Assessing the Effect of Telemedicine Implementation on Patient Satisfaction With and Adherence to Gynecologic Appointments

INTRODUCTION: The COVID-19 pandemic led to a rapid increase in telemedicine visits to ensure delivery of essential health services while minimizing infection exposure. While there have been studies related to telemedicine in other specialties, there is a paucity of data assessing the effect of telemedicine visits in gynecology. The purpose of this study is to evaluate whether and how implementation of telemedicine affects patient adherence to and satisfaction with scheduled gynecologic appointments. METHODS: A retrospective review of 1,170 patients who participated in gynecologic telemedicine visits and 5,303 patients who participated in in-person gynecologic visits between March 1, 2020, and December 1, 2021, was performed to evaluate demographic information, chief complaint, and visit attendance. A cross-sectional survey of 1,248 patients who participated in gynecologic telemedicine visits between these dates was also performed to evaluate perceptions of satisfaction, access, quality and safety, and convenience of telemedicine. Institutional review board exempt protocol HP-00099093. RESULTS: The average no-show rate for gynecologic telemedicine visits was 2% compared to 22% for in-person gynecologic visits (P <.001). 33/1,249 patients responded to the survey. Sixty-nine percent (23/33) of survey respondents were satisfied with telemedicine visits. CONCLUSION: This study supports the continued incorporation of telemedicine into standard gynecologic practice to increase patient adherence with visits. Our gynecologic telemedicine no-show rates are significantly lower than patients' overall no-show rates for in-person visits. These outcomes may be associated with patients' satisfaction with telemedicine visits because of their being convenient, time saving, and less disruptive to their day. [ FROM AUTHOR] Copyright of Obstetrics & Gynecology is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Advance Care Planning in Obstetrics: Effectiveness of a Didactic Intervention on Provider Comfort and Knowledge

INTRODUCTION: Within obstetrics care, it can be difficult to discuss death and advances directives (AD). Recent maternal illnesses and deaths secondary to COVID-19 highlight the importance of these conversations. There is little available research regarding AD in obstetrics, especially within medical education. This study aimed to establish a baseline of obstetric provider comfort and knowledge with this material, provide education, and then reassess comfort and knowledge. METHODS: Institutional review board committee approval was waived for this study. A pre-intervention survey, including a unique identifier to allow for pairing of pre/post-surveys, was emailed to residents of a large university obstetrics and gynecology department with questions assessing comfort and knowledge of AD. The intervention was a 45-minute lecture covering definitions and local state laws relating to AD. A postsurvey, with identical questions to the presurvey, was sent 2 weeks after the intervention. Only paired responses were analyzed, using paired t test. RESULTS: Twenty-three residents (96% of program) participated in the presurvey;17 (71%) participated in the postsurvey. All were matched to presurvey responses and analyzed. In the presurvey, 41% of respondents were usually or always comfortable identifying surrogate decision makers, which increased to 82% in the postsurvey, a 41% difference (P =.01). With regards to the knowledge-based questions, the mean correct response was 56% in the presurvey and 87% in the postsurvey, a 31% difference (P <.001). CONCLUSION: A simple didactic intervention showed improvement in comfort and knowledge surrounding topics of AD for ob-gyn residents. Additional research relating to patient awareness of AD during pregnancy could be explored. [ FROM AUTHOR] Copyright of Obstetrics & Gynecology is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Early Enteral Feeding With Prebiotic-Containing Formula in Critically Ill Mechanically Ventilated Covid-19 Patients

Background: Optimal supportive care which includes adequate nutrient delivery remains the cornerstone in managing critically ill patients with COVID-19. Nutrition guiding principles for critically ill patients with COVID-19 strongly recommend providing early enteral nutrition (EEN) within 24-36 hours of admission to the intensive care unit (ICU) or within 12 hours of placement on mechanical ventilation (MV). Moreover, data show critically ill COVID-19 patients have negative alterations in their gut microbiome which is attributed to many factors including insufficient EN and fiber provision. The success and tolerance of EEN with a prebiotic formula in patients with COVID 19 is unknown. Here we aimed to assess, before and after implementation of an enteral feeding protocol, the achievement of EEN, estimated energy goals, and tolerance of a prebiotic formula in MV patients with COVID-19. Method(s): Data were collected and analyzed retrospectively from June 2020-May 2021 and prospectively from June 2021-January 2022. A protocol to promote EEN and improve nutrition delivery with a prebiotic-containing formula to patients within the seven days of ICU admission was created and implemented in June 2021 in the Medical ICU. Time to start EEN following invasive MV was assessed. Feeding adequacy over the first seven days of ICU admission was calculated by dividing the mean total calories of formula infused over the first seven ICU days by the estimated goal calories/day. The average number of bowel movements (BM) over the first seven ICU days was used to evaluate feeding tolerance. To determine the impact of inflammation and co-morbid conditions on feeding adequacy and tolerance, admission C-reactive protein (CRP) and Charlson Comorbidity Index (CCI) were trended with feeding adequacy. The Institutional Review Board approved the study. Result(s): A total of 343 patient records were analyzed with 203 patients in retrospective (R) and 140 patients in prospective groups (P). The post- MV feeding initiation time was shorter after implementing the feeding protocol (Mean 45.2 vs 33.8 hrs, and Interquartile Range (IQR) of Median (hrs) (18, 51) vs (16, 43) for the R and P groups, respectively (p = 0.04). Achievement of feeding goal rates were similar between groups (30.0 % vs 29.5%) (p >0.05). A prebiotic-containing formula was received in 36.2 % of patients in the R group versus 43.4 % in the P group. Providing a prebiotic formula had no impact on achieving goal nutrition in either period. In the R group, patients receiving the non-prebiotic formula had a higher total 7-days BM occurrence compared to the prebiotic formula group (8 vs 5.9 BMs/7 days, p = 0.03). In the P group there were no differences in the number of BMs between non-prebiotic and prebiotic formula groups (5.3 vs 5.0 BMs/7 days, p >0.05). Higher admission CRP and CCI values trended with higher incidence of inadequate feeding. Mean CCI was 4.42 and 4.17 for patients who received less than 25% goal feeding compared to those who received >80% of their goal feeds, respectively. Mean CRP was 12.3 and 11.4 for patients who received < 25% goal feeds compared to those who received >80% of goal feeds, respectively (p > 0.05). There were no differences in overall ICU length of stay between the R (11.7 days) and P (11.1 days) groups. (p = 0.34) Conclusion(s): EEN protocol implementation decreased time to EEN initiation in mechanically ventilated COVID-19 patients but did not affect patients in achieving goal nutrition in the first week of their ICU stay. Furthermore, COVID-19 patients tolerated EEN with prebiotic containing formulas. Further research is warranted to determine the impact of EEN with a prebiotic formula on the gut microbiome in critically ill MV patients with COVID-19.

