Changes In National Guidelines Research Articles

Comparison of Fluid Replacement with Sterofundin ISO® vs. Deltajonin® in Infants Undergoing Craniofacial Surgery-A Retrospective Study.

The purpose of this study was to compare the effects of Sterofundin ISO® (SF) therapy with the balanced isochloremic solution Deltajonin® (DJ) (106 mmol/L chloride) on the acid-base status in infants undergoing craniofacial surgery. This retrospective, non-blinded study included 100 infants undergoing craniectomy due to isolated nonsyndromic sagittal craniosynostosis. The first 50 infants received Sterofundin ISO®. Due to changes in national guidelines, the infusion was changed to the isoionic Deltajonin® in an additional 50 infants in 2017. Pre- and postoperative values of chloride, pH, base excess, bicarbonate, and albumin and phosphate were determined, and the strong-ion difference, strong-ion gap, anion gap, and weak acids were calculated. Both groups were comparable in terms of their age, sex, underlying disease, preoperative electrolytes (except K at 3.9 ± 0.3 mmol/L (SF) vs. 4.1 ± 0.3 mmol/L (DJ) and lactate 8.7 ± 2.1 (SF) vs. 9.6 ± 2.6 mmol/L (DJ)). In the Sterofundin ISO® group, hyperchloremic metabolic acidosis was observed in 19 patients, whereas only 2 infants in the Deltajonin® group had hyperchloremic metabolic acidosis. The postoperative chloride level was 111 ± 2.7 mmol/L (SF) vs. 108 ± 2.4 mmol/L (DJ). The difference in anion gap was 12.5 ± 3.0 mmol/L (SF) vs. 14.6 ± 2.8 mmol/L (DJ), and the difference in SIDa (apparent strong-ion difference) was 30.9 mmol/L (SF) vs. 33.8 mmol/L (DJ). Hyperchloremic acidosis can be induced by the volume replacement with high-chloride-concentration crystalloids such as Sterofundin ISO®. This can be detected using the Stewart model.

MRSA PCR improves sensitivity of detection of colonization in neonates

Background: Neonates colonized with methicillin-resistant Staphylococcus aureus (MRSA) are at high risk of developing life-threatening MRSA infection. Due to lack of evidence, national guidelines do not currently recommend a specific methodology for detecting MRSA colonization. We hypothesize that surveillance for MRSA colonization via polymerase chain reaction (PCR) is superior to culture for the detection of colonization. Methods: In this retrospective study, we compared results of MRSA surveillance by 2 methodologies, culture and PCR, after implementation of an MRSA surveillance and decolonization protocol in the Texas Children’s Hospital Pavilion for Women, a 42-bed neonatal intensive care unit. MRSA colonization of 3 body sites via the 2 methodologies was assessed from June 2017 through December 2020. All neonates were screened for MRSA upon admission to the NICU and weekly thereafter until MRSA-positive or discharged. Swab specimens were initially tested by PCR (Xpert MRSA NxG, Cepheid) and when MRSA-positive reflexed to culture to recover the organism for further characterization. This study was approved through the Baylor College of Medicine Institutional Review Board. Results: During the study period, 2,351 neonates were assessed for MRSA colonization by PCR; 81 (3.4%) infants were PCR positive (Fig. 1). Of those 81, 57 (70.4%) had concordant MRSA PCR and culture results, and 24 (29.6%) were MRSA PCR positive but no isolate was recovered in culture. Also, 8 specimens were indeterminate by PCR. However, 1 infant who was negative by culture but was PCR positive developed an MRSA orbital infection. Compared to PCR, the overall sensitivity of MRSA culture was 70.4% (range, 57.7%–80.8%, depending on the year) (Table 1). Conclusions: PCR is more sensitive than culture for detecting MRSA colonization in neonates. Utilizing a PCR method enhances the ability to identify MRSA colonized infants more readily and allows for prompt initiation of infection control interventions including isolation precautions and decolonization strategies. Reflex to culture remains important for strain characterization during outbreak investigations and for additional susceptibility testing. Resource utilization and cost–benefit analyses should be done in future studies to influence changes in national guidelines for the control of Staphylococcus aureus colonization and infection in neonatal intensive care units.Disclosures: None

Examining Children and adolescent mental health trajectories during the COVID-19 pandemic: Findings from a year of the Co-SPACE study.

