Department of Clinical Oncology, Barretos Cancer Hospital, Barretos, São Paulo CEP 14784-400, Brazil.
BMC Med Res Methodol. 2014 Jan 21;14:8. doi: 10.1186/1471-2288-14-8.
Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients must be in a clinically stable condition. This is particularly problematic in palliative care (PC) settings because advanced cancer patients are prone to a faster rate of clinical deterioration. The aim of this study was to evaluate the methods by which multi-symptom and health-related qualities of life (HRQoL) based on patient-reported outcomes (PROs) have been validated in oncological PC settings with regards to test-retest reliability.
A systematic search of PubMed (1966 to June 2013), EMBASE (1980 to June 2013), PsychInfo (1806 to June 2013), CINAHL (1980 to June 2013), and SCIELO (1998 to June 2013), and specific PRO databases was performed. Studies were included if they described a set of validation studies. Studies were included if they described a set of validation studies for an instrument developed to measure multi-symptom or multidimensional HRQoL in advanced cancer patients under PC. The COSMIN checklist was used to rate the methodological quality of the study designs.
We identified 89 validation studies from 746 potentially relevant articles. From those 89 articles, 31 measured test-retest reliability and were included in this review. Upon critical analysis of the overall quality of the criteria used to determine the test-retest reliability, 6 (19.4%), 17 (54.8%), and 8 (25.8%) of these articles were rated as good, fair, or poor, respectively, and no article was classified as excellent. Multi-symptom instruments were retested over a shortened interval when compared to the HRQoL instruments (median values 24 hours and 168 hours, respectively; p = 0.001). Validation studies that included objective confirmation of clinical stability in their design yielded better results for the test-retest analysis with regard to both pain and global HRQoL scores (p < 0.05). The quality of the statistical analysis and its description were of great concern.
Test-retest reliability has been infrequently and poorly evaluated. The confirmation of clinical stability was an important factor in our analysis, and we suggest that special attention be focused on clinical stability when designing a PRO validation study that includes advanced cancer patients under PC.
患者报告结局的验证需要达到有效性和可靠性标准。在可靠性分析参数中，重测信度是一个重要的心理测量属性。重新测试的患者必须处于临床稳定状态。这在姑息治疗（PC）环境中尤其成问题，因为晚期癌症患者更容易更快地出现临床恶化。本研究的目的是评估基于患者报告的结局（PRO）的多症状和健康相关生活质量（HRQoL）的方法，在姑息治疗环境中，在重测信度方面的验证。
对 PubMed（1966 年至 2013 年 6 月）、EMBASE（1980 年至 2013 年 6 月）、PsychInfo（1806 年至 2013 年 6 月）、CINAHL（1980 年至 2013 年 6 月）和 SCIELO（1998 年至 2013 年 6 月）进行了系统检索，以及特定的 PRO 数据库。如果研究描述了一套验证研究，则将其纳入研究。如果研究描述了一套开发用于测量 PC 下晚期癌症患者的多症状或多维 HRQoL 的仪器的验证研究，则将其纳入研究。使用 COSMIN 清单对研究设计的方法学质量进行评分。
我们从 746 篇潜在相关文章中确定了 89 篇验证研究。在这 89 篇文章中，有 31 篇测量了重测信度，并纳入了本综述。对用于确定重测信度的标准的总体质量进行批判性分析后，这些文章中有 6 篇（19.4%）、17 篇（54.8%）和 8 篇（25.8%）分别被评为良好、中等和差，没有一篇文章被评为优秀。与 HRQoL 仪器相比，多症状仪器的重测间隔更短（中位数分别为 24 小时和 168 小时；p = 0.001）。在设计中包含临床稳定性客观确认的验证研究，在疼痛和全球 HRQoL 评分的重测分析中，结果更好（p < 0.05）。统计分析及其描述的质量令人非常关注。
重测信度的评估很少且评估质量差。临床稳定性的确认是我们分析中的一个重要因素，我们建议在设计包括姑息治疗下晚期癌症患者的 PRO 验证研究时，特别注意临床稳定性。
