Effects of Adherence to an mHealth Tool for Self-Management of COPD Exacerbations.

Purpose: Poor adherence to COPD mobile health (mHealth) has been reported, but its association with exacerbation-related outcomes is unknown. We explored the effects of mHealth adherence on exacerbation-free weeks and self-management behavior. We also explored differences in self-efficacy and stages of grief between adherent and non-adherent COPD patients. Patients and Methods: We conducted secondary analyses using data from a recent randomized controlled trial (RCT) that compared the effects of mHealth (intervention) with a paper action plan (comparator) for COPD exacerbation self-management. We used data from the intervention group only to assess differences in exacerbation-free weeks (primary outcome) between patients who were adherent and non-adherent to the mHealth tool. We also assessed differences in the type and timing of self-management actions and scores on self-efficacy and stages of grief (secondary outcomes). We used generalized negative binomial regression analyses with correction for follow-up length to analyze exacerbation-free weeks and multilevel logistic regression analyses with correction for clustering for secondary outcomes. Results: We included data of 38 patients of whom 13 (34.2%) (mean (SD) age 69.2 (11.2) years) were adherent and 25 (65.8%) (mean (SD) age 68.7 (7.8) years) were non-adherent. Adherent patients did not differ from non-adherent patients in exacerbation-free weeks (mean (SD) 31.5 (14.5) versus 33.5 (10.2); p=0.63). Although statistically not significant, adherent patients increased their bronchodilator use more often and more timely, contacted a healthcare professional and/or initiated prednisolone and/or antibiotics more often, and showed at baseline higher scores of self-efficacy and disease acceptance and lower scores of denial, resistance, and sorrow, compared with non-adherent patients. Conclusion: Adherence to mHealth may be positively associated with COPD exacerbation self-management behavior, self-efficacy and disease acceptance, but its association with exacerbation-free weeks remains unclear. Our results should be interpreted with caution by this pilot study's explorative nature and small sample size.

Chronic comorbid conditions and asthma exacerbation occurrence in a general population sample.

Chronic comorbid conditions are common in adults with asthma, and some may influence a patient's asthma exacerbation risk. We explored associations between eighteen chronic comorbid conditions and asthma exacerbation occurrence in adults with asthma in a cross-sectional study nested within a cohort study using data from the two-yearly US National Health and Nutrition Examination Survey (NHANES) program. Data of 2387 adults with self-reported doctor-diagnosed current asthma from the 2007 to 2018 NHANES surveys were selected. Investigated chronic comorbidities were: angina pectoris; congestive heart failure; coronary heart disease; depression; diabetes mellitus; soft and hard drug use; gastroesophageal reflux; gout; history of heart attack; history of stroke; hypercholesterolemia; hypertension; kidney failure; liver conditions; obesity; rheumatoid arthritis; and thyroid problems. Outcome was defined as asthma exacerbation category: no, moderate, or severe exacerbation(s) in the past year. Ordinal logistic regression analysis with correction for potential confounders was used to estimate odds ratios (OR) for moderate or severe exacerbations. Observed associations with increased severe asthma exacerbation occurrence were: obesity (OR = 1.67; 95% confidence interval 1.24, 2.26), and rheumatoid arthritis (OR = 1.55; 1.04, 2.30). History of stroke (OR = 1.95; 1.22, 3.11) and rheumatoid arthritis (OR = 1.33; 1.00, 1.75) showed associations with increased moderate exacerbation occurrence. Age-stratified analysis showed soft drug use, obesity, depression, thyroid problems, and rheumatoid arthritis to be associated with moderate and/or severe exacerbation occurrence in one or more 10-year age strata. In conclusion, several chronic comorbid conditions were associated with asthma exacerbation occurrence, which confirms but also complements previous studies. Our observations contribute to understanding exacerbation risk estimation and, ultimately, personalized asthma management.

Pragmatic trial on inhaled corticosteroid withdrawal in patients with COPD in general practice.

The therapeutic value of inhaled corticosteroids (ICSs) for COPD is limited. In published RCTs, ICS could be withdrawn in COPD patients without increasing exacerbation risk when bronchodilator treatment is optimized. Here we report on the feasibility and risks of ICS withdrawal in Dutch general practice for COPD patients without an indication for ICSs. In our pragmatic trial, general practitioners decided autonomously which of their COPD patients on ICS treatment could stop this, how this was done, and whether additional bronchodilator therapy was needed. We recruited 62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices. In 32 patients (55.2%, 95% CI: 42.5-67.3%) ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation. ICS withdrawal was successful in just over half of the patients with COPD without an indication for ICS.

