Delays In Access Research Articles

Clinical Presentation, Care Pathways, and Delays in Access to Specialized Care in Patients With Systemic Lupus Erythematosus: A Study From Lupus Midwest Network (LUMEN).

We aimed to characterize presentation and care pathways of patients with systemic lupus erythematosus (SLE), and delays in access to SLE-specialized care. We included patients with incident SLE from the Lupus Midwest Network registry. Time from the first medical encounter for SLE clinical manifestation to access to SLE-specialized care, physician diagnosis, and treatment was estimated. Delays were defined as ≥6 months to access specialized care. We compared SLE manifestations, disease activity, and Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage indexes (SDI) between patients with and without delays. Logistic regression models assessed associations with delays. The study included 373 patients with SLE. The median time to access SLE-specialized care was 1.1 (95% confidence interval [CI] 0.9-1.5) months, time to diagnosis was 30.6 (95% CI 18.9-48.1) months, and time to treatment initiation was 4.7 (95% CI 3.9-8.4) months. Approximately 25% of patients (93 out of 373) experienced delays accessing specialized care, which were associated with fewer SLE manifestations at first SLE-related encounter (fewer than two SLE domains; 92% vs 72%, P < 0.001). Patients with mucocutaneous or musculoskeletal manifestations were less likely to experience delays, whereas hematologic (odds ratio [OR] 1.71, 95% CI 1.03-2.84) or antiphospholipid antibodies domains (OR 6.05, 95% CI 2.46-14.88) were associated with delays. Delays were associated with damage at first access to SLE-specialized care (SDI ≥1; 30% vs 7%, P < 0.001). Patients follow a heterogeneous pathway to receive care. One-fourth of patients experienced delays accessing SLE-specialized care, which was associated with disease-related damage. Fewer manifestations, hematologic manifestations, or antiphospholipidantibodies were associated with delays.

The Impact of Laparoscopic Treatment on Fertility Outcomes in Patients with Severe Endometriosis

Background: Endometriosis, a prevalent gynecological disorder affecting women of reproductive age, is a significant cause of infertility, especially in severe cases involving extensive adhesions, endometriomas, and deep infiltrating lesions. In Bangladesh, the delay in diagnosis and limited access to advanced treatments, including laparoscopic surgery, poses challenges to improving fertility outcomes for women with severe endometriosis. Objective: This study aimed to assess the impact of laparoscopic treatment on fertility outcomes in patients with severe endometriosis, particularly in a resource-limited healthcare setting in Bangladesh. Methods: This retrospective cohort study included 78 women with severe endometriosis from tertiary hospitals in Dhaka and Khulna, Bangladesh. All participants had previously experienced unsuccessful in vitro fertilization (IVF) attempts and subsequently underwent laparoscopic surgery between 2015 and 2024. Data collection involved reviewing primary and secondary data from these tertiary hospitals, including medical records and operative reports, and was supplemented by follow-up interviews for comprehensive analysis. Variables such as patient age, infertility duration, previous IVF cycles, operative findings, and postoperative fertility outcomes were analyzed using SPSS, with statistical significance set at P &lt; .05. Results: The mean age of patients was 34.3 years, and the average duration of infertility was 52.9 months. Post-laparoscopic surgery, 42.3% (33/78) of women successfully delivered, with 7% achieving spontaneous conception. Younger age, fewer prior IVF cycles, and a normal uterine appearance on transvaginal ultrasound were significantly associated with improved fertility outcomes. Salpingectomy was more common among those who delivered (70%), though the removal of ovarian endometriomas did not significantly impact fertility success. Conclusion: Laparoscopic treatment significantly improves fertility outcomes in Bangladeshi women with severe endometriosis, even in a resource-limited setting. Age, normal ovarian function, and uterine appearance were key factors influencing reproductive success. These findings underscore the importance of timely surgical intervention for endometriosis-related infertility, highlighting the need for improved access to laparoscopic surgery in low-resource healthcare systems.

A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs.

