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Enhancing user guidance via visual and auditory real-time feedback during subcutaneous injections-combined with automated injection-data logging-has the potential to improve self-injection outcomes and increase user confidence. To meet these objectives, a Smart Autoinjector Accessory (SAA) was developed to help patients, caregivers, and healthcare practitioners (HCPs) manage the injection process more effectively. This human factors validation study assessed whether the SAA, together with its Instructions for Use (IFU), could be operated safely and effectively with an autoinjector by the intended user population. Seventy-five untrained participants (patients, n=45; caregivers, n= 15; HCPs, n=15) were evaluated on completion of SAA use tasks and IFU knowledge tasks in a simulated use environment. All participants (75/75, 100%) successfully delivered the full dose with the associated autoinjector. A total of 1196 out of 1200 use tasks (99.7%) delivering a simulated injection with the SAA and 2772 out of 2775 knowledge tasks (99.9%) concerning content in the IFU were completed successfully. Therefore, the overall results show near perfect success rates. All observed errors were isolated to individual participants, and no patterns of recurring use- or knowledge-task errors were found. Root cause analysis attributed these errors to inattention rather than deficiencies in the IFU clarity or device design. This study shows that the intended users can operate the SAA safely and effectively. Given the strong usability outcomes, the results warrant further investigation into the SAA's potential to improve treatment adherence and persistence in longer-term studies. In post-launch use, the SAA could play a key role in facilitating the onboarding of inexperienced patients or those undergoing more complex treatment regimens. Beyond individual therapy, the SAA also holds promise in digitalizing real-world evidence collection for post-market insights and clinical drug development, supporting decentralized clinical trial designs, where patients administer injections at home rather than in clinical environments.

We present Gemini/GHOST high-resolution spectra of five stars observed in two low surface brightness Milky Way satellites, Sagittarius II (Sgr2) and Aquarius II (Aqu2). For Aqu2, the velocities and metallicities of the two stars are consistent with membership in a dark-matter-dominated ultra-faint dwarf galaxy (UFD). The chemical abundance ratios suggest inefficient star formation from only one or a few supernovae (e.g., low Na, Sr, Ba), and enriched potassium (K) from super-AGB stars. For Sgr2, the velocity and metallicity dispersions of its members are not clearly resolved, and our detailed chemical abundances show typical ratios for metal-poor stars, with low dispersions. There is only one exception—we report the discovery of an r-process enhanced star (Sgr 2584, [Eu/Fe] = +0.7 ± 0.2; thus, an r-I star). As r-I stars are found in both UFDs (Tuc III, Tuc IV, and Grus II) and globular clusters (M15 and M92), then this does not help to further classify the nature of Sgr2. Our exploration of Sgr2 demonstrates the difficulty in classifying some of the faintest (ambiguous) satellites. We advocate for additional diagnostics in analyzing the ambiguous systems, such as exploring radial segregation (by mass and/or chemistry), N-body simulations, and the need for dark matter to survive Galactic tidal effects. The spectra analyzed in this paper were taken as part of the GHOST commissioning observations, testing faint observation limits (G < 18.8) and the single and double integrated field unit observing modes.

The Gemini High-resolution Optical SpecTrograph (GHOST) is the newest high-resolution spectrograph to be developed for a large-aperture telescope, recently deployed and commissioned at the Gemini-South telescope. In this paper, we present the first science results from the GHOST spectrograph taking during its commissioning runs. We have observed the bright metal-poor benchmark star HD 122563, along with two stars in the ultrafaint dwarf galaxy Reticulum II (Ret ii), one of which was previously identified as a candidate member, but did not have a previous detailed chemical abundance analysis. We find that this candidate (GDR3 0928) to be a bona fide member of Ret ii, and from a spectral synthesis analysis it is also revealed to be a CEMP-r star, with significant enhancements in several light elements (C, N, O, Na, Mg, and Si), in addition to featuring an r-process enhancement like many other Ret ii stars. The light-element enhancements in this star resemble the abundance patterns seen in the CEMP-no stars of other ultrafaint dwarf galaxies, and are thought to have been produced by an independent source from the r-process. These unusual abundance patterns are thought to be produced by faint supernovae, which may be produced by some of the earliest generations of stars.

