Clinical usability study of a home-based self-administration transcranial direct current stimulation for primary dysmenorrhea: A randomized controlled trial.

This study tested the usability of a home-based self-administration transcranial direct current stimulation (tDCS) device designed specifically for women's health needs. This is a single center triple blinded clinical usability study for a new wireless, Bluetooth-controlled wearable tDCS device for women's health. The study aims to evaluate the usability and effective blinding of a home-based tDCS system. A total of forty-nine women of reproductive age were randomly allocated (1:1) to receive one session of active tDCS (n = 24) or sham tDCS (n = 25) over the motor and dorsolateral prefrontal cortex. Each participant self-administered one 20-minute session without supervision following guidance on a software application alone. The System Usability Scale (SUS) and the Patient Global Impression of Change (PGIC) were used to evaluate the usability of the system. Regardless of sham or active conditions, all users found the system easy to use without the support of researchers. Usability scores were considered to be "excellent" in both groups and no significant difference was found between sham and active groups showing effective blinding of the device (Active group: 93.7 (83.1-97.5); Sham group 90 (86.2-95) p = 0.79) and PGIC (Active group: 2 (1-2.75); Sham group 2 (1-2) p = 0.99) using an unpaired t-test or non-parametric statistical tests accordingly. The new Bluetooth-controlled wearable tDCS device is easy, safe to use and completely controlled by a smartphone app. This device is focused on women's health and will be tested as an alternative treatment for chronic pelvic pain and mood disturbance associated with menstrual cycles in further research.

Pen Devices for Insulin Self-Administration Compared With Needle and Vial: Systematic Review of the Literature and Meta-Analysis.

OBJECTIVES: Pen devices offer advantages compared with vial and syringe (VaS). The purpose of this article was to evaluate efficacy of pen devices compared to VaS. METHODS: A systematic review of literature was performed in 8 different databases. References were independently screened and selected. Primary observational or experimental studies comparing pen devices with VaS for insulin administrations were included. Studies on specific populations were excluded. Risk of bias was evaluated using appropriate tools. Data on glycosylated hemoglobin (HbA1c), hypoglycemia, adherence, persistence, patient preference, and quality of life (QOL) were collected. Meta-analysis was performed when appropriate. Heterogeneity and risk of publication bias were evaluated. Otherwise, descriptive analyses of the available data was done. RESULTS: In all, 10 348 articles were screened. A total of 17 studies were finally selected: 7 experimental and 10 analytical. The populations of the included articles were mainly composed of adults with type 2 diabetes mellitus. Important risk of bias was found in all of the articles, particularly experimental studies. Meta-analyses were performed for HbA1c, hypoglycemia, adherence and persistence. Pen device showed better results in mean HbA1c change, patients with hypoglycemia, adherence and persistence compared to VaS. No difference was observed in number of patients achieving <7% HbA1c. Preference studies showed a tendency favoring pen devices, however nonvalidated tools were used. One QoL study showed improvements in some subscales of SF-36. CONCLUSIONS: There is evidence that pen devices offer benefits in clinical and, less clearly, patient-reported outcomes compared to VaS for insulin administration. However, these results should be taken with caution.

Study of inhaler technique in asthma patients: differences between pediatric and adult patients.

OBJECTIVE: Inhaler technique comprises a set of procedures for drug delivery to the respiratory system. The oral inhalation of medications is the first-line treatment for lung diseases. Using the proper inhaler technique ensures sufficient drug deposition in the distal airways, optimizing therapeutic effects and reducing side effects. The purposes of this study were to assess inhaler technique in pediatric and adult patients with asthma; to determine the most common errors in each group of patients; and to compare the results between the two groups. METHODS: This was a descriptive cross-sectional study. Using a ten-step protocol, we assessed inhaler technique in 135 pediatric asthma patients and 128 adult asthma patients. RESULTS: The most common error among the pediatric patients was failing to execute a 10-s breath-hold after inhalation, whereas the most common error among the adult patients was failing to exhale fully before using the inhaler. CONCLUSIONS: Pediatric asthma patients appear to perform most of the inhaler technique steps correctly. However, the same does not seem to be true for adult patients.