Alternative funding programs (AFPs) seek to reduce health plan sponsor costs, for example by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs) via an AFP vendor as a third-party. To describe patients' experiences and specialty medication access with AFPs. A survey method consisting of 26 optional single-choice and multiple-choice questions with branching logic divided across 5 sections (related to patient challenges with AFPs) was administered to patients recruited from an experienced AFP online patient panel and a patient advocacy group. The survey assessed patients' awareness of AFPs from their employers, experience with the patient assistance program application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of delay in access. All descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels; statistical analyses were carried out for the exploratory analyses. The final sample included 227 patients. Most patients (61% [136/223]) first heard of the AFP as part of their health benefit when trying to obtain their medication. Of 198 patients, 88% reported being stressed because of the medication coverage denial and the uncertainty of obtaining their medication. More than half of patients (54% [115/213]) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for 68.2 days (approximately 2 months); 24% (51/215) reported the wait for the medication worsened their condition and 64% (138/215) reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. A significantly higher proportion of patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% [19/30] vs 81% [52/64]; P = 0.022), whereas more patients with lower incomes (<$50,000 vs >$50,000) reported not receiving any medication (12% [7/57] vs 5% [7/129]; P = 0.657), although these differences were not significant. Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being, and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their health plan.

Effect of insurance type on Management of Vancouver B Periprosthetic Fractures: length of stay, discharge destination and cost implications.

To assess the effect of private versus public insurance on hospital length of stay, discharge destination, and costs in managing Vancouver B periprosthetic femoral fractures (PFF). A retrospective cohort study of PFF patients operatively managed at five public trauma centers. The primary outcome was hospital length of stay. Secondary outcomes included discharge destination and costs related to implants and hospital beds. The study included 195 PFF cases (133 public, 62 private). Private patients had lower ASA scores (2.8 versus 3.1, P = 0.006) and were more likely to come from independent residences (87% versus 74%, P = 0.045). Private patients spent 8 fewer days in the hospital (12 ± 8 versus 20 ± 19 days, P < 0.001) and were more often discharged to rehabilitation (74% versus 48%, P = 0.003). Public hospital costs were higher for public patients ($37 456 versus $25 324, P = 0.005), largely due to longer stays. Implant costs were similar between private and public patients, but patients that underwent revision surgeries increased costs significantly compared to patients that underwent open reduction and internal fixation alone ($6257 versus $3511, P < 0.001). Private insurance was linked to shorter hospital stays and increased discharge to rehabilitation. Public PPF patients incur an average cost of $37 456 for public hospitals, compared to $25 324 for private patients. Delays in public patient rehabilitation access may prolong hospital stays, suggesting a need for alternative care pathways, such as PPF tailored home-based rehabilitation and support programs.

American Thyroid Association Policy Statement: Impact of Changes in Fine Needle Aspiration Biopsy Reimbursement on Clinical Care of Patients with Thyroid Nodules in the United States.

Introduction: The Clinical Affairs Committee of the American Thyroid Association has developed this statement to describe recent changes in the billing and coding of ultrasound-guided fine needle aspiration procedures of thyroid nodules, and to raise awareness of the adverse consequences that have arisen as a result. Review: A reduction in payment of ultrasound-guided fine needle aspiration procedures was enacted by the Centers for Medicare and Medicaid Services in 2019. The Clinical Affairs Committee has sought to examine the effects of the change in reimbursement on the care of patients with thyroid diseases. Summary: The historical background of the changes in payment structure for ultrasound-guided fine needle aspiration of thyroid nodules is discussed. The years 2019 and 2020 saw a significant decline in claims for ultrasound-guided fine needle aspiration procedures, concomitant with a shift in the performance of these procedures away from non-facility outpatient settings and a rise in costs to the health care system. Conclusion: Several negative consequences of the decrease in reimbursement for ultrasound-guided fine needle aspiration of thyroid nodules have arisen. This has led to significant concern among clinicians who care for patients with thyroid diseases regarding delays in patient access to care and diagnosis, and a diminished pool of qualified thyroid specialists to perform these procedures in the future.

Current Capacity for Diagnosing Alzheimer's Disease in Germany and Implications for Wait Times.

