Skin-Mountable Biosensors and Therapeutics: A Review.

Miniaturization of electronic components and advances in flexible and stretchable materials have stimulated the development of wearable health care systems that can reflect and monitor personal health status by health care professionals. New skin-mountable devices that offer seamless contact onto the human skin, even under large deformations by natural motions of the wearer, provide a route for both high-fidelity monitoring and patient-controlled therapy. This article provides an overview of several important aspects of skin-mountable devices and their applications in many medical settings and clinical practices. We comprehensively describe various transdermal sensors and therapeutic systems that are capable of detecting physical, electrophysiological, and electrochemical responses and/or providing electrical and thermal therapies and drug delivery services, and we discuss the current challenges, opportunities, and future perspectives in the field. Finally, we present ways to protect the embedded electronic components of skin-mountable devices from the environment by use of mechanically soft packaging materials.

Evaluation of the IncoStress device for urinary incontinence: a feasibility study and pilot randomised controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the feasibility of recruitment to and outcomes from a pilot randomised study of the IncoStress device as an adjunct to conservative treatment for urinary incontinence. METHODS: Women with urinary incontinence were randomised on a 2:1 basis to usual care (control) or usual care plus use of the IncoStress device (intervention). Process outcomes (retention and compliance) were recorded plus symptom outcomes (IQOL and ICIQ-FLUTS questionnaires). A sample of participants took part in an interview to understand the frequency of use of the device and satisfaction. RESULTS: Eighty women (51 intervention, 29 control) were recruited. Follow-up responses were obtained from 34 intervention group (66.7%) and 17 (58.6%) control patients. Women used the device for a median 3 days a week (0-7), 18 out of 34 (53%) found it easy to use and 21 (61.8%) were satisfied with the device. Median IQOL score in the intervention group improved from a baseline of 42.4 (0-94) to 68.2 (5-98) at follow-up and in the control group from 45.5 (0-88) to 53.0 (0-94). Median ICIQ-FLUTS score in the intervention group improved from 14.5 (6-35) to 12.5 (4-26) and in the control group from 15.0 (5-35) to 14.0 (6-38). CONCLUSIONS: Recruitment and randomisation were feasible and robust. This study demonstrates that a large-scale RCT is feasible and the IncoStress has potential value.

The effect of continuous elastic outside distraction on the expressions of vascular endothelial cell growth factor and microvessel density in female porcine nipple.

BACKGROUND: We have proposed a method to correct the inverted nipple with good clinical results. The aim of the study presented here is to show the effect of continuous elastic distraction on the expression of vascular endothelial growth factor and microvessel density in the female porcine nipple. This article also explores the probable mechanism correction of inverted nipples. METHODS: Four female 3-month-old pigs each with 12 nipples were used. Four nipples of each minipig were used as control with the other eight nipples continuously distracted with prefabricated instruments. The nipples were excised at weeks 2, 4, 8, and 12 after distraction. Immunohistochemical staining was performed to observe the expression of vascular endothelial cell growth factor (VEGF) and CD34 in those tissues. The integral optical density of VEGF-positive cells and microvessel density (MVD) were also counted. RESULTS: The volumes of the nipples all increased after traction compared with those of the control group. The diameters and heights of the nipples showed significant changes (P<0.01). In immunohistochemical staining, the expressions of VEGF and CD34 of all distracted groups were positive. The staining intensity of traction groups was moderate and that of the control groups was weakly positive. The integral optical density of VEGF-positive cells and MVD compared with the control group were significantly different (P<0.01), and there was a significant positive correlation in MVD and VEGF. CONCLUSION: Continuous elastic distraction can promote the expression of some growth factors in nipples.

Therapeutic apheresis instrumentation.

This article provides a concise overview of therapeutic apheresis medicine instrumentation. Three instrument modalities are discussed: (1) centrifugation-based instruments, (2) extracorporeal photopheresis instruments (a subset of centrifugation-based instruments), and (3) column-based instruments.

Nanotechnology and nuclear medicine; research and preclinical applications.

The birth of nanotechnology in human society was around 2000 years ago and soon found applications in various fields. In this article, we highlight the current status of research and preclinical applications and also future prospects of nanotechnology in medicine and in nuclear medicine. The most important field is cancer. A regular nanotechnology training program for nuclear medicine physicians may be welcome.

