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Nevin Manimala Statistics

Evaluating a digital tool for supporting people affected by breast cancer: a prospective randomized controlled trial-the ADAPT study

Support Care Cancer. 2024 Oct 21;32(11):740. doi: 10.1007/s00520-024-08923-3.

ABSTRACT

PURPOSE: This study reports the findings from the ADAPT randomized controlled trial (RCT), concerning the impact of a digital tool for supported self-management in people affected by breast cancer on patient activation as the primary outcome, with health-related quality of life (HRQoL), and health status as secondary outcomes.

METHODS: Women with early-stage breast cancer were randomly assigned to standard care (control) or standard care in addition to the breast cancer digital tool (intervention). Data were collected using a demographic questionnaire, the Patient Activation Measure (PAM-13), the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), and the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline, 6 weeks, 3 months, 6 months, and 1 year from diagnosis. Linear mixed effect model regression was used to assess the effect of the digital tool over the first year from diagnosis while correcting for intra-participant correlation.

RESULTS: A total of 166 participants were included, with 85 being randomized into the intervention. No significant differences (p > 0.05) in the PAM-13 scores, EORTC QLQ-C30 scales (global QoL, physical functioning, emotional functioning, pain, fatigue), and EQ-5D-5L Index between the control and intervention groups were observed. It is important to note that there was significant non-adherence within the intervention group.

CONCLUSION: The breast cancer digital tool had no statistically significant impact on patient activation, HRQoL, and health status over time compared to standard care alone in women with early-stage breast cancer. Future research should focus on identifying and addressing barriers to digital tool engagement to improve efficacy. Clinical trial information The study was registered at https://clinicaltrials.gov (NCT03866655) on 7 March 2019 ( https://clinicaltrials.gov/study/NCT03866655 ).

PMID:39432189 | DOI:10.1007/s00520-024-08923-3

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Factors affecting the syncopal episodes in pediatric vasovagal syncope

Neurol Sci. 2024 Oct 21. doi: 10.1007/s10072-024-07822-z. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate factors that influence the syncopal episodes in pediatric vasovagal syncope (VVS).

METHODS: A retrospective analysis was performed on the clinical data of 2908 children who were diagnosed with VVS for the first time between January 2001 and February 2023. The study examined the linear relationships among age, sex, height, weight, heart rate (HR), blood pressure, hemodynamic type, and head-up tilt test (HUTT) mode in relation to the onset of syncope.

RESULTS: (1) Comparative analysis of intergroup differences revealed statistically significant variations in sex, age, height, weight, HR, systolic blood pressure, hemodynamic classification, and HUTT mode among syncopal episodes groups (P < 0.05); (2) Univariate analysis identified age, female, height, weight, VVS-cardioinhibited type (VVS-CI), VVS-mixed type (VVS-M) as potential risk factors for syncope episodes. Conversely, HR and sublingual nitroglycerin HUTT (SNHUT) emerged as potential protective factors against syncope episodes. (3) Multivariate analysis indicated that the frequency of syncope episodes increased by 0.27/0.02 for each unit increase in age/weight. When females compared to males and VVS-CI and VVS-M compared to VVS-vasoinhibited type (VVS-VI), the frequency of syncope episodes increased by 1.36, 0.53, and 0.66 respectively. Furthermore, SNHUT was associated with a reduction in the number of syncope episodes by 0.34 relative to basic HUTT.

CONCLUSION: Female, age, weight, VVS-CI, and VVS-M were identified as independent risk factors for syncopal episodes, while SNHUT was recognized as an independent protective factor against syncopal episodes.

PMID:39432179 | DOI:10.1007/s10072-024-07822-z

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Evaluation of a risk-sharing agreement for atezolizumab treatment in patients with non-small cell lung cancer: a strategy to improve access in low-income countries

Oncologist. 2024 Oct 19:oyae272. doi: 10.1093/oncolo/oyae272. Online ahead of print.

ABSTRACT

BACKGROUND: Using immune checkpoint inhibitors (IO) is a promising approach to maximize clinical benefits for patients with non-small cell lung cancer (NSCLC). PD-L1 expression serves as a predictive factor for treatment outcomes with IO. However, the high cost of this treatment creates significant barriers to access. Substantial evidence demonstrates the sustained clinical benefits experienced by patients who respond to immunotherapy. While IOs show promise in NSCLC treatment, their high cost poses access barriers.

AIM: This study focused on a prospective cost analysis conducted at a high-specialty health facility to assess the economic implications of implementing a risk-sharing agreement (RSA) for atezolizumab in NSCLC.

METHODS: The study included 30 patients with advanced NSCLC, with the pharmaceutical company funding the initial cycles. If patients responded, a government program covered costs until disease progression.

