Cristina Morciano

Graft selection in arthroscopic anterior cruciate ligament reconstruction

BackgroundAnterior 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 methodsA 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.ResultsAutograft 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).ConclusionsAutograft 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.

The Italian guidelines for early intervention in schizophrenia: development and conclusions

Aim: The effectiveness of early intervention in schizophrenia is still under discussion. The guidelines described in the present paper were aimed at contributing to the current debate by providing Italian practitioners, families, patients and health managers with evidence‐based information on early intervention. They also examined the diagnostic tools that are currently available for assessing different stages of psychotic disorders.

Policies on conflicts of interest in health care guideline development: a cross-sectional analysis

Objective To assess whether organisations that develop health care guidelines have conflict of interest (COI) policies and to review the content of the available COI policies. Methods Survey and content analysis of COI policies available in English, French, Spanish, and Italian conducted between September 2014 and June 2015. A 24-item data abstraction instrument was created on the basis of guideline development standards. Results The survey identified 29 organisations from 19 countries that met the inclusion criteria. From these organisations, 19 policies were eligible for inclusion in the content analysis. Over one-third of the policies (7/19, 37%) did not report or did not clearly report whether disclosure was a prerequisite for membership of the guideline panel. Strategies for the prevention of COI such as divestment were mentioned by only two organisations. Only 21% of policies (4/19) used criteria to determine whether an interest constitutes a COI and to assess the severity of the risk imposed. Conclusions The finding that some organisations, in contradiction of widely available standards, still do not have COI policies publicly available is concerning. Also troubling were the findings that some policies did not clearly report critical steps in obtaining, managing and communicating disclosure of relationships of interest. This in addition to the variability encountered in content and accessibility of COI policies may cause confusion and distrust among guideline users. It is in the interest of guideline users and developers to design an agreed-upon, comprehensive, clear, and accessible COI policy.

Developing methodology for the creation of clinical practice guidelines for rare diseases: A report from RARE-Bestpractices

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.

Italian guidelines for noninvasive imaging assessment of focal liver lesions: development and conclusions.

Objectives To develop guidelines for the noninvasive imaging assessment of focal liver lesions comparing different imaging modalities focused on (i) evaluating the imaging techniques in terms of (a) diagnostic accuracy; (b) role in the management of oncologic patients; (c) follow-up of benign lesions; and (ii) developing standard procedure for their use in patients with focal liver lesions that require targeted diagnostic characterization. Methods An explicit search strategy was used to conduct a systematic review of the literature in the English language from January 2000 to October 2007; the search covered PubMed, Embase, Pascal, SciSearch, and Cochrane Library databases. A panel of experts evaluated the selected studies and conveyed their view. Results The online search yielded 4960 titles and abstracts from which 176 studies were considered suitable for the final adherence-to-guidelines topic evaluation. An evidence grading system was not used as the guideline topic and the heterogeneity of the collected data did not fit with the currently used hierarchy of evidence. A panel of experts formulated several recommendations with grade and level which were expressed narratively and nonschematically. Conclusion The recommendations reported in the study are based on an extensive literature evaluation and were developed by considering the appropriateness of the choice of the imaging techniques while noninvasively detecting and characterizing focal liver lesions.

European Reference Networks and Guideline Development and Use: Challenges and Opportunities.

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.

The Italian National Centre for Rare Diseases: where research and public health translate into action

The Italian National Centre for Rare Diseases (CNMR) is the result of a strategic approach, which the National Institute of Health (ISS) has been developing for more than 10 years, to deal with the public health challenges associated with rare diseases (RDs). The CNMR was formally established within the ISS in 20081. Its mission is to promote and develop experimental research and public health actions, as well as to provide technical expertise and information on RDs and orphan drugs, for the prevention, treatment and surveillance of these diseases. It is also the national focal point for information and communication for patients suffering from one of several thousand RDs, and for their families, collaborating with the national organisations of patients suffering from RDs. The Centre employs a wide range of scientific and technical expertise from various fields (medicine, genetics, molecular biology, epidemiology, public health, psychology, sociology etc.) and holds a network of national and international collaborations, which allow the development of a sound and integrated approach to RDs. The CNMR provides expert advice to the Italian Ministry of Health (MOH), to the National Health Council, to the National Health Service (NHS), and collaborates with the Regions, which are responsible for the provision of health services in the Italian devolved health system. Expert advice on RDs is also provided at EU and at international level. Since its establishment, the Centre has developed into a lively and propulsive hub for experimental research, public health, information, communication and training on RDs in Italy, and for patient empowerment. In addition, it has contributed to networks and scientific boards at national, European and international level and has implemented a number of strategic projects on RDs. The Centre is in continuous evolution in order to follow closely the pace of science and research, the emerging needs of patients, the solicitations of policy makers, and the demands of the health system.

Managing Conflicts of Interest in Practice Guidelines Panels

ceived “a steroid injection in the parasacrococygeal region,” which makes it unclear whether SMT or the steroids were responsible for any observed effects. The statistical combination of such heterogeneous studies may be hard to justify from a clinical point of view. Furthermore, although the authors downgraded the quality of evidence from high to moderate due to inconsistency of results according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE), risk of bias was not adequately taken into account. For example, for the outcome of pain in studies comparing SMT with other therapies, 50% of studies were considered to have a high risk of bias, which seems like low-quality evidence. Figure 2 of this systematic review2 also indicates that SMT was not superior to sham therapies regarding the outcome of pain and the quality of evidence was considered moderate at best. A more appropriate conclusion may be that there was moderate-quality evidence that SMT was nonsuperior to sham and low-quality evidence that it was superior to other therapies.

P119 The Rare-Best practices Project: An Overview

Background RARE-Best Practices is a 4-year project (2013-2016) funded by the EU FP7. Objective Developing a sustainable networking platform, supporting an efficient exchange of reliable and up to date information on the management of rare diseases (RD) to improve patient health outcomes. Methods RARE-Best Practices will reach its goals by promoting collaboration among partners with a strong track record in RD research as well as in clinical practice guidelines (CPG) and systematic review development from academic institutions, governmental bodies, patients organisations and networks. Results Project expected outputs: 1) identification of challenges to be considered in deriving high quality standards for CPG on RD; 2) creation of transparent procedures and criteria for the evaluation and the collection of CPG on RD in a publicly searchable database; 3) identification of the available notations for graphic representation of processes within CPG to improve user understandability and implementation; 4) production of mechanisms to identify and prioritise RD clinical research needs to optimise the research agenda on RD; 5) development of training activities targeted to key stakeholders to disseminate process and tools for developing and evaluating CPG. Discussion/Implication for Guidelines Developers Users RARE-Best Practices will address the patients and health care providers demand for updated and high quality CPG on RD. It intends also to respond to the Directive 2011/24/EU which encourages EU MS to the development of European Reference Networks in the area of RD which, among other criteria and conditions, ‘should have the capacity to produce good practice guidelines’.