The Effect of Medical Technology Innovations on Patient Outcomes, 1990-2015: Results of a Physician Survey.

BACKGROUND: Developments in diagnostics, medical devices, procedures, and prescription drugs have increased life expectancy and quality of life after diagnosis for many diseases. Previous research has shown that, overall, increased investment in medical technology has led to increased health outcomes. In addition, the value of investment in specific innovations, particularly in new pharmaceuticals or biopharmaceuticals, has frequently been shown through an evaluation of the associated health outcomes and costs. Value assessments for all medical technologies and interventions are an important consideration in current debates on access and affordability of health care in the United States. OBJECTIVE: To identify practicing physician impressions of the historical effect of postdiagnosis innovations in medical technology on patient outcomes within the 8 health conditions that have the largest effect on health in the United States. METHODS: National statistics were used to identify the 8 conditions responsible for the most mortality and morbidity within the United States between 1990 and 2014. A physician survey was developed for each major condition to obtain physician opinion on the extent to which pharmaceuticals and biopharmaceuticals, medical devices, diagnostics, and surgical procedures contributed to improvements in postdiagnosis mortality and morbidity outcomes over the evaluated period. Respondents were provided with a fifth category, "cannot allocate," to account for postdiagnosis outcome gains resulting from other factors such as public health interventions. RESULTS: The conditions identified as having the greatest effect on morbidity and mortality since 1990 were breast cancer, ischemic heart disease, human immunodeficiency virus infection, diabetes, unipolar depression, chronic obstructive pulmonary disease, cerebrovascular disease, and lung cancer. After excluding other factors, physicians specializing in these conditions, with a mean of 21.4 years in practice, considered pharmaceuticals and biopharmaceuticals as having the greatest postdiagnosis effect across all 8 conditions, with 56% of outcome gains attributed to this innovation category. Diagnostics was the second biggest contributor at 20%. CONCLUSIONS: Physician perceptions indicated that attention should be paid to value assessments of innovative diagnostics, devices, and surgical procedures, as well as to pharmaceuticals and biopharmaceuticals, before goals for allocating health care expenditures among the different innovations are determined. DISCLOSURES: Funding for this study was provided by the National Pharmaceutical Council, a health policy research group that receives its funding from biopharmaceutical manufacturers. Wamble is employed by RTI Health Solutions, which received funding from the National Pharmaceutical Council to conduct this research. Ciarametaro and Dubois are employed by the National Pharmaceutical Council.

Facial asymmetry correction with moulded helmet therapy in infants with deformational skull base plagiocephaly.

PURPOSE: The recommendation issued by the American Academy of Pediatrics in the early 1990s to position infants on their back during sleep to prevent sudden infant death syndrome (SIDS) has dramatically reduced the number of deaths due to SIDS but has also markedly increased the prevalence of positional skull deformation in infants. Deformation of the base of the skull occurs predominantly in very severe deformational plagiocephaly and is accompanied by facial asymmetry, as well as an altered ear position, called ear shift. Moulded helmet therapy has become an accepted treatment strategy for infants with deformational plagiocephaly. The aim of this study was to determine whether facial asymmetry could be corrected by moulded helmet therapy. MATERIALS AND METHODS: In this retrospective, single-centre study, we analysed facial asymmetry of 71 infants with severe deformational plagiocephaly with or without deformational brachycephaly who were undergoing moulded helmet therapy between 2009 and 2013. Computer-assisted, three-dimensional, soft-tissue photographic scanning was used to record the head shape before and after moulded helmet therapy. The distance between two landmarks in the midline of the face (i.e., root of the nose and nasal septum) and the right and left tragus were measured on computer-generated indirect and objective 3D photogrammetry images. A quotient was calculated between the two right- and left-sided distances to the midline. Quotients were compared before and after moulded helmet therapy. Infants without any therapy served as a control group. RESULTS: The median age of the infants before onset of moulded helmet therapy was 5 months (range 3-16 months). The median duration of moulded helmet therapy was 5 months (range 1-16 months). Comparison of the pre- and post-treatment quotients of the left vs. right distances measured between the tragus and root of the nose (n = 71) and nasal septum (n = 71) revealed a significant reduction of the asymmetry (Tragus-Nasion-Line Quotient: 0.045-0.022; p < 0.0001; Tragus-Subnasale-Line Quotient: 0.045-0.021; p < 0.0001). The control group without treatment showed no significant change in the quotient (Tragus-Nasion-Line Quotient no helmet: 0.049-0.055/Tragus-Subnasale-Line Quotient no helmet: 0.039-0.055). CONCLUSION: Moulded helmet therapy can correct facial symmetry in infants with deformational plagiocephaly and associated facial and basal skull asymmetry.

