Receipt Of Testing Research Articles

Prostate Specific Antigen (PSA) testing practices in an academic healthcare organization

Background: It is estimated that one out of nine men will be diagnosed with prostate cancer in their lives. However, there is so much debate about the impact of guidelines in prostate specific antigen (PSA) screening for early detection of prostate cancer. Although some studies have examined variation in PSA-based screening for prostate cancer, they have not considered the impact that the type of health insurance and clinician specialty may have in PSA-screening practices. Methods: Retrospective medical chart review of 500 male patients (40–69 years old). ANOVAS and logistic regression tested for significant differences in the variables of interest. Results: The majority (83%) of patients did not receive any type of PSA-testing during the study period. Patients of older age and those having private insurance were more likely to have a PSA-test. Of those patients who had PSA testing (n = 83), half received it for prostate cancer screening. The majority of the PSA-tests performed (n = 214) were ordered by urologists, received by White patients, and covered by private insurance. Conclusions: In this study, type of health insurance and age were associated with receipt of a PSA test, as opposed to race. Considering that male patients usually go to the urologists only when they have prostate symptoms, primary care clinicians may benefit from continued education on counseling patients, especially those who may be at elevated risk, regarding the importance of prostate health and PSA exams in general.

Cervical screening uptake: A cross-sectional study of self-reported screening attitudes, behaviours and barriers to participation among South Asian immigrant women living in Australia.

Introduction:Cervical cancer remains a major cause of morbidity and mortality among women from low and lower middle-income countries, as well as underserved population subgroups in high-income countries. Migration from South Asia to Australia has increased over the last decade, and immigrant women from this region have been reported as a subgroup, with less than optimal cervical screening participation in Australia. This study examined cervical screening uptake and associated behavioural attitudes among South Asian immigrant women living in Queensland Australia.Methods:A cross-sectional, Internet-based survey was used to collect data from a convenience sample of 148 South Asian women living in Queensland. The main outcome measure was receipt of cervical screening test ever (yes/no) and its recency (within 2 years/more than 2 years). The survey also examined participants’ views on barriers towards screening and ways to enhance it.Results:Of 148 women who completed the survey, 55.4% (n = 82) reported ever having a cervical screening test before and 43.9% (n = 65) reported having it in previous two years. Not having a previous cervical screening test was significantly associated with duration of stay in Australia for less than five years, not having access to a regular general practitioner (GP), not being employed, having low cervical cancer knowledge level and not knowing if cervical screening test is painful or not. Most commonly reported barriers to screening uptake included considering oneself not at risk, lack of time and lack of information. The most favoured strategy among participants was encouragement by GP and awareness through social media advertisements.Conclusion:This study provided insights into factors that need consideration when developing future targeted interventions.

Screening for diabetes and prediabetes: the newest communication opportunities

Type 2 diabetes mellitus (DM-2) and prediabetes are serious diseases that can lead to early disability and death. DM-2 can remain undiagnosed for many years; therefore, screening is one of the main assistants of a doctor in establishing a diagnosis, allowing to start treatment as early as possible.Research objective: early identification of patients with prediabetes and DM-2 using an online questionnaire.Materials and methods. The study was carried out online using the Google Forms platform, where a questionnaire was created based on Appendix 3 “Form of risk assessment of diabetes mellitus-2” of the Unified clinical protocol of primary and secondary (specialized) medical care “Type 2 diabetes mellitus”, approved by order of the Ministry of Health of Ukraine No. 1118 dated 12.21.2012, as well as additional questions on nutrition and physical activity. As of June 2021, the study involved 209 patients (151 women and 58 men) who did not have a documented diagnosis of DM-2 or prediabetes.Results. Most of the respondents (89 people) were overweight. 51 respondents had grade I obesity, 31 respondents had grade II, and 7 patients had a body mass index > 40 kg/m2, which corresponds to grade III obesity. Only 49 respondents had a healthy weight, which corresponds to a body mass index 18.5–24.9 kg/m2. 29 (19.21%) women had a history of childbirth with a child weighing more than 4 kg. The diagnosis of polycystic ovary disease (a risk factor for the DM-2) was in 34 (22.52%) women. Upon receipt of laboratory tests, we established a diagnosis of prediabetes in 28 (13.40%) patients, and a diagnosis of DM-2 in 17 (8.13%) people.Conclusions. It is necessary to search for new opportunities in communicating with patients during the COVID-19 pandemic, one of which is online questionnaires based on regulatory documents.

The impact of cumulative colorectal cancer screening delays: A simulation study.

