Treatment Satisfaction Research Articles

Dupilumab Improves Patient-Reported Outcomes as Early as 1 Month among Adults with Prurigo Nodularis in Clinical Practice: Initial Results from the RELIEVE-PN Study

Introduction: Dupilumab is a monoclonal antibody approved in the United States (US) for patients aged ≥18 years with prurigo nodularis (PN). This analysis evaluated the real-world initial impact of dupilumab therapy on symptoms and treatment satisfaction among US adults with PN. Methods: RELIEVE-PN is an ongoing longitudinal prospective patient survey study assessing the real-world effectiveness of dupilumab in the treatment of adult patients with PN. Adults with PN were recruited through the US dupilumab patient support program and surveyed before (baseline) and 1 month after dupilumab initiation. PN symptoms over the last 7 days were assessed using the worst-itch numeric rating scale (WI-NRS), average-itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS (range 0 [no symptom] to 10 [most severe symptom] for all). Treatment satisfaction with current therapy was evaluated using a 7-point Likert scale from “extremely satisfied” to “extremely dissatisfied”. Results: Of 84 patients (mean age, 57.5 years; 79.8% female; 83.3% White) completing the baseline survey and initiating dupilumab, 62 (mean age, 56.4 years; 77.4% female; 83.9% White) completed the Month 1 survey. At baseline, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning/tingling NRS were 7.70 (2.24), 6.45 (2.25), 5.06 (2.87), and 5.51 (3.02), respectively. By month 1, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS improved to 5.56 (2.89), 4.35 (2.23), 3.40 (2.46), and 3.76 (2.60), respectively (p<0.001 for all). Additionally, significantly more patients reported they were satisfied with current PN treatment(s) at 1 month after dupilumab treatment initiation vs prior to starting dupilumab (77.4% vs 13.1%; p<0.001). Conclusion: Early results from the RELIEVE-PN study demonstrate improvement in symptoms and patient satisfaction with therapy as early as 1-month from treatment initiation of dupilumab. Further comparative research is needed to confirm these findings. Acknowledgment: Research was funded by Sanofi and Regeneron Pharmaceuticals Inc.

Intraprocedural Three-Dimensional Imaging Registration Optimizes Magnetic Resonance Imaging–Guided Focused Ultrasound and Facilitates Novel Applications

BACKGROUND AND OBJECTIVE: Transcranial magnetic resonance–guided focused ultrasound (MRgFUS) has revolutionized ablative treatment of essential tremor in recent years. However, limitations in precision targeting may account for suboptimal efficacy and significant side effects. We describe a simple intraprocedural three-dimensional image-guided lesion shaping technique that can improve overall outcomes of MRgFUS for essential tremor and facilitate expansion to novel indications. METHODS: A retrospective review of 84 consecutive MRgFUS procedures performed at Pennsylvania Hospital was performed. Comparison of patient demographics, treatment parameters, and clinical outcomes before and after implementation of this protocol was conducted. Further application of this technique in pallidotomy treatments and ablative disconnection of hypothalamic hamartoma are described. RESULTS: After implementation, the median of total number of sonications (7 vs 9, P = .001), number of therapeutic sonications (3 vs 4, P < .0001), and interval time between the first and last sonication (46:10 vs 68:53 minutes, P = .0004) were significantly reduced. Patients expressed greater satisfaction of treatment (94.1% vs 82.4%, P = .018), greater global impression of change (CGI) (7 vs 6, P = .033), and reduced median number of side effects at 6 months (0 vs 1, P = .026). We also successfully implemented this protocol for novel indications. CONCLUSION: Intraprocedural lesion shaping for MRgFUS is a simple and versatile imaging protocol augmentation that improves ablation precision and can improve treatment efficacy and broader neurological application.

Treatment Preferences of Physicians Treating Adult Patients with Attention-Deficit/Hyperactivity Disorderin the United States and Canada: A Discrete Choice Experiment.

