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Effects of GOLD-Adherent Prescribing on COPD Symptom Burden, Exacerbations, and Health Care Utilization in a Real-World Setting.

ABSTRACT: Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines recommend specific drug therapy protocols for chronic obstructive pulmonary disease (COPD) patients based on symptoms and exacerbation risk. This study used electronic health records (EHRs) to assess the effect of adherence and nonadherence to GOLD prescribing guidelines on COPD symptom burden, exacerbations, and health care resource utilization (HCRU) during the 180 days following index treatment start. Included patients had COPD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 490.xx, 491.xx, 492.xx, 496.xx), a valid GOLD stage within the study period (January 1, 2007 to December 31, 2012), and were 40 to 90 years of age at first GOLD staging (GOLD date). Adherence or nonadherence to GOLD-defined prescribing was based on COPD medication prescribed within 180 days on either side of the GOLD date. Of 4234 patients included in the analysis, approximately 36% were prescribed GOLD-adherent pharmacotherapy. Prevalence of all COPD-related symptoms during the 180 days following index treatment start were significantly reduced in the GOLD-adherent (n=1531) versus the GOLD-nonadherent group (n=2703). GOLD-adherent prescribing was associated with significant reductions in proportions of patients with all-cause hospitalizations and emergency department (ED) visits (unadjusted odds ratios [ORs], 0.69 and 0.63, respectively), as well as respiratory-specific ED visits (unadjusted OR, 0.65), compared with GOLD-nonadherent prescribing. In analyses that divided patients receiving GOLD-nonadherent treatment into undertreated and overtreated patients, undertreatment was associated with significant increases in many COPD symptoms, and both undertreatment and overtreatment were associated with increases in some HCRU endpoints. GOLD-adherent prescribing delivers moderate benefits with respect to COPD symptoms and HCRU.

SUBMITTER: Mannino DM

PROVIDER: S-EPMC5556885 | biostudies-other | 2015 Jun

REPOSITORIES: biostudies-other

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Effects of GOLD-Adherent Prescribing on COPD Symptom Burden, Exacerbations, and Health Care Utilization in a Real-World Setting.

Mannino David M DM Yu Tzy-Chyi TC Zhou Huanxue H Higuchi Keiko K

Chronic obstructive pulmonary diseases (Miami, Fla.) 20150619 3

Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines recommend specific drug therapy protocols for chronic obstructive pulmonary disease (COPD) patients based on symptoms and exacerbation risk. This study used electronic health records (EHRs) to assess the effect of adherence and nonadherence to GOLD prescribing guidelines on COPD symptom burden, exacerbations, and health care resource utilization (HCRU) during the 180 days following index treatment start. Included patients h ...[more]

PMID: 28848845

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Project description:ObjectiveMost exacerbations are mild to moderate, and antibiotic treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is recommended for patients with severe exacerbations or severe underlying chronic obstructive pulmonary disease (COPD). Therefore, we aimed to investigate the patient factors that are associated with the prescription of antibiotics for inappropriate indication in AECOPD.Material and methodsThis study was an observational cross-sectional study conducted in an outpatient clinic. The patients diagnosed with AECOPD and prescribed an antibiotic by a pulmonary physician were enrolled in the study. These prescriptions were documented by the pharmacist who asked the patient about the three cardinal symptoms. Appropriate and inappropriate prescription groups were defined by the types of exacerbations, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD report.ResultsThere were 138 patients, predominantly male (83%), with a mean age of 64 (±9) years. A total of 64% of the prescriptions were appropriate; however, there were 50 (36%) patients with inappropriate antibiotic prescription according to the mentioned criteria. When we compared the patient factors between the appropriate and inappropriate antibiotic prescriptions, there was no statistically significant difference in terms of age, Forced expiratory volume in first second % (FEV1%) predicted, FEV1 ml, forced vital capacity (FVC) ml, FEV1/FVC, and amount (packs/year) of smoking (p>0.05 for all parameters). FVC% was statistically significantly lower in the appropriate antibiotic prescription group compared with that in the inappropriate antibiotic prescription group (p=0.049).ConclusionThis study shows that most pulmonary physicians have a tendency to prescribe antibiotics for AECOPD according to the defined GOLD criteria. However, some of the physicians also prefer to prescribe antibiotics self-directedly, irrespective of the GOLD criteria. A physician-based questionnaire can be completed for future studies to define the underlying reasons for antibiotic prescription demands for cases of mild AECOPD.

