The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval ...and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.
Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.
Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.
European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.
Purpose
Annual rates of knee arthroplasty are increasing in all developed countries, imposing a significant economic and organizational burden; it is crucial to forecast the future need for knee ...arthroplasty, to assist stakeholders in planning strategies and investments, especially in a country like Italy, with the largest proportion of elderly citizens in Europe. Few epidemiological studies have been performed worldwide to estimate the demand for future knee replacement, and a variety of methods have been proposed.
Methods
We investigated the epidemiology of knee arthroplasty performed in Italy in the last 15 years and projected incidence rates up to the year 2050, utilizing, comparing, and adapting the available methodologies.
Results
From 2001 to 2016, 812,639 primary TKA were performed in Italy on patients over 40. The total number of surgeries increased by 262% with an average annual growth rate of 6.6%.
Conclusions
Adopting the best fitting projection method, an increase of 45% in incidence rate is expected for 2050.
At the beginning of the COVID-19 emergency, non-urgent surgical procedures had to be deferred, but also emergencies were reduced. To assess the global trend of pacemaker (PM) and implantable ...cardiac-defibrillator (ICD) procedures performed in Italy before, during, and after the first COVID-19 emergency, all the Italian hospital discharge records related to PM/ICD procedures performed between 2012 and 2021, sent to the National Institute of Health, were reviewed. Compared to 2019, in 2020, there was a reduction of first PM implants (52,216 to 43,962, −16%;
p
< 0.01), but not replacements (16,591 to 17,331, + 4%;
p
= 0.16). In particular, in April 2020, there was a drop of first implants (− 53,4% vs the average value of April 2018 and April 2019;
p
< 0.01), while the reduction of replacements was less evident (−32.6%; p = NS). In 2021, PM procedures increased to values similar to the pre-pandemic period. A reduction of ICD procedures was observed in 2020 (22,355, −7% toward 2019), mainly in April 2020 (− 46% vs April 2018/April 2019;
p
= 0.03). In 2021, the rate of ICD procedures increased (+ 14% toward 2020). A non-significant reduction of “urgent” procedures (complete atrioventricular block for PM and ventricular fibrillation for ICD), even in April 2020, was observed. In 2020, there was a reduction of first PM implants and ICDs, offset by increased activity in 2021. No decrease in PM replacements was observed, and the drop in “urgent” PM and ICD procedures was not statistically significant.
Background: The Directive 2011/24/EU OJEU 2011, L88/45 on the application of patient rights in cross-border health care requires the European Commission to support Member States in the development of ...European reference networks (ERNs). These ERNs are meant to ease the access of patients to highly specialized health care and to facilitate the cooperation at the European Union level in particular medical domains where expertise is scarce, especially in the rare disease area. Methods: The Directive 2011/24/EU OJEU 2011, L88/45 and the recent Commission Delegated Decision OJEU 2014, L147/71 as well as the Implementing Decision OJEU 2014, L147/79 require ERNs and health care providers wishing to join ERNs to have the capacity of developing good practices guidelines. Results: This provision results in a number of challenges but also opportunities for Member States with respect to guideline production. Member States could consider the importance of devoting resources to build efficient systems and capacities for the development and implementation of trustworthy guidelines. Furthermore, they could adopt a cooperative approach to optimize guideline production across countries. Finally, they could promote the establishment of new research governance based on systematically identified research gaps and prioritized as well as communicated research recommendations. Conclusion: Member States are at a decisive point in establishing the details to ensure the transparent and effective functioning of ERNs. Producing explicit plans for the development and use of trustworthy guidelines should be an essential part of this effort.
Background
Anterior cruciate ligament (ACL) surgical reconstruction is performed with the use of an autogenic, allogenic or synthetic graft. The document issued by the Italian National Guidelines ...System (SNLG, Sistema Nazionale Linee Guida) at the National Institute of Health aims to guide orthopaedic surgeons in selecting the optimal graft for ACL reconstruction using an evidence-based approach.
Materials and methods
A monodisciplinary panel was formed to define a restricted number of clinical questions, develop specific search strategies and critically appraise the literature using the grading of recommendations assessment, development, and evaluation (GRADE) method. The final draft was shared by the panel and then sent to four external referees to assess its readability and clarity, its clinical relevance and the feasibility of recommendations.
