Current Medical Research and Opinion最新文献

Objective: To assess incremental all-cause healthcare resource utilization (HCRU) and costs among people living with HIV (PLWH) with and without chronic kidney disease (CKD) in the United States.

Methods: A retrospective administrative claims analysis was conducted using Optum's de-identified Clinformatics^® Data Mart Database (Jan 2020-Dec 2022). Adult PLWH with ≥1 pharmacy claims for anchor antiretroviral (ART) agent in 2021 (index date: earliest anchor ART claim) were followed for 12 months or to the end of continuous enrollment and stratified based on the baseline presence of CKD (yes/no). Differences between CKD groups in per-person-per-month (PPPM) HCRU and costs (converted to 2023 USD) were estimated using multivariable generalized linear models adjusted for baseline characteristics.

Results: Of 22,402 PLWH identified, 3,753 (16.8%) had CKD. PLWH with versus without CKD were older (mean age 63.35 vs 53.02 years), a larger proportion were women (23.2% vs >18.0%) or Black (35.7% vs 29.0%), and they had higher mean Quan-Charlson Comorbidity Index scores (3.23 vs 0.92) and baseline total costs ($5,259 vs $3,644); all p<0.001. Compared to PLWH without CKD, PLWH with CKD had significantly higher unadjusted all-cause PPPM HCRU and costs (all p<0.001), and significantly greater all-cause adjusted PPPM HCRU, total costs, medical costs, and inpatient costs (all p<0.001), whereas adjusted pharmacy costs were significantly lower (p=0.025).

Conclusions: PLWH with CKD generally experience greater HCRU and cost burden than those without CKD. These increases may be mitigated by recognizing modifiable CKD risk factors and tailoring HIV care, which may also improve overall health of PLWH.

The rapid evolution of digital technologies has transformed clinical trials, offering improved efficiency and broader patient participation. However, in India, the transition to digital clinical trials presents multiple challenges, including regulatory uncertainties, ethical concerns, infrastructural limitations, and patient participation barriers. Ethics committees face a lack of trained personnel, unfamiliarity with digital guidelines, and delays in approvals, while regulatory bodies struggle with evolving frameworks and compliance issues. Additionally, sponsors and trial sites encounter difficulties in data security, patient engagement, and technology integration. Addressing these challenges requires a collaborative effort involving regulatory reforms, ethical training, enhanced digital infrastructure, and the implementation of standardized processes. Nevertheless, recent initiatives highlight successful digital adoption, supported by frameworks like the New Drugs and Clinical Trials Rules 2019 and Digital Personal Data Protection Act 2023. This review explores the challenges and proposes strategic solutions to optimize digital clinical trials in India. By leveraging India's digital health momentum and fostering multisectoral collaboration, the clinical research ecosystem can become more agile, equitable, and globally aligned.

Objective: This study aimed to provide a comprehensive analysis of long-term treatment patterns, biologic treatment sequencing, healthcare resource utilization (HCRU), and costs in biologic-naïve patients with CD.

Methods: This retrospective analysis utilized data from the IQVIA PharMetrics Plus claims database (2014-2022), representative of the United States (US) commercially insured population under 65 years. Biologic-naïve adults (≥18 years) with CD were included if they had ≥12 months of continuous enrollment before and after initiating Food and Drug Administration (FDA)-approved biologics (2015-2021). Outcomes included treatment persistence, switching, dose escalation, augmentation, and HCRU over 12-36 months of follow-up. Dose escalation and augmentation were defined based on therapy adjustments or concurrent use of conventional treatments. Descriptive and Kaplan-Meier analyses were conducted using SAS 9.4 to evaluate treatment patterns and outcomes.

