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Background Discrete choice experiments (DCEs) are frequently used to study preferences and quantify tradeoffs in decision making. It is important to understand how stable their results are. Objective To investigate to what extent an extreme change in context, the COVID-19 pandemic, affected preferences for vaccine priority setting, as observed in an earlier DCE. Methods We replicated a DCE in which participants had to prioritize vaccination programs for public funding. The initial DCE was executed in Flanders (Belgium) right before the onset of the SARS-CoV-2 pandemic (December 2019, N = 1,636). The replicated DCE was executed 6 months later when the population was in lockdown (April 2020, N = 1,127). A total of 612 respondents participated in both waves of the DCE. We used panel mixed logit models to quantify attribute and level importance and compared utility estimates for consistency. Results The number of vaccine-preventable deaths became less important during the pandemic than before, whereas the influential attributes, the vaccine’s contribution to disease eradication and certainty about vaccine effectiveness became even more important. Respondents attached equal importance to the number of patients with transient or permanent morbidity, to the disease’s economic impact as well as to its equity profile. Conclusion Different preferences for vaccine priority setting were observed during the first COVID-19 lockdown as compared with before, although these differences were, given the extreme nature of the changing circumstances, relatively small. Highlights We replicated a discrete choice experiment (DCE) about vaccine priority setting during the first COVID-19 lockdown and compared results with those from the original setting. The major attributes, contribution to disease eradication, and scientific certainty about vaccine effectiveness became even more important than they already were, whereas avoidable mortality became less important. Respondents attached equal importance to the number of patients with transient or permanent morbidity, to the disease’s economic impact as well as to its equity profile. An extreme change in directly related context to the choice assignment led to changes in stated preferences, although these changes were relatively small, given the extreme change in context. Priorities in the second DCE were even less aligned with cost-effectiveness analysis than those observed initially.

The present aim was to estimate direct health care costs of patients suffering from post-traumatic trigeminal neuropathy (PTTN) and to compare the use of health care services, medications, and costs between temporary and persistent (>3 months) PTTN cohorts. A pre-existing clinical dataset of PTTN patients visiting a tertiary orofacial pain clinic in Belgium was utilized, including symptoms and quality of life measurements. Cost and resource utilization data were obtained by Belgium's largest health insurance provider for a period of 5 years after onset. Data from 158 patients was analyzed. The average cost per patient in the first year after injury was €2353 (IQR 1426-4499) with an out-of-pocket expense of 25% of the total cost. Hospitalization and technical interventions were the main drivers of cumulative costs, followed by consultation costs. For each cost category, expenditure was significantly higher in patients with persistent PTTN than in those with temporary PTTN (median 5-year total costs in persistent PTTN patients yielded €8866 (IQR 4368-18191) versus €4432 (IQR 2156-9032) in temporary PTTN, p

Background Mental health problems during and after pregnancy such as depression, anxiety, post-traumatic stress disorder (PTSD), or addiction are common and can have lifelong implications for both parents and offspring. This review investigates the cost-effectiveness of interventions tackling these problems, assesses the methodological quality of included studies, and indicates suggestions for further research. Methods Thirteen databases were searched for economic evaluations of interventions related to antenatal, perinatal, and postnatal mental health conditions, published between 2000 and September 2021, in high-income countries. Results Thirty-nine studies met all inclusion criteria. Interventions considered were screening programs, pharmacological treatments, and various forms of psychosocial and psychological support. Six studies reported that the intervention was cost-saving. Eighteen were cost-effective and seven likely to be cost-effective. Only six studies included health outcomes for the child; one study considered paternal health. The time horizon for which costs and consequences were considered was for most evaluations limited to 1 year (n = 18) or 2 years (n = 11) postpartum. Conclusions Given the importance of the subject, a relatively low number of studies have investigated the cost-effectiveness of interventions tackling mental health problems during and after pregnancy. The scant evidence available suggests good overall value for money. Likely, cost-effectiveness is underestimated as costly long-term consequences on offspring are systematically excluded. No evidence was found for several frequently occurring conditions. Further research is required to obtain reliable, long-term effectiveness data and to address the methodological challenges related to measuring all relevant health outcomes for all parties affected.

Sometimes healthcare will affect the health of people living in the future, or their chance of coming into existence. Should such outcomes be valued in health-economic evaluation? Guidelines implicitly recommend their inclusion but this rule has counterintuitive implications and is not consistently applied in practice. We suggest making a distinction between "necessary" and "potential" future lives in Health Technology Assessment. Necessary lives will exist independent of our healthcare choices and should be included. Potential lives are choice-dependent and should be excluded. This rule offers intuitive solutions within the HTA framework, and it changes the cost-effectiveness of several interventions where necessary future lives are affected.

Belgium is often seen as an outlier in the international experience with the coronavirus disease 2019. We summarize the unfolding of the pandemic in Belgium from February to December 2020, discuss the countermeasures that were implemented and provide some explanations why the numbers indicate a stronger pandemic in Belgium than in its neighbouring countries. To some extent, the seemingly poor performance of Belgium is a measurement artefact. Yet, there were indeed particular factors in Belgium that unnecessarily increased the toll of the pandemic. In the first wave insufficient priority was given to protect care homes. The second wave was larger than necessary due to a failure to timely implement restrictive measures. The latter can, at least partly, be explained by a unique political situation: a temporary, minority government in the middle of a major crisis.

