Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized controlled trial (TRICOLON study).

BACKGROUND: Medication non-adherence is a significant problem in patients with Chronic Obstructive Pulmonary Disease (COPD). Efforts to address this issue are receiving increased attention. Simplifying treatment by prescribing single-inhaler triple therapy (SITT) as an alternative to multi-inhaler triple therapy (MITT) or with smart inhalers are often considered potential solutions. However, the actual impact of these innovations on adherence and clinical outcomes is unclear. METHODS: To address this knowledge gap we first conducted a literature review focusing on two research questions: 1) the difference in adherence between SITT and MITT users in COPD, and 2) the effect of smart inhalers on adherence in COPD. Separate searches were conducted in PubMed and two authors independently assessed the articles. In addition, we present a protocol for a study to acquire knowledge for the gaps identified. RESULTS: To address the first research question, 8 trials were selected for further review. All trials were observational, i.e. randomized controlled trials were lacking. Seven of these trials showed higher adherence and/or persistence in patients on SITT compared with patients on MITT. In addition, four studies showed a positive effect of SITT on various clinical outcomes. For the second research question, 11 trials were selected for review. While most of the studies showed a positive effect of smart inhalers on adherence, there was considerable variation in the results regarding their effect on other clinical outcomes. The TRICOLON (TRIple therapy COnvenience by the use of one or multipLe Inhalers and digital support in ChrONic Obstructive Pulmonary Disease) trial aims to improve understanding regarding the effectiveness of SITT and smart inhalers in enhancing adherence. This open-label, randomized, multi-center study will enroll COPD patients requiring triple therapy at ten participating hospitals. In total, 300 patients will be randomized into three groups: 1) MITT; 2) SITT; 3) SITT with digital support through a smart inhaler and an e-health platform. The follow-up period will be one year, during which three methods of measuring adherence will be used: smart inhaler data, self-reported data using the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis in scalp hair samples. Finally, differences in clinical outcomes between the study groups will be compared. DISCUSSION: Our review suggests promising results concerning the effect of SITT, as opposed to MITT, and smart inhalers on adherence. However, the quality of evidence is limited due to the absence of randomized controlled trials and/or the short duration of follow-up in many studies. Moreover, its impact on clinical outcomes shows considerable variation. The TRICOLON trial aims to provide solid data on these frequently mentioned solutions to non-adherence in COPD. Collecting data in a well-designed randomized controlled trial is challenging, but the design of this trial addresses both the usefulness of SITT and smart inhalers while ensuring minimal interference in participants' daily lives. TRIAL REGISTRATION: NCT05495698 (Clinicaltrials.gov), registered at 08-08-2022. Protocol version: version 5, date 27-02-2023.

Care needs of chronically ill patients with intellectual disabilities in Dutch general practice: patients' and providers' perspectives.

BACKGROUND: To reduce the impact of chronic diseases (cardiovascular disease, diabetes mellitus type 2, and chronic lung disease (asthma or chronic obstructive pulmonary disease (COPD)), it is imperative that care is of high quality and suitable to patients' needs. Patients with intellectual disabilities (ID) differ from the average patient population in general practice because of their limitations in adaptive behaviour and intellectual functioning, and concomitant difficulties recognising and reacting to disease symptoms, proactively searching health information, and independently managing diseases effectively. Because of these differences, information on their care needs is essential for suitable chronic disease management (CDM). Inadequate recognition of the care needs of this vulnerable population may hamper the harmonisation of evidence-based and person-centred care, compounded by issues such as stigma, misconceptions, and diagnostic overshadowing. This study therefore aimed to explore the needs of patients with ID from perspectives of both patients and of healthcare providers (HCPs) in the context of CDM in general practice. METHODS: This qualitative study recruited patients with ID for face-to-face individual interviews and HCPs for focus groups. With the Chronic Care Model as the underlying framework, semi-structured interviews and focus-group guides were defined to explore patients' care needs and HCPs' perspectives. All interviews and focus groups were audio-recorded and transcribed verbatim. Using Atlas.ti software, data were analysed using reflexive thematic analysis. RESULTS: Between June and September 2022, 14 patients with ID and cardiovascular disease, diabetes mellitus type 2, and/or asthma/COPD were interviewed; and 32 general practitioners and practice nurses participated in seven focus groups. We identified six care needs underpinning suitable CDM: trusting relationship between patient and HCP; clear expectations about the CDM process; support in disease management; directive decision-making; support in healthy lifestyle; accessible medical information. CONCLUSIONS: This vulnerable patient population has complex care needs that must be acknowledged for suitable CDM. Although HCPs largely recognise these needs, organisational factors and lack of training or experience with patients with ID hamper HCPs' ability to fully adjust care provision to these needs. Access to, and knowledge of, easy-language information on chronic diseases and communication guidelines could aid HCPs to facilitate patients in managing their diseases more adequately.