Clinical improvement 2 years after starting elexacaftor/tezacaftor/ivacaftor in patients with advanced lung disease

Background: With the introduction of new cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy (elexacaftor/tezacaftor/ ivacaftor), peoplewith CF experiencing severe lung disease can experience significant improvements in clinical symptoms. Method(s): This single-center institutional review board-approved retrospective chart review identified patients with advanced lung disease who met criteria for a compassionate use or expanded access program because of high risk of death or transplant need within 2 years. Clinical data collection for all patients began at baseline, 2 to 4 weeks after therapy initiation, and continued every 3 months for 2 years. Datawere collected on demographic characteristics, clinic progress notes, clinical labs, forced expiratory volume in 1 minute (FEV1),weight, body mass index, respiratory colonization, and hospitalizations after drug initiation. Patients also completed sinus and chest computed tomography (CT) to track clinical changes. Result(s): Eighteen people with CF (aged 15-49, 56% male) from a large midwestern CF center who initiated drug therapy between July and September 2019 in an inpatient hospital or clinic setting were identified. Clinical markers (Table 1) indicated that modulator therapy was well tolerated and not discontinued by any participant;safety lab values did not indicate medical concern or discontinuation. There were 90 admissions for the group in the 2 years before therapy and 17 admissions during the 2 years after, although seven of the posttherapy admissions were for nonrespiratory indications. Monitoring results indicated the safety of modulator therapy because there were no adverse clinical occurrences or laboratory events, and all patients presented with universal stabilization. There have been no deaths and no transplants. Unlike lumacaftor/ivacaftor, therewere no problems with chest tightness or any difficulty with troublesome increases in expectoration burden or choking during initiation of therapy. Most had significant reduction in or loss of spontaneous cough and sputum production. The impact on microbial colonization is unclear, because even in this severe group, inability to produce sputum on command led to considerable missing data in follow-up, leaving colonization status at follow-up unclear. Conclusion(s): This study focused on people with CF who qualified for modulator therapy based on advanced lung disease. Initiation of modulator therapy was deemed safe and resulted in objective positive changes in nutrition;cough;FEV1);and subjective reports of clinical status, level of activity, and reduction in burden of treatment. No evidence was found of difficulty managing the increased expectoration during initial therapy. Limitations were noted in missing data during the COVID-19 pandemic, small sample size, and delayed follow-up for drug monitoring.(Table Presented) Clinical indicators before and after modulator therapy *Completed post-drug initiation (earlier than 12 months), **24 months before and after therapy initiationCopyright © 2022, European Cystic Fibrosis Society. All rights reserved

Rates of Hypoglycemia with Reduced- vs. Standard-Dose Insulin for Hyperkalemia Treatment in Renal Insufficiency

Objective: The primary objective was to assess the difference in rates of hypoglycemia (blood glucose (BG) <=70 mG/dL) when using reduced-dose (5 units) vs. standard-dose (10 units) of IV regular insulin for hyperkalemia treatment in renal insufficiency. Secondary objectives include the efficacy of insulin dose on potassium reduction and evaluating the difference in rates of severe hypoglycemia (BG <=54 mG/dL) between the groups. Method(s): This was a retrospective chart review of patients with renal insufficiency treated with IV regular insulin for hyperkalemia at a tertiary care teaching hospital from June 2020 to June 2021, with institutional review board approval. Inclusion criteria encompassed patients aged 18 years and older with elevated baseline potassium (>=5.5 mEq/L), estimated glomerular filtration rate < 30 mL/min/1.73m2, end stage renal disease, or presence of acute kidney injury, having received either 5 or 10 units of IV regular insulin for hyperkalemia, and had documented glucose and potassium levels after insulin administration. Patients who were pregnant, had diabetic ketoacidosis, or a baseline BG <=70 mG/dL were excluded. Data collection included patient demographics, diabetes history, relevant labs at time of elevated potassium, doses of insulin and dextrose administered for hyperkalemia treatment, presence of coronavirus-19 infection, glucose levels within 6 hours and first potassium level within 24 hours following insulin administration, concurrent use of potassium-lowering agents, insulin outside of hyperkalemia treatment, or steroids, and mortality. Result(s): Out of 409 patients included, 92 were in the 10-unit group and 317 in the 5-unit group. The rate of hypoglycemia in the 5-unit arm vs. the 10-unit arm was 6.9% vs. 8.7% (p=0.649), respectively. The rate of severe hypoglycemia between the 5-unit arm and the 10-unit arm was 3.2% vs 5.4% (p=0.682), respectively. The percent normalization of potassium was not statistically different between the 5-unit group and the 10-unit group (59% vs. 68%;p=0.115), with the same mean reduction in potassium from baseline (0.8 mEq/L (p=0.947)). Administration of concurrent treatments for hyperkalemia was similar between the groups, with dialysis being the only one with statistical significance in normalization of potassium. Patient characteristics that could have an impact on risk of hypoglycemia were studied and analyzed, including pre-treatment BG, history of diabetes mellitus, insulin naive, and patient weight. In patients with hypoglycemia (n=30) vs. those without hypoglycemia (n=379), there was a significantly different mean pre-treatment BG (113 mG/dL vs. 178 mG/dL, p<0.001). Discussion/Conclusion: There was no significant difference in rates of hypoglycemia and severe hypoglycemia between the 5-unit vs. 10-unit groups. There was no significant change in potassium normalization between the two insulin doses. Because of the small number of hypoglycemia events, larger studies are needed to better understand if 5 units of regular insulin is a safer option for the treatment of hyperkalemia in renal insufficiency.Copyright © 2023

