Prospective validation of smartphone-based heart rate and respiratory rate measurement algorithms.

Background: Measuring vital signs plays a key role in both patient care and wellness, but can be challenging outside of medical settings due to the lack of specialized equipment. Methods: In this study, we prospectively evaluated smartphone camera-based techniques for measuring heart rate (HR) and respiratory rate (RR) for consumer wellness use. HR was measured by placing the finger over the rear-facing camera, while RR was measured via a video of the participants sitting still in front of the front-facing camera. Results: In the HR study of 95 participants (with a protocol that included both measurements at rest and post exercise), the mean absolute percent error (MAPE) ± standard deviation of the measurement was 1.6% ± 4.3%, which was significantly lower than the pre-specified goal of 5%. No significant differences in the MAPE were present across colorimeter-measured skin-tone subgroups: 1.8% ± 4.5% for very light to intermediate, 1.3% ± 3.3% for tan and brown, and 1.8% ± 4.9% for dark. In the RR study of 50 participants, the mean absolute error (MAE) was 0.78 ± 0.61 breaths/min, which was significantly lower than the pre-specified goal of 3 breaths/min. The MAE was low in both healthy participants (0.70 ± 0.67 breaths/min), and participants with chronic respiratory conditions (0.80 ± 0.60 breaths/min). Conclusions: These results validate the accuracy of our smartphone camera-based techniques to measure HR and RR across a range of pre-defined subgroups.

Estimating cost savings of pharmacogenetic testing for depression in real-world clinical settings.

The burden of depression significantly impacts the patient, the health care system, and society, at large. Medication management guided by pharmacogenetics has been shown to increase therapeutic efficacy and improve symptoms in patients diagnosed with depression, but limited data are available on the cost savings of pharmacogenetic-guided interventions outside of psychiatric clinical specialties. Our study utilizes published health care costs and clinical patient outcome data to model the economic impact of pharmacogenetic-guided treatment for depression in a variety of clinical settings. Assuming a test cost of USD$2,000 for pharmacogenetic testing, the model predicts a savings of USD$3,962 annually per patient with pharmacogenetic-guided medication management.

Cost-Effectiveness of a Pharmacogenetic Test to Guide Treatment for Major Depressive Disorder.

BACKGROUND: Recent clinical trials indicate that pharmacogenetic-guided treatment of major depressive disorder (MDD) results in higher treatment response rates by genetically matching patients to medications and avoiding a trial-and-error process. OBJECTIVE: To evaluate the cost-effectiveness of a pharmacogenetic test (IDGx) that has demonstrated effectiveness compared with standard of care (SOC) medication management among patients with varied MDD severity. METHODS: Data from a large prospective, randomized controlled trial of treatment-naive patients or patients with inadequately controlled MDD in general practice and psychiatric treatment settings were used to build a Markov state-transition probability model. Analyses were conducted from the societal perspective. Treatment response rates, mortality rates, direct and indirect medical costs, and utility inputs were derived from the reference study and published scientific literature. The cost of the pharmacogenetic test was $2,000. A 3% discount rate was used to discount costs and effects. Univariate one-way sensitivity analyses were performed to determine the effect of input parameters on net monetary benefit. RESULTS: For moderate to severe MDD, the model estimated a cumulative effect over 3 years of 2.07 quality-adjusted life-years (QALYs) for the pharmacogenetic-guided treatment group and 1.97 QALYs for the SOC group, including a lower probability of death from suicide (0.328% and 0.351%, respectively). Total costs over 3 years were $44,697 (IDGx) and $47,295 (SOC). This difference includes a savings of $2,918 in direct medical costs and $1,680 in indirect costs. Results were more pronounced when only severely depressed patients were evaluated. CONCLUSIONS: Pharmacogenetic testing among moderate to severe MDD patients improved QALYs and resulted in cost savings. Sensitivity analyses supported the robust nature of the current findings of the dominant IDGx test to guide treatment. DISCLOSURES: Funding for this analysis was provided by AltheaDx, which is the manufacturer of the IDgenetix test. AltheaDx personnel assisted in the study design, data collection, and review of the manuscript. Maciel and Garces are employed by AltheaDx. Groessl has received funding as a consultant from American Specialty Health.

Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility.

