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Aim: To independently confirm that the 40-gene expression profile (40-GEP) test can identify patients with high-risk cutaneous squamous cell carcinoma who are more or less likely to benefit from adjuvant radiation therapy (ART).Materials & methods: Primary cutaneous squamous cell carcinoma tumors from two academic centers received retrospective 40-GEP testing and were analyzed for 5-year metastasis-free survival and projected time to event.Results: Random sampling of matched patient pairs (n = 52 ART-treated; 371 no ART) showed a median 50% decrease in 5-year progression rate for ART-treated patients (vs no ART) with 40-GEP Class 2B. Class 2A was associated with a modest ART benefit, but not Class 1.Conclusion: The 40-GEP identified patients most likely to benefit from ART (Class 2B) and those that can consider deferring treatment (Class 1).
Independent validation study: 40-GEP identifies patients with cutaneous squamous cell carcinoma who would be most likely to benefit from adjuvant radiation therapy.
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ABSTRACT: Comparing studies of molecular ancillary diagnostic tests for difficult-to-diagnose cutaneous melanocytic neoplasms presents a methodological challenge, given the disparate ways accuracy metrics are calculated. A recent report by Boothby-Shoemaker et al investigating the real-world accuracy of the 23-gene expression profile (23-GEP) test highlights this methodological difficulty, reporting lower accuracy than previously observed. However, their calculation method-with indeterminate test results defined as either false positive or false negative-was different than those used in previous studies. We corrected for these differences and recalculated their reported accuracy metrics in the same manner as the previous studies to enable appropriate comparison with previously published reports. This corrected analysis showed a sensitivity of 92.1% (95% confidence interval [CI], 82.1%-100%) and specificity of 94.4% (91.6%-96.9%). We then compared these results directly to previous studies with >25 benign and >25 malignant cases with outcomes and/or concordant histopathological diagnosis by ≥3 dermatopathologists. All studies assessed had enrollment imbalances of benign versus malignant patients (0.8-7.0 ratio), so balanced cohorts were resampled according to the lowest common denominator to calculate point estimates and CIs for accuracy metrics. Overall, we found no statistically significant differences in the ranges of 23-GEP sensitivity, 90.4%-96.3% (95% CI, 80.8%-100%), specificity, 87.3%-96.2% (78.2%-100%), positive predictive value, 88.5%-96.1% (81.5%-100%), or negative predictive value, 91.1%-96.3% (83.6%-100%) between previous studies and the cohort from Boothby-Shoemaker et al with this unified methodological approach. Rigorous standardization of calculation methods is necessary when the goal is direct cross-study comparability.
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Introduction: Language that assumes gender and sex are binary and aligned is pervasive in medicine and is often used when teaching on physiology and pathology. Information presented through this lens oversimplifies disease mechanisms and poorly addresses the health of gender and sexually diverse (GSD) individuals. We developed a training session to help faculty reference gender and sex in a manner that would be accurate and inclusive of GSD health. Methods: The 1-hour session for undergraduate and graduate medical educators highlighted cisgender and binary biases in medical teachings and introduced a getting-to-the-root mindset that prioritized teaching the processes underlying differences in disease profiles among gender and sex subpopulations. The training consisted of 30 minutes of didactic teaching and 20 minutes of small-group discussion. Medical education faculty attended and self-reported knowledge and awareness before and after the training. Results were compared using paired t tests. Expenses included fees for consultation and catering. Results: Forty faculty participated (pretraining survey n = 36, posttraining survey n = 21). After the training, there was a significant increase in self-reported awareness of the difference between gender and sex (p = .002), perceived relevance of gender to teachings (p = .04), and readiness to discuss physiological drivers of sex-linked disease (p = .005). Discussion: Participants reported increased understanding and consideration of gender and sex in medical education; feedback emphasized a desire for continued guidance. This easily adaptable session can provide an introduction to a series of medical teachings on gender and sex.
