Conner Cara L, Redding Mersady C, Seker Emel, Greer Melody L, Williams Tremaine B, Garza Maryam Y
University of Arkansas for Medical Sciences, Little Rock, Arkansas.
University of Texas Health Sciences at San Antonio, San Antonio, Texas.
J Registry Manag. 2025 Spring;52(1):6-15.
Clinical data registries provide a rich source of real-world data that can be leveraged by clinicians, researchers, and public health professionals to address some of the current health challenges faced in society today. The relative usefulness of a registry depends on the ability to gather data and the overall quality of the data. To assess existing datarelated processes, including barriers and facilitators to data collection and submission, we conducted an observational case study to evaluate sites submitting data to a prominent state-based trauma registry.
A mixed-methods approach was undertaken to evaluate existing processes and barriers to data collection for the Arkansas Trauma Registry (ATR). A series of interviews and observations were conducted with trauma registry personnel from level I-IV trauma centers across the state of Arkansas to collect data on current data-related processes. To facilitate observations, a think-aloud protocol was used to gather keystroke-level modeling (KLM) data. Additional observational data (qualitative) were collected regarding site processes and workflows pertaining to the collection and submission of registry data to the ATR. Following the observations, informal, semi-structured interviews were conducted to assess the participants' perspectives on current data-related processes, potential barriers to data collection or submission, and any recommendations for improvement. All sessions were recorded, and de-identified transcripts and session notes were used for analysis. Quantitative analyses were performed on the KLM data derived from observations to determine time spent performing end-to-end registry-related activities. Qualitative data from interviews were reviewed and coded by 2 independent reviewers. The qualitative codings were adjudicated by the reviewers using a consensus-driven approach. Themes were then extrapolated to generate the final set of results.
Seven unique staff members (trauma registrars, coordinators, supervisors, and directors) participated in the study, having completed both observation and interview sessions. These participants were from 5 unique trauma centers (one level I, one level II, two level III, and one level IV). Through the observations, we were able to characterize the typical operational flow for level I-IV trauma centers participating in the ATR, confirming a primarily manual process was used across all sites. Furthermore, the KLM analysis demonstrated that, on average, site staff would need close to 26 total hours to identify, abstract, and transcribe a single, relatively complex trauma registry case (meaning all 288 registry data elements were captured). Results from interviews further emphasized the exhaustive nature of the current data collection processes across sites, regardless of trauma level classification. Five common themes were identified across all 7 interviews: data quality; manual processes; resources and technology; site environment and staffing; and training. Across each theme, interviewees provided their perspectives on various activities and procedures at their site, as well as on the overarching trauma registry program. Many positive perspectives were shared, and several negative perspectives and perceived issues were noted. Interviewees also provided recommendations for improving internal site processes and streamlining the way in which data are collected and submitted to the ATR.
Automation of data entry, improved training resources, and adequate staffing are critical areas of improvement for efficiently abstracting registry data. By streamlining manual inputs into the registry, registrars could minimize time spent consolidating and abstracting recurring data. Conclusion: These results illuminate existing data-related practices of sites participating in the ATR and the outcomes measures for process improvement efforts. These challenges are not unique to the trauma domain and are encountered by registries across a variety of therapeutic areas. Thus, attempts to develop integrated and interoperable solutions to streamline and improve data collection would benefit all registries.
临床数据登记处提供了丰富的真实世界数据来源,临床医生、研究人员和公共卫生专业人员可以利用这些数据来应对当今社会面临的一些当前健康挑战。登记处的相对有用性取决于收集数据的能力和数据的整体质量。为了评估现有的数据相关流程,包括数据收集和提交的障碍与促进因素,我们进行了一项观察性案例研究,以评估向一个著名的州级创伤登记处提交数据的站点。
采用混合方法来评估阿肯色州创伤登记处(ATR)现有数据收集流程及障碍。我们与阿肯色州各级I - IV创伤中心的创伤登记处人员进行了一系列访谈和观察,以收集有关当前数据相关流程的数据。为便于观察,采用出声思维协议来收集按键级建模(KLM)数据。还收集了有关向ATR收集和提交登记数据的站点流程及工作流程的其他观察数据(定性)。观察之后,进行了非正式的半结构化访谈,以评估参与者对当前数据相关流程的看法、数据收集或提交的潜在障碍以及任何改进建议。所有会议均进行了记录,并使用去识别化的笔录和会议记录进行分析。对从观察中得出的KLM数据进行定量分析,以确定执行与登记处相关的端到端活动所花费的时间。访谈的定性数据由两名独立评审员进行审查和编码。评审员采用共识驱动的方法对定性编码进行裁决。然后推断出主题以生成最终结果集。
七名不同的工作人员(创伤登记员、协调员、主管和主任)参与了该研究,他们都完成了观察和访谈环节。这些参与者来自五个不同的创伤中心(一个I级、一个II级、两个III级和一个IV级)。通过观察,我们能够描述参与ATR的I - IV级创伤中心的典型操作流程,确认所有站点都主要采用手动流程。此外,KLM分析表明,平均而言,站点工作人员识别、提取和转录一个相对复杂的创伤登记案例(即捕获所有288个登记数据元素)总共需要近26个小时。访谈结果进一步强调了各站点当前数据收集流程的详尽性,无论创伤级别分类如何。在所有7次访谈中确定了五个共同主题:数据质量;手动流程;资源和技术;站点环境与人员配备;以及培训。在每个主题中,受访者都对其站点的各种活动和程序以及总体创伤登记计划发表了看法。分享了许多积极的观点,也指出了一些消极的观点和察觉到的问题。受访者还提供了改进内部站点流程以及简化数据收集和提交给ATR方式的建议。
数据录入自动化、改进培训资源和充足的人员配备是有效提取登记数据的关键改进领域。通过简化向登记处的手动输入,登记员可以将用于整理和提取重复数据的时间降至最低。结论:这些结果揭示了参与ATR的站点现有的数据相关实践以及流程改进工作的成果指标。这些挑战并非创伤领域所独有,各种治疗领域的登记处都会遇到。因此,尝试开发集成且可互操作的解决方案来简化和改进数据收集将使所有登记处受益。