Asthma and COPD management of patients with intellectual disabilities in general practice.

People with intellectual disabilities experience overall poorer health and healthcare access than the general population. It is largely unknown how this applies to asthma and chronic obstructive pulmonary disease (COPD) management by general practitioners (GPs). In a 10-year retrospective matched cohort study, n = 34,429, we examined year prevalence of asthma and COPD in adult patients with and without intellectual disabilities and potential differences in the delivery of asthma and COPD disease management activities in Dutch general practices (2010-2019). We collected information on patient characteristics, comorbidity, consultation patterns, use and outcomes of asthma/COPD control questionnaires, spirometry measurement, pulmonology referrals, and prescribed medication. Asthma patients with intellectual disabilities suffered more frequently from obesity (53.2% vs. 39.5% without intellectual disabilities), and both asthma and COPD patients with intellectual disabilities were more frequently current smokers (45.2% vs. 22.1% without intellectual disabilities, and 76.6% vs. 51.4% without intellectual disabilities, respectively). Also, a statistically significant larger number of asthma patients with intellectual disabilities were prescribed antibiotics (69.9% vs. 54.5%). COPD patients with intellectual disabilities, compared with matched controls without intellectual disabilities, received significantly more often either no COPD-related practice consultation at all (respectively 20.8% vs. 8.5%, p = 0.004) or a large number of practice consultations (>31 consultations, respectively 16.7% vs. 5.3%, p = 0.004). For asthma, there was no statistical difference between patients with or without intellectual disabilities regarding the number and type of consultations. The asthma year point prevalence in patients with intellectual disabilities was, from 2014 onward, significantly higher, and in 2019 was 8.7% vs. 6.0% for people without intellectual disabilities. For COPD, it was comparable in both groups. Both asthma and COPD patients with intellectual disabilities appeared considerably younger in age than patients without intellectual disabilities. Our findings warrant further research into the causes of the differences found for asthma and COPD and whether they also infer differences in the quality or the effectiveness of GP disease management, especially for young adults with intellectual disabilities.

Transmural collaborative care model for the review of antipsychotics: a feasibility study of a complex intervention.

General practitioners (GPs) are often unaware of antipsychotic (AP)-induced cardiovascular risk (CVR) and therefore patients using atypical APs are not systematically monitored. We evaluated the feasibility of a complex intervention designed to review the use of APs and advise on CVR-lowering strategies in a transmural collaboration. A mixed methods prospective cohort study in three general practices in the Netherlands was conducted in 2021. The intervention comprised three steps: a digital information meeting, a multidisciplinary meeting, and a shared decision-making visit to the GP. We assessed patient recruitment and retention rates, advice given and adopted, and CVR with QRISK3 score and mental state with MHI-5 at baseline and three months post-intervention. GPs invited 57 of 146 eligible patients (39%), of whom 28 (19%) participated. The intervention was completed by 23 (82%) and follow-up by 18 participants (64%). At the multidisciplinary meeting, 22 (78%) patients were advised to change AP use. Other advice concerned medication (other than APs), lifestyle, monitoring, and psychotherapy. At 3-months post-intervention, 41% (28/68) of this advice was adopted. Our findings suggest that this complex intervention is feasible for evaluating health improvement in patients using AP in a trial.

