Dataset Information

Semaglutide single-dose pen-injector: Post hoc analysis of summative usability testing for weight management.

ABSTRACT: Subcutaneous semaglutide, at a 2.4 mg once-weekly maintenance dose, is approved in the United States for weight management in individuals with a body mass index (BMI) of 30 kg/m² or higher, or with a BMI of 27 kg/m² or higher and at least one obesity-related co-morbidity. To investigate the usability of the semaglutide pen-injector in individuals who met these criteria, we report post hoc analysis of the summative (human factors validation) usability testing and safety analysis involving patients with type 2 diabetes (an obesity-related co-morbidity) with the same pen-injector, limited to the 26 out of 30 patients with a BMI of 27 kg/m² or higher (11 pen-injector-naïve, 15 pen-injector-experienced) and 15 non-pharmacist healthcare professionals (HCPs). Participants performed two simulated injections into an injection pad. No potentially serious use errors occurred. Mean subjective ease-of-use rating on a seven-point scale, where 1 = difficult and 7 = easy, was 6.9 for the second injection in all three groups. These results suggest that the semaglutide pen-injector is easy to use and not associated with serious use errors when used by pen-injector-naïve or pen-injector-experienced patients meeting the requirement for weight management with semaglutide treatment, and by non-pharmacist HCPs.

SUBMITTER: Klonoff DC

PROVIDER: S-EPMC9292194 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Semaglutide single-dose pen-injector: Post hoc analysis of summative usability testing for weight management.

Klonoff David C DC Bassock Stephanie S Engels Ella E Frederiksen Marie M Marber Matthew M Qvist Marianne M Sparre Thomas T Snitker Søren S

Diabetes, obesity & metabolism 20210831 11

Subcutaneous semaglutide, at a 2.4 mg once-weekly maintenance dose, is approved in the United States for weight management in individuals with a body mass index (BMI) of 30 kg/m<sup>2</sup> or higher, or with a BMI of 27 kg/m<sup>2</sup> or higher and at least one obesity-related co-morbidity. To investigate the usability of the semaglutide pen-injector in individuals who met these criteria, we report post hoc analysis of the summative (human factors validation) usability testing and safety anal ...[more]

PMID: 34338402

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Project description:BackgroundOnly 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional.ObjectiveWe evaluated the safety and usability of an over-the-counter hearing aid prior to Food and Drug Administration approval and market release.MethodsWe first conducted a formative usability test of the device and associated app with 5 intended users to identify outstanding safety and usability issues (testing round 1). Following design modifications, we performed a summative usability test with 15 intended users of the device (testing round 2). We concurrently conducted a test with 21 nonintended users (ie, users with contraindications to use) to ascertain if consumers could determine when they should not use the device, based on the packaging, instructions, and labeling (testing round 3). Participants were asked to complete 2-5 tasks, as if they were using the hearing aid in real life. After each task, participants rated the task difficulty. At the end of each session, participants completed a 10-question knowledge assessment and the System Usability Scale and then participated in debriefing interviews to gather qualitative feedback. All sessions were video recorded and analyzed to identify use errors and design improvement opportunities.ResultsUsability issues were identified in all 3 usability testing rounds. There were minimal safety-related issues with the device. Round 1 testing led to several design modifications which then increased task success in round 2 testing. Participants had the most difficulty with the task of pairing the hearing aids to the cell phone. Participants also had difficulty distinguishing the right and left earbuds. Nonintended users did not always understand device contraindications (eg, tinnitus and severe hearing loss). Overall, test findings informed 9 actionable design modifications (eg, clarifying pairing steps and increasing font size) that improved device usability and safety.ConclusionsThis study evaluated the usability and safety of an over-the-counter hearing aid for adults with mild to moderate hearing loss. Human factors engineering methods identified opportunities to improve the safety and usability of this direct-to-consumer medical device for individuals with perceived mild-moderate hearing loss.

Project description:ImportanceObesity is associated with numerous psychosocial complications, making psychiatric safety a consideration for treating people with obesity. Few studies have investigated the psychiatric safety of newly available antiobesity medications.ObjectiveTo evaluate the psychiatric safety of subcutaneous semaglutide, 2.4 mg, once weekly in people without known major psychopathology.Design, setting, and participantsThis post hoc analysis of pooled data from the randomized, double-blind, placebo-controlled, multicenter phase 3a STEP 1, 2, and 3 trials (68 weeks; 2018-2020) and phase 3b STEP 5 trial (104 weeks; 2018-2021) included adults with overweight or obesity; STEP 2 participants also had type 2 diabetes. Trial designs have been published previously.InterventionsSemaglutide, 2.4 mg, vs placebo.Main outcomes and measuresDepressive symptoms and suicidal ideation/behavior were assessed using the Patient Health Questionnaire (PHQ-9) and Columbia-Suicide Severity Rating Scale, respectively. Psychiatric and nervous system disorder adverse events were investigated.ResultsThis analysis included 3377 participants in the STEP 1, 2, and 3 trials (2360 women [69.6%]; mean [SD] age, 49 [13] years) and 304 participants in STEP 5 (236 women [77.6%]; mean [SD] age, 47 [11] years). In the STEP 1, 2, and 3 trials, mean (SD) baseline PHQ-9 scores for the semaglutide, 2.4 mg, and placebo groups were 2.0 (2.3) and 1.8 (2.3), respectively, indicating no/minimal symptoms of depression. PHQ-9 scores at week 68 were 2.0 (2.9) and 2.4 (3.3), respectively; the estimated treatment difference (95% CI) between groups was -0.56 (-0.81 to -0.32) (P < .001). Participants treated with semaglutide vs placebo were less likely to shift (from baseline to week 68) to a more severe category of PHQ-9 depression (odds ratio, 0.63; 95% CI, 0.50-0.79; P < .001). Based on the Columbia-Suicide Severity Rating Scale, 1% or fewer of participants reported suicidal ideation/behavior during treatment, with no differences between semaglutide, 2.4 mg, and placebo. Psychiatric disorder adverse events were generally balanced between groups. Similar results were observed in STEP 5.Conclusions and relevanceThe results of this post hoc analysis suggest that treatment with semaglutide, 2.4 mg, did not increase the risk of developing symptoms of depression or suicidal ideation/behavior vs placebo and was associated with a small but statistically significant reduction in depressive symptoms (not considered clinically meaningful). People with obesity should be monitored for mental health concerns so they can receive appropriate support and care.Trial registrationClinicalTrials.gov Identifiers: STEP 1 (NCT03548935), 2 (NCT03552757), 3 (NCT03611582), and 5 (NCT03693430).

