Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Lifestyle intervention for prevention of diabetes:determinants of success for future implementation

Lifestyle interventions are reported to reduce the risk of type 2 diabetes in high-risk individuals after mid- and long-term follow-up. Information on determinants of intervention outcome and adherence and the mechanisms underlying diabetes progression are valuable for a more targeted implementation. Weight loss seems a major determinant of diabetes risk reduction, whereas physical activity and dietary composition may contribute independently. Body composition and genetic variation may also affect the response to intervention. Lifestyle interventions are cost-effective and should be optimized to increase adherence and compliance, especially for individuals in the high-risk group with a low socioeconomic status, so that public health policy can introduce targeted implementation programs nationwide. The aims of this review are to summarize the mid- and long-term effects of lifestyle interventions on impaired glucose tolerance and type 2 diabetes mellitus and to provide determinants of intervention outcome and adherence, which can be used for future implementation of lifestyle interventions

Data-driven shared decision-making: a paradigm shift

At first sight, shared decision-making and data science seem like two vastly different fields. Yet, despite their differences, both fields could, if combined, reinforce clinical utility for both. Here we describe a new paradigm called data-driven shared decision-making (dSDM), an extension of the existing shared decision-making paradigm. In dSDM, data’s role and its interaction with the patient and doctor are made explicit. Furthermore, we describe the opportunities and challenges of combining data science and shared decision-making into this new paradigm. We believe that dSDM will bridge the gap between the need for patient empowerment and the need for more personalized medicine

Data-driven shared decision-making: a paradigm shift

At first sight, shared decision-making and data science seem like two vastly different fields. Yet, despite their differences, both fields could, if combined, reinforce clinical utility for both. Here we describe a new paradigm called data-driven shared decision-making (dSDM), an extension of the existing shared decision-making paradigm. In dSDM, data’s role and its interaction with the patient and doctor are made explicit. Furthermore, we describe the opportunities and challenges of combining data science and shared decision-making into this new paradigm. We believe that dSDM will bridge the gap between the need for patient empowerment and the need for more personalized medicine

Health Literacy and eHealth:Challenges and Strategies

Given the impact of health literacy (HL) on patients' outcomes, limited health literacy is a major barrier to improve cancer care globally. HL refers to the degree in which an individual is able to acquire, process, and comprehend information in a way to be actively involved in their health decisions. Previous research found that almost half of the population in developed countries have difficulties in understanding health-related information. With the gradual shift toward the shared decision making process and digital transformation in oncology, the need for addressing low HL issues is crucial. Decision making in oncology is often accompanied by considerable consequences on patients' lives, which requires patients to understand complex information and be able to compare treatment methods by considering their own values. How health information is perceived by patients is influenced by various factors including patients' characteristics and the way information is presented to patients. Currently, identifying patients with low HL and simple data visualizations are the best practice to help patients and clinicians in dealing with limited health literacy. Furthermore, using eHealth, as well as involving HL mediators, supports patients to make sense of complex information

The barriers and facilitators of radical innovation implementation in secondary healthcare: A systematic review

Purpose: This study aimed to identify the barriers and facilitators related to the implementation of radical innovations in secondary healthcare. Design/methodology/approach: A systematic review was conducted and presented in accordance with a PRISMA flowchart. The databases PubMed and Web of Science were searched for original publications in English between the 1st of January 2010 and 6th of November 2020. The level of radicalness was determined based on five characteristics of radical innovations. The level of evidence was classified according to the level of evidence scale of the University of Oxford. The Consolidated Framework for Implementation Research was used as a framework to classify the barriers and facilitators. Findings: Based on the inclusion and exclusion criteria, nine publications were included, concerning six technological, two organizational and one treatment innovation. The main barriers for radical innovation implementation in secondary healthcare were lack of human, material and financial resources, and lack of integration and organizational readiness. The main facilitators included a supportive culture, sufficient training, education and knowledge, and recognition of the expected added value. Originality/value: To our knowledge, this is the first systematic review examining the barriers and facilitators of radical innovation implementation in secondary healthcare. To ease radical innovation implementation, alternative performance systems may be helpful, including the following prerequisites: (1) Money, (2) Added value, (3) Timely knowledge and integration, (4) Culture, and (5) Human resources (MATCH). This study highlights the need for more high-level evidence studies in this area

The barriers and facilitators of radical innovation implementation in secondary healthcare: A systematic review

Purpose: This study aimed to identify the barriers and facilitators related to the implementation of radical innovations in secondary healthcare. Design/methodology/approach: A systematic review was conducted and presented in accordance with a PRISMA flowchart. The databases PubMed and Web of Science were searched for original publications in English between the 1st of January 2010 and 6th of November 2020. The level of radicalness was determined based on five characteristics of radical innovations. The level of evidence was classified according to the level of evidence scale of the University of Oxford. The Consolidated Framework for Implementation Research was used as a framework to classify the barriers and facilitators. Findings: Based on the inclusion and exclusion criteria, nine publications were included, concerning six technological, two organizational and one treatment innovation. The main barriers for radical innovation implementation in secondary healthcare were lack of human, material and financial resources, and lack of integration and organizational readiness. The main facilitators included a supportive culture, sufficient training, education and knowledge, and recognition of the expected added value. Originality/value: To our knowledge, this is the first systematic review examining the barriers and facilitators of radical innovation implementation in secondary healthcare. To ease radical innovation implementation, alternative performance systems may be helpful, including the following prerequisites: (1) Money, (2) Added value, (3) Timely knowledge and integration, (4) Culture, and (5) Human resources (MATCH). This study highlights the need for more high-level evidence studies in this area