Prophylactic Mesh Placement During Formation of an End-colostomy Reduces the Rate of Parastomal Hernia: Short-term Results of the Dutch PREVENT-trial.

OBJECTIVE: The aim of this study was to investigate the incidence of parastomal hernias (PSHs) after end-colostomy formation using a polypropylene mesh in a randomized controlled trial versus conventional colostomy formation. BACKGROUND: A PSH is the most frequent complication after stoma formation. Symptoms may range from mild abdominal pain to life-threatening obstruction and strangulation. The treatment of a PSH is notoriously difficult and recurrences up to 20% have been reported despite the use of mesh. This has moved surgical focus toward prevention. METHODS: Augmentation of the abdominal wall with a retro-muscular lightweight polypropylene mesh was compared with the traditional formation of a colostomy. In total, 150 patients (1:1 ratio) were included. The incidence of a PSH, morbidity, mortality, quality of life, and cost-effectiveness was measured after 1 year of follow-up. RESULTS: There was no difference between groups regarding demographics and predisposing factors for PSH. Three out of 67 patients (4.5%) in the mesh group and 16 out of 66 patients (24.2%) in the nonmesh group developed a PSH (P = 0.0011). No statistically significant difference was found in infections, concomitant hernias, SF-36 questionnaire, Von Korff pain score, and cost-effectiveness between both study groups. CONCLUSION: Prophylactic augmentation of the abdominal wall with a retromuscular lightweight polypropylene mesh at the ostomy site significantly reduces the incidence of PSH without a significant difference in morbidity, mortality, quality of life, or cost-effectiveness.

A Network Meta-Analysis of Clinical Management Strategies for Treatment-Resistant Hypertension: Making Optimal Use of the Evidence.

BACKGROUND: With the addition of surgical interventions to current medicinal treatments, it is increasingly challenging for clinicians to rationally choose among the various options for treating patients with apparent treatment-resistant hypertension (ATRHTN). This study aims to establish the comparative effectiveness of mineralocorticoid receptor antagonists (MRA), renal denervation (RDN), darusentan and central arteriovenous anastomosis (CAA) for patients with ATRHTN by performing a network meta-analysis. METHODS: Data Sources: Studies from recent meta-analyses for RDN and placebo effect were supplemented with a systematic search for MRAs in ATRHTN in the Pubmed, EMBASE, CINAHL and Cochrane databases through November 2016. STUDY SELECTION: Randomized controlled trials comparing treatment options for patients with ATRHTN. DATA EXTRACTION AND SYNTHESIS: Data were extracted using predefined data extraction forms, including the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. A Bayesian random effects model was used to conduct a network meta-analysis. Spironolactone was used as the main comparator. Main Outcomes and Measures: Reduction in 24-h ambulatory blood pressure measurement (ABPM). RESULTS: Twenty articles met our inclusion criteria, and seven treatment alternatives were compared. Compared to MRA, CAA had the highest probability of being more effective, further reducing 24-h SBP (-4.8 mmHg [-13.0, 3.7]) and 24-h DBP (-9.7 mmHg [-18, -0.63]). This difference is likely to be clinically meaningful, with a probability of 78 and 96% at a threshold of a 2-mmHg reduction in blood pressure. CONCLUSIONS: When compared to MRA as anchor, darusentan, CAA and RDN are not more effective in achieving a clinically significant reduction in ambulatory blood pressure in individuals with apparent treatment-resistant hypertension.

Establishing a composite endpoint for measuring the effectiveness of geriatric interventions based on older persons' and informal caregivers' preference weights: a vignette study.

