Gaining consensus on emotional wellbeing themes and preferences for digital intervention type and content to support the mental health of young people with long-term health conditions: A Delphi study.

BACKGROUND: Young people (YP) with long-term conditions (LTCs) are at greater risk of psychological distress than those without LTCs. Despite this, there is a scarcity of quality digital interventions designed to help improve mental wellbeing in this population. The aim of this study was to determine what YP, parents and health professionals preferred for future interventions. METHODS: Twenty-six YP with asthma, diabetes and/or epilepsy (the three most common LTCs in YP), 23 parents of YP with LTCs and 10 health professionals mainly in paediatric specialisms (total n = 59) took part in an online Delphi study to gain consensus (set at 75% agreement) on four questions across three rounds. Participants ordered psychological themes that may be experienced by YP with LTCs by importance and ranked digital intervention types and delivery modes by importance or usefulness. The most common results were reported if no consensus was reached by round 3. RESULTS: Participants preferred a mobile phone app (73% agreement) and a mixture of one-on-one and group support for an intervention (75% agreement). The two highest ranked psychological themes were anxiety (44%) and wanting to appear 'normal' (38%), and the top intervention type was 'general counselling' (54% agreement). CONCLUSION: There was a clear desire for an app to help with the psychological aspects of living with LTCs and for a combination of one-to-one and group intervention elements. Anxiety and wanting to appear 'normal' might be two closely linked psychological challenges that could be addressed by a single intervention. IMPLICATIONS: The results will be important to consider for a future intervention, although further consultation will be needed for app development. PATIENT OR PUBLIC CONTRIBUTION: Two YP with a LTC provided feedback on the study protocol including the aims and procedures of the project. Another six YP with LTCs were consulted on an early draft of the study questionnaire (the four questions), which was subsequently revised. Once the project began, a patient and public involvement group consisting of two YP with LTCs and one parent of a YP with an LTC gave feedback on the research process, lay report of the results and dissemination plan.

Fine tuning of CpG spatial distribution with DNA origami for improved cancer vaccination.

Multivalent presentation of ligands often enhances receptor activation and downstream signalling. DNA origami offers a precise nanoscale spacing of ligands, a potentially useful feature for therapeutic nanoparticles. Here we use a square-block DNA origami platform to explore the importance of the spacing of CpG oligonucleotides. CpG engages Toll-like receptors and therefore acts to activate dendritic cells. Through in vitro cell culture studies and in vivo tumour treatment models, we demonstrate that square blocks induce Th1 immune polarization when CpG is spaced at 3.5 nm. We observe that this DNA origami vaccine enhances DC activation, antigen cross-presentation, CD8 T-cell activation, Th1-polarized CD4 activation and natural-killer-cell activation. The vaccine also effectively synergizes with anti-PD-L1 for improved cancer immunotherapy in melanoma and lymphoma models and induces long-term T-cell memory. Our results suggest that DNA origami may serve as a platform for controlling adjuvant spacing and co-delivering antigens in vaccines.

Economic evaluation of a trial exploring the effects of a web-based support tool for parents of children with juvenile idiopathic arthritis.

OBJECTIVE: To explore the cost-effectiveness of a web-based support tool for parents of children with Juvenile Idiopathic Arthritis. METHODS: A multi-centred randomised controlled trial was conducted in paediatric rheumatology centres in England. The WebParC intervention consisted of online information about JIA and its treatment and a toolkit using cognitive-behavioural therapy principles to support parents manage their child's JIA. An economic evaluation was performed alongside the trial involving 220 parents. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress, with two dimensions; difficulty and frequency. These measures along with costs were assessed post intervention at 4 months and 12 months. Costs were calculated for healthcare usage using a UK NHS economic perspective. Data was collected and analysed on the impact of caring costs on families. Uncertainty around cost effectiveness was explored using bootstrapping and cost-effectiveness acceptability curves. RESULTS: The intervention arm showed improved average Pediatric Inventory for Parents scores for the dimensions of frequency and difficulty, of 1.5 and 3.6 respectively at 4 months and. 0.35 and 0.39 at 12 months, representing improved PIP scores for the intervention arm. At both 4 and 12 month follow up the average total cost per case was higher in the control group when compared with the intervention arm with mean differences of £360 (95% CI £29.6 to £691) at 4 months and £203 (95% CI £16 to £390) at 12 months. The probability of the intervention being cost effective ranged between 49% and 54%. CONCLUSION: The WebParC intervention led to reductions in primary and secondary healthcare resource use and costs at 4 and 12 months. The intervention demonstrated particular savings for rheumatology services at both follow ups. Future economies of scale could be realised by health providers with increased opportunities for cost effectiveness over time. TRIAL REGISTRATION: ISRCTN, ISRCTN13159730.

