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The COVID-19 pandemic placed a spotlight on the potential to dramatically increase the use of telehealth across the cancer care continuum, but whether and how telehealth can be implemented in practice in ways that reduce, rather than exacerbate, inequities are largely unknown. To help fill this critical gap in research and practice, we developed the Framework for Integrating Telehealth Equitably (FITE), a process and evaluation model designed to help guide equitable integration of telehealth into practice. In this manuscript, we present FITE and showcase how investigators across the National Cancer Institute's Telehealth Research Centers of Excellence are applying the framework in different ways to advance digital and health equity. By highlighting multilevel determinants of digital equity that span further than access alone, FITE highlights the complex and differential ways structural determinants restrict or enable digital equity at the individual and community level. As such, achieving digital equity will require strategies designed to not only support individual behavior but also change the broader context to ensure all patients and communities have the choice, opportunity, and resources to use telehealth across the cancer care continuum.
Subject(s)
COVID-19 , Continuity of Patient Care , Neoplasms , Telemedicine , Humans , Neoplasms/therapy , Neoplasms/epidemiology , COVID-19/epidemiology , Continuity of Patient Care/organization & administration , United States , SARS-CoV-2 , Health Equity , Healthcare Disparities , Health Services Accessibility , PandemicsABSTRACT
BACKGROUND: In recent years the US health-care system has witnessed a substantial increase in telehealth use. Telehealth enhances health-care access and quality and may reduce costs. However, there is a concern that the shift from in-person to telehealth care delivery may differentially improve cancer care access and quality in certain clinical settings and for specific patient populations while potentially exacerbating disparities in care for others. Our National Cancer Institute-funded center, called Telehealth Research and Innovation for Veterans with Cancer (THRIVE), is focused on health equity for telehealth-delivered cancer care. We seek to understand how social determinants of telehealth-particularly race and ethnicity, poverty, and rurality-affect the use of telehealth. METHODS: THRIVE draws from the Health Disparities Research Framework and the Consolidated Framework for Implementation Research. THRIVE consists of multiple cores that work synergistically to assess and understand health equity for telehealth-delivered cancer care. These include the Administrative Core, Research and Methods Core, Clinical Practice Network, and Pragmatic Trial. RESULTS: As of October 2023, we identified and trained 5 THRIVE scholars, who are junior faculty beginning a research career. We have reviewed 20 potential pilot studies, funding 6. Additionally, in communication with our funders and advisory boards, we have adjusted our study design and analytic approach, ensuring feasibility while addressing our operational partners' needs. CONCLUSIONS: THRIVE has several key strengths. First, the Veterans Health Administration's health-care system is large and diverse regarding health-care setting type and patient population. Second, we have access to longitudinal data, predating the COVID-19 pandemic, about telehealth use. Finally, equitable access to high-quality care for all veterans is a major tenet of the Veterans Health Administration health-care mission. As a result of these advantages, THRIVE can focus on isolating and evaluating the impact of social determinants of telehealth on equity in cancer care.
Subject(s)
Neoplasms , Telemedicine , Veterans , Humans , Neoplasms/therapy , Neoplasms/epidemiology , United States/epidemiology , Health Services Accessibility , Healthcare Disparities , COVID-19/epidemiology , United States Department of Veterans Affairs , Health EquityABSTRACT
Prostate-specific antigen (PSA)-based prostate cancer screening is a preference-sensitive decision for which experts recommend a shared decision making (SDM) approach. This study aimed to examine PSA screening SDM in primary care. Methods included qualitative analysis of audio-recorded patient-provider interactions supplemented by quantitative description. Participants included 5 clinic providers and 13 patients who were: (1) 40-69 years old, (2) Black, (3) male, and (4) attending clinic for routine primary care. Main measures were SDM element themes and "observing patient involvement in decision making" (OPTION) scoring. Some discussions addressed advantages, disadvantages, and/or scientific uncertainty of screening, however, few patients received all SDM elements. Nearly all providers recommended screening, however, only 3 patients were directly asked about screening preferences. Few patients were asked about prostate cancer knowledge (2), urological symptoms (3), or family history (6). Most providers discussed disadvantages (80%) and advantages (80%) of PSA screening. Average OPTION score was 25/100 (range 0-67) per provider. Our study found limited SDM during PSA screening consultations. The counseling that did take place utilized components of SDM but inconsistently and incompletely. We must improve SDM for PSA screening for diverse patient populations to promote health equity. This study highlights the need to improve SDM for PSA screening.
