联合临床试验问卷(JoinCT)的编制与验证。

IF 1.4 4区 医学 Q4 ONCOLOGY
Shirin Hui Tan, Teck Long King, Shirley Siang Ning Tan, Wei Hong Lai, Mohamad Adam Bujang, Pei Jye Voon
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引用次数: 0

摘要

目的:参与者招募一直是临床试验中的一个主要挑战。本研究旨在开发和验证加入临床试验问卷(JoinCT),探讨患者加入临床试验的意愿和相关因素。方法:本问卷开发研究分为四个阶段:(i)探索和理解主题,(ii)问卷开发,(iii)内容有效性测试,最后,(iv)问卷现场测试。在现场测试阶段,对具有不同社会形态背景和医疗条件的癌症患者进行了JoinCT的横断面自管理调查。除内容有效性外,Cronbach’s alpha用于评估领域的内部一致性,验证性因素分析用于评估JoinCT框架的模型拟合度。结果:共有389名受访者参加了调查。根据现场数据收集阶段的结果,JoinCT由四个自变量领域组成,即“知识”、“利益感知”、“风险感知”和“信心”。唯一的因变量是参与临床试验的意愿。最小Cronbach’sα为0.937,模型对JoinCT总体框架的拟合也很好,比较拟合指数(>0.90)、均方根误差近似值(结论:JoinCT问卷成功验证,具有良好的信度和有效性,模型拟合良好。影响参与临床试验意愿的主要因素是知识、对益处的感知、对风险的感知和信心。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Development and validation of Join Clinical Trial Questionnaire (JoinCT).

Development and validation of Join Clinical Trial Questionnaire (JoinCT).

Aim: Participant recruitment has always been a major challenge in clinical trials. This study aimed to develop and validate the Join Clinical Trial Questionnaire (JoinCT), exploring the willingness to join a clinical trial and associated factors in patients.

Methods: This questionnaire development study involved four phases: (i) exploring and understanding the subject matter, (ii) questionnaire development, (iii) content validity testing, and lastly, (iv) field-testing of the questionnaire. For the field-testing phase, a cross-sectional self-administered survey of JoinCT was conducted among cancer patients with various socio-demographic backgrounds and medical conditions. Besides content validity, Cronbach's alpha was used to evaluate the internal consistency of domains, and confirmatory factor analysis was used to evaluate the model fit of the JoinCT framework.

Results: A total of 389 respondents participated in the survey. Based on the results obtained from a field data collection phase, JoinCT consisted of four independent variables domains, namely "knowledge", "perception of benefits", "perception of risks", and "confidence". The only dependent variable was the willingness to participate in a clinical trial. The minimum Cronbach's alpha was 0.937, and the model fit for the overall framework of JoinCT is also excellent with Comparative Fit Index (> 0.90), root mean square error approximation (< 0.08), and Standardized Root Mean Square Residual (< 0.08).

Conclusions: The Join Clinical Trial Questionnaire (JoinCT) was successfully validated with excellent reliability and validity, and a good model fit. The main factors that contribute to willingness to participate in clinical trials are knowledge, perception of benefits, perception of risks, and confidence.

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来源期刊
CiteScore
3.40
自引率
0.00%
发文量
175
审稿时长
6-12 weeks
期刊介绍: Asia–Pacific Journal of Clinical Oncology is a multidisciplinary journal of oncology that aims to be a forum for facilitating collaboration and exchanging information on what is happening in different countries of the Asia–Pacific region in relation to cancer treatment and care. The Journal is ideally positioned to receive publications that deal with diversity in cancer behavior, management and outcome related to ethnic, cultural, economic and other differences between populations. In addition to original articles, the Journal publishes reviews, editorials, letters to the Editor and short communications. Case reports are generally not considered for publication, only exceptional papers in which Editors find extraordinary oncological value may be considered for review. The Journal encourages clinical studies, particularly prospectively designed clinical trials.
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