Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial

Background Adherence to medicines is low for a variety of reasons, including the cost borne by patients. Some jurisdictions publicly fund medicines for the general population, but many jurisdictions do not, and such policies are contentious. To our knowledge, no trials studying free access to a wide range of medicines have been conducted. Methods and findings We randomly assigned 786 primary care patients who reported not taking medicines due to cost between June 1, 2016 and April 28, 2017 to either free distribution of essential medicines (n = 395) or to usual medicine access (n = 391). The trial was conducted in Ontario, Canada, where hospital care and physician services are publicly funded for the general population but medicines are not. The trial population was mostly female (56%), younger than 65 years (83%), white (66%), and had a low income from wages as the primary source (56%). The primary outcome was medicine adherence after 2 years. Secondary outcomes included control of diabetes, blood pressure, and low-density lipoprotein (LDL) cholesterol in patients taking relevant treatments and healthcare costs over 2 years. Adherence to all appropriate prescribed medicines was 38.7% in the free distribution group and 28.6% in the usual access group after 2 years (absolute difference 10.1%; 95% confidence interval (CI) 3.3 to 16.9, p = 0.004). There were no statistically significant differences in control of diabetes (hemoglobin A1c 0.27; 95% CI −0.25 to 0.79, p = 0.302), systolic blood pressure (−3.9; 95% CI −9.9 to 2.2, p = 0.210), or LDL cholesterol (0.26; 95% CI −0.08 to 0.60, p = 0.130) based on available data. Total healthcare costs over 2 years were lower with free distribution (difference in median CAN$1,117; 95% CI CAN$445 to CAN$1,778, p = 0.006). In the free distribution group, 51 participants experienced a serious adverse event, while 68 participants in the usual access group experienced a serious adverse event (p = 0.091). Participants were not blinded, and some outcomes depended on participant reports. Conclusions In this study, we observed that free distribution of essential medicines to patients with cost-related nonadherence substantially increased adherence, did not affect surrogate health outcomes, and reduced total healthcare costs over 2 years. Trial registration ClinicalTrials.gov NCT02744963.

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Abstract 502: Effect of Intensive Versus Standard Blood Pressure Control on Stroke and Serious Adverse Event: A Bivariate Analysis on the Net Clinical Benefit

Arteriosclerosis Thrombosis and Vascular Biology ◽

10.1161/atvb.37.suppl_1.502 ◽

2017 ◽

Vol 37 (suppl_1) ◽

Author(s):

Jolanta Marszalek ◽

Sara Mehrsefat ◽

Gerald Chi

Keyword(s):

Blood Pressure ◽

Adverse Event ◽

Clinical Benefit ◽

Risk Difference ◽

Bivariate Analysis ◽

Forest Plot ◽

Efficacy And Safety ◽

Serious Adverse Event ◽

Safety Outcomes ◽

Net Clinical Benefit

Background: Intensive blood pressure (BP) control is associated with a reduced risk of stroke but a greater risk of serious adverse event (SAE), thereby offsetting the benefit-to-risk ratio of this strategy. Methods: Using a previously described method of bivariate analysis, efficacy and safety outcomes were collectively analyzed as net clinical benefit (NCB) based on data from three randomized controlled trials comparing intensive versus standard BP control among 17,115 patients (ACCORD, SPS3, and SPRINT trials). Bivariate risk difference was assessed by the minimum distance from NCB curve to 95% CI of risk difference in all-cause stroke and SAE. Results: Compared to standard BP target, intensive strategies reduced all-cause stroke by 0.70% (95% CI: 0.19% to 1.21%; P = 0.007) and increased SAE by 1.85% (95% CI: 1.35% to 2.34%; P < 0.0001). With a non-inferiority margin of 25%, standard strategy was preferable with respect to NCB in diabetics (bivariate risk difference: 1.29% [0.40% to 2.31%]) and in patients without diabetes or prior stroke (1.55% [0.76% to 2.37%]). Among patients with stroke history, intensive strategy failed to achieve non-inferiority in NCB (-0.18% [-1.01% to 0.83%]). Conclusions: Bivariate analysis is a novel method that allows simultaneous display and assessment of efficacy and safety outcomes. Among patients with cardiovascular risk factors, intensive BP control failed to demonstrate a favorable risk-benefit profile against standard BP control with respect to the tradeoff between stroke and SAE. Figure 1. Net clinical benefit of intensive vs standard BP control Figure 2. Forest plot of bivariate risk difference in stroke and SAE

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Epoprostenol for the treatment of increasing oxygenator pressure drop during cardiopulmonary bypass. A case report

Perfusion ◽

10.1177/0267659117729746 ◽

2017 ◽

Vol 33 (3) ◽

pp. 228-231 ◽

Cited By ~ 2

Author(s):

Anders Karl Hjärpe ◽

Björn Reinsfelt

Keyword(s):

Blood Pressure ◽

Adverse Event ◽

Case Report ◽

Cardiopulmonary Bypass ◽

High Risk ◽

Pressure Drop ◽

Serious Adverse Event ◽

Increased Pressure

A change of oxygenator during cardiopulmonary bypass is a technically high-risk procedure with potential for a serious adverse event for the patient. This case report describes a case of increased pressure drop and pre-oxygenator blood pressure during cardiopulmonary bypass successfully treated with pre-oxygenator-administered epoprostenol.