The objective of this study was to evaluate the effect of pharmacogenetics-guided treatment on patients diagnosed with depression and/or anxiety, in a diverse set of clinical settings, as compared to the standard of care. The trial design followed a prospective, randomized, subject- and rater-blinded approach enrolling 685 patients from clinical providers specializing in Psychiatry, Internal Medicine, Obstetrics & Gynecology, and Family Medicine. The NeuroIDgenetix® test uses a genetic variant panel of ten genes, along with concomitant medications, to make medication management recommendations based on gene-drug and drug-drug interactions for over 40 medications used in the treatment of depression and anxiety. Pharmacogenetic testing was performed at the initial screening visit and baseline patient assessments were determined using the 17-item Hamilton Rating Scale for Depression (HAM-D17) and the Hamilton Rating Scale for Anxiety (HAM-A). Following enrollment and randomization, pharmacogenetic results for subjects assigned to the experimental group were provided to physicians to guide treatment selection, while control subjects were treated according to the usual standard of care. HAM-D17 and HAM-A assessments were collected at 4 weeks, 8 weeks, and 12 weeks after baseline to assess the efficacy of therapeutic selection. In patients diagnosed with depression, response rates (p = 0.001; OR: 4.72 [1.93-11.52]) and remission rates (p = 0.02; OR: 3.54 [1.27-9.88]) were significantly higher in the pharmacogenetics-guided group as compared to the control group at 12 weeks. In addition, patients in the experimental group diagnosed with anxiety showed a meaningful improvement in HAM-A scores at both 8 and 12 weeks (p = 0.02 and 0.02, respectively), along with higher response rates (p = 0.04; OR: 1.76 [1.03-2.99]). From these results, we conclude that pharmacogenetic-guided medication selection significantly improves outcomes of patients diagnosed with depression or anxiety, in a variety of healthcare settings.

Economic Evaluation of Implementing a Novel Pharmacogenomic Test (IDgenetix®) to Guide Treatment of Patients with Depression and/or Anxiety.

BACKGROUND: The response to therapeutics varies widely in patients with depression and anxiety, making selection of an optimal treatment choice challenging. IDgenetix®, a novel pharmacogenomic test, has been shown to improve outcomes by predicting the likelihood of response to different psychotherapeutic medications. OBJECTIVE: The objective of this study was to estimate the cost effectiveness of implementing a novel pharmacogenomic test (IDgenetix®) to guide treatment choices in patients with depression and/or anxiety compared with treatment as usual from the US societal perspective. METHODS: We developed a discrete event simulation to compare clinical events, quality-adjusted life-years, and costs of the two treatment strategies. Target patients had a Hamilton Rating Scale for Depression Score ≥ 20 and/or a Hamilton Rating Scale for Anxiety score ≥ 18 at baseline. Remission, response, and no response were simulated based on the observed rates in the IDgenetix® randomized controlled trial. Quality-adjusted life-years and direct and indirect costs attributable to depression and anxiety were estimated and compared over a 3-year time horizon. We conducted extensive deterministic and probabilistic sensitivity analyses to assess the robustness of the results. RESULTS: The model predicted cumulative remission rates of 78 and 66% in IDgenetix® and treatment as usual groups, respectively. Estimated discounted quality-adjusted life-years were 2.09 and 1.94 per patient for IDgenetix® and treatment as usual, respectively, which resulted in 0.15 incremental quality-adjusted life-years (95% credible interval 0.04-0.28). The total costs after accounting for a US$2000 test cost were US$14,124 for IDgenetix® compared with US$14,659 for treatment as usual, suggesting a US$535 (95% credible interval - 2902 to 1692) cost saving per patient in the IDgenetix® group. Incremental quality-adjusted life-year gain (0.49) and cost savings (US$6800) were substantially larger in patients with severe depression (Hamilton Rating Scale for Depression score ≥ 25). CONCLUSION: Using the IDgenetix® test to guide the treatment of patients with depression and anxiety may be a dominant strategy, as it improves quality-adjusted life-years and decreases overall costs over a 3-year time horizon.

