Categories
Nevin Manimala Statistics

A.R.R.O.W.2: Once- vs twice-weekly carfilzomib, lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma

Blood Adv. 2024 Jul 18:bloodadvances.2024013101. doi: 10.1182/bloodadvances.2024013101. Online ahead of print.

ABSTRACT

Twice-weekly carfilzomib (27 mg/m2) plus lenalidomide and dexamethasone (KRd27) is a standard-of-care in relapsed/refractory multiple myeloma (RRMM). Once-weekly carfilzomib regimens have shown clinical benefits with improved patient convenience. This open-label, phase 3, multicenter, randomized study aimed to demonstrate noninferiority of the overall response rate (ORR) for once-weekly carfilzomib (56 mg/m2) plus Rd (KRd56) vs twice-weekly KRd27 in RRMM. A total of 454 patients were randomized (1:1) to receive carfilzomib as once-weekly 30-minute infusions of 56 mg/m2 (KRd56; n=228) or twice-weekly 10-minute infusions of 27 mg/m2 (KRd27; n=226). Baseline characteristics were balanced between groups. ORR was 82.5% (95% confidence interval [CI], 76.9‒87.2) in the once-weekly group vs 86.3% (95% CI, 81.1‒90.5) in the twice-weekly group (risk ratio, 0.954 [95% CI, 0.882‒1.032]) and did not meet the threshold for statistical significance of noninferiority (P=0.0666). Complete response or better was obtained in 46.9% of patients in the once-weekly arm and 36.3% in the twice-weekly arm. The proportions of patients who achieved complete response and were also assessed negative for minimal residual disease were 21.5% and 18.1%, respectively (odds ratio, 1.235 [95% CI, 0.775‒1.970]). Progression-free survival was comparable between groups (hazard ratio, 0.945 [95% CI, 0.617‒1.447]). The safety profile was similar for both groups. In conclusion, although statistical significance for noninferiority of ORR was not achieved, the efficacy and safety of once-weekly KRd56 were similar to those of twice-weekly KRd27 and once-weekly KRd56 may be an effective and convenient treatment option for patients with RRMM. This trial was registered at www.clinicaltrials.gov as #NCT03859427.

PMID:39024542 | DOI:10.1182/bloodadvances.2024013101

Categories
Nevin Manimala Statistics

Discordance Between the Initial Diagnosis of Sarcomas and Subsequent Histopathological Revision and Molecular Analyses in a Sarcoma Reference Center in Brazil

JCO Glob Oncol. 2024 Jul;10:e2300431. doi: 10.1200/GO.23.00431.

ABSTRACT

PURPOSE: To investigate the discordance in sarcoma diagnoses between nonspecialized institutions following revision by dedicated sarcoma pathologists at a reference center in Brazil and the relevance of molecular pathology in this context.

METHODS: We conducted a retrospective analysis of sarcoma samples initially analyzed at outside laboratories and subsequently reviewed by two specialized pathologists between January 2014 and December 2020. After obtaining demographic and tumor characteristics, pathology results were matched and classified as complete discordance (CD; benign v malignant, sarcoma v other malignancies), partial concordance (similar diagnosis of connective tumor, but different grade/histological subtype/differentiation), and complete concordance (CC). The concordance for histology or grade, and the role of molecular assessments supporting the diagnosis were also independently determined. Statistical analyses were conducted through the kappa coefficient of agreement and adherence by χ2 test, χ2 test by Person, and Fisher exact test.

RESULTS: In total, 197 cases were included, with samples obtained predominately from male patients (57.9%) and localized/primary tumors (86.8%). Following revision, the most frequent final diagnoses were undifferentiated pleomorphic sarcoma (17.8%), well-differentiated/dedifferentiated liposarcoma (8.6%), and leiomyosarcoma (7.6%). CD was found in 13.2%, partial discordance in 45.2%, and CC in 41.6% of reviews (P < .001). We found a concordance for histology or grade of 53.5% (P < .001) and 51.8% (P < .001), respectively. Molecular assessments, comprising next-generation sequencing panels (79.5%) and fluorescent in situ hybridization (20.5%), were performed in 44 (22.3%) cases, with findings classified as of diagnostic relevance in 31.8%.

