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RAPP,日间手术患者术后恢复的系统电子评估:一项混合方法研究设计的研究方案,包括多中心、两组、平行、单盲随机对照试验和定性访谈研究。

RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies.

作者信息

Nilsson U, Jaensson M, Dahlberg K, Odencrants S, Grönlund Å, Hagberg L, Eriksson M

机构信息

Faculty of Medicine and Health, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.

School of Business, Örebro University, Örebro, Sweden.

出版信息

BMJ Open. 2016 Jan 13;6(1):e009901. doi: 10.1136/bmjopen-2015-009901.

Abstract

INTRODUCTION

Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient-related outcomes such as mobile applications. This article describes the Recovery Assessment by Phone Points (RAPP) study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost-effective and improves postoperative recovery, health and quality of life.

METHODS AND ANALYSIS

This study has a mixed-methods study design that includes a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. 1000 patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (ie, no follow-up). The primary aim is cost-effectiveness. Secondary aims are (A) to explore whether a systematic e-assessment follow-up after day surgery has a positive effect on postoperative recovery, health-related quality of life (QoL) and overall health; (B) to determine whether differences in postoperative recovery have an association with patient characteristic, type of surgery and anaesthesia; (C) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health and QoL; and (D) to describe day surgery patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary aim will be measured at 2 weeks postoperatively and secondary outcomes (A-C) at 1 and 2 weeks and (D) at 1 and 4 months.

TRIAL REGISTRATION NUMBER

NCT02492191; Pre-results.

摘要

引言

日间手术在许多欧洲国家已是一种成熟的做法,但关于在家术后恢复的信息有限,尽管目前缺乏术后随访的标准程序。此外,在评估患者相关结局(如移动应用程序)方面,现代技术也需要改进。本文描述了通过电话评分进行恢复评估(RAPP)研究方案,这是一项混合方法研究,旨在评估日间手术患者的系统性电子评估随访是否具有成本效益,并改善术后恢复、健康状况和生活质量。

方法与分析

本研究采用混合方法研究设计,包括一项多中心、两组、平行、单盲随机对照试验和定性访谈研究。1000名年龄大于17岁且接受日间手术的患者将被随机分配至两组,一组通过智能手机应用程序进行为期14天的每日电子评估术后恢复随访,该应用程序包括瑞典版恢复质量量表(SwQoR)网络版;另一组接受标准护理(即不进行随访)。主要目的是评估成本效益。次要目的包括:(A)探讨日间手术后系统性电子评估随访是否对术后恢复、健康相关生活质量(QoL)和整体健康有积极影响;(B)确定术后恢复的差异是否与患者特征、手术类型和麻醉方式有关;(C)确定健康素养的差异是否对术后恢复、健康和生活质量有实质性和明显影响;(D)描述日间手术患者和工作人员对日间手术后系统性电子评估随访的体验。主要目的将在术后2周进行测量,次要结局(A - C)在术后1周和2周进行测量,结局(D)在术后1个月和4个月进行测量。

试验注册号

NCT02492191;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3e6/4735206/6087ca16f61f/bmjopen2015009901f01.jpg

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