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Nevin Manimala Statistics

The effect of peak serum estradiol level during ovarian stimulation on cumulative live birth and obstetric outcomes in freeze-all cycles

Front Endocrinol (Lausanne). 2023 Jul 17;14:1130211. doi: 10.3389/fendo.2023.1130211. eCollection 2023.

ABSTRACT

OBJECTIVE: To determine whether the peak serum estradiol (E2) level during ovarian stimulation affects the cumulative live birth rate (CLBR) and obstetric outcomes in freeze-all cycles.

METHODS: This retrospective cohort study involved patients who underwent their first cycle of in vitro fertilization followed by a freeze-all strategy and frozen embryo transfer cycles between January 2014 and June 2019 at a tertiary care center. Patients were categorized into four groups according to quartiles of peak serum E2 levels during ovarian stimulation (Q1-Q4). The primary outcome was CLBR. Secondary outcomes included obstetric and neonatal outcomes of singleton and twin pregnancies. Poisson or logistic regression was applied to control for potential confounders for outcome measures, as appropriate. Generalized estimating equations were used to account for multiple cycles from the same patient for the outcome of CLBR.

RESULTS: A total of 11237 patients were included in the analysis. Cumulatively, live births occurred in 8410 women (74.8%). The live birth rate (LBR) and CLBR improved as quartiles of peak E2 levels increased (49.7%, 52.1%, 54.9%, and 56.4% for LBR; 65.1%, 74.3%, 78.4%, and 81.6% for CLBR, from the lowest to the highest quartile of estradiol levels, respectively, P<0.001). Such association remained significant for CLBR after accounting for potential confounders in multivariable regression models, whereas the relationship between LBR and peak E2 levels did not reach statistical significance. In addition, no significant differences were noticed in adverse obstetric and neonatal outcomes (gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia, placental disorders, preterm birth, low birthweight, and small for gestational age) amongst E2 quartiles for either singleton or twin live births, both before and after adjustment.

CONCLUSION: In freeze-all cycles, higher peak serum E2 levels during ovarian stimulation were associated with increased CLBR, without increasing the risks of adverse obstetric and neonatal outcomes.

PMID:37529616 | PMC:PMC10390295 | DOI:10.3389/fendo.2023.1130211

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Nevin Manimala Statistics

Drivers of the socio-economic disadvantage gap in England: Sequential pathways that include the home learning environment and self-regulation as mediators

Br J Educ Psychol. 2023 Aug 1:e12629. doi: 10.1111/bjep.12629. Online ahead of print.

ABSTRACT

BACKGROUND: Socio-economic status (SES) is a powerful predictor of attainment. Research has identified multiple mechanisms that underpin the effect of SES on attainment. For example, self-regulation (processes through which individuals direct and control their attention, emotion and behaviour) has been identified as one mechanism mediating the SES attainment gap. However, previous studies have not directly tested the statistical pathways by which children from lower SES backgrounds develop low self-regulation skills and subsequently poor attainment at the end of primary school. Adding the home learning environment, which is associated with both SES and self-regulation, further fleshes out the longitudinal pathways.

AIMS: We propose and test a new model where the relationship between SES and school attainment is sequentially mediated by the family home learning environment and the child’s self-regulation.

SAMPLE: This study uses the Effective Pre-school, Primary and Secondary Education data set to study 2311 English children.

METHODS: We measured SES (via socio-economic disadvantage) based on an index of low parental education, occupation and income at age 3+. The home learning environment was measured by the Home Learning Environment Index at age 3+; self-regulation was a teacher report on the Child Social Behaviour Questionnaire at age 4+ and attainment was measured via scores on national assessments of English and Maths at age 11.

RESULTS: Our measure of disadvantage predicted attainment. The home learning environment predicted children’s self-regulation skills. The relationship between disadvantage and attainment was sequentially mediated by the home learning environment and self-regulation.

CONCLUSIONS: These findings suggest that home learning environment and self-regulation may play a sequential role in perpetuating socio-economic disparities in education.

