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手术中的质量保证——不仅仅是术后并发症的记录

[Quality assurance in surgery--more than documentation of postoperative complications].

作者信息

Grundmann R T

机构信息

Medizinische Wissenschaft, B. Braun Melsungen AG.

出版信息

Zentralbl Chir. 1996;121(3):157-66.

PMID:8867341
Abstract

This review discusses several aspects of surgical quality assurance: 1. The surgical audit to collect data and analyze postoperative complications. 2. Quality assurance by measurement of patients' postoperative long-term outcome. 3. The elaboration of therapeutical guidelines. 4. Measurement of costs and benefit of the surgical intervention including patients' postoperative quality of life. 5. Quality assurance of clinical trials and medical publications. It is demonstrated that the regular documentation of postoperative complications and an internal data analysis improve the results, dependent on the quality of the data which is best guaranteed by a neutral observer. The late results after operation are mainly influenced by the quality of the surgeon, as prove recurrence rates after hernia repair ranging between 0 and 10% using identical operation techniques, or locoregional recurrences of 30-60% after abdominal perineal resection of the rectum. The elaboration of therapeutical guidelines may be helpful for the evaluation of the benefit of the intervention and for the prevention of unnecessary operations as has been demonstrated for the treatment of symptomatic and asymptomatic carotid artery stenoses. Qualified clinical studies performed according to the GCP rules with biometrical planning, clear cut definition of the purpose of the study and listing of inclusion and exclusion criteria are the prerequisites of substantiated therapeutical guidelines. Under increasing economic pressure not only the benefit, but also the costs of treatment are of major importance, the evaluation of the cost effectiveness ratio by measuring the cost per quality adjusted year of life saved will become essential for future therapeutical recommendations.

摘要

本综述讨论了外科手术质量保证的几个方面

  1. 外科手术审计,用于收集数据并分析术后并发症。2. 通过衡量患者术后长期预后进行质量保证。3. 制定治疗指南。4. 衡量手术干预的成本和效益,包括患者术后的生活质量。5. 临床试验和医学出版物的质量保证。结果表明,术后并发症的定期记录和内部数据分析可改善结果,这取决于数据质量,而中立观察者能最好地保证数据质量。术后的远期结果主要受外科医生的质量影响,例如使用相同手术技术时,疝气修补术后的复发率在0%至10%之间,或直肠癌腹会阴切除术后局部区域复发率为30%至60%。治疗指南的制定可能有助于评估干预措施的益处并预防不必要的手术,如在有症状和无症状颈动脉狭窄的治疗中所证明的那样。根据GCP规则进行的合格临床研究,具备生物统计学规划、明确的研究目的定义以及纳入和排除标准清单,是有充分依据的治疗指南的前提条件。在经济压力不断增加的情况下,不仅治疗的益处,而且治疗成本也至关重要,通过衡量每挽救一个质量调整生命年的成本来评估成本效益比,对于未来的治疗建议将变得至关重要。

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