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  • Original Investigation Examining Excess Mortality Associated With the COVID-19 Pandemic for Renters Threatened With Eviction Nick Graetz, PhD; Peter Hepburn, PhD; Carl Gershenson, PhD; et al Editorial Theorizing Pathways Between Eviction Filings and Increased Mortality Risk Jack Tsai, PhD, MSCP Audio Renter Eviction, Excess Mortality, and COVID-19

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USPSTF Recommendation on Screening for Lung Cancer

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GMC says sorry to LGBTQ+ doctors, but wider persecution continues

GLADD delegation marching in London

Regulatory action against doctors that was based on now repealed homophobic laws casts a long shadow, say campaigners

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Changes to the uk foundation programme add further challenges for doctors pursuing clinical academic careers, home office’s use of second medical opinions to assess asylum seekers was unlawful, doctor bribes: romania finds rare success among persisting healthcare corruption across europe, the new pandemic treaty: are we in safer hands probably not, university in alabama halts ivf treatments after court rules embryos are children, us fda breakthrough therapy designation and consumer drug advertising: a recipe for confusion, latest articles.

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Risk of mortality in patients infected with SARS-CoV-2 variant of concern 202012/1: matched cohort study

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Page 1 of 84

Genetic investigation into the broad health implications of caffeine: evidence from phenome-wide, proteome-wide and metabolome-wide Mendelian randomization

Caffeine is one of the most utilized drugs in the world, yet its clinical effects are not fully understood. Circulating caffeine levels are influenced by the interplay between consumption behaviour and metabol...

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Safety, feasibility, and impact on the gut microbiome of kefir administration in critically ill adults

Dysbiosis of the gut microbiome is frequent in the intensive care unit (ICU), potentially leading to a heightened risk of nosocomial infections. Enhancing the gut microbiome has been proposed as a strategic ap...

Novel insights from our special issue on maternal factors during pregnancy that influence maternal, fetal and childhood outcomes

Immunogenicity and safety of razi recombinant spike protein vaccine (rcp) as a booster dose after priming with bbibp-corv: a parallel two groups, randomized, double blind trial.

The immunity induced by primary vaccination is effective against COVID-19; however, booster vaccines are needed to maintain vaccine-induced immunity and improve protection against emerging variants. Heterologo...

Characteristics and clinical treatment outcomes of chronic hepatitis B children with coexistence of hepatitis B surface antigen (HBsAg) and antibodies to HBsAg

The coexistence of hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (HBsAb) represents an uncommon serological pattern observed in patients with hepatitis B virus (HBV) infection, and its u...

Efficacy of interventions targeted at physician prescribers of opioids for chronic non-cancer pain: an overview of systematic reviews

To combat the opioid crisis, interventions targeting the opioid prescribing behaviour of physicians involved in the management of patients with chronic non-cancer pain (CNCP) have been introduced in clinical s...

Comparison of immune checkpoint inhibitors related to pulmonary adverse events: a retrospective analysis of clinical studies and network meta-analysis

Immune checkpoint inhibitors (ICIs) have transformed tumor treatment. However, the risk of pulmonary adverse events (PAEs) associated with ICI combination therapy is still unclear. We aimed to provide a PAE ov...

Neuregulin-1 and ALS19 (ERBB4): at the crossroads of amyotrophic lateral sclerosis and cancer

Neuregulin-1 (NRG1) is implicated in both cancer and neurologic diseases such as amyotrophic lateral sclerosis (ALS); however, to date, there has been little cross-field discussion between neurology and oncolo...

Risk-based lung cancer screening in heavy smokers: a benefit–harm and cost-effectiveness modeling study

Annual screening through low-dose computed tomography (LDCT) is recommended for heavy smokers. However, it is questionable whether all individuals require annual screening given the potential harms of LDCT scr...

Correction: Coronary microvascular function in male physicians with burnout and job stress: an observational study

The original article was published in BMC Medicine 2023 21 :477

Correction: Predicting drug response from single-cell expression profiles of tumours

The original article was published in BMC Medicine 2023 21 :476

Higher-valency pneumococcal conjugate vaccines in older adults, taking into account indirect effects from childhood vaccination: a cost-effectiveness study for the Netherlands

New 15- and 20-valent pneumococcal vaccines (PCV15, PCV20) are available for both children and adults, while PCV21 for adults is in development. However, their cost-effectiveness for older adults, taking into ...

Developing a practical neurodevelopmental prediction model for targeting high-risk very preterm infants during visit after NICU: a retrospective national longitudinal cohort study

Follow-up visits for very preterm infants (VPI) after hospital discharge is crucial for their neurodevelopmental trajectories, but ensuring their attendance before 12 months corrected age (CA) remains a challe...

Influence of light at night on allergic diseases: a systematic review and meta-analysis

Allergic diseases impose a significant global disease burden, however, the influence of light at night exposure on these diseases in humans has not been comprehensively assessed. We aimed to summarize availabl...

Association between pregnancy-related complications and development of type 2 diabetes and hypertension in women: an umbrella review

Despite many systematic reviews and meta-analyses examining the associations of pregnancy complications with risk of type 2 diabetes mellitus (T2DM) and hypertension, previous umbrella reviews have only examin...

Exploration of the potential association between GLP-1 receptor agonists and suicidal or self-injurious behaviors: a pharmacovigilance study based on the FDA Adverse Event Reporting System database

Establishing whether there is a potential relationship between glucagon-like peptide 1 receptor agonists (GLP-1RAs) and suicidal or self-injurious behaviors (SSIBs) is crucial for public safety. This study inv...

journal article medical

Efficacy of virtual reality for pain relief in medical procedures: a systematic review and meta-analysis

Effective pain control is crucial to optimise the success of medical procedures. Immersive virtual reality (VR) technology could offer an effective non-invasive, non-pharmacological option to distract patients...

Peripheral vertigo and subsequent risk of depression and anxiety disorders: a prospective cohort study using the UK Biobank

Peripheral vertigo is often comorbid with psychiatric disorders. However, no longitudinal study has quantified the association between peripheral vertigo and risk of psychiatric disorders. Furthermore, it rema...

Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial

The distal transradial access (dTRA) has become an attractive and alternative access to the conventional transradial access (TRA) for cardiovascular interventional diagnosis and/or treatment. There was a lack ...

Healthcare exposures and associated risk of endocarditis after open-heart cardiac valve surgery

Infective endocarditis (IE) following cardiac valve surgery is associated with high morbidity and mortality. Data on the impact of iatrogenic healthcare exposures on this risk are sparse. This study aimed to i...

Diagnostic and progression biomarkers in cerebrospinal fluid of Alzheimer’s disease patients

In this commentary, we address a paper published by Johnson et al. by assessing the robustness of their method to discover diagnostic biomarkers in Alzheimer’s disease (AD). In addition, we examine how these n...

Childhood maltreatment and risk of endocrine diseases: an exploration of mediating pathways using sequential mediation analysis

Adverse childhood experiences (ACEs), including childhood maltreatment, have been linked with increased risk of diabetes and obesity during adulthood. A comprehensive assessment on the associations between chi...

Co-designing care for multimorbidity: a systematic review

The co-design of health care enables patient-centredness by partnering patients, clinicians and other stakeholders together to create services.

Effects of 6-month customized home-based exercise on motor development, bone strength, and parental stress in children with simple congenital heart disease: a single-blinded randomized clinical trial

New “noncardiac” problems in children with congenital heart disease (CHD), such as developmental delay or long-term neurodevelopmental impairments, have attracted considerable attention in recent years. It is ...

Epigenetic drug screening for trophoblast syncytialization reveals a novel role for MLL1 in regulating fetoplacental growth

Abnormal placental development is a significant factor contributing to perinatal morbidity and mortality, affecting approximately 5–7% of pregnant women. Trophoblast syncytialization plays a pivotal role in th...

Artificial intelligence in the risk prediction models of cardiovascular disease and development of an independent validation screening tool: a systematic review

A comprehensive overview of artificial intelligence (AI) for cardiovascular disease (CVD) prediction and a screening tool of AI models (AI-Ms) for independent external validation are lacking. This systematic r...

PCDHGB7 hypermethylation-based Cervical cancer Methylation (CerMe) detection for the triage of high-risk human papillomavirus-positive women: a prospective cohort study

Implementation of high-risk human papillomavirus (hrHPV) screening has greatly reduced the incidence and mortality of cervical cancer. However, a triage strategy that is effective, noninvasive, and independent...

Ethnicity-specific blood pressure thresholds based on cardiovascular and renal complications: a prospective study in the UK Biobank

The appropriateness of hypertension thresholds for triggering action to prevent cardiovascular and renal complications among non-White populations in the UK is subject to question. Our objective was to establi...

Association between drinking water quality and mental health and the modifying role of diet: a prospective cohort study

Environmental factors play an important role in developing mental disorders. This study aimed to investigate the associations of metal and nonmetal elements in drinking water with the risk of depression and an...

Real-world nudging, pricing, and mobile physical activity coaching was insufficient to improve lifestyle behaviours and cardiometabolic health: the Supreme Nudge parallel cluster-randomised controlled supermarket trial

Context-specific interventions may contribute to sustained behaviour change and improved health outcomes. We evaluated the real-world effects of supermarket nudging and pricing strategies and mobile physical a...

