PRESTO 2: An International Survey to Evaluate Patients' Injection Experiences with the Latest Devices/Formulations of Long-Acting Somatostatin Analog Therapies for Neuroendocrine Tumors or Acromegaly.

INTRODUCTION: Real-world data evaluating patients' injection experiences using the latest devices/formulations of the long-acting (LA) somatostatin analogs (SSAs) lanreotide Autogel/Depot (LAN; Somatuline®) and octreotide LA release (OCT; Sandostatin®) are limited. METHODS: PRESTO 2 was a 2020/2021 e-survey comparing injection experience of adults with neuroendocrine tumors (NETs) or acromegaly treated with LAN prefilled syringe versus OCT syringe for > 3 months in Canada, Ireland, the UK and the USA (planned sample size, 304). PRIMARY ENDPOINT: the proportion of patients with injection-site pain lasting > 2 days after their most recent injection, analyzed using a multivariate logistic regression model. Secondary endpoints included interference with daily life due to injection-site pain and technical injection problems in patients with current SSA use for ≥ 6 months. RESULTS: There were 304 respondents (acromegaly, n = 85; NETs, n = 219; LAN, n = 168; OCT, n = 136; 69.2% female; mean age, 59.6 years). Fewer patients had injection-site pain lasting > 2 days after the most recent injection with LAN (6.0%) than OCT (22.8%); the odds of pain lasting > 2 days were significantly lower for LAN than OCT, adjusted for disease subgroup and occurrence of injection-site reactions (odds ratio [95% confidence interval]: 0.13 [0.06-0.30]; p < 0.0001). Injection-site pain interfered with daily life "a little bit" or "quite a bit" in 37.2% and 3.8% (LAN) versus 52.5% and 7.5% (OCT) of patients, respectively. Among patients with ≥ 6 months' experience with current SSA (92.4% of patients), technical injection problems never occurred in 76.8% (LAN) and 42.9% (OCT) of patients. CONCLUSIONS: Compared with OCT, significantly fewer patients using LAN had injection-site pain lasting > 2 days after their most recent injection. Also, fewer LAN-treated patients experienced technical problems during injection. These findings demonstrate the importance of injection modality for overall LA SSA injection experience for patients with acromegaly or NETs.

Patients with neuroendocrine tumors or acromegaly often receive long-term monthly treatment with somatostatin analogs. These injectable drugs stop the body from making an excess of certain hormones. Understanding patients' experiences of these injections helps to provide better care. The PRESTO 2 online study surveyed 304 patients in Canada, Ireland, the UK and the USA with neuroendocrine tumors or acromegaly who were being treated with a somatostatin analog, either lanreotide Autogel/Depot (LAN) or octreotide long-acting release (OCT). The survey asked about injection experience, including injection-site pain lasting > 2 days and how it affected patients' lives, anxiety before injections and technical problems during injections (like syringe blockages). The survey showed fewer patients receiving LAN than OCT had injection-site pain that lasted > 2 days, and fewer said that the pain interfered with their daily lives. There were fewer technical injection problems with LAN than with OCT. However, more patients receiving LAN than OCT felt anxious before their injection. In some countries (including Canada, Ireland and the UK, but not the USA), the patient (or family member/friend) can inject LAN if they are on a stable dose, their doctor agrees, and they received training. A nurse/doctor must inject OCT. In PRESTO 2, about 40% of non-US patients who were eligible injected themselves (or were helped by a family member/friend). This may explain why more patients reported anxiety in the LAN group. PRESTO 2 provides important insights into patients' experiences of receiving somatostatin analogs and helps identify areas for improving patient care.

Contraceptivos injetáveis acetato de medroxiprogesterona + cipionato de estradiol (25mg + 5mg) e algestona acetofenida + enantato de estradiol (150 mg + 10mg) para mulheres em idade fértil / Injectable contraceptives medroxyprogesterone acetate + estradiol cypionate (25mg + 5mg) and algestone acetophenide + estradiol enanthate (150mg + 10mg) for women of childbearing age

