Standard Of Care For Treatment Research Articles

Response to Bushnell et al regarding: “Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial”

We appreciate the comments by Bushnell et al regarding our article “Increased Stiffness and Reoperation Rate in Partial Rotator Cuff Repairs Treated With a Bovine Patch: A Propensity-Matched Trial.” We agree with these authors that trials assessing the comparative efficacy of the patch would be best performed using a control group of patients receiving standard care treatments. We also agree that the patch can initiate a robust biological response, which in the correct clinical setting can lead to excellent healing and outcomes.

Impact of multi-agent systemic therapy on all-cause and disease-specific survival for people living with HIV who are diagnosed with non-Hodgkin lymphoma: population-based analyses from the state of Georgia

For people living with HIV (PLWH) who are subsequently diagnosed with non-Hodgkin lymphoma (NHL), we investigate the impact of standard-of-care (SoC) cancer treatment on all-cause, NHL-specific, and HIV-specific survival outcomes. The focus is on a registry-derived, population-based sample of HIV + adults diagnosed with NHL within 2004–2012 in the state of Georgia. SoC treatment is defined as receipt of multi-agent systemic therapy (MAST). In multivariable survival analyses, SoC cancer treatment is significantly associated with better all-cause and NHL-specific survival, but not better HIV-specific survival across 2004–2017. Having a CD4 count <200 near the time of cancer diagnosis and Ann Arbor stage III/IV disease are associated with worse all-cause and HIV-specific survival; the effects on NHL survival trend negative but are not significant. Future work should expand the geographic base and cancers examined, deepen the level of clinical detail brought to bear, and incorporate the perspectives and recommendations of patients and providers.

Effect of Remdesivir in COVID-19 in Terms of Hospital Discharge and Mortality Benefits

Background &amp; Objective: There is no first line antiviral treatment for Corona Virus Disease 2019 (Covid-19). Remdesivir is used as antiviral drug for covid 19 in different parts of world with variable results.The objective of our study was to assess the effect of Remdesivir in Covid-19, in terms of time to discharge from hospital and mortality rate benefit. Methods: An interventional, single-center study conducted at Corona Wards of DHQ University teaching hospital Gujranwala. Two categories were made using simple random sampling technique. First category was marked 'Remdesivir group', to whom after Informed Consent Injection Remdesivir (200 mg on the principal day followed by 100 mg every day for the following four days) was given. Second category was the'Control group'; they were not given the injection Remdesivir. Total 248 patients were selected for the study. The Remdesivir category included 124 patients and the Control category involved 124 patients. Collected data was analyzed using SPSS 23.0. All baseline characters and variables in history were calculated as Mean and standard deviations for quantitative variables and as percentages for frequencies of qualitative variables. Univariate comparison for binary variables was performed with Chi-Square test. A p-value of &lt;0.05 was considered as significant. Results: In the Remdesivir category 23 (18.5%) had mild illness, 50 (40.3%) had moderate illness and 51 (41.2%) patients had severe illness. In the Control category 26 (20.9%) had mild illness, and 50 (40.3%) had moderate illness and 48(38.8%) patients had severe illness. The median hospital stay days in Remdesivir category was 13 (95% CI: 12 - 15) and total death rate was 36.44%. The median hospital stay days in Control category was 11 (95% CI: 10 - 12) and the death rate was 31.35%. p- value .40. Conclusion: The information showed that Remdesivir was not better than the standard of care treatment in shortening the hospital stay days in patients with proven Covid-19. No Mortality benefit was seen with Remdesivir treatment.

