Оценка клинической эффективности телемониторирования артериального давления и дистанционного консультирования у пациентов с неконтролируемой артериальной гипертензией
Оценка клинической эффективности телемониторирования артериального давления и дистанционного консультирования у пациентов с неконтролируемой артериальной гипертензией
Ионов М.В., Жукова О.В., Звартау Н.Э. и др. Оценка клинической эффективности телемониторирования артериального давления и дистанционного консультирования у пациентов с неконтролируемой артериальной гипертензией. Терапевтический архив. 2020; 92 (1): 49–55. DOI: 10.26442/00403660.2020.01.000481
1 Federal State Budgetary Institution “V.A. Almazov National Medical Research Center”, Saint-Petersburg, Russia;
2 Saint-Petersburg National Research University of Information Technologies, Mechanics and Optics, Saint-Petersburg, Russia;
3 Federal State Budgetary Educational Institution of Higher Education “Privolzhsky Research Medical University”, Nizhny Novgorod, Russia
Оценка клинической эффективности телемониторирования артериального давления и дистанционного консультирования у пациентов с неконтролируемой артериальной гипертензией
Ионов М.В., Жукова О.В., Звартау Н.Э. и др. Оценка клинической эффективности телемониторирования артериального давления и дистанционного консультирования у пациентов с неконтролируемой артериальной гипертензией. Терапевтический архив. 2020; 92 (1): 49–55. DOI: 10.26442/00403660.2020.01.000481
1 Federal State Budgetary Institution “V.A. Almazov National Medical Research Center”, Saint-Petersburg, Russia;
2 Saint-Petersburg National Research University of Information Technologies, Mechanics and Optics, Saint-Petersburg, Russia;
3 Federal State Budgetary Educational Institution of Higher Education “Privolzhsky Research Medical University”, Nizhny Novgorod, Russia
Цель исследования. Оценка клинической эффективности телемедицинского наблюдения и дистанционного консультирования (ТМДК) среди пациентов с неконтролируемой артериальной гипертензией (АГ) на основании методов математического анализа. Материалы и методы. В исследование включено 240 пациентов, рандомизированных в формате 2:1 в группу ТМДК (n=160, медиана возраста 47 лет) и группу стандартного наблюдения (n=80, медиана возраста 49 лет). Использовалось простое и безопасное программное обеспечение с мобильной (для пациентов) и стационарной (для врачей) платформами, обеспечивающее внесение, хранение и анализ данных самоконтроля артериального давления (АД) и удаленные консультации «врач–пациент». Предусмотрено 3-месячное наблюдение с обязательным начальным и завершающим очными визитами с оценкой офисного систолического АД (оСАД). Математическую оценку показателей эффективности проводили с помощью методов атрибутивной статистики. Основываясь на частоте достижения целевого показателя оСАД, рассчитывали показатели абсолютной эффективности (АЭ) для обеих групп, атрибутивной эффективности (АтЭ), относительной эффективности (ОЭ), популяционной атрибутивной эффективности (ПАЭ) для ТМДК, а также стандартные ошибки для каждого вида эффективности и 95% доверительные интервалы (ДИ). Результаты. Спустя 3 мес наблюдения показатели оСАД оказались значимо ниже в группе ТМДК, чем в группе контроля (–16,8±2,9 мм рт. ст. против –7,9±3,9 мм рт. ст.; р<0,001). При этом 120 пациентов в группе ТМДК и 16 пациентов в группе контроля достигли целевого уровня (АЭ 75±6,7% против 20±8,8%). АтЭ составила 55,0±11,3%, ОЭ – 3,75 (95% ДИ 1,94–5,56), ПАЭ соответствовала 36,7% (95% ДИ 24,1–49,2). Индекс потенциальной пользы ТМДК составил 1,8. Заключение. Внедрение ТМДК в процесс лечения пациентов выраженно влияет на достижение целевых показателей АД и значительно увеличивает вероятность контролируемости заболевания.