Strategies for addressing the needs of children with or at risk of developmental disabilities in early childhood by 2030: a systematic umbrella review

There are over 53million children worldwide under five with developmental disabilities who require effective interventions to support their health and well-being. However, challenges in delivering intervention...

Maternal smoking, nutritional factors at different life stage, and the risk of incident type 2 diabetes: a prospective study of the UK Biobank

This study aims to investigate potential interactions between maternal smoking around birth (MSAB) and type 2 diabetes (T2D) pathway-specific genetic risks in relation to the development of T2D in offspring. A...

Daily routine disruptions and psychiatric symptoms amid COVID-19: a systematic review and meta-analysis of data from 0.9 million individuals in 32 countries

There is currently a deficit of knowledge about how to define, quantify, and measure different aspects of daily routine disruptions amid large-scale disasters like COVID-19, and which psychiatric symptoms were...

Substantial health and economic burden of COVID-19 during the year after acute illness among US adults not at high risk of severe COVID-19

Patients recovering from SARS-CoV-2 infection and acute COVID-19 illness can experience a range of long-term post-acute effects. The potential clinical and economic burden of these outcomes in the USA is uncle...

Event rates and incidence of post-COVID-19 condition in hospitalised SARS-CoV-2 positive children and young people and controls across different pandemic waves: exposure-stratified prospective cohort study in Moscow (StopCOVID)

Long-term health outcomes in children and young people (CYP) after COVID-19 infection are not well understood and studies with control groups exposed to other infections are lacking. This study aimed to invest...

Substantial health and economic burden of COVID-19 during the year after acute illness among US adults at high risk of severe COVID-19

Post-COVID conditions encompass a range of long-term symptoms after SARS-CoV-2 infection. The potential clinical and economic burden in the United States is unclear. We evaluated diagnoses, medications, health...

Mapping heterogeneity in family planning indicators in Burkina Faso, Kenya, and Nigeria, 2000–2020

Family planning is fundamental to women’s reproductive health and is a basic human right. Global targets such as Sustainable Development Goal 3 (specifically, Target 3.7) have been established to promote unive...

Immune checkpoint inhibitors in cancer: the increased risk of atherosclerotic cardiovascular disease events and progression of coronary artery calcium

Immune checkpoint inhibitors (ICIs) have contributed to a significant advancement in the treatment of cancer, leading to improved clinical outcomes in many individuals with advanced disease. Both preclinical a...

Is the price right? Paying for value today to get more value tomorrow

Contemporary debates about drug pricing feature several widely held misconceptions, including the relationship between incentives and innovation, the proportion of total healthcare spending on pharmaceuticals,...

Isolating the effect of confounding from the observed survival benefit of screening participants — a methodological approach illustrated by data from the German mammography screening programme

Mammography screening programmes (MSP) aim to reduce breast cancer mortality by shifting diagnoses to earlier stages. However, it is difficult to evaluate the effectiveness of current MSP because analyses can ...

Impact of preconception and antenatal supplementation with myo -inositol, probiotics, and micronutrients on offspring BMI and weight gain over the first 2 years

Nutritional intervention preconception and throughout pregnancy has been proposed as an approach to promoting healthy postnatal weight gain in the offspring but few randomised trials have examined this.

Genomic characterization and immunotherapy for microsatellite instability-high in cholangiocarcinoma

Microsatellite instability-high (MSI-H) is a unique genomic status in many cancers. However, its role in the genomic features and immunotherapy in cholangiocarcinoma (CCA) is unclear. This study aimed to syste...

Mosquito odour-baited mass trapping reduced malaria transmission intensity: a result from a controlled before-and-after intervention study

Conventional vector control strategies have significantly reduced the malaria burden. The sustainability of these methods is currently challenged. Odour-based traps are emerging technologies that can complemen...

The experience of albinism in France: a qualitative study on dyads of parents and their adult child with albinism

To date, almost no research on the psychosocial implications of albinism has been conducted in France and an exploration of albinism-related experiences could be beneficial, in order to better understand this ...

Integrating multiple lines of evidence to assess the effects of maternal BMI on pregnancy and perinatal outcomes

Higher maternal pre-pregnancy body mass index (BMI) is associated with adverse pregnancy and perinatal outcomes. However, whether these associations are causal remains unclear.

Identifying the most at-risk age-group and longitudinal trends of drug allergy labeling amongst 7.3 million individuals in Hong Kong

Incorrect drug ‘allergy’ labels remain a global public health concern. Identifying regional trends of drug allergy labeling can guide appropriate public health interventions, but longitudinal or population dru...

Impact of socioeconomic status on chronic control and complications of type 1 diabetes mellitus in users of glucose flash systems: a follow-up study

This study investigates the association between socioeconomic status (SES) and glycemic control in individuals with type 1 diabetes (T1D) using flash glucose monitoring (FGM) devices within a public health sys...

Parental genetically predicted liability for coronary heart disease and risk of adverse pregnancy outcomes: a cohort study

Adverse pregnancy outcomes (APO) may unmask or exacerbate a woman’s underlying risk for coronary heart disease (CHD). We estimated associations of maternal and paternal genetically predicted liability for CHD ...

Proteomics for heart failure risk stratification: a systematic review

Heart failure (HF) is a complex clinical syndrome with persistently high mortality. High-throughput proteomic technologies offer new opportunities to improve HF risk stratification, but their contribution rema...

Interpretable artificial intelligence-based app assists inexperienced radiologists in diagnosing biliary atresia from sonographic gallbladder images

A previously trained deep learning-based smartphone app provides an artificial intelligence solution to help diagnose biliary atresia from sonographic gallbladder images, but it might be impractical to launch ...

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  • v.67(1); Jan-Mar 2021

Minimizing medical errors to improve patient safety: An essential mission ahead

Department of Pediatrics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India

1 Healthcare Accountability Lab, University of Milan, Milano, MI, Italy

Medical error has been defined as an unintentional act (either of “omission” or “commission”) or one that does not achieve its intended outcome, the failure of a planned action to be finished as intended (an “error of execution”), using an incorrect plan to achieve a goal (an “errors of planning”), or a deviation from the method of care which could or might not cause harm to the patient.[ 1 , 2 , 3 ] Thus, a medical error is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, behavior, infection, or other ailment. Medical errors include errors in diagnosis (”diagnostic errors”), errors in the administration of drugs and other medications (”medication errors”), errors in the performance of surgical procedures, in the use of other varieties of therapy, in the use of equipment, and the interpretation of laboratory findings.[ 1 , 2 , 3 ] It is critical to remember that a medical error occurs by an act performed in good faith; in contrast to medical malpractice, which is a damage or loss to a patient, as a result of the failure of a health practitioner to render proper services, either because of negligence, reprehensible lack of expertise, or even criminal intent.[ 1 , 2 , 3 ]

In the year 2000, the importance of identifying medical errors by medical institutions was highlighted by the U.S. Institute of Medicine (IOM) report “To Err is Human”; which said that greater than 1 million preventable errors in all likelihood occur every year within the U.S., and of these between 44,000 and 98,000 results in death.[ 4 ] This report had advocated that U.S. medical institutions need to initiate corrective steps to attain a 50% reduction in deaths due to medical errors over the following 5 years (by 2005).[ 4 ]

Following this worrying document, numerous Medical Error Reporting Systems (MERS) have been initiated within the developed world employing blended efforts made with the aid of governments, medical associations, and institutions to acquire more secure and higher quality patient care.[ 5 ] A few examples of these computer-handy, voluntary, and anonymous MERS designed for hospitals and health systems and accessible to health personnel include[ 5 ] the: (i) U.S. Pharmacopeia MEDMARX - a national medication error-reporting program, (ii) Centers for Disease Control's National Nosocomial Infection Survey, (iii) Medical Event Reporting System for Transfusion Medicine, (vi) the American Surgical Association's National Surgical Quality Improvement Program, (vii) Swiss Anesthesia Critical Incident Reporting System, (vii) Edinburgh Intensive Care Unit Critical Incident Reporting System, and (viii) Australian Incident Monitoring Study; that has led to documenting voluminous information on medical errors and numerous research publications highlighting the acute need for improved patient safety.[ 5 , 6 ] Nonetheless, Anderson and Abrahamson[ 7 ] have stated that healthcare professionals grossly underutilize MERS and less than 10% of medical errors are being reported. The common reasons for healthcare professionals not reporting effectively have been recognized as they being: (i) too busy in their routine and therefore too worn-out to report, (ii) unaware that they need to report, (iii) unaware how to do the reporting, (iv) wary of disciplinary or legal action or being perceived as being incompetent, (iv) demotivated by the lack of any immediate feedback and having the notion that the institution or system does not take visible corrective actions to prevent recurrence of the errors.[ 5 , 8 , 9 ] Schreiber et al .[ 6 ] have stated that 4079 related articles have been published in the period up to 2014 (most of them from the U.S., U.K., Canada, Germany, and Australia), highlighting that the access of knowledge and of safer technologies varies significantly in the different regions of the world.