CONCLUSION: In nearly 60% of the cases, the initial sarcoma diagnosis was modified when revised by a reference center and dedicated pathologists, assisted by molecular pathology techniques. These results justify the assembly of referral networks in countries with limited health care resources.

PMID:39024531 | DOI:10.1200/GO.23.00431

Categories
Nevin Manimala Statistics

Correcting Edge Defects in Self-Assembled Monolayers through Thermal Annealing

Chemphyschem. 2024 Jul 18:e202400626. doi: 10.1002/cphc.202400626. Online ahead of print.

ABSTRACT

Self-assembled monolayers (SAMs) are emerging as platform technology for a myriad of applications, yet they still possess varied spatial stability and predictability issues as their properties are heavily dependent on subtle structural features. Reducing entropy within such a system serves as one of many potential solutions to increase order and therefore coherence/precision in measured properties. Here we explore controlled thermal annealing to improve edge disorders in SAMs and significantly reduce data variance. Using both odd- and even-numbered n-alkanethiol SAMs on Au, we observe statistically significant difference in the contact angles between edge and center. Thermal annealing at 40°C significantly narrows differences between edges and centre of the SAM, albeit with significant reduction in the parity dependent odd-even effect. This study provides a pathway to improve SAMs consistency through minimal external perturbation as reflected by the minimization of odd-even effect as SAMs become increasingly ordered.

PMID:39024523 | DOI:10.1002/cphc.202400626

Categories
Nevin Manimala Statistics

Exploring uterine contractility frequency in infertile population: A comparative study among different control groups with and without a C-section defect

JBRA Assist Reprod. 2024 Jul 8. doi: 10.5935/1518-0557.20240037. Online ahead of print.

ABSTRACT

OBJECTIVE: Women undergoing IVF who have had a previous c-section (CS) have a lower live birth rate than those with a previous vaginal delivery. However, the precise underlying mechanisms need clarification. Does a previous CS affect the pattern of uterine contractility?.

METHODS: Prospective evaluation in patients undergoing frozen blastocyst embryo transfer in medicated endometrial preparation cycles. Twenty patients were included in groups: A/nulliparous. B/previous vaginal delivery. C/ previous CS without a niche, whereas fifteen patients were recruited in group D (CS and a niche). Patients employed estradiol compounds and 800 mg vaginal progesterone. A 3D-scan was performed the transfer-day where uterine contractility/minute was recorded.

RESULTS: Baseline characteristics (age, BMI, smoking, endometrial thickness) were similar. Mean frequency of uterine contractions/minute was similar between groups (1.15, 1.01, 0.92, and 1.21 for groups A, B, C, and D, respectively). There was a slight increase in the number of contractions in patients with a sonographic niche versus controls, not reaching statistical significance (p=0.48). No differences were observed when comparing patients with a previous C-section (regardless of the presence of a niche) to those without a C-section, either nulliparous (p=0.78) or with a previous vaginal delivery (p=0.80). The frequency of uterine contractions was similar between patients who achieved a clinical pregnancy and those who did not (1.19 vs. 1.02 UC/min, p=0.219, respectively).

CONCLUSIONS: Our study found no significant difference in the frequency of uterine contractility between patients with or without a previous C-section or sonographic diagnosed niche. Further investigation is necessary to understand the physiological mechanisms affecting implantation in patients with isthmocele.

PMID:39024503 | DOI:10.5935/1518-0557.20240037

Categories
Nevin Manimala Statistics

Estudio binacional sobre las agresiones de pareja en estudiantes universitarios

Vertex. 2024 Jul 10;35(164, abr.- jun.):19-32. doi: 10.53680/vertex.v35i164.543.

