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