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在评估前列腺癌真实世界主动监测结果的观察性研究中定义和衡量依从性:一项系统评价

Defining and Measuring Adherence in Observational Studies Assessing Outcomes of Real-world Active Surveillance for Prostate Cancer: A Systematic Review.

作者信息

Kith Glenda, Lisker Sarah, Sarkar Urmimala, Barr-Walker Jill, Breyer Benjamin N, Palmer Nynikka R

机构信息

San Francisco Department of Public Health, San Francisco, CA, USA; Department of Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, CA, USA.

Department of Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, CA, USA; Center for Vulnerable Populations, University of California, San Francisco, CA, USA.

出版信息

Eur Urol Oncol. 2021 Apr;4(2):192-201. doi: 10.1016/j.euo.2019.06.009. Epub 2019 Jul 6.

Abstract

CONTEXT

Evidence-based guidelines for active surveillance (AS), a treatment option for men with low-risk prostate cancer, recommend regular follow-up at periodic intervals to monitor disease progression. However, gaps in monitoring can lead to delayed detection of cancer progression, leading to a missed window of curability.

OBJECTIVE

We aimed to identify the extent to which real-world observational studies reported adherence to monitoring protocols among prostate cancer patients on AS. When reported, we sought to characterize definitions of adherence.

EVIDENCE ACQUISITION

We systematically reviewed observational studies assessing outcomes of prostate cancer patients on AS, published before March 22, 2019 in PubMed, Embase, and CENTRAL. Adherence definitions were considered time bound if they included prespecified time and binary if adherence was assessed but did not specify a time interval. We assessed study quality using the Strengthening the Reporting of Observational Studies in Epidemiology checklist.

EVIDENCE SYNTHESIS

Forty-five studies met our inclusion criteria. Eleven studies did not report any data on adherence to AS protocols. Twenty-five studies did not explicitly measure adherence, but provided relevant data (eg, number of patients who received a repeat biopsy). Six studies reported adherence using a time-bound definition, while three studies used a binary definition. Twenty-three studies provided information on patients lost to follow-up.

CONCLUSIONS

Most studies reporting outcomes of patients on AS did not measure or report adherence. When reported, adherence was often not time specific. As some AS patients will benefit from maintaining a window of curability, clinical practices and future studies should track and report adherence and associated factors.

PATIENT SUMMARY

We reviewed real-world observational studies examining outcomes of prostate cancer patients on active surveillance. Most studies did not clearly define or report adherence to monitoring protocols, which is important to consider for appropriate disease management.

摘要

背景

对于低风险前列腺癌男性患者的一种治疗选择——主动监测(AS),基于证据的指南推荐定期进行随访以监测疾病进展。然而,监测中的差距可能导致癌症进展的检测延迟,从而错过治愈窗口期。

目的

我们旨在确定真实世界观察性研究报告前列腺癌患者在AS治疗中遵循监测方案的程度。当有报告时,我们试图描述遵循的定义。

证据获取

我们系统回顾了在2019年3月22日前发表于PubMed、Embase和CENTRAL上的评估前列腺癌患者AS治疗结果的观察性研究。如果遵循定义包括预先指定的时间,则被视为有时间限制;如果评估了遵循情况但未指定时间间隔,则为二元定义。我们使用流行病学观察性研究报告强化清单评估研究质量。

证据综合

45项研究符合我们的纳入标准。11项研究未报告任何关于遵循AS方案的数据。25项研究未明确测量遵循情况,但提供了相关数据(例如接受重复活检的患者数量)。6项研究使用有时间限制的定义报告遵循情况,而3项研究使用二元定义。23项研究提供了失访患者的信息。

结论

大多数报告AS患者结果的研究未测量或报告遵循情况。当有报告时,遵循情况通常没有特定时间。由于一些AS患者将从维持治愈窗口期获益,临床实践和未来研究应跟踪并报告遵循情况及相关因素。

患者总结

我们回顾了关于前列腺癌患者主动监测结果的真实世界观察性研究。大多数研究未明确界定或报告对监测方案的遵循情况,而这对于适当的疾病管理很重要。

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本文引用的文献

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Risk of Becoming Lost to Follow-up During Active Surveillance for Prostate Cancer.前列腺癌主动监测随访丢失风险。
Eur Urol. 2018 Dec;74(6):704-707. doi: 10.1016/j.eururo.2018.08.010. Epub 2018 Aug 31.

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