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

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.

Introduction After COVID-19, many people continue to experience various symptoms for several weeks, even after a mild acute phase, and encounter difficulties when confronted with the healthcare system. Patient associations asked the Belgian Health Care Knowledge Centre to investigate the needs of these patients to improve their management. Purpose of research An online quantitative survey was conducted in 2021 among Belgian patients with history of COVID-19; having/had persisting symptoms for at least 4 weeks. Alongside questions on symptoms, treatment and impact on employment, Health-Related Quality of Life (HRQoL) before and after COVID-19 was measured through the EQ-5D-5L. A regression analysis identified the factors associated with the impact of long COVID on HRQoL. The qualitative approach consisted in 33 interviews and forum discussions among 101 patients. Results 1320 patients completed the online survey, most were symptomatic for more than 3 months. The average EQ-5D-5L index score was 0.85(95%CI:0.83-0.86) before and 0.65(95%CI:0.63-0.66) after infection. Duration, number and type of symptoms of long COVID significantly impacted HRQoL. More than half of the patients were unable to work. Qualitative part identified lack of empathy of health professionals, of systematic diagnostic approach, of interdisciplinary coordination. Patients felt misunderstood and developed their own diagnostic or treatment strategies. They questioned the value of medicine and resorted to non-reimbursed alternative therapies. Conclusions Long COVID has a significant impact on HRQoL and employment. Because of long COVID, patients were confronted, sometimes for the first time, with the imperfections of the health system. Better informing the health professionals on Long COVID patterns and management options, including reimbursement possibilities, and a comprehensive interdisciplinary assessment would give them the tools to respond to the needs of these patients.