RESULTS: A median progression-free survival of 4.67 months across populations, rising to 9.4 months for responders. The 2-year overall survival rate for the response group was 64%, significantly higher than for non-response. Without an RSA, a total treatment cost of $881 859.36 ($29 395.31/patient) was reported, compared to $530 467.12 ($17 682.24/patient) with an RSA, representing a 40% cost reduction. In responders, the average cost per year of life per patient dropped by 22%. Risk-sharing, assessed through non-parametric tests, showed a statistically significant difference in pharmacological costs (P < .001).

CONCLUSION: Implementing RSAs can optimize resource allocation, making IO treatment more accessible, especially in low-income countries.

PMID:39427228 | DOI:10.1093/oncolo/oyae272

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Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population

Oncologist. 2024 Oct 19:oyae256. doi: 10.1093/oncolo/oyae256. Online ahead of print.

ABSTRACT

BACKGROUND: In the TOPAZ-1, patients with biliary tract cancers (BTC) and recurrence within 6 months after surgery were excluded, even if this event is frequently observed in clinical practice. Our study aimed to assess if the efficacy of cisplatin-gemcitabine-durvalumab (CGD) in this population is comparable to that reported in the phase 3 trial.

METHODS: The study cohort included patients with BTC who underwent surgery on the primary tumor, experienced disease recurrence occurring ≤6 months or >6 months after surgery or after the end of adjuvant therapy and started CGD. The primary objectives were overall survival (OS) and progression free survival (PFS).

RESULTS: A total of 178 patients were enrolled. No significant differences were observed between early and late relapse groups in OS (23.4 months vs not reached; HR 1.26; 95% CI, 0.67-2.37; P = .45) and PFS [7.0 months vs 9.8 months; HR 1.3(95% CI, 0.9-2.1) P = .13]. Overall response rate and disease control rate (P = .33 and P = .62) were comparable between the 2 groups, as the overall safety profile. In addition, we compared survival outcomes between the selected population and a historical cohort of patients with BTC treated with cisplatin-gemcitabine (CG) and found that despite the absence of statistical significance, CGD showed an outcome trend compared with CG regardless of the time of recurrence after surgery or adjuvant chemotherapy [(CG ≤ 6 vs CGD ≤ 6 months: HR 0.59, 95%CI, 0.35-1.01, P = .05; HR 0.70; 95%CI, 0.46-1.06, P = .09, OS and PFS, respectively) and (CG > 6 vs. CGD > 6 months: HR 0.50; 95%CI, 0.29-0.88, P = 0.0165; HR 0.54; 95%CI, 0.35-0.84, P = .0068, OS and PFS, respectively)].

CONCLUSION: Our analysis suggests that CGD retains its efficacy independently of the timing of relapse after surgery or completion of adjuvant treatment in patients with advanced BTC.

PMID:39427227 | DOI:10.1093/oncolo/oyae256

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Nevin Manimala Statistics

Assessing the psychometric properties of the World Health Organization -five well-being index (WHO-5) in Filipino samples amid the COVID-19 pandemic

BMC Psychol. 2024 Oct 19;12(1):580. doi: 10.1186/s40359-024-01941-0.

ABSTRACT

BACKGROUND: The WHO-5 well-being index is a brief rating scale extensively used to evaluate well-being symptoms. Despite the increasing number of studies validating this instrument across different samples from different countries, its psychometric properties remain unexplored in the Philippine context. Bridging this gap, the present study assessed the psychometric properties of the WHO-5 in Filipinos amid the pandemic.

METHODS: In study one, exploratory structural equation modeling (ESEM) was conducted using a sample of Filipinos (N = 2,521) from the general population and a unidimensional model of well-being was extracted. In study two, confirmatory factor analysis (CFA) was employed to examine the one-factor model in 1,289 Filipino government workers. In study three, nomological validity was examined by performing a mediation analysis using 407 Filipino left-behind emerging adult children with dysfunctionality as mediator, pandemic-related adversities as independent variable, and well-being as the dependent variable.

RESULTS: The results of ESEM and CFA provided support for the WHO-5 one-factor model. Moreover, the negative relationship of well-being to anxiety, depression, and distress lend evidence to the scale’s criterion validity. The results of the mediation analysis performed in study three implied that those who experienced pandemic-related adversities tended to have greater dysfunctionality, and in turn, had lower levels of well-being.

CONCLUSIONS: Overall, the findings suggest that the WHO-5 well-being index is a psychometrically sound tool for measuring Filipinos’ well-being.

