Dataset Information

Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma.

ABSTRACT: BACKGROUND:The Asthma Symptom Diary was developed to assess severity of symptoms in patients with moderate to severe asthma, and has evidence supporting reliability and validity. Only limited information is available on sensitivity to change and responder definitions for the Asthma Symptom Diary. OBJECTIVES:Main study objectives were to evaluate sensitivity to change and provide responder definitions for clinically meaningful effects for the Asthma Symptom Diary. METHODS:This is a secondary analysis of Phase II clinical trial data in patients with moderate to severe asthma, Asthma Symptom Diary (ASD) was collected daily during the 24-week study. The Asthma Control Questionnaire and the Patient Global Assessment were collected at baseline, and week 12 and 24. Analysis of covariance (ANCOVA) models were used to evaluate sensitivity to change in Asthma Symptom Diary scores after 12 and 24?weeks of treatment. Anchor-based methods, using Asthma Control Questionnaire and Patient Global Assessment defined anchors, were used to identify minimal important differences and various responder criteria for changes in mean 7-day ASD score, symptomatic days, and minimal symptom days. RESULTS:Sample was 59% female, 81% White, with a mean age of 47.3 (SD?=?13.6) years. ANCOVAs demonstrated significant differences in baseline to week 12 and week 24 changes in mean 7-day Asthma Symptom Diary scores and symptomatic days by Asthma Control Questionnaire (all p?

SUBMITTER: Globe G

PROVIDER: S-EPMC6447631 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma.

Globe Gary G Wiklund Ingela I Mattera Maria M Zhang Hao H Revicki Dennis A DA

Journal of patient-reported outcomes 20190403 1

<h4>Background</h4>The Asthma Symptom Diary was developed to assess severity of symptoms in patients with moderate to severe asthma, and has evidence supporting reliability and validity. Only limited information is available on sensitivity to change and responder definitions for the Asthma Symptom Diary.<h4>Objectives</h4>Main study objectives were to evaluate sensitivity to change and provide responder definitions for clinically meaningful effects for the Asthma Symptom Diary.<h4>Methods</h4>Th ...[more]

PMID: 30945020

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Project description:BACKGROUND:Physical and psychological symptoms are the hallmark of patients' subjective perception of their illness. The purpose of this analysis was to determine if patients with COPD have distinctive symptom profiles and to examine the association of symptom profiles with systemic biomarkers of inflammation. METHODS:We conducted latent class analyses of three physical (dyspnea, fatigue, and pain) and two psychological symptoms (depression and anxiety) in 302 patients with moderate to severe COPD using baseline data from a longitudinal observational study of depression in COPD. Systemic inflammatory markers included IL1, IL8, IL10, IL12, IL13, INF, GM-CSF, TNF-? (levels >75thcentile was considered high); and CRP (levels >3 mg/L was considered high). Multinominal logistic regression models were used to examine the association between symptom classes and inflammation while adjusting for key socio-demographic and disease characteristics. RESULTS:We found that a 4-class model best fit the data: 1) low physical and psychological symptoms (26%, Low-Phys/Low-Psych), 2) low physical but moderate psychological symptoms (18%, Low-Phys/Mod Psych), 3) high physical but moderate psychological symptoms (25%, High-Phys/Mod Psych), and 4) high physical and psychological symptoms (30%, High-Phys/High Psych). Unadjusted analyses showed associations between symptom class with high levels of IL7, IL-8 (p???.10) and CRP (p?<?.01). In the adjusted model, those with a high CRP level were less likely to be in the High-Phys/Mod-Psych class compared to the Low-Phys/Low-Psych (OR: 0.41, 95%CI 0.19, 0.90) and Low-Phys/Mod-Psych classes (OR: 0.35, 95%CI 0.16, 0.78); elevated CRP was associated with in increased odds of being in the High-Phys/High-Psych compared to the High-Phys/Mod-Psych class (OR: 2.22, 95%CI 1.08, 4.58). Younger age, having at least a college education, oxygen use and depression history were more prominent predictors of membership in the higher symptom classes. CONCLUSIONS:Patients with COPD can be classified into four distinct symptom classes based on five commonly co-occurring physical and psychological symptoms. Systemic biomarkers of inflammation were not associated with symptom class. Additional work to test the reliability of these symptom classes, their biological drivers and their validity for prognostication and tailoring therapy in larger and more diverse samples is needed. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01074515 .

Project description:BACKGROUND:Severe asthma is a chronic disease contributing to disproportionate disease morbidity and mortality. From the year of 2007, many genome-wide association studies (GWAS) have documented a large number of asthma-associated genetic variants and related genes. Nevertheless, the molecular mechanism of these identified variants involved in asthma or severe asthma risk remains largely unknown. METHODS:In the current study, we systematically integrated 3 independent expression quantitative trait loci (eQTL) data (N?=?1977) and a large-scale GWAS summary data of moderate-to-severe asthma (N?=?30,810) by using the Sherlock Bayesian analysis to identify whether expression-related variants contribute risk to severe asthma. Furthermore, we performed various bioinformatics analyses, including pathway enrichment analysis, PPI network enrichment analysis, in silico permutation analysis, DEG analysis and co-expression analysis, to prioritize important genes associated with severe asthma. RESULTS:In the discovery stage, we identified 1129 significant genes associated with moderate-to-severe asthma by using the Sherlock Bayesian analysis. Two hundred twenty-eight genes were prominently replicated by using MAGMA gene-based analysis. These 228 replicated genes were enriched in 17 biological pathways including antigen processing and presentation (Corrected P?=?4.30?×?10-?6), type I diabetes mellitus (Corrected P?=?7.09?×?10-?5), and asthma (Corrected P?=?1.72?×?10-?3). With the use of a series of bioinformatics analyses, we highlighted 11 important genes such as GNGT2, TLR6, and TTC19 as authentic risk genes associated with moderate-to-severe/severe asthma. With respect to GNGT2, there were 3 eSNPs of rs17637472 (PeQTL?=?2.98?×?10-?8 and PGWAS?=?3.40?×?10-?8), rs11265180 (PeQTL?=?6.0?×?10-?6 and PGWAS?=?1.99?×?10-?3), and rs1867087 (PeQTL?=?1.0?×?10-?4 and PGWAS?=?1.84?×?10-?5) identified. In addition, GNGT2 is significantly expressed in severe asthma compared with mild-moderate asthma (P?=?0.045), and Gngt2 shows significantly distinct expression patterns between vehicle and various glucocorticoids (Anova P?=?1.55?×?10-?6). CONCLUSIONS:Our current study provides multiple lines of evidence to support that these 11 identified genes as important candidates implicated in the pathogenesis of severe asthma.

Dataset Information

Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma.

Publications

Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma.

Similar Datasets

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