Exploring characteristics of COPD patients with clinical improvement after integrated disease management or usual care: post-hoc analysis of the RECODE study.

BACKGROUND: The cluster randomized controlled trial on (cost-)effectiveness of integrated chronic obstructive pulmonary disease (COPD) management in primary care (RECODE) showed that integrated disease management (IDM) in primary care had no effect on quality of life (QOL) in COPD patients compared with usual care (guideline-supported non-programmatic care). It is possible that only a subset of COPD patients in primary care benefit from IDM. We therefore examined which patients benefit from IDM, and whether patient characteristics predict clinical improvement over time. METHOD: Post-hoc analyses of the RECODE trial among 1086 COPD patients. Logistic regression analyses were performed with baseline characteristics as predictors to examine determinants of improvement in QOL, defined as a minimal decline in Clinical COPD Questionnaire (CCQ) of 0.4 points after 12 and 24 months of IDM. We also performed moderation analyses to examine whether predictors of clinical improvement differed between IDM and usual care. RESULTS: Regardless of treatment type, more severe dyspnea (MRC) was the most important predictor of clinically improved QOL at 12 and 24 months, suggesting that these patients have most room for improvement. Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months). CONCLUSIONS: More severe dyspnea is a key predictor of improved QOL in COPD patients over time. More research is needed to replicate patient characteristics associated with clinical improvement with IDM, such that IDM programs can be offered to patients that benefit the most, and can potentially be adjusted to meet the needs of other patient groups as well. TRIAL REGISTRATION: Netherlands Trial Register, NTR2268. Registered 31 March 2010.

Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial.

BACKGROUND AND AIMS: The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients. METHODS: Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 ± 0.9 years) with moderate airflow obstruction (FEV1 55.1 ± 2.2% predicted) and impaired exercise capacity (Wmax 63.5 ± 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included. RESULTS: After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Δ1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p < 0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Δ1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Δ-1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months; only amotivation towards healthy eating yielded a significant between-group difference (Δ1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750. CONCLUSIONS: Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden.

Exploring the Impact of Adding a Respiratory Dimension to the EQ-5D-5L.

Objectives. To evaluate the impact of adding a respiratory dimension (a bolt-on dimension) to the EQ-5D-5L health state valuations. Methods. Based on extensive regression and principal component analyses, 2 respiratory bolt-on candidates were formulated: R1, limitations in physical activities due to shortness of breath, and R2, breathing problems. Valuation interviews for the selected bolt-ons were performed with a representative sample from the Dutch general public using the standardized interview protocol and software of the EuroQol group. Hybrid models based on the combined time-tradeoff (TTO) and discrete choice experiment (DCE) data were estimated to assess whether the 5 levels of the respiratory bolt-on led to significant changes in utility values. Results. For each bolt-on candidate, slightly more than 200 valuation interviews were conducted. Mean TTO values and DCE choice probabilities for health states with a level 4 or 5 for the respiratory dimension were significantly lower compared with the same health states in the Dutch EQ-5D-5L valuation study without the respiratory dimension. Results of hybrid models showed that for the bolt-on "limitations in physical activities," the utility decrements were significant for level 3 (-0.055), level 4 (-0.087), and level 5 (-0.135). For "breathing problems," the utility decrements for the same levels were greater (-0.086, -0.219, and -0.327, respectively). Conclusions. The addition of each of the 2 respiratory bolt-ons to the EQ-5D-5L had a significant effect on the valuation of health states with severe levels for the bolt-on. The bolt-on dimension "breathing problems" showed the greatest utility decrements and therefore seems the most appropriate respiratory bolt-on dimension.

The Fold-in, Fold-out Design for DCE Choice Tasks: Application to Burden of Disease.

