Evaluation of a Produce Prescription Program for Patients With Diabetes: A Longitudinal Analysis of Glycemic Control.

OBJECTIVE: Produce prescriptions have shown promise in improving diabetes care, although most studies have used small samples or lacked controls. Our objective was to evaluate the impacts of a produce prescription program on glycemic control for patients with diabetes. RESEARCH DESIGN AND METHODS: Participants included a nonrandom enrollment of 252 patients with diabetes who received a produce prescription and 534 similar control participants from two clinics in Hartford, Connecticut. The start of the COVID-19 pandemic in March 2020 coincided with program implementation. Produce prescription enrollees received vouchers ($60 per month) for 6 months to purchase produce at grocery retail. Controls received usual care. The primary outcome was change in glycated hemoglobin (HbA1c) between treatment and control at 6 months. Secondary outcomes included 6-month changes in systolic (SBP) and diastolic blood pressure (DBP), BMI, hospitalizations, and emergency department admissions. Longitudinal generalized estimating equation models, weighted with propensity score overlap weights, assessed changes in outcomes over time. RESULTS: At 6 months, there was no significant difference in change in HbA1c between treatment and control groups, with a difference of 0.13 percentage points (95% CI -0.05, 0.32). No significant difference was observed for change in SBP (3.85 mmHg; -0.12, 7.82), DBP (-0.82 mmHg; -2.42, 0.79), or BMI (-0.22 kg/m2; -1.83, 1.38). Incidence rate ratios for hospitalizations and emergency department visits were 0.54 (0.14, 1.95) and 0.53 (0.06, 4.72), respectively. CONCLUSIONS: A 6-month produce prescription program for patients with diabetes, implemented during the onset of the COVID-19 pandemic, was not associated with improved glycemic control.

A randomized, controlled trial of a stress management intervention for Latinos with type 2 diabetes delivered by community health workers: Outcomes for psychological wellbeing, glycemic control, and cortisol.

AIMS: To test the efficacy of a community health worker (CHW) delivered stress management (SM) intervention on psychosocial, glycemic, and cortisol outcomes among U.S. Latinos with type 2 diabetes. METHODS: A randomized, controlled trial compared CHW-delivered diabetes education (DE; one group session) to DE plus CHW-delivered SM (DE+SM; 8 group sessions). Psychosocial variables and urinary cortisol were measured at baseline and posttreatment. HbA1c was measured at baseline, posttreatment, and 3-month follow-up. RESULTS: In intent to treat analysis, compared to DE (n=46), DE+SM (n=61) showed significantly improved symptoms of depression, anxiety, and self-reported health status. There were no significant group effects for HbA1c, diabetes distress, or urinary cortisol. However, there was a dose response effect for HbA1c and diabetes distress; increasing attendance at SM sessions was associated with greater improvements in HbA1c and diabetes distress. CONCLUSIONS: This is the first randomized, controlled trial demonstrating that CHWs can improve psychological symptoms and self-reported health among Latinos with type 2 diabetes. Efforts to increase intervention attendance may improve HbA1c and diabetes distress.

A Novel Admixture-Based Pharmacogenetic Approach to Refine Warfarin Dosing in Caribbean Hispanics.

AIM: This study is aimed at developing a novel admixture-adjusted pharmacogenomic approach to individually refine warfarin dosing in Caribbean Hispanic patients. PATIENTS & METHODS: A multiple linear regression analysis of effective warfarin doses versus relevant genotypes, admixture, clinical and demographic factors was performed in 255 patients and further validated externally in another cohort of 55 individuals. RESULTS: The admixture-adjusted, genotype-guided warfarin dosing refinement algorithm developed in Caribbean Hispanics showed better predictability (R2 = 0.70, MAE = 0.72mg/day) than a clinical algorithm that excluded genotypes and admixture (R2 = 0.60, MAE = 0.99mg/day), and outperformed two prior pharmacogenetic algorithms in predicting effective dose in this population. For patients at the highest risk of adverse events, 45.5% of the dose predictions using the developed pharmacogenetic model resulted in ideal dose as compared with only 29% when using the clinical non-genetic algorithm (p<0.001). The admixture-driven pharmacogenetic algorithm predicted 58% of warfarin dose variance when externally validated in 55 individuals from an independent validation cohort (MAE = 0.89 mg/day, 24% mean bias). CONCLUSIONS: Results supported our rationale to incorporate individual's genotypes and unique admixture metrics into pharmacogenetic refinement models in order to increase predictability when expanding them to admixed populations like Caribbean Hispanics. TRIAL REGISTRATION: ClinicalTrials.gov NCT01318057.

