Date Of Receipt Research Articles

Project Facilitate: An analysis of the increased utilization in the oncology single patient expanded access pathway.

11029 Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face when accessing Expanded Access (EA). PF staff provide step-by-step support to oncology healthcare providers requesting use of investigational drugs to treat their patients with cancer. Since launch, PF has received an increased number of oncology single patient EA applications each calendar year. An analysis of single patient investigational new drug applications (IND) received was performed over each calendar year, starting June 1, 2020. Methods: Data was extracted from PF’s central database between June 1, 2020 and December 31, 2023. Data collected included IND receipt date, granting date, status, application type, indication, drug name, address of requestor, and patient demographics. The starting date of June 1, 2020 was chosen since it was when PF staff officially started performing clinical review of applications. Results: Of the 2791 oncology single patient expanded access applications extracted, there were 681 (24.4%) emergency INDs (eIND) and 2110 (75.6%) non-emergency single patient INDs (SPI). Applications received by calendar year increased since June 1, 2020 to December 31, 2020 (397, 14.2%), 2021 (682, 24.4%), 2022 (822, 29.5%), and 2023 (890, 31.9%). The top-3 disease areas requested include high grade glioma (262, 9.4%), multiple myeloma (213, 7.6%), and melanoma (186, 6.7%). The top-3 disease areas requested in pediatric patients < 17 years of age (568, 20.4%) include AML (88, 15.5%), high grade glioma (85, 15%), and ALL (47, 8.3%). Race and ethnicity information was provided in 32 applications containing white/Caucasian (24, 75%), Black or African American (4, 12.5%), Asian (2, 6.25%), and Hispanic or Latino (2, 6.25%). Applications were received from 46 states and 1 US territory, Puerto Rico. The top 3 states requestors resided in were CA (346, 12.4%), NY (317, 11.4%), and TX (276, 9.9%). Although rare, 22 (0.79%) applications were denied or placed on clinical hold most commonly due to curative or established therapies being available. Conclusions: Project Facilitate saw a 20.4% increase in oncology single patient expanded access requests received from calendar year 2021 compared to 2022 and an 8.3% increase from 2022 to 2023, equaling a 30.4% increase in 2023 compared to 2021. [Table: see text]

Low antibody levels associated with significantly increased rate of SARS-CoV-2 infection in a highly vaccinated population from the US National Basketball Association.

SARS-CoV-2 antibody levels may serve as a correlate for immunity and could inform optimal booster timing. The relationship between antibody levels and protection from infection was evaluated in vaccinated individuals from the US National Basketball Association who had antibody levels measured at a single time point from September 12, 2021,to December 31, 2021. Cox proportional hazards models were used to estimate the risk of infection within 90 days of serologic testing by antibody level (<250, 250-800, and >800 AU/mL1 ), adjusting for age, time since last vaccine dose, and history of SARS-CoV-2 infection. Individuals were censored on date of booster receipt. The analytic cohort comprised 2323 individuals and was 78.2% male, 68.1% aged ≤40 years, and 56.4% vaccinated (primary series) with the Pfizer-BioNTech mRNA vaccine. Among the 2248 (96.8%) individuals not yet boosted at antibody testing, 77% completed their primary vaccine series 4-6 months before testing and the median (interquartile range) antibody level was 293.5 (interquartile range: 121.0-740.5) AU/mL. Those with levels <250 AU/mL (adj hazard ratio [HR]: 2.4; 95% confidence interval [CI]: 1.5-3.7) and 250-800 AU/mL (adj HR: 1.5; 95% CI: 0.98-2.4) had greater infection risk compared to those with levels >800 AU/mL. Antibody levels could inform individual COVID-19 risk and booster scheduling.

Respiratory infections predominate after day 100 following B-cell maturation antigen–directed CAR T-cell therapy

