Cost and Utility Estimates per Modified Rankin Scale Score up to 2 Years Post Stroke: Data to Inform Economic Evaluations From a Societal Perspective.

OBJECTIVES: Model-based health economic evaluations of ischemic stroke are in need of cost- and utility estimates related to relevant outcome measures. This study aims to describe societal cost- and utility estimates per modified Rankin Scale (mRS)-score at different time points within 2 years post stroke. METHODS: Included patients had a stroke between 3 months and 2.5 years ago. mRS and EQ-5D-5L were scored during a telephone interview. Based on the interview date, records were categorized into a time point: 3 months (3M; 3-6 months), 1 year (Y1; 6-18 months), or 2 years (Y2; 18-30 months). Patients completed a questionnaire on healthcare utilization and productivity losses in the previous 3 months. Initial stroke hospitalization costs were assessed. Mean costs and utilities per mRS and time point were derived with multiple imputation nested in bootstrapping. Cost at 3 months post stroke were estimated separately for endovascular treatment (EVT)-/non-EVT-patients. RESULTS: 1106 patients were included from 18 Dutch centers. At each time point, higher mRS-scores were associated with increasing average costs and decreasing average utility. Mean societal costs at 3M ranged from €11 943 (mRS 1, no EVT) to €55 957 (mRS 5, no EVT). For Y1, mean costs in the previous 3 months ranged from €885 (mRS 0) to €23 215 (mRS 5), and from €1655 (mRS 0) to €22 904 (mRS 5) for Y2. Mean utilities ranged from 0.07 to 0.96, depending on mRS and time point. CONCLUSIONS: The mRS-score is a major determinant of costs and utilities at different post-stroke time points. Our estimates may be used to inform future model-based health economic evaluations.

Parental measurement of height in growth hormone-treated children in the hospital setting proves valid: an observational study - potential for replacement of outpatient clinic visits to the home setting.

Reliable height measurement plays a pivotal role in evaluating the efficacy of costly growth hormone (GH) therapy in children. Currently, regularly outpatient clinic visits are needed to accurately measure height. The outpatient clinic visits are time-consuming for parents as well for health care professionals. This observational study aimed to investigate the validity of parentally performed height measurements compared to height measurements in the outpatient setting. An observational study was performed at the outpatient clinic of Amalia's Children's Hospital Nijmegen. A portable stadiometer (PS) was developed for height measurements at home. Measurements with the PS were performed by the researcher (PSR) and parents/caregivers (PSP). Measurements performed with the electronic digital ruler (EDS) were considered as the gold standard. The parents were potentially unblinded for the gold standard measurement (EDS). Descriptive statistics, Wilcoxon signed-rank, and Pearson's correlation tests were performed. The Bland-Altman plots were made to illustrate the correlation of the PSR or PSP with the gold standard. The correlation between the height measurements with PSR or PSP compared to the EDS was substantial (PSR: r = 0.9998, R2 = 0.9996, P < 0.001; PSP: r = 0.9998, R2 = 0.9995, P < 0.001). However, a statistically significant underestimation of the PSR and PSP was observed (P < 0.001). The mean difference of the PSR and PSP was respectively - 0.21 cm ± 0.52 SD and - 0.30 cm ± 0.62 SD in comparison to the EDS. The Bland-Altman plots illustrated that 95% of the PSR measurements were between - 1.03 and 0.60 cm and 95% of the PSP measurements were between - 1.26 and 0.66 cm compared to the EDS. CONCLUSION: We found a strong correlation between the PSR or PSP and the EDS, with only a minor underestimation of approximately 0.2-0.3 cm. In our opinion, this underestimation is clinically irrelevant as it does not result in an adjustment in GH dose. To conclude, parental height measurements could be a promising tool as it partially replaces outpatient clinic visits needed for measurements of height. Further studies are required to confirm this statement. WHAT IS KNOWN: • The immense impact of the coronavirus disease 2019 (COVID-19) pandemic on health care has increased telemedicine worldwide. For adequate integration of telemedicine in paediatric growth hormone treatment, reliable height and weight measurements in the home setting are required. • Earlier studies have shown that parents are capable to reliable perform height measurements in healthy children. WHAT IS NEW: • To our knowledge, this is the first study to show a strong correlation between the height measurements with a portable stadiometer by parents and those made with the electronic digital ruler (gold standard) in children treated with growth hormone. There was only a minor underestimation of approximately 0.2-0.3 cm, which we anticipated to be clinically irrelevant. • Therefore, home height measurements can at least partly replace costly outpatient visits for children being treated with growth hormone as part of an uncomplicated course. Moreover, these results may also be promising for implementation in other paediatric populations besides children treated with growth hormone.