Medical Imaging Utilization Trends in Radiation Oncology over the Past Decade

<h3>Purpose/Objective(s)</h3> We quantify the increase in use of pre-treatment imaging and verification imaging in radiation oncology over the past decade. We also quantify the trend towards hypofractionation, which has partially led to increased imaging. <h3>Materials/Methods</h3> The pre-treatment and verification imaging data used are from a single, tertiary, university-affiliated cancer center. Pre-treatment imaging was defined as magnetic resonance imaging (MRI), positron emission tomography (PET) and four-dimensional computed tomography (4DCT). Verification imaging was defined as cone-beam computed tomography (CBCT). All treatment approved plans were included from 2012 to 2021. Data extraction was performed using custom scripts interfacing with the treatment planning system (TPS) and patient information system. All registered image-sets of planning CT images with either advanced pre-treatment advanced imaging or verification images in the TPS were included. Hypofractionation sub-analysis was performed according to plans above and below 4 Gy per fraction that received a combination of pre-treatment and verification imaging. <h3>Results</h3> Between 2012 and 2021, a total of 42,214 plans were included. In 2021, MRI, PET, and 4DCT pre-treatment imaging modalities were used for 14%, 5%, and 3% of patients, respectively, which was an increase from 5%, 2%, and 0%, in 2012. In 2021, 55% of patients received CBCT for verification imaging compared to only 2% of patients in 2012. In the sub-analysis, cohort receiving greater than or equal to 4 Gy per fraction from 2012 to 2021, the percent of patients receiving one of MRI or PET for pre-treatment imaging and CBCT guidance for verification imaging increased from 1% to 22%. For the cohort receiving less than 4 Gy per fraction, there was an increase from 2012 to 2021 of 0% to 14% of patients receiving at least one of MRI or PET pretreatment imaging and CBCT for verification imaging. Table 1: Annual use of advanced pre-treatment, verification imaging, hypofractionation, and associated combination imaging shown. Entries indicate the percent (%) of patients per year with the imaging modality used in their treatment. <h3>Conclusion</h3> An increase in the adoption of advanced medical imaging was observed in standard of care treatments over the past 10 years. Imaging utilization continues to increase as clinical trial evidence matures. Further analysis could focus on the gap between desired standard of care for patients and the current offerings as well as the increase in capital and human resource requirement for implementation of these advancements.

Comparisons of Patient-Reported Quality of Life and Swallowing Scores of Mucosal Sparing Radiation vs. Standard of Care for Oropharyngeal Tumors

<h3>Purpose/Objective(s)</h3> We hypothesized mucosal sparing radiation therapy (MSRT) would result in improved patient-reported quality of life (QOL) and modified barium swallowing impairment scores (MBSImp) compared to standard of care (SOC) post-operative adjuvant radiation for human papillomavirus related (HPV) oropharyngeal squamous cell carcinoma (OPSCC). <h3>Materials/Methods</h3> The results of two institutional prospective studies, the SOC arm of MC1675 (DART) and a MSRT trial, were compared to assess for differences in QOL and MBSImp. Both trials were performed with patients undergoing transoral surgery with negative margins and neck dissection. The SOC was 60 Gy to the primary mucosal site and at-risk nodal regions while MSRT excluded the primary mucosal site primarily using proton therapy. Chemotherapy was delivered in both as indicated. Shared endpoints between the studies included EORTC HN-35 (HN35) at baseline, end of treatment (EOT), 3-, 6-, 12-, 24-, and 36-months posttreatment and MBSimp studies at baseline and 12 months posttreatment. Baseline adjusted mixed models, with adjustments for multiple comparisons, were utilized to test the effect of treatment arm over time and their interaction, with statistical significance set at p<0.05. <h3>Results</h3> 127 patients were included, 64 from the SOC and 63 from the MSRT trial. Significant differences in patient characteristics included smoking history, insurance coverage, use of chemotherapy, and pathologic T and N categories. After treatment, improved QOL scores were significantly associated with MSRT for HN35 domains: pain, swallowing, speech problems, trouble with social eating, trouble with social contact, less sexuality, opening mouth, dry mouth, pain killers, nutritional supplements, feeding tube, and weight loss. When considering the interaction between treatment and time, the largest QOL difference occurred acutely (<3 months post-RT) with significant differences in pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social contact, less sexuality, opening mouth, dry mouth, sticky saliva, and feeling ill. Better scores with MSRT for trouble with social eating, pain, and dry mouth persisted 3 months post-RT, while no significant differences remained 6 months post-RT. When adjusted for baseline patient characteristics MSRT was still associated with superior scores for swallowing, senses problems, trouble with social eating, less sexuality, and feeding tube use. MBSimp from baseline to 12 months post-RT showed worsening of oral impairment (imp) score and overall imp score for SOC but not for MSRT. At 12 months MSRT was associated with less oral imp and overall imp than SOC. <h3>Conclusion</h3> MSRT for HPV+ OPSCC is associated with higher QOL scores compared to current SOC treatment in the acute and subacute setting and higher MBSimp scores at 12 months. Adding MSRT to the DART regimen for select HPV OSCC patients will be further studied.

