Acta Clinica Belgica最新文献

{"title":"Health economic modelling of diabetic kidney disease in patients with type 2 diabetes treated with Canagliflozin in Belgium.","authors":"Winde Jorissen,&nbsp;Lieven Annemans,&nbsp;Nicolas Louis,&nbsp;Andreas Nilsson,&nbsp;Michael Willis","doi":"10.1080/17843286.2021.2015554","DOIUrl":"https://doi.org/10.1080/17843286.2021.2015554","url":null,"abstract":"<p><strong>Objectives: </strong>The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial showed reduced renal and cardiovascular (CV) events in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD) treated with canagliflozin 100 mg added to Standard of Care (SoC) versus SoC alone. This led to an extension of the canagliflozin 100 mg European marketing authorisation, making canagliflozin the first pharmacological therapy to receive authorisation for the treatment of DKD since the RENAAL and IDNT trials more than 20 years ago. Given the importance of cost-effectiveness analyses in health care, this study aimed to leverage the CREDENCE trial outcomes to estimate the cost-effectiveness of canagliflozin 100 mg from the perspective of the Belgian healthcare system.</p><p><strong>Methods: </strong>A microsimulation model (CREDENCE Economic Model of DKD), developed using patient-level CREDENCE trial data, was leveraged to model the progression of DKD and CV outcomes, associated costs, and life quality. Unit costs and quality-adjusted life years (QALYs) were sourced from the literature. The time horizon was 10 years and sensitivity analyses were performed.</p><p><strong>Results: </strong>Canagliflozin was associated with sizable gains in life-years and QALYs over 10 years, and the incremental cost-effectiveness ratio cost offsets associated with reductions in CV and renal complications resulted in overall net cost savings from the perspective of the Belgian healthcare system.</p><p><strong>Conclusion: </strong>Model-based results suggest that adding canagliflozin 100 mg to SoC can improve outcomes for patients with DKD while reducing overall net costs for the Belgian healthcare system.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39642299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Should I, can I, dare I? Patients' view on stopping long-term antidepressant use, a qualitative study.","authors":"Ellen Van Leeuwen,&nbsp;Sibyl Anthierens,&nbsp;Mieke L van Driel,&nbsp;An De Sutter,&nbsp;Rani De Beir,&nbsp;Thierry Christiaens","doi":"10.1080/17843286.2021.2024384","DOIUrl":"https://doi.org/10.1080/17843286.2021.2024384","url":null,"abstract":"<p><strong>Background and aim: </strong>The rise in long-term antidepressant use is concerning. Long-term antidepressant (AD) use, much longer than recommended by guidelines, can result in risk of adverse events and generate unnecessary costs. In order to mitigate these risks, patients views about their antidepressants and how to discontinue need to be taken into account. We aimed to explore patients' experiences and views of discontinuing long-term AD, barriers and facilitators of discontinuation and required support.</p><p><strong>Methods: </strong>Semi-structured face to face interviews were conducted with 14 patients with long-term AD use in primary care. Interviews were analysed thematically.</p><p><strong>Results: </strong>Participants describe various perceptions about discontinuation. There is fear of returning to their depression, even in those who were ambivalent about the effectiveness and safety of AD continuation. Participants describe low confidence in their own coping resources, fear of stress, and previous negative experiences with stopping. This enhances their perception of AD dependence. Participants indicate the importance of the support of their GP and their social network to help them withdraw.</p><p><strong>Conclusion: </strong>Discontinuation of long-term antidepressants is a complex issue for patients. More awareness of the lack of evidence and the potential risks of long-term AD continuation is required. By raising the issue and offering support during discontinuation GPs can help their patients stop AD. A greater focus on non-pharmacological approaches of depression in primary care is needed to reduce unnecessary AD use.