Disparities in the Receipt of Systemic Treatment in Metastatic Melanoma.

BACKGROUND: In 2011, immunotherapy and targeted therapy revolutionized melanoma treatment. However, inequities in their use may limit the benefits seen by certain patients. METHODS: We performed a retrospective review of patients in the National Cancer Database for patients with stage IV melanoma from 2 time periods: 2004-2010 and 2016-2020, distinguishing between those who received systemic therapy and those who did not. We investigated the rates and factors associated with treatment omission. We employed Kaplan-Meier analysis to explore the impact of treatment on overall survival. RESULTS: A total of 19,961 patients met the inclusion criteria: 7621 patients were diagnosed in 2004-2010 and 12,340 patients in 2016-2020, of whom 54.9% and 28.3% did not receive systemic treatment, respectively. The rate of "no treatment" has decreased to a plateau of ∼25% in 2020. Median overall survival was improved with treatment in both time periods (2004-2010: 8.8 vs. 5.6 mo [ P <0.05]; and 2016-2020: 25.9 vs. 4.3 mo [ P <0.05]). Nonmedical factors associated with the omission of treatment in both periods included low socioeconomic status, Medicaid or no health insurance, and treatment at low-volume centers. In the period from 2016 to 2020, patients treated at nonacademic programs were also less likely to receive treatment. CONCLUSIONS: Systemic therapies significantly improve survival for patients with metastatic melanoma, but significant disparities exist with their receipt. Local efforts are needed to ensure all patients benefit from these revolutionary treatments.

A Medicare Physician Fee Schedule Analysis of Reimbursement Trends in Laryngology from 2000 to 2021.

OBJECTIVE: The purpose of this study is to characterize Medicare reimbursement trends for laryngology procedures over the last two decades. METHODS: This analysis used CMS' Physician Fee Schedule (PFS) Look-Up Tool to determine the reimbursement rate of 48 common laryngology procedures, which were divided into four groups based on their practice setting and clinical use: office-based, airway, voice disorders, and dysphagia. The PFS reports the physician service reimbursement for "facilities" and global reimbursement for "non-facilities". The annual reimbursement rate for each procedure was averaged across all localities and adjusted for inflation. The compound annual growth rate (CAGR) of each procedure's reimbursement was determined, and a weighted average of the CAGR for each group of procedures was calculated using each procedure's 2020 Medicare Part B utilization. RESULTS: Reimbursement for laryngology procedure (CPT) codes has declined over the last two decades. In facilities, the weighted average CAGR for office-based procedures was -2.0%, for airway procedures was -2.2%, for voice disorders procedures was -1.4%, and for dysphagia procedures was -1.7%. In non-facilities, the weighted average CAGR for office-based procedures was -0.9%. The procedures in the other procedure groups did not have a corresponding non-facility reimbursement rate. CONCLUSION: Like other otolaryngology subspecialties, inflation-adjusted reimbursements for common laryngology procedures have decreased substantially over the past two decades. Because of the large number of physician participants and patient enrollees in the Medicare programs, increased awareness and further research into the implications of these trends on patient care is necessary to ensure quality in the delivery of laryngology care. LEVEL OF EVIDENCE: NA Laryngoscope, 134:247-256, 2024.

Impact of COVID-19 on clinical practice of UK-based speech and language therapists working with school-aged children with neurodisability and oropharyngeal dysphagia: A survey.

