bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analytic and Informational Requirements in Disease Management Proposals: A Managed Care Perspective
Authors: Langley Paul C , Martin Robert E 
Published: July 2017

Objective: To outline informational and analytic requirements that one healthcare management system has implemented to ensure that disease management submissions meet common standards for evaluation and review. Context: The need for guidelines to support the scope and quality of submissions for disease management negotiation and contracting. Design: A series of task definitions are proposed to support three stages in the submission, negotiation, and implementation process: A preliminary submission, establishment of a disease state management agreement, and implementation of the disease state management agreement. Discussion: These guidelines are designed to assist companies in meeting minimum standards in their disease state management submissions. The minimum standards relate to their appreciation of the analytic complexities involved, the need to access the appropriate data sources, and the need to meet minimum contracting requirements for program delivery. Not only does application of these guidelines place all potential partners on an equal basis and allow a systematic assessment of competing proposals, but also the degree of uncertainty associated with such agreements, notably in the process of negotiation, is reduced substantially. Conclusions: Unless guidelines are implemented by managed care organizations, the prospects for entering into successful disease state management agreements may be uncertain.
Suspected Ofloxacin-Induced Seizures in an Elderly Patient
Authors: Aruna Augustine S , Tam Carlos W , Anderson Deborah S 
Published: July 2017

Objective: To report a case of probable ofloxacin-induced seizures. Case Summary: A 74-year-old white man received a single intravenous dose of ofloxacin administered over a 60-minute period. Approximately 4 hours later, he developed seizure-like tremors in all extremities, fecal incontinence, and shortness of breath with harsh, labored breathing. Ofloxacin was discontinued, and the seizure-like tremors subsided within 4 hours of onset. Discussion: The time course of events suggested that ofloxacin was the cause of a suspected seizure in this patient. Other causes of seizure were ruled out. Seizures have been reported in less than 1% of patients receiving ofloxacin. Conclusions: Ofloxacin can cause seizures, and healthcare providers should be aware of the potential for this adverse effect.
Effects of Continuous and Cyclic Hormone Replacement Therapy on the Lipoprotein Profile in Postmenopausal Women
Authors: Wilken Lori A , Casper Kristin B , Hagmeyer Kathleen O 
Published: July 2017

Objective: To provide an overview of the information concerning cyclic and continuous hormone replacement therapy (HRT) and the effects of the various regimens on the lipid profile. Data Sources: MEDLINE (January 1966–December 1996) and Index Medicus (January 1995-December 1996) searches were conducted to identify relevant studies and review articles. Bibliographies of selected articles also were reviewed. Study Selection: Studies addressing continuous and cyclic use of a progesterone formulation along with daily conjugated equine estrogen (CEE) and their effects on the lipid profiles of postmenopausal women were selected for review. Data Extraction: Applicable data were selected and used in a review format. Data Synthesis: CEE has been shown to increase high-density-lipoprotein cholesterol, which may decrease the risk of cardiovascular heart disease. Medroxyprogesterone acetate (MPA) has been added to CEE for postmenopausal HRT to prevent endometrial hyperplasia and cancer. However, MPA negates the beneficial effects of CEE on the lipid profile. Many different HRT regimens, both continuous and cyclic, are being used to increase compliance and to decrease adverse effects. Which regimen offers the best lipid profile results is evaluated in this article. Conclusions: The lipid profile effects of HRT using continuous MPA are not significantly different from those obtained with cyclic MPA. Use of a continuous MPA regimen may also offer the long-term advantages of less vaginal bleeding and increased compliance.
Correlation of the Medication Management Evaluation Instrument with Compliance in Geriatric Patients
Authors: Fritsch Michelle A , Gray Cristina D 
Published: July 2017

