Impact of an electronic monitoring intervention to improve adherence to inhaled medication in patients with asthma and Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomized Controlled Trial

Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among patients with asthma and chronic obstructive pulmonary disease (COPD) is high and patients are frequently hospitalized due to exacerbations. Reasons for uncontrolled diseases are manifold, but are often associated with poor inhalation technique and non-adherence to the prescribed treatment plan. This causes substantial mortality, morbidity, and costs to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase and maintain treatment adherence in chronic diseases is of major clinical importance.; The primary objective of this study is to investigate the impact of using specific, validated electronic devices on adherence to inhaled medication in patients with chronic obstructive lung diseases such as asthma and COPD. Furthermore, it aims to assess the impact of a reminder and close supervision of the course of disease and quality of life.; In this ongoing prospective, single-blind, randomized controlled study, adherence to inhaled medication is analyzed over a 6-month period in at least 154 in- and outpatients with asthma or COPD who have experienced at least 1 exacerbation during the last year. Adherence is measured using electronic data capture devices, which save the date and time of each inhalative device actuation and transfer these data daily via a wireless connection to a Web-based database. Patients are randomly assigned to either the intervention or the control group. The clinical intervention consists of an automated and personal reminder. The intervention group receives an audio reminder and support calls in case medication has not been taken as prescribed or if rescue medication is used more frequently than pre-specified in the study protocol. During the study, participants are assessed every 2 months in the form of clinical visits.; Recruitment started in January 2014. To date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017.; Few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With this prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of healthcare in chronically ill patients suffering from asthma or COPD.; ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (Archived by WebCite at http://www.webcitation.org/6oJq1fel0)

Daily physical activity, functional capacity and quality of life in patients with COPD

In the therapy of chronic obstructive pulmonary disease (COPD), it is a major goal to improve health-related quality of life (HRQOL). Patients with COPD often suffer from exertional dyspnea and adopt a sedentary lifestyle, which could be associated with poorer HRQOL. The aim of this study was to investigate the independent association of objectively measured daily physical activity and functional capacity with HRQOL in patients with COPD.; In this cross-sectional study conducted at the University Hospital Basel, Switzerland, 87 stable patients (58.6% male, mean age: 67.3 ± 9.6 yrs) with COPD in GOLD grades I (n = 23), II (n = 46), III (n = 12) and IV (n = 6) were investigated. To assess HRQOL, the COPD assessment test (CAT) was completed. Patients performed spirometry and 6-min walk test. Physical activity was measured by the SenseWear Mini Armband on 7 consecutive days. By performing a multiple linear regression analysis, independent predictors of CAT score were identified.; Age (β = -0.39, p = 0.001), average daily steps (β = -0.31, p = 0.033) and 6-min walk distance (β = -0.32, p = 0.019) were found to be independent predictors of CAT score, whereas physical activity duration above 3 METs (p = 0.498) and forced expiratory volume in 1 s in% of predicted (p = 0.364) showed no significant association.; This study showed that average daily steps and functional capacity are independent determinants of HRQOL in patients with COPD. This emphasizes the importance to remain active and mobile, which is associated with better HRQOL

Differences in classification of COPD patients into risk groups A-D: a cross-sectional study

The Global Initiative for Chronic Obstructive Lung Disease proposed in 2011 a new system to classify chronic obstructive pulmonary disease (COPD) patients into risk groups A-D, which considers symptoms and future exacerbation risk to grade disease severity. The aim of this study was to investigate the agreement between COPD risk group classifications using COPD assessment test (CAT) or modified Medical Research Council (mMRC) and severity grades or past-year exacerbations. Furthermore, physical activity across risk groups was examined.; 87 patients with stable COPD were classified into risk groups A-D. CAT and mMRC were completed. Severity grades I-IV were determined using spirometry and the number of past-year exacerbations was recorded. To test the interrater agreement, Cohen's Kappa was calculated. Daily physical activity was measured by the SenseWear Mini armband.; Using CAT, 65.5% of patients were in high-symptom groups (B and D). With mMRC, only 37.9% were in B and D. Using severity grades, 20.7% of patients were in high-exacerbation risk groups (C and D). With past-year exacerbations, 9.2% were in C and D. Interrater agreement between CAT and mMRC (κ = 0.21) and between severity grades and past-year exacerbations (κ = 0.31) was fair. Daily steps were reduced in risk groups B and C + D compared to A (p < 0.01), using either classification.; When classifying COPD patients into risk groups A-D, the use of CAT or mMRC and severity grades or past-year exacerbations does not provide equal results. Daily steps decreased with increasing COPD risk groups

Relationship between domain-specific physical activity and different body composition measures in a working population

With respect to the overweight epidemic, this study aimed to investigate the association between domain-specific physical activity and body composition measures in Swiss male employees.; A total of 192 healthy male adults in full-time employment were investigated. Height, weight, and waist circumference were measured and body mass index was calculated. Relative fat mass and relative muscle mass were determined by bioelectric impedance analysis. Physical activity was assessed by the validated International Physical Activity Questionnaire.; In multiple linear regressions, leisure-time activity showed an inverse association with waist circumference and relative fat mass and a positive correlation with relative muscle mass. Work activity was positively related to waist circumference and body mass index.; This study shows that leisure-time activity may be the most effective physical activity domain for body composition. Work activity does not seem to be protective against overweight

