Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand.
NHMRC Clinical Trials Centre, The University of Sydney, NSW, Australia.
J Gynecol Oncol. 2018 Sep;29(5):e81. doi: 10.3802/jgo.2018.29.e81. Epub 2018 Jun 9.
Health related quality of life (HRQOL) is a key priority for patients with ovarian cancer as there is significant morbidity associated with the disease and the treatment. It is therefore essential to include measures of HRQOL and patient reported outcomes (PROs) in all clinical trials and ideally report them in the initial manuscript. The results of these analyses help interpret the primary trial endpoints which are typically progression free survival and overall survival from the perspective of the patients, but can also assist with regulatory approval of new drugs and inform future patients regarding the potential benefits and downsides of the treatment as well as help support clinical recommendations. Including PROs in clinical trials allows patient-defined clinical benefits to be assessed in parallel to traditional survival outcomes to provide a more holistic overview and aid in the interpretation of the trial results. Given the importance of these instruments in clinical trials, greater effort is required to improve the appropriate inclusion, quality of analyses and reporting of PROs. It is also essential that all clinicians understand the intricacies of the selection, implementation and interpretation of these measures of HRQOL and PRO's and how important their contribution is to clinical trials as well as clinical practice. This review is a practical guide for clinicians to gain a better understanding of PROs and how they can be incorporated into ovarian cancer trials.
健康相关生活质量（HRQOL）是卵巢癌患者的一个关键优先事项，因为该疾病及其治疗会导致明显的发病率。因此，在所有临床试验中都必须包括 HRQOL 和患者报告的结局（PRO）测量方法，并最好在初始手稿中报告。这些分析结果有助于从患者的角度解释主要试验终点，这些终点通常是无进展生存期和总生存期，但也可以帮助新药的监管批准，并为未来的患者提供关于治疗的潜在益处和弊端的信息，以及有助于支持临床建议。将 PRO 纳入临床试验可让患者定义的临床益处与传统的生存结果并行评估，以提供更全面的概述，并有助于解释试验结果。鉴于这些工具在临床试验中的重要性，需要付出更大的努力来提高 PRO 的适当纳入、分析质量和报告。同样重要的是，所有临床医生都应了解这些 HRQOL 和 PRO 测量方法的选择、实施和解释的复杂性，以及它们对临床试验和临床实践的重要性。本综述是临床医生更好地了解 PRO 以及如何将其纳入卵巢癌试验的实用指南。