ABSTRACT

En esta investigación se dimensiona comparativamente la violencia en parejas de estudiantes de nivel universitario de la Argentina y de Ecuador y se explora la asociación con los celos y otras covariables teóricamente relevantes mediante análisis multivariado. Con un diseño de corte transversal se encuestaron 714 estudiantes (528 de la Universidad Nacional de La Plata, Argentina, y 186 de Universidad de Cuenca, Ecuador). Los instrumentos utilizados fueron el Conflict in Adolescents Dating Relationships Inventory, la Multidimensional Jealousy Scale e items ad hoc sobre fidelidad, consumo de sustancias y estrés durante la relación de pareja. Si bien se halló un predominio de la violencia verbal/emocional, el 3,8 % de los participantes alcanzó alto valor en la medida de abuso total cometido y más de la mitad informó haber cometido, por lo menos, un acto violento físico durante la relación índice. En modelo de regresión logística se verificó que la condición de pertenecer al grupo de alta violencia se asoció positiva y significativamente con los factores celos comportamentales, celos cognitivos,estrés y consumo de sustancias, y negativa y significativamente con la edad al comienzo de la relación.

PMID:39024489 | DOI:10.53680/vertex.v35i164.543

Categories
Nevin Manimala Statistics

Reinternaciones psiquiátricas: Determinantes clínicos, sociales ydemográficos en un hospital de la Ciudad de Buenos Aires

Vertex. 2024 Jul 10;35(164, abr.- jun.):40-47. doi: 10.53680/vertex.v35i164.545.

ABSTRACT

OBJETIVO: Este trabajo busca determinar las variables asociadas a las rehospitalizaciones múltiples en una sala de internación de mujeres, del Hospital de Emergencias Psiquiátricas “Torcuato de Alvear” de la Ciudad de Buenos Aires, Argentina. Método: El presente es un estudio analítico, de tipo transversal, en el que se incluyeron consecutivamente 350 pacientes de entre 18 y 65 años, hospitalizadas desde 2013 hasta diciembre de 2017 en la sala de internación de mujeres de dicho hospital. Al momento del alta se recabaron datos sociodemográficos, clínicos y sobre las condiciones de externación de todas las pacientes. Se definió internaciones múltiples al haber tenido 3 o más internaciones previas al momento de la actual internación. Para variables continuas se realizó test t o el análisis de varianza (ANOVA) en casos de distribución normal, y test de Mann- Whitney y Kruskal-Wallis en casos de distribución asimétrica. Las variables cualitativas se analizaron a través del test de chi-cuadrado con corrección de continuidad. La asociación entre variables se evaluó a través de los coeficientes de correlación de Pearson o Spearman según corresponda.

RESULTADOS: Las variables asociadas con reinternaciones múltiples fueron: el diagnóstico de Trastorno Bipolar, encontrarse realizando tratamiento al ingreso, así como la precariedad habitacional, la falta de trabajo y de autonomía económica. Conclusión: Las variables representativas de vulnerabilidad social y económica se asociaron con la utilización de camas de internación psiquiátrica. Son necesarias políticas públicas que permitan interrumpir la relación entre pobreza y patología mental.

PMID:39024487 | DOI:10.53680/vertex.v35i164.545

Categories
Nevin Manimala Statistics

Prescripción ambulatoria de clozapina en Colombia: factores relacionados con el uso de dosis inferiores a 100 mg/día

Vertex. 2024 Jul 10;35(164, abr.- jun.):82-86. doi: 10.53680/vertex.v35i164.550.

ABSTRACT

Aunque se utiliza comúnmente en la práctica clínica, la literatura científica sobre los patrones de prescripción de clozapina en Colombia es escasa. Se realizó un estudio observacional transversal en el servicio ambulatorio de una clínica de referencia en Bogotá, Colombia. Entre 2016 y 2018, se recetó clozapina a 2603 pacientes, principalmente para esquizofrenia y trastornos relacionados, trastorno afectivo bipolar y trastornos depresivos, a una dosis media de 100 mg/día. Después de controlar otras variables, la edad avanzada fue la única variable que explicó el uso de dosis inferiores a 100 mg/día. La clozapina no se utilizó sólo para la esquizofrenia resistente al tratamiento, y se necesitan estudios adicionales para explicar estas diferencias.

