Post-hoc Power Research Articles

A Modified Triangular Arthroscopic Suture-Based Fixation for Tibial Eminence Fractures: Technique, Outcome and Literature Review.

Objectives: Tibial eminence fractures account for 2% to 5% of all knee injuries. Low-grade fractures, such as Type I, are typically treated conservatively, whereas high-grade fractures, such as Types III and IV, usually require surgical intervention. This paper describes a modified surgical arthroscopic technique, which employs pull-through triangle suture fixation for Type II and Type III arthroscopic intercondylar eminence avulsion fractures. In addition, we examined the efficacy and complication rate compared to the existing literature. Methods: Data were prospectively collected for knee arthroscopy surgeries and retrospectively analyzed with a minimum two-year follow-up. Twenty-three consecutive adults underwent arthroscopic treatment of displaced intercondylar Type II and Type III eminence fractures, as evidenced by clinical examination and imaging studies between May/2008 and May/2021. The patient's knee evaluation was performed using clinical symptoms and physical examination, along with International Knee Documentation Committee (IKDC) questionnaire and Tegner Activity Score. Compared to the literature, post-hoc power was calculated based on the mean Tegner Activity Score in our analysis. Results: fifteen females and eight males (mean age 33.9 years, range 19-56 years) were enrolled. The average postoperative follow-up was 35.4 months (27-53). The post-hoc power was 95% confidence in terms of the Tegner Activity Score. The mean ± standard deviation postoperative Tegner Activity Score was 8.2 ± 1.7 (6.8-10.0). Fifteen patients were classified as IKDC A (normal), six as IKDC B (nearly normal), and two as IKDC C (abnormal). The mean IKDC subjective score was 72.7 ± 23 (23-100). Twenty-four patients achieved normal flexion degrees compared with the unaffected side, while one patient achieved a flexion of only 0-90°. The group's mean flexion range of motion was 123 ± 16° (90-150°). Conclusion: This study presents a modified surgical arthroscopic suture fixation technique for tibial eminence fractures. The procedure is relatively simple and requires no more than basic arthroscopy equipment. The clinical and radiographic results indicate that this technique is safe, efficient, enables early initiation of rehabilitation, and has a lower complication rate in a variety of aspects compared with other fixation techniques used for tibial eminence fractures.

Inhibition moderates the effect of attentional bias modification for reducing residual depressive symptoms: A randomized sham-controlled clinical trial

ObjectivesResidual symptoms represent risk factor for relapse. Attention bias modification (ABM) may reduce clinical and sub-clinical depressive symptoms, indicating that is may be of relevance when preventing relapse. Current evidence suggests that executive functions may moderate the outcome of interventions targeting depressive symptoms. MethodsWe assessed inhibition and shifting as indicators of executive functioning by means of the Color-Word Interference Test (i.e., “Stroop task”). These baseline characteristics were investigated as moderator of the effect of ABM on depression symptoms in a double-blinded randomized sham-controlled trial of ABM including patients with a history of recurrent depression (N = 301). Inclusion and follow-ups took place from January 2015 to October 2016. The trial was retrospectively registered #NCT02658682 January 2016. ResultsThe moderation analysis was based on the interaction term ABM x Stroop. Scaled inhibition scores ≤10.8, but not shifting ability, moderated the effect of ABM compared to sham on clinician-rated depression (HDRS). The difference from the 15th to the 85th percentile of the inhibition score was about 1 HDRS-point, indicating a small effect size. No moderation was found when self-reported depression and AB were the outcome. Post-hoc power calculation indicates risk of Type-II error. ConclusionWhen targeting depressive symptoms, ABM seems to be somewhat more effective in patients with weak inhibitory control. This suggests that evaluating the level of inhibition in individual patients could provide some information when making decisions about prescribing ABM to reduce residual symptoms, but the clinical implications of this is uncertain due to an overall small effect size attributable to ABM. Future studies should examine whether inhibitory control still is a relevant moderator when comparing ABM to treatment options other than the sham control condition.

The effect of lithium variation coefficient on the risk of attack in patients with bipolar disorder: A pilot study.

This study examines the association between the coefficient of variation (%CV) of lithium levels and episode risk and frequency in bipolar patients maintaining serum lithium levels within the therapeutic range. We retrospectively reviewed patients with bipolar disorder under care from 2018 to 2022. Inclusion criteria were at least 2years of follow-up, a minimum of three annual lithium level measurements within the therapeutic range. Patients were categorized based on seizure status. We calculated mean lithium levels, standard deviation (SD), and %CV. The study included 75 patients (patients with-without episodes, 39-36). Demographic data revealed no significant differences. While mean lithium levels showed no significant disparity between groups, SD and %CV were notably higher in patients with episodes (P < .05). ROC analysis demonstrated AUC values of 0.722 (95% CI: 0.607-0.836 P = .001) for %CV and 0.709 (95% CI: 0.593-0.826; P = .002) for SD. The optimal %CV cutoff was 17.39, with 67% sensitivity and 69% specificity. A weak correlation was found between %CV and the number of episodes (P = .001, r = 0.376). The post-hoc power analysis for this study was 0.78. Despite acceptable lithium levels, patients with recent episodes exhibited significant lithium level fluctuations. Integrating %CV with real-time lithium measurements during bipolar disorder follow-up may enhance clinical monitoring and seizure prediction.

