Feasibility study of the Digital Patient Benefit Assessment Scale (P-BAS): A Digital Tool to Assess Individual Patient Goals.

The study objective was to assess the feasibility of the Patient Benefit Assessment Scale (P-BAS), a digital tool designed to enable older outpatients (≥70 years) to elucidate at home their individual goals regarding their current medical issue. Several digital tools are developed to assist older people in identifying their goals, thereby facilitating the process of shared decision making. However, studies on the feasibility of these digital tools, especially in older patients, are limited. Data were collected from 36 older patients. The study comprised three stages. In stage I and II, cognitive interviews were conducted to strengthen the feasibility of the P-BAS. In stage III, 80% of the patients completed the P-BAS independently at home. The cognitive interviews provided insight into patients' interpretation and individual understanding of the digital visual P-BAS and associated opportunities for improvement, which were subsequently implemented. One conclusion is that the digital visual P-BAS might be of added value for patients and contributes to the process of shared decision making, assuring that the goals of the patient will be into account in treatment options. Findings are useful for researchers interested in technological tools that contribute to shared decision making.

Economic Evaluation of the Dr. Bart Application in Individuals With Knee and/or Hip Osteoarthritis.

OBJECTIVE: To evaluate the cost-utility and cost-effectiveness of the dr. Bart app compared to usual care in people with osteoarthritis (OA) of the knees and hips, applying a health care payer perspective. METHODS: This economic evaluation was conducted alongside a 6-month randomized controlled trial that included 427 participants. The dr. Bart app is a stand-alone eHealth application that invites users to select pre-formulated goals (i.e., "tiny habits") and triggers for a healthier lifestyle. Self-reported outcome measures were health care costs, quality-adjusted life years (QALYs) according to the EuroQol 5-dimension 3-level (EQ-5D-3L) descriptive system, the EuroQol visual analog scale (QALY VAS), patient activation measure 13 (PAM-13), and 5 subscales of the Knee Injury and Osteoarthritis Outcome Score/Hip Disability and Osteoarthritis Outcome Score. Missing data were multiply imputed, and bootstrapping was used to estimate statistical uncertainty. RESULTS: The mean ± SD age of the study participants was 62.1 ± 7.3 years, and the majority of participants were female (72%). Health care costs were lower in the intervention group compared to the group who received usual care (€-22 [95% confidence interval €-36, -3]). For QALY and QALY VAS, the probability of the dr. Bart app being cost-effective compared to usual care was 0.71 and 0.67, respectively, at a willingness-to-pay (WTP) of €10,000 and 0.64 and 0.56, respectively, at a WTP of €80.000. For self-management behavior, symptoms, pain, and activities of daily living, the probability that the dr. Bart app was cost-effective was >0.82, and the probability that the dr. Bart app was cost-effective in the areas of activities and quality of life was <0.40, regardless of WTP thresholds. CONCLUSION: This economic evaluation showed that costs were lower for the dr. Bart app group compared to the group who received usual care. Given the noninvasive nature of the intervention and the moderate probability of it being cost-effective for the majority of outcomes, the dr. Bart app has the potential to serve as a tool to provide education and goal setting in OA and its treatment options.

Optimizing the risk threshold of lymph node involvement for performing extended pelvic lymph node dissection in prostate cancer patients: a cost-effectiveness analysis.

