RESUMO
RATIONALE: In chronic obstructive pulmonary disease (COPD), the benefits of pulmonary rehabilitation (PR) tend to wane over time. Whether maintenance techniques may help sustain the benefits achieved after completion of the initial PR program remains controversial. OBJECTIVES: To determine whether a long-term (3-yr) maintenance program after PR preserves the short-term effects on outcomes in patients with COPD. METHODS: This was a multicenter prospective randomized trial including 143 patients with moderate-severe COPD, with 3 years of PR maintenance following an 8-week outpatient PR program. Patients were randomized to maintenance intervention group (IG) and standard monitoring program or control group (CG). The effects on BODE index, 6-minute-walk test distance (6MWD), and health-related quality of life were compared at 12, 24, and 36 months. MEASUREMENTS AND MAIN RESULTS: A total of 138 (96.5%) completed the 8-week program. At this time, all outcomes (BODE, 6MWD, and health-related quality of life) showed clinically and statistically significant improvements (P ≤ 0.001). During the follow-up period, the magnitude of change in 6MWD differed between IG and CG (P = 0.042), with a slight initial increase in the IG during the first year and smaller decline afterward. The BODE index changes differed between baseline and measurements at Month 24 (P = 0.043). At 3 years, the adherence rate of IG patients was 66% and 17% for the CG group (P < 0.001). CONCLUSIONS: This study shows a 2-year beneficial effect of a program of rehabilitation maintenance on the BODE index and 6MWD when compared with a standard strategy. This effect vanishes after the second year of follow-up. Clinical trial registered with www.clinicaltrials.gov (NCT 01090999).
Assuntos
Doença Pulmonar Obstrutiva Crônica/reabilitação , Teste de Esforço/estatística & dados numéricos , Feminino , Seguimentos , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Inquéritos e Questionários , Resultado do TratamentoRESUMO
The impact of blood eosinophilia in chronic obstructive pulmonary disease (COPD) remains controversial.To evaluate the prevalence and stability of a high level of blood eosinophils (≥300â cells·µL-1) and its relationship to outcomes, we determined blood eosinophils at baseline and over 2â years in 424 COPD patients (forced expiratory volume in 1â s (FEV1) 60% predicted) and 67 smokers without COPD from the CHAIN cohort, and in 308 COPD patients (FEV1 60% predicted) in the BODE cohort. We related eosinophil levels to exacerbations and survival using Cox hazard analysis.In COPD patients, 15.8% in the CHAIN cohort and 12.3% in the BODE cohort had persistently elevated blood eosinophils at all three visits. A significant proportion (43.8%) of patients had counts that oscillated above and below the cut-off points, while the rest had persistent eosinophil levels <300â cells·µL-1 A similar eosinophil blood pattern was observed in controls. Exacerbation rates did not differ in patients with and without eosinophilia. All-cause mortality was lower in patients with high eosinophils compared with those with values <300â cells·µL-1 (15.8% versus 33.7%; p=0.026).In patients with COPD, blood eosinophils ≥300â cells·µL-1 persisting over 2â years was not a risk factor for COPD exacerbations. High eosinophil count was associated with better survival.
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Eosinofilia/epidemiologia , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Idoso , Estudos de Coortes , Progressão da Doença , Eosinófilos/citologia , Feminino , Volume Expiratório Forçado , Humanos , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Espanha/epidemiologia , Análise de SobrevidaRESUMO
BACKGROUND: The use of information and communication technologies to manage chronic diseases allows the application of integrated care pathways, and the optimization and standardization of care processes. Decision support tools can assist in the adherence to best-practice medicine in critical decision points during the execution of a care pathway. OBJECTIVES: The objectives are to design, develop, and assess a clinical decision support system (CDSS) offering a suite of services for the early detection and assessment of chronic obstructive pulmonary disease (COPD), which can be easily integrated into a healthcare providers' work-flow. METHODS: The software architecture model for the CDSS, interoperable clinical-knowledge representation, and inference engine were designed and implemented to form a base CDSS framework. The CDSS functionalities were iteratively developed through requirement-adjustment/development/validation cycles using enterprise-grade software-engineering methodologies and technologies. Within each cycle, clinical-knowledge acquisition was performed by a health-informatics engineer and a clinical-expert team. RESULTS: A suite of decision-support web services for (i) COPD early detection and diagnosis, (ii) spirometry quality-control support, (iii) patient stratification, was deployed in a secured environment on-line. The CDSS diagnostic performance was assessed using a validation set of 323 cases with 90% specificity, and 96% sensitivity. Web services were integrated in existing health information system platforms. CONCLUSIONS: Specialized decision support can be offered as a complementary service to existing policies of integrated care for chronic-disease management. The CDSS was able to issue recommendations that have a high degree of accuracy to support COPD case-finding. Integration into healthcare providers' work-flow can be achieved seamlessly through the use of a modular design and service-oriented architecture that connect to existing health information systems.