The effects of monomer type, filler size, and filler content of three resin cements on the color stability of laminate veneers exposed to accelerated aging

Statement of problemCommercially available resin cements consist of various filler sizes, filler content and monomers, and it is unclear which of these factors have the greatest effect on the color stability of laminate veneers. ObjectivesTo evaluate the color stability of lithium disilicate-reinforced laminate veneers inserted with three commercial resin cements with various filler sizes/contents and monomers upon accelerated aging. MethodsVeneers were fabricated and cemented on resin abutments using three commercially available resin cements comprised of two different monomers and varying filler sizes/contents: 1) triethylene glycol dimethacrylate, TEGDMA (RelyX™ Veneer = 0.6 µm/66 %, Calibra® Esthetic Light Cure =1.2 µm/65 %); and 2) urethane dimethacrylate, UDMA (Variolink Esthetic LC = 0.1 µm/38 %). A total of 60 specimens were fabricated (n = 20 for each cement). The relative number of particles (N) and relative surface area (A) were calculated for each filler size/content. Color coordinates (L*, a*, b*) were measured, and color change (ΔE00) was calculated after cementation and following aging at 150, 300, 450, and 600 h using xenon light. Differences in color coordinates and color change were determined using repeated measures ANOVA followed by Tukey's post hoc test (α = .05). A post-hoc power analysis was performed to confirm reliability of the results. ResultsBased on a post-hoc power analysis of a repeated measures ANOVA with two between-factors and 1 within-factor, we had 89 % power to detect a difference of effect by cement type, 10 % power to detect a difference by shade, and 100 % power to detect a difference of effect by aging. The UDMA-based cement (0.1 µm/38 %) was least affected by aging, despite having the largest number of particles (N = 1010) and largest particle surface area (A = 7.02). The TEGDMA-based cements exhibited a significant color change, with 0.6 µm/66 % (A = 2.03, N = 8.12) producing a larger ΔE00 than 1.2 µm/65 % (A = 1.00, N = 1.00). ConclusionsAmong the commercial cements tested, UDMA-based resin (0.1 µm/38 %) provided better color stability than TEGDMA-based resin cements. The color change after aging was affected by the relative surface area and relative number of particles for the TEGDMA-based resin cement (0.6 µm/66 % and 1.2 µm/65 %), with a larger surface area and a higher relative number of particles, accelerated color change with aging. The present study demonstrates a novel approach to determine color stability for any resin cement with particulate filler. Clinical implicationsThe dental practitioner should be selective in choosing a commercial light cure cementation product for laminate veneers, as UDMA containing resin cement is more resistant to color changes over time than TEGDMA, regardless of the filler size/content.

Sample Size Estimation in Clinical Trials

Sample size estimation remains as a cornerstone in the meticulous planning and execution of clinical trials, pivotal for ensuring studies possess the requisite statistical power to discern meaningful treatment effects. Insufficient sample sizes compromise the robustness of findings, whereas excessively large samples inflate costs and compromise data integrity. This article meticulously explains the multifaceted factors that outline sample size determination, encompassing various factors such as research design, types of hypotheses, error thresholds, effect size considerations, validity and precision. It investigates into the scope of methodologies available for sample size computation, spanning from intricate statistical formulas to pragmatic tabular approaches. Moreover, it underscores the significance of post-hoc power analysis in retrospectively evaluating completed studies, shedding light on their statistical robustness. This literature review furnishes a nuanced understanding of the sample size estimation landscape in clinical trials, delineating their strengths, limitations, and real-world applications. Anticipating participant attrition assumes paramount importance for proactively adjusting sample sizes, ensuring studies remain methodologically sound. Equipped with a profound grasp of these principles, researchers are empowered to conduct scientifically rigorous and impactful clinical trials, furnishing compelling evidence to inform judicious decision-making in healthcare interventions.

The Bayesian Range: Simple Methods for Incorporating Bayesian Reasoning into Psychological Research for Psychologists and Psychology Students Unfamiliar with Bayes' Theorem

Bayes' theorem is used to calculate posterior probabilities of an event occurring given that a second event occurs. Advanced Bayesian statistics are now commonly used in psychology, but simpler versions can be adopted by social psychologists and psychology students who have little or no prior experience with Bayes’ Theorem using commonly obtained values. Using the post-hoc statistical power of a study, the selected alpha level for determining significance, and a subjective personal probability for the probability that a null hypothesis is false, it is possible to create a version of Bayes’ Theorem that calculates the probability that a null hypothesis is false given the null hypothesis is rejected. Because the subjective personal probability of the null being false is an estimate, the paper recommends that for novel empirical findings, researchers take one of two approaches to incorporating Bayes’ Theorem. The first is to calculate the posterior probability for a range of probabilities that the null is false. The second is to treat a novel finding as though it is unlikely to be true and give the probability that the null is false a low starting probability. With each replication, the posterior probability can be updated. Such a practice would encourage multiple replications of a novel finding before it can be reported with confidence. The emphasis of the paper is on the ready application of Bayes’ Theorem for non-experts in Bayesian statistics who are more comfortable with traditional significance testing.

