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Megan E Branda,1,2 Marleen Kunneman,1,3 Alejandra I Meza-Contreras,1,4 Nilay D Shah,5 Erik P Hess,6 Annie LeBlanc,7 Jane A Linderbaum,4 Danika M Nelson,4 Margaret R Mc Donah,8 Carrie Sanvick,9 Holly K Van Houten,10 Megan Coylewright,11 Sara R Dick,12 Henry H Ting,5 Victor M Montori1 1Knowledge and Evaluation Research Unit, Department of Medicine, Mayo Clinic, Rochester, MN, USA; 2Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA; 3Medical Decision Making, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, Netherlands; 4Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA; 5Delta Air Lines, Atlanta, GA, USA; 6Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; 7Faculty of Medicine, Laval University, Quebec City, Quebec, Canada; 8Mayo Clinic Health System, Mayo Clinic, Rochester, MN, USA; 9Department of Nursing, Mayo Clinic, Rochester, MN, USA; 10Robert D and Patricia E Kern Center for the Science of Healthcare Delivery, Mayo Clinic, Rochester, MN, USA; 11Section of Cardiovascular Medicine, Erlanger Heart and Lung Institute, Chattanooga, TN, USA; 12Education Project Management Office, Mayo Clinic, Rochester, MN, USACorrespondence: Victor M Montori, 200 First Street SW, Rochester, MN, 55905, USA, Tel +1 507-284-2511, Email Montori.victor@mayo.eduObjective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients’ knowledge and involvement in treatment decisions.Methods: In a pilot trial, patients hospitalized with AMI were randomized to the use of the AMI Choice conversation tool or to usual care. AMI Choice includes a pictogram of the patient’s estimated risk of mortality at 6 months with and without guideline-recommended medications, ie, aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors. Primary outcomes were patient knowledge and conflict with the decision made assessed via post-encounter surveys. Secondary outcomes were patient involvement in the decision-making process (observer-based OPTION12 scale) and 6-month medication adherence.Results: Patient knowledge of the expected survival benefit from taking medications was significantly higher (62% vs 16%, p< 0.0001) in the AMI Choice group (n = 53) compared to the usual care group (n = 53). Both groups reported similarly low levels of conflict with the decision to start the medications (13 (SD 24.2) vs 16 (SD 22) out of 100; p=0.16). The extent to which clinicians in the AMI Choice group involved their patients in the decision-making process was high (OPTION12 score 53 out of 100, SD 12). Medication adherence at 6-months was relatively high in both groups and not different between groups.Conclusion: The AMI Choice conversation tool improved patients’ knowledge of their estimated risk of short-term mortality after an AMI and the pros and cons of treatments to reduce this risk. The effect on patient fidelity to recommended medications of using this SDM tool and of SDM in general should be tested in larger trials enrolling patients at high risk for nonadherence.Trial Registration Number: NCT00888537.Keywords: shared decision making, acute myocardial infarction, adherence, randomized trial

Nidhi D Shah,1 Parth S Shah,2 Yash Y Panchal,3 Kalpesh H Katudia,3 Nikunj B Khatri,3 Hari Shankar P Ray,3 Upti R Bhatiya,3 Sandip C Shah,3 Bhavini S Shah,1 Mandava V Rao4 1Department of Pediatrics, Nassau University Medical Center, New York City, NY, USA; 2Department of Medicine, Lahey Hospital and Medical Center, Boston, MA, USA; 3Supratech Micropath Laboratory and Research Institute, Ahmedabad, Gujarat, India; 4School of Sciences, Gujarat University, Ahmedabad, Gujarat, India Background: Germline mutations BRCA1 and BRCA2 contribute almost equally in the causation of breast cancer (BC). The type of mutations in the Indian population that cause this condition is largely unknown.Purpose: In this cohort, 79 randomized BC patients were screened for various types of BRCA1 and BRCA2 mutations including frameshift, nonsense, missense, in-frame and splice site types. Materials and methods: The purified extracted DNA of each referral patient was subjected to Sanger gene sequencing using Codon Code Analyzer and Mutation Surveyor and next-generation sequencing (NGS) methods with Ion torrent software, after appropriate care. Results: The data revealed that 35 cases were positive for BRCA1 or BRCA2 (35/79: 44.3%). BRCA2 mutations were higher (52.4%) than BRCA1 mutations (47.6%). Five novel mutations detected in this study were p.pro163 frameshift, p.asn997 frameshift, p.ser148 frameshift and two splice site single-nucleotide polymorphisms (SNPs). Additionally, four nonsense and one in-frame deletion were identified, which all seemed to be pathogenic. Polymorphic SNPs contributed the highest percentage of mutations (72/82: 87.8%) and contributed to pathogenic, likely pathogenic, likely benign, benign and variant of unknown significance (VUS). Young age groups (20–60 years) had a high frequency of germline mutations (62/82;75.6%) in the Indian population. Conclusion: This study suggested that polymorphic SNPs contributed a high percentage of mutations along with five novel types. Younger age groups are prone to having BC with a higher mutational rate. Furthermore, the SNPs detected in exons 10, 11 and 16 of BRCA1 and BRCA2 were higher than those in other exons 2, 3 and 9 polymorphic sites in two germline genes. These may be contributory for BC although missense types are known to be susceptible for cancer depending on the type of amino acid replaced in the protein and associated with pathologic events. Accordingly, appropriate counseling and treatment may be suggested. Keywords: breast cancer, BRCA1 and BRCA2 gene mutations, polymorphic SNPs, novel types, age, NGS, Sanger gene sequencer

