Abstract：
OBJECTIVE: Real-world data (RWD) collected on patients treated as part of routine clinical care form the basis of cancer clinical registries. Capturing accurate death data can be challenging, with inaccurate survival data potentially compromising the integrity of registry-based research. Here, we explore the utility of data linkage (DL) to state-based registries to enhance the capture of survival outcomes.
METHODS: We identified consecutive adult patients with brain tumors treated in the state of Victoria from the Brain Tumour Registry Australia: Innovation and Translation (BRAIN) database, who had no recorded date of death and no follow-up within the last 6 months. Full name and date of birth were used to match patients in the BRAIN registry with those in the Victorian Births, Deaths and Marriages (BDM) registry. Overall survival (OS) outcomes were compared pre- and post-DL.
RESULTS: Of the 7,346 clinical registry patients, 5,462 (74%) had no date of death and no follow-up recorded within the last 6 months. Of the 5,462 patients, 1,588 (29%) were matched with a date of death in BDM. Factors associated with an increased number of matches were poor prognosis tumors, older age, and social disadvantage. OS was significantly overestimated pre-DL compared with post-DL for the entire cohort (pre- v post-DL: hazard ratio, 1.43; P < .001; median, 29.9 months v 16.7 months) and for most individual tumor types. This finding was present independent of the tumor prognosis.
CONCLUSIONS: As revealed by linkage with BDM, a high proportion of patients in a brain cancer clinical registry had missing death data, contributed to by informative censoring, inflating OS calculations. DL to pertinent registries on an ongoing basis should be considered to ensure accurate reporting of survival data and interpretation of RWD outcomes.
METHODS: We identified consecutive adult patients with brain tumors treated in the state of Victoria from the Brain Tumour Registry Australia: Innovation and Translation (BRAIN) database, who had no recorded date of death and no follow-up within the last 6 months. Full name and date of birth were used to match patients in the BRAIN registry with those in the Victorian Births, Deaths and Marriages (BDM) registry. Overall survival (OS) outcomes were compared pre- and post-DL.
RESULTS: Of the 7,346 clinical registry patients, 5,462 (74%) had no date of death and no follow-up recorded within the last 6 months. Of the 5,462 patients, 1,588 (29%) were matched with a date of death in BDM. Factors associated with an increased number of matches were poor prognosis tumors, older age, and social disadvantage. OS was significantly overestimated pre-DL compared with post-DL for the entire cohort (pre- v post-DL: hazard ratio, 1.43; P < .001; median, 29.9 months v 16.7 months) and for most individual tumor types. This finding was present independent of the tumor prognosis.
CONCLUSIONS: As revealed by linkage with BDM, a high proportion of patients in a brain cancer clinical registry had missing death data, contributed to by informative censoring, inflating OS calculations. DL to pertinent registries on an ongoing basis should be considered to ensure accurate reporting of survival data and interpretation of RWD outcomes.
摘要：
目的：收集的作为常规临床护理一部分的患者的真实世界数据（RWD）形成癌症临床登记的基础。获取准确的死亡数据可能具有挑战性，不准确的生存数据可能会损害基于注册表的研究的完整性。这里,我们探讨了数据链接(DL)与州注册中心的效用,以增强对生存结局的捕获.
方法：我们从澳大利亚脑肿瘤注册中心：创新与翻译（BRAIN）数据库中确定了在维多利亚州接受治疗的连续成年脑肿瘤患者，在过去6个月内没有记录死亡日期和随访。全名和出生日期用于将BRAIN注册表中的患者与维多利亚出生的患者进行匹配，死亡和婚姻（BDM）登记。比较DL前后的总生存期（OS）结果。
结果：在7,346例临床登记患者中，5,462（74％）在过去6个月内没有死亡日期和随访记录。在5462名患者中，1,588（29％）与BDM的死亡日期相匹配。与匹配数量增加相关的因素是预后不良的肿瘤，年龄较大,社会劣势。整个队列的OS与DL后相比，DL前显著高估了(DL后前：风险比，1.43；P<.001；中位数，29.9个月对16.7个月)，对于大多数个体肿瘤类型。这一发现与肿瘤预后无关。
结论：通过与BDM的链接显示，在脑癌临床注册中，有很高比例的患者丢失了死亡数据，通过信息审查做出了贡献，膨胀的操作系统计算。应考虑持续向相关注册表进行DL，以确保生存数据的准确报告和RWD结果的解释。
方法：我们从澳大利亚脑肿瘤注册中心：创新与翻译（BRAIN）数据库中确定了在维多利亚州接受治疗的连续成年脑肿瘤患者，在过去6个月内没有记录死亡日期和随访。全名和出生日期用于将BRAIN注册表中的患者与维多利亚出生的患者进行匹配，死亡和婚姻（BDM）登记。比较DL前后的总生存期（OS）结果。
结果：在7,346例临床登记患者中，5,462（74％）在过去6个月内没有死亡日期和随访记录。在5462名患者中，1,588（29％）与BDM的死亡日期相匹配。与匹配数量增加相关的因素是预后不良的肿瘤，年龄较大,社会劣势。整个队列的OS与DL后相比，DL前显著高估了(DL后前：风险比，1.43；P<.001；中位数，29.9个月对16.7个月)，对于大多数个体肿瘤类型。这一发现与肿瘤预后无关。
结论：通过与BDM的链接显示，在脑癌临床注册中，有很高比例的患者丢失了死亡数据，通过信息审查做出了贡献，膨胀的操作系统计算。应考虑持续向相关注册表进行DL，以确保生存数据的准确报告和RWD结果的解释。
