Unadjusted Rates Research Articles

Trends in Mortality After Incident Hospitalization for Heart Failure Among Medicare Beneficiaries

Despite advances in treatment and care quality for patients hospitalized with heart failure (HF), minimal improvement in mortality has been observed after HF hospitalization since 2010. To evaluate trends in mortality rates across specific intervals after hospitalization. This cohort study evaluated a random sample of Medicare fee-for-service beneficiaries with incident HF hospitalization from January 1, 2008, to December 31, 2018. Data were analyzed from February 2023 to May 2024. Unadjusted mortality rates were calculated by dividing the number of all-cause deaths by the number of patients with incident HF hospitalization for the following periods: in-hospital, 30 days (0-30 days after hospital discharge), short term (31 days to 1 year after discharge), intermediate term (1-2 years after discharge), and long term (2-3 years after discharge). Each period was considered separately (ie, patients who died during one period were not counted in subsequent periods). Annual unadjusted and risk-adjusted mortality ratios were calculated (using logistic regression to account for differences in patient characteristics), defined as observed mortality divided by expected mortality based on 2008 rates. A total of 1 256 041 patients (mean [SD] age, 83.0 [7.6] years; 56.0% female; 86.0% White) were hospitalized with incident HF. There was a substantial decrease in the mortality ratio for the in-hospital period (unadjusted ratio, 0.77; 95% CI, 0.67-0.77; risk-adjusted ratio, 0.74; 95% CI, 0.71-0.76). For subsequent periods, mortality ratios increased through 2013 and then decreased through 2018, resulting in no reductions in unadjusted postdischarge mortality during the full study period (30-day mortality ratio, 0.94; 95% CI, 0.82-1.06; short-term mortality ratio, 1.02; 95% CI, 0.87-1.17; intermediate-term mortality ratio, 0.99; 95% CI, 0.79-1.19; and long-term mortality ratio, 0.96; 95% CI, 0.76-1.16) and small reductions in risk-adjusted postdischarge mortality during the full study period (30-day mortality ratio, 0.88; 95% CI, 0.86-0.90; short-term mortality ratio, 0.94; 95% CI, 0.94-0.95; intermediate-term mortality ratio, 0.94; 95% CI, 0.92-0.95; and long-term mortality ratio, 0.95; 95% CI, 0.93-0.96). In this study of Medicare fee-for-service beneficiaries, there was a substantial decrease in in-hospital mortality for patients hospitalized with incident HF from 2008 to 2018, but little to no reduction in mortality for subsequent periods up to 3 years after hospitalization. These results suggest opportunities to improve longitudinal outpatient care for patients with HF after hospital discharge.

SURGICAL APPROACH IMPACTS PATIENT-REPORTED SYMPTOMS FOLLOWING ARTHROPLASTY FOR FEMORAL NECK FRACTURE

We aimed to examine outcomes between displaced femoral neck fracture (FNF) patients managed with total hip arthroplasty (THA) or hemi-arthroplasty (HA) via the anterolateral vs. posterior approach.We used data from the HEALTH trial (1,441 patients aged ≥50 with displaced FNFs randomized to THA vs. HA). We calculated each patient's propensity to undergo arthroplasty via the posterior approach, and matched them to 1 control (anterolateral approach) based on age (±5 years), and propensity score. We used Chi-Square/Fisher-Exact tests to compare dichotomous outcomes, and repeated measures ANOVA to examine differences in patient-reported outcomes (via the WOMAC subscores) from baseline to one-year postoperative. We used logistic regression to identify independent predictors of reoperation for instability in the posterior group.We identified 1,306 patients for this sub-analysis, 876 (67.1%) who received arthroplasty via an anterolateral approach, and 430 (32.9%) a posterior approach. The unadjusted rate of reoperation was significantly higher in the posterior group (10.7% vs. 7.1%).Following propensity score matching, we retained 790 patients (395 per group), with no between-group differences in patient, fracture, or implant characteristics. The matched cohort had a higher rate of comorbidities, and were less likely to be employed vs. the unmatched cohort. The rate of treatment for dislocation remained higher in the posterior group (6.1% vs. 2.0%) following matching.Repeated measures ANOVA revealed significantly better WOMAC pain, stiffness, function, and total scores in the posterior group. Between-group differences at 12-months were: pain - 0.59 (0.03–1.15); stiffness - 0.62 (0.35–0.87); function - 2.99 (0.12–5.86); total - 3.90 (0.24–7.56). We identified THA (vs. HA, odds ratio 2.05 [1.05–4.01]) as the only independent predictor of treatment for dislocation in the posterior group.Our analyses revealed that compromised patients with displaced FNFs who undergo arthroplasty via the posterior approach may report better symptoms at one-year vs. the anterolateral approach, despite a higher odds of reoperation for instability.

Hospital resource index, race/ethnicity, and postoperative venous thromboembolism risk: A causal mediation analysis

BackgroundWe examined whether hospital resources mediated the association between race/ethnicity and postoperative VTE, in a national cohort. MethodsNational Inpatient Sample data were restricted to major abdominal surgeries (1993–2020) performed for malignancies. Hospital resource index was as a summary measure of hospital size, teaching status, and private payor proportions. The composite VTE outcome included postoperative deep vein thrombosis and pulmonary embolism. Adjusted logistic regression with 4-way decomposition described joint and mediating effects. ResultsAmong 1,169,862 surgeries, unadjusted VTE rate was 1.0 ​% (14,789). VTE risk was 28 ​% higher for Black/African Americans (adjusted Odds Ratio ​= ​1.28, 95 ​% CI: 1.21, 1.37) relative to White/Caucasians. VTE risk was lower among Black individuals as hospital resource index increased (excess risk ​= ​−0.005, p ​< ​0.001), with an effect size of likely minimal clinical impact. ConclusionCohorts that are more vulnerable to postoperative VTE did not meaningfully benefit from improving hospital resources. It is likely that lifestyle modifying behaviors, environmental factors, and comorbidity management are more influential in reducing risks.