Amyloid-targeting therapies for Alzheimer's disease (AD) might become available in Germany soon. The combination of a large pool of prevalent cases and a complex diagnostic process to determine eligibility for these treatments is likely to challenge health systems' capacity. To analyze Germany's healthcare system capacity to identify treatment-eligible patients in a timely and equitable manner. We modeled patients' diagnostic journey and projects wait times due to capacity constraints for AD specialist visits and PET scans from 2024 to 2043. Model parameters were derived from published data and expert input. Wait times would be ∼50 months over the model horizon, if patients were referred to specialists based on a brief cognitive assessment in primary care. Wait times for patients with social health insurance are projected to be 1.9 times those of patients with private insurance, with peak wait times of around 76 and 40 months, respectively. Adding a blood test for the AD pathology as additional triage step would reduce wait times to below 24 months. In spite of having a well-resourced health system, Germany is projected to be unable to cope with the demand for biomarker-based AD diagnosis, if a disease-modifying AD treatment were introduced. As these treatments might become available by the end of 2024, decisive action, in particular dissemination of high-performing AD blood tests for triage in primary care, will be needed to prevent delays in access and potentially avoidable and inequitable disease progression.

OTHR-07 A DESCRIPTIVE EPIDEMIOLOGICAL PROFILE OF BRAIN TUMOURS IN CAMEROON

Abstract Cancer is a significant threat to public health and a leading cause of morbidity across the globe. In low- and middle-income countries, the delay in diagnosis and access to treatment has contributed to the poor outcome of brain tumors. In Cameroon, epidemiological studies on brain tumors are scarce, which contributes to the lack of knowledge of the disease behavior in our local community. We conducted a descriptive epidemiological analysis based on review of patient’s records at the Cameroon Oncology Center in Douala from 1/1/2018 to 31/12/2023. A total of 2600 charts were reviewed, of which 1.9% of the patients carried a brain tumors diagnosis. Females accounted for 34(68.0%) of the cases and the mean age was 45.4 years (SD=17.9). The most recorded types of brain tumors were brain metastasis (n=25, 50.0%), glioblastoma (n=7, 14.0%), and gliomas (n=6, 12.0%). The most common clinical manifestation associated with brain tumors included headaches (n=32, 34.4%), visual disturbance (n=18, 19.4%), and motor deficit (n=15, 16.1%).In this oncology center, Adults represent the most affected population with brain tumors because most of the children were managed at specialized pediatric oncology centers, with a female: male ratio of 3:1. Brain metastasis was the common type of brain tumor, headache was the most frequent clinical presentation.

Beyond diagnosis: using a futurist approach to improve access to radiation oncology services in South Africa

Aim Radiation oncology is an integral aspect of comprehensive cancer treatment, with approximately 50% of patients requiring curative or palliative radiotherapy intervention. In the South African public sector, radiation oncology services are constrained by various factors including service coverage, equipment and staff shortages, causing consequent delays in access to care. The National Cancer Strategic Framework for South Africa (NCSF) (2017-2022) offers strategic direction for cancer services in the country. Methods Futurist causal layered analysis (CLA) provides a comprehensive approach to exploring the multifaceted factors that influence access to radiation oncology services. Using the established layers of CLA, namely, the litany, systemic, worldview and mythical layers, the NCSF, relevant literature, and expert perspectives, were used to explore the multiple levels of influence related to radiation oncology services in South Africa. Findings Considering litany, review of process flows and radiation oncology care models could offer strategic pathways for reducing waiting times and improving access to care. From the systemic layer analysis, health system strengthening should include improving clinical governance and access to available services within both the public and private sectors. This could simultaneously address the worldview of an unconstitutional lack of access to radiation oncology care within the public health sector. The final level considered myths related to radiation oncology in South Africa, including its perceived efficacy only in advanced cancer stages, and highlighted the importance of a business case for radiation oncology services to support enhanced planning and outcomes. Conclusions CLA methodology offers new insights into the challenges and opportunities facing radiation oncology services in South Africa. By comprehensively addressing the complex causal layers impacting radiation oncology services, policymakers and stakeholders can make more informed decisions to improve access to radiation oncology care in the country. The study recommends that the entire cascade of cancer care, including treatment pathways and multi-stakeholder perspectives, should be reviewed. Internal and external factors that delay the initiation of radiotherapy should be mapped and mitigated.

Is Canada Moving towards a More Agile Regulatory Approval and Reimbursement Process with a Shifting Role for Real-World Evidence (RWE) for Oncology Drugs?

