Rounds Of Voting Research Articles

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Ultrahigh-Definition Production Codecs - The Agony of Choice

<italic xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">Video production equipment uses different codecs and settings to balance competing requirements, such as trading off between bitrate and quality. The introduction of ultrahigh-definition television (UHDTV) and high dynamic range (HDR) adds to the number of codec implementations, making codec choices harder. To help their members evaluate the visual quality of new video production codecs, the European Broadcasting Union (EBU) and the Institut für Rundfunktechnik (IRT) have organized expert viewings of the latest production codecs. Based on the plans revealed at International Broadcasting Convention (IBC) 2019, more than 200 possible codec configurations were identified. After a voting round by broadcasters, more than 40 of these configurations were selected for actual testing. The focus was on real-world products, not laboratory prototypes. Seven generations were encoded for each configuration. The peak signal-to-noise ratio (PSNR) of all sequences was calculated. Subsequently, the first, fourth, and seventh generation of each sequence was scored by expert viewers. The results indicate, that overall, the tested codec configurations perform well up to the seventh generation. For some of the algorithms, a small quality degradation was seen in noise behavior and spatial resolution but no difference in dynamic range was noticeable. There is a small discernible difference in the performance for the different transfer functions</i> .

P132 Redefining refractory disease in RA and adult polyarticular JIA: a Delphi consensus study

Abstract Background/Aims Patients who do not achieve sustained low disease activity despite drug treatments are referred to as having refractory disease. However, usage of this term varies and often does not account for any discrepancy between inflammation and persistent symptoms, adult or juvenile onset nor differences between patients’ and healthcare professionals’ perspectives. The study aimed to explore and achieve consensus on a definition of refractory disease across healthcare professionals and patients, through a mixed-methods Delphi approach. Methods Three rounds of voting (one face-to-face nominal group (n = 13), and two online rounds (ns = 40 and 53)) were conducted, in conjunction with the National Rheumatoid Arthritis Society. Participants voted on the inclusion and relevance of statements to generate a broader definition of refractory disease, derived from previous qualitative interviews with multi-disciplinary healthcare professionals and patients (adult and juvenile onset), a systematic review of current definitions and health psychology theory. The process involved voting on: a) name preferences, b) treatment and inflammation statements, c) domains for inclusion regarding symptoms and impact, and d) rating of individual components within each domain, including relevance to: i) Refractory Arthritis and ii) Disease Flare for discriminatory validity. A predetermined cut off was applied to identify which domains needed to be included, until final consensus was reached. Full NHS ethical approval was granted (London-Hampstead-18/LO/1171). Results With minimal attrition (n = 3 in both online rounds), 106 international participants including Patient Representatives, Rheumatologists, Nurses, GPs, Psychologists, Physiotherapists, Researchers, Pharmacist, Podiatrist, Occupational Therapist and a Social Worker participated. Refractory Inflammatory Arthritis was the most popular name, (25% of votes) followed by Persistent Inflammatory Arthritis (19% of votes) hence its application in the presence (Persistent Inflammation) or absence (Persistent Symptoms) of inflammation as part of the definition. Regarding treatment and inflammation, these were voted in the majority to be kept broad rather than specifying rigid cut-offs. From the original 73 components across 10 domains identified to capture symptoms and impact, initial analysis has resulted in six domains reaching consensus for inclusion. These domains cover: 1) Disease Activity, 2) Joint Involvement, 3) Pain, 4) Fatigue, 5) Functioning and Quality of Life, and 6) cs/b/tsDMARD Experiences. Within these, 18 components were identified as related and important e.g. One or two persistently active/affected joints, Reduced mobility, Disease-related Distress, Inability to perform desired activities, Repeated need of short course steroids and Disease Activity not captured by DAS28. These capture the multi-faceted presentation and experience of Refractory Inflammatory Arthritis in these two populations. Conclusion A broader definition for refractory inflammatory arthritis has been generated through a Delphi method to capture the experiences of rheumatologists, patients and multi-disciplinary healthcare professionals. This definition needs further refinement and validation to assess clinical and research utility to identify high risk patients with unmet needs. Disclosure H. Chaplin: None. A. Bosworth: None. J. Meehan: None. R. Moss-Morris: None. H. Lempp: None. S. Norton: None.

