Methodology for assessing the risks of diagnosing and prescribing treatment during direct-to-patient and their official representatives telemedicine consultations

Currently, there are no unified methodological approaches to diagnose certain diseases, syndromes, symptoms, where distant diagnostics and telemedicine-based treatment prescription are legal and feasible. There are limited and empirically generated lists of pathological conditions, accounting for possible risks. The development of regulatory and legal support for telemedicine-based medical care should be based on a scientific approach, providing for safety and quality assurance.

Objective: to develop a methodology for determining the probability of a positive outcome applicable for assessing the possibility of diagnosing and treating patients using distant interaction between healthcare professionals and patients (legal representatives) via telemedicine technologies.

Materials and methods. The study used the principles of a systematic approach. Regulatory and legal acts in the field of organization and provision of medical care were reviewed, including telemedicine-based medical services; duly approved standards of medical care; medical service flowcharts; and duly approved clinical guidelines. Analytical methods (induction, analysis, and synthesis), the method of direct placement for determining weight coefficients, as well as mathematical modeling were applied.

Results. The basic concept has been elaborated as follows: the possibility of making a diagnosis during a direct-to-patient telemedicine consultation should be determined mathematically (by calculating the risks) based on the volume and quality of data on the health status of a given patient. The concept was developed in stages: 1) development of a system of criteria for assessing the volume and quality of medical data; 2) determination of the context and methodology for using the criteria system; 3) design of a mathematical model. The methodology was intended for the provision of primary healthcare outside the healthcare facility or in outpatient settings.

Conclusions. A specific methodology was developed to assess the feasibility of distant diagnosis and effective treatment prescription, with prediction of a positive outcome in a given clinical situation. The methodology includes a system of criteria for assessing the volume and quality of medical data, requirements for the context of clinical application, and an original mathematical model. The methodology can be applied in experimental legal regimens green-lighted for the development of digital healthcare and telemedicine technologies.

1. Vladzymyrskyy AV. Patient initiated direct-to-consumer telemedicine consultations: first step for a methodology systematization. Journal of Telemedicine and eHealth. 2017; 2(4): 109-120. (In Russ).

2. Zingerman BV, Shklovsky-Kordi NE, Vorobiev AI. About telemedicine «patient to doctor». Physician and Information Technologies. 2017; 1: 61-79. (In Russ).

3. Shaderkin IA, Shaderkina VA. Remote medical consultations for patients: what has changed in Russia in 20 years. Journal of Telemedicine and eHealth. 2021; 7(2): 7-17. (In Russ).

4. Elliott T, Yopes MC. Direct-to-Consumer Telemedicine. J Allergy Clin Immunol Pract. 2019 Nov-Dec; 7(8): 2546-2552. doi: 10.1016/j.jaip.2019.06.027.

5. Hariton E, Tracy EE. Telemedicine Companies Providing Prescription-Only Medications: Pros, Cons, and Proposed Guidelines. Obstet Gynecol 2019 Nov; 134(5): 941-945. doi: 10.1097/AOG.0000000000003529.

6. Jain T, Mehrotra A. Comparison of Direct-to-Consumer Telemedicine Visits With Primary Care Visits. JAMA Netw Open. 2020 Dec 1; 3(12): e2028392. doi: 10.1001/jamanetworkopen.2020.28392.

7. Vladzymyrskyy AV. Efficiency of direct-to-patient telemedicine consultations: status praesens. Journal of Telemedicine and eHealth. 2018; 3(8): 64-70. (In Russ).

8. Morozov SP, Vladzymyrskyy AV, Simenyura SS. The quality of primary direct-to-consumer telemedicine consultations (by results of testing telemedicine services). Physician and Information Technologies. 2020; 1: 52-62. (In Russ).

9. Halpren-Ruder D, Chang AM, Hollander JE, Shah A. Quality Assurance in Telehealth: Adherence to Evidence-Based Indicators. Telemed J E Health. 2019 Jul; 25(7):599-603. doi: 10.1089/tmj.2018.0149.

10. Jain T, Lu RJ, Mehrotra A. Prescriptions on Demand: The Growth of Direct-to-Consumer Telemedicine Companies. JAMA. 2019. Jul 26. doi: 10.1001/jama.2019.9889.

11. Hersh AL, Stenehjem E, Daines W. RE: Antibiotic Prescribing During Pediatric Direct-to-Consumer Telemedicine Visits. Pediatrics. 2019. Aug;144(2). pii: e20191786B. doi: 10.1542/peds.2019-1786B.

