Pilot Plant-Based Lifestyle Medicine Program in an Urban Public Healthcare System: Evaluating Demand and Implementation.

Lifestyle interventions that optimize nutrition, physical activity, sleep health, social connections, and stress management, and address substance use, can reduce cardiometabolic risk. Despite substantial evidence that healthful plant-based diets are beneficial for long-term cardiometabolic health and longevity, uncertainty lies in how to implement plant-based lifestyle programs in traditional clinical settings, especially in safety-net contexts with finite resources. In this mixed-methods implementation evaluation of the Plant-Based Lifestyle Medicine Program piloted in a large public healthcare system, we surveyed participants and conducted qualitative interviews and focus groups with stakeholders to assess program demand in the eligible population and feasibility of implementation within the safety-net setting. Program demand was high and exceeded capacity. Participants' main motivations for joining the program included gaining more control over life, reducing medication, and losing weight. The program team, approach, and resources were successful facilitators. However, the program faced administrative and payor-related challenges within the safety-net setting, and participants reported barriers to access. Stakeholders found the program to be valuable, despite challenges in program delivery and access. Findings provide guidance for replication. Future research should focus on randomized controlled trials to assess clinical outcomes as a result of program participation.

Planting the Seed for Blood Pressure Control: The Role of Plant-Based Nutrition in the Management of Hypertension.

PURPOSE OF REVIEW: Hypertension results in significant morbidity, mortality, and healthcare expenditures. Fortunately, it is largely preventable and treatable by implementing dietary interventions, though these remain underutilized. Here, we aim to explore the role of healthy dietary patterns in hypertension management and describe approaches for busy clinicians to address nutrition effectively and efficiently with patients. RECENT FINDINGS: DASH, Mediterranean, vegetarian, and vegan diets that include minimally processed, plant-based foods as core elements have consistently shown positive effects on hypertension. Recommendations that distill the most healthful components of these diets can significantly impact patient outcomes. Clinicians can harness evidence-based dietary assessment and counseling tools to implement and support behavioral changes, even during brief office visits. Healthful plant-based dietary patterns can often effectively prevent and treat hypertension. Clinicians may help improve patient outcomes by discussing evidence-based nutrition with their patients. Future work to promote infrastructural change that supports incorporating evidence-based nutrition into medical education, clinical care, and society at large can support these efforts.

Risks of the ketogenic diet in CKD - the con part.

The ketogenic diet is a very low carbohydrate diet that has received a lot of attention for its role in the treatment of type 2 diabetes and obesity. For patients with chronic kidney disease, there is limited evidence on the risks and/or benefits of this diet. However, from the limited evidence that does exist, there are several inferences that can be drawn regarding this diet for patients with kidney disease. The ketogenic diet may not be better than comparator higher carbohydrate diets over the long term. The diet also has low adherence levels in studies lasting ≥12 months. The diet's emphasis on fat, which often comes from animal fat, increases the consumption of saturated fat, which may increase the risk of heart disease. It has the potential to worsen metabolic acidosis by increasing dietary acid load and endogenous acid production through the oxidation of fatty acids. In addition, the diet has been associated with an increased risk of kidney stones in patients using it for the treatment of refractory epilepsy. For these reasons, and for the lack of safety data on it, it is reasonable for patients with kidney disease to avoid utilizing the ketogenic diet as a first-line option given alternative dietary patterns (like the plant-dominant diet) with less theoretical risk for harm. For those adopting the ketogenic diet in kidney disease, a plant-based version of the ketogenic diet may mitigate some of the concerns with animal-based versions of the ketogenic diet.

Plant-based diets and postprandial hyperkalemia.

This Letter to the Editor is a response to St-Jules and Fouque and their interpretation of postprandial hyperkalemia, especially regarding plant-based diets. Based on the reviewed literature review, potassium kinetic studies cited by the authors include only 1 study with a food-based intervention that actually showed reduced postprandial hyperkalemia with plant-based diets. The remainder of the studies used potassium salts or supplements that behave differently compared with whole plant foods. As such, we recommend avoiding restriction of whole plant foods in patients with chronic kidney disease when solely based on the theoretical risk of postprandial hyperkalemia.

Still no direct evidence of postprandial hyperkalemia with plant foods.

