Institutional Review Board Research Articles

Part II: Enhancing Breastfeeding Experience and Self-Efficacy in Opioid-Dependent Breastfeeding Mothers—Results From the PeriWell Intervention

Objective:The PeriWell project integrates the Positive Direction Model and the Tri-Core Breastfeeding Model into a virtual support program tailored to peripartum mothers in substance use recovery. PeriWell addresses the unique challenges this population faces by offering tailored, wraparound support. This manuscript, part of a two-part series, highlights the project’s outcomes, demonstrating significant implications for maternal health practices by fostering an environment of empowerment and lactation wraparound support.Methods:This longitudinal quality improvement (QI) project spanned 24 months (2019–2021) during the COVID-19 pandemic. It involved 15 peripartum mothers in substance use recovery engaging in a virtual, single-site program. The project was approved as a QI initiative by the Institutional Review Board (IRB reference 2018-19, #89), ensuring ethical adherence and participant safety. Participants provided voluntary consent and were recruited from obstetrics and gynecology offices in Upstate New York. To evaluate participants’ confidence and belief in their breastfeeding abilities, we received author permission and utilized the validated Breastfeeding Self-Efficacy Scale-Short Form (Dennis & Faux, 1999; Dennis, 2010), guiding the tailored support provided.Results:Results indicated a significant increase in prenatal breastfeeding confidence correlated with the PeriWell approach (r= .782,n= 14,p< .001). Participants reported improved self-confidence in latching techniques and a greater appreciation of the time commitment required for successful breastfeeding. Correlational relationships provided valuable insight to enhance and amplify breastfeeding support. The findings advocate for the inclusion of targeted specialized interventions in maternal care to better meet the needs of expecting individuals.Conclusion:Cultivating a supportive peripartum environment is fundamental to maternal-child healthcare, and the PeriWell project demonstrated the efficacy of integrating tailored, virtual peripartum and breastfeeding support for expecting and postpartum mothers in substance use recovery. This quality improvement project improved maternal and infant health outcomes, such as breastfeeding self-efficacy, and highlighted the importance and value of specialized, wraparound lactation support for vulnerable populations. These findings underscore the need for continued innovation in maternal health services, particularly through empowerment and promoting breastfeeding success in recovery settings.

Rural Roads to Cognitive Resilience (RRR): A prospective cohort study protocol.

Ambient air pollution, detrimental built and social environments, social isolation (SI), low socioeconomic status (SES), and rural (versus urban) residence have been associated with cognitive decline and risk of Alzheimer's disease and related dementias (ADRD). Research is needed to investigate the influence of ambient air pollution and built and social environments on SI and cognitive decline among rural, disadvantaged, ethnic minority communities. To address this gap, this cohort study will recruit an ethnoracially diverse, rural Florida sample in geographic proximity to seasonal agricultural burning. We will (1) examine contributions of smoke-related fine particulate matter (PM2.5) exposures to SI and cognitive function; (2) determine effects of built and social environments on SI and cognitive function; and (3) contextualize SI and cognitive function among residents from different ethnoracial groups during burn and non-burn seasons. Methods: We will recruit 1,087 community-dwelling, dementia-free, >=45-year-olds from five communities in Florida's Lake Okeechobee region. Over 36 months, participants will complete baseline visits to collect demographics, health history, and health measurements (e.g., blood pressure, body mass index) and 6-month follow-ups assessing cognitive function and social isolation at each visit. A subsample of 120 participants representative of each community will wear smartwatches to collect sensor data (e.g., heart rate) and daily routine and predefined activities (e.g., GPS-captured travel, frequent destinations) over two months. Ecological momentary assessments (EMA) (e.g., whether smoke has bothered participant in last 30 minutes) will occur over two months during agricultural burning and non-burning months. PurpleAir monitors (36 total) will be installed in each community to continuously monitor outdoor PM2.5 levels. Ethics and expected impact: This study received Florida Atlantic University's Institutional Review Board approval and will require participant informed consent. We expect to identify individual- and community-level factors that increase the risk for SI and cognitive decline in a vulnerable rural population.