Background In discrete-choice experiments (DCEs), choice alternatives are described by attributes. The importance of each attribute can be quantified by analyzing respondents' choices. Estimates are valid only if alternatives are defined comprehensively, but choice tasks can become too difficult for respondents if too many attributes are included. Several solutions for this dilemma have been proposed, but these have practical or theoretical drawbacks and cannot be applied in all settings. The objective of the current article is to demonstrate an alternative solution, the fold-in, fold-out approach (FiFo). We use a motivating example, the ABC Index for burden of disease in chronic obstructive pulmonary disease (COPD). Methods Under FiFo, all attributes are part of all choice sets, but they are grouped into domains. These are either folded in (all attributes have the same level) or folded out (levels may differ). FiFo was applied to the valuation of the ABC Index, which included 15 attributes. The data were analyzed in Bayesian mixed logit regression, with additional parameters to account for increased complexity in folded-out questionnaires and potential differences in weight due to the folding status of domains. As a comparison, a model without the additional parameters was estimated. Results Folding out domains led to increased choice complexity for respondents. It also gave domains more weight than when it was folded in. The more complex regression model had a better fit to the data than the simpler model. Not accounting for choice complexity in the models resulted in a substantially different ABC Index. Conclusion Using a combination of folded-in and folded-out attributes is a feasible approach for conducting DCEs with many attributes.

Defining good health and care from the perspective of persons with multimorbidity: results from a qualitative study of focus groups in eight European countries.

OBJECTIVES: The prevalence of multimorbidity is increasing in many Western countries. Persons with multimorbidity often experience a lack of alignment in the care that multiple health and social care organisations provide. As a response, integrated care programmes are appearing. It is a challenge to evaluate these and to choose appropriate outcome measures. Focus groups were held with persons with multimorbidity in eight European countries to better understand what good health and a good care process mean to them and to identify what they find most important in each. METHODS: In 2016, eight focus groups were organised with persons with multimorbidity in: Austria, Croatia, Germany, Hungary, the Netherlands, Norway, Spain and the UK (total n=58). Each focus group followed the same two-part procedure: (1) defining (A) good health and well-being and (B) a good care process, and (2) group discussion on prioritising the most important concepts derived from part one and from a list extracted from the literature. Inductive and deductive analyses were done. RESULTS: Overall, the participants in all focus groups concentrated more on the care process than on health. Persons with multimorbidity defined good health as being able to conduct and plan normal daily activities, having meaningful social relationships and accepting the current situation. Absence of shame, fear and/or stigma, being able to enjoy life and overall psychological well-being were also important facets of good health. Being approached holistically by care professionals was said to be vital to a good care process. Continuity of care and trusting professionals were also described as important. Across countries, little variation in health definitions were found, but variation in defining a good care process was seen. CONCLUSION: A variety of health outcomes that entail well-being, social and psychological facets and especially experience with care outcomes should be included when evaluating integrated care programmes for persons with multimorbidity.

Relevant models and elements of integrated care for multi-morbidity: Results of a scoping review.

BACKGROUND: In order to provide adequate care for the growing group of persons with multi-morbidity, innovative integrated care programmes are appearing. The aims of the current scoping review were to i) identify relevant models and elements of integrated care for multi-morbidity and ii) to subsequently identify which of these models and elements are applied in integrated care programmes for multi-morbidity. METHODS: A scoping review was conducted in the following scientific databases: Cochrane, Embase, PubMed, PsycInfo, Scopus, Sociological Abstracts, Social Services Abstracts, and Web of Science. A search strategy encompassing a) models, elements and programmes, b) integrated care, and c) multi-morbidity was used to identify both models and elements (aim 1) and implemented programmes of integrated care for multi-morbidity (aim 2). Data extraction was done by two independent reviewers. Besides general information on publications (e.g. publication year, geographical region, study design, and target group), data was extracted on models and elements that publications refer to, as well as which models and elements are applied in recently implemented programmes in the EU and US. RESULTS: In the review 11,641 articles were identified. After title and abstract screening, 272 articles remained. Full text screening resulted in the inclusion of 92 articles on models and elements, and 50 articles on programmes, of which 16 were unique programmes in the EU (n=11) and US (n=5). Wagner's Chronic Care Model (CCM) and the Guided Care Model (GCM) were most often referred to (CCM n=31; GCM n=6); the majority of the other models found were only referred to once (aim 1). Both the CCM and GCM focus on integrated care in general and do not explicitly focus on multi-morbidity. Identified elements of integrated care were clustered according to the WHO health system building blocks. Most elements pertained to 'service delivery'. Across all components, the five elements referred to most often are person-centred care, holistic or needs assessment, integration and coordination of care services and/or professionals, collaboration, and self-management (aim 1). Most (n=10) of the 16 identified implemented programmes for multi-morbidity referred to the CCM (aim 2). Of all identified programmes, the elements most often included were self-management, comprehensive assessment, interdisciplinary care or collaboration, person-centred care and electronic information system (aim 2). CONCLUSION: Most models and elements found in the literature focus on integrated care in general and do not explicitly focus on multi-morbidity. In line with this, most programmes identified in the literature build on the CCM. A comprehensive framework that better accounts for the complexities resulting from multi-morbidity is needed.