Annual fecal immunochemical tests can reduce colorectal cancer incidence and mortality. However, screening is a multi-step process and most patients do not perfectly adhere to guideline-recommended screening schedules. Our objective was to compare the reduction in colorectal cancer incidence and life-years gained based on US guideline-concordant fecal immunochemical test screening to scenarios with a range of delays. The Colorectal Cancer Simulated Population model for Incidence and Natural history (CRC-SPIN) microsimulation model was used to estimate the effect of systematic departures from fecal immunochemical test screening guidelines on lifetime screening benefit. The combined effect of consistent modest delays in screening initiation (1 year), repeated fecal immunochemical test screening (3 months), and receipt of follow-up or surveillance colonoscopy (3 months) resulted in up to 1.3 additional colorectal cancer cases per 10,000, 0.4 additional late-stage colorectal cancer cases per 10,000 and 154.7 fewer life-years gained per 10,000. A 5-year delay in screening initiation had a larger impact on screening effectiveness than consistent small delays in repeated fecal immunochemical test screening or receipt of follow-up colonoscopy after an abnormal fecal immunochemical test. The combined effect of consistent large delays in screening initiation (5 years), repeated fecal immunochemical test screening (6 months), and receipt of follow-up or surveillance colonoscopy (6 months) resulted in up to 3.7 additional colorectal cancer cases per 10,000, 1.5 additional late-stage colorectal cancer cases per 10,000 and 612.3 fewer life-years gained per 10,000. Systematic delays across the screening process can result in meaningful reductions in colorectal cancer screening effectiveness, especially for longer delays. Screening delays could drive differences in colorectal cancer incidence across patient groups with differential access to screening.

Real-World Testing Patterns for Risk Assessment and Implications on the Adoption of Novel Therapeutics in Chronic Lymphocytic Leukemia: IGHV Mutation Status, FISH Cytogenetic, and Immunophenotyping

Introduction: Prognostic testing, including immunoglobulin heavy-chain variable region gene (IgHV) mutation status, cytogenetic abnormalities by fluorescence in situ hybridization (FISH), and immunophenotyping has been recommended in all newly diagnosed patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) prior to treatment initiation, and even in previously treated patients in some settings. Recent data have shown that disease with high-risk genetic features is better managed with novel agents than traditional chemoimmunotherapy. As such, the need for testing has become more relevant for disease management. However, there is limited recent data on real-world patterns of testing for risk factor assessment and in-turn, patterns of evidence-based treatment selection. This study aimed to examine: (1) the frequency and results of testing, (2) timing of testing by line of therapy, and (3) factors associated with the receipt of testing.Methods: De-identified data from the Flatiron Health EHR-derived database was used to identify patients who were ≥18 years old with newly-diagnosed CLL/SLL, who had ≥6-month continuous enrollment, and no prior treatment from January 2014 to May 2021. Testing evaluated included IgHV mutation status, FISH cytogenetic (11q deletion [del(11q)], 13q deletion [del(13q)], 17p deletion [del(17p)], Trisomy 12 [+12]) and other biomarkers (including CD38 and ZAP-70) by immunophenotyping. Descriptive analyses were conducted to examine the frequency and results in the overall population, and compared by patient characteristics and across sociodemographic groups. Multivariable logistic regression was conducted