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开发一种干预措施以优化糖尿病患者心脏手术的结局:OCTOPuS试点研究。

Developing an intervention to optimise the outcome of cardiac surgery in people with diabetes: the OCTOPuS pilot study.

作者信息

Holt Richard I G, Barnard-Kelly Katharine, Dritsakis Giorgos, Thorne Kerensa I, Cohen Lauren, Dixon Elizabeth, Patel Mayank, Newland-Jones Philip, Partridge Helen, Luthra Suvitesh, Ohri Sunil, Salhiyyah Kareem, Picot Jo, Niven John, Cook Andrew

机构信息

Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.

Southampton National Institute for Health Research Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

出版信息

Pilot Feasibility Stud. 2021 Aug 17;7(1):157. doi: 10.1186/s40814-021-00887-z.

Abstract

BACKGROUND

Cardiothoracic surgical outcomes are poorer in people with diabetes compared with those without diabetes. There are two important uncertainties in the management of people with diabetes undergoing major surgery: (1) how to improve diabetes management in the weeks leading up to an elective procedure and (2) whether that improved management leads to improved postoperative outcomes. The aim of this study was to develop and pilot a specialist diabetes team-led intervention to improve surgical outcomes in people with diabetes.

DESIGN

Open pilot feasibility study SETTING: Diabetes and cardiothoracic surgery departments, University Hospital Southampton NHS Foundation Trust PARTICIPANTS: Seventeen people with diabetes undergoing cardiothoracic surgery INTERVENTION: Following two rapid literature reviews, a prototype intervention was developed based on a previously used nurse-led outpatient intervention and tested.

PRIMARY OUTCOME

Feasibility and acceptability of delivering the intervention SECONDARY OUTCOMES: Biomedical data were collected at baseline and prior to surgery. We assessed how the intervention was used. In depth qualitative interviews with participants and healthcare professionals were used to explore perceptions and experiences of the intervention and how it might be improved.

RESULTS

Thirteen of the 17 people recruited completed the study and underwent cardiothoracic surgery. All components of the OCTOPuS intervention were used, but not all parts were used for all participants. Minor changes were made to the intervention as a result of feedback from the participants and healthcare professionals. Median (IQR) HbA was 10 mmol/mol (3, 13) lower prior to surgery than at baseline.

CONCLUSION

This study has shown that it is possible to develop a clinical pathway to improve diabetes management prior to admission. The clinical and cost-effectiveness of this intervention will now be tested in a multicentre randomised controlled trial in cardiothoracic centres across the UK.

TRIAL REGISTRATION

ISRCTN; ISRCTN10170306 . Registered 10 May 2018.

摘要

背景

与非糖尿病患者相比,糖尿病患者的心胸外科手术预后较差。在接受大手术的糖尿病患者管理中存在两个重要的不确定性:(1)如何在择期手术前几周改善糖尿病管理;(2)这种改善后的管理是否会导致术后预后改善。本研究的目的是开发并试行一项由糖尿病专科团队主导的干预措施,以改善糖尿病患者的手术预后。

设计

开放性试行可行性研究

地点

南安普敦大学医院国民保健服务信托基金的糖尿病和心胸外科

参与者

17名接受心胸外科手术的糖尿病患者

干预措施

在进行两项快速文献综述后,基于先前使用的由护士主导的门诊干预措施开发了一种原型干预措施并进行了测试。

主要结局

实施干预措施的可行性和可接受性

次要结局

在基线和手术前收集生物医学数据。我们评估了干预措施的使用情况。对参与者和医疗保健专业人员进行了深入的定性访谈,以探讨对干预措施的看法和体验以及如何改进。

结果

招募的17人中,有13人完成了研究并接受了心胸外科手术。OCTOPuS干预措施的所有组成部分都被使用了,但并非所有部分都适用于所有参与者。根据参与者和医疗保健专业人员的反馈,对干预措施进行了微小的修改。术前血红蛋白A1c的中位数(四分位间距)比基线时低10 mmol/mol(3,13)。

结论

本研究表明,有可能制定一条临床路径,在入院前改善糖尿病管理。现在将在英国各地的心胸外科中心进行一项多中心随机对照试验,以测试该干预措施的临床效果和成本效益。

试验注册

ISRCTN;ISRCTN10170306。于2018年5月10日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef01/8369692/c3567c01ad01/40814_2021_887_Fig1_HTML.jpg

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