Canada is known to have a complex pathway for new drug approval and reimbursement, resulting in delayed access for patients with serious and life-threatening diseases, such as cancer. Several recent publications from key stakeholders, including patients, physicians and policymakers, highlight patient helplessness, physician frustrations and policymakers entangled in a massive network of bureaucracy unable to make headway. Several quantitative and qualitative assessments using time from regulatory approvals to successful reimbursements confirm long review times and high rejection rates for oncology drugs, especially those receiving conditional approvals. A consensus forum of 18 Canadian oncology clinicians recently voiced frustration with the process and inability to deliver guideline-supported efficacious therapies to their patients. This manuscript compares data extracted from publicly available data sources from 2019 to June 2024 to previous publications. Methods: Public databases from Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), which is in the process of changing to Canada's Drug Agency, and the pan-Canadian Pharmaceutical Alliance (pCPA) were reviewed and the data collected were analyzed with descriptive statistics. Results: From the data, three trends emerge, (i) an increasing number of oncology drugs are receiving conditional approvals from Health Canada, (ii) the percentage of conditionally approved oncology drugs receiving positive reimbursement recommendations from CADTH is still low but appears to be improving, but delays in access are now contingent upon pCPA deciding whether to negotiate price and then the duration of any negotiation, and (iii) real-world evidence is no longer part of the decision-making for conditional approvals. A slight increase in the positive endorsement of RWE used to support CADTH recommendations was observed. Conclusions: The lack of timely access to oncology drugs hurts Canadian patients. While a small trend of improvement appears to be emerging, longer-term data collection is required to ensure sustained patient benefits.

Evaluation of a Quality Measure for Multiple Sclerosis Care: Disease-Modifying Therapy Initiation at the University of North Carolina's Outpatient Neurology Clinic.

Multiple sclerosis (MS) is a neurological condition leading to significant disability and challenges to quality of life. To slow progression and reduce relapses, it is critical to rapidly initiate disease-modifying therapy (DMT) after diagnosis. Patient demographics may play a role in timely DMT initiation. Financial barriers may also result in delays in DMT access. This retrospective, single-center, cross-sectional study included patients seen at a neurology clinic at a large academic medical center for an initial evaluation of MS between January 1, 2022, and June 30, 2022. As an indicator of the quality of care, the primary study outcome was whether patients were offered DMT initiation on their first clinic visit. Secondary outcomes evaluated the time to DMT initiation, including differences in care based on demographic factors and financial coverage. Of the 49 eligible individuals studied, 45 (91.8%) were offered DMT at their initial MS visit. Descriptive statistics appeared to demonstrate that demographic factors did not impact whether DMT was offered. However, the majority of patients experienced access barriers relating to prior authorization requirements (80.0%) and/or the need for co-pay assistance (52.0%). DMT was appropriately offered to a majority of patients at their initial MS visit, regardless of demographic considerations. No offer of DMT and delays in initiation were primarily due to the need for imaging and specialty referrals, as well as financial barriers. Medication assistance teams may play a crucial role in limiting delays and financial hurdles associated with insurance coverage and co-pay assistance.

Spinal muscular atrophy in an upper-middle-income nation before the advent of reimbursed disease-modifying therapies

ObjectiveTo elucidate the clinical characteristics and standard of care (SoC) of spinal muscular atrophy (SMA) patients in Thailand, focusing on primary endpoints: age at death and a composite of death...

Factors Determining The Delay in Access to Appropriate Emergency Obstetric Care During The Lockdown Period of The COVID-19 Pandemic: An Observational Study at A Tertiary Referral Centre

Background: The WHO declared the COVID-19 pandemic as a public health emergency of inter-national concern following which many governments around the world adopted the most radical social distancing procedure, referred to as “lockdown”, to prevent the spread of the virus. As a result, unsupervised pregnancies and the absence of routine antenatal visits lead to dreaded maternal and fetal complications. This study determines the barriers to accessing emergency care by pregnant women during the lockdown period.Subjects and Method: This prospective study was conducted during the lockdown period in Delhi from 1 May 2021 to 31 May 2021. A total of 666 pregnant and postpartum patients admitted from casualty during this period were included. The variable of the study was various factors causing delays of more than 4 hours in accessing emergency care services by these patients after the onset of symptoms was assessed. This study used the conceptual model of Three Delays. The data was collected as per predesigned proforma. The demography, Obstetric profile, and various levels of delays were noted. The data was analyzed by frequencies and percentages using SPSS version 21.Results: Among 666 enrolled participants, about 55.7% were multigravida and 48.04% belonged to the upper-lower class. Nearly 43% of patients were illiterate. Antenatal delay of &gt; 4 hours was observed in 590 patients (88.6%). In Level 1 delay, the main reasons for the delay were unawareness of danger signs (45.8%) and lockdown (30.93%). The major reason for the Level 2 delay was care declined at the previous center (33.93%). Reasons for the Level 3 delay were due to either unavailability of beds or overcrowding after reaching the facility.Conclusion: The unawareness of danger signs was the most common cause of delay. Hence, effective communication and counseling during the antenatal period have to be improved upon.