The aim of the study was to investigate the mathematical correlation of the clinical efficacy of blood pressure telemonitoring and distant counseling (BPTM) in patients in uncontrolled hypertension (HTN). Telehealth tools are widely used in HTN management. However clinical efficacy of such interventions assessed mainly in groups investigated without its populational and attributable impact. Materials and methods. The total of 240 patients were included, then randomized in 2:1 manner to BPTM group (n=160, median age 47 y.o.) and control group (n=80, median age 49 y.o). The user-friendly and secure telehealth software was provided with mobile application (patients) and desktop (doctors) platforms which allowed storage and analysis of self-BP monitoring data and remote consultations. A three-month surveillance was designed with mandatory baseline and final face-to-face visits with the assessment of office systolic BP (oSBP). Mathematical evaluation was based on target SBP rates achieved in comparator groups and included the absolute efficacies (AE), the attributable efficacy (AtE), the relative efficacy (RE) and the population attributable efficacy (PAtE). Results. BPTM group characterized by larger decrease in SBP level compared with controls (–16.8±2.9 mm Hg versus –7.9±3.9 mm Hg; р<0.001). There were 120 and 16 patients with SBP on target by the end of the study in BPTM and control group respectively (AE 75±6.7% versus 20±8.8%, p<0.001). AtE was found to be 55.0±11.3%; RE was estimated as 3.75 (95% CI 1.94–5.56) and PAtE was found to be 36.7% (95% CI 24.1–49.2). Number needed to treat to achieve target BP with BPTM was estimated as 1.8. Conclusion. Implementing BPTM into management strategy significantly increases the likelihood of BP control. The results of the study indicate a pronounced effect of BPTM on the achievement of target BP.
Keywords: hypertension, clinical efficacy, telemedicine, telemonitoring, attributive statistics, attributable efficacy, relative efficacy, number needed to treat, mathematical correlation.
Список литературы
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1. Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, et al. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018;137(12):e67-492. doi: 10.1161/CIR.0000000000000558
2. Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, et al. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016–40 for 195 countries and territories. The Lancet. 2018;392(10159):2052-90. doi: 10.1016/S0140-6736 (18)31694-5
3. Chazova IE, Zhernakova YuV, Oshchepkova EV, Shalnova SA, Yarovaya EB, Konradi AO, Boytsov SA. Prevalence of Cardiovascular Risk Factors in Russian Population of Patients with Arterial Hypertension. Kardiologiia. 2014;54(10):4-12 (In Russ.) doi: 10.18565/cardio.2014.10.4-12
4. Boytsov SA, Balanova YuA, Shalnova SA, Deev AD, Artamonova GV, Gatagonova TM, et al. Arterial Hypertension among individuals of 25-64 years old: prevalence, awareness, treatment and control. By the data from ECCD. Cardiovasc Ther Prev. 2014;13(4):4-14 (In Russ.) doi: 10.15829/1728-8800-2014-4-4-14
5. Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, et al. PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013;310(9):959-68. doi: 10.1001/jama. 2013.184182
6. Hamdidouche I, Jullien V, Boutouyrie P, Billaud E, Azizi M, Laurent S. Drug adherence in hypertension: from methodological issues to cardiovascular outcomes. J Hypertens. 2017;35(6):1133-44. doi: 10.1097/ HJH.0000000000001299
7. Lebeau JP, Cadwallader JS, Aubin-Auger I, Mercier A, Pasquet T, Rusch E, et al. The concept and definition of therapeutic inertia in hypertension in primary care: a qualitative systematic review. BMC Fam Pract. 2014;15:130. doi: 10.1186/1471-2296-15-130
8. Cowie MR, Bax J, Bruining N, Cleland JGF, Koehler F, Malik M, et al. Е-Health: a position statement of the European Society of Cardiology. Eur Heart J. 2016;37(1):63-6. doi: 10.1093/eurheartj/ehv416
9. Omboni S, Caserini M, Coronetti C. Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. High Blood Press Cardiovasc Prev. 2016;23(3):187-96. doi: 10.1007/s40292-016-0143-6
10. Omboni S, Ferrari R. The role of telemedicine in hypertension management: focus on blood pressure telemonitoring. Curr Hypertens Rep. 2015;17(4):535. doi: 10.1007/s11906-015-0535-3
11. McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, et al. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet Lond Engl. 2010;376(9736):163-72. doi: 10.1016/S0140-6736(10)60964-6
12. McManus RJ, Mant J, Franssen M, Nickless A, Schwartz C, Hodgkinson J, et al. TASMINH4 investigators. Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial. Lancet Lond Engl. 2018;391(10124):949-59. doi: 10.1016/S0140-6736 (18)30309-X