Evaluation of bidirectional causal association between cardiovascular diseases and pneumonia: A Mendelian randomization study.

Observational evidence suggests a bidirectional relationship between cardiovascular diseases (CVDs) and pneumonia. However, the causality between CVDs and pneumonia remains undetermined. Thus, we aimed to investigate the bidirectional causality between CVDs and pneumonia using Mendelian randomization (MR) analysis. Global genetic correlation analysis and bidirectional two-sample MR analysis were performed to infer the genetic correlation and causality between CVDs and pneumonia by using genome-wide association study (GWAS) summary data from GWAS meta-analysis study, FinnGen or UK Biobank consortium. Post-hoc power calculation was conducted to assess the power for detecting the causality. The linkage disequilibrium score regression analysis suggested a positive significant genetic correlation between CVDs and pneumonia. In the MR analysis, only genetically predicted ischemic stroke was causally associated with any pneumonia (odds ratio [OR]: 1.119, 95% confidence interval [CI]: 1.031-1.393), bacterial pneumonia (OR: 1.251, 95% CI: 1.032-1.516), and pneumococcal pneumonia (OR: 1.308, 95% CI: 1.093-1.565), but the causality was attenuated to non-significance after adjusting for deep venous thrombosis. However, the causal effects of pneumonia on CVDs were not detected. Post-hoc power calculations supported strong power (more than 80%) to detect the causality. Ischemic stroke is causally associated with an increased risk of pneumonia, but there is no evidence for the causal effect of pneumonia on CVDs. Our findings have important implications as they provide further support for the thrombosis risk screening as a strategy to reduce the incidence of pneumonia in patients with ischemic stroke.

Coronary embolism in left-sided infective endocarditis. A retrospective analysis from a high-volume surgical centre and review of the literature.

Septic embolization is a common and potentially life-threatening complication of infective endocarditis (IE), with a prevalence of 22-50%. While acute coronary syndrome secondary to septic embolism is rare, it poses significant risks. This study examines coronary embolism (CE) in left-sided IE, describing clinical characteristics and outcomes. We retrospectively analysed 649 patients with non-device-related left-sided IE treated between January 2013 and December 2023 in a high-volume surgical centre. CE was diagnosed via ECG, clinical and laboratory signs of acute coronary syndrome, and confirmed by coronary angiography or magnetic resonance imaging. All patients were treated according to current European Society of Cardiology guidelines. A structured follow-up was performed. Among patients included in the study, surgery was performed in 514 (79%) patients. Median follow-up duration was 4.7 years. CE occurred in 8 (1.2%) patients, and 6 (80%) of them were treated surgically. We found no significant differences in overall mortality rate between patients with or without CE (p = 0.65). Finally, cerebral embolism was significantly more frequent in patients with than without CE (75% vs 25%, p = 0.006, post-hoc power 87.8%). CE is a rare but severe complication of IE, significantly associated with cerebral embolism. Early recognition and treatment are crucial to improve patient outcomes. Multicentre studies with larger patient populations are needed to further elucidate risk factors and enhance prognosis for CE in IE patients.

Development and evaluation of multimodal AI for diagnosis and triage of ophthalmic diseases using ChatGPT and anterior segment images: protocol for a two-stage cross-sectional study.

Artificial intelligence (AI) technology has made rapid progress for disease diagnosis and triage. In the field of ophthalmic diseases, image-based diagnosis has achieved high accuracy but still encounters limitations due to the lack of medical history. The emergence of ChatGPT enables human-computer interaction, allowing for the development of a multimodal AI system that integrates interactive text and image information. To develop a multimodal AI system using ChatGPT and anterior segment images for diagnosing and triaging ophthalmic diseases. To assess the AI system's performance through a two-stage cross-sectional study, starting with silent evaluation and followed by early clinical evaluation in outpatient clinics. Our study will be conducted across three distinct centers in Shanghai, Nanjing, and Suqian. The development of the smartphone-based multimodal AI system will take place in Shanghai with the goal of achieving ≥90% sensitivity and ≥95% specificity for diagnosing and triaging ophthalmic diseases. The first stage of the cross-sectional study will explore the system's performance in Shanghai's outpatient clinics. Medical histories will be collected without patient interaction, and anterior segment images will be captured using slit lamp equipment. This stage aims for ≥85% sensitivity and ≥95% specificity with a sample size of 100 patients. The second stage will take place at three locations, with Shanghai serving as the internal validation dataset, and Nanjing and Suqian as the external validation dataset. Medical history will be collected through patient interviews, and anterior segment images will be captured via smartphone devices. An expert panel will establish reference standards and assess AI accuracy for diagnosis and triage throughout all stages. A one-vs.-rest strategy will be used for data analysis, and a post-hoc power calculation will be performed to evaluate the impact of disease types on AI performance. Our study may provide a user-friendly smartphone-based multimodal AI system for diagnosis and triage of ophthalmic diseases. This innovative system may support early detection of ocular abnormalities, facilitate establishment of a tiered healthcare system, and reduce the burdens on tertiary facilities. The study was registered in ClinicalTrials.gov on June 25th, 2023 (NCT05930444).