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PURPOSE: Previous studies document underuse of next-generation sequencing (NGS). We examined the impact to oncology care for veterans of incorporating NGS ordering into the Veterans Affairs (VA) electronic medical record (EMR) at two New York City VA Medical Centers. METHODS: We identified patients with non-small cell lung cancer and prostate cancer with oncology clinic visits and NGS testing indications between January and December 2021. Patients were divided into external ordering (EO) with visits before we implemented an EMR ordering system for NGS in July 2021, and internal ordering (IO) with visits after this date. The primary outcome was proportion of NGS testing performed in EO versus IO groups. Secondary outcomes were time between metastatic disease diagnosis to receipt of test by vendor, time of metastatic diagnosis to result, and proportion of testing by race. RESULTS: A total of 168 patients were identified, 116 EO and 52 IO patients. Between IO and EO periods, testing significantly increased from 52% to 87% (P ≤ .01); it was conducted more quickly, with time from metastatic diagnosis to sample receipt by the NGS vendor improving to median 37 days from 299 days (P = .03); and the time from documented metastatic disease to a test result improved to median 56 days from 309 days (P = .03). The proportion of tissue received by the vendor was not significantly different between the two groups. There were no significant differences in testing according to self-reported race. CONCLUSION: Integration of NGS ordering in the EMR led to increased proportion and speed of testing for a vulnerable patient population served by the country's largest health system.
Subject(s)
Electronic Health Records , High-Throughput Nucleotide Sequencing , United States Department of Veterans Affairs , Humans , Male , United States , Aged , Middle Aged , Female , Lung Neoplasms/genetics , Lung Neoplasms/therapy , Prostatic Neoplasms/genetics , Prostatic Neoplasms/therapy , Prostatic Neoplasms/diagnosis , Carcinoma, Non-Small-Cell Lung/genetics , Carcinoma, Non-Small-Cell Lung/therapyABSTRACT
Background and objective: Incidence rates for prostate cancer (PCa) diagnosis and mortality are higher for Black men. It is unknown whether similar disparities exist in survivorship care. We assessed the delivery and quality of survivorship care for Black men undergoing PCa therapy in terms of the burden of and treatment for urinary adverse events (UAEs) and erectile dysfunction (ED). Methods: We queried Optum Clinformatics data for all patients diagnosed with PCa from January 1, 2002 to December 31, 2017 and identified those who underwent primary PCa treatment. Index cohorts were identified in each year and followed longitudinally until 2017. Data for UAE diagnoses, UAE treatments, and ED treatments were analyzed in index cohorts. Cox proportional-hazards regression models were used to examine associations of race with UAE diagnosis, UAE treatment, and ED treatment. Key findings and limitations: We identified 146, 216 patients with a PCa diagnosis during the study period, of whom 55, 149 underwent primary PCa treatment. In the primary treatment group, 32.7% developed a UAE and 28.2% underwent UAE treatment. The most common UAEs were urinary incontinence (11%), ureteral obstruction/stricture (4.5%), bladder neck contracture (4.5%), and urethral stricture (3.7%). The most common UAE treatments were cystoscopy (13%), suprapubic tube placement (6%), and urethral dilation (5%). Overall, UAE diagnosis rates were higher for Black patients, who had significantly higher risk of urethral obstruction, rectourethral fistula, urinary incontinence, cystitis, urinary obstruction, and ureteral fistula. Overall, UAE treatment rates were lower for Black patients, who had significantly higher risk of fecal diversion and/or rectourethral fistula repair (adjusted hazard ratio [aHR] 1.71, 95% confidence interval [CI] 1.04-2.79). Regarding ED treatments, Black patients had higher risk of penile prosthesis placement (aHR 1.591, 95% CI 1.26-2.00) and intracavernosal injection (aHR 1.215, 95% CI 1.08-1.37). Conclusions and clinical implications: Despite a high UAE burden, treatment rates were low in a cohort with health insurance. Black patients had a higher UAE burden and lower UAE treatment rates. Multilevel interventions are needed to address this stark disparity. ED treatment rates were higher for Black patients. Patient summary: We reviewed data for patients treated for prostate cancer (PCa) and found that 32.7% were diagnosed with a urinary adverse event (UAE) following their PCa treatment. The overall treatment rate for these UAEs was 28.2%. Analysis by race showed that the UAE diagnosis rate was higher for Black patients, who were also more likely to receive treatment for erectile dysfunction.
