Generalized Estimating Equations Research Articles

Effect of nutrition education on hemoglobin level of pregnant women in Southeast Ethiopia: a cluster randomized controlled trial

BackgroundMaternal hemoglobin (Hgb) is considered an essential, modifiable risk factor for adverse pregnancy outcomes (APOs). Evidence for the effect of nutrition education on the Hgb levels of pregnant women in low-income countries, including Ethiopia, is inconclusive. This study aimed to assess the effect of nutrition education on the Hgb levels of pregnant women in urban settings in the Bale Zone, Southeast Ethiopia.MethodsA community-based two-arm parallel cluster randomized controlled trial was carried out among 447 randomly selected pregnant women attending antenatal care (224 intervention and 223 control groups) at health facilities from February to December 2021. A multistage cluster sampling technique followed by systematic sampling was used to select the pregnant women. Pregnant women who took part in the intervention arm received six nutrition education sessions, whereas pregnant women in the control group received routine standard care. We used a pretested, interviewer-administered, structured questionnaire to collect the data. The Hgb level of pregnant women was measured by collecting a finger-prick blood sample using a HemoCue Hb 301. A generalized estimating equation (GEE) model was used to isolate the net effect of the intervention on Hgb, accounting for the clustering. Beta coefficients (β) along with a 95% confidence interval (CI) were used for interpretations.ResultsThe mean difference in Hgb levels between the intervention and control groups was 0.12 ± 0.04 (P value < 0.002). The multivariable GEE linear model revealed that nutrition education significantly improved the Hgb levels of pregnant women [β = 0.36, 95% CI: (0.30, 0.43)]. An increase in the consumption of a cup of coffee or tea decreased Hgb levels by 0.14 g/dL [β = -0.14, 95% CI: (-0.23, -0.06)].ConclusionThe findings showed that a comprehensive nutrition education intervention using the health belief model (HBM) and theory of planned behaviour (TPB) designed to improve dietary diversity substantially improved hemoglobin (Hgb) levels among pregnant women. While we found no single dietary factor to be significant, in this group of pregnant women in Ethiopia, an increase in the daily consumption of a cup of coffee or tea decreased Hgb levels. As a consequence, pregnant women should be advised to limit their coffee or tea consumption. The study was registered on Clinicaltrials.gov retrospectively with the registration number PACTR202201731802989 on 24/01/2022.

Maternal age-related declines in live birth rate following single euploid embryo transfer: a retrospective cohort study

PurposeTo assess whether maternal age influences the pregnancy outcomes after single frozen euploid embryo transfer.MethodsThis retrospective analysis was conducted on 1037 cycles of single euploid embryo transfer performed at Nanjing Women and Children’s Healthcare Hospital between January 2016 and April 2023. Patients with severe uterine pathologies, immune disorders, or endocrine diseases were excluded. The cycles were categorized into three age groups: <35 years, 35–37 years, and ≥ 38 years. Primary outcomes included live birth rate, clinical pregnancy rate, early pregnancy loss, and miscarriage rate. Data were analyzed using multivariable logistic regression with generalized estimating equations (GEE) to account for confounding factors and restricted cubic splines to visualize the relationship between maternal age and pregnancy outcomes.ResultsWomen aged ≥ 38 years demonstrated a significantly diminished live birth rate (41.7%) ,which was lower than that observed in women aged < 35 years (54.5%) and 35–37 years (54.0%), with statistical significance (P < 0.05). Multivariable regression analysis revealed that compared with women aged ≥ 38 years, younger women had reduced risk of miscarriage (aOR = 0.371, 95% CI: 0.139–0.988 for the < 35 years group; aOR = 0.317, 95% CI: 0.106–0.954 for the 35–37 years group) and increased likelihood of live birth (aOR = 2.188, 95% CI: 1.154–4.147 for the < 35 years group; aOR = 2.239, 95% CI: 1.0103–4.548 for the 35–37 years group) after adjusting for relevant confounders. Additionally, the analysis showed that embryos biopsied on day 5 were linked to higher clinical pregnancy rates than those biopsied on day 6, and high-grade blastocysts were associated with superior pregnancy outcomes.ConclusionAdvanced maternal age is associated with a higher miscarriage rate and lower live birth rate following euploid embryo transfer. Despite the exclusion of aneuploidy, age-related factors beyond chromosomal abnormalities appear to impact reproductive outcomes.

