Marker Of Compliance Research Articles

Health-Related Quality of Life during 26-Week Intervention with the New Nordic Renal Diet.

The New Nordic Renal Diet (NNRD) is a whole-food approach, tailored to meet recommended guidelines in patients with moderate chronic kidney disease (stage 3b-4). The NNRD improved various metabolic and physiological endpoints during a 26-week randomized controlled study. Here, we examined the effect of dietary intervention on health-related quality of life (HRQoL). Sixty participants were recruited (NNRD group n = 30, control group n = 30) and 58 completed the study. During the intervention, the NNRD group received food boxes, and recipes once a week. The control group continued their habitual diet. HRQoL was examined at baseline and at the end of the intervention using the validated EuroQol-5D-5L, including a 5-point scale Likert questionnaire at the end of the intervention. Assessed by the EuroQol-5D-5L questionnaire, the NNRD group experienced a reduction in pain/discomfort during the intervention by 26% [-0.44 points (95% CI; -0.73, -0.16)], compared with no change in the control group [0.25 points (95% CI; -0.02, 0.53)] and a between-group difference of -0.70 points (95% CI; -1.03, -0.37, p < 0.001). A larger decrease of body fat mass was associated with a larger decrease in pain/discomfort (p = 0.014). In addition, the NNRD group reported an overall improvement in conducting usual daily activities by 23% [-0.30-point (95% CI; -0.50, -0.11)], while no change was seen in the control group [-0.02 points (95% CI; -0.21, 0.17)], with a between-group difference -0.28 points (95% CI; -0.51, -0.06, p = 0.014). A larger decrease in 24 h urine phosphorus excretion, used as a marker of compliance, was associated with a larger improvement in conducting usual daily activities (p = 0.036). The NNRD group had a clinically relevant improvement in various HRQoL outcomes.

P976 Treatment with exclusive enteral nutrition (EEN) impacts the peripheral blood mononuclear cell profile of paediatric patients with Crohn’s disease

Abstract Background Background: Despite its established clinical efficacy, the immunological effects of exclusive enteral nutrition (EEN) in Crohn’s disease (CD) are yet to be elucidated. This study investigated the impact of EEN on circulating peripheral blood mononuclear cells (PBMCs) and how any effects observed varied according to clinical response to treatment. Methods Methods: Children with active CD received EEN for eight weeks as their sole induction treatment. Blood and faecal samples were collected prior to EEN and upon EEN completion. PBMCs were isolated, stained and analysed using flow cytometry. Differences in PBMCs types were compared during EEN. Faecal calprotectin was measured with ELISA. Absence of gluten immunogenic peptide (GIP) in faeces was used as a proxy marker of EEN compliance. Results Results: Nine participants were recruited (Table 1), three of whom initiated azathioprine during their course of EEN. Following treatment with EEN a decrease in the relative number and frequency of circulating effector memory CD8+ T cells re-expressing CD45RA (TEMRA) was observed with a corresponding increase in the frequency of circulating central and effector memory CD8+ T cells (Fig. 1). When we excluded participants that commenced thiopurines during their course of EEN a decrease in the relative number of circulating TEMRA CD8+ T cells persisted and a decrease in naïve CD8+ T cells in the blood was also observed. Participants who demonstrated a decrease in faecal calprotectin 50% following treatment with EEN (n= 5) also demonstrated an increase in the frequency of circulating central memory CD8+ T cells. When focussing on participants (n=7) within our cohort who demonstrated a high-level of compliance (undetected GIP in faeces) during EEN, we again observed a decrease in number of TEMRA CD8+ T cells in blood alongside an increase in the frequency of circulating central and effector memory CD8+ T cells. Conclusion Conclusion: We observed significant changes in CD8+ T cell populations in the peripheral blood of children following treatment with EEN. These changes were observed irrespective of background immunomodulator use and persisted in participants which achieved &amp;gt;50% decrease in FC or demonstrated compliance to EEN. Our observed changes in CD8+ T cell populations, particularly the consistent increases in circulating effector and memory CD8+ T cells, are likely a consequence of the actions of EEN in decreasing the diversity and composition of the gut bacteria, therefore reducing the recruitment of effector/memory cells from the blood into the intestine.

