College of Stomatology, Chongqing Medical University, Chongqing, China.
Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences, Chongqing, China.
J Clin Periodontol. 2017 Jun;44(6):591-600. doi: 10.1111/jcpe.12716. Epub 2017 May 5.
The aim of this study was to develop and validate the first condition-specific tool to assess oral health-related quality of life (OHRQoL) impairment in association with chronic periodontitis and to use it as an outcome measure in clinical trials.
Twenty-three potential items were developed using a combined method consisting of a literature review, semi-structured patient interviews (n = 20) and expert panel 1. Subsequently, item selection was carried out by means of qualitative content analysis and quantitative classical test theory (CTT) with 110 patients and expert panel 2. Consequently, 18 items were selected and included in the final oral health impact profile for chronic periodontitis (OHIP-CP) instrument. The validity and reliability of the OHIP-CP were then examined.
A total of 238 patients participated in the validation phase of OHIP-CP. The final 18-item questionnaire was shown to have a three-domain structure. The three components "pain and functional limitation", "psychological discomfort" and "psychological disability and social handicap" explained 49.9%, 9.9%, and 6.2% of the variance, respectively, together accounting for 66.1% of the variance. In addition, the OHIP-CP was shown to be valid in distinguishing patients with varying severity of chronic periodontitis. For the convergent validity, the reported impact of chronic periodontitis based on the OHIP-CP significantly correlated with the global oral health rating. All of its three domains were found to have good levels of internal consistency with Cronbach's alpha >.7, and excellent test-retest reliability.
The OHIP-CP is the first condition-specific OHRQoL instrument for patients with chronic periodontitis. This short, reliable and valid questionnaire may serve as a valuable tool in future clinical trials.
本研究旨在开发和验证首个用于评估慢性牙周炎相关口腔健康相关生活质量(OHRQoL)损害的特定于疾病的工具,并将其用作临床试验中的结局测量指标。
采用文献回顾、半结构化患者访谈(n=20)和专家小组 1 相结合的综合方法,制定了 23 项潜在项目。随后,通过定性内容分析和定量经典测试理论(CTT),对 110 名患者和专家小组 2 进行了项目选择。最终选择了 18 项,并纳入慢性牙周炎口腔健康影响简表(OHIP-CP)。随后对 OHIP-CP 的有效性和可靠性进行了检验。
共有 238 名患者参加了 OHIP-CP 的验证阶段。最终的 18 项问卷显示具有三域结构。三个组成部分“疼痛和功能限制”、“心理不适”和“心理残疾和社会障碍”分别解释了 49.9%、9.9%和 6.2%的方差,共解释了 66.1%的方差。此外,OHIP-CP 在区分慢性牙周炎严重程度不同的患者方面具有有效性。对于收敛有效性,基于 OHIP-CP 报告的慢性牙周炎的影响与总体口腔健康评分显著相关。其三个领域均具有良好的内部一致性,克朗巴赫α值>.7,且测试-重测信度极好。
OHIP-CP 是首个针对慢性牙周炎患者的特定于疾病的 OHRQoL 工具。这个简短、可靠且有效的问卷可能在未来的临床试验中成为有价值的工具。