Increased Prevalence of Depression in Juvenile Dermatomyositis during the Covid-19 Pandemic

Background. Juvenile Dermatomyositis (JDM) is a chronic systemic vasculopathy of unknown etiology characterized by symmetrical proximal muscle weakness, raised serum concentration of muscle enzymes and pathognomonic skin rashes. Although JDM is the most common pediatric idiopathic inflammatory myopathy, it is still quite rare with an annual incidence of 3.2 cases per million children in the US. Youth with chronic disease are reported to have a higher prevalence of mental health disorders compared to healthy peers, with some research reporting up to a fourfold increase in risk. The COVID-19 pandemic has raised psychological distress among youth;data from the first year of the pandemic suggests that 1 in 4 youth globally are experiencing clinically elevated depression symptoms. The primary aim of this study is to describe the prevalence of depression in a cohort of patients with JDM to help providers better understand the mental health issues that arise in this population. This is critically important as early intervention for depression in youth with JDM has the potential to improve both medical and psychosocial outcomes. Methods. This was a cohort study measuring depression in youth with JDM at Children's Healthcare of Atlanta (CHOA). Subjects were recruited during routine outpatient visits to CHOA rheumatology clinics from August to December 2020. Subjects had a diagnosis of JDM for at least 3 months, were between 5-20 years old, and had no cognitive deficit precluding questionnaire completion. Parent completed a proxy questionnaire if the child was 5-7 years old. Depression was assessed using the Patient Questionnaire-9 (PHQ-9). Of 15 eligible subjects, all consented to the study. Informed consent/assent was obtained. CHOA Institutional Review Board approved the study. Upon identification of depression, an educational handout was offered, which also included mental health care providers. Identified suicide risk was addressed with immediate direct questioning of suicidal intent, plan or attempt within the prior week;endorsement of any of these prompted enactment of a safety plan and urgent psychiatric evaluation. Statistical comparisons were performed using SAS. Medians and interquartile ranges (IQR), mean and standard deviation and frequencies were calculated for demographic and disease related variables. The presence of depression symptoms were analyzed as binary covariates for positive screens on the PHQ-9. Results. Demographics of the 15 participants included 53% female, median age of 12 years (IQR 10.0, 19.0;range 5-20) with a range of 5-20 years. The sample was heterogeneous with respect to race/ethnicity, with 8 (53.3%) Black, 6 (40%) White and 1 (6.7%) Asian participant. Median disease duration was 4.1 years (IQR 2.2, 6.9). Calcinosis was present in 10 (67%) of patients. Five (33%) participants had active disease at the time of completing PHQ-9, all of whom had mild disease with median Physician Global Score of 0.6 (IQR 0, 0.9). Depression was identified in 6 subjects (40%): 5 subjects (33%) were classified as having mild depression and 1 subject (7%) was classified as having moderate depression. No subjects had severe depression nor endorsed suicidal ideation. There was no significant difference in depression prevalence in patients with active disease versus inactive disease. The prevalence of depression in this small cohort is similar to previously reported rates of depression in patients with JIA and SLE;notably, it is higher than rates of depression in healthy children in the US. Conclusions. This pilot study adds to our understanding of the relationship between JDM diagnosis and psychosocial functioning in children and youth. The COVID-19 pandemic has been associated with a rise in depression in all children. Our findings suggest that regardless of disease status, there is a higher prevalence of depression in JDM patients compared to their healthy peers. Given the small sample size, further studies are needed to assess depression in paediatric rheumatology clinics.

Severe COVID-19 infection predisposes patients to greater burden of hair loss

There is a growing body of evidence suggesting a link between COVID-19 infection and certain forms of hair loss, such as telogen effluvium. The present study aims to determine the prevalence of hair loss following COVID-19 infection and ascertain the role of COVID-19 severity as a risk factor for its development. A retrospective study was conducted using patient data from the Northwestern Medicine Enterprise Data Warehouse with institutional review board approval from Northwestern University. Patients aged >= 18 years with COVID-19 diagnoses between January 2020-June 2022 and >= 1 encounter with dermatology providers within 180 days post-infection were included in the study. History of COVID-19 and documented hair loss diagnoses were recorded along with demographic data. COVID-19 severity was classified based on whether the patient was given outpatient or inpatient/emergency care for COVID-19. Time-to-alopecia onset was calculated relative to the nearest preceding COVID-19 diagnosis. Pearson's chi-squared and Kaplan-Meier analysis were performed to evaluate differences in incidence and time-to-alopecia onset by severity of COVID-19 infection. Analyses were conducted using R 4.2.1. In total, 10,861 patients met the inclusion criteria for the study. Patients were more commonly female (N = 6,974, 64.2%) and White (N = 8,301, 76.4%) with a mean age of 48 years at COVID-19 diagnosis. Overall, 6.5% of COVID-19 patients treated in inpatient/emergency settings developed hair loss compared to 4.7% in outpatient settings (P = 0.009). Patients with outpatient care had a median time to alopecia diagnosis of 73 days, compared to 99 days for patients with inpatient/emergency care (P = 0.019). Our findings demonstrate hair loss following COVID-19 infection as a notable sequela of infection. Clinicians should closely monitor patients following hospitalization for COVID-19, as they may be predisposed to hair loss following infection due to psychological or physiological stress. Future studies should aim to validate our findings and explore this relationship on a larger scale.Copyright © 2023

Primary proximal hypospadias repair in in toilet-trained males is associated with a higher risk of post-operative complications and parental dissatisfaction

