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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