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Docentes Médicos , Humanos , Encuestas y Cuestionarios , Masculino , Femenino , Educación Médica/métodos , Identidad de Género , Adulto , Minorías Sexuales y de GéneroRESUMEN
PURPOSE: Adjuvant radiation therapy (ART) for cutaneous squamous cell carcinoma is recommended based on a number of wide-ranging clinicopathologic features, which encompass a broad array of patients. The 40-gene expression profile (GEP) test classifies cutaneous squamous cell carcinoma tumors into low (class 1), higher (class 2A), or highest (class 2B) risk of nodal and/or distant metastasis. This study's hypotheses are as follows: (1) local recurrence is associated with metastatic disease progression and (2) 40-GEP, by identifying high risk for metastasis, could predict a metastasis-specific benefit from ART. METHODS AND MATERIALS: Samples were obtained from 920 patients (ART-untreated: 496 class 1, 335 class 2A, and 33 class 2B; ART-treated: 11 class 1, 35 class 2A, and 10 class 2B) who were matched on clinical risk factors and stratified by ART status to create 49 matched patient strata. To control for the variety of characteristics and treatment selection bias, randomly sampled pairs of matched ART and non-ART patients comprising 10,000 resampled cohorts were each analyzed for 5-year metastasis-free survival and predicted time to metastatic event. RESULTS: Of 96 patients experiencing local recurrence, 56.3% experienced metastasis; of those experiencing both, 88.9% experienced local recurrence before (75.9%) or concurrently (13.0%) with metastasis. After matching for clinicopathologic risk, median 5-year disease progression rates for resampled cohorts demonstrated approximately 50% improvement for class 2B ART-treated compared with ART-untreated cohorts. ART-treated class 2B cohorts had a 5-fold delay in predicted time to metastatic event and deceleration of disease progression compared with ART-untreated cohorts (Kolmogorov-Smirnov test, P < .01); this was not observed for patients with class 1 or 2A cSCC (P > .05 for each). No risk factor or staging system combined with ART status identified groups that would benefit from ART as well as 40-GEP. CONCLUSIONS: Forty-GEP identifies patients at the highest risk of nodal/distant metastasis who may derive the greatest benefit from ART, as well as patients who may have clinical indications for ART but are at low risk of metastasis. Compared with current guidelines, 40-GEP could provide greater specificity concerning the benefit of ART in individual patients.
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PURPOSE: To characterize current lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI +) health-related undergraduate medical education (UME) curricular content and associated changes since a 2011 study and to determine the frequency and extent of institutional instruction in 17 LGBTQI + health-related topics, strategies for increasing LGBTQI + health-related content, and faculty development opportunities. METHOD: Deans of medical education (or equivalent) at 214 allopathic or osteopathic medical schools in Canada and the United States were invited to complete a 36-question, Web-based questionnaire between June 2021 and September 2022. The main outcome measured was reported hours of LGBTQI + health-related curricular content. RESULTS: Of 214 schools, 100 (46.7%) responded, of which 85 (85.0%) fully completed the questionnaire. Compared to 5 median hours dedicated to LGBTQI + health-related in a 2011 study, the 2022 median reported time was 11 h (interquartile range [IQR], 6-16 h, p < 0.0001). Two UME institutions (2.4%; 95% CI, 0.0%-5.8%) reported 0 h during the pre-clerkship phase; 21 institutions (24.7%; CI, 15.5%-33.9%) reported 0 h during the clerkship phase; and 1 institution (1.2%; CI, 0%-3.5%) reported 0 h across the curriculum. Median US allopathic clerkship hours were significantly different from US osteopathic clerkship hours (4 h [IQR, 1-6 h] versus 0 h [IQR, 0-0 h]; p = 0.01). Suggested strategies to increase content included more curricular material focusing on LGBTQI + health and health disparities at 55 schools (64.7%; CI, 54.6%-74.9%), more faculty willing and able to teach LGBTQI + -related content at 49 schools (57.7%; CI, 47.1%-68.2%), and more evidence-based research on LGBTQI + health and health disparities at 24 schools (28.2%; CI, 18.7%-37.8%). CONCLUSION: Compared to a 2011 study, the median reported time dedicated to LGBTQI + health-related topics in 2022 increased across US and Canadian UME institutions, but the breadth, efficacy, or quality of instruction continued to vary substantially. Despite the increased hours, this still falls short of the number of hours based on recommended LGBTQI + health competencies from the Association of American Medical Colleges. While most deans of medical education reported their institutions' coverage of LGBTQI + health as 'fair,' 'good,' or 'very good,' there continues to be a call from UME leadership to increase curricular content. This requires dedicated training for faculty and students.
