Plain Language Summaries Supporting Patient Involvement: Lessons and Guidance from HTAi Patient and Citizen Involvement Interest Group (PCIG)
This peer-reviewed academic article published in the International Journal of Technology Assessment in Health Care evaluates the plain language Summary Information for Patient Groups template developed by HTAi Patient and Citizen Involvement Interest Group to support patient organisation involvement in Health Technology Assessment processes. Authored by Martin Coombes, Kate Morgan, Antonella Cardone (CPE), and colleagues, the article documents evaluation of pilot implementations at NICE (England, 9 submissions) and PBAC/CEEU (Australia, initial 2 submissions) testing the international Summary template based on the 2017 Scottish Medicines Consortium model. Methodology included NICE public consultation (80%+ of 103 respondents supported the initiative), Short-Life Working Group with 4 patient organisations, advisory board meeting, CEEU interviews with companies, 5 patient organisations, and CEEU representatives, and HTAi PCIG Project Subcommittee analysis. Key findings demonstrate plain language summaries increased patient organisation confidence in HTA submissions, reduced preparation time, improved quality and relevance of submissions, and helped patient organisations understand submission issues and evidence uncertainty. Challenges identified include variability in plain language level, governance concerns around company-written content requiring bias mitigation, resource requirements for completion and review, timing issues requiring early access before patient organisation submissions, and integration complexities with existing processes and local regulations. Eight recommendations for HTA bodies: establish multi-stakeholder Short-Life Working Groups, use multiple evaluation methods, clarify Summary foundation role in submissions, ensure clarity and accessibility with infographics, implement bias mitigation through HTA body review, plan adequate resource allocation, share summaries early enough to support patient input, and explore local regulation barriers during pilots.