Although St-Jules et al have presented the case for postprandial hyperkalemia with food, including plant foods, there (still) is little to no direct evidence supporting the occurrence of postprandial hyperkalemia, mostly due to a lack of studies performed exclusively using food. Food is different than salts or supplements, and it is likely that a banana behaves differently than potassium salts. A growing body of evidence supports the use of plant foods without causing hyperkalemia in patients with kidney disease. Currently, only 1 study has reported on the postprandial effects of hyperkalemia. In this study, there was a substantial reduction in the instances of postprandial hyperkalemia in participants consuming a diet that included more plant foods and more fiber. At the time of this writing, there is no evidence to support risk or safety of certain foods with regard to postprandial hyperkalemia, and additional research is warranted.

An Inconspicuous Offender: Apixaban-Induced Anticoagulant-Related Nephropathy.

Direct oral anticoagulants (DOACs) have shifted the landscape of anticoagulation over the past decade, becoming a frequently used pharmaceutical agent. The increased use of DOACs for long-term anticoagulation has led to a rise in reported anticoagulant-related adverse reactions, such as anticoagulant-related nephropathy (ARN). The occurrence of ARN is well reported with warfarin; however, there are few cases of ARN reported with DOAC use. We report the case of an elderly man with coronary artery disease and hypertension who was initiated on apixaban for atrial fibrillation three years prior to presentation but developed rapid renal decline over the six months prior to presentation. The estimated glomerular filtration rate (eGFR) had decreased precipitously from 48 mL/min/1.73 m2 to 19 mL/min/1.73 m2 with a concurrent drop in hemoglobin in the setting of persistent microscopic hematuria. A renal biopsy showed red blood cell casts consistent with glomerular hematuria, despite no crescents or signs of other forms of glomerulonephritis. The patient's renal function ceased to deteriorate and had a 35% recovery (serum creatinine 2.6 mg/dL, eGFR 25 mL/min/1.73 m2) after the discontinuation of apixaban and conversion to rivaroxaban without the use of corticosteroids. The patient reported at follow-up that he discontinued rivaroxaban four days after initiation on his own accord due to extrarenal bleeding. Our case highlights the importance of prompt recognition and treatment of the underreported but potentially significant incidence of ARN with apixaban in a patient with an otherwise unexplained kidney injury.

Neuropsychiatric Outcomes in Intensive Care Unit Survivors.

BACKGROUND: Over the last two decades, there has been phenomenal advancement in critical care medicine and patient management. Many patients recover from life-threatening illnesses that they might not have survived a decade ago. Despite a decrease in mortality, these survivors endure long-lasting sequelae like physical, mental, and emotional symptoms. METHODS: Patients after intensive care unit (ICU) discharge were assessed in a follow-up outpatient department (OPD) clinic for anxiety, stress, and depression. Patients were asked to fill out the questionnaires Depression, Anxiety and Stress Scale-21 (DASS-21) and Short Form-36 (SF-36) for assessment of health-related quality of life (HRQOL) at 4th, 6th, and 8th months after discharge. ICU data were recorded, including patients' demographics, severity of illness and length of stay, and duration of mechanical ventilation. Patients who failed to follow-up in OPD on designated dates were assessed telephonically. RESULTS: Depression showed a positive, strong, and moderate correlation between length of stay and mechanical ventilation duration. A positive correlation was found between stress and length of stay and duration of mechanical ventilation. A positive strong correlation was found between anxiety and length of ICU stay, and a moderate positive correlation was found between anxiety and duration of mechanical ventilation. A weak correlation was found between age and neuropsychiatric outcomes. CONCLUSION: The severity of depression, anxiety, and stress was significantly higher at four months compared to six months. Severity decreased with time. Prolonged ICU stay increased levels of anxiety, depression, and stress. HRQOL improved from four to six months.

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting.

Lifestyle medicine interventions that emphasize healthy behavior changes are growing in popularity in U.S. health systems. Safety-net healthcare settings that serve low-income and uninsured populations most at risk for lifestyle-related disease are ideal venues for lifestyle medicine interventions. Patient-reported outcomes are important indicators of the efficacy of lifestyle medicine interventions. Past research on patient-reported outcomes of lifestyle medicine interventions has occurred outside of traditional healthcare care settings. In this study, we aimed to assess patient-reported outcomes on nutrition knowledge, barriers to adopting a plant-based diet, food and beverage consumption, lifestyle behaviors, self-rated health, and quality-of-life of participants in a pilot plant-based lifestyle medicine program in an urban safety-net healthcare system. We surveyed participants at three time points (baseline, 3 months, 6 months) to measure change over time. After 6 months of participation in the program, nutrition knowledge increased by 7.2 percentage points, participants reported an average of 2.4 fewer barriers to adopting a plant-based diet, the score on a modified healthful plant-based diet index increased by 5.3 points, physical activity increased by 0.7 days per week while hours of media consumption declined by 0.7 h per day, and the percentage of participants who reported that their quality of sleep was "good" or "very good" increased by 12.2 percentage points. Our findings demonstrate that a lifestyle medicine intervention in a safety-net healthcare setting can achieve significant improvements in patient-reported outcomes. Key lessons for other lifestyle medicine interventions include using a multidisciplinary team; addressing all pillars of lifestyle medicine; and the ability for patients to improve knowledge, barriers, skills, and behaviors with adequate support.