Factors influencing attention-deficit/hyperactivity disorder (ADHD) treatment preferences have been studied among patients but not physicians in the United States (US) and Canada. This study assessed treatment preferences of physicians treating adult patients with ADHD in both countries. An online discrete choice experiment (DCE) was conducted (October 4-20, 2023) among physicians from Dynata's US and Canadian panel who treated adult patients with ADHD. Preference weights for efficacy (improvement in ADHD symptoms) and safety [risks of adverse events (AEs)] attributes were estimated using a conditional logistic regression model, and were used to calculate the willingness to trade-off and relative importance of the attributes. Among 510 US and 347 Canadian physicians (64.1% and 69.2% male, respectively), improvement in ADHD symptoms had a significant positive impact, and the risks of AEs (except the risk of feeling jittery in Canada) had a significant negative impact on physician preferences for ADHD treatments. US physicians were willing to tradeoff 0.44, 0.35, 0.20, 0.17, and 0.17 percentage points of improvement in ADHD symptoms to avoid a one-percentage-point risk of insomnia, nausea, feeling jittery, anxiety, and dry mouth, respectively; among Canadian physicians, these were 0.31, 0.21, 0.12, 0.20, and 0.07, respectively. The relative importance of the efficacy versus safety attributes (i.e., the risks of AEs included in the DCE taken together) was 45.5% versus 54.5% in the US and 56.3% versus 43.7% in Canada. Efficacy was the most important single attribute for physicians treating adult patients with ADHD in both the US and Canada; however, the risks of AEs taken together had greater relative importance than efficacy alone among US but not Canadian physicians. These findings highlight potential discrepancies in physician and patient preferences based on existing evidence and underscore the importance of shared decision-making, which may in turn increase patients' treatment satisfaction.

Disability and Patient-Reported Satisfaction in Women with Idiopathic Intracranial Hypertension: A Comparative Study of Venous Sinus Stenting and Medical Management

Objective: Patients with chronic idiopathic intracranial hypertension (IIH) commonly experience a high level of disability and low satisfaction with medical treatment. We aim to evaluate long-term functional improvement and patient satisfaction in IIH patients with similar symptoms by comparing venous sinus stenting (VSS) to standard medical therapy. Methods: We conducted a cross-sectional questionnaire study of 111 IIH patients, comparing 37 adult female patients who underwent venous sinus stenting with 74 patients treated medically. Propensity score matching was used to balance age and presence of papilledema at presentation between groups. Headache-related disability was evaluated using the Migraine Disability Assessment Scale (MIDAS), while general function and treatment satisfaction were assessed using custom questionnaires. Electronic medical records and the results of imaging upon diagnosis were reviewed retrospectively. Results: The stented group reported significantly better outcomes in physical well-being (median 4.0 vs. 1.0, p < 0.001), task completion (4.0 vs. 1.0, p < 0.001), work/school persistence (5.0 vs. 1.0, p < 0.001), and mental well-being (4.0 vs. 1.0, p < 0.001). Additionally, the stented group had a lower proportion of patients with severe MIDAS (MIDAS > 4, 24.3% vs. 47.9%, p = 0.017). Logistic regression suggested venous stenting as a protective factor against severe MIDAS scores (OR = 0.174, p = 0.004). Conclusion: Cerebral venous stenting in patients with IIH is associated with lower disability and higher patient satisfaction from medical treatment compared to those treated with medications only. These findings suggest that venous sinus stenting may be a valuable treatment option for selected IIH patients. However, larger prospective studies are needed to further validate our results.

Microfocused Ultrasound With Visualization (MFU-V) Effectiveness and Safety: A Systematic Review and Meta-Analysis.

Microfocused ultrasound with visualization (MFU-V) is an advanced, non-invasive cosmetic procedure widely used in skin lifting and tightening. We performed a systematic review and meta-analysis to evaluate the aesthetic effectiveness, patients' satisfaction, skin quality, and safety profile of MFU-V treatment. A comprehensive search of 5 bibliographic databases up to 2023 was conducted. Pooled effect estimates using random effects models and corresponding 95% confidence intervals (95% CI) were calculated. Out of 4,019 references, 42 studies were included. Meta-analysis showed 89% of patients (95% CI: 81- 94%; I2: 63%, n=411) demonstrated some degree of global aesthetic improvement, as assessed by investigators. Similarly, 84% of patients (95% CI: 73- 91%; I2: 64%, n=312) reported improvement following treatment. Satisfaction of any level was reported by 84% of patients (95% CI: 61- 94%; I²: 52%, n=326), and 62% (95% CI: 37- 82%; I²: 3%, n=172) when 'neutral' as a response was provided for the patients. Skin quality (e.g., wrinkles, texture) also improved. Patients reported a pooled mean pain score of 4.85 (95% CI: 4.35, 5.35; I2: 97%, n=785), indicating moderate pain. Common adverse events included erythema, edema, swelling, bruising, and tenderness, all of which were generally mild to moderate in severity. Overall, our analysis demonstrated a notable increase in global aesthetic improvement and patients' satisfaction following MFU-V treatment, accompanied by moderate pain and a generally favorable safety profile. However, the potential misclassification of neutral responses as positive could result in an overestimation of the treatment's efficacy. These findings highlight the need for well-designed trials to further explore MFU-V's clinical applications.

