The concept of control in chronic obstructive pulmonary disease: Development of the criteria and validation for use in clinical practice

Guidelines of treatment of chronic obstructive pulmonary disease (COPD) identify symptom reduction and prevention of exacerbations as the main goals of therapy. Initial pharmacological treatment must be guided by these parameters, and effectiveness must be assessed at each clinical visit. However, there is no clear guidance as to how this assessment must be performed. The concept of control has been well developed in asthma, but it has been elusive in COPD. Patients with COPD may not be completely free from symptoms or exacerbations even under optimized therapy; therefore, control in COPD does not mean cure or absence of symptoms, but rather reaching the best clinical status possible according to the level of disease severity. A control tool has been developed based on a cross sectional evaluation of the impact of the disease and a longitudinal evaluation of stability. Low impact is a disease status defined by at least 3 of the following: low levels of dyspnoea, absence of or white sputum, low use of rescue medication and self-declared walking time of more than 30 minutes a day, and stability is the absence of moderate or severe exacerbations in the previous 3 months. Control can also be defined by COPD Assessment Test (CAT) scores ≤ 10 units for patients with FEV1 ≥ 50% and 16 for patients with FEV1 < 50% and stability as a change in CAT ≤ 2 units. Control of COPD is then defined as a status of low impact and stability. The control tool has been validated prospectively in several studies and has demonstrated to be sensitive to clinical changes and to have a good predictive value for poor outcomes. Clinical criteria are more reliable than CAT scores for the evaluation of control. The control tool is a quick and inexpensive method to evaluate clinical status and future risk of exacerbations that can be used at all levels of healthcare. Концепция контроля при лечении хронической обструктивной болезни легких: разработка критериев и валидация для клинического применения (перевод с английского)По данным рекомендаций, при лечении хронической обструктивной болезни легких (ХОБЛ) в качестве главных целей лечения выделяются купирование симптомов и предотвращение обострений. При первоначальной медикаментозной терапии следует руководствоваться именно этими параметрами, а эффективность должна оцениваться при каждом посещении пациентом врача. Однако четких рекомендаций о том, как именно проводить такую оценку, не существует. Концепция контроля хорошо разработана при лечении бронхиальной астмы, однако для ХОБЛ сформулировать таковую оказалось намного труднее. Пациенты с ХОБЛ могут продолжать испытывать симптомы болезни, даже получая оптимальную терапию; таким образом, контроль над ХОБЛ означает не полное излечение или отсутствие симптомов, а достижение наилучшего возможного клинического статуса при данной степени тяжести заболевания. Авторами данной статьи разработан инструмент для определения контроля над ХОБЛ на основе поперечного среза данных о нагрузке на здоровье пациента и лонгитюдинальной оценки стабильности его состояния. Низкая нагрузка определяется как удовлетворяющая минимум 3 критериям из следующих: низкий уровень одышки; отсутствие мокроты или белая мокрота; малое использование симптоматической терапии; 30 мин ходьбы пешком в день согласно самооценке. Стабильность определяется как отсутствие умеренно тяжелых или тяжелых обострений в предшествующие 3 мес. Контроль также осуществляется по результатам теста по оценке степени тяжести ХОБЛ (COPD Assesment Test – CAT) следующим образом: ≤ 10 единиц – для пациентов, у которых показатель объема форсированного выдоха за 1-ю секунду (ОФВ1) составляет ≥ 50 %; ≤ 16 – при ОФВ1 < 50 %; стабильность определяется как изменение оценки по CAT ≤ 2 единиц. Таким образом, контроль над ХОБЛ определяется как состояние стабильно низкой нагрузки на здоровье. Инструмент для определения контроля валидирован проспективно по данным ряда исследований, при этом продемонстрированы чувствительность к изменениям клинического состояния пациентов и бόльшая прогностическая ценность по отношению к негативным исходам. Кли - нические критерии оказались надежнее в определении статуса контроля, чем баллы по CAT. Таким образом, концепция контроля – это быстрый и недорогой метод оценки клинического статуса и риска обострений в будущем, который пригоден к использованию на всех уровнях здравоохранения