The effect of task complexity and gender differences on EFL learners’ writing performance

The current study investigates the Effect of Task Complexity and Gender Differences on EFL Learners’ Writing Performance. Task complexity is the inherent cognitive demands of the tasks imposed on the learners by the structure of the tasks. It is investigated along the resource-dispersing variables of pre-task planning time, post-task editing time and prior knowledge. This study also tries to intertwine the concepts of task complexity and sociolinguistics (i.e., gender differences). The participants are 160 high school students (80 males and 80 females) studying at international schools in Riyadh City, Saudi Arabia. The writing topics were selected among the essay prompts similar to those of the IELTS test using the cause-and-effect essay task type. A series of T-Test and one-way ANOVAs were used for detecting the significant differences within the same gender and across genders, Cronbach's alpha (α) for the task reliability, Wilk’s Lambda for variable contributions, Partial Eta squared (ηp2) for the effect size, and the Observed Power (or post-hoc power) for the test statistical power. This study is thought to be laden with manifold implications for varied stakeholders within the realm of didactics, including language teachers, learners, syllabus designers, test developers, educational bodies and many other individuals in the ministries of education and higher education. Should this be done, it can contribute to improving EFL undergraduate students’ ability to a level of writing production that is more likely to be satisfactory. The current study found different effects of task complexity on EFL learners’ writing performance across gender. There were both similar and different impacts on CAF metrics between the writing tasks across genders. The results indicate a partial support to the predictions of Skehan and Foster (2001) and those of Robinson (2005) where there is a partial increase in the CAF scores along the resource-dispersing variables. Conversely, findings show no support to the Gender Similarities Hypothesis (GSH) by J. S. Hyde (2005). This study also explored the effect percentage of task complexity along the resource dispersing variables planning time, editing time and prior knowledge on CAF. Besides, the researcher sorted the significant CAF metrics within same gender and across genders according to their occurrence and percentage in the performance of the current student participants.It is recommended that pedagogical tasks should be sequenced for learners on the basis of increasing in their cognitive complexity to help promote learners' performance in terms of accuracy, fluency, and complexity. In addition, educators should motivate male students to engage more and perform better in the writing classes; syllabus designers should introduce new teaching methodologies that help bridge the gap in gender differences between boys and girls.

Intraocular pressure after combined photorefractive keratectomy and corneal collagen cross-linking for keratoconus

PurposeThe purpose of this prospective study was to evaluate the effect of combined photorefractive keratectomy (PRK) and corneal collagen cross-linking (CXL) on intraocular pressure (IOP) in patients with keratoconus (KC).MethodsWe included 64 eyes of 34 patients (19 males and 15 females; age: 19-40y) with stages 1–2 keratoconus which had undergone combined wavefront-optimized photorefractive keratectomy and corneal collagen cross linking. Two other groups of patients were added as controls: the PRK group including 110 eyes of 57 patients (23 males and 34 females; age: 18-44y) which had undergone wavefront-optimized photorefractive keratectomy for myopic refractive errors, and the CXL group including 36 eyes of 23 patients (14 males and 9 females; age: 12-38y) with keratoconus, not filling the inclusion criteria for combined PRK and CXL, which had undergone corneal collagen cross-linking. IOP was recorded preoperatively and postoperatively at 3, 6 and 12 months follow-up visits.ResultsPreoperative IOP in both CXL (12.1 ± 2.53 mmHg) and PRK + CXL (13.2 ± 2.50 mmHg) groups was significantly lower than PRK group (15.8 ± 3.10 mmHg) (F = 30.505, p < 0.001). At 3 months postoperatively, IOP showed no statistically significant difference between the three studied groups (F = 1.821, p = 0.164). At 6 months postoperatively, IOP in the CXL group (14.6 ± 2.64 mmHg) was significantly higher than both PRK (13.4 ± 2.27 mmHg) and PRK + CXL (13.3 ± 2.62 mmHg) groups (F = 3.721, p = 0.026). At 12 months postoperatively, IOP in the CXL group (14.3 ± 2.69 mmHg) was significantly higher than the PRK group (13.2 ± 2.23 mmHg) and was higher than PRK + CXL group (13.3 ± 2.59 mmHg) although not statistically significant (F = 3.393, p = 0.035).Regarding the percent of change from preoperative IOP, a statistically significant difference between the three studied groups was detected at 3, 6 and 12 months postoperatively (H = 117.459, 109.303, 122.694 respectively, p < 0.001). The median percent of change from preoperative IOP in the PRK group was −16.7%, −15%, and −16.7%, in the CXL group was + 14.3%, + 19.4%, and + 19.1%, while in PRK + CXL group was 0% at 3, 6 and 12 months postoperatively. (Post-hoc power analysis 75%).ConclusionsCombined PRK and CXL in patients with KC shows no significant effect on IOP, in contrast to either procedure performed separately.