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39803459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The efficiency of the EmERGE pathway to provide continuity of care for medically stable people living with HIV in Belgium.","authors":"Eduard J Beck,&nbsp;Sundhiya Mandalia,&nbsp;Platonas Yfantopoulos,&nbsp;Christopher I Jones,&nbsp;Stephen Bremner,&nbsp;Jennifer Whetham,&nbsp;Marie Wittevrongel,&nbsp;Ludwig Apers","doi":"10.1080/17843286.2021.2004697","DOIUrl":"https://doi.org/10.1080/17843286.2021.2004697","url":null,"abstract":"The life-expectancy of people living with HIV (PLHIV) has increased due to the earlier and increased use of antiretroviral drugs (ARVs) [1]. The life-expectancy of PLHIV now approximates that of people not living with HIV [2]. Increased life-expectancy will increase the number of PLHIV including those aged 50 years or older [3]. NonHIV cancers, cardiovascular disease, and other noncommunicable diseases (NCDs) are the most common comorbidities in older PLHIV and the most common cause of death of PLHIV in high-income countries. These NCDs also are becoming more prevalent in lowand middle-income countries [4,5] and PLHIV will increasingly need to use HIV and non-HIV health and social services. As part of their HIV-response, many countries are monitoring and evaluating the use, cost, outcome and impact of health services for PLHIV and tracking them across sites [6], which can assist in developing more integrated and cost-effective health services [7]. Mobile Health (mHealth), or the use of wireless technology to deliver health services and information using mobile communication devices, such as mobile phones or other devices [8,9], plays an important role in linking and integrating health services. An increased use of mHealth has been seen in Belgium [10], the United States [11] and other countries as part of their respective responses to their 2020 COVID-19 epidemic. mHealth provides an increasingly important role to ensure continuity of medical and paramedical care in countries, including the management of acute and chronic diseases, such as cancer services [12]. The published studies on mHealth interventions, however, indicate the variable effectiveness of mHealth tools, for those that were HIV-specific [8,9,13] or mHealth tools for other chronic diseases [14,15]. Most of these studies were performed in high-income countries; however, mHealth is increasingly being used in lowand middle-income countries [16–21]. The Evaluating mHealth technology in HIV to improve Empowerment and healthcare utilisation: Research and innovation to Generate Evidence for personalised care (EmERGE) Project co-designed, developed and implemented a new digital mHealth Pathway, including a mobile health application (App) [22]. This allowed for the electronic transfer of personal health information to people living with medically stable HIV and communication with their caregivers [12]. A recent review identified nine functions that an mHealth App ought to fulfil [9]. These functions covered many of the communication aspects, but two important aspects were missing: firstly, that data collected, transmitted, and stored at either end are protected in terms of their confidentiality and security (Table 1); secondly such technology needs to be affordable and efficient [23]. Most studies to date have not included the cost for developing, implementing, and supporting these mHealth Apps, let alone assess their cost-effectiveness or potential cost-savings that mHealth potentially pro","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39642208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aseptic meningitis after SARS-CoV-2 Pfizer/BioNTech vaccination.","authors":"Valérie Dupon,&nbsp;Stijn Arnaert,&nbsp;Eline Van Haute,&nbsp;Friedel Vulsteke,&nbsp;Günter Diet,&nbsp;Gert De Schoenmakere","doi":"10.1080/17843286.2021.2015101","DOIUrl":"https://doi.org/10.1080/17843286.2021.2015101","url":null,"abstract":"ABSTRACT Objective Aseptic meningitis is a rare, but possible severe side effect after SARS-CoV-2 Pfizer/BioNTech vaccination. Case Presentation Recently, a first case of aseptic meningitis after the first shot of mRNA-BNT162b2 SARS-CoV-2 (Pfizer/BioNTech) vaccine was reported. We present the first case of a 34-year-old woman without relevant medical history developing aseptic meningitis after her 2nd Pfizer/BioNTech vaccination. She was admitted with severe headache and fever for 5 days prior to her presentation at the emergency department. An extensive work-up of the clinical problem could narrow the differential diagnosis. Symptoms resolved after methylprednisolone therapy. Conclusion This case highlights a rare but important side effect after vaccination that primary physicians and neurologists should be aware of in order to identify and efficiently manage these patients.","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39705365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Asparaginase-induced