Additional Visits Research Articles

Provider Burden Associated With Apremilast Adverse Events

Introduction: In December 2021, the US Food and Drug Administration (FDA) expanded its initial approval for apremilast to include moderate and severe cases of psoriasis. However, real-world epidemiology data regarding the use of apremilast, the influence of adverse events (AEs), and the burden of AEs on managing physicians, has been lacking. This retrospective, observational, multisite study aimed to describe real-world patient characteristics, AEs (including diarrhea, nausea, and headache), and healthcare provider-level burden associated with the psoriasis treatment apremilast in the US. Methods: Dermatologists abstracted medical record data for adults treated with apremilast on or after January 1, 2018, who had ≥3 months of data available. Dermatologist and patient characteristics, including demographics and clinical characteristics, AEs, and provider burden in managing AEs were summarized using descriptive statistics. Results: Forty-seven dermatologists nationwide responded to a survey and conducted a chart review of 308 patients. Dermatologists practiced in various US geographic regions. The most common practice setting was in a private community with 2 to 5 physicians (34.0%). Most patients were White (74.4%), non-Hispanic (86.0%), and male (55.2%). The mean age at diagnosis was 43.6 years (SD, 16.8 years). AEs occurred in 29.2% of patients, with the most common being diarrhea (16.2%), followed by nausea (13.6%) and headache (4.9%). Diarrhea mostly occurred ≤30 days into treatment (87.2%) and resulted in 1 additional office visit (39.5%) and 3 phone calls per patient to their providers (34.9%). Nausea mostly occurred within 30 days (70.2%) and resulted in 1 additional visit (29.7%) and 1 phone call per patient (35.1%). The burdens of managing both diarrhea and nausea were similar, although diarrhea resulted in more phone calls to the healthcare provider. Conclusion: Diarrhea and nausea were common and resulted in an additional time and resource burden on dermatologists and their staff. Future research on the AE burden on providers and patients related to apremilast is needed.

QLTI-16. QUALITY IMPROVEMENT PROJECT (QIPR) FOR IMPLEMENTATION OF PSYCHOSOCIAL ASSESSMENTS FOR ONCOLOGY CLINICAL CARE

Abstract BACKGROUND Patient-reported outcomes (PROs) have been used to assess individuals’ quality of life (QoL) throughout cancer treatment. Individuals with cancer often experience physical, psychological, and social challenges. It is crucial to evaluate their QoL to provide supportive care services to improve survival and treatment outcomes in real-world cancer clinical settings. Patients’ ability to engage with completing PROs is critical to ensuring PRO implementation efficacy. This QIPR (UF: 2216) examined these completion rates in coordinated medical-behavioral cancer care. METHODS Questionnaires delivered to neuro-oncology and psycho-oncology patients through the electronic health record (EHR) prior to scheduled office visits were: PROMIS – Anxiety, Depression, Pain Interference, Ability to Participate in Social Roles, and Cognitive and Physical Function. Data collection occurred from July 2023-January 2024. Descriptive statistics were calculated to assess battery completion rates. Information from the first 3 encounters following initiation of the battery into clinical practice were analyzed. RESULTS Of 906 scheduled encounters, 491 (54.2%) were attended by 280 unique patients. The battery was completed at least once by 106 (37.9%) patients. 72.6% (N=77) of these patients completed the battery at the first scheduled visit at which it was assigned. Of patients with 2 scheduled visits (N=25, 23.6%); 24.0% (N=6) completed the battery at both visits. Of patients that had 3 scheduled visits (N=12, 11.3%); 16.7% (N=2) completed it at all 3 visits. CONCLUSION Only approximately 38% of patients completed the battery at least once across 3 consecutive visits. The highest battery completion rate was at the first visit at which it was assigned. Completion rates were lower across additional visits. Future work will seek to understand barriers and facilitators of these completion rates to optimize implementation of PROs in coordinated medical-behavioral oncology care.

Older Adults Benefit From Virtual Support for Continuous Glucose Monitor Use But Require Longer Visits.

