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Weibin Shi,1,2 Renuka Rudra,1,2 To-Nhu Vu,3 Yuri Gordin,1,2 Ryan Smith,1,2 Allen R Kunselman4 1Department of Physical Medicine and Rehabilitation, Penn State Health Milton S Hershey Medical Center, Penn State College of Medicine, Hershey, PA, USA; 2Penn State Hershey Rehabilitation Hospital, Hummelstown, PA, USA; 3Department of Anesthesiology & Perioperative Medicine, Penn State Health Milton S Hershey Medical Center, Penn State College of Medicine, Hershey, PA, USA; 4Department of Public Health Sciences, Penn State Hershey College of Medicine, Hershey, PA, USACorrespondence: Weibin Shi; To-Nhu Vu Email wshi@pennstatehealth.psu.edu; tonhuvu@pennstatehealth.psu.eduBackground: Sensory stimulation threshold (SST) has been used as a surrogate marker to target a nerve branch for radiofrequency (RF) denervation; however, the validity of SST as a prognostic marker is still under debate.Objective: To assess whether lower SST values correlate with better outcomes of radiofrequency denervation for facetogenic low back pain.Design: Prospective cohort study.Patients: Sixty-seven patients who underwent radiofrequency denervation for low back pain.Methods: Correlations, between the average percentage of pain relief from diagnostic medial branch block (MBB) and RF denervation procedure outcome, and between SST and RF denervation procedure outcome, were analyzed using Spearman correlation coefficient (rs). Wilcoxon rank sum test was performed to assess whether magnitude and duration of pain relief following RF denervation differed by the levels of SST (< 0.5 and ≥ 0.5) or pain relief (< 80% and ≥ 80%) from diagnostic MBB.Results: There was a positive correlation between pain relief after diagnostic MBB and pain relief 2 weeks after denervation (rs 0.31, 95% CI 0.08 to 0.51, p < 0.01), but not between pain relief after MBB and pain relief 6 months after denervation, nor pain relief duration after denervation. There was a negative correlation between SST and pain relief 6 months after denervation (rs − 0.41, 95% CI − 0.59 to − 0.18, p < 0.001). There was also a negative correlation between SST and pain relief duration after denervation (rs − 0.33, 95% CI − 0.53 to − 0.09, p < 0.01).Conclusion: SST is a viable measurement with which to guide needle placement during RF denervation for lumbar facet pain, and enhances pain relief outcomes.Keywords: sensory stimulation threshold, radiofrequency ablation, lower back pain, lumbar facet arthropathy, outcome

Objective: To estimate whether continuous oral contraceptive pills (OCPs) will result in more pain relief in primary dysmenorrhea patients than cyclic OCPs, which induce withdrawal bleeding with associated pain and symptoms.Methods: We conducted a double-blind, randomized, controlled trial comparing continuous to a cyclic 21-7 OCP regimen (gestodene 0.075 mg and ethinyl estradiol 20 microgram) for 6 months in 38 primary dysmenorrhea patients. The primary outcome was the difference in subjective perception of pain as measured by the visual analog scale over a period of 6 months.Results: Twenty-nine patients completed the study. In both groups, pain reduction measured by visual analog scale declined over time and was significant at 6 months compared with baseline, with no difference between groups. Continuous regimen was superior to cyclic regimen after 1 month (mean difference -27.3, 95% confidence interval [CI] -40.5 to -14.2; P<.001) and 3 months (mean difference -17.8, 95% CI -33.4 to -2.1; P=.03) of treatment. Secondary outcomes noted no difference between groups in terms of menstrual distress as measured by the Moos Menstrual Distress Questionnaire. After 6 months, there was an increase in weight and a decrease in systolic blood pressure in the continuous group compared with the cyclic group.Conclusion: Both regimens of OCPs are effective in the treatment of primary dysmenorrhea. Continuous OCPs outperform cyclic OCPs in the short term, but this difference is lost after 6 months.Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00517556.Level Of Evidence: I. [ABSTRACT FROM AUTHOR]

BACKGROUND: Whole-grain foods are associated in observational studies with a lower body mass index and lower cardiovascular disease (CVD) risk. However, few clinical trials have tested whether incorporating whole grains into a hypocaloric diet increases weight loss and improves CVD risk factors. OBJECTIVE: The aim of this study was to determine whether including whole-grain foods in a hypocaloric (reduced by 500 kcal/d) diet enhances weight loss and improves CVD risk factors. DESIGN: Obese adults (25 M, 25 F) with metabolic syndrome were randomly assigned to receive dietary advice either to avoid whole-grain foods or to obtain all of their grain servings from whole grains for 12 wk. All participants were given the same dietary advice in other respects for weight loss. RESULTS: Body weight, waist circumference, and percentage body fat decreased significantly (P<0.001) in both groups over the study period, but there was a significantly (P=0.03) greater decrease in percentage body fat in the abdominal region in the whole-grain group than in the refined-grain group. C-reactive protein (CRP) decreased 38% in the whole-grain group independent of weight loss but was unchanged in the refined-grain group (P=0.01 for group x time interaction). Total, LDL, and HDL cholesterol decreased in both diet groups (P<0.05). Dietary fiber and magnesium intakes increased in the whole-grain but not the refined-grain group (P=0.007 and P<0.001, respectively, for group x time interaction). CONCLUSIONS: Both hypocaloric diets were effective means of improving CVD risk factors with moderate weight loss. There were significantly (P<0.05) greater decreases in CRP and percentage body fat in the abdominal region in participants consuming whole grains than in those consuming refined grains. Copyright © 2008 American Society for Nutrition [ABSTRACT FROM AUTHOR]

OBJECTIVE: Using basal specimens from original gonadotropin radioimmunoassays, it was not possible to differentiate prepuberty from puberty hence gonadotropin-releasing hormone or gonadotropin-releasing hormone analog (GnRHa) testing was required to make this distinction. Third-generation gonadotropin assays have far greater specificity and sensitivity. Using a group of patients who had the diagnosis of central precocious puberty (CPP) verified or excluded by using GnRHa and traditional diagnostic criteria, the objective of this study was to determine if a single basal gonadotropin measurement was adequate to verify the diagnosis of CPP by using 2 third-generation gonadotropin assays. METHODS: Girls referred for assessment of early puberty had previously been evaluated for central precocious puberty including gonadotropin-releasing hormone analog stimulation testing with gonadotropin measurements by 2 different chemiluminescent third-generation immunoassays. Diagnosis of central precocious puberty was made on the basis of the response to the gonadotropin-releasing hormone analog, and clinical criteria. Girls with central precocious puberty had luteinizing hormone responses ranging from 9.1 to 67.6 U/L, the prepubertal luteinizing hormone response range was 0.2 to 5.0 U/L. Basal serum luteinizing hormone and follicle-stimulating hormone concentrations from these girls have been assessed to determine the utility of using such a single sample to diagnose central precocious puberty. RESULTS: Basal luteinizing hormone levels using the 2 third-generation gonadotropin assays were sufficient to diagnose central precocious puberty in >90% of the girls. Luteinizing hormone values were undetectable in both assays with different lower limits of detection (<0.15 and <0.20 U/L) in 29 of 34 prepubertal girls; the detectible values in 5 girls ranged from 0.20 to 0.66 U/L. All girls with central precocious puberty had values of >0.83 U/L, except a single value of 0.46 U/L. The basal follicle-stimulating hormone failed to differentiate prepubertal girls from those with central precocious puberty, whereas luteinizing hormone/follicle-stimulating hormone ratios would seem to have limited discernment. CONCLUSION: A single basal luteinizing hormone measurement is adequate to document a pubertal hypothalamic-pituitary-ovarian axis in most but not all girls with central precocious puberty. [ABSTRACT FROM AUTHOR]