Through the years research publications have highlighted that behavioral modifications in healthcare professionals (doctors, nurses, residents, pharmacists) are essential to make sure medical treatments are safer.[ 5 , 10 , 11 , 12 , 13 , 14 , 15 ] A few recent examples include the successful implementation of point-of-care ultrasound (”POCUS”) in decreasing diagnostic errors and reducing time to diagnosis in severely ill patients being evaluated in the emergency department.[ 10 ] Mohanty et al .[ 11 ] have analyzed the MEDMARX database to identify steps needed to prevent medication errors in patients receiving intravenous patient-controlled analgesia. It is widely recognized that patients are at risk of medication discrepancies all through transitions in care while getting admitted to the hospital, transferred to some other unit/intensive care unit, and while being discharged from the hospital. To thwart such errors the U.S.'s Institute for Healthcare Improvement (IHI) has formulated the idea of medication reconciliation for healthcare professionals.[ 16 ] Medication reconciliation is the process of creating the most accurate list possible of all medications a patient is taking; which include drug name, dosage, frequency, and the route; and comparing that listing against the physician's admission, transfer, and/or discharge orders, to provide accurate medications to the patient at all transition points inside the hospital.[ 16 ] A recent systematic review by Manias et al .[ 12 ] has recognized a few single and combined interventions which can be effective in reducing medication errors in medical and surgical settings. This review has stated that: (i) prescribing errors were decreased through pharmacist-led medication reconciliation, computerized medication reconciliation, pharmacist partnership, prescriber education, medication reconciliation with the aid of skilled mentors, and computerized physician order entry (CPOE) as single interventions. CPOE systems are designed to replace a medical institution's paper-based ordering system and have the capability to be a powerful solution for limiting hospital medical errors.[ 17 ] They permit physicians to electronically write the overall range of orders, maintain an online medication administration record, and evaluate modifications made to order by successive health personnel.[ 17 ] Medication administration errors had been decreased with the aid of CPOE and the usage of an automated drug distribution system as single interventions. Combined interventions had been also discovered to be effective in reducing errors during prescribing or administrating medications. But no interventions had been observed to reduce dispensing error rates.[ 12 ] The World Health Organization Surgical Safety Checklist (WHO SSC), a simple, realistic tool that any surgical team in the world can use, is now recommended globally to prevent surgical site infection, ensure safer anesthesia, reduce mortality and also improve communication within the surgical team and with patients.[ 13 , 14 , 15 ]

Many hospitals with adequate resources have a comprehensive device of electronic medical records that can be analyzed to locate adverse drug events (ADEs); that are a major cause of morbidity and mortality worldwide. Medication errors are believed to be accountable for up to 20% of ADEs in patients during hospitalization.[ 18 ] In 2003, the IHI presented the Trigger Tool for measuring ADEs.[ 18 ] The tool identifies potential ADEs by well-defined clues present in patients' records, namely triggers. By using ADEs, pre-defined triggers are screened within the patients' chart until they are found. This procedure is followed by tracking the trigger retrospectively, a process that might reveal an ADE. This automated screening tool is getting used in many hospitals and contributing to reducing medication errors.[ 19 ] To enhance the quality and decrease the variations in care inside intensive care units (ICUs), the IHI has introduced the concept of care bundles.[ 20 ] Care bundles incorporate three to five evidence-informed practices, which need to be delivered collectively and continuously, to assist improve patient outcomes and decrease medical errors.[ 20 , 21 ] Lengthy working hours and heavy workloads are being increasingly recognized as factors that cause stress, chronic fatigue, and sooner or later burnout in physicians, residents, and nurses.[ 22 , 23 , 24 ] Burnout in these healthcare professionals is being recognized to result in suboptimal patient care practices and appreciably increase the risk of medical errors.[ 22 , 23 , 24 ]

Regrettably, even though two decades have passed since the IOM report, medical errors are still omnipresent; and deaths due to medical errors continue to be under-reported in almost all medical institutions and hospitals.?[ 7 , 25 , 26 ] Referring to the U.S., Makary and Daniel[ 26 ] have lately reiterated that over the last two decades the situation has in all likelihood worsened. Medical errors now probably account for as many as 251,000 deaths yearly (four times greater than the IOM estimate); that's 9.5% of all deaths in the U.S. and the third main cause of death after heart disease and cancer.[ 26 ] Wilson et al .[ 27 ] have reported that medical errors causing deaths may be more rampant in low- and middle-income countries. Makary and Daniel[ 26 ] have stated that medical errors are not included on death certificates or in rankings of cause of death because a major limitation of the death certificate is that it is based on assigning an International Classification of Disease (ICD) code to the cause of demise. As a result, causes of death not associated with an ICD code, which includes human and system factors, are not documented.[ 26 ] According to the WHO, 117 countries, including India, code their mortality data using the ICD system as the primary indicator of health status.[ 28 ] The current ICD-10 coding system has limited ability to capture most types of medical errors. At best, there are only some codes wherein the role of errors may be inferred, such as the code for anticoagulation inflicting adverse effects and the code for overdose events.[ 26 ] Makary and Daniel[ 26 ] have endorsed that when a medical error results in loss of life, both the physiological cause of the death and the associated problem with the delivery of care ought to be mentioned on death certificates. These factors raised by Makary and Daniel are well taken, but we must also take into account that attributing a death to medical error is a complex and challenging task that requires an analytical process with several implications. It is not always (maybe only in glaring cases) possible to attribute the cause of death to medical error immediately at the time of writing the death certificate.

To conclude, medical errors are an important public health global problem and pose a serious threat to patient safety and quality of care. Although medical errors are inevitable, decisive actions can be taken to noticeably lessen them and enhance patient safety. To attain this, an abiding culture dedicated to decreasing medical errors needs to be created at regional, national, and international levels. Because of the high-cost factor, many hospitals have been sluggish to invest in technologies, such as electronic medical records, MERS, CPOE systems, and care bundles that have helped lessen medical errors and enhance patient safety.[ 7 ] Government authorities ought to provide monetary incentives to medical institutions to invest in computerized technologies related to strengthening patient safety.[ 7 ] A “no blame” safety culture that would inspire ?healthcare professionals to actively report medical errors should be established in medical institutions.[ 6 , 29 , 30 , 31 ] Hospital management should provide well-timed feedback and implement visible corrective measures on an ongoing basis so that healthcare professionals continue to utilize these technologies optimally.[ 5 , 9 ] A wholesome healthy working environment along with the sagacious implementation of work-hour limitations would help prevent burnout in healthcare professionals.[ 32 ] Constant awareness, responsible attitude, and accountable professionalism by every member of the teamwork are key elements that contribute to reduce medical errors. Ensuring patient safety is not only a vital mission ahead but ought to be a commitment in a just healthcare system.

This paper is in the following e-collection/theme issue:

Published on 22.2.2024 in Vol 26 (2024)

Living Lab Data of Patient Needs and Expectations for eHealth-Based Cardiac Rehabilitation in Germany and Spain From the TIMELY Study: Cross-Sectional Analysis

Authors of this article:

Author Orcid Image

Original Paper

  • Boris Schmitz 1, 2 , PhD   ; 
  • Svenja Wirtz 1, 2 , MSc   ; 
  • Manuela Sestayo-Fernández 3 , BSc   ; 
  • Hendrik Schäfer 1, 2 , MSc   ; 
  • Emma R Douma 4 , MSc   ; 
  • Marta Alonso Vazquez 3 , MSc   ; 
  • Violeta González-Salvado 5 , MD   ; 
  • Mirela Habibovic 4 , PhD   ; 
  • Dimitris Gatsios 6 , PhD   ; 
  • Willem Johan Kop 4 , PhD   ; 
  • Carlos Peña-Gil 5 , MD   ; 
  • Frank Mooren 1, 2 , MD  

1 Department of Rehabilitation Sciences, Faculty of Health, University of Witten/Herdecke, Witten, Germany

2 Center for Medical Rehabilitation, DRV Clinic Königsfeld, Ennepetal, Germany

3 Health Research Institute of Santiago de Compostela, Santiago de Compostela, Spain

4 Center of Research on Psychological Disorders and Somatic Diseases, Tilburg University, Tilburg, Netherlands

5 Cardiology and Coronary Care Department, IDIS, CIBER CV, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain

6 Capemed, Ioannina, Greece

Corresponding Author:

Boris Schmitz, PhD

Department of Rehabilitation Sciences

Faculty of Health

University of Witten/Herdecke

Alfred-Herrhausen-Straße 50

Witten, 58455

Phone: 49 23339888 ext 156

Email: [email protected]

Background: The use of eHealth technology in cardiac rehabilitation (CR) is a promising approach to enhance patient outcomes since adherence to healthy lifestyles and risk factor management during phase III CR maintenance is often poorly supported. However, patients’ needs and expectations have not been extensively analyzed to inform the design of such eHealth solutions.

Objective: The goal of this study was to provide a detailed patient perspective on the most important functionalities to include in an eHealth solution to assist them in phase III CR maintenance.

Methods: A guided survey as part of a Living Lab approach was conducted in Germany (n=49) and Spain (n=30) involving women (16/79, 20%) and men (63/79, 80%) with coronary artery disease (mean age 57 years, SD 9 years) participating in a structured center-based CR program. The survey covered patients’ perceived importance of different CR components in general, current usage of technology/technical devices, and helpfulness of the potential features of eHealth in CR. Questionnaires were used to identify personality traits (psychological flexibility, optimism/pessimism, positive/negative affect), potentially predisposing patients to acceptance of an app/monitoring devices.

