Draft Criteria Research Articles

Establishing evidence criteria for implementation strategies in the US: a Delphi study for HIV services

BackgroundThere are no criteria specifically for evaluating the quality of implementation research and recommending implementation strategies likely to have impact to practitioners. We describe the development and application of the Best Practices Tool, a set of criteria to evaluate the evidence supporting HIV-specific implementation strategies.MethodsWe developed the Best Practices Tool from 2022–2023 in three phases. (1) We developed a draft tool and criteria based on a literature review and key informant interviews. We purposively selected and recruited by email interview participants representing a mix of expertise in HIV service delivery, quality improvement, and implementation science. (2) The tool was then informed and revised through two e-Delphi rounds using a survey delivered online through Qualtrics. The first and second round Delphi surveys consisted of 71 and 52 open and close-ended questions, respectively, asking participants to evaluate, confirm, and make suggestions on different aspects of the rubric. After each survey round, data were analyzed and synthesized as appropriate; and the tool and criteria were revised. (3) We then applied the tool to a set of research studies assessing implementation strategies designed to promote the adoption and uptake of evidence-based HIV interventions to assess reliable application of the tool and criteria.ResultsOur initial literature review yielded existing tools for evaluating intervention-level evidence. For a strategy-level tool, additions emerged from interviews, for example, a need to consider the context and specification of strategies. Revisions were made after both Delphi rounds resulting in the confirmation of five evaluation domains – research design, implementation outcomes, limitations and rigor, strategy specification, and equity – and four evidence levels – best, promising, more evidence needed, and harmful. For most domains, criteria were specified at each evidence level. After an initial pilot round to develop an application process and provide training, we achieved 98% reliability when applying the criteria to 18 implementation strategies.ConclusionsWe developed a tool to evaluate the evidence supporting implementation strategies for HIV services. Although specific to HIV in the US, this tool is adaptable for evaluating strategies in other health areas.

Defining pediatric trauma center resource utilization: Multidisciplinary consensus-based criteria from the Pediatric Trauma Society.

Pediatric trauma triage and transfer decisions should incorporate the likelihood that an injured child will require pediatric trauma center (PTC) resources. Resource utilization may be a better basis than mortality risk when evaluating pediatric injury severity. However, there is currently no consensus definition of PTC resource utilization that encompasses the full scope of PTC services. Consensus criteria were developed in collaboration with the Pediatric Trauma Society (PTS) Research Committee using a modified Delphi approach. An expert panel was recruited representing the following pediatric disciplines: prehospital care, emergency medicine, nursing, general surgery, neurosurgery, orthopedics, anesthesia, radiology, critical care, child abuse, and rehabilitation medicine. Resource utilization criteria were drafted from a comprehensive literature review, seeking to complete the following sentence: "Pediatric patients with traumatic injuries have used PTC resources if they..." Criteria were then refined and underwent three rounds of voting to achieve consensus. Consensus was defined as agreement of 75% or more panelists. Between the second and third voting rounds, broad feedback from attendees of the PTS annual meeting was obtained. The Delphi panel consisted of 18 members from 15 institutions. Twenty initial draft criteria were developed based on literature review. These criteria dealt with airway interventions, vascular access, initial stabilization procedures, fluid resuscitation, blood product transfusion, abdominal trauma/solid organ injury management, intensive care monitoring, anesthesia/sedation, advanced imaging, radiologic interpretation, child abuse evaluation, and rehabilitative services. After refinement and panel voting, 14 criteria achieved the >75% consensus threshold. The final consensus criteria were reviewed and endorsed by the PTS Guidelines Committee. This study defines multidisciplinary consensus-based criteria for PTC resource utilization. These criteria are an important step toward developing a criterion standard, resource-based, pediatric injury severity metric. Such metrics can help optimize system-level pediatric trauma triage based on likelihood of requiring PTC resources. Diagnostic Test/Criteria; Level II.

Levels of Gynecologic Care: A Task Force Consensus Statement.