Background: The study objective was to determine the impact of cardiopulmonary bypass perfusion modalities on cerebral hemodynamics and clinical outcomes in congenital cardiac surgery patients stratified by acyanotic versus cyanotic heart disease., Methods: A total of 159 pediatric (age <18 years) cardiac surgery patients were prospectively randomized to pulsatile or nonpulsatile cardiopulmonary bypass and stratified by type of congenital heart disease: acyanotic versus cyanotic. Intraoperative cerebral gaseous microemboli counts and middle cerebral artery pulsatility index were assessed. Organ injury was quantified by Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24, 48, and 72 h postoperatively. Additional outcomes included Pediatric Risk of Mortality-3 score, vasoactive-inotropic score, duration of mechanical ventilation, intensive care and hospital length of stay, and 180-day mortality. Heterogenous variance linear models (ie, ANOVA and mixed models) and χ 2 tests were used to compare groups for continuous and categorical variables, respectively., Results: Within congenital heart disease subgroups, patients randomized to nonpulsatile versus pulsatile bypass had similar preoperative and operative characteristics. While the intraoperative pulsatility index was higher in the pulsatile subset of both acyanotic and cyanotic groups ( P  < .05), regional cerebral oxygen saturation, mean arterial pressure, and gaseous microemboli counts were similar. Postoperative PELOD-2 scores decreased at similar rates in the acyanotic and cyanotic subgroups regardless of the perfusion modality utilized. There were also no significant between-group differences in the additional postoperative outcomes by perfusion modality in either acyanotic or cyanotic groups., Conclusions: Despite patients undergoing pulsatile cardiopulmonary bypass experiencing a more physiologic pulsatility index in both acyanotic and cyanotic groups, no significant differences in cerebral hemodynamics or clinical outcomes were appreciated., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Context: Polycystic ovary syndrome (PCOS) is a common, heritable endocrinopathy that is a common cause of anovulatory infertility in reproductive age women. Variants in LMNA cause partial lipodystrophy, a syndrome with overlapping features to PCOS., Objective: We tested the hypothesis that rare variation in LMNA contributes to PCOS pathogenesis and selects a lipodystrophy-like subtype of PCOS., Design, Setting, and Participants: We sequenced LMNA by targeted sequencing a discovery cohort of 811 PCOS patients and 164 healthy controls. We then analyzed LMNA from whole-exome sequencing (WES) of a replication cohort of 718 PCOS patients and 281 healthy controls., Main Outcome Measures: Variation in the LMNA gene, hormone and lipid profiles of participants., Results: In the discovery cohort, we identified 8 missense variants in 15/811 cases, and 1 variant in 1/172 reproductively healthy controls. There is strong evidence for association between the variants and PCOS compared to gnomAD non-Finnish European population controls (χ2=17, p=3.7x10-5, OR=2.9). In the replication cohort, we identified 11 unique variants in 15/718 cases, and 1 variant in 281 reproductively healthy controls. Again, there is strong evidence for association with population controls (χ2=30.5, p=3.4x10-8, OR= 4.0). In both the discovery and replication cohorts, variants in LMNA identify women with PCOS with high triglycerides and extreme insulin resistance., Conclusions: Rare missense variation in LMNA is reproducibly associated with PCOS and identifies some individuals with lipodystrophy-like features. The overlap between this PCOS phenotype and genetic partial lipodystrophy syndromes warrants further investigation into additional lipodystrophy genes and their potential in PCOS etiology., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. See the journal About page for additional terms.)

Pilot studies, when properly designed and implemented, are an important tool that provide critical information for the development and potential success of a subsequent, larger trial. In fact, these small-scale studies are commonly used to assess the feasibility of whether a larger trial should be initiated. A popular investigator question is whether a pilot study requires a formal statistical power calculation. In general, the answer is "no"; however, the sample size needs to be justified on the basis of the goal of the pilot study., Competing Interests: Declaration of Interests A.R.K. declares stock ownership in Merck., (Copyright © 2024 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Genicular nerve radiofrequency ablation (GNRFA) is a popular and effective procedure to treat arthritic knee pain. For refractory arthritic pain that fails conservative treatment, total knee arthroplasty (TKA) has been an excellent option. Unfortunately, 15-30% of people who undergo a TKA continue to experience pain and stiffness in the knee. The treatment options for post-TKA knee pain are limited. Pain providers have been trialing GNRFA on this pain condition. However, convincing evidence of its efficacy in treating post-TKA pain is still lacking., Methods: This is a retrospective study of 73 patients who had undergone genicular nerve RFA, 46 (63.01%) with osteoarthritic pain, and 27 (36.99%) with post-TKA pain. We compared the outcomes (pain relief, function, and complications) between these two groups at 3 months and 6 months after RFA., Results: Before RFA, there was no significant difference in initial pain and functional level between these two groups. After RFA, the two groups had comparable pain relief at 3 months (p = 0.68) and 6 months (p = 0.53), and similar functionality at 3 months (p = 0.36) and 6 months (p = 0.65).The overall success rate (≥50% pain relief after RFA) was 80.82%, 95% CI: 70.34%-88.22% (osteoarthritic group 80.43%, 95% CI: 66.83%-89.35%, post-TKA 81.48%, 95% CI: 63.30%-91.82%, P = 0.91) at 3-month follow-up and 56.16%, 95% CI: 44.76%-66.95% (osteoarthritic group 56.52%, 95% CI: 42.25%-69.79%, post-TKA 55.56%, 95% CI: 37.31%-72.41%, P = 0.94) at 6-month follow-up.There were no reported complications in either group., Conclusions: Genicular Nerve Radiofrequency Ablation (GNRFA) holds the potential to be equally effective for both post-TKA knee pain and osteoarthritic knee pain., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Competing Interests: Dr. Kunselman received funding from Merck. Dr, Barbaro’s institution received funding from the National Institutes of Health (NIH) (R01 HL153519); they disclosed they are on the ELSO Board of Directors; they received support for article research from the NIH; they disclosed use of off-label ECMO. Dr. Thomas received funding from Bayer AG. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Background: Uncontrolled hemorrhage is the leading cause of preventable death in combat and civilian trauma. Efficacious hemostatic agents in junctional hemorrhage can quell blood loss and improve survival. We hypothesized that a novel hemostatic foam of starch and chitosan would improve hemostasis, and thereby increase survival in a swine femoral artery hemorrhage model when compared with CombatGauze (CG)., Methods: A novel hemostatic foam of starch and chitosan was created and modified during the study period. Thirty pigs (four excluded) were assigned to treatment using either foam version 1 (FV1, n = 9) or 2 (FV2, n = 8), or (n = 9) in a standard swine femoral artery hemorrhage model. Animals were observed for 150 minutes. Outcomes assessed included hemostasis, survival, posttreatment blood loss, IV fluid volume, and hemodynamic and laboratory trends., Results: Hemostasis prior to 150 minutes was similar with 44.4%, 77.8%, and 50% of swine treated with CG, FV1 and FV2, respectively (Kaplan-Meyer and log-rank test [KM-LR] p > 0.05). Survival to 150 minutes was improved in swine treated with FV1 (100%) compared with CG (55.6%) (KM-LR p = 0.02). Survival was similar between FV1 and FV2 (75%) (KM-LR p > 0.05), and between CG and FV2 (KM-LR p > 0.05). Using mixed model for longitudinal data, mean arterial pressure decreased significantly in CG- and FV2-treated swine, while there was no significant change in mean arterial pressure in FV1-treated swine. Trends in lactic acid, hematocrit, platelets, INR, and thrombelastography were more favorable for FV1 compared with CG., Conclusion: In this preclinical study of junctional hemorrhage, survival was improved in swine treated with version 1 of a novel chitosan/starch foam compared with CG. Trends in hemodynamics and laboratory data were also more favorable in the FV1-treated swine. This novel hemostatic foam may be an effective alternative to current hemostatic agents., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The objective of this retrospective review was to evaluate whether or not pulsatile flow improves cerebral hemodynamics and clinical outcomes in pediatric congenital cardiac surgery patients., Methods: This retrospective study included 284 pediatric patients undergoing congenital cardiac surgery with cardiopulmonary bypass support utilizing nonpulsatile (n = 152) or pulsatile (n = 132) flow. Intraoperative cerebral gaseous microemboli counts, pulsatility index, and mean blood flow velocity at the right middle cerebral artery were assessed using transcranial Doppler ultrasound. Clinical outcomes were compared between groups., Results: Patient demographics and cardiopulmonary bypass characteristics between groups were similar. Although the pulsatility index during aortic crossclamping was consistently higher in the pulsatile group ( P  < .05), a significant degree of pulsatility was also observed in the nonpulsatile group. No significant differences in mean cerebral blood flow velocity, regional cerebral oxygen saturation, or gaseous microemboli counts were observed between the perfusion modality groups. Clinical outcomes, including intubation duration, intensive care unit and hospital length of stay, and mortality within 180 days were similar between groups., Conclusions: Although the pulsatility index was greater in the pulsatile group, other measures of intraoperative cerebral perfusion and short-term outcomes were similar to the nonpulsatile group. These findings suggest that while pulsatile perfusion represents a safe modality for cardiopulmonary bypass support, its use may not translate into detectably superior clinical outcomes., Competing Interests: The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (© 2023 The Author(s).)

