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Chimeric antigen receptor T-cell therapies (CAR-T therapies) are a type of advanced therapy medicinal product (ATMP) that belong to a new generation of personalised cancer immunotherapies. This paper compares the approval, availability and financing of CAR-T cell therapies in ten countries. It also examines the implementation of this type of ATMP within the health care system, describing the organizational elements of CAR-T therapy delivery and the challenges of ensuring equitable access to all those in need, taking a more systems-oriented view. It finds that the availability of CAR-T therapies varies across countries, reflecting the heterogeneity in the organization and financing of specialised care, particularly oncology care. Countries have been cautious in designing reimbursement models for CAR-T cell therapies, establishing limited managed entry arrangements under public payers, either based on outcomes or as an evidence development scheme to allow for the study of real-world therapeutic efficacy. The delivery model of CAR-T therapies is concentrated around existing experienced cancer centres and highlights the need for high networking and referral capacity. Some countries have transparent and systematic eligibility criteria to help ensure more equitable access to therapies. Overall, as with other pharmaceuticals, there is limited transparency in pricing, eligibility criteria and budgeting decisions in this therapeutic area., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objectives: To estimate the cost-effectiveness of sacrum multilayer silicone foam dressings as an adjuvant prophylactic therapy compared to standard pressure ulcer prevention in a hospital population at high risk for pressure ulcer development., Methods: An economic evaluation is performed from a healthcare payer's perspective. This evaluation is based on a Belgian publicly funded pragmatic randomized controlled trial (RCT), linked with real-world data from administrative claims database and a Belgian cost analysis. A cost-consequences analysis with a one-year time horizon is performed., Results: The RCT has shown that the risk of developing a new pressure ulcer on the sacrum was statistically significantly reduced by 41 % in the treatment group (RR = 0.59, 95 % CI 0.35-0.98, p = 0.04). The absolute risk reduction of 2.0 % (95 % CI -0.1-4.1 %) coincides with a number needed to treat of 50.0 to prevent one new pressure ulcer of category II or worse. The evolution of quality of life is on average negative for patients who developed a pressure ulcer before day 3, while it is positive for patients without pressure ulcers. In a scenario with conservative assumptions, i.e. without inclusion of price discounts for the multilayer silicone foam dressings and only including costs during the hospitalization, pressure ulcer prevention with dressings on the sacrum was already cost-neutral., Conclusions: The preventive use of silicone adhesive multilayer foam dressings on the sacrum for a population similar to the pragmatic trial population can be supported both from a clinical and economic point of view., Competing Interests: Declaration of competing interest MN, CDM, SD and EM are members of the KCE Expert Team. KCE is a federal institution. KCE's mission is to advise policymakers on decisions relating to health care and health insurance on the basis of scientific and objective research. KCE has no interest in companies (commercial or non-commercial, i.e. hospitals and universities), associations (e.g. professional associations, unions), individuals or organisations (e.g. lobby groups) that could be positively or negatively affected (financially or in any other way) by the implementation of the recommendations. MN, CDM, SD and EM have no relevant interests to declare. DB has the following interests to declare: Membership of the European Pressure Ulcer Advisory Panel (EPUAP), European Wound Management Association (EWMA), and International Skin Tear Advisory Panel (ISTAP)). Participation in pressure ulcer research (investigator initiated) funded by industry developing prophylactic multi-layer foam dressings. Research grant provided by Mölnlycke Healthcare (Core Outcome Sets in clinical studies on bordered foam dressings). Member of International Wound Dressing Technology Expert Panel (IWDTEP) - Mölnlycke Healthcare. Fees for speaking at scientific meetings by companies in this sector (Mölnlycke Healthcare, Smith & NephewSmith & Nephew, 3M Healthcare, Flen Pharma)., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: The study was undertaken to assess the association between certification and volume of breast centres on the one hand and survival on the other in patients with invasive breast cancer (IBC)., Methods: The study comprises a cohort of 46,035 patients diagnosed with IBC between 2014 and 2018, selected from the nation-wide Belgian Cancer Registry (BCR) database, which was linked with health insurance, hospital discharge and vital status data. Overall and relative survival probabilities were obtained with Kaplan-Meier method and an actuarial approach based on Ederer II, respectively. The associations between centre certification/volume and relative survival were assessed using Poisson models, adjusted for potential confounders., Results: Five years after the diagnosis of IBC, the observed and relative survival probabilities for the cohort were 83.4 % (95 %CI: [83.1, 83.8]) and 93.3 % (95 %CI: [92.9, 93.7]), respectively. After adjustment for age and combined tumour stage, the risk to die from BC was 44 % higher (EHR: 1.44, 95 %CI: [1.24, 1.66]) for patients treated in a low-volume centre and 30 % higher (EHR: 1.30, 95 %CI: [1.14, 1.48]) for patients treated in a medium-volume centre, compared to high-volume centres. Likewise, the risk to die from BC was 30 % higher (EHR: 1.30, 95 %CI: [1.15, 1.48], p < 0.001) for patients treated in a non-certified centre (representing 23.8 % of the cohort), compared to patients treated in a coordinating breast clinic., Conclusion: This population-based study reveals that BC survival is higher when patients are treated in certified and high-volume breast clinics., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Although metastatic cutaneous melanoma is associated with an unfavorable prognosis, innovative therapies including immunomodulating agents and targeted therapies have shown survival benefits in clinical trials. We assessed the impact of the introduction of innovative drugs into clinical practice on the survival of patients with metastatic cutaneous melanoma during the period 2004-2017, in Belgium. The evolution of associated expenses was also analyzed., Methods: This is a retrospective population-based study using data from the national Belgian Cancer Registry, compulsory health insurance, and administrative survival data. The immunomodulating drugs were ipilimumab, nivolumab and pembrolizumab, while targeted therapies included vemurafenib, dabrafenib and trametinib., Results: We did not identify a trend for improvement over time. Median survival (years) was 1.5 (95% CI: 1.1-1.8) in 2004-2008, 1.1 (95% CI: 0.8-1.5) in 2009-2013, and 1.6 (95% CI: 1.3-2.4) in 2014-2017, respectively. In contrast, survival improved in those with unknown primary tumor localization. In this group, median survival time was 2.0 (95% CI: 1.4-2.9) in the most recent period, while it was 1.1 (95% CI: 0.7-1.3) in 2009-2013, and 0.9 (95% CI: 0.6-1.2) in 2004-2008. The uptake of innovative drugs remained modest, with no drug being used by more than 30% of patients. Yearly expenditure was almost non-existent, and gradually increased, reaching several million euros in 2014-2017., Conclusion: Patients with metastatic cutaneous melanoma who were diagnosed between 2004 and 2017 showed no apparent improvement in survival. In contrast, increased survival was observed in the subgroup of patients with unknown primary tumor localization., (© 2024 the International Society of Dermatology.)

