Validation of ACCESS: an automated tool to support self-management of COPD exacerbations.

BACKGROUND: To support patients with COPD in their self-management of symptom worsening, we developed Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS), an innovative software application that provides automated treatment advice without the interference of a health care professional. Exacerbation detection is based on 12 symptom-related yes-or-no questions and the measurement of peripheral capillary oxygen saturation (SpO2), forced expiratory volume in one second (FEV1), and body temperature. Automated treatment advice is based on a decision model built by clinical expert panel opinion and Bayesian network modeling. The current paper describes the validity of ACCESS. METHODS: We performed secondary analyses on data from a 3-month prospective observational study in which patients with COPD registered respiratory symptoms daily on diary cards and measured SpO2, FEV1, and body temperature. We examined the validity of the most important treatment advice of ACCESS, ie, to contact the health care professional, against symptom- and event-based exacerbations. RESULTS: Fifty-four patients completed 2,928 diary cards. One or more of the different pieces of ACCESS advice were provided in 71.7% of all cases. We identified 115 symptom-based exacerbations. Cross-tabulation showed a sensitivity of 97.4% (95% CI 92.0-99.3), specificity of 65.6% (95% CI 63.5-67.6), and positive and negative predictive value of 13.4% (95% CI 11.2-15.9) and 99.8% (95% CI 99.3-99.9), respectively, for ACCESS' advice to contact a health care professional in case of an exacerbation. CONCLUSION: In many cases (71.7%), ACCESS gave at least one self-management advice to lower symptom burden, showing that ACCES provides self-management support for both day-to-day symptom variations and exacerbations. High sensitivity shows that if there is an exacerbation, ACCESS will advise patients to contact a health care professional. The high negative predictive value leads us to conclude that when ACCES does not provide the advice to contact a health care professional, the risk of an exacerbation is very low. Thus, ACCESS can safely be used in patients with COPD to support self-management in case of an exacerbation.

Integral Health Status-Based Cluster Analysis in Moderate-Severe COPD Patients Identifies Three Clinical Phenotypes: Relevant for Treatment As Usual and Pulmonary Rehabilitation.

PURPOSE: The purposes of the study are to identify clinical phenotypes that reflect the level of adaptation to the disease and to examine whether these clinical phenotypes respond differently to treatment as usual (TAU) and pulmonary rehabilitation (PR), the latter with its strong emphasis on improving adaptation. METHODS: Clusters were identified by a cluster analysis using data on many subdomains of the four domains of health status (HS) (physiological functioning, functional impairment, symptoms and quality of life) in 160 outpatients with chronic obstructive pulmonary disease (COPD) receiving TAU. By discriminant analysis in the TAU sample, all 459 PR patients could be assigned to one of the identified clusters. The effect of TAU and PR on HS was examined with paired t tests. RESULTS: Three distinct phenotypes were identified in the TAU sample. Two types were labelled adapted: phenotype 1 (moderate COPD-low impact on HS, n = 53) and phenotype 3 (severe COPD-moderate impact on HS, n = 73). One type was labelled non-adapted: phenotype 2 (moderate COPD-high impact on HS, n = 34). After 1-year TAU, the integral health status of all patients did not improve in any subdomain. In contrast, at the end of PR, significant improvements in HS were found in all three phenotypes especially the non-adapted. CONCLUSIONS: Different phenotypes exist in COPD that are based on behavioural aspects (i.e. the level of adaptation to the disease). Non-adapted patient responds better to treatments with a strong emphasis on improving adaptation by learning the patient better self-management skills. Knowing to which clinical phenotype a patient belongs helps to optimize patient-tailored treatment.

Assessing the stages of the grieving process in chronic obstructive pulmonary disease (COPD): validation of the Acceptance of Disease and Impairments Questionnaire (ADIQ).

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) encounter many (gradual) losses due to their disease, which trigger a grieving process. This process is characterized by stages of denial, resistance, sorrow, and acceptance. PURPOSE: This study examined whether these stages are conceptually distinct and whether the Acceptance of Disease and Impairments Questionnaire (ADIQ) can validly and reliably measure these stages in three samples of patients with COPD in the Netherlands. METHODS: Exploratory factor analysis (EFA) was performed on 145 outpatients with moderate to severe COPD. Confirmatory factor analyses were performed on 303 outpatients with mild to very severe COPD and 127 patients entering an inpatient pulmonary rehabilitation program. Furthermore, internal reliability, construct validity, sensitivity to change, and floor and ceiling effects were examined. RESULTS: EFA yielded a four-factor solution that explained 73.2 % of variance. Confirmatory factor analyses showed a good fit of the four-factor structure in all study samples. Cronbach's alpha reliability coefficients were .79 or higher. Subscales showed to be sensitive to change. CONCLUSIONS: Four distinct stages of grief are recognized in COPD. The ADIQ is a valid and reliable instrument to measure these stages: denial, resistance, sorrow, and acceptance. Measuring the stages of grieving is important for disease management: addressing patients with a specific therapeutic approach for the stage they are in could help to motivate patients to engage in self-management and change their lifestyle.