BACKGROUND: Extended pelvic lymph node dissection (ePLND) may be omitted in prostate cancer (CaP) patients with a low predicted risk of lymph node involvement (LNI). The aim of the current study was to quantify the cost-effectiveness of using different risk thresholds for predicted LNI in CaP patients to inform decision making on omitting ePLND. METHODS: Five different thresholds (2%, 5%, 10%, 20%, and 100%) used in practice for performing ePLND were compared using a decision analytic cohort model with the 100% threshold (i.e., no ePLND) as reference. Compared outcomes consisted of quality-adjusted life years (QALYs) and costs. Baseline characteristics for the hypothetical cohort were based on an actual Dutch patient cohort containing 925 patients who underwent ePLND with risks of LNI predicted by the Memorial Sloan Kettering Cancer Center web-calculator. The best strategy was selected based on the incremental cost effectiveness ratio when applying a willingness to pay (WTP) threshold of €20,000 per QALY gained. Probabilistic sensitivity analysis was performed with Monte Carlo simulation to assess the robustness of the results. RESULTS: Costs and health outcomes were lowest (€4,858 and 6.04 QALYs) for the 100% threshold, and highest (€10,939 and 6.21 QALYs) for the 2% threshold, respectively. The incremental cost effectiveness ratio for the 2%, 5%, 10%, and 20% threshold compared with the first threshold above (i.e., 5%, 10%, 20%, and 100%) were €189,222/QALY, €130,689/QALY, €51,920/QALY, and €23,187/QALY respectively. Applying a WTP threshold of €20.000 the probabilities for the 2%, 5%, 10%, 20%, and 100% threshold strategies being cost-effective were 0.0%, 0.3%, 4.9%, 30.3%, and 64.5% respectively. CONCLUSION: Applying a WTP threshold of €20.000, completely omitting ePLND in CaP patients is cost-effective compared to other risk-based strategies. However, applying a 20% threshold for probable LNI to the Briganti 2012 nomogram or the Memorial Sloan Kettering Cancer Center web-calculator, may be a feasible alternative, in particular when higher WTP values are considered.

Medication burden in epilepsy: Exploring the impact of non-epilepsy concomitant drugs load.

PURPOSE: To determine the burden of non-epilepsy drugs on people with epilepsy, using administrative health care data. METHODS: The Achmea Health Insurance Database (AHID) contains health claims data from 25 % of the Dutch population. From the AHID, we selected all policyholders with coverage for at least one full calendar year between 2006-2009. We included adults with diagnostic codes for epilepsy and randomly selected two frequency-matched controls per case. We labeled drugs dispensed at least twice per calendar year as chronic and excluded antiseizure medications. We estimated and compared the prevalence of chronic medication use, number of chronic medications used, number of prescriptions dispensed, Rx Risk comorbidity index, and drug burden index (DBI) between people with epilepsy and controls. RESULTS: Non-epilepsy chronic medication use was more frequent in people with epilepsy than controls (67 % versus 59 %, p < 0.001). People with epilepsy had an increased DBI (average 0.19 versus 0.10, p < 0.001), used more chronic medications (median 2 versus 1, p < 0.001) and had more prescriptions dispensed (median 7 versus 3, p < 0.001). The DBI and number of unique chronic medications were higher among older (>60 years) than younger (<60 years) subjects in cases and controls. Non-epilepsy chronic medication use was more prevalent in people with epilepsy across all therapeutic drug classes and most comorbidities measured using the Rx Risk score. CONCLUSION: Chronic non-epilepsy medication use is more prevalent among people with epilepsy. The medication burden is higher among elderly with epilepsy and could partially explain the lower quality of life of people with epilepsy with comorbidities.

Development and evaluation of a tailored e-self-management intervention (dr. Bart app) for knee and/or hip osteoarthritis: study protocol.

BACKGROUND: This paper describes (the development of) an eHealth tool (dr. Bart app) to enhance self-management and to optimize non-surgical health care utilization in patients with knee and/or hip osteoarthritis (OA) and presents a study aiming 1) to study the effectiveness of the dr. Bart app on health care use 2) to explore differences in use, usability and the clinical outcomes of the dr. Bart app between the Netherlands and Germany. METHODS: The dr. Bart app is a fully automated eHealth application and is based on the Fogg model for behavioural change, augmented with reminders, rewards and self-monitoring to reinforce app engagement and health behaviour. The dr. Bart app propose goals to a healthier lifestyle based on machine learning techniques fed by data collected in a personal profile and choosing behaviour of the app user. Patients ≥50 years with self-reported knee and/or hip OA will be eligible to participate. Participants will be recruited in the community through advertisements in local newspapers and campaigns on social media. This protocol presents a study with three arms, aiming to include 161 patients in each arm. In the Netherlands, patients are randomly allocated to usual care or dr. Bart app and in Germany all patients receive the dr. Bart app. The primary outcome of the first research question is the number of self-reported consultations in secondary health care. The primary outcome of the second research question (comparison between the Netherlands and Germany) is self-management behaviour assessed by the patient activation measure (PAM-13) questionnaire. Secondary outcomes are costs, health-related quality of life, physical functioning and activity, pain, use and usability of the dr. Bart app. Data will be collected through three online questionnaires (at baseline and after 3 and 6 months after inclusion). DISCUSSION: This study will gain insight into the effectiveness of the dr. Bart app in the (conservative) treatment of patients with knee and/or hip OA and differences in the use and usability of the dr. Bart app between the Netherlands and Germany. TRIAL REGISTRATION: Dutch Trial Register (Trial Number NTR6693 / NL6505 ). Registration date: 4 September 2017.