SPAGRM: effectively controlling for sample relatedness in large-scale genome-wide association studies of longitudinal traits

Sample relatedness is a major confounder in genome-wide association studies (GWAS), potentially leading to inflated type I error rates if not appropriately controlled. A common strategy is to incorporate a random effect related to genetic relatedness matrix (GRM) into regression models. However, this approach is challenging for large-scale GWAS of complex traits, such as longitudinal traits. Here we propose a scalable and accurate analysis framework, SPAGRM, which controls for sample relatedness via a precise approximation of the joint distribution of genotypes. SPAGRM can utilize GRM-free models and thus is applicable to various trait types and statistical methods, including linear mixed models and generalized estimation equations for longitudinal traits. A hybrid strategy incorporating saddlepoint approximation greatly increases the accuracy to analyze low-frequency and rare genetic variants, especially in unbalanced phenotypic distributions. We also introduce SPAGRM(CCT) to aggregate the results following different models via Cauchy combination test. Extensive simulations and real data analyses demonstrated that SPAGRM maintains well-controlled type I error rates and SPAGRM(CCT) can serve as a broadly effective method. Applying SPAGRM to 79 longitudinal traits extracted from UK Biobank primary care data, we identified 7,463 genetic loci, making a pioneering attempt to conduct GWAS for these traits as longitudinal traits.

Effects of 12-month physical and cognitive training on sarcopenia determinants in older adults: a subgroup analysis of a randomised clinical trial

BackgroundLow physical activity is a major risk for sarcopenia. Whether training according to physical activity guidelines accompanied with cognitive training is effective on sarcopenia, remains unclear.AimsWe investigated whether the effects of 12-month physical and cognitive training (PTCT) and physical training (PT) on grip and knee extension strength, muscle mass, and walking speed differed between older adults with and without sarcopenia.MethodsCommunity-dwelling older adults (N = 314, mean age 74.5 ± 3.8 years, 60% women) who did not meet physical activity guidelines were randomized to PTCT and PT groups. PT for both groups included supervised and home-based multicomponent physical training. Cognitive training (CT) included computer-based exercises for executive functioning. Sarcopenia was determined according to the European Working Group on Sarcopenia in Older People 2019 criteria. Generalized estimation equation analysis were conducted.ResultsCompared to PT, PTCT had no additive effect on strength, muscle mass, or walking speed in participants with or without sarcopenia. In pooled data (PT + PTCT) change in the grip strength was greater in sarcopenia (n = 49) group compared to non-sarcopenia (n = 264) group (interaction, p =.014). Both groups improved knee extension strength, and walking speed, but no statistically significant difference between the groups were observed. Muscle mass did not change in either group.ConclusionPhysical training according to physical activity recommendations improves muscle strength, walking speed, and maintains muscle mass in sarcopenia. Additional cognitive training had no benefits on these outcomes.Trial registration numberISRCTN52388040 and date of registration 20/1/2017.

Effectiveness of a Social Cognitive Theory-based health education intervention on depression (SCODESS) among mothers of children with cancer in Klang Valley, Selangor, Malaysia-A quasi-experimental study.

Mothers caring for children with cancer often experience depression, affecting maternal and family well-being. Prior studies suggest that theory-based health education can significantly reduce this depression. This study aimed to develop, validate, implement, and evaluate the effects of a Social Cognitive Theory (SCT)-based health education intervention on depression (SCODESS), as well as cancer-related knowledge, self-efficacy, perceived stress, coping skills, and social support among mothers of children with cancer at University Hospitals in Klang Valley. A quasi-experimental study was conducted with mothers from two University Hospitals in Klang Valley, Selangor. The intervention group is Hospital Pakar Kanak-Kanak Universiti Kebangsaan Malaysia (HPKK UKM) and the control group is the Universiti Malaya Medical Centre (UMMC). A total of 95 participants were included (50 intervention, 45 control). The intervention comprised online health education videos delivered over one week, and the control group received a poster. Data were collected at baseline (T1), immediately post-intervention (T2), and at two months post-intervention (T3). The effects of SCODESS intervention were analysed using Generalised Estimating Equation (GEE) analysis. The baseline response rate was 60.53% with a 2.17% loss to follow-up at T2 and 7.60% at T3. The GEE analysis showed no significant effects of SCODESS intervention on depression scores at T2 (p = 0.909) and T3 (p = 0.622) compared to the control group at baseline. However, statistically significant increases were observed in cancer-related knowledge scores at T2 (β = 0.66, 95%CI: 0.21, 9.20, p = 0.002) and T3 (β = 1.18, 95%CI: 0.65, 1.70, p<0.001), and in the problem-focused coping scores at T2 (β = 2.50, 95% CI 0.42, 4.58, p-value = 0.018), and T3 (β = 2.42, 95% CI 0.13, 4.72, p-value = 0.038) in the intervention group compared to the control group at baseline. No significant intervention effects were observed on other outcomes. This study validated the applicability of SCT-based intervention on depression scores among mothers of children with cancer. The SCODESS intervention did not significantly reduce depression scores but significantly increased cancer-related knowledge and problem-focused coping scores. As a potential preventive strategy for depression, the content of the SCODESS intervention should be revisited, emphasizing cancer-related knowledge and problem-focused coping as crucial components. It is recommended that tailored interventions focusing on these areas be offered to every mother of children with cancer, whether they are in the ward, clinic, or daycare.