BACKGROUND: The Older Persons and Informal Caregivers Survey Minimal Dataset's (TOPICS-MDS) questionnaire which measures relevant outcomes for elderly people was successfully incorporated into over 60 research projects of the Dutch National Care for the Elderly Programme. A composite endpoint (CEP) for this instrument would be helpful to compare effectiveness of the various intervention projects. Therefore, our aim is to establish a CEP for the TOPICS-MDS questionnaire, based on the preferences of elderly persons and informal caregivers. METHODS: A vignette study was conducted with 200 persons (124 elderly and 76 informal caregivers) as raters. The vignettes described eight TOPICS-MDS outcomes of older persons (morbidity, functional limitations, emotional well-being, pain experience, cognitive functioning, social functioning, self-perceived health and self-perceived quality of life) and the raters assessed the general well-being (GWB) of these vignette cases on a numeric rating scale (0-10). Mixed linear regression analyses were used to derive the preference weights of the TOPICS-MDS outcomes (dependent variable: GWB scores; fixed factors: the eight outcomes; unstandardized coefficients: preference weights). RESULTS: The mixed regression model that combined the eight outcomes showed that the weights varied from 0.01 for social functioning to 0.16 for self-perceived health. A model that included "informal caregiver" showed that the interactions between this variable and each of the eight outcomes were not significant (p > 0.05). CONCLUSION: A preference-weighted CEP for TOPICS-MDS questionnaire was established based on the preferences of older persons and informal caregivers. With this CEP optimal comparing the effectiveness of interventions in older persons can be realized.

Evaluation of an eHealth intervention in chronic care for frail older people: why adherence is the first target.

BACKGROUND: Older people suffering from frailty often receive fragmented chronic care from multiple professionals. According to the literature, there is an urgent need for coordination of care. OBJECTIVE: The objective of this study was to investigate the effectiveness of an online health community (OHC) intervention for older people with frailty aimed at facilitating multidisciplinary communication. METHODS: The design was a controlled before-after study with 12 months follow-up in 11 family practices in the eastern part of the Netherlands. Participants consisted of frail older people living in the community requiring multidisciplinary (long-term) care. The intervention used was the health and welfare portal (ZWIP): an OHC for frail elderly patients, their informal caregivers and professionals. ZWIP contains a secure messaging system supplemented by a shared electronic health record. Primary outcomes were scores on the Instrumental Activities of Daily Living scale (IADL), mental health, and social activity limitations. RESULTS: There were 290 patients in the intervention group and 392 in the control group. Of these, 76/290 (26.2%) in the intervention group actively used ZWIP. After 12 months follow-up, we observed no significant improvement on primary patient outcomes. ADL improved in the intervention group with a standardized score of 0.21 (P=.27); IADL improved with 0.50 points, P=.64. CONCLUSIONS: Only a small percentage of frail elderly people in the study intensively used ZWIP, our newly developed and innovative eHealth tool. The use of this OHC did not significantly improve patient outcomes. This was most likely due to the limited use of the OHC, and a relatively short follow-up time. Increasing actual use of eHealth intervention seems a precondition for large-scale evaluation, and earlier adoption before frailty develops may improve later use and effectiveness of ZWIP.

Which frail older patients use online health communities and why? A mixed methods process evaluation of use of the Health and Welfare portal.

