Health systems and telemedicine adoption for diabetes and hypertension care.

OBJECTIVES: The COVID-19 pandemic accelerated telemedicine use nationally, but differences across health systems are understudied. We examine telemedicine use for adults with diabetes and/or hypertension across 10 health systems and analyze practice and patient characteristics associated with greater use. STUDY DESIGN: Encounter-level data from the AMGA Optum Data Warehouse for March 13, 2020, to December 31, 2020, were analyzed, which included 3,016,761 clinical encounters from 764,521 adults with diabetes and/or hypertension attributed to 1 of 1207 practice sites with at least 50 system-attributed patients. METHODS: Linear spline regression estimated whether practice size and ownership were associated with telemedicine during the adoption (weeks 0-4), de-adoption (weeks 5-12), and maintenance (weeks 13-42) periods, controlling for patient socioeconomic and clinical characteristics. RESULTS: Telemedicine use peaked at 11% to 42% of weekly encounters after 4 weeks. In adjusted analyses, small practices had lower telemedicine use for adults with diabetes during the maintenance period compared with larger practices. Practice ownership was not associated with telemedicine use. Practices with higher proportions of Black patients continued to expand telemedicine use during the de-adoption and maintenance periods. CONCLUSIONS: Practice ownership was not associated with telemedicine use during first months of the pandemic. Small practices de-adopted telemedicine to a greater degree than medium and large practices. Technical support for small practices, irrespective of their ownership, could enable telemedicine use for adults with diabetes and/or hypertension.

Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease - a randomized clinical trial.

IMPORTANCE: Healthcare concepts for chronic diseases based on tele-monitoring have become increasingly important during COVID-19 pandemic. OBJECTIVE: To study the effectiveness of a novel integrated care concept (NICC) that combines tele-monitoring with the support of a call centre in addition to guideline therapy for patients with atrial fibrillation, heart failure, or treatment-resistant hypertension. DESIGN: A prospective, parallel-group, open-label, randomized, controlled trial. SETTING: Between December 2017 and August 2019 at the Rostock University Medical Center (Germany). PARTICIPANTS: Including 960 patients with either atrial fibrillation, heart failure, or treatment-resistant hypertension. INTERVENTIONS: Patients were randomized to either NICC (n = 478) or standard-of-care (SoC) (n = 482) in a 1:1 ratio. Patients in the NICC group received a combination of tele-monitoring and intensive follow-up and care through a call centre. MAIN OUTCOMES AND MEASURES: Three primary endpoints were formulated: (1) composite of all-cause mortality, stroke, and myocardial infarction; (2) number of inpatient days; (3) the first plus cardiac decompensation, all measured at 12-months follow-up. Superiority was evaluated using a hierarchical multiple testing strategy for the 3 primary endpoints, where the first step is to test the second primary endpoint (hospitalization) at two-sided 5%-significance level. In case of a non-significant difference between the groups for the rate of hospitalization, the superiority of NICC over SoC is not shown. RESULTS: The first primary endpoint occurred in 1.5% of NICC and 5.2% of SoC patients (OR: 3.3 [95%CI 1.4-8.3], p = 0.009). The number of inpatient treatment days did not differ significantly between both groups (p = 0.122). The third primary endpoint occurred in 3.6% of NICC and 8.1% of SoC patients (OR: 2.2 [95%CI 1.2-4.2], p = 0.016). Four patients died of all-cause death in the NICC and 23 in the SoC groups (OR: 4.4 [95%CI 1.6-12.6], p = 0.006). Based on the prespecified hierarchical statistical analysis protocol for multiple testing, the trial did not meet its primary outcome measure. CONCLUSIONS AND RELEVANCE: Among patients with atrial fibrillation, heart failure, or treatment-resistant hypertension, the NICC approach was not superior over SoC, despite a significant reduction in all-cause mortality, stroke, myocardial infarction and cardiac decompensation. Trial registration ClinicalTrials.gov Identifier: NCT03317951.

Managing hypertension in a Rohingya refugee camp: a brief report.

