Registry Record Research Articles

Abstract Su903: Prognostic Value of Early Grey-White Ratio in the presence of Hypercapnia after Cardiac Arrest

Background: Cerebral edema following cardiac arrest can be quantified by measuring the ratio of grey matter to white matter radiodensity (GWR). Decreased GWR may reflect edema from irrecoverable neuronal cell death or reversible hyperemia driven by hypercapnia. We tested for an interaction between GWR and partial pressure of carbon dioxide (PCO2) predicting outcomes. Methods: We identified comatose post-arrest patients treated at our single center between 2010 and 2023 who underwent brain computed tomography (CT) imaging within 24 hours and PCO2 measured within one hour of CT. We extracted demographics, GWR, and PCO2 from our prospective registry and electronic health record. We scaled and centered data, then fit a multivariate logistic model to quantify the interaction between GWR and PCO2 in predicting survival. Results: Of 901 included patients, 356 (40%) were female, median [IQR] age was 61 [51-70], and 221 (25%) survived to discharge. CTs were obtained 4.18 [2.8-5.7] hours post-arrest. PCO2 was sampled within 36 median [24-47] minutes of CT. The median PCO2 was 47 [39-59] mmHg. GWR predicted survival (coefficient estimate 1.16, 95% confidence interval [CI], 0.91-1.44, p < 0.001, but PCO2 (-0.11, 95% CI -0.32-0.09, p = 0.29) did not. There was no significant interaction between GWR and PCO2 (0.009, 95% CI -0.24-0.29, p = 0.95). Conclusion: There is no evidence of PCO2 modifying the association of early GWR with survival after resuscitation from cardiac arrest.

Extended versus Standard Proning Duration for COVID-19-associated Acute Respiratory Distress Syndrome: A Target Trial Emulation Study.

Rationale: Prone positioning for ⩾16 hours in moderate-to-severe acute respiratory distress syndrome (ARDS) improves survival. However, the optimal duration of proning is unknown. Objectives: To estimate the effect of extended versus standard proning duration on patients with moderate-to-severe coronavirus disease (COVID-19) ARDS. Methods: Data were extracted from a five-hospital electronic medical record registry. Patients who were proned within 72 hours of mechanical ventilation were categorized as receiving extended (⩾24 h) versus standard (16-24 h) proning based on the first proning session length. We used a target trial emulation design to estimate the effect of extended versus standard proning on the primary outcome of 90-day mortality and secondary outcomes of ventilator liberation and intensive care unit (ICU) discharge. Analytically, we used inverse probability of treatment weighted (IPTW) Cox or Fine-Gray regression models. Results: A total of 314 patients were included; 234 received extended proning, and 80 received standard-duration proning. Patients who received extended proning were older, had greater comorbidity, were more often at an academic hospital, and had shorter time from admission to mechanical ventilation. After IPTW, characteristics were well balanced. Unadjusted 90-day mortality in the extended versus standard proning groups was 39% versus 58%. In doubly robust IPTW analyses, we found no significant effects of extended versus standard proning duration on mortality (hazard ratio [95% confidence interval], 0.95 [0.51-1.77]), ventilator liberation (subdistribution hazard, 1.60 [0.97-2.64], or ICU discharge (subdistribution hazard, 1.31 [0.82-2.10]). Conclusions: Using target trial emulation, we found no significant effect of extended versus standard proning duration on mortality, ventilator liberation, or ICU discharge. However, given the imprecision of estimates, further study is justified.

Improving Identification of Patients Experiencing Homelessness in the Electronic Health Record: A Curated Registry Approach.

Identification of persons experiencing homelessness (PEH) within healthcare systems is critical to facilitate patient and population-level interventions to address health inequities. We created an enhanced electronic health record (EHR) registry to improve identification of PEH within a safety net healthcare system. We compared patients identified as experiencing homelessness in 2021, stratified by method of identification (i.e., through registration data sources versus through new EHR registry criteria). Sociodemographic and clinical characteristics, healthcare utilization, engagement with homeless service providers, and mortality. In total, 10,896 patients met the registry definition of a PEH; 30% more than identified through standard registration processes; 78% were identified through only one data source. Compared with those identified only through registration data, PEH identified through new registry criteria were more likely to be female (42% vs. 25%, p < 0.001), Hispanic/Latinx or Black/African American (30% versus 25% and 25% vs. 18%, p < 0.0001), and Medicaid or Medicare beneficiaries (74% vs. 67% and 16% vs.10%, respectively, p < 0.0001). New data sources also identified a higher proportion of patients: at extremes of age (16% < 18years and 9% ≥ 65years vs. 2% and 5%, respectively, p < 0.0001), with increased clinical risk (31% with CRG 6-9 vs. 18%, p < 0.0001), and with a mental health diagnosis (56% vs. 42%, p < 0.0001), and a lower proportion of patients with a substance use diagnosis (39% vs. 54%, p < 0.0001) or criminaljustice involvement (8% vs. 15%, p < 0.0001). Newly identified patients were more likely to be engaged in primary care (OR 2.03, 95% CI 1.83-2.26) but less likely to be engaged with homeless service providers (OR 0.70, 95% CI 0.63-0.77). Commonly utilized methods of identifying PEH within healthcare systems may underestimate the population and introduce reporting biases. Recognizing alternate identification methods may more comprehensively and inclusively identify PEH for intervention.

