Patient Population Research Articles

Barriers to Offering Organ Preservation for Rectal Cancer in a Predominantly Hispanic Safety Net Hospital.

Total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC) has shown promise in achieving pathologic complete response (pCR) and enabling organ preservation through watch-and-wait (WW) strategies. However, implementation of WW protocols in diverse patient populations and safety-net hospitals faces unique challenges. The objective of this study is to evaluate TNT outcomes and identify barriers to WW implementation in a predominantly Hispanic safety-net hospital in South Texas. A retrospective review was conducted of 40 LARC patients treated with TNT at an academic tertiary referral center in South Texas between 2018 and 2023. Patient demographics, disease characteristics, and pCR rates were analyzed. A survey of multidisciplinary providers assessed perceived institutional and patient-related barriers to WW implementation. The cohort was 70% Hispanic, with a median age of 54 years. Most patients had advanced disease at diagnosis (57.5% T4, 65% N2). The pCR rate was 18.5% (5/27) among patients undergoing surgery. Re-review of MRIs for pCR patients revealed that 2/5 had minimal residual disease. The provider survey identified MRI quality variability, lack of dedicated treatment coordinators, and concerns about patient compliance and financial barriers as key obstacles to WW implementation. Despite advanced disease presentation in a predominantly Hispanic population, TNT achieved pCR rates comparable to international trials. Institutional and patient-level barriers to WW were identified, informing the development of a tailored WW protocol for this unique patient population.

Industry Perspective on First-in-Human and Clinical Pharmacology Strategies to Support Clinical Development of T-Cell Engaging Bispecific Antibodies for Cancer Therapy.

T-cell-engaging bispecific antibodies (TCEs) that target tumor antigens and T cells have shown great promise in treating cancer, particularly in hematological indications. The clinical development of TCEs often involves a lengthy first-in-human (FIH) trial with many dose-escalation cohorts leading up to an early proof of concept (POC), enabling either a no-go decision or dose selection for further clinical development. Multiple factors related to the target, product, disease, and patient population influence the efficacy and safety of TCEs. The intricate mechanism of action limits the translatability of preclinical models to the clinic, thereby posing challenges to streamline clinical development. In addition, unlike traditional chemotherapy, the top dose and recommended phase II doses (RP2Ds) for TCEs in the clinic are often not guided by the maximum tolerated dose (MTD), but rather based on the integrated dose-response assessment of the benefit/risk profile. These uncertainties pose complex challenges for translational and clinical pharmacologists (PK/PD scientists), as well as clinicians, to design an efficient clinical study that guides development. To that end, experts in the field, under the umbrella of the American Association of Pharmaceutical Scientists, have reviewed learnings from published literature and currently marketed products to share perspectives on the FIH and clinical pharmacology strategies to support early clinical development of TCEs.

A Cost-Utility Analysis of Ferric Derisomaltose Versus Ferric Carboxymaltose in Patients with Iron Deficiency Anemia in China.

Intravenous (IV) iron is the recommended treatment for patients with iron deficiency anemia (IDA) unresponsive to oral iron treatment, in whom oral iron is contraindicated, or where rapid iron replenishment is required. Ferric derisomaltose (FDI) and ferric carboxymaltose (FCM) are high-dose, rapid-infusion, IV iron formulations that have recently been compared in three head-to-head randomized controlled trials (RCTs), which showed significantly higher incidence of hypophosphatemia after administration of FCM than FDI. The present study objective was to evaluate the cost-utility of FDI versus FCM in a population of patients with IDAin China. A previously-published patient-level simulation model was used to model the cost-utility of FDI versus FCM in China. The number of infusions of FDI and FCM was modeled based on the approved posology of the respective formulations using simplified tables of iron need in a population of patients with body weight and hemoglobin levels informed by a Chinese RCT of FCM. Data on the incidence of hypophosphatemia was obtained from the PHOSPHARE-IDA RCT, while data on disease-related quality of life were obtained from SF-36v2 data from the PHOSPHARE-IBD RCT. Over the 5-year time horizon, patients received 3.98 courses of iron treatment on average, requiring 0.90 fewer infusions of FDI than FCM (7.69 vs. 6.79). This resulted in iron procurement and administration cost savings of renminbi (RMB) 206 with FDI (RMB 3,519 vs. RMB 3,312). Reduced incidence of hypophosphatemia-related fatigue resulted in an increase of 0.07 quality-adjusted life years and further cost savings of RMB 782 over 5years, driven by reduced need for phosphate testing and replenishment. FDI was therefore the dominant intervention. The results showed that FDI would improve patient quality of life and reduce direct healthcare expenditure versus FCM in patients with IDA in China.

