Belgian Centers Research Articles

Mental health of sexual assault victims and predictors of their use of support from in-house psychologists at Belgian sexual assault care centres

ABSTRACT Background: Sexual assault (SA) can induce a negative impact on victims’ mental health. Specialised SA services generally offer medical care and a forensic examination to SA victims. However, there is a large variation in how these services provide mental health support. Objective: This study aims to assess mental health problems of SA victims attending the Belgian Sexual Assault Care Centres (SACCs) and identify predictors for victims’ use of support from in-house psychologists. Method: Health records of victims ≥ 16 years who presented within one week post-SA to one of the three Belgian SACCs between 25 October 2017 and 31 October 2019 were reviewed. An AIC-based stepwise backward binary logistic regression was used to analyse the association between victim, assault, service use and mental health characteristics and follow-up by a SACC-psychologist. Results: Of the 555 victims, more than half had a history of mental health problems. Of those assessed, over 70% showed symptoms of posttraumatic stress disorder (PTSD), depression and/or anxiety disorder. One in two victims consulted a SACC-psychologist. Victims with a mental health history (OR 1.46, p = .04), victims accompanied by a support person during acute care (OR 1.51, p = .04), and victims who were assaulted by an acquaintance in comparison to those assaulted by a stranger (OR 1.60, p = .039) were more likely to attend their appointment with the SACC-psychologist. Conclusion: The study reaffirms the high mental health burden among victims attending specialised SA services, stressing the need to provide effective mental health interventions at these services and improve their longer-term use by victims. Prescheduling of appointments with an in-house psychologist in combination with phone reminders may improve the uptake of such services. Health care providers must be vigilant about potential barriers faced by victims without a mental health history or social support in attending appointments with mental health professionals.

Automated Urinary Chemokine Assays for Noninvasive Detection of Kidney Transplant Rejection: A Prospective Cohort Study

Prior studies have demonstrated the diagnostic potential of urinary chemokines C-X-C motif ligand 9 (CXCL9) and CXCL10 for kidney transplant rejection. However, their benefit in addition to clinical information has not been demonstrated. We evaluated the diagnostic performance for detecting acute rejection of urinary CXCL9 and CXCL10 when integrated with clinical information. Single-center prospective cohort study. We analyzed 1,559 biopsy-paired urinary samples from 622 kidney transplants performed between April 2013 and July 2019 at a single transplant center in Belgium. External validation was performed in 986 biopsy-paired urinary samples. We quantified urinary CXCL9 (uCXCL9) and CXCL10 (uCXCL10) using an automated immunoassay platform and normalized the values to urinary creatinine. Urinary chemokines were incorporated into a multivariable model with routine clinical markers (estimated glomerular filtration rate, donor-specific antibodies, and polyoma viremia) (integrated model). This model was then compared with the tissue diagnosis according to the Banff classification for acute rejection. Acute rejection detected on kidney biopsy using the Banff classification. Chemokines integrated with routine clinical markers had high diagnostic value for detection of acute rejection (n=150) (receiver operating characteristic area under the curve 81.3% [95% CI, 77.6-85.0]). The integrated model would help avoid 59 protocol biopsies per 100 patients when the risk for rejection is predicted to be below 10%. The performance of the integrated model was similar in the external validation cohort. The cross-sectional nature obviates investigating the evolution over time and prediction of future rejection. The use of an integrated model of urinary chemokines and clinical markers for noninvasive monitoring of rejection could enable a reduction in the number of biopsies. Urinary chemokines may be useful noninvasive biomarkers whose use should be further studied in prospective randomized trials to clarify their role in guiding clinical care and the use of biopsies to detect rejection after kidney transplantation. Urinary chemokines CXCL9 and CXCL10 have been suggested to be good noninvasive biomarkers of kidney transplant rejection. However, defining a context of use and integration with clinical information is necessary before clinical implementation can begin. In this study, we demonstrated that urinary chemokines CXCL9 and CXCL10, together with clinical information, have substantial diagnostic accuracy for the detection of acute kidney transplant rejection. Application of urinary chemokines together with clinical information may guide biopsy practices following kidney transplantation and potentially reduce the need for kidney transplant biopsies.

Measuring the prevalence of autistic traits in a cohort of adults living with HIV or taking HIV pre-exposure prophylaxis and mapping safer-sex barriers and facilitators: a study protocol

IntroductionAutistic individuals identify with a wider range of sexual orientations than non-autistic individuals, including higher rates of bisexual orientation in autistic men. Gay, bisexual and other men who have sex...