P896 You Can Lead a Horse to Water But You Can’t Make it Drink: A Study on Medication Adherence of Inflammatory Bowel Disease Patients in Ireland

Abstract Background Medication adherence is important in ensuring adequate treatment of Inflammatory Bowel Disease (IBD). The High Tech Hub (HTH) is an online system used in Ireland to prescribe and monitor the ordering of High-Tech Medication, specifically oral small molecules and subcutaneously-delivered biologics. We aimed to observe compliance rates of treatment in our centre, observe trends between different medication and identify factors associated with adherence. Methods We extracted prescribing and medication dispensing information from the HTH database for our centre between May and November 2023. We collected information on patient demographics such as age and gender, patient disease subtype, medication class and duration of prescription given against the duration of prescription collected by the patient with an 85% threshold as a marker of compliance to treatment. Statistical analysis was used to compare differences in adherence between subsets of the population and a multivariate regression model was used to identify factors associated with adherence. Results We extracted information from 824 prescriptions from 644 unique patients. The median age was 42 years (IQR 32-52) with 52.2% males. 60.7% (n=391) had Crohn’s Disease, 33.4% (n=215) had Ulcerative Colitis and 3.1% (n=20) had IBD-U. Majority of patients, 77.3% (n=498), were on Anti-TNF medication, followed by 13.2% (n=75) on anti-Interleukins, 6.2% (n=40) on JAK Inhibitors and 3.3% (n=21) Anti-Integrins. 6.5% (n=42) of patients required dose optimization during the 6-month observation and 1.7% (n=11) required a change of medication. 9.5% (n=61) of patients collected prescriptions for steroids. Further analysis demonstrated no significant difference in adherence within gender (Male: 61.0% vs. Female 53.6%, p=0.056), age (&amp;lt;25 years: 66.2%, 25-39 years: 55.0%, 40-54 years: 58.6%, ≥55 years: 54.6%, p=0.346), disease type (Crohn’s: 58.6%, Ulcerative Colitis: 56.7%, IBD-U: 50%, p=0.776), medication class (Anti-TNF: 56.4%, Anti-Interleukin: 65.9%, Anti-Integrin: 57.1%, JAK Inhibitor: 52.5%, p=0.378). However, we found significant lower adherence rates in patients who required dose optimization (21.4% vs. 60.0%, p&amp;lt;0.001) and those who required a change in medication (18.2% vs. 58.1%, p=0.008) in the observation window. There was also a lower rate of adherence noted in those who received prescriptions for steroids (45.9% vs 58.9%, p=0.051). Conclusion There was a high rate of non-adherence noted in our IBD population, worse in those who ended up requiring dose optimization or change in therapy. Addressing compliance by monitoring the online dispensing of medication may be a useful way to ensure adequate treatment and avoid unnecessary treatment escalation.

The Dicrotic Notch: Mechanisms, Characteristics, and Clinical Correlations.

The dicrotic notch (DN) has long been considered a marker of arterial stiffness and compliance. Herein, we explored the recent developments in vascular medicine research in an attempt to assess the DN utility in clinical cardiovascular medicine. Since its discovery, several studies have attempted to measure the changes in different parameters of the DN in physiological and pathological states. Despite the significance of their findings, the clinical role of the DN remained limited. This may have been related to the difficulty of measuring the DN via indwelling arterial catheters in the past. However, over the past two decades, several non-invasive methods have been developed, which may re-ignite interest in DN research. The DN may have broader applications in clinical cardiovascular medicine. Further research is needed to establish the accuracy of DN non-invasive measurement methods and compare its prognostic value to other circulatory parameters.

Alterations in retinal pulse wave velocity under experimental ocular hypertension.

Impairments of blood flow and autoregulation have been implicated in diabetic retinopathy and glaucoma. Thus, identifying biomarkers of retinal vascular compliance and regulatory capacity is of potential value for understanding the pathophysiology and evaluating onset or progression of disease. Pulse wave velocity (PWV) represents the speed of the pulse-propagated pressure wave within blood vessels and has shown promise as a marker of vascular compliance. The purpose of the current study was to report a method for comprehensive assessment of retinal PWV based on spectral analysis of pulsatile intravascular intensity waveforms and determine alterations due to experimental ocular hypertension. Retinal PWV was linearly related to vessel diameter. Increased retinal PWV was associated with elevated intraocular pressure. Retinal PWV has the potential to serve as a vasoregulation biomarker for investigating vascular factors that contribute to the development of retinal diseases in animal models.

