<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Chloé Mayeur</style></author><author><style face="normal" font="default" size="100%">Heidi Mertes</style></author><author><style face="normal" font="default" size="100%">Wannes Van Hoof</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Do genomic passports leave us more vulnerable or less vulnerable? Perspectives from an online citizen engagement</style></title><secondary-title><style face="normal" font="default" size="100%">Humanities and Social Sciences Communications</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">genomic passport</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2023</style></year><pub-dates><date><style  face="normal" font="default" size="100%">Jan-12-2023</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">10</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Since genomics is becoming commonplace in healthcare for the diagnosis, treatment, and prevention, the prospect of generating a genomic passport for all citizens is gaining traction. While this would have many advantages, it raises ethical issues requiring societal debate alongside academic reflection. Hence, Sciensano—the Belgian scientific Institute of Public Health—organised an online citizen engagement on genomic information usage, including a question on a genomic passport for all. The inductive thematic analysis of participants’ contributions highlighted vulnerability as a fundamental concern, while this has not received sufficient attention so far in genomics. Participants expressed their vulnerability in two ways. First, the genomic passport would inform them about their ontological vulnerability. By revealing their constitutional weaknesses (predisposition to diseases), it reminds them that everyone is unavoidably and perennially at risk of being harmed. Second, the misuse of the genomic passport can add situational vulnerabilities (e.g., discrimination causing psychological and economic harm). Moreover, the fundamental uncertainty in genomics—how will such sensitive information be used, and how will the science evolve?—exacerbates these vulnerabilities. This article ends with recommendations to alleviate these vulnerabilities in genomics now and in the future in which the genomic passport may become a reality.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">1</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">M. Arbyn</style></author><author><style face="normal" font="default" size="100%">Stefanie Costa</style></author><author><style face="normal" font="default" size="100%">Ardashel Latsuzbaia</style></author><author><style face="normal" font="default" size="100%">Eliane Kellen</style></author><author><style face="normal" font="default" size="100%">Paolo Girogi Rossi</style></author><author><style face="normal" font="default" size="100%">Clementina E Cocuzza</style></author><author><style face="normal" font="default" size="100%">Partha Basu</style></author><author><style face="normal" font="default" size="100%">Castle, Philip E</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">HPV-based Cervical Cancer Screening on Self-samples in the Netherlands: Challenges to Reach Women and Test Performance Questions.</style></title><secondary-title><style face="normal" font="default" size="100%">Cancer Epidemiol Biomarkers Prev</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Early Detection of Cancer</style></keyword><keyword><style  face="normal" font="default" size="100%">Female</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Mass Screening</style></keyword><keyword><style  face="normal" font="default" size="100%">Netherlands</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomaviridae</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomavirus Infections</style></keyword><keyword><style  face="normal" font="default" size="100%">specimen handling</style></keyword><keyword><style  face="normal" font="default" size="100%">Uterine Cervical Neoplasms</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2023</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2023 Feb 06</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">32</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;In 2017, cervical cancer screening in the Netherlands switched from cytology to human papillomavirus (HPV) testing using the validated PCR-based cobas 4800. Women could order and subsequently received a free self-sampling kit (Evalyn Brush) at their home address instead of clinician sampling. In the laboratory, the shipped brush was placed into 20 mL of PreservCyt fluid, before testing. In the first 2 years of the new program, only 7% of screening tests were performed on a self-sample. Those who chose self-sampling versus clinician sampling were more likely to have never been screened previously and differed also with respect to sociodemographic factors. Subsequent more active promotion and increasing the ease to obtain kits increased the proportion opting for self-sampling (16% in 2020). HPV positivity and detection rate of precancer (CIN3+) were lower in the self-sampling compared with the clinician-sampling group (adjusted ORs of 0.65 and 0.86, respectively). Although population differences may partially explain these results, self-samples may have been too dilute, thereby reducing the analytic and clinical sensitivity. The Dutch findings demonstrate the importance of optimizing outreach, specimen handling and testing protocols for self-samples to effectively screen the target population and reach in particular the women at highest risk for cervical cancer. See related article by Aitken et al., p. 183.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">2</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Mylène Duivon</style></author><author><style face="normal" font="default" size="100%">Marie Lange</style></author><author><style face="normal" font="default" size="100%">Giulia Binarelli</style></author><author><style face="normal" font="default" size="100%">Johan Lefel</style></author><author><style face="normal" font="default" size="100%">Isabelle Hardy-Léger</style></author><author><style face="normal" font="default" size="100%">Regine Kiasuwa</style></author><author><style face="normal" font="default" size="100%">Jean-Baptiste Méric</style></author><author><style face="normal" font="default" size="100%">Cécile Charles</style></author><author><style face="normal" font="default" size="100%">Florence Joly</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Improve the management of cancer-related cognitive impairment in clinical settings: a European Delphi study.</style></title><secondary-title><style face="normal" font="default" size="100%">J Cancer Surviv</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2023</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2023 Nov 07</style></date></pub-dates></dates><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;PURPOSE: &lt;/b&gt;Cancer-related cognitive impairment (CRCI) is under-addressed by healthcare professionals owing to a lack of clinical management guidelines. This European Delphi study proposes recommendations to healthcare professionals for the management of CRCI in patients with non-central nervous system (non-CNS) cancers.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;METHODS: &lt;/b&gt;Twenty-two recommendations were developed based on a literature review and authors' clinical experience, split into three categories: screening, cognitive assessment, intervention. The survey included European professionals, experts in CRCI. The Delphi method was used: experts rated the clinical relevancy of recommendations on a 9-point Likert scale in three rounds. A recommendation was accepted if all votes were between 7 and 9. Recommendations not accepted in round 1 and round 2 were deleted, or modified and rated in round 3.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;RESULTS: &lt;/b&gt;Eighteen professionals (psychologists, physicians, researchers) voted and accepted 15 recommendations. Experts recommended the systematic screening of CRCI, followed by a short objective cognitive assessment, if complaints screened. A comprehensive evaluation is recommended if CRCI persists 6 months post-treatment. Cognitive rehabilitation, physical activity, meditative-movement therapy, and multimodal intervention should be offered. Recommendations about frequency and duration of interventions, the professional to administer cognitive rehabilitation and the use of meditation and cognitive training without psychoeducation were not accepted.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;CONCLUSIONS: &lt;/b&gt;This survey provides 15 recommendations to assist healthcare professionals in detecting, assessing and offering interventions for CRCI.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;IMPLICATIONS FOR CANCER SURVIVORS: &lt;/b&gt;These recommendations should be included in supportive care to help healthcare professionals to detect CRCI and propose the best available intervention for patients with cognitive complaints. Developing CRCI management in clinical settings would improve patients' quality of life.&lt;/p&gt;
</style></abstract></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Cindy Simoens</style></author><author><style face="normal" font="default" size="100%">Gheit, Tarik</style></author><author><style face="normal" font="default" size="100%">Ridder, Ruediger</style></author><author><style face="normal" font="default" size="100%">Ivana Gorbaslieva</style></author><author><style face="normal" font="default" size="100%">Holzinger, Dana</style></author><author><style face="normal" font="default" size="100%">Lucas, Eric</style></author><author><style face="normal" font="default" size="100%">Rehm, Susanne</style></author><author><style face="normal" font="default" size="100%">Peter Vermeulen</style></author><author><style face="normal" font="default" size="100%">Martin Lammens</style></author><author><style face="normal" font="default" size="100%">Olivier Vanderveken</style></author><author><style face="normal" font="default" size="100%">Kumar, Rekha Vijay</style></author><author><style face="normal" font="default" size="100%">Gangane, Nitin</style></author><author><style face="normal" font="default" size="100%">Alessandro Caniglia</style></author><author><style face="normal" font="default" size="100%">Maffini, Fausto</style></author><author><style face="normal" font="default" size="100%">Maria Belén Lloveras Rubio</style></author><author><style face="normal" font="default" size="100%">Anantharaman, Devasena</style></author><author><style face="normal" font="default" size="100%">Chiocca, Susanna</style></author><author><style face="normal" font="default" size="100%">Brennan, Paul</style></author><author><style face="normal" font="default" size="100%">Madhavan R Pillai</style></author><author><style face="normal" font="default" size="100%">Sankaranarayanan, Rengaswamy</style></author><author><style face="normal" font="default" size="100%">Bogers, Johannes</style></author><author><style face="normal" font="default" size="100%">Pawlita, Michael</style></author><author><style face="normal" font="default" size="100%">Tommasino, Massimo</style></author><author><style face="normal" font="default" size="100%">M. Arbyn</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Accuracy of high-risk HPV DNA PCR, p16(INK4a) immunohistochemistry or the combination of both to diagnose HPV-driven oropharyngeal cancer</style></title><secondary-title><style face="normal" font="default" size="100%">BMC Infectious Diseases </style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">HPV DNA PCR; p16(INK4a) IHC; HPV mRNA; Oropharyngeal carcinoma; HPV-AHEAD</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">06 August 2022</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">22</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;h3&gt;Background&lt;/h3&gt;

