Precision Nutrition Model Predicts Glucose Control of Overweight Females following the Consumption of Potatoes High in Resistant Starch

Individual glycemic responses following dietary intake result from complex physiological processes, and can be influenced by physical properties of foods, such as increased resistant starch (RS) from starch retrogradation. Predictive equations are needed to provide personalized dietary recommendations to reduce chronic disease development. Therefore, a precision nutrition model predicting the postprandial glucose response (PPGR) in overweight women following the consumption of potatoes was formulated. Thirty overweight women participated in this randomized crossover trial. Participants consumed 250 g of hot (9.2 g RS) or cold (13.7 g RS) potatoes on two separate occasions. Baseline characteristics included demographics, 10-day dietary records, body composition, and the relative abundance (RA) and α-diversity of gut microbiota. Elastic net regression using 5-fold cross-validation predicted PPGR after potato intake. Most participants (70%) had a favorable PPGR to the cold potato. The model explained 32.2% of the variance in PPGR with the equation: 547.65 × (0 [if cold, high-RS potato], ×1, if hot, low-RS potato]) + (BMI [kg/m2] × 40.66)—(insoluble fiber [g] × 49.35) + (Bacteroides [RA] × 8.69)—(Faecalibacterium [RA] × 73.49)—(Parabacteroides [RA] × 42.08) + (α-diversity × 110.87) + 292.52. This model improves the understanding of baseline characteristics that explain interpersonal variation in PPGR following potato intake and offers a tool to optimize dietary recommendations for a commonly consumed food.

Eligibility of Dapagliflozin and Empagliflozin in a Real-World Heart Failure Population

Aims. This study is aimed at investigating the eligibility in a real-world heart failure population for the DAPA-HF (testing dapagliflozin) and EMPEROR-reduced (testing empagliflozin) trials, comparing the eligible real-world patients to trial participants and to characterize the noneligible patients. Methods. Medical records of all heart failure patients who had a diagnosis of heart failure from the Heart Centre or Department of Internal Medicine at Umeå University Hospital were reviewed. Results. 2433 of the hospital’s uptake population of 150 000 had a diagnosis of heart failure. 681 patients had left ventricle ejection fraction ≤ 40 % , and of these 352 (52%) and 268 (39%) patients met eligibility criteria for DAPA-HF and EMPEROR-reduced, respectively. Comparing eligible patients in our population with the DAPA-HF- and EMPEROR-reduced trial populations, we found that eligible real-world patients were older (79.0 vs. 66.2 years and 80.3 vs. 67.2 years, respectively), had worse renal function (eGFR 54.4 vs. 66.0 ml/min/1.73m2 and 49.5 vs. 61.8 ml/min/1.73m2, respectively), higher prevalence of atrial fibrillation (56.0% vs. 36.1% and 53.0% vs. 35.6%, respectively), and lower prevalence of diabetes mellitus (21.0% vs. 41.8% and 26.1% vs. 49.8%, respectively). The main reasons for ineligibility were low NT-proBNP or low eGFR. Noneligible patients differed according to reason for ineligibility, where patients with low NT-proBNP were generally younger and healthier, and patients with low eGFR were older and had more comorbidities. Conclusions. 39-52% of patients with heart failure and reduced ejection fraction in this real-world heart failure population were eligible for SGLT2-inhibitor treatment, corresponding to 11-14% of all heart failure patients. Compared to trial participants, eligible real-world patients were significantly older with worse renal function, more atrial fibrillation, and less diabetes mellitus. Trial entry criteria exclude comparatively young and healthy patients, as well as comparatively old patients with more comorbid conditions.

Hahnemann and the methodology of pathogenetic trials in healthy volunteers: a reappraisal.

This article assesses the guidelines and protocols that Hahnemann developed for homeopathic pathogenetic trials (HPTs) - often referred to as proving - and reappraise them in the light of more recent knowledge and protocols for clinical trials involving human subjects. Innovative features and methods introduced by Hahnemann and aimed at reducing bias are noted. A number of features which are now known to lead to bias in trials and which may be included in the reporting of symptoms are discussed in relation to HPTs. These features include: absence of control groups, absence of random allocation, absence of blinding, the inclusion of trivial and pre-existing symptoms, the inclusion of well-known acquaintances as trial participants, and the lack of definition of the healthy state. Advice from experts and papers published in recent decades related to the design of HPTs are discussed. The importance of developing methods to screen participants in HPTs for susceptibility to the tested medicine is discussed. The absence of trials meeting high quality standards in their design is highlighted. The article concludes with a plea for researchers to show the same desire for rigour and innovation that Hahnemann did in the development of HPTs, whilst fully recognising the requirements and protocols necessary for any trial of medicines on human beings, so that, as Hahnemann wanted, only reliable symptoms from HPTs will be admitted in the materia medica and clinical practice.

