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长期随访一项针对尿症状服务的随机对照试验。

Long term follow-up of a randomised controlled trial of services for urinary symptoms.

机构信息

Department of Health Sciences, University of Leicester, 22-28 Princess Road West, Leicester LE1 6TP, UK.

出版信息

BMC Health Serv Res. 2011 Mar 14;11:58. doi: 10.1186/1472-6963-11-58.

DOI:10.1186/1472-6963-11-58
PMID:21401941
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3068079/
Abstract

BACKGROUND

Given the extent and priority of urinary symptoms there is little evidence available to inform service provision in relation to the long term effects of interventions. This study aims to determine the long term (6 year) clinical effectiveness and costs of a new continence nurse led service compared to standard care for urinary symptoms.

METHODS

A long term follow-up study of a 2-arm, non-blinded randomised controlled trial that recruited from a community based population between 1998-2000 in Leicestershire and Rutland UK was undertaken. 3746 men and women aged 40 years and over were followed up from the original trial. The continence nurse practitioner (CNP) intervention comprised a continence service provided by specially trained nurses delivering evidence-based interventions using pre-determined care pathways. The standard care (SC) arm comprised access to existing primary care including General Practitioner and continence advisory services in the area.

PRIMARY OUTCOME

Improvement in one or more symptom. Secondary outcomes included: a) Leicester Impact scale; b) patient perception of problem; c) number of symptoms alleviated and cost-effectiveness; all were recorded at long term follow-up (average 6 years) post-randomisation.

RESULTS

Overall at long-term follow-up (average 6 years) significantly more individuals in the CNP group (72%) had improved (i.e had fewer symptoms) compared to those in the SC group (67%) (difference of 5% 95% (CI = 0.6 to 9;p = 0.02)).

CONCLUSION

The differences in outcome between the two randomised groups shown immediately post treatment had decreased by half in terms of symptom improvement at long term follow-up. Although the difference was statistically significant, the clinical significance may not be, although the direction of the difference favoured the new CNP service.

摘要

背景

鉴于尿症状的严重程度和优先级,几乎没有证据可以为干预的长期效果提供信息。本研究旨在确定新的导尿护士主导服务与标准护理相比对尿症状的长期(6 年)临床效果和成本。

方法

对 1998-2000 年在英国莱斯特郡和拉特兰郡进行的一项基于社区的人群的 2 臂、非盲随机对照试验进行了长期随访研究。3746 名年龄在 40 岁及以上的男性和女性从原始试验中随访。导尿护士从业者(CNP)干预措施包括由经过专门培训的护士提供的导尿服务,使用预先确定的护理路径提供基于证据的干预措施。标准护理(SC)组包括获得现有初级保健服务,包括该地区的全科医生和导尿咨询服务。

主要结果

一项或多项症状改善。次要结果包括:a)莱斯特影响量表;b)患者对问题的感知;c)缓解症状的数量和成本效益;所有这些都在随机分组后长期随访(平均 6 年)时记录。

结果

总体而言,在长期随访(平均 6 年)时,CNP 组(72%)的个体有改善(即症状较少)的比例明显高于 SC 组(67%)(差异为 5%,95%CI=0.6 至 9;p=0.02)。

结论

两组随机分组后立即出现的结果差异,在长期随访时,在症状改善方面减少了一半。尽管差异具有统计学意义,但临床意义可能不大,尽管差异的方向有利于新的 CNP 服务。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4189/3068079/c3713b15fca7/1472-6963-11-58-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4189/3068079/8a0ab74048f1/1472-6963-11-58-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4189/3068079/c3713b15fca7/1472-6963-11-58-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4189/3068079/8a0ab74048f1/1472-6963-11-58-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4189/3068079/c3713b15fca7/1472-6963-11-58-2.jpg

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Three-year follow-up of a factorial randomised controlled trial of two decision aids for newly diagnosed hypertensive patients.
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