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Table 5 Key lessons learned for design of future evaluations of home tests for influenza and other respiratory pathogens

From: Evaluating an app-guided self-test for influenza: lessons learned for improving the feasibility of study designs to evaluate self-tests for respiratory viruses

Study Design Feature Advantages Disadvantages
Integrated study functions streamlined into a mobile application • Reduced resources needed for recruitment
• Efficiency in expanding geographic reach
• Maintained protocol standardization between participants
• Single interface which simplified study procedures and aided participant engagement (e.g. participant took the study questionnaire while they waited for the test results)
• Resources needed to develop app
• No human interaction with risks to study fidelity:
➜ Unable to verify accuracy of self-reported responses
➜ Difficult to verify if participants conducted the swabbing correctly without marker of human DNA
Recruitment using online marketing through social media • Expanded geographic reach
• Ability to target specific groups and regions
• Improves generalizability (people in the community versus recruitment in a clinic seeking care)
• Facilitates tailoring of recruitment materials compared to paper based recruitment materials
• Can be expensive
• Financial incentives noted in online recruitment can attract participants only interested in financial reward
• Avoid recruitment materials that advertise monetary incentive
Determining eligibility through Self-reported symptoms • Prevents exposure of study staff to ILI • Unable to verify eligibility information provided by the participant
• We accepted participants with ILI symptoms longer than 72 h
Shipping of test kit to and from study lab • Prevents exposure of ILI to study staff and potentially people at a health care clinic
• Central distribution of study kits allowed for quality control
• Despite priority and overnight shipping, shipping and time to participants taking the test took too long to capture many participants early in their illness
Return of reference sample • Facilitated reference sampling, without need for study staff or clinic visits
• Low error rate and participants reported that it was easy to collect
• Study design did not stress rapid return of the sample thus lead to longer times to return to study lab and spoiled UTM fluid
• Time of the year/temperature may impact UTM fluid stability