Breast Cancer Screening Interval: Effect on Rate of Late-Stage Disease at Diagnosis and Overall Survival.

Controversy continues regarding the effect of screening mammography on breast cancer outcomes. We evaluated late-stage cancer rate and overall survival (OS) for different screening intervals using a real-world institutional research data mart. Patients having both a cancer registry record of new breast cancer diagnosis and prediagnosis screening history between 2004 and 2019 were identified from our institutional research breast data mart. Time interval between the two screening mammograms immediately preceding diagnosis and the time to cancer diagnosis were determined. Screening interval was deemed annual if ≤15 months, biennial if >15 and ≤27 months, intermittent if >27 months, and baseline if only one prediagnosis screen was known. The primary end point was late-stage cancer (TNM stage IIB or worse), and the secondary end point was OS. The association of screening interval and late-stage cancer was analyzed using multivariable logistic regression adjusting for prediagnosis characteristics. Proportional hazards regression was used for survival analysis. Potential lead time was analyzed using survival from a uniform fixed time point. In total, 8,145 patients with breast cancer had prediagnosis screening mammography in the timeframe. The percentage of late-stage cancers diagnosed increased significantly with screening interval with 9%, 14%, and 19% late stages for annual, biennial, and intermittent groups (P < .001), respectively. The trend persisted regardless of age, race, and menopausal status. Biennial and intermittent groups had substantially worse OS than the annual screened group, with relative hazards of 1.42 (95% CI, 1.11 to 1.82) and 2.69 (95% CI, 2.11 to 3.43), respectively, and 1.39 (95% CI, 1.08 to 1.78) and 2.01 (95% CI, 1.58 to 2.55) after adjustment for potential lead time. Annual mammographic screening was associated with lower risk of late-stage cancer and better OS across clinical and demographic subgroups. Our study suggests benefit of annual screening for women 40 years and older.

Empowering mind-body wellness: effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy

BackgroundBeing diagnosed with Breast Cancer (BC) is a crisis that throws the patient’s life out of balance. Cancer-related fatigue is a debilitating sign experienced by women during and after BC treatment. Regular physical exercise may help mitigate patients’ fatigue, enhance coping abilities, improve their quality of life, and overall well-being. In parallel, psychological interventions are geared toward normalizing the lived painful experiences among oncology patients.Objectiveto examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.MethodsA quasi-experimental study was conducted in the Oncology Surgical Department and chemotherapy unit at the Alexandria Main University Hospital, Egypt. A total of 60 women were randomly allocated to either to the study or the control groups. Women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping while the control group received the routine care.ResultsThe study revealed a significant decline in the fatigue mean scores among participants in the intervention group from 136.10 ± 27.76 to 98.43 ± 25.99 (p < 0.001). Similarly, there was a significant decrease in the patients’ mean scores of maladaptive coping, helplessness/ hopelessness (p = 0.014), and anxious preoccupation (p = 0.008). In contrast, there is a noticeable increment in the scores of adaptive coping, such as fighting spirit (p = 0.012), cognitive avoidance (p = 0.002), and fatalism (p = 0.009).ConclusionBundling seated exercises and psychological rehabilitation interventions using the teach-back approach have been proven to be simple and inexpensive non-pharmacological methods of reducing cancer-related fatigue and improving coping skills among women post-mastectomy.Trial registration numberNCT06360276, ClinicalTrails.gov, Retrospectively registered (April 8th, 2024), URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT06360276.

Update: Vitamin D3 and calcium carbonate supplementation for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology (VITALITY trial): study protocol for a randomised placebo-controlled trial

BackgroundOf the 2 million children living with HIV globally, 90% live in sub-Saharan Africa. Despite antiretroviral therapy, longstanding HIV infection is associated with several chronic complications in children including growth failure, particularly stunting and delayed puberty. Vitamin D deficiency, which is highly prevalent among children living with HIV in sub-Saharan Africa, has further adverse impact on bone health. This trial aims to establish whether supplementation with vitamin D3 and calcium carbonate improves musculoskeletal health among peripubertal children living with HIV. This paper is an update to an already existing protocol that was previously published in Trials in 2022 and details changes in the trial outcomes.Methods/designWe will conduct an individually randomised, double-blinded, placebo-controlled trial of weekly high-dose vitamin D3 (20,000 IU) plus daily calcium carbonate (500 mg) supplementation for 48 weeks. Eight hundred and forty children living with HIV aged 11–19 years taking ART for ≥ 6 months will be enrolled and followed up for 96 weeks. The primary outcome is DXA-measured total body less-head bone mineral density Z-score (TBLH-BMD) at 48 weeks and is an update to the previous primary outcome total body less-head bone mineral content adjusted for lean mass (TBLH-BMCLBM) Z-score. The primary outcome was updated to address the substantial differences in distributions of TBLH-BMCLBM Z-score between the two sites as a result of software differences of the DXA machines. Secondary outcomes are DXA-measured TBLH-BMD Z-score adjusted for height at 48 weeks a new secondary outcome, lumbar spine bone mineral apparent density Z-score, number of respiratory infections, lean muscle mass and grip-strength at 48 and 96 weeks, and TBLH-BMD Z-score at 96 weeks. Sub-studies will investigate the effect of the intervention on vitamin D3 pathway metabolites and markers of bone turnover, intestinal microbiota, and innate and acquired immune function.DiscussionThis is the largest trial to date of vitamin D supplementation in children living with HIV. Intervening to address deficits in bone accrual through childhood is critical for optimising adolescent and early adult bone health, and prevention of later adult osteoporotic fractures. Trial results will draw attention to the need to screen for and treat long-term comorbidities in children living with HIV in resource-limited settings.Trial registrationPan African Clinical Trials Registry PACTR20200989766029. Registered on September 3, 2020. URL of trial registry record: https://pactr.samrc.ac.zaTrial statusParticipant follow-up completed; data analysis ongoing.

Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial

BackgroundChildren with genetic conditions are at increased risk for mental health and neurodevelopmental problems, often accompanied by significant parental distress. Genetic and family factors can impact children and parents’ mental health. Early parenting interventions, like the Incredible Years® programs, have demonstrated to improve parental distress and children’s mental health. The recent version for young children with language delays or autism spectrum disorder (IY-ASLD®) has shown to be feasible and effective to support parents in their children’s developmental trajectories. The effectiveness of treatments for children with genetic conditions and neurodevelopmental problems is largely unexplored, leaving significant gaps in evidence-based options. Clinicians lack guidance, especially when patients exhibit language or social communication impairments but do not meet diagnostic criteria for a full-blown autism spectrum disorder (ASD). We aim to fill this gap, providing evidence on the feasibility and effectiveness of the IY-ASLD® intervention for such patients.MethodsWe designed a prospective multicenter pragmatic randomized controlled trial including approximately 68 children aged 3 to 7 years, recruited from three tertiary care reference hospitals. Inclusion criteria will necessitate genetic confirmation of a neurodevelopmental disorder along with language, communication, or socialization difficulties. Individuals with an ASD diagnosis will be excluded. All subjects are included in a territorial register for rare conditions (ReMin, Registre de Malalties Minoritàries de Catalunya). Families will randomly be assigned to the intervention or the control group. The intervention will be held online by clinical psychologists and child and adolescent psychiatrists.DiscussionOur group has recently piloted the online implementation of the IY-ASLD® intervention for the first time in Spain, for parents of children with language delays, socialization difficulties, or ASD, but not genetically determined. Our multicenter research consortium is well-positioned to recruit patients with rare conditions and implement efficient treatment pathways within the National Health System. Given the geographical dispersion of families affected by rare conditions, the online format offers logistical advantages and improved therapy access, enhancing homogeneity across all patients. The results of this study will inform clinicians and policymakers about evidence-based treatment options for this vulnerable and overlooked group of young children.Trial registrationClinicalTrials.gov NCT06125093. Date of registration: first submitted 2023–10-23; first posted 2023–11-09. URL of trial registry record.

In Search of the Truth: Choice of Ground Truth for Predictive Modeling of Trauma Team Activation in Pediatric Trauma.

Assigning trauma team activation (TTA) levels for trauma patients is a classification task that machine learning models can help optimize. However, performance is dependent on the "ground-truth" labels used for training. Our purpose was to investigate 2 ground truths, the Cribari matrix and the Need for Trauma Intervention (NFTI), for labeling training data. Data were retrospectively collected from the institutional trauma registry and electronic medical record, including all pediatric patients (age <18 years) who triggered a TTA (January 2014 to December 2021). Three ground truths were used to label training data: (1) Cribari (Injury Severity Score >15 = full activation), (2) NFTI (positive for any of 6 criteria = full activation), and (3) the union of Cribari+NFTI (either positive = full activation). Of 1,366 patients triaged by trained staff, 143 (10.47%) were considered undertriaged using Cribari, 210 (15.37%) using NFTI, and 273 (19.99%) using Cribari+NFTI. NFTI and Cribari+NFTI were more sensitive to undertriage in patients with penetrating mechanisms of injury (p = 0.006), specifically stab wounds (p = 0.014), compared with Cribari, but Cribari indicated overtriage in more patients who required prehospital airway management (p < 0.001), CPR (p = 0.017), and who had mean lower Glasgow Coma Scale scores on presentation (p < 0.001). The mortality rate was higher in the Cribari overtriage group (7.14%, n = 9) compared with NFTI and Cribari+NFTI (0.00%, n = 0, p = 0.005). To prioritize patient safety, Cribari+NFTI appears best for training a machine learning algorithm to predict the TTA level.