Results: All the patients in this study owned a smartphone, while 30%-40% used smartwatches and fitness trackers. Patients expressed the need for an eHealth platform that is user-friendly, personalized, and easily accessible, and 71% (56/79) of the patients believed that technology could help them to maintain health goals after CR. Among the offered components, support for regular physical exercise, including updated schedules and progress documentation, was rated the highest. In addition, patients rated the availability of information on diagnosis, current medication, test results, and risk scores as (very) useful. Of note, for each item, except smoking cessation, 35%-50% of the patients indicated a high need for support to achieve their long-term health goals, suggesting the need for individualized care. No major differences were detected between Spanish and German patients (all P >.05) and only younger age ( P =.03) but not sex, education level, or personality traits (all P >.05) were associated with the acceptance of eHealth components.

Conclusions: The patient perspectives collected in this study indicate high acceptance of personalized user-friendly eHealth platforms with remote monitoring to improve adherence to healthy lifestyles among patients with coronary artery disease during phase III CR maintenance. The identified patient needs comprise support in physical exercise, including regular updates on personalized training recommendations. Availability of diagnoses, laboratory results, and medications, as part of a mobile electronic health record were also rated as very useful.

Trial Registration: ClinicalTrials.gov NCT05461729; https://clinicaltrials.gov/study/NCT05461729

Introduction

The application of eHealth technology in cardiac rehabilitation (CR) is being increasingly adopted to enhance patient outcomes. eHealth, which involves the use of digital health technologies, has the potential to facilitate CR programs to offer better, more efficient, and cost-effective care. CR is a crucial aspect of the recovery process after a cardiac event, aiming to reduce the risk of future events and improve the quality of life of patients [ 1 , 2 ]. The European Society of Cardiology defines CR as a multifactorial intervention with core components in patient assessment, physical activity, diet/nutritional counselling, risk factor control, patient education, psychosocial management, vocational advice, and lifestyle behavior change, including patients’ adherence and self-management [ 3 ]. The CR process is typically divided into 3 stages. During phase I, patients discuss their cardiovascular risk factors and health situation in the acute clinic after a coronary intervention or surgery with their treating physician or a CR nurse. This brief phase lasts only a few days and aims to get patients moving as soon as possible, encouraging mild levels of physical activity [ 4 ]. Phase II, the reconditioning phase, occurs at inpatient or outpatient CR centers or even in the home environment with various levels of support. This multidisciplinary phase includes education on risk factors, supervised exercise training, and psychological support, with the goal of improving patients’ exercise capacity, functional mobility, and self-management skills [ 5 ]. In phase III, also referred to as the maintenance phase, patients continue their care in a community or home-based setting. Phase III is the longest and least structured phase of CR, aiming at lifelong self-care with continuous risk factor management and regular physical activity to maintain the achievements made during phase II [ 4 , 6 ]. However, adherence to a healthy lifestyle, including regular physical activity and risk factor management, during phase III maintenance is challenging and often poorly supported [ 7 , 8 ]. The main reasons for suboptimal adherence to phase III CR include patient-related factors (eg, motivation) and unsustainable costs for lifelong patient support in addition to usual care by general practitioners or cardiologists [ 9 , 10 ]. In addition, patient barriers such as time and travel burden may add to lower adherence and uptake of maintenance programs.

Information and communication technology in the form of eHealth applications has undergone recent developments by targeting reduction of possible barriers of initiation and continued engagement in CR [ 11 ]. The advantages of eHealth include less time investment and constraints due to the absence of travel, option of continuous monitoring, and possibility for patients to manage their disease independently [ 12 , 13 ]. The use of eHealth technologies allows for personalization and tailoring of CR programs to individual needs, leading to higher effectiveness and improved outcomes for patients. Furthermore, eHealth applications allow for different CR aspects to be targeted independently or in a combined and synergistic manner and may have positive effects on physical activity, medication adherence, mood states, anxiety, and depression in cardiac patients [ 14 ]. However, there is no uniform eHealth platform available combining all aspects of CR for patients with cardiovascular disease over the continuum of care, including phase III maintenance. Although challenging on a technological level, user acceptance and applicability in day-to-day setting are key for implementation and success of such a solution. In addition, factors such as technological skills, trustworthiness, and overall individual attitude toward eHealth need to be considered [ 15 - 17 ].

Based on this background, the goal of this study was to provide a detailed description of the patient perspective on the most important aspects to be included in an eHealth solution to assist phase III CR maintenance. This report is part of the multistakeholder project TIMELY, which aims at developing a personalized eHealth platform to assist patients over the continuum of the disease according to recent coronary artery disease (CAD) guidelines [ 18 ]. TIMELY employs artificial intelligence–powered CR components in a patient app connected with a patient management platform and decision support tools for case managers and clinicians. Additionally, artificial intelligence–powered conversational agents (chatbots) will be provided to engage in motivational conversations with patients based on behavior change techniques with the goal of optimizing program and exercise adherence. The development of the TIMELY eHealth solution is guided by a Living Lab approach that allows researchers to co-design innovations such as TIMELY with patients in a real-life context to increase acceptance [ 19 ]. Multiple feedback loops are included at pivotal developing stages, incorporating patients and clinicians in a modified Delphi approach [ 20 , 21 ]. Within the TIMELY prospective study, patients are equipped with different devices as part of the envisioned solution, including a long-term 3-channel electrocardiogram (ECG) patch, a hemodynamic monitor for blood pressure measurement and pulse wave analysis, and a wrist-worn activity tracker. This report describes patients’ needs and expectations for eHealth-based CR collected within the TIMELY Living Lab in CR centers from Germany and Spain.

Approach and Participants

To characterize patients’ needs and expectations for an eHealth-based phase III CR maintenance system, a guided survey was conducted at medical rehabilitation centers Clinic Königsfeld, Germany, and University Hospital of Santiago de Compostela, Spain, between July 2021 and March 2022, aiming at a representative sample of ~80 participants. Patients were asked to participate during their inpatient (Germany) or outpatient (Spain) CR program, and participants were recruited consecutively without further selection. Patients diagnosed with CAD were eligible while participating in a structured center-based CR program.

Ethics Approval

This study complied with the Helsinki Declaration “Ethical Principles for Medical Research Involving Human Subjects” and was approved by the ethics committee of University Witten/Herdecke (115/2020) and Servizo Galego de Saúde (2021/190). All participants gave their written informed consent before participating in this study. This study is part of the TIMELY observational trial (ClinicalTrials.gov: NCT05461729), which aims to characterize the progress of patients with CAD during phase II and phase III CR.

Patients’ Characteristics

Patients’ anthropometric and clinical data, including severity of CAD, type of intervention, and comorbidities (rated using the D’Hoore comorbidity index [ 22 ]) were extracted from electronic health records by clinical personnel. Patients’ highest level of education was documented and specified by country. Hauptschule and Educación primaria were defined as primary, Realschule and Educación secundaria obligatoria or vocational training as secondary, and Abitur or Bachillerato as tertiary education in Germany (DE) and Spain (ES), respectively. A university degree was classified as the highest educational category. For comparability and due to differing educational systems in Germany and Spain, the level of education was categorized as “lower/equal to high school” (first two levels) or “higher than high school” (all other higher levels).

Interview-Based Survey

This survey was developed with experts from a clinical and theoretical perspective by using the Delphi method until consensus was reached. The survey (20 items) was composed of 3 parts: (1) importance of different CR components in general, (2) digital literacy and current usage of technology/technical devices, and (3) helpfulness of the potential features of eHealth in CR ( Multimedia Appendix 1 ). Closed questions were used with a list of provided answers rated on a 5-point Likert scale (1=unimportant/not useful; 5=very important/very useful). A filter question was used, which optionally exempted participants who indicated that they would never use an eHealth platform linked to devices. These participants were asked for their reasons for refusing to use an eHealth platform. The survey was pretested with selected patients in Clinic Königsfeld, and adaptations for wordings were made, where necessary. The final version of the survey was translated to German (SW and BS) and Spanish (MSF and MA) by at least 2 researchers for each translation. The survey was conducted by researchers of the local rehabilitation center. Questions were read to the patients, and further explanation was provided if needed. Investigators documented the answers by using a paper-pencil version or an electronic version of the survey ( Multimedia Appendix 1 ).

Questionnaires

In a subset of 40 German patients with CAD, questionnaires were used to identify personal traits potentially predisposing patients for acceptance of an app or monitoring devices to document the progress of CR (ie, questions Q12 and Q13 of the survey). Psychological flexibility was assessed using the Acceptance and Action Questionnaire version 2 (AAQ-2) [ 23 ], and the Revised Life Orientation Test (LOT-R) [ 24 ] was used to identify patients’ optimism/pessimism. The Type D scale for social inhibition (DS-14) [ 25 ] was used to assess negative affectivity, social inhibition, and type D personality. In addition, the Positive and Negative Affect Schedule (PANAS) was applied [ 26 ].