Surface topography demonstrates gradual improvement in spinal range of motion in all three planes following posterior spinal fusion in adolescent idiopathic scoliosis.

After posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS), there is alteration in trunk range of motion (ROM) in the coronal, sagittal and axial planes. Previous studies have shown that ROM decreases with increased number of levels fused, which may affect the ROM between patients who undergo non-selective thoracic fusion (NSF) and selective thoracic fusion (STF) patient groups. This study sought to longitudinally evaluate the ROM of the trunk in patients with AIS who underwent posterior spinal fusion, using surface topography, comparing STF and NSF patient motion at multiple time points postoperatively. A retrospective review of data from a single-center prospective registry was conducted. Inclusion criteria required subjects to span 11-21 years of age at surgery, a diagnosis of AIS, and valid ROM measurements obtained via ST scanning. Axial, sagittal and coronal ROM was performed at six timepoints: preoperative, 6 weeks, 3, 6, 12, and 24 months postoperative. All patients had an upper instrumented vertebra (UIV) of T2, T3 or T4, and a lower instrumented vertebra (LIV) of T12, L1, L2 or L3. STF was defined as an LIV of T12 or L1, and NSF as LIV as L2 or L3. SRS22r was collected at all time points. Generalized estimation equation modeling across timepoints were conducted. 54 patients were evaluated: 40 patients in the NSF group (average preoperative Cobb angle of 56.4 ± 12.3°) and 14 in the STF group (average preoperative Cobb angle of 57.4° ± 6.7°). In the NSF group, ROM in the coronal and axial planes decreased significantly postoperatively and remained significantly decreased at 24 months postoperatively (25% decrease in the axial plane, 20% in the coronal plane). Sagittal ROM had significant decrease in ROM at all time points, but at 2 years postoperatively was no longer significant, although still 17% decreased. In the STF group, all three planes had significantly decreased initially but axial and coronal planes returned to baseline (no significant difference from preoperative values) at 24 months, while sagittal plane motion remained significantly diminished, although only by 4%. STF demonstrated no difference in SRS22r total, pain or self-image scores between preoperative and 2 years, while NSF had worse SRS22r total, pain, and self image scores at 2 years vs. preoperative values. When comparing NSF to STF, there was diminished axial, sagittal and coronal plane range of motion at 24 months postoperatively, but no differences in SRS22r total. The coronal, sagittal, and axial ROM as measured by ST demonstrated significant decreases from preoperative to postoperative following PSF; however, this deficit trends towards improvement over time. Our data demonstrates that at two years, NSF has poorer motion than STF patients in all three planes.

Does the transition from face-to-face to face-to-screen improve oral health literacy? A non-inferiority randomized controlled trial

BackgroundIn recent years, more attention has been paid to virtual education methods in the field of oral health. Oral health literacy (OHL) plays a major role in reducing oral health inequalities. Individuals with inadequate health literacy are more susceptible to oral disorders. This study was a parallel randomized controlled trial with a non-inferiority design that aimed to compare a virtual educational intervention with traditional in-person education to improve OHL.MethodsThis study was conducted in adults visiting a university dental school, from February 2022 to May 2023. After the inclusion and exclusion criteria were checked and informed consent was obtained, the participants were randomly allocated into two groups by balanced block randomization. One group received in-person education in the waiting room, and the other received an educational video through an online messenger. The Oral Health Literacy Adult Questionnaire (OHL-AQ) assessed participants’ OHL levels before, immediately after, and three months after the intervention. The researchers who analysed the data were blinded. Generalized estimating equation (GEE) analysis was used to compare the groups (P < 0.05). The non-inferiority margin was determined using the fixed-margin method.ResultsIn total, 149 individuals participated. Seventy-five patients were randomly allocated to the in-person group, and 74 were allocated to the virtual group; their data were analysed. GEE analysis revealed no significant difference in the change of OHL scores immediately after the intervention between the two groups (P = 0.07). However, at the three-month follow-up, the in-person group exhibited a significantly greater improvement in OHL scores compared to the virtual group (P = 0.03). After three months, virtual education was inferior to in-person education, unlike in the immediate post-test.ConclusionAfter three months, an online video sent in a messenger environment was less effective than traditional in-person education in improving OHL.Trial registrationThe trial protocol was registered in the Iranian Registry of Clinical Trials (IRCT) on 08–02-2022, (IRCT20220106053643N1||http://www.irct.ir/).

