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术前患者同意等待期的概念:对51例肩关节镜手术病例的前瞻性研究。

The concept of a waiting period for preoperative patient consent: Prospective study of 51 shoulder arthroscopy cases.

作者信息

Coudane H, Mangin M, Karam Y, Seivert V, Mainard D, Danan J L, Py B, Lighezzolo-Alnot J

机构信息

Service de chirurgie orthopédique traumatologique et arthroscopique, hôpital Central, CHRU de Nancy, 29, avenue du Maréchal-de-Lattre de Tassigny, 54035 Nancy, France; Équipe universitaire de recherche, (EA 7299) pratiques professionnelles, aspects méthodologiques, éthiques et juridiques, université de Lorraine, 13, place Carnot, 54035 Nancy, France.

Service de chirurgie orthopédique traumatologique et arthroscopique, hôpital Central, CHRU de Nancy, 29, avenue du Maréchal-de-Lattre de Tassigny, 54035 Nancy, France; Équipe universitaire de recherche, (EA 7299) pratiques professionnelles, aspects méthodologiques, éthiques et juridiques, université de Lorraine, 13, place Carnot, 54035 Nancy, France.

出版信息

Orthop Traumatol Surg Res. 2017 Sep;103(5):791-794. doi: 10.1016/j.otsr.2017.03.025. Epub 2017 May 31.

DOI:10.1016/j.otsr.2017.03.025
PMID:28578097
Abstract

INTRODUCTION

The French Code of Public Health (CSP) does not explicitly require that patients should be given a certain amount of time to think about a procedure, except for cosmetic surgery, where 15 days is required (Art. L 6322-2 CSP). We hypothesized that patients require a waiting period during their decision-making process for scheduled shoulder arthroscopy procedure.

MATERIALS AND METHODS

This prospective observational study of 51 patients analysed the concept of a waiting period based on a 10-item questionnaire. A comparative statistical approach was used and the P values were calculated using a paired Wilcoxon rank-sum test.

RESULTS

Of the 51 patients, 42 (82%) rejected the concept of a waiting period before the procedure and 37 patients (73%) did not want a mandatory waiting period imposed by law.

DISCUSSION

This study looked at the decision-making process during scheduled orthopaedic surgery and differentiated between the conscious and unconscious approach corresponding to an active and passive waiting period. A waiting period does not allow patients to make a conceptually deliberative decision that conforms to the criteria defined by the French Health Authority. This study rejects the need for a mandatory waiting period imposed on surgeons and patients as it does not integrate itself into the informative model of ethical decision-making for scheduled shoulder arthroscopy.

TYPE OF STUDY

Prospective, observational; level of evidence IV.

摘要

引言

法国《公共卫生法典》(CSP)并未明确要求患者在考虑手术时应给予一定时间,除了整形手术,整形手术需要15天的考虑时间(《公共卫生法典》第L 6322 - 2条)。我们假设患者在决定是否进行预定的肩关节镜检查手术过程中需要一段等待期。

材料与方法

这项对51名患者进行的前瞻性观察研究基于一份包含10个条目的问卷分析了等待期的概念。采用了比较统计方法,并使用配对威尔科克森秩和检验计算P值。

结果

在51名患者中,42名(82%)拒绝在手术前有等待期的概念,37名患者(73%)不希望有法律规定的强制等待期。

讨论

本研究观察了预定骨科手术过程中的决策过程,并区分了与主动和被动等待期相对应的有意识和无意识方法。等待期并不能让患者做出符合法国卫生当局定义标准的概念性审慎决策。本研究拒绝对外科医生和患者强制规定等待期的必要性,因为它并未融入预定肩关节镜检查伦理决策的信息模型。

研究类型

前瞻性观察性研究;证据等级IV。

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