Nivel de conocimientos, actitudes y aptitudes en infecciones intrahospitalarias del personal asistencial de un hospital de baja y uno de alta complejidad, en Antioquia / Level of Knowledge, Attitudes and Skills as for Hospital-Acquired Infections in Health Care Staff of a Low and a High-Complexity Hospital in Antioquia / Nível de conhecimento, atitudes e aptidões em infecções hospitalares de profissionais de saúde de um hospital de baixa e um hospital de alta complexidade em Antioquia

Introducción. Según la Organización Mundial de la Salud, en instituciones de países en desarrollo las infecciones nosocomiales podrían superar el 25%; en Colombia, en 2012 estas representaban el 4.7% de las causas de muerte según Secretaría de Salud de Bogotá. El Ministerio de Salud señaló a Antioquia como el departamento con la tasa más alta en Infecciones Asociadas a la Atención en Salud (IAAS). Objetivo. Evaluar el nivel de conocimientos, actitudes y aptitudes en IAAS por parte del personal asistencial de un hospital de baja y uno de alta complejidad, en Antioquia. Metodología. Estudio descriptivo transversal, 66 participantes entre médicos, auxiliares de enfermería y enfermeros de urgencias y hospitalización. Intervalo de confianza del 90%. Criterios de inclusión: llevar mínimo tres meses trabajando en el hospital, en todos los tipos de contratación. Exclusión: no aceptar participación y personal asistencial con funciones administrativas. Se aplicó un instrumento con preguntas cerradas sobre los conocimientos, actitudes y aptitudes en IAAS. Resultados. Enfermería tuvo mayor nivel en conocimientos, auxiliares de enfermería en prácticas y los médicos tuvieron menor puntaje con un 24%. En actitud, el personal de ambos hospitales percibía las actividades asociadas a la atención en salud como importantes, pero rutinarias. Discusión. El componente de conocimientos representa el mayor problema para la población, más específicamente la temática sobre lavado de manos, los médicos presentaron mayor número de puntajes por debajo del 60%. Conclusiones. El estudio sugiere que los profesionales de ambos hospitales, independientemente de su profesión, poseen mejores bases prácticas que teóricas, la actitud no parece tener relación con las otras variables.

Introduction. According to the World Health Organization, nosocomial infection rate in institutions from developing countries could exceed 25%; in Colombia, in 2012 these represented 4.7% of the causes of death according to the Health Secretariat of Bogotá The Ministry of Health has identified Antioquia as the department with the highest rate of Healthcare-Associated Infections (HAI). Objective. To assess the level of knowledge, attitudes and skills in HAIs by the healthcare staff of a low and a high complexity hospital in Antioquia. Methodology. Cross-sectional descriptive study, 66 participants thereof including physicians, nursing assistants and emergency and hospitalization nurses. 90% confidence interval. Inclusion criteria: at least three months working in the hospital, under all types of contracts. Exclusion: staff not accepting participation and assistance staff with administrative functions. An instrument with closed questions on knowledge, attitudes and skills in HAIs was applied. Results. Nursing staff had the highest level in knowledge, nursing assistants in practice and physicians had the lowest score with 24%. As for attitudes, staff at both hospitals identified the activities associated with health care as important, but routinary. Discussion. The knowledge component stands as the greatest issue for this population, more specifically the hand washing topic, with physicians recording the greater number of scores below 60%. Conclusions. The study suggests that practitioners in both hospitals, regardless of their professional duties, have a better practical than theoretical basis; attitude does not seem to be related to the other variables.

Introdução. Segundo a Organização Mundial da Saúde, em instituições de países em desenvolvimento, as infecções nosocomiais podem ultrapassar 25%; na Colômbia, em 2012, representavam 4.7% das causas de morte, segundo o Ministério da Saúde de Bogotá. O Ministério da Saúde indicou Antioquia como o departamento com maior índice de Infecções Associadas à Atenção à Saúde (IAAS). Objetivo. Avaliar o nível de conhecimento, atitudes e aptidões em IAAS da equipe assistencial de um hospital de baixa complexidade e um hospital de alta complexidade, em Antioquia. Metodologia. Estudo descritivo transversal, com 66 participantes entre médicos, auxiliares de enfermagem e enfermeiros de emergência e internação. Intervalo de confiança de 90%. Critérios de inclusão: trabalhar no hospital há, no mínimo, três meses, em todos os tipos de vínculos. Exclusão: não aceitar participação e pessoal de saúde com funções administrativas. Foi aplicado um instrumento com questões fechadas sobre conhecimentos, atitudes e aptidões em IAAS. Resultados. A enfermagem apresentou maior nível de conhecimento, os auxiliares de enfermagem e os médicos obtiveram menor pontuação com 24%. Na atitude, os funcionários de ambos os hospitais perceberam as atividades associadas aos cuidados de saúde como importantes, mas rotineiras. Discussão. O componente conhecimento representa o maior problema para a população, mais especificamente a questão da lavagem das mãos, os médicos apresentaram o maior número de pontuações abaixo dos 60%. Conclusões. O estudo sugere que os profissionais de ambos os hospitais, independentemente da profissão, possuem melhores bases práticas do que teóricas; a atitude não parece estar relacionada com as demais variáveis.

Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial.

Objective: Pharmacogenetic testing holds promise as a personalized medicine tool by permitting individualization of pharmacotherapy in accordance with genes influencing therapeutic response, side effects, and adverse events. The authors evaluated the effect on outcomes for patients diagnosed with neuropsychiatric disorders of pharmacogenetics (PGx)-guided treatment compared to usual standard of care. Methods: This was a prospective, randomized study of 237 patients at an outpatient community-based psychiatric practice conducted between April 2015 and October 2015. Baseline patient assessments and a buccal swab were collected for pharmacogenetic testing at study initiation. For the experimental group, PGx results were provided to the clinicians as guides to treatment. Control subjects were treated according to the usual standard of care with no clinician reference to their PGx results. Neuropsychiatric Questionnaire (NPQ) and Symbol Digit Coding Test (SDC) scores and adverse drug events, hospitalizations, and medication information were collected at 30, 60, and 90 days. Results: More than half (53%) of patients in the control group reported at least 1 adverse drug event compared to 28% of patients with PGx-guided medication management (P = .001). NPQ and SDC scores improved for both groups, but no statistical difference in efficacy as measured by these assessments was observed within the 90-day observation period. Conclusions: Pharmacogenetic testing may facilitate psychiatric drug therapy with greater tolerability and similar efficacy compared to standard of care. Trial Registration: ClinicalTrials.gov Identifier: NCT02411123​​.

Ganglio centinela positivo en estadios iniciales de cáncer de mama. 2018. Resumen de recomendaciones / Positive sentinel lymph node in early stages of breast cancer. 2018. Summary of recommendations

Sabemos que el estado de la axila sigue siendo un factor pronóstico determinante y fundamental en la elección del tratamiento adyuvante de nuestras pacientes. Varios ensayos clínicos han hecho esfuerzos para intentar demostrar que la biopsia del ganglio centinela es tan efectiva como la linfadenectomía en cuanto a la estadificación. Estos mismos estudios evidenciaron que, en la gran mayoría de los casos ­del 40% al 60%­, ese ganglio centinela es el único metastásico. Por lo tanto, luego se quiso demostrar la efectividad de esa biopsia de ganglio centinela, no solo en cuanto a la eficacia de la estadificación, sino en cuanto al control local, incluso en pacientes con hasta uno o dos ganglios comprometidos pero que recibieron el tratamiento local adecuado, esto es, la exéresis adecuada, el tratamiento radiante completo y el tratamiento adyuvante que correspondiera en esos casos

Micrometástasis y células tumorales aisladas en ganglio centinela en pacientes con cáncer de mama: experiencia del Instituto Alexander Fleming / Micrometastases and isolated tumor cells in the centinela node in patients with breast cancer: experience of the Instituto Alexander Fleming

Introducción: el rol del vaciamiento axilar en pacientes con cáncer de mama (CM) con micrometástasis o células tumorales aisladas (CTA) en el ganglio centinella (GC) es controvertido. Objetivos: analizar retrospectivamente pacientes con CM y micrometástasis o CTA en el GC, en términos descriptivos histológicos, terapéuticos y evolución clínica. Métodos: mil veintidós (1.022) biopsias del GC en pacientes con CM (período 1998-2010) fueron evaluadas histológicamente y con inmunohistoquímica. Los tratamientos adyuvantes y los patrones de recurrencia fueron evaluados retrospectivamente de las historias clínicas. Resultados: doscientos treinta y ocho (238) pacientes (23.2%) presentaron GC+. Ciento cuarenta y tres (143) casos (60.0%) fueron macrometástasis, 58 casos (24.3%) micrometástasis y 37 casos (15.5%) CTA. De 58 pacientes con micrometástasis, 75.8% realizó VAG. Veintiocho (28) pacientes (75.6%) de 37 pacientes con CTA no completaron VAG. El porcentaje de GNC+ en las pacientes con micrometástasis y CTA fue 22.7% y 11.0%, respectivamente. Todas las pacientes recibieron tratamiento adyuvante. La mediana de seguimiento fue 54 meses. No hubo recurrencias axilares. El 5% de ambos grupos presentó recurrencias a distancia. La sobrevida libre de eventos es del 94% a 48 meses en ambos grupos. No hubo diferencias estadísticamente significativas para eventos y sobrevida global entre CTA y MIC (p=0.49). Conclusiones: en nuestro estudio las pacientes con micrometástasis y CTA no presentaron recurrencias axilares. No hubo diferencias entre ambos grupos con relación a sobrevida libre de eventos y sobrevida global...