Predictive value of enhanced CT and pathological indicators in lymph node metastasis in patients with gastric cancer based on GEE model

ObjectivesA predictive model was developed based on enhanced computed tomography (CT), laboratory test results, and pathological indicators to achieve the convenient and effective prediction of single lymph node metastasis (LNM) in gastric cancer.MethodsSixty-six consecutive patients (235 regional lymph nodes) with pathologically confirmed gastric cancer who underwent surgery at our hospital between December 2020 and November 2021 were retrospectively reviewed. They were randomly allocated to training (n = 38, number of lymph nodes = 119) and validation (n = 28, number of lymph nodes = 116) datasets. The clinical data, laboratory test results, enhanced CT characteristics, and pathological indicators from gastroscopy-guided needle biopsies were obtained. Multivariable logistic regression with generalised estimation equations (GEEs) was used to develop a predictive model for LNM in gastric cancer. The predictive performance of the model developed using the training and validation datasets was validated using receiver operating characteristic curves.ResultsLymph node enhancement pattern, Ki67 level, and lymph node long-axis diameter were independent predictors of LNM in gastric cancer (p < 0.01). The GEE-logistic model was associated with LNM (p = 0.001). The area under the curve and accuracy of the model, with 95% confidence intervals, were 0.944 (0.890–0.998) and 0.897 (0.813–0.952), respectively, in the training dataset and 0.836 (0.751–0.921) and 0.798 (0.699–0.876), respectively, in the validation dataset.ConclusionThe predictive model constructed based on lymph node enhancement pattern, Ki67 level, and lymph node long-axis diameter exhibited good performance in predicting LNM in gastric cancer and should aid the lymph node staging of gastric cancer and clinical decision-making.

Effect of pre-school sound exposure on children’s hearing function: results from preparatory studies assessing hearing function by distortion product otoacoustic emissions

Objective This study investigated the potential impact of sound exposure in preschools on children’s hearing function by measuring distortion product otoacoustic emissions (DPOAE) over time. Design A longitudinal repeated-measures approach was employed to evaluate how DPOAE amplitudes varied with sound exposure and pre-school attendance duration, analysed using general estimation equation (GEE) modelling. Study sample The sample included 62 children aged three to six years attending preschools. Sound exposure levels and DPOAE amplitudes were measured during time being indoor. Results Average indoor sound levels (time indoors (Ti)) were 81 dB LAeqTi, with highest noise events reaching 112 dB LAFmax. A total of 31 measurements (52%) exceeded 80 dB LAeqTi. GEE analysis showed a significant decrease in DPOAE amplitudes at 6000 and 8 kHz in the right ear in relation to sound exposure levels, suggesting a sound level-dependent effect. Time spent in pre-school revealed a decrease in DPOAE amplitudes at 3000 and 4 kHz in the right ear over the day and week, indicating cumulative effects of sound exposure. Conclusions The findings suggest that pre-school sound exposure may adversely affect children’s hearing, particularly at higher frequencies and over time. Further research is needed to validate these results and explore long-term implications of early-age noise exposure.

Comparative Assessment of Antibiotics and Probiotics: Adjuvants in Nonsurgical Periodontal Treatment for Smokers With Generalized Periodontitis.

Introduction Humankind is suffering from the misuse and overuse of antibiotics, leading to antibiotic resistance. At this point, probiotics, if found effective, can lead to a better future. Probiotics are nothing but a colony of living-friendly bacteria. Lactobacillus reuteri is essential for use as a probiotic among many healthy bacteria. This study aims to compare the effectiveness of probiotics in periodontal treatment. Methods One hundred smokers diagnosed with chronic generalized periodontitis were randomly assigned into two groups. Group A received a seven-day course of amoxicillin 500 mg three a day and metronidazole 500 mg twice daily, followed by 30 days of probiotics, while Group B received a placebo antibiotic for seven days and 30 days of L. reuteri probiotics (2×10⁸ CFU daily). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), attachment loss (AL), and bleeding on probing (BOP), were utilized to assesat baseline, month one, and month one. Baseline differences were adjusted using the generalized estimating equation (GEE) model. Results At month three, Group B (probiotics) showed a significantly lower PI (0.52±0.49 vs. 0.88±0.52,p<0.001) and a 23% greater reduction in PD (p=0.004) compared to Group A (antibiotics + probiotics). These findings highlight the effectiveness of probiotics alone in improving periodontal health in smokers. Conclusions Both groups showed equal effectiveness in improving periodontal health. Hence, probiotics should be preferred over antibiotics.

Sample Size Estimation for Correlated Count Data With Changes in Dispersion.

Clinical endpoints based on repeated measurements arise in many clinical research studies, and require specialized methods for sample size and power calculations. In clinical trials that measure counts over time, such as bleeding events in hemophilia, the dispersion of their distributions might change upon treatment and the measurements might be correlated. The generalized estimating equations (GEE) approach has been widely used for modeling correlated data and comparing rates. In this paper, we investigate the properties of GEE when applied to count outcomes with changes in dispersion. We derive general closed-form formulas to estimate sample size when the dispersion parameters and distributions of count data vary across two correlated measurements based on the GEE approach. These formulas allow for power and sample size estimation for intra-participant comparison of rates before and after an intervention, randomized controlled trials with equal allocation, or matched pairs designs. These formulas are derived for the following distributions: Poisson, negative binomial, zero-inflated Poisson, and zero-inflated negative binomial distributions, and do not assume that measurements before and after an intervention come from the same distribution. Furthermore, we propose modified methods for estimating sample size and confidence intervals for the negative binomial distributions to overcome Type I error inflation, which is especially useful for large changes in the negative binomial dispersion parameter. We perform simulations, and evaluate the performance of the empirical power and Type I error over a range of parameters. Applications and R functions implementing the methods are also provided.

