Changes

To maximize their impact, guidelines should be free of conflicts of interest (COI) – situations in which the judgment of an individual involved in developing a guideline is unduly influenced (or seen to be unduly influenced) by a secondary interest (such as the opportunity to derive personal benefit).<ref name=":4" />

To maximize their impact, guidelines should be free of conflicts of interest (COI) – situations in which the judgment of an individual involved in developing a guideline is unduly influenced (or seen to be unduly influenced) by a secondary interest (such as the opportunity to derive personal benefit).<ref name=":4" />

Given several high-profile news stories within and outside Canada,<ref>Johnson L, Stricker RB. Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process. Journal of Medical Ethics. 2009;35:283-288.</ref><ref>Lenzer J. French guidelines are withdrawn after court finds potential bias among authors. BMJ. 2011 Jun 24;342:d4007. </ref><ref>Howlett, K. Conflicts of interest didn’t influence new opioid standards: review. The Globe and Mail [online]. September 7, 2017. Available from: https://www.theglobeandmail.com/news/national/conflicts-of-interest-didnt-influence-new-opioid-standards-review/article36199835/</ref><ref>Dwyer, D. WHO drops opioid guidelines after criticism of corporate influence. The BMJ. 2019:365. Available from: https://www.bmj.com/content/365/bmj.l4374</ref><ref>Cosgrove L, Bursztajn HJ, Erlich DR, Wheeler EE, Shaughnessy AF. Conflict of interest and clinical guidelines. J Eval Clin Pract. 2013;19: 674-681.</ref><ref>The Canadian Press. Co-author of controversial meat study did not disclose ties to ‘classic front group’. National Post. October 5, 2019. Available from: https://nationalpost.com/news/canada/scientist-responds-to-critique-of-industry-ties-after-publishing-study-on-red-meat</ref><ref>Cohen D, Brown E. Surgeons withdraw support for heart disease advice. BBC Newsnight. December 9, 2019. Available from: https://www.bbc.com/news/health-50715156.</ref> the health community that benefits from evidence-based guidance and policy, and Canadians more generally, are increasingly aware of the importance of disclosing and managing COI in guidelines. These examples demonstrate the considerable reputational and other risks that poorly managed COI in the context of guidelines could pose to PHAC and its partners. Beyond that, proper management of COI is an established criterion for assessing guideline quality.<ref>Brouwers MC, Kho ME, Browman GP, Burgers J, Cluzeau F, Feder G, Fervers B, Graham, ID, Grimshaw J, Hanna S, Littlejohns P, Makarski J, Zitzelsberger L on behalf of the AGREE Next Steps Consortium. AGREE II: Advancing guideline development, reporting and evaluation in healthcare.  Can Med Assoc J.  2010;182:E839-842.</ref>  

Given several high-profile news stories within and outside Canada,<ref>Johnson L, Stricker RB. Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process. Journal of Medical Ethics. 2009;35:283-288.</ref><ref>Lenzer J. French guidelines are withdrawn after court finds potential bias among authors. BMJ. 2011 Jun 24;342:d4007. </ref><ref>Howlett, K. Conflicts of interest didn’t influence new opioid standards: review. The Globe and Mail [online]. September 7, 2017. Available from: https://www.theglobeandmail.com/news/national/conflicts-of-interest-didnt-influence-new-opioid-standards-review/article36199835/</ref><ref>Dwyer, D. WHO drops opioid guidelines after criticism of corporate influence. The BMJ. 2019:365. Available from: https://www.bmj.com/content/365/bmj.l4374</ref><ref>Cosgrove L, Bursztajn HJ, Erlich DR, Wheeler EE, Shaughnessy AF. Conflict of interest and clinical guidelines. J Eval Clin Pract. 2013;19: 674-681.</ref><ref>The Canadian Press. Co-author of controversial meat study did not disclose ties to ‘classic front group’. National Post. October 5, 2019. Available from: https://nationalpost.com/news/canada/scientist-responds-to-critique-of-industry-ties-after-publishing-study-on-red-meat</ref><ref>Cohen D, Brown E. Surgeons withdraw support for heart disease advice. BBC Newsnight. December 9, 2019. Available from: https://www.bbc.com/news/health-50715156.</ref><ref>Connolly A. Canadians can now see conflicts of interest declared by COVID-19 vaccine task force. Sept 22, 2020. Available from:https://globalnews.ca/news/7351016/covid-19-vaccine-task-force-conflicts-of-interest-disclosures/</ref><ref>Lexchin J, Mintzes B, Bero L, Gagnon M-A, Grundy Q. Canada’s COVID-19 Vaccine Task Force needs better transparency about potential conflicts of interest. The Conversation. Oct 8, 2020. Available from:https://theconversation.com/canadas-covid-19-vaccine-task-force-needs-better-transparency-about-potential-conflicts-of-interest-147323</ref> the health community that benefits from evidence-based guidance and policy, and Canadians more generally, are increasingly aware of the importance of disclosing and managing COI in guidelines. These examples demonstrate the considerable reputational and other risks that poorly managed COI in the context of guidelines could pose to PHAC and its partners. Beyond that, proper management of COI is an established criterion for assessing guideline quality.<ref>Brouwers MC, Kho ME, Browman GP, Burgers J, Cluzeau F, Feder G, Fervers B, Graham, ID, Grimshaw J, Hanna S, Littlejohns P, Makarski J, Zitzelsberger L on behalf of the AGREE Next Steps Consortium. AGREE II: Advancing guideline development, reporting and evaluation in healthcare.  Can Med Assoc J.  2010;182:E839-842.</ref>  

PHAC has taken steps towards addressing the issue of COI in guideline development by hosting a Best Brains Exchange on the topic<ref name=":5">Canadian Institutes of Health Research. Reducing and managing conflicts of interest in clinical practice guideline development: do we need Pan-Canadian standards? Government of Canada, 2019. Available from: http://www.cihr-irsc.gc.ca/e/51455.html</ref> in collaboration with CIHR. This meeting, which took place in January 2019, brought together over 60 participants representing academia, guideline producing groups from Canada and internationally, journal editors, and federal and provincial governments.  