Safety and effectiveness of methylphenidate ER multi-unit pellet system in ADHD patients: An open label study

Background: Attention deficit hyperactive disorder (ADHD) is a neurodevelopmental disorder occurring in children and adults. Pharmacotherapy remains the cornerstone of ADHD treatment. Stimulants such as methylphenidate are effective and have been one of the best studied and most frequently used treatment for ADHD. However, different delivery mechanisms and devices may potentially impact patient experience and real-life outcomes.Aim: This study evaluated the effectiveness of Multiple-Unit Pellet System Delivered Extended-Release Methylphenidate (Contramyl XR) on symptom control and reported outcomes in ADHD patients, in a real-world setting.Setting: A phase IV, open label, flexible dose, prospective, observational study conducted at six sites covering five provinces of South Africa.Methods: About 119 participants with ADHD (both newly diagnosed [treatment-naïve] and methylphenidate-treated [switch-over] patients) were enrolled and initiated either on Contramyl XR or switched over from methylphenidate to Contramyl XR. Primary efficacy was assessed by Weiss Functional Impairment Rating Scale (WFIRS) over 12 weeks.Results: In all, 117 participants completed the study (treatment-naïve patients: 46% [n = 55] and switch-over patients: 54% [n = 64]). Mean change from baseline in total WFIRS (95% confidence interval) was –17.7 (–21.1, –14.3; p 0.001) at week 4 and –29.3 (–33.5, –25.2; p 0.001) at week 12. At week 12, there was significant improvement in WFIRS scores, with treatment satisfaction reported by treatment-naïve patients. Switch-over patients also demonstrated comparable effectiveness.Conclusion: Contramyl XR was found to be clinically effective either as de novo or as switch therapy. It was well tolerated, and all patients chose to continue with the treatment option.Contribution: Despite distinct and different delivery mechanism of Contramyl XR, this study provides evidence for using it as an alternate treatment option versus reference methylphenidate, in both treatment-naïve and switch-over ADHD patients. Study participants willingness to continue Contramyl XR therapy post study, further strengthens the confidence on the effectiveness of Contramyl XR in managing ADHD patients.

Oral Semaglutide Use in Type2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.

Oral semaglutide is a glucagon-like peptide1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA1C) and body weight changes in relevant subgroup analyses. This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA1C from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA1C, body weight, and body mass index. Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA1C and body weight from baseline to week38 were - 1.0%-point (95%CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA1C reduction and body weight loss. Interaction was also observed between higher baseline HbA1C and more pronounced decrease in HbA1C. No significant interactions were detected between clinical outcomes and age or physician setting. The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction. NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).

A Comprehensive Systematic Review of Depression and Anxiety in Adults with Pyoderma Gangrenosum

Background: Pyoderma gangrenosum (PG) is a rare, chronic inflammatory skin disease characterized by painful, necrotic ulcers that frequently lead to disfiguring scars and significantly impact patients’ quality of life. This interplay between PG and mental health issues like anxiety and depression underscores the need for holistic approaches to manage both the physical and psychological challenges faced by PG patients. Methods: This systematic review adhered to the PRISMA 2020 guidelines, focusing exclusively on full-text articles published in English between 2015 and 2024. Result: A total of over 600 publications were initially identified through the database search. Following a rigorous three-stage screening process, eight studies were selected for comprehensive analysis. These studies were critically examined to provide an in-depth evaluation of depression and anxiety among adults with pyoderma gangrenosum. Conclusion: Pyoderma gangrenosum, a chronic autoimmune disorder, significantly impacts patients' mental health due to painful ulcers, visible lesions, and social isolation. Untreated depression can exacerbate pain perceptions and reduce treatment satisfaction. Healthcare providers must screen for and address mental health conditions in PG patients, utilizing psychological support and counseling to address both physical and mental health issues.