Exploring the link between serum betaine levels and hyperuricemia risk in middle-aged and older adults: insights from a prospective cohort study.

Betaine is connected to various cardio-metabolic outcomes, yet its relationship with hyperuricemia remains uncertain. We aimed to longitudinally investigate the association between serum betaine levels and the risk of hyperuricemia in middle-aged and older adults. This study utilized data from the Guangzhou Nutrition and Health Study (GNHS). Participants were enrolled between 2008 and 2010, with follow-ups conducted every three years, comprised an analysis sample of 2204 adults aged 40-75. Baseline serum betaine levels were assessed using high-performance liquid chromatography-tandem mass spectrometry. Serum uric acid (SUA) levels were measured at baseline and every three years thereafter. Linear mixed-effects models (LMEMs) and generalized estimating equations (GEEs) were employed to examine the longitudinal association between serum betaine levels and SUA levels, as well as hyperuricemia risk, respectively. LMEMs indicated that compared to individuals in the lowest quartile (Q1) of serum betaine levels, those in the highest quartile (Q4) exhibited the lowest SUA levels (Q4 vs. Q1: β -8.19, 95% CI -16.32 to -0.06, P-trend = 0.023). Each standard deviation increase in betaine (16.5 µmol/L) was associated to SUA levels decrease of -3.28 (-6.10, -0.45). Results from the GEE model suggested a 19% reduction in the odds of hyperuricemia (OR = 0.81; 95% CI: 0.68, 0.95, P-trend = 0.051) in the Q4 group compared to the Q1 category. Our findings highlight a negative association between serum betaine levels and SUA levels, as well as the risk of hyperuricemia in middle-aged and older adults, which is more pronounced in individuals with better dietary quality. This trial was registered at clinicaltrials.gov as NCT03179657. Website: https://clinicaltrials.gov/ct2/show/NCT03179657.

Deproteinized Bovine Bone Mineral With Collagen for Anterior Maxillary Ridge Augmentation: A Retrospective Cohort Study.

This study aimed to assess the effects of deproteinized bovine bone mineral with collagen (DBBMC) combined with deproteinized bovine bone mineral (DBBM) on facial alveolar bone augmentation in the anterior maxillary region. Patients receiving dental implant placement with simultaneous lateral bone augmentation using DBBM (control group) or DBBMC combined with DBBM (test group) were included in the study. The radiographic assessment of facial alveolar bone, such as facial horizontal bone thickness (FHBT), facial vertical bone level (FVBL), and square of facial bone (SFB), was taken by cone beam computed tomography (CBCT). Generalized estimated equation (GEE) was performed to identify influencing factors associated with the contraction in square of facial bone (SFBC). A total of 164 implants from 164 patients were included in this study. After 6 months post-surgery, the SFBC and the alterations of FHBT and FVBL in the test group were significantly higher than those in the control group (p < 0.05). After 1-2 years after restorations, the SFBC and the alterations of FHBT and FVBL in the test group were significantly lower than those in the control group (p < 0.05). Spearman correlation analysis demonstrated a positive correlation between the alterations of FVBL and FHBT at the implant platform level in the test group (rs = 0.322, p = 0.001; rs = 0.349, p = 0.002). Implant timing of early loading (p = 0.014) and the implant site of the central incisor (p = 0.040) were significantly associated with the SFBC. The applications of DBBMC combined with DBBM achieved better facial alveolar bone augmentation in the anterior maxillary region, especially in early implant placement.

Dynamic Nutrition Strategies for Anorexia Nervosa: Marker-Based Integration of Calories and Proteins

