Development and validation of an instrument (CSII - Brazil) to assess users' conceptual and procedural knowledge of continuous subcutaneous infusion systems

ABSTRACT Objective: To develop, adapt and validate an instrument named "CSII - Brazil" to assess users' conceptual and procedural knowledge of continuous subcutaneous insulin infusion systems. Materials and methods: Methodological and exploratory study developed in three stages: a) instrument development; b) content validation and cultural adaptation (evaluation by a committee of experts and pre-test with CSII users); c) psychometric validation through instrument application in a sample of 60 patients by means of the web tool e-Surv. Internal consistency and reproducibility analyses were performed within IBM SPSS Statistics 20 programming environment. Results: The 16 multiple-choice question instrument successfully attained a content validity index of 0.97, showing satisfactory internal consistency, with 0.61 Cronbach's alpha [95% CI 0.462-0.746] and an intraclass correlation coefficient of 0.869 [95% CI: 0.789-0.919] between the test and retest scores. Conclusion: The CSII - Brazil instrument is considered adequate and validated to assess continuous subcutaneous infusion system users' conceptual and procedural knowledge.

Development and validation of an instrument (CSII - Brazil) to assess users' conceptual and procedural knowledge of continuous subcutaneous infusion systems.

OBJECTIVE: To develop, adapt and validate an instrument named "CSII - Brazil" to assess users' conceptual and procedural knowledge of continuous subcutaneous insulin infusion systems. METHODS: Methodological and exploratory study developed in three stages: a) instrument development; b) content validation and cultural adaptation (evaluation by a committee of experts and pre-test with CSII users); c) psychometric validation through instrument application in a sample of 60 patients by means of the web tool e-Surv. Internal consistency and reproducibility analyses were performed within IBM SPSS Statistics 20 programming environment. RESULTS: The 16 multiple-choice question instrument successfully attained a content validity index of 0.97, showing satisfactory internal consistency, with 0.61 Cronbach's alpha [95% CI 0.462-0.746] and an intraclass correlation coefficient of 0.869 [95% CI: 0.789-0.919] between the test and retest scores. CONCLUSION: The CSII - Brazil instrument is considered adequate and validated to assess continuous subcutaneous infusion system users' conceptual and procedural knowledge.

Advancing continuous subcutaneous insulin infusion in vivo: New insights into tissue challenges.

Continuous Subcutaneous Insulin Infusion (CSII) is superior to conventional insulin therapy as it improves glycemic control thus reducing the probability of diabetic complications. Notwithstanding CSII's benefits, insulin dependent diabetic patients rarely achieve optimal glucose control. Moreover, CSII is only FDA approved for 3 days and often fails prematurely for reasons that have not been fully elucidated. We hypothesize that phenolic compounds, such as m-cresol and phenol, which are present in all commercial insulin formulations are responsible for the tissue reaction occurring at the insulin infusion site. This hypothesis was examined with in vitro cell cultures and a mouse air-pouch model to determine cellular and tissue reactions following infusions with saline, phenolic compounds, (i.e., commercial diluent), and insulin. We demonstrated that diluent and insulin were cytotoxic to cells in culture at sub-clinical concentrations (e.g., >1:10 of commercial insulin). Air pouch studies demonstrated that infusion of either diluted insulin or diluent itself induced three to five-fold level of recruited leukocytes as compared to saline. At both 3- and 7-days post infusion, these were predominantly neutrophils and macrophages. We conclude that phenolic compounds in commercial insulin preparations are cell and tissue toxic, which contributes to the failure of effective insulin infusion therapy.

Tissue Response to Subcutaneous Infusion Catheter.

Insulin infusion pump, continuous glucose monitoring (CGM), and insulin infusion set (IIS) have been developed to be increasingly feasible for people with type 1 diabetes (T1D). Several recently approved CGMs are transitioning from 7-day to 10-day wear time without the need for fingerprick recalibration. Nevertheless, studies and improvements on IIS, a critical part of insulin pump therapy, have been limited. In particular, the recommended wear time of IIS is still 2-3 days, which can hardly match the current duration of CGM for potential closed-loop system development. It is generally believed that both the inserted catheter and the subsequent infused insulin drug could induce particular subcutaneous tissue response and skin-related complications at the infusion site. In certain cases, poor glycaemic control, increased risk of hypoglycemia, and serious cosmetic impact on people with diabetes were observed. Skin complication has also been attributed as an important factor resulting users to discontinue insulin pump therapy. This article provides the rare systematic review of IIS induced subcutaneous tissue responses and skin complications, including the impacts from the inserted catheters, the subcutaneous infused insulin, and the adhesive or tape used to immobilize the catheter. The FDA's recommendation for the frequency of IIS change was further discussed. Future studies on this topic are required to further understand the IIS-related problems, and future strategies could be developed accordingly to significantly reduce the incidence of these problems, extend the wear time, and increase the acceptance of insulin pump based therapy.

