Tips and best practices for conducting in-person user experience research with vulnerable populations in the COVID-19 era
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionPublic health and social measures for containing and controlling the spread of COVID-19 have caused industries worldwide to re-think how to safely exist in a post-pandemic world. As an essential service, the pharmaceutical industry has found ways to bring life-saving products to market with innovative modifications and precautions for conducting research safely (Carayon & Perry, 2020; Collins McLaughlin et al., 2020).
Adjusting in-person research protocols to ensure safe conduct of research while still adhering to regulatory requirements of human factors evaluations to demonstrate safe and effective use in a simulated-use environment (FDA, 2016) can pose significant challenges. Furthermore, the risks are heightened for patient populations that are particularly vulnerable to complications from COVID-19, yet these populations are necessary for testing the medical devices and drugs intended to treat their conditions.
This work aims to provide medical and pharmaceutical practitioners with techniques and best practices for conducting successful in-person, user experience research with vulnerable populations in the COVID-19 era (Table 1), when a risk-benefit analysis concludes that such research is warranted. The techniques for vulnerable patient populations are more expansive than a general patient population study. For example, due to the difficulty of recruiting patients with lower incidence rates and decreased interest in participating in in-person activities, alternative methods need to be employed. Table 1 summarizes several methods for successful in-person research with vulnerable patient populations across the following categories: participant recruitment, communication, and protective measures.
Table 1. Techniques and best practices for conducting successful in-person user experience research with vulnerable patient populations.
Category Techniques and best practices
• Build a participant database: allows for flexibility in scheduling within a study (e.g., if a participant drops out or if conditions dictate a delay in testing) and when planning a program of research with multiple study site locations
• Strategic advertising and study promotion (flyers, advocacy groups, referral networks)
• Increase lead time for recruitment (about 1 month or more per 25 participants needed)
• Cover transportation costs to increase the potential reach of the participant recruit
• Allow and encourage caregivers to attend sessions with participants; compensate those who attend
• Provide consent form ahead of session digitally, as well as an opportunity for participants to ask questions remotely (via phone, email) ahead of the session to determine risk
• Communicate protective measures in multiple channels of information and by multiple study team members ahead of the study start time (e.g., website, consent form, screener, email reminders)
• Screen for COVID-19 symptoms the day before the study starts via a set of questions asked over the phone
• Use contact tracing to limit the spread of COVID-19 by alerting all personnel involved if anyone exhibits symptoms in the weeks following testing
• Consult external agencies (e.g., Institutional Review Board) to review all study protocols for safety and ethics
• Utilize personal protective equipment (PPE) for study personnel and participants (e.g., masks, face shields, gloves, barriers)
• Limit the number of people in test rooms and abide by social distancing recommendations as much as possible
• Structure facility to have a one-way directional flow to limit the number of interactions between people present
• Revise waiting room protocol to have participants wait in their cars before the study starts
• Conduct temperature checks for all study attendees (personnel and participants) upon entry
• Use medical grade sanitization products, UV lights, and air purifier systems to maintain a sanity environment
• Use individual sets of stimuli as much as possible to reduce the need for sanitization between participants
By employing a multi-pronged approach to recruitment, communication, and protective measures, there is a higher likelihood of participant show rates and completing test sessions. The techniques presented in this work have been used successfully to facilitate several in-person human factors studies with vulnerable patient populations and can assist other practitioners looking for proven techniques to incorporate into their practice.