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1.
Thromb Haemost ; 122(1): 142-150, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-33765685

RESUMEN

BACKGROUND: There are few large studies examining and predicting the diversified cardiovascular/noncardiovascular comorbidity relationships with stroke. We investigated stroke risks in a very large prospective cohort of patients with multimorbidity, using two common clinical rules, a clinical multimorbid index and a machine-learning (ML) approach, accounting for the complex relationships among variables, including the dynamic nature of changing risk factors. METHODS: We studied a prospective U.S. cohort of 3,435,224 patients from medical databases in a 2-year investigation. Stroke outcomes were examined in relationship to diverse multimorbid conditions, demographic variables, and other inputs, with ML accounting for the dynamic nature of changing multimorbidity risk factors, two clinical risk scores, and a clinical multimorbid index. RESULTS: Common clinical risk scores had moderate and comparable c indices with stroke outcomes in the training and external validation samples (validation-CHADS2: c index 0.812, 95% confidence interval [CI] 0.808-0.815; CHA2DS2-VASc: c index 0.809, 95% CI 0.805-0.812). A clinical multimorbid index had higher discriminant validity values for both the training/external validation samples (validation: c index 0.850, 95% CI 0.847-0.853). The ML-based algorithms yielded the highest discriminant validity values for the gradient boosting/neural network logistic regression formulations with no significant differences among the ML approaches (validation for logistic regression: c index 0.866, 95% CI 0.856-0.876). Calibration of the ML-based formulation was satisfactory across a wide range of predicted probabilities. Decision curve analysis demonstrated that clinical utility for the ML-based formulation was better than that for the two current clinical rules and the newly developed multimorbid tool. Also, ML models and clinical stroke risk scores were more clinically useful than the "treat all" strategy. CONCLUSION: Complex relationships of various comorbidities uncovered using a ML approach for diverse (and dynamic) multimorbidity changes have major consequences for stroke risk prediction. This approach may facilitate automated approaches for dynamic risk stratification in the significant presence of multimorbidity, helping in the decision-making process for risk assessment and integrated/holistic management.


Asunto(s)
Aprendizaje Automático/normas , Medición de Riesgo/normas , Accidente Cerebrovascular/clasificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Algoritmos , Estudios de Cohortes , Femenino , Humanos , Revisión de Utilización de Seguros/estadística & datos numéricos , Modelos Logísticos , Aprendizaje Automático/estadística & datos numéricos , Masculino , Medicare/estadística & datos numéricos , Persona de Mediana Edad , Multimorbilidad/tendencias , Estudios Prospectivos , Medición de Riesgo/métodos , Medición de Riesgo/estadística & datos numéricos , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Estados Unidos/epidemiología
2.
BMC Cancer ; 21(1): 665, 2021 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-34082720

RESUMEN

BACKGROUND: An important number of breast and ovarian cancer cases is due to a strong genetic predisposition. The main tool for identifying individuals at risk is recognizing a suggestive family history of cancer. We present a prospective study on applying three selected clinical guidelines to a cohort of 1000 Slovenian women to determine the prevalence of at-risk women according to each of the guidelines and analyze the differences amongst the guidelines. METHODS: Personal and family history of cancer was collected for 1000 Slovenian women. Guidelines by three organizations: National Comprehensive Cancer Network (NCCN), American College of Medical Genetics in cooperation with National Society of Genetic Counselors (ACMG/NSGC), and Society of Gynecologic Oncology (SGO) were applied to the cohort. The number of women identified, the characteristics of the high-risk population, and the agreement between the guidelines were explored. RESULTS: NCCN guidelines identify 13.2% of women, ACMG/NSGC guidelines identify 7.1% of women, and SGO guidelines identify 7.0% of women from the Slovenian population, while 6.2% of women are identified by all three guidelines as having high-risk for hereditary breast and ovarian cancer. CONCLUSIONS: We identified 13.7% of women from the Slovenian population as being at an increased risk for breast and ovarian cancer based on their personal and family history of cancer using all of the guidelines. There are important differences between the guidelines. NCCN guidelines are the most inclusive, identifying nearly twice the amount of women as high-risk for hereditary breast and ovarian cancer as compared to the AGMG/NSCG and SGO guidelines in the Slovenian population.


