澳大利亚和新西兰透析和移植登记处的数据质量：试点审计。

Data quality of the Australia and New Zealand Dialysis and Transplant Registry: a pilot audit.

机构信息

Department of Renal Medicine, Nambour General Hospital, Nambour, Queensland, Australia; The University of Queensland, Sunshine Coast Clinical School, Nambour General Hospital, Nambour, Queensland, Australia.

出版信息

Nephrology (Carlton). 2013 Oct;18(10):665-70. doi: 10.1111/nep.12126.

DOI:10.1111/nep.12126

PMID:23841726

Abstract

AIM

Most clinical registries in Australia, including the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA), do not audit submitted data. Inaccurate data can bias registry analysis. This study aimed to audit data submitted to ANZDATA from a single region.

METHODS

A retrospective audit of individual haemodialysis patient data recorded by ANZDATA at 31 December 2009 was completed by nephrologists in a blinded fashion. Original data were recorded by nursing staff. Patients received treatment at a public hospital, two affiliated satellite haemodialysis units, and three private haemodialysis units.

RESULTS

Fifty-one audits were completed of a total 175 patients (29.1%) undertaking haemodialysis in 2009. Primary renal disease was correct in 86.3% (95%CI: 74.3-93.2), although errors in type of glomerulonephritis were common. Date of first dialysis (± 1-month error margin) was correct for 93.6%. Creatinine at first dialysis (± 10% error margin) was correct in 74.4%. Baseline comorbidity accuracy included: peripheral vascular disease (sensitivity 36.4% (95%CI: 24.6-50.1), specificity 82.8% (95%CI: 70.2-90.7)), ischaemic heart disease (sensitivity 69.2% (95%CI: 55.6-80.2), specificity 88.0% (95%CI: 76.3-94.3)), chronic lung disease (sensitivity 25.0% (95%CI: 15.2-38.3), specificity 93.6% (95%CI: 83.4-97.7)), diabetes (sensitivity 86.4% (95%CI: 74.4-93.2), specificity 96.6% (95%CI: 87.5-99.1)), cerebrovascular disease (sensitivity 75.0% (95%CI: 61.7-84.8), specificity 95.3% (95%CI: 85.8-98.6)), and ever smoked (sensitivity 83.3% (95%CI: 70.3-91.4), specificity 71.4% (95%CI: 57.3-82.3)). Non-melanoma skin cancer was under-reported and inaccurate.

CONCLUSION

Data accuracy was favourable compared with other renal registry validation studies. Data accuracy may be improved by education and training of collectors. A larger audit is necessary to validate ANZDATA.

摘要

目的

澳大利亚的大多数临床注册中心，包括澳大利亚和新西兰透析和移植注册中心（ANZDATA），并不审核提交的数据。不准确的数据可能会影响注册中心的分析结果。本研究旨在对单一地区向 ANZDATA 提交的数据进行审核。

方法

对 2009 年 12 月 31 日 ANZDATA 记录的单个血液透析患者数据进行回顾性审核，由肾病学家以盲法方式进行。原始数据由护理人员记录。患者在一家公立医院、两家附属卫星血液透析单位和三家私人血液透析单位接受治疗。

结果

对 2009 年接受血液透析的 175 名患者中的 51 名患者（29.1%）进行了审核。原发性肾脏疾病的正确诊断率为 86.3%（95%CI：74.3-93.2），尽管肾小球肾炎的类型存在错误。首次透析的日期（±1 个月误差范围）正确的比例为 93.6%。首次透析时的肌酐值（±10%误差范围）正确的比例为 74.4%。基线合并症的准确性包括：外周血管疾病（敏感性 36.4%（95%CI：24.6-50.1），特异性 82.8%（95%CI：70.2-90.7））、缺血性心脏病（敏感性 69.2%（95%CI：55.6-80.2），特异性 88.0%（95%CI：76.3-94.3））、慢性肺部疾病（敏感性 25.0%（95%CI：15.2-38.3），特异性 93.6%（95%CI：83.4-97.7））、糖尿病（敏感性 86.4%（95%CI：74.4-93.2），特异性 96.6%（95%CI：87.5-99.1））、脑血管疾病（敏感性 75.0%（95%CI：61.7-84.8），特异性 95.3%（95%CI：85.8-98.6））和曾吸烟（敏感性 83.3%（95%CI：70.3-91.4），特异性 71.4%（95%CI：57.3-82.3））。非黑色素瘤皮肤癌报告不足且不准确。