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Nevin Manimala Statistics

Post Hoc Analysis of Rapid and Deep Prostate-specific Antigen Decline and Patient-reported Health-related Quality of Life in SPARTAN and TITAN Patients with Advanced Prostate Cancer

Eur Urol Oncol. 2023 Dec 9:S2588-9311(23)00280-8. doi: 10.1016/j.euo.2023.11.015. Online ahead of print.

ABSTRACT

BACKGROUND: Adding apalutamide to androgen-deprivation therapy (ADT) resulted in a rapid (at 3- and 6-mo treatment) and deep prostate-specific antigen (PSA) decline (to ≤0.2 ng/ml or ≥90% from baseline), improved overall survival, reduced risk of disease progression, and prolonged health-related quality of life (HRQoL) in nonmetastatic castration-resistant prostate cancer (nmCRPC) in SPARTAN and metastatic castration-sensitive PC (mCSPC) in TITAN.

OBJECTIVE: To evaluate the association of a rapid, deep PSA decline at 3 and 6 mo achieved with the addition of apalutamide to ADT with patient-reported outcomes (PROs) in SPARTAN and TITAN.

DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis of SPARTAN and TITAN PRO data was performed.

INTERVENTION: Apalutamide versus placebo plus concurrent ADT.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PROs were assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P; SPARTAN and TITAN), Brief Pain Inventory-Short Form (BPI-SF; TITAN), and Brief Fatigue Inventory (BFI; TITAN) at baseline, prespecified cycles during treatment, and after progression for ≤1 yr. The association between a deep PSA decline at landmark 3 or 6 mo of apalutamide and the time to worsening of PROs was assessed using the Kaplan-Meier methodology and Cox proportional-hazard modeling.

RESULTS AND LIMITATIONS: Among 806 SPARTAN and 525 TITAN apalutamide-treated patients, the median treatment duration was 32.9 and 39.3 mo, respectively. Patients achieving a deep PSA decline at 3 mo had longer time to worsening in FACT-P total, FACT-P physical well-being, BPI-SF worst pain intensity, or BFI worst fatigue intensity. The 6-mo PSA decline results were similar. Limitations of patient characteristics in clinical studies should be considered.

CONCLUSIONS: Attaining a deep and rapid PSA decline at 3 mo with apalutamide plus ADT was associated with longer preservation of overall HRQoL and physical well-being in nmCRPC and mCSPC.

PATIENT SUMMARY: Quality of life is maintained in individuals with advanced prostate cancer who achieve a deep prostate-specific antigen decline at 3 mo of apalutamide plus drugs that lower male sex hormones.

PMID:38072759 | DOI:10.1016/j.euo.2023.11.015

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Higher prevalence of benign tumors in men with testicular tumors and history of treated cryptorchidism

Urol Oncol. 2023 Dec 9:S1078-1439(23)00413-1. doi: 10.1016/j.urolonc.2023.11.016. Online ahead of print.

ABSTRACT

OBJECTIVES: To identify if surgically treated cryptorchidism correlated with testicular tumor pathology at presentation.

MATERIALS AND METHODS: An institutional database of patients treated for testicular cancer between 2003 and 2020 was reviewed. Inclusion criteria included orchiectomy patients. Exclusion criteria included unknown cryptorchidism history or pathology or laterality of orchiectomy. Data collection included demographics, surgical history, and tumor marker status.

RESULTS: A total of 435 patients were included. Thirty-three of these patients had a history of UDT. There was no statistical difference in age at orchiectomy, laterality of orchiectomy, or lymphovascular invasion with regard to UDT history. There was a statistical difference in tumor pathology after orchiectomy, P = 0.03. On secondary analysis, benign pathology was significantly more common in patients with a history of UDT (15.2%) than without (4.7%), P = 0.01. Mixed GCT was also found at a significantly lower rate in patients with a history of UDT (18.2%) compared to those with no history of UDT (37.3%), P = 0.03. There were no statistically significant differences in other pathology.

CONCLUSION: Previous studies have shown that there is a greater rate of seminoma in patients with testicular cancer in an undescended testis. This study shows that in patients with a history of UDT compared to those without a history of UDT, there is a greater percentage of patients with benign testicular masses after orchiectomy. Guideline based practices including monthly self-examination and testis-sparing surgery for appropriate patients may reduce rates of radical orchiectomy for benign tumors.

PMID:38072736 | DOI:10.1016/j.urolonc.2023.11.016

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Nevin Manimala Statistics

Evaluation of a pilot online education program to develop midwives’ knowledge, skill and confidence in perinatal mental health in rural South Australia

Women Birth. 2023 Dec 9:S1871-5192(23)00308-6. doi: 10.1016/j.wombi.2023.11.005. Online ahead of print.