Parth S Shah,1 Nidhi D Shah,2 Hari Shankar P Ray,3 Nikunj B Khatri,3 Ketan K Vaghasia,3 Rutvik J Raval,4 Sandip C Shah,3 Mandava V Rao5 1Department of Medicine, Lahey Hospital and Medical Center, Boston, MA, 2Department of Pediatrics, Nassau University Medical Centre, New York, NY, USA; 3Supratech Micropath Laboratory and Research Institute, 4Department of Zoology, 5School of Sciences, Gujarat University, Ahmedabad, Gujarat, India Background: β-Thalassemia is the most prevalent genetic disorder in India. Its traits and coinheritance vary from mild to severe conditions, resulting in thalassemia minor, intermediate, and major, depending upon many factors.Purpose: The objective of this study was to identify the incidence of β-thalassemia traits, their coinheritance, and mutations, as well as to support the patients already diagnosed with β-thalassemia in East-Western Indian population for better management.Patients and methods: Seventy-five referral cases for β-thalassemia were analyzed for various β-thalassemia traits, heterozygosity, and homozygosity conditions. Blood phenotypic parameters using cell counter and capillary electrophoresis were investigated. Analyses of eight common mutations of thalassemia in India were carried out using polymerase chain reaction-amplification refractory mutation system, end point polymerase chain reaction, and DNA sequencing methods.Results: Of these (75) referral cases from East-Western Indian region, 68 were positive for β-thalassemia (90.67%). The majority of case types were of β-thalassemia minor (49, 65.33%), followed by HbE traits (6, 8.0%) and β-thalassemia major, including heterozygous and homozygous (5, 6.66%; 4, 5.33%) types and then HbE homozygous (2, 2.66%), as well as one each of the HbE/β-thalassemia and HbD/β-thalassemia (1, 1.34%) combination. Mutation analysis also revealed that the highest frequency of mutation was c.92+5G>C (41, 60.29%) followed by deletion 619bp (9, 13.23%) and c.79G>A (8, 11.76%) in our study group. Five cases (nos. 24, 27, 33, 58, and 71) exhibited coinheritance between β0/β+ (2), β0/β D (1), and c.124_127delTTCT/β+ or β0 (2) affecting the Rajasthani and Gujarati populations in our study of the Western region of India.Conclusion: We strongly recommend these Western populations for genetic screening before adopting reproductive technologies and interracial marital relations. Keywords: β-thalassemia traits, coinheritance, hematogram, capillary electrophoresis, PCR-ARMS, DNA sequencing, mutation analysis, East-Western India

Paul Y Takahashi,1 Lindsey R Haas,2 Stephanie M Quigg,1 Ivana T Croghan,1 James M Naessens,2 Nilay D Shah,2 Gregory J Hanson11Division of Primary Care Internal Medicine, Department of Medicine, 2Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USAPurpose: Patients leaving the hospital are at increased risk of functional decline and hospital readmission. The Employee and Community Health service at Mayo Clinic in Rochester developed a care transition program (CTP) to provide home-based care services for medically complex patients. The study objective was to determine the relationship between CTP use, 30-day hospital readmission, and Emergency Room (ER) visits for adults over 60 years with high Elder Risk Assessment scores.Patients and methods: This was a pilot prospective cohort study that included 20 patients that used the CTP and 20 patients discharged from the hospital without using the CTP. The medically complex study patients were drawn from the department of Employee and Community Health population between October 14, 2011 and September 27, 2012. The primary outcomes were 30-day hospital readmission or ER visit after discharge from the hospital. The secondary outcomes were within-group changes in grip strength, gait speed, and quality of life (QOL). Patients underwent two study visits, one at baseline and one at 30 days postbaseline. The primary analysis included time-to-event from baseline to rehospitalization or ER visit. Paired t-tests were used for secondary outcomes, with continuous scores.Results: Of the 40 patients enrolled, 36 completed all study visits. The 30-day hospital readmission rates for usual care patients were 10.5% compared with no readmissions for CTP patients. There were 31.6% ER visits in the UC group and 11.8% in the CTP group (P = 0.37). The secondary analysis showed some improvement in physical QOL scores (pre: 32.7; post: 39.4) for the CTP participants (P < 0.01) and no differences in gait speed or grip strength.Conclusion: Based on this pilot study of care transition, we found nonsignificant lower hospital and ER utilization rates and improved physical QOL scores for patients in the CTP group. However, the data leads us to recommend future studies with larger sample sizes (N = 250).Keywords: case management, cohort study, frailty, geriatrics