Statistical Analysis

Statistical analyses were performed using the open access program Jamovi (version 2.2.2, The Jamovi project) and SPSS (version 29, IBM Corp). Data are presented as mean and standard deviation, median and range for the Likert rating scales, or n (%) as indicated. Normality was tested using Shapiro-Wilks test. Between group differences were tested using independent 2-sided t -test or analysis of variance. Nonparametric tests were used to investigate group differences in Likert scale data (Mann Whitney U and Kruskal Wallis test). The associations of sex, age, education level as well as different psychological constructs with openness to using eHealth were analyzed between groups (general willingness [yes/maybe] and patients not willing to use eHealth [no]) by using chi-square test or Mann Whitney U test as indicated. To analyze the combined predictive values of multiple patients’ characteristics on eHealth acceptance, we used multivariate linear regression and naïve Bayes classification. The statistical significance level was set at P <.05.

Seventy-nine patients participated in the guided survey (Germany, n=49; Spain, n=30; 16/79, 20% females). The mean age (in years) of the patients was 57 (SD 7; range 37-79) ( Table 1 ). In Germany, our sample population was comparable in terms of sex and age to patients with CAD in general (registry data) [ 27 ] and to patients with CAD undergoing CR in particular (mean 54.9, SD 7.0 years, in-house data). Further comparison of the study sample to German patients with CAD undergoing CR showed considerable similarity also in terms of ST-elevation myocardial infarction/non–ST-elevation myocardial infarction (~75%), number of affected vessels (1 vessel disease, ~30%-40%), and performed intervention (bypass, ~20%; all in-house data). For Spain, our study sample was comparable to patients with CAD undergoing CR in terms of age (~61 years), ST-elevation myocardial infarction/non–ST-elevation myocardial infarction (~85%), number of affected vessels (1 vessel disease, ~60%), and performed intervention (bypass, ~5%; all in-house data, region Galicia). Overall, in terms of the education level, 87% (69/79) of the participants were ≤high school and 13% (10/79) were >high school ( Table 1 ). Comparisons between countries suggested good comparability even though the age (in years) of the Spanish participants (mean 62, SD 10) was higher than that of the German participants (mean 56, SD 6; P <.001), which was associated with a significantly higher burden of comorbidities (median ES 2.3, IQR 1-8; median DE 1.6, IQR 0-7; P =.03). The percentage of former smokers among patients with CAD in Germany was significantly higher than that in Spain (27/49, 55% vs 7/30, 24%; P <.001). Overall, 30% (24/79) of the included participants were active smokers. Of the 79 participants, >85% (67/79) indicated that they (highly) appreciated being involved in the planning of a future eHealth solution.

a P values were calculated using independent 2-sided t test (nonnormally distributed data were analyzed by Mann Whitney U test) and analysis of variance (nonnormally distributed variables were analyzed by Kruskal-Wallis rank sum test).

b P <.05 for within-group comparison.

c Comorbidity index was calculated according to the modified D’Hoore comorbidity index.

d Primary education is known as Hauptschule in Germany (DE) and educación primaria in Spain (ES).

e Secondary education is known as Realschule in Germany (DE) and educación secundaria obligatoria or vocational training in Spain (ES).

f Tertiary education is known as Abitur in Germany and Bachillerato in Spain.

Digital Literacy and Current Usage of Technology

For the assessment of the use of technology among patients and their associated digital literacy, participants were asked what devices they owned, for which purpose the devices were used, and how experienced they were with health/fitness apps. All patients owned a smartphone, while a significantly lower proportion of Spanish patients owned a tablet (ES: 11/30, 37%; DE: 34/49, 69%; P =.005) ( Figure 1 ). The majority of patients also owned a notebook or PC (ES: 18/30, 60%; DE: 25/30, 84%). Smartwatches (ES: 10/30, 33%; DE: 16/49, 33%) and fitness trackers (ES: 9/30, 30%; DE: 21/49, 43%) were used by a significant proportion of the participants with no differences between centers. Although smartphone, tablet, and notebook/PC were predominantly used for communication and information by the patients, a difference for smartwatch/fitness trackers was recorded in that up to 40% (12/30) of the Spanish patients used those devices also for entertainment. This was only reported by 6% (3/49) of the German patients ( P =.06). Instead, 50% (25/49) of the German patients used wearables and associated apps for documentation (including physical activity), which was only reported by 20% (6/30) of the Spanish patients ( P >.05). In terms of experience with automatic blood pressure monitors, 62% (49/79) of the patients reported their level of experience as “experienced” to “very experienced,” and 29% (23/79) and 13% (10/79) reported this level of experience for fitness trackers and health apps, respectively ( Multimedia Appendix 1 ). Of note, more than 40% (32/79) of the patients reported at least some experience with health or fitness apps.

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Rating of CR Components

To assess how patients rated the importance of different CR components for disease management, we recorded their feedback on separate aspects of CR (using 5-point rating scales). Patients’ overall rating of the importance of CR components along the continuum of care for risk reduction was very high, including regular physical exercise (median 5, IQR 3-5), healthy diet (median 5, IQR 3-5), stress management (median 5, IQR 1-5), smoking cessation (median 5, IQR 1-5), optimal medication (median 5, IQR 3-5), motivation for lifestyle changes (median 5, IQR 3-5), and overall risk factor management (median 5, IQR 2-5), with no significant difference between the 2 centers. Patients also rated their individual need for support during phase III CR maintenance in the beforementioned areas, revealing large interindividual differences with all items ranging from 1 to 5. In general, patients expressed a high need for support for regular physical exercise (median 4, range 1-5), less need for support for smoking cessation (median 1, range 1-5; only active smokers were asked), and less support for healthy diet (median 3, range 1-5), stress management (median 3, range 1-5), medication (median 3, range 1-5), motivation for lifestyle changes (median 3, range 1-5), and risk factor management (median 3, range 1-5). Of note, for each item except from smoking cessation, 35%-50% of the patients indicated a high need for support (≥4) to achieve their long-term health goals, suggesting a need for individualized care. The subgroup of patients expressing low perceived smoking cessation support needs was analyzed further to investigate if it includes patients with high-risk phenotypes. However, this analysis did not suggest an elevated risk for these patients, as age, sex, BMI, disease severity (bypass performed [yes/no]), and comorbidity index were similar to those of the group of smokers indicating need for smoking cessation support.

Rating of eHealth Components to Assist in Phase III CR Maintenance

Overall, 71% (56/79) of the patients reported that they considered technology, including mobile apps, to be helpful in maintaining health goals after phase II CR. To investigate the specific needs and expectations for an eHealth system to assist in phase III CR maintenance, we asked patients about the features that would be the most helpful for reaching their individual health goals if they were free to choose from a predefined set of options. The presented features were selected by the TIMELY investigators involving cardiologists, rehabilitation experts, behavioral change experts, sports scientists, and by considering recent literature on eHealth in CR [ 6 ]. Selected features were grouped into 3 categories for the presentation of results, including exercise-related features, clinical/medical components, and motivational/other features ( Figure 2 ) and were analyzed for differences between nationality, age groups, and men versus women. No significant differences between nationalities were detected for exercise-related features or medical-related entities. In the domain of other CR components, overall progression documentation was significantly rated as more useful/more needed by German patients (median 5, range 1-5) than by Spanish patients (median 4, range 1-5; P <.001). German patients also rated “individual feedback of a real person” more useful than Spanish patients (median 5, range 1-5 vs median 4, range 3-5; P =.005, respectively). With respect to motivational features, Spanish patients rated the possibility to “share progress with friends and family” as more useful than German patients (median 4, range 1-5 vs median 2, range 1-5]; P =.02, respectively). When asked about the preferred frequency for motivational messages, only 5% of the patients answered “several times a day.” Approximately 27% (21/79) preferred to receive messages once a day, 26% (20/79) every other day, and 9% (7/79) did not want to receive messages. Approximately 32% (25/79) indicated that they would prefer a flexible schedule for messages. Of note, no differences in preference for any suggested features were detected between women and men or among age groups. However, the score for most items ranged from 1 to 5, highlighting that perceived usefulness of potential eHealth features differs substantially between individuals.

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Factors Associated With Acceptance of eHealth in CR Maintenance

To investigate the factors associated with the acceptance of eHealth, we used questionnaires to analyze factors such as sex, age, clinical data, educational as well as psychological factors. Questionnaires involved LOT-R for optimism/pessimism, AAQ-2 for psychological flexibility, DS-14 for social inhibition, and PANAS for positive/negative affectivity. Education level was not associated with the acceptance of eHealth components ( Table 2 ). No differences were observed with regard to acceptance between women and men, but younger age was significantly associated with more acceptance of monitoring devices ( P =.03), while only a tendency was seen for willingness to use a mobile app ( P =.11). Of note, only 6% (3/49) of the patients who accepted eHealth indicated they would likely not use eHealth components because of privacy concerns, and 8% (4/49) of the patients did not like the idea of being monitored. Although multivariate linear regression analysis did not identify a combination of factors associated with eHealth acceptance, naïve Bayes classification suggested that eHealth acceptance may potentially be predicted based on younger age, a lower AAQ-2 score indicating psychological flexibility, and the index event (having experienced myocardial infarction). Willingness to use a mobile app was predicted with an overall accuracy of 97.9% (using age and AAQ-2), and the acceptance of monitoring devices was predicted with an overall accuracy of 91.7% (using age, AAQ-2, and myocardial infarction). However, validation in an independent data set was not performed.

a Data are given as n (%) and median and range. Patients were asked if they would use a mobile app for their cardiac rehabilitation maintenance support and if they would use monitoring devices (eg, blood pressure monitor, electrocardiogram, activity tracker) during maintenance. Options provided were yes/maybe or no. Between-group comparison was performed using chi-square test or Mann-Whitney U test.

b Three missing. Only German patients (n=40) were involved.

c LOT-R: Revised Life Orientation Test; 2 dimensions; range 0-12 (higher = larger optimism/pessimism).

d AAQ-2: Acceptance and Action Questionnaire version 2; range 7-49 (higher = greater psychological inflexibility).

e DS-14: Type D scale for social inhibition; 2 dimensions; range 0-28 (higher = larger negative affectivity/social inhibition).

f PANAS: Positive and Negative Affect Schedule; 2 dimensions; range 0-10 (higher = larger affect).

