Promoting inclusion in clinical trials-a rapid review of the literature and recommendations for action.

BACKGROUND: Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. METHODS: A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. RESULTS: Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. CONCLUSIONS: Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population's particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.

Lifestyle Behavior Changes and Associated Risk Factors During the COVID-19 Pandemic: Results from the Canadian COVIDiet Online Cohort Study.

BACKGROUND: The COVID-19 pandemic and related lockdowns have impacted lifestyle behaviors, including eating habits and physical activity; yet, few studies have identified the emerging patterns of such changes and associated risk factors. OBJECTIVE: This study aims to identify the patterns of weight and lifestyle behavior changes, and the potential risk factors, resulting from the pandemic in Canadian adults. METHODS: Analyses were conducted on 1609 adults (18-89 years old; n=1450, 90.1%, women; n=1316, 81.8%, White) of the Canadian COVIDiet study baseline data (May-December 2020). Self-reported current and prepandemic weight, physical activity, smoking status, perceived eating habits, alcohol intake, and sleep quality were collected through online questionnaires. Based on these 6 indicator variables, latent class analysis (LCA) was used to identify lifestyle behavior change patterns. Associations with potential risk factors, including age, gender, ethnicity, education, income, chronic diseases, body image perception, and changes in the stress level, living situation, and work arrangement, were examined with logistic regressions. RESULTS: Participants' mean BMI was 26.1 (SD 6.3) kg/m2. Of the 1609 participants, 980 (60.9%) had a bachelor's degree or above. Since the pandemic, 563 (35%) had decreased income and 788 (49%) changed their work arrangement. Most participants reported unchanged weight, sleep quality, physical activity level, and smoking and alcohol consumption, yet 708 (44%) reported a perceived decrease in eating habit quality. From LCA, 2 classes of lifestyle behavior change emerged: healthy and less healthy (probability: 0.605 and 0.395, respectively; Bayesian information criterion [BIC]=15574, entropy=4.8). The healthy lifestyle behavior change group more frequently reported unchanged weight, sleep quality, smoking and alcohol intake, unchanged/improved eating habits, and increased physical activity. The less healthy lifestyle behavior change group reported significant weight gain, deteriorated eating habits and sleep quality, unchanged/increased alcohol intake and smoking, and decreased physical activity. Among risk factors, body image dissatisfaction (odds ratio [OR] 8.8, 95% CI 5.3-14.7), depression (OR 1.8, 95% CI 1.3-2.5), increased stress level (OR 3.4, 95% CI 2.0-5.8), and gender minority identity (OR 5.5, 95% CI 1.3-22.3) were associated with adopting less healthy behaviors in adjusted models. CONCLUSIONS: The COVID-19 pandemic has appeared to have influenced lifestyle behaviors unfavorably in some but favorably in others. Body image perception, change in stress level, and gender identity are factors associated with behavior change patterns; whether these will sustain over time remains to be studied. Findings provide insights into developing strategies for supporting adults with poorer mental well-being in the postpandemic context and promoting healthful behaviors during future disease outbreaks. TRIAL REGISTRATION: ClinicalTrials.gov NCT04407533; https://clinicaltrials.gov/ct2/show/NCT04407533.

COVID-19 vaccination uptake amongst ethnic minority communities in England: a linked study exploring the drivers of differential vaccination rates.

BACKGROUND: Despite generally high coronavirus disease 2019 (COVID-19) vaccination rates in the UK, vaccination hesitancy and lower take-up rates have been reported in certain ethnic minority communities. METHODS: We used vaccination data from the National Immunisation Management System (NIMS) linked to the 2011 Census and individual health records for subjects aged ≥40 years (n = 24 094 186). We estimated age-standardized vaccination rates, stratified by ethnic group and key sociodemographic characteristics, such as religious affiliation, deprivation, educational attainment, geography, living conditions, country of birth, language skills and health status. To understand the association of ethnicity with lower vaccination rates, we conducted a logistic regression model adjusting for differences in geographic, sociodemographic and health characteristics. ResultsAll ethnic groups had lower age-standardized rates of vaccination compared with the white British population, whose vaccination rate of at least one dose was 94% (95% CI: 94%-94%). Black communities had the lowest rates, with 75% (74-75%) of black African and 66% (66-67%) of black Caribbean individuals having received at least one dose. The drivers of these lower rates were partly explained by accounting for sociodemographic differences. However, modelled estimates showed significant differences remained for all minority ethnic groups, compared with white British individuals. CONCLUSIONS: Lower COVID-19 vaccination rates are consistently observed amongst all ethnic minorities.