Facilitators and barriers to the transition from outpatient clinic visits to home-based check-ups for children being treated with growth hormone: a mixed-methods study.

Although the coronavirus disease 2019 (COVID-19) pandemic accelerated the adoption and expansion of telemedicine worldwide, little is known about the transition to home-based care for children. This study aims to investigate the facilitators and barriers to the transition from outpatient clinic visits to home-based check-ups (HBCU), for children being treated with growth hormone. A mixed-methods study was performed at Amalia Children's Hospital (Radboud University Medical Centre, Nijmegen), consisting of questionnaires and semi-structured and focus group interviews. For the quantitative part, the Measurement Instrument for Determinants of Innovation (MIDI) was utilised to investigate the facilitators and barriers for the 81 participants regarding the transition to HBCU. The MIDI questionnaire is comprised of four domains: the innovation-, user-, organisation-, and the socio-political scale. Descriptive statistics were performed for analysing the questionnaires. For the qualitative part, interviews with 10 participants derived from the questionnaire and the two focus group interviews were conducted, to gain more in-depth information about the research topic, until data saturation was reached. The interviews were analysed by using the reflective thematic approach, starting with deductive coding and followed by inductive coding. Several facilitators were recognised in our study: procedural clarity, self-efficacy, convenience, patient-centred care, increased accuracy in height measurements, social support, client/patient satisfaction/cooperation, patient-centred care, the flexibility and adaptivity of HBCU, physical start-up period of HBCU, and a potential decrease in healthcare costs. However, several barriers were also noted in our study: poor compatibility with current practice, lack of consultation within the team, feeling of being less controlled by physicians, unsettledness of the organisation, an increased workload for the staff, and insufficient information communication technology (ICT) facilities. CONCLUSION: This study revealed that HBCU have considerable benefits for both patients and healthcare professionals, from the standpoint of innovation, user, and socio-political points of view. The identified facilitators and barriers to HBCU should be taken into account when further steps of implementing HBCU are considered. WHAT IS KNOWN: • The Corona-Virus-Disease 2019 (COVID-19) pandemic has had an immense impact on health care worldwide. A substantial amount of the outpatient clinic visits for children treated with growth hormone was, as a result of the pandemic, transferred to online consultation. Transitioning paediatric growth hormone treatment to the home setting may be favorable for children and their parents/caregivers) as well for healthcare professionals. • Insights regarding facilitators and barriers is vital for the successful implementation and adoption of home-care technologies. WHAT IS NEW: • To our knowledge, we are first to report on and explicit the facilitators and barriers of the transition to home-based check-ups, via online consultation for children being treated with growth hormone. • Both children and healthcare professionals reported major facilitators and some minor barriers to the transition to home-based check-ups, illustrating their potential value. These facilitators and barriers should be considered while working towards implementation of home-based check-ups.

Economic evaluations of nonpharmacological treatments for drug-resistant epilepsy: A systematic review.