Objectives: To investigate outcomes associated with conventional roller or centrifugal pumps during neonatal venovenous extracorporeal membrane oxygenation (ECMO). Our primary hypothesis is that in comparison with conventional roller-pump support, centrifugal pump use is associated with greater odds of survival. Our secondary hypothesis is that centrifugal pump use is associated with lesser odds of complications., Design: Retrospective cohort identified using the Extracorporeal Life Support Organization (ELSO) registry 2016 to 2020 dataset., Setting: All ECMO centers reporting to the ELSO registry., Patients: All neonates (≤ 28 d) supported with venovenous ECMO and cannulated via right internal jugular vein using dual-lumen venovenous cannulas and polymethyl pentene membrane oxygenators., Interventions: None., Measurements and Main Results: A total of 612 neonates (centrifugal, n = 340; conventional roller, n = 272) were included in the analysis. Using a multivariable logistic regression model, centrifugal pump use-as opposed to roller pump use-was associated with lesser odds of survival (odds ratio [OR], 0.53; 95% CI, 0.33-0.84; p < 0.008). Thrombosis and clots in the circuit components were also associated with lesser odds of survival (OR, 0.28; 95% CI, 0.16-0.60; p < 0.001). We failed to show that hemolysis was an independent variable for survival (OR, 0.60; 95% CI, 0.31-1.19; p = 0.14). The primary diagnosis of neonatal aspiration/meconium aspiration is associated with more than seven-fold greater odds of survival (OR, 7.57; 95% CI, 4.02-15.74; p < 0.001)., Conclusions: Contrary to our hypotheses, conventional roller pump use was associated with greater odds of survival. While thrombosis and clots in circuit components were independent variables for lesser odds of survival, further research is needed better to understand the use of centrifugal pumps in neonatal practice., Competing Interests: Dr. Kunselman received funding from Merck and Novavax. Dr. Barbaro’s institution received funding from the National Institutes of Health (NIH) Acute respiratory distress Syndrome in Children and Extracorporeal membrane oxygenation initiation strategies impact on Neuro-Development (R01 HL153519) and the NIH Training to Advance Care Through Implementation science in Cardiac And Lung illnesses (K12 HL138039); he disclosed that he is the Extracorporeal Life Support Organization Registry Chair; he received support for article research from the NIH; he disclosed the off-label product use of extracorporeal membrane oxygenation. Dr. Alexander’s institution received funding from Novartis. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Background: Genicular nerve radiofrequency ablation (RFA) is an effective procedure to alleviate knee pain. This procedure has been proven to be safe, except in the inferior lateral quadrant (ILQ) due to its innervation being near the common fibular nerve (CFN). Given the complexity of this approach, pain physicians do not routinely perform RFA in the ILQ, leading to inadequate pain relief in this region., Methods: This is a retrospective study of 54 patients who had undergone genicular nerve RFA. Thirty patients had genicular nerve RFA of the knee joint including the ILQ innervated by the inferolateral genicular and recurrent fibular nerves, while 24 patients had RFA of the knee joint without involvement of the ILQ. We compared the outcomes (pain relief, function, and complications) in the patients with and without ILQ RFA at 3 months and 6 months after RFA., Results: There was no significant difference in initial pain and functional level before RFA between these two groups. After RFA, the two groups had comparable pain relief at 3 months (p ​= ​0.06) and 6 months (p ​= ​0.20), and similar functionality at 3 months (p ​= ​0.29) and 6 months (p ​= ​0.12). There were no reported complications after RFA with or without ILQ RFA., Conclusions: RFA of the innervation to the ILQ of the knee is as safe and effective as all other anterior quadrants., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Postoperative opioid prescribing has historically lacked information critical to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. This data evaluates pain control, satisfaction with pain control, and opioid utilization among patients undergoing isolated mid-urethral sling (MUS) randomized to one of two different opioid prescribing regimens. This study was registered on clinicaltrials.gov (NCT04277975). Women undergoing isolated MUS by a Female Pelvic Medicine and Reconstructive Surgery physician at a Penn State Health hospital from June 1, 2020 to November 22, 2021 were offered enrollment into this prospective, randomized, open-label, non-inferiority clinical trial. Participants gave informed consent and were enrolled by a member of the study team. Allocation was concealed to patient and study personnel until randomization on the day of surgery. Preoperatively, all participants completed baseline demographic and pain surveys including CSI-9, PCS, and Likert pain score (scale 0-10). Participants were randomized to either receive a standard prescription of ten 5 mg tablets oxycodone provided preoperatively (standard) or opioid prescription provided only upon patient request postoperatively (restricted). Randomization was performed by the study team surgeon using the REDCap randomization module on the day of surgery. Following MUS, subjects completed a daily diary for 1 week, i.e., postoperative day (POD) 0 through 7. Within the dairy, subjects provided the following information: average daily pain score, opioid use and amount of opioid utilized, other forms of pain management, satisfaction with pain control, perception of the amount of opioid prescribed, and need for pain management hospital/clinic visits. The online Prescription Drug Monitoring Program (PDMP) was queried for all patients to determine if prescriptions for opioids were filled during the postoperative period. The primary outcome was average postoperative day 1 pain score and an a priori determined margin of non-inferiority was set at 2 points. Secondary outcomes included whether subject filled an opioid prescription (indicated by the online PDMP), opioid use (yes/no), satisfaction with pain control (on a scale of 1= "much worse" to 5= "much better" than expected), and how subjects felt about the amount of opioid prescribed (on a scale of 1="prescribed far more" to 3="prescribed the right amount" to 5="prescribed far less" opioid than needed). 82 participants underwent isolated MUS placement and met inclusion criteria; 40 were randomized to the standard arm and 42 to the restricted group. Within this manuscript, we detail the data obtained from this randomized clinical trial and the methods utilized., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Objective: The primary objective of this study was to report surgical outcomes for cesarean delivery (CD) patients following the implementation of an Enhanced Recovery after Surgery (ERAS) pathway based on the ERAS Society recommendations. The primary outcome for which the study was powered was the length of stay (LOS)., Methods: This IRB-approved cohort study was conducted at a single tertiary-care labor and delivery unit and utilized a pre-post intervention design. Our ERAS for CD protocol was designed using the ERAS Society recommendations and implemented globally for every patient admitted to the labor and delivery unit including both scheduled and unscheduled cases. The study was designed to have at least 85% power to detect a 6-h difference in length of stay (LOS) between the pre-intervention and post-intervention cohorts, assuming a standard deviation of 18 h. A total of 339 records were included for data analysis, 170 in the pre-intervention cohort and 169 in the post-intervention cohort. To assess the difference between groups with respect to the primary outcome of LOS, linear regression was used with and without adjusting for covariates. Differences in dichotomous secondary outcomes were assessed using binary logistic regression. Differences in continuous secondary outcomes were assessed via a two-sample t -test or Wilcoxon rank sum test. Individual components of protocol adherence were compared using chi-square tests., Results: Mean LOS was 80.5 ± 22.9 h and 82.3 ± 28.0 h, pre- and post-intervention respectively. There was no difference in LOS between the 2 cohorts (difference of means = 1.8 h; 95% confidence interval (CI): (-3.7, 7.3); p  = .51). Cesarean procedure infection decreased from 11.8% pre-intervention to 5.3% post-intervention, corresponding to a 58% decrease in odds of cesarean procedure infection (odds ratio (OR)=0.42; 95% CI: (0.19, 0.96); p  = .04). Inpatient opioid use also significantly decreased in the post-intervention cohort with a median MME per 12 h-period of 5.1 (25 th percentile = 2.2, 75 th percentile = 7.8) pre-intervention and 3.3 (25 th percentile = 1.0, 75 th percentile = 7.6) post-intervention ( p  = .04)., Conclusion: The results of this study support the implementation of an ERAS for CD protocol based on ERAS Society recommendations as evidenced by the statistically significant decrease observed in both procedure-related infection rates and inpatient opioid use. We did not find a significant difference in LOS, which leaves room for further investigation into factors that impact LOS after CD.

