Van Rompaey V, Yung M, Van de Heyning P
Department of Otorhinolaryngology and Head & Neck Surgery, Antwerp University Hospital, Edegem, Belgium.
B-ENT. 2010;6(3):189-94.
Clinical auditing is a systematic process for improving quality of care. The primary goal is to compare current practice with established standards. A common dataset enables the comparison of results, and takes into account the effect of case mix, surgical techniques and follow-up periods on outcome. The Common Otology Database (COD) is a joint effort of an international group of otologists to standardise reporting on middle ear surgery, including myringoplasty, ossiculoplasty, stapes surgery and cholesteatoma removal. It aims to identify audit data using the internet (http://www.ear-audit.net), provide a storage system for otological data, to create a prospective database allowing statistical analysis with sufficient power and to produce standards for comparative auditing.
The COD provides two levels of data entry, anonymising surgeon and patient data. Level 1 is designed for general otorhinolaryngologists and trainees, and only records main outcomes. Level 2 is designed for benchmark otologists and includes detailed information about pathologies, risk factors, aim of surgery, surgical findings, procedures, follow-up periods and complications. Level-2 surgeons are required to submit pre-operative data on all patients scheduled for surgery in order to eliminate bias as a result of selective reporting.
The COD began in January 2004 and is continuously including patients. In May 2009, 2,291 cases were entered in the level-2 benchmark database, including 1,218 myringoplasties (53.2%), 576 ossiculoplasties (25.1%), 695 stapes surgeries (30.3%) and 532 cholesteatoma surgeries (23.2%). Currently, 151 surgeons use the database system (levels 1 and 2 combined). Eighteen otologists were invited to contribute to the level 2 database. Eight contributors complied with the validation criteria. Others did not cooperate, citing a lack of resources to support data input, or their health system discouraging follow-up. Some were also reluctant to have their outcome data subjected to external validation.
The COD has engaged the otological community to participate in a large-scale audit of current practice. The number of surgical procedures included has attained a level of power that will allow introductory statistical analysis.
临床审计是提高医疗质量的系统过程。其主要目标是将当前的医疗实践与既定标准进行比较。通用数据集能够对结果进行比较,并考虑病例组合、手术技术和随访期对结果的影响。通用耳科学数据库(COD)是国际耳科医生团队的一项共同努力,旨在规范中耳手术的报告,包括鼓膜成形术、听骨链成形术、镫骨手术和胆脂瘤切除术。其目的是利用互联网(http://www.ear-audit.net)识别审计数据,提供耳科数据存储系统,创建一个具有足够统计效力的前瞻性数据库,并制定比较审计标准。
COD提供两级数据录入,对手术医生和患者数据进行匿名处理。一级数据录入面向普通耳鼻喉科医生和实习生,仅记录主要结果。二级数据录入面向标杆耳科医生,包括有关病理、风险因素、手术目的、手术发现、手术过程、随访期和并发症的详细信息。要求二级数据录入的手术医生提交所有计划手术患者的术前数据,以消除选择性报告导致的偏差。
COD于2004年1月启动,患者数量不断增加。2009年5月,2291例病例录入二级标杆数据库,其中鼓膜成形术1218例(53.2%)、听骨链成形术576例(25.1%)、镫骨手术695例(30.3%)、胆脂瘤手术532例(23.2%)。目前,151名手术医生使用该数据库系统(一级和二级合计)。18名耳科医生受邀为二级数据库提供数据。8名贡献者符合验证标准。其他人员未合作,理由是缺乏支持数据录入的资源,或其卫生系统不鼓励随访。一些人也不愿让其结果数据接受外部验证。
COD促使耳科领域参与了对当前医疗实践的大规模审计。所纳入的手术例数已达到可进行初步统计分析的数量。