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Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation (Preprint)

10.2196/preprints.13137 ◽

2018 ◽

Author(s):

Victoria Mazoteras-Pardo ◽

Ricardo Becerro-De-Bengoa-Vallejo ◽

Marta Elena Losa-Iglesias ◽

Daniel López-López ◽

Patricia Palomo-López ◽

...

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

General Population ◽

Systolic Blood Pressure ◽

Diastolic Blood Pressure ◽

European Society ◽

Absolute Difference ◽

Blood Pressure Monitor ◽

Pressure Monitor ◽

Convenience Sample

BACKGROUND High blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers. OBJECTIVE We sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population. METHODS This study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants. RESULTS iHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate. CONCLUSIONS iHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.

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Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation

JMIR mhealth and uhealth ◽

10.2196/13137 ◽

2019 ◽

Vol 7 (3) ◽

pp. e13137

Author(s):

Victoria Mazoteras-Pardo ◽

Ricardo Becerro-De-Bengoa-Vallejo ◽

Marta Elena Losa-Iglesias ◽

Daniel López-López ◽

Patricia Palomo-López ◽

...

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

General Population ◽

Systolic Blood Pressure ◽

Diastolic Blood Pressure ◽

European Society ◽

Absolute Difference ◽

Blood Pressure Monitor ◽

Pressure Monitor ◽

Convenience Sample

Background High blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers. Objective We sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population. Methods This study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants. Results iHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate. Conclusions iHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.

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Risk factors for cardiovascular diseases and development of prehypertension

ZHurnal «Patologicheskaia fiziologiia i eksperimental`naia terapiia» ◽

10.25557/0031-2991.2018.03.37-43 ◽

2018 ◽

pp. 37-43

Author(s):

В.В. Шерстнев ◽

М.А. Грудень ◽

В.П. Карлина ◽

В.М. Рыжов ◽

А.В. Кузнецова ◽

...

Keyword(s):

Risk Factors ◽

Blood Pressure ◽

Cardiovascular Disease ◽

Ldl Cholesterol ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Hdl Cholesterol ◽

Serum Levels ◽

Left Ventricular ◽

Optimal Blood Pressure

Цель - исследование взаимосвязи факторов риска сердечно-сосудистых заболеваний и развития предгипертонии. Методика. Проведен сравнительный и корреляционный анализы показателей модифицируемых и немодифицируемых факторов риска сердечно-сосудистых заболеваний у обследованных лиц в возрасте 30-60 лет с «оптимальным» артериальным давлением, (n = 63, АД <120/80 мм рт.ст.) и лиц с предгипертонией (n = 52, АД = 120-139/80-89 мм рт.ст.). Результаты. Показано, что лица с предгипертонией по сравнению с группой лиц, имеющих «оптимальное» артериальное давление характеризуются статистически значимо повышенным содержанием холестерина и холестерина липопротеидов низкой плотности, интеллектуальным характером трудовой деятельности, а также значимыми сочетаниями факторов риска: повышенный уровень холестерина липопротеидов низкой плотности с интеллектуальным характером трудовой деятельности; повышенное содержание креатинина с уровнем триглициридов; наследственная отягощенность по заболеваниям почек и интеллектуальным характером трудовой деятельности; наследственная отягощенность по сахарному диабету и гипертрофия левого желудочка сердца. У лиц с предгипертонией документированы перестройки структуры взаимосвязи (количество, направленность и сила корреляций) между показателями факторов риска в сравнении с лицами, имеющими «оптимальное» артериальное давление. Заключение. Выявленные особенности взаимосвязей факторов риска сердечно-сосудистых заболеваний при предгипертонии рассматриваются как проявление начальной стадии дизрегуляционной патологии и нарушения регуляции физиологических систем поддержания оптимального уровня артериального давления. The aim of the study was to investigate the relationship between risk factors for cardiovascular disease and development of prehypertension. Methods. Comparative and correlation analyses of modifiable and non-modifiable risk factors for cardiovascular disease were performed in subjects aged 30-60 with «optimal» blood pressure (n = 63, BP <120/80 mm Hg) and prehypertension (n = 52, BP = 120-139 / 80-89 mm Hg). Results. The group with prehypertension compared with the «optimal» blood pressure group had significantly increased serum levels of low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol, sedentary/intellectual type of occupation, and significant combinations of risk factors. The risk factor combinations included an increased level of LDL cholesterol and a sedentary/intellectual occupation; increased serum levels of creatinine and triglycerides; hereditary burden of kidney disease and a sedentary/intellectual occupation; hereditary burden of diabetes mellitus and cardiac left ventricular hypotrophy. In subjects with prehypertension compared to subjects with «optimal» blood pressure, changes in correlations (correlation number, direction, and strength) between parameters of risk factors were documented. Conclusion. The features of interrelationships between risk factors for cardiovascular disease observed in prehypertension are considered a manifestation of early dysregulation pathology and disordered regulation of physiological systems, which maintain optimal blood pressure.

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