背景:麻风病的病例检测延迟(CDD)定义为从最初的体征和症状发作到诊断时间之间的时间段。一个工具,由一份调查问卷和一份详细的研究人员指南组成,其中包括典型皮肤体征的照片和关于确定事件发生时间的注释,是为了确定最近诊断的麻风病人的这一延迟时间。该研究的目的是确定该CDD评估工具的可靠性和一致性。
方法:本研究在埃塞俄比亚进行,莫桑比克和坦桑尼亚。考虑了两种类型的一致性:随着时间的推移(测试-重测可靠性)和跨不同研究人员(评估者间可靠性)。对167名麻风患者进行了CDD问卷调查,这些患者在纳入前6个月内被诊断出。一个月后,同一研究人员或另一名研究人员对同一患者重新进行了CDD问卷。重测和评估者间可靠性均使用组内相关系数(ICC)进行评估,其中大于或等于0.7的值被认为是可接受的。
结果:在这项研究中,10名参与者(6.0%)年龄在15岁以下,56名(33.5%)为女性。在重测评估中,第一次和第二次访谈的平均CDD为23.7个月(95%CI14.4-34.8)和24.0个月(95%CI14.8-33.2),分别。重测信度的ICC为0.99(95%CI0.994-0.997)。对于评估者间可靠性评估,第一次和第二次访谈显示平均CDD为24.7个月(95%CI18.2-31.1)和24.6个月(95%CI18.7-30.5),分别,ICC为0.90(95%CI0.85-0.94)。在测试重测中发现0.46个月的测量标准误差,在评估者之间的测量中发现1.03个月。参与者在第一次和第二次访谈中给出的大多数答案是匹配的(≥86%)。大多数不匹配的答案属于0-2个月的延迟类别(≥46%)。
结论:该工具,包括一份问卷,以确定新诊断的麻风病人的CDD,在三个非洲国家得到了验证。测试-重新测试和评估者之间的测量表明,该仪器是可靠的,并且测量一致。该工具可用于常规麻风病计划以及研究环境。
BACKGROUND: Case detection delay (CDD) in
leprosy is defined as the period between the onset of the first signs and symptoms and the time of diagnosis. A tool, consisting of a questionnaire and a detailed guide for researchers, which includes photos of typical skin signs and notes on establishing the timing of events, was developed to determine this period of delay in months in recently diagnosed
leprosy patients. The aims of the study were to determine the reliability and consistency of this CDD assessment tool.
METHODS: This study was conducted in Ethiopia, Mozambique and Tanzania. Two types of consistency were considered: over time (test-retest reliability) and across different researchers (interrater reliability). A CDD questionnaire was administered to 167
leprosy patients who were diagnosed within 6 months prior to their inclusion. One month later, the same or another researcher re-administered the CDD questionnaire to the same patients. Both test-retest and interrater reliability were assessed using the intraclass correlation coefficient (ICC), where a value greater than or equal to 0.7 is considered acceptable.
RESULTS: In this study, 10 participants (6.0%) were under 15 years of age, and 56 (33.5%) were women. In the test-retest assessment, the mean CDD from the first and second interviews was 23.7 months (95% CI 14.4-34.8) and 24.0 months (95% CI 14.8-33.2), respectively. The ICC for test-retest reliability was 0.99 (95% CI 0.994-0.997). For the interrater reliability assessment, the first and second interviews revealed a mean CDD of 24.7 months (95% CI 18.2-31.1) and 24.6 months (95% CI 18.7-30.5), respectively, with an ICC of 0.90 (95% CI 0.85-0.94). A standard error of measurement of 0.46 months was found in the test-retest and 1.03 months in the interrater measurement. Most answers given by participants during the first and second interviews were matching (≥86%). Most non-matching answers were in the 0-2 month delay category (≥46%).
CONCLUSIONS: The tool, including a questionnaire to determine the CDD of newly diagnosed
leprosy patients, was validated in three African countries. The test-retest and interrater measurements demonstrated that the instrument is reliable and measures consistently. The tool can be used in routine
leprosy programmes as well as in research settings.
BACKGROUND: This trial is registered with The Netherlands Trial Register (NTR), now available via International Clinical Trial Registry Platform (ICTRP) with registration number NL7294 (NTR7503), as well as with The Pan African Clinical Trials Registry (PACTR) with registration number PACTR202303742093429.