Age- and sex-specific prevalence of chronic comorbidity in adult patients with asthma: A real-life study.

The presence of comorbidity can be associated with poorer asthma outcomes. Previous prevalence studies focused on a limited selection of comorbid conditions in asthma only. We aimed to determine age- and sex-specific prevalence estimates for the full range of chronic comorbid conditions in adult asthma patients by performing a retrospective cohort study based on 32,787 medical records of patients aged ≥16 years with asthma from 179 general practices in the Netherlands. Age- and sex-specific prevalence estimates of 76 chronic comorbidities and 14 disease categories based on International Classification of Primary Care codes were determined. Chronic comorbidity was present in 65.3% of male asthma patients and 72.8% of female asthma patients, with female patients having a higher mean (SD) of 2.0 (2.1) comorbidities compared to male patients (1.7 (2.0)). This mean increased to 5.0 (2.7) conditions in the 75+ age group. Most prevalent comorbidities were hypertension (20.1%), osteoarthritis (11.5%), eczema (11.5%) and dyspepsia (10.7%). Compared to male asthma patients, female asthma patients showed higher odds for the presence of other chronic conditions in eight disease categories. Neurological (odds ratio [OR]; 95% confidence interval 2.01; 1.76-2.29), blood forming/lymphatics (OR 1.83; 1.38-2.42) and musculoskeletal diseases (OR 1.82; 1.69-1.95) showed the highest association with female sex. In conclusion, the presence of chronic comorbidity is the norm in adults with asthma and it is more prevalent in female than in male asthma patients. The odds of having a specific comorbid condition may differ between the sexes. Attention in guidelines on how to handle comorbidities may lead to a more targeted treatment for comorbidities and more patient-centred asthma management.

Primary care cohort study in the sequence of diagnosing chronic respiratory diseases and prescribing inhaled corticosteroids.

To prevent unnecessary use of inhaled corticosteroids (ICS), ICS treatment should only be started when the diagnostic process of asthma and COPD is completed. Little is known about the chronological order between these diagnoses and the start of ICS. We performed a retrospective cohort study, based on electronic medical records of 178 Dutch general practices, to explore the temporal relations between starting continuous use of ICS and receiving a diagnosis of asthma and/or COPD. The database included information of patients who were registered with a diagnosis of asthma and/or COPD in one of the practices during January 1, 2012 and December 31, 2013. Two or more successive prescriptions of ICS within 6 months were considered as continuous ICS treatment. The chronological order of events based on available dates were analysed using descriptive analyses. For 8507 patients with asthma, 4024 patients with COPD, and 801 patients with asthma-COPD overlap (ACO), the order of events could be analysed. In total, 1857 (14.4%) patients started ICS prior to their diagnosis, 11.5, 20.8, and 10.0% of patients with asthma, COPD, and ACO, respectively. In 53.4% of the patients, the first prescription of ICS was a combination inhaler with a long-acting bronchodilator. In this real-life primary care cohort, one in seven patients started ICS treatment prior to their diagnosis and approximately half of the patients started with a combination inhaler. Our findings suggest that there is relevant room for improvement in the pharmaceutical management of patients with these chronic respiratory diseases.

Point of care microspirometry to facilitate the COPD diagnostic process in primary care: a clustered randomised trial.

We studied if pre-bronchodilator FEV1/FEV6 determinations with microspirometers by GPs improve the diagnostic process for COPD in a 6-8 month clustered randomised controlled trial in Dutch general practices ( http://www.trialregister.nl : NTR4041). GPs allocated to microspirometry (MI) used COPD-6® microspirometers in patients ≥50 years old with a smoking history and respiratory complaints that could indicate undiagnosed COPD and ask to refer patients for full spirometry if MI was positive (FEV1/FEV6 <0.73). Introduction of the COPD-6® was postponed in the usual care (UC) group. GPs of both study arms were asked to list all patients that fulfilled study criteria and at the end of the study we screened the electronic medical record system for number of patients that fulfilled study criteria and visited their GP within the study period. Main end point was a documented diagnostic conclusion of COPD within 3 months after the patient's visit. We used multilevel logistic regression with correction for relevant covariates. Next, we described the process of care. 21 practices (88 GPs) participated and 416 possible undiagnosed COPD patient visited these practices in the study period. 78 (of 192 visiting) subjects were listed by MI GPs and diagnostic conclusions were documented in 77%, compared to 61 listed (of 224 visiting) subjects and 44% with documented diagnostic conclusions by UC GPs (Odds Ratio: OR: 4.3, 95%CI: 1.6-11.5). Microspirometry improved the diagnostic process for possible underlying COPD in patients who consulted their GP with respiratory symptoms, but the majority of possible undiagnosed COPD patients remained unrecognised by GPs.