LEGAL PROTECTION OF PUBLIC MORALITY - AXIOLOGY OF LEGAL RELATIONS AND LAW ENFORCEMENT ACTIVITIES IN UKRAINE: A MODERN COMPARATIVIST APPROACH

The purpose of the article is to study the modern comparative approach to determining the influence of the level of the legal protection of public morality on the axiological component of legal relations and law enforcement activities in Ukraine within the framework of theoretical and legal discourse. As a result of the conducted analysis, it is necessary to state that the axiology of legal relations in society in the general system of coordinates and interaction with other types of social relations is permanently permeated by the categories of social morality. At most, morality is a system of principles, and a spindle of social principles, which permeates all types of social relations without exception, is the starting point for their generally human and philosophical qualification, a marker of compliance with the needs of modernity. The article establishes that law enforcement activity is a special type of social relations, since on the one hand it interacts prominently with society, the widest circle of legal subjects, almost without exception, on the other hand, it is a narrow-profile, specialized activity of persons authorized to do so. Therefore, it was established that the law enforcement sphere is at the same time the so-called issuer, creator, and developer of moral principles, as rule narrow-branch ones, which, at the same time, clearly intersect and interact with general social principles, complementing each other, penetrating into other spheres of sectoral social relations, supplementing them, changing, transforming legal validity, etc. It was established that the level of public morality of law enforcement officers directly affects the state of compliance with public morality by civil society, and vice versa: the level of public morality of society draws a demarcation line for the system of permissible worldview and behavioral principles of law enforcement agencies. At most, it seems quite obvious that one of the most effective means of acceptance by law enforcement agencies of values, principles, ideas, and norms of public morality is the maximum integration of law enforcement agencies into the social, human plane, their immersion in the urgent needs of society, its requests, the spirit of the law as much as possible, to which it aspires. At the same time, the so-called "humanization" of law enforcement agencies is, on the one hand, a demand of society for the law enforcement system and, at the same time, a guarantee of the protection of public morality, because only humanized law enforcement agencies are able to ensure and guarantee the specified process.

ESTIMATED PULSE WAVE VELOCITY INDEPENDETLY PREDICTS SURVIVAL-TO-DISCHARGE IN PATIENTS REQUIRING EXTRACORPOREAL MEMBRANE OXYGENATION: A SINGLE-CENTRE RETROSPECTIVE COHORT STUDY

ESTIMATED PULSE WAVE VELOCITY INDEPENDETLY PREDICTS SURVIVAL-TO-DISCHARGE IN PATIENTS REQUIRING EXTRACORPOREAL MEMBRANE OXYGENATION: A SINGLE-CENTRE RETROSPECTIVE COHORT STUDY

Corneal Hysteresis, Intraocular Pressure, and Progression of Glaucoma: Time for a "Hyst-Oric" Change in Clinical Practice?

It is known that as people age their tissues become less compliant and the ocular structures are no different. Corneal Hysteresis (CH) is a surrogate marker for ocular compliance. Low hysteresis values are associated with optic nerve damage and visual field loss, the structural and functional components of glaucomatous optic neuropathy. Presently, a range of parameters are measured to monitor and stratify glaucoma, including intraocular pressure (IOP), central corneal thickness (CCT), optical coherence tomography (OCT) scans of the retinal nerve fibre layer (RNFL) and the ganglion cell layer (GCL), and subjective measurement such as visual fields. The purpose of this review is to summarise the current evidence that CH values area risk factor for the development of glaucoma and are a marker for its progression. The authors will explain what precisely CH is, how it can be measured, and the influence that medication and surgery can have on its value. CH is likely to play an integral role in glaucoma care and could potentially be incorporated synergistically with IOP, CCT, and visual field testing to establish risk stratification modelling and progression algorithms in glaucoma management in the future.

South Asian-Specific MYBPC3 Δ25bp Deletion Carriers Display Hypercontraction and Impaired Diastolic Function Under Exercise Stress.

