Utility of IMP3, p53, and S100P immunohistochemical stains in distinguishing reactive atypia from dysplasia in cholecystectomy specimens.

BACKGROUND: Distinguishing reactive atypia from dysplasia in cholecystectomy specimens can be histologically challenging. The aim of this study was to evaluate the utility of IMP3, p53, and S100P immunostains in differentiating reactive atypia from dysplasia in cholecystectomies. METHODS: Fifty-four cholecystectomies were reviewed and characterized into 5 groups: 2 normal, 29 reactive atypia, 16 low-grade dysplasia, 2 high-grade dysplasia, and 5 adenocarcinoma. IMP3, p53, and S100P immunostains were performed and evaluated. IMP3 (nuclear) and S100P (nuclear or nuclear/cytoplasmic) were categorized into negative or positive expression, and p53 was categorized into wild-type and aberrant/mutant expression. Chi-square test was used for statistical analysis. RESULTS: The patients were mostly middle-aged women (mean 44, range 19-87 years, 81% female), with predominantly Hispanic White ethnicity (80%). The majority of the normal and reactive atypia cases showed negative IMP3 (100% and 75.9%, respectively) and wild-type p53 (100% and 89.7%, respectively) staining. Over half (56.3%) of the low-grade dysplasia and all the high-grade dysplasia cases showed IMP3 positivity. Aberrant p53 staining pattern was seen in half of both low and high-grade dysplasia cases. Adenocarcinoma showed IMP3 positivity in 80% and p53 aberrancy in all cases. S100P showed no statistical significance among the diagnostic categories. Significant differences in staining patterns were found between reactive atypia vs. low-grade dysplasia, and reactive atypia vs. low-grade + high-grade dysplasia using a combination of IMP3 and p53 stains (all p < 0.05). CONCLUSIONS: In challenging cholecystectomies, IMP3 positivity or aberrant p53 expression may serve as a useful adjunct to support a diagnosis of dysplasia over reactive atypia.

Alpha-Fetoprotein-Producing Esophageal Adenocarcinoma With Enteroblastic, Yolk Sac Tumor-Like, and Hepatoid Carcinoma Differentiation: A Rare Case and Literature Review.

We report a case of a 65-year-old man with alpha-fetoprotein (AFP)-producing esophageal adenocarcinoma that microscopically consisted of a polymorphous blend of enteroblastic, yolk sac-like, and hepatoid carcinoma components of variable proportions. No histological evidence of Barrett's esophagus was identified. Two weeks post-endoscopic mucosal mass resection, the serum AFP level was 1434.6 ng/mL. The patient underwent radiation and chemotherapy but developed metastatic lung lesions. At 18 months post-resection, the patient is alive. AFP-producing esophageal adenocarcinoma is a rare entity. We reviewed reported cases for clinicopathological features, treatment strategies, and prognosis.

Potential Bias in Image-Guided Procedure Research: A Retrospective Analysis of Disclosed Conflicts of Interest and Open Payment Records.

PURPOSE: To assess the prevalence of positive conflicts of interest (COI) disclosures in United States-based interventional radiology (IR) research as well as the level of agreement between disclosed financial relationships and Open Payment Data for top-cited image-guided procedure research. MATERIALS AND METHODS: All publications in volume 30 (2019) of the Journal of Vascular and Interventional Radiology (JVIR) were reviewed to estimate the prevalence of COI disclosures in IR research. Publications were categorized as primary research, systematic review, or other. The prevalence was subsequently compared across JVIR publication subtypes and categories and on the basis of whether they were device-focused publications using χ2 tests. Additionally, the Web of Science database was searched for the top 10 most cited studies of 10 common image-guided procedures with available U.S. physician payment data. The payments were categorized as historical (>1 year prior to publication) or active (<1 year prior to publication) and compared with the disclosed financial COIs using 1-way analysis of variance. RESULTS: Positive COI disclosures were present in 114 (29%) of the 397 publications in JVIR volume 30. Positive COI disclosures were most prevalent in standards of practice (50%, P = .01) and more prevalent in device-focused publications (54% vs 23%, P < .01). Among the 396 authors of 100 United States-based top-cited image-guided procedure publications, 383 (97%) failed to disclose at least 1 active financial relationship, with an average of $57,937 in undisclosed payments per publication. CONCLUSIONS: COI are prevalent in IR, similar to other areas of healthcare research, and COI in top-cited image-guided procedure research are often underreported.