Non-communicable diseases have overtaken communicable diseases as the most common cause of death worldwide, with the majority of these deaths in low-income and middle-income countries. Hypertension alone causes over nine million deaths per year.Since 2017, around 750 000 Rohingya refugees have fled violence in Myanmar into Cox's Bazar District in Bangladesh. We describe a quality improvement project focused on the management of hypertension in Rohingya refugees in three primary health facilities within the Rohingya refugee camps. The aim of the project was to create a sustainable hypertension service within existing primary care services.A number of plan-do-study-act cycles were performed to improve care, with methods including: creating a specialised clinic, writing a treatment algorithm, training of pharmacists, engaging community health workers and educational programmes for staff and patients.In 2020, 554 patients were engaged in the new hypertension service. Of these, 358 (64.6%) returned for follow-up at least once. Mean systolic blood pressure (BP) was 141.7 (SD 60.0) mm Hg and mean diastolic BP was 88.1 (SD 11.1) mm Hg. Patients engaged in treatment had a significant reduction of BP of 8.2 (95% CI 5.4 to 11.0)/6.0 (95% CI 4.1 to 7.9) mm Hg (p<0.0001).Our project shows that it is possible to create a hypertension service in a challenging humanitarian crisis, which can successfully improve the control of hypertension, although retention in care can be difficult.

Wearable blood pressure measurement devices and new approaches in hypertension management: the digital era.

Out-of-office blood pressure (BP) measurement is considered an integral component of the diagnostic algorithm and management of hypertension. In the era of digitalization, a great deal of wearable BP measuring devices has been developed. These digital blood pressure monitors allow frequent BP measurements with minimal annoyance to the patient while they do promise radical changes regarding the diagnostic accuracy, as the importance of making an accurate diagnosis of hypertension has become evident. By increasing the number of BP measurements in different conditions, these monitors allow accurate identification of different clinical phenotypes, such as masked hypertension and pathological BP variability, that seem to have a negative impact on cardiovascular prognosis. Frequent measurements of BP and the incorporation of new features in BP variability, both enable well-rounded interpretation of BP data in the context of real-life settings. This article is a review of all different technologies and wearable BP monitoring devices.

Rapid Evaluations of Telehealth Strategies to Address Hypertension: A Mixed-Methods Exploration at Two US Health Systems During the COVID-19 Pandemic.

Telehealth is a promising intervention for hypertension management and control and was rapidly adopted by health systems to ensure continuity of care during the COVID-19 pandemic. Rapid evaluations of telehealth strategies at 2 US health systems explored how telehealth affected health care access and blood pressure outcomes among populations disproportionately affected by hypertension. Both health systems implemented telehealth strategies to maintain continuity of health care services during the COVID-19 pandemic. The evaluations used a mixed-method approach; qualitative interviews were conducted with key staff, and quantitative analyses were performed on patient electronic health record data. Both health systems exhibited similar trends in telehealth use, which allowed for continued access to health care for some patients but hindered other patients who had limited access to the internet or the equipment needed. Telehealth provides opportunities for blood pressure control and management. Further evaluation is needed to understand the role of broadband internet access as a social determinant of health and its impact on equitable patient access to health care.

Impact of COVID-19-related care disruptions on blood pressure management and control in community health centers.

BACKGROUND: Uncontrolled hypertension is a leading risk factor for cardiovascular disease. To ensure continuity of care, community health centers (CHCs) nationwide implemented virtual care (telehealth) during the pandemic. CHCs use the Centers for Medicare & Medicaid Services (CMS) 165v8 Controlling High Blood Pressure measure to report blood pressure (BP) control performance. CMS 165v8 specifications state that if no BP is documented during the measurement period, the patient's BP is assumed uncontrolled. METHODS: To examine trends in BP documentation and control rates in CHCs as telehealth use increased during the pandemic compared with pre-pandemic period, we assessed documentation of BP measurement and BP control rates from December 2019 - October 2021 among persons ages 18-85 with a diagnosis of hypertension who had an in-person or telehealth encounter in 11 CHCs. Rates were compared between CHCs that did and did not implement self-measured BP monitoring (SMBP). RESULTS: The percent of patients with hypertension with no documented BP measurement was 0.5% in December 2019 and increased to 15.2% (overall), 25.6% (non-SMBP CHCs), and 11.2% (SMBP CHCs) by October 2021. BP control using CMS 165v8 was 63.5% in December 2019 and decreased to 54.9% (overall), 49.1% (non-SMBP), and 57.2% (SMBP) by October 2021. When assessing BP control only in patients with documented BP measurements, CHCs largely maintained BP control rates (63.8% in December 2019; 64.8% (overall), 66.0% (non-SMBP), and 64.4% (SMBP) by October 2021). CONCLUSIONS: The transition away from in-person to telehealth visits during the pandemic likely increased the number of patients with hypertension lacking a documented BP measurement, subsequently negatively impacting BP control using CMS 165v8. There is an urgent need to enhance the flexibility of virtual care, improve EHR data capture capabilities for patient-generated data, and implement expanded policy and systems-level changes for SMBP, an evidence-based strategy that can build patient trust, increase healthcare engagement, and improve hypertension outcomes.

