Neil Bertelsen of the HTAi Patient and Citizen Involvement in HTA Interest Group (PCIG), outlines why tools and resources to encourage patient involvement in HTA Early Dialogue processes with patients are essential
Early Dialogues with regulators are a well-established process in which medicines developers have the opportunity to discuss their research plans and gain advice and feedback on their planned approach. Patient engagement and involvement in these dialogues is needed to ensure that patient experience, perspectives and knowledge is captured as part of this dialogue.
However, engagement of patients in these Early Dialogue processes is an emerging discipline among HTA bodies, with a range of methods being piloted and used. There remains a clear need to provide adaptable tools and resources to support patient engagement processes for HTA bodies and provide guidance on suitable methods and approaches, says Neil Bertelsen, who led the PARADIGM working group that designed this tool.
“Our aim was to focus on the HTA Early Dialogue process to ensure that patients are engaged at this very important time. It is at the Early Dialogue stage that medicine developers can still change their plans based on the feedback they receive. So having patient engagement in Early Dialogues benefits the patient community by ensuring that their perspectives are part of this process,” he explains.
It also benefits medicine developers by providing them with insights and critique from the patient perspective, leading to better designed clinical trials that are more focused on capturing the impacts of a condition and its treatment in a way that better reflects the patient experience and needs.
According to Bertelsen, this tool could not have been created without the engagement, support and input from multiple HTA bodies. The group first engaged in a four-step process that led to the identification of tools that would benefit HTA bodies conducting Early Dialogues. Step one was a scoping meeting, where HTA bodies that already conducted Early Dialogues and involved patients in the process were included. “At this meeting, we focused on understanding the main challenges that those conducting Early Dialogues face,” Bertelsen says.
A larger HTA workshop then followed, where a wider selection of HTA bodies attended: some of which do not conduct Early Dialogues yet; some that only conduct Early Dialogues as part of the EUnetHTA process; and some that conduct their own Early Dialogues and include patients in their process. This workshop focused on the rationale of why patients should be engaged and the specific barriers to involving patients in an Early Dialogue process, and the outputs allowed the working group to develop a prioritized set of needs identified by the HTA bodies as the most important areas to focus on for the PARADIGM tools.
After another workshop, at which the tools were refined, draft tools were then written and shared with key members of the HTAi Patient & Citizen Involvement in HTA Group (PCIG). Further consultations with HTA bodies active in Early Dialogue processes were conducted, and in parallel, all the patient-facing tools were shared for public consultation via the PARADIGM consultation process. After this step, the tools were refined based on the feedback and finalised.
“We would like to thank the EUnetHTA Early Dialogue Working Party for ensuring we had such a diverse and active range of HTA bodies involved in these steps,” says Bertelsen. “In addition, we would like to thank the Pan-Canadian HTA body, CADTH, and the HTA body for England, NICE, who attended the workshop(s) and provided many insights and documents that helped further refine the tools that we developed.”
A primary consideration for the working group was that the tools needed to be developed and written for HTA bodies. Bertelsen explains that the experience of the HTAi is that tools that are easily adaptable to different HTA systems work best.
“That is why we wanted the tools to remain in Microsoft Word format so that HTA bodies can easily edit these to match their needs. We also needed each tool to be relatively short and independent of each other, so that an HTA body could take the tools they need.” This means the toolkit is deliberately designed to consist of many one and two-page templates, fact-sheets, checklists and guidance.
According to Bertelsen, the main challenge in devising the tool is that each HTA body performs Early Dialogues in a unique way, with no two processes identical.
“In the last of our HTA workshops, we focused on this and distilled the different processes down into two main engagement methods that HTA bodies use – face-to-face multi-stakeholder meetings and/or interviews with patients. By focusing the toolkit on helping with these two interaction methods, we were able to create a range of tools that are adaptable to all the main Early Dialogue processes. We also developed a range of additional tools that are useful to HTA bodies, regardless of the interaction methods used,” he explains. This includes finding, recruiting and contracting patients into the Early Dialogue process, as well as explaining the concept of Early Dialogues and the need for patient engagement in the process.
The group also expects that many of the tools will be eventually used by other stakeholders; many of the checklists and templates can easily be adapted for other stakeholders hosting multi-stakeholder meetings, for example.
Although the use of Early Dialogue by HTA bodies is in its nascence, the number doing so continues to grow.
“As each HTA body considers how to engage patients, or how to improve an existing patient engagement process, we see the tools as being a foundational resource to speed up and assist with this thinking and implementation. We hope that the impact of this toolkit will be to encourage more HTA bodies to build in patient engagement as they develop their processes,” Bertelsen says.