Study of inhaler technique in asthma patients: differences between pediatric and adult patients / Estudio sobre la técnica inhalatoria en pacientes asmáticos: diferencias entre pacientes pediátricos y adultos

Objective: Inhaler technique comprises a set of procedures for drug delivery to the respiratory system. The oral inhalation of medications is the first-line treatment for lung diseases. Using the proper inhaler technique ensures sufficient drug deposition in the distal airways, optimizing therapeutic effects and reducing side effects. The purposes of this study were to assess inhaler technique in pediatric and adult patients with asthma; to determine the most common errors in each group of patients; and to compare the results between the two groups.Methods: This was a descriptive cross-sectional study. Using a ten-step protocol, we assessed inhaler technique in 135 pediatric asthma patients and 128 adult asthma patients.Results: The most common error among the pediatric patients was failing to execute a 10-s breath-hold after inhalation, whereas the most common error among the adult patients was failing to exhale fully before using the inhaler.Conclusions: Pediatric asthma patients appear to perform most of the inhaler technique steps correctly. However, the same does not seem to be true for adult patients.

Objetivo: La técnica inhalatoria es un conjunto de procedimientos mediante el cual se administra un fármaco al sistema respiratorio. Se caracteriza por ser utilizada como primera línea para tratar las enfermedades pulmonares. Su correcta ejecución garantiza un mayor depósito del fármaco en la vía aérea distal, optimizando sus efectos terapéuticos y disminuyendo los efectos secundarios. Los objetivos de este estudio son describir la ejecución de la técnica inhalatoria en un grupo de pacientes asmáticos pediátricos versus un grupo de pacientes asmáticos adultos, definir los errores más comunes en cada grupo de pacientes y comparar los resultados entre ambos grupos.Métodos: Estudio descriptivo, transversal. Se evaluó la técnica inhalatoria según un protocolo de diez pasos en 135 pacientes asmáticos pediátricos y 128 pacientes asmáticos adultos.Resultados: Se encontró que el error más común en los pacientes pediátricos fue no realizar una apnea de 10 s después de la inhalación, mientras que en los pacientes adultos el principal error fue no exhalar completamente antes de aplicar el inhalador.Conclusiones: Se determinó que los pacientes asmáticos pediátricos cumplen con la mayoría de los pasos para una correcta técnica inhalatoria, lo que no se observa en los pacientes adultos.

Nearly pain-free self-administration of subcutaneous methotrexate with an autoinjector: results of a phase 2 clinical trial in patients with rheumatoid arthritis who have functional limitations.

BACKGROUND: A methotrexate autoinjector (MTXAI) was developed for self-administration of subcutaneous (SC) methotrexate by patients with rheumatoid arthritis (RA). The MTXAI circumvents the need for vials, needles, and syringes and may therefore improve dosing accuracy, handling risks, and patient adherence. OBJECTIVES: The objective of this study was to evaluate actual human use of the MTXAI in patients with RA and determine its reliability, robustness, safety, local tolerance, and ease of use. METHODS: In this phase 2, multicenter, open-label, single-dose, single-arm, in-clinic US study, adults (N = 101) treated with methotrexate for 3 months or longer were trained to use the MTXAI and assigned to 10, 15, 20, or 25 mg methotrexate based on previous treatment and disease status. Patients completed training confirmation and ease-of-use questionnaires. Pain was evaluated immediately after self-administration and at follow-up with a 100-mm visual analog scale (0 = no pain, 100 = worst possible pain). RESULTS: At screening, 90.1% of patients had moderate to severe functional limitations (class II-IV). All patients successfully completed the study. All devices functioned correctly and as intended. The device was rated easy to use by 98%, and instructions clear and easy to follow by 100% of patients. On the visual analog scale, mean and median pain scores were 3.6/100 and 1.0/100 mm, respectively, immediately after self-administration, and were lower at follow-up. Most patients (92.3%) had no administration-site erythema; 7.7% had minimal erythema. CONCLUSIONS: The SC MTXAI was well tolerated and considered easy to use by patients with RA. Improving SC methotrexate delivery may increase patient tolerance of self-administration, possibly improving adherence.