Testing for alpha-1 antitrypsin in COPD in outpatient respiratory clinics in Spain: A multilevel, cross-sectional analysis of the EPOCONSUL study

Background Alpha-1 antitrypsin deficiency (AATD) is the most common hereditary disorder in adults, but is under-recognized. In Spain, the number of patients diagnosed with AATD is much lower than expected according to epidemiologic studies. The objectives of this study were to assess the frequency and determinants of testing serum α1-antitrypsin (AAT) levels in COPD patients, and to describe factors associated with testing. Methods EPOCONSUL is a cross-sectional clinical audit, recruiting consecutive COPD cases over one year. The study evaluated serum AAT level determination in COPD patients and associations between individual, disease-related, and hospital characteristics. Results A total of 4,405 clinical records for COPD patients from 57 Spanish hospitals were evaluated. Only 995 (22.5%) patients had serum AAT tested on some occasion. A number of patient characteristics (being male [OR 0.5, p < 0.001], ≤55 years old [OR 2.38, p<0.001], BMI≤21 kg/m2 [OR 1.71, p<0.001], FEV1(%)<50% [OR 1.35, p<0.001], chronic bronchitis [OR 0.79, p < 0.001], Charlson index ≥ 3 [OR 0.66, p < 0.001], or history or symptoms of asthma [OR 1.32, p<0.001]), and management at a specialized COPD outpatient clinic [OR 2.73,p<0.001] were identified as factors independently associated with ever testing COPD patients for AATD. Overall, 114 COPD patients (11.5% of those tested) had AATD. Of them, 26 (22.8%) patients had severe deficiency. Patients with AATD were younger, with a low pack-year index, and were more likely to have emphysema (p<0.05). Conclusion Testing of AAT blood levels in COPD patients treated at outpatient respiratory clinics in Spain is infrequent. However, when tested, AATD (based on the serum AAT levels ≤100 mg/dL) is detected in one in five COPD patients. Efforts to optimize AATD case detection in COPD are needed.SEPA

Концепция контроля при лечении хронической обструктивной болезни легких: разработка критериев и валидация для клинического применения (перевод с английского)

Guidelines of treatment of chronic obstructive pulmonary disease (COPD) identify symptom reduction and prevention of exacerbations as the main goals of therapy. Initial pharmacological treatment must be guided by these parameters, and effectiveness must be assessed at each clinical visit. However, there is no clear guidance as to how this assessment must be performed. The concept of control has been well developed in asthma, but it has been elusive in COPD. Patients with COPD may not be completely free from symptoms or exacerbations even under optimized therapy; therefore, control in COPD does not mean cure or absence of symptoms, but rather reaching the best clinical status possible according to the level of disease severity. A control tool has been developed based on a cross sectional evaluation of the impact of the disease and a longitudinal evaluation of stability. Low impact is a disease status defined by at least 3 of the following: low levels of dyspnoea, absence of or white sputum, low use of rescue medication and self-declared walking time of more than 30 minutes a day, and stability is the absence of moderate or severe exacerbations in the previous 3 months. Control can also be defined by COPD Assessment Test (CAT) scores ≤ 10 units for patients with FEV1 ≥ 50% and 16 for patients with FEV1 &lt; 50% and stability as a change in CAT ≤ 2 units. Control of COPD is then defined as a status of low impact and stability. The control tool has been validated prospectively in several studies and has demonstrated to be sensitive to clinical changes and to have a good predictive value for poor outcomes. Clinical criteria are more reliable than CAT scores for the evaluation of control. The control tool is a quick and inexpensive method to evaluate clinical status and future risk of exacerbations that can be used at all levels of healthcare.По данным рекомендаций, при лечении хронической обструктивной болезни легких (ХОБЛ) в качестве главных целей лечения выделяются купирование симптомов и предотвращение обострений. При первоначальной медикаментозной терапии следует руководствоваться именно этими параметрами, а эффективность должна оцениваться при каждом посещении пациентом врача. Однако четких рекомендаций о том, как именно проводить такую оценку, не существует. Концепция контроля хорошо разработана при лечении бронхиальной астмы, однако для ХОБЛ сформулировать таковую оказалось намного труднее. Пациенты с ХОБЛ могут продолжать испытывать симптомы болезни, даже получая оптимальную терапию; таким образом, контроль над ХОБЛ означает не полное излечение или отсутствие симптомов, а достижение наилучшего возможного клинического статуса при данной степени тяжести заболевания. Авторами данной статьи разработан инструмент для определения контроля над ХОБЛ на основе поперечного среза данных о нагрузке на здоровье пациента и лонгитюдинальной оценки стабильности его состояния. Низкая нагрузка определяется как удовлетворяющая минимум 3 критериям из следующих: низкий уровень одышки; отсутствие мокроты или белая мокрота; малое использование симптоматической терапии; 30 мин ходьбы пешком в день согласно самооценке. Стабильность определяется как отсутствие умеренно тяжелых или тяжелых обострений в предшествующие 3 мес. Контроль также осуществляется по результатам теста по оценке степени тяжести ХОБЛ (COPD Assesment Test – CAT) следующим образом: ≤ 10 единиц – для пациентов, у которых показатель объема форсированного выдоха за 1-ю секунду (ОФВ1) составляет ≥ 50 %; ≤ 16 – при ОФВ1 &lt; 50 %; стабильность определяется как изменение оценки по CAT ≤ 2 единиц. Таким образом, контроль над ХОБЛ определяется как состояние стабильно низкой нагрузки на здоровье. Инструмент для определения контроля валидирован проспективно по данным ряда исследований, при этом продемонстрированы чувствительность к изменениям клинического состояния пациентов и бόльшая прогностическая ценность по отношению к негативным исходам. Кли - нические критерии оказались надежнее в определении статуса контроля, чем баллы по CAT. Таким образом, концепция контроля – это быстрый и недорогой метод оценки клинического статуса и риска обострений в будущем, который пригоден к использованию на всех уровнях здравоохранения