Asunto(s)
Detección Precoz del Cáncer/normas , Asesoramiento Genético/normas , Pruebas Genéticas/normas , Síndrome de Cáncer de Mama y Ovario Hereditario/epidemiología , Guías de Práctica Clínica como Asunto , Derivación y Consulta/normas , Adolescente , Adulto , Detección Precoz del Cáncer/estadística & datos numéricos , Femenino , Asesoramiento Genético/estadística & datos numéricos , Predisposición Genética a la Enfermedad , Pruebas Genéticas/estadística & datos numéricos , Síndrome de Cáncer de Mama y Ovario Hereditario/diagnóstico , Síndrome de Cáncer de Mama y Ovario Hereditario/genética , Humanos , Persona de Mediana Edad , Prevalencia , Estudios Prospectivos , Derivación y Consulta/estadística & datos numéricos , Medición de Riesgo/métodos , Medición de Riesgo/normas , Medición de Riesgo/estadística & datos numéricos , Eslovenia/epidemiología , Adulto Joven
3.
PLoS One ; 16(3): e0248633, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33735191

RESUMEN

Factors for overall survival after pancreatic ductal adenocarcinoma (PDAC) seem to be nodal status, chemotherapy administration, UICC staging, and resection margin. However, there is no consensus on the definition for tumor free resection margin. Therefore, univariate OS as well as multivariate long-term survival using cancer center data was analyzed with regards to two different resection margin definitions. Ninety-five patients met inclusion criteria (pancreatic head PDAC, R0/R1, no 30 days mortality). OS was analyzed in univariate analysis with respect to R-status, CRM (circumferential resection margin; positive: ≤1mm; negative: >1mm), nodal status, and chemotherapy administration. Long-term survival >36 months was modelled using multivariate logistic regression instead of Cox regression because the distribution function of the dependent data violated the requirements for the application of this test. Significant differences in OS were found regarding the R status (Median OS and 95%CI for R0: 29.8 months, 22.3-37.4; R1: 15.9 months, 9.2-22.7; p = 0.005), nodal status (pN0 = 34.7, 10.4-59.0; pN1 = 17.1, 11.5-22.8; p = 0.003), and chemotherapy (with CTx: 26.7, 20.4-33.0; without CTx: 9.7, 5.2-14.1; p < .001). OS according to CRM status differed on a clinically relevant level by about 12 months (CRM positive: 17.2 months, 11.5-23.0; CRM negative: 29.8 months, 18.6-41.1; p = 0.126). A multivariate model containing chemotherapy, nodal status, and CRM explained long-term survival (p = 0.008; correct prediction >70%). Chemotherapy, nodal status and resection margin according to UICC R status are univariate factors for OS after PDAC. In contrast, long-term survival seems to depend on wider resection margins than those used in UICC R classification. Therefore, standardized histopathological reporting (including resection margin size) should be agreed upon.


Asunto(s)
Carcinoma Ductal Pancreático/terapia , Páncreas/patología , Neoplasias Pancreáticas/terapia , Pancreaticoduodenectomía/estadística & datos numéricos , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Carcinoma Ductal Pancreático/diagnóstico , Carcinoma Ductal Pancreático/mortalidad , Carcinoma Ductal Pancreático/patología , Quimioterapia Adyuvante/métodos , Quimioterapia Adyuvante/estadística & datos numéricos , Femenino , Fluorouracilo/administración & dosificación , Estudios de Seguimiento , Humanos , Irinotecán/administración & dosificación , Estimación de Kaplan-Meier , Leucovorina/administración & dosificación , Masculino , Márgenes de Escisión , Persona de Mediana Edad , Terapia Neoadyuvante/métodos , Terapia Neoadyuvante/estadística & datos numéricos , Estadificación de Neoplasias , Oxaliplatino/administración & dosificación , Páncreas/cirugía , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/mortalidad , Neoplasias Pancreáticas/patología , Pancreaticoduodenectomía/normas , Estudios Retrospectivos , Medición de Riesgo/métodos , Medición de Riesgo/normas , Medición de Riesgo/estadística & datos numéricos , Factores de Tiempo , Resultado del Tratamiento
4.
Int J Toxicol ; 40(2): 178-195, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33297815

RESUMEN

Development of toxicology-based criteria such as occupational exposure levels (OELs) are rarely straightforward. This process requires a rigorous review of the literature, searching for patterns in toxicity, biological plausibility, coherence, and dose-response relationships. Despite the direct applicability, human data are rarely used primarily because of imprecise exposure estimates, unknown influence of assumptions, and confounding factors. As a result, high reliance is often placed on laboratory animal data. Often, data from a single study is typically used to represent an entire database to extrapolate an OEL, even for data-rich compounds. Here we present a holistic framework for evaluating epidemiological, controlled in vivo, mechanistic/in vitro, and computational evidence that can be useful in deriving OELs. It begins with describing a documented review process of the literature, followed by sorting of data into either controlled laboratory in vivo, in silico/read-across, mechanistic/in vitro, or epidemiological/field data categories. Studies are then evaluated and qualified based on rigor, risk of bias, and applicability for point of departure development. Other data (eg, in vitro, in silico estimates, read-across data and mechanistic information, and data that failed to meet the former criteria) are used alongside qualified epidemiological exposure estimates to help inform points of departure or human-equivalent concentrations that are based on toxic end points. Bayesian benchmark dose methods are used to estimate points of departure and for estimating uncertainty factors (UFs) to develop preliminary OELs. These are then compared with epidemiological data to support the OEL and the use and magnitude of UFs, when appropriate.