Background: A 25-base pair (25bp) intronic deletion in the MYBPC3 gene enriched in South Asians (SAs) is a risk allele for late-onset left ventricular (LV) dysfunction, hypertrophy, and heart failure (HF) with several forms of cardiomyopathy. However, the effect of this variant on exercise parameters has not been evaluated.Methods: As a pilot study, 10 asymptomatic SA carriers of the MYBPC3Δ25bp variant (52.9 ± 2.14 years) and 10 age- and gender-matched non-carriers (NCs) (50.1 ± 2.7 years) were evaluated at baseline and under exercise stress conditions using bicycle exercise echocardiography and continuous cardiac monitoring.Results: Baseline echocardiography parameters were not different between the two groups. However, in response to exercise stress, the carriers of Δ25bp had significantly higher LV ejection fraction (%) (CI: 4.57 ± 1.93; p < 0.0001), LV outflow tract peak velocity (m/s) (CI: 0.19 ± 0.07; p < 0.0001), and higher aortic valve (AV) peak velocity (m/s) (CI: 0.103 ± 0.08; p = 0.01) in comparison to NCs, and E/A ratio, a marker of diastolic compliance, was significantly lower in Δ25bp carriers (CI: 0.107 ± 0.102; p = 0.038). Interestingly, LV end-diastolic diameter (LVIDdia) was augmented in NCs in response to stress, while it did not increase in Δ25bp carriers (CI: 0.239 ± 0.125; p = 0.0002). Further, stress-induced right ventricular systolic excursion velocity s' (m/s), as a marker of right ventricle function, increased similarly in both groups, but tricuspid annular plane systolic excursion increased more in carriers (slope: 0.008; p = 0.0001), suggesting right ventricle functional differences between the two groups.Conclusions: These data support that MYBPC3Δ25bp is associated with LV hypercontraction under stress conditions with evidence of diastolic impairment.

Longitudinal Analysis of Hydroxyurea and Fetal Hemoglobin in Adult Patients with Sickle Cell Anemia

▪Introduction:Hydroxyurea (HU) was the first FDA-approved therapy for sickle cell anemia (SCA) and remains the most well-established disease-modifying therapy, reducing painful crisis and improving morbidity and mortality. HU improves outcomes through the upregulation of fetal hemoglobin (HbF). Dosing is highly variable with doses ranging from <10-35 mg/kg/day. Most dosing strategies escalate with a goal of mild myelosuppression, commonly defined using an absolute neutrophil count (ANC) between 2,000-4,000 and platelets >80,000. Macrocytosis is often used as a surrogate marker for compliance and effect. Despite its well-established effectiveness, clinical use remains limited with only 12% of adults with SCA taking HU. The reasons for this are multifactorial but include skepticism by both providers and patients regarding its effectiveness in the adult population. Some experts suggest up to 30% of adults are non-responders with no significant HbF change, and many believe that the effect of HU fades with time. Dosing strategies are usually quite conservative to prevent excessive myelosuppression, though dose is highly correlated with clinical effect and ultimate %HbF. There is very limited real-world data regarding long term effectiveness of HU in adults with SCA over time.Methods:We retrospectively analyzed the records of the 109 adults with SCA currently treated in our multidisciplinary sickle cell clinic. Data from 1/1/2011-6/30/2021 was collected, including genotype, HU prescription status, current and maximum laboratory values (HbF, MCV, ANC), and number of admissions for painful crisis.We performed Wilcoxon rank sum testing between pts prescribed and not prescribed HU and measures of HbF (peak, average and current) and number of admissions for painful crisis over the study period.Results:Among 106 pts (3 excluded from analysis, 2 for lack of data and 1 for post-transplant status), 79 are currently prescribed HU (75%). Among our 63 pts with HbSS genotype 58 are prescribed HU (92%). Average HbF over time for all pts prescribed HU was 11.9%. Average peak HbF was 18.1% and average current HbF is 12.4%. In the pts not prescribed HU HbF average, peak and current levels were 5.5%, 6.7%, and 5.0% respectively.HU prescription was significantly associated with increased HbF at peak, average, and current levels (p-value <0.001, Figure A). HU prescription was also significantly associated with decreased number of admissions for painful crisis (p-value 0.001). Among pts prescribed HU, MCV levels >100 at time of peak HbF were associated with higher peak levels than pts with MCV <100 (p-value <0.001, Figure B). Larger peak HU doses were also correlated with higher MCVs at the time of peak HbF levels (Figure C). Larger current HU doses were also significantly associated with higher current HbF levels (Figure, D). Doses >9.9m/kg were associated with significantly higher HbF levels however there was no significant difference between dose levels 10-19.9mg/kg and 20-29.9 or 20-29.9 and 30-39.9mg/kg (p-values 0.02, 0.68 and 0.84 respectively).Among pts prescribed HU, 34 obtained ANC levels <4000 at the times of peak HbF and 24 at the current dosing level (43% and 30% respectively). 24 pts obtained both MCV>100 and ANC <4000 at time of peak HbF and only 11 achieved both at current dosing levels (30% and 14% respectively).Conclusion:In our adult multidisciplinary sickle cell clinic prescribing rates are well above current HU usage for adults with SCA. Our data notes that elevated HbF levels can be maintained over long periods of time. HU prescription was significantly associated with increased HbF levels and reduced admissions for painful crisis. This was despite a majority of pts not meeting target prescribing levels of ANC <4000 and MCV >100. While higher peak HbF levels were significantly associated with higher HU doses, this was only true for doses above 9.9 mg/kg. Further investigation is needed to explore the factors contributing to suboptimal HbF and MCV response, including careful assessment with medication adherence and dose selection. Overall, these data illustrate the importance of dosing and suggest that one size dosing of HU for adults with SCA does not fit all. We hypothesize that there may be a role individualized dosing strategies in adults with SCA, incorporating factors such as pharmacokinetics and renal function to achieve the optimal dose for each patient. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