Radiological signs of femoroacetabular impingement are linked to pelvic version in asymptomatic subjects

IntroductionWith the recent interest in hip-spine relationship, the link between femoroacetabular impingement (FAI) and the lumbar-pelvic-femoral complex (LPFC) appears decisive. The objectives of this study were (1) to compare the pelvic version, as well as (2) all the parameters of the LPFC between two populations of healthy subjects, comparing those with radiological signs of FAI to those without and finally, (3) to evaluate the LPFC parameters according to the type of FAI. HypothesisAsymptomatic subjects with radiological signs of FAI had superior pelvic anteversion. Materials and methodThis retrospective study was based on a prospective cohort of 118 voluntary asymptomatic patients including 62 men (52.5%) with a mean age of 25.6 years±4.4 (19–39). The following parameters: pelvic version (PV), pelvic incidence (PI), lumbar lordosis (LL), sacral slope (SS), hip flexion, intrinsic (IER) and extrinsic (EER) extension reserve were measured using EOS imaging™ in the reference standing position and the lunge position. The radiological signs of FAI (cam, pincer, mixed) were identified on these acquisitions then separated into 2 groups. The first was the group presenting with one or more images of FAI (FAI+) and the second group with no images of FAI (FAI–). ResultsThere were 143 hips in the FAI+ group compared to 93 hips in the FAI– group. There were 36.4% cams and 45% pincers. With an average of 9.08°±7.81 (–11.0; 27.0) versus 12.33°±8.94 (–5.0; 55.0), the PV was significantly lower (p=0.022) in the FAI+ group compared to the FAI– group. A post-hoc power analysis on the primary outcome (PV) confirmed sufficient power (1–β=0.809). Compared to the FAI– group, the cam group presented a significantly lower IER and EER (respectively p=0.014 and p=0.047). The comparative analysis between the FAI– and pincer groups found a significant difference in PI (p=0.001), PV (p<0.001), IER (p=0.017) and hip flexion (p<0.001), SS in lunge position (p=0.031) and EER (p=0.039). ConclusionAsymptomatic subjects with radiographic signs of FAI present with weak pelvic version when standing. This pelvic hyper-anteversion is mainly found in the event of a radiological pincer sign. Level of evidenceIII, retrospective comparative study.

The relation between thrombus burden and early mortality risk in inpatients diagnosed with COVID-19-related acute pulmonary embolism: a retrospective cohort study

BackgroundCOVID-19-related acute pulmonary thromboembolism (APE) is associated with poor outcomes in patients with COVID-19. There are studies investigating the association between thrombus burden and high risk of early mortality in the pre-COVID-19 period. This study aimed to evaluate the relationship between clot burden and early mortality risk in COVID-19-related APE patients.MethodsIn this single-center retrospective cohort study, the data of hospitalized adult patients followed up for COVID-19-related APE between April 1, 2020, and April 1, 2021, were electronically collected. A radiologist evaluated the computed tomography (CT) findings and calculated the Mastora scores to determine clot burden. The early mortality risk group of each patient was determined using 2019 the European Society of Cardiology guidelines.ResultsOf the 87 patients included in the study, 58 (66.7%) were male, and the mean age was 62.5±16.2 years. There were 53 (60.9%) patients with a low risk of mortality, 18 (20.7%) with an intermediate-low risk, and 16(18.4%) with an intermediate-high/high risk. The median total simplified Mastora scores were 11.0, 18.5, and 31.5 in the low, the intermediate-low, and the intermediate-high/high-risk groups, respectively (p = 0.002). With the 80.61% of post-hoc power of the study, intermediate-high/high early mortality risk was associated statistically significantly with the total simplified Mastora score (adj OR = 1.06, 95%CI = 1.02–1.11,p = 0.009). Total simplified Mastora score was found to predict intermediate-high/high early mortality risk with a probability of 0.740 (95% CI = 0.603–0.877): At the optimal cut-off value of 18.5, it had 75.0% sensitivity, 66.2% specificity, 33.3% positive predictive value, and 92.2% negative predictive value.ConclusionsThe total simplified Mastora score was found to be positively associated with early mortality risk and could be useful as decision support for the risk assessment in hospitalized COVID-19 patients. Evaluation of thrombus burden on CT angiography performed for diagnostic purposes can accelerate the decision of close monitoring and thrombolytic treatment of patients with moderate/high risk of early mortality.