Early intramuscular adrenaline administration is associated with improved survival from out-of-hospital cardiac arrest

BackgroundEarly administration of adrenaline is associated with improved survival after out-of-hospital cardiac arrest (OHCA). Delays in vascular access may impact the timely delivery of adrenaline. Novel methods for administering adrenaline before vascular access may enhance survival. The objective of this study was to determine whether an initial intramuscular (IM) adrenaline dose followed by standard IV/IO adrenaline is associated with improved survival after OHCA. Methods Study DesignWe conducted a before-and-after study of the implementation of an early, first-dose IM adrenaline EMS protocol for adult OHCAs. The pre-intervention period took place between January 2010 and October 2019. The post-intervention period was between November 2019 and May 2024. SettingSingle-center urban, two-tiered EMS agency. ParticipantsAdult, nontraumatic OHCA meeting criteria for adrenaline use. InterventionSingle dose (5 mg) IM adrenaline. All other care, including subsequent IV or IO adrenaline, followed international guidelines. Main Outcomes and MeasuresThe primary outcome was survival to hospital discharge. Secondary outcomes were time from EMS arrival to the first dose of adrenaline, survival to hospital admission, and favorable neurologic function at discharge. ResultsAmong 1405 OHCAs, 420 (29.9%) received IM adrenaline and 985 (70.1%) received usual care. Fifty-two patients received the first dose of adrenaline through the IV or IO route within the post-intervention period and were included in the standard care group analysis. Age was younger and bystander CPR was higher in the IM adrenaline group. All other characteristics were similar between IM and standard care cohorts. Time to adrenaline administration was faster for the IM cohort [(median 4.3 min (IQR 3.0–6.0) vs. 7.8 min (IQR 5.8–10.4)]. Compared with standard care, IM adrenaline was associated with improved survival to hospital admission (37.1% vs. 31.6%; aOR 1.37, 95% CI 1.06–1.77), hospital survival (11.0% vs 7.0%; aOR 1.73, 95% CI 1.10–2.71) and favorable neurologic status at hospital discharge (9.8% vs 6.2%; aOR 1.72, 95% CI 1.07–2.76). ConclusionIn this single-center before-and-after implementation study, an initial IM dose of adrenaline as an adjunct to standard care was associated with improved survival to hospital admission, survival to hospital discharge, and functional survival. A randomized controlled trial is needed to fully assess the potential benefit of IM adrenaline delivery in OHCA.

Evaluating the relationship between health-related social needs, patient demographics, and access to biologics in patients with moderate-to-severe asthma in Bronx, NY

Objectives This study assesses the relationship between patient age, gender, race, socioeconomic status, social determinants of health (SDoH), and access to biologics (products isolated from natural sources that target specific molecules, proteins, and cells) in patients with moderate-to-severe asthma in Bronx, NY. Methods Cohort of 289 patients with moderate-to-severe asthma treated at Montefiore Medical Center (MMC) from 2018 to 2020 was used. Patient demographics, self-reported social needs, and neighborhood socioeconomic characteristics were analyzed. Neighborhood socioeconomic status was estimated by determining median income in patients’ residential zip codes using 2020 Census data and grouping patients based on whether neighborhood median income was above or below New York State (NYS) median ($71,117/year). Area Deprivation Index tool (ADI) was used as an additional measure of neighborhood socioeconomic status. Results Patients living in regions with incomes below NYS median found to have longer wait times between biologic approval to administration than patients living in regions above median income (p = 0.012). Mean time from insurance approval to biologic administration was significantly different between Black and Latinx patients (p = 0.009). No significant difference found for patient regional income status and time from biologic prescription to approval. No significant differences in access to biologics were found for age, gender, number of health-related social needs, or patient ADI quartile. Conclusions Patients who live in areas of NYC where median income is below NYS median are more likely to experience delays in access to biologics, specifically due to time between approval and administration of medication.

