Publications by authors named "David Jenkins"

730 Publications

Glycemic Index, Glycemic Load, and Cardiovascular Disease and Mortality.

N Engl J Med 2021 Feb 24. Epub 2021 Feb 24.

From the Departments of Nutritional Sciences and Medicine, Temerty Faculty of Medicine, University of Toronto (D.J.A.J.), and Li Ka Shing Knowledge Institute, St. Michael's Hospital Toronto (D.J.A.J., K.S.), Toronto, the Population Health Research Institute (M.D., S.I.B., K.T., S.Y.) and Department of Health Research Methods, Evidence, and Impact (A.M., S.I.B.), McMaster University, and McMaster University and Hamilton Health Sciences (S.R.), Hamilton, ON, Faculté de Pharmacie, Université Laval, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.P.), the Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa (A.P.), and the Department of Medicine, Queen's University, Kingston, ON (K. Yeates) - all in Canada; the Madras Diabetes Research Foundation, Chennai (V.M.), and St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore (S.S.) - both in India; the International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo (A.A.); Estudios Clínicos Latino América, Rosario, Santa Fe, Argentina (R.D.); the Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, and Sahlgrenska University Hospital, Gothenburg, Sweden (A.R.); Universidad de la Frontera, Temuco, Chile (F.L.); the Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia (P.L.-J.); the Medical Research and Biometrics Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing (W.L., X.L.); the Department of Internal Medicine, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey (A.O.); the Institute for Community and Public Health, Birzeit University, Birzeit, Palestine (R.K.); Advocate Research Institute, Advocate Health Care, Downers Grove, IL (R.K.); Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran (N.M.); the Department of Cardiac Sciences, King Fahad Cardiac Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia (K.F.A.); the Department of Physiology, University of Zimbabwe College of Health Sciences, Harare (J.C.); Hatta Hospital, Dubai Medical College, Dubai Health Authority, Dubai, United Arab Emirates (A.H.Y.); the Department of Community Health Sciences and Medicine, Aga Khan University, Pakistan (R.I.); Universiti Teknologi MARA, Sungai Buloh, and UCSI University, Selangor (K. Yusoff), and the Department of Community Health, University Kebangsaan Malaysia Medical Center, Kuala Lumpur (N.I.) - both in Malaysia; the Department of Social Medicine, Wroclaw Medical University, Wroclaw, Poland (K.Z.); and the School of Life Sciences, Independent University, Dhaka, Bangladesh (R.Y.).

Background: Most data regarding the association between the glycemic index and cardiovascular disease come from high-income Western populations, with little information from non-Western countries with low or middle incomes. To fill this gap, data are needed from a large, geographically diverse population.

Methods: This analysis includes 137,851 participants between the ages of 35 and 70 years living on five continents, with a median follow-up of 9.5 years. We used country-specific food-frequency questionnaires to determine dietary intake and estimated the glycemic index and glycemic load on the basis of the consumption of seven categories of carbohydrate foods. We calculated hazard ratios using multivariable Cox frailty models. The primary outcome was a composite of a major cardiovascular event (cardiovascular death, nonfatal myocardial infarction, stroke, and heart failure) or death from any cause.

Results: In the study population, 8780 deaths and 8252 major cardiovascular events occurred during the follow-up period. After performing extensive adjustments comparing the lowest and highest glycemic-index quintiles, we found that a diet with a high glycemic index was associated with an increased risk of a major cardiovascular event or death, both among participants with preexisting cardiovascular disease (hazard ratio, 1.51; 95% confidence interval [CI], 1.25 to 1.82) and among those without such disease (hazard ratio, 1.21; 95% CI, 1.11 to 1.34). Among the components of the primary outcome, a high glycemic index was also associated with an increased risk of death from cardiovascular causes. The results with respect to glycemic load were similar to the findings regarding the glycemic index among the participants with cardiovascular disease at baseline, but the association was not significant among those without preexisting cardiovascular disease.

Conclusions: In this study, a diet with a high glycemic index was associated with an increased risk of cardiovascular disease and death. (Funded by the Population Health Research Institute and others.).
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http://dx.doi.org/10.1056/NEJMoa2007123DOI Listing
February 2021

Estimating the causal effect of BMI on mortality risk in people with heart disease, diabetes and cancer using Mendelian randomization.

Int J Cardiol 2021 Feb 14. Epub 2021 Feb 14.

Division of Endocrinology, Diabetes & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Oxford Rd, Manchester M13 9PL, UK; Diabetes, Endocrinology and Metabolism Centre, Peter Mount Building, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester M13 0HY, UK.

Background: Observational data have reported that being overweight or obese, compared to being normal weight, is associated with a lower risk for death - the "obesity paradox". We used Mendelian randomization (MR) to estimate causal effects of body mass index (BMI) on mortality risks in people with coronary heart disease (CHD), type 2 diabetes mellitus (T2DM) or malignancy in whom this paradox has been often reported.

Methods: We studied 457,746 White British UK Biobank participants including three subgroups with T2DM (n = 19,737), CHD (n = 21,925) or cancer (n = 42,612) at baseline and used multivariable-adjusted Cox models and MR approaches to describe relationships between BMI and mortality risk.

Results: Observational Cox models showed J-shaped relationships between BMI and mortality risk including within disease subgroups in which the BMI values associated with minimum mortality risk were within overweight/obese ranges (26.5-32.5 kg/m). In all participants, MR analyses showed a positive linear causal effect of BMI on mortality risk (HR for mortality per unit higher BMI: 1.05; 95% CI: 1.03-1.08), also evident in people with CHD (HR: 1.08; 95% CI: 1.01-1.14). Point estimates for hazard ratios across all BMI values in participants with T2DM and cancer were consistent with overall positive linear effects but confidence intervals included the null.

Conclusion: These data support the idea that population efforts to promote intentional weight loss towards the normal BMI range would reduce, not enhance, mortality risk in the general population including, importantly, individuals with CHD.
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http://dx.doi.org/10.1016/j.ijcard.2021.02.027DOI Listing
February 2021

Associations of cereal grains intake with cardiovascular disease and mortality across 21 countries in Prospective Urban and Rural Epidemiology study: prospective cohort study.

BMJ 2021 02 3;372:m4948. Epub 2021 Feb 3.

Population Health Research Institute (PHRI), McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada.

Objective: To evaluate the association between intakes of refined grains, whole grains, and white rice with cardiovascular disease, total mortality, blood lipids, and blood pressure in the Prospective Urban and Rural Epidemiology (PURE) study.

Design: Prospective cohort study.

Setting: PURE study in 21 countries.

Participants: 148 858 participants with median follow-up of 9.5 years.

Exposures: Country specific validated food frequency questionnaires were used to assess intakes of refined grains, whole grains, and white rice.

Main Outcome Measure: Composite of mortality or major cardiovascular events (defined as death from cardiovascular causes, non-fatal myocardial infarction, stroke, or heart failure). Hazard ratios were estimated for associations of grain intakes with mortality, major cardiovascular events, and their composite by using multivariable Cox frailty models with random intercepts to account for clustering by centre.