Objective: To assess the Medication Management Evaluation Instrument (MMEI), which has been shown to detect patient difficulties in compliance but has never been correlated with actual compliance. The goal was to determine the value of this instrument as a predictor of compliance difficulties. Methods: Volunteer patients in the Kansas City Veterans Affairs Medical Center currently enrolled in the Geriatric Evaluation and Management Clinic participated in this study. The MMEI, the Jacob's Cognitive Capacity Screening Examination (CCSE), and a pill count (at enrollment and at 6 wk) were conducted on all patients with medications meeting the inclusion criteria. Results: Twenty-two patients participated in the study, with eight compliance data dropouts. Follow-up averaged 44.7 days (range 32–62). The mean age was 71.3 years (range 66–81). The CCSE score was significantly lower in those who had problems defining how to take a medication four times daily than in those who did not (p = 0.002). Compliance ranged from 27.1% to 189% (>100% indicates overcompliance). The CCSE average score was 25.1/30 (range 17–30). Other measures in the MMEI were not statistically significant. Conclusions: Higher cognitive function was found to correlate with better management of complex regimens. On the basis of these data, the MMEI score does not appear to correlate with compliance. Changes in study design and increased power may provide better assessment of correlation.
State Prescription Label Requirements in the United States
Authors: Rappaport Harvey M 
Published: July 2017

Objective: To determine the current legal requirements for prescription labels and to explore the usefulness of this information in determining the utility of a standardized prescription label. Data Sources: State prescription label regulations were requested from Board of Pharmacy executives. Study Selection: Label requirements for prescriptions dispensed in community, noninstitutional pharmacies were selected for review. Data Extraction: Data were compiled, sorted by state, and analyzed as either federally mandated or additional state requirements. Additional state requirements were divided into 16 categories and analyzed by category. Data Synthesis: Responses were received from all 50 states. Five states did not list all federal label requirements. Medication name was the most frequently added requirement, followed by medication strength and name of manufacturer if the medication was generic. Only in New Jersey are pharmacists allowed to add directions not included in the prescription. Conclusions: States were consistent in the proper use of federal prescription label requirements. However, there was little agreement on what additional information should appear on the label. Nevertheless, there appears to be consensus for the name of the medication to be on the label. There also appears to be fairly strong consensus that medication strength and quantity should appear on the label. There is little interest in expanding the current directions-for-use requirement. Finally, the results support the utility of a standardized prescription label format.
Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer
Authors: Mougalian Sarah S. , Epstein Lianne N. , Jhaveri Ami P. , Han Gang , Abu-Khalaf Maysa , Hofstatter Erin W. , DiGiovanna Michael P. , Silber Andrea L.M. , Adelson Kerin , Pusztai Lajos , Gross Cary P. 
Published: July 2017

Introduction Up to 40% of patients with breast cancer may not adhere to adjuvant endocrine therapy. Therapy-related adverse effects (AEs) are important contributors to nonadherence. We developed a bidirectional text-message application, BETA-Text, that simultaneously tracks adherence, records symptoms, and alerts the clinical team. Patients and Methods We piloted our intervention in 100 patients. The intervention consisted of text messages to which patients responded for 3 months: daily, evaluating adherence; weekly, evaluating medication-related AEs; and monthly, regarding barriers to adherence. Concerning responses prompted a telephone call from a clinic nurse. The primary objective was to assess patient acceptance of this intervention using self-reported surveys. To compare participants with the general population at our institution, we assessed 100 consecutively treated patients as historical controls using medical record review. Results We approached 141 consecutive patients, 100 (71%) of whom agreed to participate and 89 of whom completed the intervention. A majority of patients reported that the intervention was easy to use (98%) and helpful in taking their medication (96%). Four patients discontinued therapy before 3 months, and 93% of patients who continued therapy took ≥ 80% of their medication. The frequency of AEs reported by participants via text was higher than that reported in clinical trials: hot flashes (72%), arthralgias (53%), and vaginal symptoms (35%). Approximately 39% of patients reported one or more severe AE that prompted an alert to the provider team to call the patient. Conclusion A daily bidirectional text-messaging system can monitor adherence and identify AEs and other barriers to adherence in real time without inconveniencing patients. AEs of endocrine therapy, as detected using this texting approach, are more prevalent than reported in clinical trials.
Prospective Evaluation of Magnetic Resonance Imaging and [18F]Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography at Diagnosis and Before Maintenance Therapy in Symptomatic Patients With Multiple Myeloma Included in the IFM/DFCI 2009 Trial: Results of the IMAJEM Study
Authors: Moreau Philippe , Attal Michel , Caillot Denis , Macro Margaret , Karlin Lionel , Garderet Laurent , Facon Thierry , Benboubker Lotfi , Escoffre-Barbe Martine , Stoppa Anne-Marie , Laribi Kamel , Hulin Cyrille , Perrot Aurore , Marit Gerald , Eveillard Jean-Richard , Caillon Florence , Bodet-Milin Caroline , Pegourie Brigitte , Dorvaux Veronique , Chaleteix Carine , Anderson Kenneth , Richardson Paul , Munshi Nikhil C. , Avet-Loiseau Herve , Gaultier Aurelie , Nguyen Jean-Michel , Dupas Benoit , Frampas Eric , Kraeber-Bodere Françoise 
Published: July 2017

