Nevin Manimala

J Am Pharm Assoc (2003). 2024 Aug 10:102172. doi: 10.1016/j.japh.2024.102172. Online ahead of print.

ABSTRACT

BACKGROUND: North Carolina (NC) House Bill 96, effective February 2022, enabled trained immunizing pharmacists across the state to prescribe hormonal contraceptives (HCs). However, the extent and barriers to deployment are unknown. The purpose of this study was to describe the uptake and challenges from outpatient pharmacists who trained to provide HCs in an outpatient practice to assist others in the implementation of this service.

OBJECTIVES: The primary objective was to estimate the proportion of trained NC pharmacists who provided HCs in an outpatient setting. The secondary objective was to identify barriers during the implementation of this service.

METHODS: This cross-sectional, anonymous, web-based survey was emailed on December 13, 2022, to NC-licensed pharmacists enrolled in the required training. A reminder email was sent on January 10, 2023, with all responses considered up to January 31, 2023. Pharmacists licensed in NC who performed at least 50% of their clinical practice in an outpatient setting were included. The primary endpoint was having prescribed HC (Y/N). All endpoints were analyzed using descriptive statistics.

RESULTS: Of 1633 pharmacists eligible, 96 completed responses were included in the analysis (5.9%). Training was incomplete in 11 of 96 (11.5%), and 66 of 96 (68.8%) completed the training without implementing the service. Of the remaining 19 of 96 (19.8%) that developed a HC service, 15 of 96 (15.6%) had prescribed HCs. Among the 15 prescribing pharmacists, all reported positive patient feedback, while 7 reported improved job satisfaction. Among all 96 respondents, barriers reported included time constraints (49%) and a lack of appropriate reimbursement (43.8%).

CONCLUSION: Few HC-trained NC outpatient pharmacists are prescribing HCs. Addressing prescribing barriers would potentially expand the scope of this service and further innovate the outpatient pharmacy setting.

PMID:39127934 | DOI:10.1016/j.japh.2024.102172

J Bone Miner Res. 2024 Aug 4:zjae126. doi: 10.1093/jbmr/zjae126. Online ahead of print.

ABSTRACT

There is a strong association between total hip bone mineral density (THBMD) changes after 24 months of treatment and reduced fracture risk. We examined whether changes in THBMD after 12- and 18 months of treatment are also associated with fracture risk reduction. We used individual patient data (n = 122 235 participants) from 22 randomised, placebo-controlled, double-blind trials of osteoporosis medications. We calculated the difference in mean percent change in THBMD (active-placebo) at 12, 18, and 24 months using data available for each trial. We determined the treatment-related fracture reductions for the entire follow-up period, using logistic regression for radiologic vertebral fractures and Cox regression for hip, non-vertebral, “all” (combination of non-vertebral, clinical vertebral, and radiologic vertebral) fractures, and all clinical fractures (combination of non-vertebral and clinical vertebral). We performed meta-regression to estimate the study-level association (r2 and 95% confidence interval) between treatment-related differences in THBMD changes for each BMD measurement interval and fracture risk reduction. The meta-regression revealed that for vertebral fractures, the r2 (95% confidence interval) was 0.59 (0.19, 0.75), 0.69 (0.32, 0.82), and 0.73 (0.33, 0.84) for 12, 18 and 24 months, respectively. Similar patterns were observed for hip: r2 = 0.27 (0.00, 0.54), 0.39 (0.02, 0.63), and 0.41 (0.02, 0.65); non-vertebral: r2 = 0.27 (0.01, 0.52), 0.49 (0.10, 0.69), and 0.53 (0.11, 0.72); all fractures: r2 = 0.44 (0.10, 0.64), 0.63 (0.24, 0.77), and 0.66 (0.25, 0.80); and all clinical fractures: r2 = 0.46 (0.11, 0.65), 0.64 (0.26, 0.78), and 0.71 (0.32, 0.83), for 12-, 18- and 24-month changes in THBMD, respectively. These findings demonstrate that treatment-related THBMD changes at 12, 18 and 24 months are associated with fracture risk reductions across trials. We conclude that BMD measurement intervals as short as 12 months could be used to assess fracture efficacy, but the association is stronger with longer BMD measurement intervals.

PMID:39127916 | DOI:10.1093/jbmr/zjae126

Int J Gynaecol Obstet. 2024 Aug 11. doi: 10.1002/ijgo.15794. Online ahead of print.