BACKGROUND: Unplanned rehospitalizations occur frequently in older patients. Drug-related problems constitute a major and largely preventable cause with inappropriate prescribing being a substantial culprit. Solutions are needed to reduce this risk by targeting pharmacotherapy both during and after hospital stay. Therefore, we aim to perform a randomized controlled trial in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health-related outcomes. METHODS/DESIGN: The study concerns a monocenter, non-blinded, randomized controlled trial that will take place at the acute geriatric wards of a large academic hospital. Patients being in a palliative stage with active therapy withdrawal or patients discharged to another ward within the same hospital or another hospital are excluded. In total, 828 patients will be randomized (1:1) to the usual care or intervention group. The multifaceted clinical pharmacy intervention comprises medication reconciliation at admission and discharge, medication review, patient/caregiver education, intensified communication with primary care providers and post-discharge follow-up, which also includes a telepharmacology service. The primary endpoint is defined as the time to an all-cause, unplanned hospital revisit within six months after discharge. Other health-related outcomes such as drug-related readmissions, quality of life and number of potentially inappropriate medications will be analyzed as secondary endpoints. Patient inclusion started in February 2021. DISCUSSION: This study will provide useful insights regarding the impact of clinical pharmacy interventions on geriatric wards with the goal to optimize health-related outcomes such as hospital revisits. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04617340. ispartof: CONTEMPORARY CLINICAL TRIALS vol:119 ispartof: location:United States status: published

IntroductionChildren become ill quite often, mainly because of infections, most of which can be managed in the community. Many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. Point-of-care C reactive protein (POC CRP) testing, prescription guidance and safety-netting advice can help safely reduce antibiotic prescribing to acutely ill children in ambulatory care as well as save costs at a systems level.Methods and analysisThe ARON (Antibiotic prescribing Rate after Optimal Near-patient testing in acutely ill children in ambulatory care) trial is a pragmatic cluster randomized controlled superiority trial with a nested process evaluation and will assess the clinical and cost effectiveness of a diagnostic algorithm, which includes a standardised clinical assessment, a POC CRP test, and safety-netting advice, in acutely ill children aged 6 months to 12 years presenting to ambulatory care. The primary outcome is antibiotic prescribing at the index consultation; secondary outcomes include clinical recovery, reconsultation, referral/admission to hospital, additional testing, mortality and patient satisfaction. We aim to recruit a total sample size of 6111 patients. All outcomes will be analysed according to the intent-to-treat approach. We will use a mixed-effect logistic regression analysis to account for the clustering at practice level.Ethics and disseminationThe study will be conducted in compliance with the principles of the Declaration of Helsinki (current version), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. Ethics approval for this study was obtained on 10 November 2020 from the Ethics Committee Research of University Hospitals Leuven under reference S62005. We will ensure that the findings of the study will be disseminated to relevant stakeholders other than the scientific world including the public, healthcare providers and policy-makers. The process evaluation that is part of this trial may provide a basis for an implementation strategy. If our intervention proves to be clinically and cost-effective, it will be essential to educate physicians about introducing the diagnostic algorithm including POC CRP testing and safety-netting advice in their daily practice.Trial registration numberClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results)

ispartof: TBV - Tijdschr Bedrijfs- en Verzekeringsgeneeskd vol:29 issue:9 pages:21-22 status: published

Economic evaluation guidelines increasingly prescribe inclusion of all future costs. We point at an important dimension of future costs that is systematically neglected. Healthcare can affect future offspring, either through affecting the patient’s fertility or through determining future offspring’s health. As we show, the future costs associated to these changes can be substantial and they will vary across interventions and demographic groups. However, a systematic inclusion of these future offspring costs would raise many problems on its own. Based on the population ethics concept of necessitarianism, we suggest that only those future costs that spring from ‘necessary’ future lives should be included in future cost calculations, while all costs associated to ‘potential’ future lives can be ignored. This approach allows excluding most future offspring costs and avoids skewed cost-effectiveness outcomes of interventions with fertility effects, while taking into account the economic implications of preventing disease in future generations that will exist by necessity. Overall, future generations expose a substantial gap in today’s Health Technology Assessment (HTA) methodology and further discussion of the issues they raise is needed. ispartof: Pharmacoeconomics vol:40 issue:2 pages:141-147 ispartof: location:New Zealand status: Published online

Fear of a reduced exogenous boosting effect of varicella vaccination and its impact on population health and wellbeing seems to be the main reason why many countries have hesitated to implement thi...

