Kamran Rakhshan, Algu Leah, Leveille Cameron F, Stewart Claire R, Abid Khizar, Lipner Shari R, Klassen Anne F, Rae Charlene
Michael G. DeGroote School of Medicine, McMaster University, 1280 Main Street W, Hamilton, ON, Canada.
Faculty of Health Sciences, McMaster University, 1280 Main Street W, Hamilton, ON, Canada.
Arch Dermatol Res. 2022 Apr;314(3):223-237. doi: 10.1007/s00403-021-02222-1. Epub 2021 Apr 5.
Nail conditions have an impact on appearance, function, and quality of life of patients. Patient reported outcome measures (PROMs) are important tools for evaluating treatment success from the patient perspective. It is important to understand the quality of PROMs to help guide selection of appropriate tools. The aim of this study was to critically appraise the psychometric properties of nail-specific PROMs using COSMIN guidelines. A systematic review was conducted in May 2019 to identify development and validation articles for nail-specific PROMs. Abstracts and subsequent full-texts were screened by two reviewers for eligibility. Data were extracted for study characteristics and psychometric properties. The risk of bias checklist was completed, and ratings applied to psychometric properties as per COSMIN guidelines. Modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria were applied based on the risk of bias checklist to assess methodological quality. The review identified 3289 articles of which 430 full-text articles were screened, nine of which met eligibility criteria. Included papers were for seven PROMs and in total reported on 31of 49 possible measurement properties. Of the 31 measurement properties reported, nine (29%) were rated as insufficient or indeterminate. The modified GRADE methodological quality rating was low or very low for 16 (32.7%) measurement properties, and 18 (36.7%) measurement properties were not described by any PROM. Currently there are no nail-specific PROMS available that demonstrate adequate validity, reliability, or responsiveness, according to COSMIN guidelines. Further research is required to assess missing or insufficiently tested measurement properties in all the PROMs identified.
指甲状况会对患者的外观、功能及生活质量产生影响。患者报告结局测量指标（PROMs）是从患者角度评估治疗效果的重要工具。了解PROMs的质量对于指导选择合适的工具很重要。本研究的目的是使用COSMIN指南严格评估指甲特异性PROMs的心理测量特性。2019年5月进行了一项系统评价，以确定指甲特异性PROMs的开发和验证文章。两名评审员对摘要及随后的全文进行筛选以确定是否符合纳入标准。提取了研究特征和心理测量特性的数据。完成了偏倚风险清单，并根据COSMIN指南对心理测量特性进行评分。基于偏倚风险清单应用改良的推荐分级评估、制定与评价（GRADE）标准来评估方法学质量。该评价共识别出3289篇文章，其中筛选了430篇全文文章，9篇符合纳入标准。纳入的论文涉及7种PROMs，总共报告了49种可能测量特性中的31种。在报告的31种测量特性中，9种（29%）被评为不足或不确定。16种（32.7%）测量特性的改良GRADE方法学质量评级为低或非常低，18种（36.7%）测量特性未被任何PROM描述。根据COSMIN指南，目前尚无具有足够效度、信度或反应度的指甲特异性PROMs。需要进一步研究来评估所有已识别的PROMs中缺失或测试不足的测量特性。