Alpha emitter radium-223 in patients with metastatic castration-resistant prostate cancer: A cost-utility analysis.

Objective: To assess the cost effectiveness of radium-223 dichloride for patients with metastatic castration-resistant prostate cancer (mCRPC) in China. Materials and methods: A Markov model was developed to estimate the long-term health and economic outcomes of radium-223 plus best standard care (BSC) treatment and BSC only for bone mCRPC patients over a lifetime horizon. The patients and interventions were modeled according to the ALSYMPCA trial. Costs were collected from a Chinese health system perspective. Utility values were derived from the published literature. The base-case model results were quality-adjusted life year (QALY), total cost, and incremental cost-utility ratio (ICUR). Uncertainty analyses were performed to assess the robustness of our conclusions. Results: Compared with the BSC arm, radium-223 achieved an excess 0.344 QALYs with an incremental cost of $29,459, resulting in an ICUR of $85,647 per QALY. The probability of Ra-223 being cost effective for the patients with bone mCRPC was sharply low (<0.5%) at a willingness-to-pay threshold of $38,136/QALY. Uncertainty analyses revealed that the model is robust to all the input parameters. Conclusion: Radium-223 is unlikely to be cost effective in patients with bone mCRPC at the current WTP threshold, from a Chinese health system perspective. In affluent areas with a high per-capita GDP, radium-223 therapy may be cost effective.

Transoral Incisionless Fundoplication in Patients With Barrett's Esophagus

During the past several decades, esophageal adenocarcinoma (EAC) has become one of the fastest growing cancers in the Western world, with over a 7-fold increase in incidence.1,2 Barrett's esophagus (BE) is a known precursor of EAC, and the risk of progression from BE to EAC correlates with the degree of dysplasia.3-5 Thus, early detection and treatment of dysplastic BE is paramount for prevention of EAC. The current standard of care for treatment of dysplastic BE is endoscopic eradication therapy (EET) with endoscopic mucosal resection of visible lesions followed by ablative therapy for remaining flat BE.

Cost-Effectiveness of Acthar Gel Versus Standard of Care for the Treatment of Exacerbations in Moderate-to-Severe Systemic Lupus Erythematosus.

Despite current standard of care (SoC), there is an unmet need for the treatment of active systemic lupus erythematosus (SLE). The study assessed the cost-effectiveness of Acthar® Gel (repository corticotropin injection) versus SoC treatment in patients with active, moderate-to-severe SLE from the US payer and societal perspectives over 2 and 3 years. Cost-effectiveness model was developed using a probabilistic cohort-level state-transition approach. Patients received Acthar Gel in an exacerbation state, and the outcomes were assessed at the end of a 3-month cycle for response achievement based on the probability of treatment success with Acthar Gel. Patients may sustain the response or experience an exacerbation. For the base case scenario, moderate-to-severe SLE was defined as British Isles Lupus Assessment Group (BILAG)-2004 ≥ 20 or SLE Disease Activity Index 2000 (SLEDAI-2K) ≥ 10 and clinical response was based on SLE responder index (SRI)-4. Clinical response, productivity loss, and utility were derived from a phase 4 SLE trial; cost and disutility estimates were sourced from the literature. From a payer perspective, Acthar Gel versus SoC resulted in an incremental cost-effectiveness ratio (ICER) of $133,110 per quality-adjusted life-year (QALY) and $94,818 per QALY over 2 and 3 years, respectively. From a societal perspective, Acthar Gel versus SoC results in an ICER of $70,827 per QALY and $32,525 per QALY over 2 and 3 years, respectively. Results from the sensitivity and scenario analyses are consistent with those of the base case model. Acthar Gel is a cost-effective, value-based treatment option for appropriate patients with moderate-to-severe SLE at a willingness-to-pay threshold of $150,000 over 2-3 years from the US payer and societal perspectives. Acthar Gel results in the reduction of direct medical and indirect costs.

Midazolam nasal spray to treat intermittent, stereotypic episodes of frequent seizure activity: pharmacology and clinical role, a comprehensive review.

An intranasal formulation of midazolam, Nayzilam, has been FDA-approved to treat intermittent, stereotypic episodes of frequent seizure activity. Nayzilam is easy to administer and can quickly treat seizures that occur outside of the hospital. The intra-nasal route of administration allows non-medical personal to administer the drug which makes it more accessible and user-friendly in the event of a seizure. Many studies have indicated quick cessation of seizures with Nayzilam compared to rectal diazepam, which has been the standard of care treatment. Nayzilam has been proven to be safe and effective for acute seizures in children, deeming it a revolutionary alternative in times where intravenous administration is not possible.

