Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
92,821
result(s) for
"Clinical assessment"
Sort by:
Revised FDI criteria for evaluating direct and indirect dental restorations—recommendations for its clinical use, interpretation, and reporting
ObjectivesThe FDI criteria for the evaluation of direct and indirect dental restorations were first published in 2007 and updated in 2010. Meanwhile, their scientific use increased steadily, but several questions from users justified some clarification and improvement of the living document.Materials and methodsAn expert panel (N = 10) initiated the revision and consensus process that included a kick-off workshop and multiple online meetings by using the Delphi method. During and after each round of discussion, all opinions were collected, and the aggregated summary was presented to the experts aiming to adjust the wording of the criteria as precisely as possible. Finally, the expert panel agreed on the revision.ResultsSome categories were redefined, ambiguities were cleared, and the descriptions of all scores were harmonized to cross-link different clinical situations with possible management strategies: reviewing/monitoring (score 1–4), refurbishment/reseal (score 3), repair (score 4), and replacement (score 5). Functional properties (domain F: fracture of material and retention, marginal adaptation, proximal contact, form and contour, occlusion and wear) were now placed at the beginning followed by biological (domain B: caries at restoration margin, hard tissue defects, postoperative hypersensitivity) and aesthetic characteristics (domain A: surface luster and texture, marginal staining, color match).ConclusionThe most frequently used eleven categories of the FDI criteria set were revised for better understanding and handling.Clinical relevanceThe improved description and structuring of the criteria may help to standardize the evaluation of direct and indirect restorations and may enhance their acceptance by researchers, teachers, and dental practitioners.
Journal Article
Joint Clinical Assessment in the EU HTA Regulation—Would Drugs Supported by Single-Arm Trials Fit Under Evaluation?
The Joint Clinical Assessment (JCA) evaluates the relative effectiveness (RE) of interventions over comparators. While randomised control trials (RCTs) are considered the gold standard, single-arm trials (SATs) require an external control for accurate RE estimation. This study reviewed Health Technology Assessment (HTA) outcomes for medicinal products supported by SATs in France, Germany, Poland, and Spain, and simulated the JCA for these products based on evidence submitted in France. Among HTA evaluations published in France in 2019–2024, 16% were SAT-driven, and 5.6% of them included external controls. SAT-supported drugs had a high reimbursement approval rate (74%) and showed better HTA outcomes when controls were used. In Germany, 64% of SAT-based HTA outcomes indicated no added benefit and 30% a non-quantifiable benefit. In Poland and Spain, 63% and 72% HTA evaluations recommend reimbursement, respectively. Despite wide acceptance by Member States, experts determined that 94% of SAT-supported products would not qualify for JCA review due to insufficient evidence. Only 6% would qualify for JCA for a likely limited number of PICOs (Population–Intervention–Comparator–Outcome), but the certainty rating would be low. These findings suggest that SATs, as primary evidence, may not be suitable for JCA, potentially undermining HTA in EU Member States.
Journal Article
A history of deep brain stimulation: Technological innovation and the role of clinical assessment tools
Deep brain stimulation involves using a pacemaker-like device to deliver constant electrical stimulation to problematic areas within the brain. It has been used to treat over 40,000 people with Parkinson's disease and essential tremor worldwide and is currently undergoing clinical trials as a treatment for depression and obsessive-compulsive disorder. This article will provide an historical account of deep brain stimulation in order to illustrate the plurality of interests involved in the development and stabilization of deep brain stimulation technology. Using Latour's notion of immutable mobiles, this article will illustrate the importance of clinical assessment tools in shaping technological development in the era of medical device regulation. Given that such tools can serve commercial and professional interests, this article suggests that it is necessary to scrutinise their application in research contexts to ensure that they capture clinical changes that are meaningful for patients and their families. This is particularly important in relation to potentially ethically problematic therapies such as deep brain stimulation for psychiatric disorders.