Improving COPD Care in a Medically Underserved Primary Care Clinic: A Qualitative Study of Patient Perspectives.

We conducted a focus group study in an urban hospital-based primary care teaching clinic serving an indigent and Hispanic (predominantly Puerto Rican) population in New England in order to learn how patients with Chronic Obstructive Lung Disease (COPD) perceive their disease, how they experience their medical care, and the barriers they face managing their disease and following medical recommendations. The research team included medical doctors, nurses, a medical anthropologist, a clinical pharmacist, a hospital interpreter, and a systems analyst. Four focus groups were conducted in Spanish and English in April and May 2014. The demographic characteristics of the 25 focus group participants closely reflected the demographics of the total COPD clinic patients. The participants were predominantly female (72%) and Hispanic (72%) and had a median age of 63. The major themes expressed in the focus groups included: problems living with COPD; coping with complexities of comorbid illnesses; challenges of quitting smoking and maintaining cessation; dealing with second-hand smoke; beliefs and myths about quitting smoking; difficulty paying for and obtaining medications; positive experiences obtaining and managing medications; difficulties in using sleep machines at home; expressions of disappointment with the departure of their doctors; and overall satisfaction with the clinic health care providers. The study led to the creation of an action plan that addresses the concerns expressed by the focus study participants. The action plan is spearheaded by a designated bilingual and bicultural nurse and is now in operation.

Community health workers assisting Latinos manage stress and diabetes (CALMS-D): rationale, intervention design, implementation, and process outcomes.

Latinos have high rates of diabetes and mental distress, but lack appropriate services. A study was designed to compare enhanced standard diabetes care with enhanced standard care plus community health worker (CHW) delivered stress management for Latinos with type 2 diabetes. This paper reports intervention design and process outcomes. A formative process was used to develop and implement an eight-session, group stress management intervention. One hundred twenty-one participants completed baseline assessments; n = 107 attended diabetes education and were then randomized. Recruits reported high credibility and treatment expectancies. Treatment fidelity was high. Participants reported high treatment satisfaction and therapeutic alliance and their diabetes knowledge and affect improved over the short term. Retention and attendance at group sessions was challenging but successful relative to similar trials. This comprehensive and culturally sensitive stress management intervention, delivered by a well-trained CHW, was successfully implemented.

Breast self-examination beliefs and practices, ethnicity, and health literacy: Implications for health education to reduce disparities.

OBJECTIVE: This study aimed to quantitatively and qualitatively examine breast cancer screening practices, including breast self-examination (BSE), and health literacy among patients with chronic disease. DESIGN: A prospective, multi-method study conducted with a targeted purposive sample of 297 patients with diabetes and/or hypertension from four ethnic groups (Latino, Vietnamese, African American, White-American) at an urban community health center. SETTING: A federally qualified health center in Western Massachusetts. METHODS: In our four-year study, 297 participants completed cancer knowledge, beliefs, attitudes and screening utilization scales and measures of health literacy. In addition to survey data collection, we conducted in-depth interviews, focus groups, home visits, and chronic disease diaries (n=71). RESULTS: In focus groups, African American, Vietnamese and Latina participants offered interviewers an unprompted demonstration of BSE, reported regular BSE use at particular times of the month, and shared positive feelings about the screening method. In a sample where approximately 93% of women have had a mammogram, many also had performed BSE (85.2%). Women with adequate health literacy were more likely than those with inadequate health literacy to rely on it. Despite being positively inclined toward BSE, Vietnamese women, who had the lowest health literacy scores in our sample, were less likely to perform BSE regularly. CONCLUSIONS: BSE seemed to be an appealing self-care practice for many women in our study, but we conclude that proper BSE practices may not be reinforced equally across ethnic groups and among patients with low health literacy.

Effect of a virtual pain coach on pain management discussions: a pilot study.