Objective: To determine whether an inpatient post-cesarean analgesic regimen which separated oxycodone and acetaminophen resulted in less inpatient opioid use, when compared to a regimen using combination medications containing both acetaminophen and oxycodone in a cohort including patients of all gestational ages, acuity levels, and modes of operative anesthesia., Methods: This is a retrospective cohort study which was conducted at a single tertiary care center Labor and Delivery unit. Data were collected via retrospective chart review, and a total of 170 records were examined with a final N  = 150. Inclusion criteria were all patients over the age of 18, and >23.0 weeks gestational age, who had a singleton or twin cesarean delivery regardless of their mode of operative anesthesia and whether or not they received intrathecal opioid at time of delivery. Exclusion criteria were pregnancies of higher-level multiples (triplets or greater), prolonged intensive care unit (ICU) stay, and patients who received both combination oxycodone-acetaminophen and separately administered oxycodone. For analysis patients were classified into two groups: the "Combined Medication" group representing patients who received combination oxycodone-acetaminophen medication only ( n  = 83) and the "Separate Medication" group representing patients who received oxycodone and acetaminophen separately ( n  = 67). Differences between the groups with respect to opioid use and acetaminophen use were assessed., Results: The primary outcome was inpatient opioid medication use per 12-h period in intravenous morphine mg equivalents (MME). Patients received an average of 4.6 ± 3.5 MME IV morphine per 12 h in the Separate Medication group and 5.7 ± 3.7 MME IV morphine per 12 h in the Combined Medication group. When controlled for several covariates, the Separate Medication group took significantly fewer MME per 12-h period (mean difference = -1.2, 95% CI: (-2.3, -0.1), p  = .04). There was no appreciable difference in acetaminophen utilization between groups., Conclusions: An analgesic regimen where oxycodone is ordered separately from acetaminophen is associated with reduced inpatient opioid medication use in patients of all gestational ages, acuity levels, and modes of operative anesthesia.

Objective: To determine the feasibility, safety, and outcomes of an oil-based, iodinated contrast using office-based, ultrasound-imaged hysterosalpingography in women with infertility., Design: Randomized Controlled Double Blind Clinical Trial., Setting: Academic health center., Interventions: Tubal flushing with oil-based contrast medium (Lipiodol UF) versus saline., Main Outcome Measures: Ongoing pregnancy rate, pain, quality of life, and thyroid function., Results: Forty-eight patients (24 in each group) were analyzed. The groups were well-matched at baseline. Ongoing pregnancy was noted in 17% (4/24) of the oil-contrast group versus 37% (9/24) in the saline group. Saline group patients more frequently initiated infertility therapy in the six-month follow-up period (saline, 67% vs. oil, 33%), and no serious adverse events in either group. There were no differences in pain from the procedure between groups. There were no differences in thyroid function tests postprocedure between groups, but within the oil-contrast group, there was a slight increase in thyroid-stimulating hormone (post vs. preratio of geometric means: 1.18; 95% confidence interval [CI], 1.02-1.38) and decrease in Free T4 (postdifference vs. predifference in means: 0.08 ng/dL; 95% CI, -0.14 to -0.01). Immediately after the test, the physicians correctly guessed 79% of oil and 71% of saline randomization assignments, whereas patients correctly guessed 63% of oil and 38% of saline., Conclusions: This pilot study demonstrates the safety and feasibility of giving an oil-based contrast medium during ultrasound-imaged hysterosalpingography. Pregnancies were seen after oil-based administration, and this contrast is associated with minor thyroid function impairment., (© 2022 Published by Elsevier Inc. on behalf of American Society for Reproductive Medicine.)

Introduction: We analyzed the exclusion of pregnant and breastfeeding individuals and those capable of pregnancy in COVID-19 vaccine and clinical treatment trials., Methods: Inclusion and exclusion criteria were extracted from all listed COVID-19 vaccine and treatment clinical trials from May 1, 2020, to October 31, 2020, using the U.S. National Library of Medicine database. We report rates of rates of exclusion for pregnant and lactating individuals and requirements for contraception for pregnancy-capable participants in COVID-19 vaccine and treatment clinical trials. The analysis included the association between clinical trial exclusion and vaccine and treatment type, study location, sponsor, and phase., Results: Pregnant and lactating individuals were explicitly excluded from most COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded pregnant individuals, 73 (81.1%) excluded lactating individuals, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded pregnant individuals, 269 (54.3%) excluded lactating individuals, and 91 (18.4%) required contraception use. Although vaccine type was not associated with pregnancy exclusion, it was associated with lactation exclusion (p = .01) and contraception requirement (p < .001). Treatment type was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < .001)., Conclusions: COVID-19 vaccination and treatment clinical trials mirrored historical trends restricting participation owing to pregnancy, lactation, and contraception nonuse, despite known safety profiles. People of childbearing potential should be considered for and afforded the same opportunity as males to make informed decisions on study participation, particularly in the setting of a global pandemic., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The objective of this randomized clinical trial was to investigate the effects of perfusion modalities on cerebral hemodynamics, vital organ injury, quantified by the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) Score, and clinical outcomes in risk-stratified congenital cardiac surgery patients., Methods: This randomized clinical trial included 159 consecutive congenital cardiac surgery patients in whom pulsatile (n = 83) or nonpulsatile (n = 76) perfusion was used. Cerebral hemodynamics were assessed using transcranial Doppler ultrasound. Multiple organ injury was quantified using the PELOD-2 score at 24, 48, and 72 hours. Clinical outcomes, including intubation time, intensive care unit length of stay (LOS), hospital LOS, and mortality, were also evaluated., Results: The Pulsatility Index at the middle cerebral artery and in the arterial line during aortic cross-clamping was consistently better maintained in the pulsatile group. Demographics and cardiopulmonary bypass characteristics were similar between the 2 groups. While risk stratification with The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) Mortality Categories was similar between the groups, Mortality Categories 1 to 3 demonstrated more patients than Mortality Categories 4 and 5. There were no differences in clinical outcomes between the groups. The PELOD-2 scores showed a progressive improvement from 24 hours to 72 hours, but the results were not statistically different between the groups., Conclusions: The Pulsatillity Index for the pulsatile group demonstrated a more physiologic pattern compared with the nonpulsatile group. While pulsatile perfusion did not increase plasma-free hemoglobin levels or microemboli delivery, it also did not demonstrate any improvements in clinical outcomes or PELOD-2 scores, suggesting that while pulsatile perfusion is a safe method, it not a "magic bullet" for congenital cardiac operations., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The preferred method of fixation and surgical treatment for ligamentous Lisfranc injuries is controversial. Transarticular screws, bridge plating, fusion, and flexible fixation have been described, yet none have demonstrated superiority. Furthermore, screw fixation and plating often require secondary surgery to remove implants, leading surgeons to seek alternative fixation methods., Purpose: To compare transarticular screws and a fiber tape construct under a spectrum of biomechanical loads by evaluating the diastasis at 3 joints in the Lisfranc complex., Study Design: Controlled laboratory study., Methods: Eight matched pairs of fresh, previously frozen lower extremity cadaveric specimens were fixed with either 2 cannulated transarticular crossed screws or a fiber tape construct with a supplemental intercuneiform limb. The diastasis between bones was measured at 3 midfoot joints in the Lisfranc complex: the Lisfranc articulation, the second tarsometatarsal joint, and the intercuneiform joint. Measurements were obtained for the preinjured, injured, and fixation conditions under static loading at 50% donor body weight. Specimens then underwent cyclic loading performed at 1 Hz and 100 cycles, based on 100-N stepwise increases in ground-reaction force from 100 to 2000 N, to simulate postoperative loading from the partial weightbearing stage to high-energy activities. Failure of fixation was defined as diastasis ≥2 mm at the Lisfranc articulation (second metatarsal-medial cuneiform joint)., Results: There were no significant differences in diastasis detected at the Lisfranc articulation or the intercuneiform joint throughout all loading cycles between groups. All specimens endured loading up to 50% body weight + 1400 N. Up to and including this stage, there were 2 failures in the cannulated transarticular crossed-screw group and none in the fiber tape group., Conclusion: The fiber tape construct with a supplemental intercuneiform limb, which does not require later removal, may provide comparable biomechanical stability to cannulated transarticular crossed screws, even at higher loads., Clinical Relevance: Ligamentous Lisfranc injuries are common among athletes. Therefore, biomechanical evaluations are necessary to determine stable constructs that can limit the time to return to play. This study compares the biomechanical stability of 2 methods of fixation for ligamentous injury through a wide spectrum of loading, including those experienced by athletes.