Comparing Sciatic Nerve Block in Novel Convenient Supine Position Via Medial Approach Versus Lateral Position Via Lateral Approach

Introduction: Popliteal sciatic nerve block performed in lateral position usually requires a change in position for the patient. This is time consuming and may cause discomfort to the patient. Methods: This prospective study compared patients' preference and peri-operative outcomes in supine position via medial approach to the sciatic nerve and lateral position via lateral approach to the nerve. Prospective registration of this study with NHG Human Research Protection Programme was on 9 Sept 2021. Institutional review board approval was obtained for this study on 20 May 2022. All research participants provided written informed consent with the first patient enrolled on 05 June 2022. 50 patients from Ng Teng Fong General hospital (NTFGH) who were undergoing popliteal sciatic nerve block with or without sedation were recruited for the study and randomised to either receive the block in supine or lateral position. Results: This study showed that there were significantly more patients in the supine group preferring to be in supine position during the block with p-valve <0.001. 45.8% of patients who had the block performed in lateral position preferred supine position instead. There was no significant difference in the peri-operative outcomes or duration taken for block completion. Most patients preferred to be in the supine position for popliteal sciatic nerve block as it was more comfortable. Conclusion: Performing the block in supine position increased patient’s comfort significantly and is non-inferior to performing it in lateral position in terms of safety, efficacy and efficiency profile.

Diagnostic Accuracy of Beta-2 Transferrin Gel Electrophoresis for Detecting Cerebrospinal Fluid Rhinorrhea.

Unilateral thin clear rhinorrhea (UTCR) may represent a variety of pathologies including cerebrospinal fluid (CSF) rhinorrhea. Beta-2 transferrin (B2Tf) gel electrophoresis (GE) has become the preferred testing modality due to reportedly high sensitivity (87%-100%) and specificity (71%-100%). However, there have been relatively few studies assessing its diagnostic accuracy. The purpose of this single-institution study was to determine the accuracy of B2Tf GE in detecting CSF rhinorrhea. A single-center retrospective review was conducted from 2016 and 2024 for all patients who presented with UTCR and underwent B2Tf GE. Institutional review board approval was obtained. The gold standard for diagnostic confirmation of true and false positives (TP, FP) as well as false negatives (FN) was endoscopic exploration. The gold standard for true negative (TN) was response to medical therapy. A total of 105 patients underwent 149 B2Tf GE tests. 40 (38.1%) patients were diagnosed with CSF rhinorrhea. Of the 149 B2-Tf GE tests, there were 51 TPs, 72 TNs, 20 FPs, and 6 FNs yielding 89.5% sensitivity, 78.3% specificity, 71.8% positive predictive value, and 92.3% negative predictive value, respectively. Of the false results the most common causes for error were purulent sinusitis (n = 6, 23.1%), possible mucous contamination from nose-blowing during collection (n = 3, 11.5%), patient collection error (n = 3, 11.5%), and blood contamination (n = 1, 3.8%). Although these single-institutional data demonstrate test accuracy within ranges previously reported in the literature, they also demonstrate diagnostic limitations. Future studies should explore reasons for erroneous B2Tf GE results and how these may change clinical decision-making. IV Laryngoscope, 2024.

Early results of treatment in accordance with the NB-HR-2018 protocol in patients with high-risk neuroblastoma in the Republic of Belarus