to examine factors associated with the likelihood of receiving testing. Statistical significance was determined as a p-value of <0.05.Results: A total of 3,037 CLL patients were included (median age=73, 62.3% male, 74.6% white). The majority of patients (92%) received treatment in community practices, with 54.1% commercially-insured. We observed over half of CLL patients did not receive risk factor testing (Figure 1): IgHV mutation analyses (76.2%, n=2,315), FISH (61.5%, n=1,868) and immunophenotyping (72.1%, n=2,190). Of those who had testing, the majority (99%) had it done once prior to starting first-line therapy. Significant differences in the receipt of testing were observed between different age, gender, race/ethnicity, and regional subgroups (Table 1). Among patients who received testing, the presence of high-risk biomarkers was as follows: unmutated IgHV (56.1%), del(17p) present (14.4%), del(11q) present (16.9%), and CD38 present (30.8%). Compared to patients <65 years, testing results in elderly patients ≥65 years showed a lower presence of unmutated IgHV (53.8%) and del(11q) (15.7%) while higher del(17p) (14.7%) and +12 (28.1%). No significant disparity was observed in white vs. non-white patients except for a lower incidence of mutated IgHV and del(13q) presence. Compared to tested men, tested women had a lower presence of unmutated IgHV (53.9%), del(11q) (11.4%) and CD38+ (25.8%) while higher del(17p) (18.2%). We then investigated the impact of risk testing on therapy selection, and noted that patients with del(17p) had a higher likelihood than those who tested negative (73.6% vs. 48.4%) of being treated with novel agents (ibrutinib, acalabrutinib, or venetoclax). In contrast, 26.4% of those who tested del(17p) present and 39.8% among those who did not get tested received chemotherapy. Multivariable regression showed that patients who were older (≥65 years), female or those living in the west of U.S. were significantly less likely to receive testing.Conclusions: The NCCN guidelines recommend novel agents for patients with high-risk CLL/SLL. Thus, all patients are advised to complete risk-factor testing for both prognostication and selection of optimal, evidence-based therapy. Our real-world data highlights not only a significant gap in testing, but that this suboptimal testing is more common in vulnerable populations. We observed that despite identification of del(17), a quarter of CLL patients failed to receive novel agents in the frontline setting. Our analysis identified an unmet need for further education and refinement of clinical practice. This is necessary to achieve the best clinical outcome in CLL patients through robust risk-assessment testing and optimal therapeutic triaging. [Display omitted] DisclosuresChanan-Khan: BieGene, Jansen, Ascentage: Consultancy; Ascentage, Starton, Cellectar, NonoDev, Alpha2 Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Alpha2 Pharmaceuticals: Patents & Royalties: Tabi; Ascentage: Research Funding; Cellectar: Current equity holder in publicly-traded company; Alpha2 Pharmaceuticals, NonoDev, Starton: Current holder of stock options in a privately-held company; BeiGene, Jansen, Ascentage: Honoraria. Yang: BeiGene, Ltd.: Current Employment. Liu: BeiGene, Ltd.: Current Employment. Zimmerman: BeiGene, Ltd.: Current Employment. Tang: BeiGene, Ltd.: Current Employment. Ailawadhi: Ascentage: Research Funding; Medimmune: Research Funding; Pharmacyclics: Consultancy, Research Funding; GSK: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Genentech: Consultancy; Xencor: Research Funding; BMS: Consultancy, Research Funding; Karyopharm: Consultancy; Cellectar: Research Funding; Sanofi: Consultancy; Janssen: Consultancy, Research Funding; AbbVie: Consultancy; Beigene: Consultancy; Takeda: Consultancy.