ABSTRACT

One in five women will experience perinatal anxiety and/or depression. In South Australia, a rural health service identified a high proportion of women with risk of perinatal mental health challenges and sought additional education for midwives. In response, a six-week facilitated, online perinatal mental health education program (e-PMHEP) was piloted.

AIM: The aim of this study was to evaluate the effectiveness of the (e-PMHEP) for rural midwives, nurses and Aboriginal maternal infant care practitioners.

METHOD: Program evaluation incorporated a validated online pre/post survey to assess self-reported knowledge, skill and confidence regarding perinatal mental healthcare. Additional questions sought feedback on satisfaction and feasibility.

FINDINGS: Sixteen participants from rural South Australia engaged in the project from June to August 2022. Twelve participants completed the online pre/post survey. The overall pre/post knowledge scores were statistically significant (t = 2.73, 8df, p = 0.025) with improvement from the pre to post-test. Pre/post data also showed a measurable increase in confidence and skills. All respondents agreed that the content addressed their learning needs and would recommend this program to other practitioners.

DISCUSSION: The e-PMHEP appeared beneficial in developing knowledge, skills and confidence regarding perinatal mental healthcare in rural midwives and practitioners. Only a third of practitioners routinely developed a mental health care plan with women. Key strengths of the program included the accessible content, and the combination of an experienced mental health clinician and a facilitator with lived experience.

CONCLUSION: Providing an accessible, facilitated online perinatal mental health education program could be beneficial for rural midwives.

PMID:38072708 | DOI:10.1016/j.wombi.2023.11.005

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Stereoselective separation of psychoactive substances: Multivariate optimization and validation of a capillary electrophoresis method using carboxymethyl-β-CD/deep eutectic solvent dual system

J Pharm Biomed Anal. 2023 Dec 7;239:115897. doi: 10.1016/j.jpba.2023.115897. Online ahead of print.

ABSTRACT

A comprehensive study was performed to determine an optimum enantioseparation method for fluorine-substituted amphetamine and cathinone derivatives (fluor-amphetamine and fluor-cathinone derivatives), using a binary system consisting of carboxymethyl-β-CD (CM-β-CD) and a deep eutectic solvent (DES), namely choline chloride-ethylene glycol (ChCl-EG). Under this framework, the optimization and modeling of the separation conditions in a binary system were performed with the objective of maximizing resolution and minimizing analysis time. This was achieved through the application of response surface methodology. In particular, the effect of chiral selector concentration and percentage of DES on resolution and analysis time were investigated and optimized using a complete experimental design. The optimum enantioseparation conditions were determined to be 13.84 mM CM-β-CD and 0.15% v/v ChCl-EG for fluorine-substituted amphetamine derivatives and 14.36 mM and 0.75% v/v ChCl-EG for fluorine-substituted cathinone derivatives, respectively. This combination resulted in a baseline separation for eight out of the nine analytes studied. Overall, the results demonstrated the synergistic effect of the CM-β-CD/DES dual system and highlighted the significance of DESs as additives in capillary electrophoresis.

PMID:38071765 | DOI:10.1016/j.jpba.2023.115897

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Engaging older Australians in sexual health research: SHAPE2 survey recruitment and sample

Sex Health. 2023 Dec 11. doi: 10.1071/SH23116. Online ahead of print.

ABSTRACT

BACKGROUND: Sexual health research rarely includes older age groups and the sexual health needs of older Australians are not well understood. Older adults are online in increasing numbers; however, internet surveys involving samples of older adults and sensitive topics remain uncommon. In 2021, we developed an online survey to explore the sexual health needs of Australians aged 60+years. We describe here survey recruitment and sample obtained, comparing it with national population data (Australian Bureau of Statistics) and the sample of the similar ‘Sex, Age and Me’ study from 2015.

METHODS: We recruited 1470 people with a staggered three-phase strategy: (1) emails to organisations and community groups; (2) paid Facebook advertising; and (3) passive recruitment. Half (50.6%) found out about the study via an organisation or group and just over a third (35.7%) from Facebook.

RESULTS: The sample was equally balanced between men (49.9%) and women (49.7%) (0.4% other gender identities). Participants were aged 60-92years (median 69years) with all Australian States/Territories represented. Facebook recruits were younger, more likely to be working rather than retired, and more likely to live outside a major city, than those recruited by other means.

