Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Eating disorders (EDs), such as (atypical) Anorexia (AN) and Bulimia Nervosa (BN), are difficult to treat, causing socioeconomic impediments. Although enhanced cognitive behavioral therapy (CBT-E) is widely considered clinically effective, it may not be the most beneficial treatment for (atypical) AN and BN patients who do not show a rapid response after the first 4 weeks (8 sessions) of a CBT-E treatment. Alternatively, group schema therapy (GST) may be a valuable treatment for this ED population. Even though GST for EDs has yielded promising preliminary findings, the current body of evidence requires expansion. On top of that, data on cost-effectiveness is lacking. In light of these gaps, we aim to describe a protocol to examine whether GST is more (1) clinically effective and (2) cost-effective than CBT-E for (atypical) AN and BN patients, who do not show a rapid response after the first 4 weeks of treatment. Additionally, we will conduct (3) process evaluations for both treatments. METHODS: Using a multicenter RCT design, 232 Dutch (atypical) AN and BN patients with a CBT-E referral will be recruited from five treatment centers. Clinical effectiveness and cost-effectiveness will be measured before treatment, directly after treatment, at 6 and at 12 months follow-up. In order to rate process evaluation, patient experiences and the degree to which treatments are implemented according to protocol will be measured. In order to assess the quality of life and the achievement of personalized goals, interviews will be conducted at the end of treatment. Data will be analyzed, using a regression-based approach to mixed modelling, multivariate sensitivity analyses and coding trees for qualitative data. We hypothesize GST to be superior to CBT-E in terms of clinical effectiveness and cost-effectiveness for patients who do not show a rapid response to the first 4 weeks of a CBT-E treatment. DISCUSSION: To our knowledge, this is the first study protocol describing a multicenter RCT to explore the three aforementioned objectives. Related risks in performing the study protocol have been outlined. The expected findings may serve as a guide for healthcare stakeholders to optimize ED care trajectories. TRIAL REGISTRATION: clinicaltrials.gov (NCT05812950).

Prospective health care costs and lost work days associated with diabetes-related distress and depression symptoms among 1488 individuals with diabetes.

The aim of this study was to investigating the impact of major depression symptoms and diabetes-related distress on future health care costs and lost workdays in individuals with diabetes. We linked survey data from a random sample of a German statutory health insurance (SHI) with diabetes (n = 1488, 63.0% male, mean age 66.9 years) with their SHI data one year after the survey. Within the survey data we identified major depression symptoms (Patient Health Questionnaire-9) and diabetes-related distress (Problem Areas in Diabetes Scale). We retrieved health care costs and lost workdays from SHI data. To assess the impact of major depression symptoms and diabetes-related distress on health care costs and lost workdays, we adjusted regression models for age, sex, education, employment status, and diabetes duration, type, and severity. Major depression symptoms were associated with significantly higher costs (by a factor of 1.49; 95% CI: 1.18-1.88). Lost workdays were also more likely for respondents with depression symptoms (RR1.34; 0.97-1.86). Health care costs (by a factor of 0.81; 0.66-1.01) and the risk of lost workdays (RR 0.86; 0.62-1.18) may be lower among respondents with high diabetes-related distress. While major depression and diabetes-related distress have overlapping indicators, our results indicate different impacts on health care costs.

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.

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.

Developing the Lebanese health economic evaluation guideline.

OBJECTIVE: To report on the process of developing the Lebanese Economic Evaluation Guideline (LEEG), and to provide relevant material that could assist guideline developers in the future. METHODS: The development of the LEEG closely followed the process proposed by the World Health Organization, i.e. to set up a Guideline Development Group (composed of three Lebanese experts), to establish the rationale for developing the guideline in Lebanon, to identify its scope, to search and retrieve evidence through two systematic reviews, to assess and present the evidence, to translate the evidence into guidelines and recommendations through a deliberative process, and to consult international experts. The deliberative process included a survey, an in-person interview, and a consensus workshop with 16 Lebanese key stakeholders. Data was collected and quantitative analysis was conducted using SPSS software. International experts from Maastricht University - The Netherlands were consulted for issuing the LEEG. Supported by the Lebanese Ministry of Public Health (MoPH), the LEEG will be available for public consultation on the MoPH's webpage, and a final version will be made available thereafter. CONCLUSION: Clear and transparent reporting of the guideline development process should support international organizations as well as other developers in establishing their guidelines within their national context.

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).

Economic evaluations of interventions focusing on child abuse and neglect in high-income countries: a systematic review.

