Overview
Clinical trials continue to recruit and test subjects, even during pandemics. COVID-19 has been challenging for many CROs and Trial Sponsors determined to maintain the quality and consistency of data collected during assessments. Use of personal protective equipment poses additional challenges as face masks can directly interfere with the quality of speech. Redenlab have worked with expert clinicians, collaborators and customers to provide some guidance on continuing data collection during COVID-19. Below are some recommendations on minimizing the likelihood of contamination during assessments and suggested processes for disinfecting equipment after every use. To reduce risk, Redenlab recommends assessors wear masks throughout the assessment, the microphone’s metal surfaces are sanitized between subjects, and all windscreens are washed at the end of each use. For more information, contact us on COVID19@redenlab.com.
Before speech assessment
- Don a mask and have the subject enter the room wearing a mask
- Assist the subject with putting on the microphone headset.
- Ensure the microphone is not directly touching the subject’s face.
- Ask the subject to remove their mask and begin testing.
During Speech Assessment
- Adhere to social distancing measures.
- Speech assessments should be administered with basic PPE.
- Position yourself 6-feet from the subject in a side-by-side fashion rather than sitting face-to-face.
After Speech Assessment
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Wipe down all hard surfaces with an alcohol wipe after every subject per CDC guidelines. Carefully remove black foam windscreen and replace with a clean one.
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Gently use an alcohol wipe to clean the metal surfaces of the microphone headset. Do not bend the headset during cleaning.
Equipment care
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Clean the black foam windscreen by washing it gently with warm water and dishwashing detergent (dime-sized amount). Leave to air dry for 96 hours.
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Windscreens cannot be disinfected with alcohol or other harsh chemicals. Never put a damp windscreen on the microphone.
Clinical Assessment of Dysphagia in Neurodegenration (CADN)
The CADN is a reliable, valid, brief, quantifiable, and easily deployed assessment of swallowing in neurodegenerative disease. CADN comprises two parts, an anamnesis (part one) and consumption (part two). CADN has 11 items and can be administered and scored in an average of 7 min. Cutoff scores were identified that signal the presence of clinically meaningful dysphagia symptomatology and risk of aspiration.
