Department of Oncology, Ottawa Hospital, Ottawa, ON, Canada.
Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Syst Rev. 2023 Jul 8;12(1):117. doi: 10.1186/s13643-023-02283-5.
Randomized controlled trials (RCTs) are a critical component of evidence-based medicine and the evolution of patient care. However, the costs of conducting a RCT can be prohibitive. A promising approach toward reduction of costs and lessening of the burden of intensive and lengthy patient follow-up is the use of routinely collected healthcare data (RCHD), commonly called real-world data. We propose a scoping review to identify existing RCHD case definitions of breast cancer progression and survival and their diagnostic performance.
We will search MEDLINE, EMBASE, and CINAHL to identify primary studies of women with either early-stage or metastatic breast cancer, managed with established therapies, that evaluated the diagnostic accuracy of one or more RCHD-based case definitions or algorithms of disease progression (i.e., recurrence, progression-free survival, disease-free survival, or invasive disease-free survival) or survival (i.e., breast-cancer-free survival or overall survival) compared with a reference standard measure (e.g., chart review or a clinical trial dataset). Study characteristics and descriptions of algorithms will be extracted along with measures of the diagnostic accuracy of each algorithm (e.g., sensitivity, specificity, positive predictive value, negative predictive value), which will be summarized both descriptively and in structured figures/tables.
Findings from this scoping review will be clinically meaningful for breast cancer researchers globally. Identification of feasible and accurate strategies to measure patient-important outcomes will potentially reduce RCT budgets as well as lessen the burden of intensive trial follow-up on patients.
Open Science Framework ( https://doi.org/10.17605/OSF.IO/6D9RS ).
随机对照试验（RCT）是循证医学和患者护理发展的关键组成部分。然而，进行 RCT 的成本可能过高。一种有前途的降低成本和减轻密集而漫长的患者随访负担的方法是使用常规收集的医疗保健数据（RCHD），通常称为真实世界数据。我们提出了一项范围综述，以确定现有的乳腺癌进展和生存的 RCHD 病例定义及其诊断性能。
我们将搜索 MEDLINE、EMBASE 和 CINAHL，以确定患有早期或转移性乳腺癌的女性的原始研究，这些患者接受了既定疗法的治疗，并评估了一种或多种基于 RCHD 的病例定义或疾病进展（即复发、无进展生存期、无病生存期或侵袭性无病生存期）或生存（即乳腺癌无生存期或总生存期）的诊断准确性与参考标准测量（例如，图表审查或临床试验数据集）相比。将提取研究特征和算法描述，以及每个算法的诊断准确性测量值（例如，敏感性、特异性、阳性预测值、阴性预测值），将以描述性和结构化的图形/表格形式进行总结。
本范围综述的结果将对全球乳腺癌研究人员具有临床意义。确定可行且准确的测量患者重要结局的策略可能会降低 RCT 预算，并减轻患者密集试验随访的负担。