Journal Article
Narrative comments in internal medicine clerkship evaluations: room to grow
The use of narrative comments in medical education poses a unique challenge: comments are intended to provide formative feedback to learners while also being used for summative grades. Given student and internal medicine (IM) grading committee concerns about narrative comment quality, we offered an interactive IM Grand Rounds (GR) session aimed at improving comment quality. We undertook this study to determine the quality of comments submitted by faculty and post-graduate trainees on students' IM Clerkship clinical assessments, and to explore the potential impact of our IM-GR. Archived comments from clerkship cohorts prior to and immediately following IM-GR were reviewed. Clinical clerkship assessment comments include three sections: Medical Student Performance Assessment (MSPE), Areas of Strength, and Areas for Improvement. We adapted a previously published comment assessment tool and identified the performance domain(s) discussed, inclusion of specific examples of student performance, evidence that the comment was based on direct observations, and, when applicable, the inclusion of actionable recommendations. Scoring was based on the number of domains represented and whether an example within that domain was provided (maximum score = 10). Analysis included descriptive statistics, t-test, and Pearson correlation coefficients. We scored 697 comments. Overall, section ratings were MSPE 2.51 (SD 1.52, range 0-9), Areas of Strength 1.53 (SD 1.09, range 0-6), and Areas for Improvement 1.27 (SD 1.06, range 0-8). Significant differences were noted after Grand Rounds only in the MSPE mean scores. Within domains, trends toward increased use of specific examples in the post-GR narratives were noted. Assessment of both the breadth and depth of the included comments revealed low-quality narratives offered by our faculty and resident instructors. A focused session on best practices in writing narratives offered minimal change in the overall narrative quality, although we did notice a trend toward the inclusion of explanative examples.
Journal Article
Strengthening the EU Health Technology Assessment Regulation: Integrating National Immunization Technical Advisory Groups for Comprehensive Vaccine Assessments
Background: Given their crucial role in vaccine assessment, National Immunization Technical Advisory Groups (NITAGs) should be considered in the Regulation on Health Technology Assessment (EU HTAR) to maximize the benefits of the EU HTAR for vaccines. This review and perspective piece identifies the gaps arising from NITAGs potential lack of involvement and proposes strategies for involving them. Methods: A targeted literature and guideline review was conducted to evaluate NITAGs’ current and future role in relation to the EU HTAR. The impact of the EU HTAR on diverse national HTA frameworks was explored in a three-country case study. Recommendations were developed to leverage strengths and address weaknesses to ensure consistent and cohesive vaccine assessments. Results: The case study revealed potential overlaps between NITAGs and the EU HTAR, particularly regarding horizon scanning and joint scientific consultations. The involvement of NITAGs in national assessments varies, influencing how well joint clinical assessment reports will ultimately align with and be applicable to individual Member States. Conclusions: Stronger consideration of vaccines within the EU HTAR and NITAG involvement can streamline assessments, reduce duplication, and improve alignment between European and national processes. Strategic actions, including capacity building and collaborations between NITAGs, are key in facilitating this process.
Journal Article
Opportunities for and Challenges of Conducting Indirect Treatment Comparisons and Meta-Analyses for Vaccines in Post-EU HTA Regulation Era
The dynamic nature of infectious diseases introduces inherent challenges to the design of vaccine clinical trials, which consequently makes vaccine indirect treatment comparisons (ITCs) and meta-analyses (MAs) more challenging compared with regular pharmaceuticals. However, comparisons of efficacy and safety between vaccines are being frequently required in vaccine decision making due to a low number of head-to-head clinical trials in the vaccine landscape. The introduction of the European Union Health Technology Assessment (HTA) Regulation (EU HTAR) aims to harmonize HTA efforts across Europe. However, the EU HTAR could also escalate existing challenges for conducting vaccine MAs and ITCs. Such challenges include generating efficacy evidence in time for Joint Clinical Assessment (JCA), incorporating high levels of heterogeneity due to infectious disease-specific characteristics, and tackling a high number of PICOs per submission—likely driven by heterogeneity in the available data and differences in national vaccine calendars. Opportunities to tackle these challenges include introducing a stepwise approach to vaccine assessment in JCA, best-practice recommendations for conducting/interpreting vaccine MAs and ITCs, and condensing the number of PICOs to create larger ‘catch-all’ ITC networks. This perspective article explores these challenges and opportunities further.
