Antolín López Viña

Validation of the spanish version of the asthma control questionnaire

BACKGROUND The Asthma Control Questionnaire (ACQ) has not been validated in the Spanish population, and the fact that it requires spirometry poses an important limitation on its widespread use in the primary care setting in Spain. OBJECTIVE The aim of this study was to evaluate the psychometric properties of the Spanish version of the ACQ. METHODS In this multicenter, prospective study, consecutive adult patients with persistent asthma were recruited at 62 respiratory and allergy units across Spain. Patients were assessed at baseline and at weeks 2 and 6. The following clinical variables were recorded: lung function (forced expiratory volume in 1 second [FEV(1)]), symptoms, exacerbations, concomitant diseases, asthma severity according to the Global Initiative for Asthma international guideline, and asthma control as perceived by patients and physicians through direct ad hoc questions. The latter measures were derived specifically for this study. Patients self-completed the ACQ at all visits before the rest of the study variables were recorded. The ACQs feasibility, validity, reliability, and sensitivity to change were assessed. Cross-sectional and longitudinal validity was assessed using the relationship between ACQ score and clinical parameters. Sensitivity to change was assessed by estimating the global effect size and the minimal important difference (MID). Reliability was assessed using estimation of the Cronbach alpha coefficient (CCalpha) and intraclass correlation coefficient (ICC). RESULTS A total of 607 patients were included. The mean (SD) age was 45.6 (17.1) years and 61.4% of the patients were women. Of these 607, 235 (39%) had mild asthma; 246 (41%), moderate; and 126 (21%), severe. Mean (SD) time to complete the ACQ was 3.9 (4.4) minutes. The Pearson correlation coefficient in the relationship between ACQ and FEV(1) (% predicted value) was -0.23. ACQ was found to be significantly related to asthma severity and intensity and frequency of symptoms (coughing, wheezing, and dyspnea) (both, P < 0.001). Change in ACQ was significantly related to changes in FEV(1), intensity and frequency of symptoms, and number of exacerbations (all, P < 0.001). The global effect size of ACQ was 0.46 and the MID was 0.47 point of a maximum of 6. CCalpha was 0.90 and ICC was 0.86. CONCLUSION In these adults with asthma in Spain, the Spanish version of the ACQ was found to be a reliable and valid questionnaire, suggesting that it can be used in this population as a discriminative and evaluative instrument.

Cut-off points for defining asthma control in three versions of the Asthma Control Questionnaire

Introduction. The Asthma Control QuestionnaireTM (ACQ) was developed to assess asthma control. The objective of this study is to determine the cut-off points that best differentiate between several types of asthma control in three versions of the ACQ used in clinical practice. Materials and methods. It appears 607 adult asthmatic patients (61% female) were recruited from 43 outpatient clinics in Spain. Once the patients were stratified by severity of asthma, they were then evaluated in an epidemiological study. To determine the optimum cut-off points, the area under the receiver operating characteristics (ROC) curve, as well as sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively), was calculated for each version of the ACQ (ACQ-FEV1 (forced expiratory volume in the first second), ACQ-PEF (peak expiratory flow), and ACQ-wLF (without lung function)). Results. The optimal cut-off for ACQ-FEV1 was 1.14 (the sum of 8 points/7 items), for ACQ-PEF 1.28 (the sum of 9 points/7 items), and for ACQ-wLF 0.83 (the sum of 5 points/6 items), and the percentage of correctly classified patients was 76.5%, 77.3%, and 77.2%, respectively. A comparison of ROCs obtained from the three versions of the ACQ shows that ACQ-wLF had a significantly greater area under the curves (AUC) (p = .004) than ACQ-FEV1. Patients were considered as having some control if their ACQ-FEV1 score fell between 1.14 and 1.57, if ACQ-PEF values were between 1.28 and 1.57, or if ACQ-wLF scores ranged between 0.83 and 1.5. Conclusions. Our study, which was carried out in a manner which more closely reflects clinical practice, reveals differences in cut-offs used to define well-controlled asthma among three versions of the ACQ.

Th-2 signature in chronic airway diseases: towards the extinction of asthma−COPD overlap syndrome?

We aimed to describe the differences and similarities between patients with chronic obstructive airway disease classified on the basis of classical diagnostic labels (asthma, chronic obstructive pulmonary disease (COPD), or asthma–COPD overlap (ACOS)) or according to the underlying inflammatory pattern (Th-2 signature, either Th-2-high or Th-2-low). We performed a cross-sectional study of patients aged ≥40 years and with a post-bronchodilator forced expiratory volume in 1 s to forced vital capacity ratio ≤0.7 with a previous diagnosis of asthma (non-smoking asthmatics (NSA)), COPD or ACOS, the latter including both smoking asthmatics (SA) and patients with eosinophilic COPD (COPD-e). Clinical, functional and inflammatory parameters (blood eosinophil count, IgE and exhaled nitric oxide fraction (FeNO)) were compared between groups. Th-2 signature was defined by a blood eosinophil count ≥300 cells·μL−1 and/or a sputum eosinophil count ≥3%. Overall, 292 patients were included in the study: 89 with COPD, 94 NSA and 109 with ACOS (44 SA and 65 with COPD-e). No differences in symptoms or exacerbation rate were found between the three groups. With regards the underlying inflammatory pattern, 94 patients (32.2%) were characterised as Th-2-high and 198 (67.8%) as Th-2-low. The Th-2 signature was found in 49% of NSA, 3.3% of patients with COPD, 30% of SA and 49.3% of patients with COPD-e. This classification yielded significant differences in demographic, functional and inflammatory characteristics. We conclude that a classification based upon the inflammatory profile, irrespective of the taxonomy, provides a more clear distinction of patients with chronic obstructive airway disease. Identifying a Th-2 signature in patients with chronic airflow limitation effectively differentiates treatable traits http://ow.ly/kq1E309MMkt