Background: Postoperative opioid prescribing has historically lacked information crucial to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications., Objective: This study aimed to evaluate pain control, satisfaction with pain control, and opioid use among patients undergoing isolated midurethral sling randomized to 1 of 2 different opioid-prescribing regimens., Study Design: Patients who underwent isolated midurethral sling placement from June 1, 2020, to November 22, 2021, were offered enrollment into this prospective, randomized, open-label, noninferiority clinical trial. Participants were randomized to receive either a standard prescription of ten 5-mg oxycodone tablets provided preoperatively (standard) or an opioid prescription provided only during patient request postoperatively (restricted). Preoperatively, all participants completed baseline demographic and pain surveys, including the 9-Question Central Sensitization Index, Pain Catastrophizing Scale, and Likert pain score (scale 0-10). The participants completed daily surveys for 1 week after surgery to determine the average daily pain score, number of opioids used, other forms of pain management, satisfaction with pain control, perception of the number of opioids prescribed, and need to return to care for pain management. The online Prescription Drug Monitoring Program was used to determine opioid filling in the postoperative period. The primary outcome was average postoperative day 1 pain score, and an a priori determined margin of noninferiority was set at 2 points., Results: Overall, 82 patients underwent isolated midurethral sling placement and met the inclusion criteria: 40 were randomized to the standard arm, and 42 were randomized to the restricted group. Concerning the primary outcome of average postoperative day 1 pain score, the restricted arm (mean pain score, 3.9±2.4) was noninferior to the standard arm (mean pain score, 3.7±2.7; difference in means, 0.23; 95% confidence interval, -∞ to 1.34). Of note, 23 participants (57.5%) in the standard arm vs 8 participants (19.0%) in the restricted arm filled an opioid prescription (P<.001). Moreover, 18 of 82 participants (22.0%) used opioids during the 7-day postoperative period, with 10 (25.0%) in the standard arm and 8 (19.0%) in the restricted arm using opioids (P=.52). Of participants using opioids, the average number of tablets used was 3.4±2.3, and only 3 participants used ≥5 tablets. On a scale of 1="prescribed far more opioids than needed" to 5="prescribed far less opioids than needed," the means were 1.9±1.0 in the standard arm and 2.7±1.0 in the restricted arm (P<.001)., Conclusion: Restricted opioid prescription was noninferior to standard opioid prescription in the setting of pain control and satisfaction with pain control after isolated midurethral placement. Participants in the restricted arm filled fewer opioid prescriptions than participants in the standard arm. On average, only 3.4 tablets were used by those that filled prescriptions in both groups. Restrictive opioid-prescribing practices may reduce unused opioids in the community while achieving similar pain control., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Cutaneous microcirculatory perfusion is commonly measured using laser Doppler flowmetry (LDF) probes, which provide a continuous, non-invasive quantification of skin blood flow (SkBF). However, inhomogeneities in the skin's microvasculature density contribute to a decrease in reproducibility whenever an LDF probe is removed and replaced, as is the case during pre- and post-intervention or between-day measurements. Therefore, this study aimed to determine whether increasing the total number of individual LDF probes in a localized area improves the reproducibility of the measurement. Seven laser Doppler probes were secured in a custom-made acrylic holder designed to attach to the skin's surface easily. SkBF, local skin temperature (Tsk), and blood pressure (BP) were assessed in 11 participants (6 M, 5 F, 42 ± 15 years). SkBF and Tsk were measured from the dorsal forearm (arm trial) for 5 min. Next, the multi-laser device was moved to the lateral side of the calf (leg trial), and measurements were obtained for 5 min. Each arm and leg trial was cyclically repeated three times, and all trials were separated by intermissions lasting 10-15 min. The average SkBF and the cutaneous vascular conductance (CVC) from all possible LDF probe combinations were not statistically different across the three arm and leg trials. Two-way mixed-effects models with absolute agreement were used to compute the intraclass correlation coefficient (ICC) for CVC, and the minimum ICC increased with the addition of LDF probes. The ICC of the average CVC from seven LDF probes was 0.96 between the arm trials and 0.91 between the leg trials, which suggests that there is excellent reliability and little difference between trials following the removal and replacement of the device. Moreover, all individual ICC values from ≥3 LDF probe combinations were greater than 0.70 (i.e., good reliability). These data suggest that SkBF measurements with multiple laser Doppler probes in a custom-made holder have excellent reproducibility after replacing the probes within the same participant. Therefore, this application could provide more reproducible assessments between repeated measurements (e.g., before and after exercise or clinical procedures) where the LDF probes must be removed and replaced within the same location., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Luck, Kunselman, Herr, Blaha, Sinoway and Cui.)

Objective: Adverse childhood experiences (ACEs) are linked to worsening overall health outcomes and psychological diagnoses. Routine screening, particularly in patients with postpartum depression (PPD), would identify patients who could benefit from interventions to prevent the perpetuation of ACEs and establish a system of preventative care to mitigate the risks of adverse health outcomes associated with high ACE scores. The purpose of this study is to explore the link between ACEs and PPD to advocate for the use of the ACE questionnaire as a routine screening tool in all pregnant patients diagnosed with PPD. We hypothesize that a cohort of patients with PPD will be more likely to have high-risk ACE scores than the general female population., Study Design: Our IRB approved, retrospective cohort study identified all patients diagnosed with PPD at an academic medical center between January 2015 and December 2019. The subjects were identified using retrospective chart review. Subjects were recruited via telephone and asked to complete an ACE questionnaire. Questionnaires were sent via RedCap. ACE scores were calculated, categorized as 0, 1, 2, 3, or 4 or more ACEs, and compared to the prevalence in the original Kaiser-CDC ACE study female cohort using a chi-square goodness-of-fit test., Results: There were 132/251 surveys completed (53% response rate). In our PPD population, 19.3% had 0 ACEs, 17.0% had 1 ACE, 13.1% had 2 ACEs, 16.5% had 3 ACEs, and 34.1% had 4 or more ACEs. These percentages were significantly different from the Kaiser-CDC ACE Study percentages of 34.5, 24.5, 15.5, 10.3, and 15.2%, respectively ( p < 0.001)., Conclusion: Our unique study showed that women with PPD are more likely to have high-risk ACE scores than the general female population. This finding has important implications in regards to counseling, intervening to prevent perpetual ACEs, and establishing important provider-patient relationships for life-long preventative care.Non-gendered language is used when possible throughout. However, the wording from studies cited in this paper was preserved., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Prentice, Otaibi, Stetter, Kunselman and Ural.)

Purpose  The aim of this article is to investigate the impact of a 1-minute video describing resident training with a cataract surgical simulator on patients' perceptions regarding resident involvement in cataract surgery and to identify factors associated with patient willingness to have cataract surgery performed by a resident. Design  Cross-sectional survey. Methods  An anonymous Likert-style survey was conducted among 430 consecutive adult patients who presented for eye examination at the Penn State Health Eye Center. The survey included questions regarding demographics, understanding of the medical training hierarchy, and patient willingness to have a resident perform their cataract surgery. There were six questions regarding patient willingness to have residents perform their cataract surgery and the second question in this set informs the patient that residents are supervised by an experienced cataract surgeon. Patients were randomly assigned to one of two groups: patients in Group 1 completed the survey only, while patients in Group 2 watched a 1-minute video describing resident training with a cataract surgical simulator prior to completing the survey. Results  Four hundred fourteen of the 430 patients (96.3%) completed the survey. Overall, 24.7% ( n  = 102) of respondents expressed willingness to allow an ophthalmology resident to perform their cataract surgery, and that proportion increased to 54.0% ( n  = 223) if the patient was informed that the resident would be supervised by an experienced cataract surgeon. Patients in Group 2 were twice as likely compared with patients in Group 1 to express willingness to allow an ophthalmology resident to perform their cataract surgery (odds ratio 1.92 [1.18-3.11], p  = 0.009). Conclusions  A thorough informed consent process including information regarding attending supervision and a brief video detailing resident training with a cataract surgery simulator may increase patient willingness to allow resident participation in cataract surgery., Competing Interests: Conflict of Interest None., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).)

