Variation in telemedicine usage in gynecologic cancer: Are we widening or narrowing disparities?

INTRODUCTION: Telemedicine rapidly increased with the COVID-19 pandemic and could reduce cancer care disparities. Our objective was to evaluate sociodemographic (race, insurance), patient, health system, and cancer factors associated with telemedicine use in gynecologic cancers. METHODS: We conducted a retrospective cohort study of patients with endometrial cancer and epithelial ovarian cancer with at least one visit from March 2020 to October 2021, using a real-world electronic health record-derived database, representing approximately 800 sites in US academic (14%) and community practices (86%). We used multivariable Poisson regression modeling to analyze the association of ever using telemedicine with patient, sociodemographic, health system, and cancer factors. RESULTS: Of 3950 patients with ovarian cancer, 1119 (28.3%) had at least one telemedicine visit. Of 2510 patients with endometrial cancer, 720 (28.7%) had at least one telemedicine visit. At community cancer practices, patients who identified as Black were less likely to have a telemedicine visit than patients who identified as white in both ovarian and endometrial cancer (Ovarian: RR 0.62, 95% CI 0.42-0.9; Endometrial: RR 0.56, 95% CI 0.38-0.83). Patients in the Southeast, Midwest, West, and Puerto Rico were less likely to have telemedicine visits than patients in the Northeast. Uninsured patients were less likely, and patients with Medicare were more likely, to have one or more telemedicine visit than patients with private insurance. CONCLUSIONS: In this national cohort study, <30% of patients ever used telemedicine, and significant racial and regional disparities existed in utilization. Telemedicine expansion efforts should include programs to improve equity in access to telemedicine.

Disparities in Clinical Drug Trial Participation in Endometrial Cancer: A Real-World Analysis.

BACKGROUND: Racial disparities in clinical trial participation for uterine cancer have been reported. OBJECTIVES: We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States. STUDY DESIGN: We conducted a retrospective cohort study of patients with advanced or recurrent endometrial cancer patients diagnosed from 2013-2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors. RESULTS: Of 4,423 patients with endometrial cancer, 2,807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of endometrial cancer patients ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (RR 2.28 95% CI 1.12-4.62 and RR 2.59 95% CI 1.26-5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95%CI 0.30-0.83). CONCLUSION: Black endometrial cancer patients were disproportionately under-represented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.

Emulating Target Trials to Avoid Immortal Time Bias - An Application to Antibiotic Initiation and Preterm Delivery.

BACKGROUND: Randomized trials in pregnancy are extremely challenging, and observational studies are often the only option to evaluate medication safety during pregnancy. However, such studies are often susceptible to immortal time bias if treatment initiation occurs after time zero of follow-up. We describe how emulating a sequence of target trials avoids immortal time bias and apply the approach to estimate the safety of antibiotic initiation between 24 and 37 weeks gestation on preterm delivery. METHODS: The Tsepamo Study captured birth outcomes at hospitals throughout Botswana from 2014 to 2021. We emulated 13 sequential target trials of antibiotic initiation versus no initiation among individuals presenting to care <24 weeks, one for each week from 24 to 37 weeks. For each trial, eligible individuals had not previously initiated antibiotics. We also conducted an analysis susceptible to immortal time bias by defining time zero as 24 weeks and exposure as antibiotic initiation between 24 and 37 weeks. We calculated adjusted risk ratios (RR) and 95% confidence intervals (CI) for preterm delivery. RESULTS: Of 111,403 eligible individuals, 17,009 (15.3%) initiated antibiotics between 24 and 37 weeks. In the sequence of target trials, RRs (95% CIs) ranged from 1.04 (0.90, 1.19) to 1.24 (1.11, 1.39) (pooled RR: 1.11 [1.06, 1.15]). In the analysis susceptible to immortal time bias, the RR was 0.90 (0.86, 0.94). CONCLUSIONS: Defining exposure as antibiotic initiation at any time during follow-up after time zero resulted in substantial immortal time bias, making antibiotics appear protective against preterm delivery. Conducting a sequence of target trials can avoid immortal time bias in pregnancy studies.

Disparities in clinical trial participation in ovarian cancer: A real-world analysis.