Introduction & Objectives: Hypospadias is the most common congenital malformation of the penis. There has been a lot of recent controversy in certain countries as to whether operating on distal hypospadias is warranted, and when this should occur. Proximal hypospadias, however, is much less common, with a putative aetiology within the male programming window of the first trimester. It has an association with differences of sexual development (DSD) when diagnosed alongside cryptorchidism and the operative approach is technically more challenging. The European Association of Urology (EAU) recommends initial repair between 6-18 months of age. Material(s) and Method(s): We prospectively gathered data from 24 consecutive toilet-trained children (3-7 years) who were initially listed for proximal hypospadias repair, but who were delayed as a result of resource limitations and the ongoing supply chain effects of COVID-19. The patients were operated between July 2020 and July 2022 with a mean follow-up of 7 months (3-24months). These were compared with a cohort of 16 patients who underwent proximal hypospadias repair between 12-18 months of age in the same institution. Both single and staged procedures were included. Institutional review board approval was obtained. Patients who had previously been operated on as an infant, or who were diagnosed with a DSD, or had an associated diagnosed neuropsychiatric developmental disorder were excluded. Pre-, peri- and post-operative data were statistically compared. Result(s): Overall, 40 children underwent a total of 75 primary procedures for their proximal hypospadias (7x single stage;31 x 2-stage;2 x 3-stage). All patients had an indwelling catheter placed post-operatively, were on antibiotic prophylaxis and oxybutynin for bladder spasms. Morphine was not used post-operatively in any case. Apart from age, there were no significant demographic or racial differences between these groups. The toilettrained cohort was associated with a higher rate of urethrocutaneous fistulas (58% vs. 31%;p=0.11), catheter/stent trauma (79% vs. 6%;p<0.001), pain (54% vs. 12%;p<0.01), constipation (75% vs. 37%;p=0.02). Both Likert Scales (4 vs. 8) and parental net promoter scores (-25 vs. +68.75) were worse for the toilet trained cohort compared to the infant cohort. There were no differences in glans dehiscence, or residual chordee between both groups. Conclusion(s): Primary proximal hypospadias repair is associated with a higher degree of perioperative complications in toilet-trained kids and lower levels of parental satisfaction. These cases are not deemed to be suitable to be managed conservatively and should be offered treatment within the 6-18 months window adjusted for gestational age as endorsed by the EAU.Copyright © 2023.

Racial and Ethnic Disparities in Screening Mammography During COVID-19

Purpose: Studies conducted prior to COVID-19 suggested that racial/ethnic disparities in breast cancer screening percentages have substantially reduced over time. COVID-19 has had devastating effects on racial/ethnic minorities and resulted in delays in preventive breast cancer screening. Our purpose was to determine if racial/ethnic minorities were less likely to receive recommended breast cancer screening after the resumption of preventive care during the COVID19 pandemic. Method(s): HIPAA-compliant, institutional review board exempt retrospective cohort study was performed at a multi-location academic medical center located in the Midwest. Patients included women aged 50-74 years old between June 2021 and May 2022, derived from the electronic medical records. Primary outcomes variables included receipt of screening mammogram within the last two years. Primary exposure variables included race (American Indian/Alaska Native, Asian/Native Hawaiian/Other Pacific Islander, Black or African American, White) and ethnicity (Hispanic/Latino, and Not Hispanic/Latino). Binary outcomes were analyzed using logistic regression, adjusted for potential confounders (insurance, age, preferred language, employment status, rural status). Result(s): 37,509 female patients without histories of mastectomies were included (mean age 63.1). 73.8% of eligible patients received a mammogram within the last two years. By race, 74.7% of White patients, 57.6% of Black patients, 67.0% of Asian/Pacific Islander patients, and 60.1% of American Indian patients received a screening mammogram within the last two years. In our unadjusted analyses, Black (OR 0.46, 95% CI 0.41 to 0.52, p < 0.001), Asian (OR 0.69, 95% CI 0.60 to 0.79, p < 0.001), and American Indian patients (OR 0.51, 95% CI 0.39 to 0.66, p < 0.001) were less likely to receive recommended mammography screening. In our adjusted analyses, Black (OR 0.54, 95% CI 0.47 to 0.61, p < 0.001), Asian (OR 0.79, 95% CI 0.68 to 0.92, p = 0.003), and American Indian patients (OR 0.63, 95% CI 0.48 to 0.82, p = 0.001) were less likely to receive recommended mammography screening. By ethnicity, 74.1% of Non-Hispanic patients and 64.2% of Hispanic patients received a screening mammogram within the last two years. In our unadjusted analyses, Hispanic patients (OR 0.62, 95% CI 0.55 to 0.71, p < 0.001) were less likely to receive recommended mammography screening. In our adjusted analyses, Hispanic patients (OR 0.92, 95% CI 0.79 to 1.08, p = 0.338) were comparably likely to receive recommended mammography screening. Patients with non-English preferred languages, uninsured or Medicaid patients, and patients living in rural areas were less likely to receive recommended mammography screening (p < 0.001). Conclusion(s): Racial/ethnic minority patients were less likely to receive recommended cancer screening after the resumption of preventive breast cancer screening during the COVID-19 pandemic. Targeted outreach efforts are required to ensure equitable access to breast cancer screening for racial/ethnic minorities, patients with non-English preferred languages, uninsured, Medicaid, and rural patients.

Abnormal postpartum uterine bleeding in adolescence associated with SARS-CoV-2 infection

Background: With a prevalence of 1-3 cases per million, acquired haemophilia A (AHA) is a rare autoimmune bleeding disorder caused by the presence of neutralizing antibodies against factor VIII. Even though diagnosis of this bleeding disorder is rarely established among children and adolescents, AHA may lead to severe, life-threatening hemorrhage in this age group, and therefore it requires special caution. Case report: 19 year old primigravida with confirmed SARS-CoV-2 infection was admitted to hospital due to prolonged vaginal bleeding six weeks postpartum. All gynaecological causes of uterine bleeding were excluded, Foley catheter was placed, but the bleeding still persisted. Coagulation tests revealed isolated deranged aPTT values. Further haematology evaluation demonstrated factor VIII deficiency, presence of factor VIII inhibiting factors, and the diagnosis of AHA was proposed. The anti-inhibitor coagulant complex drug was introduced and patient has responded positively to the treatment. Conclusion(s): Due to disturbance of immune system, pregnancy and postpartum period represent predilection time for AHA development. Furthermore, viral infection in pregnancy, such as COVID-19, might be considered as an additional risk factor for AHA development and several reported cases of AHA after COVID-19 infection support this hypothesis. Even though AHA is a rare disease, due to its high mortality rate of more than 20%, it should be considered in all cases of unusual bleeding of unknown cause in all age groups. Publication of this case report is approved by Institutional Review Board.Copyright © 2023