Subcutaneous furosemide for the treatment of heart failure: a state-of-the art review.

The prevalence of heart failure (HF) is on the rise. By 2030, over eight million Americans (46% increase from current prevalence) will have heart failure. In the USA, approximately 30 billion dollars is spent annually on heart failure and this number will likely double in 2030. Thus, HF represents a significant economic burden. Acute decompensated heart failure (ADHF) is a clinical spectrum, which refers to increasing symptoms and signs of heart failure prompting an emergency room visit or hospitalization. In ADHF, inpatient administration of intravenous diuretic is the standard of care due to the variability in the absorption of oral diuretics. Within 30 days, 25-30% of these patients are readmitted with recurrent ADHF. Recent efforts have focused in reducing HF readmission, and thereby decreasing costs; hence, innovative outpatient treatment options have emerged. Subcutaneous furosemide use will potentially overcome the need to place intravenous lines, reduce associated expenses, and enable management of ADHF at home. This review presents data on the pharmacodynamics and pharmacokinetics of subcutaneous furosemide, scientific evidence on the use of this therapy in the palliative and hospice population, and its experimental use as an outpatient therapy and/or as a bridge from inpatient to home.

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

BACKGROUND: Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. METHODS: This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. RESULTS: Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. CONCLUSION: The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739.

Eficacia y seguridad en la infusión subcutánea de oxicodona mediante infusor elastomérico de larga duración / Efficacy and safety of oxycodone subcutaneous infusion using a long-term elastomeric infusion device

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Novel intrathecal and subcutaneous catheter delivery systems in the mouse.

BACKGROUND: Catheter systems that permit targeted delivery of genes, molecules, ligands, and other agents represent an investigative tool critical to the development of clinically relevant animal models that facilitate the study of neurological health and disease. The development of new sustained catheter delivery systems to spinal and peripheral sites will reduce the need for repeated injections, while ensuring constant levels of drug in plasma and tissues. NEW METHOD: Here, we introduce two novel catheter delivery systems in the mouse: the O'Buckley intrathecal catheter system for sustained delivery to the spinal region and a subcutaneous bifurcated catheter system for sustained drug delivery to both hindpaws. RESULTS: The O'Buckley intrathecal catheter system consistently distributed Evans Blue throughout the spinal cord, with the greatest concentration at the thoracic region, and with an 85% surgery success rate. The subcutaneous catheter system consistently distributed Evans Blue to the hindlimbs, with a 100% surgery success rate. COMPARISON TO EXISTING METHOD: The O'Buckley intrathecal catheter system accomplishes sustained drug delivery to the spinal region, with a 2-fold increase in surgery success rate, as compared to the traditional method. Our subcutaneous bifurcated catheter system accomplishes sustained drug delivery to both hindpaws, eliminating the need for repeated intraplantar injections. CONCLUSIONS: We have developed catheter systems that improve upon traditional methods in order to achieve sustained localized drug delivery to spinal tissues and to hindpaw tissues surrounding peripheral sciatic nerve terminals. These methods have a broad reach, and can be used to enhance behavioral, physiologic and mechanistic studies in mice.

Winged Metal Needles versus Plastic Winged and Nonwinged Cannulae for Subcutaneous Infusions in Palliative Care: A Quality Improvement Project To Enhance Patient Care and Medical Staff Safety in a Singaporean Hospital.