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Sistemas de Apoio a Decisões Clínicas , Doença Pulmonar Obstrutiva Crônica/prevenção & controle , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Algoritmos , Comunicação , Tomada de Decisões , Diagnóstico por Computador , Humanos , Desenvolvimento de Programas , Pneumologia/métodos , Software , Espirometria , Fluxo de TrabalhoRESUMO
BACKGROUND: Forced spirometry is essential for diagnosing respiratory diseases and is widely used across levels of care. However, several studies have shown that spirometry quality in primary care is not ideal, with risks of misdiagnosis. Our objective was to assess the feasibility and performance of a telemedicine-based training and quality assurance program for forced spirometry in primary care. MATERIALS AND METHODS: The two phases included (1) a 9-month pilot study involving 15 centers, in which spirometry tests were assessed by the Basque Office for Health Technology Assessment, and (2) the introduction of the program to all centers in the Public Basque Health Service. Technicians first received 4 h of training, and, subsequently, they sent all tests to the reference laboratory using the program. Quality assessment was performed in accordance with clinical guidelines (A and B, good; C-F, poor). RESULTS: In the first phase, 1,894 spirometry tests were assessed, showing an improvement in quality: acceptable quality tests increased from 57% at the beginning to 78% after 6 months and 83% after 9 months (p<0.001). In the second phase, 7,200 spirometry tests were assessed after the inclusion of 36 additional centers, maintaining the positive trend (61%, 87%, and 84% at the same time points; p<0.001). CONCLUSIONS: (1) The quality of spirometry tests improved in all centers. (2) The program provides a tool for transferring data that allows monitoring of its quality and training of technicians who perform the tests. (3) This approach is useful for improving spirometry quality in the routine practice of a public health system.
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Atenção Primária à Saúde , Garantia da Qualidade dos Cuidados de Saúde , Espirometria/normas , Telemedicina , Humanos , Estudos Longitudinais , Projetos Piloto , Estudos Prospectivos , Saúde Pública , Software , EspanhaRESUMO
Muscle injury has clinical relevance in diseased individuals because it is associated with muscle dysfunction in terms of decreased strength and/or endurance. This study was aimed at answering three questions: whether the presence of chronic obstructive pulmonary disease (COPD) is associated with peripheral muscle injury; whether muscle injury is associated with some of the relevant functional impairment in the muscles; and whether muscle injury can be solely justified by deconditioning. Twenty-one male COPD patients were eligible for the study. Seven healthy volunteers recruited from the general population were included as controls. Function of the quadriceps muscle was assessed through specific single-leg exercise (strength and endurance). Cellular (light microscopy) and subcellular (electron microscopy) techniques were used to evaluate muscle injury on biopsies from the vastus lateralis muscle. Signs of injury were found in muscles from both control and COPD patients, not only in cases showing severe airflow obstruction but also in the mild or moderate stages of the disease. Current smoking and presence of COPD were significantly associated with increased injury of the muscle as assessed by light and electron microscopy techniques. The authors conclude that peripheral muscle injury is evident in mild, moderate, and severe stages of COPD even in the absence of respiratory failure, hypercapnia, chronic steroid treatment, low body weight, or some coexisting disease. These findings support the theory that systemic factors with deleterious effect are acting on peripheral muscles of smokers with COPD, increasing the susceptibility of the muscle fibers to membrane and sarcomere injury.
