Purpose: Blood pressure telemonitoring and remote counselling (BPTM) improves blood pressure (BP) control in patients with hypertension (HTN). Studies assessing the efficacy of BPTM from a value-based perspective are lacking. We investigated whether BPTM fits all principles of the value-based approach (clinical and economic effectiveness, improvement in patient-reported outcome/experience measures (PROM/PREM)). Materials and methods: Two hundred and forty ambulatory patients with uncontrolled HTN were randomised in a 2: 1 manner to BPTM (n ¼ 160, mean age 47 y.o.) and usual care (UC, n ¼ 80; 49 y.o.) with baseline and 3-month follow-up clinic visits. BPTM employed a mobile application (for patients) and a desktop version (for clinician), which allowed communication and exchange of medical data. The main outcomes were changes in office and ambulatory systolic (S) BPs, rate of BP control. The incremental cost-effectiveness ratio (ICER) and incremental costutility ratio (ICUR) were evaluated in economic analysis. The MOS SF-36 score was taken as a PROM, and the PEQ score was used as a PREM. Results: Larger decreases in office and ambulatory SBPs (-16.8 and À8.9 mm Hg, respectively; p < .05) was achieved in BPTM group while the treatment intensity was equal (2.4 drugs). The ICER 11.1 EUR/-1 mm Hg 24-hour SBP/1 year was 75% effective as per willingness-to-pay threshold. BPTM improved PROM (þ2.1 in mean MOS SF-36; p ¼ .04), reduced long-term mortality (þ0.11 life years gained), leading to þ0.49 quality-adjusted life years (QALYs) gained as compared with UC. The ICUR was 4 169.4 EUR/QALY gained. Patient-reported experience was higher in the BPTM (þ10 PEQ, p ¼ .01). The UC group showed minor changes in MOS SF-36 and PEQ (þ1.3; þ6, respectively; p n.s.). Conclusions: Being cost-effective, BPTM incorporates both clinical benefits and patient-perceived value. Larger randomised studies are needed to confirm our findings.
Aim. Health-related quality of life in patients with arterial hypertension (HTN) is still determined by only generic patient-reported outcome measures (PROMs), although disease-specific ones are more reliable and highly valid. Previously, we reported the results of development and item-selection process of the new Russian HTN-specific PROM. The purpose of this last stage was to confirm validity, reliability, responsiveness and sensitivity of the scale and to present its final version.Material and methods. Analysis was done using data from a mass survey of patients with Grades 1-3 HTN (n=359, aged 25 to 91 y. o.) and healthy volunteers (n=48, aged 23 to 65 y.o), 407 returned questionnaires. We conducted two exploratory factor analyses (EFA) with the intermediate version of the PROM (80 questions, 20 of them HTN-specific). The Cattel’s scree test was used to select the optimal number of factors. After removing the items with a low factor loadings, a confirmatory factor analysis (CFA) was performed to assess the model’s fitindexes adequacy. The core indexes to be measured were SRMR, RMSEA, CFI. Finally, the PROM’s reliability (Cronbach’s α and McDonald’s ω) and criterion validity (responsiveness) were evaluated.Results. Both EFA with oblique and varimax rotation showed 35 questions have factor loadings ≥0,5 and assigned to one of 5 factors. The basic structure of the PROM was retained for further CFA. Most of indices of fit measured met the requirements: SRMR was 0,08, RMSEA was 0,07 (90% CI (0,07-0,08)) and CFI was 0,08, which confirms the construct validity. Both Cronbach’s α and MacDonald’s ω of each of the domains were ≥0,80 and the whole scale was 0,89 confirming satisfactory reliability. Scores of the questionnaire were positively correlated with the severity of HTN (p<0,001 for Grades 1-3 HTN) and between HTN and non-HTN patients (p=0,01 and 0,04 in psychologic and social domains respectively).Conclusion. Sequentially addressing of exploratory and confirmatory factor analyses and assessment of reliability and responsiveness allowed to form the final version of the patient-reported outcome measure for arterial hypertension. The new Russian-language questionnaire is a useful and feasible tool for routine practice and clinical trials.
Цель. Несмотря на распространенность артериальной гипертензии (АГ) и попытки перехода к ценностно-ориентированной медицине, до сих пор не существует болезнь-специфического русскоязычного инструмента для оценки качества жизни, связанного со здоровьем (КЖ). Целью первого этапа работы стало создание опросника (показателя) по исходам, сообщаемым пациентами (ПИСП) с АГ, и его первичная оценка. Материал и методы. Первым шагом создана концептуальная модель ПИСП, определено количество оцениваемых сфер и психометрика. Затем построен первичный пул вопросов: их отбор из основных универсальных и ранее валидированных шкал, предназначенных для анализа различных аспектов КЖ, и внедрение специально подготовленных АГ-специфических элементов. Третьим шагом было выполнено первичное сокращение пула вопросов, основанных на экспертном анализе и результатах пилотного оценочного исследования. Результаты. Экспертную панель составляли 4 специалиста (трое в области АГ, один -в клинической психологии). Использованы данные 14 опросников для создания списка из 264 вопросов, распределенных по 4 основным сферам (физиологическая, психологическая, социальная, сфера лечения и приверженности). Использовалась шкала Ликерта с баллами от 1 до 5 (от худшего ответа к лучшему). Проведено очное и заочное интервьюирование 30 пациентов с АГ (18 женщин, 62,1±10,5 лет) различных степеней тяжести для выявления значимых с их точки зрения дополнительных соматических жалоб, психологических и социальных проблем. Разработанные по итогам обратной связи элементы были интегрированы в соответствующие сферы опросника. Прототип ПИСП прошел пилотное исследование пациентов с АГ амбулаторного и стационарного звена (n=50, 32 женщины, средний возраст 58,3±9,6 лет), а последующий экспертный анализ привел к промежуточной и сокращенной его версии (Σ вопросов =163 (n=36 АГ-специфичных)). Заключение. Создаваемый опросник для оценки исходов, сообщаемых пациентами с артериальной гипертензией в перспективе позволит оценивать базовый уровень качества жизни, связанного со здоровьем, выявлять различия в КЖ между пациентами с разными клиническими характеристиками, определять динамику КЖ в ответ на проводимое лечение. Дальнейшая работа над опросником заключается в проведении обширного исследования с раздачей первичной версии ПИСП.
Systemic hypertension (HTN) is the most prevalent non-communicable disease and the leading cause for major cardiovascular events, renal failure and cognitive decline. The World Health Organization showed that HTN is a key area of concern for healthcare and identified this condition as one of the primary targets for intervention to reduce global morbidity and mortality. The hard-hitting AHA/ACC Guidelines on management of High blood pressure in adults published in 2017 shocked medical community and enforced reconsidering overall significance HTN once again due to the large pool of newly diagnosed individuals and higher healthcare costs. Ensuing debates around Task Force committee opinions were fomenting at every scientific session related to cardiac diseases throughout first half-year 2018 and beyond the lecture halls as well. Thus all attendees at the 28th European Congress on Hypertension and Cardiovascular Protection held in Barcelona, Spain in June were captivated with the European expert’s presented preview of the new 2018 ESH/ESC joint clinical Guidelines on diagnosis and management of HTN. This short review highlights the bullet points presented before fulltext publication. The chapters on diagnosis, risk stratification, blood pressure treatment target ranges had undergone minor but crucial corrections. Key changes include medical treatment of uncomplicated HTN and drug therapy in special groups with major comorbidities, management of resistant HTN, device-based HTN therapy and adherence interventions.
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