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Curriculum , Educación de Pregrado en Medicina , Minorías Sexuales y de Género , Humanos , Canadá , Estados Unidos , Educación de Pregrado en Medicina/normas , Encuestas y Cuestionarios , Masculino , FemeninoRESUMEN
Aim: Cutaneous melanocytic neoplasms with diagnostic and/or clinical ambiguity pose patient management challenges. Methods: Six randomized case scenarios with diagnostic/clinical uncertainty were described with/without a benign or malignant diagnostic gene expression profile (GEP) result. Results: Clinical impact was assessed by reporting the mean increase/decrease of management changes normalized to baseline (n = 32 dermatologists). Benign GEP results prompted clinicians to decrease surgical margins (84.2%). Malignant GEP results escalated surgical excision recommendations (100%). A majority (72.2%) reduced and nearly all (98.9%) increased follow-up frequency for benign or malignant GEP results, respectively. There was an overall increase in management plan confidence with GEP results. Conclusion: Diagnostic GEP tests help guide clinical decision-making in a variety of diagnostically ambiguous or clinicopathologically discordant scenarios.
Dermatologists' use of diagnostic gene expression profiles for personalized patient care. When your doctor takes a piece of a mole, that mole is looked at under the microscope by a pathologist. The pathologist is responsible for figuring out if the mole is dangerous or not. Dangerous moles are removed with surgery to make sure all the dangerous tissue is gone. Moles without a health threat are left alone. Sometimes figuring out how dangerous a mole is is difficult. The pathologist may not provide the doctor with enough information for them to know how to treat your mole. There is a test that can provide information on whether your mole is unsafe. This test is called diagnostic gene expression profiling or GEP. In this study, GEP is used to help doctors figure out how to treat a mole and how often the patient should be seen in the office for skin checks. With GEP, important changes in patient treatment were identified. These include the need for an additional surgery, how much healthy tissue should be removed during surgery and how often the patient should be seen in the office. For suspicious moles where the pathology report is unclear, GEP can provide information that leads to more appropriate and personalized patient care.
Ancillary diagnostic gene expression profile testing for ambiguous cutaneous melanocytic lesions helps optimize dermatologist recommendations for excision margin and follow-up.
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Background: Empirical decisions to select therapies for psoriasis (PSO) and atopic dermatitis (AD) can lead to delays in disease control and increased health care costs. However, routine molecular testing for AD and PSO are lacking. Objective: To examine (1) how clinicians choose systemic therapies for patients with PSO and AD without molecular testing and (2) to determine how often the current approach leads to patients switching medications. Methods: A 20-question survey designed to assess clinician strategies for systemic treatment of AD and PSO was made available to attendees of a national dermatology conference in 2022. Results: Clinicians participating in the survey (265/414, 64% response rate) ranked "reported efficacy" as the most important factor governing treatment choice (P < .001). However, 62% (165/265) of clinicians estimated that 2 or more systemic medications were typically required to achieve efficacy. Over 90% (239/265) of respondents would or would likely find a molecular test to guide therapeutic selection useful. Limitations: To facilitate ease of recall, questions focused on systemic therapies as a whole and not individual therapies. Conclusion: Clinicians want a molecular test to help determine the most efficacious drug for individual patients.
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INTRODUCTION: The validated 40-gene expression profile (40-GEP) test independently stratifies risk of regional or distant metastasis for cutaneous squamous cell carcinoma (cSCC) tumors with high-risk clinicopathologic features. This study evaluated the stratification of risk by the 40-GEP test in a large cohort of tumors with one or more high-risk factors and in clinically relevant subgroups, including tumors within National Comprehensive Cancer Network (NCCN) high- and very-high-risk groups, lower-stage BWH T1 and T2a tumors, and patients > 65 years old. METHODS: This multicenter (n = 58) performance study of the 40-GEP included 897 patients. Kaplan-Meier analyses were performed to assess risk stratification profiles for 40-GEP Class 1 (low), Class 2A (higher) and Class 2B (highest) risk groups, while nested Cox regression models were used to compare risk prediction of clinicopathologic risk classification systems versus risk classification systems in combination with 40-GEP. RESULTS: Patients classified as 40-GEP Class 1, Class 2A, or Class 2B had significantly different metastatic risk profiles (p < 0.0001). Integrating 40-GEP results into models with individual clinicopathologic risk factors or risk classification systems (Brigham and Women's Hospital, American Joint Committee on Cancer Staging Manual, 8th Edition) and NCCN demonstrated significant improvement in accuracy for prediction of metastatic events (ANOVA for model deviance, p < 0.0001 for all models). CONCLUSION: The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions.