Association between a Recalled Positive Airway Pressure (PAP) Device and Incident Cancer: A Population-Based Study.

The real-world consequences of a Philips/Respironics recall for positive airway pressure (PAP) devices distributed between 2009 and 2021 are unknown. We conducted a retrospective population-based study using health administrative databases (Ontario, Canada) on all new adult PAP users identified through the provincial funding system, free of cancer at baseline, who initiated (claimed) PAP treatment between 2012 and 2018. Everyone was followed from the PAP claim date to the earliest of incident cancer diagnosis, death, or the end of the follow-up (March 2022). We used inverse probability of treatment weighting to balance baseline characteristics between individuals on recalled devices and those on devices from other manufacturers. Weighted hazard ratios of incident cancer were compared between groups. Of 231 692 individuals identified, 58 204 (25.1%) claimed recalled devices, and 173 488 (74.9%) from other manufacturers. A meaningful baseline difference between groups (standardised difference≥0.10) was noted only by location-relevant covariates; other variables were mostly equally distributed (standardised differences≤0.06). Over a median follow-up of 6.3 years (IQR: 4.9-8.0), 11 166 (4.8%) developed cancer: unadjusted rates per 10 000 Person-Year (95 CI%) of 78.8 (76.0-81.7) in the recall group versus74.0 (72.4-75.6) in others (p=0.0034). Propensity score weighting achieved excellent balance in baseline characteristics between groups (standardised differences≤0.07). On a weighted sample, there was no statistical difference in the hazard of incident cancer between groups: cause-specific hazard ratio (recalled versus others) of 0.97, 95% CI: 0.89-1.06. In our real-world population study, compared to other manufacturers and adjusting for confounders, recalled devices do not appear to be independently associated with developing cancer.

Extended Prone Position and 90-Day Mortality in Mechanically Ventilated Patients With COVID-19.

Prone positioning (PP) has demonstrated its potential for improving outcomes in patients with ARDS who require invasive mechanical ventilation. However, the ability of prolonged proning to reduce mortality in patients with COVID-19 specifically, sessions lasting > 24 h remains uncertain. In this retrospective cohort study, we examined 158 subjects with COVID-19 pneumonia who required mechanical ventilation due to moderate-to-severe ARDS. Seventy-six subjects were placed in standard PP and 82 in extended PP, defined as prone sessions lasting at least 32 h. Our primary aim was to evaluate the effect of EPP on 90-d survival in subjects with COVID-19 with acute severe respiratory failure. To ensure the reliability of our findings and to minimize bias, we applied 3 adjustment approaches: cardinality matching (CM), matching weighting (MW), and inverse probability of treatment weighting with stabilized and trimmed weights (SW). We used Kaplan-Meier curves and Cox proportional hazard models to analyze the effects of EPP on 90-d mortality and sensitivity analysis by calculating E-values. The overall crude 90-d mortality rate was 31.7%. The unadjusted 90-d mortality rates were 19.5% in the EPP group and 44.7% in the SPP group (hazard ratio [HR] 0.35 [95% CI 0.19- 0.63], P < .001). After adjustment for confounding factors using CM, MW, and SW, baseline covariates were balanced between the 2 groups. Subjects in the EPP group exhibited lower 90-d mortality rates after adjustment using CM (HR 0.42 [95% CI 0.23-0.79], P = .007), MW (HR 0.45 [95% CI 0.21-0.95], P = .036), or SW (HR 0.29 [95% CI 0.15-0.56], P < .001). Extended PP was associated with improved 90-d survival in subjects with COVID-19 undergoing mechanical ventilation for severe ARDS. These findings suggest the potential benefit of EPP in the management of COVID-19-related respiratory failure. Further research and prospective studies are warranted to confirm and elucidate the underlying mechanisms of this association.

50 National trends in the surgical management of renal cell carcinoma in Germany

Abstract Background The incidence of RCC is increasing worldwide. For most patients with localized RCC, surgery remains the preferred treatment option. We aimed to investigate whether international trends towards minimally invasive procedures and nephron-sparing surgery are reflected in Germany. Methods Pseudonymized inpatient billing data from the AOK (Allgemeine Ortskrankenkassen), a non-profit oriented health insurance organization in Germany, was used for the conduct of the study. A total of 43,936 RCC cases were identified in which either a partial nephrectomy (PN, n = 20,030) or radical nephrectomy (RN, n = 21,906) was performed between 2012 and 2021. The proportions of different surgical procedures over time, as well as mortality (90 days), transfusion rate, reinterventions, and general postsurgical complications (30 days), were evaluated. Due to the use of pseudonymized data, no ethics vote was required. Results During the period of observation, there was a significant shift from RN to PN, with an increase in the proportion of PN among all procedures from 41.0% (1,918/4,684) in 2012 to 57.4% (2,274/3,960) in 2021 (p &amp;lt;0.001). Open surgery decreased for PN and RN but still accounted for the majority of all procedures (2021: 53.2% of PN and 65% of RN). Mortality was higher among patients with RN compared to PN (in hospital: 1.9% vs. 0.6%, 90 days: 4.7% vs. 1.2%). While general complication rates were similar (19.4% after PN versus 20.4% after RN), the reintervention rate was slightly higher after PN at 10.7% than after RN at 7.9%. Transfusion rates decreased significantly in several subgroups, favoring PN and minimally invasive approaches. Open surgical procedures were associated with higher unadjusted complication rates. Conclusions Despite shifts in favor of nephron-sparing surgery and minimally invasive surgery during the study period, open surgery remained the dominant surgical option for the treatment of renal cell carcinoma in Germany as of 2021. The adoption of laparoscopic and robotic-assisted techniques appears to reduce overall perioperative morbidity and consequently improve the quality of care in Germany. Further studies are required to examine patient level trends between type of surgical procedure, complication rates, and oncologic outcomes. Optimizing the assessment of the quality of care would enable further improvement of the quality itself.

