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| | 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. |
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| − | == PHAC disclosure of interest form for guideline development ==
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| − | Diclosure of interests is the first step towards the proper management of any COIs that may be present. However, a common challenge among guideline developers is that disclosure forms often do not solicit sufficient detail to allow for a fulsome assessment for the presence of COI. In order to carry out an assessment, as described in the section below, we must rely on disclosure of information related to those factors. Figure 1 provides an overview of the link between disclosures and assessments of interests, and the identification and management of COI.[[File:COI processes.jpg|center|frame|622x622px|<u>Figure 1.</u> An overview of processes involved in the disclosure and assessment of interests, and identification and management of COI]]
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| − | Thus, PHAC has developed a disclosure of interest form that can be adapted by a wide variety of users, that solicits the details required to allow for an assessment to determine the presence of COI, as outlined in the following section. This disclosure form has been designed to be used in conjunction with the COI assessment tool provided below, but does not need to be. Groups may adopt the form as is, or adapt it to better suit the particular needs of their guideline development group. Note that certain elements of the form (e.g., PHAC privacy notice statement) are specific to external advisory bodies that serve PHAC.
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| − | [[Images/b/b2/PHAC DOI form 11Sept2020 v9.0.docx|Download PHAC Dislosure of Interest Form (last updated Sept 11, 2020)]]
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| − | == PHAC COI assessment tool for guideline development ==
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| − | There is an important distinction to make between disclosed interests, and the presence of COI. Expert advisory panelists providing advice to PHAC or otherwise developing guidance (e.g., clinical practice guidelines) may have a wide variety of affiliations and interests. As noted by the World Health Organization, "''The declaration of one or more secondary interests (declaration of interests) does not automatically mean that a conflict of interest is present: there is a distinction between the two. A transparent and objective process for assessing a declaration of interests is required to determine if a conflict exists and what its effects might be, and to manage any significant conflict of interest."''<ref name=":1">World Health Organization. WHO handbook for guideline development (2nd Edition); Chapter 6 Declaration and management of interest. WHO 2014. Available from: <nowiki>https://apps.who.int/medicinedocs/en/m/abstract/Js22083en/</nowiki></ref>
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| − | Individuals involved with guidance development panels (within PHAC, Health Canada, or otherwise) are regularly collecting disclosures of interests from their panel members. Groups have expressed challenges in determining if COI is present and how to best manage COI. A variety of approaches are currently being used to determine COI and associated management options, and approaches are not always well documented, leading to concerns about consistency and transparency.
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| − | PHAC therefore sought to develop a structured COI assessment tool that can:
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| − | * Aid the processes of COI management for groups that work with external bodies of experts
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| − | * Be used to consistently and transparently evaluate disclosed interests for the presence of COI, and determine the ideal management approach
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| − | * Be flexible and adaptable enough to fit the needs of a variety of groups in different contexts
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| − | This tool was informed by an environmental scan of factors used to assess for the presence of COI, as well as approaches to COI management, among the international guideline community. Factors commonly considered in assessing for COI include:
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| − | * Relevancy/specificity to the topic<ref name=":0">Schünemann HJ, Al-Ansary LA, Forland F, et al. Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015;163:548–553.</ref><ref name=":1" /><ref name=":2">Haute Autorité de Santé. Guide des déclarations d’intérêts et de gestion des conflits d’intérêts. HAS 2013 (revised 2017). Available: <nowiki>https://www.has-sante.fr/portail/upload/docs/application/pdf/guide_dpi.pdf</nowiki> (accessed May 15 2019).</ref><ref>National Institute for Health and Care Excellence. Policy on declaring and managing interest for NICE advisory committees. NICE, April 2018. Available: <nowiki>https://www.nice.org.uk/Media/Default/About/Who-we-are/Policies-and-procedures/declaration-of-interests-policy.pdf</nowiki> (accessed April 4 2019).</ref>
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| − | * Recency/currency<ref name=":1" /><ref name=":2" /><ref name=":3">Agence de Médecine Préventive. Prevention of Conflicts of Interest in NITAGs: Principles and guidance to implement Conflict of Interest management policy. AMP 2017. Available: <nowiki>http://www.nitag-resource.org/media-center/document/3465</nowiki> (accessed May 15 2019). </ref>
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| − | * Frequency of the interest/relationship<ref name=":2" /><ref name=":3" />
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| − | * Duration and depth of the relationship<ref name=":1" /><ref name=":3" />
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| − | * Amount (for financial interests)<ref name=":1" /><ref name=":3" />
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| − | * The role of the individual in the guideline process/decision-making<ref name=":1" /><ref name=":2" />
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| − | The PHAC tool allows for a structured and transparent assessment of the above factors (with provided instructions and rubrics), to allow the assessor to come to a final judgment about the presence of COI. Use of the tool involves the following steps:
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| − | # Interests are disclosed by the expert in the DOI form (see PHAC COI disclosure form for guideline development)
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| − | # Interests disclosed in forms by experts are input into the tool by the assessor
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| − | # Assessor makes a judgment on relevancy and other key considerations
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| − | # Based on those factors, a judgment is made on the presence (yes/no) and type of COI (financial, non-financial) and how significant the COI is (low, moderate, high), with the aid of a rubric/algorithm
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| − | Figure 2 provides a conceptual schematic of the tool. '''Detailed instructions for assessing each factor and making judgments on the type and significance of COI are included in the tool.'''
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| − | [[File:COI tool.jpg|center|frame|573x573px|<u>Figure 2.</u> Conceptual schematic of the PHAC COI assessment tool. Information that will be disclosed in the PHAC disclosure of interest form are in red. Other considerations could, for example, be whether a published article was based on opinion versus simply restating published evidence. It could also be, for example, if an honorarium or grant was paid to the individual’s institution versus directly to them. ]]
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| − | As noted in Figure 1, when COIs are deemed to be present, the next step is management of those COIs. To facilitate consistent and transparent approaches to managing COI, an algorithm has been developed (Figure 3)to help guide assessors to suggested management options taking into account:
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| − | * The type of COI (direct/indirect financial, non-financial)
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| − | * The severity of COI (low, moderate high)
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| − | * Internationally recognized principles for the management of COI (e.g., GIN<ref name=":6" />)
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| − | '''This algorithm to guide users on how to manage COI is included in the COI assessment tool, along with detailed instructions for users.'''
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| − | [[File:COI Tool Algorithm .jpg|center|frame|<u>Figure 3.</u> Algorithm for determining management options for COI. The management options provided herein are suggestions that take into account international standards such as the GIN principles, and can be modified to suit the individual needs of each guideline group. Where multiple options are presented, the choice may depend on the number of COI identified, the presence of COI among other panelists involved in a guideline, and how strict a stance the group wishes to take on COI.|852x852px]]
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| − | [[Images/4/4d/PHAC COI Tool 19Aug2020.xlsx|Download PHAC COI Assessment Tool (last updated Aug 19, 2020)]]
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| | == Guidelines International Network (GIN) checklist == | | == Guidelines International Network (GIN) checklist == |