Review Period Research Articles

CASH CRUNCH AND THE NIGERIAN ECONOMY

This study examined cash crunch and the Nigerian economy. To achieve this objective, relevant data used spanning from 1981-2022 were obtained for the review period from the Central Bank of Nigeria (CBN) Statistical Bulletin and World Bank Indicators. Descriptive statistics, Augmented Dickey Fuller (ADF) Unit root test, Granger causality and Ordinary Least Square (OLS) regression were the analytical tools for this study. Real Gross Domestic Product growth rate (RGDPgr) was used as the dependent variable, while Cash crunch proxy with prime lending rate (CC), Domestic credit by Banks to private sector (DCBPS), Loan to deposit ratio (LDR), Inflation Rate (INFR), Money supply growth rate (MSgr) as the independent variables. Based on the analysis, there exist positive relationship between RGDPgr, CC, DCBS, LDR, and M2gr and a negative relationship existed RGDPgr and INFR. The F-statistic of the regression output stood at 6.208930, this implies that the regression plane is statistically significant. It was also, revealed that cash crunch had negative and significant effect on the Nigerian economy C = -11.97721, P < 0.05 (0.0265 < 0.05), while the overall Prob.(F-Statistic) 0.000302 is less than the 0.05 level of significance implies that there is a statistical significant relationship between the variables. R2= 0.463044 implies that about 46.30% of the total variation in the model specified was accounted for by the independent variables. LDR is platykurtic, RGDPgr, CC, DCBPS, INFR and M2gr are leptokurtic, according to the descriptive analysis, which also showed that all the variables were normally distributed; All the variables were stationary and significant at their respective values. There is the existence of a long-run relationship between the variables indicated by Johansen co-integration equation. Therefore, cash crunch has negative effect on investment in an economy. In conclusion, cash crunch had negative and significant impact on the expansion of Nigerian economy for the period studied. The study recommended that the government through CBN should modified most of its tools and incorporate some of the macro prudential variables in its dealings so as to have robust grips of the economy with the intention of suppressing the adverse effect of inflationary pressure in the economy.
 Keywords: Cash Crunch, Domestic Credit By Banks To Private Sector, Inflation, Money Supply And Nigerian Economy.

Glaucoma Agreement in New Zealand (GAINZ)

ABSTRACT Clinical Relevance With an ageing population, ophthalmologists are becoming burdened with glaucoma management, and patient care can be delayed. Therefore, the use of optometrists in glaucoma management can help alleviate the burden. Background The ageing population and subsequent rise of glaucoma prevalence are putting a strain on the public health system in New Zealand. Glaucoma collaborative care between optometrists and ophthalmologists has been gaining support with the aim to reduce this burden on ophthalmologists. There has been little investigation of the agreement in care and management of mild-to-moderate severity glaucoma patients by optometrists and ophthalmologists. Methods One hundred and three glaucomatous eyes were used in a survey where clinical history and examination, intraocular pressures (IOPs), visual field testing and optical coherence tomography (OCT) imaging were evaluated for glaucoma progression and decision-making regarding subsequent management by four participants. Two participants were glaucoma-credentialled optometrists (Group 1), and the other two were glaucoma specialists (Group 2). Results With respect to glaucoma progression, Spearman coefficients identified strong agreement between the two groups for IOP, visual fields and overall status and moderate agreement for OCT imaging. A confusion matrix was used to analyse management and found 80% ± 10% agreement between the two groups. Review periods gave an agreement of 55% ± 20% between the two groups. Conclusion There was strong agreement in the assessment of glaucoma progression between the two groups. The 80% level of agreement for subsequent management between the two groups is comparable to other published reports. These results provide some reassurance that a collaborative care system can perform safely and as intended.

