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Journal Article•DOI•

Primary Care COPD Patients Compared with Large Pharmaceutically-Sponsored COPD Studies : An UNLOCK Validation Study

Annemarije L Kruis1, Björn Ställberg2, Rupert Jones3, Ioanna Tsiligianni4, Karin Lisspers2, Thys van der Molen4, Janwillem W. H. Kocks4, Niels H. Chavannes1 •
Leiden University1, Uppsala University2, University of Plymouth3, University Medical Center Groningen4
05 Mar 2014-PLOS ONE (Public Library of Science)-Vol. 9, Iss: 3
TL;DR: Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations, as hitherto unknown GOLD I exacerbation characteristics are revealed.
Abstract: Background: Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care. Objective: We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials. Methods: Baseline data of seven primary care databases (n = 3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria. Results: Overall, patients included in the LPCS were younger (mean difference (MD)-2.4; p = 0.03), predominantly male (MD 12.4; p = 0.1) with worse lung function (FEV1% MD -16.4; p = 1 and >= 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had >= 1 exacerbations per year and 12% had >= 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT). Conclusion: Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.

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Citations
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Journal Article•DOI•
Associations between chronic comorbidity and exacerbation risk in primary care patients with COPD

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Janine A M Westerik1, Esther Metting2, Job F M van Boven2, Waling Tiersma1, Janwillem W. H. Kocks2, Tjard Schermer1 •
Radboud University Nijmegen1, University Medical Center Groningen2
06 Feb 2017-Respiratory Research
TL;DR: Having another chronic respiratory disease beside COPD showed the highest risk for developing a new exacerbation and several chronic comorbidities were associated with having frequent exacerbations and increased exacerbation risk.
Abstract: COPD often coexists with chronic conditions that may influence disease prognosis. We investigated associations between chronic (co)morbidities and exacerbations in primary care COPD patients. Retrospective cohort study based on 2012–2013 electronic health records from 179 Dutch general practices. Comorbidities from patients with physician-diagnosed COPD were categorized according to International Classification of Primary Care (ICPC) codes. Chi-squared tests, uni- and multivariable logistic, and Cox regression analyses were used to study associations with exacerbations, defined as oral corticosteroid prescriptions. Fourteen thousand six hundred three patients with COPD could be studied (mean age 67 (SD 12) years, 53% male) for two years. At baseline 12,826 (88%) suffered from ≥1 comorbidities, 3263 (22%) from ≥5. The most prevalent comorbidities were hypertension (35%), coronary heart disease (19%), and osteoarthritis (18%). Several comorbidities showed statistically significant associations with frequent (i.e., ≥2/year) exacerbations: heart failure (odds ratio [OR], 95% confidence interval: 1.72; 1.38–2.14), blindness & low vision (OR 1.46; 1.21–1.75), pulmonary cancer (OR 1.85; 1.28–2.67), depression 1.48; 1.14–1.91), prostate disorders (OR 1.50; 1.13–1.98), asthma (OR 1.36; 1.11–1.70), osteoporosis (OR 1.41; 1.11–1.80), diabetes (OR 0.80; 0.66–0.97), dyspepsia (OR 1.25; 1.03–1.50), and peripheral vascular disease (OR 1.20; 1.00–1.45). From all comorbidity categories, having another chronic respiratory disease beside COPD showed the highest risk for developing a new exacerbation (Cox hazard ratio 1.26; 1.17–1.36). Chronic comorbidities are highly prevalent in primary care COPD patients. Several chronic comorbidities were associated with having frequent exacerbations and increased exacerbation risk.

88 citations

Cites background from "Primary Care COPD Patients Compared..."

  • ..., the COPD population without selection of any kind, which is unprecedented and impossible to derive from clinical trial populations [21]....

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Journal Article•DOI•
Comorbidity and health-related quality of life in patients with severe chronic obstructive pulmonary disease attending Swedish secondary care units.

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Josefin Sundh1, Gunnar Johansson2, Kjell Larsson3, Anders Lindén3, Claes-Göran Löfdahl4, Christer Janson2, Thomas Sandström5 •
Örebro University1, Uppsala University2, Karolinska Institutet3, Lund University4, Umeå University5
22 Jan 2015-International Journal of Chronic Obstructive Pulmonary Disease
TL;DR: It is concluded that comorbid conditions, in particular chronic bronchitis, depression, osteoporosis, and musculoskeletal symptoms, should be taken into account in the clinical management of patients with severe COPD.
Abstract: Introduction: Our understanding of how comorbid diseases influence health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD) is limited and in need of impr ...