CONCLUSIONS: Using the recruitment methods described, we successfully obtained a diverse and fairly representative sample of older Australians within the constraints of a convenience sample and on a modest budget. This research sheds light on ways to engage an under-served demographic in sexual health research. Our experience shows that many older adults are amenable to recruitment for online sexual health surveys using the approaches outlined.

PMID:38071758 | DOI:10.1071/SH23116

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Perspectives of community pharmacists on extended pharmacy services and value-added services in Malaysia: a cross-sectional survey

Int J Pharm Pract. 2023 Dec 10:riad087. doi: 10.1093/ijpp/riad087. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to investigate patterns of extended pharmacy services (EPS) provided by Malaysian community pharmacists and their willingness to provide value-added services (VAS) in addition to EPS. Additionally, this study examined the barriers to the effective implementation of these two services.

METHOD: A cross-sectional survey was conducted using a self-administered questionnaire among community pharmacists in Selangor and Kuala Lumpur. Convenience sampling was done, and descriptive statistics and correlation analysis were performed.

RESULTS: Two hundred and thirty-six pharmacists participated. The most rendered EPS were nutritional supplements, hypertension management, and diabetic management, while chronic kidney disease management, smoking cessation, and mental health services were the least rendered. Pharmacists were willing to provide medication waste management and vaccination as VAS but were less inclined towards therapeutic drug monitoring and sterile compounding. Barriers included limited access to medical records of patients, lack of designated counselling areas, and concerns about remuneration. High sales pressure and busy workloads were additional barriers to providing VAS. Continuous professional development (CPD) positively influenced pharmacists’ engagement in EPS and VAS.

CONCLUSIONS: This study highlights service provision trends and areas for improvement. Addressing identified barriers, such as enhancing access to patient records and establishing designated counselling areas, can improve service delivery. Remuneration models and workload management strategies should be considered to alleviate barriers related to sales pressure and time constraints. Promoting CPD opportunities is crucial for enhancing pharmacist engagement and optimizing EPS and VAS.

PMID:38071745 | DOI:10.1093/ijpp/riad087

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On the Connection Between Language Change and Language Processing

Cogn Sci. 2023 Dec;47(12):e13384. doi: 10.1111/cogs.13384.

ABSTRACT

Previous studies provided evidence for a connection between language processing and language change. We add to these studies with an exploration of the influence of lexical-distributional properties of words in orthographic space, semantic space, and the mapping between orthographic and semantic space on the probability of lexical extinction. Through a binomial linear regression analysis, we investigated the probability of lexical extinction by the first decade of the twenty-first century (2000s) for words that existed in the first decade of the nineteenth-century (1800s) in eight data sets for five languages: English, French, German, Italian, and Spanish. The binomial linear regression analysis revealed that words that are more similar in form to other words are less likely to disappear from a language. By contrast, words that are more similar in meaning to other words are more likely to become extinct. In addition, a more consistent mapping between form and meaning protects a word from lexical extinction. A nonlinear time-to-event analysis furthermore revealed that the position of a word in orthographic and semantic space continues to influence the probability of it disappearing from a language for at least 200 years. Effects of the lexical-distributional properties of words under investigation here have been reported in the language processing literature as well. The results reported here, therefore, fit well with a usage-based approach to language change, which holds that language change is at least to some extent connected to cognitive mechanisms in the human brain.

PMID:38071744 | DOI:10.1111/cogs.13384

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Chromocolposcopy with fluorescein sodium for detection of premalignant and malignant lesions of the cervix: A cross-sectional study

Int J Gynaecol Obstet. 2023 Dec 10. doi: 10.1002/ijgo.15283. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to explore the utility of fluorescein sodium (FNa) as a contrast agent for colposcopy to detect premalignant and malignant lesions of cervix. The primary objective was to determine and compare the percentage detection of premalignant and malignant lesions of FNa and acetic acid (AA) positive areas.

METHODS: This study included 120 screen positive women who underwent colposcopy using both 3% AA and FNa (0.06%). Observations for FNa staining were made under blue filter and directed biopsies were taken from acetowhite and fluorescent green areas. Benign lesions were considered as disease-negative and low grade squamous intraepithelial lesions (LSIL), high grade SIL (HSIL), and invasive cancer were considered as disease-positive. Correlation between histopathology and FNa and AA was determined by Kappa statistics.

RESULTS: The mean age was 39.59 ± 10.73 years and median parity was 2. Out of 120 patients, 57 had benign lesions, 18 had LSIL, 33 had HSIL and 12 had invasive carcinomas. Sensitivity was 98.41% versus 64.91% respectively and specificity was 85.71% versus 35.09% respectively with FNa and AA. Diagnostic accuracy of FNa and AA was 82.50% versus 61.60%. There was good agreement between FNa staining and final histopathology and fair agreement between AA application and HPE (κ = 0.643 vs 0.213, P < 0.001).