Мониторинг обрабатывающей промышленности: оценка устойчивого развития

The article presents and tests a methodology for assessing the sustainable development of the Russian manufacturing industry, based on publicly available annual data from the Federal State Statistics Service (Rosstat) and the Ministry of Natural Resources and Environment of the Russian Federation over the period 2010-2022. To assess the sustainability of the industry, 32 indicators from three main areas - economic (13), social (10), and environmental (9) - were used. These indicators include measures of output, investment, fixed assets, innovation, efficiency of resource use, profitability, organization of employment, labor protection, occupational safety and health, wages, environmental investments, waste management, atmospheric and water pollution, and energy consumption. All indicators were standardized and subjected to logical checks to ensure that an increase in their values corresponded to an improvement in the relevant aspect of the industry. This allowed for a comprehensive assessment of the sustainability of Russian manufacturing. Estimates using the proposed methodology demonstrate the degree of change in indicators over time and do not necessitate the presence of normative values, which may be controversial. The findings indicate an increase in the overall indicator of sustainable development for the analyzed period of 17.9%. Approximately half of this increase is due to improvements in the environmental sector, which rose by 28%. The economic and social components contributed approximately a quarter each to the improvement in the composite measure of sustainable development in the manufacturing industry, rising by 13.4% and 13% respectively over the review period. Problem areas have also been identified where improvement is minimal or the situation is worsening: the situation with fixed assets, innovation, waste management and employment.

An integrated inventory model for a supply chain system with two competing retailers, carbon emissions, and price-and-service dependent demand

This study develops a mathematical model for a supply chain system with a single supplier and two competing retailers. The selling price and service level are two aspects determining the demand. Investments in service level are also considered to enhance the service environment in the stores. Both parties in the supply chain system employ a periodic review policy to regulate the inventory level in a stochastic setting. This study includes a carbon tax regulation to reduce emissions in the observed system. The proposed model contributes to the current inventory literature by allowing the inclusion of price and service-dependent demand, competition between two retailers, investment in service level, and carbon emissions. The objective of this study is to maximize the joint total profit by optimizing the selling price, service level, safety factor, review period, and number of shipments. An algorithm is developed to solve the proposed problem and its application is validated with a numerical example. The results show that retailers' demand level, selling price, and service are sensitive to emissions and profit. Additionally, investment and carbon tax regulations are effective in raising service levels and reducing emissions, respectively. This research can help decision-makers select the optimal action to improve the effectiveness of the supply chain system, optimize product sales, and emphasize environmental considerations.

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P).

Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP®/Haemocomplettan® P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986-June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.

Developing digital competencies of nursing professionals in continuing education and training - a scoping review.

The German health and care system is transforming due to advancing digitalization. New technological applications in nursing, such as social and assistance robotics, artificial intelligence and legal framework conditions are increasingly focused in numerous research projects. However, the approaches to digitalization in nursing are very different. When integrating technologies such as robotics and artificial intelligence into nursing, it is particularly important to ensure that ethical and human aspects are taken into account. A structured classification of the development of digitalization in nursing care is currently hardly possible. In order to be able to adequately deal with this digital transformation, the acquisition of digital competences in nursing education programs is pivotal. These include the confident, critical and creative use of information and communication technologies in a private and professional context. This paper focuses on the question which specific training offers already exist at national and international level for nursing professions to acquire digital competences. A scoping review according to the PRISMA scheme was conducted in the PubMed and CINAHL databases. The search period for the scoping review extended from 2017 to 2024. The selection of the studies took place by inclusion and exclusion criteria and the content-related orientation of the publications. After reviewing the titles and abstracts, eight studies were included. Of these, four were published in German-speaking countries and another four in international English-language journals. The topic of digitization of the nursing professions and the question of how nurses can acquire digital competences is gaining international attention. Nevertheless, the research on explicit continuing education programs for nursing professions is still undifferentiated. No specific continuing education offer for the development of digital competences of nursing professionals was identified. Many authors remained at the meta-level when developing methodological concepts for the acquisition of digital competences. The systematic integration of digitalization into higher education and continuing vocational training is mentioned in the publications. The development of theory- and research-based educational frameworks, which can be used as a basis for curricula in nursing studies and continuing education, is highly recommendable.