There is a need to enhance patient and practitioner pain communications. A pain communication plus virtual pain coach intervention was tested in the primary care setting for the effect on communication of osteoarthritis pain information by older adults aged ≥60 years, on practitioners' pain management changes, and on older adults' reduced pain and depressive symptoms 1 month later. A randomized controlled pilot study design was used. Twenty-three older adults with osteoarthritis pain were randomly assigned to the pain communication plus virtual pain coach group or the pain communication-only group. Pain communication consisted of a video of important osteoarthritis pain information. The coach consisted of practicing out loud with a virtual pain coach via laptop computer. Pain and depressive symptoms were measured with, respectively, the Brief Pain Inventory Short Form and the Beck Depression Inventory II before intervention and 1 month later. Immediately after the intervention, older adults had their primary care visits, which were audiotaped, transcribed, and content analyzed for older adults' communicated pain information and practitioners' pain management changes. Older adults in the pain communication plus virtual pain coach group described significantly more pain source information and were prescribed significantly more osteoarthritis pain treatments than older adults in the pain communication-only group. A nonsignificant trend in pain intensity and depressive symptoms reduction resulted for older adults in the pain communication plus virtual pain coach group 1 month later. The virtual pain coach presents a possible strategy for increasing pain management discussions between practitioners and older adults with persistent pain.

Development of a pharmacogenetic-guided warfarin dosing algorithm for Puerto Rican patients.

AIM: This study was aimed at developing a pharmacogenetic-driven warfarin-dosing algorithm in 163 admixed Puerto Rican patients on stable warfarin therapy. PATIENTS & METHODS: A multiple linear-regression analysis was performed using log-transformed effective warfarin dose as the dependent variable, and combining CYP2C9 and VKORC1 genotyping with other relevant nongenetic clinical and demographic factors as independent predictors. RESULTS: The model explained more than two-thirds of the observed variance in the warfarin dose among Puerto Ricans, and also produced significantly better 'ideal dose' estimates than two pharmacogenetic models and clinical algorithms published previously, with the greatest benefit seen in patients ultimately requiring <7 mg/day. We also assessed the clinical validity of the model using an independent validation cohort of 55 Puerto Rican patients from Hartford, CT, USA (R(2) = 51%). CONCLUSION: Our findings provide the basis for planning prospective pharmacogenetic studies to demonstrate the clinical utility of genotyping warfarin-treated Puerto Rican patients.

The effect of a Spanish virtual pain coach for older adults: a pilot study.

OBJECTIVE: To pilot test the effects of a virtual pain coach on ambulatory Spanish-speaking older adults with pain from osteoarthritis. METHODS: A randomized, controlled design was used. Eighteen Spanish-speaking older adults were randomly assigned to the virtual pain coach and pain communication education group, or to the pain communication education-only group. All participants viewed the pain communication videotape. Participants in the virtual pain coach group practiced talking about their osteoarthritis pain with the virtual pain coach. Immediately after the respective intervention, participants had their ambulatory medical visit. Pain intensity and pain interference with activities were measured with the Brief Pain Inventory, and depressive symptoms were measured with the Beck Depression Inventory II at baseline and 1 month later. RESULTS: No significant group difference emerged for pain intensity, pain interference with activities, or depressive symptoms 1 month later. More older adults in the virtual pain coach group reported a change from nonuse to use of opioids at 1 month, 50% vs 0% of the education only group, Fisher's exact test, P = 0.023. CONCLUSIONS: Preliminary data indicate that the Spanish virtual pain coach might assist Spanish-speaking older adults to talk with their practitioner about their osteoarthritis pain and obtain opioid treatment changes, but that pain and depressive symptoms continue unchanged 1 month later. Additional refinement and testing is required for the Spanish-speaking virtual pain coach to determine acceptability and outcomes for assisting Spanish-speaking older adults to communicate about their pain with their primary care practitioner.

Exposure to non-therapeutic INR in a high risk cardiovascular patient: potential hazard reduction with genotype-guided warfarin (Coumadin) dosing.

