Group discussions

It is important to make it very clear from the start of any guideline project that there are processes and tools that can be used to assess the quality of evidence and risk of bias. There should be training for the health workforce (providers and researchers) to help them understand how to use these tools. Ethics committees and guideline development team members could be trained on ethical and scientific assessment of study design.

A range of changes to the way clinical trials are designed and funded are supported, including:

• increasing the scientific appraisal of research projects before submitting proposals to ethics committees. This ensures robust design to determine the therapeutic benefit of drugs and any superiority to existing products
  
• encouraging researchers to involve real people in trials so that the applicability of the drugs to the appropriate populations is rigorously tested
  
• requiring researchers to provide full access to all trial data in a way that it can be easily and publicly accessed
  
• promoting the independent funding of research rather than relying on industry-funded research, such as through the introduction by government of a prescriptive 5% tax on the pharmaceutical industry to cover the funding of independent clinical research
  
• increasing the transparency of all clinical trial data and making this information freely available. For example, research funders/purchasers should require registration of trials and access to all trial data if industry seeks to have public reimbursement of its products
  
• providing feedback on the usefulness of the research undertaken so that the funders of Australian research can commission the research that is needed.
  

Guideline development teams need to be seen to be independent and have a Chair without any conflicts of interest and, if required, an expert Co-chair. To ensure that guideline teams adopt processes for interpreting evidence in a way that addresses the risk of bias, the following strategies are proposed:

• provide training on a standard methodology for conducting systematic searches of databases to find the most relevant and appropriate data
  
• provide training on reporting on critical appraisal of the evidence (e.g. detecting bias, interpreting the trial results and reporting risk and benefit data)
  
• ensure that teams include the right mix of people appraising the studies. Evidence should be reviewed by multidisciplinary teams.
  
• introduce standards for guideline development processes, such as recording sources of funding for guideline development teams, ensuring that guidelines are peer reviewed and open for public consultation
  
• ensure that there is a balance of the kind of evidence that is used in the development of guidelines (e.g. looking at issues from different perspectives such as remote rural issues and also qualitative data)
  
• acknowledge where there are areas of disagreements between guideline team members in the published guidelines.
  

It is important that people involved in guideline development and the assessment of therapeutic evidence have appropriate skills and expertise in their work. However, there should be a range or balance and diversity of interests represented – they should not be dominated by one group or one approach.

Before inviting people to join a guideline team, find out about each prospective team member's interests.

Discuss the need for transparency of interests with the people invited to be part of a guideline or project team. Advise them that their declarations of interests will be shared with other members of the group and published with the guideline.

There should be full public disclosure of all pecuniary and non-pecuniary interests of the group members so that the interests can be actively managed by the Chair.

Provide the Chairs of guideline development groups with training on the range of strategies available to manage conflicts of interest.

There needs to be a clear policy describing the steps that can be adopted to manage conflicts, and the process for making decisions should be agreed in advance. These processes should be reported in guidelines or other publications.

Processes for managing conflicts should include:

• being clear that full disclosure is a requirement of participation
  
• recording points of difference or disagreement
  
• recording how declared interests were managed during meetings
  
• ensuring that the process includes a way to keep sensitive or personal interests private and shared only with the Chair.
  

Clinicians and consumers want to rely on the credibility of the agency providing advice. There needs to be clear information explaining that disclosure of interests is not ‘naming and blaming’, but is a credible professional and ethical operating process.

End users want to be able to assess the significance of the interest, to know that a process of managing the interest has been followed, and to be given advice about how to interpret the impact of the interest.

It would be useful to research what effect disclosures have on the perception of reliability of guidelines.

Should guideline developers such as Therapeutic Guidelines and other guideline development agencies include being agents for change? Should they take on an ‘activist’ role, promoting change in practice and addressing public health outcomes in guidelines?

Some of the activities guideline developers could consider include:

• advocating for greater access to clinical trial results
  
• identifying and prioritising areas of unmet patient need that require more research
  
• advocating for increased public funding for clinical trials
  
• developing strategies to help people understand how to use guidelines
  
• taking on a broader role with consumer information (e.g. promoting evidence-based consumer information resources to accompany guidelines)
  
• broadening the scope of guidelines to include diagnosis and social determinants of health. Guideline developers could actively consider a wider range of interventions (beyond drug therapy) for inclusion in guidelines and also address deprescribing issues.
  
• including discussion about the effectiveness of complementary and alternative therapies in guidelines and having an agreed process for assessing the evidence/effectiveness of these therapies
  
• extending the remit of guidelines to include implementation activities.