The life of a laboratory requisition form: Patient compliance with clinical laboratory testing in a Canadian primary care health region

ObjectiveTo examine patient laboratory testing compliance by tracking time to submission of laboratory requisitions in Southern Alberta, Canada as part of a quality improvement initiative. MethodsData was collected retrospectively from patients from the Chinook Primary Care Network in Alberta, Canada, who received a laboratory requisition consisting of a complete blood count (CBC) test order between September 1, 2016 and August 31, 2017. To allow for all laboratory requisitions created to be submitted within one year, the study collection period was from September 1, 2016 to August 31, 2018. Patient age, sex, and dates of laboratory requisition creation and submission were collected. The days-to-test-submission served as a marker of compliance. Association of age, sex, and clinic location with time to laboratory requisition completion was determined using Cox regression analysis. ResultsDuring the study period, 70.4% (n = 1607) of laboratory requisitions created were completed within one year, and over half (50.5%) of the laboratory requisitions ordered were completed within two weeks. There were no significant associations between time to laboratory requisition submission and sex or clinic locations (P > 0.05), but there were significant associations between patients who were 20–49 or 70–79 and increased laboratory requisition compliance (P < 0.05). However, 26.0% of the laboratory requisitions created were not submitted at all. ConclusionsThis was the first study that quantified the proportion and timing of laboratory requisitions that were submitted by patients in a primary care setting. Community patients should be engaged and educated regarding the importance of complying with their physician-ordered laboratory requests in a timely manner.

Blood ketone measurement as a test for dietary compliance in cardiac sarcoid patients undergoing 18f-fluorodeoxyglucose positron emission tomography

Abstract Funding Acknowledgements Type of funding sources: None. Background Imaging with 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) is used as part of diagnosis and monitoring response to therapy in patients with cardiac sarcoidosis. In order to supress myocardial uptake of 18F-FDG patients prepare with a low carbohydrate diet followed by an 18-hour overnight fast. Failure to comply with the protocol results in diffuse myocardial 18F-FDG uptake which confounds diagnostic interpretation. Purpose To assess if point of care blood ketones could be used as a marker of dietary compliance and association with suppression of myocardial 18F-FDG uptake on PET scan. Method Patients (n = 26, 57 ± 4 years, 65% Male) from a single centre were instructed to follow standard preparation protocol prior to 18F-FDG PET/CT. After confirmation of dietary compliance, blood glucose and blood ketones were recorded using point of care devices. Images were graded based on the pattern of myocardial 18F-FDG uptake. Results There was no clear correlation between blood ketones in relation to dietary compliance or myocardial 18F-fluorodeoxyglucose uptake. In those with myocardial 18F-FDG uptake maximum standardized uptake value (SUV max) within the myocardium ranged from 2.3 to 9.8 (Mean 5.3) and ketone from 0.1 – 0.7 (normal &amp;lt;0.6). Non-diabetic patients and those on steroids achieved adequate fasting glucose without significant rise in blood ketones. 60% of diabetic patients demonstrated mildly elevated ketones between 0.6-1.5mmol/L. Conclusion Current protocol with low carbohydrate diet and 18-hour fast achieves adequate quality of images in majority of patients, without significant change in blood ketones. Therefore, blood ketones cannot be used to confirm dietary compliance. Diabetic patients on insulin may benefit from ketone measurement due to risk of diabetic ketoacidosis.

