Perspectives of Patients with Insulin-Treated Type 1 and Type 2 Diabetes on Hypoglycemia: Results of the HAT Observational Study in Central and Eastern European Countries

INTRODUCTION: The aim of this study was to determine the level of awareness of hypoglycemia, the level of fear for hypoglycemia, and the response to hypoglycemic events among insulin-treated diabetes patients from Central and Eastern Europe (CEE). The impact of hypoglycemia on the use of healthcare resources and patient productivity was also assessed. METHODS: This was a multicenter, non-interventional, two-part, patient self-reported questionnaire study that comprised both a retrospective cross-sectional evaluation and a prospective observational evaluation. Study participants were insulin-treated adult patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) from CEE. RESULTS: Most patients (85.4% T1DM and 83.6% T2DM) reported normal hypoglycemia awareness. The median hypoglycemia fear score was 5 out of 10 for T1DM and 4 out of 10 for T2DM patients. Patients increased glucose monitoring, consulted a doctor/nurse, and/or reduced the insulin dose in response to hypoglycemia. As a consequence of hypoglycemia, patients took leave from work/studies or arrived late and/or left early. Hospitalization was required for 31 (1.2%) patients with T1DM and 66 (2.1%) patients with T2DM. CONCLUSION: Hypoglycemia impacts patients' personal and social functioning, reduces productivity, and results in additional costs, both direct (related to increased use of healthcare resources) and indirect (related to absenteeism. FUNDING: Novo Nordisk

Does the timing of parental migration matter for child growth? A life course study on left-behind children in rural China

BACKGROUND: China’s unprecedented internal migration has left 61 million rural children living apart from parents. This study investigates how being left behind is associated with children’s growth, by examining children’s height and weight trajectories by age, testing the accumulation and critical period life course hypotheses. METHODS: Data were drawn from five waves of the China Health and Nutrition Survey (CHNS). Multiple cohorts of children under 6 years old from 1997–2009 were examined (N = 2,555). Growth curve models investigated whether height and weight trajectories differ for children who were left behind at different stages of the life course: in early childhood (from ages 0–5 but not afterwards), in later childhood (from ages 6 to 17 only), and in both early and later childhood (from ages 0–5 and from ages 6–17), compared to their peers from intact households. RESULTS: Boys who were left behind at different life stages of childhood differed in height and weight growth compared with boys from intact families. No significant associations were found for girls. As young boys turned into adolescents, those left behind in early childhood tended to have slower height growth and weight gain than their peers from intact households. There was a 2.8 cm difference in the predicted heights of boys who were left behind in early childhood compared to boys from intact households, by the age of 14. Similarly, the difference in weight between the two groups of boys was 5.3 kg by the age of 14. CONCLUSIONS: Being left behind during early childhood, as compared to not being left behind, could lead to slower growth rates of height and weight for boys. The life course approach adopted in this study suggests that early childhood is a critical period of children’s growth in later life, especially for boys who are left behind. The gender paradox in China, where sons are preferred, but being left behind appears to affect boys more than girls, needs further exploration

Personal factors associated with health-related quality of life in persons with morbid obesity on treatment waiting lists in Norway

Purpose To explore relationships of socio-demographic variables, health behaviours, environmental characteristics and personal factors, with physical and mental health variables in persons with morbid obesity, and to compare their health-related quality of life (HRQoL) scores with scores from the general population. Methods A cross-sectional correlation study design was used. Data were collected by self-reported questionnaire from adult patients within the first 2 days of commencement of a mandatory educational course. Of 185 course attendees, 142 (76.8%) volunteered to participate in the study. Valid responses on all items were recorded for 128 participants. HRQoL was measured with the Short Form 12v2 from which physical (PCS) and mental component summary (MCS) scores were computed. Other standardized instruments measured regular physical activity, social support, self-esteem, sense of coherence, self-efficacy and coping style. Results Respondents scored lower on all the HRQoL subdomains compared with norms. Linear regression analyses showed that personal factors that included self-esteem, self-efficacy, sense of coherence and coping style explained 3.6% of the variance in PCS scores and 41.6% in MCS scores. Conclusion Personal factors such as self-esteem, sense of coherence and a high approaching coping style are strongly related to mental health in obese persons

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

Evidence-Based Policy Making for Public Health Interventions in Cardiovascular Diseases: Formally Assessing the Feasibility of Clinical Trials

Implementation of prevention policies has often been impeded or delayed due to the lack of randomized controlled trials (RCTs) with hard clinical outcomes (eg, incident disease, mortality). Despite the prominent role of RCTs in health care, it may not always be feasible to conduct RCTs of public health interventions with hard outcomes due to logistical and ethical considerations. RCTs may also lack external validity and have limited generalizability. Currently, there is insufficient guidance for policymakers charged with establishing evidence-based policy to determine whether an RCT with hard outcomes is needed before policy recommendations. In this context, the purpose of this article is to assess, in a case study, the feasibility of conducting an RCT of the oft-cited issue of sodium reduction on cardiovascular outcomes and then propose a framework for decision-making, which includes an assessment of the feasibility of conducting an RCT with hard clinical outcomes when such trials are unavailable. We designed and assessed the feasibility of potential individual- and cluster-randomized trials of sodium reduction on cardiovascular outcomes. Based on our assumptions, a trial using any of the designs considered would require tens of thousands of participants and cost hundreds of millions of dollars, which is prohibitively expensive. Our estimates may be conservative given several key challenges, such as the unknown costs of sustaining a long-term difference in sodium intake, the effect of differential cotreatment with antihypertensive medications, and long lag time to clinical outcomes. Thus, it would be extraordinarily difficult to conduct such a trial, and despite the high costs, would still be at substantial risk for a spuriously null result. A robust framework, such as the one we developed, should be used to guide policymakers when establishing evidence-based public health interventions in the absence of trials with hard clinical outcomes

Correlates of fear of hypoglycemia among patients with type 1 and 2 diabetes mellitus in outpatient hospitals in Zambia

Background: Severe hypoglycemia is a burdensome complication of diabetes mellitus that can induce fear of hypoglycemia and contribute to suboptimal glycemic control. The challenge is to achieve and maintain adequate glycemic control while avoiding episodes of severe hypoglycemia. The purpose of the study was to determine how common fear of hypoglycemia was in Zambian out-patients with diabetes and also to explore correlates of fear of hypoglycemia. Methods: One hundred fifty-seven individuals with types 1 and 2 diabetes participated in the study. Fear of Hypoglycemia Scale, Diabetes Self-Care Inventory, Problem Areas in Diabetes, and the Major Depression Inventory were completed. Multiple linear regression models were computed to assess the association between fear of hypoglycemia and psychological factors. Results: About 19% [16.3% type 1 and 12.6% type 2] of individuals with diabetes based on item endorsement expressed fear of hypoglycemia especially among individuals with type 1 diabetes. After controlling for demographic variables, diabetes self-care (ß = 0.24, p \u3c 0.05), and diabetes specific distress (ß = 0.41, p \u3c 0.001) were associated with fear of hypoglycemia. Conclusion: Fear of hypoglycemia was common and was positively associated with diabetes specific emotional distress and diabetes self-care. Interventions to avert fear of hypoglycemia are needed while optimizing glycemic control through managing diabetes care and emotion distress in individuals with diabetes