影響父母讓其嬰幼兒參與臨床試驗之意願及其相關因素之探討-以腦膜炎雙球菌疫苗為例

A Study of the Factors Affecting Parental Decisions Regarding Their Infants or Toddlers Joining the Clinical Trials: An Illustration of Meningococcal Vaccine

葉嘉貞(Chia-Chen Yeh)

指導教授 ： 高碧霞

國立臺灣大學/醫學院/護理學研究所/碩士(2014年)

https://doi.org/10.6342/NTU.2014.02866

摘要

研究背景:由世界衛生統計資料顯示兒童用藥錯誤發生率為成人的三倍，其原因為缺乏良好的臨床試驗，來制定出對兒童安全有效的用藥指南，但兒童藥物臨床試驗的困難度主要在受試者招募不易，因兒童臨床試於必須經過父母的同意才可進行，但願意讓小朋友參與臨床試驗的父母屈指可數。
研究目的:本研究以2009~2010年在台灣進行的腦膜炎雙球菌疫苗人體試驗為例，瞭解台灣父母對嬰幼兒臨床試驗的參與意願及影響其意願之相關因素。
研究方法: 本研究運用混合方法（Mixed methods design），以量性為主，質性為輔之研究設計。量性部分以結構性問卷調查，立意取樣臺灣擁有0~2歲之健康嬰幼兒的父母49名；質性部分，以自擬之訪談大綱，立意取樣49名父母中的10名進行訪談，來瞭解父母對嬰幼兒腦膜炎雙球菌疫苗臨床試驗的參與意願及影響其意願之相關因素。
研究結果：34位父母(佔69.38%)是偏向不贊同讓其嬰幼兒去參與這個臨床試驗的，而影響其決定是否參與臨床試驗的五個構面因素中，父母的重視度依序為:試驗的風險及安全性考量(4.13+0.69)、利他人動機(3.56+0.85)、利自己動機(3.54+0.75)、正向經驗及因素的影響及(3.43+0.85)經濟因素的影響(2.82+1.09)。十七項決策因素中，影響父母同意其嬰幼兒參與臨床試驗之相關因素有:對自己的小孩有幫助(r=.52, p<0.01)、可以獲得較多及較佳的醫療照顧(r=.48, p<0.01)、可幫助其他嬰幼兒(r=.34, p<0.05)、可以幫助醫學的進步(r=.35, p<0.05)、與試驗相關的診療，可以免負擔費用(r=.45, p<0.01)、可以獲得額外贈品(r=.44, p<0.01)、有補助車馬費(r=.37, p<0.01)、醫護人員推薦情形(r=.29, p<0.05)。這些決策因素與質性訪談結果相呼應，其主要理由認為臨床試驗的風險其實是很低的，在可以承擔風險，且自己又無損失的情形下，希望可以對醫學有所貢獻。影響其不同意的相關因素有:擔心試驗過程會造成寶寶的不舒服(r=-.36, p<0.05)、覺得自己的孩子被當成試驗品(r=-.39, p<0.01)，其主要理由為認為臨床試驗的風險其實是很高的，除非疾病已無藥可治，唯有試驗用藥，不然絕不會讓小朋友參加臨床試驗。父母基本屬性方面，小孩個數多的父母，參與試驗的意願較低；父母的年齡愈大，愈不擔心藥物的副作用(r=-.29, p<0.05)；父母的教育程度愈高，對試驗的風險及安全性考量的重視度是愈高的(r=.32, p<0.05)。
結論:研究結果顯示，父母對於嬰幼兒腦膜炎雙球菌疫苗臨床試驗的參與意願是明顯偏低的，其主要理由為對試驗的風險及安全仍有所擔心，不希望小孩成為白老鼠。因此，醫護人員未來在招募未成年受試者時，應多方收集試驗產品的相關安全性數據以供父母參考，以期能提升其參與的意願。

關鍵字

臨床試驗 ； 嬰幼兒 ； 父母 ； 參與意願 ； 腦膜炎雙球菌疫苗

並列摘要

Background: According to the data of World Health Statistics, the rate of children’s medication errors is three times that of adults, and one of the reasons is that there is no good clinical study to give a suitable pediatric dosage. The main difficulty of pediatric clinical trials is recruiting volunteers, because clinical trials in children must be under parental consent, but only a handful of parents willing to let children participating in clinical trials.
Purpose: this research study the relevant factors of Taiwan parents’ willingness in participating in clinical trials by the meningococcal vaccine human trials previously conducted in Taiwan between 2009 and 2010, for example.
Methods: This study uses a hybrid approach (Mixed methods design), which relies mainly on quantitative method supplemented by qualitative method. Quantitative part structured questionnaire survey, and 49 parents who have 0-2 years of healthy infants in Taiwan are selected by purposive sampling. In qualitative method section, 10 of the 49 parents are selected by purposive sample, and interviewed with author.
Results: The results show that 34 parents (representing 69.38%) do not agree to let their children participate in the clinical trial. The five structure factors of parents’ willingness are ranked by the parents’ attention: the risk and safety of clinical trial (4.13+0.69), altruistic motives (3.56+0.85), egoistic motive (3.54+0.75), the influence of positive experience (3.43+0.85), and economic factors (2.82+1.09). The relevant factors of parents’ willingness to let their children participate in clinical trials include: helping their own children (r=.52, p<0.01), getting more and better care (r=.48, p<0.01), helping other infants and toddlers (r=.34, p<0.05), helping medical advances (r=.35, p<0.05), avoiding the burden and costs of trial-related treatment (r=.45, p<0.01), getting extra gifts (r=.44, p<0.01), getting subsidized transportation fee (r=.37, p<0.01), and medical personnel’s recommendations (r=.29, p<0.05). These findings are congruent to the qualitive interviews. The major reason of agreement is that they think the risk of human trial is very low, so they want to help some medical advanced, and do not affect their self-interest. The factors of parents’ unwillingness to participate the trials include: worrying the process of trials will make children uncomfortable (r=-.36, p<0.05), and the consideration of their own children become experimental subjects (r=-.39, p<0.01). The major reason of opposition is the consideration of the safety of clinical trial, so they do not think over trials except there is no remedy for the disease but clinical trial. The significant predictors of parental attributes are the parents who have many children have lower willingness to participate in the human trials (r=-.29, p<0.05); older parents are more willing to have their child participate in clinical trials (r=-.29, p<0.05); more educated parents more likely to attach importance on the risk of clinical trials(r=.32, p<0.05).
Conclusion: The results of this study indicate that the parents’ willingness in participating in the meningococcal vaccine human trials is obviously low. The major concerns of parents are the consideration of the risk of clinical trial, and unwillingness to let children become experimental subjects. It is hoped that medical personnel should collect more data or document of safety in the trial to be reference for parents having young children, to increase parents’ willingness at the beginning of recruiting volunteers.

並列關鍵字

clinical trial ； infant and toddler ； parent ； willingness of participation ； meningococcus vaccine

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