Nevin Manimala

J Clin Psychiatry. 2023 Aug 16;84(5):22m14643. doi: 10.4088/JCP.22m14643.

ABSTRACT

Objective: To assess the efficacy of cariprazine, a dopamine D₃-preferring D₃/D₂ and serotonin 5-HT_1A receptor partial agonist, as adjunctive treatment for patients with major depressive disorder (MDD) and inadequate response to ongoing antidepressant therapy (ADT).

Methods: This randomized, double-blind, placebo-controlled study was conducted from November 2018 to September 2021. Adults with MDD per DSM-5 criteria were randomized (1:1:1) to cariprazine 1.5 mg/d or 3 mg/d plus ADT, or placebo plus ADT. The primary and secondary endpoints were change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score and Clinical Global Impressions-Severity of Illness (CGI-S) score, respectively.

Results: A total of 249 placebo-, 250 cariprazine 1.5 mg/d-, and 251 cariprazine 3 mg/d-treated patients were included in the modified intent-to-treat population. At week 6, the least squares mean change in MADRS total score was -13.8 for cariprazine 1.5 mg/d, -14.8 for cariprazine 3 mg/d, and -13.4 for placebo; differences versus placebo were not statistically significant. Mean change from baseline in CGI-S scores at week 6 was not significant for cariprazine versus placebo, although a trend toward significance was observed for 3 mg/d (P = .0573 [not adjusted for multiplicity]). Common treatment-emergent adverse events (≥ 5% either cariprazine group and twice placebo) were akathisia and insomnia.

Conclusions: There were no statistically significant differences for cariprazine 1.5 or 3 mg/d versus placebo on the primary or secondary outcomes. Cariprazine was generally well tolerated, and no new safety concerns were detected.

Clinical Trials Registration: ClinicalTrials.gov identifier NCT03739203.

PMID:37585254 | DOI:10.4088/JCP.22m14643

JMIR Form Res. 2023 Aug 16;7:e41774. doi: 10.2196/41774.

ABSTRACT

BACKGROUND: Data on dietary intakes in Russian adults and children are assessed very infrequently primarily due to the time, cost, and burden to the participants for assessing dietary patterns. To overcome some of those challenges, the use of web-based 24-hour recall methods can be successfully used.

OBJECTIVE: The study objective is to assess the extent of agreement between a self-administered and an interviewer-administered 24-hour dietary recall in Russian adults and school-aged children using an adaptation of a web-based 24-hour recall tool.

METHODS: This web-based dietary assessment tool is based on a previously validated tool, which has been adapted to the Russian diet and language. A randomized 50% (n=97) of 194 participants initially completed a self-administered web-based dietary recall, followed by an interviewer-administered 24-hour dietary recall later that same day, and vice versa for the other 50% (n=97) of participants. Following at least 1 week wash-out period, during visit 2, participant groups completed the 2 dietary recalls in the opposite order. Statistical analysis was carried out on the intake results from both methods for the 2 recalls. Finally, an evaluation questionnaire on ease-of-use of the tool was also completed.

RESULTS: In total, intakes of 28 nutrients and energy were analyzed in this study. The Bland-Altman analysis showed that between 98.4% and 90.5% of data points were within the limits of agreement among all age groups and nutrients analyzed. A “moderate to excellent” reliability between the 2 methods was observed in younger children. In older children, a “moderate to good” reliability was observed, with the exception of sodium. In adults, “moderate to excellent” reliability between both methods was observed with the exception of vitamins B1, B2, and B6, and pantothenic acid. The level of agreement between the categorization of estimates into thirds of the intake distribution for the average of the 2 days was satisfactory, since the percentages of participants categorized into the same tertile of intake were ˃50%, and the percentages of participants categorized into the opposite tertile of intake were <10%. The majority of respondents were very positive in their evaluation of the web-based dietary assessment tool.

CONCLUSIONS: Overall, the web-based dietary assessment tool performs well when compared with a face-to-face, interviewer-administered 24-hour dietary recall and provides comparable estimates of energy and nutrient intakes in Russian adults and children.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04372160; https://clinicaltrials.gov/ct2/show/NCT04372160.

PMID:37585243 | DOI:10.2196/41774

JAMA Dermatol. 2023 Aug 16. doi: 10.1001/jamadermatol.2023.2634. Online ahead of print.

ABSTRACT

IMPORTANCE: There are limited prognostic statistics and data available on survival outcomes for patients with mycosis fungoides (MF) in Asia.