Preconceptionele uitgebreide dragerschapsscreening: een genetische test voor koppels met een kinderwens

Preconception expanded carrier screening: a genetic test for couples planning to conceive Approximately 1% to 2% of all couples have a risk of conceiving a child with a severe recessive disorder. Genetic expanded carrier screening (ECS) can determine this risk and allows couples planning a pregnancy to make informed reproductive choices. The Belgian genetic centers developed the ‘Belgian Genetic Expanded Carrier Screening’ (BeGECS), an ECS for 1,248 genes. The center for medical genetics (CMGG) of the Ghent University Hospital already received samples from over 350 couples. This article discusses the results of the first 250 analyses. Of the 250 couples, 70% consulted in the context of a preimplantation genetic testing (PGT) trajectory. These couples had an already known carriership in 1 or both partners of an autosomal dominant, autosomal recessive and/or X-linked disorder. These risks are of course not included in the results of the BeGECS analyses. The BeGECS analyses showed that 15 couples (6%) were at risk of having a child with an autosomal recessive disorder and 5 (2%) of having a child with a severe phenotype. In 7 couples (2.8%), 1 of the partners was carrier of an X-linked disorder. In 26% of those screened, individual carriership was identified for 1 of the highly frequent autosomal recessive disorders. Couples who are aware of this risk, prior to pregnancy, can make autonomous informed reproductive choices. To allow every couple to choose for ECS, it is essential that offering the test becomes part of standard preconception care.

Cognitive rehabilitation and aerobic exercise for cognitive impairment in people with progressive multiple sclerosis (CogEx): a randomised, blinded, sham-controlled trial

Cognitive dysfunction in people with relapsing-remitting multiple sclerosis can improve with cognitive rehabilitation or exercise. Similar effects have not been clearly shown in people with progressive multiple sclerosis. We aimed to investigate the individual and synergistic effects of cognitive rehabilitation and exercise in patients with progressive multiple sclerosis. CogEx was a randomised, sham-controlled trial completed in 11 hospital clinics, universities, and rehabilitation centres in Belgium, Canada, Denmark, Italy, UK, and USA. Patients with progressive multiple sclerosis were eligible for inclusion if they were aged 25-65 years and had an Expanded Disability Status Scale (EDSS) score of less than 7. All had impaired processing speed defined as a performance of 1·282 SD or greater below normative data on the Symbol Digit modalities Tests (SDMT). Participants were randomly assigned (1:1:1:1), using an interactive web-response system accessed online from each centre, to cognitive rehabilitation plus exercise, cognitive rehabilitation plus sham exercise, exercise plus sham cognitive rehabilitation, or sham exercise plus sham cognitive rehabilitation. The study statistician created the randomisation sequence that was stratified by centre. Participants, outcome assessors, and investigators were blinded to group allocation. The study statistician was masked to treatment during analysis only. Interventions were conducted two times per week for 12 weeks: cognitive rehabilitation used an individualised, computer-based, incremental approach to improve processing speed; sham cognitive rehabilitation consisted of internet training provided individually; the exercise intervention involved individualised aerobic training using a recumbent arm-leg stepper; and the sham exercise involved stretching and balance tasks without inducing cardiovascular strain. The primary outcome measure was processing speed measured by SDMT at 12 weeks; least squares mean differences were compared between groups using linear mixed model in all participants who had a 12-week assessment. The trial is registered with ClinicalTrials.gov, NCT03679468, and is completed. Between Dec 14, 2018, and April 2, 2022, 311 people with progressive multiple sclerosis were enrolled and 284 (91%) completed the 12-week assessment (117/311 [38%] male and 194/311 [62%] female). The least squares mean group differences in SDMT at 12 weeks did not differ between groups (p=0·85). Compared with the sham cognitive rehabilitation and sham exercise group (n=67), differences were -1·30 (95% CI -3·75 to 1·16) for the cognitive rehabilitation plus exercise group (n=70); -2·78 (-5·23 to -0·33) for the sham cognitive rehabilitation plus exercise group (n=71); and -0·71 (-3·11 to 1·70) for the cognitive rehabilitation plus sham exercise group (n=76). 11 adverse events possibly related to the interventions occurred, six in the exercise plus sham cognitive rehabilitation group (pain, dizziness, and falls), two in the cognitive rehabilitation plus sham exercise group (headache and pain), two in the cognitive rehabilitation and exercise group (increased fatigue and pain), and one in the dual sham group (fall). Combined cognitive rehabilitation plus exercise does not seem to improve processing speed in people with progressive multiple sclerosis. However, our sham interventions were not inactive. Studies comparing interventions with a non-intervention group are needed to investigate whether clinically meaningful improvements in processing speed might be attainable in people with progressive multiple sclerosis. MS Canada.

