Changes in Out-of-Pocket Spending for Common Oral Cancer Medications After the Inflation Reduction Act.

This economic evaluation assesses changes to patient out-of-pocket spending for oral cancer medications before and after the Inflation Reduction Act.

Telehealth visit type and patient-reported outcomes among patients with cancer.

BACKGROUND: Relaxed licensing restrictions on telehealth use during the COVID-19 pandemic allowed broad use irrespective of visit type. As these telehealth waivers expire, optimal uses of telehealth must be assessed to inform policy and clinical care. We evaluated patient experience associated with telehealth and in-person new or established visits. METHODS: Patients seen in-person and via telehealth for urologic cancer care from August 2019 to June 2022 received a survey on satisfaction with care, perceptions of communication during their visit, travel time, travel costs, and days of work missed. We assessed survey responses with descriptive statistics. RESULTS: Surveys were completed for 1,031 patient visits (N = 494 new visits, N = 537 established visits). Satisfaction rates were high for all visit modalities among new and established patients (mean score range 59.9-60.7 [maximum 63], P > 0.05). Patient-rated quality of the encounter did not differ by visit type and modality (P > 0.05, for nearly all comparisons). New in-person patient visits were associated with significantly higher travel costs (mean $496.10, SD $1021) compared with new telehealth visits (mean $26.60, SD $141; P < 0.001); 27% of new in-person patients required plane travel and 41% required a hotel stay (P < 0.001 vs. 0.8% and 3.2% of new telehealth patients, respectively). CONCLUSIONS: Satisfaction outcomes among patients with urologic cancer receiving new patient telehealth care equaled those of new patients cared for in-person while costs were significantly lower. Offering telehealth exemption beyond COVID-19 licensing waivers to include new patient visits would allow for ongoing delivery of high-quality urologic cancer care irrespective of geographic location.

Integrative Drug Screening and Multiomic Characterization of Patient-derived Bladder Cancer Organoids Reveal Novel Molecular Correlates of Gemcitabine Response.

BACKGROUND AND OBJECTIVE: Predicting response to therapy for each patient's tumor is critical to improving long-term outcomes for muscle-invasive bladder cancer. This study aims to establish ex vivo bladder cancer patient-derived organoid (PDO) models that are representative of patients' tumors and determine the potential efficacy of standard of care and curated experimental therapies. METHODS: Tumor material was collected prospectively from consented bladder cancer patients to generate short-term PDO models, which were screened against a panel of clinically relevant drugs in ex vivo three-dimensional culture. Multiomic profiling was utilized to validate the PDO models, establish the molecular characteristics of each tumor, and identify potential biomarkers of drug response. Gene expression (GEX) patterns between paired primary tissue and PDO samples were assessed using Spearman's rank correlation coefficients. Molecular correlates of therapy response were identified using Pearson correlation coefficients and Kruskal-Wallis tests with Dunn's post hoc pairwise comparison testing. KEY FINDINGS AND LIMITATIONS: A total of 106 tumors were collected from 97 patients, with 65 samples yielding sufficient material for complete multiomic molecular characterization and PDO screening with six to 32 drugs/combinations. Short-term PDOs faithfully represent the tumor molecular characteristics, maintain diverse cell types, and avoid shifts in GEX-based subtyping that accompany long-term PDO cultures. Utilizing an integrative approach, novel correlations between ex vivo drug responses and genomic alterations, GEX, and protein expression were identified, including a multiomic signature of gemcitabine response. The positive predictive value of ex vivo drug responses and the novel multiomic gemcitabine response signature need to be validated in future studies. CONCLUSIONS AND CLINICAL IMPLICATIONS: Short-term PDO cultures retain the molecular characteristics of tumor tissue and avoid shifts in expression-based subtyping that have plagued long-term cultures. Integration of multiomic profiling and ex vivo drug screening data identifies potential predictive biomarkers, including a novel signature of gemcitabine response. PATIENT SUMMARY: Better models are needed to predict patient response to therapy in bladder cancer. We developed a platform that uses short-term culture to best mimic each patient's tumor and assess potential sensitivity to therapeutics.

Attitudes and barriers toward video visits in surgical care: Insights from a nationwide survey among surgeons.