Assuntos
Doença Pulmonar Obstrutiva Crônica/patologia , Músculo Quadríceps/patologia , Músculos Respiratórios/patologia , Fumar/efeitos adversos , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/complicações , Músculo Quadríceps/lesões , Músculo Quadríceps/ultraestrutura , Músculos Respiratórios/lesões , Músculos Respiratórios/ultraestruturaRESUMO
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is increasingly considered a heterogeneous condition. It was hypothesised that COPD, as currently defined, includes different clinically relevant subtypes. METHODS: To identify and validate COPD subtypes, 342 subjects hospitalised for the first time because of a COPD exacerbation were recruited. Three months after discharge, when clinically stable, symptoms and quality of life, lung function, exercise capacity, nutritional status, biomarkers of systemic and bronchial inflammation, sputum microbiology, CT of the thorax and echocardiography were assessed. COPD groups were identified by partitioning cluster analysis and validated prospectively against cause-specific hospitalisations and all-cause mortality during a 4 year follow-up. RESULTS: Three COPD groups were identified: group 1 (n=126, 67 years) was characterised by severe airflow limitation (postbronchodilator forced expiratory volume in 1 s (FEV(1)) 38% predicted) and worse performance in most of the respiratory domains of the disease; group 2 (n=125, 69 years) showed milder airflow limitation (FEV(1) 63% predicted); and group 3 (n=91, 67 years) combined a similarly milder airflow limitation (FEV(1) 58% predicted) with a high proportion of obesity, cardiovascular disorders, diabetes and systemic inflammation. During follow-up, group 1 had more frequent hospitalisations due to COPD (HR 3.28, p<0.001) and higher all-cause mortality (HR 2.36, p=0.018) than the other two groups, whereas group 3 had more admissions due to cardiovascular disease (HR 2.87, p=0.014). CONCLUSIONS: In patients with COPD recruited at their first hospitalisation, three different COPD subtypes were identified and prospectively validated: 'severe respiratory COPD', 'moderate respiratory COPD', and 'systemic COPD'.
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Doença Pulmonar Obstrutiva Crônica/classificação , Idoso , Métodos Epidemiológicos , Feminino , Volume Expiratório Forçado/fisiologia , Hospitalização/estatística & dados numéricos , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Oxigênio/sangue , Pressão Parcial , Prognóstico , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Classe Social , Espanha/epidemiologiaRESUMO
RATIONALE: Inflammation and oxidative stress contribute to muscle dysfunction in patients with chronic obstructive pulmonary disease (COPD). Oxidants contained in cigarette smoke (CS) induce adverse effects on tissues through oxidative phenomena. OBJECTIVES: To explore oxidative stress and inflammation in quadriceps of human smokers and in diaphragm and limb muscles of guinea pigs chronically exposed to CS. METHODS: Muscle function, protein oxidation and nitration, antioxidants, oxidized proteins, inflammation, creatine kinase activity, and lung and muscle structures were investigated in vastus lateralis of smokers, patients with COPD, and healthy control subjects and in diaphragm and gastrocnemius of CS-exposed guinea pigs at 3, 4, and 6 months. MEASUREMENTS AND MAIN RESULTS: Compared with control subjects, quadriceps muscle force was mildly but significantly reduced in smokers; protein oxidation levels were increased in quadriceps of smokers and patients with COPD, and in respiratory and limb muscles of CS-exposed animals; glycolytic enzymes, creatine kinase, carbonic anydrase-3, and contractile proteins were significantly more carbonylated in quadriceps of smokers and patients with COPD, and in respiratory and limb muscles of CS-exposed guinea pigs. Chronic CS exposure induced no significant rise in muscle inflammation in either smokers or rodents. Muscle creatine kinase activity was reduced only in patients with COPD and in both diaphragm and gastrocnemius of CS-exposed animals. Guinea pigs developed bronchiolar abnormalities at 4 months of exposure and thereafter. CONCLUSIONS: CS exerts direct oxidative modifications on muscle proteins, without inducing any significant rise in muscle inflammation. The oxidative damage to muscle proteins, which precedes the characteristic respiratory changes, may contribute to muscle loss and dysfunction in smokers and patients with COPD.