Valoración externa de las recomendaciones de la GEMA2009 por un panel multiprofesional de expertos en asma

OBJECTIVES To assess the level of agreement on the GEMA 2009 clinical recommendations by a Spanish expert panel on asthma. MATERIALS AND METHODS The study was divided into four stages: 1) establishment of a 9 member scientific committee (GEMA authors) for selection of GEMA recommendations to use in the survey; 2) formation of a panel of 74 professionals with expertise in this field (pulmonologists, allergists, family doctors, ear, nose and throat and paediatric specialists); 3) Delphi survey in two rounds, sent by mail, with intermediate processing of opinions and a report to the panel members; and 4) analysis and discussion of results for the Scientific Committee. RESULTS Seventy four participants completed the two rounds of survey. During the first round, a consensus was reached in 49 out of 56 questions analysed. Following discussion by the panel, the consensus was increased to a total of 53 items in the survey. With respect to the remaining questions, Insufficient consensus was obtained on the rest of the questions, due to differing views between sub-specialists, or lack of criteria by most of the experts. CONCLUSIONS The external analysis by asthma experts from different specialities showed a high level of professional agreement with the GEMA 2009 recommendations in Spain (96.5%). The disagreement shown in three recommendations reflect the lack of a high level evidence. These issues represent areas of interest for future research.

External assessment of the GEMA2009 recommendations by a multidisciplinary expert panel on asthma

Abstract Objectives To assess the level of agreement on the GEMA 2009 clinical recommendations by a Spanish expert panel on asthma. Materials and methods The study was divided into four stages: 1) establishment of a 9 member scientific committee (GEMA authors) for selection of GEMA recommendations to use in the survey; 2) formation of a panel of 74 professionals with expertise in this field (pulmonologists, allergists, family doctors, ear, nose and throat and paediatric specialists); 3) Delphi survey in two rounds, sent by mail, with intermediate processing of opinions and a report to the panel members; and 4) analysis and discussion of results for the Scientific Committee. Results Seventy four participants completed the two rounds of survey. During the first round, a consensus was reached in 49 out of 56 questions analysed. Following discussion by the panel, the consensus was increased to a total of 53 items in the survey. With respect to the remaining questions, Insufficient consensus was obtained on the rest of the questions, due to differing views between sub-specialists, or lack of criteria by most of the experts. Conclusions The external analysis by asthma experts from different specialities showed a high level of professional agreement with the GEMA 2009 recommendations in Spain (96.5 %). The disagreement shown in three recommendations reflect the lack of a high level evidence. These issues represent areas of interest for future research.

Asma grave y resistente al tratamiento: conceptos y realidades

Existe un pequeno porcentaje de pacientes con asma en los que no se consigue el control de la enfermedad a pesar de una pauta terapeutica que incluya esteroides inhalados a dosis altas junto a β2-agonistas de accion prolongada. Aunque cuantitativamente son pocos, cualitativamente son muy importantes, ya que son los que tienen mayor morbilidad y los que suponen mas gastos sanitarios por el asma. Este grupo de pacientes puede englobarse dentro del termino “asma de control dificil” y deben separarse de otros tipos de asma mal controlada en las que la causa de la falta de control puede ser evitable, como que el diagnostico sea erroneo, exista alguna comorbilidad, esten presentes factores agravantes, o el paciente no cumpla el tratamiento. Ante un paciente con tratamiento aparentemente adecuado y con su asma mal controlada, antes de prescribir mas farmacos es crucial identificar y tratar todas las condiciones que puedan estar causando el mal control siguiendo un protocolo sistematico y riguroso.

Mixed Th2 and non-Th2 inflammatory pattern in the asthma–COPD overlap: a network approach