Using a Single Irb for Nih-Funded Multisite Trials

As clinical trials evolve, the oversight by Institutional Review Boards (IRBs) has also evolved to meet everexpanding needs for both efficiency and changing regulatory requirements in the protection of human subjects. The most significant regulatory change to occur was the change to the Revised Common Rule Research Provision (45 CFR 46.114(b)) that went into effect on 20 January 2020, requiring all cooperative research subject to the Common Rule to use a single Institutional Review Board (sIRB) to review the research. Since the Common Rule affects all federally funded research, clinical trialists performing multicenter trials using federal grants are now required to use an sIRB instead of individual IRBs at each research site in their trials. For those multicenter trialists, using an sIRB offers efficiencies in time and effort which can aid in bringing trial results to fruition both faster and at a lower cost while still providing protection to human subjects. While commercial sIRBs have been available for many years, sIRBs placed at academic institutions and health care systems are relatively new. They can offer the benefit of lower cost for trialists within an institution, and better overall trial management by having more frequent communication and discussion regarding trial issues as well as improved safety management through aggregate safety review. They can also offer increased speed of research review with cooperative planning between trialist and the sIRB representatives. This session will focus on the use of sIRBs from various perspectives to give the view from an academic sIRB, from end users of both an academic sIRB and a health system IRB, and guidance from a clinical regulatory specialist regarding maintaining a trial master file while using an sIRB. Mr. Jarrod Feld from the University of Iowa will present from his perspective as the External IRB Coordinator at the University of Iowa. Mr. Feld coordinates reliance and compliance for University of Iowa human research studies which use the University of Iowa Institutional Review Board as their sIRB, and studies where Iowa relies on another institutional IRB. Mr. Feld also provides guidance to investigators on using an sIRB. Using his experience, Mr. Feld will outline the nature of reliance agreements, discuss working with a range of local IRBs to develop understanding regarding the reliance program and outline best practices for using an sIRB, and discuss enhanced safety management oversight when using an sIRB for large multisite trial. Ms. Tina Neill-Hudson from the University of Iowa will present from her experience as the sIRB Liaison for both the Acute to Chronic Pain Signature (A2CPS) Consortium, an NIH (National Institutes of Health)- funded multisite observational trial, and the Fibromyalgia and TENS in Physical Therapy Study (FM TIPS) study, an NIH-funded embedded pragmatic clinical trial. Ms. Neill-Hudson works with relying sites on completing the necessary regulatory documents needed for reliance agreements and sIRB approval. Ms. Neill-Hudson will discuss the process for obtaining reliance for institutions who may or may not have local IRB oversight and provide examples of specific steps and procedures for obtaining sIRB approval in a timely manner. Ms. Neill-Hudson will speak to the importance of having an sIRB liaison on the study team and the use of SMART IRB. Ms. Catherine Gladden from MassGeneral Brigham will present on using an sIRB for multicenter NIHfunded trials. Ms. Gladden will discuss the use of a Consortium-level reliance agreement and role of the local IRBs. Ms. Gladden oversees the sIRB liaison team at the Coordinating Center for the NeuroNEXT Network and works with the sIRB and local IRBs to ensure local policies and requirements are followed while maintaining compliance with the sIRB and the NeuroNEXT reliance agreement. Ms. Gladden will be discussing best practices for using an sIRB in a multicenter trial and discuss the experience of using an sIRB in the safety management plan. Ms. Cynthia Diltz from the University of Iowa wi l present on the topic of managing a trial master file while using an sIRB. Ms. Diltz will speak on her experience with electronic trial master files versus hard copy master files, and in using commercial software for trial master file management. Using an electronic trial master file is a necessity in the scheme of using an sIRB to assist sponsors and individual clinical research sites to view Institutional Review Board documents in real time and to provide a single storage location for documentation of Institutional Review Board approvals and activities such as continuing review. This session is timely due to the change to the Common Rule mandating the use of an sIRB for all research subject to the Common Rule, which has the most significant impact on trialists at academic institutions and health care systems. In an era of the need for timely study results for use in addressing urgent public health policy concerns, using an sIRB is becoming a necessity. The speed with which clinical trials need to be managed by an IRB has accelerated during recent public health care crises, notably the COVID-19 pandemic. In addition, it is likely that there will be changes to local IRBs as the norm becomes using an sIRB for any research subject to the Common Rule. Investigators and clinical site staff will require education on the evolution of human subject's protection and research review happening at an sIRB instead of within their local IRBs, and assistance in understanding the process and planning for success will be crucial.

Identifying and Examining Ethical Considerations Facing Data Monitoring Committees

The COVID-19 pandemic has exposed numerous unresolved research ethics challenges particularly for Data Monitoring Committees (DMCs). DMCs have worked to ensure the ongoing social value of research as rapid changes occur in health policy and epidemiology and there is substantial pressure to release early findings to the public. Unlike Institutional Review Boards, DMCs are charged with carefully monitoring ongoing research, but with limited ethical guidance and often without representation from all host countries. This article highlights ethical challenges for DMCs and lessons learned from the COVID-19 pandemic. DMCs have long faced high-stakes decisions in clinical trials including whether to continue, modify, or terminate a trial based on emerging trial data. Trial protocols, statistical analysis plans, and data monitoring charters establish principles for DMC decisionmaking;however, there has not been a great deal of systematic examination of the ethical issues faced by DMCs. For example, which ethical considerations should be addressed by DMCs as opposed to Institutional Review Boards or researchers is often unclear. Formal guidance rarely addresses whether DMCs should monitor the representativeness of trial participants as compared with the target population for the intervention. Furthermore, post-trial issues have received limited attention. Should DMCs ensure the accuracy of press releases and manuscripts detailing study findings? How should DMCs determine when to unblind participants after a study is over if it is relevant for their medical decision-making? In this presentation, we will report preliminary results of a qualitative study of DMC members (i.e. statisticians, clinicians, and ethicists). We will highlight persistent controversies, the range of roles DMCs are expected to play in monitoring clinical trials, and variation in formal guidance about the ethical obligations of DMCs. We will also examine the question of whether and when ethicists should serve on DMCs. We will conclude by identifying critical ethical issues facing DMCs that warrant further attention.