PELICAN: Content evaluation of patient-centered care for children with asthma based on an online tool.

BACKGROUND: We assessed the content of an intervention which integrates individual goals in outpatient clinic asthma management (based on self management principles) of children 6-12 years of age. METHODS: This is a content evaluation study and was part of a randomized controlled multicenter trial with 9 months follow-up in five Dutch outpatient asthma clinics among children with asthma aged 6-12 years. Information on children's individual problems and their level of impairment (as indicated by the Pelican instrument), asthma management goals, and actions (as indicated by written action plans) was collected. Satisfaction of parents, children, and nurses were assessed with questionnaires and analyzed with descriptive statistics. RESULTS: Most frequently identified problems by children (n = 42) were "cough," "cigarette smoke," and "shortness of breath." Eighty-two percent of items that were selected by children showed room for improvement. About 2-7 actions were formulated and children had an active role in more than 76% of the actions. "Using rescue medication prior to activities/triggers," and "talk to others about your asthma" were most frequently recommended. Children thought the Pelican instrument was easy (95%) and fun (65%) and both parents and nurses were positive about the incorporation of the program in asthma management. Following barriers were found: (1) only 25% of goals was formulated according to SMART principles; (2) traditional management aspects (such as medication use) are often treated instead of individual problems of children. CONCLUSION: Implementation of patient-centered care based on the Pelican instrument is recommended in specialized care, although more extensive training of nurses in PCC will improve the successful execution of the evaluated treatment. Pediatr Pulmonol. 2016;51:993-1003. © 2016 Wiley Periodicals, Inc.

Are asthma patients at increased risk of clinical depression? A longitudinal cohort study.

OBJECTIVE: In this study, we assessed whether adult patients with asthma are more likely to be diagnosed with depression than diabetes patients or "healthy" controls during follow-up in primary care. METHODS: Data from the Nijmegen Continuous Morbidity Registration were used to assess the risk for a first depression. Patients with asthma were compared with patients with diabetes and with two healthy controls matched on age, gender, socioeconomic status and attending general practice. With Cox proportional hazard analysis, we compared the risk of depression between these groups. These analyses were corrected for relevant covariates including a time-depending variable for multimorbidity. Explorative subgroup analyses were done for age, gender, socioeconomic status and multimorbidity. RESULTS: Cumulative incidence of depression in asthma patients was 5.2%, in DM patients 4.1% and in control subjects 3.3%. The hazard ratios for a first episode of depression in the asthma patients (n = 795) compared to DM patients (n = 1033) and control subjects after correction for covariates were 1.11 (95% CI 0.60-2.04) and 1.18 (95% CI 0.78-1.79), respectively. Exploratory analyses showed that asthma patients without multimorbidity were at higher risk for a depression compared to reference groups, while asthma patients with multimorbidity were at lower risk for depression. CONCLUSION: Asthma patients were not more likely to be diagnosed with a first depression compared to "healthy" control subjects or diabetes patients. The influence of multimorbidity on depression risk in asthma patients warrants further study.

PELICAN: a cluster-randomized controlled trial in Dutch general practices to assess a self-management support intervention based on individual goals for children with asthma.