Assessing how lung cancer screening guidelines contribute to racial disparities in screening access.

Background: Lung cancer (LC) is the leading cause of cancer-related deaths in the United States (U.S.), with non-White people who smoke often bearing the burden of the highest rate of LC mortality. This is often due to later stage diagnoses, leading to poor prognosis and outcomes. We assess here how the eligibility criteria for LC screening set by the U.S. Preventive Services Task Force (USPSTF) and the Centers for Medicare and Medicaid Services (CMS) could contribute to racial disparities in screening access. Methods: This paper analyzes data from the National Health and Nutrition Examination Survey (NHANES), an annual survey conducted by the Centers for Disease Control and Prevention (CDC) that gathers health and nutrition data from a representative sample of the U.S. population. After excluding those who were ineligible for LC screening, the final cohort of participants was 5,001, which consisted of 2,669 people who formerly smoked and 2,332 people who currently smoke. Results: Out of 608 participants who were eligible for LC screening, 77.5% were non-Hispanic White (NHW) and 8.7% were non-Hispanic Black (NHB) participants versus 69.4% and 10.8% among 4,393 ineligible participants. Age, pack-years, and age along with pack-years were the most frequent reasons for ineligibility. LC screening ineligible NHW participants were statistically significantly older and had higher mean pack-years than the other racial and ethnic groups. NHB participants among the ineligible group had higher urinary cotinine levels compared to NHW participants. Conclusions: This paper underscores the need for more individualized risk estimates when determining eligibility for LC screening, which could include biomarkers of smoking exposure. The analysis shows that current screening criteria, which rely solely on factors such as age and pack years, contribute to LC racial disparities.

Change in cardiometabolic risk factors in a pilot safety-net plant-based lifestyle medicine program.

Introduction: Interventions emphasizing healthful lifestyle behaviors are proliferating in traditional health care settings, yet there is a paucity of published clinical outcomes, outside of pay-out-of-pocket or employee health programs. Methods: We assessed weight, hemoglobin A1c (HbA1c), blood pressure, and cholesterol for 173 patients of the Plant-Based Lifestyle Medicine Program piloted in a New York City safety-net hospital. We used Wilcoxon signed-rank tests to assess changes in means, from baseline to six-months, for the full sample and within baseline diagnoses (i.e., overweight or obesity, type 2 diabetes, prediabetes, hypertension, hyperlipidemia). We calculated the percentage of patients with clinically meaningful changes in outcomes for the full sample and within diagnoses. Findings: The full sample had statistically significant improvements in weight, HbA1c, and diastolic blood pressure. Patients with prediabetes or overweight or obesity experienced significant improvements in weight and those with type 2 diabetes had significant improvements in weight and HbA1c. Patients with hypertension had significant reductions in diastolic blood pressure and weight. Data did not show differences in non-high-density lipoprotein cholesterol (non-HDL-C), but differences in low-density lipoprotein cholesterol (LDL-C) were approaching significance for the full sample and those with hyperlipidemia. The majority of patients achieved clinically meaningful improvements on all outcomes besides systolic blood pressure. Conclusion: Our study demonstrates that a lifestyle medicine intervention within a traditional, safety-net clinical setting improved biomarkers of cardiometabolic disease. Our findings are limited by small sample sizes. Additional large-scale, rigorous studies are needed to further establish the effectiveness of lifestyle medicine interventions in similar settings.

The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study.