BACKGROUND: The COVID-19 pandemic and response changed clinical service delivery and practice for speech and language therapists (SLTs) in the United Kingdom. SLTs work with children with neurodisability regarding both difficulties with their communication and eating and drinking skills (oropharyngeal dysphagia). This survey aimed to specifically explore the impact of the COVID-19 pandemic on SLT practice for school-aged children with dysphagia. METHODS: UK-based SLTs working with school-aged children with neurodisability and oropharyngeal dysphagia were recruited to share their perceptions on the impact of COVID-19 on practice. Four questions focusing on COVID-19 impact were part of a larger online survey exploring SLT clinical practice regarding mealtime management of children with neurodisability and oropharyngeal dysphagia, which included demographic information, service delivery, assessment and intervention practices. COVID-19 impact questions were a mixture of multiple choice and free text responses. The survey was disseminated using professional networks and social media, between 14 May and 30 July 2021. Data were analysed using descriptive statistics and qualitative content analysis. RESULTS: One hundred and two participants answered at least one of the four COVID-19 questions. Eighty-two per cent of SLTs either agreed or strongly agreed that COVID-19 impacted on service delivery to children and families. Negative impacts on service delivery included school absences/closures, home visiting restrictions, families declining input and/or having barriers to telehealth use and the impact of mask wearing on interactions. Positive impacts included increased telehealth access and skills, increased contact with families and focus on children's eating and drinking function within the home environment. Participants aimed to maintain the increased contact with families alongside a hybrid service delivery approach of in-person and virtual appointments. CONCLUSIONS: This survey provides novel information capturing SLT practice change across two waves of COVID-19 and return to in-person practice for UK children with neurodisability.

Comprehensive Pharmacist-led Transitions-of-care Medication Management around Hospital Discharge Adds Modest Cost Relative to Usual Care: Time-and-Motion Cost Analysis.

Optimal medication management is important during hospitalization and at discharge because post-discharge adverse drug events (ADEs) are common, often preventable, and contribute to patient harms, healthcare utilization, and costs. Conduct a cost analysis of a comprehensive pharmacist-led transitions-of-care medication management intervention for older adults during and after hospital discharge. Twelve intervention components addressed medication reconciliation, medication review, and medication adherence. Trained, experienced pharmacists delivered the intervention to older adults with chronic comorbidities at 2 large U.S. academic centers. To quantify and categorize time spent on the intervention, we conducted a time-and-motion analysis of study pharmacists over 36 sequential workdays (14 519 min) involving 117 patients. For 40 patients' hospitalizations, we observed all intervention activities. We used the median minutes spent and pharmacist wages nationally to calculate cost per hospitalization (2020 U.S. dollars) from the hospital perspective, relative to usual care. Pharmacists spent a median of 66.9 min per hospitalization (interquartile range 46.1-90.1), equating to $101 ($86 to $116 in sensitivity analyses). In unadjusted analyses, study site was associated with time spent (medians 111 and 51.8 min) while patient primary language, discharge disposition, number of outpatient medications, and patient age were not. In this cost analysis, comprehensive medication management around discharge cost about $101 per hospitalization, with variation across sites. This cost is at least an order of magnitude less than published costs associated with ADEs, hospital readmissions, or other interventions designed to reduce readmissions. Work is ongoing to assess the current intervention's effectiveness.

Effect of a Peer Comparison and Educational Intervention on Medical Test Conversation Quality: A Randomized Clinical Trial.

Importance: Medical test overuse and resulting care cascades represent a costly, intractable problem associated with inadequate patient-clinician communication. One possible solution with potential for broader benefits is priming routine, high-quality medical test conversations. Objective: To assess if a peer comparison and educational intervention for physicians and patients improved medical test conversations during annual visits. Design, Setting, and Participants: Randomized clinical trial and qualitative evaluation at an academic medical center conducted May 2021 to October 2022. Twenty primary care physicians (PCPs) were matched-pair randomized. For each physician, at least 10 patients with scheduled visits were enrolled. Data were analyzed from December 2022 to September 2023. Interventions: In the intervention group, physicians received previsit emails that compared their low-value testing rates with those of peer PCPs and included point-of-care-accessible guidance on medical testing; patients received previsit educational materials via email and text message. Control group physicians and patients received general previsit preparation tips. Main outcomes and measures: The primary patient outcome was the Shared Decision-Making Process survey (SDMP) score. Secondary patient outcomes included medical test knowledge and presence of test conversation. Outcomes were compared using linear regression models adjusted for patient age, gender, race and ethnicity, and education. Poststudy interviews with intervention group physicians and patients were also conducted. Results: There were 166 intervention group patients and 148 control group patients (mean [SD] patient age, 50.2 [15.3] years; 210 [66.9%] female; 246 [78.3%] non-Hispanic White). Most patients discussed at least 1 test with their physician (95.4% for intervention group; 98.3% for control group; difference, -2.9 percentage points; 95% CI, -7.0 to 1.2 percentage points). There were no statistically significant differences in SDMP scores (2.11 out of 4 for intervention group; 1.97 for control group; difference, 0.14; 95% CI, -0.25 to 0.54) and knowledge scores (2.74 vs 2.54 out of 4; difference, 0.19; 95% CI, -0.05 to 0.43). In poststudy interviews with 3 physicians and 16 patients, some physicians said the emails helped them reexamine their testing approach while others noted competing demands. Most patients said they trusted their physicians' advice even when inconsistent with educational materials. Conclusions and Relevance: In this randomized clinical trial of a physician-facing and patient-facing peer comparison and educational intervention, there was no significant improvement in medical test conversation quality during annual visits. These results suggest that future interventions to improve conversations and reduce overuse and cascades should further address physician adoption barriers and leverage patient-clinician relationships. Trial Registration: ClinicalTrials.gov Identifier: NCT04902664.

