Tag: nevin manimala

J Racial Ethn Health Disparities. 2023 Apr 18. doi: 10.1007/s40615-022-01486-1. Online ahead of print.

ABSTRACT

BACKGROUND: There are few conflicting results regarding the treatment and outcomes of Hispanic patients with pancreatic cancer. This study comprehensively evaluated the differences in baseline characteristics, treatments, genomic testing, and outcomes among Hispanic (H) and Non-Hispanic (NH) patients with early-stage (ES) and late-stage (LS) pancreatic cancer (PC).

METHODS: This is a retrospective analysis from 2013 to 2020 of 294 patients with pancreatic ductal adenocarcinoma; data collected included patient demographics, clinical characteristics, treatment regimens, response, germline and somatic genetic testing, and survival outcomes. Excluded those with insufficient data. Univariate comparisons used parametric and nonparametric tests as appropriate to evaluate for differences between H and NH groups. Fisher’s exact tests were performed to evaluate the difference in frequency. Kaplan-Meier and Cox regression analysis assessed the survival.

RESULTS: The analysis included 198 patients who had a late-stage disease and 96 patients with early-stage disease at the time of diagnosis. Among the early-stage patients, the median age at diagnosis was 60.7 years in the H versus 66.7 years in the NH (p = 0.03). No other differences were observed in baseline characteristics, treatments offered, and median overall survival (NH 25 vs. H 17.7 months, p = 0.28). Performance status, negative surgical margins, and adjuvant therapy were clinically significant and univariable with improved OS (p < 0.05), regardless of ethnicity. Hispanic patients with early pancreatic cancer were noted to be at a greater risk of death with a statistically significant hazard ratio of 3.1 (p = 0.005, 95% CI, 1.39-6.90). Among the late-stage patients, Hispanic patients with ≥ 3 predisposing risk factors for pancreatic cancer were 44% vs. 25% of NH (p = 0.006). No significant differences were noted in baseline characteristic treatments, progression-free, and median overall survivals (NH 10.0 vs. 9.2 months, p = 0.4577). In the late-stage genomic testing, germline testing performed in NH 69.4% vs. H 43.9% (p = 0.003) revealed no difference among groups. For the somatic testing, the pathogenic variants with actionable mutations were 2.5% of NH and 17.6% of H patients (p = 0.03).

CONCLUSION: Hispanic patients with early-stage pancreatic adenocarcinoma present at a younger age and with more risk factors in the late stage. These patients have significantly lower overall survival compared to their non-Hispanic counterparts. Hispanic patients in our study were 2.9 less likely to receive germline screening and more like to have somatic genetic actionable pathogenic variants. Overall, only a minority of all patients were enrolled in a pancreatic cancer clinical trial or offered genomic testing, highlighting a critical need and missed opportunity in advancing progress and improving outcomes for this disease, mainly in the underrepresented Hispanic population.

PMID:37071331 | DOI:10.1007/s40615-022-01486-1

Ophthalmol Ther. 2023 Apr 18. doi: 10.1007/s40123-023-00709-w. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was to evaluate the safety and efficacy of a violet-light filtering intraocular lens (IOL) compared to a colorless IOL control.

METHODS: This was a prospective, bilateral, randomized, comparative, patient/evaluator-masked multi-center clinical trial at 12 sites in the USA. Patients underwent standard small-incision phacoemulsification cataract extraction. Visual acuity, contrast sensitivity, and color vision were tested 12 months postoperatively. Patient satisfaction and vision-related quality of life were evaluated based on directed patient responses obtained from a binocular subjective questionnaire.

RESULTS: A total of 250 subjects were bilaterally implanted with the violet-light filtering TECNIS monofocal ZV9003 (n = 126) and colorless TECNIS monofocal ZA9003 (n = 124). Mean uncorrected distance visual acuity (UDVA) was 0.123 LogMAR for ZV9003 and 0.116 LogMAR for the ZA9003 group. Mean corrected distance visual acuity (CDVA) was 0.00 LogMAR for both groups. No significant difference was found between the groups for 22/25 questionnaire categories, including color perception. A significant difference was found in favor of the ZV9003 group for day driving, night driving, and frustration with vision. Contrast sensitivity mean difference was < 0.05 log units across all lighting conditions and spatial frequencies.

CONCLUSION: No difference was found between groups for visual acuity, contrast sensitivity, color testing, and adverse events as well as with the majority of optical/visual symptoms. A statistical difference was noted in driving and frustration with eyesight that may be related to benefits of using a violet-light filtering chromophore. Overall, the violet-light filtering ZV9003 showed excellent visual acuity and contrast sensitivity results with a low incidence of optical/visual symptoms.