Aim: The aim of this study was to validate the Delirium Observation Screening Scale (DOSS) in a population of long-term care facility (LTCF) residents in Flanders. Currently there is no validated screening tool for delirium available for the population in this setting in Flanders., Methods: A multisite, cross-sectional study was conducted in six LTCFs. A total of 338 residents aged 65 years and older were included. Sociodemographic and clinical data, including data from the Montreal Cognitive Assessment (MoCA), Confusion Assessment Method (CAM) and DOSS, were obtained by three trained nurse researchers. For the DOSS, internal consistency was determined, and inter-rater reliability was calculated. To validate the DOSS, the sensitivity, specificity, and positive and negative predictive value of the DOSS relative to the CAM were determined through receiver operating characteristic analysis. This article adheres to the Strengthening the Reporting of Observational Studies (STROBE) checklist for observational research., Results: For 338 residents, delirium assessments were completed during an early or late shift. The prevalence of delirium was 14.2% as measured with the DOSS. The reliability (α) for the CAM and DOSS was assessed, as was the inter-rater reliability (κ) and the area under the curve. The sensitivity and specificity for a cut-off value of 3 on the DOSS by Youden's index were very high, as was the negative predictive value. The positive predictive value was good., Conclusions: This study showed that the DOSS is a reliable and valid instrument to screen for delirium in LTCF residents in Flanders. Geriatr Gerontol Int 2024; 24: 619-625., (© 2024 Japan Geriatrics Society.)

Aim: Although infant- and family-centered developmental care (IFCDC) is scientifically grounded and offered in many hospitals to some extent, it has not yet been universally implemented as the standard of care. In this article, we aim to identify barriers to the implementation of IFCDC in Belgian neonatal care from the perspective of neonatal care providers., Methods: We conducted 8 online focus groups with 40 healthcare providers working in neonatal care services. An inductive thematic analysis was carried out by means of Nvivo., Results: The focus groups revealed barriers related to contextual, hospital, and neonatal unit characteristics. Barriers found in the hospital and neonatal unit were related to financing, staffing, infrastructure, access to knowledge/information and learning climate, leadership engagement, and relative priority of IFCDC. Contextual barriers were related to peer pressure and partnerships, newborn/parent needs and resources, external policy, and budgetary incentives., Conclusion: Three main barriers to IFCDC implementation have been identified. Resources (staffing, financing, and infrastructure) must be available and aligned with IFCDC standards, knowledge and information have to be accessible and continuously updated, and hospital management should support IFCDC implementation to create an enabling climate, including compatibility with the existing workflow, learning opportunities, and priority setting., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Unfinished care refers to the situation in which nurses are forced to delay or omit necessary nursing care. The objectives was: 1) to measure the prevalence of unfinished nursing care in intensive care units during the COVID-19 pandemic; 2) to examine whether unfinished nursing care has a mediating role in the relationship between nurse working environment and nurse-perceived quality of care and risk of burnout among nurses., Design: A national cross-sectional survey., Setting: Seventy-five intensive care units in Belgium (December 2021 to February 2022)., Main Outcome Measures: The Practice Environment Scale of the Nursing Work Index was used to measure the work environment. The perception of quality and safety of care was evaluated via a Likert-type scale. The risk of burnout was assessed using the Maslach Burnout Inventory scale., Results: A total of 2,183 nurse responses were included (response rate of 47.8%). Seventy-six percent of nurses reported at least one unfinished nursing care activity during their last shift. The staffing and resource adequacy subdimension of the Practice Environment Scale of the Nursing Work Index had the strongest correlation with unfinished nursing care. An increase in unfinished nursing care led to significantly lower perceived quality and safety of care and an increase in high risk of burnout. Unfinished nursing care appears to be a mediating factor for the association between staffing and resource adequacy and the quality and safety of care perceived by nurses and risk of burnout., Conclusions: Unfinished nursing care, which is highly related to staffing and resource adequacy, is associated with increased odds of nurses being at risk of burnout and reporting a lower level of perceived quality of care., Implications for Clinical Practice: The monitoring of unfinished nursing care in the intensive care unit is an important early indicator of problems related to adequate staffing levels, the well-being of nurses, and the perceived quality of care., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Different sets of quality indicators are used to identify areas for improvement in ovarian cancer care. This study reports transparently on how (surgical) indicators were measured and on the association between hospital volume and indicator results in Belgium, a country setting without any centralisation of ovarian cancer care., Methods: From the population-based Belgian Cancer Registry, patients with a borderline malignant or invasive epithelial ovarian tumour diagnosed between 2014 and 2018 were selected and linked to health insurance and vital status data (n = 5119). Thirteen quality indicators on diagnosis and treatment were assessed and the association with hospital volume was analysed using logistic regression adjusted for case-mix., Results: The national results for most quality indicators on diagnosis and systemic therapy were around the predefined target value. Other indicators showed results below the benchmark: genetic testing, completeness of staging surgery, lymphadenectomy with at least 20 pelvic/para-aortic lymph nodes removed, and timely start of chemotherapy after surgery (within 42 days). Ovarian cancer care in Belgium is dispersed over 100 hospitals. Lower volume hospitals showed poorer indicator results compared to higher volume hospitals for lymphadenectomy, staging, timely start of chemotherapy and genetic testing. In addition, surgery for advanced stage tumours was performed less often in lower volume hospitals., Conclusions: The indicators that showed poorer results on a national level were also those with poorer results in lower-volume hospitals compared to higher-volume hospitals, consequently supporting centralisation. International benchmarking is hampered by different (surgical) definitions between countries and studies., Competing Interests: Declaration of competing interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Elsevier Ltd, BASO ∼ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Background: The COVID-19 pandemic has given rise to an increasing number of patients with 'long COVID'. Long COVID is the persistence of symptoms for weeks or months after an infection by SARS-CoV-2. It often impacts on the professional life of affected people., Aims: The aim of this study is to understand the experiences and needs of people with long COVID in relation to their return to work., Methods: A qualitative study, combining individual interviews and online forum discussions, was performed early 2021, as part of a larger mixed method study on the needs of long COVID patients in Belgium., Results: One hundred and thirty-four people participated in the study. Participants described various clinical symptoms precluding their return to work. They also face sceptical reactions from employers and colleagues and a lack of support from the social welfare system to facilitate their return to work. These barriers have various impacts, including psychological ones, likely to compromise the professional future of long COVID patients., Conclusions: While the analysis of patients' experiences shows variation in long COVID patients' experiences with return to work, it may help occupational physicians and healthcare practitioners to better take up their crucial role in the return to work of long COVID patients, including raising employers' and colleagues' awareness of the specific difficulties related to long COVID., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Nirmatrelvir-ritonavir (NR) was approved to treat SARS-CoV-2 positive outpatients at high risk of progression to severe disease, based on a randomized trial in unvaccinated patients. Effectiveness in vaccinated patients and against Omicron has not yet been confirmed by clinical trial data, but a recent meta-analysis suggested good real-world effectiveness based on 12 studies. We updated this meta-analysis by searching Medline and Embase databases for studies assessing effectiveness of NR on mortality, hospitalization, composite outcome of hospitalization and/or death, and progression to severe disease, published between October 1, 2022 and May 22, 2023. Random effects meta-analysis and subgroup analysis for vaccinated patients was performed. A total of 32 studies were included in the meta-analysis. Pooled RR for the effect of NR on mortality, hospitalization, hospitalization and/or mortality, and progression to severe disease were 0.36 (95% confidence interval [CI]: 0.25-0.52), 0.43 (CI: 0.37-0.51), 0.52 (CI: 0.45-0.61) and 0.54 (CI: 0.41-0.73), respectively. A subgroup analysis on vaccinated patients indicated lower effectiveness of NR on mortality (RR: 0.55, CI: 0.45-0.68), but similar effectiveness for hospitalization, hospitalization and/or mortality, or progression to severe disease (RR: 0.52, 0.58, and 0.66, respectively). This updated meta-analysis robustly confirms the protective effects of NR on severe COVID-19 outcomes., (© 2024 Belgian Health Care Knowledge Centre. Journal of Medical Virology published by Wiley Periodicals LLC.)

