Registries in Pediatric Anesthesia Research: Opportunities and Challenges

By Lisa K. Lee, MD and John Fiadjoe, MD

Registries are an ideal way to collate the experience of several centers. The SPA has fostered and supported the growth of a number of quality improvement and research registries. Examples include:

• Wake Up Safe (WUS) – Founded in 2005, tracks serious adverse events occurring in pediatric anesthesia and aims to use analysis of these adverse events for learning1
• Pediatric Regional Anesthesia Network (PRAN)  -  Founded in 2007, tracks data on the practice, risks and complications of regional anesthetics performed in children2
• The Pediatric Difficult Intubation (PeDI) Registry – Founded in 2011, tracks data on patients who are anticipated or found to be difficult airways3
• The Craniofacial Surgery Perioperative Registry from the Pediatric Craniofacial Collaborative Group (PCCG)-  Founded in 2011, tracks outcomes in children with craniosynostosis undergoing complex cranial vault reconstruction4
• The Society for Pediatric Anesthesia Improvement Network (SPAIN) – Founded in 2014, tracks perioperative management and postoperative recovery for surgical procedures where perioperative care is variable and outcomes are uncertain or inconsistent5

Analysis of data from each of these registries has contributed significantly to our knowledge and understanding of perioperative pediatric care. In this article, we will examine some of the benefits of these registries and consider some of the challenges associated with their creation and maintenance.

Benefits of a Registry

1. Enable research on rare, but important outcomes or diseases that would be difficult to study at a single center.
   Although randomized controlled trials are often touted as the gold standard in research, certain outcomes or diseases are so rare that attempting to design and conduct a multi-institutional randomized controlled trial may not be financially or temporally feasible. Registries can provide real-world snapshots of current treatment practices, outcomes and patient mix and serve as a powerful tool for quickly answering emerging questions at significantly lower cost. Registries may also serve as a starting point to obtain data for a pilot study. With large registries, the data can be used to create risk calculators for identifying vulnerable populations. An example of this is the Pediatric Surgical Risk Calculator which was built on data from >180,000 operations across 67 hospitals which participated in American College of Surgeons National Surgical Quality Improvement Program Pediatric Registry from 2012-2014.6 Finally, pooling of data from multiple institutions also increases the generalizability of the research results.
2. Decrease the barriers to conducting research and promote collaborations.
   While examination and analysis of secondary data still requires IRB approval, this process can often be expedited. Registries can also provide opportunities for researchers to network with individuals from other institutions. The relationships formed can facilitate identification of the pressing research questions and foster the planning and conduct of future prospective clinical trials. A registry could also permit cross-institutional queries of de-identified data and allow for targeted recruitment.
3. Enable tracking of quality improvement initiatives and help disseminate best clinical practices.
   Registries may identify new techniques that improve outcomes, provide timely access to best clinical practices and the opportunity to answer clinical questions in an evolving environment. The sharing of this information may help low volume institutions adopt best practices. Institutions that regularly contribute data may also use the registry for benchmarking their performance to other sites. Overall, well-designed registries facilitate better clinical care.

Challenges
Registries are not without their challenges (setup costs, time, maintenance costs, account management). There are administrative costs to maintain the registry, grant access to interested parties and manage access accounts.  Decisions also need to be made regarding the exact inclusion/exclusion criteria for patient entry into the registry as well as what data should be collected. A balance needs to be struck between having enough details to answer a multitude of research questions from the same data set and making the data entry process easy for potential contributors. Due to patient privacy concerns and to meet HIPAA standards, the data needs to be maintained in a private, secured server and a process in place to archive the data, in case of data loss, deletion or corruption. Other issues that may need to be addressed include deciding how secure access to the data in the registry should be allowed and whether these maintenance costs should be shared among participating institutions.

Concerns Regarding Data Veracity
Although all attempts are made to ensure the data entered is correct and that all sites contributing data are using the same units (kg vs. pounds), interpreting inclusion/exclusion criteria and data definitions in the same manner, errors can call registry findings into question. In some cases, manual review of data entries at regular intervals may be required to identify, remove or correct erroneous entries. Missing data is also a challenge. Although imputation methods exist to address this problem, statistical methods may not be able to make up for poor quality data. Data management applications such as REDCap (Research Electronic Data Capture)7 can be useful for addressing some of these issues because it has built in data validation features that help avoid difficulties with data analysis due to typos, inconsistent capitalizations, abbreviations, etc.

Capture of cases, selection bias
Since the majority of these registries are self-reporting, there may be biases that limit the number of complications being reported. Conversely, complications themselves may be an impetus for entering a case and may also skew the true incidence of an event. Because of this, the impact of selection bias can be difficult to delineate. In a previous study, barriers to reporting complications into a registry included: concern for punitive repercussions, feelings of incompetence, poor education about what constitutes an event, lack of feedback, and the perception that reporting had no value.8 All of these factors could affect the validity of studies using data collected from a registry.

Despite all of these challenges, registries can be invaluable resource for researchers. Forty manuscripts have been published to date from SPA registries, with 705 citations of these manuscripts and an average Altmetric Attention Score of 7. Conclusions drawn from analysis of data from these registries have shaped the practice of pediatric anesthesia.

References

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2. Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.
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