SAHMRI Women & Kids, South Australian Health & Medical Research Institute, Adelaide, Australia; School of Public Health, The University of Adelaide, Adelaide, Australia.
School of Health and Related Research, The University of Sheffield, Sheffield, England, UK.
Value Health. 2020 Mar;23(3):388-396. doi: 10.1016/j.jval.2019.10.015. Epub 2020 Jan 23.
To systematically review the quality of reporting on the application of switching adjustment approaches in published oncology trials and industry submissions to the National Institute for Health and Care Excellence Although methods such as the rank preserving structural failure time model (RPSFTM) and inverse probability of censoring weights (IPCW) have been developed to address treatment switching, the approaches are not widely accepted within health technology assessment. This limited acceptance may partly be a consequence of poor reporting on their application.
Published trials and industry submissions were obtained from searches of PubMed and nice.org.uk, respectively. The quality of reporting in these studies was judged against a checklist of reporting recommendations, which was developed by the authors based on detailed considerations of the methods.
Thirteen published trials and 8 submissions to nice.org.uk satisfied inclusion criteria. The quality of reporting around the implementation of the RPSFTM and IPCW methods was generally poor. Few studies stated whether the adjustment approach was prespecified, more than a third failed to provide any justification for the chosen method, and nearly half neglected to perform sensitivity analyses. Further, it was often unclear how the RPSFTM and IPCW methods were implemented.
Inadequate reporting on the application of switching adjustment methods increases uncertainty around results, which may contribute to the limited acceptance of these methods by decision makers. The proposed reporting recommendations aim to support the improved interpretation of analyses undertaken to adjust for treatment switching.
系统评价发表的肿瘤学试验和向英国国家卫生与保健优化研究所（National Institute for Health and Care Excellence，NICE）提交的行业报告中关于转换调整方法应用的报告质量。尽管已经开发了秩保持结构失效时间模型（rank preserving structural failure time model，RPSFTM）和逆概率 censoring 权重（inverse probability of censoring weights，IPCW）等方法来解决治疗转换问题，但这些方法在卫生技术评估中并未得到广泛接受。这种有限的接受度可能部分是由于其应用报告不佳所致。
通过在 PubMed 和 nice.org.uk 上搜索，分别获得了已发表的试验和行业提交的材料。根据作者对这些方法的详细考虑，制定了一份报告建议清单，用于评估这些研究的报告质量。
13 项已发表的试验和 8 项向 nice.org.uk 提交的材料符合纳入标准。RPSFTM 和 IPCW 方法实施情况的报告质量普遍较差。很少有研究表明调整方法是否是预先指定的，超过三分之一的研究没有为选择的方法提供任何理由，近一半的研究忽略了进行敏感性分析。此外，RPSFTM 和 IPCW 方法的实施方式往往不明确。
对转换调整方法应用的报告不足增加了结果的不确定性，这可能是决策者对这些方法接受度有限的原因之一。所提出的报告建议旨在支持对调整治疗转换的分析进行更准确的解释。