Sleep problems and work injury types : a study of 180 patients in a Swiss emergency department

INTRODUCTION: Sleep problems present a risk for work injuries and are a major occupational health concern worldwide. Knowledge about the influence of sleep problems on work injury patterns is limited. Therefore, the aim of this study was to identify potential associations between different types of work injuries and sleep quality, sleep duration, and daytime sleepiness. METHODS: In this hospital-based study, 180 male and female patients with work injuries were recruited at the Emergency Department of the University Hospital Basel, Switzerland, from December 1st 2009 to June 30th 2011. The data on work injury characteristics, sleep problems, and potential confounders, such as demographic, health, lifestyle, occupational and environmental factors, were collected. Multivariable logistic regression analyses were performed to investigate the relationship between sleep problems and various types of work injury. RESULTS: Each dimension of sleep problems - sleep quality, sleep duration and daytime sleepiness - was a significant risk factor for at least one type of work injury. The strongest association was found for musculoskeletal injuries and falls with short sleep duration (odds ratio [OR] 5.41, 95% confidence interval [CI] 1.81-16.22). The standardised scores of the Pittsburgh sleep quality index (PSQI) and the Epworth sleepiness scale (ESS) did not discriminate between injury types. CONCLUSION: Employees with sleep problems were more likely to suffer from certain types of work injuries. This should be considered by employers monitoring work injuries and implementing prevention measures in the company's health and safety management

Predictors of increased daytime sleepiness in patients with chronic obstructive pulmonary disease: a cross-sectional study

Background; . Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from increased daytime sleepiness. The aim of this study was to identify potential predictors of subjective daytime sleepiness with special regard to sleep-related breathing disorder and nocturnal activity.; Methods; . COPD patients were recruited at the University Hospital Basel, Switzerland. COPD risk groups A-D were determined according to spirometry and COPD Assessment Test (CAT). Breathing disorder evaluation was performed with the ApneaLink device. Nocturnal energy expenditure was measured with the SenseWear Mini Armband. Subjective daytime sleepiness was recorded using the Epworth Sleepiness Scale (ESS).; Results; . Twenty-two patients (36%) were in COPD risk group A, 28 patients (45%) in risk group B, and 12 patients (19%) in risk groups C + D (; n; = 62). Eleven patients (18%) had a pathological ESS ≥ 10/24. ESS correlated positively with CAT (; r; = 0.386,; p; < 0.01) and inversely with age (; r; = -0.347,; p; < 0.01). In multiple linear regression age (; β; = -0.254,; p; < 0.05), AHI (; β; = 0.287,; p; < 0.05) and CAT score (; β; = 0.380,; p; < 0.01) were independent predictors of ESS, while nocturnal energy expenditure showed no significant association (; p; = 0.619).; Conclusion; . These findings provide evidence that daytime sleepiness in COPD patients may partly be attributable to nocturnal respiratory disturbances and it seems to mostly affect younger patients with more severe COPD symptoms

Screening for obstructive sleep apnea among hospital outpatients.

BACKGROUND:Obstructive sleep apnea syndrome (OSAS) is common in adults. People with OSAS have a higher risk of experiencing traffic accidents and occupational injuries (OIs). We aimed to clarify the diagnostic performance of a three-channel screening device (ApneaLinkTM) compared with the gold standard of full-night attended polysomnography (PSG) among hospital outpatients not referred for sleep-related symptoms. Furthermore, we aimed to determine whether manual revision of the ApneaLinkTM autoscore enhanced diagnostic performance. METHODS:We investigated 68 patients with OI and 44 without OI recruited from the University Hospital Basel emergency room, using a cross-sectional study design. Participating patients spent one night at home with ApneaLinkTM and within 2 weeks slept for one night at the sleep laboratory. We reanalyzed all ApneaLinkTM data after manual revision. RESULTS:We identified significant correlations between the ApneaLinkTM apnea-hypopnea index (AHI) autoscore and the AHI derived by PSG (r = 0.525; p <0.001) and between the ApneaLinkTM oxygen desaturation index (ODI) autoscore and that derived by PSG (r = 0.722; p <0.001). The ApneaLinkTM autoscore showed a sensitivity and specificity of 82% when comparing AHI ≥5 with the cutoff for AHI and/or ODI ≥15 from PSG. In Bland Altman plots the mean difference between ApneaLinkTM AHI autoscore and PSG was 2.75 with SD ± 8.80 (β = 0.034), and between ApneaLinkTM AHI revised score and PSG -1.50 with SD ± 9.28 (β = 0.060). CONCLUSIONS:The ApneaLinkTM autoscore demonstrated good sensitivity and specificity compared with the gold standard (full-night attended PSG). However, Bland Altman plots revealed substantial fluctuations between PSG and ApneaLinkTM AHI autoscore respectively manually revised score. This spread for the AHI from a clinical perspective is large, and therefore the results have to be interpreted with caution. Furthermore, our findings suggest that there is no clinical benefit in manually revising the ApneaLinkTM autoscore

