Institutional Review Board Research Articles

Implementation of a Multidisciplinary Enhanced Recovery After Surgery (ERAS) Program for Cytoreductive Surgery (CRS) With Hyperthermic Intraperitoneal Chemotherapy (HIPEC).

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) can be associated with prolonged hospital stays. A novel Enhanced Recovery After Surgery (ERAS) based on ERAS Society guidelines was designed and implemented. The primary outcome was ERAS compliance. Secondary outcomes included length of stay (LOS) and postoperative complications. A retrospective study on patients who underwent CRS/HIPEC between 2018 and 2022, with ERAS implementation in 2022. Health records were reviewed. Statistical analysis included descriptive statistics, Wilcoxon tests, Student t-test, and χ2 and binomial negative regression. Health Ethics Research Board approval was obtained. Eighty patients underwent CRS/HIPEC: 59 in the pre-ERAS group and 21 in the post-ERAS group. Groups were similar in age, comorbidities, and Peritoneal Carcinomatosis Index. ERAS compliance increased from 32.8% to 70.8% (p < 0.001). Median LOS decreased from 14 to 9 days (p < 0.001). Comparing pre-ERAS to post-ERAS showed no significant difference in the major morbidity rate (13.6% vs. 9.5%) or 30-day readmission (9.4% vs. 4.8%) and no mortalities. Controlling for patient characteristics, the mean LOS decreased by 6.94 days (p < 0.001). Implementation of an ERAS CRS/HIPEC program is safe and allows for improved compliance to ERAS protocols and a significant reduction in LOS.

INhaled Sedation versus Propofol in REspiratory failure in the Intensive Care Unit (INSPiRE-ICU1): protocol for a randomised, controlled trial

IntroductionSedation in mechanically ventilated adults in the intensive care unit (ICU) is commonly achieved with intravenous infusions of propofol, dexmedetomidine or benzodiazepines. Significant limitations associated with each can impact their...

Reporting ethical approval in case reports and case series in 12 consecutive years: A systematic review.

Our study describes the reported rate of the Institutional Review Board (IRB) approval, declaration of Helsinki (DoH), and informed consent in the case reports and case series and investigates factors associated with the ethical approval report. We searched PubMed for case reports and case series from 2006 to 2017. Annually, we obtained the first 20 articles of a case report cluster from 20 distinct publications. This analysis initially contained at least 2400 papers, with 100 papers each study design and year. Only 26 (5.4%) of 480 included studies reported IRB approval, DoH approval, and participant informed consent; 58 (12.1%) reported two out of three ethical statements (DoH, informed consent, IRB); and 151 (31.5%) reported only one, leading to nearly 245 studies (51.0%) did not report any ethical approval item. Both clusters mentioned the DoH the least. Only years, ages, ethical item types, and cluster types were associated with ethical reporting practices. This study found the serious under-reporting of ethical practices in both case reports and case series.

Infection control nursing competency model for nurses in intensive care units: A Delphi study

Intensive care unit (ICU) nurses require advanced expertise and skills in critical care and need infection control nursing competency (ICNC). Given the lack of research on it, this study aimed to develop a model of ICU nurses' ICNC. A Delphi panel consisting of experts in intensive care nursing and infection control was organized to provide discerning and professional perspective on ICNC. Approved by the Institutional Review Board, a 3-round Delphi survey was conducted via email from July to December 2023. The content validity ratio and the coefficient of variation were calculated for panel responses. Among 17, 15 nurses (88.2%) participated and completed the surveys. About80% were female, and the panel had an average working experience of 14.2years specifically in theICUs or infection control departments at hospitals. After the initial round, a preliminary model was developed, consisting of 10 main components and 59 subelements. After eliminating 5 elements with content validity ratio values below 0.49 in the second survey, the final model, consisting of 10 main components and 54 subelements, was confirmed in the third survey. ICU nurses' ICNC can be understood based on this study's results, and further research can be designed to improve this competency.

Protocol for a community-based, household-randomised, dose-response trial to assess the acceptability, nutritional effects and safety of double-fortified salt containing iodine and folic acid compared with iodised salt among non-pregnant Ethiopian women of reproductive age (DFS-IoFA).