Medicaid Reimbursement for Total Hip and Knee Arthroplasty: A State-by-State Analysis Compared With Medicare

BackgroundMedicare (MCR) reimbursement for arthroplasty procedures has been declining, but little has been reported on Medicaid (MCD) reimbursement. We sought to determine MCD reimbursement rates using state MCD data for nine arthroplasty procedure codes and compare them to MCR rates. MethodsThe Centers for Medicare & Medicaid Services physician fee schedule was used to collect MCR reimbursement rates, and state MCD fee schedules were accessed to collect MCD rates for nine procedures encompassing primary and revision hip and knee arthroplasty surgery. State MCR and MCD rates were compared to determine the mean dollar difference and dollar difference per relative value unit. A cost of living adjustment was performed using the Medicare Wage Index for each state. Coefficients of variation were calculated for each state to determine overall variability between the two systems. ResultsThe mean reimbursement rates for MCD were lower for eight of the nine codes used in the study. Medicaid reimbursed physicians an average of 11.3% less overall and 23.1% less when adjusted for cost of living. The amount of variability in the MCR rates was low with a consistent coefficient of variation of 0.06, but was higher in the MCD rates with a range of 0.26 to 0.29 in the unadjusted rates and 0.34 to 0.37 in the adjusted rates. There was a mean $6.73 decreased reimbursement per relative value unit for MCD procedures. ConclusionsFor the most common arthroplasty procedures, MCD reimbursed physicians less than MCR on average. MCD also demonstrated increased variability when compared to MCR rates between states.

Mortality among veterans with epilepsy: Temporal significance of traumatic brain injury exposure.

Epilepsy is associated with significant mortality risk. There is limited research examining how traumatic brain injury (TBI) timing affects mortality in relation to the onset of epilepsy. We aimed to assess the temporal relationship between epilepsy and TBI regarding mortality in a cohort of post-9/11 veterans. This retrospective cohort study included veterans who received health care in the Defense Health Agency and the Veterans Health Administration between 2000 and 2019. For those diagnosed with epilepsy, the index date was the date of first antiseizure medication or first seizure; we simulated the index date for those without epilepsy. We created the study groups by the index date and first documented TBI: (1) controls (no TBI, no epilepsy), (2) TBI only, (3) epilepsy only, (4) TBI before epilepsy, (5) TBI within 6 months after epilepsy, and (6) TBI >6 months after epilepsy. Kaplan-Meier estimates of all-cause mortality were calculated, and log-rank tests were used to compare unadjusted cumulative mortality rates among groups compared to controls. Cox proportional hazard models were used to compute hazard ratios (HRs) with 95% confidence intervals (CIs). Among 938 890 veterans, 27 436 (2.92%) met epilepsy criteria, and 264 890 (28.22%) had a TBI diagnosis. Mortality was higher for veterans with epilepsy than controls (6.26% vs. 1.12%; p < .01). Veterans with TBI diagnosed ≤6 months after epilepsy had the highest mortality hazard (HR = 5.02, 95% CI = 4.21-5.99) compared to controls, followed by those with TBI before epilepsy (HR = 4.25, 95% CI = 3.89-4.58), epilepsy only (HR = 4.00, 95% CI = 3.67-4.36), and TBI >6 months after epilepsy (HR = 2.49, 95% CI = 2.17-2.85). These differences were significant across groups. TBI timing relative to epilepsy affects time to mortality; TBI within 6 months after epilepsy or before epilepsy diagnosis was associated with earlier time to death compared to those with epilepsy only or TBI >6 months after epilepsy.

The impact of incomplete revascularization on survival in minimal invasive off-pump coronary artery surgery: a propensity score analysis of 1,149 cases.

Minimally invasive concepts are increasingly influential in modern cardiac surgery. This study aimed to evaluate the effect of completeness of revascularization on clinical outcomes and overall survival in minimally invasive, thoracoscopic coronary artery bypass grafting (CABG) surgery. We retrospectively evaluated a consecutive series of 1,149 patients who underwent minimally invasive off-pump CABG with single, double, or triple-vessel revascularization between 2007 and 2018. Of these patients, 185 (16.1%) had incomplete revascularization (IR) (group I), and 964 (83.9%) had complete revascularization (CR) (group C). We used gradient boosted propensity score estimation to account for possible confounding variables. Median age was 69 years, interquartile range (IQR) 60-76 years, and median EuroSCORE II was 4, IQR 2-7. Of the 1,149 patients, 495 patients suffered from two vessel disease (VD) and 353 presented with three VD. Long-term median follow-up 5.58 (3.27-8.48) years was available for 1,089 patients (94.8%). The incidence of recurrent or persisting angina, myocardial infarction, redo-bypass surgery, and stroke during follow-up did not differ significantly between groups. During follow-up, there were 47 deaths in group I and 172 deaths in group C. The 1-, 3-, 5-, 8-, and 10-year unadjusted survival rates were 94%, 84%, 75%, 62%, and 51% for group I, and 97%, 94%, 88%, 77%, and 72% for group C, respectively (long-rank test P<0.001), favouring CR. Following risk adjustment the long-rank test P value for survival was 0.23. In minimally invasive coronary surgery, IR resulted in decreased long-term survival, but did not achieve statistical significance after risk adjustment. However, IR should only be used in carefully selected cases.