P-366 Short- and long-term safety outcomes in patients undergoing fertility preservation (FP) with controlled ovarian stimulation prior to chemotherapy

Abstract Study question The Impact of pre-chemotherapy fertility preservation (FP) with controlled ovarian stimulation (COS) on mortality and complications in cancer patients Summary answer The 5-year survival was higher in women who proceeded with FP than those who did not. What is known already FP in the form of egg/embryo freezing is a well-established option to preserve fertility in patients requiring gonadotoxic treatment. This method introduces a slight delay in chemotherapy initiation, raising theoretical concerns about its impact on long-term patient outcomes. Additionally, safety concerns exist for estrogen-sensitive pathologies. However, data on safety outcomes, especially mortality and cancer recurrence in women undergoing fertility preservation, remain limited. Study design, size, duration This study utilized a prospectively collected database of 603 patients referred from the UK South and South East cancer network for fertility preservation to a tertiary Assisted Conception Unit between 2003 and 2019. Participants/materials, setting, methods All female patients attended the Fertility Preservation Service post-cancer diagnosis to discuss options. Patient demographics, stimulation details, and treatment outcomes were recorded. Living status was confirmed up to January 2024 through Health Record Registry. Data analysis included basic demographics, hazard ratios, and 5-year survival analysis, with a log-rank test comparing patients who received or did not receive fertility preservation treatment. Main results and the role of chance As many as 603 patients were counselled re: FP over the studied period. The biggest majority of patients n = 320 (53%) had a diagnosis of breast cancer, followed by 67 patients (11.1%) presenting with lymphomas. The majority of counselled patients (n = 340 (56.4%)) went ahead with fertility preservation. Mean age of participants was 32.7 with an average BMI of 24.6, average AMH of 19.2 pmol/L, and median AFC of 15. Short term complication was estimated at 2% of the sample. Successful stimulation was noted in almost all cases (cancellation rate 1.5%) requiring on average 14 days to complete the treatment. A short protocol was mainly used (98% of cases) with a median daily FSH injection at 300 IU/L and an average oocyte yield of 14. Mortality in patients who received fertility preservation was estimated and the respective hazard ratio was 0.74 (95% CI 0.47 to 1.15, p = 0.18). With regards to survival, the log-rank test yielded a chi-square value of 3.9 with 1 degree of freedom. The resulting p-value was 0.05, indicating a statistically significant difference in survival probabilities between patients who underwent fertility preservation compared to those who did not (p = 0.05). Limitations, reasons for caution Information on the cause of death was unavailable, limiting the ability to minimize bias and estimate disease recurrence. However, the young age of the patient population reduces the likelihood of death due to unrelated medical conditions. Wider implications of the findings The data suggests that fertility preservation with controlled ovarian stimulation is a safe option for cancer patients. This finding provides reassurance to patients considering this well-established fertility treatment, offering realistic chances of survival. Trial registration number not applicable

Institutional Guideline May Not Be Enough to Change Practice in the Management of Traumatic Hemothorax (HTX) and Pneumothorax (PTX) Management

Traumatic hemothorax and pneumothorax (HTX/PTX) are traditionally treated with large-bore chest tubes, which can lead to pain and complications. Recent studies suggest pigtail catheters can be utilized as a non-inferior alternative. The Departments of Surgery and Emergency Medicine at NewYork Presbyterian – Weill Cornell Medical Center developed an institutional guideline to standardize tube size for treating traumatic HTX/PTX, aiming to reduce the use of large-bore thoracotomy tubes without causing adverse patient outcomes. This project at NYP-WCM included patients over 18 years of age admitted with thoracic injuries resulting in HTX or PTX treated with a chest tube from January 2022 to November 2023. Patients were identified through ICD codes in the trauma registry and electronic medical record. The primary outcome was adherence to the newly developed guideline for placing thoracostomy tubes. Conversion from pigtail to larger-bore chest tube and other adverse events were secondary outcomes. We identified 18 pre-guideline and 27 post-guideline HTX/PTX patients meeting the criteria. Before the guideline implementation, 15 out of 18 patients (83%) received care consistent with the guideline (no large-bore chest). After implementation, 25 out of 27 patients (93%) received care consistent with the guideline. Based on chart review, none of the patients in the pigtail cohort experienced complications or required conversion to a larger chest tube. Although the impact was modest, implementation of the institutional guideline correlates with a reduction in “unnecessary” large-bore chest tubes for treating traumatic HTX/PTX and showed a trend toward pigtail adoption. Placement of pigtails was not linked to negative complications or treatment failure, indicating a non-inferior safety and effectiveness profile for addressing traumatic HTX/PTX.

Premature Death, Suicide, and Nonlethal Intentional Self-Harm After Psychiatric Discharge

