Work productivity in rheumatoid arthritis patients from two Latin American countries treated with tofacitinib or biological DMARDs.

OBJECTIVE: To evaluate work productivity of adult Latin American patients with rheumatoid arthritis (RA) treated with tofacitinib and biological disease-modifying anti-rheumatic drugs (bDMARDs) measured by the Work Productivity and Activity Impairment (WPAI) in RA questionnaire at 0- and 6-month follow-up. METHODS: This non-interventional study was performed in Colombia and Peru. Evaluated the effects of tofacitinib and bDMARDs in patients with RA after failure of conventional DMARDs. The WPAI-RA questionnaire was administered at baseline and at the 6-month (±1 month) follow-up. The results are expressed as least squares means (LSMs), and standard errors (SEs). RESULTS: One hundred patients treated with tofacitinib and 70 patients treated with bDMARDs were recruited. Twenty-eight percent of patients from the tofacitinib group and 40.0% from the bDMARDs group were working for pay at baseline. At month 6, the changes in absenteeism, presenteeism, and work impairment due to health were -18.3% (SE 7.7), -34.8% (SE 5.9), and -11.0% (SE 16.5), respectively, in the tofacitinib group and -19.4% (SE 8.0), -34.8% (SE 6.2), and -15.9% (SE 15.0), for the bDMARD group. CONCLUSION: For patients who reported working, there were improvements in presenteeism, absenteeism, and work impairment due to health in both groups. TRIAL REGISTRATION: NCT03073109.

Método de incorporación estratégica de tecnología biomédica para instituciones de salud / Method of strategic incorporation of biomedical technology for health institutions / Método de incorporação estratégica de tecnologia biomédica para instituições de saúde

Los costos continuos, altos e innecesarios de la tecnología, la escasa atención del paciente, las decisiones tomadas por personas con poca experiencia y el desperdicio de recursos públicos dedicados a la salud, generan la necesidad de desarrollar un proceso racional y sistemático para la incorporación de equipos médicos. El objetivo de este trabajo fue hacer que un método comience con una recopilación de información a través de una revisión de la literatura y la implementación de una encuesta para diagnosticar el estado de los procesos de incorporación en diferentes instituciones de salud y saber cuáles son las etapas críticas y los pasos a seguir en cada uno de ellos. El método se implementó en un caso real con la adquisición de dos tecnologías: el acelerador lineal y un esterilizador de vapor. El método fue validado con dos expertos responsables de la adquisición de estos equipos para determinar su usabilidad e importancia en el proceso de incorporación de la tecnología biomédica. La validación mostró resultados cuantitativos y positivos para ambas tecnologías, ya que los expertos estuvieron satisfechos con cada uno de los aspectos evaluados y el informe final proporcionado por el método.

The continued high and unnecessary costs of technology, poor patient care, decisions made by people with little experience and waste of public resources devoted to health. All generate a need to develop a rational and systematic process for the incorporation of medical equipment. The aim of this work was to create such a method through collection of information, a literature review and implementation of a survey to diagnose the status of the processes of incorporation into different healthcare institutions and learn the critical stages and steps to be performed in each. The method was implemented in a real case with the acquisition of two technologies, a linear accelerator and a steam sterilizer. The method was validated with two experts responsible for the acquisition of this equipment to determine its usability and importance in the process of incorporation of biomedical technology. Validation showed quantitative and positive results for both technologies because the experts were satisfied with each of the aspects evaluated and the final report provided by the method.

Os altos e desnecessários custos continuados da tecnologia, a escassa atenção aos pacientes, as decisões tomadas por pessoas com pouca experiência e o desperdício de recursos públicos dedicados à saúde, geram a necessidade de desenvolver um processo racional e sistemáticos para a incorporação de equipamentos médicos. Os objetivos deste trabalho foram fazer um método que comece com uma compilação de informação através de uma revisão da literatura e a implementação de uma sondagem para diagnosticar o estado dos processos de incorporação nas diferentes instituições de saúde e saber quais são as etapas críticas e os passos a seguir em cada um deles. O método implementou-se num caso real com a aquisição de duas tecnologias, o acelerador linear e um esterilizador de vapor. Este foi validado com dois peritos responsáveis da aquisição destes equipamentos para determinar sua usabilidade e importância no processo de incorporação da tecnologia biomédica. A validação mostrou resultados quantitativos e positivos para ambas tecnologias, já que os peritos estiveram satisfeitos com cada um dos aspectos avaliados e o relatório final proporcionado pelo método.

3D evaluation of maxillary arches in unilateral cleft lip and palate patients treated with nasoalveolar moulding vs. Hotz's plate.