The integrated care of asthma in Switzerland (INCAS)-study: Patients' perspective of received asthma care and their interest in asthma education

OBJECTIVE For successful long-term asthma care, self-management education is a cornerstone. Little is known about associations between patients' interest in education, asthma control and care delivery. We compared patients' characteristics, asthma control and patients' perspective about asthma care in subjects with and without interest in asthma education. Moreover, we assessed reasons, why patients denied participating in asthma education. METHODS Baseline data of 223 patients with asthma (age 43 ± 12 years, 38% male, 58% non-smokers, 13% current smokers), who participated in a multicentre longitudinal controlled study, are reported. At baseline, patients completed the Asthma Control Test (ACT), the Patient Assessment Chronic Illness Care questionnaire (PACIC 5A) and stated their interest in an asthma education programme. RESULTS Overall, 34% of all participants showed uncontrolled asthma. One hundred and twenty-five (56%) patients were interested in education. Compared to patients without interest, they were characterised by male gender (p = 0.013), worse asthma control (p < 0.001), and perception of lower quality of chronic asthma care delivery, in particular lower self-management support (p < 0.001). Main reasons for rejecting asthma education were having sufficient asthma knowledge, having only mild asthma, receiving adequate medical support and lack of time. CONCLUSIONS More than half of the patients were interested in asthma education. Interest was associated with worse asthma control and lower receipt of care according to the Chronic Care Model. Considering these aspects, this approach may help to improve care quality and allow targeting interventions to those patients who are interested in becoming active participants in their care and who might benefit most

Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial

The burden of asthma and COPD among patients is high and people affected are frequently hospitalized due to exacerbations. There are numerous reasons for the lack of disease control in asthma and COPD patients. It is associated with non-adherence to guidelines on the part of the health care provider and with poor inhalation technique and/or non-adherence to the prescribed treatment plan by the patient. This study aims to present data on inhaler technique and its impact on quality of life (QoL) and symptom control in a typical population of patients with chronic lung disease from a randomized controlled trial on medication adherence.; For this cross-sectional analysis, 165 asthma and COPD patients were analyzed. Correct application of inhaler devices was tested using pre-defined checklists for each inhaler type. QoL and symptom control were investigated using COPD Assessment Test (CAT) and Asthma Control Test (ACT). Spirometry was used to measure forced vital capacity (FVC) and forced expiratory volume in one second (FEV; 1; ).; Overall, incorrect inhalation technique ranged from 0 to 53% depending on the type of inhaler. COPD patients with incorrect device application had a higher CAT sum score compared to those with a correct device application (P = .02). Moreover, COPD patients with incorrect device application were more likely to suffer from cough (P = .03) and were more breathless while walking uphill or a flight of stairs (P = .02). While there was no significance found in asthma patients, COPD patients who used their devices correctly had a significantly better mean FEV; 1; % predicted at baseline compared to those who applied their devices incorrectly (P = .04).; Correct inhalation of prescribed medication is associated with improved health status and lung function. These findings should encourage health professionals to provide instructions on correct inhalation technique and to regularly re-evaluate the patients' inhalation technique.; ClinicalTrials.gov: NCT0238672 , Registered 14 February 2014

Obstructive sleep apnea syndrome and sleep disorders in individuals with occupational injuries

Abstract Background Some sleep disorders are known risk factors for occupational injuries (OIs). This study aimed to compare the prevalence of obstructive sleep apnea syndrome (OSAS) in a population of patients with OIs admitted to the emergency room (ER) with hospital outpatients as controls. Methods Seventy-nine patients with OIs and 56 controls were recruited at the University Hospital of Basel, Switzerland between 2009 and 2011. All patients completed a questionnaire and underwent a full-night attended polysomnography (PSG). We considered an apnea–hypopnea index (AHI) > 5 as an abnormal finding suggestive of a diagnosis of OSAS. Results Patients with OIs did not differ from controls regarding sex, age, body mass index, and job risk of OI. Patients with OIs tended to have an abnormal AHI (n = 38 [48%] vs. n = 16 [29%], odds ratio [OR] = 2.32 [95% confidence interval (CI):1.05–5.13]), and a higher AHI (8.0 vs. 5.6 events/h; Cohen’s d 0.28, p = 0.028) compared with controls. Patients with OIs also had abnormal limb movement index, arousal index, and signs of sleep bruxism compared with controls. Compared with 36 controls (66%), 70 patients with OIs (89%) had either excessive daytime sleepiness (EDS), and/or an abnormal finding during PSG (OR = 4.32, 95% CI:1.65–11.52). However, patients with OIs did not differ from controls regarding EDS or oxygen desaturation index. Conclusions Patients treated in the ER for OI had more abnormal findings suggestive of OSAS or other sleep disorders compared with a control group of hospital outpatients. Screening for these conditions should be part of the postaccident medical investigation