A major concern throughout the COVID-19 pandemic has been on young people's experiences with mental health. In this study we mapped children and adolescents' mental health trajectories over 13 months of the pandemic and examine whether family, peer, and individual-level factors were associated with trajectory membership. This study focuses on a sub-sample from the Co-SPACE study of 3322 children and adolescents (aged 4-16years) for whom parents completed a survey at Time 0 and at least one follow-up survey between March 2020 and May 2021. We used growth mixture models to examine trajectories in emotional, conduct, and hyperactivity/inattention difficulties using the Strengths and Difficulties Questionnaire and multinomial logistic regression models to estimate factors associated with individual trajectory membership. The average trend in young people's mental health appeared to follow changes in national guidelines regarding the pandemic. Distinct trends in GMM models highlighting individual differences showed that a 5-trajectory model best explained the changes in emotional problems whilst 4-trajectory models best explained variation in hyperactivity/inattention and conduct problems. While most young people followed low stable (62%-85%) or moderate stable (28%) symptom trajectories, 14%-31% experienced very high, high stable or increasing mental health difficulties. Young people following high stable trajectories were more likely to have special educational needs and/or neurodevelopmental disorders, parents reporting higher levels of distress and parent-child conflict, and were less likely to have at least one close friend. Most young people adapted well and experienced low stable symptoms, but nearly one third experienced high stable or increasing mental health difficulties. Young people with complex needs and parents with higher psychological distress were particularly vulnerable to high stable problems while those with positive peer relationships were less vulnerable. This study offers insight into potential factors that can be addressed using targeted interventions to improve the wellbeing of parents and young people in the event of future lockdowns and school closures.

Association of Race and Ethnicity With Initial Prescription of Antiretroviral Therapy Among People With HIV in the US

Integrase strand transfer inhibitor (INSTI)-containing antiretroviral therapy (ART) is currently the guideline-recommended first-line treatment for HIV. Delayed prescription of INSTI-containing ART may amplify differences and inequities in health outcomes. To estimate racial and ethnic differences in the prescription of INSTI-containing ART among adults newly entering HIV care in the US and to examine variation in these differences over time in relation to changes in treatment guidelines. Retrospective observational study of 42 841 adults entering HIV care from October 12, 2007, when the first INSTI was approved by the US Food and Drug Administration, to April 30, 2019, at more than 200 clinical sites contributing to the North American AIDS Cohort Collaboration on Research and Design. Combined race and ethnicity as reported in patient medical records. Probability of initial prescription of ART within 1 month of care entry and probability of being prescribed INSTI-containing ART. Differences among non-Hispanic Black and Hispanic patients compared with non-Hispanic White patients were estimated by calendar year and time period in relation to changes in national guidelines on the timing of treatment initiation and recommended initial treatment regimens. Of 41 263 patients with information on race and ethnicity, 19 378 (47%) as non-Hispanic Black, 6798 (16%) identified as Hispanic, and 13 539 (33%) as non-Hispanic White; 36 394 patients (85%) were male, and the median age was 42 years (IQR, 30 to 51). From 2007-2015, when guidelines recommended treatment initiation based on CD4+ cell count, the probability of ART initiation within 1 month of care entry was 45% among White patients, 45% among Black patients (difference, 0% [95% CI, -1% to 1%]), and 51% among Hispanic patients (difference, 5% [95% CI, 4% to 7%]). From 2016-2019, when guidelines strongly recommended treating all patients regardless of CD4+ cell count, this probability increased to 66% among White patients, 68% among Black patients (difference, 2% [95% CI, -1% to 5%]), and 71% among Hispanic patients (difference, 5% [95% CI, 1% to 9%]). INSTIs were prescribed to 22% of White patients and only 17% of Black patients (difference, -5% [95% CI, -7% to -4%]) and 17% of Hispanic patients (difference, -5% [95% CI, -7% to -3%]) from 2009-2014, when INSTIs were approved as initial therapy but were not yet guideline recommended. Significant differences persisted for Black patients (difference, -6% [95% CI, -8% to -4%]) but not for Hispanic patients (difference, -1% [95% CI, -4% to 2%]) compared with White patients from 2014-2017, when INSTI-containing ART was a guideline-recommended option for initial therapy; differences by race and ethnicity were not statistically significant from 2017-2019, when INSTI-containing ART was the single recommended initial therapy for most people with HIV. Among adults entering HIV care within a large US research consortium from 2007-2019, the 1-month probability of ART prescription was not significantly different across most races and ethnicities, although Black and Hispanic patients were significantly less likely than White patients to receive INSTI-containing ART in earlier time periods but not after INSTIs became guideline-recommended initial therapy for most people with HIV. Additional research is needed to understand the underlying racial and ethnic differences and whether the differences in prescribing were associated with clinical outcomes.