A Quantitative Exploration of the Consistency of Visual Rhythms and Social Values in Oil Painting Art

Abstract In the process of oil painting creation, creators present their ideology to the audience through diversified ways of expression so as to produce spiritual resonance with the audience. In this paper, the consistency of social and artistic values of color in oil painting art is studied from three aspects: color attributes, visual rhythm, and color psychological effects. Combined with the HSV color model, the relationship between hue, saturation, and brightness values, which in turn describes color harmony and aesthetics, is used to assess the artistic and social value of oil painting art. Finally, by taking oil paintings of the Literary Review Period style and Classical style as samples, the social and artistic value consistency of oil paintings can be analyzed through color. The results of the study show that when the value of the color attributes of Rembrandt’s oil paintings in the Literary Review Period reaches 240, the saturation value rises sharply, and the hue value likewise falls sharply, forming a strong color focus, making the paintings more toned down and fresh, and alluding to the spirit of resistance that the creator wants to express. The social attributes of purity and solemnity are created when color characteristics are purified, and saturation is smoothed in classical-style oil paintings.

Evaluation of logistics management information system and availability of non-program tracer drugs in public health facilities in Bahir Dar City, Northwest Ethiopia.

The logistics management information system (LMIS) plays a crucial role in effective record-keeping and reporting, ensuring efficient management of stock status and consumption data. A proficient LMIS improves accountability and supports informed logistic decisions in healthcare. Conversely, a subpar LMIS negatively affects essential medicine availability, compromising overall healthcare service efficiency. This study aimed to evaluate the status of the logistics management information system and the availability of non-program tracer drugs (NPTDs) in public health facilities within Bahir Dar City. This study employed an institutional-based cross-sectional study. Data were collected from February 20 to April 30, 2022 in 12 public health facilities located in Bahir Dar City. Structured questionnaire and data abstraction formats were used to gather pertinent data. After checking for completeness, the data were analyzed using Microsoft Excel and SPSS version 23. The primary analytical outcomes involved descriptive statistics, encompassing frequencies, averages, and percentages, which were subsequently presented in tables and figures. Bin card and Internal Facility Report and Resupply Form were the only blank LMIS tools available in all health facilities, while stock-record card was the least available, present in only 2(16.7%) facilities. Nine health facilities (75%) used self-prepared forms to request NPTDs from the Ethiopian Pharmaceutical Supply Agency (EPSA) at the end of the review period, whereas 7(58.3%) used official letters for emergency orders. Additionally, seven health facilities (58.3%) used the Health Commodities Management Information System On the day of the visit, 78.68% of NPTDs were available. Tetracycline eye ointment 1% had the longest stock-out duration, lasting for a mean 69.64 days. Rather than using the RRF, most of facilities opted for their own forms to request NPTDs from EPSA. While it is advisable for all health facilities to maintain continuous availability of tracer drugs, this study revealed that the current state of non-program tracer drug availability falls short of meeting this expectation.

Prevalence and Outcome of Repeat Caesarean Delivery: A Retrospective Review in Rasheed Shekoni Federal University Teaching Hospital Dutse, North-west Nigeria

Background: Caesarean section is the most common Obstetric surgical procedure. Repeat CS has been a significant contributor to the overall increase in CS rate and accounts for about one- third of all caesarean deliveries worldwide. Objective: This study aimed to determine the prevalence and outcome of repeat Caesarean section. Materials and methods: The study was a 3-year retrospective review of Caesarean sections, carried out between 1st July 2020 and 31st June 2023 in the department of Obstetrics and Gynecology of Rasheed Shekoni Federal University Teaching hospital. The case files of the participants were retrieved from the record department. Data analysis was carried out using IBM statistical package for social sciences (SPSS) version 26. Measured variables were expressed in frequencies and percentage. Test for association was done using chi-square non-parametric test, setting P-value at <0.05. Results: A total of 144 were repeat caesarean deliveries were performed out of 344 Caesarean sections done during the review period, giving an incidence rate of 41.9%. The mean age of the patients was 30.42 ± 50 years and the mean parity was 4.47±2.62. Most (51.39%) of the repeat CS were elective. Majority (93.06) of the patients had EBL ≤1000ml and most (82.6%) of the babies delivered had 5th minute Apgar score of ≥7. Conclusion: The repeat Caesarean section rate in this study is high. Similarly, the emergency Caesarean section rate at first and second order repeat Caesarean deliveries is high. Additionally maternal and fetal complications are higher among women lower order Caesarean deliveries.