Systems of care have been established for obstetrics, trauma, and neonatology. An American College of Obstetricians and Gynecologists Presidential Task Force was established to develop a care system for gynecologic surgery. A group of experts who represent diverse perspectives in gynecologic practice proposed definitions of levels of gynecologic care using the Delphi method. The goal is to improve the quality of gynecologic surgical care performed in the United States by providing a framework of minimal institutional requirements for each level. Subgroups developed draft criteria for each level of care. The entire Task Force then met to reach consensus regarding the levels of care final definitions and parameters. The levels of gynecologic care framework focuses on systems of care by considering institutional resources and expertise, providing guidance on the provision of care in appropriate level facilities. These levels were defined by the ability to care for patients of increasing risk, complexity, and comorbidities, organizing gynecologic care around hospital capability. This framework can also be used to inform the escalation of care to appropriate facilities by identifying patients at risk and guiding them to facilities with the skills, expertise, and capabilities to safely and effectively meet their needs. The levels of gynecologic care framework is intended for use by patients, hospitals, and clinicians in the United States to guide where elective surgery can be done most safely and effectively by specialists and subspecialists in obstetrics and gynecology. The key features of the levels of gynecologic care include ensuring provision of risk-appropriate care and regionalization of care by facility capabilities.

Prioritisation of Informed Health Choices (IHC) key concepts to be included in lower secondary school resources: A consensus study.

The Informed Health Choices Key Concepts are principles for thinking critically about healthcare claims and deciding what to do. The Key Concepts provide a framework for designing curricula, learning resources, and evaluation tools. To prioritise which of the 49 Key Concepts to include in resources for lower secondary schools in East Africa. Twelve judges used an iterative process to reach a consensus. The judges were curriculum specialists, teachers, and researchers from Kenya, Uganda, and Rwanda. After familiarising themselves with the concepts, they pilot-tested draft criteria for selecting and ordering the concepts. After agreeing on the criteria, nine judges independently assessed all 49 concepts and reached an initial consensus. We sought feedback on the draft consensus from other stakeholders, including teachers. After considering the feedback, nine judges independently reassessed the prioritised concepts and reached a consensus. The final set of concepts was determined after user-testing prototypes and pilot-testing the resources. The first panel of judges prioritised 29 concepts. Based on feedback from teachers, students, curriculum specialists, and members of the research team, two concepts were dropped. A second panel of nine judges prioritised 17 of the 27 concepts that emerged from the initial prioritisation and feedback. Based on feedback on prototypes of lessons and pilot-testing a set of 10 lessons, we determined that it was possible to introduce nine concepts in 10 single-period (40-minute) lessons. We included eight of the 17 prioritised concepts and one additional concept. Using an iterative process with explicit criteria, we prioritised nine concepts as a starting point for students to learn to think critically about healthcare claims and choices.

Beyond PTSD: Client presentations of developmental trauma disorder from a national survey of clinicians.

The emergence of updated Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM-5]; American Psychiatric Association, 2013) criteria for posttraumatic stress disorder (PTSD), which includes modified criteria for young children, raises questions regarding the need for developmentally appropriate standalone psychiatric diagnosis encompassing complex trauma presentations in children. The present study addresses these questions by examining how DSM-5 PTSD and proposed developmental trauma disorder (DTD) diagnoses relate to functional impairment and trauma exposure using clinician-report surveys. We surveyed psychotherapists across the United States, and asked them to report on the symptom characteristics, functional impairment, and trauma exposure of children, adolescents, and young adults under their care (n = 210; age range = 2-21). We fit symptom data to the draft criteria for (1) DTD, a proposed trauma diagnosis for children and (2) existing criteria for adult and child/preschool PTSD. Results indicated that comorbidity between DTD and PTSD was high (52.4% and 59.9% for adult and child/preschool criteria, respectively). Comorbid DTD/PTSD and DTD-alone groups had more functional domains impacted and greater exposure to some types of trauma relative to the other groups. These findings speak to the relationship between trauma complexity and wide-ranging symptom presentations, provide support for research and clinical emphasis on a developmentally informed diagnosis, and may support existing treatment approaches. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology.

Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions. Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives. Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n=12) and fetal (n=19) AE definitions and severity grading criteria were developed and ratified by consensus. This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

Remote and Indigenous Broadband: A Comparison of Canadian and US Initiatives and Indigenous Engagement

