一项随机对照试验的方法学描述：比较儿童新诊断为1型糖尿病时基于医院的护理和基于医院的家庭护理。

A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.

作者信息

Tiberg Irén, Carlsson Annelie, Hallström Inger

机构信息

Division of Nursing, Department of Health Sciences, Lund University, 221 00 Lund, Sweden.

出版信息

Open Nurs J. 2011;5:111-9. doi: 10.2174/18744346011050100111. Epub 2011 Nov 18.

DOI:10.2174/18744346011050100111

PMID:22371819

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3263442/

Abstract

AIM AND OBJECTIVE

To describe the study design of a randomised controlled trial with the aim of comparing two different regimes for children with newly diagnosed type 1 diabetes; hospital-based care and hospital-based home care.

BACKGROUND

Procedures for hospital admission and sojourn in connection with diagnose vary greatly worldwide and the existing evidence is insufficient to allow for any conclusive determination of whether hospital-based or home-based care is the best alternative for most families. Comparative studies with adequate power and outcome measurements, as well as measurements of cost-effectiveness are needed.

DESIGN

The study design was based on the Medical Research Council framework for complex interventions. After two to three days with hospital-based care, children between the ages of 3 and 16 were randomised to receive either continued hospital-based care for a total of 1-2 weeks or hospital-based home care, which refers to specialist care in a home-based setting. The trial started in March 2008 at a University Hospital in Sweden and was closed in September 2011 when a sufficient number of children according to power calculation, were included. The primary outcome was the child's metabolic control during the following two years. Secondary outcomes were set to evaluate the family and child situation as well as the organisation of care.

DISCUSSION

Childhood diabetes requires families and children to learn to perform multiple daily tasks. Even though intervention in health care is complex with several interacting components entailing practical and methodological difficulties, there is nonetheless, a need for randomised controlled trials in order to evaluate and develop better systems for the learning processes of families that can lead to long-term improvement in adherence and outcome.

TRIAL REGISTRATION

Trial Register NCT00804232.

摘要

目的

描述一项随机对照试验的研究设计，旨在比较针对新诊断的1型糖尿病儿童的两种不同治疗方案；住院治疗和住院家庭护理。

背景

全球范围内，与诊断相关的住院程序和住院时间差异很大，现有证据不足以确定住院治疗或家庭护理对大多数家庭来说哪种是最佳选择。需要进行有足够效力和结局测量的比较研究，以及成本效益测量。

设计

该研究设计基于医学研究委员会的复杂干预框架。在接受两到三天的住院治疗后，3至16岁的儿童被随机分配接受总共1至2周的持续住院治疗或住院家庭护理，后者指在家庭环境中的专科护理。该试验于2008年3月在瑞典的一家大学医院开始，并于2011年9月结束，当时根据效力计算纳入了足够数量的儿童。主要结局是儿童在接下来两年中的代谢控制情况。次要结局用于评估家庭和儿童状况以及护理组织情况。