BACKGROUND: Significant disparities exist in clinical trial participation in non-gynecologic cancers, but little is known about disparities in ovarian cancer trial participation. Our objective was to examine patient, sociodemographic (race/ethnicity, insurance), cancer, and health system factors associated with clinical trial participation in ovarian cancer. METHODS: We conducted a retrospective cohort study of patients with epithelial ovarian cancer diagnosed from 2011 to 2021, using a real-world electronic health record derived database, representing around 800 sites of care in US academic and community practices. We used multivariable Poisson regression modeling to analyze the association of ever participating in an ovarian cancer clinical drug trial with patient, sociodemographic, health system, and cancer factors. RESULTS: Of the 7540 patients with ovarian cancer, 5.0% (95% CI 4.5-5.5) ever participated in a clinical drug trial. Patients of Hispanic or Latino ethnicity were 71% less likely to participate in clinical trials (RR 0.29, 95% CI 0.13-0.61) than non-Hispanic patients, and patients whose race was unknown or other than Black or White were 40% less likely to participate in clinical trials (RR 0.68, 95% CI 0.52-0.89). Patients who had Medicaid insurance were 51% less likely (RR 0.49, 95% CI 0.28-0.87) and those with Medicare were 32% (RR 0.48-0.97) less likely to participate in clinical trials than privately-insured patients. CONCLUSION: In this national cohort study, only 5% of patients with ovarian cancer participated in clinical drug trials. Interventions are needed to decrease race, ethnicity, and insurance disparities in clinical trial participation.

Equitable implementation of S.A.F.E. Firearm: A multi-method pilot study.

Attention to health equity is critical in the implementation of firearm safety efforts. We present our operationalization of equity-oriented recommendations in preparation for launch of a hybrid effectiveness-implementation trial focused on firearm safety promotion in pediatric primary care as a universal suicide prevention strategy. In Step 1 of our process, pre-trial engagement with clinican partners and literature review alerted us that delivery of a firearm safety program may vary by patients' medical complexity, race, and ethnicity. In Step 2, we selected the Health Equity Implementation Framework to inform our understanding of contextual determinants (i.e., barriers and facilitators). In Step 3, we leveraged an implementation pilot across 5 pediatric primary care clinics in 2 health system sites to study signals of inequities. Eligible well-child visits for 694 patients and 47 clinicians were included. Our results suggested that medical complexity was not associated with program delivery. We did see potential signals of inequities by race and ethnicity but must interpret with caution. Though we did not initially plan to examine differences by sex assigned at birth, we discovered that clinicians may be more likely to deliver the program to parents of male than female patients. Seven qualitative interviews with clinicians provided additional context. In Step 4, we interrogated equity considerations (e.g., why and how do these inequities exist). In Step 5, we will develop a plan to probe potential inequities related to race, ethnicity, and sex in the fully powered trial. Our process highlights that prospective, rigorous, exploratory work is vital for equity-informed implementation trials.

Predictive Risk Score for Postparathyroidectomy Hungry Bone Syndrome in Patients With Secondary Hyperparathyroidism.

PURPOSE: Secondary hyperparathyroidism (SHPT) frequently affects patients with end-stage renal disease. Hungry bone syndrome (HBS) is a common complication among patients who undergo parathyroidectomy for SHPT and may cause prolonged hospitalization or require intensive care. The objective of this study is to develop a scoring system to stratify patients according to their risk of developing HBS. METHODS: A retrospective cohort study was performed using the US Renal Data System (2010-2021). Univariable and multivariable logistic regression models were developed and weighted ß-coefficients from the multivariable model were used to construct a risk score for the development of HBS. Positive and negative predictive values were assessed. RESULTS: Of 17 074 patients who underwent parathyroidectomy for SHPT, 19.4% developed HBS. Intensive care unit admission was more common in patients who developed HBS (33.5% vs 24.6%, P < .001). On multivariable logistic regression analysis, younger age, renal osteodystrophy, longer duration of dialysis, longer duration of kidney transplant, and higher Elixhauser score were significantly associated with HBS. A risk score based on these clinical factors was developed, with a total of 6 possible points. Rates of HBS ranged from 8% in patients with 0 points to 44% in patients with 6 points. The risk score had a poor positive predictive value (20.3%) but excellent negative predictive value (89.3%) for HBS. CONCLUSION: We developed a weighted risk score that effectively stratifies patients by risk for developing HBS after parathyroidectomy. This tool can be used to counsel patients and to identify patients who may not require postoperative hospitalization.

Spending Analysis of Machine Learning-Based Communication Nudges in Oncology.