Journal Article
The PICO Puzzle: Can Public Data Predict EU HTA Expectations for All EU Countries?
With the European Union (EU) Health Technology Assessment (HTA) regulation, Joint Clinical Assessments (JCA) are now required for oncological and advanced therapy medicinal products. The JCA assessment scope is determined through the PICO framework (Population, Intervention, Comparator, Outcome). Given the tight JCA timelines, Health Technology Developers (HTD) must anticipate PICO elements early to prepare dossiers effectively. This study investigates whether PICO can be predicted across EU member states using publicly available information. A systematic literature review was conducted to identify relevant peer-reviewed articles. Additionally, an extensive search of publicly available HTA documents, including reports, methodological guidelines, submission templates, and market access information was performed across 29 European countries. Relevant information for PICO anticipation was extracted. For many member states, a wealth of relevant information is publicly accessible: 66% have HTA reports publicly available, 79% have HTA methodological guidelines, 69% have dossier templates, and 100% have market access status lists. Between countries, the requirements for population and outcomes are largely aligned, making comparator the central element in PICO anticipation. PICO can be anticipated reliably based on public information. HTDs must be prepared to adjust their strategies as national procedures adapt, ensuring alignment with both current and emerging EU and national requirements.
Journal Article
EU Joint Clinical Assessment: A Framework for Optimising Use with Cost-Effectiveness Decision-Making
The introduction of the European Union (EU) Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 marks a transformative step in harmonizing health technology assessments (HTAs) across EU member states. This article explores the implications of JCA, particularly in oncology, for member states who utilize cost-effectiveness (CE) analysis and health technology developers (HTDs) who produce this evidence. The JCA framework attempts to standardise the assessment of relative clinical effectiveness and safety across the EU to input into national appraisals. Importantly, it excludes economic evaluations that may be required nationally, necessitating HTDs to align their CE models with the JCA PICO (Population/Intervention/Comparator/Outcome) parameters outlined by member states. This article discusses the challenges and opportunities for aligning JCA and CE modelling outcomes, contrasting evidence requirements between JCA and CE frameworks. It highlights the potential increase in complexity due to the diverse comparators in PICO surveys, necessitating the use of indirect comparison methodologies. It further underscores the importance of early communication between HTDs and HTA bodies to ensure timely, relevant, and pragmatic decision-making. By sharing national PICOs upfront to support national evidence generation, the JCA framework’s potential to aid high-quality decision-making and improve patient access to innovative medicines can be maximised.
Journal Article
ARM’s Perspective on the First Joint Clinical Assessments for ATMPs: Challenges and Opportunities on the Path Ahead
Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases—including rare cancers—for patients with few or no viable treatment options. At the same time, the inherent complexities of ATMPs pose challenges to traditional HTA frameworks. Unlike conventional treatments, ATMPs are often one-time therapies with a high magnitude of effect. However, their long-term durability remains uncertain at launch. The Joint Clinical Assessment (JCA), under the EU’s Health Technology Assessment (HTA) Regulation, represents a once-in-a-generation opportunity to consolidate the strengths of national HTA processes into a unified framework that accounts for the specificities of ATMPs and streamlines decision-making, cementing Europe’s position as a pioneer in innovative HTA approaches. While concerns remain regarding the suitability of current JCA methodologies for ATMPs, the HTA Regulation continues to bring the HTA ecosystem closer together, with numerous benefits already emerging from EU-wide collaboration on JCAs. This article outlines the HTA challenges posed for and by ATMPs, and ARM’s perspective on the JCA’s implementation. A ‘fit for purpose’ JCA holds the promise to unlocking these therapies’ benefits for individuals across Europe.
Journal Article