German Heart Surgery Report 2023: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery.

Based on a voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (DGTHG) in 1980, a well-defined but limited dataset of all cardiac and vascular surgery procedures performed in 77 German heart surgery departments is reported annually. For the year 2023, a total of 168,841 procedures were submitted to the registry. Of these operations, 100,606 are defined as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 28,996 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 2.8:1) was 97.6%; 97.7% for the 39,859 isolated heart valve procedures (23,727 transcatheter interventions included); and 99.2% for 19,699 pacemaker/implantable cardioverter defibrillator procedures. Concerning short and long-term mechanical circulatory support, a total of 2,982 extracorporeal life support/extracorporeal membrane oxygenation implantations and 772 ventricular assist device implantations (left/right ventricular assist device, BVAD, total artificial heart) were reported. In 2023, 324 isolated heart transplantations, 248 isolated lung transplantations, and 2 combined heart-lung transplantations were performed. This annually updated registry of the DGTHG represents nonrisk adjusted voluntary public reporting and encompasses acute data for nearly all heart surgical procedures in Germany. It constitutes trends in heart medicine and represents a basis for quality management (e.g., benchmark) for all participating institutions.

Trends in rate of hypertensive disorders of pregnancy and associated morbidities in Canada: a population-based study (2012-2021).

Hypertensive disorders of pregnancy (HDP) are a leading cause of severe maternal morbidity (SMM). We sought to explore trends in HDP and related morbidity outcomes in Canada. In this retrospective population-based study, we used hospital discharge data from Canada, excluding Quebec, to identify females who had an HDP diagnosis during a birth admission between 2012 and 2021. We analyzed temporal and geographical trends in HDP, as well as temporal trends in adverse outcomes associated with HDP. Among 2 804 473 hospital admissions for birth between 2012 and 2021, the rate of any HDP increased from 6.1% to 8.5%, including pre-existing hypertension (0.6% to 0.9%), gestational hypertension (3.9% to 5.1%), and preeclampsia (1.6% to 2.6%). For 2017-2021 combined, relative to Ontario (6.9%), HDP were significantly more prevalent in nearly all other Canadian regions. For example, in Newfoundland and Labrador, the rate was 10.7% (unadjusted rate ratio 1.56, 95% confidence interval 1.49-1.63). Among females with any HDP, rates of cesarean delivery rose from 42.0% in 2012 to 44.3% in 2021, as did acute renal failure (0.4% to 0.6%), while rates of early preterm delivery, intrauterine fetal death, maternal hospital length of stay (≥ 7 d), admission to the maternal intensive care unit, severe hemorrhage, and SMM trended downward. The rate of HDP has risen across Canada, with a concomitant decline in some HDP-associated morbidities. Ongoing surveillance of HDP is needed to assess the factors associated with temporal trends, including the effectiveness of evolving HDP prevention and management efforts.

The Continuing Impact of the COVID-19 Pandemic on Diabetic Retinopathy Screenings

ABSTRACT Purpose This retrospective observational study of health claims data seeks to quantify the prolonged impact of the COVID-19 pandemic on DR screening rates in central Massachusetts. Methods Retrospective claims data from the UMass Memorial Managed Care Network were collected for the years of 2018–2022. Comprehensive and DR screening exams were identified using CPT codes for patients with diabetes. Data were derived from claims submitted by the UMass Memorial Managed Care network to four insurance programs via CPT billing code for comprehensive and DR screening exams for patients with diabetes. Over one million claims for the years 01/2018–05/2022 were collected. Results We found a significant decrease in unadjusted DR screening rates in the post-lockdown period compared to the pre-COVID-19 period (p < 0.001). Bivariate analysis revealed a 15.1% decrease in weekly DR screenings during post-lockdown (RR = 0.849, 95% CI = 0.811, 0.888). After adjusting for seasonal variation, the mean weekly DR screening rate was 12% lower in the post-lockdown period, with a 95% CI of 6.1% to 17.5% decrease (Adjusted RR = 0.880, 95% CI = 0.825, 0.939 Stratified analysis based on patient status revealed a significant decrease in adjusted DR screening rates for established patients post-lockdown compared to pre-pandemic (p < 0.0001), while no significant difference was observed for new patients (p > 0.05). Conclusion The impact of COVID-19 on DR screening and treatment rates persisted even after the resumption of non-essential care services, with a discrepancy between new and established patients. Future research should work to identify and overcome the barriers to DR screening.

Assessing the effect of COVida orphans and vulnerable children support services on viral load coverage and suppression among children and adolescents living with HIV in four provinces in Mozambique

ABSTRACT Orphans and vulnerable children (OVC) programs focusing on improving HIV outcomes for children and adolescents living with HIV (C&ALHIV) may improve viral load (VL) testing coverage, a critical step toward achieving VL suppression. In Mozambique, we conducted a retrospective medical record review comparing VL testing coverage and suppression between C&ALHIV receiving OVC support and two cohorts of non-participants constructed using propensity score matching. We collected data for 25,783 C&ALHIV in Inhambane, Maputo City, Nampula, and Tete between October 2020-September 2021. Unadjusted rates of VL testing were 62.9% among OVC participants compared with 39.2% and 50.4% of non-participants in OVC support and non-OVC support districts, respectively. In multivariate models, OVC participants were 18 and 10 percentage points more likely to have received a VL test than non-participants in OVC districts (p < 0.01) and non-OVC districts (p < 0.01), respectively. OVC participants under 5 years old were significantly more likely to have received a VL test than their same-age counterparts in both comparison groups. Overall, the OVC program did not demonstrate significant effects on VL suppression. This approach could be replicated in other contexts to improve testing coverage. It is crucial that clinical partners and governments continue to share data to enable timely monitoring through OVC programming.