Kidney trajectory charts improve GP management of patients with reduced kidney function: a randomised controlled vignette study.

The stages of chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) reference ranges are currently determined without considering age. To determine whether a chart that graphs age with eGFR helps GPs make better decisions about managing patients with declining eGFR. A randomised controlled vignette study among Australian GPs using a percentile chart plotting the trajectory of eGFR by age. Three hundred and seventy-three GPs received two case studies of patients with declining renal function. They were randomised to receive the cases with the chart or without the chart, and asked a series of questions about how they would manage the cases. In an older female patient with stable but reduced kidney function, use of the chart was associated with GPs in the study recommending a longer follow-up period, and longer time until repeat pathology testing. In a younger male First Nations patient with normal but decreasing kidney function, use of the chart was associated with GPs in the study recommending a shorter follow-up period, shorter time to repeat pathology testing, increased management of blood pressure and lifestyle, and avoidance of nephrotoxic medications. This represents more appropriate care in both cases. Having access to a chart of percentile eGFR by age was associated with more appropriate management review periods of patients with reduced kidney function, either by greater compliance with current guidelines or greater awareness of a clinically relevant kidney problem.

Child Neurology and Neurodevelopmental Disabilities Program Directors’ Opinions on Preference Signaling in the 2023-2024 NRMP Match: A Survey

Changes in residency recruitment have significantly altered how programs and applicants evaluate each other including virtual interviews, discontinuation of the United States Medical Licensing Exam Step 2 Clinical Skills exam, and transition of United States Medical Licensing Exam Step 1 to pass-fail scoring. To improve program-applicant fit, the Electronic Residency Application Service introduced supplemental application features including geographic preference, program signaling, and the opportunity to highlight impactful and meaningful experiences. We sought to evaluate child neurology (CN) and neurodevelopmental disabilities (NDD) program director's (PD) opinions regarding these changes. A 10-question anonymous survey was sent to CN (n=75) and NDD (n=8) PDs. The questions centered on PDs' opinions regarding components of the supplemental application, having a standard application review period and in-person recruitment activities. Answer choices to the questions were all close-ended. Respondents could select questions to complete. Thirty-eight CN residency PDs (49%) and 4 NDD residency PDs (50%) responded to the survey. Among CN PDs, there was strong support for use of the supplemental application questions and for the use of 3 program signals per applicant. Most PDs supported a standardized application review period prior to programs sending interview offers; however, there was no consensus on the appropriate length of time. Nearly half agreed with virtual-only interviews, and 62% agreed with the option of in-person second-look visits. CN PDs generally support many of the recent or proposed changes to residency recruitment. The impact of these changes on recruitment will be a topic of future investigation.

Deep learning for the prediction of clinical outcomes in internet-delivered CBT for depression and anxiety.

In treating depression and anxiety, just over half of all clients respond. Monitoring and obtaining early client feedback can allow for rapidly adapted treatment delivery and improve outcomes. This study seeks to develop a state-of-the-art deep-learning framework for predicting clinical outcomes in internet-delivered Cognitive Behavioural Therapy (iCBT) by leveraging large-scale, high-dimensional time-series data of client-reported mental health symptoms and platform interaction data. We use de-identified data from 45,876 clients on SilverCloud Health, a digital platform for the psychological treatment of depression and anxiety. We train deep recurrent neural network (RNN) models to predict whether a client will show reliable improvement by the end of treatment using clinical measures, interaction data with the iCBT program, or both. Outcomes are based on total improvement in symptoms of depression (Patient Health Questionnaire-9, PHQ-9) and anxiety (Generalized Anxiety Disorder-7, GAD-7), as reported within the iCBT program. Using internal and external datasets, we compare the proposed models against several benchmarks and rigorously evaluate them according to their predictive accuracy, sensitivity, specificity and AUROC over treatment. Our proposed RNN models consistently predict reliable improvement in PHQ-9 and GAD-7, using past clinical measures alone, with above 87% accuracy and 0.89 AUROC after three or more review periods, outperforming all benchmark models. Additional evaluations demonstrate the robustness of the achieved models across (i) different health services; (ii) geographic locations; (iii) iCBT programs, and (iv) client severity subgroups. Results demonstrate the robust performance of dynamic prediction models that can yield clinically helpful prognostic information ready for implementation within iCBT systems to support timely decision-making and treatment adjustments by iCBT clinical supporters towards improved client outcomes.