BACKGROUND: Surgeons rapidly adopted video visits during the COVID-19 pandemic. However, video visit use among surgeons has significantly declined, pointing to the need to better understand current attitudes and barriers to their use in surgical care. METHODS: From August 2022 to March 2023, a nationwide survey was conducted among practicing surgeons in 6 specialties. The survey included multiple-choice and free-response questions based on an implementation determinants framework, covering demographics, provider, patient, and organizational factors. RESULTS: A total of 170 surgeons responded (24% response rate). Overall, 67% of surgeons said their practice lacked motivation for video visit implementation. Additionally, 69% disagreed with using video visits as the sole means for preoperative surgical consultation, even with relevant medical history, labs, and imaging. Nearly 43% cited the need for a physical examination, whereas 58% of surgeons said video visits carried a greater malpractice risk than in-person visits. Other barriers included technological limitations, billing, and care quality concerns. Nevertheless, 41% agreed that video visits could improve outcomes for some patients, and 60% expressed openness to using video visits exclusively for postoperative consultations in uncomplicated surgeries. CONCLUSION: Surgeons recognize the potential benefits of video visits for certain patients. However, perceived barriers include the need for a physical examination, technological limitations, care quality concerns, and malpractice risks.

Telemedicine in urologic oncology care: Will telemedicine exacerbate disparities?

INTRODUCTION: Disparities in prostate, bladder, and kidney cancer outcomes are associated with access to care. Telemedicine can improve access but may be underutilized by certain patient populations. Our objective was to determine if the patient populations who suffer worse oncologic outcomes are the same as those who are less likely to use telemedicine. METHODS: Using an institutional database, we identified all prostate, bladder and kidney cancer encounters from March 14, 2020 to October 31, 2021 (n = 15,623; n = 4, 14; n = 3,830). Telemedicine was used in 13%, 8%, and 12% of these encounters, respectively. We performed random effects modeling analysis to examine patient and provider characteristics associated with telemedicine use. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were reported as measures of association. RESULTS: Among prostate, bladder, and kidney cancer patients, Black patients had lower odds of a telemedicine encounter (OR 0.51, 95% CI 0.37-0.69; OR 0.22, 95% CI 0.07-0.70; OR 0.46, 95% CI 0.24-0.86), and patients residing in small and isolated small rural towns areas had higher odds of a telemedicine encounter (OR 1.44, 95% CI 1.09-1.91; OR 2.12, 95% CI 1.14-3.94; OR 1.89, 95% CI 1.12-3.19). Compared to providers in practice ≤5 years, providers in practice for 6 to 15 years had significantly higher odds of a telemedicine encounter for prostate and bladder cancer patients (OR 4.10, 95% CI 1.4511.58; OR 3.42, 95% CI 1.09-10.77). CONCLUSION: The lower rates of telemedicine use among Black patients could exacerbate pre-existing disparities in prostate, bladder, and kidney cancer outcomes.

Perceived vs Actual Shared Decision-Making Behavior Among Urologists: A Convergent, Parallel, Mixed-Methods Study of Self-Reported Practice.

OBJECTIVE: To evaluate the association between self-perceived use of shared decision-making among urologists with use of validated prediction tools and self-described surgical decision-making. METHODS: This is a convergent mixed methods study of these parallel data from two modules (Shared Decision Making and Validated Prediction tools) within the 2019 American Urological Association (AUA) Annual Census. The shared decision-making (SDM) module queried aspects of SDM that urologists regularly used. The validated prediction tools module queried whether urologists regularly used, trusted, and found prediction tools helpful. Selected respondents to the 2019 AUA Annual Census underwent qualitative interviews on their surgical decision-making. RESULTS: In the weight sampled of 12,312 practicing urologists, most (77%) reported routine use of SDM, whereas only 30% noted regular use of validated prediction tools. On multivariable analysis, users of prediction tools were not associated with regular SDM use (31% vs 28%, P = .006) though was associated with use of decision aids f (32% vs 26%, P < .001). Shared decision-making emerged thematically with respect to matching treatment options, prioritizing goals, and navigating challenging decisions. However, the six specific components of shared decision-making ranged in their mentions within qualitative interviews. CONCLUSION: Most urologists report performing SDM as supported by its thematic presence in surgical decision-making. However, only a minority use validated prediction tools and urologists infrequently mention specific SDM components. This discrepancy provides an opportunity to explore how urologists perform SDM and can be used to support integrated strategies to implement SDM more effectively in clinical practice.