Email recruitment for chronic pain clinical trials: results from the LAMP trial

BackgroundRecruitment for clinical trials and large-scale studies is challenging, especially for patients with complex conditions like chronic pain. Email recruitment has the potential to increase efficiency, to reduce costs, and to improve access for underrepresented patient populations. The objective of this study was to examine the effectiveness, efficiency, and equitability of email versus postal mail recruitment for the Learning to Apply Mindfulness to Pain (LAMP) study, a three-site clinical trial of mindfulness-based interventions for chronic pain.MethodsPatients with chronic pain diagnoses were recruited from three United States Department of Veterans Affairs (VA) facilities using the VA electronic health record (EHR). Recruitment materials were sent using either postal mail (n = 7986) or email (n = 19,333). Patients in the email recruitment group were also mailed introductory postcards before any emails. Mailing addresses and email addresses were obtained from the EHR. Effectiveness was measured by the response rate of patients who logged into the secure LAMP study website. Efficiency was measured by the number of days from when the recruitment materials were sent to when patients logged into the LAMP portal as well as the estimated costs of each recruitment approach. To assess equitability, we examined whether email recruitment was less effective for underrepresented populations, based on demographic information from the EHR.ResultsEffectiveness—unadjusted response rates were greater for email versus postal-mail recruitment (18.9% versus 6.3%), and adjusted response rates were over three times greater for email recruitment (RR = 3.5, 95% CI 3.1–3.8) based on a multivariable analysis controlling for age, gender, race, ethnicity, rurality, and site. Efficiency—email recruitment had a significantly lower mean response time (1 day versus 8 days) and a lower cost. Equity—email recruitment led to higher response rates for all subpopulations, including older, non-White, Hispanic, rural, and female Veterans.ConclusionsEmail recruitment is an effective, efficient, and equitable way to recruit VA patients to large-scale, chronic pain clinical trials.Trial registrationClinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.

Electronic Health Record–Based Nudge Intervention and Axillary Surgery in Older Women With Breast Cancer

Choosing Wisely recommendations advocate against routine use of axillary staging in older women with early-stage, clinically node-negative (cN0), hormone receptor-positive (HR+), and HER2-negative breast cancer. However, rates of sentinel lymph node biopsy (SLNB) in this population remain persistently high. To evaluate whether an electronic health record (EHR)-based nudge intervention targeting surgeons in their first outpatient visit with patients meeting Choosing Wisely criteria decreases rates of SLNB. This nonrandomized controlled trial was a hybrid type 1 effectiveness-implementation study with subsequent postintervention semistructured interviews and lasted from October 2021 to October 2023. Data came from EHRs at 8 outpatient clinics within an integrated health care system; participants included 7 breast surgical oncologists. Data were collected for female patients meeting Choosing Wisely criteria for omission of SLNB (aged ≥70 years with cT1 and cT2, cN0, HR+/HER2- breast cancer). The study included a 12-month preintervention control period; baseline surveys assessing perceived acceptability, appropriateness, and feasibility of the designed intervention; and a 12-month intervention period. A column nudge was embedded into the surgeon's schedule in the EHR identifying patients meeting Choosing Wisely criteria for potential SLNB omission. The primary outcome was rate of SLNB following nudge deployment into the EHR. Similar baseline demographic and tumor characteristics were observed before (control period, n = 194) and after (intervention period, n = 193) nudge deployment. Patients in both the control and intervention period had a median (IQR) age of 75 (72-79) years. Compared with the control period, unadjusted rates of SLNB decreased by 23.1 percentage points (46.9% SLNB rate prenudge to 23.8% after; 95% CI, -32.9 to -13.8) in the intervention period. An interrupted time series model showed a reduction in the rate of SLNB following nudge deployment (adjusted odds ratio, 0.26; 95% CI, 0.07 to 0.90; P = .03). The participating surgeons scored the intervention highly on acceptability, appropriateness, and feasibility. Dominant themes from semistructured interviews indicated that the intervention helped remind the surgeons of potential Choosing Wisely applicability without the need for additional clicks or actions on the day of the patient visit, which facilitated use. This study showed that a nudge intervention in the EHR significantly decreased low-value axillary surgery in older women with early-stage, cN0, HR+/HER2- breast cancer. This user-friendly and easily implementable EHR-based intervention could be a beneficial approach for decreasing low-value care in other practice settings or patient populations. ClinicalTrials.gov Identifier: NCT06006910.

P-679 The impact of polycystic ovary syndrome (PCOS) on placental pathology among singleton livebirths conceived following in-vitro fertilization (IVF) or ovulation induction/intrauterine insemination (OI/IUI) treatments

