Luo Zhen, Tu Chaofeng, Li Li, Peng Lingli
Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA, Changsha, 410008, Hunan, China.
Xiangya Nursing School, Central South University, Changsha, Hunan Province, 410013, China.
Heliyon. 2024 Jul 23;10(15):e34945. doi: 10.1016/j.heliyon.2024.e34945. eCollection 2024 Aug 15.
Preimplantation genetic testing (PGT) can reduce the risk of familial genetic diseases, chromosome abnormalities, and recurrent abortions. It is unclear whether genetic counselees with PGT indications understand and accept the implications of PGT. A well-developed and validated tool is needed to evaluate the knowledge, attitude, and practice (KAP) levels of genetic counselees with PGT indications. The purpose of this study was to develop and validate a PGT KAP questionnaire (PGT-KAP-Q) for genetic counselees with PGT indications.
First, we established an item pool based on a literature review and qualitative interviews. Second, we developed the PGT-KAP-Q using the Delphi method. Third, we evaluated the quality of the questionnaire using item analysis and psychometric evaluation. The item analysis included extreme value comparison, application of the correlation and Cronbach's alpha (α) coefficient methods, and factor analysis. We also evaluated the content and structural validity of the questionnaire, as well as the internal consistency, test-retest reliability, and split-half reliability.
After the literature review and interviews, and based on three rounds of expert consultations, we formed a 43-item questionnaire. In the validity analysis, the item's content validity index (I-CVI) and the average scale level CVI (S-CVI/Ave) values (>0.78 and >0.95, respectively) confirmed the questionnaire's content validity. Exploratory factor analysis showed that all 43 items had strong factor loadings (>0.4), and the three factors of the PGT-KAP-Q explained 51.97 % of the total variance. The Cronbach's α coefficient for the questionnaire was 0.95 ( < 0.05), the split-half reliability was 0.76 ( < 0.05) and the test-retest reliability coefficient was 0.78 ( < 0.05).
The 43-item PGT-KAP-Q for genetic counselees with PGT indications is reliable and valid. It contains a moderate number of items, is easy for patients to understand and accept, and can be used for clinical research and applications.
植入前基因检测（PGT）可降低家族性遗传病、染色体异常和反复流产的风险。尚不清楚有PGT指征的遗传咨询对象是否理解并接受PGT的影响。需要一种完善且经过验证的工具来评估有PGT指征的遗传咨询对象的知识、态度和行为（KAP）水平。本研究的目的是为有PGT指征的遗传咨询对象开发并验证一份PGT KAP问卷（PGT-KAP-Q）。
首先，我们基于文献综述和定性访谈建立了一个项目池。其次，我们采用德尔菲法开发了PGT-KAP-Q。第三，我们使用项目分析和心理测量评估来评估问卷的质量。项目分析包括极值比较、相关性和克朗巴哈α（α）系数方法的应用以及因子分析。我们还评估了问卷的内容和结构效度，以及内部一致性、重测信度和分半信度。
经过文献综述和访谈，并基于三轮专家咨询，我们形成了一份包含43个条目的问卷。在效度分析中，条目的内容效度指数（I-CVI）和平均量表水平CVI（S-CVI/Ave）值（分别>0.78和>0.95）证实了问卷的内容效度。探索性因子分析表明，所有43个条目都有很强的因子载荷（>0.4），PGT-KAP-Q的三个因子解释了总方差的51.97%。问卷的克朗巴哈α系数为0.95（P<0.05），分半信度为0.76（P<0.05），重测信度系数为0.78（P<0.05）。
这份针对有PGT指征的遗传咨询对象的43个条目的PGT-KAP-Q是可靠且有效的。它包含的条目数量适中，患者易于理解和接受，可用于临床研究和应用。