There is a need for representative research on serious adverse outcomes following discharge from psychiatric hospitalization. To compare rates of premature death, suicide, and nonlethal intentional self-harm after psychiatric discharge with rates in the general population and investigate associations of these outcomes with relevant variables associated with the index psychiatric hospitalization. This retrospective cohort study included all residents from Catalonia, Spain (7.6 million population), who had psychiatric hospitalizations between January 1, 2014, and December 31, 2018, and were older than 10 years at the index (first) hospitalization. Follow-up was until December 31, 2019. Statistical analysis was performed from December 1, 2022, through April 11, 2024. Socioeconomic status, psychiatric diagnoses, duration of index hospitalization, and number of previous psychiatric hospitalizations. Postdischarge premature death (ie, all-cause death before age 70 years) and suicide (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision [ICD-10] code range X60-X84), identified using mortality data, and postdischarge nonlethal intentional self-harm, identified using electronic health record and self-harm case register data. Standardized mortality ratios (SMRs) compared rates of premature death and suicide between the cohort and the general population. Fully adjusted, multivariable, cause-specific Cox proportional hazards regression models for the 3 outcomes were fitted. A total of 49 108 patients discharged from psychiatric hospitalization were included (25 833 males [52.6%]; mean [SD] age at discharge, 44.2 [18.2] years). During follow-up, 2260 patients (4.6%) died prematurely, 437 (0.9%) died by suicide, and 4752 (9.7%) had an episode of nonlethal intentional self-harm. The overall SMR for premature death was 7.5 (95% CI, 7.2-7.9). For suicide, SMR was 32.9 (95% CI, 29.9-36.0) overall and was especially high among females (47.6 [95% CI, 40.2-54.9]). In fully adjusted sex-stratified hazard models, postdischarge premature death was associated with cognitive disorders (adjusted hazard ratio [AHR], 2.89 [95% CI, 2.24-3.74] for females; 2.59 [95% CI, 2.17-3.08] for males) and alcohol-related disorders (AHR, 1.41 [95% CI, 1.18-1.70] for females; 1.22 [95% CI, 1.09-1.37] for males). Postdischarge suicide was associated with postdischarge intentional self-harm (AHR, 2.83 [95% CI, 1.97-4.05] for females; 3.29 [95% CI, 2.47-4.40] for males), with depressive disorders (AHR, 2.13 [95% CI, 1.52-2.97]) and adjustment disorders (AHR, 1.94 [95% CI, 1.32-2.83]) among males, and with bipolar disorder among females (AHR, 1.94 [95% CI, 1.21-3.09]). Postdischarge intentional self-harm was associated with index admissions for intentional self-harm (AHR, 1.95 [95% CI, 1.73-2.21] for females; 2.62 [95% CI, 2.20-3.13] for males) as well as for adjustment disorders (AHR, 1.48 [95% CI, 1.33-1.65] for females; 1.99 [95% CI, 1.74-2.27] for males), anxiety disorders (AHR, 1.24 [95% CI, 1.10-1.39] for females; 1.36 [95% CI, 1.18-1.58] for males), depressive disorders (AHR, 1.54 [95% CI, 1.40-1.69] for females; 1.80 [95% CI, 1.58-2.04] for males), and personality disorders (AHR, 1.59 [95% CI, 1.46-1.73] for females; 1.43 [95% CI, 1.28-1.60] for males). In this cohort study of patients discharged from psychiatric hospitalization, risk for premature death and suicide was significantly higher compared with the general population, suggesting individuals discharged from psychiatric inpatient care are a vulnerable population for premature death and suicidal behavior.

Effect of low-level laser therapy on en masse retraction in females with bimaxillary dentoalveolar protrusion : A single-center randomized clinical trial.

Acceleration of tooth movement has gained remarkable attention during the last decade. The aim of this study was to evaluate the effect of low-level laser therapy (LLLT) on en masse retraction of upper anterior teeth in adult women with bimaxillary dentoalveolar protrusion. In this two-arm parallel trial, 36women with bimaxillary dentoalveolar protrusion were randomly divided into two equal groups. Eligibility criteria included classI Angle molar relationship, good general and oral health as well as no systemic disease or syndrome. Four temporary anchorage devices (TADs) were used in the upper and lower arches for anchorage purposes. A 0.019×0.025-inch stainless steel wire with crimped hooks just distal to the maxillary canines was inserted. Nickle titanium (NiTi) closed coil springs (200 g/side) were employed for en masse retraction following extraction of the first premolars. In the laser group (LG), retraction of the upper anterior teeth was done along with the application of LLLT on days0, 3, 7, and 14 after extraction and then repeated biweekly until the end of retraction. Retraction was completed without LLLT application in the nonlaser group (NLG). Data concerning the rate of retraction as well as first molars and anterior positional changes were gained from digitized models and cone beam computed tomography (CBCT) scans taken just before extraction and at the end of retraction. Treatment-associated pain and root resorption were evaluated using visual analogue scale (VAS) and CBCT scans, respectively. Four patients dropped out prior to follow-up. The duration of retraction was 10.125 ± 2.876 and 13.643 ± 3.455 months in the LG and NLG, respectively. The LG showed astatistically significant faster rate of en masse retraction (0.833 ± 0.371 mm/month) compared to the NLG (0.526 ± 0.268 mm/month; P ≤ 0.035). The observed root resorption was significantly less in the LG (P ≤ 0.05) with comparable pain scores in both groups. Within the constraints of the parameters of the LLLT used in the current study and despite the statistically significant results on the rate of en masse retraction and the associated root resorption, LLLT did not demonstrate aclinically relevant effect that justifies its use to enhance en masse retraction. Clinicaltrials.gov TRIAL REGISTRATION NUMBER: NCT05183451 DATE OF REGISTRATION: January10, 2022, "Retrospectively registered" URL OF TRIAL REGISTRY RECORD: https://www. gov/study/NCT05183451.

Potentially inappropriate medications and their association with frailty, unplanned hospitalizations, and mortality in patients with cancer treated in the national U.S. Veterans Affairs Healthcare System.