A case to illustrate the utility of genetic screening in warfarin (Coumadin) management is reported. A 45 year-old woman of Puerto Rican ancestry was admitted to the emergency room twice within one month with chest pain. She was diagnosed with congestive heart failure, which was stabilized both times. At her second release, warfarin therapy was initiated at 5 mg/ day to prevent thrombus formation and was lowered to 3.75 mg/day at day 7 by her primary physician. International Normalized Ratio (INR) test results in the follow-up period at days 1, 7, and 10 of warfarin therapy were 4.5, 6.5, and 7.3, respectively-far in excess of the therapeutic range, despite the lower dosage in effect from day 7 onward. The patient achieved target INR over the next 43 days after downward adjustment of the dose to a dose of 1.5 mg/day by trial and error. DNA-typing specific for the CYP2C9*2,*3,*4,*5,*6 alleles and seven variants in the VKORC1 gene, including the VKORC1-1639 G > A polymorphism, revealed the presence of combinatorial CYP2C9*2/*3 and VKORC1-1639 G/A genotypes in this patient. Entering the patient's demographic and genotype status data into independent algorithms available in the public domain to predict effective warfarin dose yielded predicted doses which ranged from 1.5 to 1.8 mg/day. Notably, the prediction of 1.5 mg/day, which was generated by the online resource www.warfarindosing.org, coincided with the patient's actual effective warfarin dose. We conclude that the rapid rise in INR observed upon the initiation of warfarin therapy and the final effective warfarin dose of 1.5 mg/day, are attributable in some part to the presence of two minor alleles in CYP2C9, which together significantly reduce warfarin metabolism. Warfarin genotyping can therefore inform the clinician of the predicted effective warfarin dose. The results highlight the potential for warfarin genetic testing to improve patient care.

Hypertension in Puerto Ricans in the Continental United States.

INTRODUCTION: Puerto Ricans comprise one of the largest growing minority groups in the United States, yet data about hypertension in this population is lacking. OBJECTIVE: To review published literature concerning the epidemiology, morbidity, mortality, patient awareness, and treatment of hypertension in Puerto Ricans in the United States. LITERATURE REVIEW: The MEDLINE database was queried for English citations, dealing specifically with hypertension in Puerto Ricans. Most of the eligible studies were observational and qualitative in design and objectives. RESULTS: Data about the prevalence of hypertension, attributable morbidity and mortality, and treatment of hypertension in Puerto Ricans in the United States were limited or not available. CONCLUSIONS: Studies about hypertension in Puerto Ricans are few. Most studies are observational and the rare clinical trials have major design flaws. Puerto Ricans with hypertension appear to have some common characteristics with other racial groups in the United States, but also have unique considerations in the epidemiology, perception and awareness of hypertension and the management and control of hypertension.

A 32-year-old patient with hemolytic anemia and fulminant hepatic failure.

Wilson's disease presenting as acute hemolytic anemia and fulminant hepatic failure is a rare and poorly recognized disorder. We report a patient who developed hemolytic anemia and fulminant hepatic failure as the initial manifestations of Wilson's disease. The diagnosis was established by the findings of low serum ceruloplasmin, elevated urinary copper and elevated hepatic copper concentration. Liver transplantation is the only effective means of treatment in patients presenting with Wilsonian fulminant hepatic failure. Despite intensive medical therapy our patient had a fatal outcome before transplantation could be undertaken. The objective of this report is to discuss the clues to diagnosis in this form of Wilson's disease, as delay in diagnosis seems to be responsible for the high mortality.

Physicians-in-training attitudes toward caring for and working with patients with alcohol and drug abuse diagnoses.