INTRODUÇÃO: Estima-se que metade das gestações ocorram sem planejamento, em todo o mundo. Como consequência, aumenta também a chance de aborto, com incremento estimado de 51 para 61 por 1.000 mulheres entre 1990-1994 e 2015-2019. A contracepção com métodos modernos é considerada uma estratégia custo-efetiva e fundamental para alinhamento entre a possível vontade de ter filhos e outros determinantes que impactam na escolha das pessoas envolvidas. Os métodos contraceptivos podem ser classificados em tradicionais ou modernos, de curta ou de longa duração, sendo considerados, de forma geral, como métodos tradicionais a abstinência sexual e os comportamentais. Os métodos modernos de ação curta são os orais, injetáveis, preservativos e diafragmas; e os métodos modernos de ação prolongada, DIU e implantes. Os anticoncepcionais injetáveis, quando combinados, contêm além do progestogênio sintético, um éster de estrogênio natural ­ o estradiol, diferentemente dos estrogênios sintéticos presentes nos anticoncepcionais orais. A posologia desses anticoncepcionais pode ser mensal, bimestral ou trimestral dependendo da sua composição e em relação aos orais po

A laboratory evaluation of nozzle tip damage in four generations of intraocular lens injector systems using a self-developed damage scale.

During intraocular lens (IOL) implantation it is not uncommon for the injector's nozzle-tip to get damaged. However, the damage has not been systematically described or evaluated using an objective scale. In this study we developed our own system-the Heidelberg Score for IOL Injector Damage ("HeiScore"), which was used to grade 60 injectors from four generations of injector models (Monarch III D, AcrySert C, UltraSert, AutonoMe) made by the same manufacturer. (Alcon Laboratories Inc.) HeiScore has six grades of nozzle-tip damage: no damage (which was graded 0); slight scratches (1), deep scratches (2), extensions (3), cracks (4) and bursts (graded number 5). The score for each injector model was the sum of all grades (total number), and we could compare the four injector models. The injectors showed varying damage profiles, from "no damage" to "crack". A tendency of a lower damage score in the newer generations of IOL injectors was noted. However, a statistically significant difference was observed only between Monarch III D and AutonoMe. The "Heidelberg Score for IOL Injector Damage" could efficiently and effectively evaluate the damage to IOL injector systems, which might help manufacturers optimize the positioning of the IOL in the injector during pre-loading.

OnabotulinumtoxinA injection towards the SPG for treating symptoms of refractory chronic rhinosinusitis with nasal polyposis: a pilot study.

BACKGROUND AND OBJECTIVE: The main objective of this prospective, open, uncontrolled pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in 10 patients with refractory chronic rhinosinusitis with nasal polyposis (CRSwNP) using a novel injection tool, the MultiGuide®. MATERIAL AND METHODS: A one-month baseline period was followed by bilateral injections of 25 U BTA in the SPG and a follow-up of 12 weeks. The primary outcome was adverse events (AE), and the main efficacy outcome was a 50% reduction in visual analogue scale (VAS) symptoms for nasal obstruction and rhinorrhea in months 2 and 3 post-treatment compared to baseline. RESULTS: We registered 13 AEs, none of which were serious, however, one patient experienced diplopia which moderately affected his daily activities. The symptoms slowly improved and resolved 4 weeks after injection. Five patients were treatment responders with at least 50% median reduction in the nasal obstruction, and four were treatment responders concerning rhinorrhea. CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide® in patients with CRSwNP appears to be safe but with a potential for moderately disabling side effects. The study indicates a beneficial effect on nasal obstruction.

Economic and clinical outcomes of pegfilgrastim via prefilled syringe vs on-body injector: a real-world data analysis.

BACKGROUND: Pegfilgrastim is available as a prefilled syringe (PFS) and an on-body injector (OBI). Whether the administration method of pegfilgrastim affects the effectiveness and health care resources has not been evaluated in the setting of routine care. OBJECTIVE: To compare real-world clinical and economic outcomes between PFS and OBI methods of administration. METHODS: This was a retrospective observational study in patients diagnosed with breast cancer or non-Hodgkin lymphoma who received myelosuppressive chemotherapy and prophylactic use of pegfilgrastim via PFS or OBI between January 1, 2017, and May 31, 2018, according to MarketScan research databases. A propensity score was used to match the PFS cohort 1:1 to the OBI cohort. Outcomes were compared among the matched cohorts using a generalized linear model and generalized estimating equations with log-link function. RESULTS: 3,152 patients were identified. After matching, the final sample included 2,170 patients, representing 1,085 in each cohort. The incidence of febrile neutropenia (FN) in the first chemotherapy cycle was 1.01% for OBI (95% CI = 0.56-1.82) vs 1.48% for PFS (95% CI = 0.91-2.39; P = 0.336). In all chemotherapy cycles (total cycles = 7,467), the FN incidence was 0.91% for OBI (95% CI = 0.64-1.30) vs 1.22% for PFS (95% CI = 0.90-1.64; P = 0.214). There was no statistically significant difference in adjusted per-member per-month all-cause total cost health care resource utilization (HCRU) for hospitalizations, emergency department visits, and pharmacy claims. CONCLUSIONS: In a matched cohort of patients representing real-world utilization, there was no statistically or clinically meaningful difference in FN incidence between OBI and PFS methods of pegfilgrastim administration. There was no difference in total HCRU or total costs. OBI and PFS methods of administration are both indicated for patients requiring prophylactic pegfilgrastim, which is important considering that biosimilar PFS options are now available. DISCLOSURES: This study was funded by Sandoz, Inc. Wang, Li, and K. Campbell are employees of Sandoz, Inc. Schroader and D. Campbell are employees of Xcenda, which was contracted by Sandoz, Inc., to provide study and manuscript development. McBride reports receiving payment from Sandoz, Inc., as a consultant, unrelated to this study; Coherus for advisory board and speaker engagements; and Pfizer for advisory board participation during the time of this study.