This study was undertaken to systematically identify and critically appraise all published full economic evaluations assessing the cost-effectiveness of nonpharmacological interventions for patients with drug-resistant epilepsy. The Population, Intervention, Comparison, Outcome, Study criteria was used to design search strategies for the identification and selection of relevant studies. Literature search was performed using the MEDLINE (via PubMed), Embase, International Health Technology Assessment, National Institute for Health Research Economic Evaluation Database, and Cost-Effectiveness Analysis Registry databases to identify articles published between January 2000 and May 2023. Web of Science was additionally used to perform forward and backward referencing. Title, abstract, and full-text screening was performed by two independent researchers. The Consensus Health Economic Criteria (CHEC) checklist and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 were applied for quality assessment. A total of 4470 studies were identified, of which 18 met our inclusion criteria. Twelve of the studies conducted model-based economic evaluation, and others were trial-based. Three studies showed that epilepsy surgery was cost-effective in adults, whereas this remained inconclusive for children (two positive, three negative). Three studies showed negative economic outcome for ketogenic diet in children. One of four studies showed positive results for self-management. For vagus nerve stimulation, one study showed positive results in adults and another one negative results in children. One recent study showed cost-effectiveness of responsive neurostimulation (RNS) in adults. Finally, one study showed promising but inconclusive results for deep brain stimulation (DBS). The mean scores for risk of bias assessment (based on CHEC) and for reporting quality (CHEERS 2022) were 95.8% and 80.5%, respectively. This review identified studies that assessed the cost-effectiveness of nonpharmacological treatments in both adults and children with drug-resistant epilepsy, suggesting that in adults, epilepsy surgery, vagus nerve stimulation, and RNS are cost-effective, and that DBS and self-management appear to be promising. In children, the cost-effectiveness of epilepsy surgery remains inconclusive. Finally, the use of ketogenic diet was shown not to be cost-effective. However, limited long-term data were available for newer interventions (i.e., ketogenic diet, DBS, and RNS).

A consensus-based checklist for the critical appraisal of cost-of-illness (COI) studies.

OBJECTIVES: To develop a consensus-based checklist that can be used as a minimum standard to appraise the comprehensiveness, transparency and consistency of cost-of-illness (COI) studies. This is important when, for instance, reviewing and assessing COI studies as part of a systematic review or when building an economic model. METHODS: The development process of the consensus-based checklist involved six steps: (i) a scoping review, (ii) an assessment and comparison of the different checklists and their questions, (iii) the development of a (preliminary) checklist, (iv) expert interviews, (v) the finalization of the checklist, and (vi) the development of guidance statements explaining each question. RESULTS: The result was a consensus-based checklist for the critical appraisal of COI studies, comprising seventeen main questions (and some additional subquestions) across three domains: (i) study characteristics; (ii) methodology and cost analysis; and (iii) results and reporting. Guidance statements were developed describing the purpose and meaning behind each question and listing examples of best practice. The following answer categories were suggested to be applied when answering the questions in the checklist: Yes, Partially, No, Not Applicable, or Unclear. CONCLUSIONS: The consensus-based checklist for COI studies is a first step toward standardizing the critical appraisal of COI studies and is one that could be considered a minimum standard. The checklist can help to improve comprehensiveness, transparency and consistency in COI studies, to address heterogeneity, and to enable better comparability of methodological approaches across international studies.

Expert opinion on a consensus-based checklist for the critical appraisal of cost-of-illness (COI) studies: qualitative interviews.

OBJECTIVES: This study explored experts' views on the development of a proposed checklist for cost-of-illness (COI) studies. It also investigated experts' perspectives on the use of COI studies and quality/critical appraisal tools used for COI studies as well as their experiences with the use of these tools. METHODS: Semi-structured, open-ended interviews were conducted with health economists and other experts working with COI studies and with experience of developing health economic guidelines or checklists. Participants were selected purposively using network and snowball sampling. A framework approach was applied for the thematic data analysis. Findings were reported narratively. RESULTS: Twenty-one experts from eleven different countries were interviewed. COI studies were found to be relevant to estimate the overall burden of a disease, to draw attention to disease areas, to understand different cost components, to explain cost variability, to inform decision making, and to provide input for full economic evaluations. Experts reported a lack of a standardized critical appraisal tool for COI studies. Their experience related predominantly to guidelines and checklists designed for full economic evaluations to review and assess COI studies. The following themes emerged when discussing the checklist: (i) the need for a critical appraisal tool, (ii) format and practicality, (iii) assessing the questions, (iv) addressing subjectivity, and (v) guidance requirements. CONCLUSIONS: The interviews provided relevant input for the development of a checklist for COI studies that could be used as a minimum standard and for international application. The interviews confirmed the important need for a checklist for the critical appraisal of COI studies.

An introduction to health technology assessment and health economic evaluation: an online self-learning course.