BACKGROUND: Hepatocellular cancer (HCC) is associated with high mortality, and early diagnosis leads to better survival. Patients with cirrhosis, especially due to nonalcoholic fatty liver disease and viral hepatitis, are at higher risk of developing HCC and form the main screening group. The current screening methods for HCC (6-monthly screening with serum alpha fetoprotein and ultrasound liver) have low sensitivity; hence, there is a need for better screening markers for HCC. OBJECTIVE: Our study, TENDENCY, aims to validate the novel screening markers (methylated septin 9, urinary volatile organic compounds, and urinary peptides) for HCC diagnosis and study these noninvasive biomarkers in liver disease. METHODS: This is a multicenter, nested case-control study, which involves comparing the plasma levels of methylated septin 9 between confirmed HCC cases and patients with cirrhosis (control group). It also includes the comparison of urine samples for the detection of HCC-specific volatile organic compounds and peptides. Based on the findings of a pilot study carried out at University Hospital Coventry & Warwickshire, we estimated our sample size to be 308 (n=88, 29% patients with HCC; n=220, 71% patients with cirrhosis). Urine and plasma samples will be collected from all participants and will be frozen at -80 °C until the end of recruitment. Gas chromatography-mass spectrometry will be used for urinary volatile organic compounds detection, and capillary electrophoresis-mass spectrometry will be used for urinary peptide identification. Real-time polymerase chain reaction will be used for the qualitative detection of plasma methylated septin 9. The study will be monitored by the Research and Development department at University Hospital Coventry & Warwickshire. RESULTS: The recruitment stage was completed in March 2023. The TENDENCY study is currently in the analysis stage, which is expected to finish by November 2023. CONCLUSIONS: There is lack of effective screening tests for hepatocellular cancer despite higher mortality rates. The application of more sensitive plasma and urinary biomarkers for hepatocellular cancer screening in clinical practice will allow us to detect the disease at earlier stages and hence, overall, improve HCC outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44264.

Trends in prostate cancer incidence among Black men in the Caribbean and the United States.

BACKGROUND: Prostate cancer incidence is highest for Black men of the African diaspora in the United States and Caribbean. Recent changes in recommendations for prostate cancer screening have been shown to decrease overall prostate cancer incidence and increase the likelihood of late stage disease. However, it is unclear how trends in prostate cancer characteristics among high risk Black men differ by geographic region during the changes in screening recommendations. METHODS: In this study, we used population-based prostate cancer registry data to describe age-adjusted prostate cancer incidence trends from 2008 to 2015 among Black men from six geographic regions. We obtained data on incident Black prostate cancer patients from six cancer registries (in the United States: Florida, Alabama, Pennsylvania, and New York; and in the Caribbean: Guadeloupe and Martinique). After age standardization, we used descriptive analyses to compare the demographics and tumor characteristics by cancer registry site. The Joinpoint regression program was used to compare the trends in incidence by site. RESULTS: A total of 59,246 men were analyzed. We found the highest incidence rates (per 100,000) for prostate cancer in the Caribbean countries (181.99 in Martinique and 176.62 in Guadeloupe) and New York state (178.74). Incidence trends decreased significantly over time at all sites except Martinique, which also showed significantly increasing rates of late stage (III/IV) and Gleason score 7+ tumors. CONCLUSIONS: We observed significant differences in prostate cancer incidence trends among Black men after major changes prostate screening recommendations. Future studies will examine the factors that differentially influence prostate cancer trends among the African diaspora.

Risks and Benefits of Different Dietary Patterns in CKD.

Food has the potential to cause and exacerbate many lifestyle diseases. Or it can be used to prevent and treat illnesses like primary hypertension, the metabolic syndrome, and insulin resistance. In parallel, there is also a growing body of evidence of the role of diet in the treatment of kidney disease and its ensuing complications. Popular diets for this purpose have included low-carbohydrate diets, including the ketogenic diet, and higher carbohydrate diets like Mediterranean diets and other plant-based dietary patterns. Low-carbohydrate diets have not shown harm in patients with kidney disease and may benefit a select few. Mediterranean diets have an established record of cardioprotective benefits but also may be beneficial for the kidney. Intermittent fasting has benefits for metabolic health, but limited research exists on the risk or benefit for patients with kidney disease. Plant-based diets, especially those that are lower in protein, may slow kidney disease progression, mitigate uremia, and delay dialysis initiation. Although each dietary pattern has its unique pros and cons, most healthful dietary patterns favor the inclusion of whole, unprocessed foods, preferably from plant-based sources. In this perspective, we discuss the risks and benefits of major popular diets to help guide health care professionals in treating patients with kidney disease.

Common Clinical Trial Amendments, why they are submitted and how they can be avoided: a mixed methods study on NHS UK Sponsored Research (Amendments Assemble).

