Support Unit Research Articles

The Public Records (Scotland) Act 2011: creating a culture that values public records

Purpose The Public Records (Scotland) Act 2011, implemented in January 2013, celebrated its 10th anniversary this year. This case study aims to examine the implementation of the Act. The Act was born out of the “Historical Abuse Systemic Review: Residential Schools and Children’s Homes in Scotland 1950–1995”, published in 2007. This review identified problems for care leavers and abuse survivors attempting to trace records about themselves, family members or medical issues. It demonstrated an urgent need to take action to preserve historical records and protect the information rights of Scottish citizens, particularly those of the most vulnerable. Scottish Ministers wanted the Act not just to regulate recordkeeping but to change the culture of recordkeeping. Is it doing this? Design/methodology/approach The Act’s guiding principle is continuous improvement. It does not presume records management perfection from public authorities but requires that they assess their arrangements, identify gaps in provision and deliver a commitment to close these gaps over time. This case study draws on the Keeper of the Records of Scotland’s strategy of affecting change through compliance, engagement and advocacy. We can evidence the impact of the legislation through the various tools created to support its administration: scrutiny mechanisms and statutory penalty embedded in the Act; evidence-based compliance under a “Records Management Plan” (RMP); stakeholder surgeries and conferences that address challenges, examine failings, learn from and share successes and explore development opportunities; Progress Update Review mechanism: a self-assessment tool from which we draw evidence of progress or lapses; and webinars and surveys to remain alert to stakeholder issues. Our engagement provides the qualitative and quantitative data required to accurately update Scottish Ministers. Findings Undeniably, the Act is making a difference. It has transformed the recordkeeping landscape in Scotland over the past decade. The legislation has given the Keeper of the Records of Scotland influence and has acted as a national lever for change. For example, an authority employing a records manager and establishing a support unit as a consequence of our address to its Board; and the NHS Scotland Records Management Group, established as a consequence of the Act, now advises NHS senior management. Originality/value There is no doubt about progress on the ground. However, because of the fiscal problems of the 2008 financial crisis, Brexit, COVID and the current cost-of-living crisis, public authority finances are extremely strained. What does this mean for Scottish Ministers’ ambition to change the culture of recordkeeping? What are the challenges for the next decade? Good recordkeeping is not only about efficiencies but about accountable, trustworthy and transparent government. Can the Act meet these challenges?

Cutaneous leishmaniasis in British troops following jungle training in Belize: Cumulative incidence and potential risk practices

BackgroundBritish soldiers undergoing jungle training in Belize typically experience a relatively low risk of developing cutaneous leishmaniasis. However, an uncharacteristically large outbreak of cutaneous leishmaniasis occurred in 2022. This study aimed to determine the cumulative incidence of the disease and highlight potential shortcomings in personal protective measures to mitigate exposure to sand fly vector bites. MethodsA retrospective analysis was conducted on medical records of cutaneous leishmaniasis cases between 2005 and 2022, as well as on questionnaire responses regarding personal protective measures administered to cutaneous leishmaniasis cases in 2022. Data were sourced from Defence Public Health Unit, Military Environmental Health Department and British Army Training Support Unit Belize. ResultsEighty-one confirmed clinical cutaneous leishmaniasis cases were recorded between 2005 and 2022, with a substantial peak (38 cases) in 2022. Most cases occurred during the wet season. Pre-2022, the median cumulative incidence per 8-week deployment was 0.90 % (Q1–Q3: 0.34 %–1.34 %), with an annual variation of 0.2 % to 2.0 %. In 2022, the cumulative incidence spiked to 4.22 %, associated with a risk ratio of 5.3 (95 % C.I.s, 3.41, 8.16), and rising to a cumulative incidence of 7.3 % in a single unit of 450 men (33 cases) in late 2022. These values are significantly higher than the median cumulative incidence of all previous years, and to published reports for other cutaneous leishmaniasis -endemic regions. Troop responses identified limitations in the supply of optimal equipment, and in sand fly bite and leishmaniasis risk avoidance information provided by the pre-deployment health education programme. Compliance with health education advise was also suboptimal, with irregular use of insect repellents, protective clothing / head netting, and insecticide-treated hammocks. ConclusionsThe reasons behind the unusually high numbers of cutaneous leishmaniasis cases and cumulative incidence in 2022 remain unclear, emphasising the need to improve personal protective measures provision and implement a comprehensive health education programme for troops undergoing jungle training in Belize.