Cardiovascular diseases impose an enormous burden on patients and society. New health technologies promise to lower this burden; however, novel treatments often come at a high cost. In the Netherlands, health technology assessment (HTA) is increasingly being used to inform policy bodies about the optimal distribution of scarce healthcare resources and to guide decision-making about financing and reimbursement. In particular, economic evaluations, as one pillar of HTA, are frequently used to compare the costs and effects of different interventions. This paper aims to define HTA and its relevance to healthcare policy as well as providing a comprehensive overview of the methodology of economic evaluations targeting health professionals and researchers with limited prior knowledge of this subject. Accordingly, different types of economic evaluations are introduced, together with their respective costs and outcomes. Further, the results of economic evaluations are explained, along with techniques for performing them and methods for coping with uncertainty. In addition to this paper-based learning format, each chapter is complemented by a video lecture with further information and practical examples, helping to better understand and analyse health economic studies.

Quality of life and societal costs in hypertrophic cardiomyopathy: protocol of the AFFECT-HCM study.

BACKGROUND: Ever since the first description of hypertrophic cardiomyopathy (HCM), the most common genetic cardiac disease, tremendous progress has been made in the evaluation and management of HCM patients, but little attention has been focused on the impact of HCM on societal costs and quality of life (QoL). AIMS: This paper describes the study protocol for the AFFECT-HCM study into burden of disease (BoD), which aims to estimate health-related QoL and societal costs in HCM patients and genotype-positive phenotype-negative (G+/P-) relatives during a one-year follow-up study, and relate this to the phenotypical HCM expression. METHODS: A total of 400 Dutch HCM patients and 100 G+/P- subjects will be followed for one year in a prospective, multi-centre, prevalence-based BoD study. Societal costs will be measured via a bottom-up approach using the cost questionnaires iMCQ and iPCQ. For QoL, the generic EQ-5D-5L and disease-specific Kansas City Cardiomyopathy Questionnaire will be used. QoL and societal costs will be compared with phenotype-specific HCM characteristics and other determinants to identify factors that influence BoD. Accelerometry will test the correlation between BoD and physical activity. CONCLUSION: The AFFECT-HCM study will evaluate the BoD in HCM patients and G+/P- subjects to improve the understanding of the societal and economic impact of HCM.

A systematic literature review of economic evaluations and cost-of-illness studies of inherited cardiomyopathies.

Hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM) are commonly inherited heart conditions associated with a high risk of heart failure and sudden cardiac death. To understand the economic and societal disease burden, this study systematically identified and reviewed cost-of-illness (COI) studies and economic evaluations (EEs) of various interventions for HCM and DCM. A literature search was performed in MEDLINE, EMBASE, NHS EED, EconLit and Web of Science to identify COI studies and EEs published between 1 January 2010 and 28 April 2021. The selection of studies and their critical appraisal were performed jointly by two independent researchers. For the quality assessment, the 'Consensus on Health Economic Criteria' list was used. Two COI studies and 11 EEs were eligible for inclusion. Cost-effectiveness varied among interventions and depended on the targeted patient population. Both COI studies identified only hospitalisation costs in HCM. The mean study quality was high in EEs but low in COI studies. Most studies excluded costs for patients, caregivers and productivity losses. Overall, knowledge of the societal and economic burden of inherited cardiomyopathies is limited. Future research needs to include quality-adjusted life years and a broader range of costs to provide an information base for optimising care for affected patients.

Economic evaluation of deep brain stimulation compared with vagus nerve stimulation and usual care for patients with refractory epilepsy: A lifetime decision analytic model.