BACKGROUND: Frail older people often receive fragmented care from multiple providers. According to the literature, there is an urgent need for coordination of care. Online and eHealth tools are increasingly used to improve coordination. However, there are significant barriers to their implementation in frail older people. OBJECTIVE: Our aim was to (1) evaluate differences in use of a personal online health community (POHC) for frail older people in relation to personal characteristics, and (2) explore barriers and facilitators for use as experienced by older people and their informal caregivers, using the case of the Health and Welfare Information Portal (ZWIP). METHODS: This is a mixed methods study. For the quantitative analysis, we used POHC usage information (2 years follow-up) and baseline characteristics of frail older people. For the qualitative analysis, we used semistructured interviews with older people and their informal caregivers. Participants were recruited from 11 family practices in the east of the Netherlands and frail older people over 70 years. The ZWIP intervention is a personal online health community for frail older people, their informal caregivers, and their providers. ZWIP was developed at the Geriatrics Department of Radboud University Medical Center. We collected data on POHC use for 2 years as well as relevant patient characteristics. Interview topics were description of use, reasons for use and non-use, and user profiles. RESULTS: Of 622 frail patients in the intervention group, 290 were connected to ZWIP; 79 used ZWIP regularly (at least monthly). Main predictors for use were having an informal caregiver, having problems with activities of daily living, and having a large number of providers. Family practice level predictors were being located in a village, and whether the family practitioners had previously used electronic consultation and cared for a large percentage of frail older people. From 23 interviews, main reasons for use were perceiving ZWIP to be a good, quick, and easy way of communicating with providers and the presence of active health problems. Important reasons for non-use were lack of computer skills and preferring traditional means of consultation. CONCLUSIONS: Only 27.2% (79/290) of frail older enrolled in the POHC intervention used the POHC frequently. For implementation of personal online health communities, older people with active health problems and a sizable number of health care providers should be targeted, and the informal caregiver, if present, should be involved in the implementation process. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 11165483; http://www.controlled-trials.com/isrctn/pf/11165483 (Archived by WebCite at http://www.webcitation.org/6U3fZovoU).

Return to sender: Unraveling the role of structural and social network ties in patient sharing networks.

Healthcare is increasingly delivered through networks of organizations. Well-structured patient sharing networks are known to have positive associations with the quality of delivered services. However, the drivers of patient sharing relations are rarely studied explicitly. In line with recent developments in network and integration theorizing, we hypothesize that structural and social network ties between organizations are uniquely associated with a higher number of shared patients. We test these hypotheses using a Bayesian zero-dispersed Poisson regression model within the Additive and Multiplicative Effects Framework based on administrative claims data from 732,122 dermatological patients from the Netherlands in 2017. Our results indicate that 2.6% of all dermatological patients are shared and that the amount of shared patients is significantly associated with structural (i.e. emergency contracts) and social (i.e. shared physicians) ties between organizations, confirming our hypotheses. We also find some evidence that patients are shared with more capable organizations. Our findings highlight the role of relational ties in the way health services are delivered. At the same time, they also raise some potential anti-trust concerns.

The impact of an 'evergreening' strategy nearing patent expiration on the uptake of biosimilars and public healthcare costs: a case study on the introduction of a second administration form of trastuzumab in The Netherlands.

In this paper, we explore dynamic market share and public healthcare costs of trastuzumab's evergreening (subcutaneous) variant during introduction of trastuzumab's competitive biosimilar variants in the Netherlands. We used a time series design to assess dynamic market share of trastuzumab's evergreening variant after introducing trastuzumab's biosimilar variants, focusing on the number of treatments and patients. The public healthcare costs of this evergreening strategy were estimated using administrative claims data. Our results show that the original trastuzumab was completely replaced by the subcutaneous and biosimilar variants. The uptake of the subcutaneous form peaked at 50% market share but after the introduction of biosimilars progressively reduced to a market share of 20%, resulting in a more competitive market structure. The public healthcare costs for trastuzumab significantly decreased after the introduction of the biosimilars. After the introduction of the biosimilars, a substantial price drop is visible, with the subcutaneous version, still under patent, also falling sharply in price but less strongly than the iv/biosimilar version. As the costs are publicly funded, we recommend a more explicit societal debate to consider if the potential benefits of subcutaneous Herceptin® (and other similar medicines) are worth the additional costs, and at which price it should be reimbursed as the part of the benefit package.

A validation of the ICECAP-O in a population of post-hospitalized older people in the Netherlands.