DNA methylation biomarkers to identify epigenetically abnormal spermatozoa in male partners from couples experiencing recurrent pregnancy loss

ABSTRACT Previously, we showed that DNA methylation defects in spermatozoa from male partners of couples undergoing recurrent pregnancy loss (RPL) could be a contributing paternal factor. In the present study, we aimed to determine whether the methylation levels of selected imprinted genes can be used as diagnostic markers to identify epigenetically abnormal spermatozoa sample in these cases. The methylation levels of selected imprinted genes in spermatozoa, which were previously found to be differentially methylated, were combined into a probability score (between 0–1) using multiple logistic regression. Different combinations of these genes were investigated using Receiver Operating Characteristic analysis, and the threshold values were experimentally validated in an independent cohort of 38 control and 45 RPL spermatozoa samples. Among the different combinations investigated, a combination of five imprinted genes comprising IGF2-H19 DMR, IG-DMR, ZAC, KvDMR, and PEG3 (AUC = 0.88) with a threshold value of 0.61 was selected with a specificity of 90.41% and sensitivity of 70%. The results from the validation study indicated that 97% of the control samples had probability scores below this threshold, whereas 40% of the RPL samples were above this threshold with a post-hoc power of 97.8%. Thus, this combination can correctly classify control samples and potentially identify epigenetically abnormal spermatozoa samples in the male partners of couples undergoing RPL. We propose that the combined DNA methylation levels of these imprinted genes can be used as a diagnostic tool to identify spermatozoa samples with epigenetic defects which could contribute to the pathophysiology of RPL and the couple could be counselled appropriately.

Mortality after emergency unit fluid bolus in febrile Ugandan children.

Pediatric fluid resuscitation in sub-Saharan Africa has traditionally occurred in inpatients. The landmark Fluid Expansion as Supportive Therapy (FEAST) trial showed fluid boluses for febrile children in this inpatient setting increased mortality. As emergency care expands in sub-Saharan Africa, fluid resuscitation increasingly occurs in the emergency unit. The objective of this study was to determine the mortality impact of emergency unit fluid resuscitation on febrile pediatric patients in Uganda. This retrospective cohort study used data from 2012-2019 from a single emergency unit in rural Western Uganda to compare three-day mortality for febrile patients that did and did not receive fluids in the emergency unit. Propensity score matching was used to create matched cohorts. Crude and multivariable logistic regression analysis (using both complete case analysis and multiple imputation) were performed on matched and unmatched cohorts. Sensitivity analysis was done separately for patients meeting FEAST inclusion and exclusion criteria. The analysis included 3087 febrile patients aged 2 months to 12 years with 1,526 patients receiving fluids and 1,561 not receiving fluids. The matched cohorts each had 1,180 patients. Overall mortality was 4.0%. No significant mortality benefit or harm was shown in the crude unmatched (Odds Ratio [95% Confidence Interval] = 0.88 [0.61-1.26] or crude matched (1.00 [0.66-1.50]) cohorts. Adjusted cohort analysis (including both complete case analysis and multiple imputation) and sensitivity analysis of patients meeting FEAST inclusion and exclusion criteria all also failed to show benefit or harm. Post-hoc power calculations showed the study was powered to detect the absolute harm seen in FEAST but not the relative risk increase. This study's primary finding is that fluid resuscitation in the emergency unit did not significantly increase or decrease three-day mortality for febrile children in Uganda. Universally aggressive or fluid-sparing emergency unit protocols are unlikely to be best practices, and choices about fluid resuscitation should be individualized.

P-484 PGT-A and euploid transfer is more efficient than untested transfer in patients obtaining 1 or 2 blastocysts: a propensity score matching-based study