Collaboration between oncogeriatrics and DAC: the experience of Ucog Poitou-Charentes

The mission of oncogeriatric coordination units (OCU) is to facilitate the coordination of professionals at all stages of the care pathway for cancer patients aged 75 and over. OCU Poitou-Charentes works with the Vienne coordination support unit (CSU 86) to ensure that patients in vulnerable and complex situations receive regular follow-up and support at home. Here's a look back at an experiment launched ten years ago.

A prediction model of PTSD in the Israeli population in the aftermath of october 7th, 2023, terrorist attack and the Israel–Hamas war

BackgroundOn October 7th, 2023, a mass terror attack was launched by Hamas militants, which was followed by the Israel-Hamas war. These events constitute a nationwide trauma with major ramifications for public mental health. This article presents an evidence-based model for the prediction of the prevalence of posttraumatic stress disorder (PTSD) related to the terrorist attack and the war.Main body: The creation of the model consisted of several steps. Firstly, the Israeli population was divided into six groups based on the intensity, context, and type of traumatic exposure (direct exposure to terror, close proximity to terror, soldiers in combat and support units, intense exposure to rocket attacks, moderate exposure to rocket attacks, and indirectly affected communities), and the population size of each group was assessed using official national databases. Secondly, an estimation of the expected prevalence of PTSD in each of the exposure groups was based on a review of the relevant literature. A random-effects meta-analysis of the prevalence rates was conducted separately per each exposure group. Finally, the predicted number of PTSD causalities in the population was calculated by multiplying the group size and the PTSD prevalence estimation. Based on population size and estimated PTSD prevalence within each exposure category, the model predicts that approximately 5.3% (N = 519,923) of the Israeli population (95% confidence interval, 1.64–9%), may develop PTSD as a result of the terrorist attack and the war.ConclusionsThe predicted number of individuals with PTSD following mass trauma is expected to be considerable. The presented model can assist policymakers, clinicians, and researchers in preparing and devising adequate interventions for the mental health needs of large populations. Moreover, this model can be applied in other instances of mass-trauma exposure.

Design by Transitional Committee: learning from the Green Climate Fund

ABSTRACT In 2022 at the UN climate conference in Sharm el-Sheikh (COP27), countries agreed to establish a new fund for loss and damage. This decision was one of the most significant outcomes of the COP, and something Small Island Developing States had spent the previous three decades calling for. The approach taken to realize this new funding arrangement includes many similarities to that taken to create a similarly significant new fund twelve years earlier – the Green Climate Fund (GCF) – including its design by a Transitional Committee. The aim of this article is to assess the extent to which the ambitions for the GCF have been realized, with a view to informing the ongoing design and early implementation of the new fund. To do this, the article compares the GCF’s present-day outcomes to its original intentions as described by the COP16 decision text. This paper finds that the GCF’s operation today only partially reflects the ambitions expressed at COP16. While the ambition for a Board with equal representation by developing and developed countries has been achieved, ambitions to expand the sources of finance and increase funding for adaptation have been mixed. The influence of the World Bank was a key point of tension over the GCF’s Transitional Committee period, and the Bank continues in the Trustee role today. The role of the Committee’s Technical Support Unit – the group of staff seconded from various international development banks and agencies to provide technical and administrative support to the GCF’s Transitional Committee – had an outsized influence on the shape of the GCF, such that these organizations continue to receive the bulk of GCF funding today. These findings suggest a greater plurality of voices providing such technical inputs would enhance the design of new funding bodies. The creation of new international finance institutions is relatively rare, so understanding the history of the GCF’s design is important for contextualising discussions about other climate finance options.

A month of diagnostic imaging studies in an acute supportive/palliative care unit.

The aim was to assess the characteristics of patients who required imaging studies during admission to an acute supportive palliative care unit (ASPCU). A consecutive number of patients who performed imaging studies during ASPCU admission in a month period were assessed. Epidemiological data, ongoing anticancer treatment, cancer diagnosis, reasons for admission, referral, and type of imaging study were recorded. Indications, findings, consequent actions for treatment, prognosis, and discharge were also collected. Twenty-one of 56 patients admitted to ASPCU in the period taken into consideration were assessed. Pain and deterioration of the general condition were the most frequent indications for admission. Computed tomography (CT) was the most frequent imaging study performed. Indications for performing imaging studies depended on individual clinical needs. Findings suggested different clinical decisions, after a comprehensive oncological and palliative care assessment and family conference, the most frequent of which was to withdraw oncological treatments. The majority of patients underwent transition to palliative care and were discharged home or to hospice. Imaging studies were of paramount importance for clinical treatment and decision-making process in an intensive ASPCU. There is the need to explore the need and the possible outcomes of imaging studies, as well cost-effectiveness in any ASPCU.