Paul Y Takahashi,1 Gregory J Hanson,1,2 Bjorg Thorsteinsdottir,1 Holly K Van Houten,3 Nilay D Shah,3 James M Naessens,3 Jennifer L Pecina41Division of Primary Care Internal Medicine, 2Kogod Center of Aging, 3Division of Health Science Research, 4Department of Family Medicine, Mayo Clinic, Rochester, MN, USABackground: Using telemedicine for older adults with multiple comorbid conditions is a potential area for growth in health care. Given this older, ailing population, providers should discuss end-of-life care with patients.Objective: To determine the relationship between telemonitoring and hospice enrollment compared to usual care among older adults with chronic health problems.Methods: This was a secondary evaluation of a randomized controlled trial. The trial was performed at an academic medical center. Patients who were over the age of 60 and had a high risk of hospitalization and emergency department visits were recruited to the study. The primary outcome was hospice enrollment, and the secondary outcome was the mean number of days in hospice. The data were analyzed using Chi-squared tests and time-to-event analysis.Results: The average age of the cohort was 80.3 years. Nine patients (9.6%) in the telemonitoring group were enrolled in hospice care, whereas four patients (4.0%) in the usual care group were enrolled (P = 0.12). The mean number of days in hospice was 57.9 (SD ± 99.2) for the telemonitoring group, and 119.3 (SD ± 123.8) for the usual care group (P = 0.36). There was no significant difference regarding time to hospice referral.Conclusion: In this pilot analysis, there were no differences noted between groups in the number of patients that entered into hospice or the amount of time they stayed in hospice care. This was a small trial, and the power to detect a difference was 36%. It was encouraging that twice the number of patients enrolled in hospice care in the telemonitoring group compared to usual care despite the insignificant finding. Further research may determine the effect of telemonitoring upon hospice referral.Keywords: hospice, elderly, telemonitoring, palliative care

We describe a simulation optimization method to design PSA screening policies based on expected quality adjusted life years (QALYs). Our method integrates a simulation model in a genetic algorithm which uses a probabilistic method for selection of the best policy. We present computational results about the efficiency of our algorithm. The best policy generated by our algorithm is compared to previously recommended screening policies. Using the policies determined by our model, we present evidence that patients should be screened more aggressively but for a shorter length of time than previously published guidelines recommended. [ABSTRACT FROM AUTHOR]

Objective: This study was a retrospective data-based analysis of health care utilization and costs for patients diagnosed as having bipolar disorder compared with patients with diagnoses of depression, diabetes, coronary artery disease, or asthma.Methods: Data were from an employer-based health plan. Consistent diagnosis and continuous enrollment from 2004 to 2007 were used to identify the study population (total N = 7,511), including those with bipolar disorder (N = 122), depression (N = 1,290), asthma (N = 2,770), coronary artery disease (N = 1,759), diabetes (N = 1,418), and diabetes with coronary artery disease (N = 455). Resource utilization quantified as cost (total, specialty care, psychiatric outpatient) and number of visits (specialty care and outpatient psychiatric care) was compared across groups.Results: Patients with bipolar disorder had higher adjusted mean per member per month (PMPM) costs than any other comparison group except for those with both diabetes and coronary artery disease. The cost was predominantly related to pharmacy costs and both inpatient and outpatient psychiatric care. A subset of 20% of patients with bipolar disorder accounted for 64% of the total costs. This subgroup of patients was more likely to be female, to have frequent hospital stays, and to have a higher number of comorbidities. Depressed patients, in contrast to bipolar disorder patients, had higher adjusted mean PMPM costs in primary care and nonpsychiatric inpatient costs.Conclusions: Health care costs for bipolar disorder exceeded those for several common chronic illnesses. These data provide further evidence for employers, insurers, and providers to seek innovative models to deliver effective and efficient care to individuals with bipolar illness. [ABSTRACT FROM AUTHOR]

PURPOSE: Drug expenditure trends in 2007 and 2008, projected drug expenditures for 2009, and factors likely to influence drug expenditures are discussed. SUMMARY: Various factors are likely to influence drug expenditures in 2009, including drugs in development, the diffusion of new drugs, drug safety concerns, generic drugs, Medicare Part D, and changes in the drug supply chain. The increasing availability of important generic drugs and drug safety concerns continue to moderate growth in drug expenditures. The drug supply chain remains dynamic and may influence drug expenditures, particularly in specialized therapeutic areas. Initial data suggest that the Medicare Part D benefit has influenced drug expenditures, but the ultimate impact of the benefit on drug expenditures remains unclear. From 2006 to 2007, total U.S. drug expenditures increased by 4.0%, with total spending rising from $276 billion to $287 billion. Drug expenditures in clinics continue to grow more rapidly than in other settings, with a 9.9% increase from 2006 to 2007. Hospital drug expenditures increased at a moderate rate of only 1.6% from 2006 to 2007; through the first nine months of 2008, hospital drug expenditures increased by only 2.8% compared with the same period in 2007. CONCLUSION: In 2009, we project a 0-2% increase in drug expenditures in outpatient settings, a 1-3% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model (CCM). PARTICIPANTS AND METHODS: As part of the CCM, 97 primary care physicians at 6 primary care practices in Rochester, MN, referred 639 patients to an on-site diabetes educator between July 1, 2001, and December 31, 2003. On first referral, physicians were centrally randomized to receive a telemedicine intervention (specialty advice and evidence-based messages regarding medication management for cardiovascular risk) or no intervention, keeping outcome assessors and data analysts blinded to group assignment. After each subsequent clinical encounter, endocrinologists reviewed an abstract from the patient's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail. Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes. Outcome measures included diabetes care processes (diabetes test completion), outcomes (metabolic and cardiovascular risk factors, estimated coronary artery disease risk), and patient costs (payer perspective). RESULTS: During the intervention, 951 (70%) of the 1361 endocrinology reviews detected performance gaps and resulted in a message; primary care physicians reported using 49% of messages in patient care. With a mean of 21 months' follow-up, the intervention, compared with control, did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease (adjusted mean difference, -1%; 95% confidence interval, -19% to 17%). The intervention group incurred lower costs (P=.02) but not in diabetes-related costs. CONCLUSION: Specialty telemedicine did not significantly enhance the value of CCM in primary care. [ABSTRACT FROM AUTHOR]