Background As work and health are closely interlinked, it is important to carefully monitor employees. However, limited resources restrict in-depth follow-up. Aims This study was aimed to develop a low-cost screening instrument for employees’ overall health status, that can be used across industries and that allows triaging workers to in-depth health surveillance in case of indications of health or functioning problems. Methods We developed a new questionnaire-based algorithm built on multiple predictors to assess the need for further follow-up. We used a systematic review, Delphi panel (n = 9) and focus group (n = 5) to determine the predictors, tested for language pitfalls in a pilot study and evaluated the questionnaire’s validity in two separate studies. Study 1 (n = 60) analysed the discriminatory power of the instrument by comparing it to the assessment of an occupational physician in a sample of employees from diverse occupational settings. Study 2 (n = 869) appraised the factor structure and internal consistency of the screening tool in a sample of employees from the hospital sector. Results Risk factors, current physical and mental health, functioning, absenteeism, job satisfaction and lifestyle were identified as the most relevant predictors. Study 1 showed the survey had good criterion validity (area under the curve = 0.72). Study 2 (N = 869, 28% response) demonstrated the internal consistency (Cronbach’s α = 0.94), and a factor analysis confirmed a second-order factor structure with adequate model fit (comparative fit index = 0.96, root mean square error of approximation = 0.04 and standardized root mean square residual = 0.07). Conclusions This questionnaire can be used to triage workers for occupational health follow-up and can, additionally, be useful to describe the epidemiology of work-related illness.

Background Adverse drug events following inappropriate prescribing in the hospital cause a substantial and avoidable medical and economic burden to hospitals, payers and patients alike. A clinical rule-based, pharmacist-led medication-review service, the 'Check of Medication Appropriateness' (CMA) was implemented in the University Hospitals Leuven. The CMA is shown to be effective in reducing potentially inappropriate prescriptions. Aim This study investigated whether this centralised clinical pharmacy service is cost-effective. Method We performed a cost-effectiveness analysis of three clinical rules of the CMA, targeting adverse drug events at three levels of severity: A) persistent opioid-induced constipation, B) ketorolac-induced gastrointestinal bleeding and C) drug-induced Torsade de Pointes. A decision tree was developed for each clinical rule. Both intervention costs as well as total costs associated with the occurrence of an adverse drug event were considered. The outcomes were reported in the form of an incremental cost-effectiveness ratio, expressed as an incremental cost per adverse drug event avoided. Results Applying clinical rules to avoid persistent opioid-induced constipation and ketorolac-induced gastrointestinal bleeding were cost-saving. Implementation of a medication check to avoid drug-induced Torsade de Pointes costed €8,846 per Torsade de Pointes avoided. Conclusion Our study provides strong indications that the CMA is worth its investment for clinical rules targeting (very) common adverse drug events, that can be avoided with limited expenses. Further research is required to assess the full CMA. The proposed model may be useful to perform cost-effectiveness analyses of other centralised clinical pharmacy services targeting inappropriate prescribing, at the level of individual adverse drug events.

In the face of limited COVID-19 vaccine supply, governments have had to identify priority groups for vaccination. In October 2020, when it was still uncertain whether COVID-19 vaccines would be shown to work in trials, we conducted a discrete choice experiment and a best-worst ranking exercise on a representative sample of 2060 Belgians in order to elicit their views on how to set fair vaccination priorities. When asked directly, our respondents prioritized the groups that would later receive priority: essential workers, the elderly or those with pre-existing conditions. When priorities were elicited indirectly, through observing choices between individuals competing for a vaccine, different preferences emerged. The elderly were given lower priority and respondents divided within two clusters. While both clusters wanted to vaccinate the essential workers in the second place, one cluster (N = 1058) primarily wanted to target virus spreaders in order to control transmission whereas the other cluster (N = 886) wanted to prioritize those who were most at risk because of a pre-existing health condition. Other strategies to allocate a scarce resource such as using a "lottery", "first-come, first-served" approach or highest willingness-to-pay received little support.