Crafts in the Time of Coronavirus

Crafts in the Time of Coronavirus

Using mixed methods in logistics and supply chain management research: current state and future directions

PurposeMixed methods research is useful to enhance theoretical and practical research contributions. However, single methods have predominated much logistics and supply chain management (LSCM) research. This paper presents a review of mixed methods research across ten years in LSCM to determine their usage, identify benefits and inhibitors, and provide suggestions for LSCM researchers to realise the benefits from using mixed methods.Design/methodology/approachThis paper adopts a mixed methods approach through a quantitative analysis of methods used in six leading LSCM journals, an e-mail survey of mixed methods article authors during the review period, and four published case studies that used mixed methods.FindingsOnly 144 (ten percent) of all empirical articles were published using mixed methods during the review period. A range of benefits and inhibitors regarding mixed methods adoption were found. Suggestions for LSCM authors include research training in mixed methods use and developing a project-specific research design due to the specificity and complexity associated with mixed methods research.Originality/valueLSCM is at a critical juncture, shaped by new contexts, themes and challenges, and would benefit from different research approaches and methods. This paper contributes to the LSCM domain through analysing the current state, benefits and inhibitors of mixed methods research in LSCM journals to provide a renewed call to action and guidelines for mixed methods LSCM research, and suggesting research design adaptation to enable agile and resilient research when investigating rapidly changing and complex phenomena.

Associations Between Age-Related Hearing Loss, Cognitive Impairment, and Multiple Chronic Conditions in a Group Care Setting.

The purpose of this study was to explore the relationships between hearing loss, cognitive status, and a range of health outcomes over a period of 2 years in a sample of older adults who are enrolled in Program of All-Inclusive Care for the Elderly, which is a Medicare/Medicaid beneficiary program for individuals who are nursing home eligible but living in the community at time of enrollment. The sample (N = 144) includes a diverse (47% White/non-Hispanic, 35% Black/African American, and 16% Latin/Hispanic) group of adults ranging from 55 to 93 years old. We used medical chart data to measure respondents' cognitive and health status, including chronic conditions and hospital use. Hearing status was measured once at the beginning of the 2-year review period. We used logistic regression and negative binomial hurdle models for analyses. We used latent class analysis (LCA) to explore the extent to which respondents cluster into a set of "health profiles" characterized by their hearing, cognitive status, and health conditions. We found that hearing loss is weakly associated with heart disease and diabetes and associated with cerebrovascular disease and falls; cognitive impairment is also associated with cerebrovascular disease and the number of falls. LCA indicates that respondents cluster into a variety of health profiles with a consistent pairing of hearing loss and depression. The results are largely consistent with associations reported in epidemiological studies that include age-related hearing loss. Of particular interest in this study is the LCA that suggested that all of the profiles associated with a high likelihood of hearing loss included a high risk of depression. The co-occurrence of these two factors highlights the need to identify and treat hearing loss in older adults, especially as part of the treatment plan for individuals with depressive symptoms.