Cost-Effectiveness Analysis of the DiagnOSAS Screening Tool Compared With Polysomnography Diagnosis in Dutch Primary Care.

STUDY OBJECTIVES: The growing recognition of obstructive sleep apnea (OSA) as a serious health condition, increasing waiting lists for sleep tests, and a high proportion of unnecessary referrals from general practice highlight the need for alternative diagnostic strategies for OSA. This study's objective was to investigate the cost-effectiveness of DiagnOSAS, a screening tool that strives to facilitate fast and well-informed referral to hospitals and sleep clinics for diagnosis, in The Netherlands. METHODS: A Markov model was constructed to assess cost-effectiveness in men aged 50 years. The diagnostic process of OSA was simulated with and without DiagnOSAS, taking into account the occurrence of hazardous OSA effects: car accidents, myocardial infarction, and stroke. The cost-effectiveness of "DiagnOSAS Strategy" and a "Rapid Diagnosis Scenario," in which time to diagnosis was halved, was assessed. RESULTS: Base case results show that, within a 10-year time period, DiagnOSAS saves €226 per patient at a negligible decrease (< 0.01) in quality-adjusted life-years (QALYs), resulting in an incremental cost-effectiveness ratio of €56,997/QALY. The "Rapid Diagnosis Scenario" dominates usual care (ie, is both cheaper and more effective). For a willingness-to-pay threshold of €20,000/QALY the probability that the "DiagnOSAS Strategy" and "Rapid Diagnosis Scenario" are cost-effective equals 91.7% and 99.3%, respectively. CONCLUSIONS: DiagnOSAS appears to be a cost-saving alternative for the usual OSA diagnostic strategy in The Netherlands. When DiagnOSAS succeeds in decreasing time to diagnosis, it could substantially improve health outcomes as well.

The predictive value of an adjusted COPD assessment test score on the risk of respiratory-related hospitalizations in severe COPD patients.

We evaluated whether a chronic obstructive pulmonary disease (COPD) assessment test (CAT) with adjusted weights for the CAT items could better predict future respiratory-related hospitalizations than the original CAT. Two focus groups (respiratory nurses and physicians) generated two adjusted CAT algorithms. Two multivariate logistic regression models for infrequent (≤1/year) versus frequent (>1/year) future respiratory-related hospitalizations were defined: one with the adjusted CAT score that correlated best with future hospitalizations and one with the original CAT score. Patient characteristics related to future hospitalizations ( p ≤ 0.2) were also entered. Eighty-two COPD patients were included. The CAT algorithm derived from the nurse focus group was a borderline significant predictor of hospitalization risk (odds ratio (OR): 1.07; 95% confidence interval (CI): 1.00-1.14; p = 0.050) in a model that also included hospitalization frequency in the previous year (OR: 3.98; 95% CI: 1.30-12.16; p = 0.016) and anticholinergic risk score (OR: 3.08; 95% CI: 0.87-10.89; p = 0.081). Presence of ischemic heart disease and/or heart failure appeared 'protective' (OR: 0.17; 95% CI: 0.05-0.62; p = 0.007). The original CAT score was not significantly associated with hospitalization risk. In conclusion, as a predictor of respiratory-related hospitalizations, an adjusted CAT score was marginally significant (although the original CAT score was not). 'Previous respiratory-related hospitalizations' was the strongest factor in this equation.

Prognostic assessment in COPD without lung function: the B-AE-D indices.