Introduction: Child abuse and neglect are together considered to be an important public health problem with a high individual and societal burden. Different interventions have been developed to prevent, diagnose, or treat maltreatment. While their effectiveness has been synthesized in prior reviews, the analysis of their cost-effectiveness is less common. The aim of this study is to synthesize and analyse economic evaluations of interventions focusing on child abuse and neglect in high-income countries. Methods: A systematic literature review was performed using MEDLINE, EMBASE, EconLit, PsycInfo and NHS EED. This study follows the PRISMA guidelines and double scoring was performed. The review includes trial- and model-based economic evaluations of preventive, diagnostic, and treatment related interventions in children up to 18 years or their caregivers. Risk of bias was assessed using the CHEC-extended checklist. The results are presented in a cost-effectiveness plane. Results: Of 5,865 search results, the full texts of 81 were analyzed, resulting in the inclusion of 11 economic evaluations. Eight of the included studies focus on prevention of child abuse and neglect, one study on diagnosis, and two on treatment. The heterogeneity between studies did not allow for the quantitative pooling of results. Most interventions were cost-effective, with the exception of one preventive and one diagnostic intervention. Conclusion: This study was subject to some limitations, as no gray literature was included, and the selection of studies may have been arbitrary due to varying terminologies and methodologies in the field. However, the quality of studies was high, and several interventions showed promising results. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021248485, identifier: CRD42021248485.

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.

@ease peer-to-peer youth walk-in centres in The Netherlands: A protocol for evaluating longitudinal outcomes, follow-up results and cost-of-illness.

AIM: Innovative youth mental health services around the globe vigorously work on increasing highly needed mental health care accessibility but their service users and care effectiveness have rarely been studied. The Dutch youth walk-in centres of @ease opened in 2018, with currently 11 locations at which free anonymous peer-to-peer counselling is offered to young people aged 12-25. The aim of this protocol is to outline the to-be-conducted research at @ease. METHODS: Three studies are outlined: (1) an outcome evaluation of @ease visits using hierarchical mixed model analyses and change calculations, (2) a cost-of-illness study using calculations for costs of truancy and care usage among these help-seeking young people, with regression analyses for risk group identification, and (3) a follow-up evaluation at three, six and 12 months to assess long-term effects after ending @ease visits. Data provided by young people include demographics, parental mental illness, truancy, past treatment, psychological distress (CORE-10) and health-related quality of life (EQ-5D-5L). Social and occupational functioning (SOFAS), suicidal ideation and need for referral are rated by the counsellors. Questionnaires are filled out at the end of every visit and at follow-up via e-mail or text, provided permission is given. DISCUSSION: Research regarding the visitors and effectiveness of the @ease services is fully original. It offers unique insights into the mental wellbeing and cost-of-illness of young people who may otherwise remain unseen while suffering from a high disease burden. The upcoming studies shed light on this unseen group, inform policy and practice and direct future research.

A roadmap for applying machine learning when working with privacy-sensitive data: predicting non-response to treatment for eating disorders.

OBJECTIVES: Applying machine-learning methodology to clinical data could present a promising avenue for predicting outcomes in patients receiving treatment for psychiatric disorders. However, preserving privacy when working with patient data remains a critical concern. METHODS: In showcasing how machine-learning can be used to build a clinically relevant prediction model on clinical data, we apply two commonly used machine-learning algorithms (Random Forest and least absolute shrinkage and selection operator) to routine outcome monitoring data collected from 593 patients with eating disorders to predict absence of reliable improvement 12 months after entering outpatient treatment. RESULTS: An RF model trained on data collected at baseline and after three months made 31.3% fewer errors in predicting lack of reliable improvement at 12 months, in comparison with chance. Adding data from a six-month follow-up resulted in only marginal improvements to accuracy. CONCLUSION: We were able to build and validate a model that could aid clinicians and researchers in more accurately predicting treatment response in patients with EDs. We also demonstrated how this could be done without compromising privacy. ML presents a promising approach to developing accurate prediction models for psychiatric disorders such as ED.

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.