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.

Acceptability of risk-based triage in cervical cancer screening: A focus group study.

BACKGROUND: Compared to the previous cytology-based program, the introduction of primary high-risk human papillomavirus (hrHPV) based screening in 2017 has led to an increased number of referrals. To counter this, triage of hrHPV-positive women in cervical cancer screening can potentially be optimized by taking sociodemographic and lifestyle risk factors for cervical abnormalities into account. Therefore, it is essential to gain knowledge of the views of women (30-60 years) eligible for cervical cancer screening. OBJECTIVE: The main goal of this qualitative study was to gain insight in the aspects that influence acceptability of risk-based triage in cervical cancer screening. DESIGN: A focus group study in which participants were recruited via four general medical practices, and purposive sampling was used to maximize heterogeneity with regards to age, education level, and cervical cancer screening experiences. APPROACH: The focus group discussions were transcribed verbatim and analyzed using reflexive thematic analysis. PARTICIPANTS: A total of 28 women (average age: 45.2 years) eligible for cervical cancer screening in The Netherlands participated in seven online focus group discussions. Half of the participants was higher educated, and the participants differed in previous cervical cancer screening participation and screening result. KEY RESULTS: In total, 5 main themes and 17 subthemes were identified that determine the acceptability of risk-stratified triage. The main themes are: 1) adequacy of the screening program: an evidence-based program that is able to minimize cancer incidence and reduce unnecessary referrals; 2) personal information (e.g., sensitive topics and stigma); 3) emotional impact: fear and reassurance; 4) communication (e.g., transparency); and 5) autonomy (e.g., prevention). CONCLUSION: The current study highlights several challenges regarding the development and implementation of risk-based triage that need attention in order to be accepted by the target group. These challenges include dealing with sensitive topics and a transparent communication strategy.

Primary healthcare competencies needed in the management of person-centred integrated care for chronic illness and multimorbidity: Results of a scoping review.

BACKGROUND: Chronic disease management is important in primary care. Disease management programmes focus primarily on the respective diseases. The occurrence of multimorbidity and social problems is addressed to a limited extent. Person-centred integrated care (PC-IC) is an alternative approach, putting the patient at the centre of care. This asks for additional competencies for healthcare professionals involved in the execution of PC-IC. In this scoping review we researched which competencies are necessary for healthcare professionals working in collaborative teams where the focus lies within the concept of PC-IC. We also explored how these competencies can be acquired. METHODS: Six literature databases and grey literature were searched for guidelines and peer-reviewed articles on chronic illness and multimorbidity in primary care. A data synthesis was carried out resulting in an overview of the competencies that healthcare professionals need to deliver PC-IC. RESULTS: Four guidelines and 21 studies were included and four core competencies could be derived through the synthesis: 1. interprofessional communication, 2, interprofessional collaborative teamwork, 3. leadership and 4. patient-centred communication. Included papers mostly lack a clear description of the competencies in terms of knowledge, skills and attitudes which are necessary for a PC-IC approach and on how these competencies can be acquired. CONCLUSION: This review provides insight on competencies necessary to provide PC-IC within primary care. Research is needed in more depth on core concepts of these competencies which will then benefit educational programmes to ensure that healthcare professionals in primary care are better equipped to deliver PC-IC for patients with chronic illness and multimorbidity.

Development of a Person-Centred Integrated Care Approach for Chronic Disease Management in Dutch Primary Care: A Mixed-Method Study.