&lt;p&gt;The incidence of high-risk human papillomavirus (hrHPV)-driven head and neck squamous cell carcinoma, in particular oropharyngeal cancers (OPC), is increasing in high-resource countries. Patients with HPV-induced cancer respond better to treatment and consequently have lower case-fatality rates than patients with HPV-unrelated OPC. These considerations highlight the importance of reliable and accurate markers to diagnose truly HPV-induced OPC.&lt;/p&gt;

&lt;h3&gt;Methods&lt;/h3&gt;

&lt;p&gt;The accuracy of three possible test strategies, i.e. (a) hrHPV DNA PCR (DNA), (b) p16(INK4a)&amp;nbsp;immunohistochemistry (IHC) (p16), and (c) the combination of both tests (considering joint DNA and p16 positivity as positivity criterion), was analysed in tissue samples from 99 Belgian OPC patients enrolled in the HPV-AHEAD study. Presence of HPV E6*I mRNA (mRNA) was considered as the reference, indicating HPV etiology.&lt;/p&gt;

&lt;h3&gt;Results&lt;/h3&gt;

&lt;p&gt;Ninety-nine OPC patients were included, for which the positivity rates were 36.4%, 34.0% and 28.9% for DNA, p16 and mRNA, respectively. Ninety-five OPC patients had valid test results for all three tests (DNA, p16 and mRNA). Using mRNA status as the reference, DNA testing showed 100% (28/28) sensitivity, and 92.5% (62/67) specificity for the detection of HPV-driven cancer. p16 was 96.4% (27/28) sensitive and equally specific (92.5%; 62/67). The sensitivity and specificity of combined p16 + DNA testing was 96.4% (27/28) and 97.0% (65/67), respectively. In this series, p16 alone and combined p16 + DNA missed 1 in 28 HPV driven cancers, but p16 alone misclassified 5 in 67 non-HPV driven as positive, whereas combined testing would misclassify only 2 in 67.&lt;/p&gt;

&lt;h3&gt;Conclusions&lt;/h3&gt;

&lt;p&gt;Single hrHPV DNA PCR and p16(INK4a)&amp;nbsp;IHC are highly sensitive but less specific than using combined testing to diagnose HPV-driven OPC patients. Disease prognostication can be encouraged based on this combined test result.&lt;/p&gt;
</style></abstract></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>27</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">James Maddocks</style></author><author><style face="normal" font="default" size="100%">Louise Mathieu</style></author><author><style face="normal" font="default" size="100%">Nathan Courbon</style></author><author><style face="normal" font="default" size="100%">Rosie Richards</style></author><author><style face="normal" font="default" size="100%">Marlies Saelaert</style></author><author><style face="normal" font="default" size="100%">Wannes Van Hoof</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Healthy Data, an online citizen consultation about health data reuse – intermediate report</style></title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Data Space</style></keyword><keyword><style  face="normal" font="default" size="100%">Health data</style></keyword><keyword><style  face="normal" font="default" size="100%">Health Data Space</style></keyword><keyword><style  face="normal" font="default" size="100%">HP-JA2020-1</style></keyword><keyword><style  face="normal" font="default" size="100%">Joint Action</style></keyword><keyword><style  face="normal" font="default" size="100%">TEHDAS</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">30/06/2022</style></date></pub-dates></dates><publisher><style face="normal" font="default" size="100%">Sciensano</style></publisher><pub-location><style face="normal" font="default" size="100%">Brussels, Belgium</style></pub-location><pages><style face="normal" font="default" size="100%">31</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;h2&gt;Introduction&lt;/h2&gt;

&lt;p&gt;The present report is an overview of participants’ opinions gathered through a pilot public econsultation conducted between December 2021 and May 2022, primarily in France, Belgium and the UK, in order to develop citizen inspired recommendations regarding the reuse of their data and their role in this governance. The Healthy Data online consultation platform aimed to inform citizens about health data reuse, deliberate together with citizens about an ethical, legal and societal framework and produce recommendations for the development of the European Health Data Space.&lt;/p&gt;

&lt;h2&gt;Methods&lt;/h2&gt;

&lt;p&gt;To reach a broad audience, a largescale communication campaign was launched, including many partnering organisations who leveraged their networks to bring attention to the initiative. A large body of content was created in different formats, such as text, videos, visuals, an interactive quiz and cases. The content was updated regularly to attract different publics. Every piece of content provided neutral information and was centred around key questions about health data reuse.&lt;/p&gt;

&lt;h2&gt;Results:&lt;/h2&gt;

&lt;p&gt;4.244 citizens completed the interactive quiz and 5.932 ideas about health data reuse were shared on the platform. These contributions were thematically analysed to identify the overall narrative and the key values and principles that need to be respected when establishing the European Health Data Space.&lt;/p&gt;

&lt;h3&gt;Considerations about data and data reuse:&lt;/h3&gt;

&lt;p&gt;The contributors considered data to be powerful: It is going to exist somewhere with the perpetual potential to be used to do something which impacts the person behind the data. This power can be harnessed for good, but also cause harm, so it is important to be conscious of this power and to respect the rights of the people behind the data. The citizens identified fundamental individual and social aspects in health data. On the one hand, citizens wrote about ‘my data’, ‘I own my data’, ‘I should be in control’. On the other hand, they would talk about reuse systems, platforms, scientific research, databases, commercial use, … which can all be defined as fundamentally social in the sense that it is intrinsic to these practices that health data of many individuals is combined.&lt;/p&gt;

&lt;h3&gt;Finding a balance between benefits and risks of health data reuse:&lt;/h3&gt;