OBJECTIVE: Insufficient asthma management leads to impaired health-related quality of life (HRQL). The aim of this study is to assess whether individualized self-management (ISM) support will improve HRQL in children with asthma compared to enhanced usual care (EUC) in Dutch general practices. METHODS: A cluster-randomized controlled trial with 9-month follow-up. ISM is a nurse-led intervention that is optimized to the needs of children, leading to a written action plan. Power calculation demanded inclusion of 170 children (aged 6-11 years) diagnosed with asthma and active medication use. RESULTS: Outcomes were HRQL of the child (Paediatric Asthma Quality of Life Questionnaire, PAQLQ-s) and several secondary outcomes. Data of 29 children (mean age 8.6 years, SD 1.7) were analyzed; ISM (n = 15) or EUC (n = 14). Logistic regression analysis (minimal clinical important difference; MCID ≥ 0.5) and descriptive analyses were performed. Despite high PAQLQ-s score at baseline (median ISM 6.35, EUC 6.02), a substantial number of subjects from both groups showed MCID of HRQL (ISM 33%, EUC 57%). Treatment differences on HRQL were not significant (OR 0.38, 95% CI 0.08, 1.69). Secondary outcomes did not show significant differences either, with exception of PAQLQ-s symptoms domain score in favor of EUC. CONCLUSION: Due to recruitment problems and underpowered analyses, no firm conclusions on the effectiveness of ISM support for childhood asthma in primary care could be drawn. Still, this study can be considered a valuable pilot study and in the future, there might be better capacity in general practices to commit to such treatment.

Diagnostic accuracy of pre-bronchodilator FEV1/FEV6 from microspirometry to detect airflow obstruction in primary care: a randomised cross-sectional study.

BACKGROUND: Forced expiratory volume in 1s/forced expiratory volume in 6 s ( FEV1/FEV6) assessment with a microspirometer may be useful in the diagnostic work up of subjects who are suspected of having COPD in primary care. AIM: To determine the diagnostic accuracy of a negative pre-bronchodilator (BD) microspirometry test relative to a full diagnostic spirometry test in subjects in whom general practitioners (GPs) suspect airflow obstruction. METHODS: Cross-sectional study in which the order of microspirometry and diagnostic spirometry tests was randomised. Study subjects were (ex-)smokers aged ≥50 years referred for diagnostic spirometry to a primary care diagnostic centre by their GPs. A pre-BD FEV1/FEV6 value <0.73 as measured with the PiKo-6 microspirometer was compared with a post-BD FEV1/FVC (forced vital capacity) <0.70 and FEV1/FVC

Megatrials for bronchodilators in chronic obstructive pulmonary disease (COPD) treatment: time to reflect.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is an important cause of morbidity and mortality worldwide. Although (long-acting) bronchodilators are used to relieve symptoms, the impact of bronchodilators on COPD mortality remains an unresolved issue. Our aim was to explore the results and the interpretations of the results of studies of bronchodilator treatment from high-impact COPD trials. METHODS: We searched PubMed and Embase for primary publications of randomized controlled trials with more than 1000 participants with COPD and that studied the effectiveness of long-acting bronchodilator treatment. We assessed population characteristics, primary outcomes, focus of outcomes, and possible bias from concomitant pulmonary medication. RESULTS: We retrieved 5 primary publications of large trials. Participants tended to be patients with rather severe COPD who were cared for at a hospital. Only half of the primary outcomes were statistically significant. Reports tended to focus on statically significant outcomes and not necessarily on primary outcomes or outcomes of the whole study population. The relevance of study outcomes was rarely discussed. DISCUSSION: The rather small effects of bronchodilators in a COPD population that is not representative for daily care, together with the tendency of relying on statistical rather than clinical significance, hampers translation to the large number of patients with COPD in the community.

Using the DOSE index to predict changes in health status of patients with COPD: a prospective cohort study.

BACKGROUND: The severity of chronic obstructive pulmonary disease (COPD) should not be based on the level of airflow limitation alone. A multicomponent index such as the DOSE index (dyspnoea score (D), level of airflow obstruction (O), current smoking status (S), and exacerbations (E)) has the potential to predict important future outcomes in patients with COPD more effectively than the forced expiratory volume in one second. Health status deterioration should be prevented in COPD patients. AIMS: To investigate whether the DOSE index can predict which patients are at risk of a clinically relevant change in health status. METHODS: A prospective cohort study was performed using data from primary and secondary care. The DOSE score was determined at baseline and the 2-year change in the Clinical COPD Questionnaire (CCQ) score was calculated. Linear regression analysis was performed for the effect of a high DOSE score (≥ 4) on the change in CCQ score. RESULTS: The study population consisted of 209 patients (112 patients from primary care). Overall, a high DOSE score was a significant predictor of a change in CCQ score after 2 years (0.41, 95% CI 0.13 to 0.70), particularly in primary care patients. CONCLUSIONS: A DOSE score of ≥ 4 has the ability to identify COPD patients with a greater risk of future worsening in health status.