AbstractInfections are an important complication after B-cell maturation antigen (BCMA)–directed chimeric antigen receptor (CAR) T-cell therapy and risks may differ between the early and late periods. We evaluated infections in 99 adults who received a first BCMA–directed CAR T-cell therapy (commercial and investigational autologous BCMA CAR T-cell products at the recommended phase 2 dose) for relapsed/refractory multiple myeloma between November 2016 and May 2022. Infections were recorded until day 365, if patients experienced symptoms with a microbiologic diagnosis, or for symptomatic site-specific infections treated with antimicrobials. One-year cumulative incidence functions were calculated based on time to first respiratory infection using dates of infection-free death and receipt of additional antineoplastic therapies as competing risks. Secondary analysis evaluated risk factors for late respiratory infections using univariate and multivariable Cox regression models. Thirty-seven patients (37%) experienced 64 infectious events over the first year after BCMA–directed CAR T-cell therapy, with 42 early infectious events (days, 0-100), and 22 late infectious events (days, 101-365). Respiratory infections were the most common site-specific infection and the relative proportion of respiratory infections increased in the late period (31% of early events vs 77% of late events). On multivariable analysis, hypogammaglobulinemia (hazard ratio [HR], 6.06; P = .044) and diagnosis of an early respiratory viral infection (HR, 2.95; P = .048) were independent risk factors for late respiratory infection. Respiratory infections predominate after BCMA CAR T-cell therapy, particularly after day 100. Hypogammaglobulinemia and diagnosis of an early respiratory infection are risk factors for late respiratory infections that may be used to guide targeted preventive strategies.

EDITORIAL. El dilema del Editor ante las circunstancias actuales de la comunicación científica.

Recently the scientific community has been the subject of much controversy due to some facts that have arisen. One was the withdrawal of journals by the Web of Science for not carrying out adequate peer review processes and publishing articles lacking in scientific rigor in exchange for high publication costs. In fact, it can be verified that it is common to find works that appear accepted just two or three days after the date of receipt, making it doubtful of an adequate review. Many advocate “Open Science” as the freedom to commu-nicate results without the consent of referees or the sometimes very rigorous requirements of scientific journals. Another example case was that of a researcher sanctioned by his Uni-versity for considering the excessive authorship of works published by the said individual in a very short time, which seems to be doubtful. It is common to find cases of researchers advising working groups from various countries outside their country of origin, perhaps only as statistical analysts or offering their recognized names to stimulate the citation of an in-stitution or country. It would then be appropriate to ask the question: What would be the number of publications that an author may have so that it is not suspected of gratifying or convenient authorship, for himself or for the institution to which he belongs? On the other hand, it is known that authorship of papers may be obtained in high-impact journals through payments or citations that do not correspond to the topic dealt with in the work. Indeed, we have discovered some contributions with out-of-context citations in Investigación Clínicathrough a rigorous analysis of the references. Worse still, it is the communication, carried out by any individual who is not an expert in a field, through the most popular social net-works, of concepts that deeply permeate public opinion in general, being transmitted as if they were proven facts and therein the danger, in the specific case of Medicine, damage to health. For all of the above, the Editors of scientific journals must be very vigilant and ready to discuss the advantages or inconveniences of modern initiatives, the influence of social media in disseminating information, and knowing how to interpret their impact on public health. On the other hand, Journals have to balance the role of citations and impact indexes in the projection of Science individuals, as some academic institutions in European (Spain) or Asian (China) countries are doing.

Identification of cancer chemotherapy regimens and patient cohorts in administrative claims: challenges, opportunities, and a proposed algorithm

BackgroundReal-world evidence is a valuable source of information in healthcare. This study describes the challenges and successes during algorithm development to identify cancer cohorts and multi-agent chemotherapy regimens from claims data to perform a comparative effectiveness analysis of granulocyte colony stimulating factor (G-CSF) use.MethodsUsing the Biologics and Biosimilars Collective Intelligence Consortium’s Distributed Research Network, we iteratively developed and tested a de novo algorithm to accurately identify patients by cancer diagnosis, then extract chemotherapy and G-CSF administrations for a retrospective study of prophylactic G-CSF.ResultsAfter identifying patients with cancer and subsequent chemotherapy exposures, we observed only 12% of patients with cancer received chemotherapy, which is fewer than expected based on prior analyses. Therefore, we reversed the initial inclusion criteria to identify chemotherapy receipt, then prior cancer diagnosis, which increased the number of patients from 2,814 to 3,645, or 68% of patients receiving chemotherapy had diagnoses of interest. Additionally, we excluded patients with cancer diagnoses that differed from those of interest in the 183 days before the index date of G-CSF receipt, including early-stage cancers without G-CSF or chemotherapy exposure. By removing this criterion, we retained 77 patients who were previously excluded. Finally, we incorporated a 5-day window to identify all chemotherapy drugs administered (excluding oral prednisone and methotrexate, as these medications may be used for other non-malignant conditions) as patients may fill oral prescriptions days to weeks prior to infusion. This increased the number of patients with chemotherapy exposures of interest to 6,010. The final cohort of included patients, based on G-CSF exposure, increased from 420 from the initial algorithm to 886 using the final algorithm.ConclusionsMedications used for multiple indications, sensitivity and specificity of administrative codes, and relative timing of medication exposure must all be evaluated to identify patient cohorts receiving chemotherapy from claims data.