&lt;p&gt;The purpose behind reuse was a key question for participants. They generally supported health data reuse to support the common good (they mention: improve public health, healthcare, research and policy). Conversely, many contributors were against reuse for commercial purposes. Commercial aspects of health data reuse are often referred to within contributions. If some participants argued that involved private actors can be beneficial in multiple ways, a strong majority shares their concerns regarding their involvement within health data reuse. Participants referred to the need to protect their privacy and to acknowledge the technological limits of data security. In this regard, anonymization was the most mentioned concept within the consultation, but it divided participants on whether data should be anonymized or not. Overall, citizens also believed that the chosen safeguards should depend on the level data has been anonymised. Finally, some participants believed a certain form of citizens’ control was legitimate and should be allowed to minimize risks from health data reuse. Healthy Data, an online citizen consultation about health data reuse – intermediate report 4&lt;/p&gt;

&lt;h3&gt;Information, Communication and Engagement:&lt;/h3&gt;

&lt;p&gt;Citizens expressed a broad range of preferences regarding the information they wish to receive, the methods used to communicate with them and the opportunities that are provided with for engagement. Views range from a preference for none of the above either because of an objection towards the reuse of data or their perceived ability to participate in decision making, through to complex processes that would allow for citizens to know in real time what data is being used, who it is being used by, how they are using it and what their intentions are. At this higher level of complexity and involvement, they would also have an ability to make decisions about each and every potential of reuse of data. In reality though, results suggest that citizens views sit somewhere between these two extremes and allow for citizens to receive information and communication that is personalised to them, and engagement mechanisms that give a place to individual citizens, their representatives, and professionals in such a way so as to allow reuse that supports the public interest, promotes the safe and ethical reuse of data, and is conducted in a transparent and inherently trust building manner.&lt;/p&gt;

&lt;h3&gt;Framework:&lt;/h3&gt;

&lt;p&gt;A solid framework for health data reuse could be an overarching safeguard against reuse-associated risks, yet only if citizens trusted the authorities behind it. In case of a lack of trust, however, citizens usually did not trust health data reuse, nor its regulatory framework. A framework should also create transparency and allow for citizen involvement in the governance of health data reuse, if desired. Trusting the authorities behind the framework could decrease the wish to be involved yet being informed about reuse usually remained a necessary condition for public trust. Conversely, a certain distrust regarding the current framework could instigate the wish for a more active involvement of different stakeholders, including citizens. Participants also expressed specific ideas about the legal, ethical and societal dimensions of a suitable framework. A binding legislation for health data reuse, possibly starting from existing regulations such as the GDPR, should delineate authorised data users and reuse purposes. It should also clarify accountability claims and foresee in preventive and sanctioning measures regarding data abuse. Besides, ethical standards should define an overarching code of conduct. Confidentiality, equality, and individual freedom were mentioned as values of utmost importance. Finally, the framework should respect societal values that acknowledge the collective nature of health data reuse. Solidarity and avoiding discrimination were central concerns within the societal dimension of health data reuse.&lt;/p&gt;

&lt;h2&gt;Discussion:&lt;/h2&gt;

&lt;p&gt;Citizens’ attitudes towards health data reuse can be described as conditional beneficence, as they perceive it as beneficial at a societal level but also as potentially dangerous. Several aspects seem to have a major impact on their preferences. First, commercial aspects have a major impact on citizens’ perceptions of health data reuse and the framework that should be put in place. Then, whether data is anonymized or not seems to have a fundamental influence over citizen support for a general framework or other safeguards. As a basic rule, health data should be reused for goals that are in line with citizens’ values. The overall framework for health data reuse should pursue the common good and include solidarity-based values, while implementing appropriate safeguards. Healthy Data, an online citizen consultation about health data reuse – intermediate report 5 This conditional beneficence is based on both trust and the fear that health data might be reused against citizens, since complete control is not possible. Trust is of utmost importance and should be earned and fostered by respecting citizens’ values. One of these central values is co-creation, in which citizens need to be treated as partners and the framework for health data reuse needs to be co-constructed by them and other stakeholders.&lt;/p&gt;

&lt;h2&gt;Conclusion:&lt;/h2&gt;

&lt;p&gt;It is up to stakeholders to develop a framework based on this conditional beneficence, ideally in an open dialogue with citizens. This report serves as a starting point for discussions to translate citizens’ contributions about what the EHDS should look like.&lt;/p&gt;
</style></abstract><reprint-edition><style face="normal" font="default" size="100%">TEHDAS Consortium Partners</style></reprint-edition></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">J Thouvenin</style></author><author><style face="normal" font="default" size="100%">C Van Marcke</style></author><author><style face="normal" font="default" size="100%">L Decoster</style></author><author><style face="normal" font="default" size="100%">Gordana Raicevic</style></author><author><style face="normal" font="default" size="100%">K Punie</style></author><author><style face="normal" font="default" size="100%">Marc Van den Bulcke</style></author><author><style face="normal" font="default" size="100%">R Salgado</style></author><author><style face="normal" font="default" size="100%">Els Van Valckenborgh</style></author><author><style face="normal" font="default" size="100%">B Maes</style></author><author><style face="normal" font="default" size="100%">S Joris</style></author><author><style face="normal" font="default" size="100%">D Vander Steichel</style></author><author><style face="normal" font="default" size="100%">K Vranken</style></author><author><style face="normal" font="default" size="100%">S Jacobs</style></author><author><style face="normal" font="default" size="100%">F Dedeurwaerdere</style></author><author><style face="normal" font="default" size="100%">G Martens</style></author><author><style face="normal" font="default" size="100%">H Devos</style></author><author><style face="normal" font="default" size="100%">F P Duhoux</style></author><author><style face="normal" font="default" size="100%">M Rasschaert</style></author><author><style face="normal" font="default" size="100%">P Pauwels</style></author><author><style face="normal" font="default" size="100%">K Geboes</style></author><author><style face="normal" font="default" size="100%">J Collignon</style></author><author><style face="normal" font="default" size="100%">S Tejpar</style></author><author><style face="normal" font="default" size="100%">J-L Canon</style></author><author><style face="normal" font="default" size="100%">Michael Peeters</style></author><author><style face="normal" font="default" size="100%">A Rutten</style></author><author><style face="normal" font="default" size="100%">T Van de Mooter</style></author><author><style face="normal" font="default" size="100%">J Vermeij</style></author><author><style face="normal" font="default" size="100%">D Schrijvers</style></author><author><style face="normal" font="default" size="100%">W Demey</style></author><author><style face="normal" font="default" size="100%">W Lybaert</style></author><author><style face="normal" font="default" size="100%">J Van Huysse</style></author><author><style face="normal" font="default" size="100%">J Mebis</style></author><author><style face="normal" font="default" size="100%">A Awada</style></author><author><style face="normal" font="default" size="100%">K B M Claes</style></author><author><style face="normal" font="default" size="100%">Aline Hébrant</style></author><author><style face="normal" font="default" size="100%">J Van der Meulen</style></author><author><style face="normal" font="default" size="100%">B Delafontaine</style></author><author><style face="normal" font="default" size="100%">I Vanden Bempt</style></author><author><style face="normal" font="default" size="100%">J Maetens</style></author><author><style face="normal" font="default" size="100%">Maïté de Hemptinne</style></author><author><style face="normal" font="default" size="100%">S Rottey</style></author><author><style face="normal" font="default" size="100%">P Aftimos</style></author><author><style face="normal" font="default" size="100%">J De Grève</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">PRECISION: the Belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment.</style></title><secondary-title><style face="normal" font="default" size="100%">ESMO Open</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Belgium</style></keyword><keyword><style  face="normal" font="default" size="100%">Genomics</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Medical Oncology</style></keyword><keyword><style  face="normal" font="default" size="100%">Neoplasms</style></keyword><keyword><style  face="normal" font="default" size="100%">Precision Medicine</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2022 Aug</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">7</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;PRECISION is an initiative from the Belgian Society of Medical Oncology (BSMO) in collaboration with several stakeholders, encompassing four programs that aim to boost genomic and clinical knowledge with the ultimate goal to offer patients with metastatic solid tumors molecularly guided treatments. The PRECISION 1 study has led to the creation of a clinico-genomic database. The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) and GeNeo studies will increase the number of patients with advanced cancer that have comprehensive genotyping of their cancer. The PRECISION 2 project consists of investigator-initiated phase II studies aiming to provide access to a targeted drug for patients whose tumors harbor actionable mutations in case the matched drug is not available through reimbursement or clinical trials in Belgium.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">4</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>27</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Zoé Perrin</style></author><author><style face="normal" font="default" size="100%">Louise Mathieu</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Citizens’ perception of and engagement with health data secondary use and sharing in Europe – a literature review</style></title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Data Space</style></keyword><keyword><style  face="normal" font="default" size="100%">Health data</style></keyword><keyword><style  face="normal" font="default" size="100%">Health Data Space</style></keyword><keyword><style  face="normal" font="default" size="100%">HP-JA2020-1</style></keyword><keyword><style  face="normal" font="default" size="100%">Joint Action</style></keyword><keyword><style  face="normal" font="default" size="100%">TEHDAS</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">25/11/2021</style></date></pub-dates></dates><pages><style face="normal" font="default" size="100%">32</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Executive Summary The secondary use and sharing of health data can be beneficial for public health and improve healthcare in multiple ways. However, many challenges of different nature arise when health data is being processed. The role of citizens in the processing of health data seems to be increasingly acknowledged at the European political level. Nonetheless, the only form of citizen’s involvement that seems to exist in the legislation is the pre-requirement for consent. This exploratory literature review aims at deepening our knowledge on citizens’ perceptions of and involvement with the secondary use of health data in Europe. It will help us identifying the key insights which have to be considered in our two next deliverables: a citizen e-consultation, and recommendations to encourage the involvement of citizens in the future European Health Data Space, which will be delivered to the EU Commission. This executive summary highlights the key conclusions that we drew from this literature review.&lt;/p&gt;