To compare the three-dimensional changes occurring in the maxillary arch during the use of modified pre-surgical nasoalveolar moulding (PNAM) and Hotz's plate. A clinical trial including 32 children with unilateral cleft lip and palate (UCLP), 16 treated with Hotz's plate and 16 with PNAM, was performed. Impressions of the maxillary arches were taken: A. prior to pre-surgical orthopaedics, B. before cheiloplasty and C. after cheiloplasty. Models were digitised using a stereophotogrammetric instrument, and geodesic distances were calculated: anterior, canine and posterior widths of the arch, and lengths and cleft depths of the larger and shorter segments. The time and treatment effects were assessed by two-factor anova. A significant effect of treatment was found for cleft depth at the larger segment: children treated with Hotz's plate had significantly deeper cleft than children treated with PNAM. All distances significantly changed during time: the anterior and canine widths decreased, while the posterior width, the lengths and depths of the cleft segments increased. Significant treatment per time interactions was found. The anterior and canine widths reduced more with PNAM between time points A and B while Hotz's treatment was more effective between B and C. The shorter segment depth increased more between B and C with PNAM, and between A and B with Hotz's plate. During pre-surgical orthopaedics, therapy with PNAM obtained the best results in reducing the width at the anterior segment of the cleft. This treatment gave a lower increase in cleft depth than treatment with Hotz's plate.

[Impact of Lean methodology to improve care processes and levels of satisfaction in patient care in a clinical laboratory]. / Impacto de la metodología Lean en la mejora de procesos asistenciales y niveles de satisfacción en la atención de pacientes en un laboratorio clínico.

INTRODUCTION: The application of the Lean methodology in health institutions is an effective tool to improve the capacity and workflow, as well as to increase the level of satisfaction of patients and employees. OBJECTIVE: To optimise the time of outpatient care in a clinical laboratory, by implementing a methodology based on the organisation of operational procedures to improve user satisfaction and reduce the number of complaints for delays in care. MATERIAL AND METHODS: A quasi-experimental before and after study was conducted between October 2011 to September 2012. XBar and S charts were used to observe the mean service times and standard deviation. The user satisfaction was assessed using service questionnaires. RESULTS: A reduction of 17 minutes was observed in the time of patient care from arrival to leaving the laboratory, and a decrease of 60% in complaints of delay in care. Despite the high staff turnover and 38% increase in the number of patients seen, a culture of empowerment and continuous improvement was acquired, as well as greater efficiency and productivity in the care process, which was reflected by maintaining standards 12 months after implementation. CONCLUSION: Lean is a viable methodology for clinical laboratory procedures, improving their efficiency and effectiveness.

Comparative evaluation of the potency and antigenicity of two distinct BoNT/A-derived formulations.

IncobotulinumtoxinA (Xeomin®) and onabotulinumtoxinA (BOTOX®) are unique botulinum neurotoxin type A (BoNT/A)-derived drugs. IncobotulinumtoxinA utilizes the naked 150 kDa holotoxin portion of BoNT/A, whereas onabotulinumtoxinA uses the complete native 900 kDa complex as drug substance. On the basis of purportedly similar pharmacological characteristics, these formulations were evaluated for potency by LD50 and mouse Digit Abduction Score (DAS) bioassays. DAS was also used to assess antigenicity. Full-range DAS dose-response profiles were achieved with four lots of each product, with similar observations between lots for a given product. Between products, however, the mean DAS potency of incobotulinumtoxinA (ED50 range 7.0-10.2 U/kg) was significantly lower than that of onabotulinumtoxinA (ED50 range 4.4-6.4 U/kg), consistent with lower measured potencies in the LD50 assay for incobotulinumtoxinA (potency range 62-82 U). In assessments of DAS duration of effect at similar unit doses, the observed lower potency of incobotulinumtoxinA translated into decreased peak efficacy and dose effect over time (i.e. shorter duration). In contrast, at equi-efficacious doses yielding near-maximal DAS responses, both toxin formulations were uniformly inhibited in a statistically significant manner when preincubated with rabbit-derived, onabotulinumtoxinA-neutralizing antibodies, supporting the position that inhibition of 150 kDa holotoxin serves as the common basis for neutralization and, therefore, incobotulinumtoxinA would not be expected to be effective in onabotulinumtoxinA-immunoresistant subjects (and vice versa). Further, with lower lot-to-lot relative potency, incobotulinumtoxinA is not dose-equivalent or interchangeable with onabotulinumtoxinA, suggesting that various aspects of drug product formulation may influence observed pharmacology.