82 citations

Cites methods from "Primary Care COPD Patients Compared..."

  • ...Chronic bronchitis, musculoskeletal symptoms, osteoporosis, and depression were associated with worse HRQL....

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  • ...We conclude that the chronic bronchitis phenotype and musculoskeletal symptoms in COPD patients indicate a higher risk of low HRQL....

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  • ...The outcomes of CAT and SGRQ show a fairly good correlation in patients with COPD.7 Many COPD patients suffer from more than one condition,8 and comorbidities are known to influence mortality, morbidity, and hospitalizations as well as HRQL.9–11 The associations of cardiovascular disease, depression, and underweight with poor HRQL are well documented,12–15 although our understanding of these associations remains limited....

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  • ...Depression is common in COPD.8 The finding that depression influenced EQ-5D index in our study is consistent with and confirms previous studies, in which depression in COPD was associated with worse HRQL as assessed using EQ-5D,31 SGRQ,32 and Clinical COPD Questionnaire (CCQ).14 Heart disease influences HRQL when estimated by both the generic instrument SF-12 and the disease-specific instrument SGRQ in COPD.12,15 In our study, both generic and disease-specific HRQL instruments were used, but we were not able to identify an association of cardiovascular disease and lower HRQL. Underweight is associated with worse SGRQ score in COPD,13 but no associations with HRQL were found in the present study....

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  • ...It cannot be excluded that the use of a broad definition of cardiovascular disease may have masked an association between cardiovascular disease and HRQL....

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Journal Article•DOI•
Improving the Management of COPD in Women.

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Christine Jenkins1, Kenneth R. Chapman2, James F. Donohue3, Nicolas Roche4, Ioanna Tsiligianni5, MeiLan K. Han6 •
The George Institute for Global Health1, University Health Network2, University of North Carolina at Chapel Hill3, Paris Descartes University4, University Medical Center Groningen5, University of Michigan6
01 Mar 2017-Chest
TL;DR: A multifaceted approach is required to address COPD in women, including greater awareness, minimization of risk, and further elucidation of the sex-specific factors that affect risk, disease progression, and treatment success.

82 citations

Cites background from "Primary Care COPD Patients Compared..."

  • ...There is a need for future trials to include more female participants and to prespecify subanalyses on the basis of sex to study whether biological differences affect the way women respond to medications and therapeutic strategies.(82) In addition, studies should consider the use of sex as a variable in its own right....

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  • ...Analyses suggest that clinical trial populations differ from real-world patients, particularly in sex distribution.(82) There is a need for future trials to include more female participants and to prespecify subanalyses on the basis of sex to study whether biological differences affect the way women respond to medications and therapeutic strategies....

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Journal Article•DOI•
Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective

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MeiLan K. Han1, Carlos H. Martinez1, David H. Au2, David H. Au3, Jean Bourbeau4, Cynthia M. Boyd5, Richard D. Branson6, Gerard J. Criner7, Ravi Kalhan8, Thomas J Kallstrom9, Angela King, Jerry A. Krishnan10, Suzanne C. Lareau11, Todd A. Lee10, Kathleen O. Lindell12, David M. Mannino13, Fernando J. Martinez14, Catherine A. Meldrum1, Valerie G. Press15, Byron Thomashow16, Laura Tycon, Jamie L. Sullivan17, John MacLaren Walsh, Kevin C. Wilson18, Kevin C. Wilson19, Jean Wright20, Barbara P. Yawn21, Patrick M. Zueger10, Surya P. Bhatt22, Mark T. Dransfield22, Mark T. Dransfield2 •
University of Michigan1, Veterans Health Administration2, University of Washington3, McGill University Health Centre4, Johns Hopkins University School of Medicine5, University of Cincinnati6, Temple University7, Northwestern University8, American Association for Respiratory Care9, University of Illinois at Chicago10, University of Colorado Denver11, University of Pittsburgh12, University of Kentucky13, Cornell University14, University of Chicago15, Columbia University Medical Center16, The Heritage Foundation17, American Thoracic Society18, Boston University19, Carolinas Healthcare System20, University of Minnesota21, University of Alabama at Birmingham22
01 Jun 2016-The Lancet Respiratory Medicine
TL;DR: This Commission summarises expert opinion from key stakeholders-patients, caregivers, and medical professionals, as well as representatives from health systems, insurance companies, and industry-to understand barriers to care delivery and propose potential solutions.

