PMID- 28848921
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 2372-952X (Print)
IS  - 2372-952X (Electronic)
IS  - 2372-952X (Linking)
VI  - 4
IP  - 2
DP  - 2017 Mar 2
TI  - Responder Analyses for Treatment Effects in COPD Using the St George's 
      Respiratory Questionnaire.
PG  - 124-131
LID - 10.15326/jcopdf.4.2.2017.0130 [doi]
AB  - 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.
FAU - Jones, Paul W
AU  - Jones PW
AD  - Institute of Infection and Immunity, St George's University of London, United 
      Kingdom.
AD  - Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.
FAU - Gelhorn, Heather
AU  - Gelhorn H
AD  - Evidera, Bethesda, Maryland.
FAU - Wilson, Hilary
AU  - Wilson H
AD  - Evidera, Bethesda, Maryland.
FAU - Karlsson, Niklas
AU  - Karlsson N
AD  - Research and Development, AstraZeneca, Gothenburg, Sweden.
FAU - Menjoge, Shailendra
AU  - Menjoge S
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
FAU - Mullerova, Hana
AU  - Mullerova H
AD  - Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.
FAU - Rennard, Stephen I
AU  - Rennard SI
AD  - Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, 
      Omaha.
AD  - Research and Development, AstraZeneca, Cambridge, United Kingdom.
FAU - Tal-Singer, Ruth
AU  - Tal-Singer R
AD  - Research and Development, GlaxoSmithKline, King of Prussia, Pennsylvania.
FAU - Merrill, Debora
AU  - Merrill D
AD  - COPD Foundation, Washington, D.C.
FAU - Tabberer, Maggie
AU  - Tabberer M
AD  - Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom.
LA  - eng
PT  - Journal Article
DEP - 20170302
PL  - United States
TA  - Chronic Obstr Pulm Dis
JT  - Chronic obstructive pulmonary diseases (Miami, Fla.)
JID - 101635411
PMC - PMC5559111
OTO - NOTNLM
OT  - CBQC
OT  - COPD Biomarkers Qualification Consortium
OT  - SGRQ
OT  - SGRQ threshold
OT  - St George's Respiratory Questionnaire
OT  - forced expiratory volume in 1 second
OT  - responder rates
COIS- PWJ, NK, SM, HM, SIR, RTS and MT are employees of the pharma companies who funded 
      this analysis. KR is a former employee of Pfizer. HG and HW participated in this 
      project as employees of Evidera, a company which performs work for hire for 
      multiple pharmaceutical and device companies in outcomes research. DM has nothing 
      to declare.
EDAT- 2017/08/30 06:00
MHDA- 2017/08/30 06:01
PMCR- 2017/03/02
CRDT- 2017/08/30 06:00
PHST- 2017/08/30 06:00 [entrez]
PHST- 2017/08/30 06:00 [pubmed]
PHST- 2017/08/30 06:01 [medline]
PHST- 2017/03/02 00:00 [pmc-release]
AID - 10.15326/jcopdf.4.2.2017.0130 [doi]
PST - epublish
SO  - Chronic Obstr Pulm Dis. 2017 Mar 2;4(2):124-131. doi: 
      10.15326/jcopdf.4.2.2017.0130.