Assessment of patient knowledge and perceptions towards orthodontic treatment in the Aljouf Region, Saudi Arabia: a cross-sectional study

Background In orthodontic treatment, it is most important to assess the patient’s perspective of malocclusion because these perceptions are fundamental to determining the patient’s demands and level of treatment satisfaction. This study was done to assess the knowledge and perception of residents of the Aljouf Region of Saudi Arabia seeking orthodontic treatment. Furthermore, we determined the factors associated with the patients’ knowledge and perception of orthodontic treatment. Methods This cross-sectional study was conducted using a pre-tested and validated questionnaire among patients seeking orthodontic treatment who were registered at King Abdulaziz Hospital, Sakaka, and primary health centers. We identified the associated factors using binomial logistic regression analysis. Finally, we applied Spearman’s correlation test to identify the correlation between knowledge and perception. Results A total of 282 individuals participated in the current study, of which 53.3% were female and 46.1% were male. About one-third (36.9%) of patients had a low level of knowledge, 35.5% had a medium level of knowledge, and 27.7% had a high level of knowledge regarding orthodontic treatment. A total of 20.6% had low perceptions, 42.9% had medium perceptions, and 36.5% had high perceptions of orthodontic care. A significant correlation was found between age and gender, knowledge (p = 0.001), and perception (p = 0.040). Moreover, we observed a positive correlation between knowledge and perception (Spearman’s rho = 0.297, p = 0.001). Conclusion People in Aljouf have poor knowledge and medium perception regarding orthodontic treatment. We recommend that the concerned authorities make a health educational plan for the patients seeking orthodontic treatment.

Abstract 4136334: Treatment Satisfaction With an “Inclisiran First” Implementation Strategy Versus Usual Care in Patients With Atherosclerotic Cardiovascular Disease

Background: Despite the availability of effective lipid-lowering therapies (LLTs), most patients (pts) with ASCVD do not meet guideline-recommended LDL-C goals. In VICTORION-INITIATE (NCT04929249), an “inclisiran first” (IF) strategy of adding inclisiran immediately on failure to achieve LDL-C &lt;70 mg/dL, despite maximally tolerated statin therapy, in pts with ASCVD led to significantly higher LDL-C goal attainment vs usual care (UC) at Day 330. Objective: To evaluate change from baseline to Day 330 in pt-reported treatment satisfaction with an IF implementation strategy vs UC in pts with ASCVD enrolled in VICTORION-INITIATE. Methods: VICTORION-INITIATE, a Phase 3b, open-label, prospective trial, was conducted at 45 representative clinical sites across 20 US states. Pts randomized 1:1 (stratified by insurance status) received inclisiran 284 mg (300 mg inclisiran sodium) at Days 0, 90, and 270 plus UC or UC alone (lipid management directed by treating physicians). We evaluated change from baseline to Day 330 in pt-reported satisfaction with IF vs UC using the validated 11-question Treatment Satisfaction Questionnaire for Medication (TSQM)-II comprising 4 domains (effectiveness, side effects, convenience, and global satisfaction) scored from 0–100. As a post-hoc analysis of a pre-specified exploratory endpoint, we analyzed the difference in least-squares (LS) mean change in TSQM-II domain scores for IF vs UC using ANCOVA with baseline scores as a covariate. Results: We randomized 450 patients: median age 67 years, 30.9% female, 25.8% with a history of statin intolerance. From baseline to Day 330, difference in LS mean change (95% confidence interval) in TSQM-II scores for IF (n=139) vs UC (n=105) was significant (p&lt;0.001) for effectiveness (10.4 [5.4, 15.5]), convenience (10.5 [5.8, 15.2]), and global satisfaction (12.1 [7.2, 16.9]). Statistical comparison was not applicable for the side effects domain at Day 330 due to the small sample size (IF: n=6, UC: n=7). On Day 330, mean scores for IF exceeded UC for each TSQM-II question (Figure). Conclusions: An IF implementation strategy resulted in significantly greater change from baseline to Day 330 across multiple domains of pt-reported treatment satisfaction vs UC.