Outcomes of hepatocellular carcinoma by etiology with first-line atezolizumab and bevacizumab: a real-world analysis.

Hepatocellular carcinoma (HCC) is a common and deadly form of liver cancer. Combination atezolizumab and bevacizumab has improved the outcomes for patients with advanced disease. We sought to determine the impact of etiology on outcomes of patients treated with atezolizumab and bevacizumab. This study used a real-world database. The primary outcome was overall survival (OS) by etiology of HCC; the secondary outcome was real-world time to treatment discontinuation (rwTTD). Time-to-event analyses was performed by the Kaplan-Meier method; the log-rank test to assess for differences by etiology from date of first receipt of atezolizumab and bevacizumab. The Cox proportional hazards model was used to calculate hazard ratios. In total, 429 patients were included (n = 216 Viral-HCC; n = 68 Alcohol-HCC; n = 145, NASH-HCC). The median overall survival for the entire cohort was 9.4months (95% CI 7.1-10.9). Compared with Viral-HCC, the hazard ratio (HR) of death was 1.11 (95% CI 0.74-1.68, p = 0.62) for Alcohol-HCC and was 1.34 (95% CI 0.96-1.86, p = 0.08) for NASH-HCC. The median rwTTD for the entire cohort was 5.7months (95% CI 5.0-7.0months). The HR of rwTTD was 1.24 (95% CI 0.86-1.77, p = 0.25) for Alcohol-HCC and was 1.31 (95% CI 0.98-1.75, p = 0.06) in reference to TTD with Viral-HCC. In this real-world cohort of patients with HCC receiving first-line atezolizumab and bevacizumab, we did not identify an association between etiology and OS or rwTTD. This suggests that the efficacy of atezolizumab and bevacizumab may be similar across HCC etiologies. Further prospective studies are needed to confirm these findings.

Racial differences in survival and healthcare resource utilization among Medicaid-insured adults with metastatic castration-sensitive prostate cancer.

26 Background: Racial inequalities in healthcare have long existed in the United States, with Black or African American (BAA) men having higher overall cancer death rates compared to other racial or ethnic groups. One of the greatest disparities is in prostate cancer (PC), which disproportionately affects BAA men, though when matched for stage, whether outcomes differ by race is controversial. This study assessed differences in overall survival (OS) and healthcare resource utilization (HRU) by race in Medicaid-insured patients with metastatic castration-sensitive prostate cancer (mCSPC). Methods: This retrospective longitudinal cohort study evaluated de-identified administrative claims data from the Centers for Medicare and Medicaid Services 100% Medicaid data files, from 01/01/2010 - 12/31/2018. The study included adult patients with a diagnosis for PC, ≥1 claim for androgen deprivation therapy (ADT), diagnosis of metastasis before or within 90 days after ADT, and continuous eligibility for ≥6 months pre-index (defined baseline period) and ≥3 months post-index. The date of first receipt of ADT or first receipt of novel hormonal therapy or docetaxel if initiated within 30 days before ADT defined the index date. OS and HRU were assessed from the index date to the earliest of end of continuous eligibility, data availability, or death. A multivariable Cox proportional hazards model of OS and a multivariable Poisson model of HRU were implemented and controlled for age, plan type, region, median state income, residence in a state with Medicaid expansion, index year, Charlson comorbidity index (CCI), baseline HRU, and clinical characteristics. Results: The study included 1,488 patients with mCSPC (467 [31%] BAA, 446 [30%] White [W], 219 [15%] Hispanic [H], 356 [24%] Other races [O]). H were the oldest (mean age 68 years), followed by O (67 years), W (64 years), and BAA (63 years). BAA and H had the highest CCI (0.6), followed by O (0.5), and W (0.4). Median unadjusted OS was 71.3 months in H, 57.1 months in O, 52.1 months in BAA, and 44.9 months in W. After adjustment, H had significantly lower risk of death compared to W (hazard ratio [95% confidence interval (CI)]: 0.65 [0.43, 0.96]) and BAA patients had comparable survival to W (0.91 [0.69, 1.22]). Adjusted incidence rate ratios (IRR) showed significantly lower incidence of PC-related outpatient (OP) visits for BAA as compared to W (IRR [95% CI]: 0.71 [0.55, 0.99]), per patient per year. The remaining HRU endpoints were not significantly different among racial groups. Conclusions: Among Medicaid-insured adult patients with mCSPC, H were more likely to live longer than W patients. BAA patients had similar survival and lower rates of PC-related OP visits as compared with W, which shows differential use of PC-related healthcare resources between BAA and W.