Secondary Bacterial Infections in Critically Ill COVID-19 Patients Admitted in the Intensive Care Unit of a Tertiary Hospital in Romania.

Background: The outbreak of the COVID-19 pandemic caught healthcare systems in many countries unprepared. Shortages of personnel, medicines, disinfectants, and intensive care unit (ICU) capacities, combined with inadvertent use of antibiotics and emergence of drug-resistant secondary infections, led to a surge in COVID-19-related mortality. Objective: We aimed to evaluate the prevalence of secondary bacterial infections and the associated antibiotic resistance in a temporary established ICU dedicated to COVID-19 patients. We also assessed the utility of clinical and routine laboratory data as predictors of secondary infections and mortality in these patients. Methods: We examined the medical records of 243 patients admitted to the COVID-19 Medical Support Unit of Târgu Mures, Romania, between 1 August 2020 and 31 January 2021. Results: Among the 243 patients admitted to the COVID-19 Medical Support Unit of Târgu Mures between 1 August 2020 and 31 January 2021, 59 (24.3%) presented secondary infections. Acinetobacter baumannii and Klebsiella pneumoniae were the most frequent isolates (31.1% and 18.9%, respectively), most of them multidrug resistant. Chronic obstructive pulmonary disease had a higher prevalence in patients who developed secondary infections (p = 0.012). Secondary infections were associated with longer stay in the ICU and with higher mortality (p = 0.006 and p = 0.038, respectively). Conclusions: Early identification of secondary infections and proper use of antibiotics are necessary to limit the spread of multidrug-resistant microorganisms in COVID-19 patients admitted in the ICU.

Early Mortality in Cardiac Surgery - Is Lactate Significant?

Serum lactate is a consequence of tissue hypoperfusion and has been used routinely for patient management following cardiac surgery. This study aims to determine the association of lactate with early mortality and postoperative morbidity. This is a prospective cohort study carried out in the Department of Cardiovascular and Thoracic Surgery, King George's Medical University (India), from January 2020 to December 2022. A total of 270 patients were included in this study. Serum lactate levels were measured preoperatively, intraoperatively on-pump, coming off-pump, and at six, 12, 24, and 48 hours postoperatively. Early mortality was noted in 17 cases (6.3%). While both lactate and lactate clearance correlated with duration of mechanical ventilation, vasopressor duration, and intensive care unit and hospital stay, correlation with early mortality was noted only with lactate at 24 hours. Logistic regression analysis demonstrated that lactate levels at preoperative period (adjusted odds ratio [OR] 4.76 [1.67-13.59], P=0.004) and at 24 hours after bypass (OR 1.21 [1.00-1.47], P=0.046) and vasopressor duration (OR 1.11 [1.04-1.19], P=0.002) are independent predictors of mortality. Receiver operating characteristic curve analysis showed that arterial lactate on-pump, off-pump, and at six, 12, and 24 hours after surgery had significant area under the curve for predicting mortality. Arterial lactate and lactate clearance show good correlation with duration of mechanical ventilation, vasopressor support, and intensive care unit and hospital stay and can serve as a good indicator to guide therapeutic decisions in postoperative period. However, it fails to be a sensitive predictor of mortality.