Adopting a Less Healthy Lifestyle Pattern During the COVID-19 Pandemic Is Modulated by Body Image Dissatisfaction and Increased Stress in Adults of the Canadian COVIDiet Study

Objectives The COVID-19 pandemic and related lockdowns may impact lifestyle behaviors including eating habits and physical activity;few studies identified emerging patterns of such changes and associated risk factors. Objectives were to identify patterns of weight and lifestyle behavior change resulting from the pandemic in Canadian adults;and potential risk factors. Methods Analyses were conducted on 1,609 adults (18–89 y;90.1% women;81.8% White) of the Canadian COVIDiet study baseline data (May-Dec 2020). Self-reported current and pre-pandemic weight, physical activity, smoking status, perceived eating habits, alcohol intake and sleep quality were collected by online questionnaires. Based on these 6 indicator variables, categorized into 3–5 levels of change, latent class analysis (LCA) was used to identify lifestyle behavior change patterns. Associations with potential risk factors including age, gender, ethnicity, education, income, chronic diseases, body image perception, and changes in stress level, living situation and work arrangement were examined with logistic regressions. Results Participants’ mean BMI was 26.8 ± 6.7;61% had > = bachelor's degree. Since the pandemic, 21% could not always afford balanced meals, 35% had decreased income and 49% changed work arrangement. From LCA, 2 classes of lifestyle behavior change emerged;“healthy” and “less healthy” (probability: 0.58 and 0.42;BIC = 19,354.8, entropy = 5.5). “Healthy” class participants more frequently reported unchanged weight, sleep quality, smoking and alcohol intake, unchanged/improved eating habits and increased physical activity. The “less healthy” class reported significant weight gain, deteriorated eating habits and sleep quality, unchanged/increased alcohol intake and smoking, and decreased physical activity. Among risk factors, body image dissatisfaction [OR = 12.2, 95%CI (9.4–15.8)] and increased stress level [(OR = 5.0, 95%CI (3.8, 6.4)] were associated with adopting “less healthy” behaviors in adjusted models. Conclusions The COVID-19 pandemic appeared to have influenced lifestyle behaviors unfavorably in some but favorably in others. Body image perception and change in stress level may have modulated these changes;whether these will sustain overtime remains to be studied. Funding Sources McGill University.

Admission Blood Glucose Level and Its Association With Cardiovascular and Renal Complications in Patients Hospitalized With COVID-19.

OBJECTIVE: To investigate the association between admission blood glucose levels and risk of in-hospital cardiovascular and renal complications. RESEARCH DESIGN AND METHODS: In this multicenter prospective study of 36,269 adults hospitalized with COVID-19 between 6 February 2020 and 16 March 2021 (N = 143,266), logistic regression models were used to explore associations between admission glucose level (mmol/L and mg/dL) and odds of in-hospital complications, including heart failure, arrhythmia, cardiac ischemia, cardiac arrest, coagulation complications, stroke, and renal injury. Nonlinearity was investigated using restricted cubic splines. Interaction models explored whether associations between glucose levels and complications were modified by clinically relevant factors. RESULTS: Cardiovascular and renal complications occurred in 10,421 (28.7%) patients; median admission glucose level was 6.7 mmol/L (interquartile range 5.8-8.7) (120.6 mg/dL [104.4-156.6]). While accounting for confounders, for all complications except cardiac ischemia and stroke, there was a nonlinear association between glucose and cardiovascular and renal complications. For example, odds of heart failure, arrhythmia, coagulation complications, and renal injury decreased to a nadir at 6.4 mmol/L (115 mg/dL), 4.9 mmol/L (88.2 mg/dL), 4.7 mmol/L (84.6 mg/dL), and 5.8 mmol/L (104.4 mg/dL), respectively, and increased thereafter until 26.0 mmol/L (468 mg/dL), 50.0 mmol/L (900 mg/dL), 8.5 mmol/L (153 mg/dL), and 32.4 mmol/L (583.2 mg/dL). Compared with 5 mmol/L (90 mg/dL), odds ratios at these glucose levels were 1.28 (95% CI 0.96, 1.69) for heart failure, 2.23 (1.03, 4.81) for arrhythmia, 1.59 (1.36, 1.86) for coagulation complications, and 2.42 (2.01, 2.92) for renal injury. For most complications, a modifying effect of age was observed, with higher odds of complications at higher glucose levels for patients age <69 years. Preexisting diabetes status had a similar modifying effect on odds of complications, but evidence was strongest for renal injury, cardiac ischemia, and any cardiovascular/renal complication. CONCLUSIONS: Increased odds of cardiovascular or renal complications were observed for admission glucose levels indicative of both hypo- and hyperglycemia. Admission glucose could be used as a marker for risk stratification of high-risk patients. Further research should evaluate interventions to optimize admission glucose on improving COVID-19 outcomes.

