Department of Health Planning and Economics, National School of Public Health, Institute of Health Carlos III, Madrid, Spain
Department of Medicine, University of Valencia/INCLIVA Health Research Institute and Centro de Investigación en Red de Salud Mental (CIBERSAM), Valencia, Spain.
BMJ Open. 2022 Apr 29;12(4):e058738. doi: 10.1136/bmjopen-2021-058738.
Health services generate large amounts of routine health data (eg, administrative databases, disease registries and electronic health records), which have important secondary uses for research. Increases in the availability and the ability to access and analyse large amounts of data represent a major opportunity for conducting studies on the possible relationships between complex diseases. The objective of this study will be to evaluate the design, methods and reporting of studies conducted using observational routinely collected health data for investigating the link between cancer and neurodegenerative diseases.
This is the protocol for a meta-research study. We registered the study protocol within the Open Science Framework: https://osf.io/h2qjg. We will evaluate observational studies (eg, cohort and case-control) conducted using routinely collected health data for investigating the associations between cancer and neurodegenerative diseases (such as Alzheimer's disease, amyotrophic lateral sclerosis/motor neuron disease, Huntington's disease, multiple sclerosis and Parkinson's disease). The following electronic databases will be searched (from their inception onwards): MEDLINE, Embase and Web of Science Core Collection. Screening and selection of articles will be conducted by at least two researchers. Potential discrepancies will be resolved via discussion. Design, methods and reporting characteristics in each article will be extracted using a standardised data extraction form. Information on general, methodological and transparency items will be reported. We will summarise our findings with tables and graphs (eg, bar charts, forest plots).
Due to the nature of the proposed study, no ethical approval will be required. We plan to publish the full study in an open access peer-reviewed journal and disseminate the findings at scientific conferences and via social media. All data will be deposited in a cross-disciplinary public repository.
卫生服务机构产生了大量常规健康数据(例如,行政数据库、疾病登记处和电子健康记录),这些数据对于研究具有重要的次要用途。可获取和访问及分析大量数据的能力不断提高,这为开展关于复杂疾病之间可能存在的关系的研究提供了一个重要机会。本研究的目的将是评估使用观察性常规收集的健康数据进行的研究的设计、方法和报告,以调查癌症和神经退行性疾病之间的联系。
这是一项元研究的方案。我们在开放科学框架(Open Science Framework)中注册了研究方案:https://osf.io/h2qjg。我们将评估使用常规收集的健康数据进行的观察性研究(例如,队列和病例对照研究),以调查癌症和神经退行性疾病(如阿尔茨海默病、肌萎缩性侧索硬化症/运动神经元病、亨廷顿病、多发性硬化症和帕金森病)之间的关联。将从以下电子数据库中搜索(从其成立开始):MEDLINE、Embase 和 Web of Science Core Collection。至少由两名研究人员进行文章的筛选和选择。如有潜在差异,将通过讨论解决。使用标准化的数据提取表提取每个文章的设计、方法和报告特征。将报告一般、方法学和透明度项目的信息。我们将使用表格和图形(例如,条形图、森林图)总结我们的发现。
由于拟议研究的性质,不需要获得伦理批准。我们计划在开放获取的同行评议期刊上全文发表研究结果,并在科学会议和社交媒体上传播研究结果。所有数据将被存储在一个跨学科的公共存储库中。