Asunto(s)
Contaminantes Ocupacionales del Aire/normas , Contaminantes Ocupacionales del Aire/toxicidad , Guías como Asunto , Exposición Profesional/legislación & jurisprudencia , Exposición Profesional/normas , Medición de Riesgo/normas , Valores Limites del Umbral , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estados Unidos
5.
Regul Toxicol Pharmacol ; 117: 104746, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-32911461

RESUMEN

Pharmaceutic products designed to perturb the function of epigenetic modulators have been approved by regulatory authorities for treatment of advanced cancer. While the predominant effort in epigenetic drug development continues to be in oncology, non-oncology indications are also garnering interest. A survey of pharmaceutical companies was conducted to assess the interest and concerns for developing small molecule direct epigenetic effectors (EEs) as medicines. Survey themes addressed (1) general levels of interest and activity with EEs as therapeutic agents, (2) potential safety concerns, and (3) possible future efforts to develop targeted strategies for nonclinical safety assessment of EEs. Thirteen companies contributed data to the survey. Overall, the survey data indicate the consensus opinion that existing ICH guidelines are effective and appropriate for nonclinical safety assessment activities with EEs. Attention in the framework of study design should, on a case by case basis, be considered for delayed or latent toxicities, carcinogenicity, reproductive toxicity, and the theoretical potential for transgenerational effects. While current guidelines have been appropriate for the nonclinical safety assessments of epigenetic targets, broader experience with a wide range of epigenetic targets will provide information to assess the potential need for new or revised risk assessment strategies for EE drugs.


Asunto(s)
Industria Farmacéutica/normas , Control de Medicamentos y Narcóticos , Epigénesis Genética/efectos de los fármacos , Preparaciones Farmacéuticas/normas , Encuestas y Cuestionarios , Animales , Evaluación Preclínica de Medicamentos/normas , Evaluación Preclínica de Medicamentos/tendencias , Industria Farmacéutica/tendencias , Control de Medicamentos y Narcóticos/tendencias , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Epigénesis Genética/genética , Humanos , Preparaciones Farmacéuticas/administración & dosificación , Medición de Riesgo/normas , Medición de Riesgo/tendencias
6.
Int J Cancer ; 147(9): 2345-2354, 2020 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-32319676

RESUMEN

Differentiated thyroid cancer (DTC) is the most common endocrine malignancy with a growing incidence worldwide. The initial conventional management is surgery, followed by consideration of 131 I treatment that includes three options. These are termed remnant ablation (targeting benign thyroid remnant), adjuvant (targeting presumed microscopic DTC) and known disease (targeting macroscopic DTC) treatments. Some experts mostly rely on clinicopathologic assessment for recurrence risk to select patients for the 131 I treatment. Others, in addition, apply radioiodine imaging to guide their treatment planning, termed theranostics (aka theragnostics or radiotheragnostics). In patients with low-risk DTC, remnant ablation rather than adjuvant treatment is generally recommended and, in this setting, the ATA recommends a low 131 I activity. 131 I adjuvant treatment is universally recommended in patients with high-risk DTC (a primary tumor of any size with gross extrathyroidal extension) and is generally recommended in intermediate-risk DTC (primary tumor >4 cm in diameter, locoregional metastases, microscopic extrathyroidal extension, aggressive histology or vascular invasion). The optimal amount of 131 I activity for adjuvant treatment is controversial, but experts reached a consensus that the 131 I activity should be greater than that for remnant ablation. The main obstacles to establishing timely evidence through randomized clinical trials for 131 I therapy include years-to-decades delay in recurrence and low disease-specific mortality. This mini-review is intended to update oncologists on the most recent clinical, pathologic, laboratory and imaging variables, as well as on the current 131 I therapy-related definitions and management paradigms, which should optimally equip them for individualized patient guidance and treatment.


