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).This trial is funded by grants of the Dutch Asthma Foundation (NAF 3.4.07.043), fonds NutsOhra (0802–74), Nijmegen Centre for Evidence Based Practice (NCEBP) and Radboud University Nijmegen Medical Centre

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

Contains fulltext : 88307.pdf (publisher's version ) (Open Access)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

Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial

OBJECTIVE To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. DESIGN 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. SETTING 15 general practices in the eastern part of the Netherlands. PARTICIPANTS Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. INTERVENTIONS A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative). OUTCOME MEASURES The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. RESULTS 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). CONCLUSIONS Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. TRIAL REGISTRATION Clinical trials NCT00128765.This study was funded by the Netherlands Organisation for Health Research and Development (ZonMw) and Partners in Care Solutions for COPD (PICASSO). The funding sources had no role in the design, conduct, or reporting of the stud

How GPs value guidelines applied to patients with multimorbidity: A qualitative study

Objectives: To explore and describe the value general practitioner (GPs) attribute to medical guidelines when they are applied to patients with multimorbidity, and to describe which benefits GPs experience from guideline adherence in these patients. Also, we aimed to identify limitations from guideline adherence in patients with multimorbidity, as perceived by GPs, and to describe their empirical solutions to manage these obstacles. Design: Focus group study with purposive sampling of participants. Focus groups were guided by an experienced moderator who used an interview guide. Interviews were transcribed verbatim. Data analysis was performed by two researchers using the constant comparison analysis technique and field notes were used in the analysis. Data collection proceeded until saturation was reached. Setting: Primary care, eastern part of The Netherlands. Participants: Dutch GPs, heterogeneous in age, sex and academic involvement. Results: 25 GPs participated in five focus groups. GPs valued the guidance that guidelines provide, but experienced shortcomings when they were applied to patients with multimorbidity. Taking these patients’ personal circumstances into account was regarded as important, but it was impeded by a consistent focus on guideline adherence. Preventative measures were considered less appropriate in (elderly) patients with multimorbidity. Moreover, the applicability of guidelines in patients with multimorbidity was questioned. GPs’ extensive practical experience with managing multimorbidity resulted in several empirical solutions, for example, using their ‘common sense’ to respond to the perceived shortcomings. Conclusions: GPs applying guidelines for patients with multimorbidity integrate patient-specific factors in their medical decisions, aiming for patient-centred solutions. Such integration of clinical experience and best evidence is required to practise evidence-based medicine. More flexibility in pay-for-performance systems is needed to facilitate this integration. Several improvements in guideline reporting are necessary to enhance the applicability of guidelines in patients with multimorbidity

Exploring the impact of chronic obstructive pulmonary disease (COPD) on diabetes control in diabetes patients: a prospective observational study in general practice

Background:Little is known about the association between COPD and diabetes control parameters.Aims:To explore the association between comorbid COPD and longitudinal glycaemic control (HbA 1C) and systolic blood pressure (SBP) in a primary care cohort of diabetes patients.Methods:This is a prospective cohort study of type 2 diabetes patients in the Netherlands. In a mixed model analysis, we tested differences in the 5-year longitudinal development of HbA 1C and SBP according to COPD comorbidity (present/absent). We corrected for relevant covariates. In subgroup effect analyses, we tested whether potential differences between diabetes patients with/without COPD were modified by age, sex, socio-economic status (SES) and body mass index (BMI).Results:We analysed 610 diabetes patients. A total of 63 patients (10.3%) had comorbid COPD. The presence of COPD was not significantly associated with the longitudinal development of HbA 1C (P=0.54) or SBP (P=0.33), but subgroup effect analyses showed significant effect modification by SES (P<0.01) and BMI (P=0.03) on SBP. Diabetes patients without COPD had a flat SBP trend over time, with higher values in patients with a high BMI. For diabetes patients with COPD, SBP gradually increased over time in the middle-And high-SES groups, and it decreased over time in those in the low-SES group.Conclusions:The longitudinal development of HbA 1C was not significantly associated with comorbid COPD in diabetes patients. The course of SBP in diabetes patients with COPD is significantly associated with SES (not BMI) in contrast to those without COPD. Comorbid COPD was associated with longitudinal diabetes control parameters, but it has complex interactions with other patient characteristics. Further research is needed

The effect of comorbidity on glycemic control and systolic blood pressure in type 2 diabetes: A cohort study with 5 year follow-up in primary care