Background/Objectives: Anorexia nervosa (AN) is a severe psychiatric disorder characterized by profound nutritional deficits and significant alterations in body composition, cellular integrity, and hydration. Nutritional rehabilitation is critical not only for weight restoration but also for improving body composition and metabolic functions. However, optimal strategies for integrating caloric and protein intake to achieve balanced recovery remain underexplored. This study aims to evaluate the interactions between caloric/protein intake and time on quantitative (weight and BMI) and qualitative (body composition and cellular health) outcomes, and to identify markers that predict recovery trajectories and guide personalized nutritional interventions. Methods: This retrospective observational study analyzed 79 patients with AN admitted to Villa Miralago for six months of nutritional rehabilitation. Anthropometric and body composition parameters—including body weight (BW), body mass index (BMI), fat mass (FM), fat-free mass (FFM), body cell mass (BCM), phase angle (PA), and hydration markers (TBW and ECW)—were assessed at baseline (T0), 3 months (T1), and 6 months (T2). Generalized Estimating Equations (GEEs) were used to evaluate the effects of caloric and protein intake over time. Results: Significant increases in BW (+6.54 kg, p &lt; 0.0001) and BMI (+2.47 kg/m2, p &lt; 0.0001) were observed, alongside improvements in FM, FFM, and BCM. PA increased significantly (+0.47°, p &lt; 0.0001), indicating enhanced cellular health. TBW increased (+1.58 L, p &lt; 0.0001), while ECW% decreased, reflecting improved fluid distribution. Caloric intake predominantly influenced early fat mass recovery, while protein intake was crucial for preserving lean tissues and promoting cellular regeneration. Interaction effects between caloric/protein intake and time revealed dynamic changes in body composition, underscoring the need for adaptive strategies. Conclusions: This study highlights the importance of a dynamic, marker-based approach to nutritional rehabilitation in AN. Integrating caloric and protein intake with advanced body composition and hydration markers enables personalized interventions and balanced recovery, shifting AN treatment toward a focus on qualitative improvements overweight restoration alone.

Associations between urinary parabens and thyroid hormone homeostasis across trimesters in Taiwanese pregnant women.

Few studies have explored the link between paraben exposure and thyroid hormone homeostasis in pregnant women across trimesters. The present study involved 97 pregnant women from southern Taiwan (2013-2014), and involved measuring urinary methyl, ethyl, propyl, and butyl parabens, as well as serum thyroid hormones and related indices, such as Structure Parameter Inference Approach-Glandular Disturbance [SPINA-GD], and SPINA Global Turnover [SPINA-GT]). Generalized estimating equations (GEE) were applied to examine the effect of longitudinal paraben exposure on thyroid hormone homeostasis. We found that propylparaben and butylparaben levels were associated with increased FT4 levels at the second visit (β = 0.07, p = 0.019; β = 0.08, p = 0.002), respectively. The GEE analysis further supported these associations, indicating the positive association between propylparaben levels and both T3 and FT4 levels over time (β = 0.05, p = 0.019 and β = 0.05, p = 0.026, respectively). Moreover, butylparaben levels were positively associated with FT4 (β = 0.05, p = 0.004) and inversely associated with the T4/FT4 ratio and SPINA-GD values (β = -0.04, p = 0.039 and β = -1.63, p = 0.004, respectively). In the GEE and BKMR analyses, a positive association was observed between PrP or paraben mixtures and T3 and FT4 levels, respectively. The findings of this study indicate that paraben and paraben mixtures have the potential to disrupt thyroid homeostasis by exerting a diverse hormonal effect. Further research is required to substantiate these conclusions in larger sample size populations.

Estimating Skeletal Maturity by Segmented Linear Modeling of Key AP Wrist Radiographic Parameters.

The recently described Modified Fels wrist skeletal maturity system (mFels wrist SMS) allows for accurate skeletal maturity estimation using a single anteroposterior wrist radiograph but requires evaluation of 8 parameters. A faster method may have clinical utility in the outpatient setting. The 8 anteroposterior wrist radiographic parameters comprising the mFels wrist SMS were analyzed in 80 children. Segmented linear regression and generalized estimating equation (GEE) analyses were used to identify the subsets of parameters most important for accurate skeletal maturity estimation for different patient demographics and parameter scores. This process produced multiple abbreviated Fels wrist skeletal maturity system options (abFels wrist SMS), which require fewer parameters. The accuracy of the resulting abFels wrist SMS options was evaluated and compared with the full 8-parameter mFels wrist SMS, the Greulich and Pyle system (GP) optimized with age and sex data, and the Sanders Hand System (SHS) optimized with age and sex data. A total of 372 wrist radiographs from 42 girls (age range, 7 to 15y) and 38 boys (age range, 9 to 16y) were included. The abFels wrist SMS options required fewer parameters (range, 2 to 7 parameters, one option with 2 to 4 parameters) than the full mFels wrist SMS (8 parameters). Skeletal age estimates produced by the full mFels SMS were more accurate than GP (P<0.001), SHS (P<0.001), and similar to the all of the abFels wrist SMS options (P>0.05). The mFels wrist SMS made fewer outlier estimations (estimation >1y off from the patient's actual skeletal age) than GP (P<0.05), and made similar rates of outlier estimations compared with SHS (P>0.05) and the abFels wrist SMS options (P>0.05). An abbreviated version of the Modified Fels wrist SMS estimates skeletal maturity with comparable accuracy to the full version but only requires 2 to 4 parameters for quicker use.

Application of a Validated Assessment Tool to Compare Autonomy and Operative Performance Between Surgical Residency Programs.