Legal characteristics of the bank deposit (deposit) agreement

Holding on the deposit of funds are their transfer in cash or non-cash in foreign, or national currency, banknote or bank currency and at the expense of the owner for compliance under certain conditions in accordance with the contract.&#x0D; The agreement of the bank deposit is concluded in writing. If the bank's deposit agreement or certificates and other documents that meet the requirements of the bank's legislation, regulations or other provisions which corresponds to the written form of the bank deposit agreement (bank rules) and the customs of business.&#x0D; The agreed condition that the bank has the right to change the rate of interest on the deposit in a one-way order is invalid. Interest on bank deposits is accrued from the date of receipt of the deposit by the bank and ends on the day before the depositor accepts the deposit or debiting the funds from the account of the account.&#x0D; In judicial practice, there is no unanimity on the question of whether the heir has the right to receive interest on the relevant contract of the bank deposit (deposit) and the right of way of life after the death of the depositor of funds until the actual return of the deposit.&#x0D; We consider it expedient to make changes to paragraph 3 of Chapter 71 of the Civil Code of Ukraine on further improvement of legislative provisions on deposit obligations, in particular by limiting and regulating the range of entities with the right to provide this type of financial services complying with their compliance with the established legislation with the requirements for professional students of this market focusing on the economic base of the main types of their activities, clarification of the legal regime of those involved in the depository fund of financial institutions and active assets defining the permissible limits between the establishment of legal succession and harmonization of approaches to the mechanism of accrual of interest in the investigated obligations

Abstract 2791: Integrating biospecimen science approaches into clinical assay development-PAR 22-049

Abstract Introduction to the problem: Biospecimens are the essential starting materials for the biomarker assays that enable precision medicine. Biospecimen preanalytical factors can directly influence molecular results from assays conducted for basic research, biomarker discovery, and biomarker validation, and can also influence the development of validated clinical assays. The U.S. National Cancer Institute (NCI) Biorepositories and Biospecimen Research Branch supports extramural research as a part of this FOA to investigate and mitigate preanalytical challenges facing clinical assay development and analytical validation in a variety of biospecimen types. The overall goal of this initiative is to expedite biomarker clinical assay development through evidence based standardization of biospecimen handling practices. The work is centered on emerging and clinically relevant biomarker assays conducted on a variety of molecular platforms. Proposed solution and methods: Researchers may investigate tissue and fluid biospecimens including core biopsies, fine needle aspirates, tissue exudates, blood, urine, saliva, breast milk, feces, sweat, CSF, and pleural and esophageal aspirates. Investigator designed experiments explore how different biospecimen preanalytical conditions affect biomarkers in a clinical setting. To date, ten grants have been funded. The grants address important areas in biospecimen science in both liquid and solid biopsy biopsies in breast cancer, glioblastomas, lung cancer, bladder cancer, prostate cancer, cutaneous and peripheral T cell lymphoma. Investigators can collaborate with each other and with the NCI, FDA and NIST through the U01 funding mechanism. Conclusions: The results from this research program will elucidate how analytical quantification of clinically relevant biomarkers is affected by patient context factors, variation in biospecimen collection, processing, and storage procedures, and how such effects can be mitigated to improve the development, performance and accuracy of clinical biomarker assays utilized in clinical research and patient care. The receipt dates for this program, PAR 22 049 in 2022, are January 11, 2022, June 7th, 2022, and September 13th, 2022. Citation Format: Lokesh Agrawal, Abhi Rao, Ping Guan, Miguel Ossandon, Helen Moore. Integrating biospecimen science approaches into clinical assay development-PAR 22-049 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2791.

915-P: Annual Wellness Visits and Preventive Care Utilization among Medicare Beneficiaries in the Diabetes Belt and Surrounding Areas

