Korábbi változatok

What to know/do (and why) Overview

('nouns and verbs' - what goes in rows below in each table are the 'lists' associated with this the bullets in this row)

include: what tools to use under what circumstance. Information about the item so people can match it to their need.

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Regarding Terminologies: HL7 Project "Guidelines for a Standardized Terminology Knowledge base"

Regarding Value Sets recommend the following process (applies to anticoagulation, testing/triage, vaccines, steroids, and any other topic):

1. Take inventory of what value sets you’ll need (be specific)
2. Check Alliance website or Value Set Authority Center (VSAC), we might have already published some of them among the 600+ value sets
3. If certain value sets are not present or you are unsure, contact Victor Lee (Victor_Lee@ClinicalArchitecture.com) to inquire or to request development

Clinical Architecture and other Alliance collaborators are donating our efforts, and Clinical Architecture is leveraging its software tooling, hosting infrastructure, and manual labor to donate all of the COVID-19-related value set content to the public domain (i.e., completely free, no strings attached). That being said, we all have day jobs, so we appreciate having as much lead time as possible to fulfill requests. Happy to take questions.

COVID specific systematic and rapid reviews

• L*VE/Epistemonikos
• COVID-NMA
• COVID-END inventory
• ESP COVID-19 Evidence Reviews

COVID specific mixed (reviews and trials)

• NIPH COVID-19 Living Evidence Map
• EBSCO COVID-19 Information Portal
•  University of Michigan COVID-19 Best Evidence Front Door

COVID specific Trials

• Cochrane COVID-19 study register
• ClinicalTrials.gov/COVID-19
• DoctorEvidence CORD-19 Dataset Search
• EBSCO COVID-19 Information Portal

• NEWS2 predicts severity/mortality at admission
• Annals IM, hospitalized patient trajectories
• Sensitivity, Specificity Predictive Values of Tests for COVID-19 in ED
• PREDI-CO Risk assessment tool

• For steroids systematic meta-review, 8 sources have been identified these are (MEDLINE, CORD-19, L-OVE/Episteminokos, NIH iSearch COVID-19, EuropePMC, WHO COVID-19 Database, EMBASE + Prospero) 

• Librarian Reserve Corps
  • COVID-Evidence Project - building a database to gather all the evidence around a drug (University of Basil - currently focused on hydroxychloroquine, but model could be adaptable to other targets)
  • Identification of sources to identify primary studies - validation study of specialized COVID-19 databases (systematic reviewers are going to different sources - this effort is to identify best practices)
  • Advocate for librarian representation in searches and reviews - leverage skillsets/best practices in this work
    [SLMC]: close gaps between needs that clinicians are seeing on the front line and topics covered in reviews guidelines
• COKA Evidence/ Tools WG [Project Google Drive](work in process)

• Indico’s SaaS approach allows an efficient asynchronous, distributed volunteer workflow for traditional Title/Abstract and Full-Text screening based on PICO inclusion/exclusion criteria with client-defined conflict resolution.

• Framework slides: Applying Standards to the Evidence Domain (from the COKA Evidence Ecosystem Liaison WG)
• Add patient voice in the selection of the PICOTTS

• includes evaluation of quality of evidence 
• also needs to address processing of real world evidence
• [weave in ICER - search ISER opioids]

• For people creating evidence syntheses
  • See if work on planned topic has been done already - search L*VE/Epistemonikos (2K reviews - cover many questions - only a fraction registered in PROSPERO; most reviews are out of date - only 3% have all the trials they should), PROSPERO for what's in the pipeline. Make sure that any existing reviews look at outcomes that are pertinent to your needs [leverage COMET - outcome measures], etc. that of interest for the need at hand. Very hard for user to identify a review that's up to date. Existing systematic reviews can be assessed for quality using the tools listed below (AMSTAR, DART, or Oxman-Guyatt). COVID-END repository of Best Evidence Syntheses can be helpful here.
  • Need to have access to raw data that fed into the review so it's more re-usable.
  • important to understand end-user needs so that the review can be aimed at addressing them
  • AHRQ has methods guides, Cochrane has them. Are there tools for this on COVID - e.g., Resources and tools for researchers considering and conducting
    COVID-19 evidence syntheses (From COVID-END Synthesizing WG)
• Study Quality Assessments
  • For randomized trials (including open label), evaluate using the newest version of the RoB2 (15 March 2019) Source = https://www.riskofbias.info/
  • For non-randomized intervention studies including cohort studies, evaluate using the newest version of the ROBINS-I (version 19 September 2016)Source = https://www.riskofbias.info/
  • For case-control studies evaluate using the Newcastle Ottawa scale for case-control studies. (Note that the ROBINS-I has not yet been adapted for use with case-control study designs – but keep watch out for this) Source = http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp
  • For cross-sectional studies evaluate using the NIH/NHLBI tool Source = https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools
  • For case-series studies consider evaluations using the Specialist Unit for Review Evidence (SURE) checklist. It is older and may have been replaced with newer tools. Source =https://www.cardiff.ac.uk/specialist-unit-for-review-evidence/resources/critical-appraisal-checklists
  • For guidelines, evaluate using AGREE II. https://www.agreetrust.org/agree-ii/
  • For systematic reviews, consider using AMSTAR II: https://www.bmj.com/content/358/bmj.j4008 An alternative would be Documentation and Appraisal Review Tool (DART) https://www.wjgnet.com/2308-3840/full/v3/i3/142.htm Or an older tool called Guyatt-Oxman: https://cdnlinks.lww.com/permalink/jbjs/b/jbjs_2017_03_06_dijkman_48_sdc1.pdf