PMID:37527934 | DOI:10.1111/bjep.12629

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Nevin Manimala Statistics

High-speed countercurrent chromatography with offline detection by electrospray mass spectrometry and nuclear magnetic resonance detection as a tool to resolve complex mixtures: A practical approach using Coffea arabica leaf extract

Phytochem Anal. 2023 Aug 1. doi: 10.1002/pca.3271. Online ahead of print.

ABSTRACT

INTRODUCTION: Many secondary metabolites isolated from plants have been described in the literature owing to their important biological properties and possible pharmacological applications. However, the identification of compounds present in complex plant extracts has remained a great scientific challenge, is often laborious, and requires a long research time with high financial cost.

OBJECTIVES: The aim of this study was to develop a method that allows the identification of secondary metabolites in plant extracts with a high degree of confidence in a short period of time.

MATERIAL AND METHODS: In this study, an ethanolic extract of Coffea arabica leaves was used to validate the proposed method. Countercurrent chromatography was chosen as the initial step for extraction fractionation using gradient elution. Resulting fractions presented a variation of compounds concentrations, allowing for statistical total correlation spectroscopy (STOCSY) calculations between liquid chromatography coupled with high-resolution tandem mass spectrometry (LC-HRMS/MS) and NMR across fractions.

RESULTS: The proposed method allowed the identification of 57 compounds. Of the annotated compounds, 20 were previously described in the literature for the species and 37 were reported for the first time. Among the inedited compounds, we identified flavonoids, alkaloids, phenolic acids, coumarins, and terpenes.

CONCLUSION: The proposed method presents itself as a valid alternative for the study of complex extracts in an effective, fast, and reliable way that can be reproduced in the study of other extracts.

PMID:37527932 | DOI:10.1002/pca.3271

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Nevin Manimala Statistics

Frozen Sections in Decision-Making Regarding the Axillary Procedures in Breast Conserving Surgery for Intraductal Carcinoma at Preoperative Diagnosis

J Korean Med Sci. 2023 Jul 31;38(30):e224. doi: 10.3346/jkms.2023.38.e224.

ABSTRACT

BACKGROUND: Axillary evaluation is unnecessary for pure ductal carcinoma in situ (DCIS); however, it is performed because of the risk of upstaging to invasive cancer. We assessed the role of intraoperative frozen section (IOF) biopsy in reducing invasive cancer upstaging and axillary evaluation in preoperative DCIS patients.

METHODS: We reviewed patients with preoperative DCIS who underwent breast-conserving surgery (BCS) with IOF biopsy. Positive IOF biopsy findings were defined as the presence of invasive or micro-invasive cancer. The IOF biopsy and permanent pathology findings were compared.

RESULTS: Seventy-eight patients underwent BCS with IOF biopsy. Six patients showed positive IOF biopsy findings; five of these patients showed concordant permanent pathology findings. Sentinel lymph node biopsy (SLNB) was positive in one patient. Thirteen patients with invasive breast cancer were missed by IOF biopsy; they underwent SLNB during the second surgery. None of them had metastatic lymph nodes. The sensitivity and specificity of IOF biopsy were 27.7% and 98.3%, respectively, with 82.1% accuracy. None of the other factors showed statistically significant relationships with the permanent pathology findings, except for the IOF biopsy findings.

CONCLUSION: IOF evaluation can aid in detecting the invasiveness of tumors in patients with preoperative DCIS.

PMID:37527907 | DOI:10.3346/jkms.2023.38.e224

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Nevin Manimala Statistics

Hypothesis testing procedure for binary and multi-class F1 -scores in the paired design

Stat Med. 2023 Aug 1. doi: 10.1002/sim.9853. Online ahead of print.