To explore the longitudinal effect of chronic comorbid diseases on glycemic control (HbA1C) and systolic blood pressure (SBP) in type 2 diabetes patients. Methods In a representative primary care cohort of patients with newly diagnosed type 2 diabetes in The Netherlands (n = 610), we tested differences in the five year trend of HbA1C and SBP according to comorbidity profiles. In a mixed model analysis technique we corrected for relevant covariates. Influence of comorbidity (a chronic disease already present when diabetes was diagnosed) was tested as total number of comorbid diseases, and as presence of specific disease groups, i.e. cardiovascular, mental, and musculoskeletal disease, malignancies, and COPD. In subgroup effect analyses we tested if potential differences were modified by age, sex, socioeconomic status, and BMI. Results The number of comorbid diseases significantly influenced the SBP trend, with highest values after five years for diabetes patients without comorbidity (p = 0.005). The number of diseases did not influence the HbA1C trend (p = 0.075). Comorbid musculoskeletal disease resulted in lower HbA1C at the time of diabetes diagnosis, but in higher values after five years (p = 0.044). Patients with cardiovascular diseases had sustained elevated levels of SBP (p = 0.014). Effect modification by socioeconomic status was observed in some comorbidity subgroups. Conclusions Presence of comorbidity in type 2 diabetes patients affected the long-term course of HbA1C and SBP in this primary care cohort. Numbers and types of comorbidity showed differential effects: not the simple sum of diseases, but specific types of comorbid disease had a negative influence on long-term diabetes control parameters. The complex interactions between comorbidity, diabetes control and effect modifiers require further investigation and may help to personalize treatment goals

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

The Relationship Between Real-World Inhaled Corticosteroid Adherence and Asthma Outcomes:A Multilevel Approach

Background: Low inhaled corticosteroid (ICS) adherence is associated with increased asthma burden. This relationship is likely bidirectional, and may vary across adherence stages (initiation, implementation, and persistence). Studies rarely examine reciprocal influences. Objective: To investigate the relationship between ICS implementation and asthma-related outcomes over 2 years, considering bidirectionality and temporal sequence. Methods: Primary care records (1987-2012) from the Optimum Patient Care Research Database, United Kingdom, were used. Eligible patients were 6 years or older and had 3 or more years of continuous registration starting 1 year before ICS initiation (index date), physician-diagnosed asthma, 2 or more ICS and/or short-acting β-agonist prescriptions each follow-up year, and no long-acting β-agonists, leukotriene receptor antagonists, or maintenance oral corticosteroids in the preceding year. ICS implementation (percentage of days covered) and risk domain asthma control (RDAC; no asthma-related hospitalizations, emergency visits, or outpatient visits and no oral corticosteroid or antibiotic prescriptions with evidence of respiratory review) were estimated for each prescription interval (period between 2 successive prescriptions). Multilevel analyses modeled bidirectional relationships between ICS implementation and RDAC (and its components), controlling for sociodemographic and clinical characteristics. Results: In prescription data from 10,472 patients, ICS implementation in the preceding interval did not predict RDAC, but was weakly positively associated with simultaneous RDAC. Being male, non–current smoker, without chronic obstructive pulmonary disease diagnosis, and with fewer than 4 comorbidities significantly increased odds of RDAC. Asthma-related antibiotics and outpatient visits in the same interval and short-acting β-agonist overuse in the preceding and same interval predicted lower ICS implementation. Conclusions: Patients may adapt their ICS use to their current needs without this impacting later RDAC.</p

Asthma control cost-utility randomized trial evaluation (ACCURATE): the goals of asthma treatment

Contains fulltext : 97659.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination) therapy should be used for long periods in an attempt to achieve complete control of all features of asthma. An additional question is whether patients and society value the potential incremental benefit, if any, sufficiently to concur with such a treatment approach. We assessed patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical control: 1. sufficiently controlled asthma 2. strictly controlled asthma 3. strictly controlled asthma based on exhaled nitric oxide as an additional disease marker DESIGN: 720 Patients with mild to moderate persistent asthma from general practices with a practice nurse, age 18-50 yr, daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year), will be identified via patient registries of general practices in the Leiden, Nijmegen, and Amsterdam areas in The Netherlands. The design is a 12-month cluster-randomised parallel trial with 40 general practices in each of the three arms. The patients will visit the general practice at baseline, 3, 6, 9, and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an internet-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months and at each unplanned visit. Differences in societal costs (medication, other (health) care and productivity) will be compared to differences in the number of limited activity days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS). This is the first study to assess patient preferences and cost-effectiveness of asthma treatment strategies driven by different target levels of asthma control. Trial registration: Netherlands Trial Registration NTR1756