The development of new criteria for high-risk neuroblastoma treatment optimization and the introduction of new approaches to its management are a pressing problem in modern pediatric oncology. In this study, we aimed to develop and implement new high-risk and ultra-high-risk criteria, introduce tandem autologous hematopoietic stem cell transplantation (HSCT) as consolidation therapy for high-risk neuroblastoma patients as well as to assess patient tolerability of this treatment. The study was approved by the Independent Ethics Committee and the Scientific Council of the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. In 2018, a new protocol called NB-HR-2018 was developed and implemented at the Center for Pediatric Oncology, Hematology, and Immunology (Belarus) that included new criteria defining high-risk groups. Twenty-three patients were treated according to the new protocol, with 20 of them receiving autologous HSCT. The comparison group included 56 high-risk patients who had undergone treatment in accordance with the NB 2004 protocol. Tandem autoHSCT significantly reduces the rates of underlying disease relapse/progression (p = 0.047) and demonstrates better event-free survival rates (56 ± 12% vs 36 ± 6%; р = 0.445). The use of the new high-risk criteria and the new treatment method (tandem autologous HSCT) is concluded to be a reasonable approach since it significantly reduces disease relapse rates and is well tolerated by the patients.

A Description of the Dental Health and Treatment of Ukraine Military at U.S. Army Clinics in Germany.

Since the start of the Russo-Ukrainian war, most reports have focused on trauma and combat conditions. Trauma care is essential; however, disease and nonbattle injuries (DNBIs) also burden armies and reduce combat effectiveness. Dental emergencies (DEs) account for a substantial portion of DNBI, but there is limited information on Ukrainian military dental readiness. In September 2023, investigators were informed that Ukrainian military personnel were treated for DEs at 2 dental clinics in Germany. The investigators requested deidentified data from the Corporate Dental System (CDS), which is a repository for dental treatment records utilized by the U.S. Army. The data request captured DE treatment performed for Ukrainian military personnel in Germany from January 1, 2023, to September 20, 2023. The CDS report on DE encounters included the following: Gender, age, procedure codes, and provider narratives. This study was approved by the U.S. Army Institute of Surgical Research Institutional Review Board as research not involving human subjects and provided Log Number H-24-030nh. The CDS report captured 408 Ukrainian military DE encounters. A total of 360 Ukrainian military personnel were treated for DE during the 9-month reporting period in 2023. Oral surgery was the most common DE treatment category and accounted for 55.8% (N = 201) of DE procedures. Restorative dentistry procedures accounted for 18.1% of DE procedures. Of the 27 multiple category treatments, 25 had oral surgery procedures as one of the treatments. Restorative dentistry procedures were performed in 19 of the multiple category cases. The DEs in the Ukrainian military cohort suggest that chronic, untreated dental disease has progressed without routine care for years. The assertion that caries has progressed to a nonrestorable condition is supported by the distribution that 63% of all DE visits included oral surgery treatment. Based on the distribution of dental treatment, US dental officers must be proficient in oral surgery and prosthodontic care.

Implementation lessons learned from the University of California’s Diabetes Prevention Program Initiative

BackgroundThe University of California’s Diabetes Prevention Program (UC DPP) Initiative was implemented systemwide to address diabetes and obesity risk on all 10 campuses. As little is known about implementing lifestyle change programs in university settings, we examined implementation partners’ (i.e., UC DPP leaders and campus leads) perceptions of factors influencing program success on UC campuses.MethodsWe conducted qualitative interviews with UC DPP leaders and campus leads to examine challenges and opportunities with university-based DPP delivery models. Interviews were recorded, professionally transcribed, and reviewed in detail by the research team. Transcripts were analyzed using rapid qualitative analysis (RQA). The study was approved by the UCLA Institutional Review Board. All implementation partners provided verbal informed consent.ResultsTwenty-six implementation partners (8 UC DPP leaders and 18 campus leads) completed interviews in 2021. Seven themes were identified as critical for implementation, including (1) marketing and recruitment (i.e., market and recruit broadly through established channels as well as target at-risk populations); (2) enrollment (i.e., offer the program during convenient times and let participants know what to expect); (3) use an adaptable, evidence-based program; (4) secure funding for the program, participants, lifestyle coaches, and space; (5) hire experienced and dedicated staff and lifestyle coaches; (6) ensure leadership support; and (7) utilize campus linkages and resources. Perceptions of challenges faced with respect to these themes are also described.ConclusionsThis is one of the first studies to examine the challenges and opportunities of delivering an intensive lifestyle change program across 10 university sites. Understanding factors that enhance success of university-based diabetes prevention programs can facilitate UC DPP efforts and help inform delivery strategies of health and wellness programs across other university settings more broadly.