Assuntos
Debilidade Muscular/etiologia , Debilidade Muscular/metabolismo , Músculo Esquelético/metabolismo , Estresse Oxidativo , Doença Pulmonar Obstrutiva Crônica/complicações , Fumar/efeitos adversos , Animais , Biomarcadores/metabolismo , Anidrase Carbônica III/metabolismo , Creatina Quinase/metabolismo , Citocinas/metabolismo , Cobaias , Humanos , Immunoblotting , Pulmão/metabolismo , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/metabolismo , Espécies Reativas de Nitrogênio/metabolismo , Espécies Reativas de Oxigênio/metabolismo , Fumar/metabolismo , Fatores de TempoRESUMO
BACKGROUND: There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR). RESEARCH QUESTION: To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR. STUDY DESIGN AND METHODS: A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care). RESULTS: Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI -4.1/+43.8)] and Chronic Respiratory Disease Questionnaire - Emotion score [0.4 points (0-0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0-15.4)] and Chronic Respiratory Disease Questionnaire - Emotion [0.5, (0.2-0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (-32.3/0.8) in linear models. CONCLUSIONS: The TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function. CLINICALTRIALS. GOV IDENTIFIER: NCT03247933.
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Doença Pulmonar Obstrutiva Crônica , Telerreabilitação , Exercício Físico , Humanos , Qualidade de Vida , CaminhadaRESUMO
INTRODUCTION AND OBJECTIVES: Eccentric contractions are those that occur after a muscle has been stretched, and they can predispose the muscle to damage. Most previous studies have been performed on limb muscles, and the potential consequences of eccentric contractions on the respiratory muscles are therefore unknown. The aim of this study was to evaluate the effects of repeated eccentric contractions on diaphragmatic function. METHODS: In 6 dogs, the diaphragm was stretched by applying pressure on the abdominal wall, and consecutive series of eccentric contractions were induced by bilateral supramaximal stimulation. The effect of these contractions on the diaphragm was then evaluated by applying bilateral twitch and tetanic stimulation of the phrenic nerves and measuring the changes in abdominal pressure and the shortening of the right and left hemidiaphragms (by sonomicrometry). Structural study of the muscle was also performed in 4 animals. RESULTS: Eccentric contractions were successfully achieved in all cases. Stimulation-induced diaphragmatic pressures became lower immediately after these contractions: twitch pressure fell by 53% and tetanic pressure by 67% after the first 10 eccentric contractions (P<.001 in both cases). Tetanic stimulation also demonstrated an early deterioration in contractility, which fell by 29% in the right hemidiaphragm (P<.05) and by 14% in the left hemidiaphragm (P<.001). Functional impairment was persistent, lasting at least 12 hours, and was associated with sarcomeric and sarcolemmal damage. CONCLUSIONS: This experimental model, which enabled the effects of eccentric contractions to be studied in the diaphragm, revealed a deterioration of muscle function that persisted for hours and that appeared to be partly due to structural damage. In the clinical setting, physiologic or therapeutic maneuvers that increase the resting length of the diaphragm should be used with caution.
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Diafragma/fisiologia , Animais , Cães , Contração MuscularRESUMO
A functional definition of chronic obstructive pulmonary disease (COPD) based on airflow limitation has largely dominated the field. However, a view has emerged that COPD involves a complex array of cellular, organic, functional, and clinical events, with a growing interest in disentangling the phenotypic heterogeneity of COPD. The present review is based on the opinion of the authors, who have extensive research experience in several aspects of COPD. The starting assumption of the review is that current knowledge on the pathophysiology and clinical features of COPD allows us to classify phenotypic information in terms of the following dimensions: respiratory symptoms and health status, acute exacerbations, lung function, structural changes, local and systemic inflammation, and systemic effects. Twenty-six phenotypic traits were identified and assigned to one of the 6 dimensions. For each dimension, a summary is provided of the best evidence on the relationships among phenotypic traits, in particular among those corresponding to different dimensions, and on the relationship between these traits and relevant events in the natural history of COPD. The information has been organized graphically into a phenotypic matrix where each cell representing a pair of phenotypic traits is linked to relevant references. The information provided has the potential to increase our understanding of the heterogeneity of COPD phenotypes and help us plan future studies on aspects that are as yet unexplored.