Effect of weight loss on early left atrial myopathy in obese patients without known cardiovascular disease

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): BHF &amp; NIHR BRC Introduction Obesity is strongly associated with increased risk of heart failure and ischaemic stroke independently of associated co-morbidities. Left atrial (LA) reservoir dysfunction, a marker of atrial distensibility and compliance, is an early pathophysiological change which precedes the onset of cardiovascular disease in patients with obesity. It is unclear whether a weight loss intervention may be sufficient to reverse LA reservoir dysfunction. Purpose To longitudinally assess whether a weight loss intervention normalizes LA reservoir function by cardiac magnetic resonance (CMR) feature-tracking in patients with obesity and only subclinical cardiovascular disease and compared this age and sex matched non-obese normal weight controls. Methods A total of 45 patients with severe obese (age = 45 ± 11 years, body mass index = 39.1 ± 6.7 kg/m2, 51 ± 18 kg of excess body weight [EBW], 67% female) underwent CMR for quantification of LA and left ventricular (LV) size and function before and a median of 373 days following weight loss intervention. Weight loss was achieved by means of a very-low calorie diet (N = 28; 800 kcal/day) or by bariatric surgery (N = 17). A total of N = 27 non-obese healthy controls (age = 41 ± 12 years, body mass index = 22.3 ± 2.4 kg/m2, 75% female) underwent the same CMR protocol once. Results At baseline, patients with obesity displayed signs of atrial myopathy with increased LA volume and reduced LA reservoir function as compared to normal-weight controls (both P &amp;lt; 0.05, Figure 1) alongside increased LV mass and hyper-normal LV ejection fraction [LVEF] (both p &amp;lt; 0.01). As expected, weight loss led to a significant reduction of LA volume and LV mass with normalization of LVEF regardless of the degree of weight loss achieved (all P &amp;lt; 0.05, Figure 2). By contrast, only a large weight loss (&amp;gt;46.6% EBW, in red in Figure 2) was sufficient to improve and normalize the LA reservoir function (P &amp;lt; 0.05, Figure 2). On the other hand, moderate or milder weight loss (in orange and red) had no significant effect on LA reservoir function (both P &amp;gt; 0.05). Conclusion Successful weight loss can completely revert early LA myopathic phenotype in obese patients without known cardiovascular disease although this can be achieved only with larger weight loss targets.

Longer-Term Soy Nut Consumption Improves Vascular Function and Cardiometabolic Risk Markers in Older Adults: Results of a Randomized, Controlled Cross-Over Trial