1620 Background: We previously operationalized the NCCN list of high-risk medications in older adults into a measurable scale—Geriatric Oncology Potentially Inappropriate Medications (GO-PIMs)—to aid oncology teams in identifying PIMs and understand their impact (1). This scale revealed that PIMs were prevalent and associated with frailty in older patients with blood cancers. The current study aims to evaluate the ability of GO-PIMs to identify high-risk medications and their impact in patients with both solid and liquid tumors managed in a large national healthcare system. Methods: We performed a retrospective cohort study using data from the national Veterans Affairs (VA) Cancer Registry and electronic health record, including all veterans newly diagnosed with a solid or liquid malignancy in the years 2000-2023.The number of GO-PIMs for each patient were measured among outpatient pharmacy prescriptions in the 90 days preceding the initial diagnosis date (the index date). We evaluated the association of PIMs with baseline frailty (the electronic Veterans Affairs-Frailty Index [VA-FI], categorized as nonfrail [0-0.2], mildly frail [&gt;0.2-0.3], and moderate-to-severely frail [&gt;0.3]), time to unplanned hospitalization, and mortality in multivariable models adjusting for age, gender, cancer type and stage, Charlson comorbidity index, and socioeconomic factors (rurality, area deprivation index, and history of homelessness). Results: Among 307,487 newly diagnosed patients (median age 68.5, IQR 62.1-75.8; most common cancers: prostate [20.5%], lung [23.1%], GI [21.3%]), GO-PIMs were prevalent (39% patients with ≥1 GO-PIM). The most common classes of PIMs were SSRIs (12.4%); opioids (10.7%); benzodiazepines (9.5%), and corticosteroids (9.5%). Each additional PIM increased the odds of being mild or moderate-to-severely frail at diagnosis by 65%, controlling for all covariates (ordinal regression adjusted OR [aOR] 1.65, 95% CI 1.63-1.66). Increasing number of PIMs was also associated with a higher hazard of unplanned hospitalization (Cox regression aHR 1.04, 95% CI 1.04-1.05) and death (Cox regression aHR 1.05, 95% CI 1.05-1.06), controlling for frailty and all covariates. Conclusions: Independently of cancer type and stage, comorbidity, and other covariates, increasing PIMs identified by the GO-PIMs scale was associated with an increased risk of frailty at diagnosis, unplanned hospitalization in follow-up, and death. We are implementing the GO-PIMs scale in a clinician-facing application that will automate real-time detection of PIMs and recommendations for oncology teams in routine clinical practice. 1. Hshieh and DuMontier et al., J Natl Compr Canc Netw, 2022.

CMR provides comparable measurements of diastolic function as echocardiography

Clinical application of cardiac magnetic resonance (CMR) is expanding but CMR assessment of LV diastolic function is still being validated. The purpose of this study was to validate assessments of left ventricular (LV) diastolic dysfunction (DD) using CMR by comparing with transthoracic echocardiography (TTE) performed on the same day. Patients with suspected or diagnosed cardiomyopathy (n = 63) and healthy volunteers (n = 24) were prospectively recruited and included in the study. CMR diastolic parameters were measured on cine images and velocity-encoded phase contrast cine images and compared with corresponding parameters measured on TTE. A contextual correlation feature tracking method was developed to calculate the mitral annular velocity curve. LV DD was classified by CMR and TTE following 2016 guidelines. Overall DD classification was 78.1% concordant between CMR and TTE (p < 0.0001). The trans-mitral inflow parameters correlated well between the two modalities (E, r = 0.78; A, r = 0.90; E/A, r = 0.82; all p < 0.0001) while the remaining diastolic parameters showed moderate correlation (e’, r = 0.64; E/e’, r = 0.54; left atrial volume index (LAVi), r = 0.61; all p < 0.0001). Classification of LV diastolic function by CMR showed good concordance with standardized grades established for TTE. CMR-based LV diastolic function may be integrated in routine clinical practice.Name of the registry: Technical Development of Cardiovascular Magnetic Resonance Imaging. Trial registration number: NCT00027170. Date of registration: November 26, 2001. URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT00027170

Information on Measles, Mumps and Rubella Vaccine in the Copenhagen School Health Records Register.

The Copenhagen School Health Record Register (CSHRR) includes health information from school examinations and is now updated with information on measles, mumps and rubella vaccines for the cohorts born from 1977 to 1994. The aim of this study is to provide a comprehensive description and validation the newly digitised vaccine information in the CSHRR. We describe the data collection and the newly digitalised information in the CSHRR. We investigate the extent to which the full CSHRR population is representative of Copenhagen and the entire Danish population. Furthermore, we explore how the registry information on vaccination uptake based on reimbursement data matches the vaccine information obtained from CSHRR for the period during which both data are available. The CSHRR population matches closely the complete population of all schoolchildren in Copenhagen, and information on vaccine uptake in CSHRR matches with vaccine registry data for later cohorts. However, a sizable proportion of the immigrant children in the CSHRR have missing information on vaccination. Removing children who have had no additional immunisations enhances data quality. The CSHRR covers a large share of the Danish population and includes detailed vaccine information. By linking the data to other registry data, the updated CSHRR is valuable resource for future research.