Guidelines on the diagnosis, clinical assessments, treatment and management for CLN2 disease patients

BackgroundCLN2 disease (Neuronal Ceroid Lipofuscinosis Type 2) is an ultra-rare, neurodegenerative lysosomal storage disease, caused by an enzyme deficiency of tripeptidyl peptidase 1 (TPP1). Lack of disease awareness and the non-specificity of presenting symptoms often leads to delayed diagnosis. These guidelines provide robust evidence-based, expert-agreed recommendations on the risks/benefits of disease-modifying treatments and the medical interventions used to manage this condition.MethodsAn expert mapping tool process was developed ranking multidisciplinary professionals, with knowledge of CLN2 disease, diagnostic or management experience of CLN2 disease, or family support professionals. Individuals were sequentially approached to identify two chairs, ensuring that the process was transparent and unbiased. A systematic literature review of published evidence using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance was independently and simultaneously conducted to develop key statements based upon the strength of the publications. Clinical care statements formed the basis of an international modified Delphi consensus determination process using the virtual meeting (Within3) online platform which requested experts to agree or disagree with any changes. Statements reaching the consensus mark became the guiding statements within this manuscript, which were subsequently assessed against the Appraisal of Guidelines for Research and Evaluation (AGREEII) criteria.ResultsTwenty-one international experts from 7 different specialities, including a patient advocate, were identified. Fifty-three guideline statements were developed covering 13 domains: General Description and Statements, Diagnostics, Clinical Recommendations and Management, Assessments, Interventions and Treatment, Additional Care Considerations, Social Care Considerations, Pain Management, Epilepsy / Seizures, Nutritional Care Interventions, Respiratory Health, Sleep and Rest, and End of Life Care. Consensus was reached after a single round of voting, with one exception which was revised, and agreed by 100% of the SC and achieved 80% consensus in the second voting round. The overall AGREE II assessment score obtained for the development of the guidelines was 5.7 (where 1 represents the lowest quality, and 7 represents the highest quality).ConclusionThis program provides robust evidence- and consensus-driven guidelines that can be used by all healthcare professionals involved in the management of patients with CLN2 disease and other neurodegenerative disorders. This addresses the clinical need to complement other information available.

A demonstration of using formal consensus methods within guideline development; a case study

BackgroundRecommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are potential biases in group decision making, and formal consensus methods may help reduce these.MethodsWe conducted a case study using formal consensus, to develop one set of recommendations within the Neonatal Parenteral Nutrition guideline being produced for the National Institute for Health and Care Excellence. Statements were generated through identification of published guidelines on several topics relating to neonatal parenteral nutrition. Ten high quality guidelines were included, and 28 statements were generated; these statements were rated by the committee via two rounds of voting. The statements which resulted in agreement were then used to develop the recommendations.ResultsThe approach was systematic and provided transparency. Additionally, a number of lessons were learnt; including the value of selecting the appropriate topic, giving adequate time to the process, and ensuring methodologies are understood by the committee for their value and relevance.ConclusionFormal consensus is a valuable option for use within guideline development when specific criteria are met. The approach provides transparent methodology, ensuring clarity on how recommendations are developed.

Creating Standardized Tools for the Pharmacist-Led Assessment and Pharmacologic Management of Adult Canadians Wishing to Quit Smoking: A Consensus-Based Approach.

Tobacco use continues to be recognized as the single most preventable cause of death worldwide. As the gatekeepers of and experts on pharmacotherapy, pharmacists play a vital role in facilitating smoking cessation. While existing frameworks have enabled pharmacists to provide smoking cessation services in Canada for many years, the way in which they are delivered vary considerably across the nation. The purpose of this initiative was to create standardized tools for the pharmacists providing cessation services to ensure all Canadians wishing to stop smoking have equal access to consistent, evidence-based care. An iterative process using repeated rounds of voting was employed to establish consensus among key opinion leaders on the most important items to include in tools for the pharmacist-led assessment and pharmacologic management of Canadian adults wishing to stop smoking. The results were used to create eight standardized documents for national use by pharmacists: a readiness to quit assessment tool, a patient consent form, a patient assessment form for past users of tobacco and/or tobacco-like products, a patient assessment form for current users of tobacco and/or tobacco-like products, a treatment algorithm, a treatment plan summary form, a prescribing documentation form, and a follow-up & monitoring documentation form. Although not described in detail in these documents, other strategies for smoking cessation (e.g., non-pharmacologic strategies (including quitting “cold turkey” and behavioural interventions), harm reduction strategies, etc.) should be considered when pharmacotherapy is inappropriate or undesired; care should be individualized based on a patient’s previous experiences and current motivation. No single approach to treatment is endorsed by the authors. The consensus-based approach described here provides a suggested framework for harmonizing the pharmacist-led management of other ailments to optimize patient care.