Several composite markers have been proposed for risk assessment in chronic obstructive pulmonary disease (COPD). However, choice of parameters and score complexity restrict clinical applicability. Our aim was to provide and validate a simplified COPD risk index independent of lung function.The PROMISE study (n=530) was used to develop a novel prognostic index. Index performance was assessed regarding 2-year COPD-related mortality and all-cause mortality. External validity was tested in stable and exacerbated COPD patients in the ProCOLD, COCOMICS and COMIC cohorts (total n=2988).Using a mixed clinical and statistical approach, body mass index (B), severe acute exacerbations of COPD frequency (AE), modified Medical Research Council dyspnoea severity (D) and copeptin (C) were identified as the most suitable simplified marker combination. 0, 1 or 2 points were assigned to each parameter and totalled to B-AE-D or B-AE-D-C. It was observed that B-AE-D and B-AE-D-C were at least as good as BODE (body mass index, airflow obstruction, dyspnoea, exercise capacity), ADO (age, dyspnoea, airflow obstruction) and DOSE (dyspnoea, obstruction, smoking, exacerbation) indices for predicting 2-year all-cause mortality (c-statistic: 0.74, 0.77, 0.69, 0.72 and 0.63, respectively; Hosmer-Lemeshow test all p>0.05). Both indices were COPD specific (c-statistic for predicting COPD-related 2-year mortality: 0.87 and 0.89, respectively). External validation of B-AE-D was performed in COCOMICS and COMIC (c-statistic for 1-year all-cause mortality: 0.68 and 0.74; c-statistic for 2-year all-cause mortality: 0.65 and 0.67; Hosmer-Lemeshow test all p>0.05).The B-AE-D index, plus copeptin if available, allows a simple and accurate assessment of COPD-related risk.

Cost-Effectiveness of a Community-Based Exercise Programme in COPD Self-Management.

INTRODUCTION: Information regarding cost-effectiveness of community-based exercise programmes in COPD is scarce. Therefore, we have investigated whether a community-based exercise programme is a cost-effective component of self-management for patients with COPD after 2 years of follow-up. METHODS: All included COPD patients participated in four self-management sessions. Additionally, patients in the COPE-active group participated in an 11-month community-based exercise programme led by physiotherapists. Patients trained 3 times/week for 6 months and two times/week during the subsequent 5 months. In both periods, one of these weekly training sessions was home-based (unsupervised). No formal physiotherapy sessions were offered to COPE-active patients in the second year. A decision analytical model with a 24-month perspective was used to evaluate cost-effectiveness. Incremental cost-effectiveness ratios (ICER) were calculated and cost-effectiveness planes were created. RESULTS: Data of 77 patients participating in the exercise programme and 76 patients in the control group were analysed. The ICER for an additional patient prevented from deteriorating at least 47.5 meters on the ISWT was €6257. The ICER for an additional patient with a clinically relevant improvement (≥ 500 steps/day) in physical activity was €1564, and the ICER for an additional quality-adjusted life year (QALY) was €10 950. CONCLUSION: Due to a lack of maintenance of beneficial effects on our primary outcome exercise capacity after 2 years of follow-up and higher costs of the programme, the community-based exercise programme cannot be considered cost-effective compared to self-management programmes only. Nevertheless, the ICERs for the secondary outcomes physical activity and QALY are generally considered acceptable.

Dealing With Missing Behavioral Endpoints in Health Promotion Research by Modeling Cognitive Parameters in Cost-Effectiveness Analyses of Behavioral Interventions: A Validation Study.

Cost-effectiveness analyses (CEAs) of behavioral interventions typically use physical outcome criteria. However, any progress in cognitive antecedents of behavior change may be seen as a beneficial outcome of an intervention. The aim of this study is to explore the feasibility and validity of incorporating cognitive parameters of behavior change in CEAs. The CEA from a randomized controlled trial on smoking cessation was reanalyzed. First, relevant cognitive antecedents of behavior change in this dataset were identified. Then, transition probabilities between combined states of smoking and cognitions at 6 weeks and corresponding 6 months smoking status were obtained from the dataset. These rates were extrapolated to the period from 6 to 12 months in a decision analytic model. Simulated results were compared with the 12 months' observed cost-effectiveness results. Self-efficacy was the strongest time-varying predictor of smoking cessation. Twelve months' observed CEA results for the multiple tailoring intervention versus usual care showed € 3188 had to be paid for each additional quitter versus € 10,600 in the simulated model. The simulated CEA showed largely similar but somewhat more conservative results. Using self-efficacy to enhance the estimation of the true behavioral outcome seems a feasible and valid way to estimate future cost-effectiveness.