BACKGROUND AND OBJECTIVES: A comparison of metal needles and plastic cannulae (winged and nonwinged) for continuous subcutaneous infusion was done during a quality improvement project to reduce device-induced complications at our hospital. Design, Setting, and Measurements: Data were collected on incidence of site reactions (bruising, swelling, erythema, and blisters); mechanical complications (kinking and dislodgement); device durability; type, and volume of medications; and incidence of needle-stick injuries. All infusion devices used for patients in the Palliative Care Service from February 3 to March 26, 2014 were studied. Devices examined were: winged metal needle (Venofix(®), 23G, B. Braun Melsungen AG, Melsungen, Germany), winged vialon cannula (BD Nexiva™, 24G, Becton Dickinson Infusion Therapy Systems Inc., Sandy, UT), and nonwinged polyurethane cannula (Introcan Safety(®), 24G, B. Braun Medical, Mundelein, IL). RESULTS: Thirty devices (10 per type) were used. Incidence of site reactions was 50.0%, 10.0%, and 0.0% for the metal needles, polyurethane cannulae, and vialon cannulae, respectively. Incidence of mechanical complications was 20.0% for the polyurethane cannulae and 0.0% for the metal needles and vialon cannulae. Duration of use was up to 60 hours, 83 hours, and 113 hours for the metal needles, polyurethane cannulae, and vialon cannulae, respectively. Daily volumes infused were up to 28.9 mL, 60.0 mL, and 29.4 mL for the metal needles, polyurethane cannulae, and vialon cannulae, respectively. No needle-stick injuries occurred. CONCLUSIONS: The winged vialon cannula was the most durable, with no site reactions or mechanical complications, tolerating a volume comparable to that of the metal needle. We suggest its utilization for continuous subcutaneous infusions and consideration of future randomized controlled trials with an integrated economic evaluation for further in-depth comparisons of subcutaneous indwelling devices.

Effect of Insulin Dilution on Lowering Glycemic Variability in Pump-Treated Young Children with Inadequately Controlled Type 1 Diabetes.

BACKGROUND: We investigated whether in young children with inadequately controlled type 1 diabetes and technical problems with continuous subcutaneous infusion of insulin at 100 units/mL the switch to insulin diluted to 10 units/mL (U10) can limit technical problems and improve glycemic control. SUBJECTS AND METHODS: Diluted U10 insulin was started in three children 3.8, 3.2, and 1.3 years old with a hemoglobin A1c (HbA1c) level (mean±SD) of 8.1±0.17% (65±1.7 mmol/mol) and insulin dose of 8.80±2.93 units/day. Patients were evaluated with continuous glucose monitoring (iPro™2; Medtronic Minimed, Northridge, CA) and a quality of life questionnaire (PedsQL™; www.pedsql.org/ ) and surveyed for pump-related problems at baseline and after 3 and 9 months of U10 insulin therapy. RESULTS: Continuous glucose monitoring records showed that glycemic variability assessed by SD and M100 decreased significantly (P=0.0085 and P=0.0482, respectively). HbA1c levels dropped to 7.3±1.00% (56±11.0 mmol/mol) after 3 months and to 6.7±0.55% (50±6.1 mmol/mol) after 9 months (P=0.12). Technical difficulties were minimized. CONCLUSIONS: These results suggest that the use of U10 insulin decreases glycemic variability and improves hampered pump therapy in young children with inadequately controlled type 1 diabetes.

Intradermal insulin infusion achieves faster insulin action than subcutaneous infusion for 3-day wear.

Rapid uptake previously demonstrated by intradermal (ID) drug administration indicates compound delivery within the dermis may have clinical and pharmacological advantages for certain drug therapies. This study is the first clinical trial to evaluate continuous microneedle-based drug infusion, device wearability, and intradermal microneedle insulin kinetics over a multi-day (72 h) wear period. This was a single center, open-label, two-period crossover study in T1DM patients on continuous subcutaneous insulin infusion (CSII). Patients received treatment during interventional visits: one SC and one ID basal/bolus infusion of insulin aspart (NovoRapid® U-100) administered over 3 days in a randomized order. Twenty-eight patients were randomized and exposed to trial product, and 23 completed the study. Bolus insulin infusions were given prior to standardized breakfast and lunch test meals on each of the three treatment days. Blood samples were drawn at predefined time points for measurements of insulin aspart and blood glucose in serum. The primary endpoint insulin Tmax demonstrated that ID bolus infusion was associated with a significantly shorter Tmax with statistically significantly smaller intra-subject variability, compared to SC infusion, and this difference was maintained over three treatment days. Analyses of secondary PK endpoints corresponded with the primary endpoint findings. Postprandial glycemic response was significantly less pronounced after ID bolus: For most endpoints ID vs. SC, differences were statistically significant within the 0-1.5 or 0-2 h time period. Intradermal delivery of insulin is a viable delivery route alternative providing reduced time for insulin absorption with less intra-subject variability and lower glycemic response.