Implementation of an At-home Blood Pressure Measurement Protocol in a Hypertension Management Clinical Trial During the COVID-19 Pandemic.

BACKGROUND: The Dietary Approaches to Stop Hypertension eating plan is an evidence-based treatment of hypertension; however, adherence to the Dietary Approaches to Stop Hypertension is low. To improve adherence to the Dietary Approaches to Stop Hypertension among adults with hypertension, we designed Nourish, a 2-arm, 12-month randomized controlled trial. The COVID-19 pandemic necessitated a change from in-person to remotely delivered visits, requiring substantial protocol modifications to measure blood pressure accurately and safely for secondary outcome data. PURPOSE: The purpose of this article is to describe the implementation of an at-home blood pressure measurement protocol for the Nourish trial. CONCLUSION: Our investigator team and study staff developed and implemented a robust and feasible blood pressure measurement protocol to be executed within an at-home format. CLINICAL IMPLICATIONS: The described blood pressure measurement protocol provides a framework for use in future clinical trials and clinical settings in which a remote visit is preferred or required.

Human-centered design of clinical decision support for management of hypertension with chronic kidney disease.

BACKGROUND: Primary care providers face challenges in recognizing and controlling hypertension in patients with chronic kidney disease (CKD). Clinical decision support (CDS) has the potential to aid clinicians in identifying patients who could benefit from medication changes. This study designed an alert to control hypertension in CKD patients using an iterative human-centered design process. METHODS: In this study, we present a human-centered design process employing multiple methods for gathering user requirements and feedback on design and usability. Initially, we conducted contextual inquiry sessions to gather user requirements for the CDS. This was followed by group design sessions and one-on-one formative think-aloud sessions to validate requirements, obtain feedback on the design and layout, uncover usability issues, and validate changes. RESULTS: This study included 20 participants. The contextual inquiry produced 10 user requirements which influenced the initial alert design. The group design sessions revealed issues related to several themes, including recommendations and clinical content that did not match providers' expectations and extraneous information on the alerts that did not provide value. Findings from the individual think-aloud sessions revealed that participants disagreed with some recommended clinical actions, requested additional information, and had concerns about the placement in their workflow. Following each step, iterative changes were made to the alert content and design. DISCUSSION: This study showed that participation from users throughout the design process can lead to a better understanding of user requirements and optimal design, even within the constraints of an EHR alerting system. While raising awareness of design needs, it also revealed concerns related to workflow, understandability, and relevance. CONCLUSION: The human-centered design framework using multiple methods for CDS development informed the creation of an alert to assist in the treatment and recognition of hypertension in patients with CKD.

Commitment to Hypertension Control During the COVID-19 Pandemic: Million Hearts Initiative Exemplars.

Hypertension is a major risk factor for cardiovascular diseases, but 3 of 4 US adults do not have their blood pressure adequately controlled. Million Hearts (US Department of Health and Human Services) is a national initiative that promotes a set of priorities and interventions to optimize delivery of evidence-based strategies to manage cardiovascular disease, including hypertension. The COVID-19 pandemic, however, has disrupted routine care and preventive service delivery. We identified examples of clinical and health organizations that adapted services and care processes to continue a focus on monitoring and controlling hypertension during the pandemic. Eight Hypertension Control Exemplars were identified and interviewed. They reported various adapted care strategies including telemedicine, engaging patients in self-measured blood pressure monitoring, adapting or implementing medication management services, activating partnerships to respond to patient needs or expand services, and implementing unique patient outreach approaches. Documenting these hypertension control strategies can help increase adoption of adaptive approaches during public health emergencies and routine care.

Predictive Factors for the Care and Control of Hypertension Based on the Health Belief Model Among Hypertensive Patients During the COVID-19 Epidemic in Sirjan, Iran.