How does injury compensation affect health and disability in patients with complaints of whiplash? A qualitative study among rehabilitation experts-professionals.

PURPOSE: To explore rehabilitation professionals' opinions about the influence and the pathways of injury compensation (IC) on health and disability in patients with whiplash associated disorder (WAD). METHODS: Semi-structured interviews were performed among a purposeful selected sample of Dutch expert-professionals in the field of rehabilitation of patients with WAD. Inclusion continued until saturation was reached. Inductive and deductive thematic analyses were performed. RESULTS: Ten rehabilitation expert-professionals (five females), working as physician, psychologist or physiotherapist, were interviewed. All expert-professionals acknowledged that IC can influence rehabilitation, health and disability. The expert-professionals provided three causal pathways; a pathway through prolonged distress, a behavioral pathway, and patient characteristics that may either attenuate or worsen their response. They assess the influence of IC mainly with interview techniques. Most professionals discuss the potential influence of IC with their patients, because they want to give clear information to the patient. Some emphasize that their role is neutral in relation with the IC. Others mention that financial consequences can accompany functional improvement. CONCLUSIONS: Rehabilitation expert-professionals believe that IC may affect rehabilitation, health and disability in patients with WAD. Three pathways are mentioned by the experts-professionals. IMPLICATIONS FOR REHABILITATION: According to rehabilitation expert-professionals, an injury compensation (IC) can lead to distress, by creating a (conscious or unconscious) conflict of interests within a patient between striving for compensation on one hand, and recovery on the other hand. Patient characteristics can either attenuate or worsen IC-related distress. Reliable and valid tools need to be developed to assess the influence of IC on health, disability and rehabilitation, and to limit the negative effects. Rehabilitation professionals can discuss the possible unintended effects of IC with their patients to clarify their current situation.

(Cost-)effectiveness of self-treatment of exacerbations in patients with COPD: 2 years follow-up of a RCT.

BACKGROUND AND OBJECTIVE: Long-term effectiveness of action plans in patients with chronic obstructive pulmonary disease (COPD) is minimally investigated. We have evaluated the (cost-)effectiveness of a self-management programme with or without self-treatment of exacerbations after 2 years follow-up. METHODS: Self-management with or without self-treatment of exacerbations was randomly assigned to patients. All patients participated in four self-management meetings. Patients in the self-treatment group (STG) also learned to use an action plan to start a course of prednisolone and/or antibiotics in case of worsening of symptoms. Primary outcome was the duration and severity of exacerbations. RESULTS: Data of 70 COPD patients in the STG and 72 patients in the control group (CG) were analysed. Over 2 years, the median number of exacerbation days was significantly lower in the STG (50, IQR: 32-115) compared with the CG (82, IQR: 22-186) (P = 0.047), as was the mean symptom score of an exacerbation (STG: 43.4, IQR 27.2-68.6 vs CG: 55.9, IQR: 31.2-96.8) (P = 0.029). Also, patients in the STG visited the respiratory physician and emergency department less frequently than patients in the CG with incidence rate ratios of 1.52 (95% CI: 1.28-1.79) and 2.27 (95% CI: 1.11-4.62), respectively. Direct medical costs per patient over 2 years were €1078 lower in the STG. CONCLUSION: Self-treatment of exacerbations is beneficial in COPD patients without significant comorbidities because it reduces exacerbation duration, exacerbation severity and health-care utilization leading to considerable cost savings.

Relationship between self-reported disability and functional capacity in patients with whiplash associated disorder.

