回顾性分析南非心血管试验点的患者保留率

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
L. Burgess, N. Sulzer
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引用次数: 4

摘要

通讯:Lesley J Burgess TreAD研究/心脏病科,内科,Tygerberg医院和Stellenbosch大学,Parow,南非电话+27 21 931 7825传真+27 21 933 3597电子邮件lesley@treadresearch.com介绍:患者退出对研究成本和研究结果的有效性产生负面影响。目的:调查南非一个心血管试验地点患者的流失率和停药原因。方法:随机选择过去10年进行的研究,回顾性检查患者的损耗率和停药原因。结果:共检查了50项研究,持续时间从3到45个月不等。共有1386名患者被随机分组。其中,88.9%完成了所有预定的研究访问,平均损失率为11.1% (n = 154)。终止治疗的原因包括死亡(39.6%)、撤回同意(33.1%)、不良事件(22.7%)和重新安置(4.5%)。无患者失访。结论:低流失率和没有任何患者失去随访是一个专门的保留计划的结果,在这个计划中,每个站点的工作人员都在保持患者参与临床试验的积极性和兴趣方面发挥着关键作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Retrospective analysis of a South African cardiovascular trial site’s patient retention rates
Correspondence: Lesley J Burgess TreAD research/Cardiology Unit, Department of internal Medicine, Tygerberg hospital and Stellenbosch University, Parow, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 email lesley@treadresearch.com Introduction: Patient dropouts negatively affect study cost and validity of study results. Objectives: To investigate the attrition rate and reasons for patient discontinuations at a cardiovascular trial site in South Africa. Methods: Studies conducted over the past 10 years were randomly selected and retrospectively examined for attrition rates and reasons for patient discontinuation. Results: A total of 50 studies with a duration ranging from 3 to 45 months were examined. A total of 1386 patients were randomized. Of these, 88.9% completed all scheduled study visits, resulting in a mean 11.1% (n = 154) attrition rate. Reasons for discontinuation included death (39.6%), withdrawal of consent (33.1%), adverse events (22.7%), and relocation (4.5%). There were no patients lost to follow-up. Conclusion: The low attrition rate and absence of any patients lost to follow-up are the result of a dedicated retention plan in which each site staff member has a crucial role to play in keeping patients motivated and interested in participating in a clinical trial.
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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