This paper compares funding and other policies for broadband for rural and Indigenous regions initiated by the Canadian and US regulators and policy agencies. In 2016, the CRTC determined that broadband was to be considered a basic service available to all Canadians and set targets for universal broadband at 50 mbps download and 10 mbps upload speed. The Commission also recognized that public sector funding could be required to accomplish the goal of extending broadband to rural and remote regions, but deferred addressing specifics of a broadband fund. In 2019, the CRTC initiated a consultation on draft criteria for a broadband fund. It then published a call for proposals and has provided funding for several projects. Based on comments from small and Indigenous providers who participated in the consultation, the CRTC opened a further proceeding on barriers to deployment of broadband and then on regulatory measures to make access to poles and other existing terrestrial infrastructure more efficient. In the U.S., among FCC broadband funding programs that include rural and Tribal regions are the Rural Digital Opportunity Fund, which will commit at least $20.4 billion over the next decade to support high-speed broadband networks in rural America (approved in 2020 by the previous administration) and the Emergency Broadband Connectivity Fund, a broadband subsidy for consumers, announced in January 2021. The FCC also opened a Rural Tribal Priority Window for licenses to use 2.5 GHz spectrum for networks on Tribal lands in 2020. This paper compares the issues raised and policies adopted or proposed by the CRTC and the FCC concerning remote and Indigenous broadband access and affordability, and activities related to Indigenous engagement in policy and regulatory issues in each country. It concludes with lessons from the Canadian and US regulatory experience that can be relevant for rural and Indigenous regions in other countries.

Towards classification criteria for early-stage knee osteoarthritis: A population-based study to enrich for progressors

ObjectiveTo facilitate a greater likelihood of favorable response to new disease-modifying therapies, recruitment of patients at an earlier stage of their disease into clinical trials may be an attractive strategy. Hence, there is a need to develop widely accepted classification criteria for early-stage knee osteoarthritis (OA). We have proposed a set of classification criteria for early-stage knee OA (2018 classification criteria) now being further refined. Here, we test the draft criteria for enrichment for clinical and structural progression. DesignPerformance of the 2018 classification criteria for early stage knee OA was tested using data from the Osteoarthritis Initiative (OAI). The OAI comprises data of 4796 men and women aged 45–79 years with or at risk for knee OA at baseline. Based on the 2018 classification criteria, a knee with Kellgren & Lawrence (K&L) grade of 0-I, two out of four Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales equal or less than 85, and presence of at least one of joint line tenderness or crepitus, was considered as early-stage knee OA. Knees with K&L grade 0-I that did not fulfill the 2018 criteria, were considered as controls. Logistic regression analysis was used to evaluate the predictive performance of the criteria set for structural as well as clinical progression. We further explored the discriminatory capability of criteria by including the average KOOS4 score, and relevant clinical examination findings such as the presence of effusion and/or Heberden's nodes. ResultsWe identified 1315 (27%) knees from OAI fulfilling the 2018 early-stage knee OA classification criteria. The female to male ratio was higher in the early knee OA group compared to controls. The early-stage knee OA group were on average slightly younger and had higher body mass index vs controls (mean [SD] age: 59.2 [8.9] years vs. 60.2 [9.1] and mean [SD] BMI 28.3 [7.0] vs. 26.8 [6.0]). By applying the 2018 criteria, there was a substantial enrichment compared to controls at 48 and 96 months for both structural (OR=1.1–1.4, and AUC=0.72–0.74) and clinical progressors (OR=2.1–2.5, 95% and AUC=0.66). Expanding the clinical examination findings by including joint effusion and/or Heberden's nodes improved the enrichment for both structural and clinical progressors (OR=4.2, 95% confidence interval=3.2–5.5 and OR=3.3, 95% confidence interval=2.8–3.5, respectively). Replacing scoring of the 4 separate KOOS domains by a KOOS4 score performed comparably. ConclusionsThe proposed 2018 early-stage knee OA classification criteria showed encouraging performance characteristics with regard to an enrichment for structural and clinical progression using longitudinal OAI data. Our results indicate that the addition of clinical findings improves the performance of previous criteria to define early-stage disease and risk for progression.

Co-constructing the assessment criteria for EFL writing by instructors and students: A participative approach to constructively aligning the CEFR, curricula, teaching and learning