PMID:39024483 | DOI:10.53680/vertex.v35i164.550

Categories
Nevin Manimala Statistics

Development and Implementation of a Safety Incident Report System for Health Care Discipline Students During Clinical Internships: Observational Study

JMIR Med Educ. 2024 Jul 18;10:e56879. doi: 10.2196/56879.

ABSTRACT

BACKGROUND: Patient safety is a fundamental aspect of health care practice across global health systems. Safe practices, which include incident reporting systems, have proven valuable in preventing the recurrence of safety incidents. However, the accessibility of this tool for health care discipline students is not consistent, limiting their acquisition of competencies. In addition, there is no tools to familiarize students with analyzing safety incidents. Gamification has emerged as an effective strategy in health care education.

OBJECTIVE: This study aims to develop an incident reporting system tailored to the specific needs of health care discipline students, named Safety Incident Report System for Students. Secondary objectives included studying the performance of different groups of students in the use of the platform and training them on the correct procedures for reporting.

METHODS: This was an observational study carried out in 3 phases. Phase 1 consisted of the development of the web-based platform and the incident registration form. For this purpose, systems already developed and in use in Spain were taken as a basis. During phase 2, a total of 223 students in medicine and nursing with clinical internships from universities in Argentina, Brazil, Colombia, Ecuador, and Spain received an introductory seminar and were given access to the platform. Phase 3 ran in parallel and involved evaluation and feedback of the reports received as well as the opportunity to submit the students’ opinion on the process. Descriptive statistics were obtained to gain information about the incidents, and mean comparisons by groups were performed to analyze the scores obtained.

RESULTS: The final form was divided into 9 sections and consisted of 48 questions that allowed for introducing data about the incident, its causes, and proposals for an improvement plan. The platform included a personal dashboard displaying submitted reports, average scores, progression, and score rankings. A total of 105 students participated, submitting 147 reports. Incidents were mainly reported in the hospital setting, with complications of care (87/346, 25.1%) and effects of medication or medical products (82/346, 23.7%) being predominant. The most repeated causes were related confusion, oversight, or distractions (49/147, 33.3%) and absence of process verification (44/147, 29.9%). Statistically significant differences were observed between the mean final scores received by country (P<.001) and sex (P=.006) but not by studies (P=.47). Overall, participants rated the experience of using the Safety Incident Report System for Students positively.

CONCLUSIONS: This study presents an initial adaptation of reporting systems to suit the needs of students, introducing a guided and inspiring framework that has garnered positive acceptance among students. Through this endeavor, a pathway toward a safety culture within the faculty is established. A long-term follow-up would be desirable to check the real benefits of using the tool during education.

TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov NCT05350345; https://clinicaltrials.gov/study/NCT05350345.

PMID:39024005 | DOI:10.2196/56879

Categories
Nevin Manimala Statistics

Assessing the Clinical Effectiveness of an Exergame-Based Exercise Training Program Using Ring Fit Adventure to Prevent and Postpone Frailty and Sarcopenia Among Older Adults in Rural Long-Term Care Facilities: Randomized Controlled Trial

J Med Internet Res. 2024 Jul 18;26:e59468. doi: 10.2196/59468.

ABSTRACT

BACKGROUND: Frailty and sarcopenia are geriatric syndromes of increasing concern and are associated with adverse health outcomes. They are more prevalent among long-term care facility (LTCF) users than among community dwellers. Exercise, especially multicomponent and progressive resistance training, is essential for managing these conditions. However, LTCFs, particularly in rural areas, face challenges in implementing structured exercise programs due to health care professional shortages. Moreover, older adults often become bored with repetitive exercise training and may lose interest over time. The Nintendo Switch Ring Fit Adventure (RFA) exergame is a novel exergame that combines resistance, aerobic, and balance exercises and offers a potential solution by boosting motivation in an immersive manner and reducing staff intervention needs.

OBJECTIVE: We aimed to evaluate the clinical effectiveness of an exergame-based exercise training program delivered via RFA (exergame-RFA) in improving muscle mass and functional performance among older adult LTCF users.