The HyperPed-COVID international registry: Impact of age of onset, disease presentation and geographical distribution on the final outcome of MIS-C

ObjectivesThe aim of the study was to establish an international multicenter registry to collect data on patients with Multisystem Inflammatory Syndrome in Children (MIS-C), in order to highlight a relationship between clinical presentation, age of onset and geographical distribution on the clinical outcome. Study designMulticenter retrospective study involving different international societies for rare immunological disorders.1009 patients diagnosed with MIS-C between March and September 2022, from 48 centers and 22 countries were collected. Five age groups (<1, 1–4, 5–11, 12–16, >16 years) and four geographic macro-areas, Western Europe, Central-Eastern Europe, Latin America, Asian-African resource-limited countries (LRC), were identified. ResultsTime to referral was significantly higher in LRC. Intensive anti-inflammatory treatment, including biologics, respiratory support and mechanic ventilation were more frequently used in older children and in European countries. The mortality rate was higher in very young children (<1 year), in older patients (>16 years of age) and in LRC. Multivariate analysis identified the residence in LRC, presence of severe cardiac involvement, renal hypertension, lymphopenia and non-use of heparin prophylaxis, as the factors most strongly associated with unfavorable outcomes. ConclusionsThe stratification of patients by age and geographic macro-area provided insights into the clinical presentation, treatment and outcome of MIS-C. The mortality and sequelae rates exhibited a correlation with the age and geographical areas. Patients admitted and treated in LRC displayed more severe outcomes, possibly due to delays in hospital admission and limited access to biologic drugs and to intensive care facilities.

Advancing HER2-low breast cancer management: enhancing diagnosis and treatment strategies.

Recent evidence brought by novel anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates is leading to significant changes in HER2-negative breast cancer (BC) best practices. A new targetable category termed 'HER2-low' has been identified in tumors previously classified as 'HER2-negative'. Daily practice in pathology and medical oncology is expected to align to current recommendations, but patient access to novel anticancer drugs across geographies might be impeded due to local challenges. An expert meeting involving ten regional pathology and oncology opinion leaders experienced in BC management in four Central and Eastern Europe (CEE) countries (Bulgaria, Croatia, Serbia, Slovenia) was held. Herein we summarized the current situation of HER2-low metastatic BC (mBC), local challenges, and action plans to prevent delays in patient access to testing and treatment based on expert opinion. Gaps and differences at multiple levels were identified across the four countries. These included variability in the local HER2-low epidemiology data, certification of pathology laboratories and quality control, and reimbursement conditions of testing and anticancer drugs for HER2-negative mBC. While clinical decisions were aligned to international guidelines in use, optimal access to testing and innovative treatment was restricted due to significant delays in reimbursement or limitative reimbursement conditions. Preventing delays in HER2-low mBC patient access to diagnosis and novel treatments is crucial to optimize outcomes. Multidisciplinary joint efforts and pro-active discussions between clinicians and decision makers are needed to improve care of HER2-low mBC patients in CEE countries.

Disparity in oncology therapy access and differences in clinical pathological features and outcomes in indigenous population lung cancer (LC): A retrospective study from Martinique.