OBJECTIVE: To determine the prognostic factors and survival outcomes of patients with MF among a cohort in China.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cohort study of patients with MF who received treatment at a tertiary referral center for skin lymphoma (Peking University First Hospital, Beijing, China) from August 1, 2009, to August 31, 2021. Data were analyzed from September 1, 2021, to December 31, 2022.

MAIN OUTCOMES AND MEASURES: Overall survival (OS), disease-specific survival (DSS), and progression-free survival (PFS); for prognostic factors, hazard ratios (HRs), and adjusted HRs (aHRs; adjusted for sex, age, and overall TNMB [tumor, node, metastasis, blood] stage) determined using the Cox proportional hazards model.

RESULTS: The study cohort comprised 461 patients with MF (median [range] age at diagnosis, 46 [5-87] years; 275 [59.7%] men and 186 [40.3%] women; 461 [100%] Chinese). The overall 5-year rate was 82.2% for OS, 83.5% for DSS, and 79.6% for PFS. Stage-specific 5-year OS rates were 95.7% for stage IA, 93.2% for IB, 95.7% for IIA, 70.1% for IIB, 55.3% for III, and 23.6% for IV. Compared with a UK cohort, our Chinese cohort had a younger median age at diagnosis (46 years vs 54 years) and a more favorable 5-year OS (82.2% vs 75.0%); however, after adjusting for age, the discrepancy in the 5-year OS rate was diminished (77.3% vs 76.4%). Cox models revealed that unfavorable predictors of OS, PFS, and DSS, respectively, were: age older than 60 years (aHR [95% CI], 2.25 [1.28-3.96]; 2.09 [1.16-3.76]; 2.27 [1.39-3.72]); advanced TNMB stage; advanced overall stage; large-cell transformation (aHR [95% CI], 2.16 [1.17-3.99]; 2.29 [1.21-4.33]; 2.21 [1.26-3.86]); and elevated lactate dehydrogenase levels (aHR [95% CI], 3.92 [1.64-9.36]; 4.77 [1.86-12.22]; 5.05 [2.23-11.42]). Biological sex and plaque lesion type were not associated with prognosis among this study cohort.

CONCLUSION AND RELEVANCE: The findings of this retrospective cohort study of patients with MF in China suggest that Asian patients are diagnosed at a younger age and have a higher 5-year OS compared with patients of other races in studies in other countries (predominantly White). Prognostic factors were similar to those of previous studies, except for patient sex and plaque lesion type.

PMID:37585188 | DOI:10.1001/jamadermatol.2023.2634

JAMA Cardiol. 2023 Aug 16. doi: 10.1001/jamacardio.2023.2418. Online ahead of print.

ABSTRACT

IMPORTANCE: Fluoroquinolone use has been associated with increased hospitalization with aortic aneurysm or dissection in noninterventional studies, but the reason for this observed association is unclear.

OBJECTIVE: To determine the association between fluoroquinolone use and aortic aneurysm or dissection using multiple study designs and multiple databases to increase the robustness of findings.

DESIGN, SETTING, AND PARTICIPANTS: Cohort and case-crossover studies were conducted separately in 2 databases of UK primary care records. Clinical Practice Research Datalink Aurum and GOLD primary care records were linked to hospital admissions data. Adults with a systemic fluoroquinolone or cephalosporin prescription between April 1997 and December 2019 were included in the cohort study. Adults hospitalized with aortic aneurysm or dissection within the eligibility period were included in the case-crossover study. Individuals meeting inclusion criteria in the case-crossover study were matched 1:3 to control individuals on age, sex, index date, and clinical practice to adjust for calendar trends in prescribing. Data were analyzed from January to July 2022.

EXPOSURES: Systemic fluoroquinolone or comparator antibiotic.

MAIN OUTCOMES AND MEASURES: Hazard ratios (HRs) were estimated in the cohort study for the association between prescription of fluoroquinolones and hospitalization with aortic aneurysm or dissection using stabilized inverse probability of treatment-weighted Cox regression. Odds ratios (OR) were estimated in the case-crossover study for the association between systemic fluoroquinolone use and hospitalization with aortic aneurysm or dissection using a conditional logistic regression model. Estimates were pooled across databases using fixed-effects meta-analysis.

