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前列腺癌临床试验中生活质量评估的小型综述:需要采取以患者为中心的方法,代表患者提出合适的治疗方案。

A mini-review of quality of life as an outcome in prostate cancer trials: patient-centered approaches are needed to propose appropriate treatments on behalf of patients.

机构信息

SPHERE (MethodS for Patients-centered outcomes and HEalth Research), INSERM UMR 1246, Nantes University, IRS2 - 22 boulevard Bénoni Goullin, 44200, Nantes, France.

CHU Nantes University Hospital, Nantes, France.

出版信息

Health Qual Life Outcomes. 2018 Mar 5;16(1):40. doi: 10.1186/s12955-018-0870-6.

Abstract

BACKGROUND

Patients with prostate cancer (PC) may be ready to make trade-offs between their quantity and their quality of life. For instance, elderly patients may prefer the absence of treatment if it is associated with a low-risk of disease progression, compared to treatments aiming at preventing disease progression but with a substantial deterioration of their Health-Related Quality of Life (HRQoL). Therefore, it seems relevant to compare the treatments by considering both survival and HRQoL. In this mini-review, the aim was to question whether the potential trade-offs between survival and HRQoL are considered in high impact factor journals.

METHODS

The study was conducted from the PubMed database for recent papers published between May 01, 2013, and May 01, 2015. We also restricted our search to nine medical journals with 2013 impact factor > 15.

RESULTS

Among the 30 selected studies, only six collected individual HRQoL as a secondary endpoint by using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. In four studies, the time to HRQoL change was analyzed, but its definitions varied. In two studies, the mean changes in HRQoL between the baseline and the 12- or 16-week follow-up were analyzed. None of the six studies reported in a single endpoint both the quantity and the quality of life.

CONCLUSIONS

Our mini-review, which only focused on recent publications in journals with high-impact, suggests moving PC clinical research towards patient-centered outcomes-based studies. This may help physicians to propose the most appropriate treatment on behalf of patients. We recommend the use of indicators such as Quality-Adjusted Life-Years (QALYs) as principal endpoint in future clinical trials.

摘要

背景

前列腺癌(PC)患者可能愿意在生活质量和数量之间进行权衡。例如,与旨在预防疾病进展但会大幅降低患者健康相关生活质量(HRQoL)的治疗相比,老年患者可能更倾向于选择无治疗,如果这种治疗与疾病进展的低风险相关。因此,通过考虑生存和 HRQoL 来比较治疗似乎是合理的。在本次迷你综述中,我们旨在探讨在高影响因子期刊中是否考虑了生存和 HRQoL 之间的潜在权衡。

方法

本研究基于 PubMed 数据库,检索了 2013 年 5 月 1 日至 2015 年 5 月 1 日之间发表的近期论文。我们还将检索范围限制在 9 种影响因子高于 15 的医学期刊。

结果

在 30 项入选的研究中,仅有 6 项研究使用前列腺癌患者生活质量量表(FACT-P)作为次要终点来收集个体 HRQoL。在 4 项研究中,分析了 HRQoL 变化的时间,但定义各不相同。在 2 项研究中,分析了 HRQoL 在基线和 12 或 16 周随访之间的平均变化。这 6 项研究中没有一项报告了单一终点的生存和生活质量。

结论

我们的迷你综述仅关注高影响因子期刊中的近期出版物,表明 PC 临床研究应向以患者为中心的结局研究发展。这可能有助于医生为患者提供最合适的治疗方案。我们建议在未来的临床试验中使用质量调整生命年(QALYs)等指标作为主要终点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ede/5836440/332ca99f1c56/12955_2018_870_Fig1_HTML.jpg

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