Pilz Micha J, Thurner Anna M M, Storz Lisa M, Krepper Daniela, Giesinger Johannes M
Health Outcomes Research Unit, University Hospital of Psychiatry II Medical University of Innsbruck, Innrain 43a, Innsbruck, 6020, Austria.
Health Qual Life Outcomes. 2025 Jun 3;23(1):55. doi: 10.1186/s12955-025-02387-7.
Thresholds for clinical importance (TCIs) were previously established for the cancer-specific patient reported outcome (PRO) measures EORTC QLQ-C30, EORTC QLQ CAT Core, and EORTC QLQ-C15-PAL. TCIs aim to aid the interpretation of scores for individual patients at a single point in time. They intend to indicate whether a symptom or functional health limitation is of clinical relevance, i.e., requires to be discussed with healthcare professionals. In this systematic scoping review, we aimed to describe the uptake of TCIs by the research community and discuss opportunities and threats in their application to PRO data.
We systematically searched PubMed and Web of Science databases that contained search terms on the respective PRO measures and TCIs. Additionally, we performed a hand search on citations of the original TCI articles on Google Scholar. Articles were included if they applied TCIs in the analysis or the interpretation of PRO data or in clinical practice. Data concerning the study design, the use of TCIs, the terminology, and the application of TCIs were extracted.
A total of 512 articles were identified. After title, abstract and full-text screening, data extraction was performed on 117 of these articles. Most articles reported on longitudinal-observational (n = 55) or cross-sectional observational (n = 49) studies, whereby the most frequent cancer populations having mixed diagnoses (n = 25), breast cancer (n = 23), haematological malignancies (n = 18), or colorectal cancer (n = 11). Various terms were used to refer to the concept of TCIs, with "thresholds for clinical importance" being the most frequently used term (n = 63; 50.8%). Strikingly, 41 of the 117 articles (35.0%) reported that TCIs were applied to group-level data (e.g. mean scores), which is a clearly unintended application of the TCIs.
TCIs are frequently used by the research community and thus enhanced the interpretability of PRO data in oncology. While most studies correctly applied TCIs in their analysis and interpretation, further guidance and clarification on their use are required. This article aims to contribute to this endeavour.
先前已针对癌症特异性患者报告结局（PRO）指标欧洲癌症研究与治疗组织生活质量问卷C30（EORTC QLQ-C30）、欧洲癌症研究与治疗组织核心生活质量问卷（EORTC QLQ CAT Core）以及欧洲癌症研究与治疗组织生活质量问卷C15-PAL确定了临床重要性阈值（TCIs）。TCIs旨在帮助在单个时间点对个体患者的评分进行解读。它们旨在表明一种症状或功能健康限制是否具有临床相关性，即是否需要与医疗保健专业人员进行讨论。在这项系统性综述中，我们旨在描述研究界对TCIs的应用情况，并讨论将其应用于PRO数据时的机遇和挑战。
我们系统检索了PubMed和Web of Science数据库，这些数据库包含有关各自PRO指标和TCIs的检索词。此外，我们在谷歌学术上对原始TCI文章的引用进行了手工检索。如果文章在PRO数据的分析或解读中或在临床实践中应用了TCIs，则纳入该文章。提取了有关研究设计、TCIs的使用、术语以及TCIs应用的数据。
共识别出512篇文章。经过标题、摘要和全文筛选后，对其中117篇文章进行了数据提取。大多数文章报道的是纵向观察性研究（n = 55）或横断面观察性研究（n = 49），其中最常见的癌症人群为混合诊断（n = 25）、乳腺癌（n = 23）、血液系统恶性肿瘤（n = 18）或结直肠癌（n = 11）。用于指代TCIs概念的术语多种多样，其中“临床重要性阈值”是最常用的术语（n = 63；50.8%）。引人注目的是，117篇文章中有41篇（35.0%）报告称TCIs被应用于组水平数据（如平均分），这显然是对TCIs的一种非预期应用。
研究界经常使用TCIs，从而提高了肿瘤学中PRO数据的可解释性。虽然大多数研究在分析和解读中正确应用了TCIs，但仍需要对其使用进行进一步的指导和澄清。本文旨在为这一努力做出贡献。