pseudohyponatremia, a case-driven working strategy in pediatric patients.","authors":"A Evenepoel,&nbsp;P Herroelen,&nbsp;K Lanckmans,&nbsp;J van der Werff Ten Bosch,&nbsp;M Martin,&nbsp;I Weets,&nbsp;A van Dalem","doi":"10.1080/17843286.2021.1992583","DOIUrl":"https://doi.org/10.1080/17843286.2021.1992583","url":null,"abstract":"<p><strong>Objectives: </strong>When using indirect ion-selective electrode (ISE) methods, hypertriglyceridemia leads to pseudohyponatremia due to water displacement artifacts. Multiple strategies exist to minimize this interference. Our objective was to create a patient-friendly one-tube-fits-all testing setup without compromising the method robustness.</p><p><strong>Methods: </strong>Four strategies were evaluated in a single patient with hypertriglyceridemia. Additionally, the interchangeability between the Cobas 8000 and ABL Flex was evaluated on samples (n = 2274) with different total protein (TP) concentrations. Finally, a proof-of-concept (n = 40) was performed by re-measuring the routine sample with the ABL90 Flex.</p><p><strong>Results: </strong>ABL90 flex results and calculated sodium did not suffer from the presence of high triglyceride levels. We did not observe any significant differences between the three groups (P > 0.05) of sample types (arterial vs. venous plasma vs. venous whole blood after mixing up) nor for the analysers (Roche vs. ABL90 Flex). Passing-Bablok and Bland-Altman tests revealed interchangeability.</p><p><strong>Conclusion: </strong>In future cases of hypertriglyceridemia, 1500 mg/dL will be used as a preliminary threshold for reliable sodium determination. Routine Li-heparin samples can be used for accurate sodium determination without any need for extra arterial or venous blood gas tubes, offering a patient-friendly test setup for similar cases.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39531939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antimicrobial prescription in severe COVID-19 and CAP: a matched case-control study.","authors":"J Fierens,&nbsp;L De Bus,&nbsp;K Colpaert,&nbsp;J Boelens,&nbsp;B Gadeyne,&nbsp;J Decruyenaere,&nbsp;E Van Braeckel,&nbsp;P Depuydt","doi":"10.1080/17843286.2021.1996068","DOIUrl":"https://doi.org/10.1080/17843286.2021.1996068","url":null,"abstract":"<p><strong>Background: </strong>In severe coronavirus diseases 2019 (COVID-19), a high and potentially excessive use of antimicrobials for suspected bacterial co-infection and intensive care unit (ICU)-acquired infections has been repeatedly reported.</p><p><strong>Objectives: </strong>To compare an ICU cohort of community-acquired pneumonia (CAP) with a cohort of severe COVID-19 pertaining to co-infections, ICU-acquired infections and associated antimicrobial consumption.</p><p><strong>Methods: </strong>We retrospectively compared a cohort of CAP patients with a cohort of COVID-19 patients matched according to organ failure, ICU length of stay (LOS) and ventilation days. Patient data such as demographics, infection focus, probability and severity, ICU severity scores and ICU and in-hospital mortality, days of antimicrobial therapy (DOT) and number of antimicrobial prescriptions, using an incremental scale, were registered and analysed. The total number of cultures (sputum, urinary, blood cultures) was collected and corrected for ICU LOS.</p><p><strong>Findings: </strong>CAP patients (n = 148) were matched to COVID-19 patients (n = 74). Significantly less sputum cultures (68.2% versus 18.9%, P < 0.05) and bronchoalveolar lavages (BAL) (73.7% versus 36.5%, P < 0.05) were performed in COVID-19 patients. Six (8.1%) COVID-19 patients were diagnosed with a co-infection. Respectively, 58 of 148 (39.2%) CAP and 38 of 74 (51.4%) COVID-19 patients (P = 0.09) developed ICU-acquired infections. Antimicrobial distribution, both in the number of prescriptions and DOT, was similar in both cohorts.</p><p><strong>Conclusions: </strong>We found a low rate of microbiologically confirmed bacterial co-infection and a high rate of ICU-acquired infections in COVID-19 patients. Infection probabilities, antimicrobial prescriptions and DOT were comparable with a matched CAP cohort.