PELICAN: A quality of life instrument for childhood asthma: study protocol of two randomized controlled trials in primary and specialized care in the Netherlands.

BACKGROUND: Asthma is one of the major chronic health problems in children in the Netherlands. The Pelican is a paediatric asthma-related quality of life instrument for children with asthma from 6-11 years old, which is suitable for clinical practice in primary and specialized care. Based on this instrument, we developed a self-management treatment to improve asthma-related quality of life. The Pelican intervention will be investigated in different health care settings. Results of intervention studies are often extrapolated to other health care settings than originally investigated. Because of differences in organization, disease severity, patient characteristics and care provision between health care settings, extrapolating research results could lead to unnecessary health costs without the desired health care achievements. Therefore, interventions have to be investigated in different health care settings when possible. This study is an example of an intervention study in different health care settings. In this article, we will present the study protocol of the Pelican study in primary and specialized care. METHOD/DESIGN: This study consists of two randomized controlled trials to assess the effectiveness of the Pelican intervention in primary and specialized care. The trial in primary care is a multilevel design with 170 children with asthma in 16 general practices. All children in one general practices are allocated to the same treatment group. The trial in specialized care is a multicentre trial with 100 children with asthma. Children in one outpatient clinic are randomly allocated to the intervention or usual care group. In both trials, children will visit the care provider four times during a follow-up of nine months. This study is registered and ethically approved. DISCUSSION: This article describes the study protocol of the Pelican study in different health care settings. If the Pelican intervention proves to be effective and efficient, implementation in primary and specialized care for paediatric asthma in the Netherlands will be recommended. TRIAL REGISTRATION: This study is registered by clinicaltrial.gov (NCT01109745).

How does asthma influence the daily life of children? Results of focus group interviews.

BACKGROUND: Health-related quality of life (HRQL) brings together various aspects of an individual's subjective experience that relate both directly and indirectly to health, disease, disability, and impairment. Although asthma is the most common chronic disease in childhood, information on pediatric patients' views on asthma-specific HRQL has not been described before. The aim of this study was to establish the components of asthma-specific HRQL, as experienced by primary school-aged asthmatic children. The generated components will be used to develop an individualized HRQL instrument for childhood asthma. METHODS: Primary school-aged asthmatic children were invited to participate in three consecutive focus group sessions. A total of five focus groups were formed. Two reviewers independently 1) identified trends in the statements and relations between HRQL components, 2) clustered the components into a small number of domains and, 3) made a model on asthma-specific HRQL based on the transcribed statements of the children. The results were compared between the two reviewers and resulted in a final model. RESULTS: Asthma influenced the life of the children physically, emotionally and socially. The most important components of HRQL were the effects on, and consequences of asthma on peer relationships (e.g., being bullied), the dependence on medication, shortness of breath, cough, limitations in activities and limitations due to the response on cigarette smoke exposure. CONCLUSION: The outcome of the focus group meetings indicates that asthma influences the life of children in various ways. Not all essential components of HRQL, according to the children, are part of existing asthma-specific HRQL instruments.

Low body mass index, airflow obstruction, and dyspnoea in a primary care COPD patient population.

AIM: The objective of our study was to explore the existence/co-existence of factors - as per American Thoracic Society (ATS)/European Respiratory Society (ERS) standards - for staging patients in a primary care COPD population. METHOD: A representative sample of COPD patients in primary care was studied. Cross-sectional information on airflow obstruction, body mass index (BMI), and dyspnoea (Modified Medical Research Council [MMRC] score) were collected. The existence/co-existence of these prognostic factors is described. RESULTS: The study sample consisted of 2,023 patients. BMI was low in 11.7%, MMRC score > or =2 was found in 28.7%, and 53.9% fulfilled the criteria of relevant airflow obstruction. Only 3.4% of this population scored on all three prognostic factors. CONCLUSION: Moderate dyspnoea and moderate airflow obstruction were rather prevalent in this primary care population, but coexistence of factors was low. Therefore, it seems that the assessment of BMI and dyspnoea represent additional information on primary care COPD patients.