Comparison of Short vs. Extended Antibiotic Durations for Patients in the Neonatal Intensive Care Unit with Late Onset, Culture-negative Sepsis

Abstract Background Culture-proven late-onset sepsis in neonates and preterm infants, defined as symptom onset after 3-7 days of life, is a common cause of morbidity and mortality. Some patients are treated with antibiotics for sepsis despite lack of positive cultures after 48 hours of incubation, potentially due to the non-traditional signs of sepsis. Controversy remains over optimal treatment durations of culture-negative sepsis with durations reported as 2 to 7 days, and rarely longer than 7 days. The primary outcome of this study is to compare lack of symptom resolution at 7 days in patients with negative cultures treated with antibiotics for either ≤72 hours or >72 hours. Methods This was a single-center, retrospective, cohort study with Institutional Review Board approval at a 60 bed, level 4, surgical referral neonatal intensive care unit from January 1, 2020, to December 31, 2021. Patients were included for screening if they were ≥7 days of age, ≤ 44 weeks postmenstrual age, and received more than 1 day of antibiotics for possible late-onset, culture-negative sepsis. Patients were then excluded if they had positive culture results from any site, diagnosis of pneumonia, were being treated for suspicion of necrotizing enterocolitis, received antibiotics prior to obtaining cultures, or had continued treatment of prior infection. Patients were divided into two groups based on antibiotic duration: ≤72 hours or >72 hours. Presenting symptoms and symptom resolution at 72 hours and 7 days were assessed. Chi-squared or Fisher’s exact tests were used for categorical comparisons. Results Of the 909 patients screened, 68 were included: 42 in the ≤72 hours group and 26 in the >72 hours group. The most prevalent symptoms prompting antibiotic initiation were elevated CRP (64.7%) and bradycardia/oxygen desaturations (78%), with elevated CRP being the initiating symptom more frequently in the >72-hour group (92% vs 48%, p<0.001). If patients had 2 or more symptoms, they were more likely to receive >72 hours of antibiotics (85% vs 62%, p=0.034). At 7 days, 28 (41%) patients had complete symptom resolution. Antibiotic duration ≤72 hours was not associated with symptom resolution at 7 days (50% symptom resolution in the ≤72-hour group vs 27% in the > 72-hour group, p=0.06). Lack of symptom resolution at 72 hours of antibiotics was associated with lack of resolution at 7 days (p<0.001). Among patients without symptom resolution at 7 days, 65% of patients had a persistently elevated CRP and 68% of patients continued to have bradycardia/oxygen desaturations. Conclusion In neonates and preterm infants with negative cultures but possible signs of sepsis, antibiotic duration does not impact 7-day symptom resolution. Results indicate that if the initiating symptom is not resolved at 72 hours despite negative cultures, it is unlikely to be resolved with additional days of antibiotics. This is likely due to the multifactorial potentially non-infectious etiology of initiating symptoms in these patients. It is appropriate to discontinue antibiotics if cultures are negative after 48 hours of incubation in this population.

A Feasibility Study of a Music Enrichment Program on Relative Reinforcing Value of Food and Home Environmental Enrichment among Families of Low Socioeconomic Status.