The prevalence of neural tube defects (NTDs) is higher in Ethiopia than most other countries, and ~84% of Ethiopian women of reproductive age (WRA) have folate insufficiency, a major risk factor for NTDs. Salt fortification with folic acid is a potential strategy to improve women's folate status, but data are needed on the acceptability, nutritional impact and safety of folic acid fortification of iodised salt. The study is designed as a community-based, household-randomised, dose-response trial. A total of 360 non-pregnant WRA 18-49 years of age will be randomly assigned to one of three intervention arms: (1) iodised salt fortified with 30 ppm folic acid to provide ~200 µg folic acid/day; (2) iodised salt fortified with 90 ppm folic acid to provide ~600 µg folic acid/day; or (3) iodised salt (comparator). The preweighed salts will be delivered to participants' homes biweekly for 26 weeks; unused salt will be collected and weighed. Fasting, venous blood samples will be collected at baseline, end line and a randomly assigned intermediate time point for assessment of folate, iodine, vitamin B12 and other micronutrient status biomarkers. Women's dietary intakes, including discretionary salt consumption, will be measured using weighed food records; 24-hour urine specimens will be analysed for sodium and iodine excretion. Primary outcomes are women's consumption of study salts, change in biomarkers of folate and iodine status and prevalence of adverse events. Results will be analysed using analysis of covariance models to estimate group mean differences for continuous outcomes, controlling for baseline measurements, and log-binomial or modified Poisson regressions for categorical outcomes. Prespecified effect modifications will be explored. The study has been approved by the Ethiopian Public Health Institute's Institutional Review Board, and the protocol has been registered with ClinicalTrials.gov (registration number NCT06223854). Study results will be published in open access scientific journals and disseminated nationally in Ethiopia. NCT06223854.

Cryptosporidiosis in individuals with inflammatory bowel disease: a scoping review protocol

IntroductionCryptosporidiosis is a leading cause of moderate-to-severe diarrhoea globally, and, while it is often self-limited, in immunocompromised individuals, the infection can be associated with significant morbidity and mortality. Diagnosis might...

Effectiveness of using a vibration device to ease pain during upper extremity injections: A randomized controlled trial

Objectives: The current study aimed to evaluate the effectiveness of using a vibration device to ease pain during upper extremity injections. Specifically, the study aims to compare the pain levels of patients who receive the injection with and without the use of vibration therapy. The results of this study may have implications for improving patient outcomes and satisfaction during routine injection procedures. Material and Methods: This randomized controlled trial included patients aged 18 years or older who were scheduled to receive an injection in the upper extremity. A total of 60 patients were enrolled and randomized to either the intervention group or the control group using a computer-generated randomization sequence. The level of satisfaction and pain levels were assessed using a visual analog scale. The study was conducted in accordance with the Declaration of Helsinki and approved by the institutional review board. Results: The mean pain score immediately after the injection was 4.03 ± 2.11 out of 10 in the vibration group (n = 30), compared to 7.4 ± 1.37 out of 10 in the control group (n = 30) (P &lt; 0.001). Patients in the vibration group also reported higher levels of satisfaction and comfort during the injection (P &lt; 0.001). No adverse events were reported in either group. Conclusion: Our study proves that using a vibration device during upper extremity injections can effectively reduce postinjection pain and improve patient satisfaction. Further research is needed to explore this intervention’s long-term effects and feasibility in different clinical settings.

Thriving Through Pain: A Whole-Person and Resilience Comparative Study Using Mobile Health Application Technology for Individuals With Self-Reported Pain Challenges