PMID:39427223 | DOI:10.1186/s40359-024-01941-0

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Maternal weight status at conception predicts offspring body fat at age 11 years: population data from the Japan Kids Body Composition Study using dual-energy X-ray absorptiometry

J Physiol Anthropol. 2024 Oct 19;43(1):26. doi: 10.1186/s40101-024-00374-3.

ABSTRACT

BACKGROUND: Maternal preconception overweight status has been reported to be associated with an increased risk of overweight offspring. However, there are no published population-based studies on the association between maternal preconception weight and offspring body fat measured by dual-energy X-ray absorptiometry (DXA). The present population-based retrospective cohort study aimed to examine the association between maternal weight at conception and offspring body fat measured by DXA.

METHODS: The source population consisted of 5th-grade students (1244 students aged 11 years) registered at 8 municipal elementary schools in Kitakata, Fukuroi, Hamamatsu, and Himeji in Japan. The present analyses included 964 participants who provided complete information. Maternal body mass index (BMI) at conception was calculated using records in the Mother and Child Health Handbook (MCHH). Offspring body fat at age 11 years was measured with the same QDR-4500A DXA instrument in a mobile test room that was brought to each school. With regard to the prediction of excess fat in offspring, the area under the curve (AUC) calculated with receiver operating characteristic curve analysis was used to quantify the diagnostic accuracy of maternal BMI at conception.

RESULTS: Adjusted odds ratios for excess body fat in offspring of the overweight mother group (odds ratios, 4.93 to 15.32) were significantly higher than those in the non-overweight mother group. For the prediction of excess offspring fat, AUCs and 95% confidence intervals for maternal BMI at conception were greater than 0.5.

CONCLUSION: Maternal overweight status at conception might be a risk factor for excess body fat in offspring. Maternal BMI values calculated using MCHH data have the potential to distinguish between the presence and absence of excess fat in the next generation.

PMID:39427220 | DOI:10.1186/s40101-024-00374-3

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Validation of the Arabic version of the Adolescent Distress-Eustress Scale (ADES)

BMC Psychol. 2024 Oct 19;12(1):578. doi: 10.1186/s40359-024-02087-9.

ABSTRACT

BACKGROUND: The current study examined the psychometric properties of an Arabic translation of the Adolescent Distress-Eustress Scale (ADES) in Saudi Arabia. It assessed the factorial structure through a confirmatory factor analysis, composite reliability through Cronbach alpha and McDonald’s omega scores, gender invariance, and convergent validity through its correlation to resilience.

METHODS: A total of 505 high school students from 21 randomly selected schools in Jeddah, Saudi Arabia (mean age of 16.66 ± 1.10 years, 52.7% females) participated in the study. The questionnaires were translated using the forward and backward technique.

RESULTS: Findings revealed good internal consistency of the Arabic ADES (McDonald’s ω being 0.82 for distress and 0.79 for eustress). Confirmatory factor analyses confirmed the two-factor structure of the scale and demonstrated measurement invariance across gender at the configural, metric, and scalar levels. Girls had higher Distress scores, while boys reported higher eustress scores, which was consistent with previous studies. Finally, the ADES distress and eustress scales were significantly correlated to resilience supporting convergent validity.

CONCLUSION: The present study supports the reliability and validity of the Arabic version of the ADES as a self-report method to assess Eustress and Distress in adolescents. Pending further validations to support the present findings, this measure can be utilized by schools, mental health providers, and researchers to support Arabic speaking adolescents globally.

PMID:39427217 | DOI:10.1186/s40359-024-02087-9

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Attitude toward virginity and its determinants among girls in Tabriz: Iran

Reprod Health. 2024 Oct 19;21(1):149. doi: 10.1186/s12978-024-01884-0.

ABSTRACT

BACKGROUND: We aimed to assess the attitude of unmarried girls towards virginity, and its determinants, comparing three age cohorts (born in the 70s, 80s, and 90s) in the city of Tabriz in northwestern Iran.

METHODS: We conducted a cross-sectional survey among 700 girls residing in Tabriz in 2021 employing a population-based cluster sampling based on health clinics and households. We collected data using a pilot-tested instrument, which comprised socio-demographic questions, and statements to assess attitudes towards virginity and its importance, the meaning of virginity, ways of losing virginity, and perception of the hymen. The data was analyzed using SPSS, version 21. Analysis of variance and independent t-test was used for bivariate analysis and linear regression was used to identify the determinants of the attitude. A p value under 0.05 was considered statistically significant.

RESULTS: Only about one-third (35.2%) of unmarried girls considered preserving virginity as an important issue for girls before marriage in current days. About 27% were uncertain and about 38% believed it was unimportant. The importance of virginity (score range 7-35) was significantly greater for girls born in the 70s than for girls born in the 80s and 90s (p < 0.05). In the multivariate linear regression model, the determinants of the importance of virginity were older age, greater religious affiliation, living with both parents and lower consumption of the internet and social networks for sexual information.

