Senin Mohd Hilmi, Sopian Mastura Mohd, Shaharuddin Bakiah, Nasir Muhammad Jaffri Mohd
Department of Transfusion Medicine, Hospital Sultanah Aminah, 80100, Johor Bahru, Johor, Malaysia.
Department of Community Health, Advanced Medical & Dental Institute, Universiti Sains Malaysia, 13200, Kepala Batas, Pulau Pinang, Malaysia.
Asian J Transfus Sci. 2024 Jan-Jun;18(1):35-44. doi: 10.4103/ajts.ajts_176_21. Epub 2022 Sep 28.
Blood transfusion warrants written informed consent from the patient. However, patients have poor knowledge regarding blood transfusions as evidenced by nonstandardized information retained by patients from the informed consent discussion. The problem stems from suboptimal patient knowledge on the elements of informed consent. This study describes the development and validation of a new questionnaire to assess the knowledge on informed consent for blood transfusion from the patients' perspective.
The development phase consisted of literature review, small group discussion, expert review meeting, content, and face validity. We evaluated the psychometric properties of Informed Consent for Blood Transfusion Questionnaire (ICBTQ) using reliability test and item response theory among a sample of 95 patients in Hospital Universiti Sains Malaysia.
ICBTQ was formulated to include sociodemographic and knowledge sections. ICBTQ possessed excellent content validity. The face validity index (FVI) of clarity and comprehension were both 0.97. Thus, the universal FVI was 0.96. One item was added following the advice given by one of the content experts. ICBTQ had excellent face validity. For the validation phase, ICBTQ demonstrated an acceptable Cronbach's Alpha value. One item was omitted in view of low corrected item-total correlation. In the item response theory (IRT) analysis, ICBTQ exhibited good difficulty and discriminatory indexes. Assessments of item-fit indicated that all items of the model were well-fitted.
Based on the IRT and reliability analysis, the knowledge section of the ICBTQ was psychometrically valid to be used among patients.
输血需要患者签署书面知情同意书。然而，患者对输血的了解不足，这从他们在知情同意讨论中保留的非标准化信息中可见一斑。问题源于患者对知情同意要素的了解不够充分。本研究描述了一种新问卷的开发与验证过程，该问卷旨在从患者角度评估对输血知情同意的了解情况。
开发阶段包括文献综述、小组讨论、专家评审会议、内容及表面效度评估。我们在马来西亚理科大学医院的95名患者样本中，使用信度测试和项目反应理论评估了《输血知情同意问卷》（ICBTQ）的心理测量特性。
ICBTQ的制定包括社会人口统计学和知识部分。ICBTQ具有出色的内容效度。清晰度和理解度的表面效度指数（FVI）均为0.97。因此，总体FVI为0.96。根据一位内容专家的建议增加了一个项目。ICBTQ具有出色的表面效度。在验证阶段,ICBTQ显示出可接受的克朗巴哈系数值。鉴于校正后的项目与总分相关性较低，删除了一个项目。在项目反应理论（IRT）分析中，ICBTQ表现出良好的难度和区分指数。项目拟合评估表明该模型的所有项目拟合良好。
基于IRT和信度分析，ICBTQ的知识部分在心理测量学上对患者是有效的。