The PEARL score predicts 90-day readmission or death after hospitalisation for acute exacerbation of COPD.

BACKGROUND: One in three patients hospitalised due to acute exacerbation of COPD (AECOPD) is readmitted within 90 days. No tool has been developed specifically in this population to predict readmission or death. Clinicians are unable to identify patients at particular risk, yet resources to prevent readmission are allocated based on clinical judgement. METHODS: In participating hospitals, consecutive admissions of patients with AECOPD were identified by screening wards and reviewing coding records. A tool to predict 90-day readmission or death without readmission was developed in two hospitals (the derivation cohort) and validated in: (a) the same hospitals at a later timeframe (internal validation cohort) and (b) four further UK hospitals (external validation cohort). Performance was compared with ADO, BODEX, CODEX, DOSE and LACE scores. RESULTS: Of 2417 patients, 936 were readmitted or died within 90 days of discharge. The five independent variables in the final model were: Previous admissions, eMRCD score, Age, Right-sided heart failure and Left-sided heart failure (PEARL). The PEARL score was consistently discriminative and accurate with a c-statistic of 0.73, 0.68 and 0.70 in the derivation, internal validation and external validation cohorts. Higher PEARL scores were associated with a shorter time to readmission. CONCLUSIONS: The PEARL score is a simple tool that can effectively stratify patients' risk of 90-day readmission or death, which could help guide readmission avoidance strategies within the clinical and research setting. It is superior to other scores that have been used in this population. TRIAL REGISTRATION NUMBER: UKCRN ID 14214

