BACKGROUND A Core Outcomes Set (COS) is an agreed minimum set of outcomes that should be reported in all clinical studies related to a specific condition. Using prostate cancer as a case study, we identified, summarized, and critically appraised published COS development studies and assessed the degree of overlap between them and selected real-world data (RWD) sources. METHODS We conducted a scoping review of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative database to identify all COS studies developed for prostate cancer. Several characteristics (i.e., study type, methods for consensus, type of participants, outcomes included in COS and corresponding measurement instruments, timing, and sources) were extracted from the studies; outcomes were classified according to a predefined 38-item taxonomy. The study methodology was assessed based on the recent COS-STAndards for Development (COS-STAD) recommendations. A 'mapping' exercise was conducted between the COS identified and RWD routinely collected in selected European countries. RESULTS Eleven COS development studies published between 1995 and 2017 were retrieved, of which 8 were classified as 'COS for clinical trials and clinical research', 2 as 'COS for practice' and 1 as 'COS patient reported outcomes'. Recommended outcomes were mainly categorized into 'mortality and survival' (17%), 'outcomes related to neoplasm' (18%), and 'renal and urinary outcomes' (13%) with no relevant differences among COS study types. The studies generally fulfilled the criteria for the COS-STAD 'scope specification' domain but not the 'stakeholders involved' and 'consensus process' domains. About 72% overlap existed between COS and linked administrative data sources, with important gaps. Linking with patient registries improved coverage (85%), but was sometimes limited to smaller follow-up patient groups. CONCLUSIONS This scoping review identified few COS development studies in prostate cancer, some quite dated and with a growing level of methodological quality over time. This study revealed promising overlap between COS and RWD sources, though with important limitations; linking established, national patient registries to administrative data provide the best means to additionally capture patient-reported and some clinical outcomes over time. Thus, increasing the combination of different data sources and the interoperability of systems to follow larger patient groups in RWD is required.

中文翻译：

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使用前列腺癌作为案例研究，对核心结果集及其“映​​射”到现实世界数据进行了范围界定审查。

背景技术核心结果集（COS）是商定的最小结果集，应在与特定疾病相关的所有临床研究中报告这些结果。以前列腺癌为例，我们确定，总结并严格评估了已发表的COS开发研究，并评估了它们与选定的真实世界数据（RWD）来源之间的重叠程度。方法我们对有效性试验的核心结果指标（COMET）计划数据库进行了范围界定审查，以确定所有针对前列腺癌开展的COS研究。从研究中提取了几个特征（即研究类型，达成共识的方法，参与者的类型，COS中包含的结果以及相应的测量工具，时间和来源）；根据预定义的38个项目分类对结果进行分类。根据最新的COS-STAndards for Development（COS-STAD）建议对研究方法进行了评估。在选定的欧洲国家/地区常规识别的COS和RWD之间进行了“映射”练习。结果检索了1995年至2017年发表的11项COS发展研究，其中8项被归类为``用于临床试验和临床研究的COS''，2项被归类为``COS用于实践''，1项被归类为``COS患者报告的结局''。推荐的结果主要分为“死亡率和生存率”（17％），“与肿瘤相关的结果”（18％）和“肾脏和泌尿系统的结果”（13％），而COS研究类型之间无相关差异。这些研究通常满足COS-STAD“范围规范”领域的标准，但不满足“ 利益相关者”和“共识过程”域。COS和链接的行政数据源之间存在约72％的重叠，但存在重大差距。与患者注册表的连接提高了覆盖率（85％），但有时仅限于较小的随访患者组。结论这项界定范围的研究确定了很少有关于前列腺癌的COS发育研究，其中一些研究已经过时，并且随着时间的推移，其方法学质量也在不断提高。这项研究表明，COS和RWD源之间存在有希望的重叠，尽管存在重要局限性。将已建立的国家患者注册表与管理数据联系起来，是最好的手段，可以随着时间的流逝进一步捕获患者报告的数据和某些临床结果。从而，