Microorganismos inusuales en placa subgingival de pacientes con periodontitis crónica / Unusual microorganisms in subgingival plaque of patients with chronic periodontitis

Fundamento: en ambientes subgingivales de pacientes con periodontitis crónica se han encontrado microorganismos inusuales que incluyen bacilos entéricos gramnegativos y levaduras. En estos pacientes la terapia mecánica o antimicrobiana puede ser ineficiente para tratar o controlar la enfermedad periodontal. La característica que comparten los microorganismos inusuales es la de ser patógenos oportunistas, ya que aprovechan las condiciones de inmunodepresión para originar o agravar una enfermedad. Objetivo: presentar la prevalencia de microorganismos inusuales en placa subgingival de pacientes con periodontitis crónica en una población colombiana. Método: se evaluaron 76 pacientes sistémicamente sanos que asistieron a las clínicas odontológicas de la Facultad de Odontología de la Universidad de Antioquia. Las muestras subgingivales se procesaron mediante cultivo. Resultados: se observaron bacilos entéricos gramnegativos en 20 (26.31 %) pacientes y levaduras en 10 (13.2 %). Conclusiones: estos hallazgos tienen implicaciones terapéuticas importantes que deben tenerse en cuenta para el manejo de los pacientes con enfermedades periodontales.

Background: subgingival environment of patients with chronic periodontitis have been found unusual microorganisms including Gram-negative enteric bacilli and yeasts. Mechanical or antimicrobial therapy in these patients may be inefficient to treat or to control periodontal disease. The common feature unusual microorganisms share is to be opportunistic pathogens, taking advantage of immunosuppression conditions to cause or aggravate the disease. Objective: to present the prevalence of unusual microorganisms in subgingival plaque of patients with chronic periodontitis in a Colombian population. Method: 76 systemically healthy patients who were presented in the dental clinic at the Dental School of Antioquia University were evaluated. Subgingival samples were processed by cultivation. Results: enteric Gram-negative bacilli in 20 patients and yeasts in 10 were observed. Conclusions: these findings have important therapeutic implications that must be taken into account for patients management with periodontal diseases.

Análisis multinivel en periodontitis / Multilevel analysis on periodontitis

Fundamento: el tratamiento en pacientes con periodontitis se realiza mediante terapia mecánica sola o combinada con antibióticos y quirúrgicamente. La evidencia científica muestra cómo algunos factores relacionados con el sujeto y el sitio del diente pueden comprometer la respuesta al tratamiento. Convencionalmente, se ha utilizado el sujeto como unidad de análisis, pero no es adecuado tratar las observaciones de cada sitio periodontal como si fueran independientes. Objetivo: comparar el efecto de los factores relacionados con los sitios de los dientes y los factores asociados con el sujeto, sobre el resultado de la terapia periodontal, en los estudios que emplean modelos multinivel en su análisis. Desarrollo: se realizó una revisión sistemática de la literatura de investigaciones dirigidas al tratamiento de periodontitis y analizadas con modelos multinivel. Los estudios que cumplieron los criterios de selección incluyeron cuatro ensayos clínicos con asignación aleatoria, un estudio cuasi-experimental y cinco estudios longitudinales, realizados en sujetos sistémicamente saludables. A diferencia de los métodos de regresión convencionales, el análisis multinivel encontró influencia de pocos factores relacionados con el individuo sobre la pérdida dental. La presencia de placa en el nivel sitio, los molares, así como los compromisos de furcación y defectos óseos angulares, se asociaron con efectos deficientes en la terapia. Conclusiones: el análisis multinivel reveló que el mayor porcentaje de la varianza se atribuye al nivel sitio, mientras el menor se debe al nivel paciente.

Background: treatment in patients with periodontitis occurs through mechanical therapy alone or combined with antibiotics and surgery. Scientific evidence shows how some factors related to the subject and the site of the tooth may compromise treatment response. Conventionally, the subject as a unit of analysis has been used, but it is not appropriate to treat observations of each periodontal site as if they were independent. Objective: to compare the effect of factors associated with the sites of the teeth and the subject associated factors, on the outcome of periodontal therapy in studies using multilevel models in its analysis. Development: a systematic review of the literature aimed at the treatment of periodontitis and analyzed with multilevel models was conducted. Four randomized clinical trials, a quasi-experiment study and five longitudinal studies, was carried out in systemically healthy subjects. Unlike conventional regression methods, the multilevel analysis found little influence of factors related tooth loss on individuals. The presence of plaque at site level, molars as well as furcation involvement and angular bone defects were associated with inadequate effects in therapy. Conclusions: multilevel analysis revealed that the highest percentage of variance is attributed to the site level, while the lower is at patient level.