Genitourinary tumors and liver transplantation: A comprehensive review.

Liver transplantation is as a crucial therapeutic option for patients with end-stage liver disease, but the persistent organ shortage emphasizes a need to explore unconventional donor sources, including individuals with a history of malignancies. This review investigates the viability of liver donation from individuals with current or past genitourinary malignancies, focusing on renal, prostate and urinary bladder cancers. The rising incidence of urogenital malignancies among potential donors is thought to result from increasing donor age. Analysis of transmission risks reveals low rates of donor-derived cancer transmission, particularly for early-stage renal and prostate cancers. Recipients with a history of genitourinary malignancy pose complex challenges regarding post-transplant immunosuppression and cancer recurrence. Nonetheless, the evidence suggests acceptable outcomes can be achieved with careful patient selection and tailored management strategies. Recommendations for pre-transplant evaluation and post-transplant surveillance are discussed, highlighting the need for individualized approaches in this patient population. Further prospective studies are warranted to refine guidelines and optimize outcomes in liver transplantation for patients with genitourinary malignancies.

Use of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks

BackgroundImproving hypertension control is a public health priority. However, consistent identification of uncontrolled hypertension using computable definitions in electronic health records (EHR) across health systems remains uncertain.MethodsIn this retrospective cohort study, we applied two computable definitions to the EHR data to identify patients with controlled and uncontrolled hypertension and to evaluate differences in characteristics, treatment, and clinical outcomes between these patient populations. We included adult patients (≥ 18 years) with hypertension (based on either ICD-10 codes of hypertension or two elevated blood pressure [BP] measurements) receiving ambulatory care within Yale-New Haven Health System (YNHHS; a large US health system) and OneFlorida Clinical Research Consortium (OneFlorida; a Clinical Research Network comprised of 16 health systems) between October 2015 and December 2018. We identified patients with controlled and uncontrolled hypertension based on either a single BP measurement from a randomly selected visit or all BP measurements recorded between hypertension identification and the randomly selected visit).ResultsOverall, 253,207 and 182,827 adults at YNHHS and OneFlorida were identified as having hypertension. Of these patients, 83.1% at YNHHS and 76.8% at OneFlorida were identified using ICD-10-CM codes, whereas 16.9% and 23.2%, respectively, were identified using elevated BP measurements (≥ 140/90 mmHg). A total of 24.1% of patients at YNHHS and 21.6% at OneFlorida had both diagnosis code for hypertension and elevated blood pressure measurements. Uncontrolled hypertension was observed among 32.5% and 43.7% of patients at YNHHS and OneFlorida, respectively. Uncontrolled hypertension was disproportionately higher among Black patients when compared with White patients (38.9% versus 31.5% in YNHHS; p < 0.001; 49.7% versus 41.2% in OneFlorida; p < 0.001). Medication prescription for hypertension management was more common in patients with uncontrolled hypertension when compared with those with controlled hypertension (overall treatment rate: 39.3% versus 37.3% in YNHHS; p = 0.04; 42.2% versus 34.8% in OneFlorida; p < 0.001). Patients with controlled and uncontrolled hypertension had similar incidence rates of deaths, CVD events, and healthcare visits at 3, 6, 12, and 24 months. The two computable definitions generated consistent results.ConclusionsWhile the current EHR systems are not fully optimized for disease surveillance and stratification, our findings illustrate the potential of leveraging EHR data to conduct digital population surveillance in the realm of hypertension management.

Systemic lupus erythematosus: an unusual presentation of stroke - a case report from Azal hospital, Sana'a, Yemen

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by various clinical manifestations and potential multi-organ involvement. It predominantly affects women, with peak incidence during middle age. Case report: This case report describes a 36-year-old female patient who presented with right-sided body weakness, fever, and headache but maintained normal speech. The patient, with a known history of SLE, was diagnosed with an ischemic stroke. Following appropriate fluid resuscitation and medical management, the patient improved. Notably, the patient had a previous ischemic stroke four years ago while on warfarin but without antiplatelet therapy. Conclusion: Our findings suggest that stroke may be an initial presentation of SLE and that warfarin alone may not adequately protect against stroke in this patient population.