The SELFIE framework for integrated care for multi-morbidity: Development and description.

BACKGROUND: The rise of multi-morbidity constitutes a serious challenge in health and social care organisation that requires a shift from disease- towards person-centred integrated care. The aim of the current study was to develop a conceptual framework that can aid the development, implementation, description, and evaluation of integrated care programmes for multi-morbidity. METHODS: A scoping review and expert discussions were used to identify and structure concepts for integrated care for multi-morbidity. A search of scientific and grey literature was conducted. DISCUSSION: meetings were organised within the SELFIE research project with representatives of five stakeholder groups (5Ps): patients, partners, professionals, payers, and policy makers. RESULTS: In the scientific literature 11,641 publications were identified, 92 were included for data extraction. A draft framework was constructed that was adapted after discussion with SELFIE partners from 8 EU countries and 5P representatives. The core of the framework is the holistic understanding of the person with multi-morbidity in his or her environment. Around the core, concepts were grouped into adapted WHO components of health systems: service delivery, leadership & governance, workforce, financing, technologies & medical products, and information & research. Within each component micro, meso, and macro levels are distinguished. CONCLUSION: The framework structures relevant concepts in integrated care for multi-morbidity and can be applied by different stakeholders to guide development, implementation, description, and evaluation.

ABC Index: quantifying experienced burden of COPD in a discrete choice experiment and predicting costs.

OBJECTIVE: The Assessment of Burden of COPD (ABC) tool supports shared decision making between patient and caregiver. It includes a coloured balloon diagram to visualise patients' scores on burden indicators. We aim to determine the importance of each indicator from a patient perspective, in order to calculate a weighted index score and investigate whether that score is predictive of costs. DESIGN: Discrete choice experiment. SETTING AND PARTICIPANTS: Primary care and secondary care in the Netherlands. 282 patients with chronic obstructive pulmonary disease (COPD) and 252 members of the general public participated. METHODS: Respondents received 14 choice questions and indicated which of two health states was more severe. Health states were described in terms of specific symptoms, limitations in physical, daily and social activities, mental problems, fatigue and exacerbations, most of which had three levels of severity. Weights for each item-level combination were derived from a Bayesian mixed logit model. Weights were rescaled to construct an index score from 0 (best) to 100 (worst). Regression models were used to find a classification of this index score in mild, moderate and severe that was discriminative in terms of healthcare costs. RESULTS: Fatigue, limitations in moderate physical activities, number of exacerbations, dyspnoea at rest and fear of breathing getting worse contributed most to the burden of disease. Patients assigned less weight to dyspnoea during exercise, listlessness and limitations with regard to strenuous activities. Respondents from the general public mostly agreed. Mild, moderate and severe burden of disease were defined as scores <20, 20-39 and ≥40. This categorisation was most predictive of healthcare utilisation and annual costs: €1368, €2510 and €9885, respectively. CONCLUSIONS: The ABC Index is a new index score for the burden of COPD, which is based on patients' preferences. The classification of the index score into mild, moderate and severe is predictive of future healthcare costs. TRIAL REGISTRATION NUMBER: NTR3788; Post-results.