Older adults may be less comfortable with continuous glucose monitoring (CGM) technology or require additional education to support use. The Virtual Diabetes Specialty Clinic study provided the opportunity to understand glycemic outcomes and support needed for older versus younger adults living with diabetes and using CGM. Prospective, virtual study of adults with type 1 diabetes (T1D, N = 160) or type 2 diabetes (T2D, N = 74) using basal-bolus insulin injections or insulin pump therapy. Remote CGM diabetes education (3 scheduled visits over 1 month) was provided by Certified Diabetes Care and Education Specialists with additional visits as needed. CGM-measured glycemic metrics, HbA1c and visit duration were evaluated by age (<40, 40-64 and ≥65 years). Median CGM use was ≥95% in all age groups. From baseline to 6 months, time 70 to 180 mg/dL improved from 45% ± 22 to 57% ± 16%; 50 ± 25 to 65 ± 18%; and 60 ± 28 to 69% ± 18% in the <40, 40-64, and ≥65-year groups, respectively (<40 vs 40-64 years P = 0.006). Corresponding values for HbA1c were 8.0% ± 1.6 to 7.3% ± 1.0%; 7.9 ± 1.6 to 7.0 ± 1.0%; and 7.4 ± 1.4 to 7.1% ± 0.9% (all P > 0.05). Visit duration was 41 min longer for ages ≥65 versus <40 years (P = 0.001). Adults with diabetes experience glycemic benefit after remote CGM use training, but training time for those >65 years is longer compared with younger adults. Addressing individual training-related needs, including needs that may vary by age, should be considered.

Real world economic evaluation of CT-FFR in patients with suspected coronary artery disease

Abstract Background Incorporation of CT-derived fractional flow reserve (CT-FFR) enhances the precision of Coronary CT Angiography (CCTA) to detect hemodynamically significant coronary artery disease (CAD). However, the financial consequences remain unclear. Purpose Our objective is to assess the economic implications of CT-FFR in the Dutch Healthcare system. Methods This retrospective, single-center cost effectiveness analysis includes patient data of a previously published study assessing the impact of routine CT-FFR availability on clinical management. We collected medical resource use for both diagnostic and therapeutic cardiovascular care with a follow-up duration of 1 year. Costs of CT-FFR analysis were set at €1000, its current price for Dutch hospitals. Median total costs at were compared using the Wilcoxon rank sum test, including a sensitivity analysis in which cost estimations (without registered maximum tariffs) were increased or decreased with 10%. Results A total of 360 patients, classified as having low to intermediate risk of CAD, were enrolled in the study – 224 in the CCTA group and 136 in the CT-FFR group. In addition to undergoing more (invasive) diagnostic testing and revascularization procedures over the studied period, patients in the CCTA-group had more outpatient clinic consultations (p&amp;lt;0.001), presented more frequently to the emergency department (p=0.035) and spend more nights in the hospital (p=0.11). Median costs were €3.347 (IQR €1.066 – €4.862) in the CCTA-group and €1.436 (IQR €1.362 - €3.943) in the CT-FFR group (p=0.091). Increasing cost estimation with 10% revealed a median of €3.431 in the CCTA-group versus €1.479 in the CT-FFR group (p=0.078), decreasing with 10% showed median costs of €3.263 in the CCTA-group and €1.392 in the CT-FFR group (p=0.118). In our sample, CT-FFR guided care would have been significantly cheaper than CCTA-guided care at or below a market price of €770. Conclusion Despite the significant reduction in additional diagnostic testing and hospital visits in the CT-FFR group, CT-FFR guided care was not cheaper than CCTA-guided care at its current market price of €1.000. Economic cost-effectiveness would have occurred from a price of €770 per analysis. The large difference between medians suggests that the lack of significance might partially be attributed to insufficient power in this relatively small sample size. Additionally, this study did not account for costs associated with loss of productivity and quality of life. However, less additional diagnostic testing, less revascularization procedures and less hospital consultations and admissions leads to reduction in hospital resource consumption and patient burden, which is an important advantage of CT-FFR as the number of referred patients increases yearly.

SGLT2 inhibitor empagliflozin prevents anthracycline-induced cardiotoxicity in a large-animal model

Abstract Background While the development of cancer therapies has significantly improved the survival of cancer patients, more than 35% of cancer survivors treated with anthracyclines will develop cardiotoxicity. There is currently a lack of preventative therapies against anthracycline-induced cardiotoxicity (AIC). AIC is characterised by a disruption in myocardial metabolism. Sodium-glucose co-transporter (SLGT2) inhibitors represent a potential therapy as they have been shown to modulate myocardial substrate utilisation in other heart-failure contexts. Purpose We developed a highly translational large-animal model to test the ability of SGLT2 inhibitor empagliflozin to prevent AIC at different doses. Methods Female Large-White pigs were randomised (2:1:1) to no treatment (AIC-control group) or empagliflozin at a daily oral dose of 10 mg or 20 mg, beginning at the start of the doxorubicin regimen and continuing to 21 weeks. All pigs received 6 doses of doxorubicin intravenous infusion (25 mg/m2/every 3 weeks) with 2 additional off-dose visits. Pigs were assessed by cardiac magnetic resonance (CMR) and MR spectroscopy (MRS) at baseline and every 3 weeks for 21 weeks. At the end of 21-week follow-up, the LV was collected and processed for analysis by transmission electron microscopy (TEM) and mitochondrial respirometry. Results The primary outcome, final LVEF, was significantly higher in pigs receiving 20 mg empagliflozin than in the AIC-control group (57.5% (IQR=55.5, 60.3) vs 47.0% (40.8, 47.8); p=0.027). Final LVEF in pigs receiving 10 mg empagliflozin was 51% (46.5, 55.5) (p=0.020 vs 20 mg empagliflozin). The 20 mg empagliflozin dose prevented the doxorubicin-induced change in cardiac metabolic substrate utilisation and was associated with preservation of myocardial energetics (ATP/PCr ratio on MRS). TEM revealed disrupted mitochondrial structure and cristae density in AIC-control pigs, while mitochondria respirometry detected deteriorated respiratory function. Both mitochondrial structure and function were preserved in empagliflozin-treated pigs, with the 20 mg dose having the strongest cardioprotective effect. Conclusion The results from our translational large-animal model provide strong evidence that SGLT2 inhibition with empagliflozin prevents AIC by preserving LV systolic function and energetics as well as mitochondrial structural integrity and function. Our results establish the basis for clinical trial testing SGLT2i therapy in patients at high risk of AIC.