BACKGROUND: Various healthcare and social services may impact not only health, but wellbeing as well. Such effects may be more fully captured by capability-wellbeing instruments than with Health-related Quality of Life (HrQol) instruments. The aim of this study is to validate the ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) capability wellbeing instrument in a population of post-hospitalized older people admitted to a hospital 3 months earlier. METHODS: 296 post-hospitalized older people in the Netherlands were interviewed 3 months after admission between September 2010 and January 2011. We investigated the convergent validity of the ICECAP-O and overall wellbeing measures (Cantril's ladder and Social Production Function: Instrument for Level of Well-being (SPF-IL)), as well as with various health measures (EQ5D, Katz-15 Instrumental Activities of Daily Living (IADL) scale, Geriatric Depression Scale (GDS) and the Medical Outcomes Study Short form (SF-20) social functioning dimension). Additionally, we assessed discriminant validity by comparing several relevant subgroups in our sample (based on age, depression, IADL dependency, living situation, etc.). We also investigated the relationship between overall wellbeing and the ICECAP-O, controlling for HrQol and background characteristics. RESULTS: This study suggests that the ICECAP-O has good convergent validity with wellbeing measures as well as health measures and discriminates between various groups of post-hospitalized older people. Wellbeing measured by both Cantril's ladder and SPF-IL is associated with the ICECAP-O in a multivariate analysis controlling for HRQoL as well. CONCLUSION: The ICECAP-O seems to be a valid instrument of capability-wellbeing in older, post-hospitalized people, showing good convergent validity with health and wellbeing instruments, and is able to discriminate between elderly with various health profiles. The ICECAP-O measure seems to capture both health and wellbeing. Therefore it is a promising instrument for assessing the outcomes of health and social services aimed at older people.

Capabilities and quality of life in Dutch psycho-geriatric nursing homes: an exploratory study using a proxy version of the ICECAP-O.

PURPOSE: To validate the ICECAP-O capability measure in psycho-geriatric elderly in nursing homes, we compared the capability scores of restrained and unrestrained clients. Both nursing staff and family were used as proxies for assessing clients' capabilities. METHOD: For 122 psycho-geriatric elderly, a total of 96 nursing professionals and 68 family members completed a proxy questionnaire. We investigated the convergent and discriminant validity of the ICECAP-O and measures of care dependency, health-related quality of life, and overall quality of life. We also directly compared ICECAP-O scores of the 56 clients for whom both nursing staff and family members had completed the questionnaire. RESULTS: Convergent validity between ICECAP-O and care dependency, health-related, and overall quality of life measures could be established, as well as discriminant validity for the restrained and unrestrained groups. Nursing and family proxy ICECAP-O tariffs were not significantly correlated. DISCUSSION: ICECAP-O measures a more general concept than health-related quality of life and can differentiate between restrained and non-restrained psycho-geriatric clients. Since nurses seem to be able to assess the current quality of life of clients using the ICECAP-O more precisely than the family proxies, for now the use of nursing proxies is recommended in a nursing home setting.

Self- and proxy-rating of the ICECAP-O for people with dementia: A cross-sectional linguistic validation study in Germany and Portugal.

BACKGROUND: The capability concept became a recognized approach to the measurement of quality of life. The ICECAP-O for older people aims to measure capabilities and has recently been used in people with dementia (self-rating) and informal carers (substituted judgement). However, linguistic validation studies have so far been lacking. METHODS: A cross-sectional cognitive interview study with 15 people with dementia (PwD) and 23 informal carers (ICs) was conducted in Germany and Portugal. Respondents were asked to reveal their understanding of the ICECAP-O and the capability approach as well as the response process. A summarising content analysis was performed. RESULTS: Despite the small sample, our linguistic validation of the German and Portuguese translations detected considerable difficulties or deviations in item comprehension when compared with the intended meaning. In some cases, the item interpretations did not reflect the entire scope of the associated capability dimension, though they were basically correct. Moreover, participants were not able to differentiate some items appropriately from one another, and some misinterpretations occurred. ICs relied mainly on observable behaviour, emotions, or verbal expressions of the PwD. Therefore, ICs found items that ask about the achievement of individual expectations or thoughts about the future difficult to assess. Only very few PwD clearly indicated that they understood the capability approach. ICs in Germany had more difficulties in understanding the capability concept than in ICs Portugal. DISCUSSION: This linguistic validation study in Germany and Portugal indicates a need for some rephrasing and refinements of the ICECAP-O translated items in both countries to fully encompass some dimensions and avoid misinterpretations. Further studies with larger samples are necessary. Based on our findings, the current German version for ICs' substituted judgement cannot be recommended for this kind of respondents without further advancements.