RESULTS: In the cohort study, we identified 3 134 121 adults in Aurum (mean [SD] age, 52.5 [20.3] years; 1 969 257 [62.8%] female) and 452 086 in GOLD (mean [SD] age, 53.9 [20.2] years; 286 502 [63.4%] female) who were prescribed fluoroquinolones or cephalosporins. In crude analyses, fluoroquinolone relative to cephalosporin use was associated with increased hospitalization with aortic aneurysm or dissection (pooled HR, 1.28; 95% CI, 1.13-1.44; P < .001) but after adjustment for potential confounders, this association disappeared (pooled adjusted HR, 1.03; 95% CI, 0.91-1.17; P = .65). In the case-crossover study, we identified 84 841 individuals hospitalized with aortic aneurysm or dissection in Aurum (mean [SD] age, 75.5 [10.9]; 23 551 [27.8%] female) and 10 357 in GOLD (mean [SD] age, 75.6 [10.5]; 2809 [27.1%] female). Relative to nonuse, fluoroquinolone use was associated with an increase in hospitalization with aortic aneurysm or dissection, but no association was found relative to other antibiotics (vs cephalosporin pooled OR, 1.05; 95% CI, 0.87-1.27; vs trimethoprim, 0.89; 95% CI, 0.75-1.06; vs co-amoxiclav, 0.98; 95% CI, 0.82-1.18).

CONCLUSIONS AND RELEVANCE: The results in this study suggest that estimates of association of fluoroquinolones with aortic aneurysm or dissection may be affected by confounding. When such confounding is accounted for, no association was evident, providing reassurance on the safety of fluoroquinolones with respect to aortic aneurysm or dissection.

PMID:37585175 | DOI:10.1001/jamacardio.2023.2418

Afr J Reprod Health. 2022 Dec;26(12s):27-37. doi: 10.29063/ajrh2022/v26i12s.4.

ABSTRACT

Despite commitments and interventions, Female Genital Mutilations (FGM) practice persists in West African countries. This research analyzes the effect of living conditions on FGM practice. Data were sourced from thirty-four demographic and health surveys conducted between 1995 and 2020 in 12 countries. The study sample consisted of 69,971 adolescent girls aged 15-19 years. Meta-regression analysis and binary logistic regression analyses showed the effect and relative contribution of study covariates on the phenomenon. The overall average prevalence of FGM is 40.7%, with a mixed effect of living conditions on FGM practice. The factors associated with FGM practice are, in order of importance, religion, level of education, ethnicity and place of residence. All factors have a direct effect on the studied phenomenon, and the level of education acts as an inhibiter of the effect of living conditions. The study suggests the need to strengthen the involvement of religious, traditional and community leaders in the definition and implementation of actions to combat FGM, as well as girl’s education, especially by maintaining them in school till completion of at least secondary school.

PMID:37585158 | DOI:10.29063/ajrh2022/v26i12s.4

Afr J Reprod Health. 2022 Jul;26(7):127-134. doi: 10.29063/ajrh2022/v26i7.13.

ABSTRACT

Despite extensive work on macrosomia, it is impossible to predict women at risk. Current prediction strategies which include clinical examination and ultrasound are imprecise. This study aims to determine the risk factors associated with macrosomia. It was a descriptive, retrospective chart review of women delivered of macrosomic neonates over a two-year period from 2015-2016. Detailed clinical and demographic information was recorded. Statistical analysis was carried out using SPSS (version 25.0 IBM, Armonk, New York, USA). Of 22 244 singleton deliveries, 415 were macrosomic infants (1.9%). The mean birth weight for macrosomic infants was 4.39 ± 0.43 (range 4-5.15) kg and males were more in number and weight. Macrosomic infants occurred more in age groups 25-29 years and peaked with BMI ≥30 kg/m2. Majority were cesarean sections compared to vaginal deliveries (56.6% vs 43.4%; p=0.006) respectively. Vaginal delivery of macrosomic infants was associated with complications. Significant differences were found between fetal macrosomia and clinical characteristics such as body mass index, parity, advanced maternal age, and male fetal sex. Hypoglycaemia was most frequent in infants born to non-diabetic mothers (98.1%). Antenatal risk factors are important in the prediction of macrosomia, but fetal and maternal outcome depends on labour management.

PMID:37585154 | DOI:10.29063/ajrh2022/v26i7.13

Afr J Reprod Health. 2022 Jul;26(7):90-101. doi: 10.29063/ajrh2022/v26i7.10.