Pilot study: Utility of long-wave infrared thermography as a correlate to transcutaneous oximetry for candidates of hyperbaric oxygen therapy.

Hyperbaric oxygen (HBO2 ) has been used as an adjunctive treatment for the care of advanced non-healing diabetic foot ulcers (DFUs). A patient's in-chamber transcutaneous oximetry measurement (TCOM) is currently the most effective predictor for response to HBO2 therapy but still excludes close to one in four patients who would benefit out of treatment groups when used for patient selection. Improving selection tools and criteria could potentially help better demonstrate HBO2 therapy's efficacy for such patients. We sought to identify if long-wave infrared thermography (LWIT) measurements held any correlation with a patient's TCOM measurements and if LWIT could be used in a response prediction role for adjunctive HBO2 therapy. To investigate, 24 patients already receiving TCOM measurements were enrolled to simultaneously be imaged with LWIT. LWIT measurements were taken throughout each patient's therapeutic course whether they underwent only standard wound care or adjunctive HBO2 treatments. A significant correlation was found between in-chamber TCOM and post-HBO2 LWIT. There was also a significant difference in the post-HBO2 LWIT measurement from 1st treatment to 6 weeks or the last treatment recorded. These initial findings are important as they indicate a possible clinical use for LWIT in the selection process for patients for HBO2 therapy. Larger studies should be carried out to further articulate the clinical use of LWIT in this capacity.

Stereotactic body radiation therapy as an alternative to adrenalectomy for the treatment of pheochromocytomas in 8 dogs.

The objective of this report is to describe the use and outcome of stereotactic body radiation therapy (SBRT) for treatment of pheochromocytomas in 8 dogs. Pheochromocytomas are an uncommon but challenging tumour to manage. Adrenalectomy is the standard of care for treatment of pheochromocytomas in both animals and humans; however, unpredictable catecholamine secretion from the tumour and vascular and local invasion of the tumour and thrombi can pose life-threatening perioperative and anaesthetic risks. SBRT has been investigated as an alternative to adrenalectomy in human patients with pheochromocytomas. Eight dogs with clinical signs, an adrenal mass, and cytology and/or urine normetanephrine/creatinine ratios consistent with pheochromocytoma were treated with SBRT in lieu of adrenalectomy. Three dogs presented with acute hemoabdomen. Seven dogs had caval tumour invasion, 3 with extension into the right atrium. Following SBRT, all dogs had complete resolution of clinical signs and reduced urine normetanephrine/creatinine ratio and/or tumour size. No significant anaesthetic complications were encountered. Acute radiation toxicity was limited to grade I gastrointestinal signs in 3 dogs and resolved within 1-2 days of symptomatic therapy. Five of 8 dogs were alive at the time of follow up, with a median follow up time of 25.8months. SBRT resulted in a favourable outcome and mitigated the life-threatening risks of adrenalectomy in these 8 dogs. SBRT may be a safe and effective alternative to adrenalectomy for pheochromocytomas in dogs with non-resectable tumours, or for owners averse to the risks of surgery.

The value of coronary computed tomography and very early invasive coronary angiography compared to standard intervention in older patients after non-ST segment elevation acute coronary syndromes