Introduction: Overprescribing by providers is a leading contributor to the opioid crisis. Despite available information regarding the role that physician prescribing plays in the community availability of opioids, guidelines for the management of acute pain remain sparse. This project aims to evaluate opioid prescribing, opioid usage patterns, and postoperative pain control in patients undergoing isolated mid-urethral sling (MUS) placement., Methods: Patients who underwent isolated MUS placement from March 19, 2019 through March 19, 2020 were contacted by telephone in May 2020 and asked a series of questions examining opioid usage, postoperative pain, what they did with unused opioids, and whether they had received education on disposal techniques. A chart review was utilized to determine the amount of opioid prescribed, the presence of any operative complications, and medical and demographic characteristics of subjects., Results: A total of 53 subjects met inclusion criteria, of which 31 participated in a phone interview. Of the 53 subjects, 54.7% received a postoperative opioid prescription, and all but two of these subjects filled their prescription. Of the interviewed subjects, only 66.6% who filled a prescription reported using opioids Fifty percent (n=6) of patients that required oxycodone reported use of four tablets (30 morphine milligram equivalents (MMEs)) or less and used for 1-2 days postoperatively. No patient reported using opioids beyond five days. Only 22.2% reported receiving instruction on opioid disposal, and 16.7% returned unused opioids to a disposal center. 87.1% of subjects rated postoperative pain as "better" or "much better" than expected., Conclusion: Patients undergoing isolated MUS placement require limited amounts of postoperative opioids, if any are needed at all, to achieve satisfactory pain control. Excess prescribed opioids, along with inadequate patient education on proper disposal techniques, may contribute towards opioids that are at risk of diversion for nonmedical use., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2021, Knutson et al.)

Background: Psychiatric disorders, including anxiety and depression, are significantly more common in patients with inflammatory bowel disease (IBD). We established an integrated psychiatry clinic for IBD patients at our tertiary center IBD clinic to provide patients with critical, but frequently unavailable, coordinated mental health services. We undertook this study to evaluate the impact of this service on psychiatric outcomes, quality of life, and symptom experience., Methods: We performed a longitudinal prospective study comparing patients who had been cared for at our integrated IBD-psychiatry clinic to those who had not. We abstracted demographic and clinical information as well as contemporaneous responses to validated surveys., Results: Thirty-six patients cared for in the IBD psychiatry clinic were compared to a control cohort of 35 IBD patients. There was a significant reduction in the Hospital Anxiety and Depression Scale (HADS) depression score over time in the study cohort ( p = 0.001), though not in the HADS anxiety score. When compared to the control group, the study cohort showed a significant reduction in the HADS depression score. No significant differences were observed in the Harvey-Bradshaw Index, Simple Clinical Colitis Activity Index, or Short IBD Questionnaire., Conclusions: This is the first study to evaluate the impact of an integrated psychiatry clinic for IBD patients. Unlike their control counterparts, individuals treated in this clinic had a significant reduction in the mean HADS depression score. Larger scale studies are necessary to verify these findings. However, this study suggests that use of an integrated psychiatry IBD clinic model can result in improvement in mental health outcomes, even in the absence of significant changes in IBD activity., (Copyright © 2021 by The Author(s). Published by S. Karger AG, Basel.)

Parkinson's disease (PD) is a neurodegenerative movement disorder that is routinely treated with levodopa. Unfortunately, long-term dopamine replacement therapy using levodopa leads to levodopa-induced dyskinesias (LID), a significant and disabling side-effect. Clinical findings indicate that LID typically only occurs following the progression of PD motor symptoms from the unilateral (Hoehn and Yahr (HY) Stage I) to the bilateral stage (HY Stage II). This suggests the presence of some compensatory interhemispheric mechanisms that delay the occurrence of LID. We therefore investigated the role of interhemispheric connections of the nigrostriatal pathway on LID expression in a rat model of PD. The striatum of one hemisphere of rats was first injected with a retrograde tracer to label the ipsi- and cross-hemispheric nigrostriatal pathways. Rats were then split into groups and unilaterally lesioned in the striatum or medial forebrain bundle of the tracer-injected hemisphere to induce varying levels of hemiparkinsonism. Finally, rats were treated with levodopa and tested for the expression of LID. Distinct subsets emerged from rats that underwent the same lesioning paradigm based on LID. Strikingly, non-dyskinetic rats had significant sparing of their cross-hemispheric nigrostriatal pathway projecting from the unlesioned hemisphere. In contrast, dyskinetic rats only had a small proportion of this cross-hemispheric nigrostriatal pathway survive lesioning. Crucially, both non-dyskinetic and dyskinetic rats had nearly identical levels of ipsi-hemispheric nigrostriatal pathway survival and parkinsonian motor deficits. Our data suggest that the survival of the cross-hemispheric nigrostriatal pathway plays a crucial role in preventing the expression of LID and represents a potentially novel target to halt the progression of this devastating side-effect of a common anti-PD therapeutic., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed to identify patient and appointment characteristics associated with no-shows to new patient appointments at a US academic ophthalmology department., Design: Cross-sectional study., Methods: This was a study of all adult patients with new patient appointments scheduled with an attending ophthalmologist at Penn State Eye Center between January 1 st and December 31 st of 2019. A multiple logistic regression model was used to assess the association between characteristics and no-show status., Results: Of 4,628 patients, 759 (16.4%) were no-shows. From the multiple logistic regression model, characteristics associated with no-shows were age (Odds Ratio (OR) for 18-40 years vs. >60 years: 3.41, 95% Confidence Interval (CI) 2.57, 4.51, p <0.001 and OR for 41-60 years vs. >60 years: 2.14, 95% CI 1.67, 2.74, p<0.001), median household income (OR for <$35,667 vs. >$59,445: 1.59, 95% CI 1.08, 2.34, p<0.001), insurance (OR for None vs. Medicare: 6.92, 95% CI 4.41, 10.86, p<0.001 and OR for Medicaid vs. Medicare: 1.54, 95% CI 1.18, 2.01, p=0.002), race (OR for Black vs. White: 2.62, 95% CI 2.00, 3.43, p<0.001 and OR for Other vs. White: 2.02, 95% CI 1.58, 2.59, p<0.001), and commute distance (OR for 5-10 mi vs. ≤5 mi: 1.73, 95% CI 1.17, 2.55, p=0.006). Appointments with longer lead times and scheduled with glaucoma or retina specialists were also significantly associated with greater no-shows., Conclusion: Certain patient and appointment characteristics were associated with no-show status. These findings may assist in the development of targeted interventions at the patient, practice, and health system levels to improve appointment attendance., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To evaluate the role of appendectomy in surgical excision of endometriosis and to assess complications associated with appendectomy., Methods: Retrospective study of women undergoing appendectomy for pelvic pain and/or endometriosis during a primary gynecologic procedure., Results: Record review was performed for 609 women who underwent appendectomy between 2013 and 2019 for pelvic pain (6.9%, 42/609), stage I-II endometriosis (63.7%, 388/609), or stage III-IV endometriosis (29.4%, 179/609). Appendiceal endometriosis (AppE) was present in 14.9% (91/609); 2.4% without endometriosis (1/42, reference group), 7.0% with stage I-II endometriosis (27/388, odds ratio [OR] 3.06, 95% confidence interval [CI] 0.41-23.11, P = 0.278), and 35.2% with stage III-IV endometriosis (63/179, OR 22.24, 95% CI 2.99-165.40, P = 0.002). AppE was significantly associated with endometriosis present in other locations (OR 5.27, 95% CI 2.66-10.43, P < 0.001). The predicted probability of identifying AppE ranged from 6% with 0 positive endometriosis sites to 56% when 4 or more sites were identified. There were no complications related to the performance of an appendectomy., Conclusion: Women with chronic pelvic pain and/or endometriosis have an increased risk of AppE. Modern appendectomy at the time of gynecologic surgery is safe, with no associated complications in this study. Our findings support the consideration of appendectomy as part of the comprehensive surgical management of endometriosis., (© 2021 International Federation of Gynecology and Obstetrics.)

