30	49 ± 19	42 ± 16	47 ± 14
FEV1, ^a(% predicted) – Exacerbation	n/a	46 ± 19	38 ± 15	30 ± 6
Blood CRP ^b(mg/L) – Stable	3.0, (1.8–10.0)	3.6, (1.5–30.0)	4.0, (0.1–10.6)	2.2, (1.0–21.0)
Blood CRP ^b(mg/L) – Exacerbation	n/a	5.4, (0.2–55.9)	13.5, (1.7–64.0)	12.4, (2.0–21.0)

Note: Data presented as ^aMean ± standard deviation and ^bMedian, interquartile range.

Abbreviations: COPD, chronic obstructive pulmonary disease; n, number; FEV_1, forced expiratory volume in 1 second; BMI, body mass index; kg, kilogram; m, meter; MRC, medical research council; AECOPD, acute exacerbation of chronic obstructive pulmonary disease; CRP, c-reactive protein.

Table 3 Characteristics of Single (n=52) and the Re-Exacerbator Cohort (n=28)

Demographics	Single Exacerbators (n = 52)	Re-Exacerbators (n = 28)
Age, ^ayears	69 ± 8	68 ± 9
Gender, Male (Female)	27 (25)	13 (15)
Duration of COPD, ^ayears	10 ± 7	8 ± 6
*FEV1, ^a(% predicted)	48 ± 19	43 ± 15
MRC Score, ^bn	3.0, 1.0	3.0, 1.5
Exacerbations in the previous 1 year, ^an	4.0 ± 2.0	4.8 ± 2.8
Exacerbations in the study, ^an	1.0	2.2 ± 0.4
Co-morbidities
None	14	4
Cardiovascular	24	15
Type 2 Diabetes Mellitus	6	8
Other	6	12
Total Co-morbidities ^an	1.2 ± 1.0	1.5 ± 0.9
COPD Medications
β2 Agonists, Short Acting, (Long Acting)	52, (46)	26, (26)
Anticholinergic, Short Acting, (Long Acting)	4, (36)	1, (24)
Inhaled Steroid	46	27
Oral Theophylline	10	6

Notes: Data presented as ^aMean ± standard deviation and ^bMedian, interquartile range. *Statistically significant difference (p<0.001).

Abbreviations: COPD, chronic obstructive pulmonary disease; n, number; FEV_1, forced expiratory volume in 1 second; BMI, body mass index; kg, kilogram; m, meter; MRC, medical research council; AECOPD, acute exacerbation of chronic obstructive pulmonary disease.

Figure 3 Sensitivity and specificity of the exacerbation prediction algorithm.

Notes: AECOPD: acute exacerbation of chronic obstructive pulmonary disease, *failure to enter a wellbeing score or perform spirometry; **AECOPD during 2-week baseline phase. The sensitivity and specificity percentages are highlighted in bold. This image is the property of the author.