77 citations

Journal Article•DOI•
Predicting frequent COPD exacerbations using primary care data

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Marjan Kerkhof, Daryl Freeman, Rupert Jones1, Alison Chisholm, David Price •
University of Plymouth1
09 Nov 2015-International Journal of Chronic Obstructive Pulmonary Disease
TL;DR: Patients at risk of exacerbation can be identified from routinely available, computerized primary care data and a robust, clinically based model to predict frequent exacerbation risk was developed.
Abstract: This study was funded by an unrestricted grant from the Respiratory Effectiveness Group (REG; www.effectivenessevaluation.org). Access to data from the Optimum Patient Care Research Database was co-funded by Research in Real-Life Ltd (RiRL, Cambridge, UK). The authors would like to thank Dr John Bukowski of WordsWorld Consulting for editorial assistance drafting this manuscript. Additional editorial support was provided by Elizabeth V Hillyer, DVM, funded by RiRL.

66 citations

References
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Journal Article•DOI•
Characterisation of COPD heterogeneity in the ECLIPSE cohort

[...]

Alvar Agusti1, Peter M.A. Calverley, Bartolome R. Celli2, Harvey O. Coxson3, Lisa D. Edwards4, David A. Lomas5, William MacNee6, Bruce E. Miller7, S.I. Rennard8, Edwin K. Silverman2, Ruth Tal-Singer7, Emiel F.M. Wouters9, Julie C. Yates4, Jørgen Vestbo10 •
University of Barcelona1, Brigham and Women's Hospital2, University of British Columbia3, Research Triangle Park4, University of Cambridge5, University of Edinburgh6, GlaxoSmithKline7, University of Nebraska Medical Center8, Maastricht University Medical Centre9, Manchester Academic Health Science Centre10
10 Sep 2010-Respiratory Research
TL;DR: The clinical manifestations of COPD are highly variable and the degree of airflow limitation does not capture the heterogeneity of the disease.
Abstract: Chronic obstructive pulmonary disease (COPD) is a complex condition with pulmonary and extra-pulmonary manifestations. This study describes the heterogeneity of COPD in a large and well characterised and controlled COPD cohort (ECLIPSE). We studied 2164 clinically stable COPD patients, 337 smokers with normal lung function and 245 never smokers. In these individuals, we measured clinical parameters, nutritional status, spirometry, exercise tolerance, and amount of emphysema by computed tomography. COPD patients were slightly older than controls and had more pack years of smoking than smokers with normal lung function. Co-morbidities were more prevalent in COPD patients than in controls, and occurred to the same extent irrespective of the GOLD stage. The severity of airflow limitation in COPD patients was poorly related to the degree of breathlessness, health status, presence of co-morbidity, exercise capacity and number of exacerbations reported in the year before the study. The distribution of these variables within each GOLD stage was wide. Even in subjects with severe airflow obstruction, a substantial proportion did not report symptoms, exacerbations or exercise limitation. The amount of emphysema increased with GOLD severity. The prevalence of bronchiectasis was low (4%) but also increased with GOLD stage. Some gender differences were also identified. The clinical manifestations of COPD are highly variable and the degree of airflow limitation does not capture the heterogeneity of the disease.

1,021 citations

Additional excerpts

  • ...Selection for large COPD studies The proportion of patients from primary care that would be eligible to be included in the LPCS ranged from 17% (TRISTAN trial) to 42% (ECLIPSE and UPLIFT study) (Table 7)....

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  • ...In addition to five large trials, we decided to include the ECLIPSE cohort study as well, because this is an important observational study often cited in guidelines, especially with regard to exacerbation frequency patterns....

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  • ...Exacerbation data Individual datasets: UNLOCK studies reporting exacerbation data were compared with baseline data of the ISOLDE, TRISTAN, TORCH, UPLIFT and ECLIPSE studies (Table 3)....

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  • ...The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT)....

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  • ...Overall mean MRC scores were similar in the UNLOCK studies compared to ECLIPSE: 2.1 (0.8) and 2.7 (1.1), respectively....