Nonfatal Firearm Injury & Subsequent Emergency Department Utilization Among Non-Elderly Adults

IntroductionThe mortality, long-term morbidity, and exacerbated healthcare needs due to firearm injury in the US are significant and growing. However, the relationship between exposure to a nonfatal firearm injury and long-term ED utilization is poorly understood. This study estimates the association between exposure to a nonfatal firearm injury and ED utilization in the subsequent year. MethodsUsing all-payer ED data among non-elderly adults in Georgia and New York, all ED visits for nonfatal firearm injuries from 2017-2018 were identified. Sociodemographic, clinical, and contextual characteristics between nonfatal firearm injury ED patients and the broader population of ED users were compared. ED utilization in the year following a nonfatal firearm injury relative to ED use in the year before, and compared to ED use by a propensity score matched control group was examined, using Poisson and negative binomial multivariable regressions. Analyses were performed in 2024. ResultsNonfatal firearm injury ED patients were disproportionately male, younger, non-Hispanic Black, uninsured, and residents of areas with low median income and high firearm ownership. Compared to a matched control group, multivariable analyses indicated that nonfatal firearm injury ED patients had significantly higher risks of having hospital admissions through the ED (aRR: 1.42), all-cause injury-related ED visits (aRR: 1.47), non-firearm injury-related ED visits (aRR: 1.26), and additional nonfatal firearm injury-related ED visits (aRR: 325.45) in the subsequent year (p<0.001 for all). About one in every eight ED users with a firearm-related injury at index also sought ED care for another nonfatal firearm injury within one year. ConclusionsNonfatal firearm-related injuries contribute to preventable harm, health inequity and increased ED utilization.

Association of the COVID-19 Pandemic With Outcomes After Anterior Cruciate Ligament Reconstruction: A Retrospective Comparative Study Examining Changes in Health Care Access, Delivery, and Functional Outcomes.

Structured rehabilitation optimizes outcomes and reduces reinjury risk after anterior cruciate ligament reconstruction (ACLR). The coronavirus 2019 (COVID-19) pandemic interrupted standard rehabilitation, possibly affecting ACLR outcomes. To characterize changes to ACLR functional outcomes related to the COVID-19 pandemic. Cohort study; Level of evidence, 3. Patients who underwent ACLR between June 11, 2019, and March 11, 2020, (postpandemic group) were compared retrospectively with those who underwent ACLR the year before (June 11, 2018, to March 11, 2019). A mixed-effects linear regression model was used to estimate group differences in isokinetic quadriceps testing. A Kaplan-Meier analysis assessed the probability of achieving >90% limb symmetry index (LSI) for isokinetic quadriceps strength at 60 deg/s and passing all return-to-sport functional outcomes at 1 year postoperatively. A total of 176 patients (80 in the control group and 96 in the postpandemic group) were included. The rate of achieving >90% LSI in isokinetic strength at 60 deg/s at 1 year postoperatively was 39% (95% CI, 27%-49%) for the control group versus 22% (95% CI, 13%-30%) for the postpandemic group (P = .01). Similarly, the rate of achieving >90% LSI in all functional tests at 1 year postoperatively was 15% (95% CI, 7%-22%) for the control group versus 7% (95% CI, 2%-12%) for the postpandemic group (P = .04). The number of in-person physical therapy visits per patient was 25.8 ± 6.8 in the control group versus 24.4 ± 7.5 in the postpandemic group (P = .23). Only the postpandemic group accessed physical therapy using remote telemedicine. Each additional telehealth rehabilitation visit was associated with a 1-week delay in achieving >90% LSI in isokinetic quadriceps strength for the postpandemic group. The COVID-19 pandemic was associated with a decrease in lower extremity strength and a lower probability of achieving limb symmetry and passing the criteria for return to sport at 1 year postoperatively. These results were not due to lack of access to physical therapy.