BACKGROUND: Hypertension is a leading risk factor for morbidity and mortality around the world. Preventing this health problem is considered an important priority. The aim of this study was to investigate the predictive factors for care and control of hypertension (CCH) according to the health belief model (HBM), in patients with hypertension during the COVID-19 epidemic in Sirjan, Iran. METHODS: In this cross-sectional study, participants were chosen by simple random sampling. Data were collected by a valid and reliable researcher-made questionnaire from 200 patients with high blood pressure aged 30-60 years. Data were analyzed by SPSS21 and analysis based on descriptive statistics, Pearson correlation coefficients, and linear regression was conducted. RESULTS: The results of Pearson correlation coefficients showed that there was a significant correlation among almost all constructs of the Health Belief Model (HBM), but the strongest correlations were between self-efficacy and perceived susceptibility (r = 0.940, P ≤ 0.001), and between perceived barriers with perceived benefits (r = -0.615, P ≤ 0.001). According to linear regression, perceived barriers (ß = -0.291), cues to action (ß = -0.590), and knowledge (ß = 0.973) predicted more than 26% of CCH variability. Knowledge had a stronger role than other variables. CONCLUSION: The results of this study show that the constructs of the Health Belief Model can predict CCH in hypertensive patients. This model can be used as a tool for designing and implementing educational interventions to increase CCH among hypertensive patients.

The Impact of a Web-Based Lifestyle Educational Program ('Living Better') Reintervention on Hypertensive Overweight or Obese Patients.

'Living Better', a self-administered web-based intervention, designed to facilitate lifestyle changes, has already shown positive short- and medium-term health benefits in patients with an obesity-hypertension phenotype. The objectives of this study were: (1) to examine the long-term (3-year) evolution of a group of hypertensive overweight or obese patients who had already followed the 'Living Better' program; (2) to analyze the effects of completing this program a second time (reintervention) during the COVID-19 pandemic. A quasi-experimental design was used. We recruited 29 individuals from the 105 who had participated in our first study. We assessed and compared their systolic and diastolic blood pressure (SBP and DBP), body mass index (BMI), eating behavior, and physical activity (PA) level (reported as METs-min/week), at Time 0 (first intervention follow-up), Time 1 (before the reintervention), and Time 2 (post-reintervention). Our results showed significant improvements between Time 1 and Time 2 in SBP (-4.7 (-8.7 to -0.7); p = 0.017), DBP (-3.5 (-6.2 to -0.8); p = 0.009), BMI (-0.7 (-1.0 to -0.4); p < 0.001), emotional eating (-2.8 (-5.1 to -0.5); p = 0.012), external eating (-1.1 (-2.1 to -0.1); p = 0.039), and PA (Time 1: 2308 ± 2266; Time 2: 3203 ± 3314; p = 0.030, Z = -2.17). Statistical analysis showed no significant differences in SPB, DBP, BMI, and eating behavior between Time 0 and Time 1 (p > 0.24). Implementation of the 'Living Better' program maintained positive long-term (3-year) health benefits in patients with an obesity-hypertension phenotype. Moreover, a reintervention with this program during the COVID-19 pandemic produced significant improvements in blood pressure, BMI, eating behavior, and PA.

Pediatrician Adherence to Guidelines for Diagnosis and Management of High Blood Pressure.

OBJECTIVES: To assess pediatrician adherence to the 2017 American Academy of Pediatrics' clinical practice guideline for high blood pressure (BP). STUDY DESIGN: Pediatric primary care practices (n = 59) participating in a quality improvement collaborative submitted data for patients with high BP measured between November 2018 and January 2019. Baseline data included patient demographics, BP, body mass index (BMI), and actions taken. Logistic regression was used to test associations between patient BP level and BMI with provider adherence to guidelines (BP measurement, counseling, follow-up, evaluation). RESULTS: A total of 2677 patient charts were entered for analysis. Only 2% of patients had all BP measurement steps completed correctly, with fewer undergoing 3-limb and ambulatory BP measurement. Overall, 46% of patients received appropriate weight, nutrition, and lifestyle counseling. Follow-up for high BP was recommended or scheduled in 10% of encounters, and scheduled at the appropriate interval in 5%. For patients presenting with their third high BP measurement, 10% had an appropriate diagnosis documented, 2% had appropriate screening laboratory tests conducted, and none had a renal ultrasound performed. BMI was independently associated with increased odds of counseling, but higher BP was associated with lower odds of counseling. Higher BP was independently associated with an increased likelihood of documentation of hypertension. CONCLUSIONS: In this multisite study, adherence to the 2017 American Academy of Pediatrics' guideline for high BP was low. Given the long-term health implications of high BP in childhood, it is important to improve primary care provider recognition and management. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03783650.

Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension.

High blood pressure is one of the most important risk factors for ischaemic heart disease, stroke, other cardiovascular diseases, chronic kidney disease and dementia. Mean blood pressure and the prevalence of raised blood pressure have declined substantially in high-income regions since at least the 1970s. By contrast, blood pressure has risen in East, South and Southeast Asia, Oceania and sub-Saharan Africa. Given these trends, the prevalence of hypertension is now higher in low-income and middle-income countries than in high-income countries. In 2015, an estimated 8.5 million deaths were attributable to systolic blood pressure >115 mmHg, 88% of which were in low-income and middle-income countries. Measures such as increasing the availability and affordability of fresh fruits and vegetables, lowering the sodium content of packaged and prepared food and staples such as bread, and improving the availability of dietary salt substitutes can help lower blood pressure in the entire population. The use and effectiveness of hypertension treatment vary substantially across countries. Factors influencing this variation include a country's financial resources, the extent of health insurance and health facilities, how frequently people interact with physicians and non-physician health personnel, whether a clear and widely adopted clinical guideline exists and the availability of medicines. Scaling up treatment coverage and improving its community effectiveness can substantially reduce the health burden of hypertension.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

Interdependence in the therapeutic compliance of hypertensive older adults during the COVID-19 pandemic.

OBJECTIVE: to analyze stimuli and behaviors related to interdependence and their implications for compliance with the therapeutic regimen of older adults with hypertension during the COVID-19 pandemic. METHOD: a multiple case, qualitative study, carried out with fifteen older adults treated at a Family Health Strategy unit. A characterization instrument and semi-structured interview were used for data collection. Data were processed in NVivo12, submitted to thematic content analysis, based on Roy's interdependence mode. RESULTS: the reports seized showed that the family has meaning as a therapeutic support network, as well as health services, neighbors, friends and religious institutions. Two categories emerged: Stimuli and adaptive behaviors related to interdependence in the pandemic: implications for compliance; Ineffective stimuli and behaviors related to interdependence in the pandemic: implications for compliance. CONCLUSION: adaptive and ineffective behaviors related to interdependence during the adjustment to the new condition of social distancing demonstrate the need for greater professional attention to achieve compliance with treatment.

Cost-Utility Analysis of the Integrated Care Models for the Management of Hypertension Patients: A Quasi-Experiment in Southwest Rural China.

Background: Hypertension has become the second-leading risk factor for death worldwide. However, the fragmented three-level "county-township-village" medical and healthcare system in rural China cannot provide continuous, coordinated, and comprehensive health care for patients with hypertension, as a result of which rural China has a low rate of hypertension control. This study aimed to explore the costs and benefits of an integrated care model using three intervention modes-multidisciplinary teams (MDT), multi-institutional pathway (MIP), and system global budget and performance-based payments (SGB-P4P)-for hypertension management in rural China. Methods: A Markov model with 1-year per cycle was adopted to simulate the lifetime medical costs and quality-adjusted life-years (QALYs) for patients. The interventions included Option 1 (MDT + MIP), Option 2 (MDT + MIP + SGB-P4P), and the Usual practice (usual care). We used the incremental cost-effectiveness ratio (ICER), net monetary benefit (NMB), and net health benefit (NHB) to make economic decisions and a 5% discount rate. One-way and probability sensitivity analyses were performed to test model robustness. Data on the blood pressure control rate, transition probability, utility, annual treatment costs, and project costs were from the community intervention trial (CMB-OC) project. Results: Compared with the Usual practice, Option 1 yielded an additional 0.068 QALYs and an additional cost of $229.99, resulting in an ICER of $3,373.75/QALY, the NMB was -$120.97, and the NHB was -0.076 QALYs. Compared with the Usual practice, Option 2 yielded an additional 0.545 QALYs, and the cost decreased by $2,007.31, yielding an ICER of -$3,680.72/QALY. The NMB was $2,879.42, and the NHB was 1.801 QALYs. Compared with Option 1, Option 2 yielded an additional 0.477 QALYs, and the cost decreased by $2,237.30, so the ICER was -$4,688.50/QALY, the NMB was $3,000.40, and the NHB was 1.876 QALYs. The one-way sensitivity analysis showed that the most sensitive factors in the model were treatment cost of ESRD, human cost, and discount rate. The probability sensitivity analysis showed that when willingness to pay was $1,599.16/QALY, the cost-effectiveness probability of Option 1, Option 2, and the Usual practice was 0.008, 0.813, and 0.179, respectively. Conclusions: The integrated care model with performance-based prepaid payments was the most beneficial intervention, whereas the general integrated care model (MDT + MIP) was not cost-effective. The integrated care model (MDT + MIP + SGB-P4P) was suggested for use in the community management of hypertension in rural China as a continuous, patient-centered care system to improve the efficiency of hypertension management.

Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension-HAEL Study: a study within a trial.

BACKGROUND: Although the prevalence of hypertension is high in older adults, clinical trial recruitment is a challenge. Our main aim was to describe the HAEL Study recruitment methods and yield rates. The secondary objectives were to explore the reasons for exclusion and to describe the characteristics of the enrolled participants. METHODS: This is a descriptive study within a trial. The HAEL Study was a Brazilian randomized two-center, parallel trial with an estimated sample of 184 participants. The recruitment strategy was based on four methods: electronic health records, word of mouth, print and electronic flyer, and press media. The yield rate was the ratio of the number of participants who underwent randomization to the total number of volunteers screened, calculated for overall, per recruitment method, by study center and by age group and sex. Additionally, we described the reasons for exclusion in the screening phase, as well as the demographic characteristics of those enrolled. The data are presented in absolute/relative frequencies and mean ± standard deviation. RESULTS: A total of 717 individuals were screened, and 168 were randomized over 32 months. The yield rate was higher for word of mouth (30.1%) in the overall sample. However, press media contributed the most (39.9%) to the absolute number of participants randomized in the trial. The coordinating center and participating center differed in methods with the highest yield ratios and absolute numbers of randomized participants. The main reason for exclusion in the screening phase was due to the physically active status in those intending to participate in the study (61.5%). Out of 220 participants included, 52 were excluded mainly because they did not meet the eligibility criteria (26.9%). Most of the screened volunteers were women (60.2%) age 60-69 years (59.5%), and most of the randomized participants were Caucasian/white (78.0%). CONCLUSIONS: Multiple recruitment methods constituted effective strategies. We observed that approximately one of every four individuals screened was allocated to an intervention group. Even so, there were limitations in obtaining a representative sample of older Brazilian adults with hypertension. Data show an underrepresentation of race and age groups. TRIAL REGISTRATION: This SWAT was not registered.

Efficacy of BAINS Circuit in Treating Critically Ill Hypoxemic COVID-19 Patients During the Second Wave of the Pandemic in India.

BACKGROUND: The COVID-19 pandemic has encouraged doctors to look for novel ways of treating patients with respiratory failure due to the limited availability of ventilators and highflow nasal cannula. The study aims to assess the efficacy of using the Bains circuit as an alternative to HFNC and NIV as life-saving tools in patients with respiratory failure during the second wave of the COVID-19 pandemic in India. METHODS: This is a prospective interventional study carried out in the intensive care unit of Shri B.M Patil Medical College Hospital and Research Centre, Vijayapur, India, from May 2021 to June 2021. All patients (n=90) with respiratory failure not responding to therapy with an oxygen mask were included. Patients were placed on Bain circuits, one end connected to a non-invasive ventilation mask fitted to the face of the patients, and the other end connected to a central oxygen port. Patients' vital parameters were assessed on an hourly basis. The blood gas analyses were done before and after using Bains. RESULTS: The study showed diabetes (33.4%), hypertension (22.2%), and diabetes with hypertension (11.1%) as comorbid factors among the ICU admitted patients. The results from the arterial blood gas analyses showed a statistically significant increase in Sp02 (%) and a decrease in respiratory rate (cycles/min) in the patients after being kept on Bains (p<0.05). Further, it showed that 72% of ICU patients with 70-79% Sp02 had a recovery by using Bains. The overall outcome of ICU admitted COVID-19 patients on Bains showed that 38.9% of patients improved and were shifted to 02/NRBM masks. CONCLUSION: The study highlights a novel concept of using the Bains circuit as an effective alternative to HFNC and NIV for oxygenation in critically ill COVID-19 patients during scarcity of NIV and HFNC at the peak of the pandemic.