Results: Analyses were based on 137 130 participants after exclusion of those with baseline cardiovascular disease. During follow-up, 9.2% (n=12 668) of these participants had a composite outcome event. The highest category of intake of refined grains (≥350 g/day or about 7 servings/day) was associated with higher risk of total mortality (hazard ratio 1.27, 95% confidence interval 1.11 to 1.46; P for trend=0.004), major cardiovascular disease events (1.33, 1.16 to 1.52; P for trend<0.001), and their composite (1.28, 1.15 to 1.42; P for trend<0.001) compared with the lowest category of intake (<50 g/day). Higher intakes of refined grains were associated with higher systolic blood pressure. No significant associations were found between intakes of whole grains or white rice and health outcomes.

Conclusion: High intake of refined grains was associated with higher risk of mortality and major cardiovascular disease events. Globally, lower consumption of refined grains should be considered.
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http://dx.doi.org/10.1136/bmj.m4948DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856570PMC
February 2021

A scoping review of causal methods enabling predictions under hypothetical interventions.

Diagn Progn Res 2021 Feb 4;5(1). Epub 2021 Feb 4.

Division of Informatics, Imaging and Data Science, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

Background: The methods with which prediction models are usually developed mean that neither the parameters nor the predictions should be interpreted causally. For many applications, this is perfectly acceptable. However, when prediction models are used to support decision making, there is often a need for predicting outcomes under hypothetical interventions.

Aims: We aimed to identify published methods for developing and validating prediction models that enable risk estimation of outcomes under hypothetical interventions, utilizing causal inference. We aimed to identify the main methodological approaches, their underlying assumptions, targeted estimands, and potential pitfalls and challenges with using the method. Finally, we aimed to highlight unresolved methodological challenges.

Methods: We systematically reviewed literature published by December 2019, considering papers in the health domain that used causal considerations to enable prediction models to be used for predictions under hypothetical interventions. We included both methodologies proposed in statistical/machine learning literature and methodologies used in applied studies.

Results: We identified 4919 papers through database searches and a further 115 papers through manual searches. Of these, 87 papers were retained for full-text screening, of which 13 were selected for inclusion. We found papers from both the statistical and the machine learning literature. Most of the identified methods for causal inference from observational data were based on marginal structural models and g-estimation.

Conclusions: There exist two broad methodological approaches for allowing prediction under hypothetical intervention into clinical prediction models: (1) enriching prediction models derived from observational studies with estimated causal effects from clinical trials and meta-analyses and (2) estimating prediction models and causal effects directly from observational data. These methods require extending to dynamic treatment regimes, and consideration of multiple interventions to operationalise a clinical decision support system. Techniques for validating 'causal prediction models' are still in their infancy.
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http://dx.doi.org/10.1186/s41512-021-00092-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7860039PMC
February 2021

Supplemental Vitamins and Minerals for Cardiovascular Disease Prevention and Treatment: JACC Focus Seminar.

J Am Coll Cardiol 2021 Feb;77(4):423-436

Department of Nutritional Sciences, Temerty, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Toronto 3D Knowledge Synthesis and Clinical Trials Unit, St. Michael's Hospital, Toronto, Ontario, Canada; Clinical Nutrition Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Ontario, Canada; Division of Endocrinology and Metabolism, St. Michael's Hospital, Toronto, Ontario, Canada.

This is an update of the previous 2018 systematic review and meta-analysis of vitamin and mineral supplementation on cardiovascular disease outcomes and all-cause mortality. New randomized controlled trials and meta-analyses were identified by searching the Cochrane library, Medline, and Embase, and data were analyzed using random effects models and classified by the Grading of Recommendations Assessment Development and Evaluation approach. This updated review shows similar findings to the previous report for preventive benefits from both folic acid and B vitamins for stroke and has been graded with moderate quality. No effect was seen for the commonly used multivitamins, vitamin D, calcium, and vitamin C, and an increased risk was seen with niacin (with statin) for all-cause mortality. Conclusive evidence for the benefit of supplements across different dietary backgrounds, when the nutrient is sufficient, has not been demonstrated.
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http://dx.doi.org/10.1016/j.jacc.2020.09.619DOI Listing
February 2021

Co-administration of viscous fiber, Salba-chia and ginseng on glycemic management in type 2 diabetes: a double-blind randomized controlled trial.

Eur J Nutr 2021 Jan 24. Epub 2021 Jan 24.

Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

Purpose: Viscous dietary fiber, functional seeds and ginseng roots have individually been proposed for the management of diabetes. We explored whether their co-administration would improve glycemic control in type 2 diabetes beyond conventional therapy.

Methods: In a randomized, double-blind, controlled trial conducted at two academic centers (Toronto, Canada and Zagreb, Croatia), individuals with type 2 diabetes were assigned to either an active intervention (10 g viscous fiber, 60 g white chia seeds, 1.5 g American and 0.75 g Korean red ginseng extracts), or energy and fiber-matched control (53 g oat bran, 25 g inulin, 25 g maltodextrose and 2.25 g wheat bran) intervention for 24 weeks, while on conventional standard of care. The prespecified primary endpoint was end difference at week 24 in HbA1c, following an intent-to-treat analysis adjusted for center and baseline.

Results: Between January 2016 and April 2018, 104 participants (60M:44F; mean ± SEM age 59 ± 0.8 years; BMI 29.0 ± 0.4 kg/m; HbA1c 7.0 ± 0.6%) managed with antihyperglycemic agent(s) (n = 98) or lifestyle (n = 6), were randomized (n = 52 test; n = 52 control). At week 24, HbA1c levels were 0.27 ± 0.1% lower on test compared to control (p = 0.03). There was a tendency towards an interaction by baseline HbA1c (p = 0.07), in which a greater reduction was seen in participants with baseline HbA1c > 7% vs ≤ 7% (- 0.56 ± 0.2% vs 0.03 ± 0.2%). Diet and body weight remained unchanged. The interventions were well tolerated with no related adverse events and with high retention rate of 84%.

Conclusions: Co-administration of selected dietary and herbal therapies was well-tolerated and may provide greater glycemic control as add-on therapy in type 2 diabetes. Registration: Clinicaltrials.gov NCT02553382 (registered on September 17, 2015).
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http://dx.doi.org/10.1007/s00394-020-02434-7DOI Listing
January 2021

Comparing tuberculosis gene signatures in malnourished individuals using the TBSignatureProfiler.

BMC Infect Dis 2021 Jan 22;21(1):106. Epub 2021 Jan 22.

Boston Medical Center, Boston, MA, USA.

Background: Gene expression signatures have been used as biomarkers of tuberculosis (TB) risk and outcomes. Platforms are needed to simplify access to these signatures and determine their validity in the setting of comorbidities. We developed a computational profiling platform of TB signature gene sets and characterized the diagnostic ability of existing signature gene sets to differentiate active TB from LTBI in the setting of malnutrition.