The Role of Primary Care Providers in Lung Cancer Screening: A Cross-Sectional Survey

BackgroundMultidisciplinary lung cancer screening (LCS) programs that perform shared decision-making visits (SDMV) and follow up annual low dose computed tomography (LDCT) have been emerging. We hypothesize that primary care providers (PCPs) prefer to refer patients to LCS programs instead of facilitating the screening process themselves. MethodsThis is a mixed-methods, cross-sectional study in which an online survey was administered to PCPs between April 2023 and June 2023. Results58 PCPs in the same hospital network participated in the study with a median age of 43 (34-51), predominance of women (77.6%), and clinicians of white and Asian race (44.8% and 48.3%). Respondents estimated that 26.1% (SD 32.4%) of their eligible patients participate in LCS screening. PCPs thought that an LCS program was equally convenient to performing screening themselves for identifying eligible patients and ordering LDCT. However, 63.8% of participants preferred an LCS program for performing SDMVs, 62.1% for ensuring annual follow-up on negative LDCTs, 70.7% for deciding next steps on positive LDCTs, and 60.4% for performing smoking cessation counseling. PCPs agreed that an LCS program saves time (69%), allows patients to receive specialty care (65.6%), addresses patient concerns (70.7%), ensures annual follow-up (77.6%), and manages abnormal findings (79.3%). However, they also expressed concerns about an additional visit for the patient (48.2%) and patient cost (46.5%). ConclusionMost PCPs believe that formal LCS programs have many benefits including providing specialized care and follow up, although there were concerns about patient time and cost.

Do Racial Disparities Impact Healthcare Costs and Resource Utilization after Total Joint Replacements?

Background Racial disparities currently exist in healthcare and can have a significant impact on patient outcomes and access to quality care. Previous studies have indicated that black patients are more likely to experience delays in treatment and increased surgical complications. Hispanic patients have more comorbidities and increased complications when undergoing orthopaedic surgeries. The purpose of this study was to evaluate the impact of racial disparities on postoperative complications and readmission rates following Total Joint Arthroplasty (TJA). Methods The largest single healthcare network database was queried to identify total joint arthroplasty patients treated in a single division between 2017 and 2021. Patient demographics including age, race, gender, and comorbidities were collected. Logistic regression and odds ratio point estimate analyses were utilized to assess for associations between race (defined as Whites, Blacks, Hispanics, Asians, and Others) and postoperative medical complications and surgical complications, which were collected for all patients. Patient outcomes included length of stay, hospital readmission status at 30 and 90 days postoperative, and emergency room (ER) visits up to 90 days. Results A total of 16,940 patients were included in this analysis consisting of 62% female, a mean age of 71 years and mean BMI of 29.4 kg/m2 . Racial demographics consisted of 61.6% White, 12.3% Black, 24.1% Hispanic, 0.8% Asian, and 1.2% Other. Race was not significantly associated with increased readmissions at 30 days (p=0.2215) and hispanic patients were 14% less likely to be readmitted within 90 days (p = 0.0208) but were not found to have differences in ER visits when compared to White patients. Black and Asian patients were not significantly more likely to visit the ER within 90 days or to be readmitted to the hospital within 90 days when compared to White patients. Race was not significantly associated with postoperative medical complications or surgical complications. Conclusions This study found a higher readmission rate of up to 20% for total joint arthroplasty patients within 90 days of follow-up. Although race did not appear to be a significant determinant of additional ER visits or readmissions, there was some variation seen amongst Hispanic patients undergoing TJR with a lower likelihood of readmission at 60 and 90 days postoperative.

General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit: a proof-of-concept study (the T1Early study)

ObjectiveType 1 diabetes (T1D) screening programmes testing islet autoantibodies (IAbs) in childhood can reduce life-threatening diabetic ketoacidosis. General population screening is required to detect the majority of children with T1D,...