Interstate Telemedicine for Urologic Cancer Care.

PURPOSE: US states eased licensing restrictions on telemedicine during the COVID-19 pandemic, allowing interstate use. As waivers expire, optimal uses of telemedicine must be assessed to inform policy, legislation, and clinical care. We assessed whether telemedicine visits provided the same patient experience as in-person visits, stratified by in- vs out-of-state residence, and examined the financial burden. MATERIALS AND METHODS: Patients seen in person and via telemedicine for urologic cancer care at a major regional cancer center received a survey after their first appointment (August 2019-June 2022) on satisfaction with care, perceptions of communication during their visit, travel time, travel costs, and days of work missed. RESULTS: Surveys were completed for 1058 patient visits (N = 178 in-person, N = 880 telemedicine). Satisfaction rates were high for all visit types, both interstate and in-state care (mean score 60.1-60.8 [maximum 63], P > .05). More patients convening interstate telemedicine would repeat that modality (71%) than interstate in-person care (61%) or in-state telemedicine (57%). Patients receiving interstate care had significantly higher travel costs (median estimated visit costs $200, IQR $0-$800 vs median $0, IQR $0-$20 for in-state care, P < .001); 55% of patients receiving interstate in-person care required plane travel and 60% required a hotel stay. CONCLUSIONS: Telemedicine appointments may increase access for rural-residing patients with cancer. Satisfaction outcomes among patients with urologic cancer receiving interstate care were similar to those of patients cared for in state; costs were markedly lower. Extending interstate exemptions beyond COVID-19 licensing waivers would permit continued delivery of high-quality urologic cancer care to rural-residing patients.

Intra-practice Urologist-level Variation in Targeted Fusion Biopsy Outcomes.

OBJECTIVE: To examine the extent to which the urologist performing biopsy contributes to variation in prostate cancer detection during fusion-guided prostate biopsy. METHODS: All men in the Michigan Urological Surgery Improvement Collaborative (MUSIC) clinical registry who underwent fusion biopsy at Michigan Medicine from August 2017 to March 2019 were included. The primary outcomes were clinically significant cancer detection rate (defined as Gleason Grade ≥2) in targeted cores and clinically significant cancer detection on targeted cores stratified by PI-RADS score. Bivariate and multivariable logistic regression analyses were performed. RESULTS: A total of 1133 fusion biopsies performed by 5 providers were included. When adjusting for patient age, PSA, race, family history, prostate volume, clinical stage, and PI-RADS score, there was no significant difference in targeted clinically significant cancer detection rates across providers (range = 38.5%-46.9%, adjusted P-value = .575). Clinically significant cancer detection rates ranged from 11.1% to 16.7% in PI-RADS 3 (unadjusted P = .838), from 24.6% to 43.4% in PI-RADS 4 (adjusted P = .003), and from 69.4% to 78.8% in PI-RADS 5 (adjusted P = .766) lesions. CONCLUSION: There was a statistically significant difference in clinically significant prostate cancer detection in PI-RADS 4 lesions across providers. These findings suggest that even among experienced providers, variation at the urologist level may contribute to differences in clinically significant cancer detection rates within PI-RADS 4 lesions. However, the relative impact of biopsy technique, radiologist interpretation, and MR acquisition protocol requires further study.

Effects of Advanced Practice Providers on Single-specialty Surgical Practice.