Dynamics of Thrombogenicity and Platelet Function and Correlation with Bleeding Risk in Patients Undergoing M-TEER Using the PASCAL System.

Transcatheter mitral valve repair is performed in a patient population at risk for thrombotic and bleeding events. The effects on platelet function and reactivity and their association with bleeding events after mitral transcatheter edge-to-edge therapy (M-TEER) have not been systematically examined. We sought to investigate the association of different parameters of platelet function and thrombogenicity with bleeding events post M-TEER. In this single-center study, 100 consecutive patients with mitral regurgitation receiving TEER were analyzed. Blood was taken directly from the guide-catheter in the left atrium before and after placing the device. Blood samples were analyzed using impedance aggregometry (Multiplate) and TEG6s. The results were compared pre- and postprocedural. The primary outcome was any bleeding complication according to the Bleeding Academic Research Consortium classification within 6 months. A total of 41 patients experienced bleeding events. TEG analysis showed a significant decrease in ADP aggregation and increase in ADP inhibition. In ROC-analysis, TEG ADP aggregation and inhibition and Multiplate ADP aggregation showed moderate predictive values for bleeding events. The delta-ADP-Test (Multiplate) showed the strongest prediction of bleeding (area under the curve: 0.69). Adding platelet function and TEG markers to a model of clinical bleeding risk factors improved the prediction for bleeding events. This study indicates that thrombogenicity might be affected immediately after M-TEER probably due to changes in flow conditions. In particular, platelet aggregation involving the ADP receptor pathway significantly correlated with postprocedural bleeding events. Whether these results could guide peri-interventional antithrombotic therapy and improve peri- and postprocedural outcome requires further investigation.

Comparison of pulmonary vein isolation between two commercially available cryoballoon systems

BackgroundPulmonary vein isolation (PVI) using cryoballoon (CB) ablation has comparable efficacy and safety to the gold standard of radiofrequency ablation in the treatment of symptomatic atrial fibrillation (AF). Initial randomized control trials were performed using Arctic Front Advance Pro™ (AFr) (Medtronic, Dublin, Ireland) CB system. Novel CB systems have recently become available, including the POLARx™ (Px) (Boston Scientific, Marlborough, Massachusetts, USA) system. We aimed to compare PVI using the Px and the AFr CB systems in our patient population in terms of efficacy, safety and procedure characteristics in a routine clinical setting.MethodsWe performed a retrospective analysis of our internal AF ablation registry, containing 452 consecutive patients (pts) that underwent first procedure cryo-PVI for symptomatic AF. Primary endpoints were AF recurrence after 3 and 12 months, complication rate, procedure duration, fluoroscopy time and fluoroscopy dose. Secondary endpoints were minimal freeze temperature, time to isolation (TTI) and temperature at TTI for each of the pulmonary veins as well as minimal esophageal temperature during the procedure.ResultsThe primary efficacy endpoints of AF recurrence after 3 and 12 months were similar between the AFr and the Px systems (25.5% vs 21.3%, p = 0.416 and 22.2% vs 20.6%, p = 0.794, respectively). Complication rates were similar (3.9% vs 6.8%, p = 0.18) between groups and consisted mostly of mild vascular complications. The AFr group showed a significantly shorter procedural duration (68 (55–77) vs 73 (60–80) min, p = 0.002), and lower fluoroscopy dose compared to the Px system. Fluoroscopy times remained similar, however. Minimal freeze temperatures and temperatures at time of isolation were significantly lower in the Px group. However, the time to isolation and minimal procedural esophageal temperature were similar in both groups.ConclusionPVI using the AFr and the Px systems showed comparable safety and efficacy. Procedural times were longer for the Px system. The Px system showed lower freeze temperature measurements but seemed to have a comparable biological effect.

Association of Serum Endocannabinoid Levels with Pancreatitis and Pancreatitis-Related Pain.