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BACKGROUND: Patients with stage I cutaneous melanoma (CM) are considered at low risk for metastasis or melanoma specific death; however, because the majority of patients are diagnosed with stage I disease, they represent the largest number of melanoma deaths annually. The 31-gene expression profile (31-GEP) test has been prospectively validated to provide prognostic information independent of staging, classifying patients as low (Class 1A), intermediate (Class 1B/2A), or high (Class 2B) risk of poor outcomes. METHODS: Patients enrolled in previous studies of the 31-GEP were combined and evaluated for recurrence-free (RFS) and melanoma-specific survival (MSS) (n = 1261, "combined"). A second large, unselected real-world cohort (n = 5651) comprising clinically tested patients diagnosed 2013-2018 who were linked to outcomes data from the NCI Surveillance, Epidemiology, and End Results (SEER) Program registries was evaluated for MSS. RESULTS: Combined cohort Class 1A patients had significantly higher RFS than Class 1B/2A or Class 2B patients (97.3%, 88.6%, 77.3%, p < 0.001)-better risk stratification than AJCC8 stage IA (97.5%) versus IB (89.3%). The SEER cohort showed better MSS stratification by the 31-GEP (Class 1A = 98.0%, Class 1B/2A = 97.5%, Class 2B = 92.3%; p < 0.001) than by AJCC8 staging (stage IA = 97.6%, stage IB = 97.9%; p < 0.001). CONCLUSIONS: The 31-GEP test significantly improved patient risk stratification, independent of AJCC8 staging in patients with stage I CM. The 31-GEP provided greater separation between high- (Class 2B) and low-risk (Class 1A) groups than seen between AJCC stage IA and IB. These data support integrating the 31-GEP into clinical decision making for more risk-aligned management plans.
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OBJECTIVES: To explore how primary care providers report discussing substance use with transgender and gender diverse (TGD) adult patients within the context of discussing gender-affirming interventions. METHODS: Between March and April 2022, in-depth, semi-structured qualitative interviews were conducted with 15 primary care providers who care for TGD patients in the Northeastern US. Thematic analysis was used to analyze interview data and identify themes. RESULTS: Two primary themes emerged among providers: 1) placing a focus on harm reduction, emphasizing reducing negative consequences of substance use, and 2) using access to gender-affirming interventions as an incentive for patients to change their substance use patterns. CONCLUSIONS: Focusing on harm reduction can emphasize reducing potential adverse outcomes while working with TGD patients towards their gender-affirmation goals. Future research should explore varying approaches to how substance use is discussed with TGD patients, as well as the interpretation of gender-affirming clinical guidelines. PRACTICE IMPLICATIONS: Findings from this study indicate a need for enhancing provider knowledge around the appropriate application of gender-affirming care guidelines. Investing in training efforts to improve gender-affirming care is critical for encouraging approaches that prioritize harm reduction and do not unnecessarily prevent access to gender-affirming interventions.
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Trastornos Relacionados con Sustancias , Personas Transgénero , Adulto , Humanos , Atención de Afirmación de Género , Reducción del Daño , Trastornos Relacionados con Sustancias/terapia , Atención Primaria de Salud , Identidad de GéneroRESUMEN
BACKGROUND: Sexual and gender minority (SGM) persons experience stark health disparities. Efforts to mitigate disparities through medical education have met some success. However, evaluations have largely focused on subjective perspectives rather than objective measures. This study aimed to quantify Boston University School of Medicine's sexual and gender minority (SGM) education through surveys of course directors (CDs) and medical students regarding where SGM topics were taught in the preclerkship medical curriculum. Responses were compared to identify concordance between faculty intention and student perceptions regarding SGM education. METHODS: A cross-sectional survey was distributed to preclerkship CDs and current medical students in Spring 2019 and 2021, respectively, regarding where in the mandatory preclerkship curriculum CDs deliberately taught and where first- and second-year students recalled having learned 10 SGM topic domains. RESULTS: 64.3% of CDs (n = 18), 47.0% of the first-year class (n = 71), and 67.3% of the second-year class (n = 101) responded to the surveys. Results indicate that, as anticipated, deliberate SGM teaching correlates with greater student recall as students recalled topics that were reported by CDs as intentionally taught at a significantly higher rate compared to those not intentionally taught (32.0% vs. 15.3%; p < 0.01). Students most commonly recalled learning SGM-related language and terminology, which is likely partly but not entirely attributed to curricular modifications and faculty development made between distribution of the faculty and student surveys, indicating the importance of all faculty being trained in appropriate SGM terminology and concepts. Discordance between faculty intention and student recall of when topics were taught reveals opportunities to enhance the intentionality and impact of SGM teaching. CONCLUSIONS: Students perceive and recall SGM content that is not listed as learning objectives, and all faculty who utilize this material in their teachings should receive foundational training and be thoughtful about how information is framed. Faculty who intentionally teach SGM topics should be explicit and direct about the conclusions they intend students to draw from their curricular content.