• For organizations consuming evidence syntheses
  • For selecting/using synthesized evidence: Is there a GRADE evidence profile? Do they make quality assessments? How comprehensive are they? Search date

--------------------

Regarding Terminologies:HL7 Project "Guidelines for a Standardized Terminology Knowledge base"

Regarding Value Sets recommend the following process (applies to anticoagulation, testing/triage, vaccines, steroids, and any other topic):

1. Take inventory of what value sets you’ll need (be specific)
2. Check Alliance website or Value Set Authority Center (VSAC), we might have already published some of them among the 600+ value sets
3. If certain value sets are not present or you are unsure, contact Victor Lee (Victor_Lee@ClinicalArchitecture.com) to inquire or to request development

Clinical Architecture and other Alliance collaborators are donating our efforts, and Clinical Architecture is leveraging its software tooling, hosting infrastructure, and manual labor to donate all of the COVID-19-related value set content to the public domain (i.e., completely free, no strings attached). That being said, we all have day jobs, so we appreciate having as much lead time as possible to fulfill requests. Happy to take questions.

• See Sources/Repositories from Identify Studies table
• ClinicalTrials.gov/COVID-19; New pubmed interface; DoctorEvidence CORD-19 Dataset Search
• PROSPERO

• Indico for highly configurable data extraction

• Underlying justification and evidence tables (critically ill and acutely ill) from ASH Anticoagulation Living Guidelines
• L*VE/Epistemonikos search on antithrombotics; can send email when new study/review/guideline is published.
• Rapid Cochrane review on anticoagulation in COVID-19 patients
• Systematic review on anticoagulants in COVID-19

• BMJ EBM rapid review on COVID tests

• SRDR+
• COVID NMA Project
• COVID-END Best Evidence Syntheses Inventory ('best evidence syntheses' on clinical management)
  • reviews that are living, up to date, high quality and where there is a GRADE evidence profile. 
• LIVING Project - living systematic review of COVID-19 interventions;
• L*VE/Epistemonikos, 
• VA Evidence Synthesis Program catalog of COVID-19 Evidence Reviews;
• GIN COVID-19 Evidence Resources
• EvidenceAid
• Usher Network for COVID-19 Evidence Reviews

• IOM Report: Finding What Works in Health Care:  Standards for Systematic Reviews
• EBM on FHIR/COKA (standards include: Evidence, EvidenceReport, EvidenceVariable, Group, Citation
• Vocabulary Map for Evidence-related resources[ Project Google Drive])
• AGREE II for rating the quality of guidelines
• [Add AMSTAR and all study quality rating tools here]

• COKA Steroids for COVID-19 Systematic Meta-Review Protocol; slides about this effort

• Resources and tools for researchers considering and conducting
  COVID-19 evidence syntheses (From COVID-END Synthesizing WG)
• GIN COVID-19 Evidence Resources
• SRDR+, Covidence, Distiller SR, RevMan, JBI Sumari
• Doctor Evidence Analytics Tool
• AHRQ EPC Methods Guides
• COMET (Core Outcome Measures in Effectiveness Trials
• Equator Network: Enhancing the QUAlity and Transparency Of health Research
• STARR Decision Tool (for rapid review approaches)

• COVID-NMA has initiated communication with all trialists to try to ensure consistent approaches e.g. selection of outcomes, reduction of risk of bias, and to invite them to contribute missing data. 
• Framework slides: Applying Standards to the Evidence Domain (from the COKA Evidence Ecosystem Liaison WG)

For people using or consuming guidance:

• COVID-END Inventory of Resources to Support Decisionmakers for evidence on public health measures, clinical management, health systems, and social and economic issues
• GIN Library of Guidelines – to search for completed, planned, or in-development guidelines
• ECRI COVID-19 Guideline Resources and ECRI Library for the full repository of guidelines

• Indico platform to assist in guideline development and dissemination.

• Guidelines Central – a repository of guidelines (structured at the recommendation level) whose developers contract with this company. Over 1.5 million healthcare professionals use the web and mobile APIs.