Projected outcomes of universal testing and treatment in a generalised HIV epidemic in Zambia and South Africa (the HPTN 071 [PopART] trial): a modelling study

The long-term impact of universal home-based testing and treatment as part of universal testing and treatment (UTT) on HIV incidence is unknown. We made projections using a detailed individual-based model of the effect of the intervention delivered in the HPTN 071 (PopART) cluster-randomised trial. In this modelling study, we fitted an individual-based model to the HIV epidemic and HIV care cascade in 21 high prevalence communities in Zambia and South Africa that were part of the PopART cluster-randomised trial (intervention period Nov 1, 2013, to Dec 31, 2017). The model represents coverage of home-based testing and counselling by age and sex, delivered as part of the trial, antiretroviral therapy (ART) uptake, and any changes in national guidelines on ART eligibility. In PopART, communities were randomly assigned to one of three arms: arm A received the full PopART intervention for all individuals who tested positive for HIV, arm B received the intervention with ART provided in accordance with national guidelines, and arm C received standard of care. We fitted the model to trial data twice using Approximate Bayesian Computation, once before data unblinding and then again after data unblinding. We compared projections of intervention impact with observed effects, and for four different scenarios of UTT up to Jan 1, 2030 in the study communities. Compared with standard of care, a 51% (95% credible interval 40-60) reduction in HIV incidence is projected if the trial intervention (arms A and B combined) is continued from 2020 to 2030, over and above a declining trend in HIV incidence under standard of care. A widespread and continued commitment to UTT via home-based testing and counselling can have a substantial effect on HIV incidence in high prevalence communities. National Institute of Allergy and Infectious Diseases, US President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill & Melinda Gates Foundation, National Institute on Drug Abuse, and National Institute of Mental Health.

Trends in infant mortality: an evaluation of forensic autopsied infants in Eastern Denmark over 39years.

SIDS is a diagnosis of exclusion applied to the death of an infant < 1year of age after an extensive post-mortem investigation. From 1980 to 2018, a total of 870 infants have been autopsied at the Section of Forensic Pathology, Department of Forensic Medicine, UCPH, covering East Denmark. In the same period, Danish national guidelines for infant care have been revised to avoid infants dying of SIDS. This study aimed to describe trends in infant autopsies regarding cause and manner of death, gender, age, month of death, sleeping position, and bed-sharing. The trends were compared to the change in national SIDS guidelines during the period of this study. Information from autopsy reports from 1980 to 2018 were collected into 55 categories designed specifically for this study. Data from 7 of these categories were chosen and processed in Excel for basic epidemiological comparison. The trends show that most infants in the study die of natural manner and most predominant causes of death are SIDS, infection, and congenital malformations. A change in national guidelines in 1991 recommending supine- or side sleeping position coincided with a reduction in the overall infant mortality and cases of SIDS. The peak age in the cohort is 90days, but stratification in decades shows the infants dying younger each decade. Through the study period, the number of infants found dead sleeping in the prone position has declined. Relatively more infants in this cohort have been found dead while bed-sharing, even though the prevalence of these cases has remained largely the same for four decades.

