Michel Philippe, Quenon Jean Luc, de Sarasqueta Anne Marie, Scemama Olivier
Comité de Coordination de l'Evaluation Clinique et de la Qualité en Aquitaine, Hôpital Xavier Arnozan, 33604 Pessac, France.
BMJ. 2004 Jan 24;328(7433):199. doi: 10.1136/bmj.328.7433.199.
To compare the effectiveness, reliability, and acceptability of estimating rates of adverse events and rates of preventable adverse events using three methods: cross sectional (data gathered in one day), prospective (data gathered during hospital stay), and retrospective (review of medical records).
Independent assessment of three methods applied to one sample.
37 wards in seven hospitals (three public, four private) in southwestern France.
778 patients: medical (n = 278), surgical (n = 263), and obstetric (n = 237).
The main outcome measures were the proportion of cases (patients with at least one adverse event) identified by each method compared with a reference list of cases confirmed by ward staff and the proportion of preventable cases (patients with at least one preventable adverse event). Secondary outcome measures were inter-rater reliability of screening and identification, perceived workload, and face validity of results.
The prospective and retrospective methods identified similar numbers of medical and surgical cases (70% and 66% of the total, respectively) but the prospective method identified more preventable cases (64% and 40%, respectively), had good reliability for identification (kappa = 0.83), represented an acceptable workload, and had higher face validity. The cross sectional method showed a large number of false positives and identified none of the most serious adverse events. None of the methods was appropriate for obstetrics.
The prospective method of data collection may be more appropriate for epidemiological studies that aim to convince clinical teams that their errors contribute significantly to adverse events, to study organisational and human factors, and to assess the impact of risk reduction programmes.
比较使用三种方法估计不良事件发生率和可预防不良事件发生率的有效性、可靠性和可接受性，这三种方法分别为横断面法（一天内收集的数据）、前瞻性法（住院期间收集的数据）和回顾性法（病历审查）。
对应用于一个样本的三种方法进行独立评估。
法国西南部七家医院（三家公立、四家私立）的37个病房。
778名患者：内科（n = 278）、外科（n = 263）和产科（n = 237）。
主要结局指标是每种方法识别出的病例（至少发生一次不良事件的患者）比例与病房工作人员确认的病例参考列表相比，以及可预防病例（至少发生一次可预防不良事件的患者）比例。次要结局指标是筛查和识别的评分者间可靠性、感知工作量以及结果的表面效度。
前瞻性法和回顾性法识别出的内科和外科病例数量相似（分别占总数的70%和66%），但前瞻性法识别出的可预防病例更多（分别为64%和40%），识别的可靠性良好（kappa = 0.83），工作量可接受，且表面效度更高。横断面法显示出大量假阳性，未识别出任何最严重的不良事件。没有一种方法适用于产科。
前瞻性数据收集方法可能更适合于流行病学研究，这些研究旨在让临床团队相信他们的错误对不良事件有重大影响，研究组织和人为因素，以及评估风险降低计划的影响。