Asunto(s)
Técnicas de Ablación/métodos , Radioisótopos de Yodo/uso terapéutico , Recurrencia Local de Neoplasia/prevención & control , Neoplasias de la Tiroides/terapia , Tiroidectomía , Adulto , Supervivencia sin Enfermedad , Relación Dosis-Respuesta en la Radiación , Humanos , Recurrencia Local de Neoplasia/epidemiología , Selección de Paciente , Guías de Práctica Clínica como Asunto , Oncología por Radiación/métodos , Oncología por Radiación/normas , Dosificación Radioterapéutica/normas , Radioterapia Adyuvante/métodos , Medición de Riesgo/normas , Glándula Tiroides/patología , Glándula Tiroides/efectos de la radiación , Glándula Tiroides/cirugía , Neoplasias de la Tiroides/mortalidad , Neoplasias de la Tiroides/patología
7.
Hepatology ; 72(6): 2206-2218, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32064645

RESUMEN

Treatment allocation is extremely complex in patients with hepatocellular carcinoma (HCC) because this neoplasm arises, in most cases, in patients with cirrhosis and additional comorbidities. The "stage hierarchy" approach, which involves linking each stage (or substage) of the disease to a specific treatment, has become the main proposed treatment strategy for the clinical management of HCC, particularly in the West. The Barcelona Clinic Liver Cancer (BCLC) scheme serves as the main example of the application of this strategy. In an attempt to increase the plasticity of the "stage hierarchy" approach as well as its adaptability to the requirements of real-world clinical practice, the latest versions of European and American guidelines have introduced certain relevant elements of flexibility, which were not intrinsic to the original BCLC scheme. These elements are as follows: the "treatment stage migration" strategy, which allows moving to another treatment (generally the one that is associated with the subsequent stage) if the approach linked with the current stage proves to be unfeasible, and the "treatment stage alternative" approach, which proposes further therapeutic options for each BCLC-defined stage. In regard to most of the solid cancers, another potential strategy is to consider the treatment decision to be hierarchically dictated by the efficacy of each therapy with complete or partial independence from the tumor stage. This concept of "therapeutic hierarchy" has been historically endorsed by the Asia-Pacific treatment algorithm as well as by the recent Italian multisociety guidelines. The present review provides a critical analysis of the different conceptual approaches to HCC management, highlighting their advantages and disadvantages and focusing on the remarkable differences between the stage-guided and the hierarchical strategies.


Asunto(s)
Carcinoma Hepatocelular/terapia , Vías Clínicas/tendencias , Neoplasias Hepáticas/terapia , Oncología Médica/tendencias , Guías de Práctica Clínica como Asunto , Carcinoma Hepatocelular/diagnóstico , Carcinoma Hepatocelular/mortalidad , Reglas de Decisión Clínica , Vías Clínicas/normas , Humanos , Neoplasias Hepáticas/diagnóstico , Neoplasias Hepáticas/mortalidad , Oncología Médica/métodos , Oncología Médica/normas , Estadificación de Neoplasias , Selección de Paciente , Pronóstico , Medición de Riesgo/métodos , Medición de Riesgo/normas , Resultado del Tratamiento
8.
J Hum Nutr Diet ; 33(1): 31-37, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31637756

RESUMEN

BACKGROUND: Despite policy guidance and quality standards, the majority of older adults with or at risk of malnutrition living in the community still remain under-detected and under-treated by health and social care professionals. The present study aimed to evaluate the concurrent validity of the Patients Association Nutrition Checklist against the 'Malnutrition Universal Screening Tool' ('MUST'). METHODS: This cross-sectional study involved 312 older adults recruited from 21 lunch and social groups. All participants were screened as per standard methodology for 'MUST'. For the Patients Association Nutrition Checklist, they provided information about signs of unintentional weight loss in the past 3-6 months, experiencing loss of appetite or interest in eating. Chance-corrected agreement (κ) was assessed. RESULTS: Mean (SD) age of participants was 79.6 (8.3) years and body mass index was 27.8 (5.6) kg m-2 . The majority (n = 197; 63%) were living alone. Using 'MUST', the overall prevalence of malnutrition was 9.9% (n = 31) comprising 6.7% at medium risk and 3.2% at high risk. There were 21.8% of participants (n = 68) rated at risk of overall malnutrition by the Patients Association Nutrition Checklist. Moderate agreement was observed between the two tools (κ = 0.47, P < 0.001). CONCLUSIONS: The Patients Association Nutrition Checklist has potential for early identification of malnutrition risk, attributed to unintentional weight loss and appetite changes with signposting to basic dietary advice and appropriate support. Further work is required to understand how this tool could be effectively used by stakeholders including volunteers, community workers and home care staff.