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BACKGROUND: Many men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse. METHODS: Our survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation-Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer ("yes"/"probably yes," "probably no"/"no"), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses. RESULTS: Our survey was completed by 84 respondents (13% response rate), with 27% indicating "probably no"/"no" to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity-Social, Motivation-Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse. CONCLUSIONS: Our study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03579680.
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The Veterans Health Administration is chartered "to serve as the primary backup for any health care services needed in the event of war or national emergency" according to a 1982 Congressional Act. This mission was invoked during the COVID-19 pandemic to divert clinical and research resources. We used an electronic mixed-methods questionnaire constructed using the Theoretical Domains Framework (TDF) and the Capability, Opportunity, and Motivation (COM-B) model for behavior change to study the effects of the pandemic on VHA researchers. The questionnaire was distributed electronically to 118 cancer researchers participating in national VHA collaborations. The questionnaire received 42 responses (36%). Only 36% did not feel that their research focus changed during the pandemic. Only 26% reported prior experience with infectious disease research, and 74% agreed that they gained new research skills. When asked to describe helpful support structures, 29% mentioned local supervisors, mentors, and research staff, 15% cited larger VHA organizations and 18% mentioned remote work. Lack of timely communication and remote work, particularly for individuals with caregiving responsibilities, were limiting factors. Fewer than half felt professionally rewarded for pursuing research related to COVID. This study demonstrated the tremendous effects of the COVID-19 pandemic on research activities of VHA investigators. We identified perceptions of insufficient recognition and lack of professional advancement related to pandemic-era research, yet most reported gaining new research skills. Individualizing the structure of remote work and ensuring clear and timely team communication represent high yield areas for improvement.
Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Pandemics , Veterans Health , Research Personnel , Medical OncologyABSTRACT
OBJECTIVE: To evaluate the efficacy of a multimodal intervention in reducing CT pulmonary angiography (CTPA) overutilization in the evaluation of suspected pulmonary embolism in the emergency department (ED). METHODS: Previous mixed-methods analysis of barriers to guideline-concordant CTPA ordering results was used to develop a provider-focused behavioral intervention consisting of a clinical decision support tool and an audit and feedback system at a multisite, tertiary academic network. The primary outcome (guideline concordance) and secondary outcomes (yield and CTPA and D-dimer order rates) were compared using a pre- and postintervention design. ED encounters for adult patients from July 5, 2017, to January 3, 2019, were included. Fisher's exact tests and statistical process control charts were used to compare the pre- and postintervention groups for each outcome. RESULTS: Of the 201,912 ED patient visits evaluated, 3,587 included CTPA. Guideline concordance increased significantly after the intervention, from 66.9% to 77.5% (P < .001). CTPA order rate and D-dimer order rate also increased significantly, from 17.1 to 18.4 per 1,000 patients (P = .035) and 30.6 to 37.3 per 1,000 patients (P < .001), respectively. Percent yield showed no significant change (12.3% pre- versus 10.8% postintervention; P = .173). Statistical process control analysis showed sustained special-cause variation in the postintervention period for guideline concordance and D-dimer order rates, temporary special-cause variation for CTPA order rates, and no special-cause variation for percent yield. CONCLUSION: Our success in increasing guideline concordance demonstrates the efficacy of a mixed-methods, human-centered approach to behavior change. Given that neither of the secondary outcomes improved, our results may demonstrate potential limitations to the guidelines directing the ordering of CTPA studies and D-dimer ordering.
