1999 年至 2019 年英国国家卫生与临床优化研究所技术评估中数据编辑实践的审核。

Audit of data redaction practices in NICE technology appraisals from 1999 to 2019.

机构信息

Health Policy, London School of Economics and Political Science, London, UK

出版信息

BMJ Open. 2021 Oct 6;11(10):e051812. doi: 10.1136/bmjopen-2021-051812.

DOI:10.1136/bmjopen-2021-051812

PMID:34615680

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8496400/

Abstract

OBJECTIVES

To assess the extent and type of data redaction in all active technology appraisals (TA) and highly specialised technology (HST) evaluations issued by the National Institute for Health and Care Excellence (NICE) from its conception of the institute to September 2019. To propose policy recommendations for transparency.

METHODS

Structured audit to establish extent of data redaction-proportion of appraisals and specific data categories and assess redaction by: indication, appraisal process, manufacturer, type of data-price, adverse events (AEs), clinical (excluding AEs), incremental quality-adjusted life-years. Longitudinal analysis over 20 years.

RESULTS

All TAs with available documentation and active recommendations (n=408) and HSTs (n=10) published from March 2000 to 11 September 2019 have been assessed for data redaction. Overall, 333 TAs (81.6%) have data redaction, 86 (25.8%) of them are heavily redacted. Clinical data (excluding AEs) are redacted in 268 (65.7%) appraisals, AE data in 128 (31.4%), price in 238 (58.3%). In total, 87% of oncology appraisals have redacted data vs 78% of non-oncology appraisals. 91% of single TAs have redacted data vs 59% of multiple TAs. 25% of final guidance documents (e.g. Final Appraisal Determination - FAD) do not report one or more instance of clinical data. Data redaction increased substantially over time, and is currently at its highest level with 100% of TAs having at least some data redaction in 2019/2020, 96% of appraisals in 2018/2019% and 94% of appraisals in 2017/2018. All 10 HST evaluations have redacted data, with 4 of them being heavily redacted.

CONCLUSIONS

Documents supporting NICE TA and HST recommendations are significantly redacted, thereby concealing clinical and economic data of importance to patients, clinicians and researchers. Documents remain redacted on the NICE website for years. Policy change is required to ensure transparency of data underpinning NICE's decisions.

摘要

目的

评估英国国家卫生与保健优化研究所（NICE）自成立以来截至 2019 年 9 月发布的所有现行技术评估（TA）和高度专业化技术（HST）评估中数据删减的程度和类型。为透明度提供政策建议。

方法

采用结构化审核方法，以确定数据删减的范围——评估的比例和特定数据类别，并通过以下方式评估删减情况：适应证、评估过程、制造商、数据类型（价格、不良事件（AE）、临床（不包括 AE）、增量质量调整生命年）。20 年来的纵向分析。

结果

评估了 2000 年 3 月至 2019 年 9 月 11 日发布的所有具有可用文件和现行建议的 TA（n=408）和 HST（n=10），以评估数据删减情况。总体而言，333 项 TA（81.6%）有数据删减，其中 86 项（25.8%）是重度删减。268 项评估删减了临床数据（不包括 AE），128 项评估删减了 AE 数据，238 项评估删减了价格数据（58.3%）。总的来说，87%的肿瘤学评估删减了数据，而非肿瘤学评估为 78%。91%的单一 TA 删减了数据，而 59%的多个 TA 删减了数据。25%的最终指导文件（如最终评估决定-FAD）未报告一个或多个临床数据实例。数据删减随着时间的推移大幅增加，目前处于最高水平，2019/2020 年 100%的 TA 至少有一些数据删减，2018/2019 年 96%的评估和 2017/2018 年 94%的评估都有数据删减。10 项 HST 评估均有数据删减，其中 4 项是重度删减。