Objectives: Although people with a migration background (MB) have more unmet mental health needs than the general population, patients with a MB are still underrepresented in mental health care services. Provider bias towards these patients has been evidenced repeatedly but its driving factors remain elusive. We assessed the moderating effect of the individual (e.g. age and ethnicity), interpersonal (e.g. healthcare provider trust), and organisational (e.g. perceived workload) factors on general practitioners (GPs) differential decision-making regarding diagnosis, treatment, and referral for a depressed patient with or without a MB., Design: An experimental study was carried out in which GPs were shown one of two video vignettes featuring adult male depressed patients, one with a MB and the other without. Belgian GPs ( n  = 797, response rate was 13%) had to decide on their diagnosis, treatment, and referral. Analysis of variance and logistic regression were used to analyse the effect of a MB, adding interaction terms for the explanatory variables., Results: Overall, we found that there were ethnic differences in GPs' decisions regarding diagnosis and treatment recommendations. GPs perceived the symptoms of the patient with a MB as less severe ( F  = 7.68, p  < 0.01) and demonstrated a reduced likelihood to prescribe a combination of medical and non-medical treatments ( F  = 11.55, p  < 0.001). Those differences increased in accordance with the GP's age and perceived workload; at an interpersonal level, we found that differences increased when the GP thought the patient was exaggerating his distress., Conclusion: This paper showed that lower levels of trust among GPs' towards their migrant patients and high GP workloads contribute to an increased ethnic bias in medical decision-making. This may perpetuate ethnic inequalities in mental health care. Future researchers should develop an intervention to decrease the ethnic inequities in mental health care by addressing GPs' trust in their migrant and ethnic minority patients.

Objectives: To study the association between hospital volume and outcomes in patients with invasive epithelial ovarian cancer (EOC)., Methods: This study included 3988 patients diagnosed with invasive EOC between 2014 and 2018, selected from the population-based database of the Belgian Cancer Registry (BCR), and coupled with health insurance and vital status data. The associations between hospital volume and observed survival since diagnosis were assessed with Cox proportional hazard models, while volume associations with 30-day post-operative mortality and complicated recovery were evaluated using logistic regression models., Results: Treatment for EOC was very dispersed with half of the 100 centres treating fewer than six patients per year. The median survival of patients treated in centres with the highest-volume quartile was 2.5 years longer than in those with the lowest-volume quartile (4.2 years versus 1.7 years). When taking the case-mix of hospitals into account, patients treated in the lowest volume centres had a 47% higher hazard to die than patients treated in the highest volume centres (HR: 1.47, 95% CI: 1.11-1.93, p = 0.006) over the first five years after incidence. A similar association was found when focussing on the surgical volume of the hospitals and considering only operated patients with invasive EOC. Lastly, the 30-day post-operative mortality decreased significantly with increasing surgical volume., Conclusions: The large dispersion of care and expertise within Belgium and the volume-outcome associations observed in this study support the implementation of the concentration of care for patients with invasive EOC in reference centres., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: While many studies on the determinants of post-COVID-19 conditions (PCC) have been conducted, little is known about the relationship between SARS-CoV-2 variants and PCC. This study aimed to assess the association between different SARS-CoV-2 variants and the probability of having PCC three months after the infection., Methods: This study was a longitudinal cohort study conducted between April 2021 and September 2022 in Belgium. In total, 8,238 adults with a confirmed SARS-CoV-2 infection were followed up between the time of their infection and three months later. The primary outcomes were the PCC status three months post infection and seven PCC symptoms categories (neurocognitive, autonomic, gastrointestinal, respiratory, musculoskeletal, anosmia and/or dysgeusia, and other manifestations). The main exposure variable was the type of SARS-CoV-2 variants (i.e. Alpha, Delta, and Omicron), extracted from national surveillance data. The association between the different SARS-CoV-2 variants and PCC as well as PCC symptoms categories was assessed using multivariable logistic regression., Results: The proportion of PCC among participants infected during the Alpha, Delta, and Omicron-dominant periods was significantly different and respectively 50%, 50%, and 37%. Participants infected during the Alpha- and Delta-dominant periods had a significantly higher odds of having PCC than those infected during the Omicron-dominant period (OR = 1.61, 95% confidence interval [CI] = 1.33-1.96 and OR = 1.73, 95%CI = 1.54-1.93, respectively). Participants infected during the Alpha and Delta-dominant periods were more likely to report neurocognitive, respiratory, and anosmia/dysgeusia symptoms of PCC., Conclusions: People infected during the Alpha- and Delta-dominant periods had a higher probability of having PCC three months after infection than those infected during the Omicron-dominant period. The lower probability of PCC with the Omicron variant must also be interpreted in absolute figures. Indeed, the number of infections with the Omicron variant being higher than with the Alpha and Delta variants, it is possible that the overall prevalence of PCC in the population increases, even if the probability of having a PCC decreases., (© 2023. The Author(s).)