Evaluation of a 3‐year teledermoscopy project in primary healthcare centres in Belgium

AbstractBackgroundWith the increasing incidence of skin cancer and limited access to specialised care, teledermoscopy (TDS) may represent a useful triage tool for skin cancer detection.ObjectivesAn evaluation of a 3‐year TDS project in primary healthcare centres (PHCs) in Belgium (TELESPOT project).MethodsA total of nine PHCs were trained to use an in‐house developed smartphone‐based application for macroscopic and dermoscopic acquisition of skin lesions, subsequently analysed independently by two investigators in a tertiary university skin cancer centre. The primary outcome was the proportion of high‐priority management (HPM) recommendations. Secondary outcomes included the TDS diagnoses, the quality of image acquisition, the mean time between HPM recommendations and subsequent surgery, the correlation between HPM reports and histopathology after surgery as well as patient and general practitioner satisfaction scores. All the endpoints were compared between the initial year of the TDS project and the subsequent 2‐year extension period of the study.ResultsOver 3 years, a total of 478 lesions were analysed in 335 patients: initial phase (105 lesions from 76 patients in six PHCs) and extension phase (373 lesions from 259 patients in nine PHCs). An HPM was recommended in 9.2% (initial and extension phases: 7.6% and 15.7%, respectively). The dermoscopic‐histological correlation achieved 84.1%. The median delay between HPM and surgery was 9 days.ConclusionsThis TDS project avoided unnecessary tertiary care visits in about 9 out of 10 cases, increased the HPM by a ninefold in comparison with the conventional care pathway and provided excellent satisfaction levels for PHCs and patients. Long‐term participation improved the triage quality for suspect skin lesions by 2.24‐fold.

The Classification of Suspected Predominant Nociplastic Pain in People with Moderate and Severe Haemophilia: A Secondary Exploratory Study.

In people with haemophilia (PwH), joint pain is a major comorbidity that is often overlooked and under-treated. It is believed that, to ensure the most successful outcome, pain management should be tailored to the predominant pain phenotype (i.e., nociceptive, neuropathic and nociplastic). The 2021 clinical criteria and grading system for nociplastic pain, established by the International Association for the Study of Pain (IASP), emphasize the necessity of early-stage identification and predominant pain type classification. Consistent with findings in other chronic musculoskeletal pain conditions, studies suggest that a subgroup of PwH suffers from nociplastic pain, i.e., pain arising from altered nociception rather than structural damage, but this has not yet been explored in PwH. This study aimed to identify PwH with "unlikely", "possible" and "probable" nociplastic pain and investigate differences in anthropometric, demographic and clinical characteristics and psychological factors between subgroups of PwH and healthy individuals.: The IASP clinical criteria and grading system were used to classify pain types in adult men with moderate or severe haemophilia recruited from two Belgian haemophilia treatment centres. Statistical analyses were applied to study between-subgroup differences. Of 94 PwH, 80 PwH (85%) were classified with "unlikely" and 14 (15%) with "at least possible" nociplastic pain (including 5 PwH (5%) with "possible" and 9 PwH (10%) with "probable" nociplastic pain). PwH in both the "unlikely" and "at least possible" nociplastic pain groups showed significantly higher levels of unhelpful psychological factors compared to healthy individuals. Additionally, age may partially account for the observed differences in body height and psychological factors. Larger sample sizes may be needed to detect more subtle between-group differences. study confirmed the presence of nociplastic pain in haemophilia, categorising a notable subgroup as individuals who experience at least possible nociplastic pain. These exploratory insights may provide a starting point for future studies and the development of more effective and tailored pain management.

Mortality-related risk factors of inpatients with diabetes and COVID-19: A multicenter retrospective study in Belgium

Background and aimsWe describe mortality-related risk factors of inpatients with diabetes and coronavirus disease 2019 (COVID-19) in Belgium. MethodsWe conducted a multicenter retrospective study from March to May, 2020, in 8 Belgian centers. Data on admission of patients with diabetes and COVID-19 were collected. Survivors were compared to non-survivors to identify prognostic risk factors for in-hospital death using multivariate analysis in both the total population and in the subgroup of patients admitted in the intensive care unit (ICU). ResultsThe study included 375 patients. The mortality rate was 26.4% (99/375) in the total population and 40% (27/67) in the ICU. Multivariate analysis identified older age (HR 1.05 [CI 1.03–1.07], P<0.0001) and male gender (HR 2.01 [1.31–3.07], P=0.0013) as main independent risk factors for in-hospital death in the total population. Metformin (HR 0.51 [0.34–0.78], P=0.0018) and renin-angiotensin-aldosterone system blockers (HR 0.56 [0.36–0.86], P=0.0088) use before admission were independent protective factors. In the ICU, chronic kidney disease (CKD) was identified as an independent risk factor for death (HR 4.96 [2.14–11.5], P<0.001). ConclusionIn-hospital mortality due to the first wave of COVID-19 pandemic in Belgium was high in patients with diabetes. We found that advanced age and male gender were independent risk factors for in-hospital death. We also showed that metformin use before admission was associated with a significant reduction of COVID-19-related in-hospital mortality. Finally, we showed that CKD is a COVID-19-related mortality risk factor in patients with diabetes admitted in the ICU.

Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial

BackgroundRecent advances in endoscopic endonasal transsphenoidal approaches (EETA) for skull base lesions have resulted in a significant increase in extent and complexity of skull base defects, demanding more elaborate and novel reconstruction techniques to prevent cerebrospinal fluid (CSF) leakage and to improve healing. Currently, commercially available fibrin sealants are often used to reinforce the skull base reconstruction. However, problems have been reported regarding hypersensitivity reactions, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) membranes as an alternative for commercially available fibrin glues in EETA-related skull base reconstruction reinforcement.Methods/designThis multicenter, prospective randomized controlled trial aims to demonstrate non-inferiority of L-PRF membranes compared to commercially available fibrin sealants in EETA cases (1) without intra-operative CSF-leak as dural or sellar floor closure reinforcement and (2) in EETA cases with intra-operative CSF-leak (or very large defects) in which a classic multilayer reconstruction has been made, as an additional sealing. The trial includes patients undergoing EETA in three different centers in Belgium. Patients are randomized in a 1:1 fashion comparing L-PRF with commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage. Secondary endpoints are identification of risk factors for reconstruction failure, assessment of rhinological symptoms, and interference with postoperative imaging. Additionally, a cost-effectiveness analysis is performed.DiscussionWith this trial, we will evaluate the safety and efficacy of L-PRF compared to commercially available fibrin sealants.Trial registrationClinicalTrials.gov NCT03910374. Registered on 10 April 2019.

Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial

OVX836, a recombinant vaccine containing the nucleoprotein of the influenza A virus A/WSN/1933 (H1N1) and the oligomerisation domain OVX313, has displayed a good safety profile and elicited dose-dependent humoral and cellular immune responses at 90 μg or 180 μg (intramuscularly) in previous clinical trials. The aim of this study was to explore higher doses, since no maximum tolerated dose had been reached. In this phase 2a, randomised, double-blind, placebo-controlled study, we recruited 137 healthy adults aged 18-55 years in a single centre in Belgium. Participants were randomly assigned (interactive web response system; block size=4) using SAS (version 9.4) to receive one single intramuscular administration of OVX836 influenza vaccine at three doses (180 μg [n=33], 300 μg [n=35], and 480 μg [n=36]) or placebo (n=33). The two primary endpoints were the safety and the cell-mediated immune response to OVX836 at the three doses in terms of change of nucleoprotein-specific IFNγ spot forming cell (SFC) frequencies in the peripheral blood mononuclear cell (PBMC) population, measured by IFNγ ELISpot, at day 8 versus pre-injection baseline (day 1). The population used for the safety analysis is the modified intention-to-treat cohort. The population used for the immunogenicity analysis is the per-protocol cohort. This trial is registered with ClinicalTrials.gov, NCT05060887, and EudraCT, 2021-002535-39. Participants were recruited between Nov 15, 2021, and Feb 1, 2022. OVX836 had a favourable safety profile up to 480 μg without reaching the maximum tolerated dose, and showed a good safety profile at all doses with mild local and systemic reactogenicity. 7 days after vaccination, although no significant differences were observed between the doses, OVX836 increased the frequency of nucleoprotein-specific IFNγ SFCs per million PBMCs from days 1 to 8 (primary endpoint): by 124 SFCs per 106 PMBCs (95% CI 67 to 180; p=0·002) at 180 μg; by 202 SFCs per 106 PMBCs (95% CI 138 to 267; p<0·0001) at 300 μg; by 223 SFCs per 106 PMBCs (95% CI 147 to 299; p<0·0001) at 480 μg; and decreased by 1 SFCs per 106 PMBCs (95% CI -24 to 22] in the placebo group (Kruskal-Wallis test p<0·0001 followed by Mann-Whitney's tests; per-protocol cohort). Dose-dependent and polyfunctional nucleoprotein-specific CD4 T-cell responses were observed, and CD8 T-cell responses were elicited at 300 μg and 480 μg (secondary endpoints). OVX836 appears to be a safe and well tolerated candidate vaccine that elicits humoral and cellular nucleoprotein-specific immune responses (including CD8 T cells at the highest dose levels) and showed a preliminary signal of protection against influenza. Therefore, OVX836 is a promising vaccine candidate for universal influenza A prevention, that warrants further trials. OSIVAX, Bpifrance, Wallonia Region, and the EUs Horizon 2020 Research and Innovation Program.

