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Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.

ABSTRACT: Little is known about factors that determine health status decline in clinical trials of COPD.To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.St George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.Data from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between deterioration in SGRQ Total score and forced expiratory volume in one second (FEV1) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV1 % predicted was seen in older patients (? 65 years) and there was an age-related change in Total score that was independent of change in FEV1. The relationship between deterioration in FEV1 and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV1 change.In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.ClinicalTrials.gov: NCT00268216.

SUBMITTER: Jones PW

PROVIDER: S-EPMC3117702 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.

Jones Paul W PW Anderson Julie A JA Calverley Peter Ma PM Celli Bartolome R BR Ferguson Gary T GT Jenkins Christine C Yates Julie C JC Vestbo Jørgen J Spencer Michael D MD

Respiratory research 20110531

<h4>Background</h4>Little is known about factors that determine health status decline in clinical trials of COPD.<h4>Objectives</h4>To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.<h4>Methods</h4>St George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.<h4>Measurements and main results</h4>Data from 4951 patients in 28 countries were avail ...[more]

PMID: 21627828

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Project description:Counseling has been suggested as a promising approach for facilitating changes in health behavior. The aim of this systematic review of counseling interventions for people with COPD was to describe: 1) counseling definitions, 2) targeted health behaviors, 3) counseling techniques and 4) whether commonalities in counseling techniques were associated with improved health behaviors. Ten databases were searched for original randomized controlled trials which included adults with COPD, used the term "counseling" as a sole or component of a multifaceted intervention and were published in the previous 10 years. Data extraction, study appraisal and coding for behavior change techniques (BCTs) were completed by two independent reviewers. Data were synthesized descriptively, with meta-analysis conducted where possible. Of the 182 studies reviewed as full-text, 22 were included. A single study provided a definition for counseling. Two key behaviors were the main foci of counseling: physical activity (n=9) and smoking cessation (n=8). Six studies (27%) reported underlying models and/or theoretical frameworks. Counseling was the sole intervention in 10 studies and part of a multicomponent intervention in 12. Interventions targeting physical activity included a mean of 6.3 (±3.1) BCTs, smoking cessation 4.9 (±2.9) BCTs and other behaviors 6.5 (±3.9) BCTs. The most frequent BCTs were social support unspecified (n=22; 100%), goal setting behavior (n=11), problem-solving (n=11) and instructions on how to perform the behavior (n=10). No studies shared identical BCT profiles. Counseling had a significant positive effect for smoking cessation and positive but not significant effect for physical activity. Counseling for health behavior change was rarely defined and effectiveness varied by target behavior. Provision of specific details when reporting studies of counseling interventions (definition, BCTs, dosage) would allow clarification of the effectiveness of counseling as an approach to health behavior change in people with COPD.

Project description:IntroductionDry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy.Methods and analysisThis cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model.EthicsThe study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants.Trial registration numberClinicalTrials.gov: NCT04532853.

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Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.

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Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.

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