ABSTRACT

In modern medicine, medical tests are used for various purposes including diagnosis, disease screening, prognosis, and risk prediction. To quantify the performance of the binary medical test, we often use sensitivity, specificity, and negative and positive predictive values as measures. Additionally, the F 1 $$ {F}_1 $$ -score, which is defined as the harmonic mean of precision (positive predictive value) and recall (sensitivity), has come to be used in the medical field due to its favorable characteristics. The F 1 $$ {F}_1 $$ -score has been extended for multi-class classification, and two types of F 1 $$ {F}_1 $$ -scores have been proposed for multi-class classification: a micro-averaged F 1 $$ {F}_1 $$ -score and a macro-averaged F 1 $$ {F}_1 $$ -score. The micro-averaged F 1 $$ {F}_1 $$ -score pools per-sample classifications across classes and then calculates the overall F 1 $$ {F}_1 $$ -score, whereas the macro-averaged F 1 $$ {F}_1 $$ -score computes an arithmetic mean of the F 1 $$ {F}_1 $$ -scores for each class. Additionally, Sokolova and Lapalme 1 $$ {}^1 $$ gave an alternative definition of the macro-averaged F 1 $$ {F}_1 $$ -score as the harmonic mean of the arithmetic means of the precision and recall over classes. Although some statistical methods of inference for binary and multi-class F 1 $$ {F}_1 $$ -scores have been proposed, the methodology development of hypothesis testing procedure for them has not been fully progressing yet. Therefore, we aim to develop hypothesis testing procedure for comparing two F 1 $$ {F}_1 $$ -scores in paired study design based on the large sample multivariate central limit theorem.

PMID:37527903 | DOI:10.1002/sim.9853

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Nevin Manimala Statistics

Analysis of the key themes in the healthcare of older people with multimorbidity in Germany: a framework analysis as part of the LoChro trial

BMJ Open. 2023 Aug 1;13(8):e069814. doi: 10.1136/bmjopen-2022-069814.

ABSTRACT

OBJECTIVES: Multimorbidity challenges healthcare systems. In Germany, coordination of healthcare for older multimorbid patients remains unstructured.This study aims to identify key themes in the healthcare of these patients and the inter-relationships between them.

DESIGN: Framework analysis of six cases based on 1-year data of primary and secondary care, patient-answered questionnaires and video material.

SETTING: Southern Germany.

PARTICIPANTS: Six multimorbid older patients participating in a randomised controlled trial that compared usual care with a local, collaborative, stepped and personalised care management approach for older people with chronic diseases (LoChro-trial). The LoChro care intervention involved a care manager who assisted participants in self-management. The primary outcome was a composite of functional health and depressive symptoms at 12 and 18 months. The LoChro-intervention had no effect on the primary outcome.

PRIMARY OUTCOME MEASURE: Key themes in the healthcare of older patients with multimorbidity and the inter-relationships between them.

METHODS: One-year data included diagnoses, treatment plans, examinations, assessments and discharge reports. Patient perspectives were assessed using the Patient Assessment of Chronic Illness Care. In three cases, videos of the LoChro intervention showed patients describing their health needs. These data were evaluated by three doctors and public health researchers. Using framework analysis, recurring themes influencing the healthcare situation of multimorbid older patients and their inter-relationships were identified.

RESULTS: Participants had an average age of 77, with 13 diagnoses, taking eight medications regularly. The five key themes describing the healthcare situation of these multimorbid patients were as follows: insufficient coordination, overuse and underuse of medical care, doctor and patient roles. Each theme covered three to four subcategories. The most significant inter-relationships between these themes were a lack of coordination leading to overuse and underuse of medical care. These were characterised by redundant inpatient stays, potential prescribing omissions and missed examinations. Deficiencies in vaccinations and secondary prevention were also demonstrated.

CONCLUSION: Coordination of care for multimorbid older patients in Germany is still deficient. Future healthcare arrangements should be explored with the participation of physicians and patients.

TRIAL REGISTRATION NUMBER: LoChro trial: DRKS00013904.

PMID:37527899 | DOI:10.1136/bmjopen-2022-069814

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Nevin Manimala Statistics

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial

BMJ Open. 2023 Aug 1;13(8):e071318. doi: 10.1136/bmjopen-2022-071318.