Uso de PCR digital para definir terapéuticas específicas y seguimiento en enfermedades autoinflamatorias / Use of digital PCR to define specific therapeutics and follow-up in autoinflammatory diseases

Las enfermedades autoinflamatorias (AIDs) son un grupo heterogéneo de desórdenes monogénicos o poligénicos, con características de disregulación inmune innata y/o adaptativa, cuyo mecanismo central es la autoinflamación pero también pueden presentarse con autoinmunidad e inmunodeficiencia. En estos últimos años el desarrollo de las tecnologías de secuenciación masiva han provocado una explosión en el descubrimiento de nuevos genes responsables de AIDs monogénicas. Esto remarca la importancia de implementar este tipo de estudios para llegar a un diagnóstico definitivo sobre todo en este grupo de patologías genéticamente muy diversas donde los fenotipos clínicos se solapan. Sin embargo, dada la presencia de variantes de significación incierta (VUS), los resultados pueden no ser concluyentes planteándose la necesidad de desarrollar pruebas funcionales para determinar la patogenicidad de dichas variantes genéticas. En nuestro grupo de trabajo estamos aplicando la PCR digital en gotas (ddPCR), una técnica cuantitativa de 3era generación altamente sensible, especifica y reproducible que no necesita de curvas de calibración, para desarrollar pruebas funcionales que permitan no sólo reclasificar variantes VUS para lograr diagnósticos definitivos sino también estudiar los mecanismos responsables de las principales AIDs que permitan una estratificación de las terapéuticas especificas a aplicar y de esta manera poder contribuir al diagnóstico, tratamiento y seguimiento de nuestros pacientes en forma personalizada. (AU)

Autoinflammatory diseases (AIDs) are a heterogeneous group of monogenic or polygenic disorders, with characteristics of inborn and/or adaptive immune dysregulation, whose central mechanism is autoinflammation but may also present with autoimmunity and immunodeficiency. In recent years the development of massive sequencing technologies has led to an exponential increase in the discovery of new genes responsible for monogenic AIDs. This emphasizes the importance of the implementation of this type of studies to make a definitive diagnosis, especially in this group of genetically very diverse diseases with overlapping clinical phenotypes. However, given the presence of variants of uncertain significance (VUS), the results may not be conclusive, raising the need to develop functional tests to determine the pathogenicity of these genetic variants. In our working group we are applying droplet digital PCR (ddPCR), a highly sensitive, specific and reproducible third generation quantitative technique that does not require calibration curves, to develop functional tests that allow not only to reclassify VUS variants to achieve definitive diagnoses but also to study the mechanisms responsible for the main AIDs that allow for the stratification of specific treatments to be used and thereby contribute to the individualized diagnosis, treatment, and follow-up of our patients (AU)

[Valvular bronchoblocation in the treatment of patients with disseminated drug-resistant pulmonary tuberculosis].

The results of treatment are analyzed in 89 patients with disseminated drug-resistant pulmonary tuberculosis. The application of an endobronchial back valve to patients with drug-resistant pulmonary tuberculosis gives rise to hypoventilation and atelectasis in the affected areas of the lung, promotes the stabilization and regression of a tuberculous process, and it is not attended by the development of endobronchial complications.