Evaluation of Social Cognition Measures for Japanese Patients with Schizophrenia Using an Expert Panel and Modified Delphi Method.

Social cognition is strongly linked to social functioning outcomes, making it a promising treatment target. Because social cognition measures tend to be sensitive to linguistic and cultural differences, existing measures should be evaluated based on their relevance for Japanese populations. We aimed to establish an expert consensus on the use of social cognition measures in Japanese populations to provide grounds for clinical use and future treatment development. We assembled a panel of experts in the fields of schizophrenia, social psychology, social neuroscience, and developmental disorders. The panel engaged in a modified Delphi process to (1) affirm expert consensus on the definition of social cognition and its constituent domains, (2) determine criteria to evaluate measures, and (3) identify measures appropriate for Japanese patients with a view toward future quantitative research. Through two online voting rounds and two online video conferences, the panel agreed upon a definition and four-domain framework for social cognition consistent with recent literature. Evaluation criteria for measures included feasibility and tolerability, reliability, clinical effectiveness, validity, and international comparability. The panel finally identified nine promising measures, including one task originally developed in Japan. In conclusion, we established an expert consensus on key discussion points in social cognition and arrived at an expert-selected set of measures. We hope that this work facilitates the use of these measures in Japanese clinical scenarios. We plan to further examine these measures in a psychometric evaluation study.

Metrics of OsteoChondral Allografts (MOCA) Group Consensus Statements on the Use of Viable Osteochondral Allograft.

Background:Osteochondral allograft (OCA) transplantation has evolved into a first-line treatment for large chondral and osteochondral defects, aided by advancements in storage protocols and a growing body of clinical evidence supporting successful clinical outcomes and long-term survivorship. Despite the body of literature supporting OCAs, there still remains controversy and debate in the surgical application of OCA, especially where high-level evidence is lacking.Purpose:To develop consensus among an expert group with extensive clinical and scientific experience in OCA, addressing controversies in the treatment of chondral and osteochondral defects with OCA transplantation.Study Design:Consensus statement.Methods:A focus group of clinical experts on OCA cartilage restoration participated in a 3-round modified Delphi process to generate a list of statements and establish consensus. Questions and statements were initially developed on specific topics that lack scientific evidence and lead to debate and controversy in the clinical community. In-person discussion occurred where statements were not agreed on after 2 rounds of voting. After final voting, the percentage of agreement and level of consensus were characterized. A systematic literature review was performed, and the level of evidence and grade were established for each statement.Results:Seventeen statements spanning surgical technique, graft matching, indications, and rehabilitation reached consensus after the final round of voting. Of the 17 statements that reached consensus, 11 received unanimous (100%) agreement, and 6 received strong (80%-99%) agreement.Conclusion:The outcomes of this study led to the establishment of consensus statements that provide guidance on surgical and perioperative management of OCAs. The findings also provided insights on topics requiring more research or high-quality studies to further establish consensus and provide stronger evidence.

Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn's disease.

Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn's disease (CD). However, there is no widely accepted luminal disease activity index. To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. An expert international panel of adult and paediatric gastroenterologists (n=15) and radiologists (n=3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1-9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, >3.5 to <6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed.

Development of physical activity and food built environment quality indicators for chronic diseases in Argentina.

Although obesity and non-communicable disease (NCD) prevention efforts to-date have focused mainly on individual level factors, the social and physical environments in which people live are now widely recognized as important social determinants of health. Obesogenic environments promote higher dietary energy intakes and sedentary behaviors, thus contributing to the obesity/NCD burden. To develop quality indicators (QIs) for measuring food and physical activity (PA)-built environments in municipalities. A literature review was conducted. Based on the best practices identified from this review, a draft set of candidate QI was retrieved. The initial 67 QIs were then evaluated by a modified Delphi panel of multidisciplinary health professionals (n = 40) to determine their relevance, validity, and feasibility in 3 rounds of voting and threaded discussion using a modified RAND/University of California, Los Angeles Appropriateness Methodology. Response rate for the panel was 89.4%. All final 42 QIs were rated as highly relevant, valid, and feasible (median rating ≥ 7 on a 1-9 scale), with no significant disagreement. The final QI set addresses for the PA domain: (i) promotion of PA; and (ii) improvements in the environment to strengthen the practice of PA; and for Food environment domain: (i) promotion of healthy eating; (ii) access to healthy foods; and (iii) promotion of responsible advertising. We generated a set of indicators to evaluate the PA and food built environment, which can be adapted for use in Latin American and other low- and middle-income countries.