A digital twin modeling and application for gear rack drilling rigs lifting system

A comprehensive digital transformation has been undergone by the oil and gas industry, wherein digital twins are leveraged to enable real-time data analysis, providing predictive and diagnostic engineering insights. The potential for developing intelligent oil and gas fields is substantial with the implementation of digital twins. A digital twin framework for gear rack drilling rigs is proposed, built upon an understanding of the digital twin composition and characteristics of the gear rack drilling rig lifting system. The framework encompasses descriptions of digital twin characteristics specific to drilling rigs, the application environment, and behavioral rules. The modeling approach integrates mechanism modeling, real-time performance response, instantaneous data transmission, and data visualization. To illustrate this framework, exemplary case studies involving the transmission unit and support unit of the lifting system are presented. Mechanism models are constructed to analyze dynamic gear performance and support unit response. Real-time data transmission is facilitated through sensor-based monitoring, enhancing the prediction speed and accuracy of dynamic performance through a synergy of mechanism modeling, machine learning, and real-time data analysis. The digital twin of the lifting system is visualized utilizing the Unity3D platform. Furthermore, functionalities on data acquisition, processing, and visualization across diverse application scenarios are encapsulated into modular components, streamlining the creation of high-fidelity digital twins. The frameworks and modeling methodologies presented herein can serve as a foundational and methodological guide for the exploration and implementation of digital twin technology within the oil and gas industry, ultimately fostering its advancement in this sector.

8158 Transient Blindness In Metformin-Associated Lactic Acidosis

Abstract Disclosure: Y. Abouelkheer: None. A. Nasir: None. M. Ibrahem: None. Transient Blindness in Metformin-associated Lactic Acidosis Background: Metformin-associated lactic acidosis (MALA) is a rare side effect of metformin use. MALA can result in acute transient blindness in patients with severe metabolic derangements. Clinical Case: A 62-year-old woman presented with severe diarrhea, poor oral intake, malaise, and vomiting on a background of metformin-treated type 2 diabetes mellitus. Laboratory investigations showed bicarbonate <2 mmol/L, anion gap 48 mmol/L, lactic acid 20.5 mmol/L, serum osmolality 352 mOsm/kg, negative urine toxicology screen, and positive SARS-CoV-2. In the emergency department, the patient developed sudden onset bilateral vision loss. The examination was remarkable for complete vision loss bilaterally in all fields, associated with minimally reactive pupils and spontaneous ocular movements with an otherwise unrevealing neurological examination. Computed Tomography (CT) of the brain with stroke protocol showed no evidence of acute intracranial process. CT angiogram of the brain and neck showed patent intracranial and cervical vasculature without high-grade stenosis, large vessel occlusion, or aneurysm. While receiving medical management with intravenous fluid resuscitation and sodium bicarbonate supplementation, the patient had a spontaneous return of vision with no additional neurological complications or deficits. The severe metabolic derangements were associated with distributive shock, requiring admission to the intensive care unit for urgent hemodialysis, pressor support, empiric antibiotics, and stress-dose steroids. Shortly after the patient’s only hemodialysis session, we noted the resolution of her critical metabolic disturbances, renal failure, and shock state. Laboratory investigations post-dialysis showed bicarbonate 12 mmol/L, anion gap 36 mmol/L, and lactic acid 10.5 mmol/L. Follow-up MRI showed chronic lacunar infarct of the left basal ganglia, and she was discharged home six days later. Conclusion: Transient blindness in MALA can mimic acute neurovascular events. Prompt correction of metabolic derangements can aid in reversing systemic symptoms and blindness. Reference: DeFronzo R, Fleming GA, Chen K, Bicsak TA. Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism. 2016;65(2):20-29. doi:10.1016/j.metabol.2015.10.014 Presentation: 6/2/2024

Building trust with children in collaborative processes within in-home child welfare services

ABSTRACT This study explores trust-building between child welfare professionals and children aged 7–12 in Norwegian in-home support unit. Through ethnographic fieldwork with 13 professionals and 12 children, alongside interviews with eight professionals, the study reveals children’s active role in assessing trustworthiness and negotiating power dynamics through dialogue. The findings show that professionals must prioritize building trust through informal, activity-based interactions, which help bridge communication gaps and enhance children’s self-esteem. The importance of reciprocity in the trust-building process is emphasized. This study highlights the value of empathetic, child-centered practices in fostering trust and collaboration within child welfare.