Methods: We curated 45 existing TB-related signature gene sets and developed our TBSignatureProfiler software toolkit that estimates gene set activity using multiple enrichment methods and allows visualization of single- and multi-pathway results. The TBSignatureProfiler software is available through Bioconductor and on GitHub. For evaluation in malnutrition, we used whole blood gene expression profiling from 23 severely malnourished Indian individuals with TB and 15 severely malnourished household contacts with latent TB infection (LTBI). Severe malnutrition was defined as body mass index (BMI) < 16 kg/m2 in adults and based on weight-for-height Z scores in children < 18 years. Gene expression was measured using RNA-sequencing.

Results: The comparison and visualization functions from the TBSignatureProfiler showed that TB gene sets performed well in malnourished individuals; 40 gene sets had statistically significant discriminative power for differentiating TB from LTBI, with area under the curve ranging from 0.662-0.989. Three gene sets were not significantly predictive.

Conclusion: Our TBSignatureProfiler is a highly effective and user-friendly platform for applying and comparing published TB signature gene sets. Using this platform, we found that existing gene sets for TB function effectively in the setting of malnutrition, although differences in gene set applicability exist. RNA-sequencing gene sets should consider comorbidities and potential effects on diagnostic performance.
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http://dx.doi.org/10.1186/s12879-020-05598-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821401PMC
January 2021

Drivers of Broad-Spectrum Antibiotic Overuse across Diverse Hospital Contexts-A Qualitative Study of Prescribers in the UK, Sri Lanka and South Africa.

Antibiotics (Basel) 2021 Jan 19;10(1). Epub 2021 Jan 19.

Department of Neuroscience, Psychology and Behaviour, University of Leicester, Leicester LE1 7RH, UK.

Antimicrobial stewardship programs focus on reducing overuse of broad-spectrum antibiotics (BSAs), primarily through interventions to change prescribing behavior. This study aims to identify multi-level influences on BSA overuse across diverse high and low income, and public and private, healthcare contexts. Semi-structured interviews were conducted with 46 prescribers from hospitals in the UK, Sri Lanka, and South Africa, including public and private providers. Interviews explored decision making about prescribing BSAs, drivers of the use of BSAs, and benefits of BSAs to various stakeholders, and were analyzed using a constant comparative approach. Analysis identified drivers of BSA overuse at the individual, social and structural levels. Structural drivers of overuse varied significantly across contexts and included: system-level factors generating tensions with stewardship goals; limited material resources within hospitals; and patient poverty, lack of infrastructure and resources in local communities. Antimicrobial stewardship needs to encompass efforts to reduce the reliance on BSAs as a solution to context-specific structural conditions.
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http://dx.doi.org/10.3390/antibiotics10010094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835907PMC
January 2021

Nut consumption and type 2 diabetes risk: a systematic review and meta-analysis of observational studies.

Am J Clin Nutr 2021 Jan 20. Epub 2021 Jan 20.

Universitat Rovira i Virgili, Department of Biochemistry and Biotechnology, Unit of Human Nutrition, Reus, Spain.

Background: Previous meta-analyses, with some methodological controversies, have assessed the relation between nut consumption and type 2 diabetes (T2D) risk and pointed to contradictory results, making desirable the performance of an updated meta-analysis.

Objectives: We aimed to systematically review and meta-analyze all the published studies investigating the relations of total nuts and different types of nuts-i.e., walnuts, peanuts, peanut butter, and total tree nuts-with the prevalence and incidence of T2D.

Methods: A systematic search was conducted in the PubMed and Cochrane databases through 12 August, 2020. The inverse variance method with fixed-effect models was used to pool data across studies, expressed as risk ratios (RRs) or ORs and 95% CIs for prospective cohort and cross-sectional studies, respectively. The Cochran Q test and I2 statistics were used to test and quantify heterogeneity, respectively. Dose-response meta-analysis was also conducted.

Results: Eight studies (5 prospective and 3 cross-sectional) were included in the quantitative synthesis. Meta-analyses of cross-sectional studies and prospective cohort studies, comparing the highest with the lowest categories, revealed a nonsignificant association between total nut consumption and T2D. Meta-analyses of prospective cohort studies showed an inverse association between peanut butter consumption and T2D incidence (RR: 0.87; 95% CI: 0.77, 0.98; I2 = 50.6%; Pheterogeneity = 0.16), whereas no association was observed between peanuts or tree nuts and T2D. There was no evidence of a linear dose-response or nonlinear dose-response gradient for total nut and peanut consumption in prospective cohort studies. The certainty of the evidence using NutriGrade was very low for all the exposures.

Conclusions: Current results do not demonstrate an association of total nut, peanut, or tree nut consumption with T2D. Peanut butter consumption may be inversely associated with this disease.This review protocol was registered at www.crd.york.ac.uk/prospero/ as CRD42020149756.
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http://dx.doi.org/10.1093/ajcn/nqaa358DOI Listing
January 2021

Lower-Body Aquatic Training Prescription for Athletes.

J Strength Cond Res 2021 03;35(3):859-869

School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland, Australia.

Abstract: Holmberg, PM, Gorman, AD, Jenkins, DG, and Kelly, VG. Lower-body aquatic training prescription for athletes. J Strength Cond Res 35(3): 859-869, 2021-Traditionally prescribed to manage various medical ailments and promote healing, aquatic immersion may provide a favorable environment to undertake preparatory training tasks given its profound biological effects that extend across most homeostatic systems. In addition to understanding these effects, which are related to the fundamental principles of hydrodynamics, there is a need to consider the acute physiomechanical responses to alterations of key constraints associated with particular preparatory tasks. Evidence suggests that the manipulation of different constraints during aquatic training can enable a unique setting to complement, supplement, or supplant land-based programming to maintain or improve physical capacities in athletes without exacerbating physiological stress. Thus, this article focuses on the interplay of constraints and their associated outcomes to provide information that can be used to program lower-body aquatic training for athletes. In addition, the aim of the article is to summarize the literature on aquatic training to highlight the outcomes that occur when certain constraints are manipulated.
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http://dx.doi.org/10.1519/JSC.0000000000003925DOI Listing
March 2021

Adherence to Mediterranean Diet, Physical Activity and Survival after Prostate Cancer Diagnosis.

Nutrients 2021 Jan 16;13(1). Epub 2021 Jan 16.

Unit of Cancer Epidemiology, Centro di Riferimento Oncologico di Aviano IRCCS, via F. Gallini 2, 33081 Aviano, Italy.

Despite the considerable number of studies investigating the Mediterranean diet in prostate cancer (PCa) etiology, very few focused on cancer survival. We assessed the pre-diagnostic diet and physical activity in a cohort of 777 men with PCa diagnosed between 1995 and 2002 in north-eastern Italy; adherence to the Mediterranean diet was evaluated through the Mediterranean Diet Score (MDS). Hazard ratios (HR) of death with confidence intervals (CI) were estimated using the Cox model, adjusting for potential confounders. During 10 years of follow-up, 208 patients (26.8%) died, 75 (9.7%) due to PCa. Patients reporting MDS ≥ 5 showed a higher overall survival than those with MDS < 5 (HR = 0.74; 95% CI: 0.56-0.99). Although high physical activity was not significantly associated with overall survival (HR = 0.79; 95% CI: 0.59-1.07), the HR for all-cause death was the lowest (HR = 0.58; 95% CI: 0.38-0.90) for men reporting MDS ≥ 5 and high physical activity compared to those reporting MDS < 5 and low/moderate physical activity. No association emerged for PCa specific survival. Study findings support the beneficial impact of pre-diagnostic adherence to the Mediterranean diet and physical activity on overall survival; they are mainly driven by risk reduction in non-prostate cancer mortality, which however accounts for about 80% of death in men with PCa.
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http://dx.doi.org/10.3390/nu13010243DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7829941PMC
January 2021

Continual updating and monitoring of clinical prediction models: time for dynamic prediction systems?