Significant reduction of indeterminate (atypical) diagnosis after implementation of The Paris System for Reporting Urinary Cytology: A single-institution study of more than 27,000 cases.

BACKGROUND: Urinary cytology is a noninvasive and cost-effective diagnostic and surveillance test in the clinical management of urothelial carcinoma (UC). The Paris System for Reporting Urinary Cytology (TPS), published in 2016, introduced definite diagnostic criteria aimed at improving performance in detecting high-grade UC (HGUC) and decreasing the indeterminate (atypical) diagnosis. METHODS: The authors retrospectively reviewed and compared urinary cytology diagnoses reported between January 2013 and December 2014 (pre-TPS, 7658 cases) and between May 2016 and April 2018 (post-TPS, 20,026 cases) to assess the influence of TPS in their practice. The time in between was used as a learning period. Follow-up information and correlation with the UroVysion fluorescence in situ hybridization test were obtained when available. RESULTS: Urinary cytology diagnoses pre-TPS included negative for UC (NUC) (n = 5293; 69.2%), atypical urothelial cells (AUC) (n = 2227; 29%), and suspicious/positive for HGUC (SHGUC/HGUC) (n = 138; 1.8%). Diagnoses post-TPS included negative for HGUC (NHGUC) (n = 18,507; 92.4%), AUC (n = 1237; 6.2%), and SHGUC/HGUC (n = 282; 1.4%). Comparing the pre-TPS and post-TPS periods, AUC diagnoses decreased from 29% to 6.2% (P < .00001), and the specificity and positive predictive value of AUC to detect HGUC significantly improved from 49% to 86% (P < .00001) and from 9% to 39% (P = .002), respectively. The correlation of an AUC diagnosis with a positive UroVysion test improved from 17% to 38% (P < .00001), whereas overall use of the UroVysion test was decreased. CONCLUSIONS: Implementation of TPS resulted in a significant reduction in AUC diagnoses that had a superior correlation with a subsequent biopsy and a UroVysion test, resulting in potential reductions in test use and medical cost.

Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation.

OBJECTIVES: Community consultation is required for clinical trials considering federal exception from informed consent (EFIC) procedures. Questions remain about the value of the community consult process and whether it adds intended protections to study subjects. Public deliberation methods that provide baseline participant education and elicit values and opinions about consent options is a novel approach for community consultation. This study evaluated the use of structured public deliberation methods to assess a community's values and opinions about informed consent procedures for a pediatric trauma trial. METHODS: This was a mixed-methods descriptive study of public deliberation sessions assessing participants' opinions about informed consent procedures for a pediatric trauma randomized controlled trial (RCT). Participants from communities with high rates of pediatric trauma were recruited via community-based organizations and social media. Deliberation focused on three consent options for a proposed RCT: 1) enrollment using EFIC procedures with no attempt to obtain informed consent, 2) enrollment using EFIC procedures after attempting to reach a parent, or 3) enrollment only with informed consent. Participant demographic data and their opinions about the proposed study and deliberative session were also collected. RESULTS: There were 102 participants across eight sessions (range of nine to 15/session, mean of 13). Most participants were female (n = 78, 76%) and a plurality were black (n = 48, 47%). The majority of participants preferred enrollment using EFIC procedures only after an attempt was made to reach a parent and informed consent was not possible (n = 56, 55%), followed by enrollment using EFIC procedures with no attempt to obtain informed consent (n = 32, 32%), and enrollment only with written informed consent (n = 13, 13%). One participant declined all options. Eighty-four participants (82%) agreed or strongly agreed that the RCT was important to do, and 79 participants (77%) said that the sessions provided enough information to make an informed decision about the proposed RCT. CONCLUSIONS: Structured public deliberation is an effective approach when consulting communities for trials considering EFIC procedures. Future studies are needed to evaluate whether public deliberation methods provide participants with enhanced understanding of clinical trials compared to other community consultation methods.

PTEN loss in prostatic adenocarcinoma correlates with specific adverse histologic features (intraductal carcinoma, cribriform Gleason pattern 4 and stromogenic carcinoma).