ABSTRACT

INTRODUCTION: Chronic kidney disease (CKD) affects 30 million Americans. Early management focused on blood pressure (BP) control decreases cardiovascular morbidity and mortality. Less than 40% of patients with CKD achieve recommended BP targets due to many barriers. These barriers include a lack of understanding of the implications of their diagnosis and how to optimise their health.This cluster randomised control trial hypothesises that the combination of early primary care CKD education, and motivational interviewing (MI)-based health coach support, will improve patient behaviours aligned with BP control by increasing patient knowledge, self-efficacy and motivation. The results will aid in sustainable interventions for future patient-centric education and coaching support to improve quality and outcomes in patients with CKD stages 3-5. Outcomes in patients with CKD stages 3-5 receiving the intervention will be compared with similar patients within a control group. Continuous quality improvement (CQI) and systems methodologies will be used to optimise resource neutrality and leverage existing technology to support implementation and future dissemination. The innovative approach of this research focuses on the importance of a multidisciplinary team, including off-site patient coaching, that can intervene early in the CKD care continuum by supporting patients with education and coaching.

METHODS AND ANALYSIS: We will test impact of BP control when clinician-delivered education is followed by 12 months of MI-based health coaching. We will compare outcomes in 350 patients with CKD stages 3-5 between intervention and control groups in primary care. CQI and systems methodologies will optimise education and coaching for future implementation and dissemination.

ETHICS AND DISSEMINATION: This study was approved by the University of Michigan Institutional Review Boards (IRBMED) HUM00136011, HUM00150672 and SITE00000092 and the results of the study will be published on ClinicalTrials.gov, in peer-reviewed journals, as well as conference abstracts, posters and presentations.

TRIAL REGISTRATION NUMBER: NCT04087798.

PMID:37527897 | DOI:10.1136/bmjopen-2022-071318

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Co-development of traumatic stress symptoms and externalising behaviour problems among foster children and the effect of complex trauma: a latent growth curve model

BMJ Open. 2023 Aug 1;13(8):e067860. doi: 10.1136/bmjopen-2022-067860.

ABSTRACT

OBJECTIVES: Foster children are disproportionately exposed to complex trauma, which may lead to multifaceted impairments that manifest in comorbid emotional and behavioural problems. As little is known about the interactions between comorbid disorders over time, the present study aims to explore the co-development of traumatic stress (TS) symptoms and externalising behaviour problems (EBP), as well as the influence of complex trauma operationalised as cumulative child maltreatment (CM).

SETTING: As part of a 3-year longitudinal study, children from six foster care facilities in Lower Austria were interviewed at three measurement points.

PARTICIPANTS: Of, in total, 263 participating children, the data of 124 children aged 10-18 years (M=13.5, 28% female) could be analysed.

PRIMARY AND SECONDARY OUTCOME MEASURES: Latent growth curve models were used to examine the co-development of TS symptoms (International Trauma Questionnaire) and EBP (Child Behaviour Checklist) over time; gender, age and cumulative CM (Childhood Trauma Questionnaire) acted as time-invariant covariates.

RESULTS: While average TS symptoms decreased over time, EBP remained stable. Findings revealed that the initial severity of EBP was both related to the initial severity of TS symptoms and predictive of their rate of change. Cumulative CM was a significant predictor of initial TS symptoms and EBP even after controlling for age and gender, but not for the rates of change.

CONCLUSIONS: Taken together, our results indicate that EBP and TS symptoms are not only cross-sectionally associated but interact with each other over time. Furthermore, an underlying complex trauma could at least partly determine the severity of the two symptom groups. In accordance with a trauma-informed care approach, our study highlights the importance of trauma-specific screening of high-risk children with complex or diffuse symptoms and argues for the benefits of treatments that focus on improving emotion regulation and social skills in addition to addressing trauma.

PMID:37527893 | DOI:10.1136/bmjopen-2022-067860

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Nevin Manimala Statistics

Feasibility of a peer-supported, WhatsApp-assisted, lifestyle modification intervention for weight reduction among adults in an urban slum of Karachi, Pakistan: a mixed-methods, single-group, pretest-post-test, quasi-experimental study

BMJ Open. 2023 Aug 1;13(8):e070913. doi: 10.1136/bmjopen-2022-070913.