Purpose Magnetic resonance imaging (MRI) and positron emission tomography–computed tomography (PET-CT) are important imaging techniques in multiple myeloma (MM). We conducted a prospective trial in patients with MM aimed at comparing MRI and PET-CT with respect to the detection of bone lesions at diagnosis and the prognostic value of the techniques. Patients and Methods One hundred thirty-four patients received a combination of lenalidomide, bortezomib, and dexamethasone (RVD) with or without autologous stem-cell transplantation, followed by lenalidomide maintenance. PET-CT and MRI were performed at diagnosis, after three cycles of RVD, and before maintenance therapy. The primary end point was the detection of bone lesions at diagnosis by MRI versus PET-CT. Secondary end points included the prognostic impact of MRI and PET-CT regarding progression-free (PFS) and overall survival (OS). Results At diagnosis, MRI results were positive in 127 of 134 patients (95%), and PET-CT results were positive in 122 of 134 patients (91%; P = .33). Normalization of MRI after three cycles of RVD and before maintenance was not predictive of PFS or OS. PET-CT became normal after three cycles of RVD in 32% of the patients with a positive evaluation at baseline, and PFS was improved in this group (30-month PFS, 78.7% v 56.8%, respectively). PET-CT normalization before maintenance was described in 62% of the patients who were positive at baseline. This was associated with better PFS and OS. Extramedullary disease at diagnosis was an independent prognostic factor for PFS and OS, whereas PET-CT normalization before maintenance was an independent prognostic factor for PFS. Conclusion There is no difference in the detection of bone lesions at diagnosis when comparing PET-CT and MRI. PET-CT is a powerful tool to evaluate the prognosis of de novo myeloma.
New Model for Estimating Glomerular Filtration Rate in Patients With Cancer
Authors: Janowitz Tobias , Williams Edward H. , Marshall Andrea , Ainsworth Nicola , Thomas Peter B. , Sammut Stephen J. , Shepherd Scott , White Jeff , Mark Patrick B. , Lynch Andy G. , Jodrell Duncan I. , Tavaré Simon , Earl Helena 
Published: July 2017

PurposeThe glomerular filtration rate (GFR) is essential for carboplatin chemotherapy dosing; however, the best method to estimate GFR in patients with cancer is unknown. We identify the most accurate and least biased method.MethodsWe obtained data on age, sex, height, weight, serum creatinine concentrations, and results for GFR from chromium-51 (51Cr) EDTA excretion measurements (51Cr-EDTA GFR) from white patients ≥ 18 years of age with histologically confirmed cancer diagnoses at the Cambridge University Hospital NHS Trust, United Kingdom. We developed a new multivariable linear model for GFR using statistical regression analysis.51Cr-EDTA GFR was compared with the estimated GFR (eGFR) from seven published models and our new model, using the statistics root-mean-squared-error (RMSE) and median residual and on an internal and external validation data set. We performed a comparison of carboplatin dosing accuracy on the basis of an absolute percentage error > 20%.ResultsBetween August 2006 and January 2013, data from 2,471 patients were obtained. The new model improved the eGFR accuracy (RMSE, 15.00 mL/min; 95% CI, 14.12 to 16.00 mL/min) compared with all published models. Body surface area (BSA)–adjusted chronic kidney disease epidemiology (CKD-EPI) was the most accurate published model for eGFR (RMSE, 16.30 mL/min; 95% CI, 15.34 to 17.38 mL/min) for the internal validation set. Importantly, the new model reduced the fraction of patients with a carboplatin dose absolute percentage error > 20% to 14.17% in contrast to 18.62% for the BSA-adjusted CKD-EPI and 25.51% for the Cockcroft-Gault formula. The results were externally validated.ConclusionIn a large data set from patients with cancer, BSA-adjusted CKD-EPI is the most accurate published model to predict GFR. The new model improves this estimation and may present a new standard of care.
Exceptional Chemotherapy Response in Metastatic Colorectal Cancer Associated With Hyper-Indel–Hypermutated Cancer Genome and Comutation of POLD1 and MLH1
Authors: Sharma Manish R. , Auman James T. , Patel Nirali M. , Grilley-Olson Juneko E. , Zhao Xiaobei , Moschos Stergios J. , Parker Joel S. , Yin Xiaoying , Hayward Michele C. , Polite Blase N. , Marangon Elena , Posocco Bianca , Toffoli Giuseppe , Hayes D. Neil , Innocenti Federico 
Published: July 2017