Every residency has the responsibility to determine the competency of its residents and their readiness to practice after graduation, but few objective tools exist to assess residents. The Zwisch grading scale is a validated assessment tool for operative performance which has been incorporated into a smartphone application, called System for Improving and Measuring Procedural Learning (SIMPL). This application allows residents and attendings to evaluate a resident's performance in real time. Since its implementation there have been no studies that have compared scores across all participating general surgery programs in order to identify if varying procedure difficulty affect supervision and performance ratings amongst programs overall. The SIMPL database was queried for attending ratings for Post Graduate Year (PGY 1-5). Meaningful autonomy (MA) was defined as passive help or supervision only and satisfactory performance (SP) was defined as practice ready or exceptional. Procedures were classified as "core" or "advanced" based on the American Board of Surgery Surgical Council on Resident Education (SCORE) criteria. Work relative value units (wRVU) obtained from the Centers for Medicare & Medicaid services data were matched to procedures and categorized into 3 groups (<13.07, 13.07-22, >22) based on previous work. Proportions of advanced and high wRVU (>22) procedures were calculated for each program and PGY and matched back to each corresponding evaluation as potential proxies to resident exposure to more complex operations. All evaluations were divided into quintiles based on the corresponding program's proportion of advanced and high wRVU procedures. Data were summarized using descriptive statistics and generalized estimating equations (GEE) logistic regression models were used to assess whether program proportions of advanced or high wRVU procedures are predictive of MA or SP overall and among PGY 5 residents. Overall, proportions across programs ranged from 2.2% to 32.5% (mean 12.4%) and 2.4%-22.9% (mean 11.9%) for advanced or high wRVU procedures respectively. Across PGY levels, the mean proportion of advanced (7.6, 9.6, 13.1, 13.4, 14.2) and high wRVU (4.4, 6.5, 9.8, 15.3, 19.8) procedures increased with each step in PGY. In descriptive analyses of the entire group, lower numbers of MA and SP were noted with increasing proportions of advanced/high RVU. The relationship was similar for all core procedures and when limited to PGY 5 residents, however it was not entirely consistent and showed no association with advanced procedures. Similarly, in the models lower adjusted odds of MA and SP were noted for evaluations from programs with higher proportions of advanced or high wRVU procedures for the overall group but this was less consistent when limited to PGY 5 residents and even more variable when limited to advanced procedures (Table 1). There is wide variation in the proportion of advanced or high wRVU procedures reported at different programs. Overall MA and SP tended to be lower for programs reporting more advanced procedures overall and equivocal in programs with higher wRVU procedures. Programs with higher percentage of advanced procedures showed an increase in MA and SP when looking at performance as a PGY5 during core procedures only. The MA and SP of PGY5s performance during advanced procedures was not changed by an increase in exposure to advanced procedures. These results indicate that programs with more advanced cases may not necessarily train surgeons with the appropriate level of skill, knowledge or confidence needed to be an independant and safe surgeon.

P-1748. Reducing Inappropriate Post-Operative Antibiotics in Pediatrics: The Optimizing PERioperative AnTibiotics In Children (OPERATIC) Trial

Abstract Background Prolonged ( &amp;gt; 24 hours) post operative antibiotic (abx) use is the most common reason for inappropriate abx use in hospitalized children occurring in 40% of cases. Effective strategies are needed to reduce inappropriate post operative abx use. One strategy, facilitation, helps people develop the skills to change the structure and processes within a system to reduce the gap between evidence and practice. This study evaluated the best strategy, order set change vs order set change + facilitation, to deimplement unnecessary post operative abxs.Figure 1:Operatic Stepped-Wedge Trial Design Stepped-wedge trial design comparing order set change only (control) versus order set change plus a facilitation workshop (intervention) attended by the ASP team at the beginning of step. Nine children’s hospitals were randomized to 1 of 3 clusters to begin the intervention at either steps 1, 2, or 3. All hospitals were in the intervention in steps 3-5. Each cluster included 3 hospitals and each step was 6 months in duration. Methods A stepped-wedge trial was conducted at 9 US children’s hospitals from 11/1/20-10/31/23 (Fig 1). After 6 months of all hospitals starting in control of changing order sets, 3 hospital antimicrobial stewardship teams in steps 1-3 participated in the intervention (int), a virtual facilitation workshop to help change order sets. The primary outcome was the rate of inappropriate post operative abxs ( &amp;gt; 24 hours) in clean and clean contaminated cases. Hospital data were collected through the National Surgical Quality Improvement Project Pediatrics. Secondary outcomes were rate of surgical site infection (SSI) and C. difficile infection (CDI). Generalized estimating equations (GEE) with logit link function were utilized to investigate the outcome changes across steps.Figure 2.All Cases All NSQIP-P clean and clean-contaminated cases inappropriate rate of post-operative antibiotic use (&amp;gt;24 hours) by step and group (control and intervention). The GEE model of inappropriate antibiotic rate is presented as the least square means with 95% Confidence intervals. Results The study included 17202 cases, 5913 control and 11289 int. Demographics included mean age of 8.4 years (sd 5.9); 51% female; 71% White, 14% Unknown, 9% Black race; and 14% Hispanic ethnicity. The common surgical specialties were orthopedics (31%), general (21%), and neurosurgery (17%). The overall post operative inappropriate rate was 10%, 11% control v. 10% int. 4 hospitals targeted spine cases (n 2733); the inappropriate rate was 28%, 33% control v. 26% int. Controlling for time and hospital, the GEE model showed a significant decrease in inappropriate post operative abx use for all cases and spine cases for the int across steps (Fig 2&amp;3 p&amp;lt; 0.001). SSI and CDI rates were not significantly increased or decreased.Figure 3.Spine CasesSpine cases inappropriate rate of post-operative antibiotic use (&amp;gt;24 hours) by step and group (control and intervention). The GEE model of inappropriate antibiotic rate is presented as the least square means with 95% Confidence intervals. Conclusion Order set change plus facilitation resulted in a significant reduction in inappropriate post operative abx use. This study is the first deimplementation trial to show the impact of a facilitation workshop on inappropriate abx use. Disclosures Jason G. Newland, MD, MEd, Moderna: Grant/Research Support|Pfizer: Grant/Research Support