Background and Aims: This investigation examined the association of pancreatitis and pancreatitis-related pain with serum levels of two endocannabinoid molecules such as anandamide (AEA) and 2-arachidonoylglycerol (2-AG) and two paracannabinoid molecules such as oleoylethanolamide (OEA) and palmitoylethanolamide (PEA). Methods: A case-control study was conducted within the Prospective Evaluation of Chronic Pancreatitis for Epidemiological and Translational Studies, including participants with no pancreas disease (N = 56), chronic abdominal pain of suspected pancreatic origin or indeterminate chronic pancreatitis (CP) (N = 22), acute pancreatitis (N = 33), recurrent acute pancreatitis (N = 57), and definite CP (N = 63). Results: Circulating AEA concentrations were higher in women than in men (p = 0.0499), and PEA concentrations were higher in obese participants than those who were underweight/normal or overweight (p = 0.003). Asymptomatic controls with no pancreatic disease had significantly (p = 0.03) lower concentrations of AEA compared with all disease groups combined. The highest concentrations of AEA were observed in participants with acute pancreatitis, followed by those with recurrent acute pancreatitis, chronic abdominal pain/indeterminant CP, and definite CP. Participants with pancreatitis reporting abdominal pain in the past year had significantly (p = 0.04) higher concentrations of AEA compared with asymptomatic controls. Levels of 2-AG were significantly lower (p = 0.02) among participants reporting abdominal pain in the past week, and pain intensity was inversely associated with concentrations of 2-AG and OEA. Conclusions: Endocannabinoid levels may be associated with stage of pancreatitis, perhaps through activation of the CB1 receptor. Validation of our findings would support the investigation of novel therapeutics, including cannabinoid receptor-1 antagonists, in this patient population.

Transcranial Doppler in 150 Congolese children with sickle cell disease

IntroductionSickle Cell Disease (SCD) ranks among the most prevalent genetic disorders globally. The incidence in sub-Saharan African countries has been estimated to be 230.000/y with a high prevalence (1%) in the Democratic Republic of Congo (DRC). Stroke is a significant complication of Sickle Cell Disease (SCD), and carries a high risk of disability and mortality. Transcranial Doppler (TCD) is currently the non-invasive exploration recommended for the prevention of stroke in young SCD patients.ObjectiveTo determine the prevalence of pathological TCD in a population of young Congolese SCA patients and to assess its association with hematological parameters.Population and methodsThis cross sectional study was carried out on 150 Congolese SS homozygous children between the ages 2–16 years old (mean age: 8.5 ± 4.0 years) in stable condition, and followed from January 1 to December 31, 2013. TCD was performed using the STOP I method in the main cerebral arteries. The risk of stroke was absent when the average maximum speed during a cycle (TAMMV) in middle cerebral artery (MCA) was &amp;lt; 170 cm/s, but present when TAMMV was borderline or conditional for values between 170 and 199 cm/s and pathological for values ≥ 200 cm/s.ResultsThe prevalence of pathological TCD was 4% while the conditional TCD prevalence was 10%. The Mean blood velocity in MCA was 114.0 cm/s. There was a significant difference in the means of WBC (p = 0.003), Hb (p &amp;lt; 0.001), Hct (p &amp;lt; 0.001), MCV (p = 0.005) parameters when comparing normal and at risk TCD (conditional and abnormal). However, no significant association was found for the categorical corresponding parametersConclusionGlobally, 14% of patients were at risk of stroke, hence the interest in integrating TCD in the routine monitoring of children with SCD in order to prevent overt stroke by implementing a chronic blood transfusion program or the use of hydroxycarbamide.

Population Pharmacokinetics of Casirivimab and Imdevimab in Pediatric and Adult Non-Infected Individuals, Pediatric and Adult Ambulatory or Hospitalized Patients or Household Contacts of Patients Infected with SARS-COV-2.