BackgroundPain is a complex condition and affects one's life beyond physical symptoms. National pain management recommendations include a whole-person approach that includes strengths (or resilience). PurposeThe purpose of this study was to examine de-identified data from the MyStrengths+MyHealth application to examine, Strengths, Challenges, and Needs for the population and a subset of the data for those with and without self-reported Challenges in the Pain concept. DesignThis cross-sectional comparative study used de-identified consumer-generated whole-person strengths data from the MyStrengths+MyHealth (MSMH) application. MethodsData was collected from various community settings between 2019 and 2023 and approved by the University's Institutional Review Board. From the sample population (N=1737), we identified those with self-reported Pain (n=1280) and without self-reported Pain (n=457) and compared Strengths, Challenges, and Needs. ResultsThe sample population (N=1737) was largely in the age range of 45-64 years (51.2%), Male (56.4%), White (90.5%), non-Hispanic/Latino (86.6%), and Married (74.2%). The Pain group (n=1280) reported significantly fewer Strengths (p<0.001) and more average Challenges and Needs (p<0.001) than the Without Pain Group (n=457) across all concepts. For the Pain Group, the most frequent Strength reported was Role Change (70.5%), the most frequent Challenge Nutrition (96.1%), and the greatest Need was Income (89.9%). ConclusionsDespite reporting Challenges and Needs, the Pain Group identified many Strengths. The Pain Group identified Role Change (70.5%) as a top Strength was surprising and may suggest adaptability to chronic pain. MSMH has potential to empower individuals to provide a comprehensive whole-person assessment and resilience which may be particularly useful for those living with chronic pain. Clinical ImplicationsThis study has clinical implications for supporting the use of digital health tools such as mobile applications for capturing contextual data directly from patients to enable nurses to provide more accessible and personalized care to patients.

Morphometric analysis of pituitary gland using magnetic resonance imaging in Indian subjects

Background: Before the advent of magnetic resonance imaging (MRI), the radiological assessment of the hypothalamic-pituitary region relied on plain radiographs and computed tomography scans. However, contemporary medical practice now widely recognizes MRI as the preferred imaging modality for this purpose. The objective is to investigate variations in size and morphology of the pituitary gland associated with age and gender. Aims and Objectives: (a) The aims of this study were as follows: To establish normative measurements of pituitary gland in South Indian population. (b) To evaluate the relationship between gender, weight, height, and body mass index in different patients using conventional MRI sequences. Materials and Methods: This cross-sectional study, approved by the Institutional Review Board, included the enrolment of 140 normal individuals. The dimensions of the pituitary gland were assessed in 140 individuals exhibiting apparently normal pituitary gland function. The height and length of the pituitary gland were measured utilizing mid-sagittal T1-weighted images (T1-WI) obtained through MRI. The width of the pituitary gland was determined using coronal T1-WI, and the pituitary gland volume was subsequently calculated. Results: This study comprised 98 females and 102 males. The anteroposterior dimension, height, and volume of the pituitary gland showed statistically significant correlations with age (P&lt;0.05), while the transverse dimension did not show a significant correlation with age (P&gt;0.05). The shape of the pituitary gland was found to have statistically significant correlations with age and gender. Conversely, the transverse diameter, height, and volume of the pituitary gland showed no significant correlations. Conclusion: The findings underscore the importance of considering pituitary size, shape, and volume in the evaluation of neuroendocrine disorders.

Statistical Analyses Plan for “MAGnItude of cigarette substitutioN after Initiation oF e-cigarettes and its ImpaCt on biomArkers of exposure and potenTial harm in dual users”: MAGNIFICAT trial

BackgroundThe substitution of combustible cigarettes (CC) with non-combustible nicotine alternatives, such as e-cigarettes (EC), significantly lowers exposure to harmful chemicals. However, many individuals who use ECs continue smoking CCs, becoming dual users and remaining at increased risk of toxin exposure. This study will examine how the reduction in cigarettes smoked per day (CPD) after switching to ECs correlates with changes in biomarkers of exposure (BoE) and potential harm (BoPH) to evaluate the extent of harm in dual users. MethodsThe study is a prospective, non-randomised, observational, longitudinal cohort study in which 250 CC smokers will be invited to use EC as part of a smoking reduction/cessation strategy. Participants will be grouped in five dual use categories based on the change from baseline in CPD at 1, 3 and 6 months, based on self-reported use in the preceding 30 days. The primary outcome of interest is the mean absolute urinary 2-cyanoethyl mercapturic acid (2CyEMA), a well-validated BoE, also assessed at 1, 3 and 6 months. Other BoE will be assessed, together with exploration of the association between varying intensities of dual use and BoPH. The association between the dual use category and levels of BoE will be evaluated using analysis of variance (ANOVA), in order to understand which BoE are best suited to identifying different levels of dual use. Exploratory assessment of the value of BoPH will similarly be evaluated, to assess whether their predictive power extends from the binary smoker/non-smoker categorization to a more nuanced dual use categorization. The specific details of the own-brand CC will be available once smokers' enrollment in the study is complete. The EC used in the study will be the KIWI 2 Pen refillable pod system, with participants given the option to choose from three different flavored e-liquids: LEAF, MIDWAY, and GLACIAL, all containing 0.9% nicotine. For specialized equipment used for biomarker analysis please refer our previous publication: https://pubmed.ncbi.nlm.nih.gov/38584934/ ConclusionEC are increasingly adopted as a harm reduction strategy in CC smokers who wish to quit smoking, the outlined Statistical Analysis Plan (SAP) provides a robust approach to understand the impact of EC on CC use and to quantify the impact of dual use on clinical outcomes using BoPH. For statistical calculations we will use R software.The subject of this SAP manuscript – trial research – due to planned medical procedures, is a subject of verification by proper ERB (Ethics Review Board) in Poland and gained required approval prior to the start of the actions. The positive opinion was granted on 22nd February 2024, with the signature number 04/24.