Cost-effectiveness of a pressure ulcer quality collaborative.

BACKGROUND: A quality improvement collaborative (QIC) in the Dutch long-term care sector (nursing homes, assisted living facilities, home care) used evidence-based prevention methods to reduce the incidence and prevalence of pressure ulcers (PUs). The collaborative consisted of a core team of experts and 25 organizational project teams. Our aim was to determine its cost-effectiveness from a healthcare perspective. METHODS: We used a non-controlled pre-post design to establish the change in incidence and prevalence of PUs in 88 patients over the course of a year. Staff indexed data and prevention methods (activities, materials). Quality of life (Qol) weights were assigned to the PU states. We assessed the costs of activities and materials in the project. A Markov model was built based on effectiveness and cost data, complemented with a probabilistic sensitivity analysis. To illustrate the results of longer term, three scenarios were created in which change in incidence and prevalence measures were (1) not sustained, (2) partially sustained, and (3) completely sustained. RESULTS: Incidence of PUs decreased from 15% to 4.5% for the 88 patients. Prevalence decreased from 38.6% to 22.7%. Average Quality of Life (Qol) of patients increased by 0.02 Quality Adjusted Life Years (QALY)s in two years; healthcare costs increased by euro2000 per patient; the Incremental Cost-effectiveness Ratio (ICER) was between 78,500 and 131,000 depending on whether the changes in incidence and prevalence of PU were sustained. CONCLUSIONS: During the QIC PU incidence and prevalence significantly declined. When compared to standard PU care, the QIC was probably more costly and more effective in the short run, but its long-term cost-effectiveness is questionable. The QIC can only be cost-effective if the changes in incidence and prevalence of PU are sustained.

Containing or shifting? Health expenditure decomposition for the aging Dutch population after a major reform.

Aging populations add to pressure on health budgets, notably in long-term care (LTC). This development is particularly significant in the Netherlands, because of its relatively large, publicly financed LTC sector. The recent LTC reform aimed to substitute institutional care with aging-in-place, and thus reduce LTC expenditure. We investigate whether the reform actually went beyond shifting institutional care expenditure to other healthcare domains. We use individual health insurance and social care claims for the entire Dutch population aged 65 years and above over the period 2012-2016 to gain an insight into total healthcare utilization by individuals. Based on this information, individuals are allocated into subgroups - care steps - according to their dependence on assistance and nursing care. We analyze the changes within and between these steps over time in order to demonstrate the substitution of care provision after the reform was implemented. The results show that as the population share in institutional care decreased, the average health expenditure on the individuals receiving this care increased. By contrast, the average expenditure in the district nursing care steps fell, partly due to reallocation of individuals between care steps. Due to the reallocation from the institutional care to aging-in-place, the reform has contributed to a slowdown in the growth of total health expenditure on those aged 65 years and over, at least in the short term.

Quality management and patient safety: survey results from 102 Hungarian hospitals.

OBJECTIVES: The aim of this study is to describe the development of quality management systems in Hungarian hospitals. It also aims to answer the policy question, whether a separate patient safety policy should be created additional to quality policies, on national as well as hospital level. METHOD: In 2005, a questionnaire survey was conducted to evaluate the existing quality management systems in all Hungarian hospitals. The relationship between the level of the development of quality management systems, the certification status and the current level of patient safety activities was investigated using linear regression. Quality was measured with the quality management system development score (QMSDS), and patient safety by the number of patient safety activities. RESULTS: 102 of 134 (76%) of the hospitals have returned the questionnaire. The average hospital has 24.5 of 35 core quality activities, and 4 of 11 patient safety activities. There is a statistically significant but weak relationship between the QMSDS and the number of patient safety activities, explaining 12% of the latter's variance. Certification (International Standards Organisation (ISO) and professional standard based) is not significantly related to patient safety. CONCLUSIONS: In our study quality by QMSDS is weakly related; however, certification is not significantly related to patient safety. We conclude that separate patient safety policies seem worthwhile to be created for the hospital sector in addition to the ongoing quality improvement efforts in Hungary.