Casirivimab (CAS) and imdevimab (IMD) are two fully human monoclonal antibodies that bind different epitopes on the receptor binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and block host receptor interactions. CAS + IMD and was developed for the treatment and prevention of SARS-CoV-2 infections. A population pharmacokinetic (PopPK) analysis was conducted using pooled data from 7598 individuals from seven clinical studies to simultaneously fit concentration-time data of CAS and IMD and investigate selected covariates as sources of variability in PK parameters. The dataset comprised CAS + IMD-treated pediatric and adult non-infected individuals, ambulatory or hospitalized patients infected with SARS-CoV-2, or household contacts of patients infected with SARS-CoV-2. CAS and IMD concentration-time data were both appropriately described simultaneously by a two-compartment model with first-order absorption following subcutaneous dose administration and first-order elimination. Clearance estimates of CAS and IMD were 0.193 and 0.236 L/day, respectively. Central volume of distribution estimates were 3.92 and 3.82 L, respectively. Among the covariates identified as significant, body weight and serum albumin had the largest impact (20-34%, and ~ 7-31% change in exposures at extremes, respectively), while all other covariates resulted in small differences in exposures. Application of the PopPK model included simulations to support dose recommendations in pediatrics based on comparable exposures of CAS and IMD between different weight groups in pediatrics and adults following weight-based dosing regimens. This analysis provided important insights to characterize CAS and IMD PK simultaneously in a diverse patient population and informed pediatric dose selection.

Impact of diabetes mellitus on endodontic treatment outcomes

Diabetes mellitus (DM) is a chronic metabolic disorder that affects various systemic functions, including oral health. Its impact on endodontic treatment outcomes has become a significant concern for dental practitioners. The relationship between DM and endodontic outcomes is complex, involving several pathophysiological mechanisms. Hyperglycemia leads to the formation of advanced glycation end-products, causing vascular dysfunction and impaired blood supply to the pulp, which exacerbates pulpal inflammation and increases the risk of necrosis. Additionally, chronic low-grade inflammation and an impaired immune response in diabetic patients contribute to a higher susceptibility to infections, delayed healing, and compromised tissue repair after endodontic procedures. Diabetic patients often experience lower success rates and prolonged recovery following endodontic treatment due to these systemic challenges. Reduced bone healing, persistent periapical lesions, and altered microbial flora are common complications that can hinder treatment success. Effective management of endodontic treatment in diabetic patients requires a multifaceted approach that includes strict glycemic control, the use of enhanced antimicrobial strategies, and the adoption of minimally invasive techniques to reduce tissue trauma. Additionally, patient education and close monitoring of the healing process are essential for minimizing complications. Understanding the pathophysiological interactions between diabetes and pulpal inflammation, as well as the factors that influence healing and success rates, is crucial for optimizing endodontic care in diabetic patients. By addressing both systemic and local factors, dental practitioners can improve the prognosis of endodontic treatment and ensure better outcomes for patients with diabetes. Ongoing research into the mechanisms underlying these complications will further enhance the ability of clinicians to manage endodontic cases effectively in this growing patient population.

Venetoclax-based salvage therapy as bridge-to-transplant is feasible and effective in patients with relapsed/refractory AML.

The BCL2-inhibitor Venetoclax (VEN) in combination with hypomethylating agents (HMA) has been approved for first-line treatment of acute myeloid leukemai (AML) patients ineligible for intensive treatment. Emerging Data suggest that VEN containing treatment strategies may also be effective in relapsed/refractory (R/R) AML, however, comparative studies with conventional treatment strategies for medically fit patients as a bridge-to transplant strategy are limited. Using propensity score matching (PSM) analysis, we compared 37 R/R AML patients, who received VEN-based salvage therapy as bridge to allogeneic hematopoietic cell transplantation (allo-HCT) with 90 patients from the German Study Alliance Leukemia (SAL) AML registry, who were treated with non-VEN-containing salvage therapy according to their treating physician's choice (TPC) including intensive and non-intensive protocols. The overall response rate (ORR=CR+CRi) among all VEN patients was significantly higher compared to the TPC control cohort (62% vs. 42%; p=0.049). Overall, 73% of VEN-treated patients vs. 63% of TPC patients were successfully bridged to allo-HCT (p =0.41). After a median follow-up of 34.3 months for the VEN cohort and 21.0 months for the TPC cohort, the median overall-survival (OS) was 15.8 months (95%-CI, 10.6-NE) and 10.5 months (95%-CI, 6.8-19.6) (p=0.15), respectively. PSM revealed a trend towards improved OS for VEN patients (HR 0.70; 95%-CI, 0.41-1.22; p=0.20). Median event free survival (EFS) was significantly longer in the VEN cohort (8.0 months) compared to the TPC cohort (3.7 months) (p=0.006). In summary, our data suggests that VEN-based salvage therapy is a safe and effective bridge to allo-HCT for this difficult-to-treat AML patient population.