Abstract Study question Does PGT-A and euploid transfer involve any clinical advantage with respect to untested transfer inpatients obtaining 1 or 2 blastocysts? Summary answer PGT-A involved less transfers, less miscarriages, and a shorter time from oocyte retrieval to cycletermination without affecting the cumulative-live-birth-rate per patient. What is known already Meiotic chromosomal aneuploidies are the main cause of implantation failures and miscarriages andshow a U-shaped association with women fertility. Their prevalence increases from 25-30% in women &amp;lt;35 years to &amp;gt; 90% around menopause. In IVF, PGT-A via comprehensive-chromosome-testing techniques allows identifying euploid blastocysts, whose live-birth-rate (LBR) per transferand miscarriage-rate (MR) per clinical pregnancy are respectively higher and lower than untestedblastocysts. From an intention-to-treat perspective, PGT-A cannot improve the cumulative-live-birth-rate (CLBR), but no report exists either of an impact on this key clinical outcome.Nevertheless, more data are needed about PGT-A performance in couples producing 1 or 2 blastocysts. Study design, size, duration We gathered a dataset of 369 non-PGT and 1461 PGT-A cycles with 1-2 blastocysts obtained bynaïve patients (April-2013 to July-2022). Patients were matched 1:1 for maternal age (36±3.1 years)and number of MII-oocytes inseminated (5.7±3.3) through propensity-score-matching, thereby producing a database of 242 cycles per arm. The primary outcome was LBR per transfer. Secondary outcomes were MR per clinical pregnancy, CLBR per concluded cycles and the time to cycle termination. Participants/materials, setting, methods ICSI of all own metaphase-II oocytes retrieved and blastocyst culture were systematically conducted. In the PGT-A group, trophectoderm biopsy without day3 zona-pellucida drilling andcomprehensive-chromosome-testing to assess full-chromosome non-mosaic aneuploidies wereperformed. Blastocyst cryopreservation was conducted via vitrification. Only euploid/untestedsingle transfers were conducted. The groups were comparable also for BMI, FSH, AMH, sperm factor, cumulus-oocyte-complexes, 2PN-zygotes, maturation, fertilization and blastulation rates. 99 and 143 patients obtained 1 and 2 blastocysts, respectively, in both groups. Main results and the role of chance The 242 non-PGT patients transferred 1.45±0.5 blastocysts. 57% and 43% performed one (N = 139) and two (N = 103) transfers, respectively. 165 patients (68%) did not undergo a fresh transfer because of OHSS risk (25%), premature progesterone elevation (20%), inadequate endometrium(23%), fever/COVID-19 (5%), couple’s will (27%).In the PGT-A group, the euploidy rate was 48.8±43.3%, 0.8±0.7 euploid blastocysts were obtained, and 0.6±0.6 transferred (N = 151) (p = 0.01 versus non-PGT). 45% of the PGT-A patients did not have euploid blastocysts (N = 110/242), 47% and 8% underwent one (N = 113) and two (N = 19) transfers, respectively. In the non-PGT and PGT-A group, the LBR per transfer was 17% (N = 61/351) versus 41%(N = 62/151; Multivariate-OR:3.9, 95%CI 2.4-6.3, adjusted-p=0.01; post-hoc power=99%). The MR was 30% (N = 26/87) versus 16% (N = 12/74; Multivariate-OR adjusted for blastocysts’ quality and day: 0.4,95%CI 0.2-0.9, adjusted-p=0.03), respectively. To date, 94% (N = 228/242) and 92%(N = 223/242) of the cycles were concluded (p = 0.5) and the CLBR was 25% (N = 57/228) versus 27%(N = 60/223; Multivariate-OR adjusted for maternal age:1.1, 95%CI 0.7-1.7, adjusted-p=0.6). The days between oocyte retrieval and cycle termination (PGT-A report without euploid blastocysts, last transfer without LB or first transfer with LB) were 125.1±144.4 and 74.5±95.6 (p = 0.01; confirmed adjusting for maternal age and number of blastocysts obtained in a linear regression). Limitations, reasons for caution Retrospective design. The mean maternal age at our private IVF center is 39 years with ≈70% requesting PGT-A. Nevertheless, all women are counseled about their age-specific prevalence ofaneuploidies. Wider implications of the findings PGT-A to assess full-chromosome non-mosaic aneuploidies and non-PGT involve similar CLBR incouples obtaining 1 or 2 blastocysts, but the former approach is faster (shorter time to cycletermination), safer (less miscarriages) and more efficient (less transfers). A cost-effectivenessanalysis is in our pipeline. Trial registration number not applicable

985-P: Is Insulin Titration Supported by a Titration App Safe? Safety Results of an RCT

A multicenter RCT in people with type 2 diabetes has shown that the use of a basal insulin titration app (myDose Coach) reduced A1c levels by 0.35 percentage points compared to titration without an app. Is the use of such a titration app associated with safety issues? We used negative binomial regressions to analyze the occurrence of adverse and serious adverse events (AE, SAE) and exposure to dangerously low (&amp;lt;54 mg/dl) or high (&amp;gt;250 mg/dl) glucose levels in 251 participants (age 60.0 years IQR 56.0 - 66.5; HbA1c 8.2 IQR 7.7 - 9.1%) randomized equally to the control and intervention groups. A total of 30 AEs (16 vs. 14 events) occurred in the control and intervention groups, of which 14 were SAEs (7 vs. 7 events). No event was judged to be associated with study participation or the interventions. The rates of dangerous low and high glucose in the control and intervention group were 0.12% vs. 0.10% for %&amp;lt; 54 mg/dl and 4.9% vs. 3.6% for %&amp;lt; 250 mg/dl, respectively (see Figure 1 for IRR and p values for superiority). A post-hoc non-inferiority test for the occurrence of %&amp;lt; 54 mg/dl and &amp;gt;250 mg/dl with non-inferiority margins of &amp;lt; 1% and &amp;lt; 5%, respectively, showed significant non-inferiority regarding the intervention group (both p &amp;lt; 0.01) with a post-hoc power by 75% respectively 55%. The results did not indicate an increased risk for insulin titration by the evaluated app compared to the control condition in terms of AE or extreme glucose excursions. Disclosure B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. T.Roos: None. K.Finke-groene: None. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. Funding Sanofi

Clockwise torque results in higher reoperation rates in left-sided femur fractures

PurposeEffects of clockwise torque rotation onto proximal femoral fracture fixation have been subject of ongoing debate: fixated right-sided trochanteric fractures seem more rotationally stable than left-sided fractures in the biomechanical setting, but this theoretical advantage has not been demonstrated in the clinical setting to date. The purpose of this study was to identify a difference in early reoperation rate between patients undergoing surgery for left- versus right-sided proximal femur fractures using cephalomedullary nailing (CMN). Materials and methodsThe American College of Surgeons National Surgical Quality Improvement Program was queried from 2016-2019 to identify patients aged 50 years and older undergoing CMN for a proximal femoral fracture. The primary outcome was any unplanned reoperation within 30 days following surgery. The difference was calculated using a Chi-square test, and observed power calculated using post-hoc power analysis. ResultsIn total, of 20,122 patients undergoing CMN for proximal femoral fracture management, 1.8% (n=371) had to undergo an unplanned reoperation within 30 days after surgery. Overall, 208 (2.0%) were left-sided and 163 (1.7%) right-sided fractures (p=0.052, risk ratio [RR] 1.22, 95% confidence interval [CI] 1.00–1.50), odds ratio [OR] 1.23 (95%CI 1.00–1.51), power 49.2% (α=0.05). ConclusionThis study shows a higher risk of reoperation for left-sided compared to right-sided proximal femur fractures after CMN in a large sample size. Although results may be underpowered and statistically insignificant, this finding might substantiate the hypothesis that clockwise rotation during implant insertion and (postoperative) weightbearing may lead to higher reoperation rates. Level of evidenceTherapeutic level II.