Longitudinal analysis on the development of hospital quality management systems in the Netherlands.

OBJECTIVE: Many changes have been initiated in the Dutch hospital sector to optimize health-care delivery: national agenda-setting, increased competition and transparency, a new system of hospital reimbursement based on diagnosis-treatment combinations, intensified monitoring of quality and a multi-layered organizational development programme based on quality improvement collaboratives. The objective is to answer the question as to whether these changes were accompanied by a further development of hospital quality management systems and to what extent did the development within the multi-layered programme hospitals differ from that in other hospitals. DESIGN: Longitudinal data were collected in 1995, 2000, 2005 and 2007 using a validated questionnaire. Descriptive analyses and multi-level modelling were applied to test whether: (1) quality management system development stages in hospitals differ over time, (2) development stages and trends differ between hospitals participating or not participating in the multi-layered programme and (3) hospital size has an effect on development stage. SETTING: Dutch hospital sector between 1995 and 2007. PARTICIPANTS: Hospital organizations. INTERVENTION: Changes through time. MAIN OUTCOME MEASURE: Quality management system development stage. RESULTS: Since 1995, hospital quality management systems have reached higher development levels. Programme participants have developed their quality management system more rapidly than have non-participants. However, this effect is confounded by hospital size. CONCLUSIONS: Study results suggest that the combination of policy measures at macro level was accompanied by an increase in hospital size and the further development of quality management systems. Hospitals are entering the stage of systematic quality improvement.

Correction: Examining the construct and known-group validity of a composite endpoint for The Older Persons and Informal Caregivers Survey Minimum Data Set (TOPICS-MDS); A large-scale data sharing initiative.

[This corrects the article DOI: 10.1371/journal.pone.0173081.].

Examining the construct and known-group validity of a composite endpoint for The Older Persons and Informal Caregivers Survey Minimum Data Set (TOPICS-MDS); A large-scale data sharing initiative.

BACKGROUND: Preference-weighted multi-faceted endpoints have the potential to facilitate comparative effectiveness research that incorporates patient preferences. The Older Persons and Informal Caregivers Survey-Composite endpoint (TOPICS-CEP) is potentially a valuable outcome measure for evaluating interventions in geriatric care as it combines multiple outcomes relevant to older persons in a single metric. The objective of this study was to validate TOPICS-CEP across different study settings (general population, primary care and hospital). METHODS: Data were extracted from TOPICS Minimum Dataset (MDS), a pooled public-access national database with information on older persons throughout the Netherlands. Data of 17,603 older persons were used. Meta-correlations were performed between TOPICS-CEP indexed scores, EuroQol5-D utility scores and Cantril's ladder life satisfaction scores. Mixed linear regression analyses were performed to compare TOPICS-CEP indexed scores between known groups, e.g. persons with versus without depression. RESULTS: In the complete sample and when stratified by study setting TOPICS-CEP and Cantril's ladder were moderately correlated, whereas TOPICS-CEP and EQ-5D were highly correlated. Higher mean TOPICS-CEP scores were found in persons who were: married, lived independently and had an education at university level. Moreover, higher mean TOPICS-CEP scores were found in persons without dementia, depression, and dizziness with falls, respectively. Similar results were found when stratified by subgroup. CONCLUSION: This study supports that TOPICS-CEP is a robust measure which can potentially be used in broad settings to identify the effect of intervention or of prevention in elderly care.

Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial.