How do dyspnoea scales compare with measurement of functional capacity in patients with COPD and at risk of COPD?

BACKGROUND: In primary care, formal functional capacity testing is not always feasible. Guidelines for family practitioners suggest the use of dyspnoea scales to assess exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). AIMS: To examine whether the use of activity-based dyspnoea scales can substitute for actual functional capacity testing. METHODS: 128 subjects (49% at risk of COPD, 24% GOLD stage I, 17% GOLD stage II, 9% GOLD stage III) performed an Incremental Shuttle Walk Test (ISWT) and completed the Medical Research Council dyspnoea scale (MRC), Baseline Dyspnoea Index (BDI), Oxygen Cost Diagram (OCD), Clinical COPD Questionnaire (CCQ), and St George's Respiratory Questionnaire (SGRQ). RESULTS: Analysis of variance showed that the relationship between the ISWT and the MRC dyspnoea scale was statistically significant but moderate (p < 0.001, R2 = 0.166). Correlations between the ISWT and the other dyspnoea scales were also moderate (correlation coefficients 0.34-0.42). Combining the dyspnoea scales in one analysis resulted in a proportion of explained variance of the ISWT of 21.4% (R2 = 0.214). CONCLUSIONS: Dyspnoea scales cannot substitute for formal functional capacity testing. Authors of COPD guidelines should consider stating more specifically that the MRC and similar scales measure (self-reported) activity-related dyspnoea but cannot replace objectively measured functional capacity.

Validity of an automated telephonic system to assess COPD exacerbation rates.

Current tools for recording chronic obstructive pulmonary disease (COPD) exacerbations are limited and often lack validity testing. We assessed the validity of an automated telephonic exacerbation assessment system (TEXAS) and compared its outcomes with existing tools. Over 12 months, 86 COPD patients (22.1% females; mean age 66.5 yrs; mean post-bronchodilator forced expiratory volume in 1 s 53.4% predicted) were called once every 2 weeks by TEXAS to record changes in respiratory symptoms, unscheduled healthcare utilisation and use of respiratory medication. The responses to TEXAS were validated against exacerbation-related information collected by observations made by trained research assistants during home visits. No care assistance was provided in any way. Diagnostic test characteristics were estimated using commonly used definitions of exacerbation. Detection rates, compliance and patient preference were assessed, and compared with paper diary cards and medical record review. A total of 1,824 successful calls were recorded, of which 292 were verified by home visits (median four calls per patient, interquartile range three to five calls per patient). Independent of the exacerbation definition used, validity was high, with sensitivities and specificities between 66% and 98%. Detection rates and compliance differed extensively between the different tools, but were highest with TEXAS. Patient preference did not differ. TEXAS is a valid tool to assess COPD exacerbation rates in prospective clinical studies. Using different tools to record exacerbations strongly affects exacerbation occurrence rates.

Course of normal and abnormal fatigue in patients with chronic obstructive pulmonary disease, and its relationship with domains of health status.

OBJECTIVE: To examine the difference between patients with normal and patients with abnormal fatigue on aspects of health status, and investigate the natural course of fatigue in patients with Chronic Obstructive Pulmonary Disease (COPD). METHODS: Fatigue, physiological functioning, functional impairment, symptoms, and Quality of Life (QoL) were measured in 168 patients with COPD, and longitudinal data on fatigue of 77 patients were collected. RESULTS: Fifty percent of patients had abnormal fatigue. Patients with abnormal fatigue reported significantly more problems on the sub-domains of functional impairment (except actual physical activity), symptoms, and QoL as compared to patients with normal fatigue. With respect to physiological functioning patients with normal fatigue scores had better exercise capacity. Four years later the percentage of patients with abnormal fatigue was increased to 64%. In 1/3 of the patients an increase of more than the minimal clinically important difference was found. CONCLUSION: Many COPD patients suffer from abnormal fatigue. Patients with abnormal fatigue have more limitations on many aspects of health status, especially on symptoms, functional impairment, and QoL. PRACTICE IMPLICATIONS: Fatigue should be evaluated in usual care with a questionnaire that corrects for normal fatigue in order to tailor treatment to patients' need.