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Journal Article•DOI•
Chronic obstructive pulmonary disease in five Latin American cities (the PLATINO study): a prevalence study

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Ana Maria Menezes1, Rogelio Pérez-Padilla, José Roberto Jardim2, Adriana Muiño3, Maria Victorina Lopez3, Gonzalo Valdivia4, Maria Montes de Oca5, Carlos Tálamo5, Pedro C. Hallal1, Cesar G. Victora1 •
Universidade Federal de Pelotas1, Federal University of São Paulo2, University of the Republic3, Pontifical Catholic University of Chile4, Central University of Venezuela5
26 Nov 2005-The Lancet
TL;DR: The results suggest that COPD is a greater health problem in Latin America than previously realised and given the high rates of tobacco use in the region, increasing public awareness of the burden of COPd is important.

925 citations

"Primary Care COPD Patients Compared..." refers background in this paper

  • ...On the other hand, physicians should be aware that the majority of mild COPD patients are often symptom free and often remain undiagnosed, as earlier demonstrated in the international BOLD and PLATINO studies [36,37]....

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Journal Article•DOI•
Effect of Pharmacotherapy on Rate of Decline of Lung Function in Chronic Obstructive Pulmonary Disease Results from the TORCH Study

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Bartolome R. Celli1, Nicola E. Thomas, Julie A. Anderson, Gary T. Ferguson, Christine Jenkins, Paul W. Jones, Jørgen Vestbo, Katharine Knobil, Julie C. Yates, Peter M.A. Calverley •
Tufts University1
15 Aug 2008-American Journal of Respiratory and Critical Care Medicine
TL;DR: Pharmacotherapy with salmeterol plus fluticasone propionate, or the components, reduces the rate of decline of FEV(1) in patients with moderate-to-severe COPD, thus slowing disease progression.
Abstract: Rationale: Chronic obstructive pulmonary disease (COPD) is characterized by an accelerated decline in lung function. No drug has been shown conclusively to reduce this decline. Objectives :I n apost hoc analysis of the Toward a Revolution in COPD Health (TORCH) study, we investigated the effects of combined salmeterol 50 mg plus fluticasone propionate 500 mg, either component alone or placebo, on the rate of post-bronchodilator FEV1 decline in patients with moderate or severe COPD. Methods: A randomized, double-blind, placebo-controlled study was conducted from September 2000 to November 2005 in 42 countries. Of 6,112 patients from the efficacy population, 5,343 were included in this analysis. Measurements and Main Results: Spirometry was measured every 24 weeks for 3 years. There were 26,539 on-treatment observations. The adjusted rate of decline in FEV1 was 55 ml/year for placebo, 42 ml/year for salmeterol, 42 ml/year for fluticasone propionate, and 39 ml/year for salmeterol plus fluticasone propionate. Salmeterol plus fluticasone propionate reduced the rate of FEV1 decline by 16 ml/ year compared with placebo (95% confidence interval [CI], 7–25;P , 0.001). The difference was smaller for fluticasone propionate and salmeterol compared with placebo (13 ml/year; 95% CI, 5–22; P 5 0.003). Rates of decline were similar among the active treatment arms. FEV1 declined faster in current smokers and patients with a lower body mass index, and varied between world regions. Patients who exacerbated more frequently had a faster FEV1 decline. Conclusions: Pharmacotherapy with salmeterol plus fluticasone propionate, or the components, reduces the rate of decline of FEV1 in patients with moderate-to-severe COPD, thus slowing disease progression. Clinical trial (GSK Study Code SCO30003) registered with www. clinicaltrials.gov (NCT00268216).

718 citations

Journal Article•DOI•
Development, validity and responsiveness of the Clinical COPD Questionnaire

[...]

