Johnson Eugenie Evelynne, Uteh Cyril Onwuelazu, Belilios Emma, Pearson Fiona
Population Health Sciences Institute, Newcastle University, Queen Victoria Road, Newcastle, NE1 4LP, UK.
NIHR Innovation Observatory, Newcastle University, Newcastle, UK.
Patient. 2025 Mar;18(2):109-114. doi: 10.1007/s40271-024-00721-7. Epub 2024 Nov 2.
The National Institute for Health and Care Excellence (NICE) produces guidance on the use of health technologies (including new and existing medicines, medical devices, diagnostics and interventional procedures) in the National Health Service. Technology Appraisals inform recommendations on the use of new and existing health technologies. As part of its health technology evaluation process, NICE ask independent research groups known as Evidence or External Assessment Groups (EAGs) to assess or evaluate the available evidence surrounding health technologies. Although patients and the public are involved in the wider NICE Heath Technology Evaluation and Assessment process, little is known about the extent to which patient and public involvement and engagement (PPIE) is undertaken and documented in EAG Reports.
This rapid scoping review aimed to discover the extent to which PPIE is currently undertaken and documented in EAG Reports, which feed into the wider NICE health technology assessment process, and whether EAG Reports contain a plain language summary.
We searched the NICE website for guidance published between 27 September, 2022 and 27 September, 2023. All records were downloaded directly from the NICE website into an Excel spreadsheet for extraction. Evaluations that were terminated before guidance was published or where an EAG Report was not available as supporting evidence were excluded. One researcher charted information regarding the type of each EAG Report, whether a plain language summary was included, and whether documentation of PPIE was included in the EAG Report either within a stand-alone section or throughout the main text of the report. A second researcher checked charted information for 20% of these records. We tabulated data and described PPIE conduct and documentation in included EAG Reports within a narrative synthesis.
A total of 97 EAG Reports were included in this rapid scoping review, the majority of which were documenting Single Technology Appraisals (N = 55). Of the 97 EAG Reports, 11 included a plain language summary. Of these 11 reports, two were Multiple Technology Appraisals, five were Diagnostic Assessment Reviews and four were Early Value Assessments. One Early Value Assessment, one Diagnostic Assessment Review and one Multiple Technology Appraisal reported that they did not conduct PPIE because of time constraints and noted that patients were involved in the wider NICE Appraisal process. Two Early Value Assessments that explicitly reported on PPIE used heterogenous methods of involvement.
There is currently limited PPIE documented in EAG Reports and inclusion of a plain language summary is uncommon. Further guidance is required to assist EAGs with embedding PPIE and a plain language summary into their Reports taking into consideration the ultra-rapid nature of the production of these reports.
英国国家卫生与临床优化研究所(NICE)针对国民医疗服务体系中卫生技术(包括新的和现有的药物、医疗设备、诊断方法及介入程序)的使用制定指南。技术评估为新的和现有的卫生技术使用建议提供依据。作为其卫生技术评估过程的一部分,NICE要求被称为证据或外部评估小组(EAGs)的独立研究小组评估围绕卫生技术的现有证据。尽管患者和公众参与了更广泛的NICE卫生技术评估和评价过程,但对于EAG报告中患者和公众参与及介入(PPIE)的开展程度和记录情况知之甚少。
这项快速范围综述旨在了解在纳入更广泛的NICE卫生技术评估过程的EAG报告中,PPIE目前的开展程度和记录情况,以及EAG报告是否包含通俗易懂的总结。
我们在NICE网站上搜索了2022年9月27日至2023年9月27日期间发布的指南。所有记录都直接从NICE网站下载到Excel电子表格中进行提取。在指南发布前终止的评估或没有EAG报告作为支持证据的评估被排除。一名研究人员梳理了关于每份EAG报告类型的信息,是否包含通俗易懂的总结,以及EAG报告中是否在单独部分或报告正文通篇包含PPIE的记录。第二名研究人员检查了这些记录中20%的梳理信息。我们将数据制成表格,并在叙述性综合分析中描述纳入的EAG报告中的PPIE开展情况及记录情况。
本快速范围综述共纳入97份EAG报告,其中大多数记录的是单一技术评估(N = 55)。在这97份EAG报告中,11份包含通俗易懂的总结。在这11份报告中,两份是多项技术评估,五份是诊断评估审查,四份是早期价值评估。一份早期价值评估、一份诊断评估审查和一份多项技术评估报告称,由于时间限制未开展PPIE,并指出患者参与了更广泛的NICE评估过程。两份明确报告了PPIE的早期价值评估采用了不同的参与方法。
目前EAG报告中记录的PPIE有限,且包含通俗易懂的总结并不常见。需要进一步的指南来协助EAG将PPIE和通俗易懂的总结纳入其报告,同时考虑到这些报告编制的超快速性质。