An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials

Histopathology is an emerging treatment target in ulcerative colitis (UC) clinical trials. Our aim was to provide guidance on standardizing biopsy collection protocols, identifying optimal evaluative indices, and defining thresholds for histologic response and remission after treatment. An international, interdisciplinary expert panel of 19 gastroenterologists and gastrointestinal pathologists was assembled. A modified RAND/University of California, Los Angeles appropriateness methodology was used to address relevant issues. A total of 138 statements were derived from a systematic review of the literature and expert opinion. Each statement was anonymously rated as appropriate, uncertain, or inappropriate using a 9-point scale. Survey results were reviewed and discussed before a second round of voting. Histologic measurements collected using a uniform biopsy strategy are important for assessing disease activity and determining therapeutic efficacy in UC clinical trials. Multiple biopsy strategies were deemed acceptable, including segmental biopsies collected according to the endoscopic appearance. Biopsies should be scored for architectural change, lamina propria chronic inflammation, basal plasmacytosis, lamina propria and epithelial neutrophils, epithelial damage, and erosions/ulcerations. The Geboes score, Robarts Histopathology Index, and Nancy Index were considered appropriate for assessing histologic activity; use of the modified Riley score and Harpaz Index were uncertain. Histologic activity at baseline should be required for enrollment, recognizing this carries operational implications. Achievement of histologic improvement or remission was considered an appropriate and realistic therapeutic target. Current histologic indices require validation for pediatric populations. These recommendations provide a framework for standardized implementation of histopathology in UC trials. Additional work is required to address operational considerations and areas of uncertainty.

CoreNASH: Multi-stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment.

The increasing prevalence and burden of nonalcoholic steatohepatitis (NASH) has spurred the development of new treatments and a need to consider outcomes used for NASH treatment decision making. Development of a NASH core outcome set (COS) can help prioritize outcomes of highest importance by incorporating the perspectives from a variety of decision makers. coreNASH was an initiative to develop a COS for NASH using a modified Delphi consensus process with a multi‐stakeholder voting panel. A candidate outcome list was created based on a literature review and key informant interviews. The candidate outcome list was then condensed and prioritized through three rounds of online voting and through discussion at an in‐person meeting. Outcomes were retained or eliminated based on predetermined consensus criteria, which included special weighting of patients’ opinions in the first two voting rounds. The coreNASH Delphi panel included 53 participants (7 patients, 10 clinicians and researchers, 7 health technology assessors, 22 industry representatives, 2 regulators, and 5 payers) who considered outcomes for two NASH‐related COS: one for NASH without cirrhosis (F2‐F3) and one for NASH with cirrhosis (F4). The initial candidate outcome list for both disease stages included 86 outcomes. The panel agreed on including two core outcomes for NASH without cirrhosis and nine core outcomes for NASH with cirrhosis in the COS. Conclusion: A consensus‐based COS has been developed that can be used across the life cycle of NASH treatments. Outcomes included can contribute to decision making for regulatory, market access, and on‐market decision making. Including the coreNASH COS in clinical development programs will facilitate improved comparisons and help decision makers assess the value of new products.

Pain Standards for Accredited Healthcare Organizations (ACDON Project): A Mixed Methods Study.

Up to 50% of cancer patients and up to 90% of those in terminal stages experience pain associated with disease progression, poor quality of life, and social impact on caregivers. This study aimed to establish standards for the accreditation of oncological pain management in healthcare organizations. A mixed methods approach was used. First, a pragmatic literature review was conducted. Second, consensus between professionals and patients was reached using the Nominal Group and Delphi technique in a step that involved anesthesiologists, oncologists, family physicians, nurses, psychologists, patient representatives, and caregivers. Third, eight hospitals participated in a pilot assessment of the level of fulfillment of each standard. A total of 37 standards were extracted. The Nominal Group produced additional standards, of which 60 were included in Questionnaire 0 that was used in the Delphi Technique. Two Delphi voting rounds were performed to reach a high level of consensus, and involved 64 and 62 participants with response rates of 90% and 87%, respectively. Finally, 39 standards for the management of cancer pain were agreed upon. In the self-evaluation, the average range of compliance was between 56.4% and 100%. The consensus standards of the ACDON Project might improve the monitoring of cancer pain management. These standards satisfied the demands of professionals and patients and could be used for the accreditation of approaches in cancer pain management.