&lt;h3&gt;Ethical considerations regarding health data secondary use and sharing&lt;/h3&gt;

&lt;p&gt;The first identified debate among our selection of articles relates to the different definitions of the concept of data ownership. Some authors do contest its applicability in the context on health data, and the myth that it provides absolute control to the owner. Several authors defend other approaches, such as a state claim to data ownership or to access to data, a collective data ownership, resulting from the multi-stage and collaborative process that creates the value of data, or such as the fact that the relationship between individuals and their health data would not be based on property but on the fact that data relates to them and that their use can affect their wellbeing. The concept of ownership is usually linked to the protection of individual rights regarding the secondary of health data, such as the respect for autonomy and the protection of privacy of the individuals. Some authors highlight that privacy should not be presumed as an absolute right. They raise the need to evaluate the ratio between risks and benefits of a particular research. The extent to which those risks can affect us is more debated, as is the question of how to determine societal benefits. Authors suggest several criteria to evaluate the public interest of a project, including the public nature of the projected benefit, the principle of distributive justice, how benefits are shared, the need for transparency, and the extent of citizens’ involvement in the secondary use of health data. Moreover, while the respect of those rights seems to be translated in practice by asking the explicit and informed consent of the individual, authors often refer to it as one of the main challenges in the context of health data secondary use. Problematic aspects of this system reportedly include its lack of adaptability to technological aspects, the impossibility to anticipate all future reuses, or the impossibility to systematically come back to the person. However, not requiring consent explicitly can have, according to these authors, a negative impact on public’s trust, which is according to many sources the cornerstone of secondary use and sharing of health data.&lt;/p&gt;

&lt;h3&gt;Citizens’ role and involvement&lt;/h3&gt;

&lt;p&gt;Our review highlights the relative novelty of perceiving the citizen-patient as a key actor of the governance of health data secondary use and sharing. His role in the ecosystem is also debated within the academic community: while there is a consensus on the need for greater transparency and education with regards to health data, it is not the case for more active forms of involvement. There is for instance no clear consensus on which kind of consent system should be implemented to authorize the secondary use and sharing of health data. Five main types of such systems have been identified and promoted in the literature covered by this review: the opt-out system – in which health data are presumed reusable for certain purposes unless the citizen explicitly oppose to it; the traditional systematic informed consent system, which can translate in dynamic consent systems – enabling citizens to dynamically consent or oppose to the use of their related health data on a dedicated website&amp;nbsp;or application; the broad consent system – where citizens indicate at the data collection point whether they agree with the use of their related health data in the future according to certain rules or principles; the tiered consent system – defining different levels of access depending on several variables, such as the objective of the project or the nature of the user; and the metaconsent system – which enables citizens to choose which type of consent system he or she would like to use. Beyond consent, other forms of citizen’s involvement mechanisms are also subject to debate within the academic community. Sources covered in this review promoted different models, including the involvement of citizens in the decision-making processes related to the governance of health data, or their participation in research projects. These models varied depending on the degree of involvement and power that citizens had on the decisions and actions taken. With regards to their involvement in the governance of health data, the presented and promoted models went from the use of public consultations and surveys to inform decisionmaking processes at the political level, through the allowance of a seat in governance bodies or access committees of databases, to the creation of data cooperatives, in which citizens are at the centre of the decision-making process. As for their involvement in research projects the different forms identified by the literature covered contributory, co-construction and citizeninitiated models. It remains to be seen which methods of citizens’ involvement would be the most suitable for the future European Health Data Space. This question needs to be asked for two types of health data secondary use and sharing systems: one the one hand, systems based on data altruism, defined defined by the Data Governance Act (Article 2, paragraph 10) as data voluntarily shared by data subjects/holders including individuals or companies for general interest purposes and addressed in TEHDAS by the WP8.2; on the other hand, systems based on the reuse of health data collected by the public and private sectors.&lt;/p&gt;

&lt;h3&gt;State of citizens’ perceptions towards health data secondary use and sharing&lt;/h3&gt;

&lt;p&gt;Finally, with regards to citizens' perceptions of the secondary use of health data and their governance, the literature review highlighted that they are mainly influenced by 4 factors, namely:&lt;/p&gt;

&lt;ol&gt;
	&lt;li&gt;the nature and objectives pursued by actors being granted access to health data&lt;/li&gt;
	&lt;li&gt;the type of governance that regulates access to health data&lt;/li&gt;
	&lt;li&gt;the measures taken to ensure the confidentiality and security of the data&amp;nbsp;&lt;/li&gt;
	&lt;li&gt;and the level of knowledge that citizens have of the topic.&lt;/li&gt;
&lt;/ol&gt;