New GOLD classification: Longitudinal data on group assignment

Rationale: Little is known about the longitudinal changes associated with using the 2013 update of the multidimensional GOLD strategy for chronic obstructive pulmonary disease (COPD). Objective: To determine the COPD patient distribution of the new GOLD proposal and evaluate how this classification changes over one year compared with the previous GOLD staging based on spirometry only. Methods: We analyzed data from the CHAIN study, a multicenter observational Spanish cohort of COPD patients who are monitored annually. Categories were defined according to the proposed GOLD: FEV1%, mMRC dyspnea, COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and exacerbations-hospitalizations. One-year follow-up information was available for all variables except CCQ data. Results: At baseline, 828 stable COPD patients were evaluated. On the basis of mMRC dyspnea versus CAT, the patients were distributed as follows: 38.2% vs. 27.2% in group A, 17.6% vs. 28.3% in group B, 15.8% vs. 12.9% in group C, and 28.4% vs. 31.6% in group D. Information was available for 526 patients at one year: 64.2% of patients remained in the same group but groups C and D show different degrees of variability. The annual progression by group was mainly associated with one-year changes in CAT scores (RR, 1.138; 95%CI: 1.074-1.206) and BODE index values (RR, 2.012; 95%CI: 1.487-2.722). Conclusions: In the new GOLD grading classification, the type of tool used to determine the level of symptoms can substantially alter the group assignment. A change in category after one year was associated with longitudinal changes in the CAT and BODE index

A Proposed Approach to Chronic Airway Disease (CAD) Using Therapeutic Goals and Treatable Traits: A Look to the Future

© 2020 Pérez de Llano et al.Chronic airflow obstruction affects a wide range of airway diseases, the most frequent of which are asthma, COPD, and bronchiectasis; they are clearly identifiable in their extremes, but quite frequently overlap in some of their pathophysiological and clinical characteristics. This has generated the description of new mixed or overlapping disease phenotypes with no clear biological grounds. In this special article, a group of experts provides their perspective and proposes approaching the treatment of chronic airway disease (CAD) through the identification of a series of therapeutic goals (TG) linked to treatable traits (TT) – understood as clinical, physiological, or biological characteristics that are quantifiable using biomarkers. This therapeutic approach needs validating in a clinical trial with the strategy of identification of TG and treatment according to TT for each patient independently of their prior diagnosis

Predictors of Hospitalized Exacerbations and Mortality in Chronic Obstructive Pulmonary Disease

Background and Aim Exacerbations of chronic obstructive pulmonary disease (COPD) carry significant consequences for patients and are responsible for considerable health-care costs?particularly if hospitalization is required. Despite the importance of hospitalized exacerbations, relatively little is known about their determinants. This study aimed to analyze predictors of hospitalized exacerbations and mortality in COPD patients. Methods This was a retrospective population-based cohort study.We selected 900 patients with confirmed COPD aged 35 years by simple random sampling among all COPD patients in Cantabria (northern Spain) on December 31, 2011. We defined moderate exacerbations as events that led a care provider to prescribe antibiotics or corticosteroids and severe exacerbations as exacerbations requiring hospital admission.We observed exacerbation frequency over the previous year (2011) and following year (2012). We categorized patients according to COPD severity based on forced expiratory volume in 1 second (Global Initiative for Chronic Obstructive Lung Disease [GOLD] grades 1?4). We estimated the odds ratios (ORs) by logistic regression, adjusting for age, sex, smoking status, COPD severity, and frequent exacerbator phenotype the previous year. Results Of the patients, 16.4%had 1 severe exacerbations, varying from 9.3%in mild GOLD grade 1 to 44%in very severe COPD patients. A history of at least two prior severe exacerbations was positively associated with new severe exacerbations (adjusted OR, 6.73; 95%confidence interval [CI], 3.53?12.83) and mortality (adjusted OR, 7.63; 95%CI, 3.41?17.05). Older age and several comorbidities, such as heart failure and diabetes, were similarly associated. Conclusions Hospitalized exacerbations occurred with all grades of airflow limitation. A history of severe exacerbations was associated with new hospitalized exacerbations and mortality

Actualización de la Guía Española de la EPOC (GesEPOC): comorbilidades, automanejo y cuidados paliativos