Inspiratory muscle capacity in Long Covid

Persistent symptoms beyond three months are common following acute infection with Covid 19 and termed Long Covid. There are a broad range of symptoms including breathlessness, fatigue, reduced exercise tolerance, chest pains, sleep disturbance and palpitations. The pathophysiology of Long Covid is poorly understood limiting treatment options. We hypothesised that diaphragm muscle weakness would be common in Long Covid and may in part be responsible for a number of the reported symptoms thereby providing a therapeutic option via inspiratory muscle training. We examined lung function, hand grip strength, Chester step test and symptom scores;mMRC (modified Medical Research Council), HADS (Hospital Anxiety And Depression), SF36 quality of life, Chalder Fatigue, in patients attending the Beacon Hospital Long Covid Clinic. Ethical approval was granted by our institutional review board. 101 patients were aged 40 +/- 14 years (Mean +/- SD). 63% were female. 75% had their acute illness managed at home. mMRC was 0 (16%), 1 (39%), 2 (34%), 3 (9%), 4 (2%). Predicted spirometry was normal however DLCO (diffusing capacity for carbon monoxide) was reduced at 86 +/- 14 % predicted as was MIP (Mean Inspiratory Pressure) at 70 +/- 25 % predicted. DLCO was significantly different when analysed by mMRC scores (ANOVA p<0.005). DLCO was correlated with MIP (R2= 0.22, p<0.0005). We propose implementing inspiratory muscle training as part of the therapeutic response to Long Covid to ascertain the role of diaphragm weakness in the pathophysiology of this syndrome and evaluate its effect on a range of presenting symptoms.

Evaluation of the attitude and behavior on COVID-19 vaccination among medical students of Texila American university-college of medicine

Background: Among the frontline healthcare workers who may encounter COVID-19 patients are medical students. It is critical to quickly reach high COVID-19 vaccination coverage rates in this population. They will be tasked with making vaccine recommendations and offering advice to people who are vaccine-resistant as future health-care providers. Aim and Objective: The present study was created to evaluate medical students' attitudes and behaviors about the COVID-19 immunization. Material(s) and Method(s): Following Institutional Review Board permission, the study was carried out at Texila American University's College of Medicine. A 15-item survey was completed by about 110 medical students to gauge their beliefs and actions on the COVID-19 vaccination. On statistical product and service solutions 16, descriptive analysis was used to analyze the data. Result(s): The majority of participants had favorable opinions toward vaccinations and believed that the COVID-19 immunization is crucial, but only 53% said that they would take part in a trial of the COVID-19 vaccine, and 65% said that they would not take the flu vaccine this flu season. The majority of students expressed the opinion that vaccinations are essential for maintaining health and that family members should also obtain them. Students who were ready to receive the vaccination right away were more inclined to believe in public health professionals, worry about side effects, and support vaccination laws. Conclusion(s): The study assessed medical students' attitudes and behaviors about receiving the COVID-19 vaccine and emphasizes the necessity for an educational curriculum regarding the vaccine's safety and efficacy to encourage uptake.Copyright © 2023 Jagan Nadipelly, et al.

THE RELATIONSHIP BETWEEN CHANGES IN EXERCISE HABITS, PHYSICAL FUNCTION, AND PSYCHOLOGICAL STATUS IN OLDER PATIENTS WITH HYPERTENSION

Objective: Self-restraint from activities due to the COVID-19 pandemic has limited the range of activities and interpersonal relationships for older persons. Moreover, prolonged restraint has been reported to increase the risk of frailty and sarcopenia. Therefore, we examined the effects of changes in exercise habits on physical function and psychological status of older patients with hypertension throughout their self-restraint lifestyle from 2020 to 2022 in the 1-year follow-up study. Design and Methods: Participants were patients with hypertension aged 65 years or older attending outpatient clinics at our institution who could obtain information on exercise habits, history of falls, comprehensive geriatric assessment, and muscle strength. We conducted the same survey in the first year and one year later. The subjects were classified into four groups by combining their exercise habits in the first year with or without one year later. That is Group A: with exercise habits at both times of the survey;Group B: with exercise habits in the first year and without exercise habits one year later;Group C: without exercise habits in the first year and with exercise habits one year later;and Group D: without exercise habits at both times of the survey. Written consent forms were obtained from all participants. Our institutional review board approved the study protocol. Results: The study participants were 183 patients (Group A: 119, Group B: 26, Group C: 17, Group D: 21). The age of the participants was 76.1 ± 5.5 years, 82 (44.8%) were male, and the duration of hypertension was 18.4 ± 11.5 years. Changes in exercise habits were not associated with physical function, history of falls, and comprehensive geriatric assessment at one year. However, when the results were examined separately for men and women, the geriatric depression scale was significantly higher in women in Group B (Dunnett test, p = 0.0094) than in Group A, suggesting that the tendency toward depression had progressed. Group B women also had more falls one year later (chi-square 12.04, p = 0.0072). Conclusions: In a 1-year follow-up study during the COVID-19 pandemic, a relatively high proportion of older patients with hypertension attending our hospital maintained their exercise habits, but 14% of cases lost their exercise habits. Only women showed the development of depression and increased risk of falls when exercise habits were lost. Women were more susceptible to the effects of environmental changes than men in older patients with hypertension.

