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Responder Analyses for Treatment Effects in COPD Using the St George's Respiratory Questionnaire.

Jones, PW; Gelhorn, H; Wilson, H; Karlsson, N; Menjoge, S; Müllerova, H; Rennard, SI; Tal-Singer, R; Merrill, D; Tabberer, M (2017) Responder Analyses for Treatment Effects in COPD Using the St George's Respiratory Questionnaire. Chronic Obstr Pulm Dis, 4 (2). pp. 124-131. ISSN 2372-952X https://doi.org/10.15326/jcopdf.4.2.2017.0130
SGUL Authors: Jones, Paul Wyatt

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Abstract

Background: Patient-reported outcomes data in clinical trials are usually reported as mean values, interpreted in comparison to a minimum clinically important difference (MCID) and ignoring the possibility of a sizable proportion of patients experiencing a worthwhile benefit when the majority did not. This analysis tested the reliability of calculated responder rates (from chronic obstructive pulmonary disease [COPD] patients) with the St George's Respiratory Questionnaire (SGRQ) using a range of responder cut-points above and below the MCID (4 units). Methods: Individual patient data (i.e., data from long-acting bronchodilator [LAB] and inhaled corticosteroids [ICS]/long-acting beta2-agonist [LABA] randomized clinical studies) in the COPD Biomarker Qualification Consortium database were used: short-term (≤1-year duration; 14,814 patients,) and medium-term (2-4 years; 12,043 patients). Responder rates versus placebo across SGRQ score change thresholds ranging from -1.5 to -8.0 were tested; differences were expressed as the odds ratio (OR) of a patient exceeding the threshold versus no change or deterioration. Results: The ORs measuring benefit of active treatment were similar across thresholds in short-term studies (LAB, ORs 1.40-1.42; LABA/ICS, 1.50-1.56) and medium-term LAB studies (ORs 1.34-1.43), whereas ORs in medium-term studies with LABA/ICS intervention showed a trend for higher response rates at higher values of threshold cut-points (1.64-1.79). In short-term studies, different thresholds had little effect on the OR between active drugs versus a trend for lower ORs with lower thresholds in medium-term studies. Conclusions: The OR for a treatment effect compared with placebo appears consistent across a range of responder cut-points. In medium-term trials, the treatment difference between active drugs suggests that use of a lower threshold would not increase the odds of observing a measured treatment difference.

Item Type: Article
Additional Information: Provided here with permission from the COPDF Foundation. Originally published at http://doi.org/10.15326/jcopdf.4.2.2017.0130
Keywords: CBQC, COPD Biomarkers Qualification Consortium, SGRQ, SGRQ threshold, St George’s Respiratory Questionnaire, forced expiratory volume in 1 second, responder rates
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Chronic Obstr Pulm Dis
ISSN: 2372-952X
Language: eng
Dates:
DateEvent
2 March 2017Published
6 February 2017Accepted
Publisher License: Publisher's own licence
PubMed ID: 28848921
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/109131
Publisher's version: https://doi.org/10.15326/jcopdf.4.2.2017.0130

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