PURPOSE: Drug expenditure trends in 2005 and 2006, projected drug expenditures for 2007, and factors likely to influence drug costs are discussed. SUMMARY: Various factors are likely to affect drug costs, including drug prices, drugs in development, and generic drugs. In 2005, there was a continued moderation of the increase in drug expenditures. Total prescription drug expenditures increased by 5.5% from 2004 to 2005, with total spending rising from $239 billion to $252 billion. Through the first nine months of 2006, hospital drug expenditures increased by only 3% compared with 2005. This moderation of the growth of prescription drug expenditures can be attributed to three major factors: availability of major prescription drugs in generic form, continued increase in cost sharing for employees in employer-sponsored health plans, and decreased use due to safety concerns. It is expected that expenditures in 2007 will be influenced by similar factors, with few costly new products reaching the market, increased concern over product safety reducing the use of older agents and slowing the diffusion of newer agents that do reach the market, and several important patent expirations, leading to slower growth in expenditures. CONCLUSION: In 2007, we project a 5-7% increase in drug expenditures in outpatient settings, a 14-16% increase in clinics, and a 4-6% increase in hospitals. [ABSTRACT FROM AUTHOR]

PURPOSE: Drug expenditure trends in 2004 and 2005, projected drug expenditures for 2006, and factors likely to influence drug costs are discussed. SUMMARY: Various factors are likely to affect drug costs, including drug prices, drugs in development, and generic drugs. In 2004 there was a continued moderation of the increase in drug expenditures. Drug expenditures increased by 8.7% from 2003 to 2004. Through the first nine months of 2005, expenditures increased by only 8.1% compared with 2004. This moderation can be attributed to several factors, including the continued trend toward higher prescription drug cost sharing for insured consumers, growing availability of generic drugs, and lack of 'blockbuster' new drugs in recent years. Drug expenditures in 2006 will likely be influenced by similar factors, with few costly new products reaching the market, increased concern over product safety slowing the diffusion of those new agents that do reach the market, and several important patent expirations, leading to slower growth in expenditures. CONCLUSION: Forecasting and managing rising drug expenditures remains a challenge. Pharmacy managers must remain vigilant in monitoring drug costs in their health system and take a proactive role in pursuing efficient drug utilization. The dynamic health policy environment further complicates drug budgeting and must be considered, especially in integrated health systems responsible for managing inpatient, outpatient, and clinic drug costs. The comparison of health-system-specific data and trends with the national information presented in this article may provide a useful context when presenting institutional drug costs to senior management. [ABSTRACT FROM AUTHOR]

Drug expenditure projections for 2003 and factors likely to influence drug costs are discussed. The United States continues to face the challenge of increased growth in health expenditures, and drug expenditures are continuing to increase faster than the growth in total health care expenditures. These increases can be largely attributed to an increase in the average age of the U.S. population and technological advancement. On the basis of price inflation and non-price inflationary factors, including increases in volume, shifts in patient and therapeutic intensity, and expected approval of new drugs, a 10-12% increase in drug expenditures in 2003 for the inpatient setting and a 13.5-15.5% increase for ambulatory care settings are forecasted. While few new drugs are expected to greatly influence expenditures in 2003, the continued diffusion of recently approved drugs such as drotrecogin alfa and nesiritide will have a dramatic impact on total drug expenditures and must be carefully considered in the budgeting process. An agent likely to have a significant impact on HIV treatment is enfuvirtide, the first in a new class of antiretrovirals (fusion inhibitors), but its high cost ($10,000-$15,000 per year) may limit patients' access to this medication. An expanded user's guide is provided to assist the reader in appropriate application of this information in the drug budgeting process. Technological, demographic, and market-based changes and changes in public policy will continue to influence pharmaceutical expenditures in the coming year. An understanding of the overall drivers of medication expenditures and vigilance in monitoring pharmaceutical innovation are critical in the effective management of these resources. [ABSTRACT FROM AUTHOR]