&lt;p&gt;According to the results of the surveys and consultations covered in this review, this knowledge is particularly low and would reportedly impede on the establishment of trust between citizens and the other stakeholders of the health data ecosystem. However, when questioned on the topic citizens express a need for greater transparency and education on health data. Another insight gained from this review is that citizens are relatively little asked to express their preferences regarding their potential involvement in the governance of health data secondary use and sharing. Moreover, health data are perceived differently by citizens compared to other types of personal data, and they express a greater need for protection and control for the former. However, this reportedly does not have a negative impact on citizens' willingness to share. Finally, some sources of the literature also highlighted that citizens do not seem to be opposed to the cross-border sharing of their data and would even in favour of it, as long as it remains within the borders of the European Union.&lt;/p&gt;
</style></abstract><reprint-edition><style face="normal" font="default" size="100%">TEHDAS Consortium Partners</style></reprint-edition></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Cindy Simoens</style></author><author><style face="normal" font="default" size="100%">Ivana Gorbaslieva</style></author><author><style face="normal" font="default" size="100%">Gheit, Tarik</style></author><author><style face="normal" font="default" size="100%">Holzinger, Dana</style></author><author><style face="normal" font="default" size="100%">Lucas, Eric</style></author><author><style face="normal" font="default" size="100%">Ridder, Ruediger</style></author><author><style face="normal" font="default" size="100%">Rehm, Susanne</style></author><author><style face="normal" font="default" size="100%">Peter Vermeulen</style></author><author><style face="normal" font="default" size="100%">Martin Lammens</style></author><author><style face="normal" font="default" size="100%">Olivier Vanderveken</style></author><author><style face="normal" font="default" size="100%">Kumar, Rekha Vijay</style></author><author><style face="normal" font="default" size="100%">Gangane, Nitin</style></author><author><style face="normal" font="default" size="100%">Alessandro Caniglia</style></author><author><style face="normal" font="default" size="100%">Maffini, Fausto</style></author><author><style face="normal" font="default" size="100%">Maria Belén Lloveras Rubio</style></author><author><style face="normal" font="default" size="100%">Anantharaman, Devasena</style></author><author><style face="normal" font="default" size="100%">Chiocca, Susanna</style></author><author><style face="normal" font="default" size="100%">Brennan, Paul</style></author><author><style face="normal" font="default" size="100%">Madhavan R Pillai</style></author><author><style face="normal" font="default" size="100%">Radhakrishna, Madhavan</style></author><author><style face="normal" font="default" size="100%">Bogers, Johannes</style></author><author><style face="normal" font="default" size="100%">Pawlita, Michael</style></author><author><style face="normal" font="default" size="100%">Tommasino, Massimo</style></author><author><style face="normal" font="default" size="100%">M. Arbyn</style></author><author><style face="normal" font="default" size="100%">HPV-AHEAD study group</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">HPV DNA genotyping, HPV E6*I mRNA detection, and p16INK4a/Ki-67 staining in Belgian head and neck cancer patient specimens, collected within the HPV-AHEAD study</style></title><secondary-title><style face="normal" font="default" size="100%">Cancer Epidemioly</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Adult</style></keyword><keyword><style  face="normal" font="default" size="100%">Aged</style></keyword><keyword><style  face="normal" font="default" size="100%">Aged, 80 and over</style></keyword><keyword><style  face="normal" font="default" size="100%">Alphapapillomavirus</style></keyword><keyword><style  face="normal" font="default" size="100%">Belgium</style></keyword><keyword><style  face="normal" font="default" size="100%">Cyclin-Dependent Kinase Inhibitor p16</style></keyword><keyword><style  face="normal" font="default" size="100%">DNA, Viral</style></keyword><keyword><style  face="normal" font="default" size="100%">Female</style></keyword><keyword><style  face="normal" font="default" size="100%">Genotype</style></keyword><keyword><style  face="normal" font="default" size="100%">Head and Neck Neoplasms</style></keyword><keyword><style  face="normal" font="default" size="100%">Head and neck neoplasms; Human papillomavirus; Human papillomavirus DNA tests; mRNA; p16(INK4a)</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Ki-67 Antigen</style></keyword><keyword><style  face="normal" font="default" size="100%">Male</style></keyword><keyword><style  face="normal" font="default" size="100%">middle aged</style></keyword><keyword><style  face="normal" font="default" size="100%">Oncogene Proteins, Viral</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomavirus Infections</style></keyword><keyword><style  face="normal" font="default" size="100%">RNA, Messenger</style></keyword><keyword><style  face="normal" font="default" size="100%">Staining and Labeling</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">jun 2021</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">72</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;BACKGROUND: &lt;/b&gt;The main risk factors for head and neck cancer (HNC) are tobacco and alcohol use. However, an important fraction of oropharyngeal cancer (OPC) is caused by human papillomaviruses (HPV), a subgroup with increasing incidence in several western countries.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;METHODS: &lt;/b&gt;As part of the HPV-AHEAD study, we assessed the role of HPV infection in 772 archived tissue specimens of Belgian HNC patients: 455 laryngeal (LC), 106 oral cavity (OCC), 99 OPC, 76 hypopharyngeal (HC), and 36 unspecified parts of the head and neck. All specimens were tested for HPV DNA (21 genotypes); whereof all HPV DNA-positives, all HPV DNA-negative OPCs and a random subset of HPV DNA-negatives of the other HNC-sites were tested for the presence of type-specific HPV RNA and p16 over-expression.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;RESULTS: &lt;/b&gt;The highest HPV DNA prevalence was observed in OPC (36.4 %), and was significantly lower (p &amp;lt; 0.001) in the other HNCs (OCC:7.5 %, LC:6.6 %). HPV16 was the most common HPV-genotype in all HNCs. Approximately 83.0 % of the HPV DNA-positive OPCs tested HPV RNA or p16-positive, compared to about 37.5 % and 44.0 % in OCC and LC, respectively. Estimation of the attributable fraction of an HPV infection in HNC was very similar for HPV RNA or p16 in addition to DNA-positivity; with 30 % for OPC, and 3 % for OCC and LC.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;CONCLUSION: &lt;/b&gt;Our study confirms the heterogeneity of HPV DNA prevalence across anatomical sites in HNC, with a predominance of HPV16 in all sites. The estimated proportion of HPV-driven HNC in Belgium, during the period 1980-2014, was 10 times higher in OPC compared to OCC and LC.&lt;/p&gt;
</style></abstract></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Aline Hébrant</style></author><author><style face="normal" font="default" size="100%">M Lammens</style></author><author><style face="normal" font="default" size="100%">C Van den Broeck</style></author><author><style face="normal" font="default" size="100%">N. D’Haene</style></author><author><style face="normal" font="default" size="100%">J Van den Oord</style></author><author><style face="normal" font="default" size="100%">A. Vanderstichele</style></author><author><style face="normal" font="default" size="100%">A Dendooven</style></author><author><style face="normal" font="default" size="100%">P Neven</style></author><author><style face="normal" font="default" size="100%">K Punie</style></author><author><style face="normal" font="default" size="100%">G Floris</style></author><author><style face="normal" font="default" size="100%">J Van der Meulen</style></author><author><style face="normal" font="default" size="100%">H A Poirel</style></author><author><style face="normal" font="default" size="100%">C Dooms</style></author><author><style face="normal" font="default" size="100%">S Rottey</style></author><author><style face="normal" font="default" size="100%">T Boterberg</style></author><author><style face="normal" font="default" size="100%">L Brochez</style></author><author><style face="normal" font="default" size="100%">MC Burlacu</style></author><author><style face="normal" font="default" size="100%">G Costante</style></author><author><style face="normal" font="default" size="100%">D Creytens</style></author><author><style face="normal" font="default" size="100%">De Paepe, P</style></author><author><style face="normal" font="default" size="100%">R De Pauwn</style></author><author><style face="normal" font="default" size="100%">B Decallonne</style></author><author><style face="normal" font="default" size="100%">F Dedeurwaerdere</style></author><author><style face="normal" font="default" size="100%">H Denys</style></author><author><style face="normal" font="default" size="100%">L Ferdinande</style></author><author><style face="normal" font="default" size="100%">R Forsyth</style></author><author><style face="normal" font="default" size="100%">M Garmyn</style></author><author><style