The current assessment in language classrooms prevailingly utilizes the criteria provided by instructors, regarding learners as passive recipients of assessment. The current study drew upon sustainable assessment and the community of practice to highlight the importance of involving learners in co-constructing the assessment criteria and argued that using the criteria provided by instructors could lead to discrepancy between assessment, teaching, and learning. It adopted a participatory approach and investigated how to involve learners in co-constructing the assessment criteria with instructors in tertiary English writing instruction in China, based on the European Language Profile (ELP), an evolved version of the Common European Framework of Reference for Languages (CEFR). Two writing instructors and 146 tertiary students played different, yet interactive roles in adapting the assessment criteria in the local context. Instructors drafted the criteria in line with curricula, teaching, learning and learners. Learners utilized the draft criteria in a training session and suggested possible modifications to the criteria in a survey. Suggestions were used to revise the descriptors alongside teachers’ reflections via reflective logs. A follow-up survey explored students’ perceptions of the feasibility and usefulness of the modified descriptors to investigate the effectiveness of co-constructing the assessment criteria for learning and reveal further improvement if necessary. Vigilant decision-making processes were thickly described regarding how assessment descriptors were selected, arranged, and modified to constructively align them with curricula, teaching, and learning. Statistical and thematic analyses were conducted to examine the accessibility, feasibility, and usefulness of the assessment descriptors prior to and after the modifications. Results substantiated the effectiveness and thus the importance of co-constructing assessment criteria for enhancing the quality of assessment criteria and developing learners’ cognitive and metacognitive knowledge of writing and assessment. Implications for language tutors regarding co-constructing assessment criteria in local contexts were deliberated on at the end of the article.

High Cost, High Need Populations Data‐Driven Decision Making for Interventions with Complex Needs’ Patients: Identifying the Right Target Population

Research ObjectiveWhile existing taxonomies describe the major groups of complex patients (prominently, the National Academy of Medicine [NAM] taxonomy), these are often at a conceptual level. Healthcare organizations often select patients for CN interventions using structured criteria based on administrative data, and program designers must make critical decisions in defining target populations. Our study aimed to provide insights to inform decisions about selecting CN populations for interventions, by conducting a review of approaches being used to operationalize CN populations in practice, and implementing various definitions in a large health plan member population to compare the characteristics of the resulting patient cohorts.Study DesignOur study involved multiple methods to identify and implement data‐driven definitions of CN patients. We interviewed internal and external subject matter experts to inform our research approach. We conducted a pragmatic literature review of studies published 2000‐2018 which used data‐driven definitions of CN populations. We conducted thematic analysis of the results to identify core concepts and variations in criteria used to define CN populations. We implemented variations of the core concepts and calculated descriptive statistics to understand the characteristics of patients within each of the resulting CN populations, including size of the population, demographics, chronic illness, health care utilization, spending, and survival.Population StudiedPatients with complex needs defined using criteria applied to the membership population of Kaiser Permanente Southern California (KPSC), a large, population‐based health plan with more than 4 million members.Principal FindingsOur literature review yielded 90 examples of CN populations; we cataloged population criteria for each. We grouped observed criteria into domains: age (reflected in 59 CN population definitions), income (12), costs (45), utilization (39), health status (35), and subjective criteria (15). We constructed a framework for classifying approaches to selecting CN populations (Figure 1). We then used KPSC data to assemble populations representing five CN patient concepts (high cost, high emergency department utilization, high inpatient utilization, multiple chronic conditions, and frail elderly); in each concept, we compared multiple population specifications. We observed within‐ and across‐concept differences in the characteristics of the resulting populations. Data presented during the session will include CN population size, demographics, utilization, comorbidity, costs, and survival.ConclusionsOur results illustrate tremendous variation in how CN populations are defined. Nearly every CN population identified through our literature review was unique in the criteria used to select patients. Furthermore, when we implemented a variety of definitional approaches in our membership, we found substantial variation in the cohorts that resulted from different approaches to patient selection. These findings have important implications for both research and health care operations. In a world of limited resources, it is imperative that we use available data to identify, understand, and target resources to the right CN populations.Implications for Policy or PracticeThese findings offer important considerations for intervention planning and implementation. Program planners should select population criteria after exploring the impact of their draft criteria and comparing alternate approaches to understand the implications of those decisions.Primary Funding SourceThe Garfield Memorial Fund.

