Please use this identifier to cite or link to this item: http://hdl.handle.net/11455/92617
標題: 糖尿病患參與臨床試驗動機探討:比較參與多次組與僅參與一次組之差異
Motivations of diabetes patients who participate clinical trials:Comparisons between the repeated group and once group
作者: 林志芬
Chih-Fen Lin
關鍵字: 五大人格特質、臨床試驗、糖尿病、認知與態度;Big Five Personality, clinical trial, diabetes, knowledge and attitude
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摘要: 
背景
隨著糖尿病盛行率逐年上升,對於人類健康威脅日益嚴重,治療糖尿病藥物市場快速成長,近年來糖尿病臨床試驗案件逐年增加,都需要招募更多的糖尿病患來參加臨床試驗。尤其是有參加過臨床試驗的糖尿病患,其參與臨床試驗的認知與經驗以及個人態度等,對後續是否繼續參加臨床試驗都可能有影響。本研究目的除了瞭解有參加過臨床試驗的糖尿病患是否繼續參加臨床試驗外,並探討當糖尿病患再度被邀請參與臨床試驗時做出決策的依據及對臨床試驗的態度與認知的程度。
方法
本研究採立意取樣、橫斷式研究,自2014年1月15日起至2014年4月07日止於中部某醫學中心之新陳代謝科門診與新陳代謝實驗室,經由試驗機構的人體試驗委員會審核核准,並經受測者書面同意後,再進行資料收集。將研究對象分成兩組:「參加多次組」與 「僅參加一次組」,以結構式問卷為訪談工具,探討兩組研究對象的人格特質、對臨床試驗的認知與態度的差異性及相關性,以及參與臨床試驗的動機。本研究工具包含:基本背景、五大人格特質量表、臨床試驗認知與態度量表,經徵求原作者及中文版作者同意後使用,三份量表皆具良好信效度表現。(Cronbach's α﹐0.71~0.91)
結果
兩組研究對象各有30人願意參加本研究。兩組參與臨床試驗者以男性居多,「參加多次組」參與臨床試驗的主要原因是可促進醫學進步、幫助他人,「僅參加一次組」參與臨床試驗的主要原因是醫師建議。以邏輯斯迴歸分析結果發現,會影響兩組研究對象多次參與臨床試驗決策的重要預測因素有三個:男性(OR =6.510,95%Cl=1.182-35.862)、參與研究結束後健康狀況的有改善 (OR =20.183,95% Cl=2.437-167.148)及臨床試驗態度愈正向(OR=1.154,95% Cl=1.050-1.268)。
結論
本研究的結論,男性、參與研究結束後健康狀況有改善以及對臨床試驗的態度愈正向,對多次參與臨床試驗的意願較高。藉由本研究的發現,能提升未來臨床試驗的招募與品質,使臨床試驗更蓬勃發展。

Background
With rapid growing numbers of diabetes and its impact on human health, there are expanding needs of diabetes patients to participate on new drugs of clinical trials. It is well recognized that patients' knowledge and attitude will affect their willingness to participate clinical trials and subsequentretentions. The aims of this project was to compare the potential reasons of diabetes patient who joined the clinical trials once versus who repeatedly to participate the clinical trials.
Methods
We conducted this study in a medical center in central Taiwan from January 15 until April 7, 2014. This study was approved by hospital IRB and all participants signed inform consent. In additional to demographic and social-economic information collection, all study participants completed three structured questionnaires with three scales: Clinical trial knowledge scale; Attitude toward randomized clinical trials and the Big Five Personality Traits, after consent of the original and the Chinese version of the authors' with acceptable reliability (Cronbach's α,0.71~0.91).
Results
A total of 60 subjects were enrolled with 30 of them in once group and 30 in repeated group. Our data indicated that men were dominant in both groups. The main reason to participate in the repeated group was to help the advance of science and may help others. However, patients in the once group were mainly followed doctors' recommendation and participated in clinical trials. Our results of the Logistic regression analysis found three independent predictors that would affect diabetic patients to repeat participating in clinical trials once or repeatedly : males (OR = 6.510,95%Cl=1.182-35.862), improved the health status at the end of study (OR =20.183,95%Cl = 2.437-167.148) and positive attitudes toward clinical trails (OR = 1.154,95%Cl=1.050-1.268).
Conclusions
In conclusion, males, improved the health status and positive attitudes toward clinical
trails may repeatedly participating in clinical trials. These factors may improve the
recruitment and quality of future trials and make clinical trials more flourish.
Key words : Big Five Personality, clinical trial, diabetes, knowledge and attitude
URI: http://hdl.handle.net/11455/92617
其他識別: U0005-2811201416193710
Rights: 同意授權瀏覽/列印電子全文服務,2017-08-31起公開。
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