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Minorías Sexuales y de Género , Estudiantes de Medicina , Humanos , Estudios Transversales , Curriculum , Docentes MédicosRESUMEN
BACKGROUND & AIMS: Low-grade dysplasia (LGD) is associated with an increased risk of progression in Barrett's esophagus (BE); however, the diagnosis of LGD is limited by substantial interobserver variability. Multiple studies have shown that an objective tissue systems pathology test (TissueCypher Barrett's Esophagus Test, TSP-9), can effectively predict neoplastic progression in patients with BE. This study aimed to compare the risk stratification performance of the TSP-9 test vs benchmarks of generalist and expert pathology. METHODS: A blinded cohort study was conducted in the screening cohort of a randomized controlled trial of patients with BE with community-based LGD. Biopsies from the first endoscopy with LGD were assessed by the TSP-9 test and independently reviewed by 30 pathologists from 5 countries per standard practice. The accuracy of the test and the diagnoses in predicting high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) were compared. RESULTS: A total of 154 patients with BE (122 men), mean age 60.9 ± 9.8 years were studied. Twenty-four patients progressed to HGD/EAC within 5 years (median time of 1.7 years) and 130 did not progress to HGD/EAC within 5 years (median 7.8 years follow-up). The TSP-9 test demonstrated higher sensitivity (71% vs mean 63%, range 33%-88% across 30 pathologists), than the pathology review in detecting patients who progressed (P = .01186). CONCLUSIONS: The TSP-9 test outperformed the pathologists in risk stratifying patients with BE with LGD. Care guided by the test can provide an effective solution to variable pathology review of LGD, improving health outcomes by upstaging care to therapeutic intervention for patients at high risk for progression, while reducing unnecessary interventions in low-risk patients.
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INTRODUCTION: Objective risk stratification is needed for patients with Barrett's esophagus (BE) to enable risk-aligned management to improve health outcomes. This study evaluated the predictive performance of a tissue systems pathology [TSP-9] test (TissueCypher) vs current clinicopathologic variables in a multicenter cohort of patients with BE. METHODS: Data from 699 patients with BE from 5 published studies on the TSP-9 test were evaluated. Five hundred nine patients did not progress during surveillance, 40 were diagnosed with high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC) within 12 months, and 150 progressed to HGD/EAC after 12 months. Age, sex, segment length, hiatal hernia, original and expert pathology review diagnoses, and TSP-9 risk classes were collected. The predictive performance of clinicopathologic variables and the TSP-9 test was compared, and the TSP-9 test was evaluated in clinically relevant patient subsets. RESULTS: The sensitivity of the TSP-9 test in detecting progressors was 62.3% compared with 28.3% for expert-confirmed low-grade dysplasia (LGD), while the original diagnosis abstracted from medical records did not provide any significant risk stratification. The TSP-9 test identified 57% of progressors with nondysplastic Barrett's esophagus (NDBE) ( P < 0.0001). Patients with NDBE who scored TSP-9 high risk progressed at a similar rate (3.2%/yr) to patients with expert-confirmed LGD (3.7%/yr). The TSP-9 test provided significant risk stratification in clinically low-risk patients (NDBE, female, short-segment BE) and clinically high-risk patients (IND/LGD, male, long-segment BE) ( P < 0.0001 for comparison of high-risk classes vs low-risk classes). DISCUSSION: The TSP-9 test predicts risk of progression to HGD/EAC independently of current clinicopathologic variables in patients with BE. The test provides objective risk stratification results that may guide management decisions to improve health outcomes for patients with BE.