Abstract Study question Are there differences in placenta pathology between PCOS and non-PCOS infertility diagnosis among singleton livebirths conceived following either IVF or OI/IUI treatments? Summary answer PCOS diagnosis when compared to non-PCOS exhibits distinctive associations within the anatomic and vascular spectrum of placental pathology. What is known already Pregnancies of women with PCOS are at higher risk for maternal and neonatal morbidity. Available studies suggest a possible association of PCOS with hypoxia-induced placental findings among natural conceptions, and a possible role of chronic, low-grade inflammation on decidualization, trophoblast invasion, and placental vascularization. Given the high prevalence of PCOS among women seeking fertility treatments there is significant interest in human placental research. Nevertheless, the impact of PCOS on placental pathology among singleton livebirths conceived with fertility treatments remains unclear. Study design, size, duration Retrospective review of data from 1398 singleton livebirths with available placenta pathology. All pregnancies were conceived following fertility treatments (IVF:1004, OI/IUI: 394) at an academic fertility center and were delivered at the same hospital between 01/2004 and 04/2022. 1196 patients had an infertility diagnosis other than PCOS (uterine factor excluded) and 193 had been diagnosed with PCOS (based on Rotterdam criteria). Placenta pathology (classified as below) was compared between PCOS and non-PCOS patients. Participants/materials, setting, methods Placental findings were reviewed by one expert pathologist and classified further as anatomic, inflammatory, infectious, and vascular [including any features of fetal(FVM) or maternal(MVM) vascular malperfusion], using the Amsterdam Workshop Consensus definitions. Primary outcomes: anatomic, inflammatory, infectious, and vascular. Parametric/non-parametric tests were used as appropriate. Adjusted odds ratios(adjOR) with 95% confidence intervals (95%CI) were calculated utilizing logistic regression, controlling for potential confounders. Subanalyses were performed separating IVF from OI/IUI-conceptions, and fresh from frozen embryo transfers(FET). Main results and the role of chance PCOS compared to non-PCOS patients were younger, with higher BMI and AMH [mean (SD): 32.9(3.5) vs 35.1(3.8) years, p &amp;lt; 0.001; 26.1(5.5) vs 24.8(5.5)kg/m2, p = 0.003; 9.1(5.8) vs 3.5(3.4)ng/ml, p &amp;lt; 0.001, respectively]. Overall, neither unadjusted rates (35.2% vs 28.8%, p:0.072; 15.9% vs 11.8%, p = 0.115; 21.8% vs 20.0%, p = 0.568; 51.0% vs 57.3%, p = 0.103, PCOS vs. non-PCOS, respectively), nor adjOR (95%CI) [1.02(0.94-1.1), 1.01(0.95-1.08), 1.02(0.94-1.09), 0.96(0.88-1.05), non-PCOS: ref] showed any differences between groups in anatomic, inflammatory, infectious, and vascular abnormalities, respectively. When separating IVF from OI/IUI-conceptions, and fresh transfers from FETs, adjOR(95%CI) revealed no differences between groups in anatomic, inflammatory, and infectious abnormalities [OI/IUI: 1.01(0.87-1.16), 1.0(0.88-1.13), 1.0(0.88-1.13); Fresh ET: 1.01(0.9-1.14), 1.02(0.95-1.1), and 0.95(0.85-1.05); FET: 1.16(0.96-1.4), 1.0(0.87-1.16), and 1.11(0.93-1.33), for anatomic, inflammatory, and infectious abnormalities, respectively, non-PCOS: ref]. Interestingly, a lower rate of vascular abnormalities was noted among PCOS patients in OI/IUI [adjOR(95%CI): 0.83(0.73-0.96)], but not among fresh or FET cycles [adjOR(95%CI): 1.05(0.91-1.19), and 0.97(0.8-1.18), respectively]. In FET cycles, within vascular abnormalities, lower rates of high grade FVM among PCOS patients were noted [adjOR(95%CI): 0.96(0.93-0.99)]. Furthermore, and although anatomic abnormalities did not differ between groups, a lower incidence of single umbilical artery [adjOR(95%CI): 0.98(0.96-0.99)] was noted among PCOS patients in IVF cycles. Limitations, reasons for caution The study is limited by its retrospective design and focuses on an infertile population undergoing treatments, limiting generalizability. Comparisons with PCOS patients conceiving naturally may provide meaningful insights. Variability among PCOS phenotypes, and other environmental, and lifestyle factors might also alter a patient’s individual pregnancy risk for placental abnormalities. Wider implications of the findings PCOS may impact placental pathology in a distinct way, within the anatomic and vascular spectrum, which might differ from that of other infertility causes and might be further altered by the treatment protocol. Our study adds to the limited human placental research specific to pregnancy of women with PCOS. Trial registration number Not Applicable

O-201 Antinuclear antibodies in women with recurrent early pregnancy loss: prevalence and impact on subsequent pregnancy outcome

Abstract Study question What is the prevalence of antinuclear antibodies (ANAs) in women with recurrent early pregnancy loss (REPL) and do they affect subsequent pregnancy outcome? Summary answer The prevalence of ANAs in women with REPL was 13.0%, and their presence did not negatively impact subsequent pregnancy outcomes, including EPL and livebirth rates. What is known already An etiological factor cannot be identified in more than half of the couples experiencing REPL. Immunologic mechanisms could be involved, with the presence of autoimmune disease (AD) associated to lower reproductive outcomes. For the mere presence of ANAs, in the absence of AD, the evidence on the association with REPL is controversial, with most studies having a small sample size with important clinical and methodological heterogeneity. Study design, size, duration This is a single-centre, retrospective cohort study from a tertiary referral hospital including 960 women referred for REPL between January 2014 and December 2019. During the entire study period, maternal serum ANA detection was part of the routine diagnostic REPL work-up, defined as two or more pregnancy losses before the 10th week of gestation, including previous spontaneous conceptions and pregnancies following autologous IVF/ICSI treatment. Participants/materials, setting, methods Women under the age of 40 at ANA analysis were eligible for inclusion. Confirmed AD, uterine anomalies, parental chromosomal abnormalities and uncontrolled endocrine disorders were exclusion criteria. The prevalence of positive ANA titers and the impact of ANA positivity on the outcome of a subsequent pregnancy were investigated with EPL rate as the main outcome parameter and biochemical pregnancy rate, clinical miscarriage rate and live birth rate as secondary outcome measures. Main results and the role of chance Positive ANA screening at a titer of ≥ 1/80 was observed in 125/940 women (13.0%), a prevalence in line with previously published data in the general population not experiencing REPL. There were no statistically significant differences in maternal age, body mass index, ethnicity, or conception method between ANA-positive and -negative women. No higher number of previous EPLs was observed in ANA-positive compared to ANA-negative women (respectively 2.7 versus 2.8, p = 0.06). Women with ANAs had significantly more thyroid antibodies (21.6% versus 10.2%, p &amp;lt; 0.001). For a subsequent pregnancy, no association was observed between ANA positivity and reproductive outcome with an unadjusted EPL rate of 30/86 (34.9%, ANA-positive) versus 206/509 (40.5%, ANA-negative, p = 0.32). Logistic regression analysis did not identify ANAs as an independent predictive risk factor for additional EPL (OR 0.73, 95%CI 0.45-1.20, p = 0.22). Similarly, there was no significant difference in live birth rates between both groups (p = 0.5), with 54/86 (62.8%) in ANA-positive and 300/509 (58.9%) in ANA-negative patients. Limitations, reasons for caution The current data are limited by the absence of a formal control group without REPL, the retrospective nature of the study and potential bias due to unmeasured confounders. Wider implications of the findings These findings further questions systematic ANA measurement in the diagnostic work-up of REPL without AD. Furthermore, when ANAs are detected, patient counselling and treatment adaptations should be considered with caution, given our inability to eventually detect any significant differences in the pregnancy outcomes between ANA-positive and -negative REPL patients. Trial registration number not applicable