Subject(s)
Pulmonary Embolism , Adult , Humans , Pulmonary Embolism/diagnostic imaging , Emergency Service, Hospital , Fibrin Fibrinogen Degradation Products , Research Design , Angiography , Tomography, X-Ray Computed , Computed Tomography Angiography , Retrospective StudiesABSTRACT
OBJECTIVE: To assess urologists' perceptions and practices related to smoking and smoking cessation. MATERIALS AND METHODS: Six survey questions were designed to assess beliefs, practices, and determinants related to tobacco use assessment and treatment (TUAT) in outpatient urology clinics. These questions were included in an annual census survey (2021) offered to all practicing urologists. Responses were weighted to represent the practicing US population of nonpediatric urologists (N = 12,852). The primary outcome was affirmative responses to the question, "Do you agree it is important for urologists to screen for and provide smoking cessation treatment to patients in the outpatient clinic?" Practice patterns, perceptions, and opinions of optimal care delivery were assessed. RESULTS: In total, 98% of urologists agreed (27%) or strongly agreed (71%) that cigarette smoking is a significant contributor to urologic disease. However, only 58% agreed that TUAT is important in urology clinics. Most urologists (61%) advise patients who smoke to quit but do not provide additional cessation counseling or medications or arrange follow-up. The most frequently identified barriers to TUAT were lack of time (70%), perceptions that patients are unwilling to quit (44%), and lack of comfort prescribing cessation medications (42%). Additionally, 72% of respondents stated that urologists should provide a recommendation to quit and refer patients for cessation support. CONCLUSION: TUAT does not routinely occur in an evidence-based fashion in outpatient urology clinics. Addressing established barriers and facilitating these practices with multilevel implementation strategies can promote tobacco treatment and improve outcomes for patients with urologic disease.
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Importance: Active surveillance (AS) is endorsed by clinical guidelines as the preferred management strategy for low-risk prostate cancer, but its use in contemporary clinical practice remains incompletely defined. Objective: To characterize trends over time and practice- and practitioner-level variation in the use of AS in a large, national disease registry. Design, Setting, and Participants: This retrospective analysis of a prospective cohort study included men with low-risk prostate cancer, defined as prostate-specific antigen (PSA) less than 10 ng/mL, Gleason grade group 1, and clinical stage T1c or T2a, newly diagnosed between January 1, 2014, and June 1, 2021. Patients were identified in the American Urological Association (AUA) Quality (AQUA) Registry, a large quality reporting registry including data from 1945 urology practitioners at 349 practices across 48 US states and territories, comprising more than 8.5 million unique patients. Data are collected automatically from electronic health record systems at participating practices. Exposures: Exposures of interest included patient age, race, and PSA level, as well as urology practice and individual urology practitioners. Main Outcomes and Measures: The outcome of interest was the use of AS as primary treatment. Treatment was determined through analysis of electronic health record structured and unstructured clinical data and determination of surveillance based on follow-up testing with at least 1 PSA level remaining greater than 1.0 ng/mL. Results: A total of 20â¯809 patients in AQUA were diagnosed with low-risk prostate cancer and had known primary treatment. The median age was 65 (IQR, 59-70) years; 31 (0.1%) were American Indian or Alaska Native; 148 (0.7%) were Asian or Pacific Islander; 1855 (8.9%) were Black; 8351 (40.1%) were White; 169 (0.8%) were of other race or ethnicity; and 10â¯255 (49.3%) were missing information on race or ethnicity. Rates of AS increased sharply and consistently from 26.5% in 2014 to 59.6% in 2021. However, use of AS varied from 4.0% to 78.0% at the urology practice level and from 0% to 100% at the practitioner level. On multivariable analysis, year of diagnosis was the variable most strongly associated with AS; age, race, and PSA value at diagnosis were all also associated with odds of surveillance. Conclusions and Relevance: This cohort study of AS rates in the AQUA Registry found that national, community-based rates of AS have increased but remain suboptimal, and wide variation persists across practices and practitioners. Continued progress on this critical quality indicator is essential to minimize overtreatment of low-risk prostate cancer and by extension to improve the benefit-to-harm ratio of national prostate cancer early detection efforts.
