Please use this identifier to cite or link to this item: http://hdl.handle.net/11455/92618
標題: 糖尿病病人參與臨床試驗動機探討--比較參與組與拒絕組之差異
Motivations of diabetes patients who participate clinical trials -- Comparisons between the participation group and refusal group
作者: 李憓盈
Hui-Ying Lee
關鍵字: 態度;臨床試驗;認知;參與意願;人格特質;attitude;clinical trial;knowledge;participating willingness;personality
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摘要: 
目的:糖尿病若控制不佳會造成一些嚴重的併發症,會造成個人健康上的危害,對於國家財政上形成龐大的負擔。為了使糖尿病病患有更好的治療,各大藥廠皆發展新藥,接受臨床試驗的人數也相對上升。本研究欲探討糖尿病病人參與臨床試驗的動機,與拒絕參與臨床試驗的原因,以及其在人口學特質及人格特質以及其對臨床試驗之認知與態度為何。
方法:本研究利用台中某醫學中心新陳代謝科門診的糖尿病患者為研究對象,共收納61人,曾經參與過臨床試驗者分配到參與組共有30人,曾被邀請參與臨床試驗但拒絕參與者為拒絕組有31人。使用問卷調查法收集兩組受試者之基本人口學資料、人格特質、參與動機以及對臨床試驗認知與態度相關資料。
結果:分析兩組之人口學特徵,在性別上參與組的男性比例比拒絕組多(87% vs.42 %, p=.001);在宗教信仰上,參與組有宗教信仰的比例較少(57% vs. 84%,p=.041)。參與組之主要參與原因為:「促進醫學進步、幫助他人」,拒絕組主要拒絕原因為:「擔心新藥副作用及安全性影響到身體」。在臨床試驗認知分數參與組的平均得分高於拒絕組(p<0.001);在臨床試驗態度分數參與組的平均得分亦高於拒絕組(p<0.01),此結果顯示參與組對臨床試驗認知與態度較為正向。使用羅吉斯分析來了解影響糖尿病人參與臨床試驗的預測因子有「性別」、「宗教信仰」、「臨床試驗認知分數」、「臨床試驗態度分數」。
結論:本研究發現:男性、對臨床試驗認知與態度分數較高者,較容易來參與臨床試驗。本研究結果可幫助臨床試驗參與醫師、研究護理師達到精確挑選合適參與臨床試驗病人,縮短研究人員工作時間,以達到高品質、高效率的臨床研究服務。

Purpose: Diabetes has become major health and economic burden in developing and developed countries. Many pharmaceutical companies are engaging new diabetes treatment drugs discovery and thus a high demanding of diabetes subjects to participate new drug clinical trials. The aim of this study is to investigate the motivations that diabetes subjects who are willing to participate a clinical trial.

Method: Diabetes outpatients with diabetes from a medical center in Taichung were recruited after obtained written consent. A total of 61 diabetes patients were enrolled. They were divided into those who ever participated (n=30) or refused (n=30) to participate a clinical trial. Demographic characteristics, social-economic status and questionnaires were collected to evaluate their personal traits, motivation, knowledge, and attitudes toward participating a clinical trial.

Results: As compared with patients who refused to participate a clinical trial refusal group, patients in participation group were more male (87% vs.42 %, p=0.001), and lower proportion to have religious belief (57% vs. 84%, p=0.041). The main reason to participate a clinical trial was 'to promote medical progress' and 'uncertainty about adverse effects and safety', respectively. Patients who joined clinical trials were more knowledgable (p<0.001) and had positive attitude (all p<0.01) toward clinical trials than those in refusal group. Results of logistic regression analysis showed that the independent predictors for patients to join a clinical trial were male sex, no religious belief, more knowledgable, and positive attitudes toward clinical trials.

Conclusion: we revealed predictors for patients to join a clinical trial were male sex, more knowledge, and positive attitudes toward clinical trials. Our findings may be useful for future recruitment of clinical trials.
URI: http://hdl.handle.net/11455/92618
其他識別: U0005-2811201416195357
Rights: 同意授權瀏覽/列印電子全文服務,2017-08-31起公開。
Appears in Collections:生命科學院碩士在職專班

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