Thys van der Molen1, Thys van der Molen2, Brigitte W. M. Willemse2, Siebrig Schokker2, Nick H. T. ten Hacken2, Dirkje S. Postma2, Elizabeth F Juniper3 •
University of Aberdeen1, University of Groningen2, University of Health Sciences Antigua3
28 Apr 2003-Health and Quality of Life Outcomes
TL;DR: The CCQ is a self-administered questionnaire specially developed to measure clinical control in patients with COPD and thirty-six smokers with and without COPD showed significant improvement in the CCQ after 2 months smoking cessation, indicating the responsiveness of theCCQ.
Abstract: The new Global Obstructive Lung Disease (GOLD) guidelines advice to focus treatment in Chronic Obstructive Pulmonary Disease (COPD) on improvement of functional state, prevention of disease progression and minimization of symptoms. So far no validated questionnaires are available to measure symptom and functional state in daily clinical practice. The aim of this study was to develop and validate the Clinical COPD Questionnaire (CCQ). Qualitative research with patients and clinicians was performed to generate possible items to evaluate clinical COPD control. Thereafter, an item reduction questionnaire was sent to 77 international experts. Sixty-seven experts responded and the 10 most important items, divided into 3 domains (symptoms, functional and mental state) were included in the CCQ (scale: 0 = best, 6 = worst). Cross-sectional data were collected from 119 subjects (57 COPD, GOLD stage I-III; 18 GOLD stage 0 and 44 (ex)smokers). Cronbach's α was high (0.91). The CCQ scores in patients (GOLD 0-III) were significantly higher than in healthy (ex)smokers. Furthermore, significant correlations were found between the CCQ total score and domains of the SF-36 (ρ = 0.48 to ρ = 0.69) and the SGRQ (ρ = 0.67 to ρ = 0.72). In patients with COPD, the correlation between the CCQ and FEV1%pred was ρ =-0.49. Test-retest reliability was determined in 20 subjects in a 2-week interval (Intra Class Coefficient = 0.94). Thirty-six smokers with and without COPD showed significant improvement in the CCQ after 2 months smoking cessation, indicating the responsiveness of the CCQ. The CCQ is a self-administered questionnaire specially developed to measure clinical control in patients with COPD. Data support the validity, reliability and responsiveness of this short and easy to administer questionnaire.

690 citations

"Primary Care COPD Patients Compared..." refers methods in this paper

  • ...The Clinical COPD Questionnaire (CCQ) was also used: this is a disease-specific 10-item questionnaire that calculates an overall score and three domain scores: symptoms, functional state and emotional state; patients are required to respond to each item on a 7-point scale with 0 representing the best possible score and 6 representing the worst possible score [35]....

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Journal Article•DOI•
Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE).

[...]

Jørgen Vestbo1, W. H. Anderson2, Harvey O. Coxson3, Courtney Crim, F Dawber2, Lisa D. Edwards, G Hagan2, Katharine Knobil2, David A. Lomas, William MacNee4, Edwin K. Silverman, Ruth Tal-Singer2, Eclipse Investigators •
University of Copenhagen1, GlaxoSmithKline2, University of British Columbia3, University of Edinburgh4
01 Apr 2008-European Respiratory Journal
TL;DR: Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points is the largest study attempting to better describe the subtypes of chronic obstructive pulmonary disease, as well as defining predictive markers of its progression.
Abstract: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and not well understood. The forced expiratory volume in one second is used for the diagnosis and staging of COPD, but there is wide acceptance that it is a crude measure and insensitive to change over shorter periods of time. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) is a 3-yr longitudinal study with four specific aims: 1) definition of clinically relevant COPD subtypes; 2) identification of parameters that predict disease progression in these subtypes; 3) examination of biomarkers that correlate with COPD subtypes and may predict disease progression; and 4) identification of novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD subtypes and predict disease progression. ECLIPSE plans to recruit 2,180 COPD subjects in Global Initiative for Chronic Obstructive Lung Disease categories II-IV and 343 smoking and 223 nonsmoking control subjects. Study procedures are to be performed at baseline, 3 months, 6 months and every 6 months thereafter. Assessments include pulmonary function measurements (spirometry, impulse oscillometry and plethysmography), chest computed tomography, biomarker measurement (in blood, sputum, urine and exhaled breath condensate), health outcomes, body impedance, resting oxygen saturation and 6-min walking distance. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points is the largest study attempting to better describe the subtypes of chronic obstructive pulmonary disease, as well as defining predictive markers of its progression.

679 citations

"Primary Care COPD Patients Compared..." refers methods in this paper

  • ...Definition of exacerbations: The definition of exacerbation used in the UNLOCK, ISOLDE [9], TRISTAN [10], TORCH [29] and ECLIPSE [32] studies was based on worsening of symptoms and the decision by a patient’s clinician (or by study personnel) to prescribe antibiotics or systemic corticosteroids, alone or in combination....

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  • ...These studies were published in the year 2000 or later: the ISOLDE [9,24,25], TRISTAN [10], TORCH [11,26–29], UPLIFT [12,30], ECLIPSE [13,31,32] and POET-COPD [14] studies....

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  • ...Furthermore, step-by-step we applied the inclusion criteria of the trials [9,10,14,29,30,32] to the UNLOCK population and calculated the proportion of patients eligible for inclusion....

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