Aspectos anatomopatologicos de la biopsia del ganglio centinela / Pathological aspects of the sentinel node biopsy

Introduccion: la biopsia del ganglio centinela (BGC) constituye un metodo minimamente invasivo para estadificar los ganglios linfaticos axilares en las pacientes con carcinoma de mama. Desde su introduccion, a mediados de la decada de 1990, se ha tratado de demostrar que, en manos experimentadas, ademas de ser minimamente invasivo, constituye un metodo confiable para predecir el estado del resto de los ganglios axilares. Sin embargo, aun quedan por resolver algunos puntos controversiales, entre ellos el manejo y procesamiento anatomopatologico del ganglio centinela (GC). Objetivos: analizar los distintos metodos de procesamiento del GC, el valor del estudio intraoperatorio, la necesidad de utilizar tecnicas especiales para su estudio y la interpretacion de las metastasis detectadas segun los distintos metodos utilizados. Materiales y metodos: entre abril de 1995 y julio de 2002 estudiamos 150 GC correspondientes a 124 pacientes portadoras de carcinoma de mama. En todos los casos realizamos el examen intraoperatorio con improntas citologicas; en parte de los casos, con cortes por congelacion y luego el estudio diferido mediante cortes seriados con hematoxilina eosina (H-E) e inmunohistoquimica (IHQ). Resultados: Noventa y cinco sobre 124 (77,6 por ciento) presentaron el o los GC negativos, y 29/124 (23,3 por ciento) positivos para compromiso tumoral. Veinte sobre 29 (69 por ciento) fueron positivos tanto en el estudio intraoperatorio como en el diferido y 9/29 (31 por ciento) fueron negativos en el estudio intraoperatorio y presentaron compromiso tumoral diferido (falsos negativos del estudio intraoperatorio). Cinco sobre 9 (55,6 por ciento) de estos falsos negativos presentaron compromiso en los cortes con H-E y 4/9 (44,4 por ciento) con IHQ; solamente 3/9 (33,3 por ciento) correspondieron a verdaderas micrometastasis segun definicion actual; 6/9 (66,7 por ciento) presentaron compromiso no mensurable. Conclusion: consideramos que la metodologia utilizada para la BGC, con examen intraoperatorio por impronta citologica y estudio diferido con cortes seriados con H-E, constituye un metodo apropiado para nuestro medio, queda por definir la necesidad de realizar tecnicas de inmunomarcacion en forma rutinaria y el significado clinico de las metastasis halladas con este metodo

Patología de los carcinomas no invasores de la mama / Pathologic of the non invasive breast cancer

El carcinoma de la mama se origina, en su comienzo, como una proliferación atípica del epitelio de los lobulillos mamarios o de los conductos galactóforos, la que rellena, total o parcialmente, la luz de los mismos (carcinoma "in situ"); luego infiltra el estroma circundante convirtiéndose en un carcinoma invasor. Es decir que, a partir del epitelio normal de los conductos y de los lobulillos mamarios, en una progresión a través de estadios intermedios, se desarrolla el carcinoma de la mama, cuya fase más temprana y de mejor pronóstico, es la forma "in situ". De acuerdo con esto, los carcinomas mamarios pueden clasificarse como carcinomas no infiltrantes o no invasores (carcinoma "in situ"), carcinoma sin infiltración evidente del esoma) y carcinomas infiltrantes o invasores. En este capítulo haremos referencia a los distintos tipos de carcinomas "in situ" de la mama; creemos de importancia, antes de analizar los distintos tipos de carcinomas no invasores, hacer un breve resumen de la histogénesis del tejido glandular mamario