BACKGROUND: Serious illness conversations (SICs) in the outpatient setting may improve mood and quality of life among patients with cancer and decrease aggressive end-of-life care. Interventions informed by behavioral economics may increase rates of SICs between oncology clinicians and patients, but the impact of these interventions on end-of-life spending is unknown. METHODS: This study is a secondary analysis of a stepped-wedge cluster randomized, controlled trial that involved nine medical oncology practices and their high-risk patients at a large academic institution between June 2019 and April 2020. The study included 1187 patients who were identified by a machine-learning algorithm as high risk of 180-day mortality and who died by December 2020. The patients were randomly assigned to standard of care (controls) or to a behavioral intervention designed to increase clinician-initiated SICs. We abstracted spending - defined as inflation-adjusted costs for acute care (inpatient plus emergency room), office/outpatient care, intravenous systemic therapy, other therapy (e.g., radiation), long-term care, and hospice - from the institution's accounting system, and we captured spending at inpatient, outpatient, and pharmacy settings. To evaluate intervention impacts on spending, we used a two-part model, first using logistic regression to model zero versus nonzero spending and second using generalized linear mixed models with gamma distribution and log-link function to model daily mean spending in the last 180days of life. Models were adjusted for clinic and wedge fixed effects, and they were clustered at the oncologist level. For all patients with at least one SIC within 6 months of death, we also calculated their mean daily spending before and after SIC. RESULTS: Median age at death was 68years (interquartile range, 15.5), 317 patients (27%) were Black or of ethnicities other than white, and 448 patients (38%) had an SIC. The intervention was associated with lower unadjusted mean daily spending in the last 6 months of life for the intervention group versus controls ($377.96 vs. $449.92; adjusted mean difference, -$75.33; 95% confidence interval, -$136.42 to -$14.23; P=0.02), translating to $13,747 total adjusted savings per decedent and $13 million in cumulative savings across all decedents in the intervention group. Compared with controls, patients in the intervention group incurred lower mean daily spending for systemic therapy (adjusted difference, -$44.59; P=0.001), office/outpatient care (-$9.62; P=0.001), and other therapy (-$8.65; P=0.04). The intervention was not associated with differences in end-of-life spending for acute care, long-term care, or hospice. Results were consistent for spending in the last 1 and 3 months of life and after adjusting for age, race, and ethnicity. For patients with SICs, mean daily spending decreased by $37.92 following the first SIC ($329.87 vs. $291.95). CONCLUSIONS: A machine learning-based, behaviorally informed intervention to prompt SICs led to end-of-life savings among patients with cancer, driven by decreased systemic therapy and outpatient spending. (Funded by the Penn Center for Precision Medicine and the National Institutes of Health; ClinicalTrials.gov number, NCT03984773.).

Cost-Comparison of Mechanical Thrombectomy and Catheter-Directed Thrombolysis in Intermediate-Risk Pulmonary Embolism.

Background: Catheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (MT) are the leading percutaneous-based therapies for the management of intermediate-risk pulmonary embolism (PE). While previous studies have demonstrated their procedural safety and efficacy, the cost implications of these interventions remain unclear. This study aims to conduct a cost-benefit analysis to evaluate the economic advantages associated with CDT and MT from the perspective of the treating hospital. Methods: A total of 372 consecutive patients with intermediate-risk acute PE who underwent either MT or CDT at 3 academic centers between 2013 and 2021 were included in this analysis. The costs of care incurred during the index hospitalization for the 2 treatment groups were collected and compared using an adjusted cost model. Results: This study compared the hospital costs of 226 patients who underwent CDT and 146 patients who underwent MT. In the unadjusted overall cohort, the use of CDT was associated with a numerical but nonsignificant increase in costs amounting to $5120 relative to MT (P = .062). This cost difference was primarily driven by the longer length of stay in the intensive care unit and hospital for CDT patients, particularly earlier in the studied timeframe. However, when accounting for confounders including variations between the treating institutions and the timing of treatment during the study period, the adjusted cost differential between CDT and MT narrowed to $1351 (P = .71). Conclusions: This multicenter cost analysis does not reveal a clear cost advantage of 1 treatment over the other for intermediate-risk PE. The observed cost differences were influenced by variations in practice patterns across the study period and among the 3 participating institutions. Future efforts should also focus on strategies to reduce the length of stay, improve efficiency, and minimize the overall cost of care for intermediate-risk PE patients.

A targeted strategic peer support intervention to increase adherence to video teletherapy exposure and response prevention treatment for obsessive-compulsive disorder: a retrospective observational analysis.