Impact of frozen section on long-term outcomes in robot-assisted laparoscopic prostatectomy.

To compare 1-year functional and 5-year oncological outcomes of men undergoing robot-assisted laparoscopic prostatectomy (RALP) with neurovascular structure-adjacent frozen-section examination (NeuroSAFE) with those in men undergoing RALP without NeuroSAFE (standard of care [SOC]). Men undergoing RALP in our centre between 1 January 2009 and 30 June 2018 were enrolled from a prospectively maintained database. Patients were excluded if they had undergone preoperative therapy or postoperative adjuvant therapy or were enrolled in clinical trials. Patients were grouped based on use of NeuroSAFE. Follow-up was censored at 5 years. The primary outcome was difference in time to biochemical recurrence (BCR) on multivariable analysis, defined as prostate-specific antigen (PSA) >0.2 ng/L on two consecutive measurements. Secondary outcomes were difference in 1-year erectile dysfunction and incontinence. In the enrolment period, 1199 consecutive men underwent RALP, of whom 1140 were eligible, including 317 with NeuroSAFE and 823 with SOC. The median PSA follow-up was 60 months in both groups. Rates of 5-year BCR were similar on Kaplan-Meier survival curve analysis (11% vs 11%; P = 0.9), as was time to BCR on multivariable Cox proportional hazards modelling (hazard ratio 1.2; P = 0.6). Compared with the SOC group at 1 year, the NeuroSAFE group had similar unadjusted rates of incontinence (5.1% vs 7.7%) and lower unadjusted impotence (57% vs 80%). On multivariable analysis, NeuroSAFE patients had equivalent risk of incontinence (odds ratio [OR] 0.59, 95% CI 0.17-1.6; P = 0.4) but significantly reduced risk of erectile dysfunction (OR 0.37, 95% CI 0.22-0.60; P < 0.001). For men undergoing RALP, compared with SOC, NeuroSAFE patients had equivalent time to BCR and risk of 1-year incontinence, and significantly lower risk of 1-year erectile dysfunction.

P-440 Idiopathic infertility does not increase rates of placental abnormalities among singleton pregnancies conceived with either in-vitro fertilization (IVF) or ovulation induction±intrauterine insemination (OI±IUI)

