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儿科牙科临床试验中的患者报告结局(PROs)。

Patient-reported Outcomes (PROs) in clinical trials in paediatric dentistry.

机构信息

Paediatric Dentistry, University of Sheffield, Sheffield, UK.

Dental Public Health, University of Sheffield, Sheffield, UK.

出版信息

Int J Paediatr Dent. 2020 Dec;31 Suppl 1:31-37. doi: 10.1111/ipd.12768. Epub 2021 Jan 17.

DOI:10.1111/ipd.12768
PMID:33458920
Abstract

Patient-reported outcomes (PROs) are reports directly from patients without interpretation by clinicians or others and captured using validated patient-reported outcome measures (PROMs). These measures are increasingly employed in clinical practice and can be incorporated into clinical trials. Benefits of using PROs include reducing observer bias; eliciting unique views on aspects important to patients and increasing public accountability. Despite inclusion in clinical trials PRO data is often under-reported and the results may not be adopted into clinical practice due to concerns about the data generated. This review discusses what PROs are and how to measure them; the benefits of using PROs; how to choose an appropriate PROM to answer the research question; considerations for using PROs in paediatric dentistry and reporting guidelines. Finally, some examples of how PROs have been included in paediatric dentistry trials are given along with discussion of the development of core outcome sets and how these may improve reporting of PROs in the future.

摘要

患者报告的结局(PROs)是指患者直接报告的结果,无需临床医生或其他人进行解释,并使用经过验证的患者报告结局测量工具(PROMs)进行采集。这些测量工具在临床实践中越来越多地被使用,并且可以纳入临床试验。使用 PROs 的好处包括减少观察者偏倚;引出患者对重要方面的独特观点,并提高公众问责制。尽管在临床试验中纳入了 PRO 数据,但由于对生成的数据的担忧,PRO 数据的报告往往不足,并且结果可能不会被纳入临床实践。这篇综述讨论了 PROs 是什么以及如何测量它们;使用 PROs 的好处;如何选择适当的 PROM 来回答研究问题;在儿科牙科中使用 PROs 的注意事项和报告指南。最后,给出了一些 PROs 如何被纳入儿科牙科试验的例子,并讨论了核心结局集的发展以及它们如何在未来改善 PROs 的报告。

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引用本文的文献

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Rethinking dental research: the importance of patient-reported outcomes and minimally clinically important difference.重新思考牙科研究:患者报告结局和最小临床重要差异的重要性
Evid Based Dent. 2024 Sep;25(3):117-118. doi: 10.1038/s41432-024-01034-2.
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The Potential Role of Dental Patient-Reported Outcomes (dPROs) in Evidence-Based Prosthodontics and Clinical Care: A Narrative Review.牙科患者报告结局(dPROs)在循证口腔修复学和临床护理中的潜在作用:一项叙述性综述
Patient Relat Outcome Meas. 2022 Jun 3;13:131-143. doi: 10.2147/PROM.S256724. eCollection 2022.
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An update of treatment modalities in children and adolescents with teeth affected by molar incisor hypomineralisation (MIH): a systematic review.
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Eur Arch Paediatr Dent. 2022 Feb;23(1):39-64. doi: 10.1007/s40368-021-00635-0. Epub 2021 Jun 10.