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Doença Pulmonar Obstrutiva Crônica/genética , Humanos , Fenótipo , Doença Pulmonar Obstrutiva Crônica/complicaçõesRESUMO
OBJECTIVE: Previous muscle activity can alter muscle contractility and lead to strength underestimation or overestimation in functional measurements. The objective of this study was to evaluate changes in the maximum pressure produced by the diaphragm after different series of spontaneous near-to-maximal isometric contractions. METHODS: Duplicate studies were performed on 6 dogs with a mean (SD) weight of 26 (7) kg. The supramaximal response of the diaphragm was achieved by simultaneous supramaximal stimulation of both phrenic nerves, both under basal conditions and after series of 5, 10, and 20 spontaneous inspiratory efforts against the occluded airway, performed before and after spinal anesthesia (which eliminates the ventilatory contribution of the intercostal muscles). The response was measured using the twitch gastric pressure (Pga) and twitch esophageal pressure (Pes) and by muscle shortening (sonomicrometry). RESULTS: The short series of 5 inspiratory efforts and, in particular, the medium series of 10 efforts produced potentiation of the contractile response, with a rise in the Pga from 3.2 (0.4) cm H(2)O to 3.7 (0.3) cm H(2)O, and from 3.5 (0.3) cm H(2)O to 3.9 (0.3) cm H(2)O, respectively (P=.05 in both cases). The potentiation was somewhat greater after subarachnoid anesthesia (an increase in the Pga of 21% after the medium series of 10 efforts with anesthesia vs 11% without anesthesia). However, the long series of 20 efforts produced a fall in the response, with a decrease in the Pga from 3.2 (0.4) cm H(2)O to 2.5 (0.3) cm H(2)O (P< .05), probably due to fatigue overcoming the effect of potentiation. CONCLUSIONS: Previous effort affects the contractile capacity of the diaphragm and it is difficult to predict the predominance of fatigue or potentiation in the response. This factor must be taken into account when determining the maximum respiratory pressures in daily clinical practice.
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Diafragma/inervação , Músculos Intercostais/inervação , Anestesia Geral/efeitos adversos , Animais , Cães , Estimulação Elétrica , Inalação , Contração Muscular/fisiologia , Nervo Frênico/fisiologia , Músculos Respiratórios/fisiologiaRESUMO
BACKGROUND: Despite the existing evidence-based smoking cessation interventions, chances of achieving that goal in real life are still low among patients with COPD. We sought to evaluate the clinical consequences of changes in smoking habits in a large cohort of patients with COPD. METHODS: CHAIN (COPD History Assessment in Spain) is a Spanish multicenter study carried out at pulmonary clinics including active and former smokers with COPD. Smoking status was certified by clinical history and co-oximetry. Clinical presentation and disease impact were recorded via validated questionnaires, including the London Chest Activity of Daily Living (LCADL) and the Hospital Anxiety and Depression Scale (HADS). No specific smoking cessation intervention was carried out. Factors associated with and clinical consequences of smoking cessation were analyzed by multivariate regression and decision tree analyses. RESULTS: One thousand and eighty-one patients with COPD were included (male, 80.8%; age, 65.2 [SD 8.9] years; FEV1, 60.2 [20.5]%). During the 2-year follow-up time (visit 2, 906 patients; visit 3, 791 patients), the majority of patients maintained the same smoking habit. Decision tree analysis detected chronic expectoration as the most relevant variable to identify persistent quitters in the future, followed by an LCADL questionnaire (cutoff 9 points). Total anxiety HADS score was the most relevant clinical impact associated with giving up tobacco, followed by the LCADL questionnaire with a cutoff value of 10 points. CONCLUSIONS: In this real-life prospective COPD cohort with no specific antismoking intervention, the majority of patients did not change their smoking status. Our study also identifies baseline expectoration, anxiety, and dyspnea with daily activities as the major determinants of smoking status in COPD. TRIAL REGISTRY: ClinicalTrials.gov; No. NCT01122758; URL: www.clinicaltrials.gov.