Results: Of 390,396 patients with a qualifying claim during the index period, 7,353 biologic-naïve patients with CD met the inclusion criteria. The cohort had a mean age of 39.2 (standard deviation [SD] = 13.8) years, 51.4% were female, and 97.2% had commercial insurance. Follow-up averaged 32.5 (SD = 17.2) months, with 59.5% having ≥24 months of follow-up. Adalimumab (50.6%) and infliximab (26.9%) were the most common first-line therapies. Ustekinumab as first-line therapy showed numerically highest persistence (12 months: 79.0%; 24 months: 69.9%) and highest dose escalation rates among biologics. Median time to augmentation was 1.5 months for first-line therapies. Total CD-related costs per year varied across therapy groups, with ustekinumab having the numerically highest costs ($135,311 [SD = 69,162]).

Conclusion: This analysis reveals variability in biologic treatment patterns. Most biologic-naïve patients start with anti-TNFs, even though other therapies show numerically higher persistence than anti-TNFs, highlighting the need for effective treatment sequencing and monitoring. Rising healthcare costs emphasize strategic decisions for effective biologics and efficient resource allocation in real-world settings.

Objective: This study aimed to investigate the potential impact of replacing alteplase with a single-bolus fibrinolytic agent, such as tenecteplase, on patient care, secondary care management and resource utilization, from the perspective of healthcare professionals practicing within Acute and Comprehensive Stroke Centers across the UK.

Methods: Semi-structured interviews were conducted to gather insights from UK-based healthcare professionals (HCPs) with experience in the administration of thrombolytic treatment or the care of acute ischemic stroke patients within the six months prior to the study initiation. Participants shared their perspective on the potential impact of transitioning to a theoretical single bolus fibrinolytic agent.

Results: Six HCPs participated in the study. All agreed that the introduction of a single-bolus thrombolytic agent could save significant stroke specialist nurse time. Participants also noted potential resource use savings, stemming from reduced use of consumables and equipment. Additionally, participants believed that the new agent was likely to improve clinical outcomes and patient wellbeing.

Conclusion: The introduction of a single-bolus thrombolytic agent to treat acute ischemic stroke could lead to significant system efficiencies in the UK. These findings are expected to be broadly generalizable to other settings and merit global consideration.

Objectives: Owing to the peaking rates and the multifaceted nature of colorectal cancers (CRC), understanding regional epidemiology and clinicopathological characteristics is critical. However, for the severe paucity in high-quality region-specific data, we aimed to determine the prevalence, distribution across age-gender, and identify common gastrointestinal pathological-features, and associations between patients' clinical-histories, definitive-diagnostic findings, and demographic-characteristics.

Methods: We retrospectively examined records of 602 patients (January 2020-December 2024). Data included demographics, diagnoses (e.g. adenocarcinoma, tubulovillous adenoma with dysplasia [TVA], dysplasia, chronic active colitis, no malignancy, polyps, or differential diagnosis), biopsy-type, and relevant clinical history. Descriptive statistics and inferential tests such as Chi-square and Mann-Whitney U were used.

Results: The cohort was 59.3% (n = 357) male and 40.7% (n = 245) female. Adenocarcinoma increased with age, peaking at 50-69 (53.0%) and females 70-89 (84.2%). TVA was prominent in males (30-49; 28.0%) and females (50-69; 36.1%). Overall, males had higher-frequencies of both adenocarcinoma (n = 137 vs. 95) and TVA (n = 73 vs. 59) compared to females. Rectosigmoid-biopsy was the most common method for diagnosing adenocarcinoma (42.4%), whereas colon-biopsy was more frequent for TVA (27.1%). The highest proportion of "No malignancy" diagnosis was in the 15-29 years age group (males: 65.4%, females: 64.7%). Clinical histories indicating "colon-tumor or polyps" were strongly associated with adenocarcinoma (47.0%) and TVA (30.3%). Significant associations were found between diagnosis and specimen-type and clinical-history and diagnosis.

Conclusions: This study highlights distinct age- and-gender-specific CRCs-patterns; particularly, prevalence of neoplastic-conditions in elderly with more frequent adenocarcinomas in males and variance of biopsy-sites by diagnosis. These support targeted-screening where more effective diagnostic and early treatment strategies are imperative in-line with the country's 2030-vision and UN's-Sustainable Development Goals-3.