CONCLUSION: Using FNa as a contrast agent during colposcopy results in greater accuracy for detection of premalignant and malignant lesions of the cervix as compared to AA.

PMID:38071725 | DOI:10.1002/ijgo.15283

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Robotic Versus Thoracoscopic Sub-lobar Resection for Octogenarians with Clinical Stage IA Non-small Cell Lung Cancer: A Propensity Score-Matched Real-World Study

Ann Surg Oncol. 2023 Dec 10. doi: 10.1245/s10434-023-14689-5. Online ahead of print.

ABSTRACT

BACKGROUND: Minimally invasive sub-lobectomy is sufficient in treating small early-stage non-small cell lung cancer (NSCLC). However, comparison of the feasibility and oncologic efficacy between robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS) in performing sub-lobectomy for early-stage NSCLC patients age 80 years or older is scarce.

METHODS: Octogenarians with clinical stage IA NSCLC (tumor size, ≤ 2 cm) undergoing minimally invasive wedge resection or segmentectomy at Shanghai Chest Hospital from 2011 to 2020 were retrospectively reviewed from a prospectively maintained database. Propensity score-matching (PSM) with a RATS versus VATS ratio of 1:4 was performed. Perioperative and long-term outcomes were analyzed.

RESULTS: The study identified 594 patients (48 RATS and 546 VATS patients), and PSM resulted in 45 cases in the RATS group and 180 cases in the VATS group. The RATS patients experienced less intraoperative bleeding (60 mL [interquartile range (IQR), 50-100 mL] vs. 80 mL [IQR, 50-100 mL]; P = 0.027) and a shorter postoperative hospital stay (4 days [IQR, 3-5 days] vs. 5 days [IQR, 4-6 days]; P = 0.041) than the VATS patients. The two surgical approaches were comparable concerning other perioperative outcomes and postoperative complications (20.00% vs. 26.11%; P = 0.396). Additionally, during a median follow-up period of 66 months, RATS and VATS achieved comparable 5-year overall survival (90.48% vs. 87.93%; P = 0.891), recurrence-free survival (83.37% vs. 83.18%; P = 0.782), and cumulative incidence of death. Further subgroup comparison also demonstrated comparable long-term outcomes between the two approaches. Finally, multivariate Cox analysis indicated that the surgical approach was not independently correlated with long-term outcomes.

CONCLUSIONS: The RATS approach shortened the postoperative hospital stay, reduced intraoperative bleeding by a statistically notable but clinically insignificant amount, and achieved long-term outcomes comparable with VATS in performing sub-lobectomy for octogenarians with early-stage small NSCLC.

PMID:38071721 | DOI:10.1245/s10434-023-14689-5

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Valproic acid for agitation in the intensive care unit: an observational study of psychiatric consults

Int J Clin Pharm. 2023 Dec 10. doi: 10.1007/s11096-023-01661-2. Online ahead of print.

ABSTRACT

BACKGROUND: Agitation is a common clinical problem encountered in the intensive care unit (ICU). Treatment options are based on clinical experience and sparse quality literature.

AIM: The aim of this study was to describe the effect of valproic acid (VPA) as adjuvant treatment for agitation in the ICU, identify predictors of response to VPA and evaluate the independent effect of VPA on agitation compared to standard of care (SOC).

METHOD: This retrospective single center observational study evaluated adult patients admitted to the ICU for whom a psychiatric consultation was requested for agitation management, with agitation defined as a Richmond Agitation Sedation Score of 2 or greater. A descriptive analysis of the proportion of agitation-free patients per day of follow-up, the incidence of agitation-related-events, as well as the evolution of co-medications use over time are presented. A logistic regression model was used to assess predictors of VPA response, defined as being agitation-free on Day 7 and generalized estimating equations were used to evaluate the independent effect of VPA as adjuvant therapy for agitation in the critically ill.

RESULTS: One hundred seventy-five patients were included in the study with 78 receiving VPA. The percentage of agitation-free patients on VPA was 6.5% (5/77) on Day 1, 14.1% (11/78) on Day 3 and 39.5% (30/76) on Day 7. Multivariate regression model for clinical and demographic variables identified female gender as predictor of response on Day 7 (OR 6.10 [1.18-31.64], p = 0.03). The independent effect of VPA was non-significant when compared to SOC.

CONCLUSION: Although VPA used as adjuvant treatment was associated with a decrease in agitation, its effect when compared to SOC did not yield significant results.

PMID:38071694 | DOI:10.1007/s11096-023-01661-2