FRI0217 SENSITIVITY AND SPECIFICITY OF 2019 DCVAS DRAFT CLASSIFICATION CRITERIA FOR GIANT CELLS ARTERITIS AND TAKAYASU ARTERITIS IN A MONOCENTRIC COHORT OF PATIENTS WITH CLINICAL DIAGNOSIS OF LARGE VESSEL VASCULITIS

Background:Recently, a new set of classification criteria for Giant Cells Arteritis (GCA) and Takayasu Arteritis (TA) has been developed by the DCVAS project and presented as draft criteria at the 19th International Vasculitis and ANCA Workshop held in Philadelphia in 2019.Objectives:The purpose of the present study is to analyze the performance of the 2019 DCVAS Draft Classification Criteria in differentiating GCA and TA in a cohort of patients with Large Vessel Vasculitis (LVV), comparing their sensitivity and specificity to 1990 ACR Classification Criteria.Methods:2019 DCVAS Draft Criteria and 1990 ACR Criteria were retrospectively applied to a cohort of 130 consecutive patients with Large Vessel Vasculitis. In all patients the diagnosis of vasculitis was histologically and/or radiologically confirmed.Results:One-hundred patients had a clinical diagnosis of GCA, 25 patients of TA and 5 patients of other form of LVV, different from GCA and TA (idiopathic isolated aortitis n:2, aortitis with retroperitoneal fibrosis n:2, isolated pulmonary arteritis n:1).Among the 100 patients clinically diagnosed as GCA (F/M: 68/32, age: 74 (60-83)) only 82 fulfilled the 1990 ACR Criteria for GCA, while all of them fulfilled the 2019 DCVAS Draft Criteria for GCA.Instead, among the 25 patients with a clinical diagnosis of TA (F/M: 21/4, age: 34 (16-48)), 22 (88%) could be classified as TA according to the 1990 ACR Criteria, 25 (100%) according to 2019 DCVAS Draft Criteria.In the group of patients diagnosed with other form of LVV (F/M: 2/3, age: 56 (38-71)) 4 patients (80%) fulfilled the 2019 DCVAS Draft Criteria for GCA, while none of them fulfilled the 2019 DCVAS Draft Criteria for TA or the 1990 ACR Criteria for GCA or TA. One of these patients did not fulfilled any classification criteria.On the contrary, one GCA patient could be classified both as GCA or TA according to the 2019 DCVAS Draft Criteria but didn’t fulfilled the 1990 ACR Criteria for GCA or TA.For GCA, 2019 DCVAS Draft Criteria shown a sensitivity of 100% and a specificity of 80%, compared to 82% and 100% of 1990 ACR Criteria. For TA, 2019 DCVAS Draft Criteria shown a sensitivity of 100% and a specificity of 99%, compared to 88% and 100% of 1990 ACR Criteria.For GCA the agreement between the two different sets of criteria was 85.5% (Cohen’s k coefficient: 0.64), for TA the agreement was 85.1% (k: 0.58).Conclusion:The new draft classification criteria shown a lower specificity if compared to the older ones, but also a higher sensitivity: in particular 2019 DCVAS Draft Criteria can better identify GCA patients with extracranial involvement, historically excluded from the 1990 ACR criteria.both GCA and TA 2019 DCVAS Draft Criteria, demonstrating that this classification well performs in differentiating GCA and TA.Table 1:GCA (n:100)TA (n:25)Other LVV (n:5)Morning stiffness in shoulders or neck43 (43%)3 (12%)0 (0%)Sudden visual loss33 (33%)2 (8%)0 (0%)Jaw or tongue claudication35 (35%)0 (0%)0 (0%)New headache/Scalp tenderness77 (77%)/30 (30%)5 (20%)/0 (0%)1 (20%)/0 (0%)Temporal Artery Exam: pathological findings34 (34%)0 (0%)0 (0%)Elevated ESR or CRP100 (100%)16 (64%)5 (100%)Temporal Artery Biopsy: vasculitis53 (53%)0 (0%)0 (0%)Temporal Artery halo sign (US)/Bilateral axillary involvement11 (11%)/11 (11%)0 (0%)/4 (16%)0 (0%)/0 (0%)FDG-PET activity throughout aorta32 (32%)13 (52%)4 (80%)Angina or ischemic cardiac pain5 (5%)4 (16%)1 (20%)Arm or leg claudication5 (5%)12 (48%)0 (0%)Arterial bruit2 (2%)19 (76%)1 (20%)Reduced pulse in upper extremity1 (1%)15 (60%)0 (0%)Carotid: reduced pulse or tenderness0 (0%)8 (32%)0 (0%)SBP difference in arms: >10/ >20 mmHg0 (0%)/1 (1%)14 (56%)/6 (24%)0 (0%)/0 (0%)Pathological Angiography or AngioCT:number of affected arteries: 1/2/>319 (19%):7/3/922 (88%):0/1/195 (100%):3/0/2Paired branch arteries involvement7 (7%)20 (80%)2 (40%)Abdominal aorta with renal or mesenteric involvement0 (0%)17 (68%)0 (0%)Disclosure of Interests:None declared