94. Implementing Online Public Deliberations on Minor Consent for Biomedical HIV Prevention Research in Diverse Cities

Purpose: Adolescents/young adults (AYA) from racial/ethnic communities have high rates of HIV but little access to biomedical research, due to complexities around consent. Requirement of parental consent for participation in biomedical research is protective and strongly supported by parents, but in biomedical HIV prevention, minors are less likely to participate in research because of concerns about disclosure. Public deliberation (PD) is a process to obtain community input on complex policy issues, by bringing together AYA and adults, who have an investment in an issue, but with potentially opposing views, to provide education, clarify values, and facilitate discussion, reflection, and recommendations. To inform institutional review boards, institutions, and investigators, PDs were held with the goal of obtaining community perspectives and recommendations on minor consent for biomedical HIV prevention research from communities affected by youth HIV. Due to COVID-19 pandemic restrictions, we used an online format and conducted PDs across four evenings. We then conducted post-deliberation interviews to describe participants' experiences in the online PD. Methods: As part of an IRB approved PD, we conducted semi-structured interviews with youth and adult community members who had participated in the deliberations, held in Tampa and Baltimore. The interviews, which were conducted over Zoom, queried deliberants about their experiences voicing their perspectives, their comfort level, their degree of trust in the deliberation process, and ideas for how to better engage future deliberants. Interviews were audio-recorded, transcribed, and field notes were generated. Data were analyzed using thematic analysis. Results: We interviewed 13 community members: seven from Tampa (African American=3, White=3, Latinax=1;AYA=2) and six from Baltimore (African American=6;AYA=1). Facilitators: Deliberants from both communities indicated that personal connections were important for building consensus and understanding. When other participants shared personal stories and perspectives, deliberants were more receptive to hearing and accepting new ideas and opinions that differed from their own. Challenges: Tampa deliberants reported that they preferred an online deliberation because it helped overcome practical barriers to in-person deliberations, such as access to transportation and long commutes. Baltimore participants indicated they would have preferred in-person interactions to build trust, increase comfort, and augment engagement. Participants from both communities discussed distrust in research due to the historical legacy of racism in research and medicine. Due to this legacy, they reported that distrust influenced their views of minor-self-consent and impacted the deliberation process around building consensus. For example, concerns about coercion of minor human subjects influenced their views on minor consent. Recommendations: Participants recommend that strategies be developed to increase engagement in the virtual space. These strategies include use of (a) breakout sessions to increase comfort with sharing;(b) personal storytelling and reviewing group agreements to increase trust, (c) early polling activities to ensure engagement, (d) and asking adults to provide space for youth to voice their perspectives. Conclusions: While online public deliberation on sensitive topics with a vulnerable population is possible, it is important for researchers to focus on providing a safe environment, to acknowledge historical racism in research, and to use methods to maximally engage participants. Sources of Support: PCORI.

147. Chlamydia and Gonorrhea Prevalence and Treatment in Detained Youths in Hawaii: A follow up Study on Strategies for Improvement

Purpose: Adolescents acquire Chlamydia trachomatis with rates in 15-19 y/o females more than 4.8x the adult population and males 2.5x higher. There is growing recognition of the health consequences of untreated sexually transmitted infections (STI) especially for women in juvenile or correctional facilities. The previous study was a retrospective analysis conducted at the only juvenile detention facility in the state of Hawaii from 2014-2017. It revealed high prevalence of STIs, Chlamydia (CT) and Gonorrhea (GC), in both males and females with fewer than half the documented infections being treated prior to discharge, indicating a need for routine and timely testing to allow treatment of those infected as opposed to a presumptive STI treatment. The purpose of this study is to look at the prevalence rate of CT and GC after implementing routine testing and to assess treatment rate upon timely result receipt. Methods: This retrospective analysis was conducted at the only juvenile detention facility in the State of Hawaii from June 1, 2020-May 31, 2021. It documented the prevalence rate of CT and GC after implementing routine testing upon detention. It also looked at the timeliness of treatment and treatment rates as the time frame marked the first year of implementing routine CT and GC urine screen upon detention and sending the screen tests at a commercial lab for timely results. This time frame is unprecedented in the era of the coronavirus pandemic. This study was approved by Hawai‘i DOH Institutional Review Board. Results: Of the 218 admissions, 187 were tested (85%). 14 refused and 17 were under the state's age of consent (15%) prohibiting routine sample collection and testing as ordered by the facility. Of the 187 tests, 75(35%) were females, 143(65%) were males. CT was prevalent in 25% of females and 7% of males. GC was found in 13% of females and 3% of the males. CT-positive tests of females sent to commercial lab were treated timely 80% of the time vs. 60% for the CT-positive tests sent to the state lab. For CT-positive tests of males and GC-positive tests of females and males, the commercial and state labs showed the same timeliness of treatment. Rates of untreated females with CT was 12%, untreated males 25%;untreated females with GC was 11%, all males with GC were treated. The average result time receipt of tests sent to commercial lab was 6 days vs.2 weeks with the state lab. Conclusions: Prevalence rate of CT and GC remained consistently higher in females than males despite females making up only a third of the census. Timely treatment rate was remarkable for tests sent to commercial lab decreasing the number of untreated youths. This avoided presumptive CT and GC treatment, further leaving out the potential for antibiotic resistance, a continuous and growing concern prompting the updates in the CDC STD treatment guidelines in 2021. Sources of Support: None.

136. Telemedicine for Adolescent and Young Adult Long-acting Reversible Contraception Initial Follow-up Visit: Outcomes Over 1 Year