La moyenne hebdomadaire des nouvelles admissions COVID des dernières semaines a conduit le SPF Santé Publique à suggérer un passage à la phase 1B du plan de Surge Capacity le 22 mars 2021. Selon cette phase 1B, les hôpitaux doivent reporter des soins non urgents afin de disposer d’une capacité hospitalière suffisante pour fournir les soins nécessaires aux patients COVID comme aux patients non-COVID. Le report et/ou le renoncement à des soins médicaux depuis le début de la crise sanitaire est devenu plus fréquent dans la population. Qu’il s’agisse d’un report de rendez-vous par les professionnels de santé ou un renoncement aux soins par les patients par crainte de contracter le coronavirus, ces soins médicaux non satisfaits pourraient conduire à une dégradation ultérieure de l’état de santé et donc directement ou indirectement à une surmortalité. Ce numéro de Regards économiques réalise un premier état des lieux de l’ampleur du renoncement aux soins durant le premier confinement à partir des données d’une enquête en ligne menée auprès de la population en Belgique au printemps 2020. L’analyse montre un important renoncement à des soins spécialistes et des examens médicaux dans la plupart des cas pour des raisons qui relèvent de l’offre de soins, notamment le fait que les hôpitaux ou les établissements de soins ont annulé ou reporté les rendez-vous médicaux ou que les professionnels de santé avaient fermé leur cabinet. Puisqu’ils sont nécessairement de plus grands utilisateurs de soins, ce sont les plus malades qui ont particulièrement renoncé à des soins médicaux. En revanche, dans le cas des soins dentaires, des disparités dans le renoncement s’observent majoritairement au détriment des plus pauvres. Une détérioration de l’état de santé de la population est donc à craindre du fait du renoncement à des soins médicaux durant le confinement et au-delà puisqu’une proportion non négligeable de personnes rapportent ne pas envisager d’aller consulter lors d’un futur besoin de soins. A partir de ces premiers résultats chiffrés de l’ampleur et les raisons du renoncement aux soins durant le premier confinement, nous formulons plusieurs points d’attention pour les décideurs politiques. Bien que nous ne soyons pas en mesure de comparer l’ampleur du renoncement aux soins au cours des confinements successifs, le maintien de l’offre de soins dans les confinements plus récents devrait permettre de limiter les externalités négatives sur les autres malades que les malades COVID-19. Le report de soins même jugés non urgents devrait être évité autant que possible. Alors que le profil des répondants à l’enquête est socialement plus avantagé que la population générale, nous avançons que ces résultats sont une borne inférieure de l’ampleur du renoncement aux soins dans la population belge et des conséquences futures sur la santé de la population. Les conséquences de soins médicaux non satisfaits sont susceptibles d’être encore plus importantes dans des sous-groupes de la population qui cumuleront non seulement un renoncement aux soins médicaux dû au confinement mais aussi un renoncement pour raisons financières s’ils subissent des pertes d’emploi ou de revenu accrues en raison de la COVID-19. Ces obstacles à l'accès aux soins de santé et les besoins insatisfaits ont mis en évidence la difficulté du système de santé à être suffisamment résilient pour absorber le choc d’une pandémie. Il sera donc important que les décideurs politiques envisagent des plans nationaux de santé publique de grande ampleur qui «ramènent» les patients vers les soins. Il s’agira non seulement d’encourager les patients dont le suivi s’est interrompu à reprendre leur traitement et à évaluer la détérioration de leur état de santé mais aussi d’encourager tous les patients qui ont manqué une opportunité de dépistage de ne pas perdre plus de temps dans l’identification potentielle de problèmes de santé sévères.

Governments regularly have to decide whether new vaccines should be adopted in their national immunization program. These choices imply complex trade-offs of epidemiological, medical and socio-economic criteria. We investigated how the population in Flanders (Belgium) wants their government to set vaccine-funding priorities. In December 2019, we executed a discrete choice experiment in a sample of the Flemish population (N = 1636). In total, we analysed 16 360 choices between vaccines competing for funding, described in terms of eight characteristics. Using a panel mixed logit model, we quantified the relative importance of each characteristic and investigated differences in preferences across respondent groups. The observed vaccine priorities were different from those that would be identified through cost-effectiveness analysis. People valued the health impact from infectious diseases differently than their weight expressed in QALYs would suggest. Mortality and frequently occurring mild illness were valued higher, whereas lasting morbidity received lower weight. Contribution of the vaccine to disease eradication and uncertainty in vaccine effectiveness were both highly influential factors. Health equity impact was also important whereas the economic impact of the disease did not matter at all. Our results can be used to incorporate public values into vaccine decision-making. ispartof: Social Science & Medicine vol:303 ispartof: location:England status: Published online

Replacing or supplementing face-to-face health screening by occupational physicians with online surveys can be attractive for various reasons. However, the (cost-)effectiveness of both depends on employees' willingness to disclose occupational health problems. This article investigates whether employees show a different willingness to disclose information in online surveys compared to face-to-face consultations with an occupational physician. Employees from four Flemish hospitals were asked whether they would disclose a range of typical occupational health problems to either surveys or physicians. The results were analyzed through chi-square tests and multilevel ordinary least squares regression. Of the 776 respondents, 26% indicated that they did not always disclose health problems. Respondents were more inclined to disclose mental health problems to a survey than face-to-face to a physician, whereas the opposite was true for medication misuse. Being male, younger, with lower educational attainment or lower trust in physicians, taking medication, or having a lower risk on alcohol abuse increased the likelihood of a person withholding information. We conclude that this study provides indications that online vs. face-to-face health check-ups have different strengths and weaknesses in this respect. These must be considered when evaluating the need to use online surveys (instead of, or together with, face-to-face contacts) for health screening. ispartof: International Journal Of Environmental Research And Public Health vol:18 issue:4 pages:1460-1460 ispartof: location:Switzerland status: published