P-718 Preimplantation genetic testing in Belgium: recommendations for the genetic centres

Abstract Study question How do genetic centres in Belgium apply international guidelines on preimplantation genetic testing (PGT)? Summary answer We present the national consensus on how to practice PGT, starting from initial patient uptake and embryo selection to follow-up of pregnancies. What is known already PGT includes PGT-M for monogenic disorders, PGT-SR for structural rearrangements and PGT-A for aneuploidy screening. The application of whole-genome technologies to trophectoderm biopsies for PGT-M and PGT-SR/A has evidenced the high prevalence of mosaicism due to chromosome segregation errors during the first mitotic divisions, making biopsy results interpretation and embryo transfer policy more challenging and complex. Guidelines from several international societies have been published in recent years to leverage the standardization of the whole PGT service. Although these are based on expertise and continuously acquiring evidence, it is widely recognized that variations in local and national regulations diversify PGT practices. Study design, size, duration Recommendations regarding PGT indications, patient counselling, embryo transfer policy, reporting, quality and pregnancy follow-up have been built to harmonize PGT services nationally. With a special focus on mosaicism, aiming to balance the highest chance for a pregnancy with the lowest risk for a chromosomally abnormal ongoing pregnancy or child. Participants/materials, setting, methods The Belgian PGT working group consists of laboratory geneticists, clinical geneticists and IVF specialists from eight nationally accredited centres. The group operates under the BeSHG umbrella and meets quarterly to formulate opinions and statements on PGT practice with the main goal of guaranteeing a high standard of care, exchange knowledge and implement a harmonized workflow. The Belgian social security system provides reimbursement of six genetic testing cycles for all PGT-M/SR patients but not for PGT-A. Main results and the role of chance PGT is offered for all monogenic and chromosomal disorders, if the causal genetic variants are known and documented. PGT for HLA-typing is allowed for the therapeutic benefit of an existing child after couple's psychological evaluation. Aneuploidy screening can be offered to specific patient groups to increase IVF success rate. However, social sexing and testing for non-medical or eugenic purposes is prohibited. At intake, the couple is counselled about the genetic aspect of the disease, psychological and financial aspects of PGT, applied methodology, including average success and misdiagnosis rate, and embryo transfer policies. Affected embryos, and embryos without diagnosis for PGT-M/SR are not transferred. For PGT-A (combined or not with PGT-M/SR), embryos are categorized as: (A) Euploid - suitable for transfer, if mosaicism is absent or below the detection threshold. (B) Mosaic transferable - suitable for transfer, but only following ranking and/or counselling and follow up, if mosaicism for any chromosome not described in (C) is detected; (C) Aneuploid or Mosaic - not suitable for transfer, if mosaicism of 8, 9, 13, 16, 18, 21 and X or full aneuploidy of any chromosome is detected. Non-invasive prenatal testing is strongly recommended to all women pregnant after PGT and is nationally reimbursed. Limitations, reasons for caution The practical recommendations, which are supplementary to the recently published ESHRE PGT recommendations, are based on expertise and data from the literature available at the time of preparation. As such, they will need regular reconsideration and an update or extension may follow when new solid scientific evidence arises. Wider implications of the findings As international recommendations represent a greatest common denominator over many local regulations, this work serves as example for drawing country-specific agreements for genetic centres. The process of consensus expert opinion formation on best practice may be applicable in other countries where PGT service is not overseen by a designated agency. Trial registration number Not applicable

Radiotherapy Use in Muscle-Invasive Bladder Cancer: Review of the Guidelines and Impact of Increased Awareness in Patient Referral at a Tertiary Center in Belgium.