Asunto(s)
Lista de Verificación/normas , Evaluación Geriátrica , Desnutrición/diagnóstico , Evaluación Nutricional , Medición de Riesgo/normas , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Vida Independiente/estadística & datos numéricos , Masculino , Desnutrición/etiología , Prevalencia , Reproducibilidad de los Resultados , Factores de Riesgo , Pérdida de Peso
9.
J Clin Endocrinol Metab ; 105(3)2020 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-31665318

RESUMEN

CONTEXT: Current American Thyroid Association (ATA) Management Guidelines for the treatment of differentiated thyroid cancer (DTC) stratify patients to decide on additional radioiodine (RAI) therapy after surgery, and to predict recurring/persisting disease. However, studies evaluating the detection of distant metastases and how these guidelines perform in patients with distant metastases are scarce. OBJECTIVE: To evaluate the 2015 ATA Guidelines in DTC patients with respect to 1) the detection of distant metastases, and 2) the accuracy of its Risk Stratification System in patients with distant metastases. PATIENTS AND MAIN OUTCOME MEASURES: We retrospectively included 83 DTC patients who were diagnosed with distant metastases around the time of initial therapy, and a control population of 472 patients (312 low-risk, 160 intermediate-risk) who did not have a routine indication for RAI therapy. We used the control group to assess the percentage of distant metastases that would have been missed if no RAI therapy was given. RESULTS: Two hundred forty-six patients had no routine indication for RAI therapy of which 4 (1.6%) had distant metastases. Furthermore, among the 83 patients with distant metastases, 14 patients (17%) had excellent response, while 55 (67%) had structural disease after a median follow-up of 62 months. None of the 14 patients that achieved an excellent response had a recurrence. CONCLUSIONS: In patients without a routine indication for RAI therapy according to the 2015 ATA Guidelines, distant metastases would initially have been missed in 1.6% of the patients. Furthermore, in patients with distant metastases upon diagnosis, the 2015 ATA Guidelines are an excellent predictor of both persistent disease and recurrence.


Asunto(s)
Adenocarcinoma Folicular/prevención & control , Endocrinología/normas , Guías de Práctica Clínica como Asunto , Cáncer Papilar Tiroideo/prevención & control , Neoplasias de la Tiroides/terapia , Adenocarcinoma Folicular/diagnóstico , Adenocarcinoma Folicular/epidemiología , Adenocarcinoma Folicular/secundario , Adulto , Anciano , Anciano de 80 o más Años , Endocrinología/métodos , Femenino , Estudios de Seguimiento , Humanos , Radioisótopos de Yodo/uso terapéutico , Masculino , Persona de Mediana Edad , Organizaciones sin Fines de Lucro/normas , Selección de Paciente , Radioterapia Adyuvante/métodos , Radioterapia Adyuvante/normas , Estudios Retrospectivos , Medición de Riesgo/métodos , Medición de Riesgo/normas , Factores de Riesgo , Sociedades Médicas/normas , Cáncer Papilar Tiroideo/diagnóstico , Cáncer Papilar Tiroideo/epidemiología , Cáncer Papilar Tiroideo/secundario , Glándula Tiroides/patología , Glándula Tiroides/cirugía , Neoplasias de la Tiroides/diagnóstico , Neoplasias de la Tiroides/epidemiología , Neoplasias de la Tiroides/patología , Tiroidectomía/normas , Estados Unidos/epidemiología
10.
Nutrition ; 71: 110617, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31837642

RESUMEN

OBJECTIVE: The aim of the study was to examine the availability of clinical practice guidelines for malnutrition in hospitals over a period of 6 y and the subsequent use of nutritional interventions in malnourished patients. METHODS: This study was conducted as a secondary data analysis of data that were collected from 2012 to 2017 in a quantitative, cross-sectional, multicenter study called the National Prevalence Measurement Quality of Care (LPZ). Data from 15 hospitals and 5650 participating patients were analyzed. RESULTS: The availability of clinical practice guidelines for malnutrition at the institutions increased from 6.7% in 2012 to 100% in 2017 (P < 0.001). The control of compliance to the guidelines increased from 28.6% to 85.7% (P < 0.001) and the documentation of malnutrition risk improved from 63.1% to 87.5% (P = 0.008). In 2017, the intervention "referral to dietitian" was used 8.3% more often (P < 0.001). The number of patients who did not receive any intervention decreased from 70% in 2012 to 55.6% in 2017 (P < 0.001). CONCLUSIONS: The availability of guidelines on malnutrition increased in participating hospitals over the 6-y study period. Regular controls of adherence to the guidelines positively correlated with their availability. More interventions to treat malnutrition were carried out in 2017. The use of clinical practice guidelines in this study was associated with more interventions treating malnutrition.