Assessing the built environment through photographs and its association with obesity in 21 countries: the PURE Study

The built environment can influence human health, but the available evidence is modest and almost entirely from urban communities in high-income countries. Here we aimed to analyse built environment characteristics and their associations with obesity in urban and rural communities in 21 countries at different development levels participating in the Prospective Urban and Rural Epidemiology (PURE) Study. Photographs were acquired with a standardised approach. We used the previously validated Environmental Profile of a Community's Health photo instrument to evaluate photos for safety, walkability, neighbourhood beautification, and community disorder. An integrated built environment score (ie, a minimum of 0 and a maximum of 20) was used to summarise this evaluation across built environment domains. Associations between built environment characteristics, separately and combined in the integrated built environment score, and obesity (ie, a BMI >30kg/m2) were assessed using multilevel regression models, adjusting for individual, household, and community confounding factors. Attenuation in the associations due to walking was examined. Analyses include 143 338 participants from 530 communities. The mean integrated built environment score was higher in high-income countries (13·3, SD 2·8) compared with other regions (10·1, 2·5) and urban communities (11·2, 3·0). More than 60% of high-income country communities had pedestrian safety features (eg, crosswalks, sidewalks, and traffic signals). Urban communities outside high-income countries had higher rates of sidewalks (176 [84%] of 209) than rural communities (59 [28%] of 209). 15 (5%) of 290 urban communities had bike lanes. Litter and graffiti were present in 372 (70%) of 530 communities, and poorly maintained buildings were present in 103 (19%) of 530. The integrated built environment score was significantly associated with reduced obesity overall (relative risk [RR] 0·58, 95% CI 0·35-0·93; p=0·025) for high compared with low scores and for increasing trend (0·85, 0·78-0·91; p<0·0001). The trends were statistically significant in urban (0·85, 0·77-0·93; p=0·0007) and rural (0·87, 0·78-0·97; p=0·015) communities. Some built environment features were associated with a lower prevalence of obesity: community beautification RR 0·75 (95% CI 0·61-0·92; p=0·0066); bike lanes RR 0·58 (0·45-0·73; p<0·0001); pedestrian safety RR 0·75 (0·62-0·90; p=0·0018); and traffic signals RR 0·68 (0·52-0·89; p=0·0055). Community disorder was associated with a higher prevalence of obesity (RR 1·48, 95% CI 1·17-1·86; p=0·0010). Community built environment features recorded in photographs, including bike lanes, pedestrian safety measures, beautification, traffic density, and disorder, were related to obesity after adjusting for confounders, and stronger associations were found in urban than rural communities. The method presents a novel way of assessing the built environment's potential effect on health. Population Health Research Institute, Hamilton Health Sciences Research Institute, Heart and Stroke Foundation of Ontario, Canadian Institutes of Health Research's Strategy for Patient Oriented Research, Ontario Support Unit, Ontario Ministry of Health and Long-Term Care, AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Servier, and GlaxoSmithKline.

Mortality Impact of Severe COVID-19 in the ICU: A Study from the Târgu Mureș Support Unit.

(1) Background: Since the onset of the COVID-19 pandemic, it has been recognized that a considerable proportion of critically ill patients may die of this disease. The current study aims to assess the overall 1-year outcomes within the UMFST COVID-19 Unit, providing valuable insights into the efficacy of specialized care facilities in managing severe cases of COVID-19. (2) Methods: This is a retrospective monocentric observational study including 294 patients confirmed to have SARS-CoV-2 infection. Demographic data and clinical and paraclinical parameters were assessed. Survival probabilities were estimated using Kaplan-Meier curves. (3) Results: Overall, the 1-year mortality was 89.4%. All deaths occurred in-hospital, with two patients dying after 28 days. Diabetes mellitus, chronic kidney failure, cerebrovascular disease, and atrial fibrillation were more prevalent in deceased patients. Thirty percent of patients needed endotracheal intubation during the first 24 h. The incidence of hospital-acquired pneumonia was higher among deceased patients. The SOFA score was significantly different between deceased vs. survivors. The survival analysis showed that the use of noradrenaline increased the likelihood of surviving COVID-19. (4) Conclusions: The severe comorbidities of the patients were the primary factors contributing to the increased mortality rate in the COVID-19 unit.

Europol’s role in the fight against cybercrime

Aim: The aim of the study is to present the role and activities of Europol’s European Cybercrime Centre (EC3) in combating cybercrime, with a particular focus on the latest technological solutions and cooperation mechanisms. Methodology: The research involved analysing the strategies and tools employed by the EC3. Data collection and analysis utilised Europol’s internal reports, publicly available sources, and case studies to provide a comprehensive overview of EC3’s activities and effectiveness. Findings: The EC3 plays a crucial role in the fight against cybercrime, particularly in dealing with transnational criminal organisations and advanced cyber threats. The EC3 is divided into three main divisions: the operational unit, the digital support unit, and the expertise unit. The operational unit maintains four permanent analytical projects, each focusing on different areas of cybercrime. Value: The study provides valuable insights into the functioning of the EC3 and its contributions to the global fight against cybercrime. It highlights Europol’s effective cooperation model, which aids in international collaboration against cyber threats. EC3’s activities significantly enhance information sharing and operational cooperation among member states, thereby increasing the effectiveness of defences against cybercrime.