Virtual clinics: the way forward for heart failure services

Virtual clinics have played a huge role in the continuation of service provision during the COVID-19 pandemic. This article provides an overview of how one heart failure clinic transferred its services to virtual clinics and what is needed to sustain these changes going forward.

Association between household size and COVID-19: A UK Biobank observational study.

OBJECTIVE: To assess the association between household size and risk of non-severe or severe COVID-19. DESIGN: A longitudinal observational study. SETTING: This study utilised UK Biobank linked to national SARS-CoV-2 laboratory test data. PARTICIPANTS: 401,910 individuals with available data on household size in UK Biobank. MAIN OUTCOME MEASURES: Household size was categorised as single occupancy, two-person households and households of three or more. Severe COVID-19 was defined as a positive SARS-CoV-2 test on hospital admission or death with COVID-19 recorded as the underlying cause; and non-severe COVID-19 as a positive test from a community setting. Logistic regression models were fitted to assess associations, adjusting for potential confounders. RESULTS: Of 401,910 individuals, 3612 (1%) were identified as having suffered from a severe COVID-19 infection and 11,264 (2.8%) from a non-severe infection, between 16 March 2020 and 16 March 2021. Overall, the odds of severe COVID-19 was significantly higher among individuals living alone (adjusted odds ratio: 1.24 [95% confidence interval: 1.14 to 1.36], or living in a household of three or more individuals (adjusted odds ratio: 1.28 [1.17 to 1.39], when compared to individuals living in a household of two. For non-severe COVID-19 infection, individuals living in a single-occupancy household had lower odds compared to those living in a household of two (adjusted odds ratio: 0.88 [0.82 to 0.93]. CONCLUSIONS: Odds of severe or non-severe COVID-19 infection were associated with household size. Increasing understanding of why certain households are more at risk is important for limiting spread of the infection.

A population-based cohort study of obesity, ethnicity and COVID-19 mortality in 12.6 million adults in England.

Obesity and ethnicity are known risk factors for COVID-19 outcomes, but their combination has not been extensively examined. We investigate the association between body mass index (BMI) and COVID-19 mortality across different ethnic groups using linked national Census, electronic health records and mortality data for adults in England from the start of pandemic (January 2020) to December 2020. There were 30,067 (0.27%), 1,208 (0.29%), 1,831 (0.29%), 845 (0.18%) COVID-19 deaths in white, Black, South Asian and other ethnic minority groups, respectively. Here we show that BMI was more strongly associated with COVID-19 mortality in ethnic minority groups, resulting in an ethnic risk of COVID-19 mortality that was dependant on BMI. The estimated risk of COVID-19 mortality at a BMI of 40 kg/m2 in white ethnicities was equivalent to the risk observed at a BMI of 30.1 kg/m2, 27.0 kg/m2, and 32.2 kg/m2 in Black, South Asian and other ethnic minority groups, respectively.

Impact of cardiometabolic multimorbidity and ethnicity on cardiovascular/renal complications in patients with COVID-19.

OBJECTIVE: Using a large national database of people hospitalised with COVID-19, we investigated the contribution of cardio-metabolic conditions, multi-morbidity and ethnicity on the risk of in-hospital cardiovascular complications and death. METHODS: A multicentre, prospective cohort study in 302 UK healthcare facilities of adults hospitalised with COVID-19 between 6 February 2020 and 16 March 2021. Logistic models were used to explore associations between baseline patient ethnicity, cardiometabolic conditions and multimorbidity (0, 1, 2, >2 conditions), and in-hospital cardiovascular complications (heart failure, arrhythmia, cardiac ischaemia, cardiac arrest, coagulation complications, stroke), renal injury and death. RESULTS: Of 65 624 patients hospitalised with COVID-19, 44 598 (68.0%) reported at least one cardiometabolic condition on admission. Cardiovascular/renal complications or death occurred in 24 609 (38.0%) patients. Baseline cardiometabolic conditions were independently associated with increased odds of in-hospital complications and this risk increased in the presence of cardiometabolic multimorbidity. For example, compared with having no cardiometabolic conditions, 1, 2 or ≥3 conditions was associated with 1.46 (95% CI 1.39 to 1.54), 2.04 (95% CI 1.93 to 2.15) and 3.10 (95% CI 2.92 to 3.29) times higher odds of any cardiovascular/renal complication, respectively. A similar pattern was observed for all-cause death. Compared with the white group, the South Asian (OR 1.19, 95% CI 1.10 to 1.29) and black (OR 1.53 to 95% CI 1.37 to 1.72) ethnic groups had higher risk of any cardiovascular/renal complication. CONCLUSIONS: In hospitalised patients with COVID-19, cardiovascular complications or death impacts just under half of all patients, with the highest risk in those of South Asian or Black ethnicity and in patients with cardiometabolic multimorbidity.