Effectiveness of case management in the prevention of COPD re-admissions: a pilot study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with high disease burden and costs, especially in the case of hospitalizations. The overall number of hospital admissions due to exacerbations of COPD has increased. It is remarkable that re-admissions account for a substantial part of these hospitalizations. This pilot study investigates the use of case management to reduce re-admissions due to COPD. METHODS: COPD patients with more than one hospitalization per year due to an exacerbation were included. The participants (n = 10) were closely monitored and intensively coached for 20 weeks after hospitalization. The case manager provided care in a person-focused manner. The case manager informed and supported the patient, took action when relapse threatened, coordinated and connected primary and secondary care. Data of 12 months before and after start of the intervention were compared. Primary outcome was the difference in number of hospitalizations. Secondary outcomes were health-related quality of life (measured by the Clinical COPD Questionnaire, CCQ) and dyspnoea (measured by the MRC Dyspnoea Scale). RESULTS: The incidence rate of hospitalizations was found to be 2.25 times higher (95% confidence interval [CI] 1.3-3.9; P = 0.004) 12 months before compared with 12 months after the start of case management. COPD patients had a mean CCQ score of 3.3 (95% CI 2.8-3.8) before and 2.4 (95% CI 1.9-2.8) after 20 weeks of case management; a difference of 1.0 (95% CI 0.4-1.6; P = 0.001). The mean MRC scores showed no significant differences before (4.3; 95% CI 3.7-4.9) and after the case management period (3.9; 95% CI 3.2-4.6); a difference of 0.4 (95% CI - 0.1 to 0.9; P = 0.114). CONCLUSIONS: This pilot study shows that the number of COPD hospital re-admissions decreased significantly after the introduction of a case manager. Moreover, there was an improvement in patient-reported health-related quality of life.

Prediction models for exacerbations in different COPD patient populations: comparing results of five large data sources.

BACKGROUND AND OBJECTIVES: Exacerbations are important outcomes in COPD both from a clinical and an economic perspective. Most studies investigating predictors of exacerbations were performed in COPD patients participating in pharmacological clinical trials who usually have moderate to severe airflow obstruction. This study was aimed to investigate whether predictors of COPD exacerbations depend on the COPD population studied. METHODS: A network of COPD health economic modelers used data from five COPD data sources - two population-based studies (COPDGene® and The Obstructive Lung Disease in Norrbotten), one primary care study (RECODE), and two studies in secondary care (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoint and UPLIFT) - to estimate and validate several prediction models for total and severe exacerbations (= hospitalization). The models differed in terms of predictors (depending on availability) and type of model. RESULTS: FEV1% predicted and previous exacerbations were significant predictors of total exacerbations in all five data sources. Disease-specific quality of life and gender were predictors in four out of four and three out of five data sources, respectively. Age was significant only in the two studies including secondary care patients. Other significant predictors of total exacerbations available in one database were: presence of cough and wheeze, pack-years, 6-min walking distance, inhaled corticosteroid use, and oxygen saturation. Predictors of severe exacerbations were in general the same as for total exacerbations, but in addition low body mass index, cardiovascular disease, and emphysema were significant predictors of hospitalization for an exacerbation in secondary care patients. CONCLUSIONS: FEV1% predicted, previous exacerbations, and disease-specific quality of life were predictors of exacerbations in patients regardless of their COPD severity, while age, low body mass index, cardiovascular disease, and emphysema seem to be predictors in secondary care patients only.

Systematic Review and Quality Appraisal of Cost-Effectiveness Analyses of Pharmacologic Maintenance Treatment for Chronic Obstructive Pulmonary Disease: Methodological Considerations and Recommendations.