Pronounced underuse of radiotherapy (RT) in muscle-invasive bladder cancer (MIBC) is reported. This study aims to assess the awareness about the role of RT in different MIBC settings and see whether this has increased since 2017. We reviewed the bladder cancer guidelines of the EAU, ESMO, NCCN, NICE, and AUA/ASCO/ASTRO/SUO, focusing on the role of RT in MIBC. In 2017, we evaluated the use of RT in MIBC in Belgium. This raised awareness about the indications of RT in different MIBC settings. Here, we present a retrospective pattern of care analysis of the RT use for MIBC patients at our center from January 2012 until December 2021. Frequency of RT use, patient, disease and treatment characteristics were compared between two 5-year periods (2012-2016 and 2017-2021). Review of the guidelines suggested that RT can be used as a treatment option in most MIBC settings. However, differences between guideline recommendations existed and high-level evidence was often lacking. Overall, 221 unique MIBC patients received RT at our center. RT use for MIBC was 39% higher in the second 5-year period (Between the same periods, the number of new MIBC registrations increased with 26%). The most pronounced increase, ie, 529%, was observed in the primary setting and was in parallel with patient preference becoming the main indication for RT. Participation in clinical trials seems to have had an important impact on the frequency of RT use in the adjuvant and metastatic setting. We provide a critical overview of the RT indications in MIBC as recommended by the international guidelines. Increased awareness about RT as a treatment option in MIBC seems to have an impact on the treatment choice in clinical practice, as was observed in our tertiary center.

Clinical practice of hereditary angioedema in Belgium: opportunities for optimized care

ABSTRACT Introduction Hereditary angioedema (HAE) is a rare disorder characterized by unpredictable painful and potentially life-threatening swelling episodes. The international WAO/EAACI guideline on the diagnosis and management of HAE was recently updated and provides up-to-date guidance for the management of. In this paper, we assessed to what extent the Belgian clinical practice was aligned with the revised guideline, and whether there were opportunities to optimise Belgian clinical practice in HAE. Methods We compared the updated international guideline for HAE with information we acquired on Belgian clinical practice, a Belgian patient registry and expert opinion analysis. The Belgian patient registry was developed with the involvement of eight Belgian reference centers for HAE patients. Eight Belgian experts, physicians in the participating centers, included patients in the patient registry and participated in the expert opinion analysis. Results The main action points to further optimise the Belgian clinical practice of HAE are Work towards total disease control and normalize patients’ life by considering the use of new and innovative long-term prophylactic treatment options; (2) inform C1-INH-HAE patients about new long-term prophylactic therapies; (3) assure the availability of on-demand therapy for all C1-INH-HAE patients; (4) implement a more universally used assessment including multiple aspects of the disease (e.g. quality of life assessment) in daily clinical practice; and (5) continue and expand an existing patient registry to assure continued data availability on C1-INH-HAE in Belgium. Conclusions In light of the updated WAO/EAACI guideline, five action points were identified and several other suggestions were made to optimise the Belgian clinical practice in C1-INH-HAE.

Burden of migraine in patients attending Belgian headache specialists: real-world evidence from the BECOME study.

Migraine is a primary headache disorder, which imposes a major burden on the sufferers. The BECOME study (Burden of migrainE in specialist headache Centers treating patients with prOphylactic treatMent failurE) attempted to characterize and assess the prevalence, burden and healthcare resource utilization of migraine patients presenting in specialized headache centers in Europe and Israel. In this paper, we will describe the patient characteristics of the Belgian headache centers. The BECOME study was a prospective, non-interventional, cross-sectional study consisting of two parts. In the first part of the study, data were collected from subjects with a diagnosis of migraine. Subsequently, patients with ≥ 4 monthly migraine days (MMD) and ≥ 1 prior preventive treatment failure (PPTF) filled out validated questionnaires to assess the burden of disease. In part 1 of the Belgian study population (N = 806), 45% of patients reported ≥ 8 MMD and 25% had failed ≥ 4 preventive treatments. In part 2 (N = 90), more than 90% of patients reported having severe impact of headache on daily life and having severe migraine-related disability. The impact was the highest for patients with ≥ 15 MMD, however, even within the patient population with < 8 MMD, the burden was significant. Almost 40% of the study population suffered from anxiety. These findings in the Belgian sample of the BECOME study demonstrate the substantial burden and unmet need for the management of difficult-to-treat migraine.

Machine Learning Algorithm to Estimate Distant Breast Cancer Recurrence at the Population Level with Administrative Data.