Abstract P246: Association Between Life’s Essential 8 Cardiovascular Health Scores During Pregnancy and Vascular Integrity in the Placenta

Background: Adverse pregnancy outcomes (APOs) identify pregnant people at increased risk of later cardiovascular disease. Poor antenatal cardiovascular health (CVH) quantified using components of the Life’s Simple 7 ideal CVH framework has been associated with higher APO incidence, indicating modifiable aspects of CVH during pregnancy may be related to pregnancy health. Placental pathology is also common in APOs, but it is unclear if antenatal CVH is directly related to placental health. Further, clinically-used dichotomous measures of placental pathology limit investigation of associations. Thus, the aim of this study was to examine the relationship between antenatal CVH and a novel, continuous marker of placental vascularization. Hypothesis: We hypothesized higher (healthier) antenatal CVH scores would be associated with higher (healthier) vascularization in the placenta. Methods: Participants enrolled in the Magee Obstetric Maternal &amp; Infant Biobank and one of two prospective observational cohort studies examining activity patterns in pregnancy (MoM Health or Pregnancy 24/7). Antenatal CVH was quantified with a pregnancy-adapted Life’s Essential 8 framework assessed during each trimester and averaged across gestation. Components included sleep, diet, smoking, objective physical activity, pre-pregnancy BMI, blood pressure, 50g glucose challenge test results, and gestational weight gain. Component scores were averaged for a composite score (possible range, 0-100; higher indicated better CVH). Immunohistochemistry of placenta tissue was performed. Sections were stained with CD34 antibody to highlight vascular endothelial cells and counterstained with hematoxylin. Whole-slide images were digitized. Software computed the number of pixels positive for CD34 (numerator) and the total pixels (denominator); the ratio was the outcome of fetal vascular percentage (FV%), or the proportion of villous tissue occupied by fetal vessels. Linear regression associated CVH scores with FV%. Results: Placenta tissue was obtained from 64 participants (mean±SD age = 32±4.9 years). CVH score averaged across gestation was 72.6±10.7 points and decreased significantly from the first to third trimester (72.8±12.7 vs. 65.1±11.9, p&lt;0.01). FV% was 26.3±5.13 percentage points. Associations between CVH scores and FV% approached but did not reach significance (p&lt;0.2) in each trimester and across gestation. A 10-point increase in CVH averaged across gestation was non-significantly associated with a 0.82 percentage point increase in FV% (p=0.18). Post-hoc power analysis of this novel metric identified sufficient power to detect a 1.5 percentage point change in FV% per 10-point change in CVH score. Conclusion: Antenatal CVH was not significantly associated with placental vasculature, though a small sample size limits conclusions. Replication in a fully-powered sample is warranted.

The Current Proposed Total Hip Arthroplasty Surgical Planning Guidelines Based on Classification of Spine Stiffness May be Flawed Due to Incorrect Assumptions

BackgroundThe available classifications and preoperative planning tools for total hip arthroplasty assume that: 1) there is no variation in the sagittal pelvic tilt (SPT) if the radiographs are repeated, and 2) there is no significant change in the postoperative SPT postoperatively. We hypothesized that there would be significant differences in postoperative SPT tilt as measured by the sacral slope, thus rendering the current classifications and tools flawed. MethodsThis study was a multicenter, retrospective analysis of preoperative and postoperative (1.5-6 months) full-body imaging of 237 primary total hip arthroplasty (standing and sitting positions). Patients were categorized as 1) stiff spine (standing sacral slope sitting sacral slope < 10°) and 2) normal spine (standing sacral slope-sitting sacral slope ≥ 10°). Results were compared using the paired t-test. The posthoc power analysis showed a power of 0.99. ResultsThe difference in mean standing and sitting sacral slope between the preoperative and postoperative measurements was 1°. However, in standing position, this difference was more than 10° in 14.4% of patients. In the sitting position, this difference was more than 10° in 34.2% of patients and more than 20° in 9.8% of patients. Postoperatively, 32.5% of patients switched groups based on the classification, which rendered the preoperative planning suggested by the current classifications flawed. ConclusionCurrent preoperative planning and classifications are based on a single acquisition of preoperative radiographs without the incorporation of possible postoperative changes in SPT. Validated classifications and planning tools should incorporate repeated measurements to determine the mean and variance in SPT and consider the significant postoperative changes in SPT.