Cirugía plástica periodontal con aloinjerto de matriz dérmica acelular: reporte de un caso / Periodontol plastic sugery with allodermic matrix: a case report

El tratamiento de recesiones gingivales ha sido una terapia frecuente en periodoncia. Muchos pacientes presentan múltiples recesiones de tejido matginales que requieren tratamiento pero la anatomía del paladar puede limitar la cantidad de tejido autégeno que se necesita, restringiendo el número de procedimientos que pueden ser realizados. Este artículo presenta el reporte del caso de un paciente con escasa banda de encía insertada y queratinizada, además de recesiones múltiples, utilizando un aloinjerto de matriz dérmica acelular para corregir estos defectos mucogingivales. Posterior a la elevación de un colgajo dividido se ubicó la matriz dérmica sobre la recesión y a continuación estas fue cubierta por el colgajo desplazado coronalmente. A los 6 meses postoperatorios, la cantidad de encía insertada fue aproximadamente de 2,5 mm, la encía se enconfraba firmemente adherida y se observaba mayor espesor del tejido gingival comparado con los niveles iniciales. El cubrimiento de las recesiones fue 100 por ciento. Dentro de los límites de este reporte y basado en estudios previos , se puede concluir que el aloinjerto de matriz dérmica acelular puede ser una técnica predecible y reduce la necesidad de cirugías múltiples para cubrir recesiones gingivales.

Evaluación de una técnica bilaminar para cubrir recesiones gingivales. Resultados preliminares / Evaluation of a bilaminar technique to cover gingival recessions. Preliminary results

El propósito de este estudio fue evaluar por un período de seis meses, el cubrimiento de recesiones radiculares usando una técnica bilaminar por medio de injertos subepiteliales de tejido conectivo bajo colgajos de espesor parcial, posicionados coronalmente. 19 recesiones vestibulares clases I y II de Miller en 5 pacientes se trataron usando una técnica bilaminar. Se evaluó el tamaño de la recesión gingival (RG) y el nivel de inserción clínica (NIC) durante seis meses posteriores a la cirugía. Las medidas fueron tomadas prequirúrgicamente, al primero, al tercero y sexto mes posquirúrgico. La estadística descriptiva fue expresada con promedios más desviación estándar (DS). Las variaciones longitudinales fueron evaluadas por medio de análisis de varianza (RG, NIC). La RG disminuyó representando un cubrimiento radicular que correspondió al 89,4 por ciento en promedio en el primer mes posquirúrgico y de 78,2 por ciento al sexto mes. El NIC disminuyó 0,96 mm en la evaluación realizada seis meses después de la cirugía.Los resultados indican que esta técnica bilaminar, la cual emplea injertos subepiteliales de tejido conectivo combinados con colgajos de espesor parcial desplazados coronalmente, es predecible para cubrir recesiones gingivales y los resultados obtenidos por ella se pueden mantener a corto plazo.

Proteínas morfogenéticas óseas / Bone morphogenetic proteins

El proceso de iniciación de la osteogénesis y la cementogénesis es fundamental para la regeneración periodontal. Uno de los grandes avances en la neoformación ósea ha sido la identificación de factores de crecimiento importantes para ella, como son las proteínas morfogenéticas óseas (PMO) que regulan la diferenciación ósea y cartilaginosa in vivo. La depuración, clonación y expresión de las PMO, señala que son esenciales para la función normal animal y en la osteogénesis postfetal es importante en el desarrollo embrionario orgánico, esquelético y de los tejidos dentales y carneofaciales. La disponibilidad de las PMO proporciona retos y oportunidades para mejorar los conocimientos que regulan la regeneración ósea y de cemento, con el fin de optimizar los resultados en el paciente

Uso de matrices alodérmicas en cirugía plástica periodontal: reporte de un caso / Use of allodermic matrices in periodontal plastic surgery: report of a case

El tratamiento de recesiones gingivales ha sido una terapia frecuente en periodoncia. Muchos pacientes presentan recesiones marginales múltiples que requieren tratamiento, pero la anatomía del paladar puede limitar la cantidad de tejido autégeno que se necesita, restringiendo el número de procedimientos que pueden ser realizados. Existen pacientes que no desean tener un trasplante adicional de tejido obtenido del paladar, debido al incremento del dolor y la morbilidad asociados con múltiples procedimientos quirúrgicos. Este artículo presenta el reporte de un caso de un pacientes con escasa banda de encía insertada y queratinizada, además de recesiones múltiples que incluyen una aparente y otras dos ocultas o reales. Como alternativa, fue utilizado un aloinjerto de matriz dérmica acelular para corregir estos defectos mucogingivales, evitando la necesidad de un segundo procedimiento quirúrgico en el paladar