Background: High uptake of Covid-19 vaccination is required to reach herd immunity. Methods: A representative sample of 2,060 Belgians were surveyed in October 2020. Regression analyses identified the predictors associated with willingness to get vaccinated against Covid-19, and attitudes toward vaccination in general. Results: 34% of the participants reported that they will definitely get vaccinated against Covid-19 and 39% that they would "probably". Intended uptake was strongly associated with age, opinion on the government's dealing with the Covid-19 pandemic, medical risk, spoken language, gender, and to a lesser extent with having known someone who was hospitalised because of Covid-19. Similar predictors were identified for attitudes to vaccination in general. Covid-19 vaccine hesitancy was more marked in age groups below 54 years old. We further analysed a sample of 17% (N = 349) found favourable to vaccination in general but not willing to be vaccinated against Covid-19. They were mainly female, young, French speaking, slightly less educated, working, and did not belong to a Covid-19 risk group. They were very dissatisfied with the government's dealing with the pandemic, and did not know someone who was hospitalised because of Covid-19. Conclusions: Vaccine hesitancy was higher for Covid-19 vaccines than for other vaccines. The part of the population being convinced of the utility of vaccination in general but hesitant about the Covid-19 vaccine is a primary interest group for tailored communication campaigns in order to reach the vaccine coverage needed for herd immunity. (c) 2021 Elsevier Ltd. All rights reserved.

Background: The uptake of a Covid-19 vaccine will be instrumental in limiting the spread of the disease as herd immunity requires coverage of up to 80% of the population. Purpose: To identify the predictors associated with the willingness to get vaccinated against Covid-19 once a vaccine becomes available, and to investigate whether they coincide with the predictors of attitudes towards vaccination in general. Methods: A representative sample of 2,060 Belgians were surveyed between 6 and 16 October 2020. Results: 34% (n=651) of the participants reported that they will definitely vaccinate against Covid-19 once a vaccine is available and 39% (n=742) that they would “probably” vaccinate. A multivariate analysis found that increased intended uptake was strongly associated with age, opinion on the government’s dealing with the Covid-19 pandemic, medical risk and spoken language, and to a lesser extent with sex and having known someone who was hospitalised because of Covid-19. Similar predictors were identified for attitudes to vaccination; however, Covid-19 vaccine hesitancy was more marked in age groups below 54 years old. We further analysed a sample of 17% (n=349) of the participants found favourable to vaccination in general but not willing to vaccinate against Covid-19. These inconsistent people were mainly female, young, French speaking, slightly less educated, and working. They also did not belong to a Covid-19 risk group, were very dissatisfied with the government’s dealing with the Covid-19 crisis, and did not know personally someone who was hospitalized because of Covid-19. Conclusions: The majority of Belgians intend to vaccinate, though uptake is lower in groups at lower risk of severe forms of Covid-19. While most of the population is aware of the collective welfare of infectious disease vaccination, Covid-19 is not perceived as any infectious disease and exhibits higher levels of vaccination hesitancy. Communication campaigns will need to inform on the safety and efficacy of Covid-19 vaccination to encourage uptake.

With the news of promising Covid-19 vaccines on the horizon comes a new challenge. The initial supply will not be sufficient to vaccinate everyone and choices will need to made over distribution. This column presents the results of an experiment in Belgium investigating people’s preferences regarding the distribution of a scarce vaccine. There was no one single strategy that was considered best by a large majority, but three strategies were ranked first by between 20-30% of respondents: prioritising essential workers, the chronically ill, and older people. Libertarian-inspired approaches (such as highest willingness-to-pay or ‘first-come, first served’) and a strict egalitarian approach (such as a lottery) were clearly the least preferred options.

Once a safe COVID-19 vaccine will become available, there will not be enough supply of it to vaccinate the entire population. Policy makers at national and international level are currently developing vaccine prioritization strategies. However, it is important that these strategies have sufficient levels of public support. We conducted a ranking exercise and a discrete choice experiment on a representative sample of 2,000 Belgians in order to elicit their preferences regarding how to distribute the COVID-19 vaccine across the population. We identified that three sub-groups had similarly high levels of support for access priority: the chronically ill, essential professions, and individuals likely to spread the virus the most. We identified two clusters of respondents. While both wanted to vaccinate essential professions, cluster one (N=1058) primarily wanted to target virus spreaders whereas cluster two (N=886) wanted to prioritize the chronically ill. Prioritizing those over 60 years of age was remarkably unpopular. Other strategies such as allocating the vaccine using a ‘lottery’, ‘first-come, first-served’ approach or willingness-to-pay received little support. Public opinion is a key variable for a successfully engaged COVID-19 policy. A strategy simultaneously prioritizing medical risk groups, essential professions and spreaders seems to be most in line with societal preferences. When asked to choose, people agree to vaccinate essential professions but disagree whether to prioritise people with high-medical risk or virus spreaders.

In addition to more narrow criteria such as safety, effectiveness and cost-effectiveness, vaccines can also be evaluated based on broader criteria such as their economic impact, contribution to disease eradication objectives, caregiver aspects, financial protection offered, equity or social acceptability. We summarize a survey executed in a sample of the population (n = 1000) in Flanders, Belgium, in which we investigated support for using these broader criteria to evaluate vaccines for funding decisions. By means of both favourable and unfavourable framings of a hypothetical vaccine across 40 value dimensions, we find support for the view that people indeed consider a broad range of medical and socio-economic criteria relevant. Several of these are not incorporated in standard evaluation frameworks for vaccines. The different results we find for different framings highlight the importance of developing a consistent a priori value framework for vaccine evaluation, rather than evaluating vaccines on an ad hoc basis. ispartof: Vaccines vol:8 issue:4 ispartof: location:Switzerland status: published