ABSTRACT

Despite efforts to reduce stillbirths and neonatal deaths, inconsistent definitions and reporting practices continue to hamper global progress. Existing data frequently being limited in terms of quality and comparability across countries. This paper addresses this critical issue by outlining the new International Classification of Disease (ICD-11) recommendations for standardized recording and reporting of perinatal deaths to improve data accuracy and international comparison. Key advancements in ICD-11 include using gestational age as the primary threshold to for reporting, clearer guidance on measurement and recording of gestational age, and reporting mortality rates by gestational age subgroups to enable country comparisons to include similar populations (e.g., all births from 154 days [22⁺⁰ weeks] or from 196 days [28⁺⁰ weeks]). Furthermore, the revised ICD-11 guidance provides further clarification around the exclusion of terminations of pregnancy (induced abortions) from perinatal mortality statistics. Implementing standardized recording and reporting methods laid out in ICD-11 will be crucial for accurate global data on stillbirths and perinatal deaths. Such high-quality data would both allow appropriate regional and international comparisons to be made and serve as a resource to improve clinical practice and epidemiological and health surveillance, enabling focusing of limited programmatic and research funds towards ending preventable deaths and improving outcomes for every woman and every baby, everywhere.

PMID:39127912 | DOI:10.1002/ijgo.15794

Ann Saudi Med. 2024 Jul-Aug;44(4):255-263. doi: 10.5144/0256-4947.2024.255. Epub 2024 Aug 1.

ABSTRACT

BACKGROUND: The appendix is a small organ with no particular known function. Primary appendiceal neoplasms (ANs) are rare. While the prevalence is increasing worldwide over the past two decades, no apparent increase in the prevalence of ANs has been reported in the Arabian Gulf States. Recently, a significant decline in the age at diagnosis of some types of ANs has been reported worldwide, with a female predominance.

OBJECTIVES: Evaluate the prevalence and clinicopathological characteristics of ANs within our institution in Saudi Arabia and compare them to limited existing studies from different regions as well as the Arabian Gulf States.

DESIGN: Retrospective cohort.

SETTING: Tertiary care center in Riyadh.

PATIENTS AND METHODS: All patients who underwent appendectomy and had the appendix submitted for histopathological evaluation between May 2015 and June 2020 were included to allow for a follow-up of 5 years or more at the time of data collection.

MAIN OUTCOME MEASURES: Demographics, clinical presentations, surgical interventions, histopathological findings, complications, and recurrence rates.

SAMPLE SIZE: 25 AN patients.

RESULTS: Of 1110 patients, 25 had ANs (13 female and 12 male participants) with a mean (standard deviation) age of 54.6 (14.1) years. Only 40% presented with acute appendicitis, 64% had comorbidities, and less than 50% underwent laparoscopic appendectomy. Histopathologically, 72% were low-grade appendiceal mucinous neoplasms (LAMNs). Complications were minimal grades (Clavien-Dindo classification), with 80% experiencing none. The mean hospital stay was 9.96 days. Local recurrence occurred in 8% of cases, and distant metastasis was documented in one adenocarcinoma case. However, the 5-year overall and disease-free survival rates were 88% and 80%, respectively.

CONCLUSIONS: The incidence of ANs is increasing in Saudi Arabia with the higher prevalence of LAMNs. The pathological examination of the resected appendix played a pivotal role in the diagnosis of ANs.

LIMITATIONS: Data collected retrospectively, a single institution, and a small population.

PMID:39127899 | DOI:10.5144/0256-4947.2024.255

Ann Saudi Med. 2024 Jul-Aug;44(4):213-219. doi: 10.5144/0256-4947.2024.213. Epub 2024 Aug 1.

ABSTRACT

BACKGROUND: In the treatment of early stage laryngeal cancers, surgery (transoral laryngeal surgery (TOLS), open partial laryngeal surgery (OPLS) and radiotherapy (RT) are used.

OBJECTIVES: Compare the oncological results of patients with early stage laryngeal squamous cell carcinoma (LSCC) treated with TOLS or RT.

DESIGN: Retrospective.

SETTINGS: Tertiary training and research hospital.

PATIENTS AND METHODS: The participants were divided into patients who underwent TOLS and RT treatment. The groups were compared with each other in terms of local recurrence, regional recurrence, distant metastasis, 3 and 5-year overall survival (OS), disease-free survival (DFS), disease-specific survival (DSS) and laryngectomy-free survival rates (LFS).

MAIN OUTCOME MEASURES: The effects of TOLS and RT treatment on local control, regional control, OS, DFS, DDS and LFS in early stage laryngeal cancers.

SAMPLE SIZE: 261.

RESULTS: The mean follow-up time was 48 (26) months. There were 186 patients who underwent TOLS and 75 patients who underwent RT treatment. Gender, cigarette/alcohol consumption, tumor localization, anterior commissure involvement, tumor grades, recurrence rates and recurrence localizations of the groups were similar. The 5-year overall, disease specific, disease free and laryngectomy-free survival rates were 85.9%, 88%, 79.4%, 96.3% in the TOLS group and 74.3%, 76.7%, 72.3%, 85.2% in the RT group (P=.034, .065, .269, .060, respectively).

