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Draft Policies for NHMRC Committees and Working Groups Developing Guidelines Submission

ID: 
8
Personal Details
Organisation Name: 
National Stroke Foundation
C. Additional Information
Please identify the best term to describe the Organisation: 
Other
E. Submission
Submission options: 
Section 1 – Policies Document
Section 2 – Key Elements and Flow Chart
Make general comments
Section 1 – Policies Document
1. Are there any gaps in the issues addressed in this document?: 

The policy does not include planned future potential conflicts of interest (COI), only existing COIs. Other international guideline standards articulate the need to manage both existing and planned conflicts. For example, from the US Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs)[1] states “disclosure should reflect all current and planned commercial (including services from which a clinician derives a substantial proportion of income), non-commercial, intellectual, institutional, and patient/public activities pertinent to the potential scope of the CPG”.




[1] Institute of Medicine (IOM) of the National Academies, Standards for Developing Trustworthy Clinical Practice Guidelines, March 2011

2. Does the document strike the right balance between ensuring adequate expertise is available to be deployed on the committee and creating a framework to ensure conflicts are managed appropriately? : 

We believe if anything the current framework is less ‘tight’ than it could be given the greater focus on COI not just for CPGs but in the clinical and research settings generally. We also believe it would be more helpful for this policy to be more explicit and less of a framework. Too much flexibility can lead to varying standards of COI management both within the NHMRC and for external guideline developers.

3. Do you have any suggestions for further guidance on matters to be declared?: 

a)      The document is clear with respect to identifying a COI. It is lacking in detail with respect to how to manage a COI.

b)      The process to declare and manage a COI could be clearer and be less discretionary. Currently, there is a lot of scope for the Senior Official which may result in differing standards of COI management. International guideline standards are quite clear with respect to declaring and managing a COI. For example, the Institute of Medicine Standards provide that COI of each GDG member should be reported and discussed by the prospective development group prior to the onset of their work. Each panel member should explain how their COI could influence the CPG development process or specific recommendations. It would be useful to have more guidance for what occurs at the COI meeting and the outcomes.

c)       The policy could be more explicit with respect to who should not be part of guideline development working group. For example, the chair or co-chairs should not be a person(s) with COI, funders should have no role in CPG development and members with COIs should represent not more than a minority of the guideline development working group.

d)      In the case where there are few experts in the field and a COI exists, one way of not losing the expertise and mitigating the COI is to use the clinician as a reviewer or consultant rather than a member of the guideline development working group.

4. Is there anything that should be declared which has not been included in this section?: 

Not that we can think of.

5. Is the amount to trigger a declaration of interests reasonable?: 

No, the financial amount whereby a conflict is declared is very small ($1000). This would capture the majority of clinicians who travelled to a conference or similar. If it is intended to capture everyone receiving a benefit then why not make the amount $100. Other countries have amounts such as $10,000 or similar. The amount should be set according to current international practice and maybe reflect the honorarium figure.

Section 2 – Key Elements and Flow Chart
1 - Are there any gaps in this section in relation to the guidance for the responsible Senior Officials at the Office of NHMRC to apply their judgement in how to manage any conflicts?: 

a)      For externally developed guidelines, will COIs be required to be posted on the NHMRC website or the website of the guideline developer, for example National Stroke Foundation? Suggest further guidance around this would be useful.

b)      The process for selecting group members based on COI is not clear -2.1.2 indicates ‘prospective group members’ are involved in a group discussion on COI. But then final decisions on group membership occur after this meeting. A more logical or flexible process would be for this meeting to occur once membership has been finalised and for all the necessary clarification of potential COI investigated by senior staff in conjunction with chair/s of the group. The NSF includes COI discussion as part of the first orientation group meeting rather than being separate. If a member chooses to update their COI form and no longer are deemed appropriate for group membership then another individual would be sort.

c)       Is it a requirement for COIs to be posted before the guideline development starts and as COIs arise or at the end of the guideline development process?

d)      There is little guidance about actually managing COIs –only listed briefly in 2.1.4c. This really is the most important part of COI as most experts will have some COI and hence managing those COI is essential. Further details/guidance is strongly recommended.

2. Is the flow chart an adequate representation of the proposed process?: 

Yes, as the process currently stands.

Comments: 

a)      The policy would be much clearer if it articulated two distinct parts of the process: recognising a COI and then managing a COI. The use of examples or case studies would help to demonstrate the difference and the various strategies available. Overall there is very little to guide actually managing COI. Given most experts would have some COI management needs to be an imperative. Currently the only reference to management strategies is 2.1.4c as examples only - we strongly advocate for further guidance to be included in this document.

b)      It would be beneficial to external guideline developers if the policy was clearer with respect to what is required from the NHMRC guideline developers and what is required from third-party guideline developers. As it stands, it is very difficult to determine what is relevant to external guideline developers and what is not or if everything is relevant to both.

c)       Where possible, the guideline development working group should be free from COI. In situations where this is not possible, the Gold standard would be for methodologists or external parties to summarise the evidence, prepare the evidence statements and write the draft recommendations.

d)      It would be useful to have definitions (glossary) for each of the key concepts.

Page reviewed: 5 November, 2012