To reduce the burden of chronic diseases on society and individuals, European countries implemented chronic Disease Management Programs (DMPs) that focus on the management of a single chronic disease. However, due to the fact that the scientific evidence that DMPs reduce the burden of chronic diseases is not convincing, patients with multimorbidity may receive overlapping or conflicting treatment advice, and a single disease approach may be conflicting with the core competencies of primary care. In addition, in the Netherlands, care is shifting from DMPs to person-centred integrated care (PC-IC) approaches. This paper describes a mixed-method development of a PC-IC approach for the management of patients with one or more chronic diseases in Dutch primary care, executed from March 2019 to July 2020. In Phase 1, we conducted a scoping review and document analysis to identify key elements to construct a conceptual model for delivering PC-IC care. In Phase 2, national experts on Diabetes Mellitus type 2, cardiovascular diseases, and chronic obstructive pulmonary disease and local healthcare providers (HCP) commented on the conceptual model using online qualitative surveys. In Phase 3, patients with chronic conditions commented on the conceptual model in individual interviews, and in Phase 4 the conceptual model was presented to the local primary care cooperatives and finalized after processing their comments. Based on the scientific literature, current practice guidelines, and input from a variety of stakeholders, we developed a holistic, person-centred, integrated approach for the management of patients with (multiple) chronic diseases in primary care. Future evaluation of the PC-IC approach will show if this approach leads to more favourable outcomes and should replace the current single-disease approach in the management of chronic conditions and multimorbidity in Dutch primary care.

How Can a Bundled Payment Model Incentivize the Transition from Single-Disease Management to Person-Centred and Integrated Care for Chronic Diseases in the Netherlands?

To stimulate the integration of chronic care across disciplines, the Netherlands has implemented single-disease management programmes (SDMPs) in primary care since 2010; for example, for COPD, type 2 diabetes mellitus, and cardiovascular diseases. These disease-specific chronic care programmes are funded by bundled payments. For chronically ill patients with multimorbidity or with problems in other domains of health, this approach was shown to be less fit for purpose. As a result, we are currently witnessing several initiatives to broaden the scope of these programmes, aiming to provide truly person-centred integrated care (PC-IC). This raises the question if it is possible to design a payment model that would support this transition. We present an alternative payment model that combines a person-centred bundled payment with a shared savings model and pay-for-performance elements. Based on theoretical reasoning and results of previous evaluation studies, we expect the proposed payment model to stimulate integration of person-centred care between primary healthcare providers, secondary healthcare providers, and the social care domain. We also expect it to incentivise cost-conscious provider-behaviour, while safeguarding the quality of care, provided that adequate risk-mitigating actions, such as case-mix adjustment and cost-capping, are taken.

Diagnostic differentiation between asthma and COPD in primary care using lung function testing.

Asthma and COPD are defined as different disease entities, but in practice patients often show features of both diseases making it challenging for primary care clinicians to establish a correct diagnosis. We aimed to establish the added value of spirometry and more advanced lung function measurements to differentiate between asthma and COPD. A cross-sectional study in 10 Dutch general practices was performed. 532 subjects were extensively screened on respiratory symptoms and lung function. Two chest physicians assessed if asthma or COPD was present. Using multivariable logistic regression analysis we assessed the ability of three scenarios (i.e. only patient history; diagnostics available to primary care; diagnostics available only to secondary care) to differentiate between the two conditions. Receiver operator characteristics (ROC) curves and area under the curve (AUC) were calculated for each scenario, with the chest physicians' assessment as golden standard. Results showed that 84 subjects were diagnosed with asthma, 138 with COPD, and 310 with no chronic respiratory disease. In the scenario including only patient history items, ROC characteristics of the model showed an AUC of 0.84 (95% CI 0.78-0.89) for differentiation between asthma and COPD. When adding diagnostics available to primary care (i.e., pre- and postbronchodilator spirometry) AUC increased to 0.89 (95% CI 0.84-0.93; p = 0.020). When adding more advanced secondary care diagnostic tests AUC remained 0.89 (95% CI 0.85-0.94; p = 0.967). We conclude that primary care clinicians' ability to differentiate between asthma and COPD is enhanced by spirometry testing. More advanced diagnostic tests used in hospital care settings do not seem to provide a better overall diagnostic differentiation between asthma and COPD in primary care patients.

Cardiovascular risk management in patients with severe mental illness or taking antipsychotics: A qualitative study on barriers and facilitators among dutch general practitioners.