12. Shi Z, Mehrotra A, Gidengil CA, Poon SJ, Uscher-Pines L, Ray KN. Quality Of Care For Acute Respiratory Infections During Direct-To-Consumer Telemedicine Visits For Adults. Health Aff (Millwood). 2018 Dec; 37(12): 2014-2023. doi: 10.1377/hlthaff.2018.05091.

13. Martinez KA, Rood M, Jhangiani N, Kou L, Boissy A, Rothberg MB. Association Between Antibiotic PrescribingforRespiratoryTractInfectionsandPatientSatisfactioninDirect-to-ConsumerTelemedicine. JAMA Intern Med. 2018. Nov 1; 178(11): 1558-1560. doi: 10.1001/jamainternmed.2018.4318.

14. Rothberg MB, Martinez KA. Influenza Management via Direct to Consumer Telemedicine: an Observational Study. J Gen Intern Med. 2020. Jan 9. doi: 10.1007/s11606-020-05640-5.

15. Hamdy RF, Park D, Dean K, Thompson J, Kambala A, Yan LD, Tong I, Liu CM. Geographic variability of antibiotic prescribing for acute respiratory tract infections within a direct-to-consumer telemedicine practice. Infect Control Hosp Epidemiol. 2021. Jun 3: 1-3. doi: 10.1017/ice.2021.84.

16. Pedrotti CHS, Accorsi TAD, De Amicis Lima K, Serpa Neto A, Lira MTSS, Morbeck RA, Cordioli E. Antibiotic stewardship in direct-to-consumer telemedicine consultations leads to high adherence to best practice guidelines and a low prescription rate. Int J Infect Dis. 2021. Apr; 105: 130-134. doi: 10.1016/j.ijid.2021.02.020.

17. Tyazhelnikov AA, Polunina NV, Kostenko EV, Polunin VS. Peculiarities of outpatient care for COVID-19 patients using telemedicine technologies. Russian Medical Journal. 2021; 2(27): 107-114. (In Russ).

18. Gannon JM, Schlesinger A, Glance J, Sujata M, Fredrick N, Wyler J, Perez G. Rapid expansion of directto-consumer telemental health during the COVID-19 pandemic: A case series. Ann Clin Psychiatry. 2021. Feb; 33(1): 27-34. doi: 10.12788/acp.0020.

19. Li KY, Zhu Z, Ng S, Ellimoottil C. Direct-To-Consumer Telemedicine Visits For Acute Respiratory Infections Linked To More Downstream Visits. Health Aff (Millwood). 2021. Apr; 40(4): 596-602. doi: 10.1377/hlthaff.2020.01741.

20. Kennedy J, Arey S, Hopkins Z, Tejasvi T, Farah R, Secrest AM, Lipoff JB. Dermatologist Perceptions of Teledermatology Implementation and Future Use After COVID-19: Demographics, Barriers, and Insights. JAMA Dermatol. 2021. May 1; 157(5): 595-597. doi: 10.1001/jamadermatol.2021.0195.

21. Levanov VM, Gena EI. Some problems of telemedicine activities legislation abroad. In: Actual Problems of Public Health Management. Ed. by IA. Pereslegina, VM. Levanov. Nizhnij Novgorod, 2021. P.99-108. (In Russ).

22. Bollmeier SG, Stevenson E, Finnegan P, Griggs SK. Direct to Consumer Telemedicine: Is Healthcare From Home Best? Mo Med. 2020. Jul-Aug; 117(4): 303-309.

23. Online Prescribig. 2021. URL: https://www.cchpca.org/topic/online-prescribing/.

24. Lacktman NM. Legal and Regulatory Issues. In: Rheuban K, Krupinski EA. eds. Understanding Telehealth. McGraw Hill. Accessed November 09, 2021. https://accessmedicine.mhmedical.com/ content.aspx?bookid=2217§ionid=187795865.

25. 50-state survey: Establishment of a patient-physician relationship via telemedicine. 2018. https:// www.ama-assn.org/system/files/2018-10/ama-chart-telemedicine-patient-physician-relationship. pdf.

26. Cui F, Ma Q, He X, Zhai Y, Zhao J, Chen B, Sun D, Shi J, Cao M, Wang Z. Implementation and Application of Telemedicine in China: Cross-Sectional Study. JMIR Mhealth Uhealth. 2020. Oct 23; 8(10): e18426. doi: 10.2196/18426.

27. China’s Health Authorities Issue New Rules on Telemedicine. 2018. https://www.ropesgray.com/en/ newsroom/alerts/2018/09/Chinas-Health-Authorities-Issue-New-Rules-on-Telemedicine.

28. Wang Y, Li B and Liu L. Telemedicine Experience in China: Our Response to the Pandemic and Current Challenges. Front. Public Health. 8: 549669. doi: 10.3389/fpubh.2020.549669.

