Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Regent Court, Regent Street, Sheffield S1 4DA, UK.
Health Policy. 2011 Oct;102(2-3):136-44. doi: 10.1016/j.healthpol.2011.06.002. Epub 2011 Jul 16.
The NICE Single Technology Appraisal (STA) process in the UK has been underway for five years. Evidence Review Groups (ERGs) critically appraise submissions from manufacturers on the clinical and cost effectiveness of new technologies. This study analysed the ERGs' assessment of the strengths and weaknesses of 30 manufacturers' submissions to the STA process.
Thematic analysis was performed on the textual descriptions of the strengths and weakness of manufacturer submissions, as outlined by the ERGs in their reports.
Various themes emerged from the data. These themes related to the processes applied in the submissions; the content of the submission (e.g. the amount and quality of evidence); the reporting of the submissions' review and analysis processes; the reliability and validity of the submissions' findings; and how far the submission had satisfied the STA process objectives.
STA submissions could be improved if attention were paid to transparency in the reporting, conduct and justification of review and modelling processes and analyses, as well as greater robustness in the choice of data and closer adherence to the scope or decision problem. Where this adherence is not possible, more detailed justification of the choice of evidence or data is required.
英国 NICE 单一技术评估（STA）流程已经进行了五年。证据审查小组（ERG）对制造商提交的新技术的临床和成本效益进行严格评估。本研究分析了 ERG 对 30 家制造商提交给 STA 流程的评估的优势和劣势。
对 ERG 在报告中概述的制造商提交材料的优势和劣势的文本描述进行了主题分析。
从数据中出现了各种主题。这些主题涉及提交材料中应用的流程；提交材料的内容（例如证据的数量和质量）；提交材料的审查和分析过程的报告；提交材料的发现的可靠性和有效性；以及提交材料在多大程度上满足了 STA 流程的目标。
如果在报告、审查和建模过程和分析的进行以及合理性、数据选择的稳健性以及更紧密地遵守范围或决策问题方面更加注重透明度，STA 提交的材料可以得到改进。如果不可能遵守这一点，则需要更详细地说明证据或数据选择的理由。