PMID:37071325 | DOI:10.1007/s40123-023-00709-w

Adv Ther. 2023 Apr 18. doi: 10.1007/s12325-023-02503-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Clinical trials often have short follow-ups, and long-term outcomes such as survival must be extrapolated. Current extrapolation methods often produce a wide range of survival values. To minimize uncertainty in projections, we developed a novel method that incorporates formally elicited expert opinion in a Bayesian analysis and used it to extrapolate survival in the placebo arm of DAPA-CKD, a phase 3 trial of dapagliflozin in patients with chronic kidney disease (NCT03036150).

METHODS: A summary of mortality data from 13 studies that included DAPA-CKD-like populations and training on elicitation were provided to six experts. An elicitation survey was used to gather the experts’ 10- and 20-year survival estimates for patients in the placebo arm of DAPA-CKD. These estimates were combined with DAPA-CKD mortality and general population mortality (GPM) data in a Bayesian analysis to extrapolate long-term survival using seven parametric distributions. Results were compared with those from standard frequentist approaches (with and without GPM data) that do not incorporate expert opinion.

RESULTS: The group expert-elicited estimate for 20-year survival was 31% (lower estimate, 10%; upper estimate, 40%). In the Bayesian analysis, the 20-year extrapolated survival across the seven distributions was 14.9-39.1%, a range that was 2.4- and 1.6-fold smaller than those produced by the frequentist methods (0.0-56.9% without and 0.0-39.2% with GPM data).

CONCLUSIONS: Using expert opinion in a Bayesian analysis provided a robust method for extrapolating long-term survival in the placebo arm of DAPA-CKD. The method could be applied to other populations with limited survival data.

PMID:37071317 | DOI:10.1007/s12325-023-02503-3

Tech Coloproctol. 2023 Apr 18. doi: 10.1007/s10151-023-02796-0. Online ahead of print.

ABSTRACT

PURPOSE: There is an ongoing debate regarding the extent of resection for splenic flexure tumors (SFT). The purpose of this study was to compare segmental and extended resections in terms of overall survival (OS) and pathologic outcomes.

METHODS: Retrospective analysis of all patients surgically treated for SFT in the National Cancer Database (NCDB) for the period 2010-2019. Outcomes of segmental and extended resections were compared and a 1:1 propensity score matching was used to match for confounders. Primary outcome was OS.

RESULTS: In total 3498/668,852 (0.5%) patients with clinical stage I-III splenic flexure adenocarcinoma in the NCDB were included. Of these, 1533 (43.8%) underwent segmental resection while 1965 (56.1%) underwent extended resection. After matching, mean OS was similar between the groups (92 vs 91 months; p = 0.94). When survival was stratified by clinical N stage, an 8-month survival benefit was shown in the extended resection group for clinical N-positive status (86 vs 78); however, this difference did not achieve statistical significance (p = 0.078). Median number of harvested lymph nodes was significantly lower in the segmental resection group (16 vs 17; p < 0.001) and the percentage of patients with fewer than 12 harvested nodes was significantly higher (18.4% vs 11.6%; p < 0.001). Length of stay was significantly shorter in the segmental resection group (5 vs 6 days; p = 0.027). There were no significant differences between the groups in terms of 30-day readmission or 30- or 90-day mortality.

CONCLUSIONS: While segmental and extended resections were associated with similar OS for clinically node-negative SFT, there might be a survival benefit for extended resection in patients with clinical evidence of lymph node involvement.

PMID:37071308 | DOI:10.1007/s10151-023-02796-0

J Digit Imaging. 2023 Apr 18. doi: 10.1007/s10278-023-00806-z. Online ahead of print.

ABSTRACT

This study is aimed to evaluate effects of deep learning image reconstruction (DLIR) on image quality in single-energy CT (SECT) and dual-energy CT (DECT), in reference to adaptive statistical iterative reconstruction-V (ASIR-V). The Gammex 464 phantom was scanned in SECT and DECT modes at three dose levels (5, 10, and 20 mGy). Raw data were reconstructed using six algorithms: filtered back-projection (FBP), ASIR-V at 40% (AV-40) and 100% (AV-100) strength, and DLIR at low (DLIR-L), medium (DLIR-M), and high strength (DLIR-H), to generate SECT 120kVp images and DECT 120kVp-like images. Objective image quality metrics were computed, including noise power spectrum (NPS), task transfer function (TTF), and detectability index (d’). Subjective image quality evaluation, including image noise, texture, sharpness, overall quality, and low- and high-contrast detectability, was performed by six readers. DLIR-H reduced overall noise magnitudes from FBP by 55.2% in a more balanced way of low and high frequency ranges comparing to AV-40, and improved the TTF values at 50% for acrylic inserts by average percentages of 18.32%. Comparing to SECT 20 mGy AV-40 images, the DECT 10 mGy DLIR-H images showed 20.90% and 7.75% improvement in d’ for the small-object high-contrast and large-object low-contrast tasks, respectively. Subjective evaluation showed higher image quality and better detectability. At 50% of the radiation dose level, DECT with DLIR-H yields a gain in objective detectability index compared to full-dose AV-40 SECT images used in daily practice.