Drug-cost projections for 2002 and factors likely to influence drug costs are discussed. The United States continues to face the challenge of increased growth in health expenditures, and pharmaceutical expenditures continue to increase significantly faster than the growth in total health care expenditures. These increases can be largely attributed to a combination of general inflation, an increase in the average age of the U.S. population, and the increased use of new technologies. On the basis of price inflation and nonprice inflationary factors, including increases in volume, shifts in patient and therapeutic intensity, and the expected approval of new drugs, we forecast a 15.5% increase in drug expenditures in 2002 for hospitals and clinics and an 18.5% increase for ambulatory care settings. One of the most substantial contributors to the rise in pharmaceutical expenditures over the past decade is the successful introduction and rapid diffusion of new pharmaceuticals. Data about many new drugs on the horizon are provided. One agent likely to have the highest impact on hospitals in the next year is drotrecogin alfa for the treatment of sepsis. The cost of this agent is expected to range from $3,000 to $10,000 per patient per course of therapy. Other factors influencing medication costs, including generic medications, legislative initiatives, and the recent acts of terrorism committed against the United States, are also discussed. Technological, demographic, and market-based changes, and possibly public policy changes, will have a dramatic influence on pharmaceutical expenditures in the coming year. An understanding of what is driving the changes is critical to the effective management of these resources. [ABSTRACT FROM AUTHOR]

Background: The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA).Methods: Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Canada, we compared the time for completion of the first review and the total review time for all applications involving novel therapeutic agents approved by the three regulatory agencies from 2001 through 2010 and determined the geographic area in which each novel therapeutic agent was first approved for use.Results: There were 510 applications for novel therapeutic agents approved from 2001 through 2010--225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P=0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States.Conclusions: For novel therapeutic agents approved between 2001 and 2010, the FDA reviewed applications involving novel therapeutics more quickly, on average, than did the EMA or Health Canada, and the vast majority of these new therapeutic agents were first approved for use in the United States. (Funded by the Pew Charitable Trusts.). [ABSTRACT FROM AUTHOR]

Purpose. Drug expenditure trends in 2008 and 2009, projected drug expenditures for 2010, and factors likely to influence drug expenditures are discussed. Summary. Various factors are likely to influence drug expenditures in 2010, including drugs in development, the diffusion of new drugs, generic drugs, health care reform, drug safety concerns, and comparative effectiveness research. The increasing availability of important generic drugs continues to moderate growth in drug expenditures. Health care reform initiatives, including the potential for biosimilars legislation, will influence drug expenditures in all settings. From 2007 to 2008, total U.S. drug expenditures increased by 1.8%, with total spending rising from $279.6 billion to $284.7 billion. Growth in drug expenditures in clinics declined to the lowest level in a decade, a 1.0% increase from 2007 to 2008. Hospital drug expenditures increased at a moderate rate of only 2.1% from 2007 to 2008; through the first nine months of 2009, hospital drug expenditures increased by 3.0% compared with the same period in 2008. Conclusion. In 2010, we project a 3-5% increase in drug expenditures in outpatient settings, a 6-8% increase in expenditures for clinic-administered drugs, and a 2-4% increase in hospital drug expenditures. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to determine the lifetime burden and risk factors for hospitalization after heart failure (HF) diagnosis in the community.Background: Hospitalizations in patients with HF represent a major public health problem; however, the cumulative burden of hospitalizations after HF diagnosis is unknown, and no consistent risk factors for hospitalization have been identified.Methods: We validated a random sample of all incident HF cases in Olmsted County, Minnesota, from 1987 to 2006 and evaluated all hospitalizations after HF diagnosis through 2007. International Classification of Diseases-9th Revision codes were used to determine the primary reason for hospitalization. To account for repeated events, Andersen-Gill models were used to determine the predictors of hospitalization after HF diagnosis. Patients were censored at death or last follow-up.Results: Among 1,077 HF patients (mean age 76.8 years, 582 [54.0%] female), 4,359 hospitalizations occurred over a mean follow-up of 4.7 years. Hospitalizations were common after HF diagnosis, with 895 (83.1%) patients hospitalized at least once, and 721 (66.9%), 577 (53.6%), and 459 (42.6%) hospitalized > or =2, > or =3, and > or =4 times, respectively. The reason for hospitalization was HF in 713 (16.5%) hospitalizations and other cardiovascular in 936 (21.6%), whereas over one-half (n = 2,679, 61.9%) were noncardiovascular. Male sex, diabetes mellitus, chronic obstructive pulmonary disease, anemia, and creatinine clearance <30 ml/min were independent predictors of hospitalization (p < 0.05 for each).Conclusions: Multiple hospitalizations are common after HF diagnosis, though less than one-half are due to cardiovascular causes. Comorbid conditions are strongly associated with hospitalizations, and this information could be used to define effective interventions to prevent hospitalizations in HF patients. [ABSTRACT FROM AUTHOR]