1599 Background: The epidemiology of cancers in terms of incidence and mortality are different in the French overseas compared to mainland France (FRANCIM 2019 data). Indigenous population are under-represented in clinical trials. Little is known about clinic-pathological features and outcomes from Caribbean islands. We report clinico-pathological features and survival in populations of patients with lung cancer (LC) and delays in access to therapy in Martinique. Methods: We conducted an academic retrospective study on patients with lung cancer (LC), treated at the University Hospital in Martinique between 2020-2022. The hospital in Martinique centralized all cancer patients in the territory for treatment. Demographic, risk factors, disease features, and treatment outcomes were collected from medical records. The molecular profile was determined using next-generation sequencing with the Archer FUSION Plex Lung v2 panel, evaluating at least EGFR, ALK, KRAS, ERBB2, MET, ROS1, BRAF, RET, NUTM1, PIK3CA, FGFR1, FGFR2, FGFR3, NRG1, NTRK1, NTRK2, NTRK3. We assessed time from symptoms to diagnosis and treatment, and overall survival (OS). Results: Overall, 268 patients (pts) were included. Pts were male in 51% cases (N=136), had a smoking history in 57% (N=139/243), with a median pack-years of 40 [IQR 22-50]. Median age was 67 years-old [IQR 58-78]. Histology was adenocarcinoma in 78% (N = 208), squamous cell in 13% (N=34), neuroendocrine tumors in 8% (N=21), and others in 2% (N=5). No small cell carcinoma diagnosed. Tumors had high PD-L1 expression (≥50%) in 18% (N=41/227) of cases. An oncogenic addiction was reported in 58% (N =105/181) of non-small cell and non-squamous lung carcinoma: EGFR36% (N=65), ALK3.3% (N=6), BRAF1.1% (N=2), KRAS13.3% (N=24). Pts had an ECOG performance status of 0-1 at diagnosis in 66% (N =162/244). LC was metastatic from diagnosis in 65% cases (N=175), with 18% having brain metastases (N=48). Median time between symptom occurrence and diagnosis was 66 days [IQR 21-171] and time between biopsy and treatment start was 56 days [IQR 31-77]. In pts with stage IV disease, 33% (N=59/175) never received a systemic treatment. In patients with at least 6 months of follow-up in the absence of death, median OS was 12.4 months (95% CI 8.6 – 17.1) overall and 8.6 months (95% CI 5.3 – 13.3) in patients with initial metastases. Conclusions: The lower overall survival rate than expected in this cancer context address the question of disparity population. One-third of LC metastatic patients did not receive systemic therapy. The local inadequacy of care pathways, leading to disparities in access to imaging, may explain the delays and poorer prognosis. A new initiative from a collaborative group with health authorities, caregivers, politicians and patient’s advocacy is actively working to improve cancer patient’s outcomes.

Mapping the Ecological Terrain of Stroke Prehospital Delay: A Nationwide Registry Study.

Delays in hospital presentation limit access to acute stroke treatments. While prior research has focused on patient-level factors, broader ecological and social determinants have not been well studied. We aimed to create a geospatial map of prehospital delay and examine the role of community-level social vulnerability. We studied patients with ischemic stroke who arrived by emergency medical services in 2015 to 2017 from the American Heart Association Get With The Guidelines-Stroke registry. The primary outcome was time to hospital arrival after stroke (in minutes), beginning at last known well in most cases. Using Geographic Information System mapping, we displayed the geography of delay. We then used Cox proportional hazard models to study the relationship between community-level factors and arrival time (adjusted hazard ratios [aHR] <1.0 indicate delay). The primary exposure was the social vulnerability index (SVI), a metric of social vulnerability for every ZIP Code Tabulation Area ranging from 0.0 to 1.0. Of 750 336 patients, 149 145 met inclusion criteria. The mean age was 73 years, and 51% were female. The median time to hospital arrival was 140 minutes (Q1: 60 minutes, Q3: 458 minutes). The geospatial map revealed that many zones of delay overlapped with socially vulnerable areas (https://harvard-cga.maps.arcgis.com/apps/webappviewer/index.html?id=08f6e885c71b457f83cefc71013bcaa7). Cox models (aHR, 95% CI) confirmed that higher SVI, including quartiles 3 (aHR, 0.96 [95% CI, 0.93-0.98]) and 4 (aHR, 0.93 [95% CI, 0.91-0.95]), was associated with delay. Patients from SVI quartile 4 neighborhoods arrived 15.6 minutes [15-16.2] slower than patients from SVI quartile 1. Specific SVI themes associated with delay were a community's socioeconomic status (aHR, 0.80 [95% CI, 0.74-0.85]) and housing type and transportation (aHR, 0.89 [95% CI, 0.84-0.94]). This map of acute stroke presentation times shows areas with a high incidence of delay. Increased social vulnerability characterizes these areas. Such places should be systematically targeted to improve population-level stroke presentation times.