Purpose: Telemedicine for adolescent and young adult (AYA) care, including long-acting reversible contraception (LARC) care, was quickly implemented in response to the COVID-19 pandemic. Therefore, outcomes of telemedicine LARC care is understudied. We compare outcomes of AYAs receiving LARC follow-up care via telemedicine and in-person over 1 year. Methods: This cohort study includes patients who had LARC, intrauterine device (IUD) or implant, inserted between 4/1/20-3/31/21 and attended an initial LARC follow-up visit at 4 US Adolescent Medicine clinics. Initial LARC follow-up visit was defined as the first visit within 12 weeks of insertion. Eligible patients were 13-26 years old, had LARC inserted without sedation, and had LARC in place for at least 12 weeks. We compared outcomes over 1 year between patients attending the initial follow-up visit via telemedicine (telemedicine attendees) to those who completed the visit in-person (in-person attendees). Outcomes included patient-reported side effects, medical menstrual management, acne management, IUD malposition or expulsion, sexually transmitted infection (STI) testing and results, and LARC removal. Descriptive statistics described the sample and compared groups. Adjusted Poisson regression examined factors associated with number of visits and adjusted logistic regression models examined the association between initial visit modality and initiation of medical menstrual management. Site-specific institutional review board approvals were obtained. Results: Our study included 194 AYAs, ages 13.9-25.7 years (mean 18.7 years, SD = 2.3) who attended an initial follow-up visit. Most AYAs (n = 168, 86.6%) attended only one visit in the 12 weeks post-insertion. Telemedicine attendees comprised 40.2% of the sample. Telemedicine and in-person attendees were similar with regards to site of LARC insertion (p =.43), age (p =.17), race/ethnicity (p =.25), prior pregnancy (p =.95), complex medical diagnoses (p =.32), menstrual diagnoses (p =.11), and reason for LARC (p =.82). In-person attendees were more likely to have the IUD than telemedicine attendees (p =.003). Bivariate analyses showed similar frequency of patient-reported symptoms over 1 year between groups. Outcomes of menstrual management (OR = 1.02, CI: 0.40-2.60), number of visits attended (RR = 1.08, CI: 0.99-1.19), acne management (p =.28), IUD expulsion (p =.13), IUD malposition (p =.51), and LARC removal (p =.95) were similar between groups. In-person attendees were more likely to have STI testing done (p =.001) than telemedicine attendees. However, no positive STI tests were captured in either group. Conclusions: Roughly two-fifths of patients presenting to an initial LARC follow-up visit did so via telemedicine. Type of LARC may influence modality of follow-up visit. Except for STI testing, outcomes over 1 year were similar regardless of the first visit modality. Reassuringly, no positive STI tests were detected in either group over 1 year of follow-up. More research is needed to determine if the decrease in STI testing for patients seeking care via telemedicine is clinically significant. Telemedicine may play an important role in AYA LARC follow-up care, and more research is needed in this area. Sources of Support: N/a.

Incorporation of a smart sock with the virtual immersive test for postural stability

Purpose of Study: Assessment of an individual's postural stability serves as an indirect measure for both physiological and biomechanical stresses placed on an individual. More recently, some individuals after COVID-19 (SARS-CoV-2) infection have been identified with neurological complaints (Post-Acute Sequelae of Covid - PASC). These individuals can also be predisposed to decreased postural stability and an increased risk for falls. The purpose of the project was to incorporate two different wearable technology (virtual reality (VR) based virtual immersive sensorimotor test - VIST and pressure senor-based smart sock) to assess postural stability among healthy and individuals with PASC to quantify the overall status of the postural control system. Methods Used: All methods were conducted based on the University's Institutional Review Board (IRB# 21-296) with informed consent. A total of 12 males and females (six healthy and six with self-reported complaints of PASC) have completed the study so far. All participants were tested using the VIST, while standing on a force platform and wearing the smart sock simultaneously. The (VIST uses a VR headset and proprietary software to test an individual's integrated sensory, motor, and cognitive processes through eight unique tests (smooth pursuits, saccades, convergence, peripheral vision, object discrimination, gaze stability, head-eye coordination, cervical neuromotor control). Center of pressure (COP) data from force platform and pressure sensor data from the smart socks were used to calculate anterior-posterior and medial-lateral postural sway variables. These postural sway variables were analyzed using an independent samples t-test between the healthy and PASC groups at an alpha set at 0.05. Summary of Results: Significant differences (p < 0.05) between healthy and individuals with PASC with anteriorposterior and medial-lateral postural sway variables derived from COP measures, with individuals with PASC exhibiting significantly greater postural sway compared to healthy individuals in all eight tests of the VIST. The measures from the smart sock, while not statistically significant, exhibited the same findings of increased postural sway in individuals with PASC compared to healthy individuals. Conclusion(s): Findings from the current analysis revealed that individuals with PASC demonstrated significantly worse postural control compared to the healthy, when challenged with various sensorimotor tests in VIST, suggesting that postural control is compromised due to PASC. While not statistically significant due to a lower sample size, the measures from smart sock also indicated the same findings of the COP measures, suggesting a promising use of wearable technology in postural control assessments. In addition to other neurological signs and symptoms of PASC, assessment of postural stability using the VIST can provide more detailed clinical measures for diagnosis, treatment, and prognosis assessments. Copyright © 2023 Southern Society for Clinical Investigation.

Geospatial Factors Interact with Baseline Health to Impact Covid-19 Mortality (Community Hospital)

INTRODUCTION: Social determinants of health have been under-reported in critically ill patients during the pandemic. We hypothesized that geospatial factors and baseline health status in our community would significantly impact outcomes from Covid-19 infection. METHOD(S): We conducted an urban, single-center, observational study of patients with Covid-19 infection admitted to our adult ICU over ten months (March 23, 2020 to January 21, 2021, after approval by our hospital's Institutional Review Board. Weekly prospective data on the Covid-19 study population were entered in our ICU's quality assurance database. Data specific to test our hypothesis-zip code of residence, functional status, and Canadian Frailty Score (1-7)-were collected from retrospective chart review. The studied population was dichotomized to access patients who resided in long-term care facilities or home residence. Five zip code regions based on sample size and the distance from the patient's residence to the hospital allowed random sampling. Statistical significance was determined using ANOVA and T-test as indicated. RESULT(S): A total of 300 patients were enrolled. Across the designated cohort-based zip code regions, the mean frailty score of patients who resided at home differed significantly (2.9+/- SE.98 vs. 3.8+/- SE. 1.28, p< 0.01). Favorable frailty scores of 1-2 had a combined death and hospice rate of 23%. Of the survivors, 30% were transferred to skilled nursing facilities (SNF) and 26% were discharged to home. Patients with frailty scores of 6-7 had a final mortality rate of 83%. Of the survivors, only 2% were transferred to a SNF and 6% were discharged to home. Compared to admitting frailty scores between 1-3, a frailty score of 4 or greater (which represented 35% of all Covid ICU patients admitted from home) had a 1.8 relative risk of death (p< 0.0001). CONCLUSION(S): In our adult Covid-19 population, geospatial factors were associated with significant variances in frailty determined on ICU admission. Worsening frailty scores were associated with marked differences in both survival and final disposition, with combined death and hospice rates as high as 80%. We recommend that these metrics be added to routine data reporting to help better characterize ICU populations and stimulate efforts to improve frailty in vulnerable populations.