Piloting a patient navigation programme for individuals living with dementia, their care partners and members of the care team: protocol for a mixed-methods evaluation

IntroductionInternationally, the number of individuals living with dementia continues to rise. Individuals living with dementia, their care partners and their care team face many barriers and challenges to accessing dementia...

Prospective Observational Study Of Surgical Site Infections In Obstetrics And Gynaecological Operations In Teaching Hospital

Background: Surgical site infections (SSI) are defined as infections occurring upto 30 days after surgery or (upto one year in patients receiving implants) and affecting either the incision or deep tissue at the operative site. SSIs are potential complications associated with any type of surgical procedure. Even though SSIs are among the most preventable hospital acquired infections, they still symbolize a significant burden in terms of patient’s morbidity and mortality leading to prolonged hospital stay and increase the patient susceptibility to other nosocomial infections affecting the financial condition of patients. Risk factors for SSIs are grouped as patient related, preoperative or pre pregnancy, intraoperative or intrapartum, and postoperative. SSI causes a substantial risk to patients and financial loses for health system because the multi-factorial causes achieving a measurable and sustained reduction in SSIs. In this context it becomes important to determine the prevalence of SSI, assess the magnitude of problem and provide a rationale to set priorities in infection control in the hospitals. Materials and Methods: The present prospective observational study was conducted on 200 patients in the Department of Obstetrics and gynaecology, at Dr B R Ambedkar Medical College and Hospital for a period of 12 months. Prior to the initiation of the study, Ethical and Research Committee clearance was obtained from Institutional Ethical Committee. Results: There was a significant statistical difference in the incidence of SSIs basing on the body mass index of subjects (pvalue:&lt;0.001). SSI incidence was high in morbidly obese subjects. There was a highly significant statistical difference in the incidence of SSIs basing on the history of previous surgeries of subjects (p-value: &lt;0.0001). SSI incidence was low in subjects with no history of previous surgeries. There was a highly significant statistical difference in the incidence of SSIs basing on the type of surgery (p-value: 0.48). SSI incidence was high in caesarean and low in tubectomy surgeries. There was a significant no statistical difference in the incidence of SSIs basing on the type of incision (p-value: 0.70). There was a highly significant statistical difference in the incidence of SSIs basing on the methods of skin closure (p-value: 0.002). SSI incidence was high in mattress method of skin closure and low in subcuticular method of skin closure. There was a highly significant statistical difference in the incidence of SSIs basing on the class of wound (p-value: 0.00001). SSI incidence was high in dirty wounds and low in clean wounds of skin closure. Conclusion: Although several preoperative risk factors (e.g., age, morbid obesity, ability to pursue a minimally invasive approach, type of gynaecologic surgery, type of incision, methods of skin closure, class of wound) may not be within the surgeon’s control, several evidence based interventions can limit the incidence of SSIs.