Background: Despite declining lung cancer death rates, minoritized patients still face health disparities compared to White patients. This study examines treatment preferences and decision-making differences among patients with non-small cell lung cancer (NSCLC) and physicians from different racial and ethnic backgrounds in the US.

Materials and methods: Two cross-sectional online surveys were conducted from March to May 2023. Respondents were recruited from an NSCLC community and research panel. Recruitment goals were set to ensure diversity, by having African American or Black (hereafter, Black), Asian, Hispanic, and White patients and physicians included. Data were summarized using descriptive statistics.

Results: Across all racial and ethnic groups (N = 157), patients reported that extending life was the most important treatment attribute. Hispanic patients assigned more importance to treatment side effect (SE) risks compared to Asian, Black, and White patients. Larger proportions of Asian (63%) and White (73%) patients prioritized quality over quantity of life compared to Black (43%) and Hispanic (40%) patients. All physician groups ranked expected overall survival, progression-free survival, and duration of response as the top three treatment attributes. On a scale of 1 (high) to 10 (low), Black physicians expressed less concern about potential SEs (6.6) than other physician groups (≤5.3). Cost of treatment was consistently ranked with lower importance; however, over 80% of Black and Hispanic physicians thought that patient out-of-pocket costs or financial status were somewhat more or very important to their treatment recommendations.

Conclusion: Patients and physicians of different racial and ethnic backgrounds may place varying importance on several treatment attributes.

Hypertension, defined as systolic blood pressure (BP) ≥140 mmHg or diastolic BP ≥90 mmHg, presents a significant challenge in perioperative settings. Perioperative hypertension is highly prevalent, affecting 25% of patients undergoing non-cardiac procedures and up to 80% of cardiac surgeries. This review aims to provide an in-depth examination of perioperative hypertension, emphasizing its impact on patient outcomes, current management strategies, and the need for standardized guidelines. Evidence from observational studies, clinical trials, and expert guidelines is analyzed to highlight gaps and best practices in perioperative BP control. A comprehensive literature review was conducted using scientific databases. Studies examining the incidence, complications, and management strategies of perioperative hypertension were included. Perioperative hypertension significantly increases the risk of adverse cardiovascular events, including myocardial infarction, stroke, and renal failure, contributing to longer hospital stays and higher healthcare costs. Patients with significant intraoperative systolic BP elevations had markedly higher risks of adverse outcomes, including approximately 1.5-fold higher mortality and a doubling of renal failure risk. Additionally, hypertension is a leading cause of elective surgery postponement. Despite its high prevalence, comprehensive management guidelines remain inadequate, resulting in inconsistent BP control strategies and suboptimal patient outcomes. The management of perioperative hypertension requires a more standardized and evidence-based approach. Current strategies emphasize individualized BP targets, optimization of antihypertensive therapy, and intraoperative haemodynamic stability. However, the lack of universally accepted guidelines hinders effective BP management. Future research should focus on developing standardized protocols to improve perioperative outcomes and reduce complications related to hypertension.

Objective: To compare healthcare utilization and costs in RSV- and influenza-vaccinated vs unvaccinated and influenza-only vaccinated older, US adults in 2023.

Methods: We used a retrospective, cohort study design and the Humana Healthcare Research database to identify individuals enrolled in a Medicare Advantage Prescription drug plan who received RSV vaccination from August 1, 2023 to December 31, 2023. Six-month follow-up through June 30, 2024 was indexed hierarchically on RSV vaccination, influenza vaccination (adults without RSV vaccination), or a primary care visit (adults without RSV and influenza vaccination). We used propensity score matching to adjust for baseline differences and generalized linear regression models to estimate difference-in-difference measures of all-cause inpatient stays, ED visits, outpatient visits, and healthcare costs in the 6 months following index compared with the 12-month baseline period.

