Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial / Programa de telerrehabilitación como estrategia de mantenimiento para pacientes con EPOC: un ensayo clínico aleatorizado de 12 meses

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. (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.

Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial.

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.

La función pulmonar no está pasada de moda / Lung Function is Not Outdated

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Telemedicina, una oportunidad para la espirometría / Telemedicine, an Opportunity for Spirometry

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Changes and Clinical Consequences of Smoking Cessation in Patients With COPD: A Prospective Analysis From the CHAIN Cohort.

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.

Prevalence of persistent blood eosinophilia: relation to outcomes in patients with COPD.

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 (≥300 cells·µL-1) and its relationship to outcomes, we determined blood eosinophils at baseline and over 2 years in 424 COPD patients (forced expiratory volume in 1 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 <300 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 <300 cells·µL-1 (15.8% versus 33.7%; p=0.026).In patients with COPD, blood eosinophils ≥300 cells·µL-1 persisting over 2 years was not a risk factor for COPD exacerbations. High eosinophil count was associated with better survival.

Benefits of Long-Term Pulmonary Rehabilitation Maintenance Program in Patients with Severe Chronic Obstructive Pulmonary Disease. Three-Year Follow-up.

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).

Farmaeconomía en asma / Pharmaeconomics in asthma

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Cost-effectiveness of combination therapy umeclidinium/vilanterol versus tiotropium in symptomatic COPD Spanish patients.

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.

Evaluación económica e impacto presupuestario de un procedimiento de telemedicina para el control de calidad de las espirometrías en atención primaria / Economic Assessment and Budgetary Impact of a Telemedicine Procedure and Spirometry Quality Control in the Primary Care Setting

OBJETIVO: Evaluar el impacto económico de un sistema de telemedicina en un sistema público de salud para la mejora de la calidad de las espirometrías (espirometrías forzadas [EF]) en atención primaria. MATERIAL Y MÉTODOS: Se ha evaluado el impacto económico de 9.039 EF realizadas en 51 centros de salud (2010-2013) mediante teleespirometría (TE) comparándose con el sistema habitual. RESULTADOS: El sistema de TE encarece el coste unitario de la EF (47,8 € vs. 39,7 €) (2013), pero logra una mejora en la calidad de las mismas (un 84% con buena calidad, frente a un 61% mediante el procedimiento habitual). El coste total de la TE ha sido de 431.974 € (358.306 € por sistema habitual), lo que supone un impacto económico de 73.668 € (2013). El aumento de gasto para EF de buena calidad realizadas con TE fue de 34.030 € (2010) y de 144.295 € (2013), mientras que para las pruebas con mala calidad fue de -15.525€ (2010) y de -70.627€ (2013). CONCLUSIÓN: Del análisis coste-efectividad se concluye que la TE es un 23% más costosa y un 46% más efectiva. Asimismo, el gasto sanitario es menor a medida que el número de EF realizadas mediante TE aumenta. La no realización de EF de mala calidad, no válidas, supone un ahorro que compensa el aumento del gasto por la realización mediante TE, siendo un sistema coste-efectivo

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

Economic Assessment and Budgetary Impact of a Telemedicine Procedure and Spirometry Quality Control in the Primary Care Setting.

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.

Normativa SEPAR sobre disfunción muscular de los pacientes con enfermedad pulmonar obstructiva crónica / Guidelines for the evaluation and treatment of muscle dysfunction in patients with chronic obstructive pulmonary disease

La disfunción muscular de pacientes con enfermedad pulmonar obstructiva crónica (EPOC) constituye una de las comorbilidades más importantes, con repercusiones negativas en su capacidad de ejercicio y calidad de vida. En la presente normativa se ha resumido la literatura publicada más recientemente sobre los diferentes aspectos del tema y se ha utilizado también la escala Grading of Recommendations Assessment, Development, and Evaluation (GRADE) de recomendaciones sobre el grado de evidencia de las diferentes propuestas de la normativa. Respecto a una población control, se estima que en un tercio de los pacientes EPOC la fuerza del cuádriceps es un 25% inferior incluso en estadios precoces de su enfermedad. Aunque tanto los músculos respiratorios como los de las extremidades están alterados, estos últimos suelen verse mayormente afectados. Diversos factores y mecanismos biológicos están involucrados en la disfunción muscular de los pacientes. Se proponen diversas pruebas para evaluar y diagnosticar el grado de afectación de los músculos respiratorios y de las extremidades (periféricos), así como identificar la capacidad de esfuerzo de los pacientes (prueba de marcha de 6 min y cicloergometría). Se describen también las posibles estrategias terapéuticas vigentes que incluyen las diversas modalidades de entrenamiento y de soporte farmacológico y nutricional

In patients with chronic obstructive pulmonary disease (COPD), skeletal muscle dysfunction is a major comorbidity that negatively impacts their exercise capacity and quality of life. In the current guidelines, the most recent literature on the various aspects of COPD muscle dysfunction has been included. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) scale has been used to make evidence-based recommendations on the different features. Compared to a control population, one third of COPD patients exhibited a 25% decline in quadriceps muscle strength, even at early stages of their disease. Although both respiratory and limb muscles are altered, the latter are usually more severely affected. Numerous factors and biological mechanisms are involved in the etiology of COPD muscle dysfunction. Several tests are proposed in order to diagnose and evaluate the degree of muscle dysfunction of both respiratory and limb muscles (peripheral), as well as to identify the patients’ exercise capacity (six-minute walking test and cycloergometry). Currently available therapeutic strategies including the different training modalities and pharmacological and nutritional support are also described

Guidelines for the evaluation and treatment of muscle dysfunction in patients with chronic obstructive pulmonary disease.

In patients with chronic obstructive pulmonary disease (COPD), skeletal muscle dysfunction is a major comorbidity that negatively impacts their exercise capacity and quality of life. In the current guidelines, the most recent literature on the various aspects of COPD muscle dysfunction has been included. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) scale has been used to make evidence-based recommendations on the different features. Compared to a control population, one third of COPD patients exhibited a 25% decline in quadriceps muscle strength, even at early stages of their disease. Although both respiratory and limb muscles are altered, the latter are usually more severely affected. Numerous factors and biological mechanisms are involved in the etiology of COPD muscle dysfunction. Several tests are proposed in order to diagnose and evaluate the degree of muscle dysfunction of both respiratory and limb muscles (peripheral), as well as to identify the patients' exercise capacity (six-minute walking test and cycloergometry). Currently available therapeutic strategies including the different training modalities and pharmacological and nutritional support are also described.

Clinical Decision Support Systems (CDSS) for preventive management of COPD patients.

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.