OBJECTIVE: To assess the effects of adding advanced practice providers to surgical practices on surgical complications, readmissions, mortality, episode spending, length of stay, and access to care. SUMMARY BACKGROUND DATA: There has been substantial growth in the number of nurse practitioners and physician assistants (ie, advanced practice providers) in the United States. The extent to which advanced practice providers have been integrated into surgical practice, and their impact on surgical outcomes and access is unclear. METHODS: Using a 20% sample of national Medicare claims, we performed a retrospective cohort study of fee-for-service beneficiaries undergoing one of 4 major procedures (coronary artery bypass graft, colectomy, major joint replacement, and cystectomy) between 2010 and 2016. We limited our study population for each procedure to patients treated by single-specialty surgical groups to ensure that the advanced practice providers have direct interactions with its surgeons and patients. All outcomes were measured at the practice level for the year before and the year after the addition of the first advanced practice provider. Outcomes included: complications, readmission, mortality, episode payments, length of stay. Models were adjusted for age, race, sex, comorbidity, socioeconomic class and procedure type. Secondary outcome: practice-level office visits by surgical group type. RESULTS: The number of advanced practice providers increased by 13%, from 6713 to 7596 between 2010 and 2016. The largest relative increases occurred in general (46.9%) and urologic (27.6%) surgical practices. The year after an advanced practice provider was added to a surgical practice, the odds of complications were 17% and 16% lower at 30- and 90-days postprocedure, respectively. Additionally, 90-day readmissions were 18% less likely and length of stay was 0.33 days shorter (a 7.1% reduction). Average 30-day and90-day episode spending was $1294.73 and $1427.76 lower, respectively ( P < 0.001). General surgical, orthopedic, and urology practices realized increases of 49.0 (95% CI 13.5-84.5), 112.0 (95% CI 83.0-140.5), and 205.0 (95% CI 117.5-292.0) in-office visits per surgeon, respectively. CONCLUSIONS: The addition of advanced practice providers to single-specialty surgical groups is associated with improvements in surgical outcomes and access. Future work should clarify the mechanisms by which advanced practice providers within surgical practices contribute to health outcomes to identify best practices for deployment.

Predictors of Video versus Audio-Only Telehealth Use among Urological Patients.

Introduction: During the COVID-19 public health emergency, telehealth use grew due to regulatory and reimbursement surrounding the use of video and audio-only visits for the evaluation and management of patients. Methods: We retrospectively reviewed patients seeking outpatient urological care from April 1, 2020 to June 30, 2020 at a urological tertiary care center. Our study was designed to determine the relative effect of demographic, socioeconomic and geographic variables on the likelihood of using video compared to an audio-only telehealth. Results: We identified 4,744 unique patients who had a urological telehealth visit. Demographic factors associated with lower probability of utilizing video telehealth were older age (ages >65 years, average marginal effect [AME] -38.3, 95% CI -40.8, -34.7), Black/African American race and American Indian and Alaska Native race (AME -9.7, 95% CI -10.7, -7.1; AME -17.1, 95% CI -18.8, -13.7, respectively), interpreter use (AME -4.5, 95% CI -5, -3.1), Medicaid insurance (AME -13.3, 95% CI -14.8, -9.8), rural residence and living in area with low broadband Internet access (AME -12.8, 95% CI -14.1, -9.1). Conclusions: Forty-four percent of patients used audio-only visits to connect with their urologists. Age, ethnicity, rurality, type of insurance and broadband access all impacted the type of telehealth used to receive urological care. Without coverage and reimbursement of audio-only visits, video telehealth could exacerbate health disparities in access to urological care.

Interstate Telehealth Use By Medicare Beneficiaries Before And After COVID-19 Licensure Waivers, 2017-20.

During the COVID-19 pandemic, all fifty states and Washington, D.C., passed licensure waivers that allowed patients to participate in telehealth visits with out-of-state clinicians (that is, interstate telehealth). Because many of these temporary flexibilities have expired or are set to expire, we analyzed trends in interstate telehealth use by Medicare beneficiaries during 2017-20, which covers the period both directly before and during the first year of the pandemic. Although the volume of interstate telehealth use increased in 2020, out-of-state telehealth made up a small share of all outpatient visits (0.8 percent) and of all telehealth visits (5 percent) overall. For individual states, out-of-state telehealth made up between 0.2 percent and 9.3 percent of all outpatient visits. We found that most out-of-state telehealth use was for established patient care and that a higher percentage of out-of-state telehealth users lived in rural areas compared with beneficiaries who did not receive care outside of their state (28 percent versus 23 percent). Our collective findings suggest that the elimination of pandemic licensure flexibilities will affect different states to varying degrees and will also affect the delivery of care for both established patients and rural patients.

Factors Associated with Decision Aid Use in Localized Prostate Cancer.