Abstract Background The optimal management of patients with non-ST elevation acute coronary syndromes (NSTEACS) remains a challenge. The merits of both computed tomography angiography (CTA) as a rule-out test for significant coronary artery disease and early invasive coronary angiography (ICA) are debated. Furthermore, there are limited data in older NSTEACS patients, who likely have more coronary artery calcification and are at higher risk of ACS-related complications. Methods This is a post hoc analysis of patients ≥75 years included in the Very Early Versus Standard Care Invasive Examination and Treatment of Patients with Non-ST-Segment Elevation Acute Coronary Syndrome Trial (VERDICT). The diagnostic accuracy of CTA was investigated in patients without previous coronary artery bypass grafting, renal dysfunction, or atrial fibrillation; the presence of a coronary artery stenosis ≥50% determined by ICA was used as reference. Patients were randomised to very early ICA within 12 hours of diagnosis or standard care (ICA within 48–72 hours of diagnosis) and followed for up to five years. The primary endpoint was the composite of all-cause mortality, nonfatal recurrent MI, hospital admission for refractory myocardial ischaemia or hospital admission for heart failure. Results From November 2010 to June 2016, 2147 patients were included in the VERDICT trial. Of these, 452 (21%) patients were ≥75 years of age. Most older patients had a GRACE score &amp;gt;140 (n=388, 88.8%). At the time of admission, older patients had lower levels of haemoglobin, estimated glomerular filtration rate, and left ventricular ejection fraction, and more often displayed elevated troponins and electrocardiogram changes indicating new ischaemia, than those &amp;lt;75 years. Of patients ≥75 years of age, 161 (35.6%) underwent CTA before ICA. Older patients had significantly higher calcium scores than younger patients (1187±1445 vs. 499±858 Agatston units, p&amp;lt;0.001). 19% of CTAs excluded significant coronary artery disease. The negative predictive value of the CTAs was 94 (95% CI 79–99)% and the sensitivity was 98 (95% CI 94–100)%, figure 1. The primary endpoint was observed more frequently in patients ≥75 years as compared to younger patients (n=222, 49% vs. n=390, 23%, p&amp;lt;0.001), even after adjustment for allocated treatment (adjusted HR 2.65, 95% CI 2.25–3.13, p&amp;lt;0.001). Among older patients randomised to very early ICA, there were no differences in the cumulated number of primary endpoints compared to older patients randomised to standard ICA (log-rank p=0.36), figure 2. Conclusion Among patients ≥75 years old with NSTEACS, CTA showed a high diagnostic accuracy. A very early ICA within 12 hours of diagnosis did not improve long-term composite outcome in these older patients with NSTEACS. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Rigshospitalets Research Foundation

Comparative, observational study of the use of artesunate injections along with standard-of-care treatment versus only standard-of-care treatment in moderate and severe acute respiratory distress syndrome cases of COVID-19-positive infections

Introduction: COVID-19 is a type of coronavirus disease belonging to the family Coronaviridae. In late December 2019, this virus emerged from Wuhan, Hubei province, China, and resulted in an outbreak in China and expanded globally. In India, the mortality rate today was 521,691 till the date-time of writing this article. Several therapeutic agents have been evaluated for the treatment of COVID-19. Materials and Methods: This was a hospital-based comparative, observational study of the use of artesunate injections with standard-of-care (SOC) treatment (group A) versus only SOC (group B) treatment in moderate-to-severe cases of COVID-19 acute respiratory distress syndrome (ARDS) patients, on a total of 130 patients (comparative group of 65 patients each). The study was done on hospitalized COVID-19-positive moderate and severe cases of ARDS from October 2020 to June 2021 at MGM Hospital and Research Centre, CBD Belapur, Navi Mumbai, Maharashtra, India. Results: One hundred and thirty patients were divided into two groups of 65 each; group A was compared with group B; group A received SOC with artesunate injections and group B received only SOC treatment. The mean age of patients in group A was 57.3 ± 12.5 years (standard deviation [SD]: 54.2–60.3) and in group B was 55.8 ± 12.5 years (SD: 52.8–58.9). Diabetes mellitus was the most comorbid condition. The inflammatory markers, respiratory rate, and SpO2 improved in group A as compared to group B. The proportion of patients progressing to noninvasive and invasive ventilation was more in group B as compared to group A (P &lt; 0.05). About 93.8% of patients (61 patients) recovered in group A compared with 72.3% of patients (47 patients) who recovered in group B. The overall death in group A was 6.2% (four patients) and 27.7% (18 patients) in group B (P &lt; 0.05), indicating the proportion of dead patients is significantly more where only SOC treatment was given. Conclusions: Artesunate injection administration accelerated recovery in our patients with moderate and severe COVID-19 disease by controlling hyperimmune response. The clinical improvement was seen by decreased levels of inflammatory markers, reduced respiratory rate, and improved oxygen saturation and showed significant survival in group A compared with group B. Artesunate injections were given 2 mg/kg body weight diluted in 1 mL 5% sodium bicarbonate solution as a bolus followed by 1 mg/kg body weight after 6 h and 2 mg/kg body weight with 1 mL sodium bicarbonate solution for next 2 days at an interval of 24 h. Patients tolerated the injections well and recovery improved, so artesunate can be considered a therapeutic option in moderate and severe cases of COVID-19 ARDS.