60 Aafco Approval and Regulatory Process for Novel Ingredients

Abstract In this presentation, we will explore different pathways in the regulatory approval process. There are three routes that individuals or companies can take to gain approval for an ingredient in a target species. The most common and rigorous of the three is the AAFCO Ingredient Definition process, which takes at least 18 months from start to finish. This process involves a six-month FDA review period of safety data generated in a target species, gathered after feeding a range of inclusions of the target ingredient. Additionally, manufacturing and analytical data are required for this process. After FDA review, there is a minimum of one year for review by the AAFCO ingredient definition committee and general membership. The second regulatory route we will discuss is Generally Recognized as Safe (GRAS). This route can be shorter but will require similar safety data and an assessment by an expert panel is recommended. FDA review of the GRAS panel findings is necessary for listing in the AAFCO original publication as GRAS. Finally, we will discuss the GRAS self-determined pathway. This does not require FDA review but entails state-by-state registration of products. This pathway will still require safety, analytical and efficacy data to support the product registration with each state.

Lamotrigine use and potential for adverse cardiac effects: A retrospective evaluation in a Veteran population

ObjectiveTo identify the impact of lamotrigine (LTG) on cardiac rhythm and conduction abnormalities for Veterans, an especially vulnerable population. BackgroundIn October 2020 the US Food and Drug Administration (FDA) added a new warning to the label of lamotrigine (Lamictal™) regarding its potential to cause cardiac rhythm and conduction abnormalities [1]. This warning came following in vitro data which suggested Class IB antiarrhythmic effects occurring at clinically achievable concentrations of lamotrigine [2]. However, it is unclear whether the in vitro findings will result in adverse clinical outcomes. Our objective was to assess for evidence for adverse clinical outcomes in a vulnerable population and examine for subtler signs of an association between lamotrigine and cardiac rhythm disturbances. MethodsA retrospective chart review was conducted using records between 10-01-2017 and 07-06-2021, identifying patients at the William S. Middleton Memorial Veterans Hospital who were prescribed lamotrigine. Data collected included: dates of lamotrigine initiation or discontinuation, lamotrigine dosing over the time of the prescription and maximum lamotrigine dose, any cardiac-related ICD-10-CM codes or a history of a cardiology appointment, EKGs with any abnormalities or changes, any concomitantly prescribed medications with known potential to cause cardiac abnormalities, any cardiac deaths. This retrospective chart review was approved by the University of Wisconsin-Madison Institutional Review Board. ResultsTwo hundred and thirty-three (189 male) patients with a lamotrigine prescription and 41.2 % (n = 96) of these patients had an EKG performed while prescribed lamotrigine. The average age of patients was 64.3 ± 13.0 (range 29 to 90) years and mean maximum lamotrigine daily dose was 250.8 ± 148.2 mg (range 25 to 800 mg). Nearly half (47.9 %, 46/96) of the patients were prescribed a concomitant sodium channel blocking medication in addition to lamotrigine. Eighty-four of the patients (87.5 %, 84/96) had a cardiac diagnosis, while 12 (12.5 %, 12/96) did not. A total of 12 deaths occurred within the review period, with two cardiac deaths from congestive heart failure. Four cases did not have information on cause of death. No LTG-associated cardiac adverse effects were noted as part of clinical care, though rash was noted in 5 cases. A total of 7 (7.3 %, 7/96) patients were found to have EKG abnormalities potentially related to lamotrigine, including 7.1 % (6/84) of those with a cardiac diagnosis and 8.3 % (1/12) of those without a cardiac diagnosis. ConclusionsWhile recent FDA warnings have suggested caution regarding cardiac complications associated with lamotrigine based on in vitro studies, the clinical implications are uncertain. Despite selecting a particularly vulnerable population, this retrospective chart review did not identify any deaths due to cardiac rhythm or conduction causes, nor demonstrate unambiguous cardiac complications related to lamotrigine. Even using permissive criteria (including any prolonged PR or QTc) to examine for subtle effects, only a low incidence (<10 %) of potential complications was found. Broader implications of this study are limited by the number of patients included and the retrospective nature of the study. Therefore, further studies are warranted to evaluate a link between cardiac complications and the use of lamotrigine, including the role of concomitant medications such as other sodium channel blocking agents and psychotropic medications.

