辅助生殖医学临床试验受试者顾虑量表的编制及因素分析

The designing and analysis of worries scale questionnaires for patients participate in the research of assisted reproductive technology

目的编制辅助生殖医学临床试验受试者顾虑量表,在量表通过信度与效度分析的前提下,评价及筛选参与/拒绝临床试验的因素。方法通过文献研究和专家咨询确定指标框架,形成预试量表,选取46名参与"拮抗剂固定方案和灵活方案在预估卵巢高反应性的中国女性不孕症患者控制性促排卵结果比较的前瞻性、非盲、随机、对照临床研究"(IISP:MISP53759)募集患者对预试量表进行条目及因素分析,调整量表的条目形成最终的正式量表。另外选取86名"IISP:MISP53759"募集患者对正式量表进行信效度评价。结果总量表的Cronbach’sα系数为0.875,Spearman-Brown折半信度为0.874。条目内容效度为0.832~0.909,平均测量类内相关性为0.874(P<0.001),12条目正式问卷适配度指标值在量表研制理论允许范围之内。75例募集患者选择接受试验(接受组),11例拒绝参与IISP实验(拒绝组),接受组和拒绝组间患者基本情况差异无统计学意义,接受组患者对受试方法可靠性(4.5±1.1)比拒绝组更为关注(3.8±1.4,P=0.04,t=1.91);接受组患者自我压力(2.9±1.5)显著低于拒绝组(3.8±1.5,P=0.02,t=-1.86)。结论辅助生殖医学临床试验受试者顾虑量表信度与效度良好,能够反映临床试验受试者顾虑,患者的自我压力及受试方法可靠性是患者参与受试的关键因素。

Objective To design the worries scale for patients who participate in the research of assisted reproductive technology and to check internal reliability and validity of the scale. To explore the factors that affect the decisions of patients who will likely or reject to participate in the clinical trial.Methods The preliminary survey questionnaire was developed based on literature research and professional consults. Totally 46 patients who participate in the“IISP： MISP53759”trial were chosen to complete the preliminary scale and the items were analyzed and revised to formulate the formal scale. Finally, 86 patients were selected for the formal survey of validity analysis and to explore possible affecting factors.Results The Cronbach’s α, Spearman-Brown validity of the scale were 0.875 and 0.874 respectively. Content validity and mean content survey correlation were 0.832-0.909 and 0.874 （P〈0.001）. Fitness of 12 items was inside the allowed range of the formal scale. A total of 75 patients chose to participate the trial while 11 patients reject to participate, demographic information between the two groups were not significantly different. The patients who will participate were more concerned about the reliability of the experimental methods （4.5±1.1） than the patients who rejected （3.8±1.4, P=0.04, t=1.91）, the self-stress of the former group （2.9±1.5） was significantly lower than the other group （3.8±1.5, P=0.02, t=-1.86）.Conclusion The scale of the research is good at reliability and validity, and is suitable for measuring the worries of patients who were target population of the research. Reliability of experimental methods and self-stress of patients were two most important influential factors of participating the trial.