OBJECTIVES: This study was undertaken to estimate the cost-effectiveness of deep brain stimulation (DBS) compared with vagus nerve stimulation (VNS) and care as usual (CAU) for adult patients with refractory epilepsy from a health care perspective using a lifetime decision analytic model. METHODS: A Markov decision analytic model was constructed to estimate the lifetime cost-effectiveness of DBS compared with VNS and CAU. Transition probabilities were estimated from a randomized controlled trial, and assumptions were made in consensus with an expert panel. Primary outcomes were expressed as incremental costs per quality-adjusted life-year (QALY) and per responder. Univariate and probabilistic sensitivity analyses were conducted to characterize parameter uncertainty. RESULTS: In DBS, 28.4% of the patients were responders, with an average of 21.38 QALYs per patient and expected lifetime health care costs of €187 791. VNS had fewer responders (22.3%), fewer QALYs (20.70), and lower lifetime costs (€156 871). CAU had the fewest responders (6.2%), fewest QALYs (18.74), and lowest total health care costs (€64 670). When comparing with CAU, incremental cost-effectiveness ratios (ICERs) showed that costs per QALY gained were slightly lower for DBS (€46 640) than for VNS (€47 155). When comparing DBS with VNS, an incremental cost per additional QALY gained of €45 170 was found for DBS. Sensitivity analyses showed that ICERs were heavily dependent on assumptions regarding loss to follow-up in the respective clinical trial. SIGNIFICANCE: This study suggests that, given current limited evidence, VNS and DBS are potentially cost-effective treatment strategies compared to CAU for patients with refractory epilepsy. However, results for DBS were heavily impacted by assumptions made to extrapolate nonresponse from the original trial. More stringent assumptions regarding nonresponse resulted in an ICER just above an acceptable willingness to pay threshold. Given the uncertainty surrounding the effectiveness of DBS and the large impact of assumptions related to nonresponse, further empirical research is needed to reduce uncertainty.

(Cost)-effectiveness and implementation of integrated community-based care for patients with severe mental illness: a study protocol.

BACKGROUND: As severe mental illness (SMI) is associated with a high disease burden and persistent nature, patients with SMI are often subjected to long-term mental healthcare and are in need of additional social support services. Community-based care and support services are organized via different providers and institutions, which are often lacking structural communication, resulting in a fragmented approach. To improve the efficiency of care provision and optimize patient wellbeing, an integrated multi-agency approach to community-based mental health and social services has been developed and implemented. AIM: To present a research protocol describing the evaluation of flexible assertive community teams integrated with social services in terms of effectiveness, cost-effectiveness, and implementation. METHODS/DESIGN: A quasi-experimental study will be conducted using prospective and retrospective observational data in patients with severe mental illness. Patients receiving care from three teams, consisting of flexible assertive community treatment and separately provided social support services (care as usual), will be compared to patients receiving care from two teams integrating these mental and social services into a single team. The study will consist of three parts: 1) an effectiveness evaluation, 2) a health-economic evaluation, and 3) a process implementation evaluation. To assess (cost-)effectiveness, both real-world aggregated and individual patient data will be collected using informed consent, and analysed using a longitudinal mixed model. The economic evaluation will consist of a cost-utility analysis and a cost-effectiveness analysis. For the process and implementation evaluation a mixed method design will be used to describe if the integrated teams have been implemented as planned, if its predefined goals are achieved, and what the experiences are of its team members. DISCUSSION: The integration of health and social services is expected to allow for a more holistic and recovery oriented treatment approach, whilst improving the allocation of scarce resources. This study aims to identify and describe these effects using a mixed-method approach, and support decision-making in the structural implementation of integrating mental and social services.

Design of an RCT on cost-effectiveness of group schema therapy versus individual schema therapy for patients with Cluster-C personality disorder: the QUEST-CLC study protocol.

BACKGROUND: Given the high prevalence of Cluster-C Personality Disorders (PDs) in clinical populations, disease burden, high societal costs and poor prognosis of comorbid disorders, a major gain in health care can be achieved if Cluster-C PDs are adequately treated. The only controlled cost-effectiveness study published so far found Individual Schema Therapy (IST) to be superior to Treatment as Usual (TAU). Group ST (GST) might improve cost-effectiveness as larger numbers can be treated in (>50%) less time compared to IST. However, to date there is no RCT supporting its (cost-) effectiveness. The overall aim of this study is to assess the evidence for GST for Cluster-C PDs and to improve treatment allocation for individual patients. Three main questions are addressed: 1) Is GST for Cluster-C PDs (cost-)effective compared to TAU? 2) Is GST for Cluster-C PDs (cost-) effective compared to IST? 3) Which patient-characteristics predict better response to GST, IST, or TAU? METHODS: In a multicenter RCT, the treatment conditions GST, IST, and TAU are compared in 378 Cluster-C PD patients within 10 sites. GST and IST follow treatment protocols and are completed within 1 year. TAU is the optimal alternative treatment available at the site according to regular procedures. Severity of the Cluster-C PD is the primary outcome, assessed with clinical interviews by independent raters blind for treatment. Functioning and wellbeing are important secondary outcomes. Assessments take place at week 0 (baseline), 17 (mid-GST), 34 (post-GST), 51 (post-booster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specific treatment are studied, e.g., childhood trauma, autistic features, and introversion. A tool supporting patients and clinicians in matching treatment to patient will be developed. An economic evaluation investigates the cost-effectiveness and cost-utility from a societal perspective. A process evaluation by qualitative methods explores experiences of participants, loved ones and therapists regarding recovery, quality of life, and improving treatment. DISCUSSION: This study will determine the (cost-)effectiveness of treatments for Cluster-C PDs regarding treatment type as well as optimal matching of patient to treatment and deliver insight into which aspects help Cluster-C-PD patients recover and create a fulfilling life. TRIAL REGISTRATION: Dutch Trial Register: NL9209 . Registered on 28-01-2021.