Diagn Progn Res 2021 Jan 11;5(1). Epub 2021 Jan 11.

Division of Informatics, Imaging and Data Science, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

Clinical prediction models (CPMs) have become fundamental for risk stratification across healthcare. The CPM pipeline (development, validation, deployment, and impact assessment) is commonly viewed as a one-time activity, with model updating rarely considered and done in a somewhat ad hoc manner. This fails to address the fact that the performance of a CPM worsens over time as natural changes in populations and care pathways occur. CPMs need constant surveillance to maintain adequate predictive performance. Rather than reactively updating a developed CPM once evidence of deteriorated performance accumulates, it is possible to proactively adapt CPMs whenever new data becomes available. Approaches for validation then need to be changed accordingly, making validation a continuous rather than a discrete effort. As such, "living" (dynamic) CPMs represent a paradigm shift, where the analytical methods dynamically generate updated versions of a model through time; one then needs to validate the system rather than each subsequent model revision.
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http://dx.doi.org/10.1186/s41512-020-00090-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7797885PMC
January 2021

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications.

Nutrients 2020 Dec 31;13(1). Epub 2020 Dec 31.

Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori-IRCCS "Fondazione G. Pascale", 80131 Napoli, Italy.

Healthy lifestyles are associated with better health-related quality of life (HRQoL), favorable prognosis and lower mortality in breast cancer (BC) survivors. We investigated changes in HRQoL after a 12-month lifestyle modification program in 227 BC survivors participating in DEDiCa trial (Mediterranean diet, exercise, vitamin D). HRQoL was evaluated through validated questionnaires: EQ-5D-3L, EORTC-QLQ-C30 and EORTC QLQ-BR23. Baseline changes were tested using analysis of variance. Multiple regression analyses were performed to assess treatment effects on HRQoL. Increases were observed in global health status ( < 0.001), physical ( = 0.003), role ( = 0.002) and social functioning ( < 0.001), body image ( < 0.001), future perspective ( < 0.001), well-being ( = 0.001), and reductions in fatigue ( < 0.001), nausea and vomiting ( = 0.015), dyspnea ( = 0.001), constipation ( = 0.049), financial problems ( = 0.012), sexual functioning ( = 0.025), systematic therapy side effects ( < 0.001) and breast symptoms ( = 0.004). Multiple regression analyses found inverse associations between changes in BMI and global health status ( = 0.048) and between serum 25(OH)D levels and breast symptoms ( = 0.002). A healthy lifestyle treatment of traditional Mediterranean diet and exercise may impact positively on HRQoL in BC survivors possibly through reductions in body weight while vitamin D sufficiency may improve BC-related symptoms. These findings are relevant to BC survivors whose lower HRQoL negatively affects treatment compliance and disease outcomes.
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http://dx.doi.org/10.3390/nu13010136DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824271PMC
December 2020

No cases of asymptomatic SARS-CoV-2 infection among healthcare staff in a city under lockdown restrictions: lessons to inform 'Operation Moonshot'.

J Public Health (Oxf) 2020 Dec 26. Epub 2020 Dec 26.

Department of Respiratory Sciences, University of Leicester, Leicester LE1 7RH, UK.

Background: Leicester was the first city in the UK to have 'local lockdown' measures imposed in response to high community rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission. As part of this response, a directive was issued by NHS England to offer testing of asymptomatic healthcare workers (HCWs) at University Hospitals of Leicester NHS Trust (UHL) for SARS-CoV-2 infection.

Methods: Between 20 July and 14 August 2020, we invited all HCWs at UHL to attend for SARS-CoV-2 testing by nucleic acid amplification (NAAT). We combined the result of this assay with demographic information from the electronic staff record.

Results: A total of 1150 staff (~8% of the workforce) volunteered. The median age was 46 years (IQR 34-55), 972 (84.5%) were female; 234 (20.4%) were of South Asian and 58 (5.0%) of Black ethnicity; 564 (49.0%) were nurses/healthcare assistants. We found no cases of asymptomatic infection. In comparison, average community test positivity rate in Leicester city was 2.6%.

Conclusions: Within the context of local lockdowns due to high community transmission rates, voluntary testing of asymptomatic staff has low uptake and low yield and thus its premise and cost-effectiveness should be re-considered.
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http://dx.doi.org/10.1093/pubmed/fdaa237DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7798961PMC
December 2020

Classroom-Based Mindfulness Training Reduces Anxiety in Adolescents: Acceptability and Effectiveness of a Cluster-Randomized Pilot Study.

J Restor Med 2020 20;10(1). Epub 2020 Jul 20.

Department of Neurology, Oregon Health & Science University (OHSU), 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.

Objective: Many high school students experience a high degree of anxiety and perceived stress. This study examined whether a classroom-based mindfulness program or a wellness program were acceptable and effective as anxiety and stress reduction interventions based on students' self-reports.

Design Setting And Participants: Thirteen health education classes (=285 students, aged 14-16 years) were randomized by classroom to one of three conditions: mindfulness, wellness, or usual health class only (passive control/ waitlist), for 8 weeks.

Outcomes: Pre- and post-intervention scores compared self-reported measures of depression, anxiety and stress.

Results: Complete data were available from nine classes (=202 students). Post-intervention anxiety scores were reduced in students who received the mindfulness intervention compared to those who received only their usual health class (β=-0.07, SE=0.03, ≤0.001; 95% CI=-0.12, -0.02). No significant between group differences were found for depression or stress (>0.4). Students' satisfaction with the mindfulness intervention they received withstood baseline credibility and expectancy effects: =0.21, =67, =0.17 for credibility; =-0.001, =67, 0.99 for expectancy. However, students' satisfaction with the wellness intervention they received was positively correlated with their pre-intervention expectations, =0.42, =47, >0.001. Fifty-two percent of the 68 students assigned to mindfulness (=35) used the iPad app for mindfulness home practice at least once; of those, 10% used it 10 or more times.

Conclusion: Eight weeks of classroom-based mindfulness, with limited home practice, reduced self-reported anxiety compared to usual health class, and withstood baseline expectancy effects in this group of high school students, a majority who come from high income families.

Clinical Implications: School- or community-based mindfulness may be an appropriate recommendation for adolescents who experience anxiety.
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http://dx.doi.org/10.14200/jrm.2020.0101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755132PMC
July 2020

ERS Statement on Chronic Thromboembolic Pulmonary Hypertension.