PURPOSE: Patients with chronic Whiplash Associated Disorders (WAD) report symptoms and disability. Neither the relationship between self-reported disability and functional capacity, nor its predictors have been investigated in patients with WAD. This was the purpose of this study. METHOD: This was a cross-sectional study. Participants were patients with WAD on sick leave. Self-reported disability was assessed with the Neck Disability Index (NDI). Functional capacity was assessed with a six-item neck functional capacity evaluation (FCE). Correlation coefficients were used to express the relationship between NDI (total and items) and FCE. Multivariate linear regression analyses were performed to identify independent predictors of NDI and FCE. RESULTS: Forty patients were measured, of whom 18 (45 %) were male. Mean age was 33 years, median duration of complaints was 12 months, and 75 % had a pending insurance claim. Correlations between NDI and FCE tests varied from -0.39 to -0.70. Independent predictors of NDI were pain intensity and a pending claim, explaining 43 % of the variance. independent predictors of fce were ndi, gender, and pain intensity, explaining 20-55 % of the variance. CONCLUSIONS: Self-reported disability and functional capacity are related but different. Both can part be predicted by pain intensity. A pending claim can predict higher self-reported disability. Both constructs are complementary and are recommended to determine disability in patients with WAD comprehensively.

A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towards COPD and frequently existing comorbidities can reduce COPD exacerbation days. We hypothesise that this approach, which combines self-initiated action plans and nurse support, will accelerate proper treatment actions and lead to better control of deteriorating symptoms. METHODS: In this multicenter randomised controlled trial we aim to include 300 patients with COPD (GOLD II-IV), and with at least one comorbidity (cardiovascular disease, diabetes, anxiety and/or depression). Patients will be recruited from hospitals in the Netherlands (n = 150) and Australia (n = 150) and will be assigned to an intervention or control group. All patients will learn to complete daily symptom diaries for 12-months. Intervention group patients will participate in self-management training sessions to learn the use of individualised action plans for COPD and comorbidities, linked to the diary. The primary outcome is the number of COPD exacerbation days. Secondary outcomes include hospitalisations, quality of life, self-efficacy, adherence, patient's satisfaction and confidence, health care use and cost data. ANALYSES: Intention-to-treat analyses (random effect negative binomial regression and random effect mixed models) and cost-effectiveness analyses will be performed. DISCUSSION: Prudence should be employed before extrapolating the use of COPD specific action plans in patients with comorbidities. This study evaluates the efficacy of tailored action plans for both COPD and common comorbidities.

Moving beyond a limited follow-up in cost-effectiveness analyses of behavioral interventions.

BACKGROUND: Cost-effectiveness analyses of behavioral interventions typically use a dichotomous outcome criterion. However, achieving behavioral change is a complex process involving several steps towards a change in behavior. Delayed effects may occur after an intervention period ends, which can lead to underestimation of these interventions. To account for such delayed effects, intermediate outcomes of behavioral change may be used in cost-effectiveness analyses. The aim of this study is to model cognitive parameters of behavioral change into a cost-effectiveness model of a behavioral intervention. METHODS: The cost-effectiveness analysis (CEA) of an existing dataset from an RCT in which an high-intensity smoking cessation intervention was compared with a medium-intensity intervention, was re-analyzed by modeling the stages of change of the Transtheoretical Model of behavioral change. Probabilities were obtained from the dataset and literature and a sensitivity analysis was performed. RESULTS: In the original CEA over the first 12 months, the high-intensity intervention dominated in approximately 58% of the cases. After modeling the cognitive parameters to a future 2nd year of follow-up, this was the case in approximately 79%. CONCLUSION: This study showed that modeling of future behavioral change in CEA of a behavioral intervention further strengthened the results of the standard CEA. Ultimately, modeling future behavioral change could have important consequences for health policy development in general and the adoption of behavioral interventions in particular.

The role of cognition in cost-effectiveness analyses of behavioral interventions.