Flash glucose monitoring system help reduce the frequency of hypoglycemia and hypoglycemic fear behavior in type 1 diabetes patients

ObjectiveHypoglycemia represents a serious acute complication in individuals with type 1 diabetes mellitus (T1DM). In order to more effectively identify and discriminate the occurrence of hypoglycemic events in patients with T1DM, this study aims to evaluate the impact of two distinct glucose monitoring systems—Flash Glucose Monitoring (FGM) and Continuous Glucose Monitoring (CGM)—on the management of blood glucose levels and the emotional responses associated with hypoglycemic episodes in individuals with T1DM.MethodIn this study, a total of 113 patients with type 1 diabetes mellitus were enrolled and allocated to two groups for the implementation of Glucose Monitoring Systems (GMS). The groups consisted of the FreeStyle Libre group (FGM, n=56) and the ipro2 group (CGM, n=57). Participants in both groups utilized GMS at least biannually and completed a set of three questionnaires: the Diabetes Monitoring and Treatment Satisfaction Questionnaire (DMTSQ), the Diabetes Specific Quality of Life (DQOL), and the Chinese Version of the Hypoglycemia Fear Survey II (CFHSII). Clinical data, CGM metrics, and questionnaire scores were collected at the initial visit and after a one-year follow-up period.ResultsThe glucose coefficient of variation (GCV) and the standard deviation of blood glucose (SDBG) were independently associated with Time Below Range (TBR). Specifically, GCV could predict TBR ≥12%, with a cut-off point of 40.55. This yielded a specificity of 88.10% and a sensitivity of 68.18% in the overall patient population. For the FreeStyle Libre group and the iPro2 group, the cut-off points were 38.69 and 40.55, respectively, with specificities of 0.74 and 0.92, and sensitivities of 0.73 and 0.86, respectively. In the FreeStyle Libre group, where the frequency of use was greater than or equal to five times per year, the hypoglycemic episodes (time/month) and CHFSII-B scores were significantly reduced at follow-up compared to baseline (7.80 ± 10.25 vs 13.95 ± 14.87; 27.37 ± 11.05 vs 38.90 ± 21.61, respectively, all P &amp;lt;0.05).ConclusionThe utilization of multiple Flash Glucose Monitoring (FGM) implementations proved to be valuable in discriminating the occurrence of hypoglycemia and mitigating the fear of hypoglycemic episodes in patients with type 1 diabetes. Within the parameters of Glucose Monitoring Systems (GMS), the glucose glycemic variability (GCV) was identified as a predictive factor for the risk of severe hypoglycemia (TBR &amp;gt; 12%). The optimal cut-off point for GCV was determined to be 40.55.

De-intensification of basal-bolus therapy by replacing prandial insulin with once-weekly subcutaneous semaglutide in individuals with well-controlled type 2 diabetes: A single-centre, open-label randomised trial (TRANSITION-T2D).

The study aims to examine the outcome of replacement of prandial insulin with once-weekly subcutaneous semaglutide in people with type 2 diabetes reasonably controlled on multiple daily insulin injections (MDI). This single-centre, randomised, open-label trial enrolled a statistically predetermined sample of 60 adults with HbA1c ≤7.5% (58 mmol/mol) receiving MDI, with a total daily dose (TDD) ≤120 units/day. Participants were assigned 2:1 to subcutaneous semaglutide 1.0 mg plus insulin degludec, or to continue MDI. The primary outcome was percentage of subjects maintaining HbA1c ≤7.5% (58 mmol/mol) at Week 26. At Week 26, 90% of semaglutide and 75% of MDI subjects maintained HbA1c ≤7.5% (≤58 mmol/mol) (p = 0.18). Mean changes (95% CI) in HbA1c, weight and percentage body weight for semaglutide versus MDI, respectively, were -0.5% (-0.7, -0.3) versus 0.0% (-0.3, 0.3; p = 0.009); -8.9 kg (-9.9, -7.8) versus 1.5 kg (-0.1, 3.1; p < 0.001); and -8.6% (-9.6, -7.6) versus 1.4% (0.0, 2.8; p < 0.001). Insulin TDD decreased 56.0% (-62.3, -49.7) with semaglutide and increased 6.7% (-2.5, 16.0) with MDI (p < 0.001). Among semaglutide subjects, 58% reduced insulin TDD > 50%, 97.5% stopped prandial insulin and 45% lost >10% body weight. Participant treatment satisfaction scores trended higher with semaglutide. Hypoglycaemia frequency was similar between groups. In people with type 2 diabetes well controlled (HbA1c ≤7.5% [≤58 mmol/mol]) on MDI ≤120 units/day, replacing multiple daily injections of prandial insulin with once-weekly subcutaneous semaglutide can maintain and even improve HbA1c, lower body weight and lessen the burden of management.