WHAT IS KNOWN AND OBJECTIVE: Polypharmacy is common, and many medications have cognitive side effects. Such effects can be transient and subside when the drug in question is discontinued or can be long-lasting with effects present for years afterwards. Although formal assessment of cognition is feasible and often undertaken in neuropsychiatric trials, these effects are usually neglected in the evaluation of any non-neuropsychiatric health intervention. Medication effects can be assessed within a cognitive footprint framework, to account for the magnitude and the duration of cognitive side effects, with some likely to have a greater and more lasting effect than others. COMMENT: Adverse event reporting suggests that many medications may be indirectly associated with cognitive effects, for example due to headaches, somnolence and 'dizziness'; however, inferring causation from adverse event reporting can be problematic. In order to better understand the impact of investigational drug and concomitant medications effect on cognition, it would be essential to ensure cognition is prioritized in drug development evaluation. It is suggested that simple instruments that can be easily incorporated into existing trial designs are used to assess the cognitive footprint of medication. WHAT IS NEW AND CONCLUSION: We present an overview of existing measures of cognition that can be integrated into drug trials in order to provide a cognitive footprint. Like quality of life testing, such tests should be administered as a standard throughout the key assessment stages of the design of the trial to ensure that any effects on this equally important outcome are also documented. Furthermore, employing routine cognition testing may also enable researchers to identify unanticipated beneficial and non-beneficial effects on cognition. Provision of such a cognitive footprint profile of drugs may provide the necessary evidence to enable decision-makers to make informed decisions on risk-benefit analysis that can subsequently make trade-offs between different drug regimens. ispartof: Journal Of Clinical Pharmacy And Therapeutics vol:45 issue:4 pages:874-880 ispartof: location:England status: published

© 2019, Springer Science+Business Media, LLC, part of Springer Nature. In a publicly financed health system, it is important that priority-setting reflects social values. Many studies investigate public preferences through surveys taken from samples, but to be representative, these samples must reflect value judgments of all relevant population subgroups. In this study, we explore whether, next to better-understood sources of heterogeneity such as age, education or gender, also differences in personality play a role in how people want to set limits to health care. We investigate the influence of dispositional optimism: whether someone anticipates a good or bad future. This is an important personality dimension that has been shown to widely reverberate into people’s lives and that can also be expected to influence people’s views on health care. To test our hypothesis, we asked a representative sample of the Belgian population (N = 750) to complete both the revised life orientation test and a discrete choice experiment about allocating healthcare resources, and we investigated the relationships between both measurements. We found that more pessimistic individuals were less supportive of using patients’ age as a selection criterion and more hesitant to invest in prevention. Since individual dispositions are usually not part of the criteria for selecting representative samples, our findings point at a potential non-response bias in studies that elicit social values. Special issue on Justice and Health ispartof: Social Justice Research vol:32 issue:2 pages:186-207 status: published

ImportanceThe mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion.ObjectiveTo estimate the research and development investment required to bring a new therapeutic agent to market, using publicly available data.Design and SettingData were analyzed on new therapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estimate the research and development expenditure required to bring a new medicine to market. Data were accessed from the US Securities and Exchange Commission, Drugs@FDA database, and ClinicalTrials.gov, alongside published data on clinical trial success rates.ExposuresConduct of preclinical and clinical studies of new therapeutic agents.Main Outcomes and MeasuresMedian and mean research and development spending on new therapeutic agents approved by the FDA, capitalized at a real cost of capital rate (the required rate of return for an investor) of 10.5% per year, with bootstrapped CIs. All amounts were reported in 2018 US dollars.ResultsThe FDA approved 355 new drugs and biologics over the study period. Research and development expenditures were available for 63 (18%) products, developed by 47 different companies. After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $1141.7 million (95% CI, $888.1 million-$1480.8 million), and the mean investment was estimated at $1559.1 million (95% CI, $1271.0 million-$1893.8 million) in the base case analysis. Median estimates by therapeutic area (for areas with ≥5 drugs) ranged from $765.9 million (95% CI, $323.0 million-$1473.5 million) for nervous system agents to $2771.6 million (95% CI, $2051.8 million-$5366.2 million) for antineoplastic and immunomodulating agents. Data were mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. Results varied in sensitivity analyses using different estimates of clinical trial success rates, preclinical expenditures, and cost of capital.Conclusions and RelevanceThis study provides an estimate of research and development costs for new therapeutic agents based on publicly available data. Differences from previous studies may reflect the spectrum of products analyzed, the restricted availability of data in the public domain, and differences in underlying assumptions in the cost calculations.