Background: Lisfranc ligamentous injuries are complex, and their treatment, along with the preferred method of fixation, is controversial. Implementing a flexible synthetic augmentation device (fibertape) has been described as an alternative to traditional screw fixation. This biomechanical study evaluated two fibertape devices with interference screw fixation: InternalBrace, and InternalBrace with supplementary intercuneiform stabilization., Methods: The diastasis and relative angular displacement between bones were measured at three midfoot joints in the Lisfranc articulation. Measurements were obtained for the pre-injured, injured, and post-fixation stages under static loading. Specimens then underwent stepwise increases in cyclic loading performed at 1 Hz and 100 cycles, at 100 N ground reaction force intervals from 500 to 1200 N to simulate postoperative loading, and then up to 1800 N to simulate high loads. Failure of fixation was defined as diastasis greater than 2 millimeters at the second-metatarsal - medial-cuneiform joint., Results: InternalBrace specimens demonstrated failures in 3 of 9 (33%) specimens at cyclic loads of 1000 N. Conversely, InternalBrace with Supplementary Limb specimens had 1 failure at 1200 N. The difference in diastasis at the second metatarsal-medial cuneiform joint was statistically significant between the two groups at higher loads of 1600N (p = 0.019) and 1800N (p = 0.029)., Conclusion: The use of InternalBrace for ligamentous Lisfranc injuries appears to provide a biomechanically viable alternative for withstanding early postoperative protected weight bearing. Furthermore, the use of a supplementary limb in addition to the InternalBrace fibertape fixation method appears to enhance its biomechanical efficacy., (Copyright © 2021. Published by Elsevier Ltd.)

Objective: To describe the prevalence of female sexual dysfunction in a well-defined polycystic ovary syndrome (PCOS) population, and to assess the impact of common PCOS treatments on sexual function., Design: Secondary analysis of a randomized controlled trial, oral contraceptive pills and weight loss in PCOS., Setting: Two academic medical centers., Patients: Women with PCOS (N = 114) defined by the Rotterdam criteria., Interventions: Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks., Main Outcome Measures: Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores after 16 weeks., Results: There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period. Overall, 33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55). Among this group, FSFI score improved after 16 weeks of Lifestyle and Combined treatments. There was no change in prevalence of sexual dysfunction in treatment groups at 16 weeks. Use of OCPs did not alter FSFI scores., Conclusion(s): Female sexual dysfunction is highly prevalent among women with PCOS. Our findings suggest that common treatments for PCOS, including intensive lifestyle modification and the combination of intensive lifestyle modification and OCPs, have the potential to improve sexual function in these women; the mechanism for these improvements is likely multifactorial., Clinical Trial Registration Number: NCT00704912., (Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To examine the effects of common treatments for polycystic ovary syndrome (PCOS) on a panel of hormones (reproductive/metabolic)., Design: Secondary analysis of blood from a randomized controlled trial of three 16-week preconception interventions designed to improve PCOS-related abnormalities: continuous oral contraceptive pills (OCPs, N = 34 subjects), intensive lifestyle modification (Lifestyle, N = 31), or a combination of both (Combined, N = 29)., Materials and Methods: Post-treatment levels of activin A and B, inhibin B, and follistatin (FST), as well as Insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 2 (IGFBP-2), glucagon, glucagon-like peptide 1 (GLP-1) and 2, and oxyntomodulin were compared to baseline, and the change from baseline in these parameters were correlated with outcomes., Results: Oral contraceptive pill use was associated with a significant suppression in activin A, inhibin A, and anti-mullerian hormone (AMH), but a significant increase in FST. IGF-1, IGFBP-2, glucagon, and GLP-2 levels were significantly decreased. Oxyntomodulin was profoundly suppressed by OCPs (ratio of geometric means: 0.09, 95% confidence interval [CI]: 0.05, 0.18, P < 0.001). None of the analytes were significantly affected by Lifestyle, whereas the effects of Combined were similar to OCPs alone, although attenuated. Oxyntomodulin was significantly positively associated with the change in total ovarian volume (rs = 0.27; 95% CI: 0.03, 0.48; P = 0.03) and insulin sensitivity index (rs = 0.48; 95% CI: 0.27, 0.64; P < 0.001), and it was inversely correlated with change in area under the curve (AUC) glucose [rs = -0.38; 95% CI: -0.57, -0.16; P = 0.001]. None of the hormonal changes were associated with live birth, only Activin A was associated with ovulation (risk ratio per 1 ng/mL increase in change in Activin A: 6.0 [2.2, 16.2]; P < 0.001)., Conclusions: In women with PCOS, OCPs (and not Lifestyle) affect a wide variety of reproductive/metabolic hormones, but their treatment response does not correlate with live birth., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Study Objective: To evaluate the diagnosis of appendiceal endometriosis (AppE) in coincidental appendectomy specimens using standard versus modified histopathologic analysis., Design: Prospective analysis of 300 consecutive patients undergoing coincidental appendectomy at the time of a primary gynecologic procedure., Setting: Academic tertiary referral hospital in the northeastern United States., Patients: Women aged 22 to 52 years undergoing gynecologic surgery for the management of endometriosis or chronic pelvic pain between 2013 and 2015., Interventions: Each appendix specimen underwent standard pathologic analysis with 4 sections performed. Modified pathologic analysis, consisting of standard analysis plus serial sectioning and complete evaluation of the appendix and mesoappendix, was then performed. The first pathologist reviewed all the slides to render a diagnosis. The slides of the subjects with abnormal pathology were rereviewed. On rereview, the diagnosis was confirmed, and the data on which protocol, standard or modified, achieved the diagnosis was rendered. The pathologist performing the second review was blinded to whether the slides from the standard or modified histopathology protocol achieved the original diagnosis. This allowed each specimen to serve as its own control., Measurements and Main Results: The primary outcome is the detection of AppE. The standard analysis identified endometriosis in 7.7% (n = 23) of appendiceal specimens, whereas the modified analysis identified endometriosis in 10.0% (n = 30; odds ratio 1.3; confidence interval, 1.1-1.7; p = .01). When all pathology findings were combined, the standard analysis identified abnormal pathology in 9.3% (n = 28) of the specimens, whereas the modified analysis identified abnormal pathology in 12.3% (n = 37; odds ratio 1.4; confidence interval, 1.1-1.7; p <.01). Other abnormal appendiceal pathology identified in this study included polyps, neuroendocrine tumors, and acute appendicitis. The average number of slides required for the standard analysis was 1.4 compared with 4.9 slides for the modified analysis. At this institution, the average increase in the cost of slide production for the modified protocol was $12.07., Conclusion: Modified pathologic analysis resulted in a significantly higher rate of diagnosis of endometriosis and abnormal pathology in coincidental appendectomy performed during a primary gynecologic procedure for endometriosis and/or chronic pelvic pain. The use of a standard pathologic protocol likely contributes to underdiagnosis of AppE. The implementation of a modified histopathologic protocol should be considered for improving diagnosis rates of appendiceal pathology in coincidental appendectomy specimens., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Optimal modalities for pain control in shoulder arthroplasty are not yet established. Although regional nerve blockade has been a well-accepted modality, complications and rebound pain have led some surgeons to seek other pain control modalities. Local injection of anesthetics has recently gained popularity in joint arthroplasty. The purpose of this study was to evaluate the effectiveness and complication rate of a low-cost local anesthetic injection mixture for use in total shoulder arthroplasty (TSA) compared with interscalene brachial plexus blockade., Methods: A total of 314 patients underwent TSA and were administered general anesthesia with either a local injection mixture (local infiltration anesthesia [LIA], n = 161) or peripheral nerve block (PNB, n = 144). Patient charts were retrospectively reviewed for postoperative pain scores, 24-hour opioid consumption, and 90-day postoperative complications., Results: Immediate postoperative pain scores were not significantly different between groups ( P  = .94). The LIA group demonstrated a trend toward lower pain scores at 24 hours postoperatively ( P  = .10). Opioid consumption during the first 24 hours following surgery was significantly reduced in the LIA group compared with the PNB group ( P < .0001). There was a trend toward fewer postoperative nerve and cardiopulmonary complications in the LIA group than the PNB group ( P  = .22 and P  = .40, respectively)., Conclusion: Periarticular local injection mixtures provide comparable pain control to regional nerve blocks while reducing opioid use and postoperative complications following TSA. Local injection of a multimodal anesthetic solution is a viable option for pain management in TSA., (© 2020 The Authors.)