Asunto(s)
Adhesión a Directriz/estadística & datos numéricos , Desnutrición , Terapia Nutricional/normas , Guías de Práctica Clínica como Asunto , Calidad de la Atención de Salud/estadística & datos numéricos , Estudios Transversales , Encuestas de Atención de la Salud , Hospitales/normas , Humanos , Evaluación Nutricional , Prevalencia , Medición de Riesgo/normas
12.
Curr Pharm Teach Learn ; 11(7): 655-657, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31227086

RESUMEN

INTRODUCTION: University professors who teach self-care and nonprescription products must decide which products and ingredients to recommend to students. The Food and Drug Administration (FDA) has approved many nonprescription ingredients as both safe and effective through the evidence-based FDA Over-the-Counter (OTC) Product Review or New Drug Application (NDA) processes. However, thousands of nonprescription products sold in community pharmacies are of unproven safety and/or efficacy. These include herbs, dietary supplements, homeopathic products, and essential oils. Selling products of unproven safety and/or efficacy can have serious consequences, exposing pharmacists to legal liability due to violations of the principles of implied and/or express warranties, as found in the Uniform Commercial Code. Further, the FDA defines products lacking proven safety and efficacy as health fraud, a crime aggressively pursued by both the FDA and the Federal Trade Commission. COMMENTARY: Faculty members who limit their nonprescription ingredient recommendations to those with FDA approval can justify those recommendations by weight of evidence. If the faculty member recommends ingredients that the FDA has not approved (e.g., kava), students should be taught that those ingredients pose unknown risks and lack proven benefit, and also that their labels virtually always lack doses proven to be safe, precautions, contraindications, and drug interactions. IMPLICATIONS: Selling unproven products can lower trust in pharmacy, cause patient harm, and expose the pharmacist to legal action. These issues should be explained to students whenever unproven products are discussed or recommended.


Asunto(s)
Responsabilidad Legal , Medicamentos sin Prescripción/uso terapéutico , Medición de Riesgo/métodos , Humanos , Medición de Riesgo/normas , Estados Unidos , United States Food and Drug Administration/organización & administración , United States Food and Drug Administration/tendencias
13.
J Am Med Dir Assoc ; 20(4): 444-450.e2, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30852170

RESUMEN

OBJECTIVES: Patients discharged to a skilled nursing facility (SNF) for post-acute care have a high risk of hospital readmission. We aimed to develop and validate a risk-prediction model to prospectively quantify the risk of 30-day hospital readmission at the time of discharge to a SNF. DESIGN: Retrospective cohort study. SETTING: Ten independent SNFs affiliated with the post-acute care practice of an integrated health care delivery system. PARTICIPANTS: We evaluated 6032 patients who were discharged to SNFs for post-acute care after hospitalization. MEASUREMENTS: The primary outcome was all-cause 30-day hospital readmission. Patient demographics, medical comorbidity, prior use of health care, and clinical parameters during the index hospitalization were analyzed by using gradient boosting machine multivariable analysis to build a predictive model for 30-day hospital readmission. Area under the receiver operating characteristic curve (AUC) was assessed on out-of-sample observations under 10-fold cross-validation. RESULTS: Among 8616 discharges to SNFs from January 1, 2009, through June 30, 2014, a total of 1568 (18.2%) were readmitted to the hospital within 30 days. The 30-day hospital readmission prediction model had an AUC of 0.69, a 16% improvement over risk assessment using the Charlson Comorbidity Index alone. The final model included length of stay, abnormal laboratory parameters, and need for intensive care during the index hospitalization; comorbid status; and number of emergency department and hospital visits within the preceding 6 months. CONCLUSIONS AND IMPLICATIONS: We developed and validated a risk-prediction model for 30-day hospital readmission in patients discharged to a SNF for post-acute care. This prediction tool can be used to risk stratify the complex population of hospitalized patients who are discharged to SNFs to prioritize interventions and potentially improve the quality, safety, and cost-effectiveness of care.


Asunto(s)
Alta del Paciente , Readmisión del Paciente , Transferencia de Pacientes , Instituciones de Cuidados Especializados de Enfermería , Anciano , Anciano de 80 o más Años , Registros Electrónicos de Salud , Femenino , Humanos , Masculino , Persona de Mediana Edad , Modelos Teóricos , Alta del Paciente/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Estudios Retrospectivos , Medición de Riesgo/normas , Estados Unidos
14.
Environ Pollut ; 244: 218-227, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30340168

RESUMEN

There is an increasing evidence linking protective effect of selenium (Se) against Pb toxicology; however, Pb exposure risk assessments usually consider only the environmental Pb contamination and dietary intake. Based on the current understanding of mechanisms of SePb interactions, the physiological function/toxicology of Se and the toxicology of Pb, a new criterion for Se and Pb exposure assessment is developed. Additionally, seven existing criteria were also used to assess the resident health risks around a smelter in China. The Pb concentrations in locally-produced foods exceeded the national tolerance limits of China and the Se in the foods were similar to those in areas with adequate Se levels. In accordance with the illustrated assessments of the new criterion and seven existing criteria, we found a large knowledge gap between the new and traditional assessments of exposure to Pb and/or Se. The new assessment criteria suggested that almost all the residents were facing the Se deficiency and 58% of the residents not only had the adverse health of Se deficiency, but also had the health risks of Pb toxicity. The Pb and Se in the hair and urine may partly support the new criterion. This study suggested that the process of Se counteracting the Pb toxicity may result in Se deficiency. Pb exposure combined Se intake should be considered in future assessments of Pb exposure (or Se intake).