Eur Respir J 2020 Dec 17. Epub 2020 Dec 17.

Université Paris-Saclay; Inserm UMR_S 999, Service de Pneumologie, Hôpital Bicêtre (AP-HP), Le Kremlin-Bicêtre, France.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism, either symptomatic or not. The occlusion of proximal pulmonary arteries by fibrotic intravascular material, in combination with a secondary microvasculopathy of vessels less than 500 µm, leads to increased pulmonary vascular resistance and progressive right heart failure. The mechanism responsible for the transformation of red clots into fibrotic material remnants has not yet been elucidated. In patients with pulmonary hypertension, the diagnosis is suspected when a ventilation/perfusion lung scan shows mismatched perfusion defects and confirmed by right heart catheterisation and vascular imaging. Today, in addition to lifelong anticoagulation, treatment modalities include surgery, angioplasty and medical treatment according to the localisation and characteristics of the lesions.This Statement outlines a review of the literature and current practice concerning diagnosis and management of CTEPH. It covers the definitions, diagnosis, epidemiology, follow up after acute pulmonary embolism, pathophysiology, treatment by pulmonary endarterectomy, balloon pulmonary angioplasty, drugs and their combination, rehabilitation and new lines of research in CTEPH.It represents the first collaboration of the European Respiratory Society (ERS), the International CTEPH Association (ICA) and the European Reference Network (ERN)-Lung in the pulmonary hypertension domain. The Statement summarises current knowledge but does not make formal recommendations for clinical practice.
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http://dx.doi.org/10.1183/13993003.02828-2020DOI Listing
December 2020

Inside the Belly of a Beast: Individualizing Nutrition for Young, Professional Male Rugby League Players: A Review.

Int J Sport Nutr Exerc Metab 2020 Dec 15:1-17. Epub 2020 Dec 15.

The University of Queensland.

Professional rugby league (RL) football is a contact sport involving repeated collisions and high-intensity efforts; both training and competition involve high energy expenditure. The present review summarizes and critiques the available literature relating the physiological demands of RL to nutritional requirements and considers potential ergogenic supplements that could improve players' physical capacity, health, and recovery during the preparatory and competition phases of a season. Although there may not be enough data to provide RL-specific recommendations, the available data suggest that players may require approximately 6-8 g·kg-1·day-1 carbohydrate, 1.6-2.6 g·kg-1·day-1 protein, and 0.7-2.2 g·kg-1·day-1 fat, provided that the latter also falls within 20-35% of total energy intake. Competition nutrition should maximize glycogen availability by consuming 1-4 g/kg carbohydrate (∼80-320 g) plus 0.25 g/kg (∼20-30 g) protein, 1-4 hr preexercise for 80-120 kg players. Carbohydrate intakes of approximately 80-180 g (1.0-1.5 g/kg) plus 20-67 g protein (0.25-0.55 g/kg) 0-2 hr postexercise will optimize glycogen resynthesis and muscle protein synthesis. Supplements that potentially improve performance, recovery, and adaptation include low to moderate dosages of caffeine (3-6 mg/kg) and ∼300 mg polyphenols consumed ∼1 hr preexercise, creatine monohydrate "loading" (0.3 g·kg-1·day-1) and/or maintenance (3-5 g/day), and beta-alanine (65-80 mg·kg-1·day-1). Future research should quantify energy expenditures in young, professional male RL players before constructing recommendations.
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http://dx.doi.org/10.1123/ijsnem.2019-0321DOI Listing
December 2020

Comparison of training responses and performance adaptations in endurance-trained men and women performing high-intensity interval training.

J Sports Sci 2020 Dec 15:1-11. Epub 2020 Dec 15.

School of Human Movement and Nutrition Sciences, The University of Queensland , Brisbane, Australia.

The efficacy of high-intensity interval training (HIIT) to elicit physiological and performance adaptations in endurance athletes has been established in men and to a lesser extent in women. This study compared lactate threshold (LT) and performance adaptations to HIIT between men and women. Nine male and eight female cyclists and triathletes completed trials to determine their LT and 40 km cycling performance before, and after 10 HIIT sessions. Each HIIT session consisted of 10 × 90 s at peak power output, separated by 60 s active recovery. Main effects showed that HIIT improved peak power output (p = 0.05; ES: 0.2); relative peak power output (W.kg; p = 0.04; ES: 0.3 and W.kg; p = 0.04; ES: 0.3); incremental time to fatigue (p = 0.01; ES: 0.4), time trial time (p < 0.001; ES: 0.7) and time trial power output (p < 0.001; ES: 0.7) equally in both sexes. Although LT power output explained 77% of the performance improvement in women, no variable explained the performance improvement in men, suggesting another mechanism(s) was involved. Although HIIT improved cycling performance in men and women, it might not be appropriate to evaluate the effectiveness of HIIT using the same variables for both sexes.
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http://dx.doi.org/10.1080/02640414.2020.1853960DOI Listing
December 2020

Dietary glycemic index, glycemic load, and chronic disease: an umbrella review of meta-analyses of prospective cohort studies.

Crit Rev Food Sci Nutr 2020 Dec 1:1-10. Epub 2020 Dec 1.

Department of Community Nutrition, School of Nutritional Science and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.

We aimed to present a comprehensive review of the association of dietary glycemic index (GI) and load (GL) with the risk of chronic disease. Published meta-analyses of prospective observational studies evaluating the association of dietary GI and GL with risk of chronic disease were identified by a search in PubMed and Scopus to November, 2020. Summary relative risks (SRRs) were recalculated using random-effects models. The certainty of evidence was rated by the GRADE approach. Eighteen meta-analyses of prospective cohort studies, reporting 19 SRRs for dietary GI and 17 SRRs for dietary GL were identified. There was a positive association between dietary GI and the risk of type 2 diabetes, coronary heart disease, and colorectal, breast, and bladder cancers, as well as between dietary GL and the risk of coronary heart disease, type 2 diabetes, and stroke. With regard to cancers at other sites, there was no significant association. The certainty of evidence ranged from very low to low. Although by GRADE classification no associations were rated stronger than low, they were classified as one grade higher when the NutriGrade system was used. Further research is needed to add evidence for the relation of dietary GI and GL with cancer risk.
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http://dx.doi.org/10.1080/10408398.2020.1854168DOI Listing
December 2020

A 5-year single-center early experience of heart transplantation from donation after circulatory-determined death donors.

J Heart Lung Transplant 2020 Dec 3;39(12):1463-1475. Epub 2020 Oct 3.

Department of Transplantation, Royal Papworth Hospital NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, United Kingdom. Electronic address:

Background: In an effort to address the increasing demand for heart transplantation within the United Kingdom (UK), we established a clinical program of heart transplantation from donation after circulatory-determined death (DCD) donors in 2015. After 5 years, we report the clinical early outcomes and impact of the program.

Methods: This is a single-center, retrospective, matched, observational cohort study comparing outcomes of hearts transplanted from DCD donors from March 1, 2015 to February 29, 2020 with those from matched donation after brain death (DBD) donors at Royal Papworth Hospital (RPH) (Cambridge, UK). DCD hearts were either retrieved using thoracoabdominal normothermic regional perfusion or the direct procurement and perfusion technique. All DBD hearts were procured using standard cold static storage. The primary outcomes were recipient 30-day and 1-year survival.