Relación entre la obesidad exógena en los niños y la velocidad de crecimiento / The obesity in the child

Estudio prospectivo, observacional y correlativo para valorar la relación entre la obesidad exógena y la velocidad de crecimiento. En conclusión la obesidad exógena se asocia a la aceleración de la velocidad, crecimiento y la maduración ósea. Esto se debe tener en cuenta tanto para la detección temprana de la obesidad y para evitar sobreestimación en la talla final de los niños obesos

Hepatitis C transmission through dialysis machines.

Hepatitis C virus antibodies (HCVAb) were studied in a total of 58 patients on chronic hemodialysis, all of whom were negative for Hepatitis B serology. The patients were evaluated by the second generation EIA test. Twenty-one of these patients, initially HCVAb(-), were dialyzed in unit A (UA), where no patients HCVAB(+) were ever dialyzed nor were patients with increased levels of serum transaminases, although they were HCVAb(-). Thirty-seven patients, also initially HCVAb(-), were dialyzed in unit B (UB), where they shared the same dialysis machines (DM) with 14 HCVAb(+) and 11 HCVAb(-) with elevated serum transaminases patients. Time on hemodialysis for UA patients was 30.95 +/- 10.74 months (range 14-52 months). In UB patients, time on dialysis was 28.46 +/- 17.33 months (range 4-78 months) (P = 0.554). The seroconversion for patients who were initially HCVAb(+) was: in UA, none became (+); and in UB, 17 patients became (+); Chi-square = 11.522 (P < 0.0001). Ten patients were transfused in UA and 23 in UB (Chi-square = 0.638; P = 0.424). In addition, 2.30 +/- 1.5 blood units were given to patients transfused in UA and 2.09 +/- 1.65 were given to patients transfused in UB (P = 0.733). This data indicates the existence of a route of vertical transmission from patient to patient through the DM, which would explain the differences between these two groups.

[Initial evaluation of aluminum concentrations in patients with nephropathy and undergoing hemodialysis at the Miguel Pérez Carreño Hospital and the University Hospital of Caracas (Venezuela)]. / Evaluación inicial de las concentraciones de aluminio en pacientes con nefropatía y sometidos a hemodiálisis en los Hospitales Miguel Pérez Carreño y Universitario de Caracas (Venezuela).

The present work reports the concentrations of aluminum in whole blood and dialysis solutions of 27 patients with chronic renal failure and under hemodialysis treatment at Miguel Pérez Carreño and University Hospitals, both from Caracas city. Aluminum levels of the water used to prepare the dialysates were also monitored and the metal mobilization during dialysis studied. Patients' mean blood aluminum concentrations (ca. 34 micrograms AI/L) were lower than those of renal individuals from Maracaibo (ca. 58 micrograms AI/L), situation related to the low metal contents of the dialysate water (ca. 14 micrograms AI/L). In addition, Caracas drinking water showed up very high aluminum concentrations, above 475 micrograms/L. There was a relationship between the renal patients' blood aluminum concentrations and (1) the metal contents of the dialysis solutions and (2) the ingestion of aluminum hydroxide-based antacids. Aluminum transfer incorporation processes toward the patients' blood were observed in both dialysis units. This was due to the favorable concentration gradients (blood aluminum concentration/dialysate aluminum concentration) established at the start of every hemodialysis treatment.

Sporadic aluminum osteomalacia: identification of patients at risk.

Chronic dialysis patients at risk for aluminum osteomalacia in areas of low water-aluminum content are not well identified. We, therefore, studied retrospectively a cohort of 59 patients who underwent bone biopsy at two hospital-based dialysis centers in Montreal (water aluminum content less than 10 micrograms/L). Overall, 25% of patients biopsied had aluminum-related osteomalacia defined by aluminum staining of more than 30% of the trabecular surface and low levels of bone formation as measured by tetracycline labeling. Multiple linear regression analysis showed high predialysis serum creatinine (P less than .05) and the amount of aluminum prescribed per month (P less than .05) as the most important determinants of aluminum staining. We conclude that aluminum-related osteomalacia can be a frequent disease entity in areas of low water-aluminum content. Our findings also suggest predialysis serum creatinine and the amount of aluminum prescribed per month are risk factors for the development of aluminum-related osteomalacia. Though the relationship between serum creatinine and aluminum staining of trabecular bone is unclear, serum creatinine is probably a marker for adequacy of dialysis in these patients.