A Systematic Literature Review of the Humanistic Burden of COPD

Figures & data

Table 1 PICOS for the Inclusion of Studies in the Humanistic Burden Review

Criteria	Inclusion Criteria	Exclusion Criteria	Rationale for Exclusion
Patient population	Age: adults (≥40 years) Sex: any Race: any Disease: patients with moderate to very severe COPD (% predicted FEV1: ≤80%)	Patient population with mild COPD Children	Limit review to core population impacted by COPD exacerbations
Interventions	Studies assessing the overall humanistic burden of COPD without the impact of an intervention were included	Studies assessing intervention impact	Focus on overall humanistic burden
Comparators	No restriction on comparators	NA	NA
Study designs	Non-interventional studies Cohort studies Case-control Registry/database studies	Case studies, case series, case reports, and literature review, and systematic reviews	Limit review inputs to controlled studies and primary sources
Publication timeframe	January 1 2006 to March 30 2020	Studies prior to 2006	Focus on recent data to reflect current situation
Countries	Australia Canada China France Germany Italy Spain UK USA	Other countries	Limit review to representative country sample across Europe, Asia, North America and Australia
Language	Studies published in the English language	Studies not published in the English language	Focus on data published via international platforms

Abbreviations: COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in one second; NA, not applicable; PICOS, Population, Intervention, Comparator, Outcomes, Study design.

Table 2 Tools Used to Assess the HRQoL Across Included Studies

	Non-Specific			Specific
	EQ-5D VAS	SF-36	SF-12	SGRQ	CAT	MRC	mMRC	CRQ	CCQ	EXACT
No. of studies	9	9	12	34	20	6	12	7	4	1

Abbreviations: CAT, COPD Assessment Test; CCQ, Clinical COPD Questionnaire; CRQ, Chronic Respiratory Questionnaire; EQ-5D VAS, EuroQol five dimensions questionnaire visual analog scale; EXACT, EXAcerbations of Chronic pulmonary disease Tool; HRQoL, health-related quality of life; MRC, Medical Research Council Dyspnea scale; mMRC, modified Medical Research Council Dyspnea Scale; SF-12, 12-item short-form survey; SF-36, 36-item short-form survey; SGRQ, St. George's Respiratory Questionnaire.

Figure 1 Flow of studies through the humanistic burden SLR.

Abbreviation: SLR, systematic literature review.

Table 3 Summary of Studies Meeting and Adhering to HRQoL Criteria

Criteria	Studies Meeting Criteria, n (%)
Did the investigator give a definition of quality of life?	6 (7)
Did the investigators state the domains they will measure as components of quality of life?	72 (88)
Did the investigators give reasons for choosing the instrument they used?	13 (16)
Did the investigator aggregate results from multiple items, domains or instruments into a single composite score for quality of life?	47 (57)
Were patients asked to give their own global rating for quality of life?	5 (6)
Was overall quality of life distinguished from health-related quality of life?	7 (9)
Were the patients invited to supplement the items listed in the instruments offered by the investigators that they considered relevant for their quality of life?	0 (0)
If so, were these supplemental items incorporated into the final rating?	0 (0)
Were patients allowed to indicate which items were personally important to them?	1 (1)
If so, were the importance ratings incorporated into the final rating?	0 (0)

Note: Studies could be counted in more than one category.

Figure 2 Mean CAT scores segregated according to GOLD stage, exacerbation history, and comorbidities. Adapted from Lopez-Campos JL, et al. Evaluation of the COPD Assessment Test and GOLD patient types: a cross-sectional analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:975–984. Dove Medical Press Limited.⁴¹

Abbreviations: CAT, COPD Assessment Test; GOLD, Global Initiative for Chronic Obstructive Lung Disease; NS, not significant.

Lopez-Campos JL, Fernandez-Villar A, Calero-Acuna C, et al. Evaluation of the COPD assessment test and GOLD patient types: a cross-sectional analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:975–984. doi:10.2147/COPD.S82781

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