Low-dose aspirin for primary prevention of cardiovascular disease: Trends in use patterns among African American adults in Minnesota, 2015–2019

Cardiovascular disease (CVD) disproportionately affects African Americans. Aspirin has long been recommended to reduce cardiovascular events. However, national guideline changes in 2016 limited the aspirin recommended population and several clinical trials questioning the utility of primary prevention aspirin were published in 2018. In light of the recent guidelines and study findings, we investigated primary prevention aspirin use among urban African American adults. Using three cross-sectional surveys, we collected data from self-identified African Americans with no CVD in 2015, 2017 and 2019, querying information on CVD risk factors, health behaviors and beliefs, and aspirin use. Poisson regression modeling was used to estimate age- and risk-factor adjusted aspirin prevalence, trends and associations. A total of 1491 African Americans adults, ages 45–79, were included in this analysis; 61% were women. There was no change in age- and risk factor-adjusted aspirin use over the 3 surveys for women (37%, 34% and 35% respectively) or men (27%, 25%, 30% respectively). However, fewer participants believed aspirin was helpful in 2019 compared to 2015—75% versus 84% (p < 0.001). Aspirin discussions with a health care practitioner were highly associated with aspirin use (adjusted RR 2.97, 95% CI 2.49–3.54) and aspirin use was 2.56 times higher (adjusted RR 95% CI 2.17–3.03) in respondents who agreed that people close to them thought they should take aspirin compared with those who disagreed or did not know. Despite major changes in national guidelines, overall primary prevention aspirin use did not significantly change in these African American samples from 2015 to 2019.

Prescribing trends of oral anticoagulants in England over the last decade: a focus on new and old drugs and adverse events reporting

Direct-acting oral anticoagulants (DOACs) are replacing conventional VKA (vitamin K antagonist, i.e., warfarin) for various indications where a therapeutic anticoagulant effect is desired. We evaluated the prescribing patterns of the DOACs and warfarin, cost implications of the increasing DOACs prescribing, and deduce the reporting of serious and fatal events, during 2009–2019 in primary care England. Prescriptions and fatal or serious adverse events reporting data, between 2009 and 2019 were analysed, using linear regression to examine the trends in prescriptions, costs, and serious and fatal events reporting. We also compared the prescribing trends of four direct-acting oral anticoagulants and warfarin, normalised to per 1000 clinical commissioning group (CCG) patient population for the year 2019 to better understand the regional differences in DOACs prescribing. The overall use of any DOACs (as a proportion of total anticoagulants) increased from 16% in 2015 to 62% in 2019 with an average increase of 87% (95% CI 83.1, 90.5) per year. The reporting of serious and fatal events associated with DOACs decreased by 6% (95% CI 12.5, − 0.1) per year. Apixaban is by far the most prescribed with an average drug cost increasing to 156% (95% CI 140, 172) per year. In England, the lowest anticoagulant prescribing region was Greater London whereas the highest prescribing regions were Yorkshire and Humber for DOACs and the East Midlands for warfarin. Interestingly, Lancashire, Merseyside, and Cheshire showed a higher usage for warfarin over DOACs. The differing prescription patterns could be a result of changes in national guidelines and increasing population. Nevertheless, DOACs appear to make an increasing contribution to total anticoagulant prescription items and costs.

Abstract 17306: Primary Prevention Aspirin Use Trends and Associations With Health Beliefs Among African Americans, 2015-2019

Introduction: Cardiovascular disease (CVD) disproportionately affects African Americans. Aspirin has long been recommended as an option to reduce cardiovascular events. However, recent clinical trials involving primary prevention aspirin have prompted changes in national guidelines restricting the aspirin recommended population. Hypothesis: Primary prevention aspirin use will decline over the 5 year period 2015-2019. Methods: Using 3 cross-sectional surveys, data were collected from self-identified African Americans in 2015, 2017 and 2019, querying information on CVD risk factors, health behaviors and beliefs, and aspirin use. Poisson regression modeling was used to estimate age- and risk-factor adjusted aspirin prevalence, trends and associations. Results: A total of 1,491 African Americans adults, ages 45-79, 61% women and no prior CVD completed surveys and were included in this analysis. There was no change in age- and risk factor-adjusted aspirin use over the 3 surveys for women (37%, 34% and 35% respectively) or men (27%, 25%, 30% respectively). However, fewer participants believed aspirin was helpful in 2019--75% vs 84% in 2015 (p&lt;0.05). In the total sample (n=1,491) aspirin discussions with a health care practitioner were highly associated with aspirin use (aRR 2.97, 95% CI 2.49-3.54), as were several health beliefs and social norms that affirm preventive behaviors and aspirin use (Figure). Conclusion: Despite major changes in national guidelines and negative perceptions of aspirin effectiveness in the media, overall primary prevention aspirin use did not significantly change in this African American sample from 2015 to 2019.