Akseptabilitas Draf Kriteria Baru Penentuan Kalender Hijriah Menurut Ahli Falak di Indonesia

In 2015 AD, 2016 AD, 2017 and 2017 there was a new discussion about the draft of new criteria for the determination of the Islamic calendar in Indonesia, namely the draft MUI criteria and the new draft criteria MABIMS, with the criteria of 3 degrees hilal height and 6.4 degree elongation. This criterion is deliberately made for the benefit and mutual agreement for the unification of the hijri calendar in Indonesia. It is hoped that the experts of the Islamic organizations in Indonesia will give their views and attitudes to the draft of new criteria to harmonize the criteria for "hilal visibility" which will be used as a reference and guideline for the determination of the beginning of the Islamic month. This study shows that both the rukyat school and the reckoning school as a whole are acceptable for the draft MUI criteria and the new draft MABIMS as the determination of the Islamic calendar in Indonesia. However, overall the distribution of the scores of the two schools is categorized as moderate, so there are those who agree, disagree, and do not agree with the draft criteria. Overall, the two new draft criteria have the opportunity to be applied in Indonesia. To realize this, it is necessary to have a dialogue between Islamic mass organizations, astronomers and fiqh experts, as well as the government as policy makers.

Developing quality criteria for patient-directed knowledge tools related to clinical practice guidelines. A development and consensus study.

BackgroundPatient‐directed knowledge tools such as patient versions of guidelines and patient decision aids are increasingly developed to facilitate shared decision making. In this paper, we report how consensus was reached within the Netherlands on quality criteria for development, content and governance of these tools.MethodA 12‐month development and consensus study. The consortium worked on four work packages: (a) reviewing existing criteria; (b) drafting the quality criteria; (c) safe‐guarding the acceptability and feasibility of the draft criteria by participatory research in on‐going tool development projects; and (d) gaining formal support from national stakeholders on the quality criteria.ResultsWe reached consensus on a 8‐step guidance; describing minimal quality criteria for (a) the team composition; (b) setting the scope; (c) identifying needs; (d) the content and format; (e) testing the draft; (f) finalizing and approval; (g) dissemination and application, and (h) ownership and revision. The participants of the on‐going tool development projects were positive about the quality criteria in general, but divided as to the degree of detail. Whereas some expressed a clear desire for procedural standards, others felt that it would be sufficient to provide only general directions. Despite the different views as to the degree of detail, consensus was reached in three stakeholder meetings.DiscussionWe successfully collaborated with all stakeholders and achieved formal support from national stakeholders on a set of minimum criteria for the development process, content and governance of patient‐directed knowledge tools.

Secure data analysis environments: can we agree on criteria for “Appropriate secure access” to linked health data?

Overall objectives or goalMany health data linkage ecosystems across the world have designed and implemented secure data analysis environments as one of their controls to protect patient privacy and confidentiality. These have been shaped by local legislation and data governance policies, available IT infrastructure and resources, and the skills and imagination of their architects. However, at present their various features and functionalities have not been reviewed, synthesised or contrasted. Burton et al [1] have proposed 12 criteria for Data Safe Havens in health and healthcare, which they conceptualise broadly as encompassing data governance and ethics, quality and curation of data repositories, and data security. Under this definition, secure analysis environments, which may or may not be integrated with data repositories, are a component of a Data Safe Haven, addressing the criterion “Appropriate secure access to individually identifying data”. To guide those building and operating these environments, and data custodians and stewards who need to assess their fitness-for-purpose, it would be of great value to discuss and agree an aggregate term (e.g. “Secure Data Lab”) that describes them, and to develop a more detailed set of criteria for what entails “Appropriate secure access” to linked health data.
 The goal of this session is to describe and document the approaches that have been taken by flagship secure data analysis environments internationally, including their approaches to authentication, assigning permissions, managing the ingress and egress of files and auditing transactions, and their responses to emerging opportunities, including cloud computing and national and international data sharing. We will explore how the interplay of physical, technical and procedural controls have been combined to create existing models, and the extent to which these can balance each other and be applied with flexibility depending on perceived risk and regimes.
 Session structurePrior to the session, we will develop a draft set of criteria for “Appropriate secure access” to linked health data. The session will comprise presentations describing existing secure analysis environments against the draft criteria, followed by a facilitated discussion. The secure data analysis environments that will be presented include:
 