Background: Respiratory syncytial virus (RSV) infections represent a substantial burden on pediatric services during winter. While the morbidity and financial burden of RSV are well studied, less is known about the organizational impact on hospital services (ie, impact on bed capacity and overcrowding and variation across hospitals)., Methods: Retrospective analysis of the population-wide Belgian Hospital Discharge Data Set for the years 2017 and 2018 (including all hospital sites with pediatric inpatient services), covering all RSV-associated (RSV-related International Classification of Diseases, 10th Version, Clinical Modification diagnoses) inpatient hospitalization by children under 5 years old as well as all-cause acute hospitalizations in pediatric wards., Results: RSV hospitalizations amount to 68.3 hospitalizations per 1000 children less than 1 year and 5.0 per 1000 children 1-4 years of age and are responsible for 20%-40% of occupied beds during the peak period (November-December). The mean bed occupancy rate over the entire year (2018) varies across hospitals from 22.8% to 85.1% and from 30.4% to 95.1% during the peak period. Small-scale pediatric services (<25 beds) are more vulnerable to the volatility of occupancy rates. Forty-six hospital sites have daily occupancy rates above 100% (median of 9 days). Only in 1 of 23 geographically defined hospital networks these high occupancy rates are on the same calendar days., Conclusions: Pediatric services tend to be over-dimensioned to deal with peak activity mainly attributable to RSV. RSV immunization can substantially reduce pediatric capacity requirements. Enhanced collaboration in regional networks is an alternative strategy to deal with peaks and reduce capacity needs., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Aim: To determine the level of evidence for innovative high-risk medical devices at market entry., Methods: We reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb-III) available between 2018 to mid-2019 on applications submitted for inclusion on their reimbursement list. We also conducted a review of the literature on evidence gaps and an analysis of relevant legal and ethical frameworks within the European context., Findings: Conformity assessment of medical devices is based on performance, safety, and an acceptable risk-benefit balance. Information submitted for obtaining CE marking is confidential and legally protected, limiting access to clinical evidence. Seven out of the 18 RIZIV-INAMI assessor reports (39%) included a randomized controlled trial (RCT) using the novel device, whilst 2 applications (11%) referred to an RCT that used a different device. The population included was inappropriate or unclear for 3 devices (17%). Only half of the applications presented evidence on quality of life or functioning and 2 (11%) presented overall survival data. Four applications (22%) included no data beyond twelve months. The findings from the literature demonstrated similar problems with the study design and the clinical evidence., Discussion and Conclusions: CE marking does not indicate that a device is effective, only that it complies with the law. The lack of transparency hampers evidence-based decision making. Despite greater emphasis on clinical benefit for the patient, the provisions of the European Medical Device Regulation (MDR) are not yet fully aligned with international ethical standards for clinical research. The MDR fails to address key issues, such as the lack of access to data submitted for CE marking and a failure to require evidence of clinical effectiveness. Indeed, a first report shows no improvement in the clinical evidence for implantable devices generated under the MDR. Thus, patients may continue to be exposed to ineffective or unsafe novel devices. The Health Technology Assessment Regulation plans for Joint Scientific Consultations for specific high-risk devices before companies begin their pivotal clinical investigations. The demanded comparative evidence should facilitate payer decisions. Nevertheless, there is also a need for legislation requiring comparative RCTs assessing patient-relevant outcomes for high-risk devices to ensure implementation, including development and implementation of common specifications for study designs., (© 2023. The Author(s).)

The hospital landscape is shifting to new care models to meet current challenges in demand, technology, available budgets and staffing. These challenges also apply to the paediatric population, leading to a reduction in paediatric hospital beds and occupancy rates. Paediatric hospital-at-home (HAH) care is used to substitute hospital care in an attempt to bring hospital services closer to children's homes. In addition, these models attempt to avoid fragmentation of care between hospitals and the community. An important prerequisite for this paediatric HAH care is that it is safe and at least as effective as standard hospital care. The aim of this systematic review is to analyse the evidence on the impact of paediatric HAH care on hospital utilisation, patient outcomes and costs. Four bibliographic databases (Medline, Embase, Cinahl and Cochrane Library) were systematically searched for RCTs and pseudo-RCTs that studied the effectiveness and safety of short-term paediatric HAH care with a focus on models as an alternative to acute hospital admissions. Pseudo-RCTs are defined as observational studies that mimic the design of an RCT, but without randomisation. Outcomes of interest were the length of stay, acute (re)admissions, adverse health outcomes, therapy adherence, parental satisfaction or experience and costs. Only articles written in English, Dutch and French conducted in upper-middle and high-income countries and published between 2000 and 2021 were included. Quality assessment was carried out by two assessors using the Cochrane Collaboration's tool for assessing the risk of bias. Reporting is done in accordance with the PRISMA guidelines. We identified 18 (pseudo) RCTs and 25 publications of low to very low quality. Most of the included RCTs focused on the neonatal population: phototherapy for neonatal jaundice, early discharge after birth combined with outpatient neonatal care. Other RCTs focused on chemotherapy for acute lymphoblastic leukaemia, diabetes type 1 education, oxygen therapy for acute bronchiolitis, an outpatient service for children with infectious diseases and antibiotic treatment for low-risk febrile neutropenia, cellulitis and perforated appendicitis. The identified study results show that paediatric HAH care is not associated with more adverse events or hospital readmissions. The impact of paediatric HAH care on costs is less clear.  Conclusions: This review suggests that paediatric HAH care is not associated with more adverse events or hospital readmissions for various clinical indications compared to a standard hospital. Because of the low to very low level of evidence, it is worthwhile to further investigate safety, efficacy and cost effects under strict and well-controlled conditions. This systematic review provides guidance on the essential elements that should be included in HAH care programmes for each type of indication and/or intervention. What is Known: • The hospital landscape is shifting new models of care to meet current challenges in demand, technology, staffing and models of care. Paediatric HAH care is one of these models. Previous literature reviews are inconclusive whether this is a safe and effective way of providing care. What is New: • New evidence suggests that paediatric HAH care for various clinical indications is not associated with adverse events or hospital readmissions compared to a standard hospital. Current evidence is characterised by a low level of quality.  • The current review provides guidance on the essential elements that should be included in HAH care programmes for each type of indication and/or intervention., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The emergence of the precision medicine paradigm in oncology has led to increasing interest in the integration of real-world data (RWD) into cancer clinical research. As sources of real-world evidence (RWE), such data could potentially help address the uncertainties that surround the adoption of novel anticancer therapies into the clinic following their investigation in clinical trials. At present, RWE-generating studies which investigate antitumour interventions seem to primarily focus on collecting and analysing observational RWD, typically forgoing the use of randomisation despite its methodological benefits. This is appropriate in situations where randomised controlled trials (RCTs) are not feasible and non-randomised RWD analyses can offer valuable insights. Nevertheless, depending on how they are designed, RCTs have the potential to produce strong and actionable RWE themselves. The choice of which methodology to employ for RWD studies should be guided by the nature of the research question they are intended to answer. Here, we attempt to define some of the questions that do not necessarily require the conduct of RCTs. Moreover, we outline the strategy of the European Organisation for Research and Treatment of Cancer (EORTC) to contribute to the generation of robust and high-quality RWE by prioritising the execution of pragmatic trials and studies set up according to the trials-within-cohorts approach. If treatment allocation cannot be left up to random chance due to practical or ethical concerns, the EORTC will consider undertaking observational RWD research based on the target trial principle. New EORTC-sponsored RCTs may also feature concurrent prospective cohorts composed of off-trial patients., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: R.S.: Nothing to declare. M.V.H.: Nothing to declare. J.B.: Nothing to declare. C.M.B.: Nothing to declare. J.J.C.: Nothing to declare. A.D.: I have received institutional research funding from Janssen and IQVIA, speaker honoraria from Janssen and Medtronic, and am founder, shareholder and employee of Medical Data Works B.V. E.A.E.: Nothing to declare. A.F.: Nothing to declare. A.G.: Nothing to declare. M.A.H.: My research is supported by funding from NIH, the US Veterans Administration, and PCORI. I am a consultant for Cytel, data science adviser for ProPublica, and member of the scientific advisory board of ADIA Lab. None of these interests or relationships have influenced my contribution to this paper. F.H.: I report that a party related to me is employed by Janssen-Cilag GmbH as principal data scientist. P.O.: I have performed consultancy work for AAA, Bayer, Curium, MSD, Janssen and have received research grants from Bayer. P.S.: I have had advisory relationships with Merck-Serono, Servier, and Merck Sharp & Dohme Corp in the last three years. H.M.V.: Nothing to declare. M.W.: I have received research grants from Quercis and Versameb, and honoraria for lectures or advisory board participation or consulting from Bayer, Curevac, Medac, Novartis, Novocure, Orbus, Philogen, Roche and Sandoz. R.W.: Nothing to declare. D.L.: I am member of the EMA Management Board, member of the EMA Health Care Professionals Working Party and of the EMA Healthcare Professionals Policy Officers’ Group, and co-chair of the EMA Cancer Medicines Forum. W.T.V.D.G.: I have performed advisory work for SpringWorks, PTC Therapeutics, Agenus and received research funding from Eli Lilly, all fees going to the institute., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Populations with a migration background have a higher prevalence of mental health problems than their native counterparts. They are also more likely to have unmet medical needs and are less frequently referred to mental health services. One potential explanation for this is that physicians, such as general practitioners (GPs), may unintentionally discriminate against migrant patients, particularly when they lack humanization. To date, no experimental study has investigated this hypothesis. This paper assesses the influence of humanization on GPs' discriminatory decisions regarding migrant patients with depression. A balanced 2 × 2 factorial experiment was carried out with Belgian GPs (N = 797) who received video-vignettes depicting either a native patient or a migrant patient with depression. Half of the respondents were exposed to a text that humanized the patient by providing more details about the patient's life story. Decisions related to diagnosis, treatment and referral were collected, as well as the time spent on each video and text, and were analysed using ANOVA. Migrant patients' symptoms were judged to be less severe than those of native patients (F = 7.71, p < 0.05). For almost all treatments, the decision was less favourable for the migrant patient. Humanization had little effect on medical decisions. We observed that GPs spent significantly more time on the vignette with the humanization intervention, especially for the migrant patients. The results indicate that ethnic differences in the management of depression persist in primary care. Humanization, however, does not mitigate those differences in medical decisions., (© 2023. The Author(s).)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have the following interests to declare: FH reports that a related party is employed by Janssen-Cilag GmbH as principal data scientist. All other authors have no interests to declare.

