Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

Miravitlles, Marc; Śliwiński, Paweł; Rhee, Chin Kook; Costello, Richard W.; Carter, Victoria; Tan, Jessica; Lapperre, Thérèse S.; Alcázar, Bernardino; Gouder, Caroline; Esquinas, Cristina; García-Rivero, Juan Luis; Kemppinen, Anu; Tee, Augustine; Román-Rodríguez, Miguel; Soler-Cataluña, Juan José; Price, David

doi:10.1016/j.rmed.2018.01.019

Cited by 28 publications

(39 citation statements)

References 28 publications

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“…Furthermore, the controlled patients had a better HRQoL throughout this period. These results corroborate previous studies that have highlighted the value of the clinical control concept as a means of evaluating and monitoring patients with COPD (11)(12)(13)(14)(15)(16).…”

Section: Discussionsupporting

confidence: 91%

“…Clinical control is de ned as the long-term persistence of a situation of low clinical impact; in other words, it is composed of a transversal dimension (the clinical impact) together with a longitudinal one (clinical stability), determined by exacerbations or worsening over time. Studies have shown that clinical control can be achieved by an acceptable proportion of patients, even among those with greater air ow limitation (11)(12)(13)(14), although control status may vary over time (15), and that patients whose condition is uncontrolled are at greater risk of unfavourable outcomes (16). However, in the absence of previous research in this area, it is unclear whether patients who are clinically controlled have less symptom burdenand a better HRQoLthan those who are not.…”

Section: Introductionmentioning

confidence: 99%

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Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients With Copd

Alcázar¹,

Fuster

García-Sidro³

et al. 2020

Preprint

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Background:The concept of clinical control has been proposed as an instrument for evaluating patients with COPD. However, the possible association between clinical control,reduced symptom severity and HRQoL has yet to be confirmed.Method: This multicentre, prospective and observational study was carried out in pulmonology clinics in Spain. The patients were followed up for six months, with a baseline visit (V0), followed by visits at three months (V1) and six months (V2). Clinical control was determinedat V1, with the application of both clinical criteria and the COPD assessment test (CAT). All patients reported their symptoms by a validated symptom diary (E-RS) using a portable device, and their HRQoL was assessed using the EQ5D questionnaire. The relationship between clinical control and E-RS andHRQoL during follow-up was assessed.Results: A total of126 patients were screened. After application of the inclusion/exclusion criteria, 93 were finally included (mean age 66 ± 8 years, 84.9% male), with a mean FEV1predicted of 49.8% ± 16.5%. Of these patients, 44 (47.3%) achieved clinical control at V1, according to CAT criteria, and 50 (53.8%), according to clinical criteria. The E-RS scores differed between controlled and uncontrolled patients at all time points, both according to CAT (mean differences of -4.6, -5.6 and -6.2 units at V0, V1 and V2 respectively, p<0.005 for all comparisons) and to clinical criteria (mean differences of -3.3, -5-6 and -4.99 units, respectively, p<0.005 for all comparisons). The controlled patients also presented a significantly better HRQoL, measured by the EQ5D questionnaire(mean difference 0.13and 0.10 at V2 by CAT or clinical criteria, respectively, p<0.05).Conclusions:Clinical control in patients with COPD, whether measured by CAT or by clinical criteria, is associated with a lower symptom load and a better HRQoL.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients With Copd

Alcázar¹,

Fuster

García-Sidro³

et al. 2020

Preprint

Self Cite

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“…A recently reported multicentre, observational study in Europe classified 21% of COPD patients as 'controlled', using the same CAT score criteria. 18 However, all patients classified had mild-to-moderate COPD. Most patients in the SPRINT cohort were elderly (median age 70 years).…”

Section: Discussionmentioning

confidence: 98%

“…Taken together, these results suggest that a CAT threshold of 10 is probably too low to define low COPD symptom burden. 18,19 In view of the lack of reversibility that is typical of COPD, the threshold might need to be adapted to the baseline severity of the disease.…”

Section: Discussionmentioning

confidence: 99%

Asthma control and COPD symptom burden in patients using fixed-dose combination inhalers (SPRINT study)

Roche

Plaza

Backer³

et al. 2020

npj Prim. Care Respir. Med.

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Previous studies have found suboptimal control of symptom burden to be widespread among patients with asthma and chronic obstructive pulmonary disease (COPD). The Phase IV SPRINT study was conducted in 10 countries in Europe to assess asthma disease control and COPD symptom burden in patients treated with a fixed-dose combination (FDC) of inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs). SPRINT included 1101 patients with asthma and 560 with COPD; all were receiving treatment with an FDC of ICS/LABA, delivered via various inhalers. Data were obtained over a 3-month period, during a single routine physician’s office visit. Asthma control was defined as Asthma Control Test (ACT) score >19. COPD symptom burden was assessed by COPD Assessment Test (CAT), with a CAT score <10 defining low COPD symptom burden. Among patients using any ICS/LABA FDC, 62% of patients with asthma had achieved disease control (ACT score >19) and 16% of patients with COPD had low symptom burden (CAT score <10).

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“…In order to define the control status, diagnostic criteria have been proposed based on a combination of different clinical parameters (degree of dyspnoea, use of rescue medication, physical activity, sputum colour, presence of exacerbations and the patients' perception of their own health), or an alternative based on the use of validated clinical questionnaires such as the CAT 56 or Clinical COPD Questionnaires (CCQ) 57 ( Table 2). These diagnosis criteria have been recently validated, demonstrating that clinical control is an objective which is attainable in the short-term, dynamic over time, sensitive to change and associated with a better outcome in the short and long-term, with a lower risk of future exacerbations and better HRQoL 55,[58][59][60] . For all these reasons, clinical control has been proposed as a new comprehensive therapeutic objective with a key role in clinical decision making 61 .…”

Section: Relevance Of Symptom Variability For Clinical Controlmentioning

confidence: 99%

Relevance of Symptom Variability for Control and Management of COPD

Soler-Cataluña¹,

Lόpez-Campos²

2021

BRN

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Physiological and cellular functions operate in a 24-hour cyclical pattern orchestrated by an endogenous process known as the circadian rhythm. Airway calibre exhibits a circadian variation with maximum values occurring around noon and minimum values in the early morning. The mechanisms behind the daily variation are complex, but it has been speculated that autonomic input to airway tissues via the vagal nerve plays an essential role. In chronic obstructive pulmonary disease (COPD), there is important daily variation of respiratory symptoms, which are present in approximately half of the patients. This time-dependent variability has important consequences since it has an impact on daily life physical activity, sleep quality, severity of symptoms, exacerbations or health-related quality of life, which in turn represents a component of instability within a period previously considered as relatively calm. This article reviews the symptomatic variability in COPD, its pathophysiological basis, characteristics, determinants, potential consequences and therapeutic implications.

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Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

Abstract: The proposed criteria of control were only fulfilled by 21% of patients. The suggested cut offs and their predictive value for poor outcomes need to be refined in prospective studies.

Cited by 28 publications

References 28 publications

Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients With Copd

Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients With Copd

Asthma control and COPD symptom burden in patients using fixed-dose combination inhalers (SPRINT study)

Relevance of Symptom Variability for Control and Management of COPD

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