Real-world data in lupus nephritis: results from a European survey on renal function testing and burden of disease progression

Objective Patients with lupus nephritis (LN), a severe renal manifestation of systemic lupus erythematosus, should be monitored for progression of chronic kidney disease to end-stage renal disease but data on renal function testing in LN patients are limited. This real-world analysis aimed to evaluate nephrologists’ use of renal function tests to support LN diagnosis and monitoring and to examine the impact of disease progression in LN patients in Europe. Methods Data were drawn from the Adelphi Lupus Disease Specific Programme, a cross-sectional survey of nephrologists and their next five consulting patients with LN in France, Germany, Italy, Spain, and the United Kingdom in 2021. Nephrologists provided demographic and clinical information for each patient and the same patients completed a self-reported questionnaire. Using a checkbox, patients provided informed consent to take part in the survey. Results Nephrologists (n = 72) provided data on 376 patients with LN. Estimated glomerular filtration rate (eGFR) or proteinuria testing was not undertaken in around 10% and 50% of these patients, respectively. Regression analysis predicted reduction in renal function (disease progression) following LN diagnosis whilst bivariate analyses showed significantly worse outcomes for patients with progressed disease: worse pain, fatigue, treatment satisfaction, and patient-reported health state and activity impairment. Conclusion Our study revealed lower-than-expected nephrologist-reported use of renal function testing to support diagnosis/monitoring of patients with LN in real-world clinical settings in Europe. Lower quality of life (QoL) was observed in patients with more progressed disease. Increased use of renal function testing is needed so that all LN patients are monitored closely to manage disease progression and avoid the associated QoL impact.

Safety of a Novel Continuous Glucose Monitoring–Informed Insulin Bolus Calculator Mobile Application for People With Type 1 or Type 2 Diabetes

BACKGROUND Managing bolus insulin dosing can be a significant burden for people with diabetes, many of whom have limited numeracy skills. Insulin bolus calculators (IBCs) may improve glycemia as well as treatment satisfaction. OBJECTIVE The purpose of this study was to demonstrate the safety of a novel, continuous glucose monitoring (CGM)-informed IBC mobile device app that applies trend arrow adjustments to bolus insulin dose recommendations. RESEARCH DESIGN AND METHODS This clinical trial was an open-label, industry-sponsored single-arm study conducted at two sites. Fifty-four participants with type 1 or type 2 diabetes were enrolled and used the IBC app on their mobile device for 30 days. Study participants were adults who were already using CGM and dosing bolus insulin. The analysis examined both noninferiority and superiority of time in range (TIR) during the study period compared with baseline. Other important end points included hypoglycemia, glucose variability, nocturnal and diurnal TIR, and diabetes distress. The per-protocol (PP) group was defined as participants who used the IBC &amp;gt;30 times during the study. RESULTS Mean TIR improved by 3.8% (95% CI 0.7–6.9%) from 69.2 to 73.0% (P = 0.017) in the PP group. This TIR corresponds to a mean of 0.9 more hours per day spent in range, and the improvement was driven by those with type 2 diabetes. There was no increase in measures of hypoglycemia or diabetes distress. Exploratory analysis revealed a reduction in measures of glucose variability. In addition, individuals with type 1 diabetes had greater improvements in diurnal TIR than in nocturnal TIR. CONCLUSION A CGM-informed IBC app that applies trend arrow adjustments to bolus insulin dose recommendations improved TIR without increasing hypoglycemia or diabetes distress in individuals with type 1 or type 2 diabetes.

TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.

Treatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies. TEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs). Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain. These outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS. ClinicalTrials.gov identifier, NCT04221191.