Objective: Medicare beneficiaries are eligible to receive free Annual Wellness Visits (AWVs) for assessing preventive care needs, identifying care resources, and scheduling visits. We previously reported that AWVs are associated with increased use of preventive care for patients with diabetes. In this study, our objective is to conduct a case-control study to examine whether AWVs are associated more strongly with preventive care use in the Diabetes Belt than in surrounding areas. Methods: We used a sample of ∼900,000 Medicare Fee-for-Service beneficiaries who lived in the Diabetes Belt and surrounding areas in 2014 - 2015. We identified patients who have used an annual foot exam, eye exam, A1c test, and microalbuminuria (MA) test and those who did not in 2015. We used the dates of service receipt and the last day of the year (12/31) as the event date for users and non-users, respectively. We looked one full year before the event date to identify any AWVs. We used propensity-score stratification to estimate log odds of 4 preventive care use of annual foot exam, eye exam, A1c test, and MA test. Results: For all four services, AWV users had significantly higher preventive care use compared to non-users. In 3 preventive services, AWVs were more strongly associated with preventive care use in the Belt than in the surrounding areas (foot exam, ORs = 2.38 vs 2.16, p &amp;lt; 0.001; A1c test, ORs = 1.44 vs. 1.36, p = 0.002; MA test, ORs = 1.70 vs. 1.44, p &amp;lt; 0.001; eye exam, ORs 1.22 vs. 1.19, p=0.063) . Discussion: AWVs appear to have stronger effects on preventive care use for patients with diabetes in the more healthcare resource-poor Diabetes Belt than in the surrounding areas. AWVs may help to reduce disparities in the use of recommended preventive care for patients with diabetes. Disclosure M.Sohn: None. T.L.Mcmurry: None. H.Kang: None. S.Kim: None. J.M.Lobo: n/a. Funding NIDDK R01DK113295

Project facilitate: Innovation and advancement in FDA’s oncology expanded access program.

e18556 Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face when accessing Expanded Access (EA). Since launch, PF continues to evolve and innovate to provide a comprehensive service to assist oncology healthcare providers requesting EA. An analysis of single-patient investigational new drugs (IND) was performed over 1 year to assess the growth and impact of the program. Methods: Data was extracted from Project Facilitate’s central database that yielded 640 single-patient INDs between June 1, 2020 and June 1, 2021. Data collected included IND receipt date, granting date, status, application type, indication, drug name, address of requestor, and patient demographics. Results: Of the 640 single-patient INDs extracted, there were 183 emergency INDs (eIND) and 457 non-emergency INDs (SPI). EA requests originated primarily from academic centers (81%) and community hospitals (18%) whereas Veterans Affairs and Military Treatment Facilities (0.5%) and Other (0.5%) were the least common. The 5 most common states requests originated from include New York (14%), California (13%), Texas (11%), Pennsylvania (7%), and North Carolina (4%). Although the current FDA Form 3926 does not request race and ethnicity information, this data was reported in 17 requests: White (8), Asian (3), Black/African American (3), American Indian or Alaskan Native (0), Native Hawaiian or Other Pacific Islander (0), Hispanic or Latino (3) and non-Hispanic or Latino (0). Age distribution was analyzed for pediatric (24%) and adult (76%) patients. Age distribution was further analyzed in geriatrics &gt;75 (10%), in pediatrics &lt; 2 (7%) and patients 2-17 years old (17%). The processing and review times for 630 applications were &lt;1 day (96%) and &gt; 1 day (4%). PF granted 100% of EA requests received in this time period. PF’s call center received 525 phone calls of which 499 (95%) were answered on the first call. PF also received 7843 emails during this period. Conclusions: Since 6/1/2020, PF started performing the reviews, processing and granting of CDER oncology EA requests that generally were performed by the FDA Review Divisions. By consolidating this process to PF, review times have drastically reduced to &lt;1 day. PF has evolved since launch to promote effective and equal access to oncology expanded access.[Table: see text]

FDA analysis of expanded access use in pediatric patients from 2015 to 2020.

1529 Background: Expanded Access is a regulatory mechanism that enables patients with a life-threatening condition or serious disease to receive treatment with an investigational drug outside of a clinical trial when no comparable or satisfactory alternative options are available. FDA has decades of experience with expanded access, but little has been reported about its use in pediatric cancer patients. Methods: FDA’s central electronic database was queried for single-patient investigational new drug (spIND) applications submitted to the Office of Oncologic Diseases between January 2015 through December 2020. Data collection included IND receipt date, IND type/status, drug name, and patient demographics. Duplicate or exempt INDs, those cancelled by the physician-sponsor before initiating therapy, and those requested for indications that occur almost exclusively in adults (e.g. lung cancer) or were missing patient age were excluded. Results: Of 2,901 unique spINDs granted, 534 (18%) were for patients less than 18 years of age. The pediatric population was 57% male, median age 6.0 years (range 0.1 to 17); race/ethnicity were reported in &lt;1%. Patients were treated in 132 zip codes across 39 states; one-quarter of submissions were from 5 large academic hospitals. Central nervous system tumors were the most common indication (Table 1). A total of 98 unique drugs were requested, with 1 to 73 spINDs for each drug; approximately 50% were for tyrosine kinase inhibitors, 25% for other small molecules, and the remainder for immunotherapies and other drug types. Median time for FDA to grant was 1 day. Follow-up information was provided for 75% (annual report or withdrawal letter); 1/3 were withdrawn within 1 year. Over the last 2 years, utilization of the program increased by 120%. Conclusions: While approximately 1% of all cancers per year are diagnosed in children under 17 years of age, 18% of spINDs over the last five years were for pediatric patients. Although utilization of this program for children is robust, efforts are needed to assess its impact on patient outcomes and ensure its availability to patients, families, and institutions more widely. These data highlight interest within the pediatric oncology community in accessing innovative therapies, which supports early investigation of promising new drugs in children.[Table: see text]