Efforts to implement and evaluate genome sequencing (GS) as a screening tool for newborns and infants are expanding worldwide. The first iteration of the BabySeq Project (2015-2019), a randomized controlled trial of newborn sequencing, produced novel evidence on medical, behavioral, and economic outcomes. The second iteration of BabySeq, which began participant recruitment in January 2023, examines GS outcomes in a larger, more diverse cohort of more than 500 infants up to one year of age recruited from pediatric clinics at several sites across the United States. The trial aims for families who self-identify as Black/African American or Hispanic/Latino to make up more than 50% of final enrollment, and key aspects of the trial design were co-developed with a community advisory board. All enrolled families receive genetic counseling and a family history report. Half of enrolled infants are randomized to receive GS with comprehensive interpretation of pathogenic and likely pathogenic variants in more than 4,300 genes associated with childhood-onset and actionable adult-onset conditions, as well as larger-scale chromosomal copy number variants classified as pathogenic or likely pathogenic. GS result reports include variants associated with disease (Mendelian disease risks) and carrier status of autosomal-recessive and X-linked disorders. Investigators evaluate the utility and impacts of implementing a GS screening program in a diverse cohort of infants using medical record review and longitudinal parent surveys. In this perspective, we describe the rationale for the second iteration of the BabySeq Project, the outcomes being assessed, and the key decisions collaboratively made by the study team and community advisory board., Competing Interests: Declaration of interests H.S.S. has received consulting income from Illumina unrelated to this work. N.D.S. is a member of the Scientific Advisory Board for Neuberg Center for Genomic Medicine. A.L.M. is a paid advisor for Nurture Genomics. B.R.K. is a member of medical advisory boards for Alexion, SpringWorks, Healx, Infixion, and Recursion and has stock options in GenomeMedical. R.C.G. has received compensation for advising Allelica, Atria, Fabric, Genome Web, and Genomic Life and is a cofounder of Genome Medical and Nurture Genomics., (Copyright © 2024 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.)

Purpose: To address patient health literacy, the American Medical Association and the National Institutes of Health recommend that readability of patient education materials should not exceed an eighth grade reading level. However, patient-facing materials often remain above the recommended average reading level. Current online calculators provide readability scores; however, they lack the ability to provide text-specific feedback, which may streamline the process of simplifying patient materials. The purpose of this study was to evaluate Chat Generative Pretrained Transformer (ChatGPT) 3.5 as a tool for optimizing patient-facing hand surgery education materials through reading level analysis and simplification., Methods: The readability of 18 patient-facing hand surgery education materials was compared by a traditional online calculator for reading level and ChatGPT 3.5. The original excerpts were then entered into ChatGPT 3.5 and simplified by the artificial intelligence tool. The simplified excerpts were scored by the same calculators., Results: The readability scores for the original excerpts from the online calculator and ChatGPT 3.5 were similar. The simplified excerpts' scores were lower than the originals, with a mean of 7.28, less than the maximum recommended 8., Conclusions: The use of ChatGPT 3.5 for the purpose of simplification and readability analysis of patient-facing hand surgery materials is efficient and may help facilitate the conveyance of important health information. ChatGPT 3.5 rendered readability scores comparable with traditional readability calculators, in addition to excerpt-specific feedback. It was also able to simplify materials to the recommended grade levels., Clinical Relevance: By confirming ChatGPT3.5's ability to assess and simplify patient education materials, this study offers a practical solution for potentially improving patient comprehension, engagement, and health outcomes in clinical settings., Competing Interests: Conflicts of Interest No benefits in any form have been received or will be received related directly to this article., (Copyright © 2024 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Objectives: Dilated cardiomyopathy (DCM) is often hereditary, with 20% to 40% of nonischemic cases showing familial linkage, yet genetic testing is underused. This report describes an unreported pathogenic nonsense variant in the Titin (TTN) gene (NM&#95;001267550.2:c.92603G>A) in a 24-year-old man with severe DCM and acute fibrinoid organizing pneumonia, highlighting a unique cardiopulmonary pathology., Methods: We conducted detailed gross, histopathologic, immunophenotypic, and exome-based DNA sequencing analysis in the workup of this case. We also included the patient's clinical and radiologic findings in our study., Results: With rapid clinical deterioration and complex comorbidities, including substance abuse and psychiatric conditions, which precluded transplantation, the patient's cardiac function progressively worsened. Autopsy findings included extreme cardiomegaly, biventricular hypertrophy, and acute and chronic pericarditis. Significant pulmonary pathology consistent with acute fibrinoid organizing pneumonia was also noted. Molecular testing confirmed a deleterious maternally inherited TTN variant that was absent in the sibling of the proband and the extant medical literature, highlighting its rarity and significance., Conclusions: This case contributes to the ongoing body of work on the impact of TTN variants on DCM. It suggests a potential link between genetic variants and complex cardiac injury patterns, emphasizing the need for further investigation into the interplay between cardiomyopathy and pulmonary pathology., (© The Author(s) 2024. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Mandibular distraction has variable outcomes in Treacher-Collins syndrome. Dual syndromic diagnosis is a rare occurrence that complicates management. Here, the authors present a patient with Treacher-Collins syndrome and severe retrognathia requiring tracheostomy who failed repeat mandibular distraction and decannulation. A genetic workup later revealed Angelman syndrome with severe developmental delay. We discuss explanations for difficulties encountered during mandibular distraction as well as surgical options for patients with Treacher-Collins who fail multiple attempts at decannulation. Overall, patients with dual diagnoses can exhibit an underlying problem in bone formation and mineralization, which challenges any attempt at craniofacial manipulation., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 by Mutaz B. Habal, MD.)