Continuous Diffused Oxygen Therapy for Wound Healing

What Is the Issue? Wounds are prevalent across health care settings, costing Canada an estimated $12 billion per year in wound care. Chronic wounds (wounds that do not heal in the typical amount of time, which can depend on the size and type of wound) can have a significant impact on a patient’s quality of life and health. Healing tissue has a high need for oxygen. Oxygen can be delivered in several ways, including topical oxygen therapy, which delivers oxygen directly to the wound. One type of topical oxygen therapy is continuously diffused oxygen (CDO) therapy, which uses a device that takes oxygen from the air and then delivers pure, humidified oxygen to the wound. We previously completed a Rapid Review on CDO therapy for wounds in 2020. This review aimed to determine if new evidence has since been published on this topic. What Did We Do? To inform decisions about CDO therapy for wound healing, we sought to identify and summarize literature comparing the clinical effectiveness and cost-effectiveness of CDO therapy versus conventional wound care. We also attempted to identify evidence-based recommendations for the use of CDO therapy. We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence published since 2019. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? CDO therapy appears to be clinically effective for treating patients with diabetic foot ulcers, particularly chronic or hard-to-heal ulcers that have not responded to standard care. Rates of adverse events were comparable between patients receiving CDO and patients receiving standard care. Two cost-effectiveness studies reported that CDO is likely to be cost-effective compared to standard care for patients with chronic, hard-to-heal diabetic foot ulcers. We identified fewer studies for other types of wounds. Preliminary evidence suggests that CDO therapy may be helpful for patients with other types of wounds that are chronic or have not responded to standard care. Reporting on adverse events was limited. Limited evidence suggests that patients receiving CDO therapy had better outcomes if their wound was debrided more frequently as well as if they received CDO therapy for a longer time. The evidence-based guidelines recommend the use of topical oxygen therapy (of which CDO is a subtype) for treating diabetic foot ulcers that have failed to heal with standard care. One guideline suggested that topical oxygen therapy may be considered for other types of non-neoplastic, hard-to-heal wounds. We did not find cost-effectiveness evidence for wounds other than diabetic foot ulcers that met the inclusion criteria for our report. We also did not identify any clinical effectiveness or cost-effectiveness evidence, or any guidelines regarding the use of CDO to treat First Nations, Inuit, and Métis patients, that met the inclusion criteria for our report. What Does This Mean? CDO therapy may be beneficial and more cost-effective than standard care for patients with hard-to-heal, chronic diabetic foot ulcers that have not responded to standard care. Evidence-based guidelines also recommend the use of CDO therapy for this patient population. The clinical effectiveness and cost-effectiveness of CDO therapy for other types of wounds is still unclear. It is also unclear if there is an optimal way to provide CDO (e.g., oxygen flow rate, debridement, length of treatment). We identified limited evidence that reported on patient ethnicity. Considering that some groups, including First Nations, Inuit, and Métis Peoples, have higher rates of diabetes than the overall population in Canada — which may lead to higher rates of diabetic foot ulcers — decision-makers involved in implementing CDO therapy should consider ways to ensure equitable access for all patients who may need this treatment.

Comparative effectiveness of combined biologic agents versus standard therapies in the treatment of plaque psoriasis: a retrospective analysis