Control in the Hospital by Extensive Clinical rules for Unplanned hospitalizations in older Patients (CHECkUP); study design of a multicentre randomized study.

BACKGROUND: Due to ageing of the population the incidence of multimorbidity and polypharmacy is rising. Polypharmacy is a risk factor for medication-related (re)admission and therefore places a significant burden on the healthcare system. The reported incidence of medication-related (re)admissions varies widely due to the lack of a clear definition. Some medications are known to increase the risk for medication-related admission and are therefore published in the triggerlist of the Dutch guideline for Polypharmacy in older patients. Different interventions to support medication optimization have been studied to reduce medication-related (re)admissions. However, the optimal template of medication optimization is still unknown, which contributes to the large heterogeneity of their effect on hospital readmissions. Therefore, we implemented a clinical decision support system (CDSS) to optimize medication lists and investigate whether continuous use of a CDSS reduces the number of hospital readmissions in older patients, who previously have had an unplanned probably medication-related hospitalization. METHODS: The CHECkUP study is a multicentre randomized study in older (≥60 years) patients with an unplanned hospitalization, polypharmacy (≥5 medications) and using at least two medications from the triggerlist, from Zuyderland Medical Centre and Maastricht University Medical Centre+ in the Netherlands. Patients will be randomized. The intervention consists of continuous (weekly) use of a CDSS, which generates a Medication Optimization Profile, which will be sent to the patient's general practitioner and pharmacist. The control group will receive standard care. The primary outcome is hospital readmission within 1 year after study inclusion. Secondary outcomes are one-year mortality, number of emergency department visits, nursing home admissions, time to hospital readmissions and we will evaluate the quality of life and socio-economic status. DISCUSSION: This study is expected to add evidence on the knowledge of medication optimization and whether use of a continuous CDSS ameliorates the risk of adverse outcomes in older patients, already at an increased risk of medication-related (re)admission. To our knowledge, this is the first large study, providing one-year follow-up data and reporting not only on quality of care indicators, but also on quality-of-life. TRIAL REGISTRATION: The trial was registered in the Netherlands Trial Register on October 14, 2018, identifier: NL7449 (NTR7691). https://www.trialregister.nl/trial/7449 .

Are intersectoral costs considered in economic evaluations of interventions relating to sexually transmitted infections (STIs)? A systematic review.

BACKGROUND/OBJECTIVE: Sexually transmitted infections (STIs) not only have an impact on the health sector but also the private resources of those affected, their families and other sectors of society (i.e. labour, education). This study aimed to i) review and identify economic evaluations of interventions relating to STIs, which aimed to include a societal perspective; ii) analyse the intersectoral costs (i.e. costs broader than healthcare) included; iii) categorise these costs by sector; and iv) assess the impact of intersectoral costs on the overall study results. METHODS: Seven databases were searched: MEDLINE (PubMed), EMBASE (Ovid), Web of Science, CINAHL, PsycINFO, EconLit and NHS EED. Key search terms included terms for economic evaluation, STIs and specific infections. This review considered trial- and model-based economic evaluations conducted in an OECD member country. Studies were included that assessed intersectoral costs. Intersectoral costs were extracted and categorised by sector using Drummond's cost classification scheme (i.e. patient/family, productivity, costs in other sectors). A narrative synthesis was performed. RESULTS: Twenty-nine studies qualified for data extraction and narrative synthesis. Twenty-eight studies applied a societal perspective of which 8 additionally adopted a healthcare or payer perspective, or both. One study used a modified payer perspective. The following sectors were identified: patient/family, informal care, paid labour (productivity), non-paid opportunity costs, education, and consumption. Patient/family costs were captured in 11 studies and included patient time, travel expenses, out-of-pocket costs and premature burial costs. Informal caregiver support (non-family) and unpaid help by family/friends was captured in three studies. Paid labour losses were assessed in all but three studies. Three studies also captured the costs and inability to perform non-paid work. Educational costs and future non-health consumption costs were each captured in one study. The inclusion of intersectoral costs resulted in more favourable cost estimates. CONCLUSIONS: This systematic review suggests that economic evaluations of interventions relating to STIs that adopt a societal perspective tend to be limited in scope. There is an urgent need for economic evaluations to be more comprehensive in order to allow policy/decision-makers to make better-informed decisions.