Implementation of a Multipronged Intervention to Improvement Inpatient Sickle Cell Disease Care

Introduction: Over the decades, many interventions have been used to improve care for patients with Sickle Cell Disease (SCD). There are 19 whole lifespan SCD centers, 30 pediatric SCD centers, and 28 adult SCD centers compared to 6,129 hospitals and over 220 children's hospitals in the US. The number of providers is insufficient to meet the needs of patients with SCD. Caring for patients without a dedicated Comprehensive SCD Center, such as our institution, can be challenging. Therefore, we developed a framework to leverage expertise in hematology, internal medicine, and emergency medicine to improve SCD patient care processes. In these settings, filling the gap in SCD care requires a multipronged creative approach that is implemented over time in a stepwise fashion. This allows time to adapt the intervention to the local medical system for more enduring change. This project looks at the longitudinal interventions that have occurred at the University of Chicago (UC) to address SCD care and discusses procedures to achieve successful implementation. Methods: In the first step, we identified the key stakeholders to determine the system's needs and goals (Table 1). This involved clinicians and staff who were interested in improving care for patients with SCD. The second step involved stakeholders creating a plan after analyzing the current care. Multipronged interventions were developed and implemented (see Figure 1 for a timeline and list of interventions). The final steps involved provider training. Furthermore, we tracked the progress of our interventions using the Electronic Medical Record (EMR). An EMR review was performed from 7/17/22 to 6/13/23 to evaluate our utilization. Descriptive statistics and Chi-Square were used to evaluate the data. This project was formally determined to be quality improvement and was therefore not overseen by the Institutional Review Board. Results: Regarding the first step, our task force comprises a large multidisciplinary group (see Table 1 for a full list). Next, it was important that we implement sustainable and useful systems (see Figure 1). In the review period, 154 patients were admitted 488 times. The SPP was used or viewed 134 times. Seventy-nine percent (122/154) of admitted patients had an IPP that was used, viewed, or created during their admission. Since the opening of the SCD Day clinic, there have been a total of 1045 SCD-related encounters, with an average of 36 patients a month or 1.7 patients a day. When comparing the review period to the same time in the prior year, the inpatient hydroxyurea protocol did not significantly improve the use of the medication. Hydroxyurea use changed from 64% to 65% of admissions and 65% to 68% of admitted patients. The inpatient SCD consult service received new consult requests in 44% of SCD admissions (214 total times). Lastly, over 100 hospitalists, resident physicians, inpatient teaching team physicians, and hematology physicians were educated along the way regarding changes in our system. Discussion: With time and a multipronged approach, achieving change in a large medical system is possible. The largest hurdle to overcome is funding. This is why our initial interventions focused on the implementation of EMR tools such as SPP, IPP, and educating providers. Though there was an up-front time cost, once completed, these interventions could be iterated on easily. It was not until 2022, that dedicated funding for a consult service could be secured. Having a large multidisciplinary team allows for creative ideas, dividing of tasks, accountability, and expertise in implementation. This does come with a limitation as it is harder to implement changes the larger the group becomes. Thus, a balance of members is vital. Frequent provider education is paramount in disseminating and improving the changes that are in the system. The plan, do, study, act model is a staple in quality improvement. It is important that there is foresight in developing a model to track the quality of care. The EMR's tools should be maximized to aid clinicians as efficiently as possible. Conclusion: Making large changes without funding or an institutional push can be challenging. Small incremental grassroots changes may be necessary until additional funding has been negotiated and secured. Meeting and exchanging ideas as a team and establishing pathways for improvement is a viable initial step.

