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理解复杂干预措施随机对照试验中的常规护理:一种多方法研究。

Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach.

机构信息

Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.

Sussex Community NHS Foundation Trust, Brighton General Hospital, Brighton, UK.

出版信息

Palliat Med. 2020 May;34(5):667-679. doi: 10.1177/0269216320905064. Epub 2020 Feb 21.

DOI:10.1177/0269216320905064
PMID:32081088
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7238505/
Abstract

BACKGROUND

Evaluations of complex interventions compared to usual care provided in palliative care are increasing. Not describing usual care may affect the interpretation of an intervention's effectiveness, yet how it can be described remains unclear.

AIM

To demonstrate the feasibility of using multi-methods to describe usual care provided in randomised controlled trials (RCTs) of complex interventions, shown within a feasibility cluster RCT.

DESIGN

Multi-method approach comprising usual care questionnaires, baseline case note review and focus groups with ward staff completed at study end. Thematic analysis of qualitative data, descriptive statistics of quantitative data, followed by methodological triangulation to appraise approach in relation to study aim.

SETTING/PARTICIPANTS: Four general medical wards chosen from UK hospitals. Purposive sampling of healthcare professionals for usual care questionnaires, and focus groups. Review of 20 patients' notes from each ward who died during admission or within 100 days of discharge.

RESULTS

Twenty-three usual care questionnaires at baseline, two focus groups comprising 20 healthcare professionals and 80 case note reviews. Triangulation of findings resulted in understanding the usual care provided to the targeted population in terms of context, structures, processes and outcomes for patients, families and healthcare professionals. Usual care was described, highlighting (1) similarities and embedded practices, (2) heterogeneity and (3) subtle changes in care during the trial within and across sites.

CONCLUSIONS

We provide a feasible approach to defining usual care that can be practically adopted in different settings. Understanding usual care enhances the reliability of tested complex interventions, and informs research and policy priorities.

摘要

背景

在姑息治疗中,与常规护理相比,对复杂干预措施的评估正在增加。不描述常规护理可能会影响干预措施有效性的解释,但如何描述常规护理仍不清楚。

目的

展示在一项可行性集群 RCT 中,使用多种方法描述复杂干预措施随机对照试验 (RCT) 中常规护理的可行性。

设计

采用多方法方法,包括在研究结束时完成的常规护理问卷、基线病历回顾和与病房工作人员的焦点小组。对定性数据进行主题分析,对定量数据进行描述性统计,然后进行方法学三角测量,以评估方法与研究目的的相关性。

地点/参与者:从英国医院中选择了四个普通内科病房。对常规护理问卷进行了有针对性的抽样,对焦点小组进行了抽样。对每个病房的 20 名死亡或出院后 100 天内死亡的患者的病历进行回顾。

结果

基线时完成了 23 份常规护理问卷,进行了 2 次焦点小组讨论,涉及 20 名医疗保健专业人员,以及 80 次病历回顾。对调查结果进行三角测量,结果了解了针对目标人群的常规护理情况,包括患者、家庭和医疗保健专业人员的背景、结构、流程和结果。描述了常规护理,突出了(1)相似之处和嵌入式实践,(2)异质性,以及(3)在试验期间和跨站点的护理细微变化。

结论

我们提供了一种可行的定义常规护理的方法,可以在不同的环境中实际采用。了解常规护理可以提高经过测试的复杂干预措施的可靠性,并为研究和政策重点提供信息。

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