Purpose: Decision aids have been found to improve patients' knowledge of treatments and decrease decisional regrets. Despite these benefits, there is not widespread use of decision aids for newly diagnosed prostate cancer (PCa). This analysis investigates factors that impact men's choice to use a decision aid for newly diagnosed prostate cancer. Materials and Methods: This is a retrospective analysis of a PCa registry from the Michigan Urological Surgery Improvement Collaborative (MUSIC). We included data from men with newly diagnosed, clinically localized PCa seen from 2018-21 at practices offering a PCa decision aid (Personal Patient Profile-Prostate; P3P). The primary outcome was men's registration to use P3P. We fit a multilevel logistic regression model with patient-level factors and included urologist specific random intercepts. We estimated the intra-class correlation (ICC) and predicted the probability of P3P registration among urologists. Results: A total of 2629 men were seen at practices that participated in P3P and 1174 (45%) registered to use P3P. Forty-one percent of the total variance of P3P registration was attributed to clustering of men under a specific urologist's care. In contrast, only 1.5% of the variance of P3P registration was explained by patient factors. Our model did not include data on socioeconomic, literacy or psychosocial factors, which limits the interpretation of the results. Conclusions: These results suggest that urologists' effect far outweighs patient factors in a man's decision to enroll in P3P. Strategies that encourage providers to increase decision aid adoption in their practices are warranted.

The Lack of a Physical Exam During New Patient Telehealth Visits Does Not Impact Plans for Office and Operating Room Procedures.

OBJECTIVE: To understand how the lack of a physical examination during new patient video visits can impact urological surgery planning during the COVID-19 pandemic. METHODS: We retrospectively reviewed 590 consecutive urology patients who underwent new patient video visits from March through May 2020 at a single academic center. Our primary outcome was procedural plan concordance, the proportion of video visit surgical plans that remained the same after the patient was seen in-person, either in clinic or on day of surgery. Median days between video and in-person visits were compared between concordant and discordant cases using the Mann-Whitney U test; P < .05 was significant. RESULTS: Overall, 195 (33%) were evaluated by new patient video visits and had a procedure scheduled, of which, 186 (95%) had concordant plans after in-person evaluation. Further, 99% of plans for in-office procedures and 91% for operating room procedures were unchanged. Four patients (2.1%) had surgical plans altered after changes in clinical course, two (1%) due to additional imaging, and three (1.5%) based on genitourinary examination findings. Days between video visit and in-person evaluation did not differ significantly in concordant cases (median 37.5 [IQR, 16 - 80.5]) as compared to discordant cases (median 58.0 [IQR, 20 - 224]; P = .12). CONCLUSIONS: Most surgical plans developed during new patient video visits remain unchanged after in-person examination. However, changes in clinical course or updated imaging can alter operative plans. Likewise, certain urologic conditions (eg, penile cancer) rely on the genitourinary examination to dictate surgical approach.

Association Between Primary Care Practice Telehealth Use and Acute Care Visits for Ambulatory Care-Sensitive Conditions During COVID-19.

Importance: During the COVID-19 pandemic, many primary care practices adopted telehealth in place of in-person care to preserve access to care for patients with acute and chronic conditions. The extent to which this change was associated with their rates of acute care visits (ie, emergency department visits and hospitalizations) for these conditions is unknown. Objective: To examine whether a primary care practice's level of telehealth use is associated with a change in their rate of acute care visits for ambulatory care-sensitive conditions (ACSC visits). Design, Setting, and Participants: This retrospective cohort analysis used a difference-in-differences study design to analyze insurance claims data from 4038 Michigan primary care practices from January 1, 2019, to September 30, 2020. Exposures: Low, medium, or high tertile of practice-level telehealth use based on the rate of telehealth visits from March 1 to August 31, 2020, compared with prepandemic visit volumes. Main Outcomes and Measures: Risk-adjusted ACSC visit rates before (June to September 2019) and after (June to September 2020) the start of the COVID-19 pandemic, reported as an annualized average marginal effect. The study examined overall, acute, and chronic ACSC visits separately and controlled for practice size, in-person visit volume, zip code-level attributes, and patient characteristics. Results: A total of nearly 1.5 million beneficiaries (53% female; mean [SD] age, 40 [22] years) were attributed to 4038 primary care practices. Compared with 2019 visit volumes, median telehealth use was 0.4% for the low telehealth tertile, 14.7% for the medium telehealth tertile, and 39.0% for the high telehealth tertile. The number of ACSC visits decreased in all tertiles, with adjusted rates changing from 24.3 to 14.9 per 1000 patients per year (low), 23.9 to 15.3 per 1000 patients per year (medium), and 27.5 to 20.2 per 1000 patients per year (high). In difference-in-differences analysis, high telehealth use was associated with a higher ACSC visit rate (2.10 more visits per 1000 patients per year; 95% CI, 0.22-3.97) compared with low telehealth practices; practices in the middle tertile did not differ significantly from the low tertile. No difference was found in ACSC visits across tertiles when acute and chronic ACSC visits were examined separately. Conclusions and Relevance: In this cohort study that used a difference-in-differences analysis, the association between practice-level telehealth use and ACSC visits was mixed. High telehealth use was associated with a slightly higher overall ACSC visit rate than low telehealth practices. The association of telehealth with downstream care use should be closely monitored going forward.