PMID:37071291 | DOI:10.1007/s10278-023-00806-z

Sci China Life Sci. 2023 Apr 13. doi: 10.1007/s11427-022-2240-6. Online ahead of print.

ABSTRACT

Cancer is one of the leading causes of human death worldwide. Treatment of cancer exhausts significant medical resources, and the morbidity and mortality caused by cancer is a huge social burden. Cancer has therefore become a serious economic and social problem shared globally. As an increasingly prevalent disease in China, cancer is a huge challenge for the country’s healthcare system. Based on recent data published in the Journal of the National Cancer Center on cancer incidence and mortality in China in 2016, we analyzed the current trends in cancer incidence and changes in cancer mortality and survival rate in China. And also, we examined several key risk factors for cancer pathogenesis and discussed potential countermeasures for cancer prevention and treatment in China.

PMID:37071289 | DOI:10.1007/s11427-022-2240-6

Sleep Breath. 2023 Apr 18. doi: 10.1007/s11325-023-02831-2. Online ahead of print.

ABSTRACT

BACKGROUND: Current studies have focused on the association of fibromyalgia syndrome (FMS) and obsctructive sleep apnea syndrome (OSAS). Results of these studies on the effect of this association have been inconsistent. The current study aimed to investigate the effect of FMS on OSAS regarding sleep quality, pressure pain threshold, fatigue, daytime symptoms, anxiety, and depression, and also to determine the relationship between OSAS severity and FMS.

METHODS: In a cross-sectional design, patients diagnosed with OSAS were evaluated in two groups comparing those with and those without FMS. Data on demographics, headache, morning fatigue, and chronic pain duration were collected. Questionnaires including the Fatigue Severity Scale (FSS), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI) were completed. Pressure pain threshold, tender points, and polysomnographic data were recorded.

RESULTS: Of 69 patients, 27 were diagnosed with FMS + OSAS and 42 were diagnosed as OSAS only. Statistically significant differences were found between the two groups in VAS, pain duration, morning fatigue, headache, BAI, tender point count, FIQ and FSS scores, and algometer measurements. All polysomnografic data were compared, and no statistically significant differences were found between the two groups. There were no statistically significant differences in the algometer, BDI, BAI, FIQ, and FSS scores when analyzed according to the severity of OSAS.

CONCLUSION: The findings suggest that FMS has no effect on polysomnographic parameters of OSAS. Headache, daytime fatigue, anxiety, depression, pain duration, and pain intensity are higher while the pressure pain threshold is lower when FMS is present. No correlation was found between OSAS severity and FMS, fatigue, pressure pain threshold, depression, and anxiety.

CLINICAL TRIAL REGISTRATION NUMBER: NCT05367167/date: April 8, 2022.

PMID:37071285 | DOI:10.1007/s11325-023-02831-2

Sports Med. 2023 Apr 18. doi: 10.1007/s40279-023-01844-x. Online ahead of print.

ABSTRACT

BACKGROUND: With the increasing professionalisation of youth sports, training load monitoring is increasingly common in adolescent athletes. However, the research examining the relationship between training load and changes in physical qualities, injury, or illness in adolescent athletes is yet to be synthesised in a systematic review.

OBJECTIVE: The aim of this review was to systematically examine the research assessing internal and external methods of monitoring training load and physical qualities, injury, or illness in adolescent athletes.

METHODS: Systematic searches of SPORTDiscus, Web of Science, CINAHL and SCOPUS were undertaken from the earliest possible records to March 2022. Search terms included synonyms relevant to adolescents, athletes, physical qualities, injury, or illness. To be eligible for inclusion, articles were required to (1) be original research articles; (2) be published in a peer-reviewed journal; (3) include participants aged between 10 and 19 years and participating in competitive sport; (4) report a statistical relationship between a measure of internal and/or external load and physical qualities, injury or illness. Articles were screened and assessed for methodological quality. A best-evidence synthesis was conducted to identify trends in the relationships reported.

