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Content Validation of Clinician-Reported Items for a Severity Measure for CDKL5 Deficiency Disorder
Journal of Child Neurology ( IF 2.0 ) Pub Date : 2021-08-11 , DOI: 10.1177/08830738211019576
Jacinta Saldaris 1 , Judith Weisenberg 2 , Elia Pestana-Knight 3 , Eric D Marsh 4 , Bernhard Suter 5 , Rajsekar Rajaraman 6 , Gena Heidary 7 , Heather E Olson 8 , Orrin Devinsky 9 , Dana Price 9 , Peter Jacoby 1 , Helen Leonard 1, 10 , Tim A Benke 11 , Scott Demarest 11 , Jenny Downs 1, 12
Affiliation  

CDKL5 deficiency disorder (CDD) results in early-onset seizures and severe developmental impairments. A CDD clinical severity assessment (CCSA) was previously developed with clinician and parent-report items to capture information on a range of domains. Consistent with US Food and Drug Administration (FDA) guidelines, content validation is the first step in evaluating the psychometric properties of an outcome measure. The aim of this study was to validate the content of the clinician-reported items in the CCSA (CCSA-Clinician). Eight neurologists leading the USA CDD Center of Excellence clinics were interviewed using the “think aloud” technique to critique 26 clinician-reported items. Common themes were aggregated, and a literature search of related assessments informed item modifications. The clinicians then participated in 2 consensus meetings to review themes and finalize the items. A consensus was achieved for the content of the CCSA-Clinician. Eight of the original items were omitted, 11 items were added, and the remaining 18 items were revised. The final 29 items were classified into 2 domains: functioning and neurologic impairments. This study enabled refinement of the CCSA-Clinician and provided evidence for its content validity. This preliminary validation is essential before field testing and further validation, in order to advance the instrument toward clinical trial readiness.



中文翻译:

CDKL5缺乏症严重程度测量的临床医生报告项目的内容验证

CDKL5 缺乏症 (CDD) 导致早发性癫痫发作和严重的发育障碍。CDD 临床严重程度评估 (CCSA) 之前是由临床医生和家长报告项目开发的,以获取一系列领域的信息。与美国食品和药物管理局 (FDA) 指南一致,内容验证是评估结果测量的心理测量特性的第一步。本研究的目的是验证 CCSA (CCSA-Clinician) 中临床医生报告项目的内容。八位领导美国 CDD 卓越中心诊所的神经学家使用“大声思考”技术对 26 个临床医生报告的项目进行了采访。共同主题被汇总,相关评估的文献检索通知项目修改。临床医生随后参加了 2 次共识会议,以审查主题并最终确定项目。CCSA-Clinician 的内容已达成共识。删去原来的8条,增加了11条,修改了剩下的18条。最后的 29 个项目分为 2 个领域:功能障碍和神经障碍。这项研究使 CCSA-Clinician 得以完善,并为其内容有效性提供了证据。这种初步验证在现场测试和进一步验证之前是必不可少的,以便将仪器推向临床试验准备阶段。最后的 29 个项目分为 2 个领域:功能障碍和神经障碍。这项研究使 CCSA-Clinician 得以完善,并为其内容有效性提供了证据。这种初步验证在现场测试和进一步验证之前是必不可少的,以便将仪器推向临床试验准备阶段。最后的 29 个项目分为 2 个领域:功能障碍和神经障碍。这项研究使 CCSA-Clinician 得以完善,并为其内容有效性提供了证据。这种初步验证在现场测试和进一步验证之前是必不可少的,以便将仪器推向临床试验准备阶段。

更新日期:2021-08-11
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