Background: Cardiac magnetic resonance is a useful clinical tool to identify late gadolinium enhancement in heart failure patients with implantable electronic devices. Identification of LGE in patients with CIED is limited by artifact, which can be improved with a wide band radiofrequency pulse sequence., Objective: The authors hypothesize that image quality of LGE images produced using wide-band pulse sequence in patients with devices is comparable to image quality produced using standard LGE sequences in patients without devices., Methods: Two independent readers reviewed LGE images of 16 patients with CIED and 7 patients without intracardiac devices to assess for image quality, device-related artifact, and presence of LGE using the American Society of Echocardiography/American Heart Association 17 segment model of the heart on a 4-point Likert scale. The mean and standard deviation for image quality and artifact rating were determined. Inter-observer reliability was determined by calculating Cohen's kappa coefficient. Statistical significance was determined by T -test as a p {less than or equal to} 0.05 with a 95% confidence interval., Results: All patients underwent CMR without any adverse events. Overall IQ of WB LGE images was significantly better in patients with devices compared to standard LGE in patients without devices ( p  = 0.001) with reduction in overall artifact rating ( p  = 0.05)., Conclusion: Our study suggests wide-band pulse sequence for LGE can be applied safely to heart failure patients with devices in detection of LV myocardial scar while maintaining image quality, reducing artifact, and following routine imaging protocol after intravenous gadolinium contrast administration., Competing Interests: Authors XM, MJ and AB were employed by company GE Healthcare. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Shah, Krishnam, Ambale Venkatesh, Khan, Smith, Jones, Koon, Mao, Janich, Brau, Salerno, Dash, Chan and Yang.)

Objective: International outreach for cleft lip and/or palate care has traditionally been characterized by foreign groups and individuals holding surgical outreach trips in low- and middle-income countries. However, this "magic bullet" approach has often been criticized for prioritizing short-term results that may disrupt local workflow. The presence and impact of local organizations that support cleft care and take on capacity building initiatives has not been well explored., Design: Eight countries previously studied as having the highest Google search demand for CL/P were chosen for the scope of the study. Local NGOs in regions were identified through a web search, and information was collected regarding the location, objectives, partnerships, and work conducted thus far., Results: Countries with a strong combination of local and international organizations included Ghana, Philippines, Nepal, Kenya, Pakistan, India, and Nigeria. The country with minimal to no local NGO presence included Zimbabwe. Local NGOs often supported education and research, training of providers and staff, spreading community awareness, offering interdisciplinary care, and opening cleft clinics and hospitals. Unique initiatives included starting the first school for children with CL/P, enrolling patients in the national healthcare to cover CL/P care, and monitoring the referral system to improve efficiencies in the healthcare system., Conclusions: Moving towards a mindset of capacity building not only involves bilateral partnerships between international host sites and visiting organizations, but also collaboration with local NGOs that have a deep understanding of local communities. Successful partnerships may help address the complex challenges regarding CL/P care faced by LMICs., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Diet is an environmental exposure implicated in the development of inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). Dietary therapy is also a tool for management of these conditions. Nutrition therapy for IBD has been shown to reduce intestinal inflammation, promote healing, and alleviate symptoms, as well as improve patients' nutrition status. Although the mechanisms of action of most nutrition therapies for IBD are not well understood, the diets are theorized to eliminate triggers for gut dysbiosis and mucosal immune dysfunction associated with the typical Western diet. Exclusive enteral nutrition and the Crohn's disease exclusion diet are increasingly being used as the primary treatment modality for the induction of remission and/or maintenance therapy in children, and in some adults, with CD. Several other diets, such as the Mediterranean diet, anti-inflammatory diet for IBD, and diets excluding gluten, FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), lactose, or other compounds, may be helpful in symptom management in both CD and UC, though evidence for biochemical efficacy is limited. In this review, we discuss the role of diet components in IBD pathogenesis and examine diets currently used in the management of children and adults with IBD. We also address practical, psychosocial, and cultural considerations for dietary therapy across diverse populations., (© 2024 American Society for Parenteral and Enteral Nutrition.)

Summary Statement: Health care policies have the potential to improve patient outcomes, access to care, and reduce health disparities. However, new policy is often tested in the field, where unintended consequences are paid for by patients. In this perspective, we argue that health care simulations, which can elucidate the potential for policy to hinder clinicians' ability to provide high-quality care, are a complement to large-scale policy evaluations in the field., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Society for Simulation in Healthcare.)

