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PHAC Conflict of Interest Toolkit for Guideline Development (view source)
Revision as of 13:37, 30 March 2020
, 13:37, 30 March 2020Added resources from international guideline community
'''Background'''
== '''Background''' ==
Clinical and public health guidelines are “systematically developed, evidence-based statements which assist providers, recipients and other stakeholders to make informed decisions about appropriate health interventions.”<ref>Institute of Medicine (US) Committee to Advise the Public Health Service on Clinical Practice Guidelines; Field MJ, Lohr KN, editors. Clinical Practice Guidelines: Directions for a New Program. Washington (DC): National Academies Press (US); 1990. Available from: https://www.ncbi.nlm.nih.gov/books/NBK235751/</ref>
Clinical and public health guidelines are “systematically developed, evidence-based statements which assist providers, recipients and other stakeholders to make informed decisions about appropriate health interventions.”<ref>Institute of Medicine (US) Committee to Advise the Public Health Service on Clinical Practice Guidelines; Field MJ, Lohr KN, editors. Clinical Practice Guidelines: Directions for a New Program. Washington (DC): National Academies Press (US); 1990. Available from: https://www.ncbi.nlm.nih.gov/books/NBK235751/</ref>
Shortly after the BBE, the Canadian Medical Association Journal, one of the foremost publishers of guidelines in Canada, announced that as of 2020, all groups publishing guidelines in their journal must adhere to the GIN principles.<ref>Kelsall D. New CMAJ policy on competing interests in guidelines. CMAJ. 2019; 191(13):E350-351. </ref> Therefore it is anticipated that a key area for national leadership in this area will be to help Canadian guideline producers (within PHAC or external) in adhering to the GIN principles, and generally implementing best practices related to COI. For some groups, this may require only small shifts in their current policies and procedures, while for other groups (e.g., smaller or with less resources) this could require considerable work. PHAC, through its Guidance Innovation Hub has been working to develop a compendium of tools that can be used by national guideline development groups to help improve their practices related to the management of COI, including adherence to the GIN principles.
Shortly after the BBE, the Canadian Medical Association Journal, one of the foremost publishers of guidelines in Canada, announced that as of 2020, all groups publishing guidelines in their journal must adhere to the GIN principles.<ref>Kelsall D. New CMAJ policy on competing interests in guidelines. CMAJ. 2019; 191(13):E350-351. </ref> Therefore it is anticipated that a key area for national leadership in this area will be to help Canadian guideline producers (within PHAC or external) in adhering to the GIN principles, and generally implementing best practices related to COI. For some groups, this may require only small shifts in their current policies and procedures, while for other groups (e.g., smaller or with less resources) this could require considerable work. PHAC, through its Guidance Innovation Hub has been working to develop a compendium of tools that can be used by national guideline development groups to help improve their practices related to the management of COI, including adherence to the GIN principles.
== Resources from the international guideline community ==
=== Example disclosure of interest forms: ===
* [https://www.atsjournals.org/doi/full/10.1164/rccm.200901-0126ST#_i12 American Thoracic Society disclosure of interests form]
* CADTH pan-Canadian Oncology Drug Review disclosure of interest form for panel members
* CADTH pan-Canadian Oncology Drug Review disclosure of interest form for clinicians
* CADTH pan-Canadian Oncology Drug Review disclosure of interest form for patient groups
* Canadian Task Force on Preventive Healthcare disclosure of interest form (see Appendix 1)
* Cochrane Collaboration disclosure of interest form
* US FDA financial disclosure report – Executive Branch
* US FDA financial disclosure report – Special Government Employees
* National Academies of Science Engineering and Medicine disclosure of interest form for general scientific and technical studies and assistance
* National Academies of Science Engineering and Medicine disclosure of interest form for studies involving program reviews and evaluations
* National Academies of Science Engineering and Medicine disclosure of interest form for studies related to government regulation
* National immunization technical advisory groups (NITAGs)
** Initial COI declaration form
** COI annual update form
** COI declaration prior to a meeting
* National Institute for Health and Care Excellence (UK) disclosure of interest form for advisory committees
* National Institute of Health and Care Excellence (UK) disclosure of interest form for board members and employees
* Scottish Intercollegiate Guideline Network (SIGN) disclosure of interest form for completion by individuals, carers, voluntary organisations and members of the public
* United States Preventive Services Task Force (USPSTF) disclosure of interest form
=== Example algorithms/process maps for COI management ===
* American Thoracic Society COI resolution procedure
* CADTH pan-Canadian Oncology Drug Review COI management overview (Appendix A)
* European Medicines Agency COI management matrix
* Institut national d’excellence en santé et en services sociaux (INESSS) diagramme de processus en matière de conflits d’intérêts (Annexe D)
* National Research Council Canada COI flowchart
* National Institute of Health and Care Excellence (UK) process for declaring interests (Appendix A)
=== Example of published summaries of disclosures ===
o Australian Technical Advisory Group on Immunisation disclosure summary
o Haute Authorité de Santé (France) examples of public disclosures of experts
=== Example scales for assessing significance of COI ===
o American Thoracic Society method for evaluating significance of COI
o World Health Organization criteria for assessing the severity of a conflict of interest (see p. 78)
o USPSTF COI significance and management table
=== GIN principles paper ===
== References ==
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