Erratum: Kinetic Study &amp; Statistical Modelling of Sarawak Peat Water Electrocoagulation System using Copper and Aluminium Electrodes

In the article “Kinetic Study &amp; Statistical Modelling of Sarawak Peat Water Electrocoagulation System using Copper and Aluminium Electrodes” by Nazeri Abdul Rahman, Nurhidayah Kumar Muhammad Firdaus Kumar, Umang Jata Gilan, Elisa Elizebeth Jihed, Adarsh Phillip, Allene Albania Linus, Dasima Nen@Shahinan, and Verawaty Ismail (Journal of Applied Science &amp; Process Engineering, 2020, Vol 7, No. 1, pp 439–456. https://doi.org/10.33736/jaspe.2195.2020), there was an error in the Manuscript History. The stated history noted that the manuscript was received on 29 April 2020. The receipt date of the manuscript should have been stated as 9 April 2020.

Timeliness of reporting process in the national routine health information system: The case of 19-year experience of Field Health Services Information System in Palawan, the Philippines

IntroductionRoutine health information system (RHIS) has been repeatedly updated to provide quality information. However, its timeliness has rarely been tracked. This study investigated the reporting status and the timeliness of quarterly reports of the national RHIS in the Philippines, based on its 19 years-operation in Palawan.MethodsWe analyzed the timeliness of 94.7% (1568/1656) of the quarterly reports that we obtained the date of receipt submitted by 22 health centers in Palawan from 1996 to 2014. The RHIS update in 2008 increased the number of reporting items and extended the submission due date since 2009 while computerized 15 health centers since 2011. We performed Fisher’s exact test to examine changing the proportion of timely reports and multiple comparisons with permutation tests for changing the mean of the quarterly median lead times, median delays and interquartile ranges (IQR), for four periods of different operational requirements in the RHIS.ResultsThe update increased the timely reports from 6.7% (70/1045) to 22.4% (117/523) (p<0.001). The delay remained stable from 14.2 days to 16.1 days (p = 0.654). However, the IQR widened 2.31 times (p = 0.004) compared to 15.7. Despite the increased burden, the continued manual data processing decreased the delay by 7.1 days (p = 0.023) and remained the IQR stable at 1.19 times (p = 0.670), while 15 health centers were computerized, it increased the delay by 6.4 days (p = 0.037) and widened the IQR by 2.87 times (p = 0).ConclusionsMore attention must be paid to controlling the timeliness of RHIS when we introduce new interventions and perform daily management. Extending the due date increased timely reports. However, introducing unfamiliar tasks increased delay and uncertainty in timeliness. In a low-resource setting, an effective intervention needs to consider modest operating procedure changes that extend the existing routines to which the staff in charge has already accustomed.

МЕЖДУНАРОДНАЯ ПРЕМИЯ А.М. ТЬЮРИНГА АССОЦИАЦИИ ВЫЧИСЛИТЕЛЬНОЙ ТЕХНИКИ: ИНФОРМАЦИОННЫЙ АНАЛИЗ

The article presents the brief information on the English mathematician and cryptographer A.M. Turing, about Association for Computing Machinery, the oldest and most powerful in the computer science community, and about the A.M. Turing Award, the highest prize in computer science, which is considered the equivalent of the Nobel Prizes in computer science. A complete list of A.M. Turing Award winners from 1966 to 2020 is given in Russian and original languages, dates of life. Analysis of the achievements of the laureates shows a complete and interesting history of the development of informatics (computer science) in the 20th and early 21st centuries. During this time, 74 people became laureates, including three women. The exact formulation of the award committee for each laureate is given, as well as their academic degrees, places and dates of receipt. Some statistical data on the laureates are also given (distribution by country, a list of thematic areas for which prizes were awarded, the average age of the laureates).