Infant Anaphylaxis: A Diagnostic Challenge.

PURPOSE OF REVIEW: Infant anaphylaxis has been increasing in incidence; however, significant gaps in the literature remain. The aim of this article is to review the most recent literature pertaining to infant anaphylaxis and discuss recent findings related to epidemiology, diagnosis, management, and prevention. RECENT FINDINGS: There is no accurate report of the incidence and prevalence of anaphylaxis in infancy. Food is the most common trigger for infant anaphylaxis reported. The diagnosis of anaphylaxis in infants is often missed, and, even when the diagnosis is made, epinephrine continues to be under-utilized. An epinephrine autoinjector with a shorter needle and lower dose is now available for infants. Concise criteria specifically focusing on infant anaphylaxis is needed to streamline its diagnosis and management. Diagnosis is underrecognized in infants leading to improper treatment. When the diagnosis is made, epinephrine continues to be under-utilized and under-prescribed in infants.

A proposal for needle projections in transcutaneous injection laryngoplasty using three-dimensionally reconstructed CT scans.

PURPOSE: This study aims to determine laryngeal dimension in relation to all three transcutaneous injection laryngoplasty (TIL) approaches (thyrohyoid, transthyroid and cricothyroid) using three-dimensionally reconstructed Computed Tomography (CT) scan and compare the measurements between sex, age group and ethnicity. METHODS: CT scans of the neck of two hundred patients were analysed by two groups of raters. For thyrohyoid approach, mean distance from the superior border of the thyroid cartilage to the laryngeal cavity (THd) and mean angle from the superior border of the thyroid cartilage to mid-true cords (THa) were measured. For transthyroid approach, mean distance from mid-thyroid cartilage to mid-true cords (TTd) and Hounsfield unit (HU) at mid-thyroid cartilage (TTc) were measured. For cricothyroid approach, mean distance from the inferior border of the thyroid cartilage to the laryngeal cavity (CTd) and mean angle from the inferior border of the thyroid cartilage to mid-true cords (CTa) were measured. RESULTS: There were statistically significant differences between males and females for all measurements except for CTa (p < 0.0001). No significant difference across age groups and ethnicities were found for all three approaches (p > 0.05). There was a significant fair positive correlation between age and TTc (p = 0.0002). For all measurements obtained, there were moderate to excellent inter-group consistency and intra-rater reliability. CONCLUSION: This study demonstrated a significant sex dimorphism that may influence the three TIL approaches except for needle angulation in the cricothyroid approach. The knowledge of laryngeal dimension is important to increase success in TIL procedure.

Retrieval of Additional Epinephrine from Adrenaclick-Style Epinephrine Autoinjectors.

Anaphylaxis is a life-threatening allergic reaction involving multiple organ systems that can result in significant morbidity and mortality if left untreated. Epinephrine is the mainstay of treatment. Most episodes of anaphylaxis resolve after a single dose of epinephrine, but biphasic and protracted courses of anaphylaxis are well described. The need for additional doses of epinephrine poses a significant challenge in the wilderness setting, because patients and providers may only carry a single autoinjector. Prior work has demonstrated successful disassembly of various brands of epinephrine autoinjectors to retrieve additional drug product for repeat dosing. We describe 2 techniques to retrieve additional doses of epinephrine from Adrenaclick-style epinephrine autoinjectors. The techniques described are off-label and are not approved by the manufacturer or the Food and Drug Administration. Wilderness providers should familiarize themselves with techniques for retrieval of additional epinephrine from various autoinjectors in light of significant differences in product design.