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39566032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the protein content of kidney stones: an explorative study.","authors":"Mieke Steenbeke,&nbsp;Marc L De Buyzere,&nbsp;Marijn M Speeckaert,&nbsp;Joris R Delanghe","doi":"10.1080/17843286.2021.1999569","DOIUrl":"https://doi.org/10.1080/17843286.2021.1999569","url":null,"abstract":"<p><strong>Objectives: </strong>Kidney stone formation is complex; urinary protein inhibitors play a major role in natural defense against stone formation. Using attenuated total-reflectance Fourier-transform infrared (ATR-FTIR) spectroscopy of kidney stones, proteins are usually not quantified and often reported as 'organic matrix', for which there is little attention: treatment of urolithiasis is based on the nature of the major organic/inorganic stone compound. Literature no longer regards urinary proteins as innocent bystander, but highlights the role of proteins as urolithiasis modulators. We explored the potential significance of the protein content of kidney stones.</p><p><strong>Methods: </strong>800 stones were analyzed using ATR-FTIR spectroscopy; spectra were corrected for protein content. The ratio of the amide I peak (1655 cm^-1) divided by the maximum peak was calculated. A subgroup of stones (n = 43) was weighed; protein concentration was assayed. Kidney stone composition was taken into account when calculating protein concentration. Electrophoresis was implemented to investigate the protein bands. Multiple regression analysis was carried out to study the influence of various demographic variables (age, gender, stone type) on protein concentration.</p><p><strong>Results: </strong>Protein concentration showed a marked variation according to the stone composition. High relative protein content (>0.4% stone mass) was found in mixed calcium apatite/calcium oxalate dihydrate stones, mixed calcium oxalate dihydrate/calcium oxalate monohydrate/calcium apatite stones, and mixed calcium oxalate monohydrate/brushite stones, whereas lower protein percentages were found in cystine, urate, and calcium oxalate monohydrate stones. Protein concentration was dependent of the patient's age.</p><p><strong>Conclusion: </strong>ATR-FTIR is a practical way for assessing protein concentration in kidney stones.</p><p><strong>List of abbreviations: </strong>A: absorbance; as, asymmetric vibrations; ATR-FTIR, attenuated total-reflectance Fourier-transform infrared; β, standardized regression coefficient; CAP, calcium apatite; COD, calcium oxalate dihydrate; COM, calcium oxalate monohydrate; CV, coefficient of variation; δ, bending vibrations; ELISA, enzyme-linked immunosorbent assay; IQR, interquartile range; IR, infrared; LOD, limit of detection; LOQ, limit of quantification; MIR, mid-infrared; N or n, amount; r, correlation; r², coefficient of determination; s, symmetric vibrations; SD, standard deviation; SE, standard error; THP, Tamm-Horsfall protein; UA, uric acid; V, stretching vibrations; VIF: variance inflation factor; ZnSe, zinc selenide.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39596455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of pathology reporting and adherence to guidelines in rectal neuroendocrine neoplasms: a Belgian national study.","authors":"Bruno Waked,&nbsp;Filip De Maeyer,&nbsp;Saskia Carton,&nbsp;Cuyle Pieter-Jan,&nbsp;Timon Vandamme,&nbsp;Chris Verslype,&nbsp;Pieter Demetter,&nbsp;Ivan Borbath,&nbsp;Liesbet Van Eycken,&nbsp;Anne Hoorens,&nbsp;Karen Geboes,&nbsp;Nancy Van Damme,&nbsp;Suzane Ribeiro","doi":"10.1080/17843286.2021.1985806","DOIUrl":"https://doi.org/10.1080/17843286.2021.1985806","url":null,"abstract":"<p><p>The incidence of neuroendocrine neoplasms (NEN) in the rectum is rising since the introduction of colonoscopy screening programs. Guidelines, such as the European NeuroEndocrine Tumor Society (ENETS) algorithm, are mainly based on expert opinion. The goal of this nationwide study is to gain a better insight into the evolution in pathology reporting and adherence to the ENETS guidelines in Belgium. In Belgium, all NENs have to be reported to the Belgian Cancer Registry. We thoroughly reviewed all available pathology reports, coded as rectal NEN between 2004 and 2015, and reclassified according to World Health Organisation (WHO) classification 2019. To evaluate the adherence to the ENETS guidelines, population-based cancer registry data were linked with the medical procedures of the Belgian Health Insurance database. A total of 670 rectal NEN were retained and 16% of the cases needed reclassification. Annual incidence between 2004 and 2015 tripled from 0,20 to 0,61 per 100.000 inhabitants. Reporting of Ki67 proliferation index ameliorated most, while reporting of tumor size, lymphovascular and perineural invasion remained disappointing. Endoscopic ultrasound was performed in only 36.6% of the cases, while the mostly recommended mode of treatment (endoscopic/surgical/no resection) was followed in the majority of the cases. Incidence of rectal NEN in Belgium increased throughout the years and quality of pathology reporting improved especially after the WHO classification update in 2010. The growing awareness and knowledge among clinicians and pathologists in the community counters the need for centralization.