Subject(s)
Prostate-Specific Antigen , Prostatic Neoplasms , Aged , Humans , Male , Cohort Studies , Prospective Studies , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/epidemiology , Prostatic Neoplasms/therapy , Retrospective Studies , Watchful Waiting , United StatesABSTRACT
BACKGROUND: Evading immune surveillance is a hallmark for the development of multiple cancer types. Whether immune evasion contributes to the pathogenesis of high-grade prostate cancer (HGPCa) remains an area of active inquiry. METHODS: Through single-cell RNA sequencing and multicolor flow cytometry of freshly isolated prostatectomy specimens and matched peripheral blood, we aimed to characterize the tumor immune microenvironment (TME) of localized prostate cancer (PCa), including HGPCa and low-grade prostate cancer (LGPCa). RESULTS: HGPCa are highly infiltrated by exhausted CD8+ T cells, myeloid cells, and regulatory T cells (TRegs). These HGPCa-infiltrating CD8+ T cells expressed high levels of exhaustion markers including TIM3, TOX, TCF7, PD-1, CTLA4, TIGIT, and CXCL13. By contrast, a high ratio of activated CD8+ effector T cells relative to TRegs and myeloid cells infiltrate the TME of LGPCa. HGPCa CD8+ tumor-infiltrating lymphocytes (TILs) expressed more androgen receptor and prostate-specific membran antigen yet less prostate-specific antigen than the LGPCa CD8+ TILs. The PCa TME was infiltrated by macrophages but these did not clearly cluster by M1 and M2 markers. CONCLUSIONS: Our study reveals a suppressive TME with high levels of CD8+ T cell exhaustion in localized PCa, a finding enriched in HGPCa relative to LGPCa. These studies suggest a possible link between the clinical-pathologic risk of PCa and the associated TME. Our results have implications for our understanding of the immunologic mechanisms of PCa pathogenesis and the implementation of immunotherapy for localized PCa.
Subject(s)
CD8-Positive T-Lymphocytes , Prostatic Neoplasms , Male , Humans , Neoplasm Grading , CD8-Positive T-Lymphocytes/pathology , Prostatic Neoplasms/pathology , Prostate/pathology , Prostate-Specific Antigen , Lymphocytes, Tumor-Infiltrating , Immunosuppressive Agents , Single-Cell Analysis , Tumor MicroenvironmentABSTRACT
PURPOSE: As the largest integrated health care system in the United States, the Veterans Health Administration (VA) is a leader in telehealth-delivered care. All 10 million Veterans cared for within the VA are eligible for telehealth. The VA cares for approximately 46,000 Veteran patients with newly diagnosed cancer and an estimated 400,000 prevalent cases annually. With nearly 38% of VA health care system users residing in rural areas and only 44% of rural counties having an oncologist, many Veterans lack local access to specialized cancer services. METHODS: We describe the VA's National TeleOncology (NTO) Service. NTO was established to provide Veterans with the opportunity for specialized treatment regardless of geographical location. Designed as a hub-and-spoke model, VA oncologists from across the country can provide care to patients at spoke sites. Spoke sites are smaller and rural VA medical centers that are less able to independently provide the full range of services available at larger facilities. In addition to smaller rural spoke sites, NTO also provides subspecialized oncology care to Veterans located in larger VA medical facilities that do not have subspecialties available or that have limited capacity. RESULTS: As of fiscal year 2021, 23 clinics are served by or engaged in planning for delivery of NTO and there are 24 physicians providing care through the NTO virtual hub. Most NTO physicians continue to provide patient care in separate traditional in-person clinics. Approximately 4,300 unique Veterans have used NTO services. Approximately half (52%) of Veterans using NTO lived in rural areas. Most of these Veterans had more than one remote visit through NTO. CONCLUSION: NTO is a state-of-the-art model that has the potential to revolutionize the way cancer care is delivered, which should improve the experience of Veterans receiving cancer care.