Racial differences in low value care among older adult Medicare patients in US health systems: retrospective cohort study.

OBJECTIVE: To characterize racial differences in receipt of low value care (services that provide little to no benefit yet have potential for harm) among older Medicare beneficiaries overall and within health systems in the United States. DESIGN: Retrospective cohort study SETTING: 100% Medicare fee-for-service administrative data (2016-18). PARTICIPANTS: Black and White Medicare patients aged 65 or older as of 2016 and attributed to 595 health systems in the United States. MAIN OUTCOME MEASURES: Receipt of 40 low value services among Black and White patients, with and without adjustment for patient age, sex, and previous healthcare use. Additional models included health system fixed effects to assess racial differences within health systems and separately, racial composition of the health system's population to assess the relative contributions of individual patient race and health system racial composition to low value care receipt. RESULTS: The cohort included 9 833 304 patients (6.8% Black; 57.9% female). Of 40 low value services examined, Black patients had higher adjusted receipt of nine services and lower receipt of 20 services than White patients. Specifically, Black patients were more likely to receive low value acute diagnostic tests, including imaging for uncomplicated headache (6.9% v 3.2%) and head computed tomography scans for dizziness (3.1% v 1.9%). White patients had higher rates of low value screening tests and treatments, including preoperative laboratory tests (10.3% v 6.5%), prostate specific antigen tests (31.0% v 25.7%), and antibiotics for upper respiratory infections (36.6% v 32.7%; all P<0.001). Secondary analyses showed that these differences persisted within given health systems and were not explained by Black and White patients receiving care from different systems. CONCLUSIONS: Black patients were more likely to receive low value acute diagnostic tests and White patients were more likely to receive low value screening tests and treatments. Differences were generally small and were largely due to differential care within health systems. These patterns suggest potential individual, interpersonal, and structural factors that researchers, policy makers, and health system leaders might investigate and address to improve care quality and equity.

Who's Accountable? Low-Value Care Received By Medicare Beneficiaries Outside Of Their Attributed Health Systems.

Policy makers and payers increasingly hold health systems accountable for spending and quality for their attributed beneficiaries. Low-value care-medical services that offer little or no benefit and have the potential for harm in specific clinical scenarios-received outside of these systems could threaten success on both fronts. Using national Medicare data for fee-for-service beneficiaries ages sixty-five and older and attributed to 595 US health systems, we describe where and from whom they received forty low-value services during 2017-18 and identify factors associated with out-of-system receipt. Forty-three percent of low-value services received by attributed beneficiaries originated from out-of-system clinicians: 38 percent from specialists, 4 percent from primary care physicians, and 1 percent from advanced practice clinicians. Recipients of low-value care were more likely to obtain that care out of system if age 75 or older (versus ages 65-74), male (versus female), non-Hispanic White (versus other races or ethnicities), rural dwelling (versus metropolitan dwelling), more medically complex, or experiencing lower continuity of care. However, out-of-system service receipt was not associated with recipients' health systems' accountable care organization status. Health systems might improve quality and reduce spending for their attributed beneficiaries by addressing out-of-system receipt of low-value care-for example, by improving continuity.

Using the behaviour change wheel and person-based approach to develop a digital self-management intervention for patients with adrenal insufficiency: the Support AI study protocol.