Comparison of Methods of Clinical Trial Emulation Utilizing Data From the Comparison of AMD Treatment Trial (CATT) and the IRIS® Registry

PurposeWe used exact matching and inverse propensity score weighting (IPSW) using real-world data (RWD) from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) to emulate the two pro re nata (prn) treatment arms from the Comparison of AMD Treatment Trial (CATT) and to compare the outcomes of the RWD arms to the two monthly treatment arms from the clinical trial. DesignRetrospective cohort study utilizing deidentified electronic health record registry data and patient-level deidentified clinical trial data SubjectsAll treatment-naive patient eyes with neovascular age-related macular degeneration treated with ranibizumab or bevacizumab only for one year from either the CATT or the IRIS Registry MethodsPatients were identified in the IRIS Registry between October 1, 2015 and December 31, 2019. After all non-imaging based inclusion and exclusion criteria from the CATT were applied, patient eyes receiving bevacizumab or ranibizumab only on a prn basis were identified as the eligible cohort. Exact matching and ISPW was applied based on age, gender, and baseline visual acuity. ResultsWe identified 427 eyes treated with ranibizumab prn and 771 eyes treated with bevacizumab prn. Using exact matching, 98% (n= 281) of CATT patient eyes in the bevacizumab monthly treatment arm and 87% (n=261) of CATT patient eyes in the ranibizumab monthly treatment arm were matched to a patient eye in the IRIS Registry. For the ranibizumab prn treatment arm, patient eyes generated using exact matching gained 1.9 letters and those generated using IPSW gained 2.8 letters (Exact Matching: 1.9 letters +/- 14.0 vs. IPSW: 2.8 letters +/- 15.0 letters, p=0.43). For the bevacizumab prn treatment arm, patient eyes generated using exact matching gained 2.4 letters and those generated using IPSW gained 2.1 letters (Exact Matching: 2.4 letters +/- 15.4 vs. IPSW: 2.1 letters +/- 16.0 letters, p=0.79). ConclusionsBoth exact matching and IPSW produced similar results in emulating the prn treatment arms of the CATT using IRIS Registry data and patient-level clinical trial data. Similar to prior real-world studies, the clinical outcomes were significantly worse in the IRIS Registry treatment arms compared to the clinical trial.

Efficacy of a Comprehensive Weight Reduction Intervention in Male Adolescents With Different FTO Genotypes.

The FTO gene polymorphisms may influence the effects of lifestyle interventions on obesity. The present study aimed to assess the influence of the rs9930506 FTO gene polymorphism on the success of a comprehensive weight loss intervention in male adolescents with overweight and obesity. This study was carried out on 96 adolescent boys with overweight and obesity who were randomly assigned to the intervention (n = 53) and control (n = 43) groups. The blood samples of the participants were collected, and the FTO gene was genotyped for the rs9930506 polymorphism. A comprehensive lifestyle intervention including changes in diet and physical activity was performed for 8 weeks in the intervention group. Following the lifestyle intervention, BMI and fat mass decreased significantly in the intervention group compared with the control group (both p < 0.05), while no change was found in weight, height or body muscle percentage between the groups. The participants in the intervention group with the AA/AG genotype and not in carriers of the GG genotype had a significantly higher reduction in BMI (-1.21 vs. 1.87 kg/m2, F = 4.07, p < 0.05) compared with the control group. The intervention in individuals with the AA/AG genotype has been significantly effective in weight loss compared with the control group. The intervention had no association effect on anthropometric indices in adolescents with the GG genotype of the FTO rs9930506 polymorphism. Name of the registry: National Nutrition and Food Technology Research Institute; Trial registration number: IRCT2016020925699N2; Date of registration: 24/04/2016; URL of trial registry record: https://www.irct.ir/trial/21447.

Does the contralateral testicular volume decide the need for diagnostic laparoscopy in cases of unilateral impalpable undescended testis?

BackgroundThis study aimed the evaluation of the value of the calculated volume of a normal testis to predict the status of its contralateral impalpable side and hence decide the importance of laparoscopic exploration.MethodsPatients with unilateral impalpable undescended testis – as confirmed by clinical and sonographic examination- were enrolled in our prospective interventional study between November 2018 and August 2022 at Elshatby University Hospital, Faculty of Medicine, Alexandria University. The volume and three-dimensional diameter of the normal contralateral testis were measured by the pre-operative US using the formula: Volume = L x W x H x π/6, where L is the length, W is the width, H is the height, and was correlated with the intra-operative laparoscopic findings.ResultsSeventy-six patients were included in our study. The age of the studied patients ranged between 6 months and 4 years with a mean of 2.17 ± 1.30 years; most of them were between one and three years old. Forty-six patients (60.5%) have left-sided impalpable testis and 30 patients (39.5%) have right-sided impalpable testis. The calculated volume of the contralateral normal testis was significantly larger in those patients who had both blind ending vas and vessels (0.89 ± 0.16) and in those who had an atrophic testis passing through the deep inguinal ring (DIR) –which was excised through the inguinal region- (0.83 ± 0.20) than in those patients who had their testes intra-abdominal (0.53 ± 0.18) or passing through the DIR to the inguinal region (0.80 ± 0.19). (Kruskal Wallis test; p < 0.001*).ConclusionsThe calculated sonographic volume of a normal testis can predict the status of its contralateral impalpable side significantly with sensitivity & specificity of 75.0% & 88.89% respectively and a cut-off point of ≤ 0.674; hence, helps in parent counselling preoperatively.Trial registrationName of the registry: Clinicaltrials.gov PRS. Trial registration number: NCT05933811. Date of registration: 10-7-2023 (retrospectively registered). URL of trial registry record: https://clinicaltrials.gov.