Results: During the 5-year study, DCD heart donation increased overall heart transplant activity by 48% (79 for DCD and 164 for DBD). There was no difference in survival at 30 days (97% for DCD vs 99% for DBD, p = 1.00) or 1 year (91% for DCD vs 89% for DBD, p = 0.72). There was no difference in the length of stay in the intensive care unit (7 for DCD vs 6 for DBD days, p = 0.24) or in the hospital (24 for DCD vs 25 for DBD days, p = 0.84).

Conclusions: DCD heart donation increased overall heart transplant activity at RPH by 48%, with no difference in 30-day or 1-year survival in comparison with conventional DBD heart transplantations. DCD heart donation is set to make a dramatic difference in the number of patients who can benefit from heart transplantation.
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http://dx.doi.org/10.1016/j.healun.2020.10.001DOI Listing
December 2020

Demographic and occupational determinants of anti-SARS-CoV-2 IgG seropositivity in hospital staff.

J Public Health (Oxf) 2020 Nov 16. Epub 2020 Nov 16.

Department of Respiratory Sciences, University of Leicester, Leicester LE1 7RH, UK.

Background: Although evidence suggests that demographic characteristics including minority ethnicity increase the risk of infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), it is unclear whether these characteristics, together with occupational factors, influence anti-SARS-CoV-2 IgG seroprevalence in hospital staff.

Methods: We conducted cross-sectional surveillance examining seroprevalence of anti-SARS-CoV-2 IgG amongst staff at University Hospitals of Leicester (UHL) NHS Trust. We quantified seroprevalence stratified by ethnicity, occupation and seniority of practitioner and used logistic regression to examine demographic and occupational factors associated with seropositivity.

Results: A total of 1148/10662 (10.8%) hospital staff members were seropositive. Compared to White staff (seroprevalence 9.1%), seroprevalence was higher in South Asian (12.3%) and Black (21.2%) staff. The occupations and department with the highest seroprevalence were nurses/healthcare assistants (13.7%) and the Emergency Department (ED)/Acute Medicine (17.5%), respectively. Seroprevalence decreased with seniority in medical/nursing practitioners. Minority ethnicity was associated with seropositivity on an adjusted analysis (South Asian: aOR 1.26; 95%CI: 1.07-1.49 and Black: 2.42; 1.90-3.09). Anaesthetics/ICU staff members were less likely to be seropositive than ED/Acute medicine staff (0.41; 0.27-0.61).

Conclusions: Ethnicity and occupational factors, including specialty and seniority, are associated with seropositivity for anti-SARS-Cov-2 IgG. These findings could be used to inform occupational risk assessments for front-line healthcare workers.
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http://dx.doi.org/10.1093/pubmed/fdaa199DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717317PMC
November 2020

The Efficacy of the Lactate Threshold: A Sex-Based Comparison.

J Strength Cond Res 2020 Nov;34(11):3190-3198

School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia.

Hoffmann, SM, Skinner, TL, van Rosendal, SP, Osborne, MA, Emmerton, LM, and Jenkins, DG. The efficacy of the lactate threshold: A sex-based comparison. J Strength Cond Res 34(11): 3190-3198, 2020-The second lactate threshold (LT2) has previously been associated with endurance performance; however, comparisons between sexes are lacking regarding its efficacy. The aim of this study was to compare LT2 between men and women, specifically regarding its (a) relationship with endurance performance and (b) capacity to establish training and competition intensities. Competitive male (mean ± SD: age, 27.7 ± 4.7 years; V[Combining Dot Above]O2max, 59.7 ± 5.2 ml·kg·min; n = 10) and female (mean ± SD: age, 27.3 ± 6.2 years; V[Combining Dot Above]O2max, 54.5 ± 5.3 ml·kg·min; n = 12) cyclists and triathletes completed an incremental cycle trial to volitional fatigue (for determination of V[Combining Dot Above]O2max and LT2 via the modified D-max method), a constant load (±5%) exercise trial of 30 minutes at LT2 power output, and a 40-km cycle time trial. The LT2 significantly correlated with 40-km cycling performance in both men (r = -0.69 to -0.77; p < 0.01-0.05) and women (r = -0.63 to -0.75; p < 0.01-0.05). All men sustained LT2 power output for 30 minutes, compared with 82% of women. Despite LT2 reflecting a similar heart rate, V[Combining Dot Above]O2, and [La] to those elicited during a 40-km time trial in both men and women, power output at LT2 was 6% higher (p < 0.05) than mean time trial power output in women, with no significant difference in men. Based on these findings, sex-specific recommendations have been suggested in regard to the use of LT2 for establishing performance potential, prescribing endurance training intensities and setting 40-km performance intensity.
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http://dx.doi.org/10.1519/JSC.0000000000002654DOI Listing
November 2020

Deprescribing practices for anticonvulsants after benign seizures secondary to high-dose tranexamic acid in a single, large UK cardiothoracic centre.

Eur J Hosp Pharm 2020 11 4;27(6):337-340. Epub 2019 May 4.

Anaesthetics and Intensive Care, Royal Papworth Hospital, Cambridge, UK.

Objective: High-dose tranexamic acid (TXA) can cause seizures in patients who have undergone pulmonary endarterectomy (PTE). Seizures secondary to TXA will resolve once the drug is excreted from the body, and the patients do not have to be on long-term anticonvulsants. The aim of the study is to find out if medication review in the hospital has led to deprescribing of anticonvulsants for TXA-associated seizures on discharge from the critical care unit (CCU) and hospital.

Methods: This is a single-centre retrospective study conducted at a tertiary cardiothoracic hospital between 2012 and 2017. The inclusion criteria consisted of all adult patients who have undergone PTE surgery. Patients who were started on anticonvulsants preoperatively or postoperatively for seizures secondary to organic causes were excluded.

Results: A total of 933 patients underwent PTE from January 2012 to August 2017. 25 patients had TXA-related seizures postoperatively and were started on anticonvulsant therapy, giving an incidence of 2.7%. 15 patients were discharged from the CCU without anticonvulsants. A further three patients had their anticonvulsants deprescribed in the ward before being discharged from the hospital.

Conclusion: Deprescribing of anticonvulsants after benign seizures secondary to high-dose TXA is facilitated by verbal and written handover, which can be improved in our hospital. A detailed handover summary, as well as a discharge letter with clearly defined instructions for drug review, is needed to make deprescribing a more robust process.
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http://dx.doi.org/10.1136/ejhpharm-2018-001844DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856121PMC
November 2020

Selenium, antioxidants, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials.

Am J Clin Nutr 2020 12;112(6):1642-1652

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.

Background: Antioxidants have been promoted for cardiovascular disease (CVD) risk reduction and for the prevention of cancer. Our preliminary analysis suggested that only when selenium was present were antioxidant mixtures associated with reduced all-cause mortality.