Hematological Toxicity of Immune Checkpoint Inhibitors: Real-World Retrospective Outcomes from a Cohort Study in Qatar

Introduction: The integration of immune checkpoint inhibitors (ICPIs) into cancer management has brought a paradigm shift in the outcome of cancer care. The incidence of hematological immune-related adverse events (Hem-irAEs) associated with ICIs is uncommon or exceedingly rare, particularly in comparison to chemotherapy (Johar, 2020). In this study, we provide an analysis of real-world experience with Hem-irAEs from the National Center of Cancer Care and Research (NCCCR) in Qatar. Methods: Patient electronic medical records (EMR) were retrospectively analyzed for all patients who received ICPIs between 2015 and 2020. Collected data included patient demographics, Hem-irAEs-related incidence, characterization, management, and outcomes of Hem-irAEs. Results Over the five-year review period, a total of 165 irAEs were experienced among the 256 patients who received ICPIs in Qatar. The incidence of Hem-irAEs was 15 events (9.1% of all irAEs) among 14 patients (5.5% of all patients). Baseline characteristics of patients experiencing Hem-irAEs are described in Table 1. Majority of patients were diagnosed with solid malignancies (n=11; 78.6%) and were pre-treated with either chemotherapy or targeted therapies (n=12; 86%). Baseline hematological functions were also acceptable in most patients as shown in Table 1. Nivolumab was the most used ICPI (n=8, 57%), followed by pembrolizumab (n=4, 29%), durvalumab (n=1, 7%) and avelumab (n=1, 7%). The most common Hem-irAE was thrombocytopenia (5/15); however, four of those events were worsening of baseline thrombocytopenia (Table 2). During this review period, two bleeding events have occurred; one was grade 1 gingival bleeding that spontaneously resolved, while the other event was grade 4 leading to severe anemia (hemoglobin 5.7 g/dL) requiring transfusion and ICPI discontinuation. Two grade 4 pancytopenia events were identified; one resolved with supportive transfusions and ICPI discontinuation, while the other resulted in fatal limbic encephalitis despite the use of intravenous immunoglobulins. There were no other fatal irAEs, but one more patient discontinued ICPI due to grade 3 anemia. Co-occurrence of non-HEM-irAEs were manifested in half of this population (n=7); majority of which were dermatitis (33.3%) and hepatitis (33.3%), followed by hypothyroidism (22.2%) and cardiac toxicity (11.2%). Conclusion Compared to the current literature describing Hem-irAEs, our center experience shows similar distribution of adverse events with thrombocytopenia and anemia. Thrombocytopenia was the most Hem-irAEs experienced followed by neutropenia and eosinophilia (1). On the other hand, our population is slightly different with the majority of cases described here being non-melanoma solid malignancies. Considering the rate of Hem-irAEs in the investigated population at NCCCR, there is a need for an integrated pathway for the diagnosis and management of these events.

Review time of oncology drugs and its underlying factors: an exploration in China.

Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed. Methods: We included all new oncology drug applications submitted to China's National Medical Product Administration (NMPA) between 1 January 2018 and 31 December 2021, and ultimately succeeded in achieving marketing approval. For each drug, the length of the NMPA review process and other major characteristics were collected, including the registration class, approval class, priority review designation, and launch delay relative to the United States, as well as the number of patients enrolled, comparator, and primary endpoint of the pivotal trials supporting the approval. Linear regression model was employed to analyze the effects of factors of interest on the NMPA review time. Results: From 2018 to 2021, NMPA received 137 oncology applications that were ultimately approved. Half of the approvals [76 (55.5%)] were first licensed in the US, leaving a median launch delay of 2.71years (IQR, 1.03-5.59) in China. In the pivotal studies, the median enrollment was 361 participants (IQR, 131-682), and the use of control groups [90 (65.7%)] and surrogate endpoints [101 (73.7%)] was prevalent. The median review time was 304days (IQR, 253-376). Multivariate analysis for log-transformed review time showed that larger enrollment ( 92) was associated with a drop of 20.55% in review time (coefficient = -0.230; 95% CI, -0.404 to -0.055; p = 0.010); and a short delay (0 delay 1.95years) was associated with a drop of 17.63% in review time (coefficient = -0.194; 95% CI, -0.325 to -0.062; p = 0.004). Discussion: The short launch delay relative to the US was one important driver to the review speed of NMPA, which might suggest its latent regulatory reliance on the other global regulator during the post-marketing period when new information on the drug's clinical benefit was still lacking.