Background: The Food and Drug Administration and European Medicines Agency typically approve market access for cancer drugs based on surrogate end-points, which do not always translate into substantiated improvements in outcomes that matter the most to patients, i.e. survival and quality of life. These drugs often, also, have a high price tag. We assessed whether there was an increase in cancer drug expenditure for a broad selection of indications, and whether this correlates with increased overall survival., Methods: This cohort study used Belgian Cancer Registry data from 125,692 patients (12 cancer indications, incidence period 2004-2017), which was linked to reimbursement and survival data. This reliably represents the Belgian situation. One-to-five year observed survival probability, median survival time, oncology drug expenditure and mean oncology drug cost per patient were reviewed., Findings: In almost all indications, total expenditure and average treatment cost for oncology drugs increased over the years (2004-2017). In contrast, mixed findings are observed for the evolution in overall survival probability and median survival time. While an absolute improvement in the 3-year survival probability of about 10% is noticed in non-small-cell lung cancer and chronic myeloid leukaemia, improvements in about half of the other indications are limited or even absent., Interpretation: The Belgian observational data indicate that assuming 'innovative' oncology drugs always add value in terms of improved survival is often unjustified. The literature also highlights the problem of using surrogate end-points, and the lack of comparative evidence showing an added value of oncology drugs for both survival and quality of life at market approval or during the post-marketing phase. Comparative studies should be conducted in the pre-marketing phase that are suitable for registration purposes, aid reimbursement decisions and support physicians and patients when making treatment decisions., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Intensive care unit (ICU) nurses are at an increased risk of burnout and may have an intention-to-leave their jobs. The COVID-19 pandemic may increase this risk., Objective: The objective of this study was to describe the prevalence of burnout risk and intention-to-leave the job and nursing profession among ICU nurses and to analyse the relationships between these variables and the work environment after two years of the COVID-19 pandemic., Design: A national cross-sectional survey of all nurses working in Belgian ICUs was conducted between December 2021 and January 2022 during the 4th and 5th waves of the COVID-19 pandemic in Belgium. The Practice Environment Scale of the Nursing Work Index (PES-NWI) was used to measure the work environment, intention-to-leave the hospital and/or the profession was assessed. The risk of burnout was assessed using the Maslach Burnout Inventory scale including emotional exhaustion, depersonalisation, and reduced personal accomplishment., Setting: Nurses in 78 out of 123 Belgian hospital sites with an ICU participated in the survey., Participants: 2321 out of 4851 nurses (47.8%) completed the entire online survey., Results: The median overall risk of burnout per hospital site (high risk in all three subdimensions) was 17.6% [P25: 10.0 - P75: 28.8] and the median proportion of nurses with a high risk in at least one subdimension of burnout in Belgian ICUs was 71.6% [56.7-82.7]. A median of 42.9% [32.1-57.1] of ICU nurses stated that they intended-to-leave the job and 23.8% [15.4-36.8] stated an intent-to-leave the profession. The median overall score of agreement with the presence of positive aspects in the work environment was 49.0% [44.8-55.8]. Overall, nurses working in the top 25% of best-performing hospital sites with regard to work environment had a statistically significant lower risk of burnout and intention-to-leave the job and profession compared to those in the lowest performing 25% of hospital sites. Patient-to-nurse ratio in the worst performing quartile was associated with a higher risk for emotional exhaustion (OR = 1.53, 95% CI:1.04-2.26) and depersonalisation (OR = 1.48, 95% CI:1.03-2.13) and intention-to-leave the job (OR = 1.46, 95% CI:1.03-2.05)., Conclusions: In this study, a high prevalence of burnout risk and intention-to-leave the job and nursing profession was observed after two years of the COVID-19 pandemic. Nevertheless, there was substantial variation across hospital sites which was associated with the quality of the work environment., Tweetable Abstract: "Burnout & intention to leave was high for Belgian ICU nurses after 2 years of COVID, but wellbeing was better with high quality work environments and more favourable patient to nurse ratios"., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflicts of interest., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: After almost 2 years of fighting against SARS-CoV-2 pandemic, the number of patients enduring persistent symptoms long after acute infection is a matter of concern. This set of symptoms was referred to as "long COVID", and it was defined more recently as "Post COVID-19 condition" by the World health Organization (WHO). Although studies have revealed that long COVID can manifest whatever the severity of inaugural illness, the underlying pathophysiology is still enigmatic., Aim: To conduct a comprehensive review to address the putative pathophysiology underlying the persisting symptoms of long COVID., Method: We searched 11 bibliographic databases (Cochrane Library, JBI EBP Database, Medline, Embase, PsycInfo, CINHAL, Ovid Nursing Database, Journals@Ovid, SciLit, EuropePMC, and CoronaCentral). We selected studies that put forward hypotheses on the pathophysiology, as well as those that encompassed long COVID patients in their research investigation., Results: A total of 98 articles were included in the systematic review, 54 of which exclusively addressed hypotheses on pathophysiology, while 44 involved COVID patients. Studies that included patients displayed heterogeneity with respect to the severity of initial illness, timing of analysis, or presence of a control group. Although long COVID likely results from long-term organ damage due to acute-phase infection, specific mechanisms following the initial illness could contribute to the later symptoms possibly affecting many organs. As such, autonomic nervous system damage could account for many symptoms without clear evidence of organ damage. Immune dysregulation, auto-immunity, endothelial dysfunction, occult viral persistence, as well as coagulation activation are the main underlying pathophysiological mechanisms so far., Conclusion: Evidence on why persistent symptoms occur is still limited, and available studies are heterogeneous. Apart from long-term organ damage, many hints suggest that specific mechanisms following acute illness could be involved in long COVID symptoms. KEY MESSAGESLong-COVID is a multisystem disease that develops regardless of the initial disease severity. Its clinical spectrum comprises a wide range of symptoms.The mechanisms underlying its pathophysiology are still unclear. Although organ damage from the acute infection phase likely accounts for symptoms, specific long-lasting inflammatory mechanisms have been proposed, as well.Existing studies involving Long-COVID patients are highly heterogeneous, as they include patients with various COVID-19 severity levels and different time frame analysis, as well.

