全国癌症和死亡登记在临床试验结局确定中的完整性和准确性——卵巢癌为例。

Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials-an ovarian cancer exemplar.

机构信息

Department of Women's Cancer, Institute for Women's Health, University College London, London, WC1E 6AU, UK.

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn, 2nd Floor, London, WC1V 6LJ, UK.

出版信息

Trials. 2021 Jan 25;22(1):88. doi: 10.1186/s13063-020-04968-x.

DOI:10.1186/s13063-020-04968-x

PMID:33494753

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7831170/

Abstract

BACKGROUND

There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on the completeness and accuracy of national ovarian cancer and death registration in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

METHODS

Of the 202,638 participants, 202,632 were successfully linked and followed through national cancer and death registries of Northern Ireland, Wales and England. Women with registrations of any of 19 pre-defined ICD-10 codes suggestive of tubo-ovarian cancer or notification of ovarian/tubal/peritoneal cancer from hospital episode statistics or trial sites were identified. Copies of hospital and primary care notes were retrieved and reviewed by an independent outcomes review committee. National registration of site and cause of death as ovarian/tubal/peritoneal cancer (C56/C57/C48) obtained up to 3 months after trial censorship was compared to that assigned by outcomes review (reference standard).

RESULTS

Outcome review was undertaken in 3110 women on whom notification was received between 2001 and 2014. Ovarian cancer was confirmed in 1324 of whom 1125 had a relevant cancer registration. Sensitivity and specificity of ovarian/tubal/peritoneal cancer registration were 85.0% (1125/1324; 95% CI 83.7-86.2%) and 94.0% (1679/1786; 95% CI 93.2-94.8%), respectively. Of 2041 death registrations reviewed, 681 were confirmed to have a tubo-ovarian cancer of whom 605 had relevant death registration. Sensitivity and specificity were 88.8% (605/681; 95% CI 86.4-91.2%) and 96.7% (1482/1533, 95% CI 95.8-97.6%), respectively. When multiple electronic health record sources were considered, sensitivity for cancer site increased to 91.1% (1206/1324, 95% CI 89.4-92.5%) and for cause of death 94.0% (640/681, 95% CI 91.9-95.5%). Of 1232 with cancer registration, 8.7% (107/1232) were wrongly designated as ovarian/tubal/peritoneal cancers by the registry and 4.0% (47/1172) of confirmed tubo-ovarian cancers were mis-registered. In 656 with death registrations, 7.8% (51/656) were wrongly assigned as due to ovarian/tubal/peritoneal cancers while 6.2% (40/645) of confirmed tubo-ovarian cancer deaths were mis-registered.

CONCLUSION

Follow-up of trial participants for tubo-ovarian cancer using national registry data will result in incomplete ascertainment, particularly of the site due in part to the latency of registration. This can be reduced by using other routinely collected data such as hospital episode statistics. Central adjudication by experts though resource intensive adds value by improving the accuracy of diagnoses.

TRIAL REGISTRATION

ISRCTN: ISRCTN22488978 . Registered on 6 April 2000.

摘要

背景

目前，人们越来越倾向于使用常规收集的健康数据来确定试验中的结果测量指标。我们报告了英国卵巢癌筛查协作试验（UKCTOCS）中全国卵巢癌和死亡登记在完整性和准确性方面的情况。

方法

在 202638 名参与者中，有 202632 名成功通过北爱尔兰、威尔士和英格兰的国家癌症和死亡登记进行了随访。从医院发病统计数据或试验现场的 19 个预先定义的 ICD-10 代码中，确定有任何提示 tubo-ovarian 癌症的登记或卵巢/输卵管/腹膜癌通知的女性。从医院和初级保健记录中检索并由独立结果审查委员会审查了记录副本。在试验审查后 3 个月内获得的 site 和死因登记（卵巢/输卵管/腹膜癌（C56/C57/C48））与结果审查分配的登记（参考标准）进行了比较。

结果

对 2001 年至 2014 年期间收到通知的 3110 名女性进行了结果审查。在 1324 例确诊为卵巢癌的患者中，有 1125 例有相关癌症登记。卵巢/输卵管/腹膜癌登记的敏感性和特异性分别为 85.0%（1125/1324；95%CI 83.7-86.2%）和 94.0%（1679/1786；95%CI 93.2-94.8%）。在审查的 2041 份死亡登记中，有 681 份被确认为 tubo-ovarian 癌症，其中有 605 份有相关死亡登记。敏感性和特异性分别为 88.8%（605/681；95%CI 86.4-91.2%）和 96.7%（1482/1533，95%CI 95.8-97.6%）。当考虑多个电子健康记录来源时，癌症部位的敏感性提高到 91.1%（1206/1324；95%CI 89.4-92.5%），死因的敏感性提高到 94.0%（640/681；95%CI 91.9-95.5%）。在有癌症登记的 1232 名患者中，有 8.7%（107/1232）被登记处错误指定为卵巢/输卵管/腹膜癌，有 4.0%（47/1172）的确诊 tubo-ovarian 癌症被错误登记。在有死亡登记的 656 名患者中，有 7.8%（51/656）被错误分配为卵巢/输卵管/腹膜癌死亡，而有 6.2%（40/645）的确诊 tubo-ovarian 癌症死亡被错误登记。