Abstract Study question Is there an adverse impact of idiopathic infertility diagnosis on placental pathology among singleton pregnancies conceived with fertility treatments? Summary answer Idiopathic infertility does not increase rates of placental abnormalities and exhibits distinctive associations within the inflammatory and vascular spectrum of placental pathology. What is known already Pregnancies resulting from fertility treatments are often considered to be at higher risk for placenta-mediated obstetric complications and subsequent adverse perinatal outcomes. Treatment induced hormonal changes altering the endometrial milieu, along with embryo manipulation and culture conditions, may impact the processes of implantation, decidualization, trophoblast invasion, and placental vascularization. Nevertheless, the impact of infertility diagnoses on placental pathology among singleton pregnancies conceived with fertility treatments has not been elucidated, and whether idiopathic infertility alters the risk of placental abnormalities remains unknown. Study design, size, duration Retrospective review of placental pathology data from 1205 singleton livebirths conceived with fertility treatments (899 IVF, and 306 OI±IUI cycles) between 01/2004 and 04/2022. Placenta pathology was reviewed by one expert pathologist and classified as anatomic, inflammatory, infectious, and vascular [including any features of fetal (FVM) or maternal (MVM) vascular malperfusion], using the Amsterdam Workshop Consensus definitions. Placental abnormalities were compared between idiopathic infertility (IdI, n: 269) and all other, non-idiopathic infertility (non-IdI, n:936) diagnoses. Participants/materials, setting, methods Primary outcomes: anatomic, inflammatory, infectious, and vascular placental abnormalities. Parametric, and non-parametric tests were used as appropriately; odds ratios (OR) with 95% confidence intervals (95%CI) were assessed through logistic regression, adjusting for maternal age, body mass index (BMI, kg/m2), race, parity, gestational age, neonatal gender, treatment type, gestational diabetes, and hypertensive disorders. Analyses were further stratified by OI±IUI vs IVF treatments [the latter further stratified into fresh and frozen embryo transfers (FET)]. Main results and the role of chance Mean age, BMI, and AMH did not differ between groups, and neither did placental weight at term. Overall, unadjusted rates of inflammatory, infectious, and vascular abnormalities did not differ between groups (12.6% vs 11.4%, p 0.568; 22.0% vs 19.1%, p 0.256; 54.5% vs 58.6%, p 0.186, respectively). However, a higher rate of anatomic abnormalities was noted among IdI patients (32.8% vs 27.1%, p 0.044, IdI vs. non-IdI, respectively). When adjusting for potential confounders, no differences were noted between groups regarding inflammatory, infectious, and vascular abnormalities, and the observed difference in anatomic abnormalities lost its significance [adjOR(95%CI); inflammatory: 0.98(0.94-1.03), infectious: 1.03(0.98-1.09), vascular: 0.96(0.90-1.02), and anatomic: 1.02(0.96-1.08), non-IdI: ref]. Similarly, when separating OI±IUI from FET and fresh IVF cycles, adjOR(95%CI) revealed no differences in anatomic, infectious, and vascular abnormalities between groups [OI±IUI: 0.97(0.85-1.1), 0.97(0.87-1.08), 0.99(0.87-1.12); FET: 1.08(0.94-1.24), 1.07(0.94-1.23), 1.04(0.98-1.11) and, fresh IVF: 1.06(0.98-1.15), 1.04(0.96-1.13), 0.96(0.87-1.07), for anatomic, infectious, and vascular, respectively]. However, lower odds of inflammatory abnormalities were noted among fresh IVF but not among FET or OI±IUI cycles in IdI [adjOR (95%CI); fresh IVF: 0.95(0.91-0.99), FET: 1.09(0.98-1.21), OI±IUI: 0.97(0.87-1.08), non-IdI: ref]. Interestingly, among vascular abnormalities studied in the programmed FET cycles, MVM showed a difference between the groups [adjOR(95%CI) 0.90(0.85-0.96), non-IdI: ref]. Limitations, reasons for caution This study is limited by its retrospective design. The reported findings are from an infertile population undergoing treatments and thus not easily generalizable to natural conceptions. Other factors, such as environmental, nutritional, and lifestyle, might alter a patient’s individual pregnancy risk for placental abnormalities. Wider implications of the findings Overall, idiopathic infertility does not appear to increase the risk for placental abnormalities. However, it may impact placental pathology in a unique way, within the vascular and inflammatory spectrum, which might differ from that of other infertility diagnoses, and might be further altered by the treatment protocol. Trial registration number Not Applicable

P-776 School-age outcomes among IVF and ICSI -conceived children: a causal inference analysis using linked population-wide data

Abstract Study question What is the causal effect of method of oocyte insemination; standard in-vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI), on childhood development at school entry? Summary answer The developmental outcomes at school entry for children conceived by ICSI, without severe male factor infertility, are equivalent to those conceived via standard IVF. What is known already Over 12 million children have been conceived globally with the assistance of assisted reproductive technology (ART). Within ART, ICSI continues to increase as the most common mode of oocyte insemination, even when not clearly indicated (i.e. without male factor infertility). Large cohort studies have suggested that ART, and ICSI in particular, may be associated with an increase in congenital abnormalities, autism spectrum disorder, developmental delay and intellectual disability. However, the studies are heterogenous and the evidence conflicting. The association between the ICSI technique itself and long-term childhood development remains unclear. Study design, size, duration Causal inference methods were used to analyse observational data in a way that emulates a target randomised clinical trial. For example, patients where standard IVF was not an option, (e.g., due to severe male factor infertility), were excluded. The state-wide cohort included linked maternal and childhood administrative data from Victoria, Australia. To eliminate potential confounding associated with IVF, comparison was made with children conceived via standard IVF (rather than conception without assistance). Participants/materials, setting, methods The study included singleton infants conceived via ART and born between 2005-2013. The primary exposure was conception via ICSI, with those born following conventional IVF insemination as controls. The outcome examined was the Australian Early Development Census (AEDC), a broad assessment of development and well-being performed in Australian schools, every triennium, at school entry (age 4-6). We combined multiple imputation and inverse probability weighting with regression adjustment to estimate population average causal effects. Main results and the role of chance The final cohort included 4,035 IVF and ICSI conceived children across the two outcome cohorts. Linked records were available for 2,468 ICSI children and 1,567 IVF-conceived controls. Maternal characteristics between the two treatment cohorts were similar for age, parity, education, language background, and number of eggs collected during treatment cycle. The ICSI conceived children were generally from residential areas of lower socio-economic status and conception was more likely to involve donated gametes. The unadjusted rate of the primary outcome; AEDC-defined “developmental vulnerability”, was 10.83% among the IVF group and 10.14% among the ICSI group. Given the use of observational data, there were missing data and inherent differences in the covariate profile between exposure cohorts. Multiple imputation, bootstrapping and doubly robust inverse probability weighted regression adjustment modelling was utilised to allow a causal interpretation of results. There was no evidence of a causal effect of ICSI-conception on the risk of AEDC-defined developmental vulnerability at school entry compared with spontaneously conceived children; adjusted risk difference -0.8% (95% CI -2.7% to 1.1%) and adjusted risk ratio 0.92 (95% CI 0.76 to 1.12). The adjustment variable set was determined a priori via a modified Delphi procedure. Limitations, reasons for caution Children who did not attend school due to severe disability were excluded, leading to potential selection bias. Within our study cohort of 2,468 ICSI children, no increased risk of developmental vulnerability was identified. It is possible that unmeasured confounders could have led to bias in estimating the treatment effects. Wider implications of the findings This study, in contrast to previous evidence, suggests that empiric use of ICSI compared with conventional IVF insemination does not affect early childhood developmental outcomes. These findings provide important reassurance for current and prospective parents, and clinicians alike. Trial registration number not applicable