Aim: Alterations in taste are distressing side effects for cancer patients receiving chemotherapy. The Center for Gastrology (Belgium) developed a self-care intervention based on taste control. This intervention contains an assessment of the individual taste and food hedonics. It provides recipes based on the individual assessed hedonics profile, so patients can self-prepare personalized meals. This study aims to describe the experiences of oncologic patients with the home baking of personalized bread., Design: A qualitative, descriptive design with individual semi-structured interviews was used., Methods: In August 2018, eleven face-to-face interviews were conducted until data saturation., Results: The analysis of the interviews revealed five major themes: "Stepping out of your role," "Having something positive to do," "gaining insight," "receiving recognition" and "practical limitations.", (© 2021 The Authors. Nursing Open published by John Wiley & Sons Ltd.)

Objective: This study aimed to establish a Belgian EQ-5D-5L value set based on the preferences of the adult Belgian general population., Methods: The most recent EuroQol Valuation Technology (EQ-VT 2.1) protocol for EQ-5D-5L valuation studies was followed. Computer-assisted personal interviews were carried out in a representative sample of the adult Belgian population. Potential respondents were randomly selected from the National Register using a multistage, stratified, cluster sampling with unequal probability design. Each respondent valued 10 or 11 health states using composite time trade-off (cTTO) and 14 health states in seven paired choice tasks using a discrete choice experiment (DCE). Different model specifications were explored and assessed based on logical consistency, goodness of fit, predictive accuracy and theoretical considerations., Results: A total of 892 respondents were included in the analyses. The sample was representative of the Belgian adult population in terms of age, sex, region of residence, educational attainment, labour market status, self-assessed health status and health-related quality of life (HRQoL). The preferred model specification was a hybrid (DCE and cTTO data combined) multiplicative eight-coefficient model with intercept random effects and correction for heteroskedasticity. Values range from - 0.532 to 1. Loss of HRQoL is highest in the dimension pain/discomfort, closely followed by anxiety/depression., Conclusions: This study developed a Belgian EQ-5D-5L value set, based on the preferences of the Belgian adult general population. It provides opportunities for future clinical and economic evaluations in healthcare, for the measurement of patient-reported outcomes and for population health assessments., (© 2022. The Author(s).)

Purpose: Experimental studies suggested that antioxidants could protect against skin carcinomas. However, epidemiological studies on antioxidant supplement use in relation to basal-cell carcinoma (BCC) and squamous-cell carcinoma (SCC) risks yielded inconsistent findings, and few prospective studies have been conducted to date. We aimed to investigate the associations between antioxidant supplement intake and keratinocyte cancer (KC) risk., Methods: E3N is an ongoing prospective cohort initiated in 1990 and involving 98,995 French women aged 40-65 years at recruitment. Intakes of dietary antioxidants were estimated via a validated dietary questionnaire in 1993 and self-reported antioxidant supplement use was collected in 1995. We used Cox models to compute hazard ratios (HRs) and 95% confidence intervals (CIs) adjusted for age and skin cancer risk factors., Results: Over 1995-2014, 2426 BCC and 451 SCC cases were diagnosed among 63,063 women. We found positive relationships between vitamin A supplement use and KC risk (HR = 1.37, 95% CI 1.15-1.62), particularly with BCC (HR = 1.40, 95% CI 1.17-1.69); and between vitamin E supplement use and risks of both BCC (HR = 1.21, 95% CI 1.03-1.52) and SCC (HR = 1.43, 95% CI 1.03-1.99). Intake of beta-carotene supplements was associated with an increased SCC risk (HR = 1.59, 95% CI 1.00-2.54). Vitamin C supplement use was not associated with KC risk. We found similar results when considering total antioxidant intake., Conclusions: Intakes of vitamin A or E supplements were associated with an increased KC risk in women. Further studies with information on doses and duration of supplement use and the ability to examine their underlying mechanisms are needed., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

This study assessed whether systemic antibiotics are beneficial or harmful in patients who present with an acute periodontal abscess or pericoronitis, with or without systemic involvement, and, if antibiotics are beneficial, which type, dosage, and duration are the most effective. Medline, Embase, and the Cochrane Library were screened from 1948 up to 1 April 2022 for systematic reviews, randomised clinical trials (RCTs), and other studies. Dedicated websites were consulted for systematic reviews, clinical practice guidelines, and health technology assessments on the topic. Outcomes of interest comprised tooth survival, swelling, pain, tooth mobility, periodontal probing depth, suppuration, adverse effects, quality of life measurements, and medication required for pain relief. Overall, five guidelines, seven systematic reviews, 15 RCTs, and 34 other studies were identified and selected for full-text assessment, but none of them fulfilled the inclusion criteria. At present there is no single randomised or non-randomised controlled trial assessing the harms and clinical effectiveness of systemic antibiotics in adults with a periodontal abscess or pericoronitis., (© 2022 Scandinavian Division of the International Association for Dental Research. Published by John Wiley & Sons Ltd.)