Recensión. El modelo PLISSIT: una propuesta de esquema conceptual para el tratamiento conductual de los problemas sexuales / Critical review. The PLISSIT model: a proposed conceptual scheme for the behavioral treatment of sexual problems

El artículo muestra una guía orientada a profesionales de la salud cuyo objetivo es ordenar los problemas sexuales y dar herramientas sobre cómo abordar los mismos a través de la teoría del aprendizaje. El modelo conceptual de Annon ha posibilitado un mejor manejo de la situación a la hora de implementar un abordaje en la esfera sexual por parte de los profesionales, y a través de esta recensión se discute su uso pertinente en la actualidad. (AU)

The article shows a guide aimed at health professionals whose objective is to order sexual problems and provide tools on how to address them through learning theory. Annon’s conceptual model has made possible a better management when implementing a sexual oriented approach by professionals, so through this critical review, its pertinent use nowadays is discussed. (AU)

A network pharmacology approach to assess Reno-protective and -curative effects of methanolic extract of Malva neglecta Wallr in gentamicin induced renal toxicity rat model

Abstract The aim of present study was to explore protective and curative effects of Malve neglecta on kidneys. In silco study with network pharmacology was performed to find out potential target organs, genes and cellular cell lines which confirmed kidneys as target organ of phyto-constituents present in Malva neglecta extract. Gentamicin (40 mg/kg, i.p) was given to induce renal toxicity. Prophylactic study was performed with 300-, 600- and 900 mg/kg doses to find out nephro-protective and -curative effects and curative potential was evaluated at 900 mg/kg dose. Renal function biomarkers, blood urea, BUN, serum creatinine and uric acid, and oxidative stress measuring biomarkers, SOD, CAT, GSH and MDA levels in kidney homogenate were quantified at the end of study. Treatment groups showed decrease in blood urea, BUN, serum creatinine and uric acid levels dose dependently and curative group also showed decline in these biomarkers. SOD, CAT, GSH levels were increased and MDA level decreased in treatment groups significantly as compared to toxic control which revealed the role of oxidative stress in renal damage and anti-oxidant power of MN. Data suggested that use of MN along with drugs causing renal toxicity may prove beneficial due to its nephro- protective and curative effects.

Perfil dos casos de câncer de mama entre acometidos no acre período de 2015 a 2019 ­ um estudo transversal / Profile of breast cancer cases between affected in acre period from 2015 to 2019 - a cross-sectional study / Perfil de los casos de cáncer de mama entre las personas afectadas en el período acre de 2015 a 2019 - un estudio transversal

Este estudo teve como objetivo analisar o perfil dos casos de câncer de mama no estado do Acre no período de 2015 a 2019. Trata-se de um estudo quantitativo com delineamento transversal. A amostra foi constituída por todos os casos de câncer de mama registrados no Acre e inseridos no Departamento de Informática do Sistema Único de Saúde (DATASUS) no período de 2015 a 2019. Foram identificados no período 293 casos da doença, com maior número de casos registrados no ano de 2019 (25,0%), sendo a maioria do sexo feminino (98,0%), na faixa etária de 40 a 49 anos (29,0%). O tempo decorrido desde o diagnóstico até o início do tratamento foi de mais de 60 dias (51,0%). A modalidade terapêutica mais utilizada foi a quimioterapia (55,0%). O local da realização do tratamento ocorreu capital do estado Rio Branco (80,0%). A maior parte dos acometidos, ainda encontra-se em tratamento (56,0%), no entanto (44,0%) evoluiu para óbito. O aumento da doença com o passar dos anos é notável no Acre. É importante destacar que ações voltadas para a prevenção e controle do câncer de mama continuam sendo fundamentais para auxiliar na diminuição do número de casos, como o rastreamento e diagnóstico precoce.

This study aimed to analyze the profile of breast cancer cases in the state of Acre in the period from 2015 to 2019. This is a quantitative study with a cross-sectional design. The sample consisted of all breast cancer cases registered in Acre and inserted in the Informatics Department of the Unified Health System (DATASUS) in the period from 2015 to 2019. In the period 293 cases of the disease were identified, with a greater number of cases registered in 2019 (25.0%), with the majority being female (98.0%), aged 40 to 49 years (29.0%). The time elapsed from diagnosis to the start of treatment was more than 60 days (51.0%). The most used therapeutic modality was chemotherapy (55.0%). The place where the treatment was performed took place in the state of Rio Branco (80.0%). Most of the people affected are still under treatment (56.0%), however (44.0%) died. The increase in the disease over the years is notable in Acre. It is important to highlight that actions aimed at the prevention and control of breast cancer continue to be fundamental to assist in reducing the number of cases, such as screening and early diagnosis.