BACKGROUND: Patients with severe mental illness (SMI) or receiving treatment with antipsychotics (APs) have an increased risk of cardiovascular disease. Cardiovascular risk management (CVRM) increasingly depends on general practitioners (GPs) because of the shift of mental healthcare from secondary to primary care and the surge of off-label AP prescriptions. Nevertheless, the uptake of patients with SMI/APs in CVRM programmes in Dutch primary care is low. OBJECTIVES: To explore which barriers and facilitators GPs foresee when including and treating patients with SMI or using APs in an existing CVRM programme. METHODS: In 2019, we conducted a qualitative study among 13 Dutch GPs. During individual in-depth, semi-structured interviews a computer-generated list of eligible patients who lacked annual cardiovascular risk (CVR) screening guided the interview. Data was analysed thematically. RESULTS: The main barriers identified were: (i) underestimation of patient CVR and ambivalence to apply risk-lowering strategies such as smoking cessation, (ii) disproportionate burden on GPs in deprived areas, (iii) poor information exchange between GPs and psychiatrists, and (iv) scepticism about patient compliance, especially those with more complex conditions. The main facilitators included: (i) support of GPs through a computer-generated list of eligible patients and (ii) involvement of family or carers. CONCLUSION: This study displays a range of barriers and facilitators anticipated by GPs. These indicate the preconditions required to remove barriers and facilitate GPs, namely adequate recommendations in practice guidelines, improved consultation opportunities with psychiatrists, practical advice to support patient adherence and incentives for practices in deprived areas.

Chronic diseases and comorbidities in adults with and without intellectual disabilities: comparative cross-sectional study in Dutch general practice.

BACKGROUND: Chronic disease and comorbidity patterns in people with intellectual disabilities (ID) are more complex than in the general population. However, incomplete understanding of these differences limits care providers in addressing them. OBJECTIVE: To compare chronic disease and comorbidity patterns in chronically ill patients with and without ID in Dutch general practice. METHODS: In this population-based study, a multi-regional primary care database of 2018 was combined with national population data to improve identification of adults with ID. Prevalence was calculated using Poisson regression to estimate prevalence ratios and 95% confidence intervals for the highest-impact chronic diseases (ischemic heart disease (IHD), cerebrovascular disease (CVD), diabetes mellitus (DM), and chronic obstructive pulmonary disease (COPD)) and comorbidities. RESULTS: Information from 18,114 people with ID and 1,093,995 people without ID was available. When considering age and sex, CVD (PR = 1.1), DM (PR = 1.6), and COPD (PR = 1.5) times more prevalent in people with than without ID. At younger age, people with ID more often had a chronic disease and multiple comorbidities. Males with ID most often had a chronic disease and multiple comorbidities. Comorbidities of circulatory nature were most common. CONCLUSIONS: This study identified a younger onset of chronic illness and a higher prevalence of multiple comorbidities among people with ID in general practice than those without ID. This underlines the complexity of people with ID and chronic diseases in general practice. As this study confirmed the earlier onset of chronic diseases and comorbidities, it is recommended to acknowledge these age differences when following chronic disease guidelines.

Exploring chronic disease prevalence in people with intellectual disabilities in primary care settings: A scoping review.

BACKGROUND: Primary care providers require accurate evidence on chronic disease prevalence in people with intellectual disabilities in order to apply this information into practice. This study aimed to map the broadness of literature on chronic disease prevalence in people with and without intellectual disabilities, and to explore main characteristics of these studies. METHOD: A scoping review of peer-reviewed literature was conducted, covering 2000 to February 2020, including literature that discussed chronic disease prevalence in people with and without intellectual disabilities, with similar data collection method for both groups. RESULTS: Nineteen studies were included. Chronic disease prevalence varied considerably between people with and without intellectual disabilities. Studies differed in their methodologies, country and age groups that were enrolled. CONCLUSIONS: Primary care providers should interpret results on disease prevalence among people with intellectual disabilities in light of the study characteristics. Researchers should always interpret prevalence rates in the context of methodology.

Challenges of Research on Person-Centered Care in General Practice: A Scoping Review.