 UNSW Sydney E-Research Institutional Cloud Architecture (ERICA)
 PopData BC Secure Research Environment (SRE)
 Institute for Clinical Evaluative Sciences (ICES) Data and Analytic Virtual Environment (IDAVE)
 Secure Anonymised Information Linkage (SAIL) Gateway
 
 Intended output or outcomeWe will write up the outcomes of the session as a scientific paper that proposes an aggregate term for secure data analysis environments for linked health data and a set of criteria for what entails “Appropriate secure access” to linked health data.
 Presenters and Facilitators
 Professor Louisa Jorm, Centre for Big Data Research in Health, UNSW Sydney, Australia
 Dr Tim Churches, South Western Sydney Clinical School, UNSW Sydney, Australia
 Professor Kim McGrail, Population Data BC, The University of British Columbia, Vancouver, Canada
 J. Charles Victor, Institute for Clinical Evaluative Sciences, Toronto, Canada
 Dr Kerina Jones, Swansea University Medical School, Wales, United Kingdom
 Professor David Ford, Swansea University Medical School, Wales, United Kingdom
 1. Burton PR, Murtagh MJ, Boyd A, et al. Data Safe Havens in health research and healthcare. Bioinformatics 2015; 31(20): 3241–3248

Human-relevant potency threshold (HRPT) for ER\u03b1 agonism

The European Commission has recently proposed draft criteria for the identification of endocrine disrupting chemicals (EDCs) that pose a significant hazard to humans or the environment. Identifying and characterizing toxic hazards based on the manner by which adverse effects are produced rather than on the nature of those adverse effects departs from traditional practice and requires a proper interpretation of the evidence regarding the chemical’s ability to produce physiological effect(s) via a specific mode of action (MoA). The ability of any chemical to produce a physiological effect depends on its pharmacokinetics and the potency by which it acts via the various MoAs that can lead to the particular effect. A chemical’s potency for a specific MoA—its mechanistic potency—is determined by two properties: (1) its affinity for the functional components that comprise the MoA, i.e., its specific receptors, enzymes, transporters, transcriptional elements, etc., and (2) its ability to alter the functional state of those components (activity). Using the agonist MoA via estrogen receptor alpha, we illustrate an empirical method for determining a human-relevant potency threshold (HRPT), defined as the minimum level of mechanistic potency necessary for a chemical to be able to act via a particular MoA in humans. One important use for an HRPT is to distinguish between chemicals that may be capable of, versus those likely to be incapable of, producing adverse effects in humans via the specified MoA. The method involves comparing chemicals that have different ERα agonist potencies with the ability of those chemicals to produce ERα-mediated agonist responses in human clinical trials. Based on this approach, we propose an HRPT for ERα agonism of 1E-04 relative to the potency of the endogenous estrogenic hormone 17β-estradiol or the pharmaceutical estrogen, 17α-ethinylestradiol. This approach provides a practical way to address Hazard Identification according to the draft criteria for identification of EDCs recently proposed by the European Commission.

Applied Swarm-based medicine: collecting decision trees for patterns of algorithms analysis

BackgroundThe objective consensus methodology has recently been applied in consensus finding in several studies on medical decision-making among clinical experts or guidelines. The main advantages of this method are an automated analysis and comparison of treatment algorithms of the participating centers which can be performed anonymously.MethodsBased on the experience from completed consensus analyses, the main steps for the successful implementation of the objective consensus methodology were identified and discussed among the main investigators.ResultsThe following steps for the successful collection and conversion of decision trees were identified and defined in detail: problem definition, population selection, draft input collection, tree conversion, criteria adaptation, problem re-evaluation, results distribution and refinement, tree finalisation, and analysis.ConclusionThis manuscript provides information on the main steps for successful collection of decision trees and summarizes important aspects at each point of the analysis.

Prerequisites and obstacles for application of the concept of high conservation value forests in Armenia

Abstract The concept of high conservation value forests (HCVF) was proposed by the Forest Stewardship Council to maintain and protect high conservation values in forests. There are six internationally agreed categories of HCVFs and criteria for their identification. Draft national classification and criteria for identification of HCVFs in Armenia were developed in 2016. Their application to the forests in Armenia can identify forest areas with respective values as the basis for defining specific management actions to maintain or protect identified values. The analysis of existing information on forest biodiversity, ecosystems and national framework revealed a number of prerequisites and obstacles for application of the concept at national level in Armenia. There are good prerequisites for identification of respective categories of HCVFs in Armenia as the basis for their protection. The main obstacles need to be solved to apply the concept at national level and protect the forests with high conservation values in Armenia.