Az Europol szerepe a kiberbűnözés elleni küzdelemben

Aim: The aim of the study is to present the role and activities of Europol’s European Cybercrime Centre (EC3) in combating cybercrime, with a particular focus on the latest technological solutions and cooperation mechanisms. Methodology: The research involved analysing the strategies and tools employed by the EC3. Data collection and analysis utilised Europol’s internal reports, publicly available sources, and case studies to provide a comprehensive overview of EC3’s activities and effectiveness. Findings: The EC3 plays a crucial role in the fight against cybercrime, particularly in dealing with transnational criminal organisations and advanced cyber threats. The EC3 is divided into three main divisions: the operational unit, the digital support unit, and the expertise unit. The operational unit maintains four permanent analytical projects, each focusing on different areas of cybercrime. Value: The study provides valuable insights into the functioning of the EC3 and its contributions to the global fight against cybercrime. It highlights Europol’s effective cooperation model, which aids in international collaboration against cyber threats. EC3’s activities significantly enhance information sharing and operational cooperation among member states, thereby increasing the effectiveness of defences against cybercrime.

Robbing the cradle: Factors promoting lecturer-on-student transactional sex relationships at a South African university

While universities have been lauded as sanctuaries of peace where students and staff pursue educational goals, there has been a marked increase in the victimisation of students by staff members who have been known to hound students for sexual favours. This increase in unethical conduct continues regardless of "sound" policies regulating university student and staff relationships. Against this background, this study sought to explore the factors shaping the pervasive practice of transactional sex between staff and students at a university in rural South Africa. Underpinned by the sexual exchange theory, the study utilised an exploratory sequential mixed-methods design. The findings categorised into four key themes—academic reasons, impunity and power dynamics, financial constraints, and peer pressure and influence—highlight the entrenched nature of this practice within the university setting. The study recommended implementing and enforcing strict policies with clear consequences for perpetrators and establishing confidential reporting systems and dedicated support units for victims.

IT Risk Management Analysis Based on ISO 31000 and Bow Tie Analysis (BTA) in Higher Education Institution

The Division of Applications and Software is a part of the Academic Support Unit (UPA) for Information and Communication Technology at Universitas Jember (UNEJ) or UPA TIK UNEJ. Based on interviews, UPA TIK UNEJ has not yet implemented risk management, leading to recurring issues in their IT services. Risk management is crucial for preventing and mitigating negative impacts that can harm the organization. Additionally, it is a requirement for internal quality management system audits, according to UNEJ Rector's Decision Number 20588/UN25/LL/2018. This study aims to identify, analyze, and assess potential risks in the Division of Applications and Software at UPA TIK UNEJ and to apply Bow Tie Analysis (BTA) to identify preventive and mitigative actions for the highest-rated risks. The approach used is ISO 31000:2018, which provides a comprehensive framework for risk management. For in-depth risk analysis, the BTA method, combining event tree analysis (ETA) and fault tree analysis (FTA), is utilized. The research begins with context establishment through interviews, followed by risk identification, analysis, assessment, and mitigation. The results show 21 risks identified in the process of developing information systems or applications. The top three priority risks are coded R02, R04, and R19. The second priority includes 17 risks, and the third priority includes 1 risk.

An attempt of a systematic approach to the typology of supportive communicative units

An attempt of a systematic approach to the typology of supportive communicative units

Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Erdafitinib vs Enfortumab Vedotin in Patients with Locally Advanced Metastatic Urothelial Carcinoma.