RESULTS: The electronic search yielded 4125 articles. Following screening and a review of references, 59 articles were included. The most commonly reported load monitoring tools were session ratings of perceived exertion (n = 29) and training duration (n = 22). Results of the best-evidence synthesis identified moderate evidence of positive relationships between resistance training volume load and improvement in strength, and between throw count and injury. However, evidence for other relationships between training load and change in physical qualities, injury, or illness were limited or inconsistent.

CONCLUSIONS: Practitioners should consider monitoring resistance training volume load for strength training. Additionally, where appropriate, monitoring throw counts may be useful in identifying injury risk. However, given the lack of clear relationships between singular measures of training load with physical qualities, injury, or illness, researchers should consider multivariate methods of analysing training load, as well as factors that may mediate the load-response relationship, such as maturation.

PMID:37071283 | DOI:10.1007/s40279-023-01844-x

Pediatr Blood Cancer. 2023 Apr 18:e30357. doi: 10.1002/pbc.30357. Online ahead of print.

ABSTRACT

INTRODUCTION: Rhabdomyosarcoma (RMS) of the chest wall presents unique management challenges and local control considerations. The benefit of complete excision is uncertain and must be weighed against potential surgical morbidity. Our aim was to assess factors, including local control modality, associated with clinical outcomes in children with chest wall RMS.

METHODS: Forty-four children with RMS of the chest wall from low-, intermediate-, and high-risk Children’s Oncology Group studies were reviewed. Predictors of local failure-free survival (FFS), event-free survival (EFS), and overall survival (OS) were assessed, including clinical characteristics and staging, primary tumor anatomic locations, and local control modalities. Survival was assessed by Kaplan-Meier analysis and the log-rank test.

RESULTS: Tumors were localized in 25 (57%) and metastatic in 19 (43%), and they involved the intercostal region (52%) or superficial muscle alone (36%). Clinical group was I (18%), II (14%), III (25%), and IV (43%), and ultimately 19 (43%) patients had surgical resection (upfront or delayed), including 10 R0 resections. Five-year local FFS, EFS, and OS were 72.1%, 49.3%, and 58.5%, respectively. Univariate factors associated with local FFS included age, International Rhabdomyosarcoma Study (IRS) group, extent of surgical excision, tumor size, superficial tumor location, and presence of regional or metastatic disease. Other than tumor size, the same factors were associated with EFS and OS.

CONCLUSIONS: Chest wall RMS has variable presentation and outcome. Local control is a significant contributor to EFS and OS. Complete surgical excision, whether upfront or after induction chemotherapy, is usually only possible for smaller tumors confined to the superficial musculature but is associated with improved outcomes. While overall outcomes remain poor for patients with initially metastatic tumors, regardless of local control modality, complete excision may be beneficial for patients with localized tumors if it can be achieved without excess morbidity.

PMID:37070563 | DOI:10.1002/pbc.30357

AIDS. 2023 Apr 14. doi: 10.1097/QAD.0000000000003576. Online ahead of print.

ABSTRACT

OBJECTIVE: Limited pharmacokinetic/pharmacodynamic data are a barrier to the well tolerated scale-up of dolutegravir-based antiretroviral therapy (ART) in children. We examined the pharmacokinetic/pharmacodynamic of the adult film-coated dolutegravir 50 mg tablets in children with HIV infection weighing at least 20 kg.

DESIGN: A prospective, observational, pharmacokinetic, and safety study.

METHODS: Treatment-experienced children with HIV weighing at least 20 kg and evidence of viral load suppression on ART were enrolled and switched to dolutegravir-based therapy. After at least 4 weeks and 7 months on dolutegravir-based therapy, blood samples were collected at 0, 1, 4, 8, 12, and 24-h postdose. Dolutegravir concentrations were measured using validated LCMS/MS and pharmacokinetic parameters calculated by noncompartmental analysis. Descriptive statistics were used to summarize pharmacokinetic parameters and comparisons with published reference values.

RESULTS: Of 25 participants, 92% were on efavirenz-based ART and 60.0% were men. Dolutegravir mean exposure, peak and trough concentrations at both pharmacokinetic visits were higher than the mean reference values in adults and children weighing 20 kg to less than 40 kg treated with 50 mg once daily, but were closer to the mean values in adults given 50 mg twice a day. Children weighing 20 kg to less than 40 kg had even higher dolutegravir exposures. The regimens were well tolerated with good virologic efficacy through week 48.

CONCLUSION: The higher dolutegravir exposure in our study population suggests that further studies and close monitoring should investigate the adverse effects of dolutegravir in more children and in the long term.

PMID:37070558 | DOI:10.1097/QAD.0000000000003576