BACKGROUND: The loss of PTEN tumor suppressor gene is one of the most common somatic genetic aberrations in prostate cancer (PCa) and is frequently associated with high-risk disease. Deletion or mutation of at least one PTEN allele has been reported to occur in 20% to 40% of localized PCa and up to 60% of metastases. The goal of this study was to determine if somatic alteration detected by PTEN immunohistochemical loss of expression is associated with specific histologic features. METHODS: Two hundred sixty prostate core needle biopsies with PCa were assessed for PTEN loss using an analytically validated immunohistochemical assay. Blinded to PTEN status, each tumor was assessed for the Grade Group (GG) and the presence or absence of nine epithelial features. Presence of stromogenic PCa was also assessed and defined as grade 3 reactive tumor stroma as previously described: the presence of carcinoma associated stromal response with epithelial to stroma ratio of greater than 50% reactive stroma. RESULTS: Eight-eight (34%) cases exhibited PTEN loss while 172 (66%) had intact PTEN. PTEN loss was significantly (P < 0.05) associated with increasing GG, poorly formed glands (74% of total cases with loss vs 49% of intact), and three well-validated unfavorable pathological features: intraductal carcinoma of the prostate (IDC-P) (69% of total cases with loss vs 12% of intact), cribriform Gleason pattern 4 (38% of total cases with loss vs 10% of intact) and stromogenic PCa (23% of total cases with loss vs 6% of intact). IDC-P had the highest relative risk (4.993, 95% confidence interval, 3.451-7.223, P < 0.001) for PTEN loss. At least one of these three unfavorable pathological features were present in 67% of PCa exhibiting PTEN loss, while only 11% of PCa exhibited PTEN loss when none of these three unfavorable pathological features were present. CONCLUSIONS: PCa with PTEN loss demonstrates a strong correlation with known unfavorable histologic features, particularly IDC-P. This is the first study showing the association of PTEN loss with stromogenic PCa.

Comparing physician and patient perceptions of quality in ambulatory care.

OBJECTIVE: If quality improvement interventions, value-based purchasing and/or certification are based on patient assessments, a common definition of quality should be shared by clinicians and patients. The study's objectives were to determine (i) how patients and clinicians define quality care, (ii) in what ways patients' and physicians' definitions differ and (iii) whether patients' definitions vary by ethnicity. DESIGN: We used the critical incident technique to interview participants about behaviors that resulted in office visits being considered either good or poor quality and compared the prevalence of different types of 'quality' behaviors reported to identify commonalities and differences. SETTING: Hawaii and Chicago. PARTICIPANTS: A total of 168 patients and 39 clinicians. RESULTS: We developed a taxonomy, comprising 9 major categories and 106 subcategories of behaviors responsible for quality visits. Almost all clinicians and patients agreed that clinical skill, rapport and health-related communication behaviors were key elements. Patients were more likely to report behaviors demonstrating thoroughness in routine examinations, spending enough time with them, engaging them and being treated with courtesy and respect as drivers of a quality office visit than were physicians. CONCLUSIONS: Increased clinician awareness of the behaviors that patients believe are the drivers of a quality office visit can help clinicians improve patients' experience of care and experience-based measures of quality.

Heart healthy and stroke free: successful business strategies to prevent cardiovascular disease.

BACKGROUND: Heart disease and stroke, the principal components of cardiovascular disease (CVD), are the first and third leading causes of death in the United States. In 2002, employers representing 88 companies in the United States paid an average of 18,618 dollars per employee for health and productivity-related costs. A sizable portion of these costs are related to CVD. RESULTS: Employers can yield a 3 dollar to 6 dollar return on investment for each dollar invested over a 2 to 5 year period and improve employee cardiovascular health by investing in comprehensive worksite health-promotion programs, and by choosing health plans that provide adequate coverage and support for essential preventive services. The most effective interventions in worksites are those that provide sustained individual follow-up risk factor education and counseling and other interventions within the context of a comprehensive health-promotion program: (1) screening, health risk assessments, and referrals; (2) environmental supports for behavior change (e.g., access to healthy food choices); (3) financial and other incentives; and (4) corporate policies that support healthy lifestyles (e.g., tobacco-free policies). The most effective practices in healthcare settings include systems that use (1) standardized treatment and prevention protocols consistent with national guidelines, (2) multidisciplinary clinical care teams to deliver quality patient care, (3) clinics that specialize in treating/preventing risk factors, (4) physician and patient reminders, and (5) electronic medical records. CONCLUSIONS: Comprehensive worksite health-promotion programs, health plans that cover preventive benefits, and effective healthcare systems will have the greatest impact on heart disease and stroke and are likely to reduce employers' health and productivity-related costs.