ABSTRACT

Pre-rupture of membranes prior labour initiation could complicate approximately 5% of pregnancies and could be associated with a high incidence of perinatal morbidity and mortality complications. The major complications could be chorioamnionitis and cord compression resulting in hypoxia. This study aimed to assess the health literacy of mothers on perinatal outcomes following pre-rupture of membranes at Thulamela B clinics of Vhembe district. A quantitative research approach with a cross-sectional descriptive design was used. The study population comprised a total of 210 lactating mothers within 6 weeks following delivery, irrespective of the mode of delivery were purposively selected. Data were collected by the researchers through self-administered questionnaires. The Statistical Package for Social Sciences (SPSS) version 25 was used for data analysis. The results are presented in the form of tables and graphs based on probability allowing judgment to be made on variables. Validity and reliability were ensured. Ethical clearance was obtained from the University of Venda Research Ethics Committee and permission to access health facilities from the Limpopo Province Department of Health. Findings revealed that limited and inadequate health literacy towards pre-rupture of membranes contributes to perinatal morbidity and mortality, with associated factors like poor antenatal care attendance, delayed health seeking, defaulting, and loss of follow-up. Recommendations to emphasise the provision of preconception and antenatal care where health information on risks and danger signs of PROM to perinatal outcomes are given were made.

PMID:37585151 | DOI:10.29063/ajrh2022/v26i7.10

Afr J Reprod Health. 2022 Nov;26(11s):79-91. doi: 10.29063/ajrh2022/v26i11.8.

ABSTRACT

Malnutrition is the main cause of two-thirds of deaths among Egyptian under five children, which could be due to reduced rates of breastfeeding, as it is one of the contributing factors. Breastfeeding is the optimal solution for health promotion to mothers and their infants. It has various benefits not only for the mother and infant but also for society. Breastfeeding educational programs are essential for the enhancement of knowledge and self-efficacy of new mothers, and to ensure a longer duration of breastfeeding. Therefore, this study aims to evaluate the effects of an interactive digital-based educational program about breastfeeding on the knowledge, attitudes, and self-efficacy of primiparous women in Egypt. A quasi-experimental study design was adopted. The study was held in Itay El-baroud maternal and child health center, whereby 120 pregnant women were purposively selected. Then, they were randomly assigned to either a study group (60) or control group (60). The derived data were statistically analysed using SPSS version 20, Pearson correlation coefficient, chi-square test and independent sample t test were utilized. Four tools were utilized for data collection. A statistically significant mean difference was found concerning total breastfeeding knowledge scores after one month and three months. The total attitude and self-efficacy scores showed highly statistically significant differences after one month and three months from the start of the program. Moreover, breastfeeding self-efficacy was found to be positively correlated with knowledge and attitude. In conclusion, the interactive digital-based educational program about breastfeeding was suggested to be effective in enhancing the knowledge, attitude and self-efficacy of the primiparous women, in combination with other health education activities. Therefore, it is recommended that web-based educational sites are created for first-time mothers.

PMID:37585136 | DOI:10.29063/ajrh2022/v26i11.8

Afr J Reprod Health. 2022 Nov;26(11):56-66. doi: 10.29063/ajrh2022/v26i11.6.

ABSTRACT

Family is the microcosm of a larger society that provides care that shapes the behavior of children. However, the different levels of attention children receive from their parents may affect their behaviour and self-esteem, which can lead to them being more vulnerable to sexual harassment. An institutional-based cross-sectional survey was conducted from March – August 2021, to assess the relationship between family birth order and prevalence of sexual harassment. The multistage sampling procedure was used to draw 1070 participants. The data was analyzed using percentages, mean, and multivariate logistic regression statistics. The multivariate logistic regression was used to estimate adjusted odds ratios (AOR) along with 95% confidence intervals (CIs). The level of significance was set at P < 0.05. The findings revealed prevalence (73.6%) of sexual harassment, and the two forms such as verbal ( = 2.63) and non-verbal sexual harassment ( = 2.56) were high. The multivariate logistic regression odds ratios adjusted shows that the middle born were approximately 2 folds (AOR = 1.62; CI = 1.14 – 2.30; P = 0.008 0.05) more likely to predict sexual harassment. The study recommended amongst others that parents in South Eastern Nigeria should refrain from given special attention to a particular child as this may predispose the unfavoured child to sexual harassment.

PMID:37585134 | DOI:10.29063/ajrh2022/v26i11.6

Afr J Reprod Health. 2022 Nov;26(11):9-14. doi: 10.29063/ajrh2022/v26i11.1.

NO ABSTRACT

PMID:37585129 | DOI:10.29063/ajrh2022/v26i11.1