High-quality population-based cancer recurrence data are scarcely available, mainly due to complexity and cost of registration. For the first time in Belgium, we developed a tool to estimate distant recurrence after a breast cancer diagnosis at the population level, based on real-world cancer registration and administrative data. Data on distant cancer recurrence (including progression) from patients diagnosed with breast cancer between 2009-2014 were collected from medical files at 9 Belgian centers to train, test and externally validate an algorithm (i.e., gold standard). Distant recurrence was defined as the occurrence of distant metastases between 120 days and within 10 years after the primary diagnosis, with follow-up until December 31, 2018. Data from the gold standard were linked to population-based data from the Belgian Cancer Registry (BCR) and administrative data sources. Potential features to detect recurrences in administrative data were defined based on expert opinion from breast oncologists, and subsequently selected using bootstrap aggregation. Based on the selected features, classification and regression tree (CART) analysis was performed to construct an algorithm for classifying patients as having a distant recurrence or not. A total of 2507 patients were included of whom 216 had a distant recurrence in the clinical data set. The performance of the algorithm showed sensitivity of 79.5% (95% CI 68.8-87.8%), positive predictive value (PPV) of 79.5% (95% CI 68.8-87.8%), and accuracy of 96.7% (95% CI 95.4-97.7%). The external validation resulted in a sensitivity of 84.1% (95% CI 74.4-91.3%), PPV of 84.1% (95% CI 74.4-91.3%), and an accuracy of 96.8% (95% CI 95.4-97.9%). Our algorithm detected distant breast cancer recurrences with an overall good accuracy of 96.8% for patients with breast cancer, as observed in the first multi-centric external validation exercise.

Coping strategies of unaccompanied refugee minors shortly after arrival in Belgium.

Unaccompanied refugee minors (URMs) are a group in an especially vulnerable situation with heightened psychological suffering due to both stressful life events and current daily stressors. Research has shown that certain coping strategies such as avoidance can be adaptive in the face of ongoing stress. We conceptualize social support as an essential coping resource that these strategies tap into. Since the interrelations between these factors are often not clear in the literature, this study strives to identify and link URMs' coping strategies, the respective coping resources and the various stressors they target, shortly after arrival in a high-income country. Seventy-nine URMs from various backgrounds were recruited in two first-phase reception centers in Belgium. In addition to self-report questionnaires to assess stressful life events and current daily stressors, we conducted semi-structured interviews, with cultural mediators if required. Thematic analysis was applied to the participants' accounts and resulted in the identification of four coping strategies: avoidance and distraction, continuity and coherence, selective reliance, and positive appraisal and acceptance. The relation between these coping strategies, the various coping resources used, and the specific stressors at which they aim are discussed. We conclude that avoidant coping and contact with the ethnic community, particularly the peer group, are fundamental strategies for successful coping. Practitioners need to support URMs in their coping efforts by providing and facilitating appropriate coping resources.

Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study.

A qualitative evaluation study of the prematurely terminated PrEgabalin Lidocaine Capsaicin Neuropathic Pain (PELICAN) study was performed. The PELICAN study aimed to examine pain management for localized neuropathic pain (LNP), as epidemiological figures have shown a high percentage of LNP patients in Belgium. The study compared systemic and topical medications according to pain relief, adverse effects, and several measures of quality of life. Achieving better study patient recruitment through qualitative research. To investigate and determine the causes of the observed recruitment problems in the PELICAN study, pain centers involved in the study as well as nonrecruiting pain centers were included. Furthermore, it aimed to highlight the positive and negative lessons learned from the conducted study and the number of obstacles the team had to overcome. A qualitative study, using a mixed methods approach, was performed. Multiple pain centers in Belgium completed an online survey, after which a structured interview was conducted to elaborate the responses in more detail. The broad topics of these meetings were feedback about the study, reviewing survey answers, and actions undertaken to enhance recruitment. Different factors contributed to the low recruitment rate in the PELICAN study, such as limited and late referral from the general practitioners to the Belgian pain centers, insufficient internal referrals from nonpain specialists, lack of specific expertise on LNP in some centers, scarcity of staff, limited reimbursement to administer complex analgesic schemes, overestimation of the patient population, and the reluctance of patients to participate in pain research. Additionally, shortcomings in the implemented study design and the need for more logistical investments were identified. The findings of the qualitative study demonstrate the need for further, more varied LNP research in Belgium, not limited to pharmacological studies. It also sheds important light on the recruitment obstacles that may be faced during these studies. Future studies could support this research by offering better proposals for feasibility and recruitment, for instance, by designing and conducting a compelling pilot study or applying social media during the recruitment phase. Clinical Trials. This trial is registered with NCT03348735. EUDRACT number 2018-003617-17.

Prevalence and determinants of fatigue in patients with IBD: a cross-sectional survey from the GETAID.