A 2-year follow-up to a randomized controlled trial on resistance training in postmenopausal women: vasomotor symptoms, quality of life and cardiovascular risk markers

BackgroundMost women experience vasomotor symptoms (VMS) during the menopausal transition. A 15-week resistance training intervention (RTI) significantly reduced moderate-to-severe VMS (MS-VMS) and improved health-related quality of life (HRQoL) and cardiovascular risk markers in postmenopausal women. Whether a short RTI could have long-term effects is unknown. We aimed to investigate whether there were intervention-dependent effects two years after a 15-week RTI on MS-VMS frequency, HRQoL, and cardiovascular risk markers in postmenopausal women.MethodsThis observational prospective cohort study is a follow-up to a randomized controlled trial (RCT) on a 15-week RTI in postmenopausal women (n = 57). The control group had unchanged low physical activity during these first 15 weeks. At the follow-up contact two years post-intervention, 35 women agreed to participate in an additional physical visit at the clinic with clinical testing, blood sampling, and magnetic resonance imaging, identical to the protocol at the baseline visit at the start of the RCT.ResultsAlthough all women showed reduced MS-VMS and increased moderate-to-vigorous physical activity (MVPA) over the 2-year follow-up compared to baseline, the groups from the original RCT (intervention group; IG, control group; CG) changed differently over time (p < 0.001 and p = 0.006, respectively) regarding MS-VMS. The IG maintained a significantly lower MS-VMS frequency than the CG at the 6-month follow-up. At the 2-year follow-up, there was no significant difference between the original RCT groups. No significant changes over time or differences between groups were found in HRQoL or cardiovascular risk markers. However, significant interactions between original RCT groups and time were found for visceral adipose tissue (p = 0.041), ferritin (p = 0.045), and testosterone (p = 0.010).ConclusionsA 15-week resistance training intervention reduced MS-VMS frequency up to six months post-intervention compared to a CG, but the effect was not maintained after two years. The RTI did neither contribute to preserved improvements of cardiovascular risk markers nor improved HRQoL after two years compared to a CG.Trial registrationClinical trials.gov registered ID: NCT01987778, trial registration date 2013–11-19.

Colocation of COVID-19 Vaccination Services at Syringe Service Programs for People Who Inject Drugs and People Experiencing Houselessness in Oregon.

Integrating vaccination services with other essential health services could increase vaccination rates among socially marginalized populations. We examined the associations between colocation of vaccines at syringe service programs and COVID-19 vaccination status among people who inject drugs and people experiencing houselessness. This study included 1891 participants aged ≥18 years at 9 sites in Oregon from July 2021 through March 2022. Participants self-reported whether they had ever received ≥1 dose of a COVID-19 vaccine. We calculated site-level COVID-19 vaccine availability and overall vaccination rates. We compared site-level vaccination rates and analyzed the association between vaccine availability and vaccination status. We found no significant difference in vaccination rates between sites that did and did not offer COVID-19 vaccines (t7 = -0.33; P = .75). We also found no significant association between vaccine availability and vaccination status. However, the odds of having received a COVID-19 vaccine were 2.79 times higher for each additional site visit during which COVID-19 vaccines were available (odds ratio [OR] = 2.79; 95% CI, 2.18-3.58; P < .001). The association between vaccine availability and vaccine status was not moderated by participant age (OR = 1.03; 95% CI, 0.99-1.07; P = .13) or housing instability (OR = 0.59; 95% CI, 0.13-2.60; P = .48). Colocating COVID-19 vaccines at syringe service programs was only positively associated with vaccination status if vaccines were offered frequently on-site. Future work should examine whether the frequency of offering vaccination services increases willingness to engage in vaccination and examine trust and convenience as potential mechanisms.

The Brain Imaging for Global Health (BRIGHT) Project: Longitudinal cohort study protocol.

There is a scarcity of prospective longitudinal research targeted at early postnatal life which maps developmental pathways of early-stage processing and brain specialisation in the context of early adversity. Follow up from infancy into the one-five year age range is key, as it constitutes a critical gap between infant and early childhood studies. Availability of portable neuroimaging (functional near infrared spectroscopy (fNIRS) and electroencephalography (EEG)) has enabled access to rural settings increasing the diversity of our sampling and broadening developmental research to include previously underrepresented ethnic-racial and geographical groups in low- and middle- income countries (LMICs). The primary objective of the Brain Imaging for Global Health (BRIGHT) project was to establish brain function - using longitudinal data from mother - for-age reference curves infant dyads living in the UK and rural Gambia and investigate the association between context-associated moderators and developmental trajectories across the first two years of life in The Gambia. In total, 265 participating families were seen during pregnancy, at 7-14 days, 1-, 5-, 8-, 12-, 18- and 24-months post-partum. An additional visit is now underway at 3-5 years to assess pre-school outcomes. The majority of our Gambian cohort live in poverty, but while resource-poor in many factors they commonly experience a rich and beneficial family and caregiving context with multigenerational care and a close-knit supportive community. Understanding the impact of different factors at play in such an environment ( i.e., detrimental undernutrition versus beneficial multigenerational family support) will (i) improve the representativeness of models of general cognitive developmental pathways from birth, (ii) identify causal pathways of altered trajectories associated with early adversity at both individual and group level, and (iii) identify the context-associated moderators ( i.e. social context) that protect development despite the presence of poverty-associated challenges. This will in turn contribute to the development of targeted interventions.