Results: RSV- and influenza-vaccinated individuals had lower ED utilization (16.1% vs 18.6%), fewer inpatient stays (5.1% vs 6.6%), and lower Per Person Per Month (PPPM) medical costs (-13.5%) compared with unvaccinated individuals. RSV- and influenza-vaccinated individuals had lower ED utilization (15.6% vs 16.6%), fewer inpatient stays (4.9% vs 5.4%), and lower PPPM medical costs (-4.7%) compared with those who were vaccinated against influenza only. All results were statistically significant at the p < 0.001 level.

Conclusions: At 6 months following RSV and influenza vaccination, there is a reduction in medical costs due to fewer inpatient stays and ED visits. This finding highlights the clinical and economic value of vaccination programs for reducing healthcare system burden and improving population health outcomes.

Objective: This study investigated the association between treatment-related adverse events (TRAEs) and clinical outcomes, including pathological response and event-free survival (EFS), in patients with resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant anti-PD-1 immuno-chemotherapy.

Methods: In this retrospective study, 176 patients receiving neoadjuvant PD-1 inhibitors plus chemotherapy (April 2020-August 2023) were analyzed to evaluate the relationships between TRAEs and two predefined clinical outcomes: pathological responses and EFS, in both overall and inverse probability of treatment weighting (IPTW)-adjusted cohorts.

Results: TRAEs occurred in 81.8% of patients, while Immune-related adverse events (irAEs) were observed in 18.2%. After IPTW, myelosuppression, the most common TRAE, occurred in 78 patients, had significantly higher rates of non-major pathological response (NMPR) (53.8% vs. 32.1%; odds ratio 2.46, 95% CI: 1.33-4.58; p < 0.01). Among patients with irAEs, rash/pruritus occurred in 20 patients, with a higher major pathological response (MPR) rate (79.8% vs.53.8%; odds ratio 0.29, 95% CI: 0.09-0.92; p = 0.049). Kaplan-Meier analysis showed that both TRAEs (p = 0.016) and myelosuppression (p = 0.044) were associated with significantly worse EFS. Rash/pruritus was closely associated with a higher MPR rate, but no significant difference was observed in EFS analysis due to the limited number of patients (p = 0.884). PD-1 inhibitor type showed no significant association with EFS (p > 0.05), although tislelizumab was linked to higher rates of fever (p = 0.001) and Hepatic dysfunction (p = 0.038).​.

Conclusions: Myelosuppression is negatively associated with favorable pathological outcomes in NSCLC patients undergoing neoadjuvant immunochemotherapy and serves as a potential predictor of EFS, offering valuable insights for guiding treatment decisions.

Voice biomarkers have been increasingly applied in disease diagnosis and monitoring because of their non-invasive, low-cost, and easily accessible features. This scoping review aimed to summarize existing evidence on voice biomarkers used in heart failure management and to describe their collection, processing, and analysis methods. Four databases (PubMed, CINAHL, Scopus, and IEEE Xplore) were searched from inception to January 10, 2024. Two reviewers independently screened studies and extracted data using a predesigned form. The review followed the Joanna Briggs Institute framework and the PRISMA-ScR guideline. Nineteen studies published between 2010 and 2023 were included. Voice biomarkers were applied for diagnosis or differential diagnosis (9/19) and for assessing or monitoring disease progression (10/19). Voice/speech (11/19) were the most common biomarkers, typically collected via microphones (6/19), phones (3/19), or applications (3/19). Common processing methods included segmentation (9/19), feature extraction (9/19), denoising (8/19), and resampling (7/19). Most studies (12/19) developed new algorithms for data analysis. Model performance was mainly evaluated by accuracy (10/19), sensitivity (7/19), and specificity (6/19). This review highlights the potential of voice/speech biomarkers in heart failure management. Their non-invasive and accessible nature supports their integration into clinical monitoring. However, standardized procedures for data collection, processing, and analysis should be established through multidisciplinary collaboration to enable reliable clinical application.