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Telemedicine , Veterans , Humans , United States , Veterans Health , Delivery of Health Care , Patient CareABSTRACT
PURPOSE: Black men have a higher risk of prostate cancer diagnosis and mortality but are less likely to receive definitive treatment. The impact of structural aspects on treatment is unknown but may lead to actionable insights to mitigate disparities. We sought to examine the associations between urology practice organization and racial composition and treatment patterns for Medicare beneficiaries with incident prostate cancer. METHODS: Using a 20% sample of national Medicare data, we identified beneficiaries diagnosed with prostate cancer between January 2010 and December 2015 and followed them through 2016. We linked urologists to their practices with tax identification numbers. We then linked patients to practices on the basis of their primary urologist. We grouped practices into quartiles on the basis of their proportion of Black patients. We used multilevel mixed-effects models to identify treatment associations. RESULTS: We identified 54,443 patients with incident prostate cancer associated with 4,194 practices. Most patients were White (87%), and 9% were Black. We found wide variation in racial practice composition and practice segregation. Patients in practices with the highest proportion of Black patients had the lowest socioeconomic status (43.1%), highest comorbidity (9.9% with comorbidity score ≥ 3), and earlier age at prostate cancer diagnosis (33.5% age 66-69 years; P < .01). Black patients had lower odds of definitive therapy (adjusted odds ratio, 0.87; 95% CI, 0.81 to 0.93) and underwent less treatment than White patients in every practice context. Black patients in practices with higher proportions of Black patients had higher treatment rates than Black patients in practices with lower proportions. Black patients had lower predicted probability of treatment (66%) than White patients (69%; P < .05). CONCLUSION: Despite Medicare coverage, we found less definitive treatment among Black beneficiaries consistent with ongoing prostate cancer treatment disparities. Our findings are reflective of the adverse effects of practice segregation and structural racism, highlighting the need for multilevel interventions.
Subject(s)
Prostatic Neoplasms , Urology , Male , Humans , Aged , United States/epidemiology , Medicare , Prostatic Neoplasms/epidemiology , Prostatic Neoplasms/therapy , Prostatic Neoplasms/diagnosis , WhiteABSTRACT
Introduction: Prostate cancer is the second leading cause of cancer deaths among men in the United States and harms Black men disproportionately. Most US men are uninformed about many key facts important to make an informed decision about prostate cancer. Most experts agree that it is important for men to learn about these problems as early as possible in their lifetime. Objectives: To compare the effect of a community health worker (CHW)-led educational session with a physician-led educational session that counsels Black men about the risks and benefits of prostate-specific antigen (PSA) screening. Methods: One hundred eighteen Black men recruited in 8 community-based settings attended a prostate cancer screening education session led by either a CHW or a physician. Participants completed surveys before and after the session to assess knowledge, decisional conflict, and perceptions about the intervention. Both arms used a decision aid that explains the benefits, risks, and controversies of PSA screening and decision coaching. Results: There was no significant difference in decisional conflict change by group: 24.31 physician led versus 30.64 CHW led (P=.31). The CHW-led group showed significantly greater improvement on knowledge after intervention, change (SD): 2.6 (2.81) versus 5.1 (3.19), P<.001). However, those in the physician-led group were more likely to agree that the speaker knew a lot about PSA testing (P<.001) and were more likely to trust the speaker (P<.001). Conclusions: CHW-led interventions can effectively assist Black men with complex health decision-making in community-based settings. This approach may improve prostate cancer knowledge and equally minimize decisional conflict compared with a physician-led intervention.
Subject(s)
Black or African American , Decision Making , Early Detection of Cancer , Prostate-Specific Antigen , Prostatic Neoplasms , Humans , Male , Prostatic Neoplasms/diagnosis , Middle Aged , Aged , Prostate-Specific Antigen/blood , Community Health Workers , Physicians/psychology , Health Knowledge, Attitudes, Practice , United StatesABSTRACT
BACKGROUND: Surgery is the most common treatment for localized small kidney masses (SKMs) up to 4 cm, despite a lack of evidence for improved overall survival. Nonsurgical management options are gaining recognition, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the trade-offs of treatment options and overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences. OBJECTIVE: This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM; that is, selection of surgical versus nonsurgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the trade-offs associated with surgical versus nonsurgical interventions. METHODS: Three phases comprise the construction and evaluation of a new web-based DA on SKM treatment. In phase 1, this DA was developed in print format through a multidisciplinary design committee incorporating patient focus groups. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics at a large academic medical center. The web-based DA applies risk communication and information about diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Questionnaires and treatment decision data will be gathered before and after viewing the educational material. RESULTS: This phase will consist of a pilot RCT from August 2022 to January 2023 to establish feasibility and preliminarily evaluate decision outcomes. Previous study phases from 2018 to 2020 supported the feasibility of providing the printed DA in urology clinics before clinical consultation and demonstrated increased patient knowledge about the diagnosis and treatment options and greater likelihood of favoring nonsurgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022. CONCLUSIONS: A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for comorbidities and treatment-related benefits and risks. Outcomes from the pilot trial will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical versus nonsurgical treatment options for their SKMs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05387863; https://clinicaltrials.gov/ct2/show/NCT05387863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/41451.
