METHODS: This study employed a mixed-methods approach, integrating qualitative and quantitative methodologies. The initial items of the scale were developed through qualitative interviews, Delphi expert consultation, and literature review, while the final items were refined through clinical testing. Qualitative interviews were conducted based on the supportive care needs framework and Maslow\'s hierarchy of needs, and scale items were constructed through a literature search and qualitative interviews. The initial version of the scale with 45 items was obtained after the items were verified and modified by expert consultation. A total of 250 CD patients admitted to the gastroenterology department of a hospital in China were selected for verification of the initial version of the scale. A self-designed general questionnaire was used to obtain patients\' medical history and sociodemographic data, and the Chinese version of the Inflammatory Bowel Disease Questionnaire (IBDQ) was used as the criterion. Exploratory factor analysis (EFA) was performed on the CD-CNS to evaluate the dimensions, factor structure, reliability, criterion validity, and construct validity.
RESULTS: EFA identified 5 dimensions and retained 27 items with strong internal consistency reliability (α = 0.940). The Cronbach\'s α coefficients for each dimension ranged from 0.824 to 0.921. Criterion validity was assessed using Spearman\'s coefficient, which demonstrated a significant correlation with the IBDQ (P < 0.050). The test-retest reliability for each dimension after two weeks ranged from 0.655 to 0.895.
CONCLUSIONS: We developed and validated a new scale that can be used to assess the care needs of CD patients. This new tool can guide the specific supportive care of CD patients.
BACKGROUND: This study was reviewed and approved by the Ethics Committee of the Second Hospital of Nanjing (2021-LS-ky-022). The study was duly registered and approved online through the Trial Center of the Second Hospital of Nanjing in 2021. Confidentiality was ensured by anonymizing all the data. The entire study process was conducted under the supervision of the Ethics Committee of Nanjing Second Hospital. Informed consent was obtained from the patients, and each patient volunteered and agreed to participate.
方法:本研究采用混合方法,整合定性和定量方法。量表的初始项目是通过定性访谈制定的,德尔福专家咨询,和文献综述,而最终的项目通过临床试验进行了细化。定性访谈是基于支持性护理需求框架和马斯洛需求层次进行的,量表项目是通过文献检索和定性访谈构建的。经过专家咨询对项目进行验证和修改后,获得了45个项目的初始版本。选择了中国某医院消化内科收治的250名CD患者,对量表的初始版本进行验证。自行设计的一般问卷用于获取患者的病史和社会人口统计学数据,并以中文版炎症性肠病问卷(IBDQ)为标准。对CD-CNS进行探索性因素分析(EFA)以评估其尺寸,要素结构,可靠性,标准有效性,并构建效度。
结果:EFA确定了5个维度,并保留了27个项目,具有很强的内部一致性可靠性(α=0.940)。每个维度的Cronbachα系数范围为0.824至0.921。使用斯皮尔曼系数评估标准效度,与IBDQ有显著相关性(P<0.050)。两周后每个维度的重测可靠性范围为0.655至0.895。
结论:我们开发并验证了一种新的量表,可用于评估CD患者的护理需求。这种新工具可以指导CD患者的具体支持治疗。
背景:本研究经南京市第二医院伦理委员会审查批准(2021-LS-ky-022)。该研究于2021年通过南京市第二医院试验中心正式注册并在线批准。通过匿名化所有数据来确保机密性。整个研究过程在南京市第二医院伦理委员会的监督下进行。获得患者知情同意,每个患者都自愿并同意参与。