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Adenocarcinoma , Esófago de Barrett , Neoplasias Esofágicas , Humanos , Masculino , Femenino , Esófago de Barrett/patología , Progresión de la Enfermedad , Neoplasias Esofágicas/patología , Adenocarcinoma/patología , HiperplasiaRESUMEN
Background: Transgender persons in the U.S. experience high levels of violence and discrimination which have been linked to adverse substance use outcomes. Despite transgender women's higher exposure to such deleterious events compared to transgender men, studies have often aggregated both transgender women and men, obfuscating potentially unique differences between these groups. The current study, guided by the Minority Stress Model, examines differences in substance use outcomes and related correlates among transfeminine and transmasculine adults. Methods: A secondary data analysis was conducted using the 2017 Patient Characteristics Survey of public mental health facilities in the state of New York (N = 1387). Controlling for theoretically relevant factors, logistic regression models were estimated to examine differences between transfeminine and transmasculine adults in alcohol-related disorder (ARD) and drug use-related disorder (DURD) diagnoses, and tobacco use. Correlates of substance use disparities were also examined within gender identity groups. Results: Overall, 35% of participants were documented as using tobacco products whereas 14 and 19% were diagnosed with ARDs and DURDs, respectively. Transfeminine participants were 1.44-times more likely to be diagnosed with ARDs relative to transmasculine adults. Compared to transmasculine and White participants, transfeminine and Black participants were 1.64- and 1.59-times more likely to be diagnosed with DURDs. Conclusions: Recognizing the observed higher hazardous substance use risk among transfeminine and Black participants, findings indicate the potential role of minority stress in health outcomes of stigmatized communities. Our findings emphasize the need for identifying prevention and treatment strategies aimed at mitigating the implications of minority stress.
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Trastornos Relacionados con Sustancias , Personas Transgénero , Humanos , Adulto , Masculino , Femenino , Identidad de Género , New York/epidemiología , Personas Transgénero/psicología , Trastornos Relacionados con Sustancias/epidemiología , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Low-grade dysplasia (LGD) in Barrett's esophagus (BE) is associated with an increased risk of progression to high-grade dysplasia or esophageal adenocarcinoma. However, because of substantial interobserver variability in the diagnosis of LGD, a patient's management plan and health outcome depend largely on which pathologist reviews their case. This study evaluated the ability of a tissue systems pathology test that objectively risk stratifies patients with BE (TissueCypher, TSP-9) to standardize management in a manner consistent with improved health outcomes for patients with BE. METHODS: A total of 154 patients with BE with community-based LGD from the prospectively followed screening cohort of the SURF trial were studied. Management decisions were simulated 500 times with varying generalist (n = 16) and expert (n = 14) pathology reviewers to determine the most likely care plan with or without use of the TSP-9 test for guidance. The percentage of patients receiving appropriate management based on the known progression/nonprogression outcomes was calculated. RESULTS: The percentage of patients with 100% of simulations resulting in appropriate management significantly increased from 9.1% for pathology alone, to 58.4% when TSP-9 results were used with pathology, and further increased to 77.3% of patients receiving appropriate management when only TSP-9 results were used. Use of the test results also significantly increased the consistency of management decisions for patients when their slides were reviewed by different pathologists ( P < 0.0001). DISCUSSION: Management guided by the TSP-9 test can standardize care plans by increasing the early detection of progressors who can receive therapeutic interventions, while also increasing the percentage of nonprogressors who can avoid unnecessary therapy and be managed by surveillance alone.