INTRODUCTION: Physicians in all specialties commonly encounter patients who abuse alcohol or illegal drugs. Working with these patient populations can be challenging and potentially engender negative attitudes. This study is designed to identify the progression of attitudinal shifts over time of physicians-in-training toward caring for substance abusing patients. METHODS AND MATERIALS: A 31-item survey was designed to capture demographic information of participants, attitudes toward treating patients with substance abuse diagnoses, previous participant education, experience in and comfort with diagnosing and treating substance abuse, and satisfaction achieved in working with this patient population. Medical students in their third and fourth years of education as well as residents in training, years one through four, were surveyed. Responses to the survey's attitudinal items were analyzed across years of training, looking for changes associated with time and experience. RESULTS: Fifty-seven percent of eligible participants anonymously completed the survey. There was general agreement across all years of training that health care professionals should be allowed continued employment in their professions when in recovery from alcohol abuse (P = 0.424) and drug abuse (P = 0.409). Across years of training there was agreement that patients can recuperate and provide meaningful contributions to society when recovering from alcohol (P = 0.847) and drug (P = 0.859) abuse. From medical school years through residency there were enhanced beliefs that alcohol-abusing patients (P = 0.027) and drug-abusing patients (P = 0.009) overutilize health care resources. Most trainees, despite year of education, believe patients who abuse alcohol (P = 0.521 and illegal drugs (P = 0.356) have challenging medical and social issues from which they can learn. There was consistency across years in the perception that providing care to alcohol-abusing patients (P = 0.679) and drug-abusing patients (P = 0.090) is repetitive and detracts from the care of others. All felt their training was adequate to care for alcohol (P = 0.628) and drug-abusing patients (P = 0.484). Satisfaction achieved in caring for alcohol (P = 0.017) and illegal drug-abusing patients (P = 0.015) consistently diminishes over years in training. CONCLUSIONS: There are positive as well as negative aspects for physicians-in-training to caring for patients with alcohol and illegal drug abuse problems. Combining effective education strategies with the needs of physicians at specific points in their education may be effective in reversing the negative trends seen in attitudes toward caring for patients with substance abuse problems.

Awareness about factors that affect the management of hypertension in Puerto Rican patients.

INTRODUCTION: There are few published reports describing the health status of Hispanic populations in the United States with chronic illnesses, such as hypertension. Most studies on hypertension in Hispanics are on Mexican-Americans and little data exist for other Hispanic subgroups, such as Puerto Ricans. Health-related issues specific to a particular Hispanic subgroup may not be generalizable to all Hispanics. Patients' perceptions and awareness of health-related issues specific to a particular medical condition play an important role in the management and outcome. OBJECTIVE: The primary objective of the study is to determine if patients' general perceptions of hypertension, hypertension-related risk factors, complications, and life-style behavior modifications correlated with various patient demographics, such as age, gender, primary language, education level, socioeconomic status, marital status, health insurance category, and employment status. The working hypothesis is that patients who are older, unmarried, less educated, Spanish-speaking only, unemployed, and have low income, are more likely to report lack of awareness to various hypertension-related issues. SETTING: Hospital-based ambulatory center with major emphasis on providing care to underserved populations of the surrounding community, of which Puerto Ricans comprised the predominant ethnic group. STUDY DESIGN: A single, bilingual interviewer administered a series of questions to Hispanic, hypertensive patients. Questions were divided into the following seven categories: patient knowledge and perception of the disease; diet and salt intake; tobacco use; alcohol use; weight control and exercise; and medication and alternative therapy use. Within each category were various questions designed to study the patients' knowledge of hypertension, self-reported compliance with behavior modifications, and patient education on these behaviors. Data from 19 Puerto Rican patients were collected and chi-square tests and pothoc power analyses were performed. Responses to the various questions were correlated to patient demographics and socioeconomic variables. RESULTS: Use of herbal teas correlated significantly with the patients' primary language. Twenty-one percent of the patients who spoke Spanish only used herbal teas for treatment of their hypertension. All patients who reported herbal medication or tea use had a middle school education. There were many trends towards statistical significance in the following categories: patient perceptions and level of formal education; patient knowledge of hypertension and language spoken; salt intake and years of schooling; and correlation of herbal use with employment status, health insurance statu, and age. CONCLUSION: Additional research must be undertaken with larger sample sizes to give validity and statistical significance to the observed findings. This study and previous research, demonstrate some of the special issues that may need to be considered in the delivery of health care to specific Hispanic patient populations.

Insulin glargine: a systematic review of a long-acting insulin analogue.