Neurophysiological and behavioral measures of pain during neonatal hip examination.

IntroductionThe aim of this study was to test the hypothesis that neonatal hip examination causes pain in newborns. Pain assessment using instruments such as the Premature Infant Pain Profile‐Revised (PIPP‐R) scale is recommended, but recently physiological and neurophysiological measures, for example, near‐infrared spectroscopy (NIRS) and galvanic skin response (GSR), have been used as well.MethodsHeart auscultation and hip examination were performed, and the response of the newborn was registered by NIRS optodes, GSR electrodes, and a pulse oximeter probe attached to the infant. The face of the newborn was filmed. Heart auscultation was used as a nonpainful reference.ResultsThe pain scores for hip examination were higher than for the heart auscultation. Near‐infrared spectroscopy showed a significant higher increase from baseline in oxygenated hemoglobin (HbO2) on both sides of the cortex at hip examination compared with at heart auscultation (P = .011 and P = .017). Mean PIPP‐R scores for the hip examination compared with heart auscultation increased from 3.0 to 8.1 (P = .000). The GSR analyses of hip examination compared with heart auscultation showed a significant increase in area under small peaks during the hip examination (P = .016), however, not when measured in peaks per second (P = .104). Interrater reliability was calculated for the NIRS interpretations, with an intraclass correlation coefficient (ICC) range of 0.93‐1.0 (P = .000).DiscussionPain in newborns can have negative consequences, and pain prevention and treatment are therefore important. We conclude that neonatal hip examinations are painful and that the pain should be treated, for example, with oral sweet solution. This is a change from present routines during neonatal hip examination and is hoped to lead to a change in national guidelines.

What is New in Management of Pediatric Tuberculosis ?

Tuberculosis continues to haunt mankind since its discovery more than a century ago. Although commendable advancements have been made in the diagnosis as well as treatment, especially in the last couple of decades, the healthcare burden of this disease worldwide is immense. Continuously evolving medical science has provided recent changes in national guidelines along with discovery of newer anti-tubercular drugs after many decades. In view of WHO declaring tuberculosis as a global health emergency and strong commitment being reflected by Government of India whereby National Strategic Plan aims to eliminate tuberculosis by 2025, it is high time that we work collectively on the goal of tuberculosis elimination. This article sums up the updates on newer anti-tubercular drugs as well as the recent changes adopted in Revised National Tuberculosis Control Program.

Sepsis management and the pediatric surgeon

Sepsis is a life-threatening condition that requires aggressive, timely, and multi-disciplinary care. Understanding the changes in national guidelines regarding definitions, diagnosis and the management of pediatric sepsis is critical for the pediatric surgeon participating in the care of these patients. The purpose of this article is to review the essential steps for the timely management of pediatric sepsis, including fluid resuscitation, antibiotics, vasopressors, and steroids. This includes a description of the key adjunct modalities of treatment, including renal replacement therapy and extracorporeal life support (ECLS).

Can a surgeon perform a macroscopic inspection of a gallbladder?

Introduction: Routine histopathologic gallbladder examination after cholecystectomy has been a point of discussion for several decades. Recent changes in national guidelines suggest a selective histopathologic examination gallbladders. The aim of this study was to evaluate the macroscopic examination by the surgeon in relation to the final histology outcome. Method: A prospective study was conducted in a Dutch teaching hospital to investigate the practice of macroscopic gallbladder examination by a surgeon compared to routine histopathology by a pathologist. All consecutive cholecystectomies were included between November 2009 and February 2011. Patient characteristics, operative procedure, conversions to laparotomy, macroscopic examination of the gallbladder mucosa, alleged necessity for microscopic analysis and final histopathology of the gallbladder were analyzed. Results: A total of 319 consecutive cholecystectomies were performed. Twenty-nine patients were treated for acute cholecystitis. Of all macroscopic examinations the surgeon identified 62 gallbladders with macroscopic abnormalities, ranging from polyps to wallthickening or ulcers. Including acute cholecystitis a total of 55 (17,2%) could have had reasons for further microscopic evaluation by the pathologist. Macroscopic examination agreement between surgeon and the pathologist was rated as “strong agreement” (κ = 0,822). The surgeon and the pathologist had disagreement on the macroscopic examination of 18 gallbladders. In these gallbladders, however, the additional histology was not relevant to clinical outcome. Conclusions: The present prospective study shows that the surgeon is capable of adequate macroscopic gallbladder examination postoperatively. We suggest to only perform selective microscopic gallbladder examination, which can result in about 80% reduction of this kind of routine histology.

Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: the TARDIS RCT.

Two antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents might be better still, providing it does not cause undue bleeding. To compare the safety and efficacy of intensive therapy with guideline antiplatelet therapy for acute ischaemic stroke and TIA. International prospective randomised open-label blinded end-point parallel-group superiority clinical trial. Acute hospitals at 106 sites in four countries. Patients > 50 years of age with acute non-cardioembolic ischaemic stroke or TIA within 48 hours of ictus (stroke). Participants were allocated at random by computer to 1 month of intensive (combined aspirin, clopidogrel and dipyridamole) or guideline (combined aspirin and dipyridamole, or clopidogrel alone) antiplatelet agents, and followed for 90 days. The primary outcome was the incidence and severity of any recurrent stroke (ischaemic, haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days by blinded telephone follow-up. Analysis using ordinal logistic regression was by intention to treat. Other outcomes included bleeding and its severity, death, myocardial infarction (MI), disability, mood, cognition and quality of life. The trial was stopped early on the recommendation of the Data Monitoring Committee after recruitment of 3096 participants (intensive, n = 1556; guideline, n = 1540) from 106 hospitals in four countries between April 2009 and March 2016. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy in 3070 (99.2%) participants with data [93 vs. 105 stroke/TIA events; adjusted common odds ratio 0.90, 95% confidence interval (CI) 0.67 to 1.20; p = 0.47]. Major (encompassing fatal) bleeding was increased with intensive as compared with guideline therapy [39 vs. 17 participants; adjusted hazard ratio (aHR) 2.23, 95% CI 1.25 to 3.96; p = 0.006]. There were no differences between the treatment groups in all-cause mortality, or the composite of death, stroke, MI and major bleeding (aHR 1.02, 95% CI 0.77 to 1.35; p = 0.88). Patients and investigators were not blinded to treatment. The comparator group comprised two guideline strategies because of changes in national guidelines during the trial. The trial was stopped early, thereby reducing its statistical power. The use of three antiplatelet agents is associated with increased bleeding without any significant reduction in recurrence of stroke or TIA. The safety and efficacy of dual antiplatelet therapy (combined aspirin and clopidogrel) versus aspirin remains to be defined. Further research is required on identifying individual patient response to antiplatelets, and the relationship between response and the subsequent risks of vascular recurrent events and bleeding complications. Current Controlled Trials ISRCTN47823388. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 48. See the NIHR Journal Library website for further project information. The Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) vanguard phase was funded by the British Heart Foundation (grant PG/08/083/25779, from 1 April 2009 to 30 September 2012) and indirect funding was provided by the Stroke Association through its funding of the Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK. There was no commercial support for the trial and antiplatelet drugs were sourced locally at each site. The trial was sponsored by the University of Nottingham.

Examining screening behaviors at a high-risk ovarian cancer clinic.

e13047 Background: Women with deleterious BRCA1/2mutations have a significantly increased lifetime risk to develop ovarian cancer. Prophylactic surgery can significantly reduce ovarian cancer risk. The Northwestern Ovarian Cancer Early Detection and Prevention Program (NOCEDPP) was established to monitor this high-risk population prior to risk-reducing surgery. For such patients, providers in the NOCEDPP recommend screening with CA-125 and transvaginal ultrasound (TVUS) biannually. The aim of this study was to examine screening rates of women who have not had surgery but attend the NOCEDPP. Methods: We reviewed electronic health records of 1,662 women who attended the NOCEDPP clinic between October 2005 – October 2015. Demographic and clinical characteristics and utilization of screening were analyzed retrospectively using descriptive statistics and Kruskal-Wallis H-tests to examine differences in screening rates by age, race, ethnicity and insurance type. Results: Of the 1,662 women initially identified, 385 had a known BRCA mutation, 303 had an appointment with at least 6 months between first and last procedure – the sample included in the final analysis. Compared with women ages 35-45 (median = 1.91) and 45+ (median = 1.18), women ages 20-35 attended the most screenings per year (median = 2.12) p = 0.001, a rate consistent with biannual recommendations. There were no significant differences in screening rate by race, ethnicity, or insurance coverage. Conclusions: Despite changes in national guidelines, providers in our high-risk clinic continue to recommend CA-125 and TVUS biannually. Our preliminary data indicates patients’ attendance is uninfluenced by race, ethnicity, or insurance coverage. Further exploration of the impact of age is warranted. Implication of findings indicate a high-risk clinic may positively impact screening behaviors above and beyond factors typically associated with non-adherence.