Implementation of patient navigation services to improve colorectal cancer health literacy in a vulnerable community health center population.

e23208 Background: Under-served community populations face social and health inequities which contribute to sub-optimal colorectal cancer (CRC) screening rates and excess mortality risk. Furthermore, these populations may not have the health literacy or food security necessary to mitigate the well-established nutrition-related risk of CRC. This quality improvement study aimed to improve CRC-related health literacy and dietary habits, with the additional goal of improving screening rates in our disadvantaged community health center population. Methods: This single-institutional study utilized the Plan-Do-Study-Act (PDSA) model to implement patient navigation services and administer a cross-sectional survey evaluating nutrition-related CRC risk. Patients eligible for screening were contacted by patient outreach coordinators prior to scheduled primary care appointments, and the survey was administered. During patient visits, outreach coordinators met with them to provide 1:1 education addressing CRC prevention, screening and nutrition. Information on free or low-cost fresh food options was provided to help address barriers such as food insecurity. The outreach coordinators also liaised with physicians to assist with coordination to services. Results: Prior to the intervention 58% of survey respondents (25/43) were not aware of any foods or dietary habits that decreased the risk of colorectal cancer; 51% (22/43) were not aware of foods that increased the risk of colorectal cancer. Most respondents (54%) were in fact not at all worried about possibly developing CRC in their lifetimes (22/41), while 34% (14/41) were a little worried, and the remainder (12%) very or extremely worried. 97% of respondents (33/34) felt more knowledgeable about CRC screening and felt more confident about improving their nutrition to reduce CRC risk after receiving the educational intervention, while 94% of respondents (31/33) stated they would subsequently make dietary changes. Conclusions: Health literacy regarding colorectal cancer was low in this underserved community population. Implementation of a patient navigation intervention led to increased knowledge and confidence in modifying dietary risk factors. However, preliminary data review did not reveal significant change in CRC screening rates during the initial phase of the intervention. One of the initially identified barriers included system-level delays in colonoscopy access. During the Act phase of the PDSA model, patient navigation services will be further optimized by workflow adaptation based on the response of outreach coordinators and patient-reported barriers regarding stool-based testing. [Table: see text]

Mind the gap: Estimating the opportunity lost due to the gap between FDA and EMA cancer drug approvals.

11030 Background: Drug regulators operate on their own timelines to assess the safety and efficacy of new drugs and/or extensions to existing indications, such that there are delays between regulators. During such a gap, patients in the “early” domain have access to the approved drug, while those in the “late” domain do not, outside of compassionate use. Our study aimed to quantify the “opportunity lost” for new therapies approved by FDA and EMA, assuming patients in the late domain receive standard-of-care (SOC) therapy – which is presumably inferior to the new drug – during the gap. Methods: Anticancer drugs approved by both FDA and EMA were identified through the HemOnc knowledgebase. Inclusion criteria included: 1) drugs approved in both domains based on the same randomized clinical trial (RCTs) for the same indication; 2) a primary time-to-event endpoint; and 3) a quantitated median time-to-event for the primary endpoint. For each included trial, the approval gap between FDA and EMA in days and the ratio of approval gap to median control arm time-to-event duration was calculated. A ratio ≥2 implies that, on average, no late domain patients starting treatment in the first half of the gap would be expected to have access to the new drug prior to an event. Results: Of 60 eligible RCTs, 59 had calculable median event durations. 25 (42%) had a primary overall survival endpoint; the most common surrogate endpoint was progression-free survival (PFS; 29/59; 49%). The median (interquartile range [IQR]) approval gap was 186 (124-271) days, with FDA being the first approver in 56/59 (95%) cases. The median (IQR) ratio of approval gap to median control arm event duration was 0.63 (0.35-1.11). Drugs with ratio ≥2 (Table) were targeted or immunotherapies; 7/8 (88%) were approved with PFS endpoint; 5/8 (62.5%) were approved for second line or later. Conclusions: Our study shows that FDA approves most drugs prior to EMA and a nontrivial number of patients may experience progression or death events while awaiting access to anticancer therapies already approved in another domain. The analysis does not take into consideration scenarios in which the new therapy is inferior to SOC or delays in patient access (due to slow uptake; regulatory barriers [in Europe/UK]; or patient affordability [in US]). Further regulatory collaboration (e.g., Project Orbis) between FDA and EMA could help to reduce and potentially ameliorate this differential in access to new cancer drugs in the future. [Table: see text]