IntroductionPlaque psoriasis is a persistent skin disorder that necessitates efficient management. This study investigates the therapeutic effectiveness and timeline for skin lesion resolution in plaque psoriasis patients treated with combined biologic agents compared to standard therapies.MethodsConducted retrospectively between March 2020 and March 2023, the study included 162 patients with moderate to severe plaque psoriasis. Participants were divided into two groups: the Control Group, which received standard treatments, and the Combined Biologic Agent Group, which received additional biologic therapy with secukinumab. Participants in the Control Group received standard treatments, while those in the Combined Biologic Agent Group received standard treatments plus secukinumab.ResultsThe results showed that the Combined Biologic Agent Group experienced a significantly faster onset of therapeutic effects, with an average time of 3.04 ± 2.25 days compared to 6.12 ± 2.06 days in the Control Group. Additionally, skin lesion resolution occurred more rapidly in the biologic agent group (7.04 ± 2.13 days) than in the control group (14.56 ± 4.73 days). By week 24, the Psoriasis Area and Severity Index (PASI) scores demonstrated a more substantial reduction in the biologic agent group, decreasing from 26.98 ± 11.28 to 2.48 ± 3.01, whereas the control group showed a reduction from 25.82 ± 10.47 to 10.40 ± 7.63. The overall effectiveness rate was higher in the biologic agent group, with no cases of ineffectiveness, compared to a 20.99% ineffectiveness rate in the control group. Furthermore, there was no recurrence of the disease in the biologic agent group, while the control group experienced an 11.11% recurrence rate. Both groups had a similar incidence of adverse reactions, indicating that the addition of biologic agents does not significantly increase the risk of adverse events.DiscussionThese findings suggest that combined biologic agent therapy offers a more effective and faster treatment option for plaque psoriasis without compromising safety. However, larger-scale clinical trials are necessary to validate these results and establish the long-term benefits and safety of this treatment approach in diverse patient populations.

Outcomes of a patient support programme for subcutaneous immunoglobulin therapy in patients with primary or secondary immunodeficiencies or chronic inflammatory demyelinating polyneuropathy.

Subcutaneous immunoglobulin (SCIg) therapy is important in the treatment of primary (PID) and secondary immunodeficiencies (SID) and chronic inflammatory demyelinating polyneuropathy (CIDP). Patient support programmes (PSPs) help patients self-administer medication regimens and play a more active role in the self-management of their medical conditions. To describe the effectiveness of the CSL Behring CARES PSP in optimising the quality use of SCIg in a hospital-free environment. This retrospective, observational study analysed records of patients enroled in the CSL Behring CARES PSP. Key outcomes were accessibility and effectiveness. Data were extracted from the patient database and analysed using descriptive methods. Seven hundred eighty-nine patients with PID (30.8%), SID (53.4%) and CIDP (15.8%) were enroled in the CARES PSP, 92.8% of whom were referred from public hospitals and the remaining from private hospitals. Of the total patient population, 697 (88.3%) received the nurse-led SCIg self-administration training and education (COACH), out of which 656 (94.1%) completed training and achieved competency after an average of 2.3 training sessions. The proportions of patients who achieved competency were similar across age groups and prior SCIg hospital education status. This is the largest real-world evidence study that describes the effectiveness of SCIg PSPs across three therapeutic disease states. These PSPs can optimise hospital resources such as infusion nurse time and allocation of infusion chairs that were once used for intravenous immunoglobulin infusions, improve patient access to SCIg therapy and enable patients self-administer SCIg outside a hospital environment.

Imaging in Spine Degenerative Joint Disease: Point-High Clinical Value of Imaging in the Correct Patient Population.

Imaging in Spine Degenerative Joint Disease: Point-High Clinical Value of Imaging in the Correct Patient Population.

Social Determinants of Health and Insurance Claim Denials for Preventive Care.