BACKGROUND: Amendments are changes made to a clinical trial after it has received regulatory approval. An amendment can take a significant amount of time and resources to develop, review and implement at participating sites. This can affect the efficient delivery of clinical trials and potentially contribute to research waste. This study aimed to establish what the most common amendments are, why they are submitted, and what, if anything, can be done to avoid them. METHODS: An explanatory sequential mixed methods design was employed. The first strand involved a content analysis on a sample of amendments, submitted in trials sponsored by a University Hospital NHS Trust between September 2009 and March 2020, to establish the most common changes and reasons for amendments. The second strand involved thematically analysing semi-structured interviews with trial stakeholders to explore their views on the reasons underpinning the submission of amendments, and the potential for efficiencies that could prevent avoidable amendments. RESULTS: Two hundred forty-two approved amendments were examined from 53 clinical research studies. The 'Addition of sites' was the most common amendment change, and the most common reason for amendments was 'To achieve the trial's recruitment target'. The root causes for avoidable amendments identified by the 11 interviewees included the following: 'Rushing the initial application knowing an amendment will be needed later', 'Not involving all the right people to input' at the start of the trial, and 'Realising it's not feasible in practice when delivering the trial'. Missing regulatory checks following an onerous and error-prone application process were also identified as the cause of some amendments. CONCLUSIONS: Trials need to be critically reviewed by various stakeholders and have sufficient time allocated to planning and feasibility assessments to avoid some amendments. This may improve clinical trial efficiency, to benefit the trial participants, researchers, funders, sponsors, and regulatory bodies, and potentially bring new treatments to patients faster.

Hyperkalemia and Plant-Based Diets in Chronic Kidney Disease.

Traditional dietary guidelines for patients with kidney disease recommend restriction of plant foods due to concerns about hyperkalemia and associated adverse events. Studies conducted over several decades have shown that the basis for these guidelines does not match the evidence. Serum potassium levels can be elevated in patients with reduced kidney function after consumption of foods with potassium-based additives or with highly concentrated potassium content such as juices, dried fruit, or purees. However, plant foods may have certain qualities that may blunt potassium retention including their alkalinizing effects, the lack of bioavailable potassium, and the impact of dietary fiber in organic plant foods on colonic potassium excretion. Furthermore, there are many benefits of plant foods that patients with kidney disease may be missing by excluding them from their diets by recommending the historical low-potassium "renal diet." Revised dietary recommendations for kidney health may encourage patient-centered kidney recipes that revolve around plant foods and do not restrict them.

Low-Protein Diets and Its Synergistic Role in the SGLT2 Inhibitor Era.

Low-protein diets (LPDs), usually defined as a daily dietary protein intake of 0.6 to 0.8 g/kg body weight, have been recommended for decades as a safe and effective lifestyle modification to ameliorate inflammatory damage and proteinuria, reduce glomerular hyperfiltration, and improve metabolic acidosis control in patients with chronic kidney disease (CKD). The mechanism for this is largely attributed to altered tubuloglomerular feedback and afferent arteriole contraction leading to decreased glomerular pressure. Additionally, low protein intake reduces urea generation, which can help delay dialysis initiation in advanced CKD. LPDs have different types including plant-dominant LPDs that can exert additional kidney protective effects as a result of dietary protein quality in addition to quantity. In addition, strong clinical evidence shows that a new class of diabetes mellitus medications, the sodium-glucose cotransporter 2 inhibitors, reduces albuminuria and slows the estimated glomerular filtration rate decline in CKD, even in patients without diabetes mellitus, especially if significant proteinuria is present. Given prior studies investigating the effect of LPDs used in conjunction with angiotensin pathway modulators, we argue that LPDs have a synergistic role in disease management and are expected to display additive effects when combined with sodium-glucose cotransporter 2 inhibitor usage or other pharmacologic agents. Even with medical therapy, it is prudent to implement tailored LPDs for different types of CKD.

Popular Diets and Kidney Stones.

Popular diets often influence dietary patterns, which have different implications for kidney stone risk. Despite the wide variety of popular diets, some general principles can be gleaned from investigating their potential impact on nephrolithiasis. Plant-based diets, including Dietary Approaches to Stop Hypertension, Mediterranean, flexitarian, and vegetarian diets, may protect against nephrolithiasis when they consist largely of unprocessed plant foods, while carbohydrate-restricted diets (including high-protein diets and the ketogenic diet) may raise kidney stone risk. Patients should be advised to consume a diet rich in whole plants, particularly fruits and vegetables, and minimize their consumption of animal proteins. Accompanying fruits and vegetables that are higher in oxalate content with more water and some dairy intake may also be useful. (We address the oxalate content of fruits and vegetables further below). Calcium consumption is an important component of decreasing the risk of kidney stones, as higher dietary calcium from dairy or nondairy sources is independently associated with lower kidney stone risk. Patients should also be advised to be conscious of fat intake, as fat in the intestinal lumen may complex with calcium and therefore increase urinary oxalate excretion. Finally, patients should avoid consumption of processed foods, which often contain added fructose and high sodium content, two factors that increase kidney stone risk.