29. Korobov VB. Comparative analysis of methods for determining the weight coefficients of «influencing factors». Sociology: methodology, methods and mathematical modeling (Sociology: 4M). 2005; 20: 54-73. (In Russ).

30. Levanov VM, Kirpichjova IS, Jashin AA, Denisenko AN., Sofronov KA. Typical mistakes during teleconsultations. Medical Almanac. 2014; 1(31): 15-18. (In Russ).

31. Chong S, Hanna T, Lamoureux C, Ma T, Weber S, Johnson J, Friedberg E, Pyatt RS, Everett CJ, Johnson TD. Interpretations of Examinations Outside of Radiologists’ Fellowship Training: Assessment of Discrepancy Rates Among 5.9. Million Examinations From a National Teleradiology Databank. AJR 2021. Nov 3. doi:10.2214/AJR.21.26656.

32. Lamoureux C, Hanna TN, Sprecher D, Weber S, Callaway E. Radiologist errors by modality, anatomic region, and pathology for 1.6 million exams: what we have learned. Emerg Radiol. 2021. Dec; 28(6): 1135-1141. doi: 10.1007/s10140-021-01959-6.

33. Morozov S, Guseva E, Ledikhova N, Vladzymyrskyy A, Safronov D. Telemedicine-based system for quality management and peer review in radiology. Insights Imaging. 2018. Jun; 9(3): 337-341. doi: 10.1007/s13244-018-0629-y.

34. Storjohann S, Kirsch M, Rosenberg B, Rosenberg C, Lange S, Syperek A, Schweikhard FP, Hosten N. The Accuracy of On-Call CT Reporting in Teleradiology Networks in Comparison to In-House Reporting. Healthcare (Basel). 2021. Apr 1; 9(4): 405. doi: 10.3390/healthcare9040405.

35. Uscher-Pines L, Mulcahy A, Cowling D, Hunter G, Burns R, Mehrotra A. Access and Quality of Care in Direct-to-Consumer Telemedicine. Telemed J E Health. 2016. Apr; 22(4): 282-7. doi: 10.1089/tmj.2015.0079.

36. Shi Z, Mehrotra A, Gidengil CA, Poon SJ, Uscher-Pines L, Ray KN. Quality Of Care For Acute Respiratory Infections During Direct-To-Consumer Telemedicine Visits For Adults. Health Aff (Millwood). 2018. Dec; 37(12): 2014-2023. doi: 10.1377/hlthaff.2018.05091.

37. Carrillo de Albornoz S, Sia KL, Harris A. The effectiveness of teleconsultations in primary care: systematic review. Fam Pract. 2021. Jul 19: cmab077. doi: 10.1093/fampra/cmab077.

38. Liu L, Shi L. Chinese Patients’ Intention to Use Different Types of Internet Hospitals: Cross-sectional Study on Virtual Visits. J Med Internet Res. 2021. Aug 13; 23(8): e25978. doi: 10.2196/25978.

39. Ray KN, Shi Z, Poon SJ, Uscher-Pines L, Mehrotra A. Use of Commercial Direct-to-Consumer Telemedicine by Children. Acad Pediatr 2019. Aug; 19(6): 665-669. doi: 10.1016/j.acap.2018.11.016.

40. Resneck JS Jr, Abrouk M, Steuer M, Tam A, Yen A, Lee I, Kovarik CL, Edison KE. Choice, Transparency, Coordination, and Quality Among Direct-to-Consumer Telemedicine Websites and Apps Treating Skin Disease. JAMA Dermatol. 2016. Jul 1; 152(7): 768-75. doi: 10.1001/jamadermatol.2016.1774.

41. Halpren-Ruder D, Chang AM, Hollander JE, Shah A. Quality Assurance in Telehealth: Adherence to Evidence-Based Indicators. Telemed J E Health. 2019. Jul; 25(7): 599-603. doi: 10.1089/tmj.2018.0149.

42. Pedrotti CHS, Accorsi TAD, De Amicis Lima K, Serpa Neto A, Lira MTSS, Morbeck RA, Cordioli E. Antibiotic stewardship in direct-to-consumer telemedicine consultations leads to high adherence to best practice guidelines and a low prescription rate. Int J Infect Dis. 2021. Apr; 105: 130-134. doi: 10.1016/j.ijid.2021.02.020.

43. Du Yan L, Dean K, Park D, Thompson J, Tong I, Liu C, Hamdy RF. Education vs Clinician Feedback on Antibiotic Prescriptions for Acute Respiratory Infections in Telemedicine: a Randomized Controlled Trial. J Gen Intern Med. 2021. Feb; 36(2): 305-312. doi: 10.1007/s11606-020-06134-0.