The development process of economic evaluation guidelines in low- and middle-income countries: a systematic review.

OBJECTIVES: To review the development of economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs), with the goal of assisting those developing EEGs in LMICs. METHODS: We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature until March 2021. We extracted data on the methods used in the EEG development process, the responsible party engaged, and the development team's composition. We conducted a quality assessment, using the Appraisal of Guidelines for Research and Evaluation-Health Systems tool, and then carried out a relative comparison. RESULTS: Fourteen EEGs and nine studies were identified. In ten countries, the Ministry of Health was responsible for handling the development process. The majority of LMICs who developed EEGs did not explicitly report the discipline of those involved in the process. The developers of EEGs followed four main steps: conducting a review on national guidelines, organizing workshops, and getting support from international experts or from organizations. One-third of the identified EEGs failed to engage multisectoral or multidisciplinary developers, and approximately 14 percent did not follow or report any recommended step. CONCLUSIONS: This study identified a scarcity of published information related to the development process and the suboptimal quality of included studies. It provides relevant material to support international organizations and developers of guidelines in LMICs in developing EEGs that fit their national context. In addition, this paper recommends a transparent approach to the design of guidelines and to reporting on the methods for developing them.

The accountability of the private sector towards citizens in times of crisis: vaccines, medicines and equipment.

In this article, we examine what the role of the private sector in times of crises is and whether the private sector is, and can be held to be, accountable. COVID-19 has amplified the difficulties with public-private partnerships and this article addresses several aspects concerning business enterprises, in particular transnational corporations, human rights and health sector activities, highlighting the key aspects to understand and address accountability issues. The article also explores accountability for the private sector, the processes to ensure accountability, and the relevance of regulation and self-regulation.

Intersectoral costs of sexually transmitted infections (STIs) and HIV: a systematic review of cost-of-illness (COI) studies.

BACKGROUND: Sexually transmitted infections (STIs) and HIV can generate costs both within and outside the health sector (i.e. intersectoral costs). This systematic review aims (i) to explore the intersectoral costs associated with STIs and HIV considered in cost-of-illness (COI) studies, (ii) to categorise and analyse these costs according to cost sectors, and (iii) to illustrate the impact of intersectoral costs on the total cost burden. METHODS: Medline (PubMed), EMBASE (Ovid), Web of Science, CINAHL, PsycINFO, EconLit and NHS EED were searched between 2009 and 2019. Key search terms included terms for cost-of-illness, cost analysis and all terms for STIs including specific infections. Studies were included that assessed intersectoral costs. A standardised data extraction form was adopted. A cost component table was established based on pre-defined sector-specific classification schemes. Cost results for intersectoral costs were recorded. The quality of studies was assessed using a modified version of the CHEC-list. RESULTS: 75 COI studies were considered for title/abstract screening. Only six studies were available in full-text and eligible for data extraction and narrative synthesis. Intersectoral costs were captured in the following sectors: Patient & family, Informal care and Productivity (Paid Labour). Patient & family costs were addressed in four studies, including patient out-of-pocket payments/co-payments and travel costs. Informal care costs including unpaid (home) care support by family/friends and other caregiver costs were considered in three studies. All six studies estimated productivity costs for paid labour including costs in terms of absenteeism, disability, cease-to-work, presenteeism and premature death. Intersectoral costs largely contributed to the total economic cost burden of STIs and HIV. The quality assessment revealed methodological differences. CONCLUSIONS: It is evident that intersectoral costs associated with STIs and HIV are substantial. If relevant intersectoral costs are not included in cost analyses the total cost burden of STIs and HIV to society is severely underestimated. Therefore, intersectoral costs need to be addressed in order to ensure the total economic burden of STIs and HIV on society is assessed, and communicated to policy/decision-makers.