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Esófago de Barrett , Neoplasias Esofágicas , Lesiones Precancerosas , Humanos , Esófago de Barrett/diagnóstico , Esófago de Barrett/terapia , Esófago de Barrett/epidemiología , Lesiones Precancerosas/patología , Progresión de la Enfermedad , Neoplasias Esofágicas/diagnóstico , Neoplasias Esofágicas/terapia , Neoplasias Esofágicas/epidemiología , Hiperplasia , Evaluación de Resultado en la Atención de SaludRESUMEN
PURPOSE: The DecisionDx-Melanoma 31-gene expression profile (31-GEP) test is validated to classify cutaneous malignant melanoma (CM) patient risk of recurrence, metastasis, or death as low (class 1A), intermediate (class 1B/2A), or high (class 2B). This study aimed to examine the effect of 31-GEP testing on survival outcomes and confirm the prognostic ability of the 31-GEP at the population level. METHODS: Patients with stage I-III CM with a clinical 31-GEP result between 2016 and 2018 were linked to data from 17 SEER registries (n = 4,687) following registries' operation procedures for linkages. Melanoma-specific survival (MSS) and overall survival (OS) differences by 31-GEP risk category were examined using Kaplan-Meier analysis and the log-rank test. Crude and adjusted hazard ratios (HRs) were calculated using Cox regression model to evaluate variables associated with survival. 31-GEP tested patients were propensity score-matched to a cohort of non-31-GEP tested patients from the SEER database. Robustness of the effect of 31-GEP testing was assessed using resampling. RESULTS: Patients with a 31-GEP class 1A result had higher 3-year MSS and OS than patients with a class 1B/2A or class 2B result (MSS: 99.7% v 97.1% v 89.6%, P < .001; OS: 96.6% v 90.2% v 79.4%, P < .001). A class 2B result was an independent predictor of MSS (HR, 7.00; 95% CI, 2.70 to 18.00) and OS (HR, 2.39; 95% CI, 1.54 to 3.70). 31-GEP testing was associated with a 29% lower MSS mortality (HR, 0.71; 95% CI, 0.53 to 0.94) and 17% lower overall mortality (HR, 0.83; 95% CI, 0.70 to 0.99) relative to untested patients. CONCLUSION: In a population-based, clinically tested melanoma cohort, the 31-GEP stratified patients by their risk of dying from melanoma.
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Melanoma , Neoplasias Cutáneas , Humanos , Melanoma/genética , Neoplasias Cutáneas/genética , Transcriptoma , Estimación de Kaplan-Meier , Melanoma Cutáneo MalignoRESUMEN
OBJECTIVE: Although most patients diagnosed with early-stage cutaneous melanoma (CM) have excellent outcomes, because of the large number diagnosed each year, many will experience recurrence or death. Prognostic testing for CM using the 31-gene expression profile (31-GEP) test can benefit patients by helping guide risk-appropriate treatment and surveillance plans. We sought to evaluate patients' attitudes toward prognostic testing with the 31-GEP and assess whether patients experience decision regret about having 31-GEP testing. METHODS: A 43-question survey was distributed by the Melanoma Research Foundation in June-August 2021 to CM patients enrolled in their database. Patients were asked questions regarding their decision to undergo 31-GEP testing and the extent to which they experienced decision regret using a validated set of Decision Regret Scale questions. RESULTS: We analyzed responses from patients diagnosed in 2014 or later (n = 120). Of these, 28 had received 31-GEP testing. Most respondents (n = 108, 90%) desired prognostic information when diagnosed. Of those who received 31-GEP testing, most felt the results were useful (n = 22 out of 24) and had regret scores significantly less than neutral regret, regardless of their test results (Class 1: p < 0.001; Class 2: p = 0.036). Further, decision regret scores were not significantly different between patients who received a Class 1 31-GEP result and those who received a Class 2 result (mean Class 1 = 1.39 and mean Class 2 = 1.90, p = 0.058). CONCLUSIONS: Most newly diagnosed CM patients desired prognostic information about their tumors. Patients who received 31-GEP testing felt it was useful and did not regret their decision to undergo 31-GEP testing.