Introduction The asthma–chronic obstructive pulmonary disease (COPD) overlap (ACO) is a clinical condition that combines features of those two diseases, and that is difficult to define due to the lack of understanding of the underlying mechanisms. Determining systemic mediators may help clarify the nature of inflammation in patients with ACO. Objectives We aimed at investigating the role and interaction of common markers of systemic inflammation (IL-6, IL-8, and tumor necrosis factor-α), Th2-related markers (periostin, IL-5, and IL-13), and IL-17 in asthma, COPD, and ACO. Methods This is a cross-sectional study of patients aged ≥40 years with a post-bronchodilator forced expiratory volume in the first second/forced vital capacity <0.70 recruited from outpatient clinics in tertiary hospitals with a clinical diagnosis of asthma, COPD, or ACO. ACO was defined by a history of smoking >10 pack-years in a patient with a previous diagnosis of asthma or by the presence of eosinophilia in a patient with a previous diagnosis of COPD. Clinical, functional, and inflammatory parameters were compared between categories using discriminant and network analysis. Results In total, 109 ACO, 89 COPD, and 94 asthma patients were included. Serum levels (median [interquartile range]) of IL-5 were higher in asthma patients than in COPD patients (2.09 [0.61–3.57] vs 1.11 [0.12–2.42] pg/mL, respectively; p=0.03), and IL-8 levels (median [interquartile range]) were higher in COPD patients than in asthma patients (9.45 [6.61–13.12] vs 7.03 [4.69–10.44] pg/mL, respectively; p<0.001). Their values in ACO were intermediate between those in asthma and in COPD. Principal component and network analysis showed a mixed inflammatory pattern in ACO in between asthma and COPD. IL-13 was the most connected node in the network, with different weights among the three conditions. Conclusion Asthma and COPD are two different inflammatory conditions that may overlap in some patients, leading to a mixed inflammatory pattern. IL-13 could be central to the regulation of inflammation in these conditions.

La guía española del manejo del asma (GEMA 4.0) está obsoleta en lo que a vacunación antineumocócica se refiere. Respuesta de los autores

We read with great interest the letter to the Editor1 contributed by Mascarós et al. on behalf the Neumoexpertos en Prevención group, which is supported by the Instituto de Investigación Sanitaria de Santiago, in collaboration with Pfizer (http://neumoexpertos. org/conflicto-de-intereses). These authors question the lack of a recommendation for anti-pneumococcal vaccination in asthma patients in the latest edition of the Spanish Guidelines for the Management of Asthma (GEMA 4.0).2 Their arguments hinge on recent consensus documents from experts recommending this intervention, and new studies that have shown its efficacy.3,4 Evidence-based clinical practice guidelines (CPG) propose recommendations when the scientific proof is available to support them. Unfortunately, in the case of the pneumococcal vaccine, the evidence is weak (or non-existent). Accordingly, it is not recommended by either the GEMA 4.0 or the most prestigious international guidelines, such as the Global Initiative for Asthma (GINA) or the British Thoracic Society (BTS). Of the 2 publications which Mascarós et al. claim provide new evidence for the efficacy of the vaccine, the study by Okapuu et al.3 is a simple arithmetic exercise based on a database crossover involving the calculation of a hypothetical number of cases needed to be treated (NNT), rather than the analysis of data gathered in a prospective clinical trial. The study by Bonten et al. (CAPITA study)4 provides evidence for the indication of the PVC13 pneumococcal vaccine in patients over 65 years of age, but cannot be used as an argument to support its indication in the asthma population, since no specific subanalysis was performed in this group. Moreover, recommendations from expert groups published in recent consensus documents that lack the support of robust studies provide only low-level (or non-existent) evidence – the type of evidence which, in general, is avoided in CPGs. Nevertheless, as the asthma population has a greater risk of presenting invasive pneumococcal disease,5 and pneumococcal vaccination is effective in preventing this infection in the general population, even if the evidence for its indication in the asthma population is weak (or non-existent), the Spanish National Health System (http://www.msssi.gob.es) has recently recommended its use in patients with severe asthma. We, the signatories of GEMA 4.0 (mostly clinical physicians), consider that pneumococcal vaccination in patients with severe asthma is probably beneficial, but as writers of evidence-based CPGs, we are obliged to limit our recommendation until rigorous proof of this indication is available. In view of these findings, it seems appropriate at the present time to go no further in recommending pneumococcal vaccination in the asthmatic population. The GEMA signatories will include this

Implicación de los servicios de neumología españoles en la asistencia, docencia e investigación en asma. Resultados de la encuesta ATENEA

UNLABELLED Although asthma is one of the most prevalent chronic respiratory diseases, the participation of Spanish pulmonology units in the management of asthma may have room for improvement. OBJECTIVE To determine the degree of involvement of the Spanish pulmonology services in the patient care, education and research related with asthma disease and especially in difficult-to-control asthma. METHODS A survey made up of 75 questions was sent to the heads of several pulmonology departments. The survey asked questions pertaining to respiratory disease care in general, and in asthma in particular, as well as the educational activities and research in asthma during the previous five years. RESULTS Out of the 107 surveys sent, 69 (645%) centers filled them out and returned them. Forty-seven (681%) met the criteria for an important level of health-care activity in asthma. However, only 29 (42%) had a monographic consultation for difficult-to-control asthma and 37 (536%) used an education program. As for postgraduate education, only 31 (449%) provided their resident physicians with specific asthma training. And in the research field, 12 (174%) reported having projects funded by SEPAR and 25 (362%) had published studies in journals with an impact factor. CONCLUSIONS Although the majority of the pulmonology centers interviewed report a notable activity in asthma patient care, their involvement in the specialized approach for difficult-to-control asthma is insufficient. Likewise, participation in educational activities and research related with the disease is inconsistent and limited to few centers.