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Feasibility and acceptability of home use of a smartphone-based urine testing application among women in prenatal care

      Objective

      Recent advances in smartphone camera quality and image-recognition algorithms make smartphone applications increasingly useful for patient care.
      • Gunter R.L.
      • Fernandes-Taylor S.
      • Rahman S.
      • et al.
      Feasibility of an image-based mobile health protocol for postoperative wound monitoring.
      Particularly, the potential future shortage of obstetricians in the Unites States
      • Rayburn W.
      The Obstetrician-Gynecologist Workforce In the United States: Facts, Figures, and Implications.
      suggests that such technologies could be valuable additions to obstetric care. Urine dipstick analysis, obtained at most prenatal visits, presents opportunity for self-testing via smartphone. We assessed feasibility and acceptability of the Dip.io (Healthy.io, Tel Aviv, Israel) smartphone-based urinalysis application/testing kit among individuals in prenatal care. Dip.io clinical trials prior to class II FDA approval in 2018

      United States Food and Drug Administration. July 2018 510(K) Clearances. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm615930.htm. Accessed July 1, 2019.

      demonstrated high (99%) reproducibility and accuracy compared to standard urine dipstick.

      Study Design

      In 2017, we recruited a convenience sample of pregnant adults for a pilot study of 1-time use of the Dip.io application (iOS- and Android-compatible) and test kit, in conjunction with a prenatal visit. The kit includes collection cup, dipstick, and color board for image capture. After informed consent in clinic, participants downloaded the application to their smartphone and took the test kit home. Participants were to self-collect and dip a urine specimen the next morning, and submit a camera image of dipstick and color board according to in-app instructions. The app then opened a brief acceptability survey, which asked about ease of use, preference for self-testing vs clinic testing, and problems encountered. Participants not submitting an image within 24 hours received reminder calls. The primary outcome was feasibility, assessed as the proportion of participants submitting an interpretable image within 48 hours. Acceptability (secondary) outcomes included ease of use, testing preference, and proportion experiencing a problem with the test. We used descriptive statistics, and χ2 analyses were used for comparisons between groups. The Johns Hopkins institutional review board approved the study, which was funded by Dip.io.

      Results

      After piloting study procedures, we enrolled 179 participants; 156 (87.2%) attempted the test. Of these, 150 (96.2%) successfully submitted image data, and 139 of those 150 (92.6%) completed the survey. The majority (93/150, 62.0%) submitted an image within 24 hours, and 57 of 150 (38.0%) submitted between 24 and 48 hours.
      The Table shows demographics and feasibility outcomes. Total test completion was similar across age and education levels. Individuals with >12 years of education vs fewer (72.7% vs 52.7%, P = .03), and those aged 26–45 years vs 18–25 years (68.8% vs 41.8%, P = .01), were more likely to complete the test without a reminder. Of 139 completing the acceptability survey, most (96.0%) found the app very easy or easy to use. Most (62.6%) preferred at-home self-testing, while 10.1% preferred in-clinic testing. Eight (5.3%) reported problems (internet connectivity, n = 3; image quality, n = 2; or test kit complaints, n = 3); all successfully submitted an image.
      TableUse of a smartphone-based urine dipstick application among a sample of women seeking prenatal care: Sample demographics (consented vs completed) and feasibility outcomes
      A. Demographic characteristicsConsented (n = 179) n (%)Completed (n = 150) n (%)
      Age
       Mean (SD), years28.1 (5.8)28.2 (5.9)
       18–25 years67 (37.4%)54 (36.0%)
       26–35 years92 (51.4%)78 (52.0%)
       36–45 years20 (11.2%)18 (12.0%)
      Highest level of education
       <9 years4 (2.2%)3 (2.0%)
       9–12 years68 (38.0%)56 (37.3%)
       Over 12 years105 (58.7%)90 (60.0%)
       Unknown2 (1.1%)1 (0.7%)
      B. Feasibility outcomesn(%
      Among those consented (n = 179)Among those attempting (n = 156)
      Number attempting to complete test15687.2(100)
      Number completing test by 48 hours15083.896.2
       Completed by 24 hours, no follow-up call9352.059.6
       Completed by 48 hours, after 1 follow-up call5329.644.0
       Completed by 48 hours, after 2 follow-up calls42.22.6
      Total completing survey13977.789.1
      Attempted, unable to complete63.43.8
      Did not complete test within 48 hours2312.8N/A
       Submitted results outside 48 hours window42.2N/A
       Never submitted results / did not report attempt1910.6N/A
      N/A, not applicable.
      Burke. Smartphone-based urinalysis. Am J Obstet Gynecol 2019.

      Conclusion

      Participants found smartphone-based dipstick testing to be feasible and acceptable, and largely preferred self-testing. Integration of day-of-visit home testing into clinic protocols and electronic health records could streamline visits for patients and providers. Smartphone technologies may also offer novel ways to improve access for those with limited resources, increase convenience, and enhance patients’ ownership over their health care. These pilot results may not be generalizable; future research could focus on younger individuals, those with lower health literacy, and individuals with high-risk pregnancies.

      References

        • Gunter R.L.
        • Fernandes-Taylor S.
        • Rahman S.
        • et al.
        Feasibility of an image-based mobile health protocol for postoperative wound monitoring.
        J Am Coll Surg. 2018; 226: 277-286
        • Rayburn W.
        The Obstetrician-Gynecologist Workforce In the United States: Facts, Figures, and Implications.
        ACOG, Washington, DC2017
      1. United States Food and Drug Administration. July 2018 510(K) Clearances. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm615930.htm. Accessed July 1, 2019.