{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T16:46:12Z","timestamp":1784306772926,"version":"3.55.0"},"reference-count":21,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"unspecified","delay-in-days":209,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int J Technol Assess Health Care"],"published-print":{"date-parts":[[2025]]},"abstract":"<jats:title>Abstract<\/jats:title>\n\t  <jats:p>Patient involvement is an increasingly recognized cornerstone of effective Health Technology Assessment (HTA). Clear, accessible information empowers patient organizations to contribute meaningfully to HTA. Therefore, an international Summary Information for Patient Groups template was developed to provide plain language summaries of new medicines being assessed. Pilots using the template were conducted in Australia in 2021 and England in 2022, providing a trial within the HTA process. In Australia, the Consumer Evidence and Engagement Unit (CEEU) used a workshop and survey, together with key stakeholder interviews, to gather feedback. In England, the National Institute for Health and Care Excellence used public consultation, surveys, and a Short-Life Working Group (SLWG). An advisory board with patient organizations provided additional insights. The feedback enabled members of the HTA International Patient and Citizen Involvement in HTA Interest Group to evaluate the potential to enhance patient organization submissions to HTA bodies and to provide recommendations on the template\u2019s implementation in HTA processes. The pilots highlighted that plain language summaries increased confidence and reduced preparation time for patient organization input to HTA. Other nonexpert stakeholders also found them valuable for fostering understanding. However, challenges remain, including mitigating bias in completed templates, allocating sufficient resources, and integrating into existing processes. The evaluation concludes that the approach holds significant potential to enhance patient organization involvement in HTA. Recommendations include setting up multi-stakeholder SLWGs, ensuring early access to summaries, and aligning implementation with local regulations. These insights provide guidance for HTA bodies to develop an approach to support patient involvement.<\/jats:p>","DOI":"10.1017\/s0266462325100408","type":"journal-article","created":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T06:26:58Z","timestamp":1753770418000},"source":"Crossref","is-referenced-by-count":6,"title":["Plain language summaries supporting patient involvement: lessons and guidance from HTAi Patient and Citizen Involvement Interest Group (PCIG)"],"prefix":"10.1017","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8354-0136","authenticated-orcid":false,"given":"Martin Andrew","family":"Coombes","sequence":"first","affiliation":[{"name":"Opened Door Consultancy Limited"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Morgan","sequence":"additional","affiliation":[{"name":"Myeloma Patients Europe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose","family":"Diaz","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth M.","family":"Oehrlein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hayley","family":"Andersen","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9238-7729","authenticated-orcid":false,"given":"Ramiro","family":"Gilardino","sequence":"additional","affiliation":[{"name":"MSD Innovation & Development GmbH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kawitha","family":"Helme","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiona","family":"Pearce","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Cardone","sequence":"additional","affiliation":[{"name":"Cancer Patients Europe"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2025,7,29]]},"reference":[{"key":"S0266462325100408_r19","unstructured":"19. National Institute for Health and Care Excellence (NICE) [Internet]. Summary of Information for Patients (SIP): Template. 2023. Available from: SIP\u00a0template.docx [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r5","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2018.00231"},{"key":"S0266462325100408_r14","unstructured":"14. Biointelect [Internet]. Broadening the evidence: Enhancing patient engagement in health technology assessment of medicines in Australia. 2019. Available from: https:\/\/www.biointelect.com\/broadening-the-evidence-report\/ [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r8","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2023.1176200"},{"key":"S0266462325100408_r6","doi-asserted-by":"publisher","DOI":"10.1186\/s40900-021-00327-5"},{"key":"S0266462325100408_r15","unstructured":"15. Single, A. Summary of Information for HCOs Trial Report: Broadening the Evidence: Recommendation 7. (2021) for Bristol Myers Squibb (Data on file)."},{"key":"S0266462325100408_r4","article-title":"Patient advocate perspectives on involvement in HTA: an international snapshot","volume":"3","author":"Scott","year":"2017","journal-title":"BMC Res Involv Engage"},{"key":"S0266462325100408_r21","unstructured":"21. Australian Government Department of and Aged Care Health [Internet]. Enhance HTA: An Enhanced Consumer Engagement Process in Australian Health Technology Assessment \u2013 A report of recommendations. 2024. Available from: https:\/\/www.health.gov.au\/sites\/default\/files\/2024-09\/enhance-hta-an-enhanced-consumer-engagement-process-in-australian-health-technology-assessment-a-report-of-recommendations.pdf [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r20","unstructured":"20. National Institute for Health and Care Excellence (NICE) [Internet]. Summary of Information for Patients (SIP): Guidance for industry on completing the template. 2023. Available from: Guidance\u00a0for\u00a0industry\u00a0when\u00a0completing\u00a0the\u00a0SIP.docx\u00a0(live.com) [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r18","unstructured":"18. National Institute for Health and Care Excellence (NICE) [Internet]. How to use the company\u2019s Summary of Information for Patients (SIP): NICE guide for patient experts. 2022. Available from: summary-of-information-for-patients-guide.docx (live.com) [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r16","unstructured":"16. Medicines Australia. The Summary of Information Pilot Survey. 2022. (Data on file)."},{"key":"S0266462325100408_r7","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.922708"},{"key":"S0266462325100408_r13","unstructured":"13. The Patients Association. Hearing the voice of patients in assessing new medicines. 2022. Report commissioned by Bristol Myers Squibb (Data on File)."},{"key":"S0266462325100408_r9","unstructured":"9. Scottish Medicines Consortium (SMC) [Internet]. Making a submission. 2020. Available from: https:\/\/www.scottishmedicines.org.uk\/making-a-submission\/ [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r17","unstructured":"17. HTAi PCIG Projects [Internet]. Resources and Materials: Plain language summaries of applications to HTA bodies for patient groups. Available from: https:\/\/htai.org\/patient-and-citizen-involvement\/ [accessed 2025 Mar 28]."},{"key":"S0266462325100408_r1","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462320000215"},{"key":"S0266462325100408_r10","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462321000167"},{"key":"S0266462325100408_r3","doi-asserted-by":"publisher","DOI":"10.1007\/978-981-10-4068-9"},{"key":"S0266462325100408_r2","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462317000976"},{"key":"S0266462325100408_r11","unstructured":"11. National Institute for Health and Care Excellence (NICE) [Internet]. A co-production approach to implementing the Summary of Information for Patients (SIP) for medicines at NICE. 2020. 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