Professor Chris Baggoley
Dr Peter Greenberg
Dr Suzanne Hill
Professor Robert Moulds
Professor Martin Tattersall
Dr Janet Wale
Professor Paul Komesaroff
Each panellist was invited to comment on the issues raised by Professor Paul Komesaroff and Associate Professor Ian Kerridge in their earlier presentations, and comments from the forum participants were also invited.
Identifying pecuniary and non-pecuniary interests
Issues of faith and religion are important to many people and are part of their make-up. Along with a number of other factors (such as their background and cultural perspectives), they contribute to each person's view of the world. It is incredibly complex, and most people are not aware of how their range of personal beliefs could influence decisions. When it comes to declaring interests, it is useful to declare faith as a possible duality of interest and to ask the group of people you are working with whether they believe it is significant enough to be a potential conflict of interest. If it is an issue, then one should disassociate oneself from the work.
By declaring the full spectrum of interests (financial, academic influence/kudos, professional or personal/family ties) early in the process, others on a group or team have a chance to consider whether it is an issue and how it can be managed. It also makes clear to others that the conflict does not create an obligation through association.
Non-industry related conflicts should also be disclosed, and there should be transparency and discussion about the effect of an interest.
Do government links and funding create potential conflicts? This is a particular consideration in cases where the government might have an established policy it wants to have upheld, or where the government may be required to consider funding activities proposed by a guideline.
Another type of conflict arises when people have gone on public record for or against a particular form of care, treatment or product and may be seen as having a fixed view that will not be swayed by evidence or other information provided to a guideline committee.
Many interests and conflicts may be hard to quantify, but it is important to strive to be as transparent as possible.
Consumers and practitioners want to trust health services and guidelines. In the past, the trust has been based on non-disclosure and placing a lot of faith in people to ‘do the right thing’, but there is now a strong clear call for disclosure on as many things as possible. There should also be more consumer representation and engagement on guideline teams. Where consumers represent organisations and decision-making bodies, the funding sources of those organisations should also be disclosed.
How to manage conflicts of interest
It is not possible to avoid the issues of bias in data and research. Agencies and guideline development teams need to choose people who are as independent as possible, and have transparent processes for them to follow. By having agreed processes, good people will not be discouraged from participation on guideline teams.
It might be useful to look at other sectors to see how they deal with conflict of interest issues. Does the jury system have processes that could help inform guideline processes for managing interests?
Is there a risk that disclosure could lull people into a false sense of confidence and assurance?
People with a range of values can bring a wealth of expertise to the development of a guideline. It is possible to separate out financial interests from expertise. There needs to be guidance about when people with ‘interests’ or expertise should be included or excluded from discussions – for example should a person involved in research about drugs or health services be part of a committee that approves that product or service? The American Thoracic Society has looked at these issues very carefully and has implemented a transparent and structured process that allows experts who have made disclosures to discuss the evidence and give their expert opinions, but excludes them from the final debate on the evidence and the formulation of recommendations. Also, the guideline panel is led by a methodologist rather than a clinical expert.
There are people with connections to industry who can nevertheless provide specialist opinions that add value and perspective to the discussion of a guideline. To gain trust in the process, the conflicts need to be declared, managed, recorded and made publicly available. The Chair of the committee should be free from competing interests.
How to decide whether the disclosure is a conflict
A nuanced approach to identifying issues and influences that may present (or appear to present) a conflict is useful. There also needs to be consideration of whether a disclosure represents (or is perceived to represent) a high- or low-level conflict or influence, and appropriate responses are required. Or perhaps the views simply represent a valuable perspective? It will be important to ascertain whether the view or belief carries with it a real or perceived obligation to an external party.
Guidelines seek to be as reliable and credible as possible. One of the guiding principles in assessing the perception of conflict that can be used is to ask the question ‘What would be the impact if this issue was reported on the front page of a major newspaper?’ The answer to the question will help to judge the most appropriate ways to understand and deal with the declared interest.
