Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study.
Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study.
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DOI：
10.1136/bmjopen-2016-013786
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发表时间：
2017-02-17
期刊：
影响因子：
2.9
通讯作者：
Avery AJ
中科院分区：
文献类型：
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作者：
Bell BG;Campbell S;Carson-Stevens A;Evans HP;Cooper A;Sheehan C;Rodgers S;Johnson C;Edwards A;Armstrong S;Mehta R;Chuter A;Donnelly A;Ashcroft DM;Lymn J;Smith P;Sheikh A;Boyd M;Avery AJ
大多数患者安全研究都集中在专科护理环境中，了解医疗错误的频率和原因，以及由此产生的不良事件的负担。然而，很少有大规模、稳健的研究调查初级保健中可避免伤害的程度和严重性。为了解决这个问题，我们将进行一项为期 12 个月的回顾性横断面研究，涉及初级保健患者的病例记录审查。我们将对全科医学 (GP) 临床计算机系统进行电子搜索，以识别可避免重大伤害的患者。根据诊所规模，将招募来自英格兰3个地区（东米德兰、伦敦和西北）的最多16家全科诊所，以获得约10万例患者的样本。我们的调查将包括对可避免的重大伤害风险最高的患者进行“增强样本”。我们将估计可避免的重大伤害的发生率，并将其表示为“每年每 100 000 名患者”。将进行单变量和多变量分析，以确定与可避免的重大伤害相关的因素。关于全科医生参与研究的决定完全是自愿的；参与同意可以随时撤回。我们不会就回顾性病例记录审查寻求个别患者的同意，但如果患者对有关该项目的宣传做出回应并表示他们不希望他们的记录被纳入，我们将遵循这些说明。我们将为卫生部的政策研究计划编写一份报告，并在科学期刊上发表几篇高质量的同行评审出版物。该研究已获得东米德兰诺丁汉 2 研究伦理委员会（参考号 15/EM/0411）的赞成意见，并且保密咨询小组批准根据 2006 年 NHS 法案第 251 条（参考号 15/CAG/0182）在未经同意的情况下访问医疗记录。
Most patient safety research has focused on specialist-care settings where there is an appreciation of the frequency and causes of medical errors, and the resulting burden of adverse events. There have, however, been few large-scale robust studies that have investigated the extent and severity of avoidable harm in primary care. To address this, we will conduct a 12-month retrospective cross-sectional study involving case note review of primary care patients. We will conduct electronic searches of general practice (GP) clinical computer systems to identify patients with avoidable significant harm. Up to 16 general practices from 3 areas of England (East Midlands, London and the North West) will be recruited based on practice size, to obtain a sample of around 100 000 patients. Our investigations will include an ‘enhanced sample’ of patients with the highest risk of avoidable significant harm. We will estimate the incidence of avoidable significant harm and express this as ‘per 100 000 patients per year’. Univariate and multivariate analysis will be conducted to identify the factors associated with avoidable significant harm. The decision regarding participation by general practices in the study is entirely voluntary; the consent to participate may be withdrawn at any time. We will not seek individual patient consent for the retrospective case note review, but if patients respond to publicity about the project and say they do not wish their records to be included, we will follow these instructions. We will produce a report for the Department of Health's Policy Research Programme and several high-quality peer-reviewed publications in scientific journals. The study has been granted a favourable opinion by the East Midlands Nottingham 2 Research Ethics Committee (reference 15/EM/0411) and Confidentiality Advisory Group approval for access to medical records without consent under section 251 of the NHS Act 2006 (reference 15/CAG/0182).