BACKGROUND: Worldwide, chronic obstructive pulmonary disease (COPD) is a highly prevalent chronic lung disease with considerable clinical and socioeconomic impact. Pharmacologic maintenance drugs (such as bronchodilators and inhaled corticosteroids) play an important role in the treatment of COPD. The cost effectiveness of these treatments has been frequently assessed, but studies to date have largely neglected the impact of treatment sequence and the exact stage of disease in which the drugs are used in real life. OBJECTIVE: We aimed to systematically review recently published articles that reported the cost effectiveness of COPD maintenance treatments, with a focus on key findings, quality and methodological issues. METHODS: We performed a systematic literature search in Embase, PubMed, the UK NHS Economic Evaluation Database (NHS-EED) and EURONHEED (European Network of Health Economics Evaluation Databases) and included all relevant articles published between 2011 and 2015 in either Dutch, English or German. Main study characteristics, methods and outcomes were extracted and critically assessed. The Quality of Health Economic Studies (QHES) instrument was used as basis for quality assessment, but additional items were also addressed. RESULTS: The search identified 18 recent pharmacoeconomic analyses of COPD maintenance treatments. Papers reported the cost effectiveness of long-acting muscarinic antagonist (LAMA) monotherapy (n = 6), phosphodiesterase (PDE)-4 inhibitors (n = 4), long-acting beta agonist/inhaled corticosteroid (LABA/ICS) combinations (n = 4), LABA monotherapy (n = 2) and LABA/LAMA combinations (n = 2). All but two studies were funded by the manufacturer, and all studies indicated favourable cost effectiveness; however, the number of quality-adjusted life-years (QALYs) gained was small. Less than half of the studies reported a COPD-specific outcome in addition to a generic outcome (mostly QALYs). Exacerbation and mortality rates were found to be the main drivers of cost effectiveness. According to the QHES, the quality of the studies was generally sufficient, but additional assessment revealed that most studies poorly represented the cost effectiveness of real-life medication use. CONCLUSIONS: The majority of studies showed that pharmacologic COPD maintenance treatment is cost effective, but most studies poorly reflected real-life drug use. Consistent and COPD-specific methodology is recommended.

Impact of financial agreements in European chronic care on health care expenditure growth.

Various types of financial agreements have been implemented in Europe to reduce health care expenditure by stimulating integrated chronic care. This study used difference-in-differences (DID) models to estimate differences in health care expenditure trends before and after the introduction of a financial agreement between 9 intervention countries and 16 control countries. Intervention countries included countries with pay-for-coordination (PFC), pay-for-performance (PFP), and/or all inclusive agreements (bundled and global payment) for integrated chronic care. OECD and WHO data from 1996 to 2013 was used. The results from the main DID models showed that the annual growth of outpatient expenditure was decreased in countries with PFC (by 21.28 US$ per capita) and in countries with all-inclusive agreements (by 216.60 US$ per capita). The growth of hospital and administrative expenditure was decreased in countries with PFP by 64.50 US$ per capita and 5.74 US$ per capita, respectively. When modelling impact as a non-linear function of time during the total 4-year period after implementation, PFP decreased the growth of hospital and administrative expenditure and all-inclusive agreements reduced the growth of outpatient expenditure. Financial agreements are potentially powerful tools to stimulate integrated care and influence health care expenditure growth. A blended payment scheme that combines elements of PFC, PFP, and all-inclusive payments is likely to provide the strongest financial incentives to control health care expenditure growth.

Investigating the association between medication adherence and health-related quality of life in COPD: Methodological challenges when using a proxy measure of adherence.