Pediatric Pneumococcal Conjugate Vaccine and Dosing Schedule Perceptions Among Health Care Providers and Caregivers in Germany, France, Spain, and Greece.

Most European infant national immunization programs (NIPs) recommend pneumococcal conjugate vaccines (PCVs), which currently cover 10-15 serotypes administered in a three-dose schedule (two primary plus one booster). Recently, a PCV covering 20 serotypes that is administered in a four-dose schedule (three primary plus one booster) was licensed. An online survey was administered to collect data from health care providers (HCPs) and caregivers of children aged 0-5 (including expectant mothers) in four European countries (Germany, France, Spain, and Greece). All caregiver respondents had a shared or full responsibility to make health decisions for their child. Data on opinions, perceptions, and openness to a change in childhood vaccination dosing schedules were collected, along with demographic information for HCPs as well as caregivers. A total of 601 HCPs and 1954 caregivers were recruited across the four countries. Nearly all HCPs (93%) agreed that broader serotype coverage against pneumococcal disease for children is a significant unmet need, and 92% had a "sense of urgency" to vaccinate children. Both HCPs and caregivers were supportive of an additional PCV dose and doctor visit, assuming it provided at least 20% more serotype coverage than what is currently available. Caregivers strongly agreed on the importance of full vaccination for pneumococcal disease, even if an extra dose and visit to the doctor was required. HCPs and caregivers were virtually unanimous in their support for a PCV with broader serotype coverage and showed a subsequent willingness to include an extra infant dose/visit. These results can help guide broader discussions regarding public health policy and vaccine administration in the context of important efforts to reduce the global disease burden associated with pneumococcal disease.

Role of the peripheral chemoreceptors in cardiovascular and metabolic control in type 2 diabetes.

Preclinical work supports a role for the peripheral chemoreceptors in the progression of cardiovascular and metabolic pathologies. In the present study, we examined peripheral chemosensitivity in adults with type 2 diabetes (T2D) and the contribution of the peripheral chemoreceptors to resting cardiovascular and metabolic control. We hypothesized that: (1) adults with T2D exhibit exaggerated peripheral chemoreflex sensitivity; (2) the peripheral chemoreceptors contribute to cardiovascular dysfunction in T2D; and (3) attenuation of peripheral chemoreceptor activity improves glucose tolerance in T2D. Seventeen adults with diagnosed T2D [six males/11 females; aged 54±11years; glycated haemoglobin (HbA1c) 7.6±1.5%] and 20 controls without T2D (9 males/11 females; aged 49±13years, HbA1c 5.2±0.4%) participated in the study. The hypoxic ventilatory response (HVR) was assessed as an index of peripheral chemosensitivity. Resting heart rate, blood pressure and minute ventilation were measured when breathing normoxic followed by hyperoxic air (1.0 ) to acutely attenuate peripheral chemoreceptor activity. A subset of participants (n=9 per group) completed two additional visits [normoxia (0.21 ), hyperoxia (1.0 )] where glucose and insulin were measured for 2h following an oral glucose challenge. HVR was augmented in adults with T2D (-0.84±0.49Lmin-1/%) vs. control (-0.48±0.40Lmin-1/%, P=0.021). Attenuation of peripheral chemoreceptor activity decreased heart rate (P<0.001), mean blood pressure (P=0.009) and minute ventilation (P=0.002); any effect of hyperoxia did not differ between groups. There was no effect of hyperoxia on the glucose (control, P=0.864; T2D, P=0.982), nor insulin (control, P=0.763; T2D, P=0.189) response to the oral glucose challenge. Peripheral chemoreflex sensitivity is elevated in adults with T2D; however, acute attenuation of peripheral chemoreflex activity with hyperoxia does not restore cardiometabolic function. KEY POINTS: Preclinical work supports a role for the peripheral chemoreceptors in the progression of cardiovascular and metabolic pathologies. In the present study, we examined peripheral chemosensitivity in adults with type 2 diabetes and the contribution of the peripheral chemoreceptors to resting cardiovascular control and glucose tolerance. We observed elevated peripheral chemoreflex sensitivity in adults with diabetes which was associated with glycaemic control (i.e. glycated haemoglobin). Notably, acute attenuation of peripheral chemoreflex activity with hyperoxia did not restore cardiometabolic function in the individuals studied.

Faricimab in Neovascular AMD Complicated by Pigment Epithelium Detachment: An AI-Assisted Evaluation of Early Morphological Changes.