Background: Delivering person-centered care is one of the core values in general practice. Due to the complexity and multifaceted character of person-centered care, the effects of person-centered care cannot be easily underpinned with robust scientific evidence. In this scoping review we provide an overview of research on effects of person-centered care, exploring the concepts and definitions used, the type of interventions studied, the selected outcome measures, and its strengths and limitations. Methods: Systematic reviews on person-centered care compared to usual care were included from Pubmed, Embase, and PsycINFO. The search was conducted in February 2021. Data selection and charting was done by two reviewers. Results: The literature search yielded 481 articles. A total of 21 full-text articles were assessed for eligibility for inclusion. Four systematic reviews, published between 2012 and 2018, were finally included in this review. All reviews used different definitions and models and classified the interventions differently. The explicit distinction between interventions for providers and patients was made in two systematic reviews. The classification of outcomes also showed large differences, except patient satisfaction that was shared. All reviews described the results narratively. One review also pooled the results on some outcome measures. Most studies included in the reviews showed positive effects, in particular on process outcomes. Mixed results were found on patient satisfaction and clinical or health outcomes. All review authors acknowledged limitations due to lack of uniform definitions, and heterogeneity of interventions and outcomes measures. Discussion: Person-centered care is a concept that seems obvious and understandable in real life but is complex to operationalize in research. This scoping review reinforces the need to use mixed qualitative and quantitative methods in general practice research. For spreading and scaling up person-centered care, an implementation or complexity science approach could be used. Research could be personalized by defining therapeutic goals, interventions, and outcome variables based on individual preferences, goals, and values and not only on clinical and biological characteristics. Observational data and patient satisfaction surveys could be used to support quality improvement. Integrating research, education, and practice could strengthen the profession, building on the fundament of shared core values.

Definition of a COPD self-management intervention: International Expert Group consensus.

There is an urgent need for consensus on what defines a chronic obstructive pulmonary disease (COPD) self-management intervention. We aimed to obtain consensus regarding the conceptual definition of a COPD self-management intervention by engaging an international panel of COPD self-management experts using Delphi technique features and an additional group meeting.In each consensus round the experts were asked to provide feedback on the proposed definition and to score their level of agreement (1=totally disagree; 5=totally agree). The information provided was used to modify the definition for the next consensus round. Thematic analysis was used for free text responses and descriptive statistics were used for agreement scores.In total, 28 experts participated. The consensus round response rate varied randomly over the five rounds (ranging from 48% (n=13) to 85% (n=23)), and mean definition agreement scores increased from 3.8 (round 1) to 4.8 (round 5) with an increasing percentage of experts allocating the highest score of 5 (round 1: 14% (n=3); round 5: 83% (n=19)).In this study we reached consensus regarding a conceptual definition of what should be a COPD self-management intervention, clarifying the requisites for such an intervention. Operationalisation of this conceptual definition in the near future will be an essential next step.

Characteristics of effective self-management interventions in patients with COPD: individual patient data meta-analysis.

It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective.Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models.14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97-0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92-0.99; RR after 12 months follow-up 0.98, 95% CI 0.96-1.00).Our results showed that longer duration of self-management interventions conferred a reduction in all-cause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes.

[Working with the Dutch Standard of Care for COPD: using the 'Nijmegen Clinical Screening Instrument' as an aid]. / Werken met de Zorgstandaard COPD: het 'Nijmegen Clinical Screening Instrument' als hulpmiddel.

In the Dutch Standard of Care for chronic obstructive pulmonary disease (COPD) the patient, not the illness, is now central. Additionally, treatment is no longer exclusively guided by the degree of airway obstruction but by the burden of disease (also called 'integral health status'). Consequently, COPD care will be more intensive and more complex. The Nijmegen Clinical Screening Instrument (NCSI) method offers a guide for the patient and the caregiver to help execute the standard of care effectively and efficiently. Using this method, the burden of disease is assessed in detail. An integral intervention helps in formulating treatment goals (patient-tailored treatment), and in motivating patients to adhere to these treatment goals. A special condensed version of the NCSI is suitable for monitoring the patient. The method is web-based, which facilitates the assessment and monitoring of the patient.

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.

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.