BACKGROUND: The distinction between unilateral aldosterone-producing adenoma or bilateral adrenal hyperplasia as causes of primary aldosteronism is usually made by adrenal CT or by adrenal vein sampling (AVS). Whether CT or AVS represents the best test for diagnosis remains unknown. We aimed to compare the outcome of CT-based management with AVS-based management for patients with primary aldosteronism. METHODS: In a randomised controlled trial, we randomly assigned patients with aldosteronism to undergo either adrenal CT or AVS to determine the presence of aldosterone-producing adenoma (with subsequent treatment consisting of adrenalectomy) or bilateral adrenal hyperplasia (subsequent treatment with mineralocorticoid receptor antagonists). The primary endpoint was the intensity of drug treatment for obtaining target blood pressure after 1 year of follow-up, in the intention-to-diagnose population. Intensity of drug treatment was expressed as daily defined doses. Key secondary endpoints included biochemical outcome in patients who received adrenalectomy, health-related quality of life, cost-effectiveness, and adverse events. This trial is registered with ClinicalTrials.gov, number NCT01096654. FINDINGS: We recruited 200 patients between July 6, 2010, and May 30, 2013. Of the 184 patients that completed follow-up, 92 received CT-based treatment (46 adrenalectomy and 46 mineralocorticoid receptor antagonist) and 92 received AVS-based treatment (46 adrenalectomy and 46 mineralocorticoid receptor antagonist). We found no differences in the intensity of antihypertensive medication required to control blood pressure between patients with CT-based treatment and those with AVS-based treatment (median daily defined doses 3·0 [IQR 1·0-5·0] vs 3·0 [1·1-5·9], p=0·52; median number of drugs 2 [IQR 1-3] vs 2 [1-3], p=0·87). Target blood pressure was reached in 39 (42%) patients and 41 (45%) patients, respectively (p=0·82). On secondary endpoints we found no differences in health-related quality of life (median RAND-36 physical scores 52·7 [IQR 43·9-56·8] vs 53·2 [44·0-56·8], p=0·83; RAND-36 mental scores 49·8 [43·1-54·6] vs 52·7 [44·9-55·5], p=0·17) for CT-based and AVS-based treatment. Biochemically, 37 (80%) of patients with CT-based adrenalectomy and 41 (89%) of those with AVS-based adrenalectomy had resolved hyperaldosteronism (p=0·25). A non-significant mean difference of 0·05 (95% CI -0·04 to 0·13) in quality-adjusted life-years (QALYs) was found to the advantage of the AVS group, associated with a significant increase in mean health-care costs of €2285 per patient (95% CI 1323-3248). At a willingness-to-pay value of €30 000 per QALY, the probability that AVS compared with CT constitutes an efficient use of health-care resources in the diagnostic work-up of patients with primary aldosteronism is less than 0·2. There was no difference in adverse events between groups (159 events of which nine were serious vs 187 events of which 12 were serious) for CT-based and AVS-based treatment. INTERPRETATION: Treatment of primary aldosteronism based on CT or AVS did not show significant differences in intensity of antihypertensive medication or clinical benefits for patients after 1 year of follow-up. This finding challenges the current recommendation to perform AVS in all patients with primary aldosteronism. FUNDING: Netherlands Organisation for Health Research and Development-Medical Sciences, Institute of Cardiology, Warsaw.

Cost-effectiveness of integrated care in frail elderly using the ICECAP-O and EQ-5D: does choice of instrument matter?