Project description:BackgroundChronic obstructive pulmonary disease (COPD) is a heterogeneous disease characterized by frequent exacerbation phenotypes independent of disease stage. Increasing evidence shows that the microbiota plays a role in disease progression and severity, but long-term and international multicenter assessment of the variations in viral and bacterial communities as drivers of exacerbations are lacking.MethodsTwo-hundred severe COPD patients from Europe and North America were followed longitudinally for 3 years. We performed nucleic acid detection for 20 respiratory viruses and 16S ribosomal RNA gene sequencing to evaluate the bacterial microbiota in 1179 sputum samples collected at stable, acute exacerbation and follow-up visits.ResultsSimilar viral and bacterial taxa were found in patients from the USA compared to Bulgaria and Czech Republic but their microbiome diversity was significantly different (P < 0.001) and did not impact exacerbation rates. Virus infection was strongly associated with exacerbation events (P < 5E-20). Human rhinovirus (13.1%), coronavirus (5.1%) and influenza virus (3.6%) constitute the top viral pathogens in triggering exacerbation. Moraxella and Haemophilus were 5-fold and 1.6-fold more likely to be the dominating microbiota during an exacerbation event. Presence of Proteobacteria such as Pseudomonas or Staphylococcus amongst others, were associated with exacerbation events (OR > 0.17; P < 0.02) but more strongly associated with exacerbation frequency (OR > 0.39; P < 4E-10), as confirmed by longitudinal variations and biotyping of the bacterial microbiota, and suggesting a role of the microbiota in sensitizing the lung.ConclusionsThis study highlights bacterial taxa in lung sensitization and viral triggers in COPD exacerbations. It provides a global overview of the diverse targets for drug development and explores new microbiome analysis methods to guide future patient management applications.

Project description:RationaleIn symptomatic patients with COPD, the decision whether to initiate maintenance treatment with a single agent or a combination of long-acting bronchodilators remains unclear.ObjectiveTo investigate whether baseline symptomatic status influences response to tiotropium/olodaterol treatment.Materials and methodsPost hoc analysis of the randomized OTEMTO® studies (NCT01964352; NCT02006732), in which patients with moderate-to-severe COPD received placebo, tiotropium 5 µg, tiotropium/olodaterol 2.5/5 µg, or tiotropium/olodaterol 5/5 µg once daily for 12 weeks via the Respimat® inhaler (Boehringer Ingelheim, Ingelheim am Rhein, Germany). Impact of baseline symptomatic status (modified Medical Research Council [mMRC] score) on response to treatment with tiotropium/olodaterol 5/5 µg, tiotropium 5 µg, or placebo at Week 12 was assessed by St George's Respiratory Questionnaire (SGRQ) total score and response rate, transition dyspnea index (TDI) focal score and response rate, and trough forced expiratory volume in 1 second response.ResultsTiotropium/olodaterol improved SGRQ total scores and response rates compared with placebo and tiotropium for patients with baseline mMRC scores 0-1 and ≥2. For tiotropium/olodaterol vs tiotropium, greater improvements were observed for patients with mMRC ≥2 (SGRQ score adjusted mean treatment difference -3.44 [95% CI: -5.43, -1.46]; P=0.0007; SGRQ response rate ORs 2.09 [95% CI: 1.41, 3.10]; P=0.0002). Dyspnea, measured by TDI score, was consistently improved with tiotropium/olodaterol vs placebo for patients with mMRC scores 0-1 and ≥2 (adjusted mean treatment difference 1.63 [95% CI: 1.06, 2.20]; P<0.0001 and 1.60 [95% CI: 1.09, 2.10]; P<0.0001, respectively). In patients with mMRC scores 0-1 and ≥2, tiotropium/olodaterol consistently improved TDI response rate and lung function vs placebo and tiotropium.ConclusionsPatients with COPD with more severe baseline dyspnea appear to derive greater health status benefit with tiotropium/olodaterol compared with tiotropium alone.

Project description:ObjectiveTo evaluate the impact of lung function, measured as forced expiratory volume in 1 second (FEV1) % predicted, on health care resource utilization and costs among patients with COPD in a real-world US managed-care population.MethodsThis observational retrospective cohort study utilized administrative claim data augmented with medical record data. The study population consisted of patients with one or more medical claims for pre- and postbronchodilator spirometry during the intake period (July 1, 2012 to June 30, 2013). The index date was the date of the earliest medical claim for pre- and postbronchodilator spirometry. Spirometry results were abstracted from patients' medical records. Patients were divided into two groups (low FEV1% predicted [,50%] and high FEV1% predicted [?50%]) based on the 2014 Global Initiative for Chronic Obstructive Lung Disease report. Health care resource utilization and costs were based on the prevalence and number of discrete encounters during the 12-month postindex follow-up period. Costs were adjusted to 2014 US dollars.ResultsA total of 754 patients were included (n=297 low FEV1% predicted group, n=457 high FEV1% predicted group). COPD exacerbations were more prevalent in the low FEV1% predicted group compared with the high group during the 12-month pre- (52.5% vs 39.6%) and postindex periods (49.8% vs 36.8%). Mean (standard deviation) follow-up all-cause and COPD-related costs were $27,380 ($38,199) and $15,873 ($29,609) for patients in the low FEV1% predicted group, and $22,075 ($28,108) and $10,174 ($18,521) for patients in the high group. In the multivariable analyses, patients in the low FEV1% predicted group were more likely to have COPD exacerbations and tended to have higher COPD-related costs when compared with patients in the high group.ConclusionReal-world data demonstrate that patients with COPD who have low FEV1% predicted levels use more COPD medications, have more COPD exacerbations, and incur higher COPD-related health care costs than those with high FEV1% predicted levels.

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Dataset Information

Effects of GOLD-Adherent Prescribing on COPD Symptom Burden, Exacerbations, and Health Care Utilization in a Real-World Setting.

Publications

Effects of GOLD-Adherent Prescribing on COPD Symptom Burden, Exacerbations, and Health Care Utilization in a Real-World Setting.

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