Asunto(s)
Exposición a Riesgos Ambientales/normas , Plomo/toxicidad , Medición de Riesgo/normas , Selenio/deficiencia , Selenio/uso terapéutico , China , Humanos
15.
J Healthc Risk Manag ; 38(3): 12-23, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30033650

RESUMEN

The objective of this retrospective analysis was to describe the development and implementation of an anesthesiologist-led multidisciplinary committee to evaluate high-risk surgical patients in order to improve surgical appropriateness. The study was conducted in an anesthesia preoperative evaluation clinic at an academic comprehensive cancer center. One hundred sixty-seven high-risk surgical patients with cancer-related diagnoses were evaluated and discussed at a High-Risk Committee (HRC) meeting to determine surgical appropriateness and optimize perioperative care. The HRC is an anesthesiologist-led model for multidisciplinary review of high-risk patients developed at Roswell Park Comprehensive Cancer Center. The group of high-risk patients in which surgery was not performed had, on average, a greater percentage of hypertension, smoking history, dyspnea, heart failure, chronic obstructive pulmonary disease, diabetes, renal failure, and sleep apnea than the group in whom surgery was performed. Only one of 107 high-risk patients who had surgery died within the first 30 days after surgery. A smaller percentage of patients died in the group that had surgery versus the group in which surgery was canceled. For all patients discussed by the HRC, the mortality was less than 2% within the first 30 days after the HRC.


Asunto(s)
Anestesia/normas , Cirugía General/normas , Guías como Asunto , Neoplasias/cirugía , Atención Perioperativa/normas , Medición de Riesgo/normas , Adulto , Anestesiólogos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
16.
Heart Rhythm ; 16(6): 943-951, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30550836

RESUMEN

BACKGROUND: The relationship between the surface electrocardiogram (ECG) T wave to intracardiac repolarization is poorly understood. OBJECTIVE: The purpose of this study was to examine the association between intracardiac ventricular repolarization and the T wave on the body surface ECG (SECGTW). METHODS: Ten patients with a normal heart (age 35 ± 15 years; 6 men) were studied. Decapolar electrophysiological catheters were placed in the right ventricle (RV) and lateral left ventricle (LV) to record in an apicobasal orientation and in the lateral LV branch of the coronary sinus (CS) for transmural recording. Each catheter (CS, LV, RV) was sequentially paced using an S1-S2 restitution protocol. Intracardiac repolarization time and apicobasal, RV-LV, and transmural repolarization dispersion were correlated with the SECGTW, and a total of 23,946 T waves analyzed. RESULTS: RV endocardial repolarization occurred on the upslope of lead V1, V2, and V3 SECGTW, with sensitivity of 0.89, 0.91, and 0.84 and specificity of 0.67, 0.68, and 0.65, respectively. LV basal endocardial, epicardial, and mid-endocardial repolarization occurred on the upslope of leads V6 and I, with sensitivity of 0.79 and 0.8 and specificity of 0.66 and 0.67, respectively. Differences between the end of the upslope in V1, V2, and V3 vs V6 strongly correlated with right to left dispersion of repolarization (intraclass correlation coefficient 0.81, 0.83, and 0.85, respectively; P <.001). Poor association between the T wave and apicobasal and transmural dispersion of repolarization was seen. CONCLUSION: The precordial SECGTW reflects regional repolarization differences between right and left heart. These findings have important implications for accurately identifying biomarkers of arrhythmogenic risk in disease.


Asunto(s)
Arritmias Cardíacas , Mapeo del Potencial de Superficie Corporal/métodos , Técnicas Electrofisiológicas Cardíacas/métodos , Sistema de Conducción Cardíaco/fisiología , Ventrículos Cardíacos , Adulto , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatología , Electrofisiología Cardíaca , Humanos , Masculino , Medición de Riesgo/métodos , Medición de Riesgo/normas
17.
Value Health ; 21(8): 993-1001, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-30098678