The Patient Protection and Affordable Care Act (ACA) eliminated out-of-pocket cost-sharing for recommended preventive care for most privately insured patients. However, patients seeking preventive care continue to face cost-sharing and administrative hurdles, including claim denials, which may exacerbate inequitable access to care. To determine whether patient demographics and social determinants of health are associated with denials of insurance claims for preventive care. This cohort study of patients insured through their employers or the ACA Marketplaces used claims and remittance data from Symphony Health Solutions' Integrated DataVerse from 2017 to 2020; analysis was completed from January to July 2024. Seeking preventive care. The primary outcome was the frequency of insurer denials for preventive services across 5 categories: specific benefit denials, billing errors, coverage lapses, inadequate coverage, and other. Subgroup analysis was performed across patient household income, education, and race and ethnicity. Secondary outcomes included charges for denied claims, approximating patients' remaining financial responsibility for care. A total of 1 535 181 patients received 4 218 512 preventive services in 2 507 943 unique visits (mean [SD] age at visits, 54.02 [13.19] years; 1 804 637 visits for female patients [71.96%]); 585 299 patients (23.30%) had an annual household income $100 000 or higher, and 824 540 patients had some college education (32.88%). A total of 20 658 individuals (0.82%) were Asian, 139 950 (5.58%) were Hispanic, 219 646 (8.76%) were non-Hispanic Black, 1 372 223 (54.72%) were non-Hispanic White, and 25 412 (1.0%1) were other races and ethnicities not included in the other 4 groups. Of preventive claims, 1.34% (95% CI, 1.32%-1.36%) were denied, consisting mainly of specific benefit denials (0.67%; 95% CI, 0.66%-0.68%) and billing errors (0.51%; 95% CI, 0.50%-0.52%). The lowest-income patients had 43.0% higher odds of experiencing a denial than the highest-income patients (odds ratio, 1.43; 95% CI, 1.37-1.50; P < .001). The least educated enrollees had a denial rate of 1.79% (95% CI, 1.76%-1.82%) compared with 1.14% (95% CI, 1.12%-1.16%) for enrollees with college degrees. Denial rates for Asian (2.72%; 95% CI, 2.55%-2.90%), Hispanic (2.44%; 95% CI, 2.38%-2.50%), and non-Hispanic Black (2.04%; 95% CI, 1.99%-2.08%) patients were significantly higher than those for non-Hispanic White patients (1.13%; 95% CI, 1.12%-1.15%). In this cohort study of 1 535 181 patients seeking preventive care, denials of insurance claims for preventive care were disproportionately more common among at-risk patient populations. This administrative burden potentially perpetuates inequitable access to high-value health care.

The obese population's views on the symptoms and risks of chronic venous insufficiency - 2 (OBVIOUS-2) cross-sectional survey.

Individuals with high body mass index (BMI) are more likely to have symptomatic LLVD than age matched populations with normal BMI. National priorities in venous disease set by the James Lind Alliance focus on improving access to healthcare and patient education. The aims of this study are to determine patient knowledge and potential burden of LLVD in a population of patients attending a UK, regional weight management service. A postal questionnaire containing 12 questions relating to LLVD and obesity was distributed to the active list of patients under the weight management medical service at Dudley Group of Hospitals between May 2022-23. Respondents were provided with a stamped, addressed envelope to return the questionnaire. Ethical approval was granted by the Hampshire Research & Ethics Committee. Some 367 questionnaires were distributed to patients currently enrolled in specialist weight management services. 103 complete responses were received (28%), Most patients were between 50 and 70 years of age. 25% of patients already had a formal diagnosis of LLVD, with a further 84 (82%) reported signs or symptoms which may be related to LLVD. Almost half (49/103, 48%) had concerns over their skin quality with a similar proportion (25/103, 51%) having sought medical help. The majority (71/103, 69%) were unaware of the association between obesity and LLVD. Twelve participants had education regarding simple adjuncts designed to improve symptoms and/or prevent ulceration (emollients, dressings, stockings, or leg elevation). Four participants had previously undergone treatment for varicose veins. In a population of patients accessing weight management services, we have demonstrated that a quarter of patients have already received a diagnosis of LLVD, however there is for a greater undiagnosed burden of LLVD in part due to lack of patient and possibly clinician awareness.

Efficacy and long-term outcomes of abdominoperineal resection using transperineal total mesorectal excision approach for rectal cancer.

Although abdominoperineal resection (APR) is essential for a certain population of patients with low rectal cancer, it is technically difficult and sometimes contains oncological disadvantages. Thus, the use of the transperineal total mesorectal excision (TpTME) approach might overcome such concerns regarding APR. In total, 27 patients who underwent conventional APR (conventional group) and 49 patients who underwent APR using the TpTME approach (TpTME group) for low rectal cancer were included. After propensity score matching, the outcomes of the 25 matched cases were compared between groups. The operative time was significantly shorter in the TpTME group than in the conventional group (452 vs. 565min, P = 0.039). Intraoperative blood loss and transfusion rates were also significantly lower in the TpTME group than in the conventional group (25mL vs. 200mL, P < 0.001 and 0% vs. 28.0%, P = 0.015, respectively). Although the incidence of postoperative complications did not differ significantly, the postoperative hospital stay was significantly shorter in the TpTME group than in the conventional group (24 vs. 36days, P = 0.001). The 5year relapse-free survival rates in the TpTME and conventional groups were 62.0% and 57.6%, respectively (P = 0.648). APR using the TpTME approach for the treatment of low rectal cancer is feasible and can achieve favorable oncological outcomes.