METHODS: This was a randomized controlled trial conducted from August 2022 to September 2023 and involved older adult LTCF users (aged ≥60 y) in rural southern Taiwan. Participants were randomized into an intervention group (exergame-RFA plus standard care) or a control group (standard care alone). The intervention, conducted seated with arm fit skills and trunk control exercises using the RFA, lasted 30 minutes twice weekly over 12 weeks. The primary outcomes measured were the Study of Osteoporotic Fractures index (serving as an indicator of frailty status) and the diagnostic criteria for sarcopenia (appendicular skeletal muscle mass index, handgrip strength, and gait speed). The secondary outcomes included functional performance (box and block test as well as maximum voluntary isometric contraction of the dominant upper extremity), muscle condition (muscle thickness measured using ultrasonography), activities of daily living (Kihon checklist), health-related quality of life (Short Form Health Survey-36), and cognitive function (brain health test). We used an intention-to-treat analysis, incorporating a simple imputation technique in statistical analysis. A mixed ANOVA, with time as a within-participant factor and intervention as a between-participant factor, was used to compare the training effects on outcomes.

RESULTS: We recruited 96 individuals, of whom 60 (62%) underwent randomization. Of these 60 participants, 55 (92%) completed the study. Significant group×time interactions were observed in the intervention group in all primary outcomes (all P<.001, except P=.01 for handgrip strength) and most secondary outcomes, including maximum voluntary isometric contraction of the biceps (P=.004) and triceps brachii (P<.001) muscles, biceps muscle thickness measured using ultrasonography (P<.001), box and block test (P<.001), Kihon checklist (physical function: P=.01, mood status: P=.003, and total: P=.003), and brain health test (P<.001).

CONCLUSIONS: The exergame-RFA intervention significantly improved muscle mass, strength, and functional performance among older adult users of rural LTCFs, offering a novel approach to addressing frailty and sarcopenia.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05360667; https://clinicaltrials.gov/study/NCT05360667.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fmed.2022.1071409.

PMID:39024000 | DOI:10.2196/59468

Categories
Nevin Manimala Statistics

Improving Wound Healing and Infection Control in Long-term Care with Bacterial Fluorescence Imaging

Adv Skin Wound Care. 2024 Jul 17. doi: 10.1097/ASW.0000000000000177. Online ahead of print.

ABSTRACT

BACKGROUND: High bacterial burden stalls wound healing and can quickly progress to infection and sepsis in complex, older-adult patients in long-term care (LTC) or skilled nursing facilities (SNFs).

OBJECTIVE: To investigate the outcomes of point-of-care fluorescence (FL) imaging (MolecuLight i:X) of bacterial loads, which are frequently asymptomatic, to inform customized wound treatment plans for patients in LTC/SNFs.

METHODS: In this retrospective pre/postinterventional cohort study, the authors compared the healing and infection-associated outcomes of 167 pressure injuries from 100 Medicare beneficiaries before and after implementation of FL imaging.

RESULTS: Most patient demographics and wound characteristics did not differ significantly between the standard-of-care (SOC; n = 71 wounds) and FL (n = 96 wounds) cohorts. Significantly more wounds (+71.0%) healed by 12 weeks in the FL cohort (38.5%) versus the SoC cohort (22.5%). Wounds in the FL cohort also healed 27.7% faster (-4.8 weeks), on average, and were 1.4 times more likely to heal per Kaplan-Meier survival analysis (hazard ratio = 1.40; 95% CI, 0.90-2.12). Infection-related complications decreased by 75.3% in the FL cohort, and a significant shift from largely systemic to topical antibiotic prescribing was evidenced.

CONCLUSIONS: Fluorescence-imaging-guided management of wounds significantly improved healing and infection outcomes in highly complex and multimorbid patients in LTC/SNFs. Proactive bacterial infection management via local treatments was enabled by earlier, objective detection. These reported outcome improvements are comparable to randomized controlled trials and cohort studies from less compromised, selectively controlled outpatient populations. Fluorescence imaging supports proactive monitoring and management of planktonic and biofilm-encased bacteria, improving patient care in a complex, real-world setting.

PMID:39023985 | DOI:10.1097/ASW.0000000000000177