Economic evaluations likely undervalue the benefits of interventions in populations receiving both health and social services, such as frail elderly, by measuring only health-related quality of life. For this reason, alternative preference-based instruments have been developed for economic evaluations in the elderly, such as the ICECAP-O. The aim of this paper is twofold: (1) to evaluate the cost-effectiveness using a short run time frame for an integrated care model for frail elderly, and (2) to investigate whether using a broader measure of (capability) wellbeing in an economic evaluation leads to a different outcome in terms of cost-effectiveness. We performed univariate and multivariate analyses on costs and outcomes separately. We also performed incremental net monetary benefit regressions using quality adjusted life years (QALYs) based on the ICECAP-O and EQ-5D. In terms of QALYs as measured with the EQ-5D and the ICECAP-O, there were small and insignificant differences between the instruments, due to negligible effect size. Therefore, widespread implementation of the Walcheren integrated care model would be premature based on these results. All results suggest that, using the ICECAP-O, the intervention has a higher probability of cost-effectiveness than with the EQ-5D at the same level of WTP. In case an intervention's health and wellbeing effects are not significant, as in this study, using the ICECAP-O will not lead to a false claim of cost-effectiveness of the intervention. On the other hand, if differences in capability QALYs are meaningful and significant, the ICECAP-O may have the potential to measure broader outcomes and be more sensitive to differences between intervention and comparators.

The influence of age on health valuations: the older olds prefer functional independence while the younger olds prefer less morbidity.

BACKGROUND: To assess the effectiveness of geriatric interventions, The Older Persons and Informal Caregivers Survey - Composite Endpoint (TOPICS-CEP) has been developed based on health valuations of older persons and informal caregivers. This study explored the influence of the raters' age on the preference weights of TOPICS-CEP's components. METHODS: A vignette study was conducted with 200 raters (mean age ± standard deviation: 72.5±11.8 years; 66.5% female). Profiles of older persons were used to obtain the preference weights for all TOPICS-CEP components: morbidity, functional limitations, emotional well-being, pain experience, cognitive functioning, social functioning, self-perceived health, and self-perceived quality of life. The raters assessed the general wellbeing of these vignettes on a 0-10 scale. Mixed linear regression analysis with interaction terms was used to explore the effects of raters' age on the preference weights. RESULTS: Interaction effects between age and the TOPICS-CEP components showed that older raters gave significantly (P<0.05) more weight to functional limitations and social functioning and less to morbidities and pain experience, compared to younger raters. CONCLUSION: Researchers examining effectiveness in elderly care need to consider the discrepancies between health valuations of younger olds and older olds when selecting or establishing outcome measures. In clinical decision making, health care professionals need to be aware of this discrepancy as well. For this reason we highly recommend shared decision making in geriatric care.

Comparing the health state preferences of older persons, informal caregivers and healthcare professionals: a vignette study.

BACKGROUND: The Older Persons and Informal Caregivers Survey-Minimum Dataset (TOPICS-MDS) collects uniform information from research projects funded under the Dutch National Care for the Elderly Programme. To compare the effectiveness of these projects a preference-weighted outcome measure that combined multidimensional TOPICS-MDS outcomes into a composite endpoint (TOPICS-CEP) was developed based on the health state preferences of older persons and informal caregivers. OBJECTIVES: To derive preference weights for TOPICS-CEP's components based on health state preferences of healthcare professionals and to investigate whether these weights differ between disciplines and differ from those of older persons and informal caregivers. MATERIALS AND METHODS: Vignette studies were conducted. Participants assessed the general wellbeing of older persons described in vignettes on a scale (0-10). Mixed linear analyses were used to obtain and compare the preference weights of the eight TOPICS-CEP components: morbidities, functional limitations, emotional wellbeing, pain experience, cognitive problems, social functioning, self-perceived health, and self-perceived quality of life (QOL). RESULTS: Overall, 330 healthcare professionals, 124 older persons and 76 informal caregivers participated. The preference weights were not significantly different between disciplines. However, the professionals' preference weights differed significantly from those of older persons and informal caregivers. Morbidities and functional limitations were given more weight by older persons and informal caregivers than by healthcare professionals [difference between preference weights: 0.12 and 0.07] while the opposite was true for pain experience, social functioning, and self-perceived QOL [difference between preference weights: 0.13, 0.15 and 0.26]. CONCLUSION: It is important to recognize the discrepancies between the health state preferences of various stakeholders to (1) correctly interpret results when studying the effectiveness of interventions in elderly care and (2) establish appropriate healthcare policies. Furthermore, we should strive to include older persons in our decision making process through a shared decision making approach.