• For guidelines, evaluate using AGREE II. https://www.agreetrust.org/agree-ii/

For people producing guidance:

• make sure that recommendations include the most specific information possible on who/what/when/where/how (and why); bring guideline consumer stakeholders to the table very early in the process of developing guidelines to ensure that the recommendations will be helpful in meeting clinical needs - and be consumable in a computable fashion. (e.g., - have a knowledge engineer in the loop - see 'make guidance computable section below for details.)
• Coding is important to support downstream computability efforts - (Need to lay out exactly what guidance producers need to know and do to make this - integrate guidance development with efforts to make computable)
• For maintenance, i.e., 'living guidance' -
  • Monitor literature (studies and systematic reviews) that relate to the focus of the guideline. Grade material is it becomes available. Don't start from scratch- leverage other efforts to process the upstream evidence. (include links in this guidance section back to pertinent tools in the 'upstream' supply chain tables above)
  • Modify the guideline according.
• GIN Library to register guidelines in process
• PICO(TTS) paradigm
• GRADEpro GDT
• WHO-INTEGRATE evidence to decision framework
• EtD Framework
• mDelphi surveys to achieve consensus
• GRADE for grading recs
• GIN-McMaster Guideline Development Checklist
• WHO Handbook for Guideline Development
• Indico platform to assist in guideline development and dissemination. Unbundled database of guideline representation that allows precise version control, recommendation-specific database elements including appropriate use, field-level keyword/coding, and consensus management via rec voting/Delphi, form/general/text-specific external feedback. "Living" is achieved by selectively applying updates to the consensus management flow and into deliverable pathways which could include publication, mobile apps, integrated web pages, and any API integrated platform.
• Many medical professional societies develop guidelines and each has their its own manual, available on the society’s website and/or published in their journal

--------------------

Regarding Terminologies: HL7 Project "Guidelines for a Standardized Terminology Knowledge base"

Regarding Value Sets recommend the following process (applies to anticoagulation, testing/triage, vaccines, steroids, and any other topic):

1. Take inventory of what value sets you’ll need (be specific)
2. Check Alliance website or Value Set Authority Center (VSAC), we might have already published some of them among the 600+ value sets
3. If certain value sets are not present or you are unsure, contact Victor Lee (Victor_Lee@ClinicalArchitecture.com) to inquire or to request development

Clinical Architecture and other Alliance collaborators are donating our efforts, and Clinical Architecture is leveraging its software tooling, hosting infrastructure, and manual labor to donate all of the COVID-19-related value set content to the public domain (i.e., completely free, no strings attached). That being said, we all have day jobs, so we appreciate having as much lead time as possible to fulfill requests. Happy to take questions.

• KHN article on educating patients about vaccines

• See Output Repositories from Synthesize Evidence table

• ASH Living Guideline on COVID anticoagulation and underlying justification and evidence tables (critically ill and acutely ill)
• NIH Guideline
• AU living Guideline
• NEJM vignette with expert opinion
• INESSS (Institut national d'excellence en santé et en services sociaux, Montreal, Quebec) published a report in June: ‘’COVID-19 and thrombotic risks’’ (https://www.inesss.qc.ca/fileadmin/doc/INESSS/COVID-19/COVID-19_INESSS_Risques_Thrombothiques.pdf)

• BMJ/Remote Triage in Ambulatory Care

• INESSS has not published any reports on testing/triage but scientific teams at INESSS have provided information to the Ministry of Health for the provincial management of the pandemic. The Institut national de santé publique du Québec (INSPQ – Quebec National Institute of Public Health) is also involved in this regard.

• Living Map of COVID-19 recommendations (Canadian Institutes of Health Research)
• ECRI COVID-19 Guideline Resources
• GIN will publish (has published?) a registry of guidelines in development (COVID and beyond)

IOM Standards: Clinical Practice Guidelines We Can Trust

• GIN COVID-19 Guidance Resources
• MAGICapp; 
• COVID-END Rapid Response Model and Tips/Tools
• GRADE
• International Patient Decision Aid Standards
• 9/15/20 Annals IM article on COVID guidelines. 
• AGREE II for assessing guideline quality and reporting;
• Africa Centre for Evidence Living Hub of COVID-19 Knowledge Hubs

• The patient's voice should always be part of guideline and HTA development. Alternatively, include parents of children or other advocates and/or healthcare consumers.
• COVID-END Recommending WG guidance on producing COVID-19 Guidelines [to be released soon]
• 2011 NAM (IOM) Standards for Guidelines
• Guideline development resources: GIN/McMaster Checklist, Australia Guidelines for Guidelines Handbook
• Methodologies for the Development of CHEST Guidelines and Expert Panel Reports 
• “Developing an institutional health technology assessment framework: the example of principles for stakeholder participation”, presents some recent developments in INESSS methods;
• “HTA Ultra-rapid responses to inform decision-making during the COVID-19 pandemic: methodological development”, summarizes the methods developed at INESSS since March to rapidly answer COVID-19 related questions for the Ministry of Health and clinicians in the health network in Quebec.