Emerging evidence suggests that low socioeconomic status (SES) home environments may play a role by promoting excess energy intake through a lack of access to non-food reinforcers. Because of the deleterious effects of SES-related disparities on child health and development, feasible and culturally acceptable interventions are urgently needed. Community-based music enrichment programs may be an ideal intervention strategy. In collaboration with a local non-profit organization and music studio, we conducted a pilot randomized controlled trial to assess the effects of a music enrichment program versus a play date control in a group of 9-24-month-old healthy infants (N = 16). The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Children's Mercy Hospital Kansas City. This study is registered with clinicaltrials.gov (NCT05868811). Overall, we found some intervention effects on the relative reinforcing value of food (RRVfood) and the home environmental enrichment measures (i.e., increased music use at home and the home language environment). Our intervention demonstrated large effects on the increased use of music at home. We did not find significant group differences in the RRVfood and home language environment, but some of the effect sizes were medium-to-large. Results also suggest that our intervention is feasible and acceptable. Parent feedback indicated that the intervention was well-liked and that the steps we took to help reduce barriers worked. Music enrichment programs may be a high-impact, low-cost strategy to address socioeconomic disparities.

A Randomized, Single-Center, Double-Blind, Controlled Case Study Evaluating Procedure Pairing of a Neurocosmetic Postprocedure Cream With Radiofrequency Microneedling for Facial Rejuvenation.

Radiofrequency (RF) microneedling produces patient discomfort which deters patients from completing the recommended treatment series. The primary objective was to determine the tolerability, safety, and efficacy of a neurocosmetic postprocedure cream post-RF microneedling in reducing patient discomfort and enhancing recovery across the length of the study and, secondarily, to evaluate against a leading comparator. The third objective was to evaluate the efficacy of the neurocosmetic on self-perceived improvement and objective grading. An Institutional Review Board (IRB) approved, fourteen-day, randomized, single-center, double-blind, controlled clinical case study was conducted with 11 healthy female subjects, 6 randomized to the neurocosmetic and 5 to the comparator cell. Following a 7-day washout period, subjects received RF microneedling (face and neck) and applied the postprocedure cream twice daily for 7 days. Objective and subjective tolerability, self-assessments, and clinical photography were performed immediately postprocedure, 24 h, three and seven days following the procedure. The neurocosmetic was tolerable and safe. Erythema and stinging immediately decreased postprocedure, postneurocosmetic application. After 24 h, 83% favorably agreed the neurocosmetic "reduced irritation on the skin post-procedure," and after 7 days, 100% favorably agreed "experience with the product was positive and I would be interested in returning for a second treatment." The neurocosmetic reduced skin tone redness in the face and neck faster and to a greater degree when measured against a comparator. The neurocosmetic postprocedure cream improved patient discomfort and enhanced recovery when used immediately post-RF microneedling and after 7 days. Pro00064211.

Contrast-Enhanced Digital Mammography for the Diagnosis and Determination of Extent of Disease in Invasive Lobular Carcinoma: Our Experience and Literature Review.

Contrast-enhanced imaging, including magnetic resonance imaging and, more recently, contrast-enhanced digital mammography (CEM), is indicated for the precise diagnosis of invasive lobular carcinoma (ILC). The aim of our study was to further validate the use of CEM for evaluation of extent of disease in ILC cases, with digital breast tomosynthesis (DBT) as an adjunct. A retrospective, institutional review board approved study was conducted in a tertiary medical center. All CEM examinations performed on ILC patients between 2017 and 2023 were reread by 2 dedicated breast radiologists. Clinical data and pathology reports were retrieved from electronic medical records. The longest diameter of the enhancing lesion was correlated to pathology findings. In addition, for each case, the readers provided brief commentary on the added value of DBT. Twenty-four CEM examinations were evaluated. The subjects in the study cohort were on average older than expected for ILC patients (74 vs 63 years) and were unable to undergo breast magnetic resonance imaging due to advanced age and comorbidities. Three subjects were treated with neoadjuvant therapy and thus were excluded from the correlation to pathology analysis. Enhancing lesions, ranging from 4-75 mm, strongly correlated to pathology results, with statistical significance. This was demonstrated for mass and nonmass lesions (r = 0.94, P < 0.001 and r = 0.99, P = 0.002, respectively). For most lesions (17/24, 71%), readers remarked that the addition of DBT allowed for improved characterization of lesion margins, mainly detecting architectural distortion. When compared with the pathology findings, ILC was accurately diagnosed and assessed using CEM. The addition of DBT was reported by the interpreting radiologists as a valuable adjunct for margin analysis.