© 2018, Springer Science+Business Media, LLC, part of Springer Nature. Although the principles of cost-effectiveness analysis have been adopted by health systems worldwide, a large majority of countries remain reluctant to specify explicit threshold values for cost-effectiveness. Nonetheless, by aiming to benchmark what counts as a reasonable ‘price’ for health gains, the threshold value is a linchpin in the framework of health technology assessment, albeit also a controversial one. The desirability of thresholds depends largely on three claims: their intention to make resource allocation more efficient, their aspiration to make decision-making more transparent and their objective to make healthcare systems more sustainable. In this paper, we draw from various disciplines such as health economics but also psychology, anthropology, sociology, political sciences and ethics to discuss the many facets of these three values, related to the threshold debate. We discuss issues of allocative efficiency, fair decision-making, realpolitik, taboos, institutional justice and the rule of rescue. Based upon these considerations, which together substantiate the precautionary principle, we conclude that the case against thresholds is stronger than the case in favor and that most countries are right to be reluctant to use explicit threshold values. ispartof: Social Justice Research vol:32 issue:2 pages:155-171 status: Published online

Ovarian stimulation with low-dose human menopausal gonadotrophin (HMG) is superior to clomiphene citrate in intrauterine insemination (IUI) cycles with respect to clinical pregnancy rate, but it is unclear whether HMG is also the more cost-effective option. The aim of this study was to compare the cost-effectiveness of ovarian stimulation with low-dose subcutaneously administred HMG (37.5–75 IU per day) to orally administred clomiphene citrate (50 mg/day from day 3–7) in an IUI programme for subfertile couples. A cost-effectiveness analysis was conducted using the results of a randomized trial, including 620 IUI cycles. The primary outcome was the incremental cost-effectiveness ratio (ICER) of using HMG versus clomiphene citrate. Results are presented from the healthcare payer perspective. The total cost per patient associated with one IUI treatment with HMG is €764, whereas it is €558 if clomiphene citrate is used, resulting in an incremental cost of €206 for HMG per treatment. The incremental clinical pregnancy rate of using HMG instead of clomiphene citrate, however, is also 5.7 percentage points higher, resulting in an ICER of HMG versus clomiphene citrate of €3615 per additional clinical pregnancy achieved. On average, HMG was found to be more cost-effective than clomiphene citrate.

Patients who are in a vegetative or minimally conscious state due to chronic coma, traumatic brain injury or who suffer from other disorders of consciousness (DoC) are resource-intensive. From a sc...

BACKGROUND: Policymakers in several European countries, concerned about the sustainability of their pension system, have raised the statutory retirement age. While several studies investigated the effect of retirement on health, the relationship between retirement and frailty is neglected. Notwithstanding, frailty is associated with adverse outcomes. OBJECTIVE: The aim of this study was to examine the relationship between age of retirement and frailty in later life. METHODS: Data of the Belgian Ageing Studies, a cross-sectional research project was used. The present study includes N=12659 participants (>60y) in 83 Flemish municipalities. To address reverse causality, only participants not retired because of health-related reasons were included. The Comprehensive Frailty Assessment Instrument, a multidimensional frailty scale with four domains (physical, psychological, social and environmental) was used to operationalize frailty. Univariate general linear regression analyses (GLM) were performed for scores on the total frailty scale and the four subdomains separately. The analysis was done for men and women separately, since both groups have different labor trajectories. RESULTS: The present study found a negative association between age of retirement and physical frailty for both men and women in later life, and total frailty for men, although the differences were small. No evidence was found for a relation between age of retirement and the other subdomains of frailty. CONCLUSIONS: The results suggest that age of retirement is not a clinically relevant predictor for frailty in later life. Differences within and between subpopulations (e.g., profession) can shed a new light on this relation. ispartof: Archives Of Gerontology And Geriatrics vol:96 ispartof: location:Netherlands status: published

Now that many countries are implementing ‘exit strategies’ from the containment measures, the health impact related to COVID-19, stress and isolation will become clear. However, there is a second wave of potential health consequences threatening us. According to economists, a worldwide economic recession is to be expected. We can therefore expect a change in the various health problems associated to a negative economic growth and its impact on employment.1 2 It is in this expected second part that occupational health and safety (OHS) can play an important role. By providing advice to workers and enterprises in creating safe employment and new, attractive ways of working, they can help in mitigating the health impact of a recession. What can be learnt from previous recessions? There is no clear answer. Recessions cause a mix of both positive and negative effects, on both morbidity and mortality. Moreover, these effects can be expected to differ in between socioeconomic groups. On the one hand, recessions have an adverse impact in terms of the health and well-being of the population. Unemployment and job uncertainty negatively influence self-esteem, stress and mental health, as well physical health. The number of suicides and overdose deaths is higher during economic crises.3 There will be fewer …

Beneficence is at the heart of medical practice, but what it exactly means for physicians to do good to their patients can be difficult to specify. Different treatment options will have different p...