RESUMEN

BACKGROUND: Despite evidence of nonproportional trade-offs in time trade-off exercises and the explicit incorporation of exponential discounting in health technology assessment calculations, quality-adjusted life-year (QALY) tariffs are currently still established under the assumption of linear time preferences. OBJECTIVES: The aim of this study was to introduce a general method of accommodating for nonlinear time preferences in discrete choice experiment (DCE) duration studies and to evaluate its impact on estimated QALY tariffs. METHODS: A parsimonious utility function is proposed that accommodates any discounting function and preserves linear time preferences as a special case. Based on an efficient DCE design and 1775 respondents from a nationally representative scientific household panel, preferences and QALY tariffs for the Dutch SF-6D were estimated while accommodating for nonlinear time preferences via exponential and hyperbolic discounting functions. RESULTS: When the discount rate was estimated directly, we found strong evidence of nonlinear time preferences (with an exponential and hyperbolic discount rate of 5.7% and 16.5%, respectively). When the discount rate was estimated as a function of health state severity, we found that years lived in better health states are discounted minus years lived in impaired health states. Finally, the best statistical fit was obtained when using a hyperbolic discount function, which resulted in smaller QALY decrements and fewer health states classified as worse than immediate death. CONCLUSIONS: Our results highlight the relevance and even necessity of a paradigm shift in health valuation studies in favor of time-preference corrected QALY tariffs, with potentially important implications for health technology assessment calculations and regulatory decisions.


Asunto(s)
Estado de Salud , Medición de Riesgo/normas , Conducta de Elección , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psicometría/instrumentación , Psicometría/métodos , Calidad de Vida/psicología , Años de Vida Ajustados por Calidad de Vida , Medición de Riesgo/métodos , Encuestas y Cuestionarios
18.
J Acad Nutr Diet ; 118(4): 724-735, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29576092

RESUMEN

It is the position of the Academy of Nutrition and Dietetics that the quality of life and nutritional status of older adults in long-term care, post-acute care, and other settings can be enhanced by individualized nutrition approaches. The Academy advocates that as part of the interprofessional team, registered dietitian nutritionists assess, evaluate, and recommend appropriate nutrition interventions according to each individual's medical condition, desires, and rights to make health care choices. Nutrition and dietetic technicians, registered assist registered dietitian nutritionists in the implementation of individualized nutrition care, including the use of least restrictive diets. Health care practitioners must assess risks vs benefits of therapeutic diets, especially for frail older adults. Food is an essential component of quality of life; an unpalatable or unacceptable diet can lead to poor food and fluid intake, resulting in malnutrition and related negative health effects. Including older individuals in decisions about food can increase the desire to eat and improve quality of life.


Asunto(s)
Geriatría/normas , Cuidados a Largo Plazo/normas , Terapia Nutricional/normas , Medicina de Precisión/normas , Atención Subaguda/normas , Academias e Institutos/organización & administración , Anciano , Anciano de 80 o más Años , Dietética/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Política Nutricional , Medición de Riesgo/normas
19.
Nutrition ; 47: 13-20, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29429529

RESUMEN

OBJECTIVES: Refeeding syndrome (RFS) can be a life-threatening metabolic condition after nutritional replenishment if not recognized early and treated adequately. There is a lack of evidence-based treatment and monitoring algorithm for daily clinical practice. The aim of the study was to propose an expert consensus guideline for RFS for the medical inpatient (not including anorexic patients) regarding risk factors, diagnostic criteria, and preventive and therapeutic measures based on a previous systematic literature search. METHODS: Based on a recent qualitative systematic review on the topic, we developed clinically relevant recommendations as well as a treatment and monitoring algorithm for the clinical management of inpatients regarding RFS. With international experts, these recommendations were discussed and agreement with the recommendation was rated. RESULTS: Upon hospital admission, we recommend the use of specific screening criteria (i.e., low body mass index, large unintentional weight loss, little or no nutritional intake, history of alcohol or drug abuse) for risk assessment regarding the occurrence of RFS. According to the patient's individual risk for RFS, a careful start of nutritional therapy with a stepwise increase in energy and fluids goals and supplementation of electrolyte and vitamins, as well as close clinical monitoring, is recommended. We also propose criteria for the diagnosis of imminent and manifest RFS with practical treatment recommendations with adoption of the nutritional therapy. CONCLUSION: Based on the available evidence, we developed a practical algorithm for risk assessment, treatment, and monitoring of RFS in medical inpatients. In daily routine clinical care, this may help to optimize and standardize the management of this vulnerable patient population. We encourage future quality studies to further refine these recommendations.


Asunto(s)
Algoritmos , Técnicas de Apoyo para la Decisión , Tamizaje Masivo/normas , Evaluación Nutricional , Síndrome de Realimentación/prevención & control , Consenso , Práctica Clínica Basada en la Evidencia/normas , Humanos , Pacientes Internos , Guías de Práctica Clínica como Asunto , Síndrome de Realimentación/diagnóstico , Medición de Riesgo/normas , Factores de Riesgo
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