Subcutaneous infusion in palliative care: a focus on the neria soft 90 infusion set.

Subcutaneous administration of medications and/or fluids can play a crucial part in supporting patients at home and thereby avoiding the need for hospitalisation. It is an area of patient care that has received little attention compared with other types of parenteral therapies. However, it is an effective and safe route for continuous administration for individuals requiring palliative care. Technological advancements have led to improved subcutaneous infusion devices, such as fine-gauge cannulae with integral sharps protection, as well as integral hypoallergenic dressings. These design features not only help to increase patient comfort but also minimise the potential for needlestick injuries, as well as providing the health professional with one sterile package containing all of the components needed to establish subcutaneous infusion. However, technological developments alone are insufficient to improve patient outcomes. Knowledge of the individual patient, together with their diagnosis and intended treatment, will influence the choice of subcutaneous infusion device, with the overall aim of minimising the potential for complications and improving comfort. This paper provides an overview of subcutaneous infusion, including the importance of patient assessment and the education and training needs of health professionals, and then focuses on one specific subcutaneous infusion device: the neria soft 90 infusion set.

Trastuzumab subcutáneo: revisión de los datos clínicos y de preferencia / Subcutaneous trastuzumab: a review of the clinical and preference data

El cáncer de mama HER2 positivo supone aproximadamente un 15% de los tumores malignos de mama. La terapia anti-HER2, principalmente representada por trastuzumab, es el pilar del tratamiento de esta enfermedad. La prolongación en la supervivencia que han conseguido las nuevas terapias anti-HER2, y el tratamiento dilatado de estas pacientes en los estadios precoces de la enfermedad así como en la enfermedad avanzada, supone un importante reto a los recursos existentes, tanto con respecto al personal sanitario y el tiempo de los hospitales de día oncológicos, como en cuanto al tiempo dedicado por las pacientes para su tratamiento. El desarrollo de una formulación subcutánea ha supuesto una disminución significativa en la utilización de estos recursos y facilidad de uso. En esta revisión, presentamos el desarrollo de esta nueva formulación, así como los datos de eficacia y preferencia (AU)

HER2-positive breast cancer accounts for approximately 15% of all malignant breast tumors. HER2-targeted therapy, mainly trastuzumab, remains the cornerstone of treatment. The increase in survival achieved by the new anti-HER2 therapies, and the prolonged treatment of these patients, both in the early and advanced breast cancer setting, poses a major challenge to existing health resources. This challenge involves the health personnel, the time consumed by oncologic day hospitals, and the time investment required by patients. The development of the new trastuzumab subcutaneous formulation has improved optimization of health resources and has increased ease of use. In the present article, we review the development of the drug, as well as efficacy and preference data (AU)

Comparison of arterial pressure and plasma ANG II responses to three methods of subcutaneous ANG II administration.

Angiotensin II (ANG II)-induced hypertension is a commonly studied model of experimental hypertension, particularly in rodents, and is often generated by subcutaneous delivery of ANG II using Alzet osmotic minipumps chronically implanted under the skin. We have observed that, in a subset of animals subjected to this protocol, mean arterial pressure (MAP) begins to decline gradually starting the second week of ANG II infusion, resulting in a blunting of the slow pressor response and reduced final MAP. We hypothesized that this variability in the slow pressor response to ANG II was mainly due to factors unique to Alzet pumps. To test this, we compared the pressure profile and changes in plasma ANG II levels during subcutaneous ANG II administration (150 ng·kg(-1)·min(-1)) using either Alzet minipumps, iPrecio implantable pumps, or a Harvard external infusion pump. At the end of 14 days of ANG II, MAP was highest in the iPrecio group (156 ± 3 mmHg) followed by Harvard (140 ± 3 mmHg) and Alzet (122 ± 3 mmHg) groups. The rate of the slow pressor response, measured as daily increases in pressure averaged over days 2-14 of ANG II, was similar between iPrecio and Harvard groups (2.7 ± 0.4 and 2.2 ± 0.4 mmHg/day) but was significantly blunted in the Alzet group (0.4 ± 0.4 mmHg/day) due to a gradual decline in MAP in a subset of rats. We also found differences in the temporal profile of plasma ANG II between infusion groups. We conclude that the gradual decline in MAP observed in a subset of rats during ANG II infusion using Alzet pumps is mainly due to pump-dependent factors when applied in this particular context.