Project description:Glycemic variability is associated with markers of microvascular and macrovascular complications and impacts quality of life in patients with type 2 diabetes. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been shown to both improve HbA1c concentration and reduce glycemic variability in patients with type 2 diabetes. GLP-1RAs increase insulin secretion and suppress glucagon in a glucose-dependent manner, which may partly explain their ability to reduce glycemic variability. However, it is not clear if HbA1c influences the effect of GLP-1RAs on glycemic variability. Oral semaglutide, the first GLP-1RA available as an oral formulation, is effective at reducing HbA1c vs a range of comparators, but its effect on glycemic variability needs to be understood. Therefore, we have assessed the change in glycemic variability and its possible relationship with HbA1c in a 52-week randomized, open-label trial (PIONEER 2) comparing oral semaglutide with the sodium-glucose co-transporter-2 (SGLT2) inhibitor empagliflozin in patients with type 2 diabetes uncontrolled on metformin. The seven-point self-measured blood glucose profile (7-point SMBG) was assessed at baseline and at weeks 26 and 52 in the PIONEER 2 trial. The standard deviation (SD) of the measurements in the 7-point SMBG profile was used as a measure of glycemic variability. An additional post-hoc mediation analysis was performed to explore the indirect effect of HbA1c concentration on the direct relationship between treatment and glycemic variability (the SD of the 7-point SMBG) at weeks 26 and 52. The results showed that the SD of the 7-point SMBG at baseline for the once-daily oral semaglutide 14 mg (N=411) and empagliflozin 25 mg (N=410) treatment arms was 2.06 and 2.05 mmol/l, respectively. The change from baseline in the SD of the 7-point SMBG in the oral semaglutide and empagliflozin arms was -0.67 and -0.44 mmol/l, respectively, at week 26, and -0.69 and -0.49 mmol/l, respectively, at week 52. The treatment differences (95% CI) for the SD of the 7-point SMBG for oral semaglutide vs empagliflozin at weeks 26 and 52 were -0.23 (-0.33, -0.12; p<0.0001) and -0.20 (-0.31, -0.09; p=0.0003) mmol/l, respectively. The mediation analysis showed that the indirect effect of HbA1c accounted for -0.06 (-0.10, -0.02; p=0.0029) and -0.03 (-0.06, 0.00; p=0.08) mmol/l of the treatment difference for the SD of the 7-point SMBG at weeks 26 and 52, respectively. In conclusion the oral semaglutide significantly reduces glycemic variability, as assessed by the SD of the 7-point SMBG, compared with empagliflozin, and most of this effect was not explained by an indirect effect of HbA1c. Clinical Trial Registration Number: NCT02863328

Project description:BackgroundInstrumented assessment of motor symptoms has emerged as a promising extension to the clinical assessment of several movement disorders. The use of mobile and inexpensive technologies such as some markerless motion capture technologies is especially promising for large-scale application but has not transitioned into clinical routine to date. A crucial step on this path is to implement standardized, clinically applicable tools that identify and control for quality concerns.ObjectiveThe main goal of this study comprises the development of a systematic quality control (QC) procedure for data collected with markerless motion capture technology and its experimental implementation to identify specific quality concerns and thereby rate the usability of recordings.MethodsWe developed a post hoc QC pipeline that was evaluated using a large set of short motor task recordings of healthy controls (2010 recordings from 162 subjects) and people with multiple sclerosis (2682 recordings from 187 subjects). For each of these recordings, 2 raters independently applied the pipeline. They provided overall usability decisions and identified technical and performance-related quality concerns, which yielded respective proportions of their occurrence as a main result.ResultsThe approach developed here has proven user-friendly and applicable on a large scale. Raters' decisions on recording usability were concordant in 71.5%-92.3% of cases, depending on the motor task. Furthermore, 39.6%-85.1% of recordings were concordantly rated as being of satisfactory quality whereas in 5.0%-26.3%, both raters agreed to discard the recording.ConclusionsWe present a QC pipeline that seems feasible and useful for instant quality screening in the clinical setting. Results confirm the need of QC despite using standard test setups, testing protocols, and operator training for the employed system and by extension, for other task-based motor assessment technologies. Results of the QC process can be used to clean existing data sets, optimize quality assurance measures, as well as foster the development of automated QC approaches and therefore improve the overall reliability of kinematic data sets.

Dataset Information

Semaglutide single-dose pen-injector: Post hoc analysis of summative usability testing for weight management.

Publications

Semaglutide single-dose pen-injector: Post hoc analysis of summative usability testing for weight management.

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