Abstract Objectives Soy foods may contribute to the beneficial effects of plant-based diets on cardiovascular disease (CVD) risk. However, their effects on vascular function have hardly been investigated. The objective was to investigate if longer-term soy nut consumption improves vascular function and cardiometabolic health in older adults. Methods Twenty-three apparently healthy participants (60–70 years; BMI between 20–30 kg/m2) participated in a randomized, controlled, single-blinded cross-over trial with an intervention (67 g of soy nuts daily providing 25.5 g soy protein) and control period (no nuts) of 16 weeks, separated by eight weeks wash-out. Volunteers followed the Dutch food-based dietary guidelines. At baseline and at 8 and 16 weeks anthropometric measurements and fasting blood samples were collected. Markers of vascular function (i.e., endothelial function, arterial stiffness, and microvascular structure) were assessed at week 16. Results No serious adverse events were reported and the soy nut regime was well tolerated. Body weight remained stable. Serum isoflavone concentrations, a marker of compliance, increased after the intervention period (daidzein: 128.3 ng/mL; 95% CI: 72.6–183.9 ng/mL; P &amp;lt; 0.001 and genistein: 439.8 ng/mL 95% CI: 246.7–632.9 ng/mL; P &amp;lt; 0.001). The brachial artery flow-mediated vasodilation (FMD) response increased by 1.49 pp (95% CI: 0.03–2.95 pp; P = 0.046) following the soy intervention, but no effect was found on the carotid artery reactivity (CAR) response. Arterial stiffness, assessed by carotid-to-femoral pulse wave velocity (PWVc-f), was unchanged. Retinal arteriolar calibers (CRAE), a measure for microvascular structure, tended to improve by 1.42 mm (95% CI: −0.05–2.90 mm; P = 0.059). Soy consumption also lowered serum LDL-cholesterol concentrations by 0.17 mmol/L (95% CI: 0.02–0.32 mmol/L; P = 0.027). HDL-cholesterol and triacylglycerol (TAG) did not change. Finally, office SBP and DBP decreased by 4 mmHg (95% CI: 0–8 mmHg; P = 0.034) and 2 mmHg (95% CI: 1–4 mmHg; P = 0.005), respectively. Conclusions A longer-term daily intake of soy nuts improved endothelial function, office blood pressure, and serum LDL-cholesterol concentrations, suggesting mechanisms by which an increased soy food intake beneficially affects CVD risk in older adults. Funding Sources This study was supported by a grant from the Alpro Foundation.

A randomized trial comparing prescribed light exercise to standard management for emergency department patients with acute mild traumatic brain injury.

Persistent post-concussion symptoms (PCS) after a mild traumatic brain injury (mTBI) or concussion do not occur in the majority of patients sustaining such injuries, but when they do occur, they have significant functional consequences for patients. Delays in return to school, work, recreational, and social activities can deeply impact quality of life and have major long-term negative life consequences that are anything but mild, despite the classification of the initial injury. Predictive abilities to determine which patients will suffer PCS are currently poor, although certain presentation characteristics may be associated, such as age at injury, the occurrence and timing of prior concussions, the mechanism of injury, and others. Research into utilization of various biomarkers as predictive tools is underway but clear answers are still forthcoming.

Accelerated pulse wave photo plethysmography-A marker of vascular compliance and cardiac autonomic functions

Accelerated pulse wave photo plethysmography-A marker of vascular compliance and cardiac autonomic functions

ІНТЕГРАЦІЯ ГЕНДЕРНОЇ ПЕРСПЕКТИВИ У ПРАВОСУДДЯ: СУЧАСНІ ВИКЛИКИ

Today, international and national legislation requires Ukraine to ensure and implement the principle of gender equality in all spheres of public life, which is related to the European integration course of the Ukrainian legal system. In connection with the above, gender studies are becoming increasingly popular in all spheres of public life, and the judiciary is no exception. This is due to the fact that judges, in their daily activities, in resolving litigation, give a legal assessment of people's actions. Thus, court decisions are a kind of indicator of the rule of law and a marker of society's compliance with democratic principles of the state. Thus, courts have the opportunity to ensure access to justice and eliminate gender discrimination through a gender approach. They have a huge potential to correct formal, material and structural inequalities through court decisions, which provides a practical opportunity to translate gender symmetry into legal reality. The article considers the mechanism of gender mainstreaming in justice as a set of measures (institutional policy) to ensure equality before the law and the court on the basis of gender; access to justice and equality in access to the profession of judge, judicial remuneration, career advancement, participation in judicial governance and self-government, and maternity protection, in a fair work-life balance for both men and women. it, etc. An integrated essential understanding of the gender perspective as a real, practical application and implementation of appropriate measures, carrying out certain actions to achieve gender equality is proposed; in ensuring gender mainstreaming in all aspects of the justice system and understanding how gender identity affects the legal status of litigants (institutional policy). The integration of a gender perspective into the judiciary is the strengthening of gender equality in all aspects of the judiciary, as judges and judges are agents of change who, through the application of the law, enable people to feel equal in their own country.

Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study.

IntroductionTobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes.Aims and MethodsThis randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90.ResultsIn continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers.Conclusionglo is a reduced-exposure tobacco product.ImplicationsThis clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely.Clinical trial registrationISRCTN81075760.