Furoscix (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs). Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation. Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity. The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.

Cerebral venous thrombosis is a rare stroke caused by occlusion of venous sinuses or smaller feeding cortical veins. Most cases usually present with headaches, seizures, or focal deficits, but rarely as movement disorders. Herein, we describe a 57-year-old female who presented with action myoclonus in the right lower extremity. Venous thrombosis involving the straight and inferior superior sagittal sinuses was noted on CT angiography. She was treated with apixaban and levetiracetam, with good control of the myoclonic jerks. However, she later developed an action myoclonus and weakness in the left leg, attributed to a new-onset venous infarction. Apixaban was shifted to enoxaparin, with the cerebral angiography showing clearing of the thrombosis in the previously affected sinuses. Workup for prothrombotic conditions predisposing to venous thrombosis was unremarkable. Anticoagulation with warfarin and a higher dose of levetiracetam eventually afforded a gradual improvement of the weakness and complete resolution of her myoclonus. Although rare, cerebral venous sinus thrombosis should also be considered as an acquired cause of action myoclonus.

Migraine pain relief is reported by more than 50% of patients who receive low dose (3 mg) of sumatriptan. Currently, there is no two-step autoinjector of low-dose sumatriptan available on the market for acute migraine treatment. To fulfill this need, a fully assembled, single-dose, subcutaneous autoinjector (sumatriptan 3 mg; product-code DFN-11) was developed. The device allows for injection with a simple two-step, push-to-inject process and provides feedback of the injection activation, progress, and completion. To determine if DFN-11 autoinjector can be used correctly and safely by migraine patients. A human factors validation study was conducted with 45 migraine patients (30 oral-only medications users; 15 injectable sumatriptan users) who performed one unaided simulated injection. Two days prior, half the oral participants were briefly trained. All others were only given the device to inspect and written instructions to review. No injections were performed during the initial session. All participants received written instructions at the injection session. All participants (45/45; 100%) performed the injection without any errors. Objective measures included device removal from packaging, cap removal, expiration date check, inspection of fluid in window, identification of allowable injection site, proper device positioning, dose confirmation, and device disposal. All participants (45/45; 100%) reported no difficulty administering the injection and no concerns about using the autoinjector during a severe migraine onset. The results showed that the DFN-11 autoinjector can be used with safe handling without patterns of confusion, failures, high-risk errors, wet injections, or patient safety risks. The DFN-11 autoinjector was validated to be used correctly and safely by migraine patients, whether they were injection experienced, unexperienced, trained, or self-trained.

Purpose: This study was designed to validate that people with schizophrenia can correctly, safely, and effectively prepare doses of Versacloz[TM] using the Versacloz oral suspension kit and instructions for use (IFU). Materials and methods: This was a prospective, open-label, simulated-use validation study of 61 people with schizophrenia who were stabilized on clozapine or were clozapine-naive and stabilized on another antipsychotic treatment. Participants were randomized to one of two groups: untrained (n=46) and trained (n=15). Participants were asked to select the proper syringe and prepare two test doses of 1, 3.5, or 5 mL, as randomly assigned. Participants in the untrained group did not receive any training on using the kit, but had access to kit materials, including packaging and the IFU; both test dose preparations were unaided. Participants in the trained group received brief training from the moderator, and then prepared one test dose during training and one unaided test dose during the study period. Prepared placebo doses were not ingested. Performance and behavior were assessed in 14 critical tasks identified in the user failure mode and effects analysis. Test dose failures or dose errors (threshold [+ or -] 0.1 mL) were assessed. Subjective participant assessments of usability were captured in interviews and IFU comprehension was probed. Results: A total of 107 test doses were prepared: 92 and 15 by the untrained and trained groups, respectively. Overall success for unassisted dose preparation was 87.9%; all test failures (failure to shake the bottle or failure to obtain the correct test dose) occurred in the untrained group. All participants selected the correct syringe for their assigned dose. Conclusion: This study shows that the Versacloz oral suspension kit and IFU can be correctly, safely, and effectively used to prepare doses by people with schizophrenia, with few instances of failure or errors observed. Keywords: Versacloz, clozapine, test dose, oral suspension, treatment-resistant schizophrenia