Early prediction and aspirin for prevention of pre-eclampsia (EPAPP) study: a randomized controlled trial.

To estimate the effect of early administration of aspirin on the prevention of pre-eclampsia in high-risk women. This was planned as a randomized, double-blind, placebo-controlled trial of aspirin for women with risk factors for pre-eclampsia. Participants were randomized to start either aspirin (81 mg/day) or placebo at 11 + 0 to 13 + 6 weeks of gestation. The primary outcome was pre-eclampsia and secondary outcomes included gestational hypertension and small-for-gestational age at birth. The trial suffered from slow recruitment, leading to a protocol change to broaden the inclusion criteria (from a minimum score of multiple risk factors to at least one risk factor for pre-eclampsia). The trial was then terminated prematurely due to continuing slow recruitment and a lack of equipoise given a change in national guidelines to administer aspirin to high-risk women. From the 53 women who were randomized, 30 were included in the final analysis. There was no evidence that the primary outcome of pre-eclampsia was prevented by low-dose aspirin (relative risk (RR) 0.88, 95% CI 0.21-3.66). Gestational hypertension was seen in two women, both in the aspirin group. There was no evidence that the occurrence of small-for-gestational age was reduced by aspirin (RR 0.88, 95% CI 0.06-12.72). Although this study was underpowered to show effectiveness of aspirin compared to placebo due to the premature termination and difficulties encountered, it highlights practical issues to inform future studies.

Abstract B83: Factors which affect cervical cancer screening in an underinsured safety net population

Abstract Background: Cervical cancer is the considered one of the most preventable and treatable female cancers. Guidelines for cervical cancer screening have changed for young (less than 21 years) women in 2009 and for all women more recently in 2012. Compliance with cervical cancer screening varies significantly in published studies. Much less is known about racial/ethnic minority groups and patients from underinsured populations. Most studies show lower compliance with cervical cancer screening in these populations. In addition, cervical cancer incidence is higher in many of these populations compared to non-Hispanic White (NHW) or high SES populations. The current study was performed to determine factors which influence use of Papanicolaou cytology smears (Pap-smears) for cervical cancer screening in an underinsured, racial/ethnic minority patient population. Methods: From January 2012 to May 2013, all patients seen at the Breast Clinic in a safety net hospital were evaluated to determine their use of Pap-smears. Sociodemographic variables were collected on all patients. Health literacy was assessed using the Newest Vital Sign (NVS) instrument. Results: Over the time period studied, 1377 consecutive patients were seen. 59 patients were excluded because they were not yet sexually active or had hysterectomy for an indication other than cervical cancer. Of the remaining 1318 patients, the average age was 45 years. Only 17% were NHW while 10% were African American and 67% were Hispanic/Latina. Only 45% spoke English as their primary language. 92% were underinsured (24% Medicaid and 68% uninsured). The mean annual income was $13,188. Overall 39% underwent a Pap-smear in past year. When evaluated by health literacy, significantly more patients with adequate health literacy underwent Pap-smears as compared to those with limited health literacy (59% vs 34%, p &amp;lt; 0.0001). Patients with fewer liver births were also more likely to use Pap-smears (2 or less: 44% vs 3 or more: 34%, p = 0.0003). Patients without a PCP had Pap -smears at rate similar to those with a PCP (37% vs 41%, p = 0.10). The type of PCP, however, did appear to make a difference as those who had a GYN were significantly more likely to have Pap-smears as compared to those who had an internist or family practitioner (65% vs 23% and 42%, p &amp;lt; 0.0001). Patients less than 21 years or older than 65 years underwent screening infrequently (11% and 11% vs. 41% (age 21-65 years), p &amp;lt; 0.0001). Race, ethnicity, language, and insurance status did not affect use of Pap-smears. Conclusions: Overall use of pap smears was suboptimal in this underinsured population. Patients with a Gynecologist as their PCP appeared more likely to have Pap-smears. Health literacy assessment can help identify patients at increased risk for underutilization of this important screening tool. Tailored interventions to target populations with limited health literacy should be considered to increase use of Pap-smears Providers do appear to be adjusting their practice in accordance with changes in national guidelines as few patients under age 21 and above age 65 underwent Pap-smears. Citation Format: Ian Komenaka, Meredith Heberer, Jesse Nodora, Chiu-Hsieh Hsu, Marcia Bouton, Sonal Gandhi, Maria Elena Martinez. Factors which affect cervical cancer screening in an underinsured safety net population. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr B83. doi:10.1158/1538-7755.DISP13-B83