Este estudio tuvo como objetivo analizar el perfil de los casos de cáncer de mama en el estado de Acre en el período de 2015 a 2019. Se trata de un estudio cuantitativo con diseño transversal. La muestra consistió en todos los casos de cáncer de mama registrados en Acre e ingresados en el Departamento de Informática del Sistema Único de Salud (DATASUS) en el período de 2015 a 2019. En el periodo se identificaron 293 casos de la enfermedad, siendo el mayor número de casos registrados en 2019 (25,0%), siendo la mayoría mujeres (98,0%), en el grupo de edad de 40 a 49 años (29,0%). El tiempo transcurrido desde el diagnóstico hasta el inicio del tratamiento fue superior a 60 días (51,0%). La modalidad terapéutica más utilizada fue la quimioterapia (55,0%). El lugar donde se realizó el tratamiento fue Rio Branco, la capital del estado (80,0%). La mayoría de los pacientes afectados siguen en tratamiento (56,0%), sin embargo, (44,0%) fallecieron. El aumento de la enfermedad a lo largo de los años es notable en Acre. Es importante destacar que las acciones dirigidas a la prevención y control del cáncer de mama siguen siendo fundamentales para ayudar a reducir el número de casos, como el cribado y el diagnóstico precoz.

Challenges in systematic reviews of therapeutic devices and procedures.

The authors discuss 3 challenges in conducting and interpreting any systematic review that are particularly relevant for systematic reviews of therapeutic devices or surgical procedures: 1) inclusion or exclusion of grey literature, 2) the role of nonrandomized studies, and 3) issues in applying the results to clinical care that are unique to the surgical and therapeutic device literature. The authors also discuss empirical evidence related to these topics and illustrate how reviewers in the Agency for Healthcare Research and Quality's Evidence-based Practice Center program have dealt with these challenges in developing evidence reports for decision makers and clinicians about therapeutic devices or surgical procedures.

Effects of low-level laser therapy on liver regeneration and laser parameters employed / Efeitos da laserterapia de baixa potência na regeneração hepática e parâmetros empregados de laser

Low-level laser therapy has several biological effects; one of them is tissue regeneration. Recent studies have been held on the application of laser therapy on the liver of rats after partial hepatectomy to promote liver regeneration. The aim of this article was to review the recent studies on the effects of low-level laser therapy on rat liver regeneration after partial hepatectomy and the laser parameters used in those studies. A review of recent relevant literature was performed in Pubmed, Scielo, Medline, and Bireme databases. Articles related to the application of low-level laser therapy on hepatic regeneration were included. Articles with hepatic regeneration in the presence of pathologies were not included. Nine studies were found matching the study criteria. In most studies, low-level laser therapy promoted liver regeneration after partial hepatectomy, without further damage to the remaining liver. Not all laser parameters required for the reproducibility of the study were described by all authors. The therapeutic use of low-level laser therapy in liver regeneration can be promising; however, since the liver is a vital organ, and the laser application is intraoperative, future studies are necessary. The parameters used must be properly described and standardized to allow the reproducibility of the study, in order to define a therapeutic window and thus, consider its clinical use. It is also essential to clarify the mechanisms by which laser promotes liver regeneration to guarantee its safety and therapeutic efficacy.

Laserterapia de baixa potência tem vários efeitos biológicos, sendo um deles a regeneração de tecido. Sua aplicação no fígado de ratos após hepatectomia parcial para promoção de regeneração hepática tem sido estudada recentemente. O objetivo deste artigo foi revisar os estudos recentes dos efeitos da laserterapia de baixa potência na regeneração de fígado de ratos após hepatectomia parcial de fígado e os parâmetros de laser empregados. Uma revisão da literatura relevante recente foi realizada nas bases de dados Pubmed, Scielo, Medline e Bireme. Artigos sobre a aplicação da laserterapia de baixa potência na regeneração de fígado foram incluídos. Artigos sobre regeneração hepática na presença de patologias foram excluídos. Nove estudos foram encontrados correspondendo aos critérios do estudo. Na maioria dos estudos, a laserterapia de baixa potência promoveu regeneração hepática após hepatectomia parcial, sem causar danos adicionais ao fígado remanescente. Não foram descritos todos os parâmetros necessários para reprodutibilidade dos estudos por todos os autores. O uso terapêutico da laserterapia de baixa potência na regeneração de fígado pode ser promissor, entretanto, como o fígado é um órgão vital e a aplicação do laser é intraoperativa, estudos futuros são necessários, assim como os parâmetros da aplicação de laser precisam ser descritos apropriadamente e padronizados, para permitir a reprodutibilidade do estudo, para que uma janela terapêutica possa ser definida e seu uso clínico possa ser considerado. Também é essencial esclarecer através de quais mecanismos o laser promove regeneração de fígado para garantir sua segurança e eficácia terapêutica.