Prevalence and Predictors of Fear of Childbirth Among the Pregnant Women Attending a Tertiary Care Hospital in Imphal-East District Manipur, North-East India: A Cross-Sectional Study

Background: Fear of childbirth (FOC) is a feeling of uncertainty and anxiousness before, during or after delivery which may increase the risk of various physical problems and mental disorders thereby affecting maternal and infant morbidity and mortality. Objectives: To estimate the prevalence of fear of childbirth and to determine its associated factors among pregnant women. Methodology: A hospital-based cross-sectional study was conducted among pregnant women attending ante-natal clinic of a tertiary-care hospital in Imphal-East District of Manipur. A 30-item questionnaire was used for data collection. Descriptive statistics, univariate and multivariate logistic regression analysis were performed to test for association taking all variables with p &lt; 0.2 for model building for the adjusted analysis. A p value &lt;0.05 was taken as level of significance. Ethical approval was obtained from the Institutional Ethics Committee. Results: Out of 431 participants, fear of childbirth was seen in 36%. Increasing age of the respondent (AOR: 0.877) and residing in urban area (AOR: 0.548) showed a protective effect but respondents having past history of abortion (AOR: 2.054) and being in the third trimester of pregnancy (AOR: 1.964) were found to have an increased risk of having ‘Fear of childbirth’ (p&lt;0.005). Conclusions: Overall, 155 (36%) of women had fear of childbirth. It is important that healthcare professionals to be aware of fear of childbirth and ensure that pregnant women receive adequate health education, counselling during regular ANC checkups.

Patch Test as a Helping Hand in Farmers with Hand Eczema

Background: Farmers are particularly exposed to a large number of allergens including fertilizers, plant allergens, soil, and manure which may be aggravated by sun exposure. Hand eczema can cause significant morbidity affecting the patient’s occupational work. Patch test is an important diagnostic tool in differentiating between irritant contact dermatitis and allergic contact dermatitis and in the latter, to identify the culprit allergen causing hand eczema. Aims: This study aimed to identify the role of patch tests in hand eczema in farmers and to identify the common causative allergens of hand eczema in farmers. Materials and Methods: Fifty farmers aged 18 years and above presenting with hand eczema were enrolled in the study after taking approval from the institutional ethics committee. Patients who were pregnant, lactating, on systemic steroids, and immunosuppressants were excluded from the study. Patch test was done using the Indian Standard series of 20 allergens approved by the Contact Dermatoses Forum of India applied to the back of the patient. The first reading was taken at 48 h, 30 min after removal of the patch, and another reading was taken at 96 h. The results were interpreted according to the International Contact Dermatitis Research Group criteria. Results: Out of 50 patients, there were 28 males and 22 females. Hyperkeratotic eczema was the most common morphology (38%). The most common allergen was parthenium (44%) followed by potassium dichromate (22.7%) and nickel (9%). Limitations: A larger sample size would have helped to better substantiate the findings of the study. Conclusion: There is an undeniable relationship with the occupation of the individual wherein agriculturists and masons had the maximum predisposition. The most common cause of hand eczema in this study was parthenium in farmers and also other allergens played an important role such as potassium dichromate, nickel, and paraphenylenediamine.

Psychological effects of Manipur violence among the internally displaced persons residing in relief camps across Imphal valley of Manipur – A cross-sectional study

ABSTRACT Background: Conflict and violence lead to the displacement of millions of people. A significant number of those who are exposed to potentially traumatic events, such as conflict and violence, may develop post-traumatic stress disorder (PTSD) and other mental health or behavioral conditions. This study plans to estimate the prevalence and associated factors of PTSD and generalized anxiety disorder (GAD) among internally displaced persons residing in different relief camps during Manipur violence. Materials and Methods: Community-based cross-sectional study was conducted among internally displaced persons (IDPs) residing in relief camps located in Imphal East District of Manipur using a pretested, semistructured, validated questionnaire consisting of PTSD checklist for DSM 5 (PCL-5) and the Generalized Anxiety Disorders Assessment tool (GAD-7). The study was approved by the Institutional Ethics Committee. Results: More than half (65.8%) of the respondents were found to have PTSD. One-fourth of the respondents (24.8%) were found to have moderate anxiety, and 15.2% have severe anxiety. Female gender, age between 20 and 59 years, marital status, and employment status after conflict were found to be significantly associated with PTSD. Marital status and witnessed destruction of property were found to be significantly associated with GAD. Around 3/4th of the respondents (235, 75.8%) reported witnessing destruction and burning of property, and 29 (9.4%) reported witnessing death of family members or friends. Around 58 (18.7%) were currently separated from family, and 25 (8.1%) had experienced some kind of trauma at the time of displacement. Conclusion: A majority of the participants have PTSD, whereas 15.2% have severe anxiety. Efforts and interventions should be made to improve the psychological well-being through psychological support and counseling from mental health professionals and provision of vocational training for income generation for the IDPs.

