To save content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about saving content to .
To save content items to your Kindle, first ensure no-reply@cambridge.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about saving to your Kindle.
Note you can select to save to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
The reimbursement of, and subsequent patient access to, high-risk medical devices (MD) and in vitro diagnostics (IVD) across Europe often vary. The Health Technology Assessment Regulation (HTAR) aims to standardize clinical evaluations through Joint Clinical Assessments. Still, national differences in reimbursement frameworks and evidence integration for MD/IVD may impede the realization of HTAR’s expected benefits. This review aims to map existing reimbursement frameworks for high-risk MD/IVD, identify key oversight structures, and evaluate the use of comparative effectiveness and safety evidence in reimbursement decisions across the EU/EEA/UK.
Methods
A scoping review was conducted according to the registered protocol (osf.io/65bdk) and was reported following the PRISMA-ScR guidelines. Results were validated through direct engagement with national organizations.
Results
Reimbursement frameworks across the EU/EEA/UK for MD/IVD vary significantly. Of the thirty-four countries reviewed, twenty-three incorporate HTA for MD/IVD reimbursement decisions; of these, only eleven countries have a formal HTA process as part of reimbursement pathways. Eight countries have structured mechanisms to address safety and effectiveness evidence uncertainty. Furthermore, twelve countries have primarily centralized processes, while six rely on regional or local decision-making.
Conclusions
This review highlights the variations in how countries integrate HTA into reimbursement frameworks for MD/IVD, how the national decisions are implemented, and how the evidence uncertainty is assessed. Some countries have a well-established reimbursement framework with formal HTA components, whereas others rely on ad hoc HTA processes. Understanding these differences can help optimize the use of HTAR-generated evidence. Further research is needed to capture ongoing reforms in response to the HTAR.
Existing guidelines on overviews of reviews and umbrella reviews recommend an assessment of the certainty of evidence, but provide limited guidance on ‘how to’ apply the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to such a complex evidence synthesis. We share our experience of developing a ‘general principles’ approach to applying GRADE to a complex overview of reviews. The approach was developed in an iterative and exploratory manner during the planning and conduct of an overview of reviews of a novel molecular imaging technique for the staging of prostate cancer, involving a formal review by a group of 11 methodologists/health services researchers. This approach was developed during the evidence synthesis process, piloted, and then applied to our ongoing overview of reviews. A ‘general principles’ approach of applying the domains of GRADE to an overview of reviews and arriving at an overall summary judgement for each outcome is presented. Our approach details additional factors to consider, including addressing both the primary study risk of bias as assessed by the included reviews and the risk of bias of the systematic reviews themselves, as well as the statistical heterogeneity observed in meta-analyses conducted within the included reviews. Our approach distilled key principles from the relevant GRADE guidelines and allowed us to apply GRADE to a complex body of evidence in a consistent and transparent way. The approach taken and the methods used to develop our approach may inform researchers working on overviews of reviews, umbrella reviews, or future methodological guidelines.
Approximately 65 million people worldwide have Long COVID. Long COVID is a complex condition with more than 200 symptoms, which can substantially affect the lives of individuals. The evidence base for Long COVID is evolving rapidly and, therefore, an up-to-date understanding of the prevalence and risk factors of Long COVID is necessary to inform service delivery and allocation of healthcare resources.
Methods
A systematic literature review was conducted. Long COVID epidemiological literature published after October 2021 was identified in the MEDLINE, Embase, and Cochrane Library databases. Data extraction and quality appraisal were completed by one reviewer and checked for accuracy and omissions by a second reviewer. The following subgroups of interest were identified: general population; children and older adults; individuals who are medically vulnerable; and individuals with a history of severe COVID-19. Narrative synthesis of the prevalence and symptoms of Long COVID and of risk factors associated with the development of Long COVID was conducted.
Results
Over 3,000 documents were identified, of which 51 primary research studies met the inclusion criteria and were deemed of fair or good quality. Long COVID prevalence estimates ranged from 1.8 to 53.1 percent in the general population; 0.1 to 65.7 percent in children; 5.6 to 80.8 percent in older adults; 12.4 to 29.7 percent in medically vulnerable individuals; and 9.8 to 94.6 percent in individuals with a history of severe COVID-19. A wide range of symptoms were identified, with fatigue and neurological and respiratory symptoms being commonly reported. Female sex and increased age were identified as risk factors for developing Long COVID.
Conclusions
Long COVID is a complex condition involving a wide range of symptoms, which may result in significant reductions in quality of life and functioning in some individuals, a substantial burden on healthcare systems, and broader economic impacts. In planning healthcare delivery for this population, a focus on multidisciplinary holistic care will be necessary.
The editors lay out new directions for law and policy on sustainable development in the context of the CITES and CITES-listed species, draws out key findings from the book, identifies elements of the future international law and governance research agenda, and offers tentative conclusions on the state of international efforts to secure implementation of the CITES in the context of global SDGs.