Background: Admission to the intensive care unit (ICU) after surgery can be associated with significant morbidity and mortality. This observational cohort study aims to identify perioperative factors associated with post-operative ICU admission in patients undergoing elective non-cardiac surgery., Methods: Data from the ACS NSQIP ® database at a tertiary care academic medical center were analyzed from January 2011 to September 2016. Univariable and multivariable logistic regression of patient and surgery-specific characteristics was performed to assess association with post-operative ICU admission. The Current Procedural Terminology (CPT) and International Classification of Diseases (ICD-9) billing codes, as well as associated outcomes, were reviewed., Results: Of 5254 database patient records, 1150 met our inclusion criteria. Elevated body mass index (BMI), longer procedure duration and a diagnosis of disseminated cancer were associated with post-operative ICU admission. Prostatectomy and morbid obesity were the most common CPT and ICD-9 codes identified. Patients who were admitted to the ICU after surgery had a longer hospital length of stay (LOS), had a higher frequency of readmission, re-operation, and in-hospital mortality., Conclusion: Admission to the ICU after elective non-cardiac surgery is common. Our analysis of the ACS NSQIP ® database identified elevated BMI, longer duration of surgery and disseminated cancer as predictors of post-operative ICU admissions in patients undergoing elective non-cardiac surgery., (© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Background: Women diagnosed with polycystic ovary syndrome (PCOS) suffer from an unfavorable cardiometabolic risk profile, which is already established by child-bearing age., Objective and Rationale: The aim of this systematic review along with an individual participant data meta-analysis is to evaluate whether cardiometabolic features in the offspring (females and males aged 1-18 years) of women with PCOS (OPCOS) are less favorable compared to the offspring of healthy controls., Search Methods: PubMed, Embase and gray literature databases were searched by three authors independently (M.N.G., M.A.W and J.C.) (last updated on 1 February 2018). Relevant key terms such as 'offspring' and 'PCOS' were combined. Outcomes were age-specific standardized scores of various cardiometabolic parameters: BMI, blood pressure, glucose, insulin, lipid profile and the sum scores of various cardiometabolic features (metabolic sum score). Linear mixed models were used for analyses with standardized beta (β) as outcome., Outcomes: Nine relevant observational studies could be identified, which jointly included 1367 children: OPCOS and controls, originating from the Netherlands, Chile and the USA. After excluding neonates, duplicate records and follow-up screenings, a total of 885 subjects remained. In adjusted analyses, we observed that OPCOS (n = 298) exhibited increased plasma levels of fasting insulin (β = 0.21(95%CI: 0.01-0.41), P = 0.05), insulin-resistance (β = 0.21(95%CI: 0.01-0.42), P = 0.04), triglycerides (β = 0.19(95%CI: 0.02-0.36), P = 0.03) and high-density lipoprotein (HDL)-cholesterol concentrations (β = 0.31(95%CI: 0.08-0.54), P < 0.01), but a reduced birthweight (β = -116(95%CI: -195 to 38), P < 0.01) compared to controls (n = 587). After correction for multiple testing, however, differences in insulin and triglycerides lost their statistical significance. Interaction tests for sex revealed differences between males and females when comparing OPCOS versus controls. A higher 2-hour fasting insulin was observed among female OPCOS versus female controls (estimated difference for females (βf) = 0.45(95%CI: 0.07 to 0.83)) compared to the estimated difference between males ((βm) = -0.20(95%CI: -0.58 to 0.19)), with interaction-test: P = 0.03. Low-density lipoprotein-cholesterol differences in OPCOS versus controls were lower among females (βf = -0.39(95%CI: -0.62 to 0.16)), but comparable between male OPCOS and male controls (βm = 0.27(95%CI: -0.03 to 0.57)), with interaction-test: P < 0.01. Total cholesterol differences in OPCOS versus controls were also lower in females compared to the difference in male OPCOS and male controls (βf = -0.31(95%CI: -0.57 to 0.06), βm = 0.28(95%CI: -0.01 to 0.56), interaction-test: P = 0.01). The difference in HDL-cholesterol among female OPCOS versus controls (βf = 0.53(95%CI: 0.18-0.88)) was larger compared to the estimated mean difference among OPCOS males and the male controls (βm = 0.13(95%CI: -0.05-0.31), interaction-test: P < 0.01). Interaction test in metabolic sum score revealed a significant difference between females (OPCOS versus controls) and males (OPCOS versus controls); however, sub analyses performed in both sexes separately did not reveal a difference among females (OPCOS versus controls: βf = -0.14(95%CI: -1.05 to 0.77)) or males (OPCOS versus controls: βm = 0.85(95%CI: -0.10 to 1.79)), with P-value < 0.01., Wider Implications: We observed subtle signs of altered cardiometabolic health in OPCOS. Therefore, the unfavorable cardiovascular profile of women with PCOS at childbearing age may-next to a genetic predisposition-influence the health of their offspring. Sensitivity analyses revealed that these differences were predominantly observed among female offspring aged between 1 and 18 years. Moreover, studies with minimal risk of bias should elucidate the influence of a PCOS diagnosis in mothers on both sexes during fetal development and subsequently during childhood., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The objective of this translational study was to evaluate the FDA-approved PediMag, CentriMag, and RotaFlow centrifugal blood pumps in terms of hemodynamic performance using simulated neonatal and pediatric extracorporeal membrane oxygenation (ECMO) circuits with different sizes of arterial and venous cannulae. Cost of disposable pump heads was another important variable for this particular study. The experimental circuit was composed of one of the centrifugal pump heads, a polymethylpentene membrane oxygenator, neonatal and pediatric arterial/venous cannulae, and 1/4-inch ID tubing. Circuits were primed with lactated Ringer's solution and packed human red blood cells (hematocrit 35%). Trials were conducted at 36°C using the three pump heads and different cannulae (arterial/venous cannulae: 8 Fr/18 Fr, 10 Fr/20 Fr, and 12 Fr/22 Fr) at various flow rates (200-2400 mL/min, 200 mL/min increments) and rotational speeds. Pseudo patient pressure was 60 mm Hg. Real-time pressure and flow data were recorded for analysis. The RotaFlow pump had a higher pressure head and flow range compared with the PediMag and CentriMag pumps at the same rotational speed and identical experimental settings (P < 0.001). The PediMag pump had lower flow output than others (P < 0.001). Small-caliber arterial cannulae and higher flow rates predictably created higher circuit pressures and pressure drops. There was no significant difference in hemodynamic energy delivered to the pseudo patient with each of the three pumps. The arterial cannula had the highest pressure drop and hemodynamic energy loss in the circuit when compared to the oxygenator and arterial tubing. The RotaFlow centrifugal pump had a significantly better hemodynamic performance when compared to the PediMag and CentriMag blood pumps at identical experimental conditions in simulated neonatal and pediatric ECMO settings. In addition, the cost of the RotaFlow pump head ($400) is 20 to 30-fold less than the other centrifugal pumps [CentriMag ($12 000) or PediMag ($8000)] that were evaluated in this translational study., (© 2019 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

The purpose of this study was to evaluate the hemodynamic properties and microemboli capture associated with different vacuum-assisted venous drainage (VAVD) vacuum levels and venous reservoir levels in a neonatal cardiopulmonary bypass circuit. Trials were conducted in 2 parallel circuits to compare the performance of Capiox Baby RX05 oxygenator with separate AF02 arterial filter to Capiox FX05 oxygenator with integrated arterial filter. Arterial cannula flow rate to the patient was held at 500 mL/min and temperature maintained at 32°C, while VAVD vacuum levels (0 mm Hg, -15 mm Hg, -30 mm Hg, -45 mm Hg, -60 mm Hg) and venous reservoir levels (50 mL, 200 mL) were evaluated in both oxygenators. Hemodynamic parameters measuring flow, pressure, and total hemodynamic energy were made in real time using a custom-made data acquisition system and Labview software. Nearly 10 cc bolus of air was injected into the venous line and gaseous microemboli detected using an Emboli Detection and Classification Quantifier. Diverted blood flow via the arterial filter's purge line and mean pressures increased with increasing VAVD levels (P < 0.01). Mean pressures were lower with lower venous reservoir levels and were greater in RX05 groups compared to FX05 (P < 0.01). Microemboli detected at the preoxygenator site increased with higher VAVD vacuum levels and lower venous reservoir levels (P < 0.01). The amount of microemboli captured by the FX05 oxygenator with integrated arterial filter was greater than by the RX05 oxygenator alone, although both oxygenators were able to clear microemboli before reaching the pseudo-patient., (© 2019 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)