The World Health Organization uses evidence juries and evidence hearings for managing conflicts of interest when the input of commercial groups or heavily sponsored groups is required.
Agencies like the Pharmaceutical Benefits Advisory Committee and Therapeutic Guidelines need to be seen to have high standards of disinterestedness because of their public roles and tasks. They provide advice on issues in the health sector that have the capacity to influence diagnosis, treatment, health outcomes and quality of life. They have an enormous amount of public credibility and integrity, and their reputations are at stake if they don't manage interests well.
Recruiting people onto guideline development groups
It is important to make every effort to find people with expertise who do not have significant ties with industry, academic conflicts or personal interests. The Pharmaceutical Benefits Advisory Committee requires members to make annual declarations of interests as well as a meeting-by-meeting declaration of interest that is recorded in the minutes. However, these declarations are not publicly disclosed, and in some cases it might be inappropriate if they were (e.g. a member of the committee declaring that a child in their family uses a drug that is being considered by the committee). Strategies such as recusal or removal from the room for the discussion of the item are used in meetings to ensure that the Committee as a whole maintains a high level of independence.
In addition to managing the conflicts or perceived conflicts of people on guideline development teams, it is also important to ensure that the members are aware of other areas and risks of bias in assessing research findings.
Guideline users want to have faith and belief in the scientific process and want to be sure that all reasonable care and scientific rigour has been applied to the guideline development. In a number of cases, guidelines are also used as training tools for new health practitioners. While there are a lot of competing kinds of information (such as activities funded by the pharmaceutical industry), there needs to be a way of assuring the users (including consumers) that guidelines have been developed using careful and independent processes. Trust and reputation of the guidelines are critical. It is important to users that the pecuniary interests, faith and beliefs of the guideline developers are clearly stated and managed, and that the evidence has been evaluated to assess the risk of bias.
Therapeutic Guidelines has a reputation for trusted, easy-to-access guidelines that are endorsed by professional colleges. Many guideline developers have a vested interest in either promoting government policy or maximising health outcomes.
The National Health and Medical Research Council has developed standards for clinical practice guidelines that require public comment on all draft guidelines so that any issues of bias can be disclosed and debated in the open. It also has conflict of interest guidelines and recently refused to approve a guideline developed by an external body (funded by taxpayers’ money) because of a conflict that was not dealt with by the developers. It is not always possible for those people developing guidelines to recognise where the perceived or real conflicts exist. It is unclear how many connections with industry are too many – what is the right number or financial limit?
Creating a framework
A framework for managing conflicts is required because it is not always clear when a conflict exists. There must be a formalised process in place that everyone knows, understands and respects. This process needs to be apparent to the people on guideline teams, the groups and agencies funding, approving and endorsing the guidelines (e.g. professional societies, non-government agencies and government agencies such as the Department of Health and Ageing and the National Health and Medical Research Council), and the users of the guidelines (e.g. health practitioners, healthcare students and health consumers). Thresholds should be agreed in advance so that it is clear how many connections with industry are too many. However, there are no absolute rules and some conflicts are hard to recognise, so there should be a process for reviewing declared conflicts as the work of the group progresses.
Declarations of conflicts are necessary but not sufficient. The time at which disclosures are made is also important. To make sure the conflicts can be managed and that the appropriate people are selected for guideline teams, disclosures should be made before inviting people to be involved. Agencies like Therapeutic Guidelines need to know the person’s background and affiliations before inviting them to participate on a guideline development group.
The overall framework of each guideline should be considered. The bigger issue beyond conflict of interest is whether the scope of the guideline is appropriate. For example, will the guideline cover a wide range of topics from diagnosis, to treatment, use of drugs and rehabilitation? It is also important to consider whether the process for considering the evidence encourages debate and provides opportunity for public consultation and comment. Guideline developers should also have a process to ensure regular updates of the guidelines so that they are relevant and provide advice on the latest most reliable evidence.