Role of CD64 and myeloperoxidase as biomarkers for early diagnosis of sepsis in pediatric intensive care unit

Globally, sepsis is the primary cause of death for children. While research conducted on adults has a significant impact on the diagnosis and treatment of sepsis in newborns and young children, there are significant factors that are pertinent to pediatrics as well. This prospective case-control study was conducted during the period from August 2020 to October 2022 after approval by the institutional ethical committee. The study included 48 critically ill children admitted at the Pediatric intensive care unit and 30 apparently healthy children as a control group. Laboratory investigations including complete blood picture, C-reactive protein (CRP), blood culture and sensitivity and plasma level of cluster of differentiation 64 (CD64) and myeloperoxidase (MPO) were investigated for all participants. A daily follow up for the signs of systemic inflammatory response syndrome (SIRS) or sepsis was done, and the patients were divided into SIRS and non-SIRS subgroups then patients were divided into two groups according to the presence of severe sepsis. A follow up CD64 and MPO sample were withdrawn from them to assess their prognostic value. SIRS was reported in 39.58 % of patients while severe sepsis was reported in 20.8%. CD64 and MPO were significantly higher in cases than controls (p= 0.003, p&lt;0.001, respectively) and, in patients with SIRs and severe sepsis CD64 was 1559.00± 367.09 pg/ml and 1547.9 4± 436.14 pg/ml, respectively. Also, MPO was significantly higher in patients with SIRS (113.58± 25.19 mU/ml) and severe sepsis (111.70± 26.50 mU/ml). CD64 and MPO significantly increased after development of sepsis in admitted patients. ROC was significantly higher for CD64 and MPO at admission than that for CRP at admission (p=0.123, p=0.014, respectively). In conclusion, plasma level of CD64 and MPO in peripheral blood can be considered an early sensitive marker for the detection and follow up of pediatric sepsis.

Utility of Sonoelastography and Magnetic Resonance Imaging in Characterization of Thyroid Nodules.

To evaluate thyroid nodules with sonoelastography and magnetic resonance imaging (MRI). The study included 28 patients with 40 thyroid nodules. Clearance was obtained from the institute's ethical clearance committee. Patients with pure cystic nodules or nodules with eggshell calcification, diffuse thyroid pathology (such as Graves' disease, Hashimoto's thyroiditis, De Quervain thyroiditis, and Riedel's thyroiditis), inaccessible nodules via fine needle aspiration cytology (FNAC), or patients with a history of thyroid gland surgery were excluded from the study. Strain elastography was performed on a Phillips iU22 machine, producing qualitative color-coded strain maps (graded using the Rago 5-point system) and semiquantitative strain ratios. MRI was performed on a Phillips ACHIEVA 1.5T magnet with a head and neck coil. Rago scores statistically correlated (χ2 = 18.052, p < 0.001) with malignant nodules, and using the receiver operating characteristic (ROC) curve, the area under the ROC curve (AUROC) for the mean strain ratio predicting malignant outcomes was 0.88 [95% confidence interval (CI): 0.767-0.992], which was also statistically significant (p < 0.001). A cutoff of mean strain ratio ≥2.48 predicted malignant outcomes with 100% specificity. T2 signal intensity ratio (SIR) and apparent diffusion coefficient (ADC) values were not statistically significant in predicting malignant outcomes. Kinetic curves were statistically significant for Rago scores (χ2 = 11.356, p = 0.045); however, no significant difference was found in predicting malignant outcomes. We concluded that sonoelastography, along with grayscale ultrasound, is a useful noninvasive technique for predicting histological outcomes. However, MRI should largely be reserved as a problem-solving tool rather than a standalone imaging modality. The kinetic curves show some degree of overlap between histologically distinct diseases, and thus large-scale multicenter trials are needed for further standardization.