BACKGROUND: The association between non-adherence to medication and health-related quality-of-life (HRQoL) in Chronic Obstructive Pulmonary Disease (COPD) remains poorly understood. Different ways to deal with methodological challenges to estimate this association have probably contributed to conflicting results. AIM: To investigate the association between medication adherence and HRQoL, thereby illustrating methodological challenges that need to be addressed. METHODS: We used longitudinal patient-level data from a cluster-randomized controlled trial (i.e. RECODE) including three-year data on type and dose of COPD maintenance medication prescribed and HRQoL (Clinical COPD Questionnaire [CCQ], st. George Respiratory Questionnaire [SGRQ], EuroQol 5-dimensions [EQ-5D]) of 511 patients. A linear mixed model was used to assess the association between adherence and HRQoL using a fixed cut-off of 80% of the proportion of days covered (PDC) to define adherence. Subsequently, we investigated the impact of differences in disease severity; lifestyle; and reversed causality, representing the methodological challenges. Additionally, we investigated the impact of changing the definition of adherence. RESULTS: In unadjusted analyses, and analyses adjusting for demographic characteristics only, SGRQ score was worse in the adherent compared to the non-adherent group. This association disappeared when correcting for disease severity and/or lifestyle. A better SGRQ score was predictive of decreased adherence in the following year. However, accounting for the previous HRQoL did not result in positive associations between adherence and HRQoL. When defining four categories of adherence, patients with a PDC between 80 and 99% had a significantly worse SGRQ score compared to patients with a PDC <60%, even after correction for lifestyle. There was no significant association between adherence and CCQ or EQ-5D. CONCLUSION: This study showed persistent methodological challenges in the investigation of the effect of medication adherence on HRQoL in COPD. A positive association of adherence and HRQoL was not found, even after adjusting for lifestyle, disease severity, and previous HRQoL.

Exploring the variation in implementation of a COPD disease management programme and its impact on health outcomes: a post hoc analysis of the RECODE cluster randomised trial.

This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes.

Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial.

OBJECTIVES: To investigate the cost-effectiveness of a chronic obstructive pulmonary disease (COPD) disease management (COPD-DM) programme in primary care, called RECODE, compared to usual care. DESIGN: A 2-year cluster-randomised controlled trial. SETTING: 40 general practices in the western part of the Netherlands. PARTICIPANTS: 1086 patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. INTERVENTIONS: A multidisciplinary team of caregivers was trained in motivational interviewing, setting up individual care plans, exacerbation management, implementing clinical guidelines and redesigning the care process. In addition, clinical decision-making was supported by feedback reports provided by an ICT programme. MAIN OUTCOME MEASURES: We investigated the impact on health outcomes (quality-adjusted life years (QALYs), Clinical COPD Questionnaire, St. George's Respiratory Questionnaire and exacerbations) and costs (healthcare and societal perspective). RESULTS: The intervention costs were €324 per patient. Excluding these costs, the intervention group had €584 (95% CI €86 to €1046) higher healthcare costs than did the usual care group and €645 (95% CI €28 to €1190) higher costs from the societal perspective. Health outcomes were similar in both groups, except for 0.04 (95% CI -0.07 to -0.01) less QALYs in the intervention group. CONCLUSIONS: This integrated care programme for patients with COPD that mainly included professionally directed interventions was not cost-effective in primary care. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NTR2268.

Mapping the clinical chronic obstructive pulmonary disease questionnaire onto generic preference-based EQ-5D values.

OBJECTIVES: To develop a model to predict EuroQol five-dimensional questionnaire (EQ-5D) values from clinical chronic obstructive pulmonary disease (COPD) questionnaire (CCQ) scores. METHODS: We used data from three clinical trials (the Randomized Clinical Trial on Effectiveness of Integrated COPD Management in Primary Care [RECODE], the Assessment Of Going Home Under Early Assisted Discharge [GO-AHEAD], and the Health Status Guided COPD Care [MARCH]). Data were randomly split into an estimation sample and a validation sample. The conceptual similarity between patient-reported CCQ and preference-based EQ-5D scores was assessed using correlation and principal-component analysis. Different types of models were estimated with increasing complexity. We selected the final models on the basis of mean absolute error and root mean square error when comparing predicted and observed values from the same population (internal validity) and from different trial populations (external validity). We also developed models for different country-specific EQ-5D value sets. RESULTS: The principal-component analysis showed that the CCQ domains functional state and mental state are associated with four dimensions of the EQ-5D. The EQ-5D dimension pain/discomfort formed a separate construct on which no CCQ item loaded. The mean observed EQ-5D values were not significantly different from the mean predicted EQ-5D values in internal validation samples but did significantly differ in external validation samples. The models underestimated EQ-5D values in milder health states and overestimated them in more severe health states. The predictive ability of the models was similar across different EQ-5D value sets. CONCLUSIONS: The models can predict mean EQ-5D values that are similar to observed mean values in a similar population. The overestimating/underestimating of the low/high EQ-5D values, however, limits its use in Markov models. Therefore, mapping should be used cautiously.

Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.

OBJECTIVE: To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. DESIGN: 24 month, multicentre, pragmatic cluster randomised controlled trial SETTING: 40 general practices in the western part of the Netherlands PARTICIPANTS: Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. INTERVENTION: General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). MAIN OUTCOME MEASURES: The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. RESULTS: Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain. CONCLUSION: In this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system. TRIAL REGISTRATION: Netherlands Trial Register NTR2268.

Are GOLD ABCD groups better associated with health status and costs than GOLD 1234 grades? A cross-sectional study.

AIMS: To investigate the association of the GOLD ABCD groups classification with costs and health-related quality of life (HR-QoL) and to compare this with the GOLD 1234 grades classification that was primarily based on lung function only. METHODS: In a cross-sectional study, we selected patients diagnosed with chronic obstructive pulmonary disease (COPD) from electronic medical records of general practices. Multi-level analysis was used with costs (medication, primary care, healthcare, societal), diseasespecific and generic HR-QoL as independent variables. Either the new or the old GOLD stages were included in the analysis together with several covariates (age, gender, living situation, co-morbidity, self-efficacy, smoking, education, employment). RESULTS: 611 patients from 28 general practices were categorised as GOLD-A (n=333), GOLD-B (n=110), GOLD-C (n=80) and GOLD-D (n=88). Patients in the GOLD-B and GOLD-D groups had the highest prevalence of co-morbidities and the lowest level of physical activity, self-efficacy, and employment. The models with GOLD ABCD groups were more strongly related to and explained more variance in costs and in disease-specific and generic HR-QoL than the models with GOLD 1234 grades. The mean Clinical COPD Questionnaire score worsened significantly, with scores 1.04 (GOLD-B), 0.4 (GOLD-C) and 1.21 (GOLD-D) worse than for patients in GOLD-A. Healthcare costs per patient were significantly higher in GOLD-B (72%), GOLD-C (74%) and GOLD-D (131%) patients than in GOLD-A patients. CONCLUSIONS: The GOLD ABCD groups classification is more closely associated with costs and HR-QoL than the GOLD 1234 grades classification. Furthermore, patients with GOLD-C had a better HR-QoL than those with GOLD-B but the costs of the two groups did not differ.

Cochrane corner: is integrated disease management for patients with COPD effective?

Patients with COPD experience respiratory symptoms, impairments of daily living and recurrent exacerbations. The aim of integrated disease management (IDM) is to establish a programme of different components of care (ie, self-management, exercise, nutrition) in which several healthcare providers (ie, nurses, general practitioners, physiotherapists, pulmonologists) collaborate to provide efficient and good quality of care. The aim of this Cochrane systematic review was to evaluate the effectiveness of IDM on quality of life, exercise tolerance and exacerbation related outcomes. Searches for all available evidence were carried out in various databases. Included randomised controlled trials (RCTs) consisted of interventions with multidisciplinary (≥2 healthcare providers) and multitreatment (≥2 components) IDM interventions with duration of at least 3 months. Two reviewers independently searched, assessed and extracted data of all RCTs. A total of 26 RCTs were included, involving 2997 patients from 11 different countries with a follow-up varying from 3 to 24 months. In all 68% of the patients were men, with a mean age of 68 years and a mean forced expiratory volume in 1 s (FEV1) predicted value of 44.3%. Patients treated with an IDM programme improved significantly on quality of life scores and reported a clinically relevant improvement of 44 m on 6 min walking distance, compared to controls. Furthermore, the number of patients with ≥1 respiratory related hospital admission reduced from 27 to 20 per 100 patients. Duration of hospitalisation decreased significantly by nearly 4 days.