Best practice guidelines in the context of rare disease ERNs. Domenica Taruscio National Centre for Rare Diseases Istituto Superiore di Sanità, Italy
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1 Best practice guidelines in the context of rare disease ERNs. Domenica Taruscio National Centre for Rare Diseases Istituto Superiore di Sanità, Italy
2 Definition: Health care guideline (RARE-Bestpractices Glossary) Health care guidelines are systematically developed statements by a systematic review of evidence and an assessment of the benefits and harms of alternative care options, which assist providers, patients and stakeholders to make informed decisions about appropriate health care for specific circumstances, including clinical interventions, public health activities, or government policies. Health care guidelines provide recommendations that describe in detail what the recommended action is and under what circumstances it should be performed.
3 Content of this presentation Health care guidelines and health care guidelines on rare disease in Europe: present scenario Health care guidelines and the EC directive on patients rights in cross-border healthcare and decisions Linking EU directive and decisions with RARE- Bestpractices goals and outputs
4 Health policies of individual European member are becoming more interconnected and interdependent 1) for the movement of patients and health professionals across national borders 2) for the creation of European Reference Networks Important consequences on the quality and safety of health services
5 Health care guidelines and health care guidelines and on rare disease in Europe: present scenario A mapping exercise illustrates the divergent status of guideline production in the EU (Legido, 2013) A more recent Rare-Bestpractices mapping exercise illustrate the considerable diversity in the extent to which EU MS have established systems to develop guideline on rare diseases Clinical guidelines for chronic conditions in the European Union Eds Legido-Quigley H. et al. The European Observatory on Health Systems and Policies-Observatory Series 30
6 Health care guidelines and health care guidelines on rare disease in Europe: present scenario Within EU all countries are showing some interest in developing and implementing health care guidelines However there is great variability among countries. Most have fragmentary initiatives led by enthusiasts Few countries have well-developed systems in place to develop health care guidelines Clinical guidelines for chronic conditions in the European Union Eds Legido-Quigley H. et al. The European Observatory on Health Systems and Policies-Observatory Series 30
7 Health care guidelines and health care guidelines and on rare disease in Europe: present scenario Which is the level of engagement in guideline production in EU? Countries with well established activities (for example long-standing programme, tradition) e.g. Belgium, England, France, Germany, Netherland, Finland, Norway, Sweden, Italy Denmark, Spain, Czech Republic Countries making progress in the development of health care guideline e.g. Luxembourg, Latvia, Hungary, Malta, Ireland Countries recently adopting some guidelines or where this are in the planning stages e.g Slovenia, Greece Clinical guidelines for chronic conditions in the European Union Eds Legido-Quigley H. et al. The European Observatory on Health Systems and Policies-Observatory Series 30
8 Health care guidelines and health care guidelines and on rare disease in Europe: present scenario Who is responsible for guidelines production in EU? Guideline produced by a central agency England, Finland and Luxemburg Multiple actors involved and there is a central component in place Austria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Malta, Norway, Romania, Spain and Sweden Multiple actors produce guidance without central coordination Belgium, Bulgaria, Greece, Ireland, Netherlands, Poland, Portugal, Slovakia, Slovenia and Switzerland Clinical guidelines for chronic conditions in the European Union Eds Legido-Quigley H. et al. The European Observatory on Health Systems and Policies-Observatory Series 30
9 Health care guidelines and health care guidelines and on rare disease in Europe: present scenario Is there any regulatory basis for the development of guidelines? The majority of countries has not legal framework HAS has the statutory duty to develop guidelines and Nice England too. The Directorate general for health in Portugal There are any formal process to assess the quality of the guidelines? (Example AG REE II) The countries with long-standing programme have also system to assess the quality of the guideline produces (England, Finland, Norway) Clinical guidelines for chronic conditions in the European Union Eds Legido-Quigley H. et al. The European Observatory on Health Systems and Policies-Observatory Series 30
10 Health care guidelines and health care guidelines and on rare disease in Europe: present scenario The value of the legal mandate is inconclusive. Spencer and Walshe suggested that having a legal requirement for quality improvement strategies was an important driver of progres, along with the activiites of professional association showever there are example of laws that exist but are not implemented (Italy) or there are highly developed systems without any legal basis (The Netherland) A study (Burgers, 2003) analyzing 86 guidelines from 10 European countries in a quest to identify predictors of high-quality guidelines, found that guidelines produced within a guidelines programme and by governamental agency scored better than their counterpart. To ensure high quality, guidelines should be produced within a structured and coordinated program Spencer E, Walshe K. National quality improvement policies and strategies in European healthcare systems. Qual Saf Health Care Feb;18 Suppl 1:i22-7. doi: /qshc PubMed PMID: ; PubMed Central PMCID: PMC Burgers JS, Cluzeau FA, Hanna SE, Hunt C, Grol R. Characteristics of high-quality guidelines: evaluation of 86 clinical guidelines developed in ten European countries and Canada. Int J Technol Assess Health Care Winter;19(1): PubMed PMID:
11 This European novel dynamic scenario and RARE-Bestpractices Rare-Bestpractices mapping exercise illustrate the divergent status of guideline on rare diseases in EU The survey is lead by Italian Chochrane Centre in collaboration with the Istituto Superiore di Sanità as part of in the RARE-Bestpractices work
12 This European novel dynamic scenario and RARE-Bestpractices 13 EU MS have not developed national programme on rare disease health care guidelines yet 3 EU MS have already national programme on rare disease health care guidelines (one on rare tumors) 4 EU MS have plans for developing national programme on RD guidelines in the near future
13 This European novel dynamic scenario and RARE-Bestpractices Why? Scarcity/absence of evidence makes guidelines on RD useless Economic reasons Adopt/adapt guideline developed by other agencies/organizations Delegate the role of guideline development to other bodies (scientific societies, research institutes) It is not a priority for our national health programme Reference centre will be designated to do it in the framework of national plan for RD
14 Health care guidelines and health care guidelines and on rare disease in Europe: present scenario Health care guideline on rare diseases Linking with the directive on patients rights in cross-border healthcare
15 EU Directive and decisions The directive on patients rights in cross-border healthcare The directive intend to provide greater clarity on the rules governing patients travelling abroad to receive treatment. It give EU Citizens the right to obtain from abroad any care not requiring a hospital stay without advance authorization Member stay may create an authorization system to enable them to manage patient flow and avoid threat to the financial and operational sustainability of their own system In both cases patients will be entitled to be reimbursed up to what would have been paid for if the care was provided at home l Legido-Quigley H, Passarani I, Knai C, Busse R, Palm W, Wismar M, McKee M. Cross-border healthcare in the European Union: clarifying patients' rights. BMJ Jan 17;342:d296. doi: /bmj.d296. PubMed PMID:
16 EU Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients rights in cross-border healthcare Article 12 European reference networks The Commission shall support Member States in the development of European reference networks between healthcare providers and centres of expertise in the Member States, in particular in the area of rare diseases These criteria and conditions shall ensure, inter alia, that European reference networks: (i) have knowledge and expertise to diagnose, follow-up and manage patients with evidence of good outcomes, as far as applicable; (ii) follow a multi-disciplinary approach; (iii) offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control; (iv) make a contribution to research;
17 EU Commission Decision C(2014)1408 final Setting out criteria and conditions that European Reference Networks and healthcare providers whishing to join a European Reference Network must fulfil: 4) To fulfil the requirement set out in point (iii) of Article 12(4)(a) of directive 2011/24/EU) offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control; the Network must:) Develop and implement clinical guideline and cross-border patient pathways 5) To fulfil the requirement set out in point (iv) of Article 12(4)(a) of directive 2011/24/EU) make a contribution to research the Network must: a) Identify and fill the research gap 7) To comply with the requirement set out in point (v) of Article 12(4)(a) of directive 2011/24/EU ( organize and teaching training activities ): (a) identify and fill training gaps
18 EU Commission Decision C(2014)1408 final To be ERN member Develop and use clinical guidelines and patways in their area of expertise (1) (1) From Criteria and condition for applicants for membership of a network ((e)(iv) Annex II) Identify and fill Training gap Identify and fill the research gap Develop and implement clinical guideline and crossborder patient pathways The network must
19 EU Commission Decision C(2014)1408 final Directive, Decision Guideline on rare diseases in EU MS. linking with RARE-Bestpractices.
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21 Platform for sharing best practices for the management of rare diseases Project funded EU funded (7FP) Coordination: National Centre for Rare Diseases-Istituto Superiore di Sanità, Rome Duration: The mandate of the RARE-Bestpractices is knowledge management to support evidence-informed decision-making of the rare disease community & also to support ERNs We do this by creating a platform with resources and tools to facilitate access and interpretation of the rare diseases synthesis of evidence
22 The RARE-Bestpractices Platform The RARE-Bestpractices Platform Knowledge Management Platform Knowledge Management Platform ( ( IT IT PLATFORM PLATFORM RAREGUIDELINES RAREGAP TRAINING TRAINING (Courses and Courses Tools) & Tools
23 For the benefits of guideline developers and of guideline users Database of health care guidelines Database of uncertainties / research recommendations Standard and tools for guideline development on rare diseases (test GRADE in rare disease context, standard of reporting, tool for CoI management, for International collaboration, for management, for patient involvment etc..) A plan of RARE-Bestpractices training courses
24 For the benefit of rare disease guideline developers Increase trasparency Facilate sharing of information (evidence table, literature search) Facilitate adaptation of guidelines Facilitate co-production of guidelines (by multiple guideline developers, agencies, patient advocacy groups..erns?)
25 For the benefit of rare disease guideline users Systematically created health care guidelines are extremely useful, invaluable for clinicians and policymakers Clinicians: Health care guideline allow clinicians to make appropriate clinical decisions (diagnosis, treatment), and communicate these decisions transparently to patients and families. Policymakers Rigorous guidelines also allow policymakers to determine whether a given treatment provides value to stakeholders, so resources can be allocated appropriately. Resource allocation is particularly important when treatment options are very costly, which is often the case in rare diseases.