Insulin self-administration technique with disposable syringe among patients with diabetes mellitus followed by the family health strategy.

This cross-sectional study aimed to describe the most common correct and incorrect self-administration techniques for insulin using disposable syringes by patients cared for by the Family Health Strategy (FHS), relate the findings to sociodemographic variables and also identify the professional responsible for teaching this technique. A total of 169 patients were selected by simple random sampling in 37 FHS units in a city in the state of Minas Gerais, Brazil from August to October 2006. The results identified errors in all the steps recommended by the American Diabetes Association and Brazilian Diabetes Association for the safe administration of insulin, from hand washing to compression on the injection site. The FHS favors the development of interventions focused on the needs of the clientele registered at the unit, stimulating self-care. Results from this study can contribute to the planning of these interventions.

Insulin self-administration technique with disposable syringe among patients with diabetes mellitus followed by the family health strategy / Técnica de auto aplicación de insulina con jeringas desechables entre usuarios con diabetes mellitus acompañados por la estrategia salud de la familia / Técnica de autoaplicação de insulina com seringas descartáveis entre os usuários com diabetes mellitus, acompanhados pela estratégia saúde da família

This cross-sectional study aimed to describe the most common correct and incorrect self-administration techniques for insulin using disposable syringes by patients cared for by the Family Health Strategy (FHS), relate the findings to sociodemographic variables and also identify the professional responsible for teaching this technique. A total of 169 patients were selected by simple random sampling in 37 FHS units in a city in the state of Minas Gerais, Brazil from August to October 2006. The results identified errors in all the steps recommended by the American Diabetes Association and Brazilian Diabetes Association for the safe administration of insulin, from hand washing to compression on the injection site. The FHS favors the development of interventions focused on the needs of the clientele registered at the unit, stimulating self-care. Results from this study can contribute to the planning of these interventions.

Se trata de un estudio seccional que tuvo como objetivó describir los errores y los aciertos más comunes de la técnica de auto aplicación de insulina, con jeringas desechables, por los usuarios, acompañados por la Estrategia Salud de la Familia (ESF), así como relacionar lo encontrado a las variables sociodemográficas e identificar al profesional responsable por las orientaciones. Participaron 169 usuarios, seleccionados por medio de un muestreo aleatorio simple, en 37 unidades de la ESF, de un municipio del Estado de Minas Gerais, entre agosto y octubre de 2006. Los resultados identificaron errores en todos los pasos recomendados por la Asociación Americana de Diabetes y la Sociedad Brasileña de Diabetes para la aplicación segura de la insulina, desde el lavado de las manos hasta la compresión del local de aplicación. La ESF favorece el desarrollo de intervenciones con foco en las necesidades de la clientela adscrita, estimulándola para el auto cuidado, y los resultados del presente estudio podrán contribuir para la planificación de esas intervenciones.

Estudo seccional que objetivou descrever os erros e os acertos mais comuns da técnica de autoaplicação de insulina, com seringas descartáveis, pelos usuários, acompanhados pela Estratégia Saúde da Família (ESF), assim como relacionar esses achados às variáveis sociodemográficas e identificar o profissional responsável pelas orientações. Participaram 169 usuários selecionados por meio de amostragem aleatória simples, em 37 unidades da ESF, de um município do Estado de Minas Gerais, entre agosto e outubro de 2006. Os resultados identificaram erros em todos os passos recomendados pela Associação Americana de Diabetes e Sociedade Brasileira de Diabetes para a aplicação segura da insulina, desde a lavagem das mãos até a compressão do local de aplicação. A ESF favorece o desenvolvimento de intervenções centradas nas necessidades da clientela adscrita, estimulando-a para o autocuidado, e os resultados do presente estudo poderão contribuir para o planejamento dessas intervenções.

[Growth hormone (GH) deficiency treatment in children: comparison between uses of pen versus bottles/syringes on GH administration]. / Tratamento da deficiência do hormônio de crescimento (GH) em crianças: comparação entre o uso de canetas versus frascos/seringas para a aplicação do GH.