CONCLUSIONS: This study indicates significant shifts in sexual attitudes among young females which may have important implications for marriage age and the culturally and age-appropriate sexual health interventions of young people.

PMID:39427204 | DOI:10.1186/s12978-024-01884-0

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Assessing primary Tokophobia among Lebanese childless men and nulliparous women: psychometric validation of the Arabic versions of the fathers’ fear of childbirth scale and Tokophobia severity scale

BMC Psychol. 2024 Oct 19;12(1):579. doi: 10.1186/s40359-024-02080-2.

ABSTRACT

INTRODUCTION: Tokophobia is an intense and pathological fear of pregnancy and childbirth. Despite its significance, no research in Lebanon has investigated primary tokophobia within the general population. Nevertheless, it is crucial to assess the attitudes of both women and men, as potential future parents, towards pregnancy and childbirth, particularly during these challenging times for the Lebanese population. Therefore, this study aims to evaluate the psychometric properties of the Tokophobia Severity Scale (TSS) and Fathers’ Fear of Childbirth Scale (FFCS) for assessing primary tokophobia among Lebanese nulliparous women and childless men, respectively.

METHODS: This cross-sectional investigation encompassed all Lebanese governorates; 651 women and 618 men were recruited via social media platforms, using a snowball sampling technique. The questionnaire included the Tokophobia Severity Scale, the Fathers’ Fear of Childbirth Scale, the Patient Health Questionnaire, and the Lebanese Anxiety Scale.

RESULTS: Factorial analysis of the TSS in women revealed a three-factor model: concerns related to personal complications (Factor 1), fetal well-being (Factor 2), and outward behavioral responses to fear (Factor 3). The FFCS also yielded a three-factor measurement model: emotional responses during the partner’s childbirth (Factor 1), concerns regarding the hospital environment during childbirth (Factor 2), and anxieties surrounding the perinatal health of both the partner and child (Factor 3). Both scales were internally consistent with Cronbach’s alpha > 0.9, indicating their reliability. The TSS and FFCS demonstrated statistically significant correlations with measures of anxiety and depression, thus attesting to convergent validity.

CONCLUSION: The results of this study provide evidence for the psychometric validity and reliability of the TSS and FFCS scales in Arabic-speaking populations. Given the previously overlooked nature of primary tokophobia in these populations, the availability of these validated instruments can significantly enhance the ability to detect and address this condition, ultimately facilitating the provision of necessary support services.

PMID:39427199 | DOI:10.1186/s40359-024-02080-2

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Assessment of ICU nurses’ competency towards delirium among critically ill patients

BMC Nurs. 2024 Oct 19;23(1):769. doi: 10.1186/s12912-024-02330-z.

ABSTRACT

BACKGROUND: ICU nurses play a critical role in managing delirium in critically ill patients, yet their competency in this area remains under-explored.

AIM: To assess ICU nurses’ competency including their knowledge, practice, and attitudes toward delirium among critically ill patients.

METHODS: A correlational descriptive study was conducted with 67 nurses in the medical intensive care unit at Suez Canal University Hospitals. Data was collected using an online survey and analyzed using descriptive statistics, ANOVA, and Pearson’s correlation.

RESULTS: Nurses showed a moderate knowledge level (M = 8.55), a low practice level (M = 6.62), and positive attitudes (M = 21.65) toward ICU delirium. ANOVA results indicated significant differences in practice scores based on educational level, F (2, 64) = 3.361, p = .041, and in knowledge scores based on ICU experience, F(3, 63) = 6.455, p < .001. Nurses with Master of Science in Nursing (MSN) degrees had higher practice scores than those with diplomas or Bachelor of Science in Nursing (BSN) degrees. There were no significant differences in knowledge and attitude scores based on educational level or age. Gender differences were minimal, with male nurses slightly outperforming female nurses. Correlation analysis showed positive relationships between age, education, ICU experience, and ICU nurses’ levels of knowledge and practice.

CONCLUSION: ICU nurses demonstrate a knowledge-practice gap in delirium management. Targeted educational interventions, mentorship programs, and a focus on practical skills are essential to enhance delirium care.

RELEVANCE TO CLINICAL PRACTICE: These findings highlight the urgent need for comprehensive delirium education and training programs for ICU nurses. By improving nurses’ knowledge and practice, healthcare organizations can significantly enhance the early detection, prevention, and management of delirium, ultimately leading to improved patient outcomes and reduced length of stay in the ICU.

PMID:39427193 | DOI:10.1186/s12912-024-02330-z