Results
Autograft shows moderate superiority compared with allograft, in relation to the relevant outcomes and the quality of selected evidence, after an appropriate risk–benefit assessment. Allograft shows higher failure rate and higher risk of infection. The panel recommends use of autografts; patellar tendon should be the first choice, due to its higher stability, while use of hamstring is indicated for subjects for whom knee pain can represent a particular problem (e.g., some categories of workers).
Conclusions
Autograft shows better performance compared with allograft and no significant heterogeneity in relation to relevant outcomes. The GRADE method allowed collation of all the information needed to draw up the recommendations, and to highlight the core points for discussion.
Rare diseases are a global public health priority; they can cause significant morbidity and mortality, can gravely affect quality of life, and can confer a social and economic burden on families and ...communities. These conditions are, by their nature, encountered very infrequently by clinicians. Thus, clinical practice guidelines are potentially very helpful in supporting clinical decisions, health policy and resource allocation. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system is a structured and transparent approach to developing and presenting summaries of evidence, grading its quality, and then transparently interpreting the available evidence to make recommendations in health care. GRADE has been adopted widely. However, its use in creating guidelines for rare diseases – which are often plagued by a paucity of high quality evidence – has not yet been explored. RARE-Bestpractices is a project to create and populate a platform for sharing best practices for management of rare diseases. A major aim of this project is to ensure that European Union countries have the capacity to produce high quality clinical practice guidelines for rare diseases. On February 12, 2013 at the Istituto Superiore di Sanità, in Rome, Italy, the RARE-Bestpractices group held the first of a series of 2 workshops to discuss methodology for creating clinical practice guidelines, and explore issues specific to rare diseases. This paper summarizes key results of the first workshop, and explores how the current GRADE approach might (or might not) work for rare diseases. Avenues for future research are also identified.
The Italian's experience of the guidelines development group is discussed through the evaluation of its ten years of activity. Focus is placed on the Italian guidelines working group organization and ...on the kind of documents developed. The horizontal architecture of the system and the several partnerships settled over time allowed the definition of a small coordinating group connected with a multitude of territorial stakeholders, such as scientific societies and local health units pertaining to the Italian National Health System. Different kinds of documents were produced, as adaptations of already existing guidelines elaborated by international institutions, short reviews addressing specific clinical issues and consensus conferences aimed at providing clinical governance on issues which lack on evidence. The steps needed to produce a high quality guideline are presented, considering and comparing all the different international experiences, to define and discuss a common and well-structured methodology, and to face the ethical and epistemological implications of each method. The multidisciplinary of the working groups, the importance of the active surveillance on conflicts of interests, the definition of a minimum set of rules to be followed during the whole activity and the transparency of all the steps are the milestones of the Italian experience. The lack of a continuous and stable source of funding and the subsequent instability of the central structure are endangering all the knowledge and the experience gained during these years of activity. It is therefore crucial to guarantee and safeguard the role of a national, independent and public institution in the supervision of the guidelines development process and the provision of clinical governance.
to assess the feasibility in clinical practice of the recommendations included in the guideline <<The management of influenza-like syndrome>>.
a prevalence study on clinical behaviour concerning drug ...prescription and hospitalization. Behaviours will be reassessed after a short follow-up (5 days).
general practitioners and paediatricians have been enrolled, who will refer about the clinical behaviours adopted toward a series of consecutively enrolled patients with influenza-like syndrome.
compliance to the recommendations has been assessed, through the proportion of patients prescribed antibiotics, and anti-inflammatory/antipyretic and antiviral drugs. The use of diagnostic tests and the number of hospitalizations have been also assessed.
clinicians, according to the recommendations included in the guideline, rarely use antiviral drugs and quick diagnostic tests, and mainly prescribe paracetamol for the treatment of pain and fever. On the other hand, they still prescribe antibiotics to more than 30% of patients on the basis of reasons not discussed in the guideline, and sometimes sustainable, even if they are not recommended. The lack of effectiveness of the recommendation concerning the use of antibiotics in guiding clinicians' behaviour, emerges particularly in two specific scenarios: the presence of comorbidities in elderly patients and the persistency of fever in children.
the use of antibiotics in course of influenza-like syndrome is not necessarily inappropriate, and should be further investigated. Some specific characteristics shown by patients are relevant for frequency and severity, and could be interpreted as effect modifiers. Therefore recommendations should take into consideration such subgroups.
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