Diminishing Availability of Trial of Labor After Cesarean Delivery in New Mexico Hospitals

To examine the availability of trial of labor after cesarean delivery (TOLAC) in New Mexico from 1998 to 2012 and maternity care providers' perception of barriers to TOLAC. Hospital maternity unit directors were surveyed regarding TOLAC availability from 1998 to 2012. Maternity care providers (obstetrician-gynecologists, certified nurse-midwives, and family medicine physicians) were surveyed in 2008 regarding resources and barriers to providing TOLAC and emergency cesarean delivery. Trial of labor after cesarean delivery was available in 100% of counties with maternity care units in 1998 (22/22); by 2008, availability decreased to 32% (7/22). After changes in national guidelines, availability increased slightly to 9 of 22 (41%) in 2012. Barriers to TOLAC included anesthesia availability (88%), hospital and medical malpractice policies (80%), malpractice cost (69%), and obstetric surgeon availability (59%). In hospitals without TOLAC services, 73% of maternity care providers indicated a surgeon could be present in the hospital within 20 minutes of the emergency delivery decision; only 43% indicated obstetric anesthesia personnel could be present within 20 minutes (P<.001). Availability of TOLAC in New Mexico has decreased dramatically. Policy changes are needed to support TOLAC access in rural and community hospitals. III.

KRAS and colorectal cancer: ethical and pragmatic issues in effecting real-time change in oncology clinical trials and practice.

Systemic therapy has led to a median survival time for patients with advanced colorectal cancer (CRC) almost fourfold longer than that expected with best supportive care, an outcome achieved through combining chemotherapeutic and targeted biologic agents. Although the latter can include anti-epidermal growth factor receptor antibodies, such as cetuximab and panitumumab, we now have strong evidence that patients whose tumors harbor mutated KRAS will not benefit from this class of agent. Acceptance of the reliability and importance of the KRAS data took several years to evolve, however, for a variety of reasons. The timeline from the presentation and publication of small, retrospective phase II studies to widespread acceptance of the KRAS predictive value and changes in behavior-specifically, modifications of ongoing national trials in advanced/metastatic CRC, changes in national guidelines and practice patterns, and adjustments to the labeled indications for the monoclonal antibodies-was lengthy. In this commentary, we discuss whether or not the process of data disclosure regarding KRAS status and treatment of advanced CRC patients was effective in permitting timely decisions regarding ongoing publicly funded clinical trials and whether or not such decisions were rational and ethical. The overall goals are to highlight lessons learned regarding early disclosure of clinical trial results, as well as vetting and adoption of new scientific data, and to propose modifications for handling similar situations in the future.

Diagnostic Value of Neurophysiological Tests in the Diagnosis of Brain Death - Do We Need Changes in National Guidelines?

For a final diagnosis of brain death one needs particular proof that the brain has fully stopped functioning. In this respect, diagnostic tests need to be used to confirm the clinical findings. Since in different countries there are various national guidelines for the determination of brain death, the aim of this study is to point to the diagnostic value of electroencephalography (EEG) and evoked potentials (EP) in verifying brain death. The need is emphasized for the two methods to be used in combination, and, accordingly, for the current national guidelines to be changed in our country and also in other countries round the world.