Purpose A 73-year-old woman with metastatic colon cancer experienced a complete response to chemotherapy with dose-intensified irinotecan that has been durable for 5 years. We sequenced her tumor and germ line DNA and looked for similar patterns in publicly available genomic data from patients with colorectal cancer. Patients and Methods Tumor DNA was obtained from a biopsy before therapy, and germ line DNA was obtained from blood. Tumor and germline DNA were sequenced using a commercial panel with approximately 250 genes. Whole-genome amplification and exome sequencing were performed for POLE and POLD1. A POLD1 mutation was confirmed by Sanger sequencing. The somatic mutation and clinical annotation data files from the colon (n = 461) and rectal (n = 171) adenocarcinoma data sets were downloaded from The Cancer Genome Atlas data portal and analyzed for patterns of mutations and clinical outcomes in patients with POLE- and/or POLD1-mutated tumors. Results The pattern of alterations included APC biallelic inactivation and microsatellite instability high (MSI-H) phenotype, with somatic inactivation of MLH1 and hypermutation (estimated mutation rate > 200 per megabase). The extremely high mutation rate led us to investigate additional mechanisms for hypermutation, including loss of function of POLE. POLE was unaltered, but a related gene not typically associated with somatic mutation in colon cancer, POLD1, had a somatic mutation c.2171G>A [p.Gly724Glu]. Additionally, we noted that the high mutation rate was largely composed of dinucleotide deletions. A similar pattern of hypermutation (dinucleotide deletions, POLD1 mutations, MSI-H) was found in tumors from The Cancer Genome Atlas. Conclusion POLD1 mutation with associated MSI-H and hyper-indel–hypermutated cancer genome characterizes a previously unrecognized variant of colon cancer that was found in this patient with an exceptional response to chemotherapy.
Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation
Authors: Giri Veda N. , Obeid Elias , Gross Laura , Bealin Lisa , Hyatt Colette , Hegarty Sarah E. , Montgomery Susan , Forman Andrea , Bingler Ruth , Kelly William K. , Dicker Adam P. , Winheld Stephanie , Trabulsi Edouard J. , Chen David Y.T. , Lallas Costas D. , Allen Brian A. , Daly Mary B. , Gomella Leonard G. 
Published: July 2017

Purpose Multigene panels are commercially available for the evaluation of prostate cancer (PCA) predisposition, which necessitates tailored genetic counseling (GC) for men. Here we describe emerging results of Genetic Evaluation of Men, prospective multigene testing study in PCA to inform personalized genetic counseling, with emerging implications for referrals, cancer screening, and precision therapy. Patients and Methods Eligibility criteria for men affected by or at high risk for PCA encompass age, race, family history (FH), and PCA stage/grade. Detailed demographic, clinical, and FH data were obtained from participants and medical records. Multigene testing was conducted after GC. Mutation rates were summarized by eligibility criteria and compared across FH data. The 95% CI of mutation prevalence was constructed by using Poisson distribution. Results Of 200 men enrolled, 62.5% had PCA. Eleven (5.5%; 95% CI, 3.0% to 9.9%) had mutations; 63.6% of mutations were in DNA repair genes. FH of breast cancer was significantly associated with mutation status ( P = .004), and FH that met criteria for hereditary breast and ovarian cancer syndrome was significantly associated with PCA (odds ratio, 2.33; 95% CI, 1.05 to 5.18). Variants of uncertain significance were reported in 70 men (35.0%). Among mutation carriers, 45.5% had personal/FH concordant with the gene. A tailored GC model was developed based on emerging findings. Conclusion Multigene testing for PCA identifies mutations mostly in DNA repair genes, with implications for precision therapy. The study highlights the importance of comprehensive genetic evaluation for PCA beyond metastatic disease, including early-stage disease with strong FH. Detailed FH is important for referrals of men for genetic evaluation. The results inform precision GC and cancer screening for men and their male and female blood relatives.
Comprehensive Molecular Characterization of Urachal Adenocarcinoma Reveals Commonalities With Colorectal Cancer, Including a Hypermutable Phenotype
Authors: Kardos Jordan , Wobker Sara E. , Woods Michael E. , Nielsen Matthew E. , Smith Angela B. , Wallen Eric M. , Pruthi Raj S. , Hayward Michele C. , McGinty Katrina A. , Grilley-Olson Juneko E. , Patel Nirali M. , Weck Karen E. , Black Peter , Parker Joel S. , Milowsky Matthew I. , Hayes D. Neil , Kim William Y. 
Published: July 2017

