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      Assessing methodological quality of Russian clinical practice guidelines and introducing AGREE II instrument in Russia

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          Abstract

          Background

          There are multiple organisations in Russia that publish clinical practice guidelines (CPGs). The demand for CPGs and appreciation of their role in healthcare provision has been steadily growing. However, quality and methodology of development of CPGs have not been systematically addressed.

          Aim

          To analyse the quality of Russian-produced CPGs for surgical treatment of hepatic-pancreatic-biliary diseases.

          Methods

          We searched Russian databases for CPGs, published between 2013 and 2017. We identified 6 relevant documents that met our inclusion criteria. We approached four experts in the field with written and verbal instructions on the use of the AGREE II questionnaire.

          Results

          All six CPGs received the highest domain scores for the domain Clarity of Presentation (46%–80%). The lowest domain scores were for the domain Editorial Independence (6%-25%). Overall, the experts put the highest total sum scores to the CPG for treating chronic pancreatitis (70%), while the lowest total sum score was attributed to the CPG for treating acute cholangitis (22%).

          Conclusions

          The overall quality of CPGs, as assessed by the four experts with the AGREE II instrument, was low. The highest scoring, best organized and most comprehensive and straightforward CPG was the one for chronic pancreatitis. The AGREE II instrument should be considered for use in Russia by guideline developers to assess existing CPGs and inform the creation of new guidelines.

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          Most cited references 11

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          AGREE II: advancing guideline development, reporting and evaluation in health care.

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            Evidence-based medicine.

             David Sackett (1997)
            Evidence-based medicine, whose philosophical origins extend back to mid-19th century Paris and earlier, is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that we individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centered clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatment and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer. Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by external evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best external evidence, practice risks becoming rapidly out of date, to the detriment of patients. The practice of evidence-based medicine is a process of life-long, self-directed learning in which caring for our own patients creates the need for clinically important information about diagnosis, prognosis, therapy, and other clinical and health care issues, and in which we (1) convert these information needs into answerable questions; (2) track down, with maximum efficiency, the best evidence with which to answer them (whether from the clinical examination, the diagnostic laboratory from research evidence, or other sources); (3) critically appraise that evidence for its validity (closeness to the truth) and usefulness (clinical applicability); (4) integrate this appraisal with our clinical expertise and apply it in practice; and (5) evaluate our performance.
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              Diagnosis and management of acute cholangitis.

              Acute cholangitis is a potentially life-threatening systemic disease resulting from a combination of infection and obstruction of the biliary tree, secondary to different underlying etiologies. Common causes of cholangitis (eg, gallstones, benign and malignant biliary strictures) are well known. However, others (eg, immunoglobulin-G subclass-4-related sclerosing cholangitis) have been described only recently, are still under evaluation, and need to gain broader attention from clinicians. The diagnosis of acute cholangitis is based on clinical presentation and laboratory data indicating systemic infection, as well as diagnostic imaging modalities revealing signs of biliary obstruction and possibly an underlying etiology. The clinical presentation varies, and initial risk stratification is important to guide further management. Early medical therapy, including fluid resuscitation and appropriate antibiotic coverage, is of major importance in all cases, followed by a biliary drainage procedure and, if possible, definitive therapy of the underlying etiology. The type and timing of biliary drainage should be based on the severity of the clinical presentation, and the availability and feasibility of drainage techniques, such as endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC), and open surgical drainage. ERCP plays a central role in the management of biliary obstruction in patients with acute cholangitis. Endoscopic ultrasound-guided biliary drainage recently emerged as a possible alternative to PTC for second-line therapy if ERCP fails or is not possible.
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                Author and article information

                Contributors
                Role: Data curationRole: Formal analysisRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                11 September 2018
                2018
                : 13
                : 9
                Affiliations
                [1 ] School of Life Sciences, Arizona State University, Tempe, Arizona, United States of America
                [2 ] Department of the Organization of Providing Medicines and Medical Devices of the Ministry of Health of the Kaliningrad Region, Kaliningrad, Russian Federation
                [3 ] Cochrane Russia, Research and Education Centre for Evidence-Based Medicine, Cochrane, Russia, and Department of Basic and Clinical Pharmacology, Kazan Federal University, Kazan, Tatarstan, Russian Federation
                University of Utah Hospital, UNITED STATES
                Author notes

