Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

Figures & data

Figure 1 Schematic representation of patient distribution of PRO data.

Abbreviation: PRO, patient-reported outcome.

Figure 2 Frequency distribution of health status assessed by SGRQ-C score according to severity of disease in the ECLIPSE cohort.

Notes: Adapted from Agusti A, Calverley PM, Celli B, et al; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010;11:122. © The Author(s) 2010. Creative Commons License available at: https://creativecommons.org/licenses/by/2.0/legalcode.¹⁷
Abbreviation: SGRQ-C, St George’s Respiratory Questionnaire for COPD.

Figure 3 Hypothetical incidence of benefit.

Abbreviation: MCID, minimum clinically important difference.

Figure 4 Hypothetical cumulative incidence of benefit.

Table 1 Hypothetical 6-month SGRQ total scores from a study comparing a LABA/LAMA combination with placebo, LAMA, and LABA

Treatment group	Change from baseline, mean	Difference vs placebo, mean	Percentage of responders	Additional number in 100 treated patients who benefit vs placebo	Odds ratio for response vs non-response vs placebo
Placebo	−2.0	–	30%	–	–
LAMA	−5.9	−3.9	48%	18	1.7
LABA	−6.1	−4.1	52%	22	1.9
LAMA/LABA	−7.0	−5.0	60%	30	2.5

Abbreviations: SGRQ, St George’s Respiratory Questionnaire; LAMA, long-acting muscarinic antagonist; LABA, long-acting β₂-agonist.

AgustiACalverleyPMCelliBEvaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) InvestigatorsCharacterisation of COPD heterogeneity in the ECLIPSE cohortRespir Res20101112220831787

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