Background: Prebiotics are nondigestible carbohydrates fermented by gut bacteria into metabolites that confer health benefits. However, evidence on their role for inflammatory bowel disease (IBD) is unclear. This study systematically evaluated the research on prebiotics for treatment of IBD., Methods: A search was performed in PubMed, Embase, Cochrane, and Web of Science. Eligible articles included randomized controlled trials or prospective observational studies that compared a prebiotic with a placebo or lower-dose control in patients with IBD. Meta-analyses were performed using random-effects models for the outcomes of clinical remission, clinical relapse, and adverse events., Results: Seventeen studies were included. For induction of clinical remission in ulcerative colitis (UC), the fructooligosaccharide (FOS) kestose was effective (relative risk, 2.75, 95% confidence interval, 1.05-7.20; n = 40), but oligofructose-enriched inulin (OF-IN) and lactulose were not. For maintenance of remission in UC, germinated barley foodstuff trended toward preventing clinical relapse (relative risk, 0.40; 95% confidence interval, 0.15-1.03; n = 59), but OF-IN, oat bran, and Plantago ovata did not. For Crohn's disease, OF-IN and lactulose were no different than controls for induction of remission, and FOS was no different than controls for maintenance of remission. Flatulence and bloating were more common with OF-IN; reported adverse events were otherwise similar to controls for other prebiotics., Conclusion: Prebiotics, particularly FOS and germinated barley foodstuff, show potential as effective and safe dietary supplements for induction and maintenance of remission in UC, respectively. The overall certainty of evidence was very low. There would be benefit in further investigation on the role of prebiotics as treatment adjuncts for IBD., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Objective: Microtia is a congenital ear deformity with variability in surgical techniques and tools across surgeons pursuing an autologous reconstruction. Different techniques have emerged over time, and surgeons opt for various tools to aid in creating the complex three-dimensional cartilaginous ear framework. The purpose of this study was to understand the current state of microtia reconstruction in the United States., Methods: Microtia surgeons affiliated with the nonprofit, Ear Community, were invited to complete a 20-item survey. Data were collected on demographic information regarding surgeons, considerations when approaching microtia repair in patients, and techniques and comfort levels. Additional data were collected on materials, tools, flaps, and skin grafts used for reconstruction., Results: Twenty-two surgeons responded to the survey reporting 3 different techniques learned and utilized in practice including the Brent, Nagata, and Firmin techniques. About two-thirds of surgeons were "extremely comfortable" with their techniques and one-third were "extremely uncomfortable" or "somewhat uncomfortable." Most respondents reported using a tunneled temporoparietal fascial flap or a posterior fascial flap along with a full-thickness skin graft for the second stage (ear elevation). Most surgeons utilized a combination of scalpels and gouges when carving the ear framework along with sutures or wire., Conclusions: This study highlights the current state of autogenous microtia reconstruction underscoring the variability in approaches and preferences. These data may guide future directions that aim to improve patient outcomes. Surgeons may gain insight into different practices and choose to adopt different aspects to enhance their surgical approach., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 by Mutaz B. Habal, MD.)

Autologous ear reconstruction remains a gold standard surgical technique for the treatment of external ear deformities. This highly technical procedure requires experience, an understanding of aesthetic principles, and a surgical approach that can consistently produce optimal results. As an experienced microtia surgeon having trained under Dr Satoru Nagata, the senior author has emphasized the importance of appropriate surgical tools during this procedure. Here, we present results of a novel surgical handle and gouge meant to optimize complex cartilage carving. The senior author regularly holds microtia workshops to help train individuals around the United States. During 2 of such workshops held in 2022, participants were given access to both the standard, commercially available surgical gouge as well as a prototype of a novel surgical gouge developed by the authors. Participants were then given a Likert-scale survey to assess their subjective feedback for both tools. Twenty-seven total participants completed the postworkshop survey. Cumulatively, the results demonstrated that participants rated the custom gouge significantly higher than its counterpart (4.2 versus 3.2, P<0.001). They also had a significantly higher likelihood of using the custom gouge again (4.1 versus 3.2, P=0.023). The custom gouge designed by the senior author demonstrated higher subjective ratings when compared with what is currently available on the market. This serves as a primary validation study that demonstrates feasibility for further assessment in a true operative setting., Competing Interests: B.P.A., N.K.R., N.D.S., and A.Y. are the co-inventors of the device discussed in the paper. The other author reports no conflicts of interest., (Copyright © 2024 by Mutaz B. Habal, MD.)

The exception point system for liver allocation in the United States allows for additional waitlist priority for candidates where the Model for End-Stage Liver Disease or Pediatric End-stage Liver Disease does not effectively represent their urgency or need for a transplant. In May 2019, the review process for liver exception cases transitioned from 11 Regional Review Boards (RRBs) to 1 National Liver Review Board (NLRB), intended to increase consistency nationwide, improve efficiency, and balance transplant access for candidates with and without exception scores. This report provides a review of liver exception request and review practices, waitlist outcomes, and transplant activity in the first 2 years after implementation of the NLRB and acuity circle-based distribution in the United States. We compared initial and extension exception request forms submitted from May 13, 2017 to May 13, 2019 (prepolicy or RRB era) to the period from February 4, 2020 to February 3, 2022 (postpolicy or NLRB era). During this time, the NLRB reviewed 10,083 initial exception requests and 12,686 extension requests. Notable postpolicy highlights include (1) an increase in the proportion of initial and extension requests that were automatically approved instead of manually reviewed; (2) a decrease in the overall approval rates of initial exception requests (87.8% for adult HCC, 64.3% for adult other diagnoses, and 71.5% for pediatric); and (3) reduction in the time from exception request submission to adjudication to a median of 3.73 days. The proportions of waitlist registration and deceased donor liver transplants for patients with exception scores decreased, and waitlist outcomes between patients with and without exception scores are now comparable. Implementation of the NLRB improved efficiency, reduced case workloads, and standardized criteria for exception cases, with similar waitlist outcomes between patients with and without exception scores and improved equity in terms of access to liver transplants., (Copyright © 2023 American Association for the Study of Liver Diseases.)