Purpose Urachal adenocarcinoma is a rare type of primary bladder adenocarcinoma that comprises less than 1% of all bladder cancers. The low incidence of urachal adenocarcinomas does not allow for an evidence-based approach to therapy. Transcriptome profiling of urachal adenocarcinomas has not been previously reported. We hypothesized that an in-depth molecular understanding of urachal adenocarcinoma would uncover rational therapeutic strategies. Patients and Methods We performed targeted exon sequencing and global transcriptome profiling of 12 urachal tumors to generate a comprehensive molecular portrait of urachal adenocarcinoma. A single patient with an MSH6 mutation was treated with the anti–programmed death-ligand 1 antibody, atezolizumab. Results Urachal adenocarcinoma closely resembles colorectal cancer at the level of RNA expression, which extends previous observations that urachal tumors harbor genomic alterations that are found in colorectal adenocarcinoma. A subset of tumors was found to have alterations in genes that are associated with microsatellite instability ( MSH2 and MSH6) and hypermutation ( POLE). A patient with an MSH6 mutation was treated with immune checkpoint blockade, which resulted in stable disease. Conclusion Because clinical trials are next to impossible for patients with rare tumors, precision oncology may be an important adjunct for treatment decisions. Our findings demonstrate that urachal adenocarcinomas molecularly resemble colorectal adenocarcinomas at the level of RNA expression, are the first report, to our knowledge, of MSH2 and MSH6 mutations in this disease, and support the consideration of immune checkpoint blockade as a rational therapeutic treatment of this exceedingly rare tumor.
All My Relatives: Exploring Nineteenth-Century Lakota Ontology and Belief
Authors: Posthumus David C. 
Published: July 2017

Abstract
This article is a reinterpretation of the ethnohistorical literature on the Lakota or Western (Teton) Sioux from a Descolian animist perspective. Applying key insights from what has been called the “ontological turn,” in particular, the dual notions of interiority and physicality and an extended notion of personhood that includes nonhumans as well as humans, this article demonstrates how a new animist framework can connect and articulate otherwise disparate and obscure elements of Lakota ethnography, offering new and exciting insights, along with the potential for a deeper understanding of traditional Lakota culture.
Results of early warning indicators for HIV/AIDS in 42 outpatient clinics in 25 northern provinces of Vietnam
Authors: Le Huong Thi , Doan Linh Thuy Thi , Pham Dung Kim , Phuc Do Huyen , Nguyen Huong Lan Thi 
Published: July 2017

Background: The emergence of HIV drug resistance (HIVDR) is an unavoidable consequence of antiretroviral therapy (ART), and HIVDR early warning indicators (EWIs) could specifically assess factors at individual clinics associated with HIVDR. Thus, the present study aimed to collect data on EWIs for HIV/AIDS at 42 outpatient clinics (OPCs) in 25 northern provinces and cities of Vietnam in 2012. Methods: A retrospective cohort study was conducted. Data was collected from 42 OPCs in 25 northern provinces between October and December 2012. The information was collected retrospectively from outpatient records from 2008 to 2011. Results: In total, 99.8% ART patients were prescribed the correct regimen when starting ART treatment. All facilities met the target of under 20% patients lost to follow-up at 12 months. A total of 33/42 facilities reached the goal for on-time appointment keeping and 37/42 facilities achieved the target of first-line retention after 12-month ARV treatment. Conclusions: EWIs should be performed routinely in HIV/AIDS facilities. The data collected will contribute to monitoring, supervision, periodic assessment, and future plans for HIV/AIDS care and treatment programs in the area.