A02 Criteria Methodology for Integrated Health and Sustainability Assessment

BackgroundThis presentation will describe a novel and innovative methodology for optimising the health and sustainability effects of a plan or policy through impact assessment. Following the 2010-2011 earthquakes disaster in Christchurch, the New Zealand government instructed the Canterbury Regional Council to develop a Land Use Recovery Plan. To ensure that the Plan would deliver land use which supported healthy living and healthy transport options, the Regional Council collaborated with the Christchurch City Council and the local public health authority to perform an integrated assessment of the health and sustainability effects of the Plan. MethodsThe assessment methodology was originally developed for assessing the impact of water management policy. The assessment team developed 37 draft criteria by which to assess the Plan. Each of the criteria had an accompanying description, e.g. “Well-functioning public transport system”, and a five point scale from, e.g. “-1 The Plan hinders provision for an integrated public transport system” to “+3 The Plan ensures an accessible integrated public system and accounts for future growth and constraints”. The criteria were used to facilitate two workshops to assess the health and sustainability impacts of the draft Plan and a revised Plan respectively. At the workshop, health, sustainability, and planning experts, and other stakeholders discussed and amended the draft criteria, assessed the Plan according to the criteria, and provided recommendations to help improve the Plan. Qualitative surveys and in-depth interviews with thematic analysis were conducted to capture the experiences of workshop participants, assessment team members, and Plan authors. To assess efficacy, the final plan was checked against the recommendations from each workshop. ResultsThe assessment resulted in substantial improvements to the health impact of the Plan. Almost all recommendations were adopted in the Plan, and the Plan authors relied heavily on feedback from the workshops. The evaluation found that the criteria assessment methodology:•Promoted discussion and facilitated agreement on consensus recommendations. Plan authors found the consensus recommendations easier to interpret than the broad range of opinions generated by traditional consultation.•Promoted collaboration among a multidisciplinary group of influential people involved in the Christchurch earthquake rebuild, including minority groups, local government, health agencies, and the private sector.•Allowed participants to have input into a very early draft of the Plan.•Gave participants a sense of ownership over the Plan. ConclusionsThe criteria methodology generates useful recommendations for transport planners, while also supporting collaboration between local government and health agencies.

Tug에 의한 반잠수식 해양 구조물 위치 유지를 위한 제반 파라메터 검토

This paper investigates the line dynamic forces connecting tugs and a floater, where the planar motion of the floater is due to the weather criteria during the position keeping of the offshore structure by tugs. The analysis situation consists of the position keeping states for the seabed mooring line connection work of the offshore structure at the offshore site. Specifically, the decision about the tug power capacity for the position keeping is essential and depends on the weather criteria, line characteristics, length of line, etc. The planar motion of the structure is constrained by the interference of the installation vessel's operational range, behavior of the underwater fairlead, and other surrounding structures. In this paper, the tug line forces and planar motion of an offshore structure are summarized dependent on the tug line length and line material characteristics in the states fora given floater draft and weather criteria. The tug line dynamic forces and planar motion evaluated here will be used to determine the proper tug power and clearance of an offshore structure.

Challenging the Scientific Foundations for an IUCN Red List of Ecosystems

AbstractThe International Union for Conservation of Nature (IUCN) is currently discussing the development of a Red List of Ecosystems (RLE) that would mirror the categories and criteria used to assess the conservation status of species. The suggested scientific foundations for the RLE are being considered by IUCN for adoption as the backbone of the RLE. We identify conceptual and operational weaknesses in the draft RLE approach, the categories, and criteria. While species are relatively well‐described units, there is no consistent means to classify ecosystems for assessing conservation status. The proposed RLE is framed mostly around certain features of ecosystems such as broad vegetation or habitat types, and do not consider major global change drivers such as climate change. We discuss technical difficulties with the proposed concept of ecosystem collapse and suggest it is not analogous to species extinction. We highlight the lack of scientific basis for the criteria and thresholds proposed by the RLE, and question the need to adopt the structure of the Red List of Species for an RLE. We suggest that the proposed RLE is open to ambiguous interpretations and uncertain outcomes, and that its practicality and benefit for conservation should be carefully evaluated before final approval.