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39485378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Local immune response as novel disease mechanism underlying abdominal pain in patients with irritable bowel syndrome.","authors":"J Aguilera-Lizarraga,&nbsp;M Florens,&nbsp;H Hussein,&nbsp;G Boeckxstaens","doi":"10.1080/17843286.2021.1996069","DOIUrl":"https://doi.org/10.1080/17843286.2021.1996069","url":null,"abstract":"<p><strong>Objectives: </strong>Irritable bowel syndrome (IBS) is the most frequently diagnosed functional gastrointestinal disorder, with a prevalence of up to 25% of the global population. IBS patients suffer from abnormal abdominal pain, or visceral hypersensitivity (VHS), associated with altered bowel habits in the absence of an organic detectable cause. The pathophysiology of the disease is incompletely understood, but the dysregulation of the brain-gut axis is well established in IBS.</p><p><strong>Methods: </strong>IBS onset is mainly triggered by infectious gastroenteritis, psychological factors, and dietary factors, but genetic predispositions and intestinal dysbiosis might also play a role. Additionally, immune activation, and particularly chronic mast cell activation, have been shown to underlie the development of abdominal pain in IBS.</p><p><strong>Results: </strong>By releasing increased levels of mediators, including histamine, mast cells sensitize enteric nociceptors and lead to VHS development. The mechanisms underlying aberrant mast cell activation in IBS are still under investigation, but we recently showed that a local break in oral tolerance to food antigens led to IgE-mediated mast cell activation and food-induced abdominal pain in preclinical models and in IBS patients.</p><p><strong>Conclusion: </strong>The concept of food-mediated VHS highlights the potential of therapies targeting upstream mechanisms of mast cell sensitization to treat IBS.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39566030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The implementation of risk minimization measures to prevent teratogenic pregnancy outcomes related to oral retinoid and valproate use in Belgium.","authors":"Xander Bertels,&nbsp;Els Mehuys,&nbsp;Koen Boussery,&nbsp;Lies Lahousse","doi":"10.1080/17843286.2021.1983708","DOIUrl":"https://doi.org/10.1080/17843286.2021.1983708","url":null,"abstract":"<p><strong>Introduction: </strong>Both oral retinoid and valproate containing medicines are highly teratogenic. Their use by women of childbearing age is controlled by risk minimization measures (RMMs) introduced by the European Medicine Agency, including the pregnancy prevention programme (PPP). In 2018, the RMMs were revised as previous measures were insufficient to prevent the use of these medicines during pregnancies.</p><p><strong>Aim & methods: </strong>A cross-sectional survey was conducted among patients, physicians and pharmacists to evaluate the implementation of the revised RMMs in Belgium. The primary outcome was compliance with key aspects of the PPP. Differences in compliance between oral retinoid and valproate stakeholders were investigated. The relationship between potential determinants (population characteristics and RMM usage) and compliance was studied via multiple logistic regression.</p><p><strong>Results: </strong>A total of 317 eligible patients, physicians and pharmacists participated. The majority of the studied patients fail to comply with the PPP, mainly driven by poor implementation of pregnancy testing. A large number of healthcare providers is unaware of the available educational materials.</p><p><strong>Conclusion: </strong>It is likely that a substantial part of Belgian women of childbearing age using oral retinoids or valproate insufficiently meet the PPP requirements. We propose to better inform healthcare providers about the mandatory PPPs and available educational materials as well as to support them with the implementation of such programmes to improve the safe use of these teratogenic medicines.</p>","PeriodicalId":7086,"journal":{"name":"Acta Clinica Belgica","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39453611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}