The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers. METHODS/DESIGN: A pragmatic, cluster randomized controlled trial with a shared control group will be conducted. Participants will be informal caregivers of people with early-stage dementia and will be recruited by local care professionals. Randomization will be carried out at the level of the care professional level in a ratio of 35% to 65% (control arm vs. intervention arm). Participants in the control arm will receive care as usual and the intervention arm will receive the blended care self-management program "Partner in Balance" within a usual care setting in the Netherlands. Data will be collected at baseline and at 3-, 6-, 12-, and 24-month follow-ups. The primary outcome for effectiveness (part 1) is care management self-efficacy. For the health-economic evaluation (part 2) total care costs and the quality of life for individuals with dementia (cost-effectiveness) and quality-adjusted life years (cost-utility) will be the base case analysis. Secondary outcomes (parts 1 and 2) will include depression, anxiety, perceived informal caregiving stress, service-use self-efficacy, quality of life, caregivers' gain, and perseverance time. A process evaluation (part 3) will investigate the internal and external validity of the intervention. DISCUSSION: In this trial, we plan to evaluate the effectiveness, cost-effectiveness, and cost-utility of "Partner in Balance" among informal caregivers of people with dementia. We expect to find a significant increase in care management self-efficacy, and the program to be cost-effective, and provide valuable insights to stakeholders of "Partner in Balance." TRIAL REGISTRATION: ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.

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.

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.

Measuring the Burden of Infodemics: Summary of the Methods and Results of the Fifth WHO Infodemic Management Conference.

Background: An infodemic is excess information, including false or misleading information, that spreads in digital and physical environments during a public health emergency. The COVID-19 pandemic has been accompanied by an unprecedented global infodemic that has led to confusion about the benefits of medical and public health interventions, with substantial impact on risk-taking and health-seeking behaviors, eroding trust in health authorities and compromising the effectiveness of public health responses and policies. Standardized measures are needed to quantify the harmful impacts of the infodemic in a systematic and methodologically robust manner, as well as harmonizing highly divergent approaches currently explored for this purpose. This can serve as a foundation for a systematic, evidence-based approach to monitoring, identifying, and mitigating future infodemic harms in emergency preparedness and prevention. Objective: In this paper, we summarize the Fifth World Health Organization (WHO) Infodemic Management Conference structure, proceedings, outcomes, and proposed actions seeking to identify the interdisciplinary approaches and frameworks needed to enable the measurement of the burden of infodemics. Methods: An iterative human-centered design (HCD) approach and concept mapping were used to facilitate focused discussions and allow for the generation of actionable outcomes and recommendations. The discussions included 86 participants representing diverse scientific disciplines and health authorities from 28 countries across all WHO regions, along with observers from civil society and global public health-implementing partners. A thematic map capturing the concepts matching the key contributing factors to the public health burden of infodemics was used throughout the conference to frame and contextualize discussions. Five key areas for immediate action were identified. Results: The 5 key areas for the development of metrics to assess the burden of infodemics and associated interventions included (1) developing standardized definitions and ensuring the adoption thereof; (2) improving the map of concepts influencing the burden of infodemics; (3) conducting a review of evidence, tools, and data sources; (4) setting up a technical working group; and (5) addressing immediate priorities for postpandemic recovery and resilience building. The summary report consolidated group input toward a common vocabulary with standardized terms, concepts, study designs, measures, and tools to estimate the burden of infodemics and the effectiveness of infodemic management interventions. Conclusions: Standardizing measurement is the basis for documenting the burden of infodemics on health systems and population health during emergencies. Investment is needed into the development of practical, affordable, evidence-based, and systematic methods that are legally and ethically balanced for monitoring infodemics; generating diagnostics, infodemic insights, and recommendations; and developing interventions, action-oriented guidance, policies, support options, mechanisms, and tools for infodemic managers and emergency program managers.

PHQ-9, CES-D, health insurance data-who is identified with depression? A Population-based study in persons with diabetes.

AIMS: Several instruments are used to identify depression among patients with diabetes and have been compared for their test criteria, but, not for the overlaps and differences, for example, in the sociodemographic and clinical characteristics of the individuals identified with different instruments. METHODS: We conducted a cross-sectional survey among a random sample of a statutory health insurance (SHI) (n = 1,579) with diabetes and linked it with longitudinal SHI data. Depression symptoms were identified using either the Centre for Epidemiological Studies Depression (CES-D) scale or the Patient Health Questionnaire-9 (PHQ-9), and a depressive disorder was identified with a diagnosis in SHI data, resulting in 8 possible groups. Groups were compared using a multinomial logistic model. RESULTS: In total 33·0% of our analysis sample were identified with depression by at least one method. 5·0% were identified with depression by all methods. Multinomial logistic analysis showed that identification through SHI data only compared to the group with no depression was associated with gender (women). Identification through at least SHI data was associated with taking antidepressants and previous depression. Health related quality of life, especially the mental summary score was associated with depression but not when identified through SHI data only. CONCLUSION: The methods overlapped less than expected. We did not find a clear pattern between methods used and characteristics of individuals identified. However, we found first indications that the choice of method is related to specific underlying characteristics in the identified population. These findings need to be confirmed by further studies with larger study samples.