The role of institutional ethics committees in Austria : Report of the Commission on Ethics and Scientific Integrity of the Karl Landsteiner University of Health Sciences 2018-2023.

Research involving human subjects or identifiable human material and data must be assessed by an ethics committee. The Karl Landsteiner University of Health Sciences has established a Commission on Ethics and Scientific Integrity to evaluate medical research conducted by its faculty and students and at its affiliated hospitals.All projects submitted to the Commission on Ethics and Scientific Integrity between 2018 and 2023 were analyzed regarding their major characteristics, the duration of the evaluation process, and votes issued.A total of 520 applications were electronically submitted during the observation period. Most of the studies were retrospective data analyses in the field of oncology, psychology and surgery. Most studies included less than 100 volunteers. Of the applications 50% received afinal vote within 5months, during which several revision rounds took place. Overall, about 77% of votes issued during the observation period were positive and 2% were rejections. In 11% files were closed due to withdrawal. In 11% final votes were pending at the end of the observation period due to requests for revisions.Our results emphasize the importance of institutional ethics committees using the example of the Commission on Ethics and Scientific Integrity at the Karl Landsteiner University. Such committees fill agap in evaluating research not covered by Austrian legal regulations. Continuous development of standards, operating procedures, and national and international collaborations are required to assess and minimize risks to trial subjects and to provide asafe and productive environment for research in human medicine and related fields.

Molecular and Clinical Features of Pancreatic Acinar Cell Carcinoma: A Single-Institution Case Series

Objectives: Acinar cell carcinoma (ACC) accounts for about 1% of pancreatic cancers. The molecular and clinical features of ACC are less characterized than those of pancreatic ductal adenocarcinoma. Methods: We retrospectively evaluated the clinical and molecular features of ACC patients who underwent germline and/or somatic molecular testing at The University of Texas MD Anderson Cancer Center from 2008 to 2022 and two cases from 2023–2024 who underwent RNA and TME analysis by Boston Gene. Patient information was extracted from our institutional database with the approval of the Institutional Review Board. Results: We identified 16 patients with available molecular testing results. Fourteen patients had metastatic disease, one had borderline resectable disease, and one had localized resectable disease at diagnosis. Fifteen patients were wild type for KRAS (one patient had unknown KRAS status). Somatic/germline mutations of DNA damage repair genes (BRCA1/2, PALB2, and ATM) were present in 5 of 12 patients tested for these genes. One patient was found to have RET fusion and responded favorably to selpercatinib for over 42 months. The median overall survival (OS) was 24 months for patients with metastatic disease. One of the additional two cases who underwent BostonGene testing was found to have NTRK1 fusion. RNA and TME analysis by Boston Gene of the two cases reported immune desert features and relatively lower RNA levels of CEACAM5, CD47, CD74, and MMP1 and higher RNA levels of CDH6 compared with PDAC.

HIV epidemic among key populations in Nigeria: results of the integrated biological and behavioural surveillance survey (IBBSS), 2020–2021

IntroductionNigeria has the fastest-growing HIV epidemic in West and Central Africa and key populations (KPs) bear a higher burden of HIV. This integrated biological and behavioural surveillance survey was conducted...

Observed Changes in the Distribution of Colon Cancer Metastasis: A National Cancer Database Review and Institutional Experience.

