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General RecommendationsAnticoagulationTesting/TriageOther (Long COVID, Vaccine, Steroids)
Key Definitions and Frameworks
  • includes evaluation of quality of evidence 
  • also needs to address processing of real world evidence
  • [weave in ICER - search ISER opioids]



What to know/do (and why) Overview


  • 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


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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.




Input Sources
Output Repositories


Standards


Initiatives


Tools/ Platforms


Other Best Practices
  • 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)
  • ACCP/CHEST notes that given the need for rapid guideline development in COVID (1-2 month timeframe), they do not have the resources needed to produce full GRADE guidelines in these topic areas. They have adopted a heavily modified approach to limit some of the steps of GRADE – given this, they typically issue “ungraded” recommendations related to COVID.

    Modification of the Rapid Guideline Development approach from GIN-McMaster: https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-018-0330-0





Produce Guidance


General RecommendationsAnticoagulationTesting/TriageOther (Long COVID, Vaccine, Steroids)
Key Definitions and Frameworks



What to know/do (and why) Overview

For people using or consuming guidance:

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 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.


ACEP/EvidenceCare ED Severity Classification/Testing/Triage Tool
Input Sources
  • See Output Repositories from Synthesize Evidence table
  • 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.


Output Repositories


Standards

IOM Standards: Clinical Practice Guidelines We Can Trust




Initiatives



Tools/ Platforms


Other Best Practices
  • 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 ChecklistAustralia 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.
  • ACCP/CHEST reports that it has been helpful having a preset document format for COVID-related documents so guidelines have a similar structure and format across topic areas. This also allows for more rapid production and development.




Make Guidance Computable

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