This study investigates the early temporal changes in pigment epithelial detachment (PED) morphology following treatment with faricimab in patients with neovascular age-related macular degeneration (nAMD). Utilizing an artificial intelligence (AI)-assisted approach, we provide a detailed quantification and characterization of the dynamics of these morphological changes. A prospective observational study was conducted on 22 eyes from 22 treatment-naïve patients with nAMD-associated PED (presenting either type 1 or type 3 macular neovascularization). Participants were administered intravitreal faricimab (6mg) at baseline and at days 30, 60, and 90. Comprehensive ophthalmic evaluations and spectral-domain optical coherence tomography (SD-OCT) imaging were conducted at baseline and at seven additional follow-up visits on days 1, 7, 14, 30, 60, 90, and 120. An AI-based automated segmentation algorithm was utilized to precisely quantify changes in PED volume, alongside intraretinal (IRF) and subretinal fluid (SRF) volumes, at each time point. Treatment with faricimab resulted in a significant reduction in mean PED volume, with an average decrease of 12% at day 1, 29% at day 7, 51% at day 14, 68% at day 30, 72% at day 60, 79% at day 90, and 84% at day 120 (p < 0.0001 for all time points). Similarly rapid and marked reductions were noted in both mean IRF (23.5% at day 1, 90.7% at day 14) and SRF (14.4% at day 1, 91.2% at day 14) volumes. The study also showed a statistically significant improvement in best-corrected visual acuity (BCVA) over the follow-up period, correlating with the reduction in PED volume. Faricimab demonstrates early and significant efficacy in improving PED architecture in patients with nAMD. The rapid morphological improvements observed in this study suggest faricimab may represent a valid therapeutic option for PEDs associated with nAMD.

Budget impact analysis of including biosimilar adalimumab on formulary: A United States payer perspective.

The biosimilar market is growing rapidly, as evidenced by 41 approvals and 37 launches to date. As adalimumab biosimilars launch in the United States, competition among biosimilar and reference adalimumab will likely increase across multiple reference indications, including rheumatology, dermatology, and gastrointestinal diseases, which may lead to decreased payer costs. To evaluate the costs of adding biosimilar adalimumab to a US commercial plan by exploring various utilization and price differential scenarios. A 3-year budget impact model for a US commercial plan of 1 million people was developed to assess switching from reference adalimumab or any self-injectable reference tumor necrosis factor (TNF) inhibitor to biosimilar adalimumab. Pharmacy and medical costs were analyzed through high- and low-conversion scenarios from reference adalimumab and the TNF inhibitor class. Price reductions of 5% to 60% relative to reference adalimumab based on previous biosimilar launches were also explored. Short-term medical costs were evaluated as additional simple and complex office visits, with scenarios of half of switch patients having 1 visit up to all switch patients having 10 visits. In a target population of 1,863 patients, switching from reference adalimumab to biosimilar adalimumab had cumulative cost savings of $5,756,073 with slow conversion (10%-20% over 3 years) and $28,780,365 with fast conversion (50%-100% over 3 years). Similar results were seen when switching from any other self-injectable reference TNF inhibitor. Cost savings more than $1 million were seen with a 10% conversion from reference adalimumab and a 15% price reduction from reference adalimumab. Additional office visit scenarios had a negligible impact on budget, with no changes in per-member-per-month costs until all switch patients had 10 additional complex visits, in which per-member-per-month costs increased by $0.02. In a hypothetical plan of 1 million lives, use of biosimilar adalimumab in commercial plans can lead to significant cost savings for payers because of increased competition. Greater and faster biosimilar conversion rates from reference adalimumab and other reference TNF inhibitors resulted in decreased costs. Additionally, even with short-term medical expenditures, cost savings were still realized when switching to biosimilar adalimumab.

Patient Satisfaction with Electronic Sick Leave Certificates: Survey of Family Medicine Outpatient Clinics

Purpose: In Slovenia, the transition from paper-based to electronic sick leave certificates (hereafter referred to as eBOLs) started at the beginning of 2020. While paper sick leave certificates are still widely used worldwide, many European countries are already reaping the benefits of using the eBOL system. This survey aimed to determine patients' satisfaction with the new eBOLs and highlight the most significant advantages and disadvantages from the patient's viewpoint. Methods: A quantitative cross-sectional survey was conducted in Maribor, Slovenia, and the surrounding area to collect quantitative data from family medicine outpatient clinics. Two hundred and fifty patients were randomly selected among those receiving either paper or electronic sick leave certificates. The survey was conducted online with a web survey link and consisted of two parts. The first part included eight items measuring patients’ experiences with electronic and paper sick leave certificates, rated on a five-point Likert scale. The second part consisted of two multiple-choice questions regarding the advantages and disadvantages of eBOLs. The data were analysed using bivariate statistical analysis. Results: Out of the 250 patients invited to participate in the study, 80 responded, resulting in a response rate of 32%. The mean age of the participants was 46.2 ± 11.2 years, with 56 (70%) women and 24 (30%) men. After more than a year of usage, 57 (71.3%) respondents expressed complete agreement that the eBOL system makes it easier for patients to manage their sick leave. Furthermore, 55 (68.8%) participants considered eBOLs as a good alternative to paper sick leave certificates. Most participants (76 (95%)) considered avoiding additional outpatient visits to manage their sick leave as the most significant advantage of using eBOLs. However, 64 (80%) respondents expressed uncertainty about the data sent by the eBOL system as the most significant disadvantage. Summary: The survey results showed that patients were already significantly satisfied with the eBOL system when it was first introduced and that their satisfaction increased with continued use. A broader survey including a larger number of Slovenian outpatient clinics and capturing both patients' and doctors' opinions would provide more precise and broader insights into the newly introduced IT system's advantages and disadvantages and its users' satisfaction.

