癌症患儿健康相关生活质量患者报告结局测量工具内容效度的批判性评价：系统评价。
A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review.
机构信息
Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Clinic of Psychiatry II, Medical University Innsbruck, Innsbruck, Austria.
Institute of Psychology, University of Innsbruck, Innsbruck, Austria.
出版信息
J Patient Rep Outcomes. 2023 Jan 19;7(1):2. doi: 10.1186/s41687-023-00540-8.
BACKGROUND
With increasing survival rates in pediatric oncology, the need to monitor health-related quality of life (HRQOL) is becoming even more important. However, available patient-reported outcome measures (PROMs) have been criticized. This review aims to systematically evaluate the content validity of PROMs for HRQOL in children with cancer.
METHODS
In December 2021, a systematic literature search was conducted in PubMed. PROMs were included if they were used to assess HRQOL in children with cancer and had a lower age-limit between 8 and 12 years and an upper age-limit below 21 years. The COSMIN methodology for assessing the content validity of PROMs was applied to grade evidence for relevance, comprehensiveness, and comprehensibility based on quality ratings of development studies (i.e., studies related to concept elicitation and cognitive interviews for newly developed questionnaires) and content validity studies (i.e., qualitative studies in new samples to evaluate the content validity of existing questionnaires).
RESULTS
Twelve PROMs were included. Due to insufficient patient involvement and/or poor reporting, the quality of most development studies was rated 'doubtful' or 'inadequate'. Few content validity studies were available, and these were mostly 'inadequate'. Following the COSMIN methodology, evidence for content validity was 'low' or 'very low' for almost all PROMs. Only the PROMIS Pediatric Profile had 'moderate' evidence. In general, the results indicated that the PROMs covered relevant issues, while results for comprehensiveness and comprehensibility were partly inconsistent or insufficient.
DISCUSSION
Following the COSMIN methodology, there is scarce evidence for the content validity of available PROMs for HRQOL in children with cancer. Most instruments were developed before the publication of milestone guidelines and therefore were not able to fulfill all requirements. Efforts are needed to catch up with methodological progress made during the last decade. Further research should adhere to recent guidelines to develop new instruments and to strengthen the evidence for existing PROMs.
背景
随着儿科肿瘤患者生存率的提高，监测健康相关生活质量（HRQOL）的需求变得更加重要。然而，现有的患者报告结局测量（PROMs）已经受到了批评。本综述旨在系统评估用于评估癌症儿童 HRQOL 的 PROM 的内容效度。
方法
2021 年 12 月，在 PubMed 中进行了系统文献检索。如果 PROM 用于评估癌症儿童的 HRQOL，且年龄下限为 8 至 12 岁，年龄上限低于 21 岁，则将其纳入研究。应用 COSMIN 方法评估 PROM 的内容效度，根据开发研究（即与新开发问卷的概念提取和认知访谈相关的研究）和内容效度研究（即评估现有问卷内容效度的新样本中的定性研究）的质量评分，对相关性、全面性和可理解性的证据进行分级。
结果
共纳入 12 种 PROM。由于患者参与度不足和/或报告质量较差，大多数开发研究的质量被评为“可疑”或“不足”。几乎没有可用的内容效度研究，且这些研究大多“不足”。根据 COSMIN 方法，几乎所有 PROM 的内容效度证据均为“低”或“极低”。只有 PROMIS 儿科概况问卷具有“中等”证据。总体而言，结果表明 PROM 涵盖了相关问题，而全面性和可理解性的结果则部分不一致或不足。
讨论
根据 COSMIN 方法，现有的用于评估癌症儿童 HRQOL 的 PROM 的内容效度证据很少。大多数工具都是在里程碑指南发布之前开发的，因此无法满足所有要求。需要努力跟上过去十年中取得的方法学进展。进一步的研究应遵循最近的指南，开发新的工具，并加强对现有 PROM 的证据支持。
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