PENDAFTARAN HAK ATAS MEREK

The right to a mark recognized by the Indonesian state is a brand that is a part of intellectual property rights as regulated in Law Number 20 of 2016 concerning Marks and Geographical Indications, which revises Law Number 15 of 2001 concerning Marks which is a problem in research on how to register and protect rights to registered marks according to Number 20 of 2016 concerning Marks and Geographical Indications. This research is a normative legal research which is descriptive, not descriptive. Mark registration submitted by the applicant to the Directorate General of Marks, Ministry of Justice and Human Rights and the approved application (individual or legal entity) will receive a certificate registered in the general register of marks. the right to a registered mark is a legal protection of the exclusive right to use the mark yourself or to give permission to other parties to use the mark within 10 years from the date of receipt of registration and can be extended by the owner/or his legal representative.

Immune-related adverse events of COVID-19 vaccination in skin cancer patients receiving immune-checkpoint inhibitor treatment

To date, few data are available regarding Adverse events (AEs) in cancer patients who are vaccinated for coronavirus disease 2019 (COVID-19) while being actively treated with Immune-checkpoint inhibitors (ICIs). We aimed to assess the safety of COVID-19 vaccines approved in Germany. Specifically, we investigated the frequency of general side effects and immune-related AEs of COVID-19 vaccination. A triage survey was used to collect the following information for patients with metastatic skin cancer: vaccine type, date of receipt of each dose of vaccine, and self-reported side effects. Clinical data were retrieved from the patients’ medical records. Of 130 patients with metastatic skin cancer, 89 patients were on immunotherapy and received COVID-19 vaccination. Of these 89 patients (median age: 64 years; 57 [64%] men), 89% had melanoma, and 71% received ICI therapy with a PD-1 antibody. Eighty-eight percent received an mRNA-based COVID-19 vaccination. The median follow-up time was 125 days after the first vaccination, and 84 days after the second. The most common observed side effects were mild to moderate pain at the injection site (40%), followed by fatigue (24%). Grade 3 irAEs were reported in eight patients, seven of whom were on nivolumab plus ipilimumab combination treatment. Of the 19 patients vaccinated within 72 h before/after ICI, five developed irAEs within 17 days (1–17 days). This small cohort study suggests that approved COVID-19 vaccinations are safe for use in cancer patients receiving ICIs. However, some precautions should be taken, especially regarding the timing of vaccination and ICI treatment.

Trends in Publication Speed of Radiation Oncology Research from 2010 to 2019

PurposeIn this investigation, we aimed to describe trends in time to acceptance (TTA) and time to online publication (TTOP) of research published in leading radiation oncology journals from 2010 to 2019. We further sought to identify journal characteristics that might influence TTA and TTOP. Methods and MaterialsWe searched the publication history of 5 leading international radiation oncology journals. For all research articles accepted from January 1, 2010, to December 31, 2019, we tabulated the date of article receipt, the date of acceptance, and the date of online publication when available. The TTA was calculated as the number of elapsed days from article receipt to acceptance, and the TTOP was calculated as the number of elapsed days from article acceptance to online publication. Using the Mann-Kendall test, we assessed for monotonic trends over time and used the post hoc Theil-Sen method to estimate rates of change. We created a multiple regression model to identify journal characteristics associated with TTA and TTOP. ResultsIn total, 10,132 articles were included. Both the TTA and the TTOP decreased significantly from 2010 to 2019 (P = .005 and P < .001, respectively), with an estimated decrease of 1.5 days per year for the TTA and 7.0 days per year for the TTOP. Multiple regression modeling revealed that a higher journal impact factor was independently associated with an increased TTA (P < .001) and a decreased TTOP (P < .001). A higher number of accepted journal articles per year was associated with a decreased TTA (P < .001) and an increased TTOP (P < .001). ConclusionsRadiation oncology research has been accepted and published online at increasingly faster rates during the past decade. The TTA may be longer in higher-impact, more selective journals, possibly suggesting a need for comprehensive peer review and complex editorial decisions. However, these articles are also published online faster after article acceptance. Future work examining patterns of acceptance and publication speed is needed to encourage rapid dissemination of practice-guiding data.