MM-531 Case Control Study of Outcomes of Autologous Stem Cell Transplantation in Jehovah's Witness Multiple Myeloma Patients

Jehovah's Witnesses (JW) persons do not accept blood transfusions. Autologous stem cell transplantation (ASCT) after using high-dose chemotherapy is the standard of care in treatment of multiple myeloma (MM). Patients usually require blood transfusions during ASCT. We sought to analyze safety outcomes of single or tandem ASCT in JW MM patients. We performed a case control study at the University of Arkansas for Medical Sciences for JW and non-JW MM patients who underwent single or tandem ASCT from 1990-2021. Matching (1:2) was done based on age, date of MM diagnosis, race/ethnicity, performance status, stage indicated by International Staging System (ISS), and number of ASCT. Wilcoxon Rank-Sum test was used to test continuous variables, while Fisher's exact test was used for categorical variables. A total of 13 JW MM patients received ASCT in the study period (8 single, 5 tandem) compared to 26 non-JW MM patients (16 single, 10 tandem). For JW patients who received single ASCT, median age was 66 (range:65.8-67.5 years), 50% were female, 62.5% were black. Average CD34 stem cells collected/infused were 23/5.8 million cells in JW compared to 30.1/5.1 million cells in non-JW, respectively. For JW patients who received tandem ASCT, median age was 49 (range:46-52 years), 50% were female, 62.5% were black. Average CD34 stem cells collected/infused were 34/10.8 million in JW compared to 21.3/8.8 million in non-JW, respectively. Lowest hemoglobin and platelets level in JW were 6.6 g/dl and 3000 k/uL, respectively. 100-days mortality for all patients was 0%. Multivariable analysis showed no significant difference in 30 days/100 days re-hospitalization, major and/or minor bleeding adverse events, response to treatment (very good partial response or better). Bloodless single/tandem ASCT can be done safely for selected JW MM patients with no significant difference in safety/outcomes.

Why aren’t more patients with breast cancer enrolled in clinical trials?

84 Background: Only 2-8% of adult patients with cancer participate in clinical trials, likely due to strict exclusion criteria as well as financial and access issues. The primary objective of this study is to understand the population of patients with breast cancer who are and are not offered a clinical trial and the impact of exclusion criteria on enrollment. Methods: Inclusion and exclusion criteria from study protocols housed in OnCore and ClinicalTrials.gov were obtained for breast cancer-specific, therapeutic clinical trials open at the University of Alabama at Birmingham (UAB) from 2016 to 2020. Patients with breast cancer receiving oncology services at UAB from 2016 to 2020 were identified from electronic health records. Race and ethnicity and address were abstracted. Address was utilized to characterize patients as living in areas of higher vs. lower deprivation (Area Deprivation Index) and rural communities (Rural-Urban Commuting Area). Chart abstraction was conducted to assess if patients were offered a trial, eligible for a trial, reason for ineligibility, and enrollment in trial vs standard of care treatment. Results: 518 patients were included; 387 were offered a trial and 131 were not. The median age of patients offered a trial was 57 years old, whereas the median age of patients who were not offered a trial was 61. The majority of patients offered a trial were more often White (72% vs. 24% African American), resided in areas of lower disadvantage (70% vs 17% most disadvantaged), and urban residents (75% vs 13% rural). Of the 387 patients offered a trial, 319 (82%) enrolled, 34 (9%) declined enrollment and chose standard of care, and the remaining 34 (9%) were interested in enrollment but later found to be ineligible. Reasons for ineligibility of the 34 patients who were offered a trial included comorbidities (n = 9), tumor size (n = 7), metastases (n = 5), and previous cancer history (n = 4). Additionally, 9 patients were ineligible for miscellaneous reasons (abnormal labs, age, prescription, trial closed to accrual, tumor characteristics). Of the 131 patients that were not offered a clinical trial, 77 (59%) were ineligible for enrollment. Reasons for ineligibility included: stage 1 disease (n = 35), tumor size and characteristics (n = 24), and comorbidities and abnormal labs (n = 18). The remaining 54 patients would have been eligible, but their provider did not offer a clinical trial. Conclusions: Most patients who are offered a clinical trial are willing to participate; physicians not offering a trial to patients appears to be a driver for low enrollment. Strict exclusion criteria related to comorbidities limit trial participation. Further work is needed to understand the relative importance of these eligibility criteria in relation to validity. Efforts should be made to include patients in clinical trials that reflect the diverse patient population that will receive the drug in the future.