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.

Exploring the wider societal impacts of sexual health issues and interventions to build a framework for research and policy: a qualitative study based on in-depth semi-structured interviews with experts in OECD member countries.

OBJECTIVES: Sexual health is a complex public health challenge and can generate wide-ranging health, social and economic impacts both within and beyond the health sector (ie, intersectoral costs and benefits). Methods are needed to capture these intersectoral impacts in economic studies to optimally inform policy/decision-making. The objectives of this study were (1) to explore the different intersectoral costs and benefits associated with sexual health issues and interventions, (2) to categorise these into sectors and (3) to develop a preliminary framework to better understand these impacts and to guide future research and policy. DESIGN: A qualitative study based on in-depth semi-structured online interviews. SETTING: OECD (Organisation for Economic Co-operation and Development) member countries. PARTICIPANTS: Professionals with expertise in the field of sexual health including clinicians, medical practitioners, sexologists, researchers, professionals working for international governmental or non-governmental health (policy) organisations and professionals involved in implementation and/or evaluation of sexual health interventions/programmes. METHODS: Sampling of participants was undertaken purposively. We conducted in-depth semi-structured online interviews to allow for a systemic coverage of key topics and for new ideas to emerge. We applied a Framework approach for thematic data analysis. RESULTS: 28 experts were interviewed. Six themes emerged from the interviews: (1) Interconnections to other areas of health (ie, reproductive health, mental health), (2) Relationships and family, (3) Productivity and labour, (4) Education, (5) Criminal justice/sexual violence, (6) Housing, addiction and other sectors. The findings confirm that sexual health is complex and can generate wide-ranging impacts on other areas of health and other non-health sectors of society. CONCLUSION: These different sectors need to be considered when evaluating interventions and making policy decisions. The preliminary framework can help guide future research and policy/decision-making. Future research could explore additional sectors not covered in this study and expand the preliminary framework.

Patient Preferences in the Management of Hidradenitis Suppurativa: Results of a Multinational Discrete Choice Experiment in Europe.

BACKGROUND AND OBJECTIVE: Hidradenitis suppurativa is a chronic inflammatory skin disease that can lead to a substantial reduction in quality of life. Recent studies revealed high levels of unmet care needs of patients with hidradenitis suppurativa, but their preferences in treatment decision making have scarcely been investigated. This study aimed to reveal which treatment attributes adult patients with HS in Europe consider most important in treatment decision-making. METHODS: A discrete choice experiment was conducted with adult patients with hidradenitis suppurativa in Europe to reveal which treatment attributes are most important when making treatment decisions. Participants were presented with 15 sets of two treatment options and asked for each to choose the treatment they preferred. The treatments were characterized by six attributes informed by a prior literature review and qualitative research: effectiveness, pain reduction, duration of treatment benefit, risk of mild adverse event, risk of serious infection, and mode of administration. A random parameter logit model was used to estimate patients' preferences with additional subgroup and latent class models used to explore any differences in preferences across patient groups. RESULTS: Two hundred and nineteen adult patients with hidradenitis suppurativa were included in the analysis (90% women, mean age 38 years). For all six treatment attributes, significant differences were observed between levels. Given the range of levels of each attribute, the most important treatment attributes were effectiveness (47.9%), followed by pain reduction (17.3%), annual risk of a mild adverse event (14.4%), annual risk of a serious infection (10.3%), mode of administration (5.3%), and duration of treatment benefit (4.8%). Higher levels of effectiveness, namely a 75% or 100% reduction in the abscess and inflammatory nodule count, were preferred over levels of effectiveness primarily investigated in randomized clinical trials of hidradenitis suppurativa (a 50% reduction). Results were largely consistent across subgroups and three latent class groups were identified. CONCLUSIONS: This study revealed the most important treatment characteristics for patients with hidradenitis suppurativa that can help inform joint patient-physician decision making in the management of hidradenitis suppurativa. Designing future hidradenitis suppurativa treatments according to stated preferences, namely, to offer higher levels of effectiveness and pain improvement without higher risks of adverse events, may increase patients' treatment concordance and lead to improved disease management outcomes.