26 RAREGUIDELINE Contains only guidelines appraised for quality using a validated tool AGREE II thereby allowing those using the database to identify which guidelines are of high quality. Inclusion criteria: Guidelines are identified through a structured process of searching known sources of guidelines including existing organizations (e.g. Guidelines International Network) and databases (National Guideline Clearinghouse, Orphanet).
27 RAREGUIDELINE RAREGUIDELINE as a resource Guideline users Retrieve information to help ensure best possible care Inform decision making Select the best quality guidelines for their context Provide feedback/input to guidelines Guideline developers Identify existing guidelines and their quality & identify gaps Collaborate e.g. invite/collate comment on draft guidelines Disseminate their new guidelines Avoid duplication of effort in producing guideline Information specialists Responsible for developing search strategies Use as search resource Generate bibliographies
28 RAREGAP Bestpractices project is the research recommendation database of the RARE- The role of research recommendations is to highlight uncertainty in existing knowledge and translating this uncertainty into proposals for future research Research recommendations are identified from existing high quality systematic reviews. Low methodological rigor may result in the identification of false uncertainties where further research is not required. RAREGAP contains details of research recommendations identified in Cochrane reviews of rare diseases
29 Training courses and tools based on the RARE-Bestpractices work to promote the development of trustworthy health care guidelines for rare diseases and their use across Europe and to support the establishment of European Reference Networks 2 Courses for guideline developers Development of treatment guidelines February 2016 Milan Istituto Superiore di Sanità Rome (Italy) Istituto Superiore di Sanità Rome (Italy) Development of diagnostic guidelines September 2016 Milan Cochrane Italy
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32 Challenges, facilitators and opportunities for the production and use of guidelines in rare diseases Challenges Facilitators Opportunities Guideline production and implementation is far from satisfactory in the EU Directive 2011/24/EU supports ERNs, which must have the capacity to produce good practices guidelines MS are at a decisive point in establishing the criteria to ensure the transparent and effective functioning of ERNs Few Countries have wellestablished systems in place sustained by regulations that provide mechanisms for quality assurance, implementation and use of clinical guidelines Many countries still rely on sporadic initiatives, others lack the capacity for evidence-based guideline development Public funds available for methodological research in guidelines i. GRADE working group EUfunded DECIDE project ii.rare-bestpractices EU - funded project iii. COMET initiative MS should consider the importance and devote resources to build efficient systems and capacities for the production of trustworthy guidelines, according to international standards Ms could adopt a cooperative approach to optimize guideline production and implementation across countries Legido-Quigley et al IV. DECIDE Morciano et al. 2015; Menaka et al. for the RARE-BestPractices Consortium, 2015
33 Challenges, facilitators and opportunities to the production and use of guidelines in rare diseases Opportunities ERNs can be a concrete opportunity for initiating processes of cooperation among MS in producing trustworthy guidelines, according to international standards Potential results of this cooperation - shared health care guidelines - identifying research gaps - formulate, prioritize and comunicate research recommendations to researchers and research funders
34 The relationship between clinical care, research and guidelines Menaka Pai et al. for the RARE-BestPractices Consortium, 2015
35 Standards for Developing Trustworthy Clinical Practice Guidelines 1. Establishing transparency 2. Management of conflict of interest; independency 3. Group composition: multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and key affected groups. Patient preferences 4. Systematic review of the existing evidence 5. Provide ratings of both the quality of evidence and the strength of the recommendations 6 Recommendations should be articulated in a standardized form 7. External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public. 8. Updating (IOM 2011)
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37 Specific challenges for guideline production in rare diseases: the PICO question P - Population: defining the population of interest is a major challenge (small numbers of patients, diagnostic uncertainty, etc.) I- C - Intervention and comparator : there is often only one treatment for any given RD. In many cases, use of placebo is not an option due to the severe course on the untreated disease. Outcomes: a key step in creating evidence-based guidelines is determing critical disease outcomes, factors important for patients, providers and health care systems. There are several challenges in defining relevant outcomes in RD (case reports, surrogate outcomes, patient reported outcomes). The most reliable outcomes only be those related to morbidity and mortality Menaka Pai et al. for the RARE-BestPractices Consortium, 2015
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39 Conclusions (1/2) The Directive 2011/24/EU is intended to provide a legal framework within the European Union to facilitate cross-border care Art 12 (Directive 2011/24/EU) supports ERNs, which must have the capacity to produce good practices guidelines Good quality guidelines, produced according to international standards, do improve health care MS have a great opportunity, through the establisment of ERNs, to foster a cooperative and coordinate approach to share exiting expertise and resources for the production and implementation of care guidelines across countries
40 Conclusions (2/2) ERNs are paramount to foster a cooperative and coordinate approach among MS to : - optimize guideline production and ameliorate quality assurance practices - identify and fill knowledge gaps - formulate, prioritize and comunicate recommendations to researchers and research funders ERNs can be an opportunity to devise a new research governance Thank you!
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