Objective: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to determine the effect of selenium supplementation alone and of antioxidant mixtures with or without selenium on the risk of CVD, cancer, and mortality.

Methods: We identified studies using the Cochrane Library, Medline, and Embase for potential CVD outcomes, cancer, and all-cause mortality following selenium supplementation alone or after antioxidant supplement mixtures with and without selenium up to June 5, 2020. RCTs of ≥24 wk were included and data were analyzed using random-effects models and classified by the Grading of Recommendations, Assessment, Development, and Evaluation approach.

Results: The meta-analysis identified 9423 studies, of which 43 were used in the final analysis. Overall, no association of selenium alone or antioxidants was seen with CVD and all-cause mortality. However, a decreased risk with antioxidant mixtures was seen for CVD mortality when selenium was part of the mix (RR: 0.77; 95% CI: 0.62, 0.97; P = 0.02), with no association when selenium was absent. Similarly, when selenium was part of the antioxidant mixture, a decreased risk was seen for all-cause mortality (RR: 0.90; 95% CI: 0.82, 0.98; P = 0.02) as opposed to an increased risk when selenium was absent (RR: 1.09; 95% CI: 1.04, 1.13; P = 0.0002).

Conclusion: The addition of selenium should be considered for supplements containing antioxidant mixtures if they are to be associated with CVD and all-cause mortality risk reduction. This trial was registered at https://www.crd.york.ac.uk/PROSPERO/ as CRD42019138268.
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http://dx.doi.org/10.1093/ajcn/nqaa245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727482PMC
December 2020

Mediterranean diet and quality of life in women treated for breast cancer: A baseline analysis of DEDiCa multicentre trial.

PLoS One 2020 8;15(10):e0239803. Epub 2020 Oct 8.

Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori-IRCCS "Fondazione G. Pascale", Napoli, Italy.

Evidence suggests a beneficial role of the Mediterranean Diet (MedDiet) on health-related quality of life (HRQoL) in healthy subjects. HRQoL is relevant in cancer therapy and disease outcomes, therefore we investigated the association between adherence to the MedDiet and HRQoL in breast cancer survivors participating in the multicentre trial DEDiCa. Diet and HRQoL were assessed at baseline in a subgroup of 309 women enrolled within 12 months of breast cancer diagnosis without metastasis (stages I-III, mean age 52±1 yrs, BMI 27±7 kg/m2). The 14-item PREDIMED questionnaire was used to analyse adherence to the MedDiet. HRQoL was assessed with three validated questionnaires measuring physical, mental, emotional and social factors: EQ-5D-3L, EORTC QLQ-C30 and EORTC QLQ-BR23. Analysis of variance (ANOVA) and multivariate analyses were performed to assess the possible role of the MedDiet on HRQoL. Patients with higher adherence to MedDiet (PREDIMED score >7) showed significantly higher scores for physical functioning (p = 0.02) and lower scores on the symptomatic pain scale (p = 0.04) assessed by the EORTC QLQ-C30 questionnaire compared to patients with a lower adherence to MedDiet (PREDIMED score ≤7). Higher scores from the EQ-5D-3L indicating higher well-being were observed mainly in participants with higher MedDiet adherence (p = 0.05). In adjusted multivariate analyses significant positive associations were found between MedDiet, physical functioning (p = 0.001) and EQ 5D-3L score (p = 0.003) while inverse associations were found with pain and insomnia symptoms (p = 0.005 and p = 0.029, respectively). These results suggest that higher adherence to the MedDiet in breast cancer survivors is associated with better aspects of quality of life, specifically higher physical functioning, better sleep, lower pain and generally higher well-being confirming findings in healthy subjects.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239803PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544033PMC
November 2020

Relation of Different Fruit and Vegetable Sources With Incident Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Prospective Cohort Studies.

J Am Heart Assoc 2020 10 1;9(19):e017728. Epub 2020 Oct 1.

Department of Nutritional Sciences Faculty of Medicine University of Toronto Ontario Canada.

Background Public health policies reflect concerns that certain fruit sources may not have the intended benefits and that vegetables should be preferred to fruit. We assessed the relation of fruit and vegetable sources with cardiovascular outcomes using a systematic review and meta-analysis of prospective cohort studies. Methods and Results MEDLINE, EMBASE, and Cochrane were searched through June 3, 2019. Two independent reviewers extracted data and assessed study quality (Newcastle-Ottawa Scale). Data were pooled (fixed effects), and heterogeneity (Cochrane-Q and I) and certainty of the evidence (Grading of Recommendations Assessment, Development, and Evaluation) were assessed. Eighty-one cohorts involving 4 031 896 individuals and 125 112 cardiovascular events were included. Total fruit and vegetables, fruit, and vegetables were associated with decreased cardiovascular disease (risk ratio, 0.93 [95% CI, 0.89-0.96]; 0.91 [0.88-0.95]; and 0.94 [0.90-0.97], respectively), coronary heart disease (0.88 [0.83-0.92]; 0.88 [0.84-0.92]; and 0.92 [0.87-0.96], respectively), and stroke (0.82 [0.77-0.88], 0.82 [0.79-0.85]; and 0.88 [0.83-0.93], respectively) incidence. Total fruit and vegetables, fruit, and vegetables were associated with decreased cardiovascular disease (0.89 [0.85-0.93]; 0.88 [0.86-0.91]; and 0.87 [0.85-0.90], respectively), coronary heart disease (0.81 [0.72-0.92]; 0.86 [0.82-0.90]; and 0.86 [0.83-0.89], respectively), and stroke (0.73 [0.65-0.81]; 0.87 [0.84-0.91]; and 0.94 [0.90-0.99], respectively) mortality. There were greater benefits for citrus, 100% fruit juice, and pommes among fruit sources and allium, carrots, cruciferous, and green leafy among vegetable sources. No sources showed an adverse association. The certainty of the evidence was "very low" to "moderate," with the highest for total fruit and/or vegetables, pommes fruit, and green leafy vegetables. Conclusions Fruits and vegetables are associated with cardiovascular benefit, with some sources associated with greater benefit and none showing an adverse association. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT03394339.
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http://dx.doi.org/10.1161/JAHA.120.017728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792377PMC
October 2020

Levonorgestrel release rates measured through analysis of two-rod contraceptive explants.

Contracept X 2020 21;2:100039. Epub 2020 Aug 21.

FHI 360, 359 Blackwell St. Suite 200, Durham, NC 27701, USA.

Objective: The objective was to characterize and compare in vivo rates of levonorgestrel (LNG) release from Sino-implant (II) and Jadelle® contraceptive implants.

Study Design: We sampled 48 Sino-implant (II) and 49 Jadelle® explant sets for residual LNG content from participants treated for up to 51 months in a randomized contraceptive efficacy trial in the Dominican Republic (DR). Additional Sino-implant (II) explants were obtained from 8 women who became pregnant in the DR trial and 10 who contributed 3 to 5 years of use in a cohort study in China. Baseline LNG loads were estimated from five unused implant sets per device type. Release profiles were estimated using mixture models that captured initial burst fractions and compared with efficacy and pharmacokinetics data from the DR trial.