The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial

BackgroundDiabetes affects 10.5% of adults globally, with type 2 diabetes accounting for 90–95% of cases. Achieving optimal glycemic control is crucial yet challenging, particularly with insulin therapy, where 30–50% of patients fail to meet treatment targets. Telemedicine can improve diabetes management but generates vast amounts of data, burdening healthcare professionals. Integrating clinical decision support tools into telemonitoring systems may enhance care efficiency and glycemic control.MethodsThe trial is a multicenter 3-month, three-arm, open-label, randomized controlled trial. The trial aims to enroll 51 participants with type 2 diabetes on insulin therapy. Participants will be divided with a 3:1:1 ratio into telemonitoring with decision support, telemonitoring without decision support, and usual care groups. The study employs connected insulin pens, continuous glucose monitors (CGMs), and activity trackers to enable telemonitoring. Outcomes measured include CGM time in range, HbA1c, hypo- and hyperglycemia incidents, total daily insulin dose, body weight, treatment satisfaction, and adherence.DiscussionTelemonitoring with decision support has the potential to revolutionize diabetes management by offering personalized treatment suggestions, thereby reducing the burden on healthcare professionals, and improving patient outcomes. This study will provide valuable insights into the effectiveness of such an approach in achieving glycemic control in people with type 2 diabetes on insulin therapy. By evaluating both clinical outcomes and patient and healthcare professionals’ satisfaction, the study aims to contribute to the development of efficient, scalable telehealth solutions for diabetes care.Trial registrationClinicalTrials.gov NCT06185296. Registered on December 14, 2023.

Effects of switching from MiniMed™ 640G to 770G on continuous glucose monitoring metrics and DTR-QOL scores: An observational study of Japanese people with type 1 diabetes mellitus.

We evaluated the effect of the MiniMed™ 770G, an insulin pump using hybrid closed-loop technology, on blood glucose management and quality of life in Japanese people with type 1 diabetes. This was a 52-week, prospective, observational study. Fifty Japanese people with type 1 diabetes switched from the MiniMed™ 640G to 770G, and we analyzed the continuous glucose monitoring data of 24 subjects who used auto mode throughout the study. We also analyzed the scores of the Diabetes Therapy-Related Quality of Life questionnaire completed by 26 auto-mode users before and after the treatment change. The baseline time in range 70-180 mg/dL was 67.3 (54.8-78.4)%, with a significant improvement beginning 8 weeks after the switch and lasting until 52 weeks. The baseline time below range <70 mg/dL was 1.9 (0.6-3.6)%, with a significant increase at week 8; however, the mean value was less than 4% throughout the study period. On the other hand, the number of blood glucose measurements significantly increased. While there was no significant difference in the overall change in the total Diabetes Therapy-Related Quality of Life score, there was a significant decrease in the treatment satisfaction score. Use of the MiniMed™ 770G improved continuous glucose monitoring metrics. However, treatment satisfaction decreased, probably due to the increased frequency of blood glucose monitoring necessary to maintain auto mode.

Enhanced walking function and quality of life in unicondylar knee replacement patients through continuous nursing intervention: A clinical study.

The knee joint anatomical structure is susceptible to external forces, which can lead to functional break down, profoundly affecting the quality of life and daily functioning of individuals. To investigate the effects of continuous nursing intervention on walking function, quality of life, and treatment satisfaction in patients undergoing unicondylar knee replacement. This prospective study included 90patients who underwent unicondylar knee arthroplasty due to unicondylar osteoarthritis. Participants were divided into two groups based on their nursing methods: the control group (n= 45) and the observation group (n= 45). Three months post-intervention, the observation group demonstrated significant improvements in knee joint range of motion, Hospital for Special Surgery Knee Score score, and Lysholm knee joint score compared to the control group (P< 0.05). The observation group also had a shorter completion time for the Timed Up and Go test and significantly higher SF-36 scores (P< 0.05 for both). Additionally, Knee Injury and Osteoarthritis Outcome Score scores in the observation group were significantly higher after three months of intervention (P< 0.05). And the observation group reported higher satisfaction rates and lower dissatisfaction rates compared to the control group (P< 0.05). Early postoperative rehabilitation guidance, regular reviews, and rehabilitation exercise guidance result in better rehabilitation outcomes, enhanced knee joint function, improved walking ability, and overall quality of life for patients undergoing unicondylar knee replacement.