Retrospective Evaluation of Cryopreserved Human Umbilical Cord Tissue Allografts in the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis.

Background: Osteoarthritis is a chronic disorder that affects the synovial joints by the progressive loss of articular cartilage. In the hip, the largest weight-bearing joint, the deterioration of articular cartilage and acetabular labrum can cause pain, diminishing the quality of life for patients. This study presents changes in reported pain scales from patients who received Wharton's jelly applications to cartilage deterioration in the hip from the observational retrospective repository at Regenative Labs. Methods: Sixty-nine patients were selected based on inclusion criteria with patient-reported pain scales, including the Numeric Pain Rating Scale and the Western Ontario and McMaster University Osteoarthritis Index, collected at the initial application, 30, and 90-day follow-up visits. Thirteen patients received a second allograft application and had additional follow-up visits at 120 and 180 days. Results: Five of the six scales used showed a statistically significant improvement in average scores across the cohort. The greatest improvements were observed in the NPRS with a 31.36% improvement after 90 days and a 44.64% improvement for patients with two applications after 180 days. The minimal clinically important difference (MCID) was also calculated to determine the perceived value of care for each patient with 44.9% of patients exceeding the MCID and 78.3% reporting at least one level of improvement. Conclusions: The positive outcomes for the patients in this cohort suggest WJ to be a promising alternative care option for patients with structural tissue degeneration in the hip refractory to the current standard of care.

Limitations of Patient-Controlled Epidural Analgesia Following Abdominoplasty.

Effective postoperative pain management is essential for patient satisfaction and an uneventful postoperative course, particularly in body contouring procedures. Systemic analgesic regimens can be supported by regional procedures, such as the transverse abdominis plane (TAP) block, but these have a limited duration of action. In contrast, thoracic epidural analgesia offers the possibility of a longer-lasting, individualized regional anesthesia administered by a patient-controlled analgesia pump. The aim of this study was to investigate the effects of a patient-controlled epidural analgesia to better classify the clinical value of this procedure in abdominoplasties. This work reviewed the digital medical charts of patients who underwent selective abdominoplasty without combined surgical procedures between September 2018 and August 2022. Evaluated data comprise the postoperative analgesia regimen, including on-demand medication, mobilization time, inpatient length of stay, and clinical outcome. The patients were grouped by the presence of a thoracic epidural catheter. This catheter was placed before anesthetic induction and a saturation dose was preoperatively applied. Postoperative PCEA patients received a basal rate and could independently administer boluses. Basal rate was individually adjusted during daily additional pain visits. The study cohort included 112 patients. Significant differences in the demand for supportive nonepidural opiate medication were shown between the patient-controlled epidural analgesia (PCEA) group (n = 57) and the non-PCEA group (n = 55), depending on the time after surgery. PCEA patients demanded less medication during the early postoperative days (POD 0: PCEA 0.13 (±0.99) mg vs non-PCEA 2.59 (±4.55) mg, P = 0.001; POD 1: PCEA 0.79 mg (±3.06) vs non-PCEA 2.73 (±3.98) mg, P = 0.005), but they required more during the later postoperative phase (POD 3: PCEA 2.76 (±5.60) mg vs non-PCEA 0.61 (±2.01) mg, P = 0.008; POD 4: PCEA 1.64 (±3.82) mg vs non-PCEA 0.07 (±2.01) mg, P = 0.003). In addition, PCEA patients achieved full mobilization later (PCEA 2.67 (±0.82) days vs non-PCEA 1.78 (±1.09) days, P = 0.001) and were discharged later (PCEA 4.84 (±1.23) days vs non-PCEA 4.31 (±1.37) days, P = 0.005). Because the postoperative benefits of PCEA are limited to potent analgesia immediately after abdominoplasty, less cumbersome, time-limited regional anesthesia procedures (such as TAP block) appear not only adequate but also more effective.