Background & Aims

Acute to Chronic Pain Signatures (A2CPS) is a longitudinal, multicenter clinical study designed to identify biosignatures of the acute to chronic pain transition in postoperative patients. Data collection was scheduled to begin during COVID shutdowns in 2020, requiring a transition from onsite to remote training to enable study progression. While many research studies were able to adapt and work remotely [1], the A2CPS protocol involved performing in-person functional, quantitative sensory testing (QST), and imaging of human subjects in a clinical population.[2] Patient facing interventional and observational projects were most disrupted when surveying medical school research opportunities. [3] We describe challenges and solutions derived by our team to provide consistent training and certification for the research staff in the A2CPS Consortium, with specific examples of lessons learned. We continued to use these virtual training techniques for their efficiency and effectiveness.

Methods

As the impact of the pandemic set in and data collection centers were brought to a standstill, the training team pivoted and focused on development of a virtual training plan for proper execution of study procedures. Our goal was to complete effective and comprehensive virtual training and certification of research assistants so they would be adequately prepared to perform study activities consistently across sites. Training sessions covered electronic data capture (REDCap and MyDataHelps), recruitment and retention, informed consent, functional testing, QST, biospecimen collection, and imaging protocols. Several methods were used to achieve training and bi-annual recertification including interactive Zoom instructional sessions with video for proper visualization and demonstration; later video certification sessions following practice and familiarization of protocols with concurrent feedback; interactive group quizzes; and training “homework” to document repeatability of QST.

Results

Virtual training imposed by the pandemic was initiated in October of 2020 with the first five study staff trained and certified for the postoperative knee cohort before the December 2020 lifting of restrictions for clinical research at that facility. Since that time, a total of 78 research staff across 5 data collection sites have been trained and certified using this virtual method. Training sessions range from 1-2 hours per session dependent on topic and number of attendees, requiring up to 8 hours of virtual meetings to fully certify staff. To maintain data rigor, and reproducibility, research staff recertify every 6 months. We correct protocol drift quickly to ensure data collection is standardized across all sites. These virtual training and recertification sessions are efficient (no travel time required), readily broken into shorter visits to accommodate schedules and attention spans, and effective based on follow-up quality assurance data checks.

Conclusions

While the COVID -19 pandemic presented researchers with profound barriers to execution of clinical studies, it also provided the impetus to pivot and redirect our efforts enabling the development of an efficient virtual training and certification methodology. This training and certification approach has been well received by those in training and continually evaluated for improvements by the training team based on feedback during each session. Based on the success and efficiency of this approach, including reduced travel costs and reduction of lost work time due to travel, we have continued to use virtual training and certification even as visiting restriction to the sites were lifted.

References

1.Elmer SJ, Durocher JJ. Moving student research forward during the COVID-19 pandemic. Adv Physiol Educ. 2020 Dec 1;44(4):741-743. doi: 10.1152/advan.00153.2020. PMID: 33205997; PMCID: PMC7686877
2.Berardi G, Frey-Law L, Sluka KA, Bayman EO, Coffey CS, Ecklund D, Vance CGT, Dailey DL, Burns J, Buvanendran A, McCarthy RJ, Jacobs J, Zhou XJ, Wixson R, Balach T, Brummett CM, Clauw D, Colquhoun D, Harte SE, Harris RE, Williams DA, Chang AC, Waljee J, Fisch KM, Jepsen K, Laurent LC, Olivier M, Langefeld CD, Howard TD, Fiehn O, Jacobs JM, Dakup P, Qian WJ, Swensen AC, Lokshin A, Lindquist M, Caffo BS, Crainiceanu C, Zeger S, Kahn A, Wager T, Taub M, Ford J, Sutherland SP, Wandner LD. Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol. Front Med (Lausanne). 2022 Apr 25;9:849214. doi: 10.3389/fmed.2022.849214. PMID: 35547202; PMCID: PMC9082267.
3.Haugh M, O’Tuathaigh C. Adapting for sustainability: Ensuring provision of research skills development for undergraduate medical students. Clin Teach. 2022 Apr;19(2):86-91. doi: 10.1111/tct.13453. Epub 2022 Jan 12. PMID: 35023293

Presenting Author

Carol GT Vance

Poster Authors

Carol Vance

PhD

University of Iowa

Lead Author

Giovanni Berardi

DPT

The University of Iowa

Lead Author

Dana Dailey

University of Iowa

Lead Author

Gregory Bernhart

BS

The University of Iowa

Lead Author

Kendall Dubois

MS

University of Michigan

Lead Author

DeAnna Hanewald

BS

University of Michigan

Lead Author

Tor Wager

Dartmouth College

Lead Author

Candy R. Wilson

BSc

The University of Iowa

Lead Author

Leigh Nadel

MSW

The University of Iowa

Lead Author

Robert J McCarthy

Pharm D

Rush University

Lead Author

Kathleen Sluka

PT

University of Iowa, Carver College of Medicine

Lead Author

Laura Frey Law

The University of Iowa

Lead Author

Stephani Sutherland

Freelance

Lead Author

Topics

  • Assessment and Diagnosis