Exposure and response prevention (ERP) therapy, a form of cognitive-behavioral therapy, is a first-line, evidence-based treatment for obsessive-compulsive disorder (OCD) for adults and children. It is effective for the majority of those who engage in it, but treatment adherence can be challenging for some due to the stress involved in the treatment as well as different life circumstances that arise. To help improve treatment adherence, NOCD, a provider of video teletherapy ERP, identifies those at risk of non-adherence using a prediction algorithm trained on a data set of N = 13,809 and provides targeted peer support interventions by individuals ("Member Advocates") who successfully completed ERP treatment for OCD. Member Advocates, using lived OCD experience as well as experience with ERP, engage at-risk patients through digital messaging to engage, educate, and encourage patients in the early stages of treatment. From June 2022 to August 2022, N = 815 patients deemed at risk were reached out to and n = 251 responded and engaged with the Member Advocates. In the at-risk patients who engaged, the intervention resulted in a significant mean 30.4% more therapy hours completed compared to those who did not engage. Additionally, engaged patients had greater reductions in OCD severity. These results have implications for how data science, digital interventions, and strategic peer-to-peer communication and support can be combined to enhance the effectiveness of treatment.

Corrigendum: Guaranteed Income and Financial Treatment (G.I.F.T.): a 12-month, randomized controlled trial to compare the effectiveness of monthly unconditional cash transfers to treatment as usual in reducing financial toxicity in people with cancer who have low incomes.

[This corrects the article DOI: 10.3389/fpsyg.2023.1179320.].

Guaranteed Income and Financial Treatment Trial (GIFT Trial or GIFTT): a 12-month, randomized controlled trial to compare the effectiveness of monthly unconditional cash transfers to treatment as usual in reducing financial toxicity in people with cancer who have low incomes.

Cancer-related financial hardship (i.e., financial toxicity) has been associated with anxiety and depression, greater pain and symptom burden, treatment nonadherence, and mortality. Out-of-pocket healthcare costs and lost income are primary drivers of financial toxicity, however, income loss is a pronounced risk factor for cancer patients with low incomes. There has been little progress in developing an income intervention to alleviate financial toxicity cancer patients with low incomes. Unconditional cash transfers (UCT), or guaranteed income, have produced positive health effects in experiments with general low-income populations, but have not yet been evaluated in people with cancer. The Guaranteed Income and Financial Treatment (GIFT) Trial will use a two-arm randomized controlled trial to compare the efficacy of a 12-month UCT intervention providing $1000/month to treatment as usual on financial toxicity, health-related quality of life and treatment adherence in people with cancer who have low-incomes. The study will recruit 250 Medicaid beneficiaries with advanced cancer from two comprehensive cancer centers in Philadelphia, obtain informed consent, and randomize patients to one of two conditions: (1) $1,000/month UCT or (2) treatment as usual. Both arms will receive information on financial toxicity and the contact information for their hospital social worker or financial advocate upon enrollment. Participants will complete online surveys at baseline, 3, 6, 9, and 12 months from enrollment to collect patient-reported data on primary (i.e., financial toxicity, health-related quality of life, and treatment adherence) and secondary outcomes (i.e., anxiety, depression, food insecurity, housing stability). Social security records will be used to explore the effect on mortality at 2, 3, and 5 years post-enrollment. Linear mixed-models will be used to analyze all primary and secondary continuous outcomes over time and general estimating equations with a logit link and binary distribution for all binary outcomes over time. Differences between treatment and control groups and treatment effects will be determined using models that control for age, gender, race, baseline food security, baseline housing stability, and baseline ECOG. Findings from this study will have significant implications for the development and implementation of programs and policies that address the financial burden of cancer and other serious illnesses.

Corrigendum: Guaranteed Income and Financial Treatment Trial (GIFT Trial or GIFTT): a 12-month, randomized controlled trial to compare the effectiveness of monthly unconditional cash transfers to treatment as usual in reducing financial toxicity in people with cancer who have low incomes.

[This corrects the article DOI: 10.3389/fpsyg.2023.1179320.].

Toxicities and Deaths From Intercurrent Disease Following Contemporary Postoperative Radiotherapy in Resected Non-Small-Cell Lung Cancer.