The thermal field of radiofrequency probes at chondroplasty settings.

PURPOSE: The purpose of this experimental study was to evaluate the thermal field produced with monopolar and bipolar radiofrequency probes located at increasing heights from the target treatment site. TYPE OF STUDY: Experimental study. METHODS: Two bipolar (ACD-50, ArthroCare, Sunnyvale, CA; VAPR-TC, Mitec Surgical Products, Westwood, MA) and one monopolar (Vulcan TAC-C II, Oratec Interventions, Menlo Park, CA) radiofrequency probes were placed in a screw-driven stage that allowed for 0.25-mm incremental height-position changes. ArthroCare ACD-50 was evaluated at settings 2 and 8. The Mitek VAPR-TC was evaluated at setting 65 degrees C and V2-20 desiccation mode. The Oratec Vulcan TAC-C II system was evaluated at preset 2, power 15, set temperature 70 degrees C. The RF-probes were evaluated at variable distances from 0 to 2 mm. A fluoroptic thermometer was used to evaluate the temperatures within a room temperature 0.9% normal saline arthroscopic simulation chamber. RESULTS: The ACD-50 setting 2 at 0 mm was 89.1 degrees C; at 0.5 mm, 71.2 degrees C; and at 2 mm it was 37.3 degrees C. The ACD-50 setting 8 at 0 mm was 87.3 degrees C; at 0.5 mm, 42.5 degrees C; and at 2 mm, 33.6 degrees C. The Mitek VAPR-TC at 0 mm was 53.1 degrees C; at 0.5 mm, 42.5 degrees C; and at 2 mm, 26.8 degrees C. The Oratec Vulcan at 0 mm was 73.9 degrees C; at 0.5 mm, 60.3 degrees C; and at 2 mm, 29.0 degrees C. Each of these radiofrequency systems produced characteristic thermal fields at these settings. CONCLUSIONS: The temperature decreases with increasing distance characteristically for each radiofrequency probe. This is clinically important because altering radiofrequency probe location may cause large variations in articular cartilage thermal exposure.

Spin-off applications of mouthguards.

The spin-off applications of mouthguards are many and varied. Their uses range from protective to therapeutic and span all areas of medicine and dentistry. The designs range from simple minor modifications of the soft athletic mouthguard to sophisticated adaptations containing gears or electric switches. Their creative applications have provided relief to the cancer patient, increased independence to the handicapped and limited mobility patient, protection to the dentition of the patient undergoing general anesthesia, relief for the TMJ syndrome sufferer, and decreased risk of damage to the teeth and palate of the intubated infant, to name only a few. The adaptations and applications of this simple device are inspired by the needs of the patient and limited only by the imagination of the provider.

Intravenous immunoglobulin therapy among pediatric patients: labeled and off-labeled indications

ABSTRACT This study was designed to evaluate utilization patterns and clinical outcome of intravenous immunoglobulin (IVIG) therapy among pediatric patients in a tertiary hospital. Demographic data, IVIG prescribed, and clinical outcome were retrospectively reviewed from the pharmacy dispensing data and patient medical records between 2007 and 2014. One hundred and fifteen instances of IVIG administration to 108 pediatric patients were recorded. A total of 61 cases (53%) and 54 cases (47%) of the IVIG administered were for labeled and off-labeled indications, respectively. Age, weight, specialty, total IVIG usage, length of hospital stays, and mortality rate were found to be significantly associated with the indication being labeled or off-labeled (p<0.05). However, there was no significant difference in terms of adverse reactions between labeled and off-labeled indications (p>0.05). Guidelines should be developed and implemented for rational and evidence-based use of IVIG to avoid unnecessary wastage.