Stakeholders find that step therapy should be evidence-based, flexible, and transparent: assessing appropriateness using a consensus approach.

BACKGROUND: Step therapy, one approach to utilization management, is used by health plans to ensure safe and clinically appropriate care while managing cost. Several patient and provider groups have each developed principles to guide the appropriate use of step therapy; however, no comprehensive multistakeholder informed set of criteria exist. OBJECTIVE: To assess multistakeholder consensus on criteria for the development and implementation of step therapy for pharmaceutical therapies. Stakeholders were asked to (a) assess the appropriateness of step therapy as a utilization management tool; (b) rate specific criteria across 5 domains (development, implementation, communication, appeals, and evaluation) of step therapy; and (c) categorize these criteria as standards or best practices. METHODS: We conducted a multiphase project culminating in a roundtable of experts representing patient, provider, plan, pharmacy, policy, and ethical perspectives. We first reviewed guiding principles, position statements, and legislative activity to draft criteria regarding step therapy protocol development, implementation, communication, and evaluation. To assess consensus across a convenience sample of experts, we employed an iterative 4-step modified Delphi method. Panelists were asked to (a) rate the overall appropriateness of step therapy, (b) rate the appropriateness of specific criteria, and (c) identify each as a standard or best practice. Appropriateness was rated from 1-9 and categorized in terciles (1-3: not appropriate, 4-6: neither, 7-9: appropriate) to assess quantitative agreement, disagreement, and indeterminate agreement. RESULTS: After the second round of voting, roundtable panelists (n = 16) disagreed on the appropriateness of step therapy for utilization management (50% appropriate, 31.25% neither, and 18.75% inappropriate). Agreement was achieved on 21 criteria across 5 themes (clinical criteria as the foundation for protocol development, implementation of protocols, transparency and communication of processes, navigation of the appeals process, and evaluation of health and administrative impact). Fourteen and seven criteria were categorized as standards and best practices, respectively. CONCLUSIONS: The stakeholders in this panel differed in their assessments of the appropriateness of step therapy but agreed regarding how these protocols should be developed, implemented, communicated, and evaluated. Most criteria were rated as standards that can be used by stakeholders when developing, implementing, and assessing step therapy processes today. DISCLOSURES: This study was funded by the National Pharmaceutical Council. Karmarkar was a fellow at the National Pharmaceutical Council and Duke-Margolis Center for Health Policy at the time this study was conducted. Dubois and Graff are employees of the National Pharmaceutical Council. This work was previously presented as a virtual poster during the AMCP 2020 eLearning Days, April 21-24, 2020.

EULAR recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs)

ObjectiveTo produce European League Against Rheumatism (EULAR) recommendations for the reporting of ultrasound studies in rheumatic and musculoskeletal diseases (RMDs).MethodsBased on the literature reviews and expert opinion (through Delphi surveys),...

The first modified Delphi consensus statement on sleeve gastrectomy.

Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5years after surgery to screen for BE. A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.

Perioperative management and anaesthetic considerations in pelvic exenterations using Delphi methodology: results from the PelvEx Collaborative.

BackgroundThe multidisciplinary perioperative and anaesthetic management of patients undergoing pelvic exenteration is essential for good surgical outcomes. No clear guidelines have been established, and there is wide variation in clinical practice internationally. This consensus statement consolidates clinical experience and best practice collectively, and systematically addresses key domains in the perioperative and anaesthetic management.MethodsThe modified Delphi methodology was used to achieve consensus from the PelvEx Collaborative. The process included one round of online questionnaire involving controlled feedback and structured participant response, two rounds of editing, and one round of web-based voting. It was held from December 2019 to February 2020. Consensus was defined as more than 80 per cent agreement, whereas less than 80 per cent agreement indicated low consensus.ResultsThe final consensus document contained 47 voted statements, across six key domains of perioperative and anaesthetic management in pelvic exenteration, comprising preoperative assessment and preparation, anaesthetic considerations, perioperative management, anticipating possible massive haemorrhage, stress response and postoperative critical care, and pain management. Consensus recommendations were developed, based on consensus agreement achieved on 34 statements.ConclusionThe perioperative and anaesthetic management of patients undergoing pelvic exenteration is best accomplished by a dedicated multidisciplinary team with relevant domain expertise in the setting of a specialized tertiary unit. This consensus statement has addressed key domains within the framework of current perioperative and anaesthetic management among patients undergoing pelvic exenteration, with an international perspective, to guide clinical practice, and has outlined areas for future clinical research.