Introduction: Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid replacement. They need to increase glucocorticoids during physical illness or major stressful situations and require parenteral hydrocortisone in the event of an adrenal crisis. Patients with AI have impaired quality of life and high mortality; approximately 1 in 6-12 patients are hospitalised at least once/year from a potentially preventable adrenal crisis. Adoption of self-management behaviours are crucial; these include adherence to medication, following "sick day rules" and associated behaviours that aid prevention and treatment of adrenal crisis such as symptom monitoring, having extra tablets, carrying a medical-alert ID and injection kit, and self-injecting when necessary. Current patient education is ineffective at supporting self-management behaviour change or reducing adrenal crisis-related hospitalisations. This research study aims to gain an in-depth understanding of the barriers and enablers to self-management for patients with AI and to develop an evidence-based digital self-management behaviour change intervention. Methods: The study is conducted in accordance with the MRC Framework for developing complex interventions. Underpinned by the Behaviour Change Wheel (BCW), the Theoretical Domains Framework (TDF), and the Person-Based Approach, this research will be conducted in two phases: Phase 1 will involve a sequential qualitative/quantitative mixed-methods study involving focus group interviews followed by a cross-sectional survey with patients with AI recruited from patient advocacy groups and endocrine clinics in the UK. Phase 2 will develop the Support AI, a website-based digital behaviour change intervention (DBCI) informed by Phase 1 findings to support self-management for patients with AI. The most appropriate behaviour change techniques (BCTs) will be selected utilising a nominal group technique with an Expert Panel of 10-15 key stakeholders. The design of the Support AI website will be guided by the Person-Based Approach using an Agile iterative "think-aloud" technique with 12-15 participants over 3 usability testing iterations. Conclusion: A theory- and evidence-based digital behaviour change intervention will be developed which will be tested in a feasibility randomised trial following completion of this study. The projected benefit includes cost-effective health care service (reduced hospitalisations and demand for specialist services) and improved health outcomes and quality of life for patients with AI.

Association of sociodemographic characteristics with utilization of sentinel lymph node biopsy for American Joint Committee on Cancer 8th edition T1b cutaneous melanoma.

Sentinel lymph node biopsy (SLNB) is an important staging and prognostic tool for cutaneous melanoma (CM). However, there exists a knowledge gap regarding whether sociodemographic characteristics are associated with receipt of SLNB for T1b CMs, for which there are no definitive recommendations for SLNB per current National Comprehensive Cancer Network guidelines. We performed a retrospective analysis of the 2012-2018 National Cancer Database, identifying patients with American Joint Committee on Cancer staging manual 8th edition stage T1b CM, and used multivariable logistic regression to analyze associations between sociodemographic characteristics and receipt of SLNB. Among 40,458 patients with T1b CM, 23,813 (58.9%) received SLNB. Median age was 62 years, and most patients were male (57%) and non-Hispanic White (95%). In multivariable analyses, patients of Hispanic (aOR 0.67, 95%CI 0.48-0.94) and other (aOR 0.78, 95%CI 0.63-0.97) race/ethnicity, and patients aged > 75 (aOR 0.33, 95%CI 0.29-0.38), were less likely to receive SLNB. Conversely, patients in the highest of seven socioeconomic status levels (aOR 1.37, 95%CI 1.13-1.65) and those treated at higher-volume facilities (aOR 1.29, 95%CI 1.14-1.46) were more likely to receive SLNB. Understanding the underlying drivers of these associations may yield important insights for the management of patients with melanoma.

Epidemiology, management, and treatment outcomes of metastatic spinal melanoma.

Metastatic spinal melanoma is a rare and aggressive disease process with poor prognosis. We review the literature on metastatic spinal melanoma, focusing on its epidemiology, management, and treatment outcomes. Demographics of metastatic spinal melanoma are similar to those for cutaneous melanoma, and cutaneous primary tumors tend to be most common. Decompressive surgical intervention and radiotherapy have traditionally been considered mainstays of treatment, and stereotactic radiosurgery has emerged as a promising approach in the operative management of metastatic spinal melanoma. While survival outcomes for metastatic spinal melanoma remain poor, they have improved in recent years with the advent of immune checkpoint inhibition, used in conjunction with surgery and radiotherapy. New treatment options remain under investigation, especially for patients with disease refractory to immunotherapy. We additionally explore several of these promising future directions. Nevertheless, further investigation of treatment outcomes, ideally incorporating high-quality prospective data from randomized controlled trials, is needed to identify optimal management of metastatic spinal melanoma.

