Carson-Stevens Andrew, McFadzean Isobel Joy, Purchase Thomas, Gwyn Sioned, Hellard Stuart, Davies Kate, Ashcroft Darren M, Avery Anthony, Campbell Stephen, Edwards Adrian, Flynn Sandra, Hewson Thomas, Ibrahim Saied, Jordan Melanie, Keers Richard N, Millar Tim, Panagioti Maria, Sanders Caroline, Senior Jane, Stevenson Caroline, Thompson Ellie, Walter Florian, de Wet Carl, Wainwright Verity, Shaw Jenny
Division of Population Medicine, Cardiff University, Cardiff, Cardiff, UK.
Wales Centre for Primary and Emergency Care Research (PRIME Centre), School of Medicine, Cardiff University, Cardiff, Cardiff, UK.
BMJ Open. 2024 Dec 20;14(12):e085607. doi: 10.1136/bmjopen-2024-085607.
Around 1 in 20 patients experience avoidable healthcare-associated harm worldwide. Despite longstanding concerns, there is insufficient information available about the safety of healthcare for prisoners. To address this, this study will investigate the scale and nature of avoidable healthcare-associated harm for prisoners in England.
We will undertake a large retrospective cross-sectional study involving a case note review of patient healthcare records in 18 prisons in England. Prisons will be purposively sampled for maximum variation of characteristics based on prison category (open, local, training, high security, female), type (publicly and privately run) and prison population size, to sample approximately 15 000 patient records. We will focus on two samples: an enhanced risk sample of prisoners, considered to be at the most risk of healthcare-associated harm, and a random sample of prisoners excluded from the enhanced risk sample, to estimate the incidence of avoidable harm, and express this as 'per 100 000 patients per year'. Avoidable harms will be characterised by type of incident(s), contributory incident(s), contributory factor(s), outcome(s) and severity of harm, prior to a thematic analysis of the relationships between those variables. Univariable and multivariable analyses will be conducted to identify factors associated with avoidable harm.
The decision regarding participation by prisons within the study will be voluntary, and their consent to participate may be withdrawn at any time. We will not seek individual patient consent for the retrospective case note review of their records, but if patients respond to publicity about the project and inform us that they do not wish their records to be included, we will adhere to their wishes. We will produce a report for the Department of Health's Policy Research Programme and several peer-reviewed publications. The study has been granted a favourable opinion by Wales Research Ethics Committee 3 (reference 19/WA/0291), Her Majesty's Prison and Probation Service (reference 2019-332) and the Confidentiality Advisory Group (CAG) to access the medical records without individual consent under Section 251 of the National Health Service Act 2006 (reference 19/CAG/0214).
全球约二十分之一的患者遭受了可避免的医疗相关伤害。尽管长期以来人们一直对此表示担忧，但关于囚犯医疗安全的信息却十分匮乏。为解决这一问题，本研究将调查英格兰囚犯中可避免的医疗相关伤害的规模和性质。
我们将开展一项大型回顾性横断面研究，对英格兰18所监狱中患者的医疗记录进行病例记录审查。将根据监狱类别（开放式、地方式、培训式、高度安全式、女子监狱）、类型（公立和私立）以及监狱人口规模，有目的地对监狱进行抽样，以实现特征的最大差异，从而抽取约15000份患者记录。我们将聚焦于两个样本：一个是被认为医疗相关伤害风险最高的囚犯强化风险样本，另一个是从强化风险样本中排除的囚犯随机样本，以估计可避免伤害的发生率，并将其表示为“每年每10万名患者”。在对这些变量之间的关系进行主题分析之前，可避免伤害将根据事件类型、促成事件、促成因素、结果和伤害严重程度进行特征描述。将进行单变量和多变量分析，以确定与可避免伤害相关的因素。
监狱参与本研究的决定将是自愿的，且它们可随时撤回参与同意书。我们不会就对其记录进行回顾性病例记录审查征求个体患者的同意，但如果患者对该项目的宣传做出回应并告知我们他们不希望其记录被纳入，我们将尊重他们的意愿。我们将为卫生部政策研究计划撰写一份报告，并发表几篇同行评审的出版物。本研究已获得威尔士研究伦理委员会3（参考编号19/WA/0291）、女王陛下监狱及缓刑服务局（参考编号2019 - 332）以及保密咨询小组（CAG）的批准意见，可根据2006年《国民健康服务法》第251条在无需个体同意的情况下获取医疗记录（参考编号19/CAG/0214）。