Политическая ситуация в Грузии: муниципальные выборы на фоне возвращения М. Саакашвили

The municipal elections in Georgia were held against the background of the return of ex-President Mikhail Saakashvili to the country and his subsequent arrest. 4 criminal cases have been opened against Saakashvili, in two of which he was sentenced to 3 and 6 years in prison. Saakashvili’s hopes to inspire the opposition electorate with his presence failed to become justified. The ruling Georgian Dream party won both the first and second rounds of voting, in which mayors of 20 major cities were elected. Nevertheless, Saakashvili's return has put the Georgian leadership in a difficult position both from the point of view of domestic and foreign policy.

Development and Validation of a New Competency Framework for Athletic Therapy in Canada

Context Competency-based education (CBE) is entrenched in educating health professionals in Canada. CBE is a framework that identifies desired performance characteristics in training competent, entry-level health professionals. Objective To update, develop, and validate a new Canadian Athletic Therapists Association (CATA) framework for athletic therapy education. Design Framework development occurred in 4 phases and was developed through a multistage process that involved a scoping review (phase 1) and consensus methodology (ie, a blending of modified Ebel and modified Delphi consensus methods; phases 2–4). Patients or Other Participants Phase 2: a total of 7 experts (program directors) from each Canadian accredited institution. Phase 3: a total of 14 experts (1 program director and educational expert from each accredited institution). Phase 4: a total of 7 experts (program directors) and 246 certified members of the CATA. Main Outcome Measure(s) Each phase consisted of a systematic process with 80% consensus agreement set a priori. In phase 1, a scoping review was conducted to identify common terminology that could be used to guide the framework development process and to identify competency frameworks used by other health professional organizations. Phase 2 consisted of adopting a common language that would serve to keep the expert group on the task at hand and avoid confusion. In phase 3, frameworks used by other health professional organizations were evaluated and used to determine the validity of the old CATA framework. In phase 4, the old CATA framework was updated and a new framework was developed and validated. Results In phase 1, the result of the scoping review yielded 368 papers, of which 5 were used to propose a common language for phase 2 and 9 highlighted competency frameworks used by other health professions for comparison in phase 3. In phase 3, the expert group voted unanimously to adopt and adapt the CanMEDS framework (ie, roles). In phase 4, the new CATA competency framework was validated, and most competencies achieved consensus. Competencies that did not achieve consensus in the first round of voting underwent face-to-face discussions via videoconferencing. After discussions, the remaining competencies were revised, and all newly worded competencies achieved consensus. Conclusions The resultant framework was validated, and most competencies achieved consensus. The new athletic therapy competency framework outlines the 165 competencies resulting from this methodical process and will hopefully facilitate interdisciplinary communication and practice.

International Delphi Expert Consensus on Safe Return to Surgical and Endoscopic Practice: From the Coronavirus Global Surgical Collaborative.

The aim of this work is to formulate recommendations based on global expert consensus to guide the surgical community on the safe resumption of surgical and endoscopic activities. The COVID-19 pandemic has caused marked disruptions in the delivery of surgical care worldwide. A thoughtful, structured approach to resuming surgical services is necessary as the impact of COVID-19 becomes better controlled. The Coronavirus Global Surgical Collaborative sought to formulate, through rigorous scientific methodology, consensus-based recommendations in collaboration with a multidisciplinary group of international experts and policymakers. Recommendations were developed following a Delphi process. Domain topics were formulated and subsequently subdivided into questions pertinent to different aspects of surgical care in the COVID-19 crisis. Forty-four experts from 15 countries across 4 continents drafted statements based on the specific questions. Anonymous Delphi voting on the statements was performed in 2 rounds, as well as in a telepresence meeting. One hundred statements were formulated across 10 domains. The statements addressed terminology, impact on procedural services, patient/staff safety, managing a backlog of surgeries, methods to restart and sustain surgical services, education, and research. Eighty-three of the statements were approved during the first round of Delphi voting, and 11 during the second round. A final telepresence meeting and discussion yielded acceptance of 5 other statements. The Delphi process resulted in 99 recommendations. These consensus statements provide expert guidance, based on scientific methodology, for the safe resumption of surgical activities during the COVID-19 pandemic.