Difficulties encountered by long COVID patients in the Belgian health system / Difficultés rencontrées par les patients COVID long dans le système de santé belge

INTRODUCTION: After contracting COVID-19, many people have continued to experience various symptoms for several weeks and months, even after a mild acute phase. These people with ‘long COVID’ faced difficulties when confronted with the healthcare system. PURPOSE OF RESEARCH: In order to better understand their experience, we supplemented the information obtained in an online survey with a mixed qualitative approach based on 33 individual interviews and discussions with 101 participants in a forum in March 2021. RESULTS: Several shortcomings were identified in the contacts of ‘long’ COVID patients with the health care system, such as the lack of listening or empathy of some health care professionals, the lack of a systematic or proactive approach during the diagnostic assessment, or the lack of interdisciplinary coordination. Patients feel misunderstood and are forced to develop their own strategies, whether for diagnosis or treatment. Patients’ discomfort has led them to question the value of medicine and to resort to unconventional therapies to alleviate their symptoms, sometimes at great cost. CONCLUSIONS: Better informing the medical profession about the manifestation of the disease and the possible treatments, including the possibilities of reimbursement, would raise awareness and give them the tools to respond to the needs of ‘ long’ COVID patients. A comprehensive assessment of the patient through an “interdisciplinary assessment” seems necessary.

Introduction: Suite à une infection COVID-19, bon nombre de personnes ont ressenti divers symptômes pendant plusieurs semaines et mois, et ce, même après une phase aiguë légère. Ces personnes atteintes de « COVID long ¼ se sont trouvées confrontées au système de soins de santé, non sans difficultés. But de l'étude: Afin de mieux comprendre leurs expériences, nous avons complété les informations obtenues via une enquête en ligne par une approche qualitative mixte, comprenant 33 entretiens individuels et les discussions de 101 participants à un forum durant le mois de mars 2021. Résultats: Plusieurs lacunes ont été mises en évidence lors des contacts des patients « COVID long ¼ avec le système de santé, comme l'absence d'écoute ou d'empathie de certains professionnels de la santé, d'approche systématique ou proactive lors du bilan diagnostique, ou encore l'absence de coordination interdisciplinaire. Les patients se sentent incompris et se voient obligés de développer leurs propres stratégies afin d'établir un diagnostic ou un traitement. Le malaise des patients les ont amenés à remettre en question la valeur de la médecine et à recourir à des thérapies non conventionnelles afin de soulager leurs symptômes, parfois à un prix élevé. Conclusions: Mieux informer le corps médical quant à la manifestation de la maladie et aux prises en charge possibles, y compris les possibilités de remboursement, permettrait de le sensibiliser et de lui donner les outils pour répondre aux besoins des patients « COVID long ¼. Évaluer de manière globale le patient via un « bilan interdisciplinaire ¼ est nécessaire.

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.

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