PHAC has taken steps towards addressing the issue of COI in guideline development by hosting a Best Brains Exchange on the topic<ref name=":5">Canadian Institutes of Health Research. Reducing and managing conflicts of interest in clinical practice guideline development: do we need Pan-Canadian standards? Government of Canada, 2019. Available from: http://www.cihr-irsc.gc.ca/e/51455.html</ref> in collaboration with CIHR. This meeting, which took place in January 2019, brought together over 60 participants representing academia, guideline producing groups from Canada and internationally, journal editors, and federal and provincial governments.  

Overall, one clear theme emerged from the BBE: The need for national leadership, national standards, national approaches, and national transparency to help bring Canada up to the level of COI management seen in other countries.<ref name=":5" /> A report summarizing the BBE presentations and discussions is available in both official languages using the following links:

Overall, one clear theme emerged from the BBE: The need for national leadership, national standards, national approaches, and national transparency to help bring Canada up to the level of COI management seen in other countries.<ref name=":5" /> A report summarizing the BBE presentations and discussions is available in both official languages using the following links:

[[Images/0/0b/BBE COI in CPG development EN FINAL.pdf|CIHR/PHAC Best Brains Exchange (English) - Reducing and managing conflicts of interest in clinical practice guideline development: Do we need Pan-Canadian standards?]]

[[Media:BBE COI in CPG development EN FINAL.pdf|CIHR/PHAC Best Brains Exchange (English) - Reducing and managing conflicts of interest in clinical practice guideline development: Do we need Pan-Canadian standards?]]

[[Images/e/e1/BBE COI in CPG development FR FINAL.pdf|Échanges Meilleurs Cerveaux IRSC/ASPC (français) - Réduction et gestion des conflits d’intérêts dans l’élaboration de recommandations pour la pratique clinique : faut-il établir des normes pancanadiennes?]]

[[Media:BBE COI in CPG development FR FINAL.pdf|Échanges Meilleurs Cerveaux IRSC/ASPC (français) - Réduction et gestion des conflits d’intérêts dans l’élaboration de recommandations pour la pratique clinique : faut-il établir des normes pancanadiennes?]]

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.  

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 developed a compendium of tools, listed on this page, 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.

PHAC, through its Guidance Innovation Hub has developed a compendium of tools, listed on this page, 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.

== Guidelines International Network (GIN) checklist ==

* [[Media:PHAC DOI form 11Sept2020 v9.0.docx|PHAC Dislosure of Interest Form (last updated Sept 11, 2020)]]

The following checklist was developed by PHAC to aid journals seeking to implement the GIN principles on COI for authors, or guideline developers assessing or updating their policies to align with the GIN principles.

* [[Media:PHAC COI Tool 16Apr2021.xlsx|PHAC COI Assessment Tool (last updated April 16, 2021)]]

A link to the document will be uploaded soon.

Following the BBE, PHAC's Guidance Innovation Hub, along with BBE organizers and participants, developed practical guidance and tools for implementing the GIN principles, based on a scan of international best practices, informal interviews with guideline developers, and the experiences of the authors. This includes a checklist to aid journals seeking to implement the GIN principles on COI for authors, or guideline developers assessing or updating their policies to align with the GIN principles.

 

The article is published in CMAJ and is available in [https://www.cmaj.ca/content/193/2/E49 English] and [https://www.cmaj.ca/content/193/9/E324 French].

== Additional resources from the international guideline community ==

== Additional resources from the international guideline community ==

=== Examples of disclosure of interest forms: ===

=== Examples of disclosure of interest forms ===

* [https://www.atsjournals.org/doi/full/10.1164/rccm.200901-0126ST#_i12 American Thoracic Society disclosure of interests form]

* [https://www.atsjournals.org/doi/full/10.1164/rccm.200901-0126ST#_i12 American Thoracic Society disclosure of interests form]

* [https://www.cadth.ca/sites/default/files/pcodr/pCODR%27s&#x20;Drug&#x20;Review&#x20;Process/pcodr-coi-guidelines-form.docx CADTH pan-Canadian Oncology Drug Review disclosure of interest form for panel members]

* [https://www.cadth.ca/sites/default/files/pcodr/pCODR%27s&#x20;Drug&#x20;Review&#x20;Process/pcodr-coi-guidelines-form.docx CADTH pan-Canadian Oncology Drug Review disclosure of interest form for panel members]

* [https://www.health.gov.au/sites/default/files/atagi-conflict-of-interest-disclosures.pdf Australian Technical Advisory Group on Immunisation disclosure summary]

* [https://www.health.gov.au/sites/default/files/atagi-conflict-of-interest-disclosures.pdf Australian Technical Advisory Group on Immunisation disclosure summary]

* [https://www.has-sante.fr/jcms/sd_700659/fr/declaration-publique-d-interets Haute Authorité de Santé (France) examples of public disclosures of experts]

* [https://www.has-sante.fr/jcms/sd_700659/fr/declaration-publique-d-interets Haute Authorité de Santé (France) examples of public disclosures of experts]

=== Examples of scales for assessing the significance of COI ===

=== Examples of scales for assessing the significance of COI ===