RESUMEN
The newly developed Assessment of Burden of COPD (ABC) scale is a 14-item self-administered questionnaire which measures the physical, psychological, emotional and/or social burden as experienced by patients with chronic obstructive pulmonary disease (COPD). The ABC scale is part of the ABC tool that visualises the outcomes of the questionnaire. The aim of this study was to assess the reliability and construct validity of the ABC scale. This multi-centre survey study was conducted in the practices of 19 general practitioners and 9 pulmonologists throughout the Netherlands. Next to the ABC scale, patients with COPD completed the Saint George Respiratory Questionnaire (SGRQ). Reliability analyses were performed with data from 162 cases. Cronbach's alpha was 0.91 for the total scale. Test-retest reliability, measured at a two week interval (n = 137), had an intra-class correlation coefficient of 0.92. Analyses for convergent validity were performed with data from 133 cases. Discriminant and known-groups validity was analysed with data from 162 cases. The ABC scale total score had a strong correlation with the total score of the SGRQ (r = 0.72, p < 0.001) but a weak correlation with the forced expired volume in 1 second predicted (r = -0.28, p < 0.001). Subgroups with more severe disease, defined by GOLD-stage, frequency of exacerbations, activity level and depression scored statistically significantly (p < 0.05) worse on almost all domains of the ABC scale than the less severe subgroups. The ABC scale seems a valid and reliable tool with good discriminative properties.
Asunto(s)
Actividades Cotidianas , Costo de Enfermedad , Depresión/psicología , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Anciano , Femenino , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Enfermedad Pulmonar Obstructiva Crónica/psicología , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a growing worldwide problem that imposes a great burden on the daily life of patients. Since there is no cure, the goal of treating COPD is to maintain or improve quality of life. We have developed a new tool, the Assessment of Burden of COPD (ABC) tool, to assess and visualize the integrated health status of patients with COPD, and to provide patients and healthcare providers with a treatment algorithm. This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary. The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months. METHODS/DESIGN: A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands. An intervention group, receiving care based on the ABC tool, will be compared with a control group receiving usual care. The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire, the Saint George Respiratory Questionnaire. Secondary outcomes will be a different questionnaire (the COPD Assessment Test), lung function and number of exacerbations. During the 18 months follow-up, seven measurements will be conducted, including a baseline and final measurement. Patients will receive questionnaires to be completed at home. Additional data, such as number of exacerbations, will be recorded by the patients' healthcare providers. A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists. Additionally, a process evaluation will be performed among patients and healthcare providers. DISCUSSION: The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines, which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment. It has been developed to classify patients, but also to provide visual insight into the burden of COPD and to provide treatment advice. TRIAL REGISTRATION: Netherlands Trial Register, NTR3788.
Asunto(s)
Algoritmos , Costo de Enfermedad , Atención Primaria de Salud , Enfermedad Pulmonar Obstructiva Crónica/terapia , Proyectos de Investigación , Atención Secundaria de Salud , Progresión de la Enfermedad , Humanos , Países Bajos , Evaluación de Procesos, Atención de Salud , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Calidad de Vida , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD. However, limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD. METHODS/DESIGN: In this randomized controlled trial situated in the primary care setting, 102 patients with mild to moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group. The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength, physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and patients' perceived effectiveness. Follow-up measurement will take place at 6 months after baseline. DISCUSSION: This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation programme. TRIAL REGISTRATION: The Netherlands National Trial Register NTR1471.