The Robison D. Harley, MD Childhood Glaucoma Research Network International Pediatric Glaucoma Registry: The First 872 Cases

PurposeTo report on epidemiologic data from an international, centralized pediatric glaucoma database of 872 patients, focusing on genetic and clinically significant factors. DesignDatabase study utilizing retrospective analysis. Subjects872 children, both female and male, were included in the database. After accounting for database coding errors, data from 865 patients with pediatric glaucoma were analyzed. Number of eyes analyzed fluctuated for each variable. MethodsThe registry is an open access, no charge, REDCap database. Participating clinical centers input data with local Institutional Review Board approval and subsequently have access for research purposes. We retrospectively reviewed 872 patients, comparing demographics, family history, country, disease presentation, and CGRN diagnoses. Analyses for each variable were conducted in SPSS Software v.28.0. Chi-square analyses were performed for nominal data, and ordinal and continuous data were analyzed using Mann-Whitney test, analysis of variance or Kruskal-Wallis tests with multiple comparisons. Main Outcome MeasuresCGRN glaucoma type and markers of clinical severity by country (laterality, cup-to-disc ratio (CTD), corneal diameter, opacification, edema; visual acuity (VA), intraocular pressure (IOP), Haab striae, axial length). Results20 clinical sites from 10 countries entered data. Centers in the USA, India, and Iran input the most data. In the USA, open angle glaucoma following cataract surgery was most common, while in India and Iran it was primary congenital glaucoma neonatal onset. Bilateral disease was more frequent in India and Iran compared to the USA (X2 = 50.6, p<0.001). Clinical measures of severity were typically worse in India compared to the USA. This included increased CTD (X2 = 24.0, p = 0.002), increased corneal diameter (X2 = 8.9, p = 0.01), presence of corneal opacification (X2 = 10.7, p = 0.001), presence of corneal edema (X2 = 11.7, p<0.001), and worse VA (U = 873.5, p<0.001). IOP and presence of Haab striae were not associated with country (p>0.05), while axial length was increased in the USA by an average of 1.04mm (U = 5787, p = 0.002). ConclusionsThis registry has potential to advance our understanding of pediatric glaucoma. Differences in family history, disease presentation, and glaucoma type suggest unique country phenotypes. Registry expansion may allow for insight into best practices for pediatric glaucoma.

Feasibility of a culturally adapted technology-delivered, family-based childhood obesity intervention for Latino/Hispanic families in rural Nebraska: the Hispanic Family Connections study protocol

IntroductionAddressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity and healthy eating among Latino/Hispanic (L/H) families living in rural communities is an important priority. However,...

E-scooter-related imaging: a new emerging high-energy trauma patient.

To quantify the volume and nature of radiological imaging performed for e-scooter related trauma presentations in a tertiary referral centre and to identify common radiological pattern of injuries. Our study received institutional review board approval. We retrospectively reviewed all anonymised radiological imaging studies performed in our institution for the term 'scooter' or 'e-scooter' between July 2020 and July 2021. The patient demographics, number of imaging studies performed and modality type as well as the nature of injuries identified were recorded. Within the study period, 147 patients with e-scooter-related injuries were referred for radiological imaging. Forty-two (29%) of those patients had positive radiological findings. The vast majority of injuries on radiographs were upper limb injuries typical of a fall on outstretched hand (FOOSH) pattern. Thirty-two patients (22%) required advanced diagnostics with CT or MRI with 11 of these patients having positive findings. Four patients suffered significant head injuries including skull fractures and/or intracranial haemorrhage. Five patients suffered facial bone fractures, and 2 suffered spinal fractures. One patient suffered a handlebar abdominal trauma with a resulting large bowel injury ultimately requiring bowel resection. E-scooter-related injuries represent a new and emerging high-energy trauma patient. These patients demonstrate injury patterns similar to other high-energy trauma such as road traffic accidents. Although the most common injuries are musculoskeletal upper limb injuries typical of FOOSH, a large proportion of these require advanced diagnostic imaging (CT, MRI) which were commonly positive for significant injuries.