Economic evaluation guidelines in low- and middle-income countries: a systematic review.

OBJECTIVES: To systematically identify the latest versions of official economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs) and explore similarities and differences in their content. METHODS: We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature. Using a predefined checklist, we extracted the key features of economic evaluation and the general characteristics of EEGs. We conducted a comparative analysis, including a summary of similarities and differences across EEGs. RESULTS: Thirteen EEGs were identified, three pertaining to lower-middle-income countries (Bhutan, Egypt, and Indonesia), nine to upper-middle-income countries (Brazil, China, Colombia, Cuba, Malaysia, Mexico, Russian Federation, South Africa, and Thailand), in addition to Mercosur, and none to low-income countries. The majority (n = 12) considered cost-utility analysis and health-related quality-of-life outcome. Half of the EEGs recommended the societal perspective, whereas the other half recommended the healthcare perspective. Equity considerations were required in ten EEGs. Most EEGs (n = 11) required the incremental cost-effectiveness ratio and recommended sensitivity analysis, as well as the presentation of a budget impact analysis (n = 10). Seven of the identified EEGs were mandatory for pharmacoeconomics submission. Methodological gaps, contradictions, and heterogeneity in terminologies used were identified within the guidelines. CONCLUSION: As the importance of health technology assessment is increasing in LMICs, this systematic review could help researchers explore key aspects of existing EEGs in LMICs and explore differences among them. It could also support international organizations in guiding LMICs to develop their own EEGs and improve the methodological framework of existing ones.

The broader societal impacts of COVID-19 and the growing importance of capturing these in health economic analyses.

AbstractThe rapid spread of the current COVID-19 pandemic has affected societies worldwide, leading to excess mortality, long-lasting health consequences, strained healthcare systems, and additional strains and spillover effects on other sectors outside health (i.e., intersectoral costs and benefits). In this perspective piece, we demonstrate the broader societal impacts of COVID-19 on other sectors outside the health sector and the growing importance of capturing these in health economic analyses. These broader impacts include, for instance, the effects on the labor market and productivity, education, criminal justice, housing, consumption, and environment. The current pandemic highlights the importance of adopting a societal perspective to consider these broader impacts of public health issues and interventions and only omit these where it can be clearly justified as appropriate to do so. Furthermore, we explain how the COVID-19 pandemic exposed and exacerbated existing deep-rooted structural inequalities that contribute to the wider societal impacts of the pandemic.

Age dependency of EQ-5D-Youth health states valuations on a visual analogue scale.

BACKGROUND: Examine whether the use of different ages has an impact on the valuation of EQ-5D-Y health states for a hypothetical child or adolescent. METHODS: A survey was administered during regular classes among a convenience sample of university students in the Netherlands. Respondents first valued 6 EQ-5D-Y health states (2 mild, 2 moderate, 2 severe) describing a hypothetical child/adolescent of a certain age on a visual analogue scale (VAS). After 1 h respondents valued the same six health states again but this time the age of the child was different. Age differed between 4, 10 and 16 year old. RESULTS: Number of respondents was 311. No significant differences in valuation of the six health states were found between the age of 10 and 16. One moderate health state was valued significantly better for a 4-year old compared to a 10 and a 16 year old. The same applied for one severe health state that was valued higher for a 4-year old compared to a 16-year old. CONCLUSION: Our study shows that, except for one moderate and one severe health state, other EQ-5D-Y health states were not valued significantly different when description of age differed. It is possible that problems in specific health domains are considered more severe for older children/adolescents compared to younger children who might still be dependent on their caregivers. Future research should examine whether our findings are also present in a broader set of EQ-5D-Y health states, with a choice-based method like TTO or DCE, and a more heterogeneous sample.