Identifying the associated risks of pneumonia in COPD patients: ARCTIC an observational study

Janson, Christer; Johansson, Gunnar; Ställberg, Björn; Lisspers, Karin; Olsson, Petter; Keininger, Dorothy L.; Uhde, Milica; Gutzwiller, F; Jørgensen, Leif

doi:10.1186/s12931-018-0868-y

Cited by 33 publications

(33 citation statements)

References 31 publications

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“…Long-term use of inhaled corticosteroid (ICS) in patients with COPD has been associated with an increased risk of non-fatal pneumonia and other local and systemic adverse events [24], and while longer duration RCTs are needed to better understand safety of longterm ICS use beyond a couple of years, they can be very costly. Comparable safety outcomes have been reported in some RCTs [25,26]; however, results of real-world studies [27][28][29]…”

Section: Safety Monitoringmentioning

confidence: 88%

Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions

Roberts

Ferguson

2020

PharmacoEconomics Open

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Randomized controlled trials (RCTs) are preferred by payers for health technology assessments and coverage decisions. However, the inclusion of a highly selective patient population and the rigorously controlled conditions in RCTs may not be reflective of real-world clinical practice. Real-world evidence (RWE) obtained from an analysis of real-world data (RWD) from observational studies can bridge gaps in evidence not addressed by RCTs and is thus valuable to public and private payers for decision-making. Through a broad literature search to obtain insights into payers' experience, we found that payers have concerns about real-world studies with respect to data quality, poor internal validity, potential bias, and lack of meaningful endpoints. However, they valued RWE to fill evidence gaps not addressed by RCTs, such as high-quality, real-world, long-term effectiveness and safety data; head-to-head drug comparisons; cost analyses for tiering formulary placement; medication use and adherence patterns; identification of relevant responder and non-responder patient subpopulations; and patient-reported outcomes (PROs). RWE can be used to assess clinically meaningful endpoints and gauge the impact of interventions on the quality of healthcare. Here, we review how payers use or can use RWD on the comparative effectiveness and safety of treatments, PROs, medication adherence and persistence, prescribing patterns, healthcare resource utilization, and patient characteristics and/or biomarkers associated with treatment response when making health technology assessments and payer coverage decisions across therapeutic areas.

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Section: Safety Monitoringmentioning

confidence: 88%

Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions

Roberts

Ferguson

2020

PharmacoEconomics Open

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“…ICSs are commonly prescribed in COPD patients [36]; however, an association has been reported between ICSs and risk of pneumonia in COPD [3, 36, 37]. While there was no difference in overall ICS use between patients with and without consolidation in our cohort, ICS use was an independent risk factor for recurrent admissions with consolidation.…”

Section: Discussionmentioning

confidence: 53%

“…It accounts for 30 000 deaths every year in the UK alone and is the second most common reason for emergency hospital admission, resulting in 90 000 admissions and 1 million bed-days per annum . Community-acquired pneumonia is also a common cause of hospital admission and death, and COPD patients are at increased risk of pneumonia [2, 3]. Acute exacerbations and pneumonia present with similar symptoms including dyspnoea, cough, sputum production and fever.…”

Section: Introductionmentioning

confidence: 99%

Validity of the diagnosis of pneumonia in hospitalised patients with COPD

et al. 2019

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RationaleExacerbations of chronic obstructive pulmonary disease (COPD) and pneumonia are two of the most common reasons for acute hospital admissions. Acute exacerbations and pneumonia present with similar symptoms in COPD patients, representing a diagnostic challenge with a significant impact on patient outcomes. The objectives of this study were to compare the prevalence of radiographic consolidation with the discharge diagnoses of hospitalised COPD patients.MethodsCOPD patients admitted to three UK hospitals over a 3-year period were identified. Participants were included if they were admitted with an acute respiratory illness, COPD was confirmed by spirometry and a chest radiograph was performed within 24 h of admission. Pneumonia was defined as consolidation on chest radiograph reviewed by two independent observersResultsThere were 941 admissions in 621 patients included in the final analysis. In 235 admissions, consolidation was present on chest radiography and there were 706 admissions without consolidation. Of the 235 admissions with consolidation, only 42.9% had a discharge diagnosis of pneumonia; 90.7% of patients without consolidation had a discharge diagnosis of COPD exacerbation. The presence of consolidation was associated with increased rate of high-dependency care admission, increased mortality and prolonged length of stay. Inhaled corticosteroid use was associated with recurrent pneumonia.ConclusionsPneumonia is underdiagnosed in patients with COPD. Radiographic consolidation is associated with worse outcomes and prolonged length of stay. Incorrect diagnosis could result in inappropriate use of inhaled corticosteroids. Future guidelines should specifically address the diagnosis and management of pneumonia in COPD.

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“…We analysed data from ARCTIC, a real-world observational study of Swedish primary care patients with COPD [12][13][14][15] . Ethical approval for the study was obtained from the local Ethical Regional Board in Uppsala, Sweden on 11 December 2014 (number: 2014-397) for accessing the National Health Register and for recruiting primary care centres to the study.…”

Section: Study Design and Patientsmentioning

confidence: 99%

Inhaled corticosteroids and the risk of type 2 diabetes among Swedish COPD patients

Ställberg

Janson

Lisspers

et al. 2020

npj Prim. Care Respir. Med.

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This study reports the association of ICS use and the risk of type 2 diabetes mellitus (T2DM) in Swedish patients with COPD using data from real-world, primary care settings. A total of 7078 patients with COPD were included in this analysis and the 5-year cumulative incidence rate per 100,000 person years was 1506.9. The yearly incidence rate per 100,000 person years ranged from 850 to 1919. Use of ICS especially at a high dose in patients with COPD was related to an increased risk of T2DM.

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Identifying the associated risks of pneumonia in COPD patients: ARCTIC an observational study

Cited by 33 publications

References 31 publications

Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions

Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions

Validity of the diagnosis of pneumonia in hospitalised patients with COPD

Inhaled corticosteroids and the risk of type 2 diabetes among Swedish COPD patients

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