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  • Telemedicine retinopathy of prematurity severity score (TeleROP-SS) versus modified activity score (mROP-ActS) retrospective comparison in SUNDROP cohort. Scientific reports Xu, C. L., Adu-Brimpong, J., Moshfeghi, H. P., Rosenblatt, T. R., Yu, M. D., Ji, M. H., Wang, S. K., Zaidi, M., Ghoraba, H., Michalak, S., Callaway, N. F., Kumm, J., Nudleman, E., Wood, E. H., Patel, N. A., Stahl, A., Lepore, D., Moshfeghi, D. M. 2023; 13 (1): 15219


    Identifying and planning treatment for retinopathy of prematurity (ROP) using telemedicine is becoming increasingly ubiquitous, necessitating a grading system to help caretakers of at-risk infants gauge disease severity. The modified ROP Activity Scale (mROP-ActS) factors zone, stage, and plus disease into its scoring system, addressing the need for assessing ROP's totality of binocular burden via indirect ophthalmoscopy. However, there is an unmet need for an alternative score which could facilitate ROP identification and gauge disease improvement or deterioration specifically on photographic telemedicine exams. Here, we propose such a system (Telemedicine ROP Severity Score [TeleROP-SS]), which we have compared against the mROP-ActS. In our statistical analysis of 1568 exams, we saw that TeleROP-SS was able to return a score in all instances based on the gradings available from the retrospective SUNDROP cohort, while mROP-ActS obtained a score of 80.8% in right eyes and 81.1% in left eyes. For treatment-warranted ROP (TW-ROP), TeleROP-SS obtained a score of 100% and 95% in the right and left eyes respectively, while mROP-ActS obtained a score of 70% and 63% respectively. The TeleROP-SS score can identify disease improvement or deterioration on telemedicine exams, distinguish timepoints at which treatments can be given, and it has the adaptability to be modified as needed.

    View details for DOI 10.1038/s41598-023-42150-w

    View details for PubMedID 37709791

  • Examining Diversity in Digital Therapeutics Clinical Trials: Descriptive Analysis. Journal of medical Internet research Adu-Brimpong, J., Pugh, J., Darko, D. A., Shieh, L. 2023; 25: e37447


    BACKGROUND: Digital therapeutics (DTx) are an emerging class of software-based medical therapies helping to improve care access and delivery. As we leverage these digital health therapies broadly in clinical care, it is important to consider sociodemographic representation underlying clinical trials data to ensure broad application to all groups.OBJECTIVE: We review current sociodemographic representation in DTx clinical trials using data from the Digital Therapeutics Alliance Product Library database.METHODS: We conducted a descriptive analysis of DTx products. We analyzed 15 manuscripts associated with 13 DTx products. Sociodemographic information was retrieved and compared with the US population's demographic distribution.RESULTS: The median study size and age of participants were 252 and 43.3 years, respectively. Of the 15 studies applicable to this study, 10 (67%) reported that females made up 65% or greater of the study cohort. A total of 14 studies reported race data with Black or African American and Asian American individuals underrepresented in 9 and 11 studies, respectively. In 7 studies that reported ethnicity, Hispanics were underrepresented in all 7 studies. Furthermore, 8 studies reported education levels, with 5 studies reporting populations in which 70% or greater had at least some college education. Only 3 studies reported health insurance information, each reporting a study cohort in which 100% of members were privately insured.CONCLUSIONS: Our findings indicate opportunities for improved sociodemographic representation in DTx clinical trials, especially for underserved populations typically underrepresented in clinical trials. This review is a step in examining sociodemographic representation in DTx clinical trials to help inform the path forward for DTx development and testing.

    View details for DOI 10.2196/37447

    View details for PubMedID 37531157