16 (PB002) - Predicting response to naratuximab emtansine, an anti-CD37 antibody-drug conjugate (ADC), in combination with rituximab in Diffuse Large B Cell Lymphoma (DLBCL), by analyzing the spatial arrangement of CD37 and CD20 positive cells using deep learning

Background: DLBCL is the most common type of Non-Hodgkin’s lymphoma, accounting for 30–40% of cases. Despite improvements in survival with standard of care treatment, up to 40% of patients have relapsed and/or refractory (R/R) disease. A phase 2 study (NCT02564744) evaluated the efficacy of naratuximab emtansine, an anti-CD37 ADC, in combination with rituximab, in 80 patients with R/R DLBCL. We performed an exploratory analysis of the study to find pathology-based biomarkers predictive of response.

Effect of standard skin care treatments on skin barrier function in X-irradiated hairless mice

ObjectiveThe effectiveness of skin care to radiation dermatitis (RD) on patients who received radiotherapy for cancer has not been clarified. The purpose of this study was to investigate the effect of moisturizers and skin washing on skin barrier function possibly leading to the development of RD using X-ray irradiated hairless mice. MethodsNine-week-old hairless mice were irradiated with 10 ​Gy of X-rays, and the skin care group had moisturizers applied or skin washing with soap from the day of irradiation during observations. The condition of the skin was observed to evaluate RD. Skin barrier function was evaluated by measuring skin temperature and transepidermal water loss (TEWL) once every two days until 25 days after X-ray irradiation. ResultsRD was not observed in all groups until 25 days after X-ray irradiation. Skin temperature tended to increase in all groups regardless of irradiation or skin care. However, unlike the control group, the measured value of TEWL in the no skin care group tended to increase in the days after the X-ray irradiation. On the other hand, TEWL was increased in the skin care group compared with the no skin care group a few days after X-ray irradiation. While TEWL was constant in the moisturizer group, the skin washing groups showed an increasing tendency of TEWL and it reached a peak at 13 days after X-ray irradiation. ConclusionsThese results suggested that the decrease in skin barrier function was caused by X-ray irradiation and also that skin washing could contribute to the deterioration of skin barrier function after X-ray irradiation.

Trends and Outcomes in Management of Thoracic Aortic Injury in Children, Adolescent, and Mature Pediatric Patients Using Data from the National Trauma Data Bank

Thoracic aortic injury (TAI) is rare in the pediatric population. Thoracic endovascular aortic repair (TEVAR) is the recommended standard of care for treatment in the adult population given its association with lower rates of mortality and morbidity than traditional open repairs for treatment of TAI. However, there are unique anatomic challenges in treating pediatric patients with TEVAR which may impact the outcomes and pediatric guidelines. We aimed to compare current management trends and outcomes between different pediatric age groups using data from the National Trauma Data Bank (NTDB). We analyzed the NTDB from 2007 to 2019 using International Classification of Diseases (ICD)-9 and -10 codes to identify patients with a TAI. We excluded patients older than 21years and any patients who died in the emergency department. The pediatric patients were stratified by age group: children (1-11years), adolescent (12-17years), and mature (18-21years) patients. Patient characteristics compared included injury mechanism and severity, TAI intervention, and outcomes between the 3 groups using bivariate analysis (analysis of variance for parametric and Kruskal-Wallis for nonparametric variables). These characteristics and outcomes were also compared by TAI intervention and injury mechanism. ICD-9 and -10 procedural codes were used to identify patients who underwent TEVAR, open aortic repair (OAR), or both. The modified Poisson regression was performed with relative risk (RR) to evaluate our primary outcome measure-mortality during the trauma admission. A total of 2,431 pediatric TAI were identified in the NTDB that met the inclusion criteria. This included 134 children (5.5%), 733 adolescent (30.2%), and 1,564 mature (64.3%) patients. Children had significantly lower median Injury Severity Scores (34.1) than the adolescent (38) or mature population (36.1) (P=0.001). The mechanism of injury differed between age groups. Children had higher rates of blunt trauma (90.3% children, 89.6% adolescent, and 86.8% mature patients) and mature patients had higher rates of penetrating trauma (6% children, 10.1% adolescent, and 12.5% mature patients) (P<0.001). TAI management also differed significantly between pediatric age groups. Mature patients had significantly higher rates of TEVAR (3% children, 25.2% adolescent, and 29.2% mature patients) and children were most likely to be treated with nonoperative management (NOM) (94% children, 67.9% adolescent, and 64.8% mature patients) (P<0.001). Patients who were treated with TEVAR were discharge home most frequently (31.8% NOM, 54.1% TEVAR, 44.3% OAR, 22.2% both TEVAR and OAR). Upon modified Poisson regression analysis, patient age was not associated with an increased risk of in-hospital mortality. Intervention with TEVAR (RR: 0.22, 95% CI: 0.15-0.33, P<0.001) and OAR (RR: 0.58, 95% CI: 0.36-0.93, P=0.024) were associated with a lower risk of mortality than NOM. TAI is less prevalent in children compared to adults. TEVAR for TAI is associated with lower risk of in-hospital mortality compared to both NOM and OAR without differences between pediatric subgroups. Further studies should be completed to determine the most appropriate management guidelines.