Obesity, chronic disease, age, and in-hospital mortality in patients with covid-19: analysis of ISARIC clinical characterisation protocol UK cohort.

BACKGROUND: Although age, obesity and pre-existing chronic diseases are established risk factors for COVID-19 outcomes, their interactions have not been well researched. METHODS: We used data from the Clinical Characterisation Protocol UK (CCP-UK) for Severe Emerging Infection developed by the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC). Patients admitted to hospital with COVID-19 from 6th February to 12th October 2020 were included where there was a coded outcome following hospital admission. Obesity was determined by an assessment from a clinician and chronic disease by medical records. Chronic diseases included: chronic cardiac disease, hypertension, chronic kidney disease, chronic pulmonary disease, diabetes and cancer. Mutually exclusive categories of obesity, with or without chronic disease, were created. Associations with in-hospital mortality were examined across sex and age categories. RESULTS: The analysis included 27,624 women with 6407 (23.2%) in-hospital deaths and 35,065 men with 10,001 (28.5%) in-hospital deaths. The prevalence of chronic disease in women and men was 66.3 and 68.5%, respectively, while that of obesity was 12.9 and 11.1%, respectively. Association of obesity and chronic disease status varied by age (p < 0.001). Under 50 years of age, obesity and chronic disease were associated with in-hospital mortality within 28 days of admission in a dose-response manner, such that patients with both obesity and chronic disease had the highest risk with a hazard ratio (HR) of in-hospital mortality of 2.99 (95% CI: 2.12, 4.21) in men and 2.16 (1.42, 3.26) in women compared to patients without obesity or chronic disease. Between the ages of 50-69 years, obesity and chronic disease remained associated with in-hospital COVID-19 mortality, but survival in those with obesity was similar to those with and without prevalent chronic disease. Beyond the age of 70 years in men and 80 years in women there was no meaningful difference between those with and without obesity and/or chronic disease. CONCLUSION: Obesity and chronic disease are important risk factors for in-hospital mortality in younger age groups, with the combination of chronic disease and obesity being particularly important in those under 50 years of age. These findings have implications for targeted public health interventions, vaccination strategies and in-hospital clinical decision making.

Feasibility of a novel mixed-nutrient supplement in a multimodal prehabilitation intervention for lung cancer patients awaiting surgery: A randomized controlled pilot trial.

OBJECTIVE: To investigate, in lung cancer patients awaiting elective surgery, the feasibility of delivering a novel four-week multimodal prehabilitation intervention and its effects on preoperative functional capacity and health-related quality of life (HRQoL), compared to standard hospital care. METHODS: Adult patients awaiting elective thoracotomy for lung cancer stages I, II or IIIa, were approached to participate in an open-label, randomized controlled trial of two parallel arms: multimodal prehabilitation combining a mixed-nutrient supplement with structured supervised and home-based exercise training, and relaxation-strategies (Prehab) or standard hospital care (Control). Feasibility was assessed based on recruitment and adherence rates to the intervention and study outcome assessment. Functional capacity, measured by the 6-min walk test (6MWT), and HRQoL were measured at baseline and after four weeks (preoperative). RESULTS: Within 5 months, 34 patients were enrolled and randomized (2:1) to Prehab (n = 24; median age = 67 years) or Control (n = 10; median age = 69 years); recruitment rate of 58.6%. The study was interrupted by the COVID-19 pandemic. Adherence to the prescribed intensity of the supervised exercise program was 84.1% (SD 23.1). Self-reported adherence to the home-based exercise program was 88.2% (SD 21) and to the nutritional supplement, 93.2% (SD 14.2). Adherence to patients' preoperative assessment was 82% and 88% in Prehab and Control, respectively. The mean adjusted difference in 4-week preoperative 6MWT between groups was 37.7 m (95% CI, -6.1 to 81.4), p = 0.089. There were no differences in HRQoL between groups. CONCLUSION: Within a preoperative timeframe, it was feasible to deliver this novel multimodal prehabilitation intervention in lung cancer patients awaiting surgery.

