Original ArticleThe Severe Respiratory Insufficiency Questionnaire was valid for COPD patients with severe chronic respiratory failure
Introduction
The evaluation of health-related quality of life (HRQL) in patients with chronic and noncurable disorders is becoming more essential in health care practice and research because it provides an important means of evaluating the human and financial costs and benefits of modern medical treatment modalities [1], [2], [3]. In clinical studies, questionnaires are the most frequently used tool for the assessment of HRQL; here, disease-specific questionnaires are postulated to be more sensitive than generic questionnaires to changes and, therefore, to be most appropriate for clinical trials in which specific therapeutic interventions are being evaluated [1].
Noninvasive positive pressure ventilation (NPPV) has been increasingly used to treat hypercapnic chronic respiratory failure (CRF) that can arise from various underlying disorders such as chest wall deformities, neuromuscular disorders, obesity hypoventilation syndrome, or chronic obstructive pulmonary disease (COPD) [4], [5]. Healing is not possible in the vast majority of CRF patients who receive life-long NPPV as a means of home mechanical ventilation (HMV). Therefore, the assessment of HRQL is extremely important in these severely ill patients.
There is overwhelming evidence to suggest that physiological parameters such as blood gases, survival, and even HRQL increase in patients with chest wall deformities or neuromuscular disorders after the implementation of HMV [6], [7], [8], [9], [10]. In contrast, there are conflicting data about patients with COPD [11], [12], [13], and the survival benefits of adding HMV to long-term oxygen therapy (LTOT) have not yet been documented [14], [15]. In addition, longitudinal studies have indicated only minor and inconsistent changes of HRQL after NPPV in stable hypercapnic COPD [15], [16], [17], [18], [19]. Although this might be due to selection bias, failing effectiveness of HMV or differences in sample size in different studies, inconsistent results might also be confounded by the different methodologies used to assess HRQL.
Well-validated health measures that specifically address HRQL in patients with severe CRF and primarily focus on COPD patients do not exist. Accordingly, if inappropriate measures are used, all conclusions regarding the impact of HMV on HRQL must be deemed premature. This calls for more appropriate studies on HRQL that are specifically tailored to better indicate the role of NPPV in patients with stable hypercapnic COPD. Recently, we developed the Severe Respiratory Insufficiency Questionnaire (SRI), which was shown to be appropriate for clinical trials aimed at assessing HRQL in CRF patients receiving HMV treatment [20]. However, the SRI has been validated for a broad spectrum of patients with CRF rather than specifically for COPD. Therefore, the aim of the present study was to reexamine the internal structure of the SRI for patients with CRF that was induced exclusively by COPD, thus providing a suitable instrument that reliably allows the longitudinal assessment of HRQL in these patients.
Section snippets
Methods
The study protocol was approved by the institutional review board for human studies of the University of Regensburg, Germany, and was performed in accordance with the ethical standards laid down in the 2000 Declaration of Helsinki. Informed written consent was obtained from all subjects.
Results
Demographic data and lung function parameters are illustrated in Table 1. All patients had severe airflow obstruction, although this tended to be more evident in patients of Group 1. These patients were also younger, but body mass index was similar compared to Group 2.
The SRI Questionnaire
The present study indicates that the SRI is a valuable tool for the assessment of specific aspects of HRQL in patients with COPD and CRF. High psychometric properties have been demonstrated by this validation study, which covers a total number of 162 patients, all with severe CRF. Two different groups of patients with somewhat different age distribution and airflow obstruction have been studied. Therefore, psychometric properties have been provided for a broad range of COPD patients with CRF.
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