The University of Louisville has observed a near 70% drop in resectable/borderline resectable metastatic colorectal cancer in the past 5 years. The aim of this study was to evaluate the distribution of colon cancer metastasis at diagnosis and at recurrence. Stage was defined by the American joint committee on cancer (AJCC) eighth edition. Institutional review board approval was granted for post hoc review of stage II and III patients with colon cancer from the University of Louisville prospective hepatic database from 2002 to 2023, as well as for the National cancer database (NCDB) Participant user file (PUF) 2021. The Surveillance epidemiology and end-results (SEER) 22 database was also utilized to corroborate the findings in the NCDB. Between 2018 and 2021 pathological M1a decreased annually (51.9-46.3%), while M1c increased year-over-year (26.6-32.4%) and M1b stayed relatively the same (21.4-21.3%). These differences were significant on chi-squared analysis with a p value of < 0.001. Univariate analysis of the post hoc review between 2017 and 2020 revealed significant differences between stage 4a and 4c in terms of race (p value 0.018), carcinoembryonic antigen (CEA) at diagnosis (p value 0.037), CEA at recurrence (p value 0.012), presence of liver metastasis (p value 0.003), and referral pattern (p value 0.014). Multivariate analysis identified stage 4b as an independent predictor for hepatic metastasis (odds ratio; OR 4.69, p value 0.011). A significant change in the distribution of colon cancer metastases has occurred at an institutional and national level over the past 3-5 years. Interdisciplinary treatment strategies will have to be modified accordingly.

Sex and Gender Considerations in Orthopaedic Research

Abstract JBJS convened a symposium to discuss the reporting of sex and gender in research studies as an imperative to improve research methods and results to benefit all patients. Barriers to improved reporting include a lack of societal and cultural acceptance of its need; a lack of education regarding appropriate terminology and appropriate statistical methods and efficient study designs; a need for increased research funding to support larger group sizes; unknown concordance of cell and animal models with humans to reflect biologic variables such as sex; and a lack of understanding of key considerations of gender, race, and other social determinants of health and how these factors intersect. Attention to developing and disseminating best-practice statistical methods and to educating investigators (at all career levels), reviewers, funders, editors, and staff in their proper implementation will aid reporting. Concomitantly, well-designed studies with sufficient rigor and adequate resources are essential to enable meaningful and reproducible research. Existing recommendations, such as the Sex and Gender Equity in Research (SAGER) guidelines, provide valuable guidance that can be applied across the research ecosystem. Academic institutions and private foundations are likely groups to assist in scientific and institutional review board guidance and study recruitment and pilot funding to generate meaningful power estimates, and to serve as sources for additional funding and presentation of workshops, educational events, and seminars. All of this needs to be conducted on an ongoing basis to ensure that sex and gender are considered in scientific analyses, where relevant.

Optic Nerve Sheath Fenestration: A Retrospective Review of Its Safety, Efficacy, and Impact on Optical Coherence Tomography.

This study aimed to evaluate the safety and efficacy of optic nerve sheath fenestration using visual acuity, perimetry, and optical coherence tomography. A retrospective review of patients who underwent an optic nerve sheath fenestration at an academic center between 2016 and 2021 was performed with institutional review board approval. Outcome measures included visual acuity, perimetric mean deviation, optic disc edema grade, improvement in symptoms, and intraoperative and postoperative complications. Optical coherence tomography data collected included macular ganglion cell volume and thickness, as well as retinal nerve fiber layer thickness. Preoperative baseline data and 1-, 6-, and 12-month postoperative data were collected. Repeated measures with a mixed-effects model were used for continuous data, and linear regression analyses were performed. A total of 55 patients (86 eyes) underwent optic nerve sheath fenestration, via a medial transconjunctival approach by the same orbital surgeon. After 12-month follow-up, visual acuity (P < 0.05), perimetric mean deviation (P < 0.05), and optic disc edema (P < 0.001) improved in the operative eye. Retinal nerve fiber layer thickness decreased from a mean of 165 to 92 µm (P < 0.001). Macular ganglion cell volume was found to have a small decrease from baseline and correlated well with visual acuity, contrast sensitivity testing, and perimetric mean deviation (P < 0.001). Optic nerve sheath fenestration performed via a medial transconjunctival approach is a safe and effective method to preserve vision in patients with papilledema, particularly in cases of fulminant or progressive idiopathic intracranial hypertension. Quantitative measurements of the macular ganglion cell layer can serve as a useful adjunct to other diagnostic testing.