BACKGROUND: Insulin glargine is the first long-acting basal insulin analogue indicated for subcutaneous administration once daily at bedtime in adults with type 1 or type 2 diabetes mellitus and pediatric patients aged > or = 6 years with type 1 diabetes. It differs in structure from native human insulin by 3 amino acids, a structural modification that provides a delayed onset of action and a constant, peakless effect that has a duration of at least 24 hours. OBJECTIVE: The goal of this article was to help determine the current place in therapy of insulin glargine by reviewing all available efficacy and tolerability data published since its introduction onto the market. METHODS: Relevant English-language articles were identified through searches of MEDLINE, PubMed, and EMBASE from 1966 to October 2002 and PREMEDLINE for November 2002. The search terms used were insulin, analogs, analogues, diabetes mellitus, glargine, HOE901, HOE-901, efficacy, safety, comparative study, treatment outcome, and case report. The reference lists of the identified articles were searched for additional relevant publications. Pharmacokinetic and pharmacodynamic data were reviewed and summarized. All large clinical trials (> or = 100 patients) evaluating the efficacy and tolerability of insulin glargine in patients with type 1 or type 2 diabetes were included in the review. Studies were compared in terms of their designs, primary and secondary efficacy parameters (glycosylated hemoglobin [HbA(1c)], fasting plasma glucose [FPG] and/or fasting blood glucose [FBG] level, incidence of hypoglycemia), and tolerability assessments. RESULTS: Fourteen trials met the criteria for inclusion in this review, 7 of them published only in abstract form. All were multicenter, randomized, open-label, parallel-group trials conducted in Europe or the United States, and ranged in duration from 4 to 52 weeks. They compared insulin glargine with neutral protamine Hagedorn (NPH) insulin given once or twice daily in >5000 patients with type 1 or type 2 diabetes, or in insulin-naive patients with type 2 diabetes that was poorly controlled by oral antidiabetic agents. Insulin doses were individually titrated to achieve a target FBG level < or =120 mg/dL (6.7 mmol/L). The studies were typically statistically underpowered to detect a significant difference in HbA(1c) between treatment groups; only 3 trials were of an adequate size to have 90% statistical power to detect a mean 0.5% difference in HbA(1c). Furthermore, analysis of the data from these trials was associated with a number of methodologic problems relating to inconsistencies in reporting. Given these limitations, the available data suggest that insulin glargine treatment produces statistically significant reductions in FPG or FBG levels at end point both compared with baseline and compared with NPH insulin (P < 0.001) without achieving overall significant improvements in HbA(1c) values. However, a recent abstract of a small 52-week trial in patients with type 1 diabetes reported a 0.4% additional decrease in HbA(1c) with insulin glargine treatment compared with NPH insulin. Patients have reported greater treatment satisfaction with insulin glargine compared with NPH insulin. The findings varied regarding weight gain, overall incidence of hypoglycemia, and incidence of nocturnal hypoglycemia. Currently, the cost of insulin glargine is twice that of NPH insulin on a per-unit basis. CONCLUSIONS: As a basal insulin replacement, insulin glargine administered once daily demonstrates a steady time-action profile over 24 hours without a pronounced peak. Based on the evidence from published clinical trials, insulin glargine appears to have equal clinical efficacy to NPH insulin, produces similar reductions in HbA(1c), and is associated with lower FPG and FBG levels and a consistent and significant reduction in the incidence of nocturnal hypoglycemia in patients with type 2 diabetes.

EKG rhythm interpretation patterns of medical interns: a needs assessment test.

Very little is known about electrocardiogram (EKG) competency interpretation of medical residents. EKG interpretative skills are requisite skills in anyone providing general medical care. A 30-item examination containing various EKG rhythms was administered to 113 medical interns prior to assumption of any clinical responsibilities. Incorrect and correct answers were recorded and plausible explanations to common incorrect answers are discussed. This study describes a four-year qualitative study about the patterns of cardiac rhythm interpretation skills of medical interns in one university-based internal medicine residency program. Future uses and implications of the results are also discussed.

Management of rosiglitazone-induced edema: two case reports and a review of the literature.

The thiazolidinediones are an important class of insulin-sensitizing agents used for the treatment of type 2 diabetes. Similar to other antidiabetic agents, use of the thiazolidinediones is limited by adverse drug reactions. Specifically, use of the thiazolidinediones is associated with a triad of fluid retention, edema, and weight gain. In premarketing clinical trials, edema was reported to occur infrequently with minimal severity. However, several published cases from postmarketing data demonstrate that thiazolidinedione-induced fluid retention, exhibited by the initial onset of peripheral edema and weight gain, can progress to a more severe form of pulmonary edema that is refractory to diuretic therapy with resolution of symptoms only through discontinuation of the offending thiazolidinedione. In clinical practice, the occurrence of edema secondary to a thiazolidinedione drug may occur more frequently than reported. Two cases presented in this report illustrate a different outpatient management approach that enables both desired glycemic control and minimal fluid retention while using the thiazolidinediones.