Effect of nutrition education and iron-folic acid supplementation on anemia among pregnant women in Ethiopia: a quasi-experimental study

The aim of this study was to assess the effect of nutrition education and counseling using health belief health model constructs along with iron-folic acid supplementation on hemoglobin level and adherence to IFAs during pregnancy. The study was a three-month quasi-experimental study design in Butajira town, Ethiopia. Community-based nutrition education and counseling sessions using the Health belief model, and IFAS for six weeks were given to the pregnant women. Compliance with iron-folic acid supplementation (IFAS) was assessed using pill counts based on the number of remaining pills in the retained prescribed bottles or strips. End-line data were collected from 97 interventions and 96 control groups of pregnant women after 6 weeks of nutrition education interventions. The analysis of the effect of the intervention was done using difference-in-difference and a generalized estimation equation (GEE) approach. At the end of the nutrition education intervention, there was a significant drop in the proportion of anemia in the intervention group compared to the control group. The prevalence of anemia among the intervention group declined from 27.8% at baseline to 7.2% after intervention. The change in the knowledge score regarding IFAS and maternal adherence to IFAS were significantly higher in the intervention group as compared to the control group (p < 0.001). In this study, the odds of adherence to IFA supplementation were 2.26 (95% CI 1.55 to 3.29) times higher among those who received nutrition education interventions as compared to the control group. Implementation of community-based nutrition education and counseling along with IFAS improved the hemoglobin level and adherence to IFAS among pregnant women. Therefore, there is need to integrate community-based nutrition education approach by using HBM constructs with antenatal IFAS distribution to improve supplementation and hemoglobin level of pregnant women.

The role of D-dimer changes in predicting delivery time in preterm premature rupture of membranes: a retrospective analysis.

Pregnancy induces a hypercoagulable state, characterized by increased coagulation factors and decreased anticoagulants, alongside ongoing fibrinolysis marked by elevated D-dimer (DD) levels. Reference values for DD in pregnancy often exceed the non-pregnant cutoff due to these changes. Elevated DD levels are common in late pregnancy and may correlate with complications such as gestational diabetes, hypertension, and preterm delivery, particularly in cases of preterm premature rupture of membranes (PPROM). This study investigates the association between DD levels, the duration from PPROM diagnosis to delivery, and neonatal outcomes. This retrospective study was conducted at the Department of Perinatology, Etlik City Hospital, Ankara, Turkey, from October 2022 to May 2023. Eighty patients with PPROM between 24 and 36weeks of gestation were included. Routine blood tests and coagulation parameters, including DD, were monitored every other day for 2weeks. Patients were classified into two subgroups based on whether labor occurred within 7days of PPROM diagnosis. Statistical analyses included the Mann-Whitney U test, Student's t test, Chi-square test, Friedman test, Durbin-Conover test, generalized estimating equations (GEE), and ROC analysis. Gestational age at admission was significantly lower in patients who delivered later than 7days post-PPROM. Significant differences were observed in ultrasonographic measurements, with larger fetal parameters in the early delivery group. Higher DD levels at the third follow-up correlated with shorter durations to delivery (p = 0.021). Longitudinal analysis showed significant fluctuations in DD levels over time, particularly near delivery. The GEE analysis demonstrated a strong inverse relationship between DD levels and time to delivery (p = 0.004), supported by ROC analysis (AUROC = 0.811). Elevated DD levels are associated with shorter durations from PPROM diagnosis to delivery, indicating their potential utility in predicting labor onset. Monitoring DD levels may help in clinical decision-making for managing PPROM, including planning neonatal care and timing of interventions.