face="normal" font="default" size="100%">T Gevaert</style></author><author><style face="normal" font="default" size="100%">J De Grève</style></author><author><style face="normal" font="default" size="100%">E Govaerts</style></author><author><style face="normal" font="default" size="100%">E Hauben</style></author><author><style face="normal" font="default" size="100%">J Kerger</style></author><author><style face="normal" font="default" size="100%">O Kholmanskikh Van Criekingen</style></author><author><style face="normal" font="default" size="100%">V Kruse</style></author><author><style face="normal" font="default" size="100%">Y Lalami</style></author><author><style face="normal" font="default" size="100%">L Lapeire</style></author><author><style face="normal" font="default" size="100%">P Lefesvre</style></author><author><style face="normal" font="default" size="100%">JP Machiels</style></author><author><style face="normal" font="default" size="100%">B Maes</style></author><author><style face="normal" font="default" size="100%">G Martens</style></author><author><style face="normal" font="default" size="100%">M Remmelink</style></author><author><style face="normal" font="default" size="100%">I Salmon</style></author><author><style face="normal" font="default" size="100%">R Sciot</style></author><author><style face="normal" font="default" size="100%">S Tejpar</style></author><author><style face="normal" font="default" size="100%">K Van de Vijver</style></author><author><style face="normal" font="default" size="100%">L Van de Voorde</style></author><author><style face="normal" font="default" size="100%">I Van den Berghe</style></author><author><style face="normal" font="default" size="100%">A Van den Bruel</style></author><author><style face="normal" font="default" size="100%">K Vandecasteele</style></author><author><style face="normal" font="default" size="100%">L Vanwalleghem</style></author><author><style face="normal" font="default" size="100%">K Vermaelen</style></author><author><style face="normal" font="default" size="100%">R Salgado</style></author><author><style face="normal" font="default" size="100%">E Wauters</style></author><author><style face="normal" font="default" size="100%">B Weynand</style></author><author><style face="normal" font="default" size="100%">Els Van Valckenborgh</style></author><author><style face="normal" font="default" size="100%">Gordana Raicevic</style></author><author><style face="normal" font="default" size="100%">Marc Van den Bulcke</style></author><author><style face="normal" font="default" size="100%">P Pauwels</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Algorithms for molecular testing in solid tumours</style></title><secondary-title><style face="normal" font="default" size="100%">Belgian Journal of Medical Oncology (BJMO</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2019</style></year><pub-dates><date><style  face="normal" font="default" size="100%">nov 2019</style></date></pub-dates></dates><number><style face="normal" font="default" size="100%">295</style></number><volume><style face="normal" font="default" size="100%">13</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;In order to advise the Federal Government on the reimbursement of molecular tests related to Personalised Medicine in Oncology, the Commission of Personalised Medicine (ComPerMed), represented by Belgian experts, has developed a methodology to classify molecular testing in oncology. The different molecular tests per cancer type are represented in algorithms and are annotated with a test level reflecting their relevance based on current guidelines, drug approvals and clinical data. The molecular tests are documented with recent literature, guidelines and a brief technical description. This methodology was applied on different solid tumours for which molecular testing is a clear clinical need.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">7</style></issue><section><style face="normal" font="default" size="100%">286</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Els Van Valckenborgh</style></author><author><style face="normal" font="default" size="100%">E Boone</style></author><author><style face="normal" font="default" size="100%">A Camboni</style></author><author><style face="normal" font="default" size="100%">JP Defour</style></author><author><style face="normal" font="default" size="100%">B Denys</style></author><author><style face="normal" font="default" size="100%">H Devos</style></author><author><style face="normal" font="default" size="100%">L Dewispelaere</style></author><author><style face="normal" font="default" size="100%">Guy Froyen</style></author><author><style face="normal" font="default" size="100%">Aline Hébrant</style></author><author><style face="normal" font="default" size="100%">P Heimann</style></author><author><style face="normal" font="default" size="100%">P Hermans</style></author><author><style face="normal" font="default" size="100%">E Heylen</style></author><author><style face="normal" font="default" size="100%">K Jacobs</style></author><author><style face="normal" font="default" size="100%">F Lambert</style></author><author><style face="normal" font="default" size="100%">Marie Le Mercier</style></author><author><style face="normal" font="default" size="100%">Els Lierman</style></author><author><style face="normal" font="default" size="100%">H Louagie</style></author><author><style face="normal" font="default" size="100%">B Maes</style></author><author><style face="normal" font="default" size="100%">MB Maes</style></author><author><style face="normal" font="default" size="100%">G Martens</style></author><author><style face="normal" font="default" size="100%">L Michaux</style></author><author><style face="normal" font="default" size="100%">Friedel Nollet</style></author><author><style face="normal" font="default" size="100%">H A Poirel</style></author><author><style face="normal" font="default" size="100%">Gordana Raicevic</style></author><author><style face="normal" font="default" size="100%">P Saussoy</style></author><author><style face="normal" font="default" size="100%">T Tousseyn</style></author><author><style face="normal" font="default" size="100%">Marc Van den Bulcke</style></author><author><style face="normal" font="default" size="100%">P Vandenberghe</style></author><author><style face="normal" font="default" size="100%">Karl Vandepoele</style></author><author><style face="normal" font="default" size="100%">P Vannuffel</style></author><author><style face="normal" font="default" size="100%">T Venken</style></author><author><style face="normal" font="default" size="100%">K Vermeulen</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Diagnostic testing in myeloid malignancies by next-generation sequencing: recommendations from the commission personalised medicine</style></title><secondary-title><style face="normal" font="default" size="100%">Belgian Journal of Hematology</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2019</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2019</style></date></pub-dates></dates><number><style face="normal" font="default" size="100%">249</style></number><volume><style face="normal" font="default" size="100%">10</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Molecular diagnostics have an increasing impact on diagnosis, risk stratification and targeted treatment in haemato-oncology. In the framework of a pilot study for the implementation of next-generation sequencing in the Belgian healthcare system, the Commission of Personalised Medicine was founded to give professional and evidence-based advice on the molecular analysis in haemato-oncology. This paper describes its recommendations for NGS analysis in myeloid malignancies. In addition, the minimally required set of genes that must be analysed is defined and algorithms for molecular workflow in myeloid malignancies are proposed.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">6</style></issue><section><style face="normal" font="default" size="100%">241</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Aline Hébrant</style></author><author><style face="normal" font="default" size="100%">K Punie</style></author><author><style face="normal" font="default" size="100%">FP Duhoux</style></author><author><style face="normal" font="default" size="100%">C Colpaert</style></author><author><style face="normal" font="default" size="100%">G Floris</style></author><author><style face="normal" font="default" size="100%">K Lambein</style></author><author><style face="normal" font="default" size="100%">P Neven</style></author><author><style face="normal" font="default" size="100%">M Berlière</style></author><author><style face="normal" font="default" size="100%">R Salgado</style></author><author><style face="normal" font="default" size="100%">M Chintinne</style></author><author><style face="normal" font="default" size="100%">K Dahan</style></author><author><style face="normal" font="default" size="100%">S Dedeurwaerdere</style></author><author><style face="normal" font="default" size="100%">J De Grève</style></author><author><style face="normal" font="default" size="100%">A de Leener</style></author><author><style face="normal" font="default" size="100%">H Denys</style></author><author><style face="normal" font="default" size="100%">R de Putter</style></author><author><style face="normal" font="default" size="100%">L Desmyter</style></author><author><style face="normal" font="default" size="100%">M Baldewijns</style></author><author><style face="normal" font="default" size="100%">D Feret</style></author><author><style face="normal" font="default" size="100%">C