CONCLUSIONS: TOLS had equal and good oncological outcomes on OS and DFS compared to RT. Anterior commissure involvement was statistically significant independent prognostic risk factor for DFS in both groups. The 5-year OS rate was greater in the TOLS groups (P=.034).

LIMITATIONS: Retrospective, but to the best our knowledge, this is the first study in Turkey with a high patient volume and a long follow-up time.

PMID:39127898 | DOI:10.5144/0256-4947.2024.213

Ann Saudi Med. 2024 Jul-Aug;44(4):264-271. doi: 10.5144/0256-4947.2024.264. Epub 2024 Aug 1.

ABSTRACT

INTRODUCTION: This study aimed to determine the efficacy and safety of autologous PRP in anal fistula.

METHODS: The search was done in electronic databases such as; PubMed, Scopus, Google Scholar, Embase, and Cochrane Library. The outcomes investigated in this study were the rate of improvement, the rate of recurrence, and the rate of fecal incontinence.

RESULTS: Cure, incontinence, and recurrence rates were 68% (95% CI, .60-.76), 27% (95% CI, .12-.46), and 18% (95% CI, .12-.26), respectively. The pooled improvement ratio in patients treated with PRP compared to control group was 1.35 times, which was statistically significant (pooled OR=1.35, 95% CI, 1.14-1.60, P<001). The pooled recurrence ratio in patients treated with PRP compared to control group was 1.17, which was not statistically significant (pooled OR=1.17, 95% CI, 0.44-3.11).

DISCUSSION: Platelet-rich plasma is an effective method of healing people with anal fistula.

PMID:39127896 | DOI:10.5144/0256-4947.2024.264

Glob Health Promot. 2024 Aug 10:17579759241261049. doi: 10.1177/17579759241261049. Online ahead of print.

ABSTRACT

This paper describes fuzzy cognitive mapping as an accessible and robust tool to strengthen community engagement in health promotion research. We outline how fuzzy cognitive mapping can combine, compare, and contextualize knowledge and priorities from diverse population groups as well as from evidence syntheses. We present procedures to represent a shared perspective across populations or population groups through reconciling maps by simple or weighted averaging. We present a novel second approach to reconciling derived from discourse analysis. We then present two procedures to contextualize one knowledge in another knowledge. The first procedure draws on Bayesian updating, providing a formal way to account for stakeholder knowledge in contextualizing other knowledge sources, including evidence syntheses. A second approach compares discourse patterns across maps derived from different sources. We provide examples of each procedure, describe how each may contribute to greater incorporation of patient- and community-level input in decision-making, and share tools for researchers interested in applications of fuzzy cognitive mapping.

PMID:39127878 | DOI:10.1177/17579759241261049

Clin Pharmacokinet. 2024 Aug 10. doi: 10.1007/s40262-024-01407-x. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Overactivation of the PI3K/AKT pathway can occur in many cancers. Capivasertib is a potent, selective pan-AKT inhibitor. The objectives of this analysis were to develop a population pharmacokinetic model for capivasertib and to quantitatively assess the impact of intrinsic and extrinsic factors on the pharmacokinetics of capivasertib.

METHODS: Pharmacokinetic data from four phase I and II studies were combined. Capivasertib was administered orally at a dose range of 80-800 mg twice daily over 28-day and 21-day cycles as monotherapy or in combination with paclitaxel or fulvestrant, using continuous dosing or one of two intermittent dosing schedules: either 4 days on, 3 days off (4/3) or 2 days on, 5 days off (2/5). Several models and approaches were tested for their ability to describe capivasertib disposition. The covariates assessed included dose, schedule, age, body weight, race, sex, creatinine clearance, hepatic function, renal function, smoking status, food effect, formulation, and concomitant use with paclitaxel, fulvestrant, cytochrome P450, family 3, subfamily A (CYP3A) inducers, CYP3A inhibitors and acid-reducing agents.