Tolerating bad health research: the continuing scandal

BackgroundAt the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things?Main textWe focus on randomised trials and look at scale, participants and cost. We randomly selected up to two quantitative intervention reviews published by all clinical Cochrane Review Groups between May 2020 and April 2021. Data including risk of bias, number of participants, intervention type and country were extracted for all trials included in selected reviews. High risk of bias trials were classed as bad. The cost of high risk of bias trials was estimated using published estimates of trial cost per-participant.We identified 96 reviews authored by 546 reviewers from 49 clinical Cochrane Review Groups that included 1,659 trials done in 84 countries. Of the 1,640 trials providing risk of bias information, 1,013 (62%) were high risk of bias (bad), 494 (30%) unclear and 133 (8%) low risk of bias. Bad trials were spread across all clinical areas and all countries. Well over 220,000 participants (or 56% of all participants) were in bad trials. The low estimate of the cost of bad trials was £726 million; our high estimate was over £8 billion. We have five recommendations: trials should be neither funded (1) or given ethical approval (2) unless they have a statistician and methodologist; trialists should use a risk of bias tool at design (3); more statisticians and methodologists should be trained and supported (4); there should be more funding into applied methodology research and infrastructure (5). ConclusionsMost randomised trials are bad and most trial participants will be in one. The research community has tolerated this for decades. This has to stop: we need to put rigour and methodology where it belongs– at the centre of our science.

E-learning moodle

The development of the Intensive Reading learning process with e-learning Moodle isa focus of attention in this study. The main purpose is to find out the effectiveness, practicality, and feasibility of e-learning Moodle that has been designed in the process of learning. The instructional model of ADDIE was the basis for this development research which involves Analysis, Design, Development, Implementation, and Evaluation. Twenty-eight students who joined the intensive reading class and eight validators who were experts in their fields became trial participants in this study. The feasibility of e-learning Moodle was validated by an evaluation sheet that was completed by six validators, who were experts in their field such as learning- media, material, and process. Furthermore, the acquisition of data from students' questionnaires becomes the main data in determining of effectiveness and practicality of the e-learning Moodle. The study indicated that learning model produced can be acceptable and eligible categories, including layout, navigation, function, and pedagogical areas. Based on the students’ answers related to the use of e-learning Moodle of Intensive reading class, it depicts to be effective and practice in all aspects of the evaluation.

The Politics of Postgenomic Reproduction: Exploring Pregnant Narratives from within a Clinical Trial

There are more large-scale pregnancy trials that implement lifestyle interventions than ever before; yet, there is a dearth of information on pregnant peoples’ experiences in such trials. Contemporary lifestyle pregnancy trials draw on epigenetics and DOHaD research to design and justify prenatal interventions on the material environment to reduce health risks in future generations. This article draws on ethnographic data from a prenatal trial in the United Kingdom and focuses specifically on the experiences of pregnant participants during the intervention phase. In this article, I develop the politics of postgenomic reproduction as a feminist and critical race framework to examine the complex and mercurial stakes of contemporary pregnancy trials. I argue that narratives of control and responsibility in epigenetic models are echoed and preceded by participants’ own embodied experience. The pregnant narratives show at once how their bodies are exposed to unpredictable and uncontrollable environmental exposures and that they are required to respond as if they have absolute control and responsibility. Attending to trial participants’ narratives from a feminist and critical race framework reveals how individualized lifestyle interventions are deeply political and racial, and carry implications for how pregnancy trials influence postgenomic reproduction.

Post-discharge decolonization of patients harboring methicillin-resistant Staphylococcus aureus (MRSA) USA300 strains: secondary analysis of the CLEAR Trial

The CLEAR Trial recently found that decolonization reduced infections and hospitalizations in MRSA carriers in the year following hospital discharge. In this secondary analysis, we explored whether decolonization had a similar benefit in the subgroup of trial participants who harbored USA300, using two different definitions for the USA300 strain-type.