SUN-LB64 Urine Phosphoethanolamine Is an Underutilized Biomarker for Hypophosphastasia

Hypophosphatasia (HPP) is a rare disease caused by a loss-of-function mutation in the ALPL gene leading to a deficiency in the tissue-non-specific isoenzyme alkaline phosphatase (ALP) and excess of extracellular inorganic pyrophosphate (PPi) and pyridoxal 5’phosphate (PLP). Patients with HPP have a widely variable clinical phenotype, from neonatal seizures and hypomineralization to isolated dental or joint disease in adults. Patients present with ALP activity levels below their age-adjusted reference interval and elevations in PLP. This variable clinical phenotype leads to significant diagnostic challenges, particularly in those with minor disease manifestations. Biomarkers for diagnosing HPP and monitoring patients on enzyme replacement therapy (ERT) are limited. Low ALP activity is not specific for HPP; it can be low in other conditions including untreated hypothyroidism, and other skeletal dysplasias. Accurate PLP assessment is limited in patients on ERT due to hydrolysis of the substrate. Phosphoethanolamine (PEA) is a substrate hydrolyzed by TNSALP and elevated levels of PEA may be observed in HPP, supporting the diagnosis of HPP, but have been reported to be non-specific. We hypothesized that urine PEA levels could be used to diagnose HPP and as a surrogate marker for ERT compliance. We performed a retrospective analysis on 83 adult patients (63F: 20M) presenting for investigation or follow-up of HPP from 7/1/2014 to 1/7/2020. Urine was sent to the Children’s Hospital in Colorado for PEA testing. Patients were diagnosed with HPP if they had ALP levels persistently below the age-adjusted reference interval, were positive for an ALPL gene mutation/had a family history of HPP and had musculoskeletal/dental symptoms consistent with the disease. Patients were negative for HPP if ALP was not persistently low, vitamin B6 levels were normal without supplementation, negative ALPL genetic testing results (when available) and no musculoskeletal/dental symptoms. PEA levels were not considered for diagnosis. The following was collected from the EMR: PEA results, diagnosis, and ERT status. PEA levels were higher in patients with HPP not on ERT (median=117.0, N=39) vs. those negative for HPP (median=24.0, N=15, p<0.0001). The receiver operator curve for PEA in diagnosing HPP had an AUC of 0.94 (SE=0.03, p<0.0001). Specificity was 100% at PEA levels >53.5 ng/ml (sensitivity=79.5%) with an NPV of 65.2% and PPV of 100%. Initial PEA values in patients with HPP and not on ERT were higher (median 117.0, N=39) than patients on ERT (median 65.0, N=16, p=0.004). Patients who began ERT had a decline in PEA levels after treatment (mean decrease 68.1%). PEA is a specific diagnostic marker for HPP in patients undergoing investigation for HPP and may be used as a surrogate marker to monitor ERT compliance. Future studies are necessary to evaluate the association between PEA levels and functional performance.

The Association of Glucocorticosteroid Treatment with WBC Count in Patients with COPD Exacerbation.

Systematic glucocorticosteroids (GCS) are used to treat chronic obstructive pulmonary disease (COPD) and can cause leukocytosis. Distinguishing the effect of GCS on leukocyte level from infection-induced leukocytosis is important. We sought to quantify the effect of chronic GCS treatment on leukocytosis level in patients with COPD exacerbation. We reviewed the records of patients with COPD exacerbation and fever hospitalized in a tertiary medical center in 2003–2014. Patients were classified according to the GCS treatment they received: chronic GCS treatment (CST), acute GCS treatment (AST), and no prior GCS treatment (NGCS). We used the eosinophil absolute count as a marker of compliance and efficacy of steroid treatment. The primary outcome was the maximal white blood cell (WBC) count within the first 24 h of admission. Of 834 patients, 161 were categorized as CST, 116 AST, and 557 NGCS. The overall maximal leukocyte count was higher and the eosinophil count lower in the two GCS therapy groups. In patients with COPD exacerbation and fever, acutely treated with GCS, the mean increase in the WBC count was more evident when the eosinophils were undetectable (absolute count of zero). This supports leukocytosis level as a marker of disease course in COPD and fever.