Efficacy and safety of a mobile app intervention in patients with inflammatory arthritis: a prospective pilot study

EULAR highlighted the essential role of digital health in increasing self-management and improving clinical outcomes in patients with arthritis. The objective of this study was to evaluate the efficacy and safety of the digital health application (DHA) in patients with inflammatory arthritis. We assessed demographic parameters, treatment regimen, disease activity, and other patient-reported outcomes at baseline and after 4 weeks of DHA use added to standard care treatment. Of 17 patients, who completed the study, 7 (41.2%) patients were male, ranging from 19 to 63 (40.5 ± 12.2) years. No significant change in antirheumatic treatment was observed during the study. Statistically significant improvements (p < 0.05) were noted for health-related quality of life (increase in Physical Component Summary of Short Form-36 (SF-36) by 23.6%) and disease activity (decrease of Clinical Disease Activity Index and Simple Disease Activity Index by 38.4% and 39.9%, respectively). Clinically significant improvement was demonstrated for SF-36 Total Score (+ 14.4%), disease activity (Rheumatoid Arthritis Disease Activity Index− 5 to 15.9%), and depression (Patient Health Questionnaire− 9 to 13.5%). None of the efficacy parameters showed negative trends. No adverse events were reported throughout the study. The usability level was high i.e., the mean mHealth Application Usability Questionnaire Score of 5.96 (max.: 7.0) demonstrated a high level of application usability. This suggests that using a personalized disease management program based on DHA significantly improves several measures of patient-reported outcomes and disease activity in patients with inflammatory arthritis in a timely manner. These findings highlight the potential of complementary digital therapy in patients with inflammatory arthritis.

Efficacy and Safety of Anticoagulants for COVID-19 Patients in the Intensive Care Unit: A Systematic Review and Meta-Analysis.

This study aims to analyze the efficacy and safety of anticoagulants for COVID-19 patients in the intensive care unit. A comprehensive search was conducted using databases such as MEDLINE, PubMed, EuropePMC, Science Direct, Google Scholar, Clinicaltrial.gov, The Cochrane Central Register of Controlled Trial (CENTRAL, Cochrane Library) and several other published articles from the systematic review up to March 31, 2021. The Newcastle-Ottawa Scale (NOS) was used for the studies' qualitative assessment. The primary outcome examined was mortality rate, while the secondary included the length of stay (LOS) in thei care unit; hospital length of stay (HOS), coagulation markers including D-dimer, Platelet count, aPTT, PT and fibrinogen; markers of inflammation specifically C-reactive protein; and other adverse events ranging from hemorrhage to thrombosis. Additionally, the quantitative synthesis was conducted using fixed and random effects model in "The Revman 5.4", while heterogeneity was tested using the I-squared (I2) measure. A total of 1,062 articles were found during the initial search step and eventually 12 were chosen to be analyzed quantitatively in a meta-analysis. Comparison of the results related to anticoagulant group with no anticoagulant or standard care treatment showed that anticoagulant group significantly reduced mortality rate with RR= 0.53; 95 % CI, 0.30-0.95; P= 0.03, with I2 = 88% and venous thromboembolism (VTE) RR = 0.53; 95% CI, 0.37-0.76; P = .0007 with I2 = 35%. Based on the results, anticoagulants can mitigate mortality rate and VTE in COVID-19 patients.