Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.
Usher Institute, University of Edinburgh, Edinburgh, UK.
BMC Med Inform Decis Mak. 2024 Oct 11;24(1):301. doi: 10.1186/s12911-024-02707-9.
Antibiotic resistant infections cause over 700,000 deaths worldwide annually. As antimicrobial stewardship (AMS) helps minimise the emergence of antibiotic resistance resulting from inappropriate use of antibiotics in healthcare, we developed ePAMS+ (ePrescribing-based Anti-Microbial Stewardship), an ePrescribing and Medicines Administration (EPMA) system decision-support tool complemented by educational, behavioural and organisational elements.
We conducted a non-randomised before-and-after feasibility trial, implementing ePAMS+ in two English hospitals using the Cerner Millennium EPMA system. Wards of several specialties were included. Patient participants were blinded to whether ePAMS+ was in use; prescribers were not. A mixed-methods evaluation aimed to establish: acceptability and usability of ePAMS+ and trial processes; feasibility of ePAMS+ implementation and quantitative outcome recording; and a Fidelity Index measuring the extent to which ePAMS+ was delivered as intended. Longitudinal semi-structured interviews of doctors, nurses and pharmacists, alongside non-participant observations, gathered qualitative data; we extracted quantitative prescribing data from the EPMA system. Normal linear modelling of the defined daily dose (DDD) of antibiotic per admission quantified its variability, to inform sample size calculations for a future trial of ePAMS+ effectiveness.
The research took place during the SARS-CoV-2 pandemic, from April 2021 to November 2022. 60 qualitative interviews were conducted (33 before ePAMS+ implementation, 27 after). 1,958 admissions (1,358 before ePAMS+ implementation; 600 after) included 24,884 antibiotic orders. Qualitative interviews confirmed that some aspects of ePAMS+ , its implementation and training were acceptable, while other features (e.g. enabling combinations of antibiotics to be prescribed) required further development. ePAMS+ uptake was low (28 antibiotic review records from 600 admissions; 0.047 records per admission), preventing full development of a Fidelity Index. Normal linear modelling of antibiotic DDD per admission showed a residual variance of 1.086 (log-transformed scale). Unavailability of indication data prevented measurement of some outcomes (e.g. number of antibiotic courses per indication).
This feasibility trial encountered unforeseen circumstances due to contextual factors and a global pandemic, highlighting the need for careful adaptation of complex intervention implementations to the local setting. We identified key refinements to ePAMS+ to support its wider adoption in clinical practice, requiring further piloting before a confirmatory effectiveness trial.
ISRCTN Registry ISRCTN13429325, 24 March 2022.
抗生素耐药性感染每年在全球导致超过 70 万人死亡。由于抗菌药物管理 (AMS) 有助于减少因医疗保健中抗生素使用不当而导致的抗生素耐药性的出现，我们开发了 ePAMS+ （基于电子处方的抗菌药物管理），这是一种电子处方和药物管理 (EPMA) 系统决策支持工具，辅以教育、行为和组织要素。
我们进行了一项非随机前后可行性试验，在使用 Cerner Millennium EPMA 系统的两家英国医院实施 ePAMS+ 。纳入了多个专业病房的患者。患者参与者对是否使用 ePAMS+ 并不知情；而处方者则知情。采用混合方法评估，旨在确定：ePAMS+ 的可接受性和可用性以及试验过程；ePAMS+ 实施和定量结果记录的可行性；以及测量 ePAMS+ 实施程度的保真度指数。对医生、护士和药剂师进行了纵向半结构化访谈，并进行了非参与观察，收集定性数据；我们从 EPMA 系统中提取了定量处方数据。通过对每入院的抗生素定义日剂量 (DDD) 的正态线性建模，量化了其变异性，为未来 ePAMS+ 有效性试验的样本量计算提供了信息。
研究于 2021 年 4 月至 2022 年 11 月期间在 SARS-CoV-2 大流行期间进行。进行了 60 次定性访谈（实施 ePAMS+ 前 33 次，实施后 27 次）。纳入了 1958 次入院（实施 ePAMS+ 前 1358 次，实施后 600 次），共包含 24884 次抗生素医嘱。定性访谈证实，ePAMS+ 的某些方面、其实施和培训是可以接受的，而其他方面（例如，能够开组合抗生素处方）则需要进一步开发。ePAMS+ 的采用率很低（600 次入院中有 28 次抗生素审查记录；每次入院 0.047 次记录），无法充分制定保真度指数。每入院的抗生素 DDD 的正态线性建模显示出 1.086 的剩余方差（对数转换尺度）。由于缺乏适应症数据，无法测量某些结果（例如，每种适应症的抗生素疗程数）。
由于背景因素和全球大流行，这项可行性试验遇到了意想不到的情况，这凸显了需要根据当地情况仔细调整复杂干预措施的实施。我们确定了对 ePAMS+ 的关键改进，以支持其在临床实践中的更广泛应用，在进行确认性有效性试验之前，需要进一步进行试点。
ISRCTN 注册 ISRCTN8626325，2022 年 3 月 24 日。