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Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Abandono do Hábito de Fumar , Idoso , Árvores de Decisões , Feminino , Humanos , Masculino , Estudos Prospectivos , Fumar/psicologia , Espanha , Inquéritos e QuestionáriosRESUMO
STUDY OBJECTIVES: To implement a chronic rat model of recurrent airway obstructions to study the obstructive sleep apnea (OSA) syndrome. DESIGN: Prospective controlled animal study. SETTING: University laboratory. PATIENTS OR PARTICIPANTS: 24 male Sprague-Dawley rats (250-300 g). INTERVENTIONS: The rats were placed in a setup consisting of a body chamber and a head chamber separated by a neck collar specially designed to apply recurrent airway obstructions with OSA patterns. Rats in the Obstruction group (n=8) were subjected to 5-s obstructions at a rate of 60 per hour, 6 h/day during 4 weeks. Sham rats (n=8) were placed in the setup but no obstructions were applied. Naive rats (n=8) were subjected to no intervention. MEASUREMENTS AND RESULTS: Breathing flow, pressure, CO2 air concentration, and SpO2 showed that the model mimicked OSA respiratory events (obstructive apneas, increased respiratory efforts, and oxygen saturation dips). Animal stress, assessed by body weight and plasma corticosterone, was not significantly different across Obstruction and Sham groups. This supports the concept that this novel model does not introduce a significant burden of stress in the rat after acclimatization to the chamber. Thromboxane-B2/6-keto-Prostaglandin-Flalpha ratio in plasma, which is an index of vasoconstriction, was significantly increased in the rats subjected to obstructions. CONCLUSIONS: The designed animal model of chronic recurrent airway obstructions is feasible and potentially useful to study the mechanisms involved in the cardiovascular consequences of OSA.
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Obstrução das Vias Respiratórias/epidemiologia , Obstrução das Vias Respiratórias/fisiopatologia , Síndromes da Apneia do Sono/epidemiologia , Síndromes da Apneia do Sono/fisiopatologia , Obstrução das Vias Respiratórias/metabolismo , Animais , Doença Crônica , Corticosterona/sangue , Modelos Animais de Doenças , Ensaio de Imunoadsorção Enzimática , Masculino , Oxigênio/metabolismo , Ratos , Ratos Sprague-Dawley , Recidiva , Síndromes da Apneia do Sono/diagnósticoRESUMO
OBJECTIVE: The benefits of a domiciliary program of pulmonary rehabilitation for patients with severe to very severe chronic obstructive pulmonary disease (COPD) are uncertain. We aimed to assess the short- and medium-term efficacy of such a program in this clinical setting. PATIENTS AND METHODS: Patients with severe COPD (stages III-IV, classification of the Global Initiative for Chronic Obstructive Lung Disease) and incapacitating dyspnea (scores 3-5, Medical Research Council [MRC] scale) were randomized to a control or domiciliary rehabilitation group. The 9-week supervised pulmonary rehabilitation program included educational sessions, respiratory physiotherapy, and muscle training in weekly sessions in the patient's home. We assessed the following variables at baseline, 9 weeks, and 6 months: lung function, exercise tolerance (3-minute walk test), dyspnea (MRC score), and health-related quality of life with the Chronic Respiratory Questionnaire (CRQ). RESULTS: Thirty-eight patients with a mean (SD) age of 68 (6) years were enrolled. The mean MRC score was 4 (0.8) and mean forced expiratory volume in 1 second was 29% of reference. Twenty-nine patients completed the study (6 months). Distance covered on the walk test increased significantly in the rehabilitation group (P=.001) and the difference was maintained at 6 months. Dyspnea also improved significantly with rehabilitation (P<.05), but the reduction was not evident at 6 months. Statistically significant improvements in symptoms related to 2 CRQ domains were detected between baseline and 9 weeks: dyspnea (3.1 [0.8] vs 3.6 [0.7]; P=.02) and fatigue (3.7 [0.8] vs 4.2 [0.9]; P=.002). A clinically relevant but not statistically significant change in mastery over disease was detected (from 4.3 to 4.9). All improvements were maintained at 6 months. CONCLUSIONS: Home-based pulmonary rehabilitation for patients with severe to very severe COPD and severe functional incapacity leads to improvements in exercise tolerance and health-related quality of life that are maintained at 6 months.
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Doença Pulmonar Obstrutiva Crônica/reabilitação , Idoso , Albuterol/análogos & derivados , Albuterol/uso terapêutico , Antropometria , Anti-Inflamatórios/uso terapêutico , Broncodilatadores/uso terapêutico , Feminino , Serviços de Assistência Domiciliar , Humanos , Masculino , Modalidades de Fisioterapia , Prednisona/uso terapêutico , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Xinafoato de Salmeterol , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
PURPOSE: Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective. METHODS: A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms measured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary health care costs (2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed. RESULTS: UMEC/VI produced additional 0.03 QALY and 590 vs TIO, leading to an ICER of 21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of 30,000/QALY. CONCLUSION: UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.