[EN]: The current health care models described in GesEPOC indicate the best way to make a correct diagnosis, the categorization of patients, the appropriate selection of the therapeutic strategy and the management and prevention of exacerbations. In addition, COPD involves several aspects that are crucial in an integrated approach to the health care of these patients. The evaluation of comorbidities in COPD patients represents a healthcare challenge. As part of a comprehensive assessment, the presence of comorbidities related to the clinical presentation, to some diagnostic technique or to some COPD-related treatments should be studied. Likewise, interventions on healthy lifestyle habits, adherence to complex treatments, developing skills to recognize the signs and symptoms of exacerbation, knowing what to do to prevent them and treat them within the framework of a self-management plan are also necessary. Finally, palliative care is one of the pillars in the comprehensive treatment of the COPD patient, seeking to prevent or treat the symptoms of a disease, the side effects of treatment, and the physical, psychological and social problems of patients and their caregivers. Therefore, the main objective of this palliative care is not to prolong life expectancy, but to improve its quality. This chapter of GesEPOC 2021 presents an update on the most important comorbidities, self-management strategies, and palliative care in COPD, and includes a recommendation on the use of opioids for the treatment of refractory dyspnea in COPD.[ES]: Los modelos de atención sanitaria actuales descritos en GesEPOC indican la mejor manera de hacer un diagnóstico correcto, la categorización de los pacientes, la adecuada selección de la estrategia terapéutica y el manejo y la prevención de las agudizaciones. Además, en la EPOC concurren diversos aspectos que resultan cruciales en una aproximación integrada de la atención sanitaria a estos pacientes. La evaluación de las comorbilidades en el paciente con EPOC representa un reto asistencial. Dentro de una valoración integral debe estudiarse la presencia de comorbilidades que tengan relación con la presentación clínica, con alguna técnica diagnóstica o con algunos tratamientos relacionados con la EPOC. Asimismo, son necesarias intervenciones en hábitos de vida saludables, la adhesión a tratamientos complejos, desarrollar capacidades para poder reconocer los signos y síntomas de la exacerbación, saber qué hacer para prevenirlos y tratarlos enmarcados en un plan de automanejo. Finalmente, los cuidados paliativos constituyen uno de los pilares en el tratamiento integral del paciente con EPOC, con los que se buscan prevenir o tratar los síntomas de una enfermedad, los efectos secundarios del tratamiento, y los problemas físicos, psicológicos y sociales de los pacientes y sus cuidadores. Por tanto, el objetivo principal de estos cuidados paliativos no es prolongar la esperanza de vida, sino mejorar su calidad. En este capítulo de GesEPOC 2021 se presenta una actualización sobre las comorbilidades más importantes, las estrategias de automanejo y los cuidados paliativos en la EPOC, y se incluye una recomendación sobre el uso de opiáceos para el tratamiento de la disnea refractaria en la EPOC.Peer reviewe

Spanish COPD Guidelines (GesEPOC) 2021: Updated Pharmacological treatment of stable COPD

The Spanish COPD Guidelines (GesEPOC) were first published in 2012, and since then have undergone a series of updates incorporating new evidence on the diagnosis and treatment of COPD. GesEPOC was drawn up in partnership with scientific societies involved in the treatment of COPD and the Spanish Patients' Forum. Their recommendations are based on an evaluation of the evidence using GRADE methodology, and a narrative description of the evidence in areas in which GRADE cannot be applied. In this article, we summarize the recommendations on the pharmacological treatment of stable COPD based on 9 PICO questions. COPD treatment is a 4-step process: 1) diagnosis, 2) determination of the risk level, 3) initial and subsequent inhaled therapy, and 4) identification and management of treatable traits. For the selection of inhaled therapy, high-risk patients are divided into 3 phenotypes: non-exacerbator, eosinophilic exacerbator, and non-eosinophilic exacerbator. Some treatable traits are general and should be investigated in all patients, such as smoking or inhalation technique, while others affect severe patients in particular, such as chronic hypoxemia and chronic bronchial infection. COPD treatment is based on long-acting bronchodilators with single agents or in combination, depending on the patient's risk level. Eosinophilic exacerbators must receive inhaled corticosteroids, while non-eosinophilic exacerbators require a more detailed evaluation to choose the best therapeutic option. The new GesEPOC also includes recommendations on the withdrawal of inhaled corticosteroids and on indications for alpha-1 antitrypsin treatment. GesEPOC offers a more individualized approach to COPD treatment tailored according to the clinical characteristics of patients and their level of complexity.Peer reviewe