Fontaine</style></author><author><style face="normal" font="default" size="100%">C Galant</style></author><author><style face="normal" font="default" size="100%">P Hilbert</style></author><author><style face="normal" font="default" size="100%">J Janssens</style></author><author><style face="normal" font="default" size="100%">D Larsimont</style></author><author><style face="normal" font="default" size="100%">P Lefesvre</style></author><author><style face="normal" font="default" size="100%">T Sticca</style></author><author><style face="normal" font="default" size="100%">MD Tkint de Roodenbeke</style></author><author><style face="normal" font="default" size="100%">I Vanden Bempt</style></author><author><style face="normal" font="default" size="100%">C Van den Broeck</style></author><author><style face="normal" font="default" size="100%">I Vandernoot</style></author><author><style face="normal" font="default" size="100%">C Sotiriou</style></author><author><style face="normal" font="default" size="100%">J Van Dorpe</style></author><author><style face="normal" font="default" size="100%">H Antoine-Poirel</style></author><author><style face="normal" font="default" size="100%">Els Van Valckenborgh</style></author><author><style face="normal" font="default" size="100%">Gordana Raicevic</style></author><author><style face="normal" font="default" size="100%">Marc Van den Bulcke</style></author><author><style face="normal" font="default" size="100%">P Aftimos</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Molecular test algorithms for breast tumours</style></title><secondary-title><style face="normal" font="default" size="100%">Belgian Journal of Medical Oncology</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2019</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2019</style></date></pub-dates></dates><number><style face="normal" font="default" size="100%">45</style></number><volume><style face="normal" font="default" size="100%">13</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;In order to advise the Federal Government on all matters related to personalised medicine in oncology, including the reimbursement of molecular tests, the Commission of Personalized Medicine (ComPerMed) has applied, for the breast tumours, the same methodology as previously applied for the digestive tumours. Meaning, the different molecular tests, represented in the shape of algorithms, are annotated with test levels — which aim to reflect their relevance based on current available data and to define the reimbursement — and are documented with recent literature, guidelines and a brief technical description.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">2</style></issue><section><style face="normal" font="default" size="100%">40</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Guy Froyen</style></author><author><style face="normal" font="default" size="100%">Marie Le Mercier</style></author><author><style face="normal" font="default" size="100%">Els Lierman</style></author><author><style face="normal" font="default" size="100%">Karl Vandepoele</style></author><author><style face="normal" font="default" size="100%">Friedel Nollet</style></author><author><style face="normal" font="default" size="100%">Elke Boone</style></author><author><style face="normal" font="default" size="100%">Joni Van der Meulen</style></author><author><style face="normal" font="default" size="100%">Koen Jacobs</style></author><author><style face="normal" font="default" size="100%">Suzan Lambin</style></author><author><style face="normal" font="default" size="100%">Sara Vander Borght</style></author><author><style face="normal" font="default" size="100%">Els Van Valckenborgh</style></author><author><style face="normal" font="default" size="100%">Aline Antoniou</style></author><author><style face="normal" font="default" size="100%">Aline Hébrant</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Standardization of Somatic Variant Classifications in Solid and Haematological Tumours by a Two-Level Approach of Biological and Clinical Classes: An Initiative of the Belgian ComPerMed Expert Panel.</style></title><secondary-title><style face="normal" font="default" size="100%">Cancers (Basel)</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2019</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2019 Dec 16</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">11</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;In most diagnostic laboratories, targeted next-generation sequencing (NGS) is currently the default assay for the detection of somatic variants in solid as well as haematological tumours. Independent of the method, the final outcome is a list of variants that differ from the human genome reference sequence of which some may relate to the establishment of the tumour in the patient. A critical point towards a uniform patient management is the assignment of the biological contribution of each variant to the malignancy and its subsequent clinical impact in a specific malignancy. These so-called biological and clinical classifications of somatic variants are currently not standardized and are vastly dependent on the subjective analysis of each laboratory. This subjectivity can thus result in a different classification and subsequent clinical interpretation of the same variant. Therefore, the ComPerMed panel of Belgian experts in cancer diagnostics set up a working group with the goal to harmonize the biological classification and clinical interpretation of somatic variants detected by NGS. This effort resulted in the establishment of a uniform, two-level classification workflow system that should enable high consistency in diagnosis, prognosis, treatment and follow-up of cancer patients. Variants are first classified into a tumour-independent biological five class system and subsequently in a four tier ACMG clinical classification. Here, we describe the ComPerMed workflow in detail including examples for each step of the pipeline. Moreover, this workflow can be implemented in variant classification software tools enabling automatic reporting of NGS data, independent of panel, method or analysis software.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">12</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Mena, Marisa</style></author><author><style face="normal" font="default" size="100%">Lloveras, Belén</style></author><author><style face="normal" font="default" size="100%">Tous, Sara</style></author><author><style face="normal" font="default" size="100%">Bogers, Johannes</style></author><author><style face="normal" font="default" size="100%">Maffini, Fausto</style></author><author><style face="normal" font="default" size="100%">Gangane, Nitin</style></author><author><style face="normal" font="default" size="100%">Kumar, Rekha Vijay</style></author><author><style face="normal" font="default" size="100%">Somanathan, Thara</style></author><author><style face="normal" font="default" size="100%">Lucas, Eric</style></author><author><style face="normal" font="default" size="100%">Anantharaman, Devasena</style></author><author><style face="normal" font="default" size="100%">Gheit, Tarik</style></author><author><style face="normal" font="default" size="100%">Castellsagué, Xavier</style></author><author><style face="normal" font="default" size="100%">Pawlita, Michael</style></author><author><style face="normal" font="default" size="100%">de Sanjosé, Silvia</style></author><author><style face="normal" font="default" size="100%">Alemany, Laia</style></author><author><style face="normal" font="default" size="100%">Tommasino, Massimo</style></author><author><style face="normal" font="default" size="100%">M. Arbyn</style></author><author><style face="normal" font="default" size="100%">Cindy Simoens</style></author></authors><translated-authors><author><style face="normal" font="default" size="100%">HPV-AHEAD study group</style></author></translated-authors></contributors><titles><title><style face="normal" font="default" size="100%">Development and validation of a protocol for optimizing the use of paraffin blocks in molecular epidemiological studies: The example from the HPV-AHEAD study.</style></title><secondary-title><style face="normal" font="default" size="100%">PLoS One</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Carcinoma</style></keyword><keyword><style  face="normal" font="default" size="100%">Europe</style></keyword><keyword><style  face="normal" font="default" size="100%">Head and Neck Neoplasms</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">India</style></keyword><keyword><style  face="normal" font="default" size="100%">Molecular Diagnostic Techniques</style></keyword><keyword><style  face="normal" font="default" size="100%">Molecular Epidemiology</style></keyword><keyword><style  face="normal" font="default" size="100%">Necrosis</style></keyword><keyword><style  face="normal" font="default" size="100%">Paraffin</style></keyword><keyword><style  face="normal" font="default" size="100%">Paraffin Embedding</style></keyword><keyword><style  face="normal" font="default" size="100%">Pilot Projects</style></keyword><keyword><style  face="normal" font="default" size="100%">Random Allocation</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2017</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2017</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">12</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Worldwide use of formalin-fixed paraffin-embedded blocks (FFPE) is extensive in diagnosis and research. Yet, there is a lack of optimized/standardized protocols to process the blocks