Vaccinatieprogramma’s zijn een hoeksteen van de volksgezondheid. De Vlaamse overheid heeft jaarlijks een vast budget gereserveerd om vaccins aan te kopen. Dit budget moet echter verdeeld worden over een steeds groter wordend aantal beschikbare vaccinkandidaten die bovendien ook nog eens gebruikt kunnen worden in een brede waaier aan mogelijke vaccinatiecombinaties en -strategieën. Prioriteiten stellen tussen al deze mogelijkheden is bijzonder moeilijk omdat verschillende aspecten (bv. veiligheid, effectiviteit, ziekte-ernst, besmettelijkheid, incidentie, prijs, maatschappelijke impact, etc.) tegelijkertijd moeten worden afgewogen. Welke vaccins uiteindelijk prioriteit krijgen heeft implicaties voor ziekte en welzijn van de bevolking want ‘kiezen is verliezen’. Een keuze om te investeren in het ene vaccinatieprogramma impliceert dat beschikbare middelen voor andere programma’s vervallen. Het is wenselijk dat deze keuzes gebaseerd worden op een consistent, onderbouwd beslismodel dat rekening houdt met alle relevante facetten van vaccinatie. Het ontwikkelen van een beslismodel dat alles wat van tel is in kaart weet te brengen, zich aan wijzigende omstandigheden kan aanpassen, rekenschap kan geven van verschillende perspectieven en vervolgens een finaal oordeel kan vellen over welke aankoop van vaccins optimaal is, is echter een enorme - zo niet onmogelijke - taak. Beslissingsmodellen zijn m.a.w. altijd beperkt en kunnen dan ook enkel beslissingen assisteren maar ze zelf niet ‘maken’. Niettemin kunnen ze wel belangrijke structuur aanbrengen in de discussie en de beschikbare informatie verduidelijken. Het is de bedoeling van dit rapport om bij te dragen aan de ontwikkeling van zo een ondersteunend beslismodel voor de prioritering van vaccinatie voor de Vlaamse overheid.

Objectives Cost-effectiveness analyses (CEA) are based on the value judgment that health outcomes (eg, quantified in quality-adjusted life-years; QALYs) are all equally valuable irrespective of their context. Whereas most published CEAs perform extensive sensitivity analysis on various parameters and assumptions, only rarely is the influence of the QALY-equivalence assumption on cost-effectiveness results investigated. We illustrate how the integration of alternative social value judgments in CEA can be a useful form of sensitivity analysis. Methods Because varicella-zoster virus (VZV) vaccination affects 2 distinct diseases (varicella zoster and herpes zoster) and likely redistributes infections across different age groups, the program has an important equity dimension. We used a cost-effectiveness model and disentangled the share of direct protection and herd immunity within the total projected QALYs resulting from a 50-year childhood VZV program in the UK. We use the UK population’s preferences for QALYs in the vaccine context to revalue QALYs accordingly. Results Revaluing different types of QALYs for different age groups in line with public preferences leads to a 98% change in the projected net impact of the program. The QALYs gained among children through direct varicella protection become more important, whereas the QALYs lost indirectly through zoster in adults diminish in value. Weighting of vaccine-related side effects made a large difference. Conclusions Our study shows that a sensitivity analysis in which alternative social value judgments about the value of health outcomes are integrated into CEA of vaccines is relatively straightforward and provides important additional information for decision makers to interpret cost-effectiveness results.

Vaccination programs generate direct protection, herd protection and, occasionally, side effects, distributed over different age groups. This study elicits the general public's view on how to balance these outcomes in funding decisions for vaccines. We performed an optimal design discrete choice experiment with partial profiles in a representative sample (N = 1499) of the population in the United Kingdom in November 2016. Using a panel mixed logit model, we quantified, for four different types of infectious disease, the importance of a person's age during disease, how disease was prevented-via direct vaccine protection or herd protection-and whether the vaccine induced side effects. Our study shows clear patterns in how the public values vaccination programs. These diverge from the assumptions made in public health and cost-effectiveness models that inform decision-making. We found that side effects and infections in newborns and children were of primary importance to the perceived value of a vaccination program. Averting side effects was, in any age group, weighted three times as important as preventing an identical natural infection in a child whereas the latter was weighted six times as important as preventing the same infection in elderly aged 65-75 years. These findings were independent of the length or severity of the disease, and were robust across respondents' backgrounds. We summarize these patterns in a set of preference weights that can be incorporated into future models. Although the normative significance of these weights remains a matter open for debate, our study can, hopefully, contribute to the evaluation of vaccination programs beyond cost-effectiveness. ispartof: Social Science and Medicine vol:228 pages:181-193 ispartof: location:England status: published

An emerging issue in occupational health and safety (OHS) is that interventions increasingly have to demonstrate that they offer sufficient value for money. To this end, the last decennia have seen more and more economic evaluation methods being employed in this field. However, several recent publications have indicated that many of the published studies suffer from important shortcomings. This paper aims to highlight difficulties in assessing the value of OHS by use of current economic evaluation methods. First, a summary framework presents an overview of the costs and benefits relevant for OHS interventions. Next, three elements from this framework are selected that are at the same time crucial to OHS value, but also challenging to measure and monetise: Effects on worker productivity, &lsquo, intangible&rsquo, benefits, such as reputation effects, and the influence of the broader legal&ndash, fiscal context in which an intervention takes place. The following sections then discuss the following research questions for each of these elements: Why is it difficult to exclude these factors from OHS economic evaluations? Why do they pose a challenge to the quality of economic evaluations in OHS? How can they be included, and what are the known advantages and disadvantages of the methods to measure these factors? Future work should investigate (and standardise) better methods to include these elements.