Assessing the Impact of Decision Aid Use on Post Prostatectomy Patient Reported Outcomes.

OBJECTIVE: To evaluate whether completing a decision aid, Personal Patient Profile - Prostate (P3P), prior to prostatectomy, affects self-reported bother from post-prostatectomy urinary incontinence and erectile dysfunction. MATERIALS AND METHODS: This retrospective analysis included data from men with newly diagnosed clinically localized, very low to intermediate risk prostate cancer who elected for prostatectomy within the Michigan Urological Surgery Improvement Collaborative between 2018-2021. Multivariable logistic regression models were used to estimate the association between P3P use and bother from post prostatectomy erectile dysfunction and urinary incontinence as measured by the Expanded Prostate Cancer Index Composite (EPIC-26). RESULTS: Among the 3987 patients included, 7% used P3P (n = 266). Men who used P3P reported significantly less bother from erectile dysfunction at 6 months vs non-users (aOR 0.42 [95% CI 0.27-0.66]). At 12 months, the effect of P3P on bother from erectile dysfunction was not statistically significant (aOR 0.62 [95% CI 0.37-1.03]). Men who used P3P did not have a statistically significant difference in bother from urinary incontinence (3-month: aOR 0.56 [95% CI 0.30-1.06]; 6-month; aOR 0.79 [95% CI 0.31-1.97]). CONCLUSION: Within the stated limitations of this study, we find that use of a decision aid for localized prostate cancer was associated with decreased odds of men being bothered from sexual dysfunction but not urinary incontinence at 6 months post prostatectomy.

Telehealth Use Before and During the COVID-19 Pandemic Among Children with Sickle Cell Anemia.

Introduction: Sickle cell anemia (SCA) is a genetic condition that predominantly affects minority populations in the United States. A lack of access to care is strongly associated with poor outcomes and quality of care among children and adolescents with SCA. The use of telehealth, which has rapidly expanded during the COVID-19 pandemic, has been shown to improve access to care for many conditions. However, the adoption of telehealth among children and adolescents with SCA is unknown. Methods: We identified children 1-17 years old with SCA continuously enrolled in Michigan Medicaid from January 2019 to December 2020. The number of in-person and telehealth outpatient visits (both urgent and routine) were summarized prepandemic (January 2019-February 2020) and during the pandemic (March 2020-December 2020); National Provider Identifier was used to identify provider specialty for telehealth visits. Results: The study population comprised 493 children with SCA with a mean age of 8.7 (±4.9) years at study entry. Prepandemic, there were 4,367 outpatient visits; 4,348 (99.6%) were in-person and 19 (0.4%) were telehealth. During the pandemic, there were 2,307 outpatient visits; 2,059 (89.3%) were in-person and 248 (10.7%) were telehealth. Telehealth visits peaked in April 2020 and declined thereafter. The majority of telehealth visits were to hematology (49%), followed by adult subspecialists (27%) and pediatrics/family medicine (14%). Discussion/Conclusions: While the overall number of outpatient visits declined during the initial months of the pandemic compared with 2019, use of telehealth rapidly increased among children and adolescents with SCA. Additional research is needed to understand patient and provider preferences for telehealth and the roles that federal and state policies can play in facilitating telehealth adoption among children and adolescents with SCA.