Evans Sue M, Smith Brian J, Esterman Adrian, Runciman William B, Maddern Guy, Stead Karen, Selim Pam, O'Shaughnessy Jane, Muecke Sandy, Jones Sue
Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
Qual Saf Health Care. 2007 Jun;16(3):169-75. doi: 10.1136/qshc.2006.019349.
To assess the effectiveness of an intervention package comprising intense education, a range of reporting options, changes in report management and enhanced feedback, in order to improve incident-reporting rates and change the types of incidents reported.
DESIGN, SETTING AND PARTICIPANTS: Non-equivalent group controlled clinical trial involving medical and nursing staff working in 10 intervention and 10 control units in four major cities and two regional hospitals in South Australia.
Comparison of reporting rates by type of unit, profession, location of hospital, type of incident reported and reporting mechanism between baseline and study periods in control and intervention units.
The intervention resulted in significant improvement in reporting in inpatient areas (additional 60.3 reports/10,000 occupied bed days (OBDs); 95% CI 23.8 to 96.8, p<0.001) and in emergency departments (EDs) (additional 39.5 reports/10,000 ED attendances; 95% CI 17.0 to 62.0, p<0.001). More reports were generated (a) by doctors in EDs (additional 9.5 reports/10,000 ED attendances; 95% CI 2.2 to 16.8, p = 0.001); (b) by nurses in inpatient areas (additional 59.0 reports/10,000 OBDs; 95% CI 23.9 to 94.1, p<0.001) and (c) anonymously (additional 20.2 reports/10,000 OBDs and ED attendances combined; 95% CI 12.6 to 27.8, p<0.001). Compared with control units, the study resulted in more documentation, clinical management and aggression-related incidents in intervention units. In intervention units, more reports were submitted on one-page forms than via the call centre (1005 vs 264 reports, respectively).
A greater variety and number of incidents were reported by the intervention units during the study, with improved reporting by doctors from a low baseline. However, there was considerable heterogeneity between reporting rates in different types of units.
评估一套干预措施的有效性，该措施包括强化教育、一系列报告选项、报告管理的改变以及强化反馈，以提高不良事件报告率并改变所报告不良事件的类型。
设计、设置与参与者：非等效组对照临床试验，涉及南澳大利亚州四个主要城市的10个干预科室和10个对照科室以及两家地区医院的医护人员。
比较对照科室和干预科室在基线期和研究期之间按科室类型、职业、医院位置、所报告不良事件类型及报告机制划分的报告率。
该干预措施使住院区域的报告率显著提高（每10000个占用床日（OBD）增加60.3份报告；95%可信区间23.8至96.8，p<0.001）以及急诊科（ED）的报告率显著提高（每10000次急诊就诊增加39.5份报告；95%可信区间17.0至62.0，p<0.001）。更多报告由以下人员生成：（a）急诊科医生（每10000次急诊就诊增加9.5份报告；95%可信区间2.2至16.8，p = 0.001）；（b）住院区域护士（每10000个OBD增加59.0份报告；95%可信区间23.9至94.1，p<0.001）；（c）匿名报告（每10000个OBD和急诊就诊合并增加20.2份报告；95%可信区间12.6至27.8，p<0.001）。与对照科室相比，该研究使干预科室出现更多的文件记录、临床管理及与攻击行为相关的不良事件。在干预科室，通过单页表格提交的报告比通过呼叫中心提交的报告更多（分别为1005份和264份报告）。
在研究期间，干预科室报告的不良事件种类更多、数量更多，且基线较低的医生的报告率有所提高。然而，不同类型科室的报告率存在相当大的异质性。