Abstract B043: Feasibility of a traceback approach to facilitate genetic testing in the Genetic Risk Analysis in Ovarian Cancer (GRACE) study

Abstract Current guidelines state that genetic testing is clinically indicated for all individuals diagnosed with ovarian cancer (OC). Individuals with a prior diagnosis of OC who have not received genetic testing represent missed opportunities to identify individuals and their families with inherited variants that put them at a higher risk for cancer. The Genetic Risk Analysis in Ovarian Cancer (GRACE) study aims to address this significant healthcare gap using a “traceback testing” approach to identify individuals with a prior diagnosis of OC and to offer genetic risk information to them and their family members. Tumor registry data at two integrated health care systems (Kaiser Permanente Northwest and Colorado) identified cases of OC diagnosed 1998-2020 with no prior genetic testing or testing limited to BRCA1/2. The study aimed to provide genetic risk information to OC survivors as well as family members of patients who were deceased by leveraging stored pathology specimens for germline testing. Comprehensive genetic testing using a panel of 60 cancer risk genes was offered; genetic testing of the familial variant was offered to first- and second-degree relatives if a pathogenic or likely pathogenic variant was detected. A total of 317 eligible OC survivors were identified from tumor registry and medical record review; 79 (25%) consented for testing. Sixteen (21%) were found to carry a pathogenic or likely pathogenic variant in a cancer risk gene. Genes with pathogenic variants included BRCA1/2, BARD1, PMS2, DICER1, MUTYH, APC, and SDHB. Of 73 relatives eligible for cascade testing, 24 consented (≈ 33% uptake) and 9 were found to carry the familial variant. The uptake of testing by OC survivors and their relatives reflects a strong interest in genetic risk information. However, practical barriers must be addressed to provide genetic risk information to relatives of individuals who are deceased. The GRACE study can inform broad implementation of future traceback programs, providing information to prevent and mitigate the burden of ovarian and other hereditary cancers. Citation Format: Larissa L. White, Yolanda K. Prado, Ana A. Reyes, Jamilyn M. Zepp, Jennifer Sawyer, Mahesh Maiyani, Rachel Zucker, Sarah Vertrees, Alan F. Rope, Sheila Weinmann, Mika Caruncho, Sandra Soo-Jin Lee, Nora B. Henrikson, Heather Spencer Feigelson, Jessica Ezzell Hunter. Feasibility of a traceback approach to facilitate genetic testing in the Genetic Risk Analysis in Ovarian Cancer (GRACE) study [abstract]. In: Proceedings of the AACR Special Conference on Ovarian Cancer; 2023 Oct 5-7; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_2):Abstract nr B043.

Head and Neck Lymphoma: Clinico-demographic Profile and Pattern of Presentations in a South Western Nigeria Tertiary Institution

Abstract&#x0D; Running title: A clinic-demographic profile and presentation of patient with head and neck lymphoma in a tertiary institution located in low-middle-income country.&#x0D; Introduction &#x0D; Lymphoma is the second most common malignancy occurring in the head and neck region. It is broadly classified into Hodgkins lymphoma (HL) and non-Hodgkins lymphoma (NHL). It affects nodal and extra-nodal. The clinical presentation is largely determined by the anatomic distribution of the disease, clinical stage of the disease, age of the patients and presence of underlying diseases.&#x0D; Aims and Objectives&#x0D; This study aims to analyse the presentation of head and neck lymphomas over a fifteen years period at Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife. The objectives include; to determine the prevalence and demographic indices (age and gender) of head and neck, document the histopathologic types, and determine the association between the anatomical sites and histopathologic subtypes of lymphomas&#x0D; Materials and Method&#x0D; This is a retrospective study among patients seen and diagnosed histologically with head and neck lymphomas between 2005 – 2019 at the departments of Oral Medicine and Pathology and Morbid Anatomy and Forensic Medicine, OAUTHC. Relevant record were retrieve from patient record and histological register from the hospital registry. Patients with incomplete data were excluded. The study was conducted in accordance with the Declaration of Helsinki, and approved by our institution Ethics Committee Board.&#x0D; Results &#x0D; A total number of 54 cases of head and neck lymphoma were analysed with a prevalence of 30.9%. Out of the 54 cases, 46 were NHL and 8 cases were HL with a ratio of 5.8:1 respectively. A male preponderance was observed (M: F; 2.4:1). The lesion commonly affects patients in 3rd and 4th decade of life. All the histologic variants were seen to affect males more than females except for the unclassified variant of HL which affected both sexes equally. Low-grade and intermediate grade NHL affected the older patients more while high grade and miscellaneous subtypes affected the younger males. The cervical lymph nodes were the most common nodal site while the jaw was the most common extra-nodal site. Eighteen (39.1%) cases of NHL were diagnosed histological as miscellaneous while high and low grade had seven (15.2%) cases each.&#x0D; Conclusion&#x0D; Head and neck lymphoma remain relatively rare. One of every six lymphoma seen was HL, with male preponderance. High grade lymphoma is seen more in the younger patient. Lymphoma affect cervical lymph node more while jaw was the most common extranodal site. Obesity may be a predisposing factor in our environment but require future study to confirm.