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OBJECTIVE: To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS: An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision-making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS: Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P < .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, P = .02). Decision satisfaction measures were similar in both arms. DISCUSSION: Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.
Subject(s)
Decision Support Techniques , Patient Participation , Decision Making , Humans , Kidney , Pilot Projects , Surveys and QuestionnairesABSTRACT
Background: The incidence and severity of coronavirus disease 19 (COVID-19) is substantially higher in men. Sex hormones may be a potential mechanism for differences in COVID-19 outcome in men and women. We hypothesized that men treated with androgen deprivation therapy (ADT) have lower incidence and severity of COVID-19. Methods: We conducted an observational study of male Veterans treated in the Veterans Health Administration from February 15th to July 15th, 2020. We developed a propensity score model to predict the likelihood to undergo Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. We performed multivariable logistic regression modeling adjusted with inverse probability weighting to examine the relationship between ADT and COVID-19 incidence. We conducted logistic regression analysis among COVID-19 patients to test the association between ADT and COVID-19 severity. Results: We identified a large cohort of 246,087 VA male patients who had been tested for SARS-CoV-2, of whom 3,057 men were exposed to ADT, and 36,096 men with cancer without ADT. Of these, 295 ADT patients and 2,427 cancer patients not on ADT had severe COVID-19 illness. In the primary, propensity-weighted comparison of ADT patients to cancer patients not on ADT, ADT was associated with decreased likelihood of testing positive for SARS-CoV-2 (adjusted OR, 0.88 [95% CI, 0.81-0.95]; p = 0.001). Furthermore, ADT was associated with fewer severe COVID-19 outcomes (OR 0.72 [95% CI 0.53-0.96]; p = 0.03). Conclusion: ADT is associated with reduced incidence and severity of COVID-19 amongst male Veterans. Testosterone and androgen receptor signaling may confer increased risk for SARS-CoV-2 infection and contribute to severe COVID-19 pathophysiology in men.
ABSTRACT
Importance: SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. Objective: To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. Design, Setting, and Participants: The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021. Interventions: Patients stratified by age, history of hypertension, and disease severity were centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo. Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone. Main Outcomes and Measures: The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. Secondary end points were time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference range, maximum severity of COVID-19, and the composite end point at 30 days. Results: The trial was stopped for futility after the planned interim analysis, at which time there were 96 evaluable patients, including 62 patients randomized to the degarelix group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%]; P = .67). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns. Conclusions and Relevance: In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. Trial Registration: ClinicalTrials.gov Identifier: NCT04397718.
Subject(s)
COVID-19 Drug Treatment , COVID-19 , Hypertension , Aged , Aged, 80 and over , Androgens , COVID-19/therapy , Hospitalization , Humans , Immunization, Passive , Male , Oxygen , SARS-CoV-2 , Treatment Outcome , United States , COVID-19 SerotherapyABSTRACT
Transgender and non-binary (TGNB) individuals often experience gender dysphoria. TGNB individuals with gender dysphoria may undergo genital gender-affirming surgery including vaginoplasty, phalloplasty, or metoidioplasty so that their genitourinary anatomy is congruent with their experienced gender. Given decreasing social stigma and increasing coverage from private and public payers, there has been a rapid increase in genital gender-affirming surgery in the past few years. As the incidence of genital gender-affirming surgery increases, a concurrent increase in the development and utilization of patient reported outcome measurement tools is critical. To date, there is no systematic way to assess and measure patients' perspectives on their surgeries nor is there a validated measure to capture patient reported outcomes for TGNB individuals undergoing genital gender-affirming surgery. Without a systematic way to assess and measure patients' perspectives on their care, there may be fragmentation of care. This fragmentation may result in challenges to ensure patients' goals are at the forefront of shared- decision making. As we aim to increase access to surgical care for TGNB individuals, it is important to ensure this care is patient-centered and high-quality. The development of patient-reported outcomes for patients undergoing genital gender-affirming surgery is the first step in ensuring high quality patient-centered care. Herein, we discuss the critical need for development of validated patient reported outcome measures for transgender and non-binary patients undergoing genital reconstruction. We also propose a model of patient-engaged patient reported outcome measure development.