Results: Estimated baseline LNG loads for Sino-implant (II) and Jadelle® were 142.8 mg and 150.5 mg, respectively (vs. the labeled 150 mg). There was an initial burst release of drug (5.6% and 7.9%, respectively) followed by an exponential decrease in LNG content evident for each device. Release rates were significantly lower for Sino-implant (II) throughout the treatment period, with estimated rates after 3 years of 24.2 mcg/day and 29.0 mcg/day for Sino-implant (II) and Jadelle®, respectively. The estimated Sino-implant (II) rate after 3 years was similar to the predicted rate after 5 years (23.6 mcg/day) for Jadelle® (rate ratio: 1.03; 95% confidence interval: 0.92-1.13).

Conclusions: Sino-implant (II) LNG release rates were significantly lower than Jadelle® with Sino-implant (II) rates through year 3 comparable to Jadelle® rates through year 5. These results reinforce the 3-year duration of action for which Sino-implant (II) was prequalified by the World Health Organization.

Implications: This analysis confirms the WHO prequalification of Sino-implant (II) for 3 years of use and supports different durations of action for Jadelle® and Sino-implant (II). It provides additional evidence that this approach can complement efficacy trials in determining duration of action of hormonal contraceptives in general.
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http://dx.doi.org/10.1016/j.conx.2020.100039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509190PMC
August 2020

Workload Differences Between Training Drills and Competition in Elite Netball.

Int J Sports Physiol Perform 2020 Sep 29:1-8. Epub 2020 Sep 29.

Purpose: To examine potential differences in internal and external workload variables between playing positions and between training drills and games within an elite netball team during training and competition.

Methods: Nine elite female netballers were monitored during 15 games and all training sessions over 28 weeks. Workload variables assessed were relative PlayerLoad (PL per minute), accelerations, decelerations, jumps, changes of direction, high-intensity events, medium-intensity events, low-intensity events, PL in a forward direction, PL in a sideways direction, PL in a vertical direction, and summated heart-rate zones using heart-rate monitors and inertial measurement units.

Results: Conditioning and match play during training were the only drills that matched or exceeded game workloads. Workloads during small-sided games were lower than game workloads for all variables. In games, goalkeeper, goal attack, and goal shooter had a greater frequency of jumps compared with other positions. Midcourt positions had a greater frequency of low-intensity events in a game.

Conclusions: Workloads during small-sided games were lower than game workloads across all external and internal variables; therefore, netball staff should modify these small-sided games if they wish them to develop game-based qualities. Specific game workload variables indicate that there are differences within some positional groups; coaches need to be aware that positional groupings may fail to account for differences in workload between individual playing positions.
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http://dx.doi.org/10.1123/ijspp.2019-0971DOI Listing
September 2020

Diagnosis of physical and mental health conditions in primary care during the COVID-19 pandemic: a retrospective cohort study.

Lancet Public Health 2020 10 23;5(10):e543-e550. Epub 2020 Sep 23.

The National Institute for Health Research Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester, UK; Division of Informatics, Imaging and Data Science, University of Manchester, Manchester, UK.

Background: To date, research on the indirect impact of the COVID-19 pandemic on the health of the population and the health-care system is scarce. We aimed to investigate the indirect effect of the COVID-19 pandemic on general practice health-care usage, and the subsequent diagnoses of common physical and mental health conditions in a deprived UK population.

Methods: We did a retrospective cohort study using routinely collected primary care data that was recorded in the Salford Integrated Record between Jan 1, 2010, and May 31, 2020. We extracted the weekly number of clinical codes entered into patient records overall, and for six high-level categories: symptoms and observations, diagnoses, prescriptions, operations and procedures, laboratory tests, and other diagnostic procedures. Negative binomial regression models were applied to monthly counts of first diagnoses of common conditions (common mental health problems, cardiovascular and cerebrovascular disease, type 2 diabetes, and cancer), and corresponding first prescriptions of medications indicative of these conditions. We used these models to predict the expected numbers of first diagnoses and first prescriptions between March 1 and May 31, 2020, which were then compared with the observed numbers for the same time period.

Findings: Between March 1 and May 31, 2020, 1073 first diagnoses of common mental health problems were reported compared with 2147 expected cases (95% CI 1821 to 2489) based on preceding years, representing a 50·0% reduction (95% CI 41·1 to 56·9). Compared with expected numbers, 456 fewer diagnoses of circulatory system diseases (43·3% reduction, 95% CI 29·6 to 53·5), and 135 fewer type 2 diabetes diagnoses (49·0% reduction, 23·8 to 63·1) were observed. The number of first prescriptions of associated medications was also lower than expected for the same time period. However, the gap between observed and expected cancer diagnoses (31 fewer; 16·0% reduction, -18·1 to 36·6) during this time period was not statistically significant.

Interpretation: In this deprived urban population, diagnoses of common conditions decreased substantially between March and May 2020, suggesting a large number of patients have undiagnosed conditions. A rebound in future workload could be imminent as COVID-19 restrictions ease and patients with undiagnosed conditions or delayed diagnosis present to primary and secondary health-care services. Such services should prioritise the diagnosis and treatment of these patients to mitigate potential indirect harms to protect public health.

Funding: National Institute of Health Research.
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http://dx.doi.org/10.1016/S2468-2667(20)30201-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7511209PMC
October 2020

Regional extracorporeal membrane oxygenation retrieval service during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic: an interdisciplinary team approach to maintain service provision despite increased demand.

Eur J Cardiothorac Surg 2020 11;58(5):875-880

Department of Cardiothoracic Surgery, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.

Objectives: Coronavirus disease 2019 is a new contagious disease that has spread rapidly across the world. It is associated with high mortality in those who develop respiratory complications and require admission to intensive care. Extracorporeal membrane oxygenation (ECMO) is a supportive therapy option for selected severely ill patients who deteriorate despite the best supportive care. During the coronavirus disease 2019 pandemic, extra demand led to staff reorganization; hence, cardiac surgery consultants joined the ECMO retrieval team. This article describes how we increased service provisions to adapt to the changes in activity and staffing.

Methods: The data were collected from 16 March 2020 to 8 May 2020. The patients were referred through a dedicated Web-based referral portal to cope with increasing demand. The retrieval team attended the referring hospital, reviewed the patients and made the final decision to proceed with ECMO.

Results: We reported 41 ECMO retrieval runs during this study period. Apart from staffing changes, other retrieval protocols were maintained. The preferred cannulation method for veno-venous ECMO was drainage via the femoral vein and return to the right internal jugular vein. There were no complications reported during cannulation or transport.

Conclusions: Staff reorganization in a crisis is of paramount importance. For those with precise transferrable skills, experience can be gained quickly with appropriate supervision. Therefore, the team members were selected based on skill mix rather than on roles that are more traditional. We have demonstrated that an ECMO retrieval service can be reorganized swiftly and successfully to cope with the sudden increase in demand by spending cardiac surgeons services to supplement the anaesthetic-intensivist roles.
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http://dx.doi.org/10.1093/ejcts/ezaa327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543471PMC
November 2020