The Ability to Use Epinephrine Autoinjector in Patients Who Receive Prescription Immediately after Anaphylaxis.

BACKGROUND: Epinephrine autoinjector (EAI) is prescribed to prevent a fatal outcome in the case of a repeated anaphylactic reactions. We wanted to determine how adult patients who received their first prescription as part of an urgent treatment of an anaphylactic reaction or at their family physician were instructed on the use of EAI. METHODS: Nurses assessing patients' knowledge asked the patient to demonstrate how to use the EAI training device. Patients who performed the critical steps correctly in 1 min were labelled as competent. RESULTS: Forty-one patients (24% women, 46 ± 5 years) came for the allergy examination 116 ± 145 days after receiving a prescription for EAI. When prescribing, the doctor or nurse explained the instructions for the use of EAI to 63.4% patients, and 31.7 patients practiced the use of EAI using a training device. At the pharmacy, 22% received explanation and 7% also practiced using a training device. Fifty-four percent of patients were able to effectively administer EAI adrenaline within 1 min. Higher education level was associated with sufficient knowledge about the use of EAI (p = 0.026). At the time of the visit to the allergy specialist clinic, 61% of patients had EAI with them. The shelf life of EAI was known to 63% of patients. CONCLUSIONS: The activities to increase the prescription rate of EAI immediately after treatment of anaphylactic episode are not sufficient to prevent severe outcome after the repeated episodes of anaphylaxis as nearly a half of patients are not able to use EAI correctly.

Rapid and precise delivery of cells in the urethral sphincter complex by a novel needle-free waterjet technology.

OBJECTIVES: To investigate the therapy of stress urinary incontinence in a preclinical setting cells were injected into the urethrae of minipigs; however, cells injected by William's needle were frequently misplaced or lost; thus, we investigated if needle-free cell injections using a novel waterjet technology facilitates precise injections in the urethral sphincter complex. MATERIALS AND METHODS: Porcine adipose tissue-derived stromal cells (pADSCs) were isolated from boars, expanded, labelled, and injected in the sphincter of female pigs by waterjet employing two different protocols. After incubation for 15 min or 3 days, the urethrae of the pigs were examined. Injected cells were visualised by imaging and fluorescence microscopy of tissue sections. DNA of injected male cells was verified by polymerase chain reaction (PCR) of the sex-determining region (SRY) gene. Cell injections by William's needle served as controls. RESULTS: The new waterjet technology delivered pADSCs faster and with better on-site precision than the needle injections. Bleeding during or after waterjet injection or other adverse effects, such as swelling or urinary retention, were not observed. Morphologically intact pADSCs were detected in the urethrae of all pigs treated by waterjet. SRY-PCR of chromosomal DNA and detection of recombinant green fluorescent protein verified the injection of viable cells. In contrast, three of four pigs injected by William's needle displayed no or misplaced cells. CONCLUSION: Transurethral injection of viable pADSCs by waterjet is a simple, fast, precise, and yet gentle new technology. This is the first proof-of-principle concept study providing evidence that a waterjet injects intact cells exactly in the tissue targeted in a preclinical in vivo situation. To further explore the clinical potential of the waterjet technology longer follow-up, as well as incontinence models have to be studied.

Fill rates and access to self-injectable epinephrine prescribed in a pediatric emergency department.

BACKGROUND: Despite its life-saving potential in anaphylaxis, self-injectable epinephrine (SIE) is frequently not administered by caregivers prior to arrival in the emergency department (ED). Prescriptions from the ED often go unfilled which may contribute to the failure to receive SIE when needed. OBJECTIVE: To determine the prescription filling rate and accessibility of SIE devices among families discharged from the Pediatric ED with an SIE prescription. METHODS: A phone survey was administered to parents of children <18 years of age prescribed SIE in the pediatric ED over 12 months. The survey inquired if they own an SIE device, the device's expiration date as confirmation, and details of their child's allergy. Variables were analyzed for association with owning SIE, having SIE accessible when prompted, and having unexpired SIE accessible. RESULTS: 170 children received prescriptions for SIE and 100 (59%) completed the survey. Eighty-four of 100 (84%) had filled the initial SIE prescription. Sixty-five of 100 (65%) had proof of having SIE, of which 29% (19/65) were expired. Only 46% (46/100) of all respondents had an accessible unexpired SIE. Patients with food allergies and those who'd visited an allergist after their ED visit had higher odds of having unexpired accessible devices. CONCLUSION: A majority of patients prescribed SIE from the ED fill their prescription; however, less than half have unexpired SIE readily available despite high rates of recurrent anaphylactic emergencies. Focusing on post-discharge planning, particularly follow-up, may prevent children with allergies from being left dangerously unprepared.

