0.60). CONCLUSION:The framework incorporates PRAOs as a way to identify cases that need to be evaluated for adverse events. Further validation of this framework is warrant with the final aim of implementation at larger scale. The implementation of this framework will enable clinicians, researchers and healthcare institutions to compare outcome rates across providers and over time. " />

BACKGROUND:The assessment of adverse events from a patient-centered view includes patient-reported adverse outcomes. An adverse outcome refers to any suboptimal outcome experienced by the patient; when adverse outcomes are identified through a patient interview these are called patient-reported adverse outcomes. An adverse event is an adverse outcome that is more likely due to the processes of medical care rather than to the mere progression of disease. In the context of a large-scale study assessing post-hospitalization adverse events, we developed a conceptual framework to assess patient-reported adverse outcomes (PRAOs). This methodological manuscript describes this conceptual framework. METHODS:The PRAO framework builds on a validated adverse event ascertainment method including three phases: Phase 1 involves an inquiry to ascertain the occurrence of any patient-reported adverse outcome. It is completed by a structured telephone interview to obtain details - from a patient perspective - on symptoms that developed and/or worsened after hospitalization. Phase 2 involves the classification of PRAOs by physicians not involved in the patient care. Physician-reviewers then rate the PRAOs using well-adopted scales to determine whether the occurrence was the natural progression of the underlying illness or due to medical care. When the PRAO is rated as "due to medical care", it is then classified as an "adverse event". Phase 3 involves the classification of adverse events as preventable or ameliorable. RESULTS:Out of the 1347 patients contacted at 1-month post-discharge, 469 reported AOs and after reviewing 369 cases, 29 were classified as AEs. Observed agreement levels between raters were 87.3, 85.5, and 85.2 % respectively displaying a good agreement (k > 0.60). CONCLUSION:The framework incorporates PRAOs as a way to identify cases that need to be evaluated for adverse events. Further validation of this framework is warrant with the final aim of implementation at larger scale. The implementation of this framework will enable clinicians, researchers and healthcare institutions to compare outcome rates across providers and over time.

译文

背景:以患者为中心的不良事件评估包括患者报告的不良后果。不良结局是指患者经历的任何次优结局;当通过患者访谈确定不良结果时,这些称为患者报告的不良结果。不良事件是一种不良后果,很可能是由于医疗过程而不是仅仅由于疾病的进展。在评估住院后不良事件的大规模研究的背景下,我们开发了一个概念框架来评估患者报告的不良结局(PRAO)。该方法论手稿描述了此概念框架。
方法:PRAO框架建立在经过验证的不良事件确定方法的基础上,包括三个阶段:第一阶段涉及对患者报告的不良结果进行确认的调查。它可以通过结构化的电话采访来完成,以从患者的角度获取住院后出现和/或恶化的症状的详细信息。第二阶段涉及不参与患者护理的医生对PRAO的分类。然后,内科医生审阅者使用公认的量表对PRAO进行评分,以确定发生的原因是潜在疾病的自然进展还是由于医疗。当PRAO被评定为“由于医疗护理”时,则将其分类为“不良事件”。第三阶段涉及将不良事件分类为可预防或可缓解。
结果:在出院后1个月接触的1347例患者中,有469例报告了AO,在审查369例后,有29例归为AE。评估者之间观察到的协议水平分别为87.3%,85.5%和85.2%,显示出良好的一致性(k> 0.60)。
结论:该框架结合了PRAO,以识别需要评估不良事件的病例。对该框架进行进一步验证是有必要的,其最终目标是大规模实施。该框架的实施将使临床医生,研究人员和医疗保健机构能够比较提供者之间以及随着时间推移的结果率。

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