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Melanoma , Neoplasias Cutáneas , Humanos , Melanoma/diagnóstico , Melanoma/genética , Melanoma/patología , Neoplasias Cutáneas/diagnóstico , Neoplasias Cutáneas/genética , Neoplasias Cutáneas/patología , Pronóstico , Transcriptoma , Perfilación de la Expresión Génica/métodos , Melanoma Cutáneo MalignoRESUMEN
OBJECTIVE: We identified common and unique barriers and facilitators of evidence-based suicide prevention practices across primary care practices with integrated behavioral health services and specialty mental health settings to identify generalizable strategies for enhancing future implementation efforts. METHOD: Twenty-six clinicians and practice leaders from behavioral health (n = 2 programs) and primary care (n = 4 clinics) settings participated. Participation included a semi-structured qualitative interview on barriers and facilitators to implementing evidence-based suicide prevention practices. Within that interview, clinicians participated in a chart-stimulated recall exercise to gather additional information about decision making regarding suicide screening. Interview guides and qualitative coding were informed by leading frameworks in implementation science and behavioral science, and an integrated approach to interpreting qualitative results was used. RESULTS: There were a number of similar themes associated with implementation of suicide prevention practices across settings and clinician types, such as the benefits of inter-professional collaboration and uncertainties about managing suicidality once risk was disclosed. Clinicians also highlighted barriers unique to their settings. For primary care settings, time constraints and competing demands were consistently described as barriers. For specialty mental health settings, difficulties coordinating care with schools and other providers in the community made implementation of suicide prevention practices challenging. CONCLUSION: Findings can inform the development and testing of implementation strategies that are generalizable across primary care and specialty mental health settings, as well as those tailored for unique site needs, to enhance use of evidence-based suicide prevention practices in settings where individuals at risk for suicide are especially likely to present.HIGHLIGHTSWe examined barriers and facilitators to suicide prevention across health settings.Common and unique barriers and facilitators across health-care settings emerged.Findings can enhance suicide prevention implementation across health-care settings.
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Salud Mental , Suicidio , Humanos , Prevención del Suicidio , Atención Primaria de Salud , Práctica Clínica Basada en la Evidencia , Investigación CualitativaRESUMEN
BACKGROUND: Transgender and gender diverse (TGD) adults experience high levels of stigma that contributes to elevated substance use and HIV sexual risk behaviors. Despite higher burdens of substance use and HIV compared to cisgender adults, TGD individuals may be less likely to engage in health care to avoid further discrimination. SETTING: This analysis included 529 TGD adults in Massachusetts and Rhode Island who were HIV negative or had an unknown HIV serostatus and were purposively sampled between March and August 2019. METHODS: We used structural equation modeling to test whether substance use, HIV sexual risk behaviors (ie, condom use, sex work, and multiple partners), and receiving gender-affirming hormone therapy mediate any observed association between TGD-related stigma and utilization of HIV prevention clinical services (ie, HIV prevention programs, PrEP use, and HIV testing). RESULTS: Substance use and HIV sexual risk mediated the relationship between TGD-related stigma and utilization of HIV prevention clinical services (ß = 0.08; 95% CI = 0.05, 0.17; P = 0.03 and ß = 0.26; 95% CI = 0.14 to 0.37; P < 0.001). Having a hormone therapy prescription was not a mediator between TGD-related stigma and HIV prevention clinical services. CONCLUSIONS: Future interventions that aim to improve HIV prevention clinical services among TGD adults should consider the impact of TGD-related stigma on participants' substance use and sexual risk behaviors. These efforts require that health care organizations and community organizations make a deliberate investment in the reach and success of interventions and programs.
Asunto(s)
Infecciones por VIH , Trastornos Relacionados con Sustancias , Personas Transgénero , Adulto , Humanos , Infecciones por VIH/prevención & control , Análisis de Clases Latentes , Identidad de Género , Estigma Social , Atención a la SaludRESUMEN
Objective: The 31-gene expression profile (31-GEP) can predict the risk of recurrence and metastasis in cutaneous melanoma (CM). We assessed the viewpoints and use of 31-GEP testing by physician assistants (PAs) and nurse practitioners (NPs) for patients with CM. Methods: NPs and PAs (n = 369) completed an 18-question online survey about their viewpoints and use of the 31-GEP risk-stratification test. Results: Most practitioners (n = 334, 90.5%) felt prognostic testing improved patient care and would recommend the 31-GEP to a colleague (n = 333, 90.2%) or a friend or family member (n = 289, 78.3%) who was diagnosed with CM. The 31-GEP test was used by 176 respondents in the preceding 12 months (53%). Among users of the 31-GEP test, 78% stated that the results would impact follow-up schedule and referral, 66% overall treatment decisions, 62% sentinel lymph node biopsy recommendations, and 50% surveillance imaging. In thin tumors (≤ 1 mm), 82% of 31-GEP users and 44% of nonusers stated that the 31-GEP results would impact their treatment plan decisions. Conclusion: The 31-GEP test significantly impacts treatment plans in CM, particularly for thin and stage I melanomas. Importantly, even nonusers stated that 31-GEP test results would impact treatment plans as well as recommendations to a friend or family member.