INTRODUCTION: The role of postoperative radiotherapy (PORT) in patients with resected locally advanced non-small-cell lung cancer (NSCLC) remains controversial due to the radiation techniques used in randomized trials. We conducted a retrospective cohort study evaluating contemporary PORT techniques to evaluate the safety of PORT and risk of death from intercurrent disease . MATERIALS AND METHODS: We analyzed consecutive patients with NSCLC treated in a single center that underwent PORT for pN2 disease and/or positive margin, with 3-dimensional conformal radiotherapy (3DRT), intensity modulated radiotherapy , or proton RT (PRT), between 2008 and 2019. Clinical details were collected including intercurrent deaths, defined as death without cancer recurrence. Kaplan-Meier and Cox-Proportional Hazards Models were used. RESULTS: Of 119 patients, 21 (17.6%) received 3DRT, 47 (39.5%) intensity modulated radiotherapy, and 51 (42.9%) PRT. Median follow-up was 40 months (range 8-136) and median RT dose was 5040cGy. Most patients (65.5%) received sequential adjuvant chemoRT; 18.5% received concurrent chemoRT. The rate of grade 3 toxicities was 9.2%. There were 13 (10.9%) deaths from intercurrent diseases, including 6 from second primary cancers and 2 from cardiopulmonary diseases. There were 2 additional deaths from cardiopulmonary disease in patients with cancer progression at time of death. Mean, V5Gy, V30Gy heart doses and mean lung doses were significantly lower with PRT. Three-year OS and disease-free-survival were 70.1% and 49.9%. CONCLUSION: PORT using contemporary techniques was well tolerated with acceptable toxicity and low rates of intercurrent deaths. Proton therapy significantly reduced heart and lung doses, but radiotherapy modality was not associated with differences in intercurrent disease.

Comparison of Staged vs Same-Day Circumferential Spinal Fusions for Adult Spinal Deformity.

BACKGROUND: Patients often undergo circumferential (anterior and posterior) spinal fusions to maximize adult spinal deformity (ASD) correction and achieve adequate fusion. Currently, such procedures are performed in staged (ST) or same-day (SD) procedures with limited evidence to support either strategy. This study aims to compare perioperative outcomes and costs of ST vs SD circumferential ASD corrective surgeries. METHODS: This is a retrospective review of patients undergoing circumferential ASD surgeries between 2013 and 2018 in a single institution. Patient characteristics, preoperative comorbidities, surgical details, perioperative complications, readmissions, total hospital admission costs, and 90-day postoperative care costs were identified. All variables were tested for differences between ST and SD groups unadjusted and after applying inverse probability weighting (IPW), and the results before and after IPW were compared. RESULTS: The entire cohort included a total of 211 (ST = 50, SD = 161) patients, 100 of whom (ST = 44, SD = 56) underwent more than 4 levels fused posteriorly and anterior lumbar interbody fusion (ALIF). Although patient characteristics and comorbidities were not dissimilar between the ST and SD groups, both the number of levels fused in ALIF and posterior spinal fusion (PSF) were significantly different. Thus, using IPW, we were able to minimize the cohort incongruities in the number of levels fused in ALIF and PSF while maintaining comparable patient characteristics. In both the whole cohort and the long segment fusions, postoperative pulmonary embolism was more common in ST procedures. After adjustment utilizing IPW, both groups were not significantly different in disposition, 30-day readmissions, and reoperations. However, within the whole cohort and the long segment fusion cohort, the ST group continued to show significantly increased rates of pulmonary embolism, longer length of stay, and higher hospital admission costs compared with the SD group. CONCLUSIONS: Adjusted comparisons between ST and SD groups showed staging associated with significantly increased length of stay, risk of pulmonary embolism, and admission costs.

Parasitic helminth infections in humans modulate Trefoil Factor levels in a manner dependent on the species of parasite and age of the host.

Helminth infections, including hookworms and Schistosomes, can cause severe disability and death. Infection management and control would benefit from identification of biomarkers for early detection and prognosis. While animal models suggest that Trefoil Factor Family proteins (TFF2 and TFF3) and interleukin-33 (IL-33) -driven type 2 immune responses are critical mediators of tissue repair and worm clearance in the context of hookworm infection, very little is known about how they are modulated in the context of human helminth infection. We measured TFF2, TFF3, and IL-33 levels in serum from patients in Brazil infected with Hookworm and/or Schistosomes, and compared them to endemic and non-endemic controls. TFF2 was specifically elevated by Hookworm infection in females, not Schistosoma or co-infection. This elevation was correlated with age, but not worm burden. TFF3 was elevated by Schistosoma infection and found to be generally higher in females. IL-33 was not significantly altered by infection. To determine if this might apply more broadly to other species or regions, we measured TFFs and cytokine levels (IFNγ, TNFα, IL-33, IL-13, IL-1ß, IL-17A, IL-22, and IL-10) in both the serum and urine of Nigerian school children infected with S. haematobium. We found that serum levels of TFF2 and 3 were reduced by infection, likely in an age dependent manner. In the serum, only IL-10 and IL-13 were significantly increased, while in urine IFN-γ, TNF-α, IL-13, IL-1ß, IL-22, and IL-10 were significantly increased in by infection. Taken together, these data support a role for TFF proteins in human helminth infection.