Background: For patients with locally advanced or metastatic urothelial carcinoma (la/mUC), prognosis is poor and effective treatment options are limited. Erdafitinib is an oral fibroblast growth factor receptor (FGFR) kinase inhibitor approved by the FDA for the treatment of adults with la/mUC harboring FGFR alterations whose disease progressed following at least 1 prior line of therapy, including a PD-1 or PD-L(1) inhibitor, based on the phase 3, randomized THOR trial (NCT03390504, Cohort 1). Objective: To compare the efficacy and safety of erdafitinib vs enfortumab vedotin-ejfv (EV) in the absence of head-to-head comparison via an anchored matching-adjusted indirect comparison (MAIC). Methods: An anchored MAIC was conducted according to the National Institute for Health and Care Excellence Decision Support Unit guidance, with physician's choice of chemotherapy (docetaxel/paclitaxel and vinflunine) as the common comparator. Individual patient data from THOR were adjusted to match published key eligibility criteria and average baseline characteristics of EV-301, such as Bellmunt risk score, liver or visceral metastases, primary site, among others. Erdafitinib was then indirectly compared with EV using the relative treatment effects for the reweighted THOR population and those published for EV-301. Results: After matching, the effective sample size for THOR was 126 patients. The MAIC-recalculated hazard ratio (95% credible interval) for erdafitinib vs EV was 0.92 (0.54, 1.57) for overall survival and 0.93 (0.55, 1.56) for progression-free survival, yielding Bayesian probabilities of erdafitinib being better than EV of 62.1% and 60.5%, respectively. For response outcomes, the MAIC-recalculated risk ratio was 1.49 (0.56, 3.90) for confirmed objective response rate and 2.89 (0.27, 30.33) for confirmed complete response with probabilities of 72.6% and 81.3% for erdafitinib being better than EV, respectively. For safety, MAIC-yielded risk ratios of 1.09 (0.99, 1.21) for any treatment-related adverse events, 0.86 (0.57, 1.28) for grade 3+ TRAEs, and 1.02 (0.98, 1.06) for any treatment-emergent adverse events. Conclusion: The MAIC indicates comparable efficacy of erdafitinib vs EV for overall survival and progression-free survival, with erdafitinib showing a higher probability of achieving deep responses. While erdafitinib is associated with slightly more adverse events compared with EV, these events seem to be less severe.

Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Erdafitinib vs Enfortumab Vedotin in Patients with Locally Advanced Metastatic Urothelial Carcinoma

Background: For patients with locally advanced or metastatic urothelial carcinoma (la/mUC), prognosis is poor and effective treatment options are limited. Erdafitinib is an oral fibroblast growth factor receptor (FGFR) kinase inhibitor approved by the FDA for the treatment of adults with la/mUC harboring FGFR alterations whose disease progressed following at least 1 prior line of therapy, including a PD-1 or PD-L(1) inhibitor, based on the phase 3, randomized THOR trial (NCT03390504, Cohort 1). Objective: To compare the efficacy and safety of erdafitinib vs enfortumab vedotin-ejfv (EV) in the absence of head-to-head comparison via an anchored matching-adjusted indirect comparison (MAIC). Methods: An anchored MAIC was conducted according to the National Institute for Health and Care Excellence Decision Support Unit guidance, with physician’s choice of chemotherapy (docetaxel/paclitaxel and vinflunine) as the common comparator. Individual patient data from THOR were adjusted to match published key eligibility criteria and average baseline characteristics of EV-301, such as Bellmunt risk score, liver or visceral metastases, primary site, among others. Erdafitinib was then indirectly compared with EV using the relative treatment effects for the reweighted THOR population and those published for EV-301. Results: After matching, the effective sample size for THOR was 126 patients. The MAIC-recalculated hazard ratio (95% credible interval) for erdafitinib vs EV was 0.92 (0.54, 1.57) for overall survival and 0.93 (0.55, 1.56) for progression-free survival, yielding Bayesian probabilities of erdafitinib being better than EV of 62.1% and 60.5%, respectively. For response outcomes, the MAIC-recalculated risk ratio was 1.49 (0.56, 3.90) for confirmed objective response rate and 2.89 (0.27, 30.33) for confirmed complete response with probabilities of 72.6% and 81.3% for erdafitinib being better than EV, respectively. For safety, MAIC-yielded risk ratios of 1.09 (0.99, 1.21) for any treatment-related adverse events, 0.86 (0.57, 1.28) for grade 3+ TRAEs, and 1.02 (0.98, 1.06) for any treatment-emergent adverse events. Conclusion: The MAIC indicates comparable efficacy of erdafitinib vs EV for overall survival and progression-free survival, with erdafitinib showing a higher probability of achieving deep responses. While erdafitinib is associated with slightly more adverse events compared with EV, these events seem to be less severe.