High-Preservation Single-Cell Operation through a Photo-responsive Hydrogel-Nanopipette System.

Single-cell and in situ cell-based operation with nanopipette approach offers a possibility to elucidate the intracellular processes and may aid the improvement of therapy efficiency and precision. We present here a photo-responsive hydrogel-nanopipette hybrid system that can achieve single-cell operation with high spatial/temporal resolution and negligible cell damage. This strategy overcomes long-time obstacles in nanopipette single-cell studies as high electric potential (ca. 1000 mV) or organic solvent is always used during operations, which would inevitably impose disturbance and damage to targeted cells. The light-triggered system promotes a potential-free, non-invasive single-cell injection, resulting in a well-retained cell viability (90 % survival rate). Moreover, the photo-driven injection enables a precisely dose-controllable single-cell drug delivery. Significantly reduced lethal doses of doxorubicin (163-217 fg cell-1 ) are demonstrated in corresponding cell lines.

The role of growth hormone device optimization in patient-reported outcomes: real-world evidence from South Korea.

BACKGROUND: Growth hormone (GH) treatment preference and adherence are affected by delivery device convenience, injection-site pain, confidence in correct dose administration, and device satisfaction. This survey investigated if switching device to NordiFlex® improved treatment experience in pediatric patients in South Korea. DESIGN AND METHODS: Patients aged 4-≤18 years were surveyed. Participants were NordiFlex® users who previously used NordiLet®/other devices. Participants compared preference, self-reported adherence, satisfaction, perceived ease of use, and device subjective benefits (across four domains: ease of use, self-efficacy, minimal disruption of daily life, positive feelings about injections) of NordiFlex® vs. previous device. RESULTS: Ninety-four patients were enrolled, of which 91.5% previously used NordiLet®. Significantly more patients preferred, and were more satisfied with NordiFlex® vs. previous device; mean score: 0.65 (95% confidence interval [CI]:0.41;0.88) and 0.61 (95% CI:0.36;0.85), respectively. Participants reported greater perceived ease of use (0.49 [95% CI:0.26;0.72]) and fewer missed injections (0.20 [95% CI:0.06;0.34], with NordiFlex® vs. previous device. Bivariate analysis showed significant associations between preference for NordiFlex® and higher scores on self-efficacy, ease of use, minimal disruption of daily life, and positive feelings about injection (all p < 0.001). CONCLUSION: These results suggest that improvements in device features could be associated with improved treatment experience.

New infusion device for use in acquisition of images during endovascular procedures: an experimental model / Novo dispositivo de infusão para a aquisição de imagens durante procedimentos endovasculares: modelo experimental

Abstract Background The contrast power injector (CPI) is the gold standard method for injecting contrast with the pressure and flow needed to generate a satisfactory images during endovascular procedures, but it is an expensive tool, narrowing its wide-scale applications. One alternative is the manual injection (MI) method, but this does not generate the pressure required for adequate visualization of anatomy. It is therefore imperative to create an alternative low-cost method that is capable of producing high quality images. Objectives To compare the injection parameters of a new mechanical device (Hand-Crank) created in a university hospital with the MI method and with the contrast power injector's ideal values. Methods A circulation phantom was constructed to simulate the pressure in the aorto-iliac territory and the injection parameters of the two methods were compared in a laboratory setting. Student's t test and the Mann-Whitney test were used for statistical analysis. Three vascular surgery residents (the authors) performed the injections (each performed 9 tests using conventional manual injection and 9 tests using the Hand-Crank, totaling 54 injections). Results There were statistical differences between the two methods (p<0.05) in total volume injected until maximum pressure was attained, pressure variation, maximum pressure, total injection time, and time to reach the maximum pressure. Conclusions The Hand-Crank can achieve higher maximum pressure, higher average flow, and lower injection time than the manual method. It is a simple, low-cost, and effective tool for enhancing injection parameters in an experimental setup. It could help to produce higher quality images in a clinical scenario.

