G-I-N 2016 conference report Olena Lishchyshyna was one of the 2016 LMIC conference participation support grant recipients. Below is an account of her experience at G-I-N 2016 and what she gained from attending the conference. Providing efficient and effective health care is a global challenge. G-I-N makes important contributions to the development of high-quality CPGs and related clinical performance measures, with a focus that extends beyond traditional domains to incorporate patient-centered outcomes relevant to population health. Participation in the 13th G-I-N Conference was especially valuable for me: 1. Opportunity for communication with like-minded people and supporters of evidence-based medicine. 2. Demonstration and discussion our achievements and barriers in this field with colleagues from other countries. 3. Ability to obtain the experience of colleagues in overcoming of similar problems. 4. Getting of useful information about new groups, areas and organisation collaborating with G-I-N. 5. Working with clinicians who are involved in the adaptation of clinical guidelines and their implementation. Means of persuasion of clinicians to use the principles of evidence-based medicine in practice. 6. Use of information technology for formalising the processes of implementation of evidence-based medicine. We look forward to output guidance in support of evidence-based medicine at all levels of decisionmaking and development of healthcare system for LMIC. I would like to note DynaMed as an information resource of current clinical information. It provides recent, objective, evidence-based information to enable physicians to make decisions at point of care making it highly useful. The knowledge and relationships that I have developed with G-I-N are unparalleled. The history of the development of CPG DEVELOPMENT CLINICAL GUIDELINES IN UKRAINE The first clinical protocols were based on the authoritative expert opinion. They were like a list of medical interventions. In 2004-2008 Ukraine participated in two projects of TACIS Program which gave understanding about evidence-based medicine and clinical practice guidelines. In 2009 Ukraine became member of G-I-N. Knowledge about evidence-based medicine was gradually transformed into legal form. In 2009, the Ministry of Health of Ukraine prepared the recommendations for the development of medical standards based on medical technologies with proven efficacy. Since 2012 we have strong directions: national standard (or unified clinical protocol) of medical care. - Unified clinical protocol of care a document that is developed on the basis of clinical guidelines and capacities of health care system; defines the process of medical care delivery, scope and its outcomes in certain disease and is approved by Ministry of Health of Ukraine. - National standard of care that is developed in small quantities according to the priorities of health care system for the most urgent health problems. Standards of medical care are the
2 foundation of healthcare system accreditation and administrative control because they contain criteria of quality and Health Care Quality Indicators. How do we do it in practice? Firstly, Methodology for the development and implementation of medical standards on the principles of evidence-based medicine is approved by the Order of the Ministry of Health in accordance with the European approaches. Implementation strategy of CPG in Ukraine Main stages Implementation in Ukraine Selection of topic Approved criteria (disease and mortality, national programs and activities of Ministry of Health and others) Development of clinical guidelines Adaptation, assessment using AGREE II, multidisciplinary approach, public discussion Dissemination of guidelines Registry of medical and technological documents and G-I-N Implementation of the guideline Medical standards with quality indicators development of local protocols Impact assessment Monitoring of health care quality indicators Update of clinical guidelines Update of medical and technological documents Nowadays, Ukraine is a country with limited resources. And the most optimal way of creation of clinical guidelines is adaptation using an experience of ADAPTE project. Step one: The Ministry of Health of Ukraine approves the composition of the working group. Working group include: - main specialists, - leading scientists, - GP`s, - patients, - nurses, - public organisations.
3 Inclusion of different specialties and administrative units to the group provides participation of experts at all stages of care, identification and critical evaluation of all the evidence on the topic, identification and consideration the problems of practical application of clinical guidelines, taking into account various opinions, recognition of clinical guideline as a reliable and cooperation in its use as the basis of standard and unified clinical protocol of medical care. There is an institute of main specialists in Ukraine. Its main tasks is organisation of the planning and implementation of activities for the development CPG and national standard (or unified clinical protocol) of medical care. Currently about 250 working groups are working on specific clinical problems. Meetings of the working groups held in accordance with the certain schedule.
