Department of Surgery, Helsingborg Hospital, Helsingborg, Lund University , Lund , Sweden.
Acta Oncol. 2013 Nov;52(8):1707-14. doi: 10.3109/0284186X.2013.805886. Epub 2013 Jun 20.
Founded in 1995, the Swedish Rectal Cancer Registry (SRCR) is frequently used for rectal cancer research. However, the validity of the registry has not been extensively studied. This study aims to validate a large amount of registry data to assess SRCR quality.
The study comprises 906 patients treated with major abdominal surgery registered in the SRCR between 1995 and 1997. SRCR data for 14 variables were scrutinized for validity against the medical records. Kappa's and Kendall's correlation coefficients for agreement between SRCR data and medical records data were calculated for 13 variables.
For 11 variables, concerning the tumor, neoadjuvant therapy, the surgical procedure, local radicality and TNM stage, data were missing in 5% or less of the registrations; for the remaining three variables, anastomotic leakage, local and distant recurrence, data were missing in 13-38%. For the variables surgery performed or not and type of surgical procedure, no data were missing. Erroneous registrations were found in less than 10% of all variables; for the variables preoperative chemotherapy and surgery performed or not, all registrations were correct. For the variables concerning neoadjuvant therapy, local radicality according to the surgeon as well as the pathologist and distant metastasis, the false-positive or -negative registrations were equally distributed, and for the variables rectal washout, rectal perforation, anastomotic leakage and local recurrence there was a discrepancy in distribution. The correlation coefficient for 12 variables ranged from 0.82 to 1.00, and was 0.78 for the remaining variable.
The validity of the SRCR was good for the initial three registry years. Thus, research based on SRCR data is reliable from the beginning of the registry's use.
瑞典直肠癌注册中心（SRCR）成立于 1995 年，常用于直肠癌研究。然而，该注册中心的有效性尚未得到广泛研究。本研究旨在验证大量的注册数据，以评估 SRCR 的质量。
该研究纳入了 1995 年至 1997 年期间在 SRCR 登记的 906 例接受大腹部手术治疗的患者。对 14 项变量的 SRCR 数据进行了详细审查，以评估其与病历记录的一致性。计算了 13 项变量的 SRCR 数据与病历记录数据之间的 Kappa 和 Kendall 相关系数。
11 项变量（涉及肿瘤、新辅助治疗、手术方式、局部根治性和 TNM 分期）的登记中，数据缺失率在 5%或以下；其余 3 项变量（吻合口漏、局部和远处复发）的登记中，数据缺失率在 13%-38%。手术是否进行和手术方式这两个变量没有数据缺失。所有变量中，错误登记率均低于 10%；对于新辅助化疗和手术是否进行这两个变量，所有登记均正确。对于新辅助治疗、局部根治性（由外科医生和病理学家评估）和远处转移等变量，假阳性或假阴性登记率分布均匀；对于直肠冲洗、直肠穿孔、吻合口漏和局部复发等变量，登记分布存在差异。12 项变量的相关系数范围为 0.82 至 1.00，其余变量的相关系数为 0.78。
在最初的三年登记期间，SRCR 的有效性良好。因此，从注册中心开始使用时起，基于 SRCR 数据的研究是可靠的。