Assuntos
Álcoois Benzílicos , Clorobenzenos , Doença Pulmonar Obstrutiva Crônica , Quinuclidinas , Brometo de Tiotrópio , Administração por Inalação , Idoso , Álcoois Benzílicos/economia , Álcoois Benzílicos/uso terapêutico , Broncodilatadores/uso terapêutico , Clorobenzenos/economia , Clorobenzenos/uso terapêutico , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Estudos Longitudinais , Masculino , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/economia , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Quinuclidinas/economia , Quinuclidinas/uso terapêutico , Índice de Gravidade de Doença , Espanha/epidemiologia , Avaliação de Sintomas/métodos , Brometo de Tiotrópio/economia , Brometo de Tiotrópio/uso terapêutico , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the economic impact of a telemedicine procedure designed to improve the quality of lung function testing (LFT) in primary care in a public healthcare system, compared with the standard method. MATERIALS AND METHODS: The economic impact of 9,039 LFTs performed in 51 health centers (2010-2013) using telespirometry (TS) compared to standard spirometry (SS) was studied. RESULTS: TS costs more per unit than SS (47.80 vs. 39.70) (2013), but the quality of the TS procedure is superior (84% good quality, compared to 61% using the standard procedure). Total cost of TS was 431,974 (compared with 358,306 for SS), generating an economic impact of 73,668 (2013). The increase in cost for good quality LFT performed using TS was 34,030 (2010) and 144,295 (2013), while the costs of poor quality tests fell by 15,525 (2010) and 70,627 (2013). CONCLUSION: The cost-effectiveness analysis concludes that TS is 23% more expensive and 46% more effective. Healthcare costs consequently fall as the number of LFTs performed by TS rises. Avoiding poor quality, invalid LFTs generates savings that compensate for the increased costs of performing LFTs with TS, making it a cost-effective method.
Assuntos
Orçamentos , Atenção Primária à Saúde , Espirometria/economia , Espirometria/normas , Telemedicina/economia , Análise Custo-Benefício , Humanos , Controle de QualidadeRESUMO
Background: There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR).Research question: To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR.Study design and methods: A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care).Results: Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI ∧4.1/+43.8)] and Chronic Respiratory Disease Questionnaire Emotion score [0.4 points (00.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.015.4)] and Chronic Respiratory Disease Questionnaire Emotion [0.5, (0.20.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (∧32.3/0.8) in linear models. (AU)
Contexto previo: Existe incertidumbre con respecto a la eficacia de los enfoques basados en telesalud en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) para mantener los beneficios logrados con la rehabilitación pulmonar (RP) intensiva.Pregunta de investigación: Determinar si un programa de telerrehabilitación pulmonar de mantenimiento (TeleRP), después de una RP inicial intensiva, es superior a la atención habitual para mantener en el tiempo los beneficios logrados por la RP intensiva.Diseño del estudio y métodos: Se realizó un ensayo clínico aleatorizado, pragmático, abierto, multicéntrico, de grupos paralelos. Se crearon 2 grupos al finalizar un programa de RP intensiva en rèc)gimen ambulatorio de 8 semanas de duración. A los pacientes del grupo de intervención (GI) se les proporcionó el equipo de entrenamiento apropiado y se les instruyó para realizar 3 sesiones de entrenamiento semanales y enviar los datos de rendimiento a travèc)s de una aplicación a una plataforma web. Se aconsejó a los pacientes del grupo de control (GC) que hicieran ejercicio regularmente (cuidado habitual).Resultados: Se aleatorizaron 94 pacientes (46 GI, 48 GC). El análisis de covarianza mostró mejoras no significativas en la distancia en la prueba de marcha de 6min (19,9m [IC 95%: ∧4,1/+43,8]) y el cuestionario de enfermedad respiratoria crónica-factor emocional (0,4 puntos [0-0,8]) en el GI. Los modelos lineales mixtos secundarios mostraron mejoras en el GI en las puntuaciones de la sección mental del SF-36 (9,7 [4,0-15,4]) y el cuestionario de enfermedad respiratoria crónica-factor emocional (0,5 puntos [0,2-0,9]), pero no se demostró asociación entre el cumplimiento y los resultados. Las exacerbaciones agudas se asociaron con una disminución marginalmente significativa en la distancia en la prueba de la marcha de 6min de 15,8m (∧32,3/0,8) en los modelos lineales.