我们正在寻求指导围绕药物/药物使用评估(逾期或Mue)审计周期的道德问题,特别是关于调查结果的出版,而且也许关于这些审计的概要。
DUE is a quality improvement activity that involves data collection and evaluation (usually by audit), followed by ‘action’ or intervention and a repeat or ‘follow-up’ audit to monitor changes in practice. DUE methodology was used for a recent national quality improvement activity overseen across approximately 60 hospitals by an independent organisation funded by the government to promote quality use of medicines. Participating hospital ‘project teams’ were asked to identify a predefined number of patients from their surgical lists for the baseline audit, obtain consent from the patient for inclusion (‘if required by local authorities’), conduct a brief postoperative patient interview regarding pain management and, after discharge, retrospectively collect pain management data from the medical record .
数据已提交国家项目团队进行排序和评估,将个人和联合业绩归还回医院。然后在每个站点进行教育干预,试图解决医疗,护理和药房问题,并利用许多工具,包括一对一的“学术细节”,演示和海报。然后在每个机构进行后续审计(与基线相同)。
提交一份手稿我们describi》杂志上ng the conduct and outcome of the project in two hospitals, and comparing these with each other and with the national results. The hospitals were not specifically identified but were labelled A and B, although one could be assumed to have been the primary institution of the authors and the other probably one of two smaller institutions in the same area health network. The methods stated that formal patient consent was not required for the inpatient interview component because the questions asked fell within routine postoperative care. Institutional Ethics Committee approval appears not to have been sought for any aspect of the project in either of the hospitals concerned although the overall project appears to have been conducted with the approval of various state health bodies and presumably individual hospital administrations, although this is not clear.
稿件在许多场地上被拒绝,主要与方法论问题有关,部分与发布大量数据集的小组集的问题有关,并将最终根据国家项目的网站发布)。然而,提交的提出了提出了有关编辑之间存在一些辩论的其他道德问题,我们寻求应对解决这些问题的帮助,因为它似乎出现这种情况可能会越来越多地提出规律性。我们的第一个问题涉及研究科目研究。在提交文件中,假设似乎是患者是受试者,他们的“招聘”是讨论的。然而,我们认为调查的主题是参与医院的工作人员,因为它是在行为干预之前和之后正在检查的药物处方管理和文件行为。
我们的第二个问题是项目的性质。它是质量保证/改进活动,不需要伦理批准其行为和/或出版结果吗?或者实际上是一项研究研究研究教育干预对医院工作人员的行为效果,因此需要伦理委员会审议,批准和可能的个人参与者(工作人员)同意?
这种情况促进了关于研究与审计之间的差异的讨论。最重要的是,如果有干预,那么就是一项研究,但有人指出,有区域差异,不同的国家对什么类型的研究需要伦理批准有不同的政策。赫尔辛基宣言讨论了“人类受试者”,因此患者和员工之间不区分。该论坛的建议是为期刊开发自己的政策,也许是委员会在其日记中出版的课程。该论坛还重申了这一事实,即使学习有道德批准,编辑也不必公布它,如果他/训练对该研究的任何方面都不满意。
应对建议我们制定有关这些情况的内部政策,这是在我们随后的编辑委员会会议上讨论的。委员会的建议被委员会非常乐于助人,特别是与我们的评估协议,员工,而不是患者是这个特殊的“实验”的主题,以及周围的一些讨论和其他案件讨论的讨论应对利益冲突(新的ICMJE指南)和临床试验登记的应对论坛会议。bob官方app
正在考虑有关利益冲突和审判登记冲突的通知,以纳入我们的作者指示,也可以为新的编辑准则提供。bob官方app
The more difficult ethical question is yet to be fully resolved. However, we will continue to deal with such cases on a case by case basis and hopefully reach consensus among the editors.