and verify the quality and presence of the targeted tissue. In the context of an international study on head and neck cancer (HNC)-HPV-AHEAD, a standardized protocol for optimizing the use of FFPEs in molecular epidemiology was developed and validated. First, a protocol for sectioning the FFPE was developed to prevent cross-contamination and distributed between participating centers. Before processing blocks, all sectioning centers underwent a quality control to guarantee a satisfactory training process. The first and last sections of the FFPEs were used for histopathological assessment. A consensus histopathology evaluation form was developed by an international panel of pathologists and evaluated for four indicators in a pilot analysis in order to validate it: 1) presence/type of tumor tissue, 2) identification of other tissue components that could affect the molecular diagnosis and 3) quality of the tissue. No HPV DNA was found in sections from empty FFPE generated in any histology laboratories of HPV-AHEAD consortium and all centers passed quality assurance for processing after quality control. The pilot analysis to validate the histopathology form included 355 HNC cases. The form was filled by six pathologists and each case was randomly assigned to two of them. Most samples (86%) were considered satisfactory. Presence of &amp;gt;50% of invasive carcinoma was observed in all sections of 66% of cases. Substantial necrosis (&amp;gt;50%) was present in &amp;lt;2% of samples. The concordance for the indicators targeted to validate the histopathology form was very high (kappa &amp;gt; 0.85) between first and last sections and fair to high between pathologists (kappa/pabak 0.21-0.72). The protocol allowed to correctly process without signs of contamination all FFPE of the study. The histopathology evaluation of the cases assured the presence of the targeted tissue, identified the presence of other tissues that could disturb the molecular diagnosis and allowed the assessment of tissue quality.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">10</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>27</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Albreht, Tit</style></author><author><style face="normal" font="default" size="100%">Regine Kiasuwa</style></author><author><style face="normal" font="default" size="100%">Marc Van den Bulcke</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">European guide on quality improvement in comprehensive cancer control</style></title></titles><dates><year><style  face="normal" font="default" size="100%">2017</style></year></dates><language><style face="normal" font="default" size="100%">eng</style></language></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">M. Arbyn</style></author><author><style face="normal" font="default" size="100%">Cindy Simoens</style></author><author><style face="normal" font="default" size="100%">Fabri, Valérie</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Deelname aan cervixkankerscreening in België - Participation au dépistage du cancer du col en Belgique</style></title><secondary-title><style face="normal" font="default" size="100%">Oncohémato</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2014</style></year><pub-dates><date><style  face="normal" font="default" size="100%">24/11/2014</style></date></pub-dates></dates><language><style face="normal" font="default" size="100%">eng</style></language><issue><style face="normal" font="default" size="100%">8</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>27</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Albreht, Tit</style></author><author><style face="normal" font="default" size="100%">Borras, Josep M</style></author><author><style face="normal" font="default" size="100%">Fiona Conroy</style></author><author><style face="normal" font="default" size="100%">Miriam Dalmas</style></author><author><style face="normal" font="default" size="100%">Antonio Federici</style></author><author><style face="normal" font="default" size="100%">Lydia Gorgojo</style></author><author><style face="normal" font="default" size="100%">Meggan Harris</style></author><author><style face="normal" font="default" size="100%">Marjetka Jelenc</style></author><author><style face="normal" font="default" size="100%">Regine Kiasuwa</style></author><author><style face="normal" font="default" size="100%">Martin Martin-Moreno</style></author><author><style face="normal" font="default" size="100%">Travado, Luzia</style></author><author><style face="normal" font="default" size="100%">Marc Van den Bulcke</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">European Guide for Quality National Cancer Control Programmes</style></title></titles><dates><year><style  face="normal" font="default" size="100%">2014</style></year></dates><language><style face="normal" font="default" size="100%">eng</style></language></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Regine Kiasuwa</style></author><author><style face="normal" font="default" size="100%">R Baeten</style></author><author><style face="normal" font="default" size="100%">M McKee</style></author><author><style face="normal" font="default" size="100%">C Knai</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Issues arising when crossing a border to give birth: an exploratory study on the French-Belgian border.</style></title><secondary-title><style face="normal" font="default" size="100%">Facts Views Vis Obgyn</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2014</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2014</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">6</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;BACKGROUND: &lt;/b&gt;Anecdotal evidence suggests that many organised initiatives for cross-border collaboration in healthcare in border regions originate from the need for women to give birth close to home. Despite this, there is remarkably little research on these practices and the specific modes of collaboration between providers and experiences and needs of these women. In this paper we describe the experiences of French women who choose to give birth in Belgium.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;STUDY DESIGN: &lt;/b&gt;We conducted semi-structured interviews with 14 key informants and captured the experiences of 14 French mothers using a 40-item questionnaire.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;RESULTS: &lt;/b&gt;The chief motivations for French mothers to cross the border to deliver a baby in Belgium were geographical proximity as well as perceived better quality of care. Several procedural differences between France and Belgium were highlighted as possibly affecting the quality of follow-up care, including the absence, in some cases, of a contact person in France, and communication problems between providers.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;CONCLUSION: &lt;/b&gt;There is a tension between the testimony of patients who are clearly satisfied and evidence of problems in communication and weak collaboration between providers on either side of this cross border collaboration. This paradox requires more research efforts to generate clear evidence of the added value of these cross-border collaborations for patients.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">3</style></issue></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>6</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Regine Kiasuwa</style></author><author><style face="normal" font="default" size="100%">Baeten, Rita</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Hospitals and borders, Seven case studies on cross-border collaboration and health system interactions.</style></title><secondary-title><style face="normal" font="default" size="100%">Strategic positioning and creative solutions: French patient flows to hospitals and polyclinics in the Belgian Ardennes (Belgium–France)</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2013</style></year></dates><number><style face="normal" font="default" size="100%">73</style></number><publisher><style face="normal" font="default" size="100%">European Observatory on Health Systems and Policies</style></publisher><pages><style face="normal" font="default" size="100%">22</style></pages><isbn><style face="normal" font="default" size="100%">9789289000536</style></isbn><language><style face="normal" font="default" size="100%">eng</style></language><issue><style face="normal" font="default" size="100%">4</style></issue><work-type><style face="normal" font="default" size="100%">Observatory Studies Series No. 31</style></work-type><reprint-edition><style face="normal" font="default" size="100%">European Observatory on Health Systems and Policies</style></reprint-edition><section><style face="normal" font="default" size="100%">51</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>27</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">L. Farrer</style></author><author><style face="normal" font="default" size="100%">S. Yghemonos</style></author><author><style face="normal" font="default" size="100%">Regine Kiasuwa</style></author><author><style face="normal" font="default" size="100%">B. Vanhercke</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Macro Drivers of Health Equity: Discussion Paper for the Expert Forum</style></title></titles><dates><year><style  face="normal" font="default" size="100%">2011</style></year></dates><language><style face="normal" font="default" size="100%">eng</style></language></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">M. 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