Principal Findings

This study aimed to define patients’ needs and expectations for eHealth-based CR to assist them during the lifelong maintenance phase. A Living Lab approach was used for German and Spanish patients with CAD to characterize their use of technology, their preferences and rating of importance for different components of a future eHealth solution for CR maintenance, as well as their general willingness to use eHealth. In brief, our main findings are (1) patients with CAD appreciated being involved in the planning of a future eHealth system, and they had sufficient levels of digital literacy, (2) patients rated the importance of CR components along the continuum of care for risk reduction as very high, (3) 71% (56/79) of the patients expected that technology could help them to maintain health goals after center-based CR, and (4) a large intraindividual heterogeneity was detected in terms of reported needs and perceived usefulness for different eHealth components.

CAD is a chronic disease, necessitating innovative approaches for effective management and support over the lifelong maintenance phase after successful intervention and rehabilitation [ 1 - 3 ]. In recent years, telemedicine and eHealth solutions have emerged as promising tools for improving the care of patients with CAD [ 6 ]. In this regard, eHealth has already been shown to be an effective alternative to phase II CR, and a recent meta-analysis suggested that telehealth-based phase II CR may be even superior to center-based programs at least for enhancing physical activity levels [ 28 - 30 ]. In addition, eHealth may have the potential to involve a large number of patients since it may also be an option for patients who cannot or do not want to attend a center-based CR. In terms of cost efficiency, Frederix et al [ 30 ] estimated that a 6-month internet-based program consisting of exercise training with telemonitoring support, text messages, and web service can be cost-efficient for up to 2 years after the end of the intervention [ 30 ]. However, the development of eHealth solutions tailored for patients with CAD requires a dynamic and patient-centered approach since low user acceptance is one of the largest barriers for success of these solutions. The European Society of Cardiology e-Cardiology Working Group reported that digital health developments are often technically driven and not based on the needs and expectations of patients, thereby calling for cocreation with patient involvement in the design [ 15 ]. The European Society of Cardiology position paper strongly emphasized that patient-related barriers and user characteristics may hinder the large-scale deployment of eHealth services. Thus, the TIMELY project includes a Living Lab as means to involve patients and patient organizations, and our analyses reflect part of this patient-centered approach.

Per definition, Living Labs represent open innovation ecosystems to cocreate, assess, and refine innovative (technical) solutions [ 19 ]. To achieve a user-centric design, Living Labs prioritize the engagement of patients together with health care professionals to ensure that the resulting applications align with the needs, preferences, and challenges faced by the specific needs of a patient group. It is however important to place Living Labs in authentic settings, as implemented in this study, where patients with CAD undergoing center-based phase II CR are involved. These patients had received comprehensive information on the etiology and treatment of their disease as well as lifestyle factors that modify CAD. The majority of the involved patients indicated that they liked the approach and appreciated being involved in the conception and development of an eHealth solution to assist them during the maintenance phase even though some indicated that too much effort might keep them from using such a solution. In terms of predictors of eHealth use, previous research on sociodemographic factors among US adult internet users suggested that patients with lower education levels had lower odds of using certain features, including web-based tracking of personal health information, using a website to support physical activity, or downloading health information to a mobile device [ 31 ]. That study also indicated that being female was a predictor of eHealth use across health care and user-generated content, while age influenced health information–seeking [ 31 ]. In comparison, our data also suggest that younger age was associated with the indicated acceptance of technology, but women were as likely as men to accept eHealth for managing their disease, and the education level was not identified as a predictor. These findings might be based on the fact that smartphones, device hardware, and mobile apps are rapidly advancing, and daily exposure lowers the barriers for patients to use technology [ 32 ]. Although our study was performed among a selected group of patients with CAD participating in a prospective study, it is interesting to compare our cohort also in terms of the necessary hardware availability, that is, smartphone ownership in this patient group in general. Between 2019 and 2020, a large cross-sectional study among cardiac inpatients in Australia reported a high frequency of smartphone ownership (85%-89%) among patients aged 50-69 years and lower ownership (~60%) in patients aged 70-79 years [ 33 ]. In our sample (mean age 57 years, SD 9 years), every patient owned a smartphone and one-third also used activity trackers/smartwatches, which might also be explained by the differences between countries (Australia vs Germany/Spain). Percentage of technology ownership as well as usage and expectations for eHealth were not different between Germany and Spain, even though the Spanish population was significantly older ( P =.001) and clinical characteristics differed to some extent. Further, CR in Spain is based on outpatient care, which, while equally effective in terms of reaching the main CR outcomes, could have affected the estimated need for eHealth in this population. Of the analyzed psychological factors, only psychological flexibility showed some predictive value for eHealth acceptance. This result partly contradicts previous findings among older (>60 years) residents of Hong Kong, wherein optimism was significantly related to perceived eHealth usefulness [ 34 ]. To what extent these differences are caused by differences in age or cultural background warrant further investigations.

State-of-the-art digital health care programs face numerous technical and interoperability hurdles that make implementation difficult. This includes transmitting physiological measurements from ECGs and blood pressure monitors as well as data from activity trackers and other wearables to a centralized platform. Respective solutions rely on wireless networks; different hardware, software, and algorithms for capturing and processing data; as well as connected dashboards. Challenges include system reliability, data quality, interoperability, and overall, the highest level of data security. We have not asked the involved patients about their opinions on system availability and stability, as these aspects as well as data security and privacy need to meet the highest standards as conditio sine qua non when providing eHealth to patients. However, information regarding these aspects needs to be provided to patients in sufficient detail, since privacy-related concerns represent considerable barriers [ 15 , 35 ]. These technical requirements and interdependencies result in high costs for any eHealth solution targeting to improve patients’ self-care. Foreseen functionalities should thus not only be based on current guidelines but should be aligned with patient needs and expectations. This study shows that patients with CAD expected considerable merit in the documentation and availability of their diagnosis, laboratory results, and current medication—all details that would be part of an electronic health record. Patients also showed interest in their overall risk score, which TIMELY will base on a biomarker score to predict the 10-year mortality risk [ 36 , 37 ]. The majority of patients rated the usefulness of blood pressure and ECG monitors as high or very high. Functionalities related to support daily physical activities and physical exercise were perceived as (very) useful, with most patients indicating a high need for progress documentation and regular updates on personalized training recommendations. This observation is relevant since commercial activity trackers have been reported to significantly increase the daily step count and aerobic capacity in patients undergoing CR [ 38 , 39 ], and a considerable number of patients were already relying on commercial solutions, which, however, do not always provide the necessary level of data protection and have not been tested sufficiently in patient populations. Functionalities related to other important parts of CR, including smoking cessation, stress management, advice on heart-healthy eating, as well as self-education, were perceived as less useful or rated neutral, likely depending on the individual perceived needs of the patients. This aspect was pronounced for smoking cessation, which was perceived as an important part of CR, but 50% of the smokers indicated that they did not want support with this health-related aspect.

Limitations

Although reporting on 2 samples of participants undergoing CR from Germany and Spain with cultural and socioeconomic differences is a strength of this study, this report may be affected by the potential study selection bias since patients participating in scientific research studies differ in terms of motivational aspects. However, our sample population did not differ with respect to the sociodemographic characteristics of the samples of patients with CAD undergoing CR who were analyzed in previous reports [ 22 ]. It should be noted that health literacy, a central factor in eHealth usage and a pivotal determinant of health in general, is a complex construct and was not assessed in all dimensions in our study population. The results of naïve Bayes classification should be interpreted with care since validation in an independent data set was not performed. The timepoint and situation of this survey may also have affected the results since patients may answer differently when asked in their home environment or with greater time interval after an acute event. Focus groups may allow for more and detailed information on the reasoning underlying the reported answers to this guided survey, and the results of focus groups within TIMELY will be reported elsewhere.

This survey involving patients undergoing CR in Germany and Spain revealed that eHealth for CR maintenance should emphasize on support for regular physical activity and physical exercise, including patient feedback on achievements and renewal of training recommendations. Devices for physiological measurements, including blood pressure and ECG monitors, were considered useful, and most patients expressed a need for the documentation of diagnosis, medication, and laboratory results in terms of an electronic health record. In general, the patients who took part in this project showed a sufficient level of digital literacy and current usage of technology to make good use of even more advanced eHealth solutions. Although only minor differences were observed among Spanish and German patients as well as between female and male patients and educational status did not appear to be a contributing factor, it is crucial to note substantial variability in patients’ individual needs and expectations. Consequently, eHealth solutions should prioritize personalization to enhance user acceptance. Next steps of the TIMELY Living Lab will involve analyses of details on the implementation of the individual CR functionalities and feedback on the mobile app design.

