South Tees NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
University of Leicester, NHS Trust, Leicester, UK.
Int Urogynecol J. 2021 Jan;32(1):135-140. doi: 10.1007/s00192-020-04388-0. Epub 2020 Jun 17.
Many advisory documents have recommended uploading of all mid-urethral sling (MUS) cases onto the British Society of Urogynaecology (BSUG) or British Association of Urological Surgeons (BAUS) database. The aim of this study was to determine whether these documents have resulted in an increase in database case acquisition for MUS surgery.
We determined the number of cases uploaded onto the BSUG and BAUS databases and cases acquired by Hospital Episode Statistics (HES) over the period January 2011-March 2017 for the 6 months prior to each document and 6 months afterwards.
There was an upsurge in data acquisition in 2013, which then declined after year end. There was a significant upsurge in case acquisition associated with the following documents: NHS Medical Director letter (p < 0.00001), the Healthcare Quality Improvement Partnership (HQIP) audit (p < 0.00001). There was a significant drop in case acquisition following the end of the HQIP audit (p < 0.00001) and the Mesh Working Group Interim report (p = 0.00325).
There was a significant increase in case acquisition with the HQIP audit and decline after it. The significant increase in case acquisition seen after the NHS MD letter in November 2012 may have been due to an overlap in the data capture between it and the HQIP audit. The levels of case acquisition do not compare to registries that are essentially compulsory and therefore we believe that voluntary databases are not effective for device post-market surveillance.
许多咨询文件建议将所有中尿道吊带(MUS)病例上传至英国泌尿妇科协会(BSUG)或英国泌尿科医师协会(BAUS)数据库。本研究旨在确定这些文件是否导致 MUS 手术数据库病例的增加。
我们确定了 2011 年 1 月至 2017 年 3 月期间每个文件之前和之后 6 个月内 BSUG 和 BAUS 数据库上传的病例数以及医院出院统计(HES)获得的病例数。
2013 年数据采集量出现激增,随后在年底后下降。以下文件与病例采集量的显著增加相关:NHS 医疗主任信函(p<0.00001)、医疗保健质量改进伙伴关系(HQIP)审计(p<0.00001)。HQIP 审计结束后(p<0.00001)和网孔工作组临时报告后(p=0.00325),病例采集量显著下降。
HQIP 审计后病例采集量显著增加,随后下降。2012 年 11 月 NHS MD 信函后病例采集量的显著增加可能是由于它与 HQIP 审计之间的数据采集重叠。病例采集水平与基本上是强制性的登记处无法相比,因此我们认为自愿数据库对于设备上市后监测无效。