Resumo Contexto A bomba injetora é o método padrão-ouro para a injeção de contraste em aortografias. Entretanto, é uma ferramenta de alto custo, o que limita o seu uso. A injeção manual surge como alternativa, mas a pressão gerada com esse método é baixa, e, por isso, a qualidade das imagens não é usualmente satisfatória. Assim, a criação de um método de baixo custo capaz de gerar imagens de qualidade é imperativo. Objetivos Comparar os parâmetros de injeção de um novo dispositivo mecânico (manivela articulada) criado em um hospital universitário com os parâmetros da injeção manual e com os valores ideais da bomba injetora. Métodos Um simulador do território aórtico foi construído, e parâmetros de injeção entre os diferentes métodos em um cenário laboratorial controlado foram analisados. O teste t de Student e o teste de Mann-Whitney foram usados para análise estatística. Três residentes de Cirurgia Vascular realizaram os testes (nove usando o novo dispositivo, e nove usando a injeção manual, totalizando 54 injeções). Resultados Houve diferença estatisticamente significativa (p < 0,05) entre os dois métodos, considerando os parâmetros: variação de pressão, pressão máxima, tempo de injeção, tempo até a pressão máxima e volume até a pressão máxima. Conclusões A manivela articulada atingiu níveis superiores de pressão e de velocidade de injeção, com menor tempo de injeção do que a injeção manual. É um dispositivo simples, de baixo custo e com resultados comparáveis à bomba injetora, o que sugere seu uso potencial na geração de imagens satisfatórias em aortografias.

Mathematical modeling and computer simulation of needle insertion into soft tissue.

In this study we present a kinematic approach for modeling needle insertion into soft tissues. The kinematic approach allows the presentation of the problem as Dirichlet-type (i.e. driven by enforced motion of boundaries) and therefore weakly sensitive to unknown properties of the tissues and needle-tissue interaction. The parameters used in the kinematic approach are straightforward to determine from images. Our method uses Meshless Total Lagrangian Explicit Dynamics (MTLED) method to compute soft tissue deformations. The proposed scheme was validated against experiments of needle insertion into silicone gel samples. We also present a simulation of needle insertion into the brain demonstrating the method's insensitivity to assumed mechanical properties of tissue.

Protocol for brain-wide or region-specific microglia depletion and repopulation in adult mice.

The advent of tools enabling the direct manipulation of microglia has furthered our understanding of their role in health and disease. Here, we present a detailed protocol allowing for microglia turnover in adult CX3CR1creERT2 × iDTR or CX3CR1creERT2 × iDTR × tdTomatoflox mice, either in a brain-wide or region-specific manner, and their subsequent isolation for downstream applications. This protocol may be used to explore microglia biology and their putative region-specific heterogeneous functional diversity, expanding our understanding of their importance in various neuroinflammatory conditions. For complete details on the use and execution of this protocol, please refer to Willis et al. (2020).

A Contemporary Warming/Restraining Device for Efficient Tail Vein Injections in a Murine Fungal Sepsis Model.

In rodent models, tail vein injections are important methods for intravenous administration of experimental agents. Tail vein injections typically involve warming of the animal to promote vasodilation, which aids in both the identification of the blood vessels and positioning of the needle into the vessel lumen while securely restraining the animal. Although tail vein injections are common procedures in many protocols and are not considered highly technical if performed correctly, accurate and consistent injections are crucial to obtain reproducible results and minimize variability. Conventional methods for inducing vasodilation prior to tail vein injections generally depend on the use of a heat source such as a heat lamp, electrical/rechargeable heat pads, or pre-heated water at 37 °C. Despite being readily accessible in a standard laboratory setting, these tools evidently suffer from poor/limited thermo-regulatory capacity. Similarly, although various forms of restraining devices are commercially available, they must be used carefully to avoid trauma to the animals. These limitations of the current methods create unnecessary variables in experiments or result in varying outcomes between experiments and/or laboratories. In this article, we demonstrate an improved protocol using an innovative device that combines an independent, thermally regulated, warming device with an adjustable restraining unit into one system for efficient streamlined tail vein injection. The example we use is an intravenous model of fungal bloodstream infection that results in sepsis. The warming apparatus consists of a heat-reflective acrylic box installed with an adjustable automatic thermostat to maintain the internal temperature at a pre-set threshold. Likewise, the width and height of the cone restraining apparatus can be adjusted to safely accommodate various rodent sizes. With the advanced and versatile features of the device, the technique shown here could become a useful tool across a range of research areas involving rodent models that employ tail vein injections.

Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

BACKGROUND: Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties. METHODS: A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ɑ. RESULTS: The literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (ɑ > 0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity. CONCLUSIONS: The ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making. TRIAL REGISTRATION: NCT03357471.