RESULTS: A total of 3963 capivasertib plasma concentrations from 441 patients were included. Capivasertib pharmacokinetics was adequately described by a three-compartment model where the apparent clearance (CL/F) presented a moderate time-dependent and dose-dependent clearance. Following oral administration of multiple doses of capivasertib (400 mg twice daily; [4/3]), the initial CL/F was 62.2 L/h (between-subject variability 39.3%), and after approximately 120 hours, CL/F decreased by 18%. The effective half-life was 8.34 h. Steady state was predicted to be reached on every third and fourth dosing day each week from the second week with exposure levels that produced robust inhibition of AKT but not of other related kinases. The area under the plasma concentration-time curve and maximum plasma concentration of capivasertib were proportional between the dose levels of 80-480 mg after multiple doses but more than proportional beyond 480 mg. Schedule, age, race, sex, creatinine clearance, hepatic function, renal function, smoking status and concomitant use with fulvestrant, CYP3A inducers, CYP3A inhibitors or acid-reducing agents were not significant covariates for capivasertib pharmacokinetics. Concomitant use of paclitaxel, food effect and formulation statistically significantly affected capivasertib pharmacokinetics, but the effect was low. Body weight was statistically significantly related to capivasertib CL/F, with a 12% reduction in CL/F at steady state and a 14% increase in the area under the curve for 12 hours at steady state and maximum concentration at steady state at a lower body weight (47 kg vs 67 kg reference).

CONCLUSIONS: Capivasertib pharmacokinetics showed moderate between-subject variability, and most covariates assessed had no significant impact. Body weight, dose, concomitant use of paclitaxel, food effect and formulation showed statistically significant effects. However, these were predicted to impact exposure to capivasertib by <20% and were not expected to be clinically relevant. Based on the population pharmacokinetics, no a priori dose adjustment is needed for intrinsic and extrinsic factors.

PMID:39127854 | DOI:10.1007/s40262-024-01407-x

Sci Rep. 2024 Aug 10;14(1):18599. doi: 10.1038/s41598-024-69462-9.

ABSTRACT

Fault detection and isolation in unmanned aerial vehicle (UAV) propellers are critical for operational safety and efficiency. Most existing fault diagnosis techniques rely basically on traditional statistical-based methods that necessitate better approaches. This study explores the application of untraditional feature extraction methodologies, namely Permutation Entropy (PE), Lempel-Ziv Complexity (LZC), and Teager-Kaiser Energy Operator (TKEO), on the PADRE dataset, which encapsulates various rotor fault configurations. The extracted features were subjected to a Chi-Square (χ²) feature selection process to identify the most significant features for input into a Deep Neural Network. The Taguchi method was utilized to test the performance of the recorded features, correspondingly. Performance metrics, including Accuracy, F1-Score, Precision, and Recall, were employed to evaluate the model’s effectiveness before and after the feature selection. The achieved accuracy has increased by 0.9% when compared with results utilizing traditional statistical methods. Comparative analysis with prior research reveals that the proposed untraditional features surpass traditional methods in diagnosing UAV propeller faults. It resulted in improved performance metrics with Accuracy, F1-Score, Precision, and Recall reaching 99.6%, 99.5%, 99.5%, and 99.5%, respectively. The results suggest promising directions for future research in UAV maintenance and safety protocols.

PMID:39127843 | DOI:10.1038/s41598-024-69462-9

J Clin Monit Comput. 2024 Aug 10. doi: 10.1007/s10877-024-01204-8. Online ahead of print.

ABSTRACT

During surgery for congenital heart disease (CHD) temperature management is crucial. Vesical (T_ves) and nasopharyngeal (T_NPH) temperature are usually measured. Whereas T_ves slowly responds to temperature changes, T_NPH carries the risk of bleeding. The zero-heat-flux (ZHF) temperature monitoring systems SpotOn™ (T_SpotOn), and Tcore™ (T_core) measure temperature non-invasively. We evaluated accuracy and precision of the non-invasive devices, and of T_ves compared to T_NPH for estimating temperature. In this prospective observational study in pediatric and adult patients accuracy and precision of T_SpotOn, T_core, and T_ves were analyzed using the Bland-Altman method. Proportion of differences (PoD) and Lin´s concordance correlation coefficient (LCC) were calculated. Data of 47 patients resulted in sets of matched measurements: 1073 for T_SpotOn vs. T_NPH, 874 for T_core vs. T_NPH, and 1102 for T_ves vs. T_NPH. Accuracy was – 0.39 °C for T_SpotOn, -0.09 °C for T_core, and 0.07 °C for T_ves. Precisison was between – 1.12 and 0.35 °C for T_SpotOn, -0.88 to 0.71 °C for T_core, and – 1.90 to 2.05 °C for T_ves. PoD ≤ 0.5 °C were 71% for T_SpotOn, 71% for T_core, and 60% for T_ves. LCC was 0.9455 for T_SpotOn, 0.9510 for T_core, and 0.9322 for T_ves. Temperatures below 25.2 °C (T_SpotOn) or 27.1 (T_core) could not be recorded non-invasively, but only with T_ves. Trial registration German Clinical Trials Register, DRKS00010720.

PMID:39127818 | DOI:10.1007/s10877-024-01204-8