Schedule of training workshop for working group of the MoH 4 Set up a working group 1 st week Search of information sources, evaluation of CPG using AGREE, choice of prototypes for adaptation 2 nd -3 rd weeks Training for working group 4 th week Adaptation of CPG, development of national standard (or unified clinical protocol) of medical care 5 th -19 th weeks External review 20 th -22 nd weeks Public discussion 23 rd -27 th weeks Analysis of proposals and comments Processing and final approval 23-27 th weeks Expertise 32 nd -33 rd weeks Submission of documents for approval to the Ministry of Health of Ukraine 34 th week
5 For effective work the group has a training workshop. Training for the working group of the Ministry of Health of Ukraine, which adapt clinical guidelines and develop national standards, consists of the following topics: a) introduction to evidence-based medicine: the relationship of evidence and clinical practice, b) formulation of clinical issues and construction of search strategies; c) skills of critical reading, d) skills of information search in electronic databases, e) systematic reviews and interpretation of their results, f) evaluation by AGREE II, g) methodology of clinical guidelines adaptation, the development of the standard of care, creation of unified clinical protocol and local protocol of medical care, h) pilot implementation of medical and technical documents. Besides, developers are involved in the implementation of a unified clinical protocol by creating a local protocol in health care settings. Training of local protocol developers conducted by following areas: a) quality management in healthcare system, b) general principles for design and implementation of local protocols, c) organisation and methods of expert work during the development of local protocols, d) main principles of evidence-based medicine, clinical and economic analysis, e) the role of local protocols in the management of healthcare quality, f) some issues of economic assessment etc. Step two: While searching guidelines the working group uses G-I-N, DynaMed and other sources. For example, many Ukrainian doctors are members of the international societies. Some of them are members of European professional medical associations and prefer these guidelines. Some prefer American clinical guidelines. Step three: Sometimes the working group finds one relevant guideline for topic; sometimes there is a need for more clinical guidelines. The choice of prototypes is based on balance between expert opinion on clinical interests and the results of evaluation of methodology clinical guidelines by AGREE II and cost of medical services. Step four: The development of clinical guidelines is a beginning and includes a few processes. Prototypes are translated preserving the content. For us all the recommendations are important, so we do not throw away. If there are several prototypes, the working group prepares a synthesis of clinical guidelines. In the absence of information on certain important issues in clinical guidelines selected as prototypes, the working group conducts an additional search. The results of search are presented as evidence tables, which provides information on each of the trial for: - source of reference (bibliographic description), - parameters of the trial (including key clinical questions, type of trial, time frame for data collection, data sources, the examined method, the number and characteristics of the studied objects), - trial objectives, - findings (including organisational, clinical, economic), - limitations of trial (criteria for inclusion / exclusion, etc.). Actually, adaptation is the analysis of the possibility of the implementation in Ukraine, considering next: - accordance with the legal framework, - licensed medicines,
- features of medical care organisation in Ukraine. 6 This is a first adaptation to the conditions and resources of Ukraine. All differences in the health system are reflected in the form of the Comments of the working group. The working group works hard, has stormy debate and finally appear draft of adapted clinical guideline and national standard (or unified clinical protocol) of medical care. At this time documents are adapted again, taking into account the available resources. Step five: Then drafts are presented on the websites for public discussion. Also reviewing of draft documents is conducted parallely. Working group adjusts the final version of the documents. Then they are approved by the Ministry of Health of Ukraine. Dissemination of clinical guidelines is conducted through placement of documents at the Registry of medical and technological documents and G-I-N websites. Registry of medical and technological documents is a specialised website that integrates national standards approved by MoH of Ukraine, unified clinical protocols of medical care, and draft documents for discussion, as well as tertiary sources of evidence-based medicine - clinical guidelines both original and adapted, which formed the basis for developed standards and protocols. Here the developers of medical and technological documents will find the regulations, which relate to medical care standardisation, manual for developers, AGREE questionnaire for the assessment of clinical guidelines quality and grounded choice of prototypes, as well as other useful methodological documents. Implementation of the guideline statements is realised through the development of local protocols in health care settings. But since hospitals are different, the local protocols also vary. Local protocols describe medical care in accordance with national standard (or unified clinical protocol) of medical care. and are adjusted to the conditions of health care settings.
7 The main barriers to the implementation strategy of CPG in Ukraine: - Many doctors are bed in evidence-based in Ukraine. - Gaps in communication between the Ministry of Health and the regional health departments, because it is developing a policy, but does not affect to funding of the healthcare system. - No liability for non-compliance with standards and generally for providing low-quality care. There are formal assessment mechanisms and no informal peer review. Therefore, we have gaps in motivation to standards performance (either financial or professional). - Gaps in equipment for the implementation of modern methods of diagnosis and treatment. - Limitation of information technologies for patients registration, recording of medical care delivery data, monitoring of quality indicators. Thus we develop Ukrainian guidelines in order to provide medical care of high quality. Our results are available at the Registry of medical and technological documents (http://www.dec.gov.ua/mtd/index_e.html). Olena Lishchyshyna, PhD The State Expert Center of the Ministry of Health of Ukraine