ABSTRACT

OBJECTIVES: This pilot study assessed whether a peer-supported, WhatsApp-assisted lifestyle modification intervention for weight reduction is feasible to execute a definitive trial.

DESIGN: A mixed-methods, single group, pretest and post-test, quasi-experimental study.

SETTING: Azam Basti, an urban slum in Karachi, Pakistan.

PARTICIPANTS: Fifty participants (males and females aged 20-60) with a body mass index of >23 kg/m2, along with their nominated peers from the same family.

INTERVENTION: Using motivational interviewing techniques, a trained nutritionist delivered the lifestyle modification intervention to the participants and peers for 3 days after the baseline assessment and then once monthly for 1 year. The intervention was delivered in groups using WhatsApp voice calls. The education sessions mainly focused on dietary modifications, physical activity advice and peer-support assignments to achieve a 5% wt loss from the participant’s initial body weight.

OUTCOMES: The feasibility measures included screening, recruitment, retention and monthly interview response rates. At 1 year, in-depth interviews (IDIs) with participants and peers were conducted to explore the facilitators, barriers, acceptability and experiences of the intervention. Changes in weight, calorie intake/day and calorie expenditure/day were also assessed.

RESULTS: The recruitment and retention rates were 32% (n=50/156) and 78% (n=39/50), respectively, while the response rate for monthly interviews ranged between 66% (n=33) and 94% (n=47). The mean weight loss at 1 year was 2.2 kg, and the reduction in mean calorie intake was 386 kcal/day. There were no changes in the mean calorie expenditure. During the IDIs, participants and peers reported intervention via WhatsApp and peer support as convenient, flexible and supportive.

CONCLUSIONS: The quantitative and qualitative findings of the current pilot study support the scale-up of this work with minor modifications to the screening method as well as close monitoring and motivational interviewing to improve adherence in terms of physical activity.

TRIAL REGISTRATION NUMBER: NCT05928338.

PMID:37527890 | DOI:10.1136/bmjopen-2022-070913

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Nevin Manimala Statistics

Risk of sexual dysfunctions in breastfeeding females: protocol for a systematic review and meta-analysis

BMJ Open. 2023 Aug 1;13(8):e074630. doi: 10.1136/bmjopen-2023-074630.

ABSTRACT

BACKGROUND: Epidemiological studies do not provide accurate statistics on the percentage of breastfeeding women experiencing sexual dysfunctions and restraining from sexual activity. The data vary between 40% and 83% in the first group and 20-50% in the second one. Despite excessive studies on contributors to intimacy changes, breast feeding received little attention from researchers. The relationship between lactation and postpartum sexual dysfunctions remains unclear. This systematic review and meta-analysis will synthesise available data and establish the link between breast feeding and sexuality problems.

METHODS AND ANALYSIS: A comprehensive literature search will be performed in biomedical databases PubMed/Medline, Scopus, Web of Science, EMBASE and CINAHL. We will extract peer-reviewed original studies written in English, Arabic or Polish from 2000 to June 2023. We will also search for reports from international health organisations and local health authorities. The preliminary search was performed on 04 April 2023. The studies must provide data on dysfunction prevalence/incidence and the strength of the relationship between breast feeding and sexuality in generally healthy women. The Covidence software will be used to perform literature screening, data extraction and quality assessment of individual studies. We will use a random-effects model meta-analysis to calculate pooled weighted frequency measures and effect size. Between-study heterogeneity will be assessed with the I2 test.

ETHICS AND DISSEMINATION: This meta-analysis does not require ethical approval because it synthesises data from previously published original studies. The final work will be published in a peer-reviewed journal and presented at scientific conferences.

PROSPERO REGISTRATION NUMBER: CRD42023411053.

PMID:37527888 | DOI:10.1136/bmjopen-2023-074630