A systematic review of barriers and enablers that health professionals experience to the delivery of type 2 diabetes care for adults with severe mental illness.

BACKGROUND: People with severe mental illness have a heightened risk for type 2 diabetes. They also experience poorer outcomes, including more diabetes complications, more emergency admissions, lower quality of life and excess mortality. AIMS: This systematic review aimed to identify health professionals' barriers to and enablers of delivering and organising type 2 diabetes care for people with severe mental illness. METHODS: Searches were conducted in Medline, EMBASE, PsycInfo, CINAHL, OVID Nursing, Cochrane Library, Google Scholar, OpenGrey, PsycExtra, Health Management Information Consortium and Ethos in March 2019, with updates in September 2019 and January 2023. There were no restrictions on study design, but studies were excluded if they did not include the perspective of health professionals or were not in English. Barriers and/or enablers of type 2 diabetes care for people with a severe mental illness were organised using the theoretical domains framework with additional inductive thematic coding. RESULTS: Twenty-eight studies were included in the review. Overall, eight domains were identified as important with barriers and enablers identified at individual, interpersonal and organisational levels. CONCLUSIONS: Focussing on providing a collaborative healthcare environment which actively supports type 2 diabetes care, fostering improved communication both between professionals and service users, ensuring clear boundaries around roles and responsibilities as well as individual skill and knowledge support alongside confidence building all offer opportunities to improve type 2 diabetes care.

Evaluating publication bias for clinical trials supporting new dermatologic drug approvals from 2003 to 2018.

The degree of publication bias and impact of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which aimed to improve clinical trial transparency, has yet to be examined for recent dermatologic drugs. The objective of our study was to estimate the degree of publication bias for clinical trials supporting FDA approval of new dermatologic drugs. This retrospective cohort study examined all phase II and III efficacy trials supporting approval of new dermatologic drugs from 2003 to 2018. FDA drug approval documents were reviewed for supportive clinical trial information, and publications were matched using PubMed and Google Scholar searches. Ratios of relative risks (RRR) comparing positive versus non-positive trials before and after FDAAA enactment served to estimate publication bias. We found that the likelihood of publishing positive versus non-positive drug trials in dermatology was unchanged before and after FDAAA enactment (RRR 0.87, 95% CI 0.37-2.08), as was the likelihood of publishing without misleading interpretation (RRR 1.51, 95% CI 0.22-10.50). There was no measurable publication bias for efficacy trials supporting new drug approvals in dermatology over the past 15 years. Fewer pre-FDAAA trials (n = 21) compared to post-FDAAA trials (n = 106) met inclusion criteria. Though not analyzed in this study, safety and secondary efficacy results are other potential sources for publication bias.

Geographic disparities in access to immunotherapy clinical trials for metastatic melanoma.

Survival outcomes for metastatic melanoma have drastically improved with the advent of immunotherapy. Access to ongoing immunotherapy clinical trials has become increasingly important to patients with advanced disease. We sought to quantify geographic disparities in access to these trials by U.S. division, region, urban/rural status, and median income. We searched ClinicalTrials.gov for interventional immunotherapy trials for metastatic melanoma from 2015 to 2021 and identified U.S. zip codes for each participating trial site. ArcGIS was used to calculate the one-way driving time from each zip code to the nearest treatment center. Melanoma burden in each zip code outside a 60 min driving radius was calculated by multiplying population by the corresponding state's cancer-specific mortality rate. χ2 tests were used to test for significance between census regions, divisions, and urban vs. rural zip codes, while logistic regression was used to quantify risk of poor access with median income. Across 148 trials, 4844 treatment centers were located in 1102 unique zip codes. 9010 zip codes were located greater than one-hour driving time from the nearest clinical trial. Southern regions were most likely to have poor access of all regions (p < 0.001), and rural status also significantly correlated with poor access (p < 0.001). For every $10,000 increase in median income, the likelihood of a zip code being within 60 min from a trial increased by 1.315. While immunotherapy continue to improve survival outcomes for metastatic melanoma, geographic access to clinical trials investigating these therapies remains a challenge for a significant proportion of the U.S. population.