1351. Use of Mail-Out Sexually Transmitted Infection Test Kits in a Telehealth Pre-exposure Prophylaxis Clinic

BackgroundStandard of care for patients receiving pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) includes HIV screening and testing for sexually transmitted infections (STIs) at all sites of potential exposure every three months. We implemented a provider and pharmacist telehealth based PrEP program as part of the HIV, Hepatitis Specialty Telehealth Access Resource (H-START) Collaborative. Due to the COVID-19 pandemic and care via telehealth, we had limited ability to collect pharyngeal or rectal swabs in clinic. We created mail-out kits including swabs and instructions for self-collection to test for rectal and pharyngeal Neisseria gonorrhea and Chlamydia trachomatis.MethodsKits were mailed out to patients between June 2020 and May 2021. Providers first confirmed patient comfort with self-swab collection during telehealth appointments. Kits included: an instruction sheet with visual diagrams for collection, swabs with appropriate labels; and a pre-paid envelope for patients to mail swabs back to our facility for laboratory testing. Prospective data collection included the date kits were mailed out to patients, the date of kit receipt at our facility and the test result. Charts were retrospectively reviewed to determine treatment completion.Results54 self-swab kits were mailed to patients. 53 of the patients were male and the average age was 41.3 years old. 38 (70.3%) swabs were returned. The median time for return of swabs was 21 days (Range 2-289). Of those returned, 5 (13.1%) were positive and all 5 patients were treated for their infection. ConclusionMail-out STI testing was effective in identifying STIs for a telehealth PrEP program and for maintaining standard of care practice during the COVID-19 pandemic. This model may increase rates of testing compliance for care provided via telehealth and decrease rates of STI transmission and complications. Better communication around returning kits in a timely-manner and understanding reasons for non-return warrant further investigation.Disclosures Monica K. Sikka, MD, FG2 (Scientific Research Study Investigator) Christopher D. Pfeiffer, MD, MHS, C. difficile Vaccine Trial (Scientific Research Study Investigator)

607. Improving Health Maintenance Among Patients with HIV by Implementing a SmartPhrase and a Care Gap in the EPIC Electronic Medical Record

BackgroundMost deaths in HIV-infected patients receiving antiretroviral therapy are now related to conditions other than AIDS. HIV infection appears to increase the risk of many non-AIDS-related conditions, highlighting the importance of preventive care, however, recommended health maintenance items unique patients with HIV (PWH) are not always accomplished. We aimed to improve health maintenance by implementing a SmartPhrase and a Care Gap package in the EPIC Electronic Medical Record (EMR). MethodsWe developed a HIV health maintenance SmartPhrase in EPIC that included the last screening dates for syphilis, gonorrhea, chlamydia, hepatitis A, hepatitis B, hepatitis C, latent tuberculosis, hyperlipidemia, diabetes and human papilloma virus and the dates of receipt of hepatitis A vaccines, hepatitis B vaccines, pneumococcal conjugate vaccines, pneumococcal polysaccharide vaccines and influenza vaccines (Figure 1). Providers can select their plan for each health maintenance item based on these data and their plans are documented in the encounter notes. Providers were educated to use the SmartPhrase in each office visit. An HIV registry was built after choosing 509 HIV related medical conditions. The health maintenance topics were displayed in a “Care Gaps” summary using the data in the HIV registry (Figure 2). Completion rates for the health maintenance items were compared before and after implementation. The health maintenance package was implemented on 3/1/2020. Figure 1. SmartPhrase .IDNOTE description and note documentation Information relevant to health maintenance and providers' plan for each health maintenance are documented in the encounter notes.Figure 2. CareGaps© 2021 Epic Systems Corporation CD4 every 6 months is displayed as a part of the health maintenance in a “Care Gaps” summary using the data in the HIV registry, whether their HIV is well controlled or not.ResultsOf the 380 patients in the registry, 162 had office visits with the ID clinic from 1/1/20 to 6/5/20. Chart review of 100 patients who had office visits after implementation was performed and compared to the 62 patients prior to implementation (Table 1). The rates of hepatitis A vaccination (P= 0.001), hepatitis B vaccination (P= 0.05) and influenza vaccination (P=0.035) were increased significantly. Pneumonia vaccine administrations and anal pap smear performance compliance remained suboptimal. Providers reported that the time they spent searching for lab results and immunization records and documenting were shortened. The rates of hepatitis A vaccination (P= 0.001), hepatitis B vaccination (P= 0.05) and influenza vaccination (P=0.035) were increased significantly.ConclusionA health maintenance package consisting of a SmartPhrase and summary display in the EMR with provider education likely helps improve health maintenance in PWH. Disclosures All Authors: No reported disclosures