University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA.
Stanford University, Palo Alto, CA, USA.
Cardiol Young. 2020 Apr;30(4):456-461. doi: 10.1017/S1047951120000438. Epub 2020 Mar 17.
The Pediatric Heart Network Normal Echocardiogram Database Study had unanticipated challenges. We sought to describe these challenges and lessons learned to improve the design of future studies.
Challenges were divided into three categories: enrolment, echocardiographic imaging, and protocol violations. Memoranda, Core Lab reports, and adjudication logs were reviewed. A centre-level questionnaire provided information regarding local processes for data collection. Descriptive statistics were used, and chi-square tests determined differences in imaging quality.
For the 19 participating centres, challenges with enrolment included variations in Institutional Review Board definitions of "retrospective" eligibility, overestimation of non-White participants, centre categorisation of Hispanic participants that differed from National Institutes of Health definitions, and exclusion of potential participants due to missing demographic data. Institutional Review Board amendments resolved many of these challenges. There was an unanticipated burden imposed on centres due to high numbers of echocardiograms that were reviewed but failed to meet submission criteria. Additionally, image transfer software malfunctions delayed Core Lab image review and feedback. Between the early and late study periods, the proportion of unacceptable echocardiograms submitted to the Core Lab decreased (14 versus 7%, p < 0.01). Most protocol violations were from eligibility violations and inadvertent protected health information disclosure (overall 2.5%). Adjudication committee reviews led to protocol changes.
Numerous challenges encountered during the Normal Echocardiogram Database Study prolonged study enrolment. The retrospective design and flaws in image transfer software were key impediments to study completion and should be considered when designing future studies collecting echocardiographic images as a primary outcome.
儿科心脏网络正常超声心动图数据库研究遇到了意外的挑战。我们旨在描述这些挑战和吸取的经验教训，以改进未来研究的设计。
将挑战分为三类：入组、超声心动图成像和违反方案。审查了备忘录、核心实验室报告和裁决日志。中心级别的问卷调查提供了有关当地数据收集流程的信息。使用描述性统计数据，并进行卡方检验确定成像质量的差异。
对于 19 个参与中心，入组方面的挑战包括机构审查委员会对“回顾性”资格的定义存在差异、高估非白人参与者、中心对西班牙裔参与者的分类与美国国立卫生研究院的定义不同，以及由于缺少人口统计学数据而排除潜在参与者。机构审查委员会修正案解决了其中的许多挑战。由于需要审查但不符合提交标准的大量超声心动图，给中心带来了意外的负担。此外，图像传输软件故障延迟了核心实验室图像审查和反馈。在研究的早期和晚期之间，提交给核心实验室的不可接受的超声心动图比例下降（14%对 7%，p<0.01）。大多数方案违规来自资格违规和无意的保护健康信息披露（总计 2.5%）。裁决委员会的审查导致了方案的改变。
在正常超声心动图数据库研究中遇到的许多挑战延长了研究的入组时间。回顾性设计和图像传输软件中的缺陷是完成研究的主要障碍，在设计未来以超声心动图作为主要结果的研究时应予以考虑。