Acknowledgments

We thank all the patients involved in this study for participating and appreciate the help of our colleagues in answering the Delphi questions to develop the survey used in this project. BS, FM, MH, CP-G, and WJK received funding from the European Commission within the H2020 framework (project TIMELY, grant agreement number 101017424).

Data Availability

The data generated during this study are available from the corresponding author upon reasonable request.

Authors' Contributions

BS, SW, and FM designed this study. SW, MSF, HS, MAV, and VG-S performed the survey and collected the data. SW, MSF, and BS analyzed the data. BS, WJK, and MH interpreted the results. BS, SW, and ERD wrote the manuscript. FM, WJK, MH, CP-G, and DG provided important intellectual content. All authors contributed to the revision of the manuscript and approved the final version of the manuscript.

Conflicts of Interest

BS is the Associate Editor of JMIR Rehabilitation and Assistive Technologies . The other authors declare no conflicts of interest.

Details of the survey.

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Abbreviations

Edited by T de Azevedo Cardoso, S He; submitted 26.10.23; peer-reviewed by J Su, D Liu, P Dilaveris; comments to author 20.12.23; revised version received 28.12.23; accepted 30.01.24; published 22.02.24.

©Boris Schmitz, Svenja Wirtz, Manuela Sestayo-Fernández, Hendrik Schäfer, Emma R Douma, Marta Alonso Vazquez, Violeta González-Salvado, Mirela Habibovic, Dimitris Gatsios, Willem Johan Kop, Carlos Peña-Gil, Frank Mooren. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 22.02.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

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A Columbia Surgeon’s Study Was Pulled. He Kept Publishing Flawed Data.

The quiet withdrawal of a 2021 cancer study by Dr. Sam Yoon highlights scientific publishers’ lack of transparency around data problems.

Supported by

Benjamin Mueller

By Benjamin Mueller

Benjamin Mueller covers medical science and has reported on several research scandals.

  • Feb. 15, 2024

The stomach cancer study was shot through with suspicious data. Identical constellations of cells were said to depict separate experiments on wholly different biological lineages. Photos of tumor-stricken mice, used to show that a drug reduced cancer growth, had been featured in two previous papers describing other treatments.

Problems with the study were severe enough that its publisher, after finding that the paper violated ethics guidelines, formally withdrew it within a few months of its publication in 2021. The study was then wiped from the internet, leaving behind a barren web page that said nothing about the reasons for its removal.

As it turned out, the flawed study was part of a pattern. Since 2008, two of its authors — Dr. Sam S. Yoon, chief of a cancer surgery division at Columbia University’s medical center, and a more junior cancer biologist — have collaborated with a rotating cast of researchers on a combined 26 articles that a British scientific sleuth has publicly flagged for containing suspect data. A medical journal retracted one of them this month after inquiries from The New York Times.

A person walks across a covered walkway connecting two buildings over a road with parked cars. A large, blue sign on the walkway says "Columbia University Irving Medical Center."

Memorial Sloan Kettering Cancer Center, where Dr. Yoon worked when much of the research was done, is now investigating the studies. Columbia’s medical center declined to comment on specific allegations, saying only that it reviews “any concerns about scientific integrity brought to our attention.”

Dr. Yoon, who has said his research could lead to better cancer treatments , did not answer repeated questions. Attempts to speak to the other researcher, Changhwan Yoon, an associate research scientist at Columbia, were also unsuccessful.

The allegations were aired in recent months in online comments on a science forum and in a blog post by Sholto David, an independent molecular biologist. He has ferreted out problems in a raft of high-profile cancer research , including dozens of papers at a Harvard cancer center that were subsequently referred for retractions or corrections.

From his flat in Wales , Dr. David pores over published images of cells, tumors and mice in his spare time and then reports slip-ups, trying to close the gap between people’s regard for academic research and the sometimes shoddier realities of the profession.

When evaluating scientific images, it is difficult to distinguish sloppy copy-and-paste errors from deliberate doctoring of data. Two other imaging experts who reviewed the allegations at the request of The Times said some of the discrepancies identified by Dr. David bore signs of manipulation, like flipped, rotated or seemingly digitally altered images.

Armed with A.I.-powered detection tools, scientists and bloggers have recently exposed a growing body of such questionable research, like the faulty papers at Harvard’s Dana-Farber Cancer Institute and studies by Stanford’s president that led to his resignation last year.

But those high-profile cases were merely the tip of the iceberg, experts said. A deeper pool of unreliable research has gone unaddressed for years, shielded in part by powerful scientific publishers driven to put out huge volumes of studies while avoiding the reputational damage of retracting them publicly.

The quiet removal of the 2021 stomach cancer study from Dr. Yoon’s lab, a copy of which was reviewed by The Times, illustrates how that system of scientific publishing has helped enable faulty research, experts said. In some cases, critical medical fields have remained seeded with erroneous studies.

“The journals do the bare minimum,” said Elisabeth Bik, a microbiologist and image expert who described Dr. Yoon’s papers as showing a worrisome pattern of copied or doctored data. “There’s no oversight.”

Memorial Sloan Kettering, where portions of the stomach cancer research were done, said no one — not the journal nor the researchers — had ever told administrators that the paper was withdrawn or why it had been. The study said it was supported in part by federal funding given to the cancer center.

Dr. Yoon, a stomach cancer specialist and a proponent of robotic surgery, kept climbing the academic ranks, bringing his junior researcher along with him. In September 2021, around the time the study was published, he joined Columbia, which celebrated his prolific research output in a news release . His work was financed in part by half a million dollars in federal research money that year, adding to a career haul of nearly $5 million in federal funds.

The decision by the stomach cancer study’s publisher, Elsevier, not to post an explanation for the paper’s removal made it less likely that the episode would draw public attention or affect the duo’s work. That very study continued to be cited in papers by other scientists .

And as recently as last year, Dr. Yoon’s lab published more studies containing identical images that were said to depict separate experiments, according to Dr. David’s analyses.

The researchers’ suspicious publications stretch back 16 years. Over time, relatively minor image copies in papers by Dr. Yoon gave way to more serious discrepancies in studies he collaborated on with Changhwan Yoon, Dr. David said. The pair, who are not related, began publishing articles together around 2013.

But neither their employers nor their publishers seemed to start investigating their work until this past fall, when Dr. David published his initial findings on For Better Science, a blog, and notified Memorial Sloan Kettering, Columbia and the journals. Memorial Sloan Kettering said it began its investigation then.

None of those flagged studies was retracted until last week. Three days after The Times asked publishers about the allegations, the journal Oncotarget retracted a 2016 study on combating certain pernicious cancers. In a retraction notice , the journal said the authors’ explanations for copied images “were deemed unacceptable.”

The belated action was symptomatic of what experts described as a broken system for policing scientific research.

A proliferation of medical journals, they said, has helped fuel demand for ever more research articles. But those same journals, many of them operated by multibillion-dollar publishing companies, often respond slowly or do nothing at all once one of those articles is shown to contain copied data. Journals retract papers at a fraction of the rate at which they publish ones with problems.

Springer Nature, which published nine of the articles that Dr. David said contained discrepancies across five journals, said it was investigating concerns. So did the American Association for Cancer Research, which published 10 articles under question from Dr. Yoon’s lab across four journals.

It is difficult to know who is responsible for errors in articles. Eleven of the scientists’ co-authors, including researchers at Harvard, Duke and Georgetown, did not answer emailed inquiries.

The articles under question examined why certain stomach and soft-tissue cancers withstood treatment, and how that resistance could be overcome.

The two independent image specialists said the volume of copied data, along with signs that some images had been rotated or similarly manipulated, suggested considerable sloppiness or worse.

“There are examples in this set that raise pretty serious red flags for the possibility of misconduct,” said Dr. Matthew Schrag, a Vanderbilt University neurologist who commented as part of his outside work on research integrity.

One set of 10 articles identified by Dr. David showed repeated reuse of identical or overlapping black-and-white images of cancer cells supposedly under different experimental conditions, he said.

“There’s no reason to have done that unless you weren’t doing the work,” Dr. David said.

One of those papers , published in 2012, was formally tagged with corrections. Unlike later studies, which were largely overseen by Dr. Yoon in New York, this paper was written by South Korea-based scientists, including Changhwan Yoon, who then worked in Seoul.

An immunologist in Norway randomly selected the paper as part of a screening of copied data in cancer journals. That led the paper’s publisher, the medical journal Oncogene, to add corrections in 2016.

But the journal did not catch all of the duplicated data , Dr. David said. And, he said, images from the study later turned up in identical form in another paper that remains uncorrected.

Copied cancer data kept recurring, Dr. David said. A picture of a small red tumor from a 2017 study reappeared in papers in 2020 and 2021 under different descriptions, he said. A ruler included in the pictures for scale wound up in two different positions.

The 2020 study included another tumor image that Dr. David said appeared to be a mirror image of one previously published by Dr. Yoon’s lab. And the 2021 study featured a color version of a tumor that had appeared in an earlier paper atop a different section of ruler, Dr. David said.

“This is another example where this looks intentionally done,” Dr. Bik said.

The researchers were faced with more serious action when the publisher Elsevier withdrew the stomach cancer study that had been published online in 2021. “The editors determined that the article violated journal publishing ethics guidelines,” Elsevier said.