Functional Outcome and Patient Satisfaction After Primary vs Secondary Arthrodesis for Lisfranc Injuries: Toward a Single-Surgery Approach.

The choice between primary arthrodesis (PA) and open reduction and internal fixation (ORIF) for acute Lisfranc injuries remains contentious. Apart from primary treatment, arthrodesis is often used for treating chronic Lisfranc injuries, including patients in whom initial ORIF or nonoperative treatment failed. The aim of this study was to compare PA and secondary arthrodesis (SA) in terms of complications and functional outcome. A retrospective cohort study was conducted on trauma patients with Lisfranc injuries treated at a level 1 trauma center between July 1, 2010, and July 1, 2020. Selected patients were evaluated at the outpatient clinic and received a survey. Demographics, injury characteristics, management, complications, and patient-reported outcomes (American Orthopaedic Foot & Ankle Society midfoot score, Foot Function Index) were analyzed. Twenty-nine of 37 potential patients (78.4%; PA n = 11, SA n = 18) completed the survey with a median follow-up of 7.1 (PA) to 9.3 (SA) years (P = .01). The majority were female (n = 18, 62.1%); the mean age of PA patients was 57.1 years (SD 14.2) compared with 43.5 years (SD 17.1) in SA patients (P = .04). In the PA group, there was no infection, 100% union, and implants were removed in 5 of 11 patients. In the SA group, 11.1% (n = 2) developed infection, malunion rate was 11.1%, implants were removed in 33.3% (n = 6), and 22.2% required revision surgery. AOFAS was "good" in PA (77.7, SD 17.3) compared with rated "fair" in SA (67.1, SD 21.3, P = .19). FFI was better in PA (26.0, SD 26.2) than SA (37.6, SD 30.8, P = .32), which exceeded the minimally important clinical difference. Although this study was limited by sample size, the overall results suggest equivalent functional outcome, pain and treatment satisfaction in primary arthrodesis compared with secondary arthrodesis patients for treatment of Lisfranc injury.

Treatment satisfaction and effectiveness of Lurasidone on quality of life and functioning in adult patients with schizophrenia in the real-world Italian clinical practice: a prospective 3-month observational study.

Although second-generation antipsychotics (SGAs) have proven to be effective therapeutic options for patients with schizophrenia, there is a notable lack of evidence on patients' subjective perspectives regarding their well-being, quality of life, and satisfaction with these medications. This study aimed to evaluate the treatment satisfaction and effectiveness of lurasidone on quality of life and functioning in adult patients with schizophrenia in real-world Italian clinical practice. This was a multicentre, national, non-interventional, single-arm, 3-month prospective study. Patients who were naive to lurasidone treatment and whose treating physician had decided to start them on this medication were enrolled and evaluated over a 3-month period. Eligible patients were adults (≥ 18 years of age) with a primary diagnosis of schizophrenia who were being treated with lurasidone (for the first time [i.e., they were lurasidone naive]) as part of routine clinical practice. Efficacy endpoints were changes in patient/caregiver treatment satisfaction (seven-point Likert scale from the Treatment Satisfaction Questionnaire for Medication), patient quality of life and functioning (QLS), investigator-rated global assessment of functioning (CGI-S, IAQ) after 6 weeks and 3 months of lurasidone, and number of relapses and hospitalizations. Sixty-one patients were enrolled and 59 completed the study. The median dosage of lurasidone at baseline was 37.00mg/day. The median duration of titration was 86.0 days (Min 28; Max 115 days); the median number of dosage changes was 1.0. At the end of 3-month observation period, the median dose of lurasidone was 74.00mg/day. QoL and Functioning Score showed a trend of improvement over time, reaching a mean change from baseline of 9.8 at the end of the study. According to the CGI-S, the percentage of patients who were "markedly or severely ill" showed a continuous decrease from baseline to 3 months, from 62.29% to 8.20%. Patient satisfaction increased over time, with 80.32% of patients reporting that they were somewhat, fairly, or very satisfied (including 63.93% who were completely or very satisfied) at the end of the study. No relapses/hospitalizations for psychiatric reasons were reported. Lurasidone was well tolerated with no safety concerns or discontinuations due to AEs. Lurasidone represents a valid option for the treatment of schizophrenia and positively affects subjective well-being, quality of life and satisfaction. NCT06527885 retrospectively registered (01/08/2024).