                Competing Interests: The authors have read the journal's policy and the authors of this manuscript have the following competing interests: Liliya E. Ziganshina is the Director of Cochrane Russia.LEZ has received remuneration from Cochrane for Russian translation work, and numerous travel and accommodation support for Cochrane events. LEZ is a member of the WHO Expert Advisory Panel on Drug Evaluation and a member of the WHO European Advisory Committee on Health Research. LEZ received travel and accommodation support from the WHO on multiple occasions. LEZ is an editorial board member of the International Journal of Risk & Safety in Medicine and has reviewed manuscripts for PLOS ONE. Dina A. Lienhard (formerly Ziganshina) is a graduate of Barrett, The Honors College at Arizona State University (ASU). She graduated with her Bachelor of Science degree in May 2018 and started a PhD program in Biology and Society in June 2018. Dina is a recipient of 2018 Moeur Award of the ASU Alumni Association for perfect record and other academic achievements. Dina is the daughter of Liliya Ziganshina. Lidiya V. Kisser is a practicing medical doctor, a clinical pharmacologist at the Municipal clinical hospital for emergency care of Kaliningrad belonging to the Ministry of Health of Kaliningrad oblast. She has been working for the Ministry of Health of Kaliningrad oblast with development of medicine reimbursement lists and guidelines and has been promoted during the editorial process to the position of Lead consultant at the Department of medicines and medical devices provision at the Ministry of Health of Kaliningrad oblast. Lidiya is a PhD student at the Department of Basic and Clinical Pharmacology at the Kazan Federal University. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

                Article
                PONE-D-18-11396
                10.1371/journal.pone.0203328
                6133363
                30204760
                © 2018 Lienhard et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 2, Tables: 2, Pages: 17
                Product
                Funding
                Funded by: Russian Government Program of Competitive Growth of Kazan Federal University (https://kpfu.ru/eng/strategy-5-top-100/roadmap-in-details)
                Award Recipient :
                The authors received no specific funding for this work. Liliya E. Ziganshina received partial salary from the Russian Government Program of Competitive Growth of Kazan Federal University ( https://kpfu.ru/eng/strategy-5-top- 100/roadmap-in-details) for development of Cochrane Russia. Another part of Liliya E. Ziganshina’s salary came from the Kazan Federal University government budget for teaching pharmacology. The Kazan Federal University receives federal government budgeting through the Ministry of Education and Science of the Russian Federation ( https://kpfu.ru/sveden; https://xn--80abucjiibhv9a.xn--p1ai/) based on the number of students taught. Dina Lienhard (Ziganshina) received an hourly wage from the Arizona State University for working as an Instructional Aide. She taught BIO181/182 (General Biology) and CHM237/238 (General Organic Chemistry) labs at the ASU Downtown Campus between Fall 2015 and Spring 2018. She also received a travel grant from Susan and Marc Mulzet National Travel Award Program to attend the American Association for the Advancement of Science (AAAS) meeting in Austin, TX in February of 2018, as well as AAAS Section L funding. There she presented her Honors Thesis research on the history of mammography guidelines in the United States. ( https://www.cbs.asu.edu/news/biology-and-society-graduate-begins-her-phd-journey). Lidiya V. Kisser received her salary from the Ministry of Health of Kaliningrad oblast ( https://www.infomed39.ru/; https://www.infomed39.ru/ministry/structures/) and PhD student stipend from the Kazan Federal University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. There was no additional external funding received for this study.
                Categories
                Research Article
                Medicine and Health Sciences
                Health Care
                Health Care Policy
                Treatment Guidelines
                Medicine and Health Sciences
                Gastroenterology and Hepatology
                Pancreatitis
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Medical Doctors
                Surgeons
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Medical Doctors
                Surgeons
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Medical Doctors
                Physicians
                Surgeons
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Medical Doctors
                Physicians
                Surgeons
                Medicine and Health Sciences
                Gastroenterology and Hepatology
                Biliary Disorders
                Cholecystitis and Biliary Colic
                Research and Analysis Methods
                Database and Informatics Methods
                Database Searching
                Medicine and Health Sciences
                Critical Care and Emergency Medicine
                People and Places
                Geographical Locations
                Asia
                Russia
                People and Places
                Geographical Locations
                Europe
                Russia
                Medicine and Health Sciences
                Gastroenterology and Hepatology
                Biliary Disorders
                Cholelithiasis
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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