The aim of this study was to compare two preparations of recombinant human GH (rGH) in the treatment of GH deficient patients. Ten prepubertal GH-deficient children were followed during 6 months. They received injections with syringe for 3 months, followed by pen administration for the subsequent 3 months. Acceptability was evaluated through a questionnaire. Waste of medication was calculated by the difference between the number of used bottles or refills and the calculated amount for the period. Treatment response was evaluated by SDS gain of height measured each 3 months. After 6 months, 90% of patients/family members declared they preferred the pen regarding technical facility and local pain, and all patients considered the pen easier to transport and store. The waste of medication was lower with pen administration, as was the final cost. We concluded that pen-administered rGH treatment is more convenient, better accepted by the patients, and leads to less waste of medication when compared to the syringe administration.

Tratamento da deficiência do hormônio de crescimento (GH) em crianças: comparação entre o uso de canetas versus frascos/seringas para a aplicação do GH / Growth hormone (GH) deficiency treatment in children: comparison between uses of pen versus bottles/syringes on GH administration

O objetivo deste estudo foi comparar as duas apresentações de GH recombinante humano (rGH) para tratamento da deficiência de GH (DGH). Dez crianças pré-púberes portadoras de DGH foram acompanhadas durante 6 meses. Elas receberam, por 3 meses, injeções com seringa e, a seguir, com canetas por mais 3 meses. A aceitabilidade foi avaliada através de questionário. O desperdício foi calculado através da diferença entre o número de frascos/refis utilizados e o previsto para o período. A resposta ao tratamento foi avaliada pelo ganho em desvio-padrão (DP) de altura medido a cada 3 meses. Após 6 meses, 90 por cento dos pacientes/familiares afirmaram preferir a caneta em termos de facilidade técnica e dor local, e todos consideraram a caneta melhor em termos de facilidade de transporte e armazenamento. O desperdício foi menor com a caneta, assim como o custo. Concluímos que a administração de rGH através de caneta é mais conveniente, melhor aceita pelos pacientes e resulta em menor desperdício quando comparada com o tratamento por seringa.

The aim of this study was to compare two preparations of recombinant human GH (rGH) in the treatment of GH deficient patients. Ten prepubertal GH-deficient children were followed during 6 months. They received injections with syringe for 3 months, followed by pen administration for the subsequent 3 months. Acceptability was evaluated through a questionnaire. Waste of medication was calculated by the difference between the number of used bottles or refills and the calculated amount for the period. Treatment response was evaluated by SDS gain of height measured each 3 months. After 6 months, 90 percent of patients/family members declared they preferred the pen regarding technical facility and local pain, and all patients considered the pen easier to transport and store. The waste of medication was lower with pen administration, as was the final cost. We concluded that pen-administered rGH treatment is more convenient, better accepted by the patients, and leads to less waste of medication when compared to the syringe administration.

A new triple-channel swivel for fluid delivery in the range of intracranial (10 nl) and intravenous (100 microliters) self-administration volumes and also suitable for microdialysis.

This paper describes a new low-torque, bubble-free and multiple-channel swivel of easy construction. This swivel combined with the use of fused silica capillary tubing to connect syringes and injectors, as we recently proposed, allow the accurate and repeated microinjection of low nanoliter volumes (10 nl) in freely moving rats, as required in the intracranial self-administration paradigm. Microinjections can be simultaneously performed in 3 different brain regions. Relatively large volumes in the 10-100 microliters range can be repeatedly administered, as in intravenous self-administration, using the traditional connections with polyethylene (PE) tubing. This swivel allows the execution of experiments involving in vivo microdialysis in up to 3 different brain areas. The internal channel has a very low dead space (4 microliters) and can be used to withdraw small liquid samples and perform on-line microdialysis in freely moving animals. This versatility makes the present swivel appropriate for sophisticated experimental designs involving combinations of intracranial, intravenous and/or intragastric self-administration with microdialysis.

Autoinjection of corpus cavernosum with papaverine: a practical application device.

A new device for the autoinjection of papaverine into the corpus cavernosum for the treatment of impotence is described. Its use is much easier than conventional tuberculine syringes.