BACKGROUND: Behavioral interventions typically focus on objective behavioral endpoints like weight loss and smoking cessation. In reality, though, achieving full behavior change is a complex process in which several steps towards success are taken. Any progress in this process may also be considered as a beneficial outcome of the intervention, assuming that this increases the likelihood to achieve successful behavior change eventually. Until recently, there has been little consideration about whether partial behavior change at follow-up should be incorporated in cost-effectiveness analyses (CEAs). The aim of this explorative review is to identify CEAs of behavioral interventions in which cognitive outcome measures of behavior change are analyzed. METHODS: Data sources were searched for publications before May 2011. RESULTS: Twelve studies were found eligible for inclusion. Two different approaches were found: three studies calculated separate incremental cost-effectiveness ratios for cognitive outcome measures, and one study modeled partial behavior change into the final outcome. Both approaches rely on the assumption, be it implicitly or explicitly, that changes in cognitive outcome measures are predictive of future behavior change and may affect CEA outcomes. CONCLUSION: Potential value of cognitive states in CEA, as a way to account for partial behavior change, is to some extent recognized but not (yet) integrated in the field. In conclusion, CEAs should consider, and where appropriate incorporate measures of partial behavior change when reporting effectiveness and hence cost-effectiveness.

Multicenter assessment of the reproducibility of volumetric radiofrequency-based intravascular ultrasound measurements in coronary lesions that were consecutively stented.

To assess in a multicenter design the between-center reproducibility of volumetric virtual histology intravascular ultrasound (VH-IVUS) measurements with a semi-automated, computer-assisted contour detection system in coronary lesions that were consecutively stented. To evaluate the reproducibility of volumetric VH-IVUS measurements, experienced analysts of 4 European IVUS centers performed independent analyses (in total 8,052 cross-sectional analyses) to obtain volumetric data of 40 coronary segments (length 20.0 ± 0.3 mm) from target lesions prior to percutaneous intervention that were performed in the setting of stable (65%) or unstable angina pectoris (35%). Geometric and compositional VH-IVUS measurements were highly correlated for the different comparisons. Overall intraclass correlation for vessel, lumen, plaque volume and plaque burden was 0.99, 0.92, 0.96, and 0.83, respectively; for fibrous, fibro-lipidic, necrotic core and calcified volumes overall intraclass correlation was 0.96, 0.94, 0.98, and 0.99, respectively. Nevertheless, significant differences for both geometrical and compositional measurements were seen. Of the plaque components, fibrous tissue and necrotic core showed on average the highest measurement reproducibility. A central analysis for VH-IVUS multicenter studies of lesions prior to PCI should be pursued. Moreover, it may be problematical to pool VH-IVUS data of individual trials analyzed by independent centers.

Cost-effectiveness of an intensive smoking cessation intervention for COPD outpatients.

INTRODUCTION: To determine the cost-effectiveness of a high-intensity smoking cessation program (SmokeStop Therapy; SST) versus a medium-intensity treatment (Minimal Intervention Strategy for Lung patients [LMIS]) for chronic obstructive pulmonary disease outpatients. METHODS: The cost-effectiveness analysis was based on a randomized controlled trial investigating the effectiveness of the SST compared with the LMIS with 12-month follow-up. The primary outcome measure was the cotinine-validated continuous abstinence rate based on intention to treat. A health care perspective was adopted, with outcomes assessed in terms of (incremental) additional quitters gained, exacerbations prevented, and hospital days prevented. Health care resource use, associated with smoking cessation, was collected at baseline and 12 months after the start of the interventions. Monte Carlo simulations were performed to evaluate the robustness of the results. RESULTS: The average patient receiving SST generated €581 in health care costs, including the costs of the smoking cessation program, versus €595 in the LMIS. The SST is also associated with a lower average number of exacerbations (0.38 vs. 0.60) and hospital days (0.39 vs. 1) per patient and a higher number of quitters (20 vs. 9) at lower total costs. This leads to a dominance of the SST compared with the LMIS. CONCLUSIONS: The high-intensive SST is more cost-effective than the medium-intensive LMIS after 1 year. This is associated with cost savings per additional quitter, prevented exacerbations, and hospital days at lower or equal costs.

Assessment of inhalation technique in children in general practice: increased risk of incorrect performance with new device.

In a general practice based population 76% of 530 children inhaling asthma medication inhaled correctly. However, important differences among inhalers were found. Children with a pressurized metered-dose inhaler without a spacer device performed worst, with only 22% inhaling without essential errors. At a second evaluation of the inhaler technique, one year after the first assessment, performances with a new device were more often incorrect versus the unchanged devices (21.1% and 10.8%, respectively; p = 0.01). Providing children with a new device should be carefully controlled over time especially because these children are error prone.