Objective: Personalised medicine (PM) allows treating patients based on their individual demographic, genomic or biological characteristics for tailoring the 'right treatment for the right person at the right time'. Robust methodology is required for PM clinical trials, to correctly identify groups of participants and treatments. As an initial step for the development of new recommendations on trial designs for PM, we aimed to present an overview of the study designs that have been used in this field., Design: Scoping review., Methods: We searched (April 2020) PubMed, Embase and the Cochrane Library for all reports in English, French, German, Italian and Spanish, describing study designs for clinical trials applied to PM. Study selection and data extraction were performed in duplicate resolving disagreements by consensus or by involving a third expert reviewer. We extracted information on the characteristics of trial designs and examples of current applications of these approaches. The extracted information was used to generate a new classification of trial designs for PM., Results: We identified 21 trial designs, 10 subtypes and 30 variations of trial designs applied to PM, which we classified into four core categories (namely, Master protocol, Randomise-all, Biomarker strategy and Enrichment). We found 131 clinical trials using these designs, of which the great majority were master protocols (86/131, 65.6%). Most of the trials were phase II studies (75/131, 57.2%) in the field of oncology (113/131, 86.3%). We identified 34 main features of trial designs regarding different aspects (eg, framework, control group, randomisation). The four core categories and 34 features were merged into a double-entry table to create a new classification of trial designs for PM., Conclusions: A variety of trial designs exists and is applied to PM. A new classification of trial designs is proposed to help readers to navigate the complex field of PM clinical trials., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

This article uses a Data Envelopment Analysis to measure scale efficiency of maternity services in Belgium and estimate the minimum efficient scale in this context. Using administrative data for all maternity services in Belgium in 2016, the minimum efficient scale is estimated at 557 deliveries per year, which is above the currently prevailing norm of 400 deliveries per year. In particular, the closure of 17 small maternity services could improve efficiency without reducing accessibility. In addition to that, further efficiency gains could be attained by increasing the scale of maternity services up to at least 900 deliveries per year. Although most services are close to scale efficiency, the mean scale inefficiency level is 13% and low scores are mainly concentrated among the smallest services. These results are robust to changes in model specifications, bootstrapping and removal of outliers. In the current context of reform of the hospital and maternity landscape in Belgium, this study shows room for improvement and the possibility to generate substantial efficiency gains that could be reinvested in the healthcare system., (© 2022 John Wiley & Sons Ltd.)

Countries with social health insurance (SHI) systems display some common defining characteristics - pluralism of actors and strong medical associations - that, in dealing with crisis times, may allow for common learnings. This paper analyses health system responses during the COVID-19 pandemic in eight countries representative of SHI systems in Europe (Austria, Belgium, France, Germany, Luxembourg, the Netherlands, Slovenia and Switzerland). Data collection and analysis builds on the methodology and content in the COVID-19 Health System Response Monitor (HSRM) up to November 2020. We find that SHI funds were, in general, neither foreseen as major stakeholders in crisis management, nor were they represented in crisis management teams. Further, responsibilities in some countries shifted from SHI funds to federal governments. The overall organisation and governance of SHI systems shaped how countries responded to the challenges of the pandemic. For instance, coordinated ambulatory care often helped avoid overburdening hospitals. Decentralisation among local authorities may however represent challenges with the coordination of policies, i.e. coordination costs. At the same time, bottom-up self-organisation of ambulatory care providers is supported by decentralised structures. Providers also increasingly used teleconsultations, which may remain part of standard practice. It is recommended to involve SHI funds actively in crisis management and in preparing for future crisis to increase health system resilience., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: General Practitioners (GPs) are the first point of contact for people from ethnic and migrant groups who have health problems. Discrimination can occur in this health care sector. Few studies, however, have investigated implicit and explicit biases in general practice against ethnic and migrant groups. This study, therefore, investigated the extent of implicit ethnic biases and willingness to adapt care to migrant patients among trainee GPs, and the factors involved therein, in order to measure explicit bias and explore a dimension of cultural competence., Methods: In 2021, data were collected from 207 trainee GPs in the French-speaking part of Belgium. The respondents passed an Implicit Association Test (IAT), a validated tool used to measure implicit biases against ethnic groups. An explicit attitude of willingness to adapt care to diversity, one of the dimensions of cultural competence, was measured using the Hudelson scale., Results: The overwhelming majority of trainee GPs (82.6%, 95% CI: 0.77 - 0.88) had implicit preferences for their ingroup to the detriment of ethnic and migrant groups. Overall, the majority of respondents considered it the responsibility of GPs to adapt their attitudes and practices to migrants' needs. More than 50% of trainee GPs, however, considered it the responsibility of migrant patients to adapt to the values and habits of the host country., Conclusions: This study found that the trainee GPs had high to very high levels of implicit ethnic bias and that they were not always willing to adapt care to the values of migrants. We therefore recommend that they are made aware of this bias and we recommend using the IAT and Hudelson scales as educational tools to address ethnic biases in primary care., (© 2022. The Author(s).)

Background: Adequate levels of health literacy (HL) are crucial to ensure good quality of health, social life and wellbeing. HL is a mediating factor in health disparities. Low HL hampers interaction with healthcare. HL is a shared responsibility of individuals and the healthcare system. Multi-dimensional programs and policies should be set up., Aim: To learn from current HL policies and action plans and to identify elements to consider for the development of national HL plans., Method: Transversal analysis of HL policies in six countries, based on a preliminary scoping review. A combination of document analysis and key informant approach. Local experts validated and completed information for their country. A transversal comparison was performed., Results: Several approaches were identified, often influenced by contextual factors, healthcare reforms and existence of centers of expertise. Some governments developed full-fledged, standalone plans, while others developed broader plans covering the entire health and care sector. Some took a conceptually driven, high level approach. Others took a pragmatic approach. And some did not have a governmental plan at all., Conclusion: Policy makers should analyse their state structure and health system, and search for local 'pockets of excellence', to develop a well-planned, substantiated HL approach for their country., (© 2021 John Wiley & Sons Ltd.)