How Well Are We Protecting Human Research Subjects?

Protecting human research subjects is an ethical mandate for all contemporary research involving human subjects. From 1974 to 1999, we had the institutional review board (IRB) system and the Common Rule, but realized that in addition to IRBs, investigators, institutions, sponsors of research, research participants, and the government, all share responsibilities in protecting human research subjects. Starting 2000, institutions established human research protection programs to ensure the rights and welfare of research participants and to meet human research ethical and regulatory requirements. Some institutions had their human research protection programs further accredited to ensure rigorous standards for quality and protection. In 2018, the Common Rule was extensively revised to modernize the regulations by enhancing protections and reducing burden for researchers. However, throughout these periods, we did not know how well we were protecting human research subjects, because we did not know how to measure human research subject protections. With the publication of human research subject protections performance metrics in 2023, it becomes possible for the first time to assess quantitatively how well we are protecting human research subjects. Research institutions can now monitor the effectiveness of their human research protection programs and identify areas of vulnerability for quality improvement. We should also be able to determine how well human research protection programs are doing in protecting human research subjects; determine whether external accreditation improves human research subject protections and whether the revised Common Rule in fact leads to enhanced protections; and identify prospectively which procedures or interventions can enhance human research subject protections.

ANALYSIS OF CD10 EXPRESSION IN PROSTATE ADENOCARCINOMA AND ITS CORRELATION WITH DIFFERENT CLINICOPATHOLOGICAL PARAMETERS AT RNTMC, UDAIPUR

Objective: The study aimed to analyze the expression of CD10 in prostate adenocarcinoma to aid in early diagnosis and anti-CD10 targeted therapy. Methods: This was a cross-sectional study conducted in the Histopathology section of the Department of Pathologyat RNTMC, Udaipur, after approval from the ethical committee and institutional review board. This study was conducted on 92 patients suspected to have prostate cancer. The cases were assessed for Gleason score, Gleason Grade, and Serum Prostate Specific Antigen (PSA) levels. We performed IHC detection of CD10 in prostatic specimens and correlated the various patterns of CD10 expression concerning histopathological diagnosis. Results: In our study, we found membranous expression in low-grade carcinomas with low Gleason score and grade. The high-grade carcinomas with high Gleason score and Grade predominantly showed cytoplasmic expression. The increased CD10 cytoplasmic expression was correlated with serum PSA level. Conclusion: In our study, CD10 was found to be relevant. The low-grade carcinomas showed membranous positivity and high-grade carcinomas showed cytoplasmic expression. One hypothesis states that cytoplasmic expression is due to the localization of CD10 in the cytoplasm. Our study favors this hypothesis as there is cytoplasmic expression in high-grade tumors. In the future, this could be used as a diagnostic marker.

GREM1 may be a biological indicator and potential target of bladder cancer

Gremlin 1 (GREM1) can regulate the development of many cancers. However, a few studies have revealed the role of GREM1 in bladder cancer (BC). To evaluate the expression and potential function of GREM1 in bladder cancer, we used R version 3.6.3 and related packages to analyze the data from common databases. Samples from our institution were assessed by immunohistochemical staining (IHC), which was approved by the Institutional Ethics Committee (K20220830). GREM1 was highly expressed in BC tissues according to the TCGA and IHC data. Data from TCGA, GSE31684, GSE32894, and IHC showed that GREM1 has significant prognostic value for BC patients. GREM1 is involved in immune and metabolism-related pathways. According to the TIDE algorithm, 61.0% of patients with low GREM1 expression responded well to immunotherapy, compared to only 13.3% in the high GREM1 expression group. High GREM1 expression was associated with sensitivity to cisplatin, docetaxel, gemcitabine, and vinblastine. Thus, GREM1 can predict prognosis and responses to immunotherapy and chemotherapy in BC patients, making it a potential biomarker and therapeutic target.