Roland Herzog, the editor of Molecular Therapy, the journal where the article appeared, said that “image duplications were noticed” as part of a process of screening for discrepancies that the journal has since continued to beef up.

Because the problems were detected before the study was ever published in the print journal, Elsevier’s policy dictated that the article be taken down and no explanation posted online.

But that decision appeared to conflict with industry guidelines from the Committee on Publication Ethics . Posting articles online “usually constitutes publication,” those guidelines state. And when publishers pull such articles, the guidelines say, they should keep the work online for the sake of transparency and post “a clear notice of retraction.”

Dr. Herzog said he personally hoped that such an explanation could still be posted for the stomach cancer study. The journal editors and Elsevier, he said, are examining possible options.

The editors notified Dr. Yoon and Changhwan Yoon of the article’s removal, but neither scientist alerted Memorial Sloan Kettering, the hospital said. Columbia did not say whether it had been told.

Experts said the handling of the article was symptomatic of a tendency on the part of scientific publishers to obscure reports of lapses .

“This is typical, sweeping-things-under-the-rug kind of nonsense,” said Dr. Ivan Oransky, co-founder of Retraction Watch, which keeps a database of 47,000-plus retracted papers. “This is not good for the scientific record, to put it mildly.”

Susan C. Beachy contributed research.

Benjamin Mueller reports on health and medicine. He was previously a U.K. correspondent in London and a police reporter in New York. More about Benjamin Mueller

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Some results uranium dioxide powder structure investigation

  • Processes of Obtaining and Properties of Powders
  • Published: 28 June 2009
  • Volume 50 , pages 281–285, ( 2009 )

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  • E. I. Andreev 1 ,
  • K. V. Glavin 2 ,
  • A. V. Ivanov 3 ,
  • V. V. Malovik 3 ,
  • V. V. Martynov 3 &
  • V. S. Panov 2  

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Features of the macrostructure and microstructure of uranium dioxide powders are considered. Assumptions are made on the mechanisms of the behavior of powders of various natures during pelletizing. Experimental data that reflect the effect of these powders on the quality of fuel pellets, which is evaluated by modern procedures, are presented. To investigate the structure of the powders, modern methods of electron microscopy, helium pycnometry, etc., are used. The presented results indicate the disadvantages of wet methods for obtaining the starting UO 2 powders by the ammonium diuranate (ADU) flow sheet because strong agglomerates and conglomerates, which complicate the process of pelletizing, are formed. The main directions of investigation that can lead to understanding the regularities of formation of the structure of starting UO 2 powders, which will allow one to control the process of their fabrication and stabilize the properties of powders and pellets, are emphasized.

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Patlazhan, S.A., Poristost’ i mikrostruktura sluchainykh upakovok tverdykh sharov raznykh razmerov (Porosity and Microstructure of Chaotic Packings of Solid Spheres of Different Sizes), Chernogolovka: IKhF RAN, 1993.

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Andreev, E.I., Bocharov, A.S., Ivanov, A.V., et al., Izv. Vyssh. Uchebn. Zaved., Tsvetn. Metall. , 2003, no. 1, p. 48.

Assmann, H., Dörr, W., and Peehs, M., “Control of HO 2 Microstructure by Oxidative Sintering,” J. Nucl. Mater. , 1986, vol. 140,issue 1, pp. 1–6.

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Elektrostal’ Polytechnical Institute (Branch), Moscow Institute of Steel and Alloys, ul. Pervomaiskaya 7, Elektrostal’, Moscow oblast, 144000, Russia

E. I. Andreev

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K. V. Glavin & V. S. Panov

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Original Russian Text © E.I. Andreev, K.V. Glavin, A.V. Ivanov, V.V. Malovik, V.V. Martynov, V.S. Panov, 2009, published in Izvestiya VUZ. Poroshkovaya Metallurgiya i Funktsional’nye Pokrytiya, 2008, No. 4, pp. 19–24.

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Andreev, E.I., Glavin, K.V., Ivanov, A.V. et al. Some results uranium dioxide powder structure investigation. Russ. J. Non-ferrous Metals 50 , 281–285 (2009). https://doi.org/10.3103/S1067821209030183

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    The American Journal of Medicine - "The Green Journal" - publishes original clinical research of interest to physicians in internal medicine, both in academia and community-based practice.AJM is the official journal of the Alliance for Academic Internal Medicine, a prestigious group comprising internal medicine department chairs at more than 125 medical schools across the U.S.

  14. Medicine and health

    Journal of Burn Care & Research. Journal of the Canadian Association of Gastroenterology. The Journal of Clinical Endocrinology & Metabolism. Journal of Crohn's and Colitis. Journal of Crohn's and Colitis Supplements. Journal of the Endocrine Society. Journal of Gerontology. The Journals of Gerontology: Series A.

  15. Minimizing medical errors to improve patient safety: An essential

    Medical errors now probably account for as many as 251,000 deaths yearly (four times greater than the IOM estimate); that's 9.5% of all deaths in the U.S. and the third main cause of death after heart disease and cancer. Wilson et al. have reported that medical errors causing deaths may be more rampant in low- and middle-income countries.

  16. Journal of Medical Internet Research

    Background: The use of eHealth technology in cardiac rehabilitation (CR) is a promising approach to enhance patient outcomes since adherence to healthy lifestyles and risk factor management during phase III CR maintenance is often poorly supported. However, patients' needs and expectations have not been extensively analyzed to inform the design of such eHealth solutions.

  17. Closing medical encounters in China's Mainland ...

    Drawing on conversation analysis, this paper explores how medical encounters are closed in China's mainland. Based on a collection of 75 naturally occurring cases, we observe two dominant conversational practices oriented to closing Chinese medical encounters: a stand-alone 'okay?' as a generic preclosing initiation, and a gratitude-expressing action as the initiation of the closing ...

  18. Cardiology articles: The New England Journal of Medicine

    Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. ... The authorized source of trusted medical research and education for the Chinese ...

  19. A call for reform in Nigerian medical doctors' work hours

    Nigeria's health-care system urgently requires reforms in the work hours of medical doctors. In September, 2023, the death of a house officer at Lagos University Teaching Hospital following a 72-h shift underscored the pressing need for these changes.1 Unlike many countries, Nigeria has no regulations safeguarding doctors from prolonged work hours. Nigerian resident doctors routinely endure a ...

  20. A Columbia Surgeon's Study Was Pulled. He Kept Publishing Flawed Data

    A proliferation of medical journals, they said, has helped fuel demand for ever more research articles. But those same journals, many of them operated by multibillion-dollar publishing companies ...

  21. Synthesis, morphology and rheology of core-shell ...

    This article describes an original sol-gel (template) method for the synthesis of a dispersed form of nanostructured wollastonite (CaSiO3), its gold nanoparticles (40-60 nm) functionalized form ...

  22. Hospitals and Pharmacies Reeling After Change Healthcare Cyberattack

    Healthcare organizations have been forced to revert to manual procedures after Change Healthcare, part of Optum, disconnected services.

  23. January 2024 Healthcare Data Breach Report

    January 2024 Healthcare Data Breach Report. Posted By Steve Alder on Feb 21, 2024. In January, 61 data breaches of 500 or more records were reported to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), which is a 22% month-over-month reduction in reported data breaches, with data breaches falling to two below the monthly average of 63 data breaches a month.

  24. Coronavirus (Covid-19)

    Nov 02. Original Article Convalescent Plasma for Covid-19-Induced ARDS B. Misset and Others. In this open-label, randomized trial in patients newly receiving mechanical ventilatory support for ...

  25. Study of modified VVER and typical PWR fuel in the HBWR ...

    Two experiments studying the standard and modified VVER fuel fabricated at the Machine-Building Plant (in Elektrostal) and PWR fuel produced according to the typical specifications were performed on the HBWR research reactor (Halden, Norway) from 1995 to 2005. The objective of these experiments was to study the effect of the structural-technological parameters on the behavior of VVER fuel in ...

  26. Sintering of Industrial Uranium Dioxide Pellets Using Microwave ...

    In this study, the possibility of sintering industrial pressed uranium dioxide pellets using microwave radiation for the production of nuclear fuel is shown. As a result, the conditions for sintering pellets in an experimental microwave oven (power 2.9 kW, frequency 2.45 GHz) were chosen to ensure that the characteristics of the resulting fuel pellets meet the regulatory requirements for ...

  27. Covid-19

    A Crisis in Public Health. The United States has 4% of the world's population but, as of July 16, approximately 26% of its Covid-19 cases and 24% of its Covid-19 deaths. 17 These startling ...

  28. Cayuga Medical Center awarded $10.45 million grant from FEMA

    U.S. Senate Majority Leader Charles E. Schumer and fellow New York Senator Kirsten Gillibrand announced a federal grant of $10.45 million Thursday for Cayuga Medical Center in Ithaca.. The funding ...

  29. Some results uranium dioxide powder structure investigation

    Features of the macrostructure and microstructure of uranium dioxide powders are considered. Assumptions are made on the mechanisms of the behavior of powders of various natures during pelletizing. Experimental data that reflect the effect of these powders on the quality of fuel pellets, which is evaluated by modern procedures, are presented. To investigate the structure of the powders, modern ...