Purpose: Health-related quality of life outcomes are increasingly used to monitor population health and health inequalities and to assess the (cost-) effectiveness of health interventions. The EQ-5D-5L has been included in the Belgian Health Interview Survey, providing a new source of population-based self-perceived health status information. This study aims to estimate Belgian population norms for the EQ-5D-5L by sex, age, and region and to analyze its association with educational attainment., Methods: The BHIS 2018 provided EQ-5D-5L data for a nationally representative sample of the Belgian population. The dimension scores and index values were analyzed using logistic and linear regressions, respectively, accounting for the survey design., Results: More than half of respondents reported problems of pain/discomfort, while over a quarter reported problems of anxiety/depression. The average index value was 0.84. Women reported more problems on all dimensions, but particularly on anxiety/depression and pain/discomfort, resulting in significantly lower index values. Problems with mobility, self-care, and usual activities showed a sharp increase after the age of 80 years. Consequently, index values decreased significantly by age. Lower education was associated with a higher prevalence of problems for all dimensions except anxiety/depression and with a significantly lower index value., Conclusion: This paper presents the first nationally representative Belgian population norms using the EQ-5D-5L. Inclusion of the EQ-5D in future surveys will allow monitoring over time of self-reported health, disease burden, and health inequalities., (© 2021. The Author(s).)

Objectives: We evaluated the quality of care for patients with squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx in Belgium., Methods: Data of the Belgian Cancer Registry were coupled with health insurance data and hospital discharge data. Quality of care and the association with hospital volume were evaluated based on six quality indicators., Results: Half of the patients were treated with primary radiotherapy, with or without systemic therapy (49.7%) and 38.1% with surgery, with or without (neo)adjuvant therapy. Single-modality treatment was provided to 78.1% of early-disease patients. Of the patients with cN0 disease, 56.4% underwent neck dissection. Postoperative radiotherapy was completed timely in 48.5% of patients. Concomitant chemotherapy was administered to 58.2% of patients <70 years with locally advanced disease. Imaging of the neck after radiotherapy was performed appropriately in 32.7% of patients. Variability between centres was considerable. No clear relationship between hospital volume and results of the individual QIs was observed., Conclusions: Results show that for the measured QIs, targets are not met and variability between centres is considerable. Through individual feedback, centres are motivated to improve the quality of care for head and neck cancer patients in Belgium., (© 2021 John Wiley & Sons Ltd.)

Background: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs)., Objectives: To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone., Methods: This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites., Results: In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49)., Conclusions: Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas., (© 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Objectives: This systematic review aimed to assess (1) whether systemic antibiotics are beneficial or harmful in healthy children who present with an odontogenic abscess in the primary dentition with or without systemic involvement and (2) if antibiotics are beneficial, which type, dosage and duration are the most effective., Materials and Methods: Electronic databases (Medline, Embase, and the Cochrane Library) were screened from 1948 up to August 2020. No filters with respect to study design were applied. Outcomes of interest included pain, swelling, pain relief, adverse effects, signs of infection, quality-of-life measurements and medication required for pain relief., Results: Altogether, 352 titles and abstracts were screened for eligibility; of these, 19 were selected for full text assessment. All were excluded because none of them fulfilled the inclusion criteria and addressed the (adjunctive) use of antibiotics in children who present with an odontogenic abscess in the primary dentition., Conclusions: At present, there is no single randomised or non-randomised clinical study evaluating the effectiveness and harms of systemic antibiotics administered in children who present with an odontogenic abscess in the primary dentition., Clinical Relevance: There is no clinical evidence to support nor to refute the use of antibiotics in children who present with an odontogenic abscess in the primary dentition without signs of local spread or systemic involvement. Given this lack of scientific evidence, the use of antibiotics cannot be recommended in these children. Well-designed clinical trials are indicated to fully understand the impact and necessity of antibiotics in these situations.

Objectives: The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation., Methods: Several working groups defined processes and methods to support assessment teams in creating high-quality assessment reports. Existing guidelines, templates, and tools were refined and missing parts were newly created and integrated into the new QMS framework. EUnetHTA has contributed to Health Technology Assessment (HTA) capacity building through training and knowledge sharing. Continuous evaluation helped to identify gaps and shortcomings in processes and structures., Results: Based on a common quality management concept and defined development and revision procedures, twenty-seven partner organizations jointly developed and maintained around forty standard operating procedures and other components of the QMS. All outputs were incorporated into a web-based platform, the EUnetHTA Companion Guide, which was launched in May 2018. Concerted efforts of working groups were required to ensure consistency and avoid duplication., Conclusions: With the establishment of a QMS for jointly produced assessment reports, EUnetHTA has taken a significant step toward a sustainable model for scientific and technical collaboration within European HTA. However, the definition of processes and methods meeting the numerous requirements of healthcare systems across Europe remains an ongoing and challenging task.

The aims of this paper were to provide an overview of available activity monitors used in research in patients with heart failure and to identify the key criteria in the selection of the most appropriate activity monitor for collecting, reporting, and analysing physical activity in heart failure research. This study was conducted in three parts. First, the literature was systematically reviewed to identify physical activity concepts and activity monitors used in heart failure research. Second, an additional scoping literature search for validation of these activity monitors was conducted. Third, the most appropriate criteria in the selection of activity monitors were identified. Nine activity monitors were evaluated in terms of size, weight, placement, costs, data storage, water resistance, outcomes and validation, and cut-off points for physical activity intensity levels were discussed. The choice of a monitor should depend on the research aims, study population and design regarding physical activity. If the aim is to motivate patients to be active or set goals, a less rigorously tested tool can be considered. On the other hand, if the aim is to measure physical activity and its changes over time or following treatment adjustment, it is important to choose a valid activity monitor with a storage and battery longevity of at least one week. The device should provide raw data and valid cut-off points should be chosen for analysing physical activity intensity levels. Other considerations in choosing an activity monitor should include data storage location and ownership and the upfront costs of the device., (© 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: The objective of this study was to map the PI culture at KCE in the context of the development of organization-wide supported position statements about PI., Methods: A nominal group technique was used to measure the PI culture at KCE. Arguments for and against PI and conditions for PI in different phases of the HTA process were collected. A literature review and interviews fed the draft position statements, for which support was assessed by means of a two-round Delphi process., Results: Arguments in favor of PI in HTA related to the relevance of the scope, expertise with data collection, bringing in fresh ideas for study design, access to survey participants, validation of data analyses, adherence to recommendations. Disadvantages and risks included the lack of scientific knowledge of involved patients, resources requirements, conflicts of interest, and heterogeneity within patient populations. Conditions for meaningful PI referred to measures mitigating the identified disadvantages. Eighteen position statements supported by KCE could be formulated., Conclusion: The KCE culture seems predominantly positive toward PI, although attitudes vary between HTA researchers. KCE recognizes the potential value of PI in HTA, but considers the level of involvement to be contingent on the topic and phase in the HTA process.