13. McKinstry B, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, et al. Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial. BMJ. 2013;346:f3030. doi: 10.1136/bmj. f3030
14. Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, et al. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013;310(1):46-56. doi:10.1001/jama.2013.6549
15. Duan Y, Xie Z, Dong F, Wu Z, Lin Z, Sun N, Xu J. Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. J Hum Hypertens. 2017;31(7):427-37. doi:10.1038/jhh.2016.99
16. Omboni S, Guarda A. Impact of Home Blood Pressure Telemonitoring and Blood Pressure Control: A Meta-Analysis of Randomized Controlled Studies. Am J Hypertens. 2011;24(9):989-98. doi: 10.1038/ajh.2011.100
17. Verberk WJ, Kessels AGH, Thien T. Telecare is a valuable tool for hypertension management, a systematic review and meta-analysis. Blood Press Monit. 2011;16(3):149-55. doi: 10.1097/MBP.0b013e328346e092
18. Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014;15:43. doi: 10.1186/1471-2296-15-43
19. Posnenkova OM, Korotin AS, Kiselev AR, Gridnev VI. Evaluation the effectiveness of remote blood pressure monitoring technology in patients with hypertension on the basis of clinical recommendations performance measures. Cardio-IT. 2015;2(2):e0203 (In Russ.) doi: 10.15275/cardioit.2015.0203
20. Kiselev AR, Gridnev VI, Shvartz VA, Posnenkova OM, Dovgalevsky PY. Active ambulatory care management supported by short message services and mobile phone technology in patients with arterial hypertension. J Am Soc Hypertens. 2012;6(5):346-55. doi: 10.1016/j.jash.2012.08.001
21. Bubnova MG, Tribuntseva LV, Ostroushko NI, Burlachuk VT, Nekhaenko NE, Prozorova GG, et al. Impact of remote follow-up on the course of hypertension. Тhe Russian Journal of Preventive Medicine. 2018;21(5):77-82 (In Russ.) doi: 10.17116/profmed20182105177
22. Boytsov SA. Realities and prospects of remote blood pressure monitoring in hypertensive patients. Therapeutic Archive. 2018;90(1):4-8 (In Russ.) doi: 10.26442/terarkh 20189014-8
23. STRIDE BP Scientific Advisory Board. Validated Devices For Home Blood Pressure Monitoring 2019. Accessed August 27, 2019 https://www.stridebp.org/bp-monitors/37-pdfs/734-home?format=pdf&tmpl=compone nt&box=home
24. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021-104. doi: 10.1093/eurheartj/ehy339
25. Forouzanfar MH, Liu P, Roth GA, Ng M, Biryukov S, Marczak L, et al. Global Burden of Hypertension and Systolic Blood Pressure of at Least 110 to 115 mm Hg, 1990-2015. JAMA. 2017;317:165-82. doi: 10.1001/jama.2016.19043
26. Vishram JKK, Borglykke A, Andreasen AH, Jeppesen J, Ibsen H, Jørgensen T, et al. MORGAM Project. Impact of age on the importance of systolic and diastolic blood pressures for stroke risk: the MOnica, Risk, Genetics, Archiving, and Monograph (MORGAM) Project. Hypertens Dallas Tex 1979. 2012;60:1117-23. doi: 10.1161/HYPERTENSIONAHA.112.201400
27. Williams B, Lindholm LH, Sever P. Systolic pressure is all that matters. Lancet Lond Engl. 2008;371:2219-21. doi: 10.1016/S0140-673 6(08)60804-1
28. Boman K, Brenander A, Gustavsson M, Furberg CD. A pilot test of a new tool for remote blood pressure monitoring. J Telemed Telecare. 2014;20(5):239-41. doi: 10.1177/1357633X14536348
29. Widmer RJ, Collins NM, Collins CS, West CP, Lerman LO, Lerman A. Digital health interventions for the prevention of cardiovascular disease: a systematic review and meta-analysis. Mayo Clin Proc. 2015;90(4):469-80. doi: 10.1016/j.mayocp.2014.12.026
30. Tucker KL, Sheppard JP, Stevens R, Bosworth HB, Bove A, Bray EP, et al. Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis. PLoS Med. 2017;14(9):e1002389. doi: 10.1371/journal.pmed.1002389
31. Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672
32. Zhukova OV, Konyshkina TM, Kononova SV. The concept of risk factors in assessing the impact of smoking on an exacerbation of chronic obstructive pulmonary disease. Therapeutic Archive. 2015;87(3):23-6 (In Russ.) doi: 10.17116/terarkh201587323-26
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1 ФГБУ «Национальный медицинский исследовательский центр им. В.А. Алмазова» Минздрава России, Санкт-Петербург, Россия;
2 ФГАОУ ВО «Санкт-Петербургский национальный исследовательский университет информационных технологий, механики и оптики» (Университет ИТМО), Санкт-Петербург, Россия;
3 ФГБУ ВО «Приволжский исследовательский медицинский университет» Минздрава России, Нижний Новгород, Россия
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Ionov M.V., Zhukova O.V., Zvartau N.E., et al. Assessment of the clinical efficacy of telemonitoring and distant counseling in patients with uncontrolled hypertension. Therapeutic Archive. 2020; 92 (1): 49–55. DOI: 10.26442/00403660.2020.01.000481