Association Between Accelerometer-Assessed Physical Activity and Severity of COVID-19 in UK Biobank.

OBJECTIVE: To quantify the association between accelerometer-assessed physical activity and coronavirus disease 2019 (COVID-19) outcomes. METHODS: Data from 82,253 UK Biobank participants with accelerometer data (measured 2013-2015), complete covariate data, and linked COVID-19 data from March 16, 2020, to March 16, 2021, were included. Two outcomes were investigated: severe COVID-19 (positive test result from in-hospital setting or COVID-19 as primary cause of death) and nonsevere COVID-19 (positive test result from community setting). Logistic regressions were used to assess associations with moderate to vigorous physical activity (MVPA), total activity, and intensity gradient. A higher intensity gradient indicates a higher proportion of vigorous activity. RESULTS: Average MVPA was 48.1 (32.7) min/d. Physical activity was associated with lower odds of severe COVID-19 (adjusted odds ratio per standard deviation increase: MVPA, 0.75 [95% CI, 0.67 to 0.85]; total, 0.83 [0.74 to 0.92]; intensity, 0.77 [0.70 to 0.86]), with stronger associations in women (MVPA, 0.63 [0.52 to 0.77]; total, 0.76 [0.64 to 0.90]; intensity, 0.63 [0.53 to 0.74]) than in men (MVPA, 0.84 [0.73 to 0.97]; total, 0.88 [0.77 to 1.01]; intensity, 0.88 [0.77 to 1.00]). In contrast, when mutually adjusted, total activity was associated with higher odds of a nonsevere infection (1.10 [1.04 to 1.16]), whereas the intensity gradient was associated with lower odds (0.91 [0.86 to 0.97]). CONCLUSION: Odds of severe COVID-19 were approximately 25% lower per standard deviation (∼30 min/d) MVPA. A greater proportion of vigorous activity was associated with lower odds of severe and nonsevere infections. The association between total activity and higher odds of a nonsevere infection may be through greater community engagement and thus more exposure to the virus. Results support calls for public health messaging highlighting the potential of MVPA for reducing the odds of severe COVID-19.

Obesity, Ethnicity, and Risk of Critical Care, Mechanical Ventilation, and Mortality in Patients Admitted to Hospital with COVID-19: Analysis of the ISARIC CCP-UK Cohort.

OBJECTIVE: The aim of this study was to investigate the association of obesity with in-hospital coronavirus disease 2019 (COVID-19) outcomes in different ethnic groups. METHODS: Patients admitted to hospital with COVID-19 in the United Kingdom through the Clinical Characterisation Protocol UK (CCP-UK) developed by the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) were included from February 6 to October 12, 2020. Ethnicity was classified as White, South Asian, Black, and other minority ethnic groups. Outcomes were admission to critical care, mechanical ventilation, and in-hospital mortality, adjusted for age, sex, and chronic diseases. RESULTS: Of the participants included, 54,254 (age = 76 years; 45.0% women) were White, 3,728 (57 years; 41.1% women) were South Asian, 2,523 (58 years; 44.9% women) were Black, and 5,427 (61 years; 40.8% women) were other ethnicities. Obesity was associated with all outcomes in all ethnic groups, with associations strongest for black ethnicities. When stratified by ethnicity and obesity status, the odds ratios for admission to critical care, mechanical ventilation, and mortality in black ethnicities with obesity were 3.91 (3.13-4.88), 5.03 (3.94-6.63), and 1.93 (1.49-2.51), respectively, compared with White ethnicities without obesity. CONCLUSIONS: Obesity was associated with an elevated risk of in-hospital COVID-19 outcomes in all ethnic groups, with associations strongest in Black ethnicities.

Challenges and opportunities for cardiology nursing in 2020: ‘Year of the Nurse and Midwife’, ‘Year of COVID-19’ or both?

We are now over halfway through the ‘Year of the Nurse and Midwife’. This month, Claire Lawson, BANCC council member, reflects on what this looks like for cardiology nurses during the COVID-19 crisis.