Introduction: Subcutaneous injection of octreotide acetate is indicated to treat adults with acromegaly and diarrhea associated with carcinoid tumors or vasoactive intestinal peptide tumors. In this formative human factors study, we evaluated the readability and comprehension of the instructions for use (IFU) and ease of use of the octreotide pen injector. Methods: The study enrolled patients and healthcare practitioners who would be using the pen injector. The IFU contained a stepwise process with illustrations to detail injection administration and safe storage of the octreotide pen injector. Participants read the IFU and familiarized themselves with the device. Participants administered 2 unaided injections into skin-like pads. Injection success was defined as an attempt that delivered the correct dose into the pad. Each injection was evaluated by objective performance and subjective measures. Objective performance measures included assessment of steps necessary to deliver the correct medication dose and ensure user safety. Subjective measures included soliciting participant feedback on perceived success and difficulties administering a dose with the octreotide pen injector, as well as suggestions for improvements. Additional goals included evaluation of the IFU and octreotide pen injector usability aspects. Results: A total of 8 patients and 3 healthcare practitioners enrolled in the study. All (n = 11) participants successfully administered both injections, leading to an overall injection success rate of 100% across twenty-two injections. Subtask errors included participants priming the pen injector with the incorrect dose (n = 1) and not holding the injection button for 10 seconds after the injection (n = 2), but neither error resulted in dosing failure. Participant suggestions for improving the IFU included changes to the illustration of the plunger, reordering statements to clarify the priming process, and detailing how long to let the pen injector come to room temperature. Conclusion: Overall, participants felt the octreotide pen injector was easy to use and the instructions were clearly written and illustrated. Participant feedback and observations by moderators of the study led to recommendations for improvements to the clarity of the IFU.

For automated external defibrillators (AEDs) to be practical for broad public use, responders must be able to use them safely and effectively. This study's objective was to determine whether untrained laypersons could accurately follow the visual and voice prompt instructions of an AED. Each of four different AED models (AED1, AED2, AED3, and AED4) was randomly assigned to a different group of 16 untrained volunteers in a simulated cardiac arrest. Four usability indicators were observed: 1) number of volunteers able to apply the pads to the manikin skin, 2) appropriate pad positioning, 3) time from room entry to shock delivery, and 4) safety in terms of touching the patient during shock delivery. Some of the 64 volunteers who participated in the study failed to open the pad packaging or remove the lining, or placed the pads on top of clothing. Fifty-percent of AED2 pads and 44% of AED3 pads were not placed directly on the manikin skin compared with 100% of AED1 and AED4 pads. Adjacent pad displacements that potentially could affect defibrillation efficacy were observed in 6% of AED1, 11% of AED2, 0% of AED3, and 56% of AED4 usages. Time to deliver a shock was within 3.5 minutes for all AEDs, although the median times for AED1 and AED4 were the shortest at 1.6 and 1.7 minutes, respectively. No significant volunteer contact with the manikin occurred during shock delivery. This study demonstrated that the AED user interface significantly influences the ability of untrained caregivers to appropriately place pads and quickly deliver a shock. Avoiding grossly inappropriate pad placement and failure to place AED pads directly on skin may be correctable with improvements in the AED instruction user interface.