Fatigue is commonly reported by patients with inflammatory bowel disease (IBD), but the determinants of IBD-related fatigue have yet to be determined. To identify the factors associated with fatigue in a large population of patients with IBD. Fatigue and nine other IBD-related disability dimensions were assessed in a cohort of 1704 consecutive patients with IBD using the IBD-disk questionnaire in a cross-sectional survey of 42 French and Belgian centers. Fatigue and severe fatigue were defined as energy subscores >5 and >7, respectively. Determinants of fatigue were assessed using univariate and multivariate analyses (odds ratios (ORs) are provided with 95% confidence intervals). The prevalence rates of fatigue and severe fatigue were 54.1% and 37.1%, respectively. Both fatigue and severe fatigue were significantly higher in patients with active disease than in patients with inactive disease (64.9% vs. 44.7% and 47.4% vs. 28.6%, respectively; p<0.001 for both comparisons). In the multivariate analysis stratified by age, sex, type of IBD and IBD activity, fatigue was associated with age >40 years (OR=0.71 [0.54-0.93]), female sex (OR=1.48 [1.13-1.93]), IBD-related sick leave (OR=1.61 (1.19-2.16]), and joint pain (OR=1.60 [1.17-2.18]), abdominal pain (OR=1.78 [1.29-2.45]), regulating defecation (OR=1.67 [1.20-2.32]), education and work (OR=1.96 [1.40-2.75]), body image (OR=1.38 [1.02-1.86]), sleep (OR=3.60 [2.66-4.88]) and emotions (OR=3.60 [2.66-4.88]) subscores > 5. Determinants of fatigue are not restricted to IBD-related factors but also include social factors, sleep, and emotional disturbances, thus supporting a holistic approach to IBD patient care.

PAI-BEL: a Belgian multicentre survey of primary adrenal insufficiency.

Primary adrenal insufficiency (PAI) is a rare disease with an increasing prevalence, which may be complicated by life-threatening adrenal crisis (AC). Good quality epidemiological data remain scarce. We performed a Belgian survey to describe the aetiology, clinical characteristics, treatment regimens, comorbidities and frequency of AC in PAI. A nationwide multicentre study involving 10 major university hospitals in Belgium collected data from adult patients with known PAI. Two hundred patients were included in this survey. The median age at diagnosis was 38 years (IQR 25-48) with a higher female prevalence (F/M sex ratio = 1.53). The median disease duration was 13 years (IQR 7-25). Autoimmune disease was the most common aetiology (62.5%) followed by bilateral adrenalectomy (23.5%) and genetic variations (8.5%). The majority (96%) of patients were treated with hydrocortisone at a mean daily dose of 24.5 ± 7.0 mg, whereas 87.5% of patients also received fludrocortisone. About one-third of patients experienced one or more AC over the follow-up period, giving an incidence of 3.2 crises per 100 patient-years. There was no association between the incidence of AC and the maintenance dose of hydrocortisone. As high as 27.5% of patients were hypertensive, 17.5% had diabetes and 17.5% had a diagnosis of osteoporosis. This study provides the first information on the management of PAI in large clinical centres in Belgium, showing an increased frequency of postsurgical PAI, a nearly normal prevalence of several comorbidities and an overall good quality of care with a low incidence of adrenal crises, compared with data from other registries.

A retrospective survey of patients with hereditary transthyretin-mediated (hATTR) amyloidosis treated with patisiran in real-world clinical practice in Belgium

IntroductionHereditary transthyretin-mediated (hATTR) amyloidosis, a genetic disease caused by mutations in the transthyretin gene, leads to progressive sensory and autonomic neuropathy and/or cardiomyopathy and is associated with renal and ophthalmologic manifestations and a poor prognosis.MethodsThis is a retrospective study based on data collected from the medical records of patients with hATTR amyloidosis treated with patisiran between 01 July 2018 and 01 February 2021. Six Belgian neuromuscular reference centers participated, covering all patisiran-treated hATTR amyloidosis patients at the study time. This study was conducted to collect data requested in the context of the reimbursement of patisiran in Belgium.ResultsThirty-one patients were diagnosed with hATTR amyloidosis with polyneuropathy, Coutinho stage 1 or 2, and eligible for active treatment during the data collection period. Of the hATTR amyloidosis patients treated with patisiran (n = 12), seven and five had polyneuropathy stages 1 and 2, respectively. Six patients had cardiac symptoms (New York Heart Association class 2 or above). Follow-up information was available for nine patients. Following patisiran treatment, eight patients showed stable or improved assessments for most neurological or cardiological parameters. Only one patient presented with worsening statuses at the end of the data collection period.ConclusionsThe patients with hATTR amyloidosis in Belgium have similar baseline demographics and disease characteristics to those studied in the patisiran APOLLO study and show a similar therapeutic response in the real-world, altering the expected disease progression in most patients.