Barriers to Evidence-Based Treatment Decision-Making in Acute Myeloid Leukemia: A Quality Improvement Initiative Across Community Oncology Practices

BackgroundAvailability of molecularly targeted therapies has rapidly changed the treatment landscape for acute myeloid leukemia (AML). With these newer treatment choices, healthcare professionals (HCPs) must consider appropriate uses of molecular testing, treatment selection based on testing results, new sets of adverse events (AEs), and an increased need for patient education and shared decision-making (SDM). In this quality improvement (QI) initiative, we assessed barriers to evidence-based treatment planning for patients with AML in 4 community oncology systems and conducted team-based audit-feedback (AF) sessions within each system to facilitate HCP goal setting to mitigate identified barriers.MethodsThe QI initiative was conducted between Dec. 7, 2020 and Feb. 10, 2021. Initially, 14 hematology/oncology HCPs completed baseline team-based surveys to assess barriers in 4 community oncology systems (Table 1). To address identified gaps, 43 HCPs in the 4 systems participated in AF sessions. Action plans were developed by the clinical teams based on survey results (Table 1). Additional pre- and post-surveys completed before and after the AF sessions measured changes in participants' confidence and competence.ResultsOn the pre-activity surveys, the most common challenges in AML management were: 1) identifying which treatment options are most appropriate (30%), 2) coordinating with other members of the care team (24%), 3) gaining/maintaining access to new therapies (15%), and 4) integrating molecular testing information into treatment decisions (15%) (Figure 1). After the 4 AF sessions, HCPs prioritized addressing these 4 challenges. In the baseline surveys, HCPs identified additional staff/resources (64%) and additional staff training/education as top resources needed to overcome these challenges.HCPs identified additional challenges in the areas of AE management and patient centered care in the baseline surveys. Identified barriers in patient centered care, specifically, shared decision making (SDM), included not enough time to engage in SDM (57%) and patients' low health literacy (57%). After the 4 AF sessions, HCPs prioritized addressing tailoring treatment decisions to achieve patient goals (42%), coordinating follow-up visits with other care team members (32%), and engaging patients in shared decision-making (21%) as goals for improving patient-centered care.Molecular testing emerged as a key challenge in AML treatment planning over the course of the QI initiative. Pre-activity, only 36% of HCPs expressed high confidence (4/5 Likert scale) in identifying which molecular tests should be ordered to guide treatment planning, and similarly only 36% were highly confident in selecting targeted therapies based on actionable mutations. HCPs also expressed dissatisfaction with ordering and timely receipt of molecular testing results in their systems. In post-activity surveys, over twice as many HCPs selected molecular testing as a challenge they were planning to address within their team (37% compared with 15% pre-activity), suggesting increased awareness of this barrier (Figure 1). Pre- to post-activity, HCPs who self-reported use of targetable mutations as an important factor in planning treatment for patients who are not candidates for induction therapy increased from 27% to 63%.Participation in the QI initiative led to improvements in clinician confidence and competence in molecular testing, treatment selection based on molecular results, AE management, and use of SDM (Figure 2).ConclusionsHCPs participating in this QI initiative identified barriers and potential areas for improvement in AML treatment planning, including barriers related to molecular testing, treatment selection and access, AE management, and patient-centered care. Participation in the AF sessions led to measurable improvements in HCP confidence and competence in key areas of AML management which may ultimately improve the quality of AML care in the community.Study Sponsor StatementThe study reported in this abstract was funded by an independent educational grant from Genentech. The grantor had no role in the study design, execution, analysis, or reporting. [Display omitted] DisclosuresBlum: Abbvie: Honoraria; AmerisourceBergen: Honoraria; Forma Therapeutics: Research Funding; Leukemia and Lymphoma Society: Research Funding; Celyad Oncology: Research Funding; Nkarta: Research Funding; Xencor: Research Funding; Syndax: Honoraria. Fathi: Seattle Genetics: Consultancy, Honoraria; Astellas: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Blueprint: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Celgene/BMS: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Agios: Consultancy, Honoraria, Research Funding; Servier: Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; Genentech: Consultancy, Honoraria; Trillium: Consultancy, Honoraria; Kura: Consultancy, Honoraria; Foghorn: Consultancy, Honoraria; Kite: Consultancy, Honoraria; Morphosys: Consultancy, Honoraria; Ipsen: Consultancy, Honoraria. Pollyea: Takeda: Honoraria; Syros: Consultancy, Honoraria; Syndax: Honoraria; Novartis: Consultancy, Honoraria; Kiadis: Honoraria; Aprea: Honoraria; Astellas: Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Foghorn: Honoraria; Genentech: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Jazz: Honoraria; Karyopharm: Consultancy, Honoraria; Amgen: Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; Teva: Research Funding.

Factors Associated With Low-Value Cancer Screenings in the Veterans Health Administration

Most clinical practice guidelines recommend stopping cancer screenings when risks exceed benefits, yet low-value screenings persist. The Veterans Health Administration focuses on improving the value and quality of care, using a patient-centered medical home model that may affect cancer screening behavior. To understand rates and factors associated with outpatient low-value cancer screenings. This cohort study assessed the receipt of low-value cancer screening and associated factors among 5 993 010 veterans. Four measures of low-value cancer screening defined by validated recommendations of practices to avoid were constructed using administrative data. Patients with cancer screenings in 2017 at Veterans Health Administration primary care clinics were included. Excluded patients had recent symptoms or historic high-risk diagnoses that may affect test appropriateness (eg, melena preceding colonoscopy). Data were analyzed from December 23, 2019, to June 21, 2021. Receipt of cancer screening test. Low-value screenings were defined as occurring for average-risk patients outside of guideline-recommended ages or if the 1-year mortality risk estimated using a previously validated score was at least 50%. Factors evaluated in multivariable regression models included patient, clinician, and clinic characteristics and patient-centered medical home domain performance for team-based care, access, and continuity previously developed from administrative and survey data. Of 5 993 010 veterans (mean [SD] age, 63.1 [16.8] years; 5 496 976 men [91.7%]; 1 027 836 non-Hispanic Black [17.2%] and 4 539 341 non-Hispanic White [75.7%] race and ethnicity) enrolled in primary care, 903 612 of 4 647 479 men of average risk (19.4%) underwent prostate cancer screening; 299 765 of 5 770 622 patients of average risk (5.2%) underwent colorectal cancer screening; 21 930 of 469 045 women of average risk (4.7%) underwent breast cancer screening; and 65 511 of 458 086 women of average risk (14.3%) underwent cervical cancer screening. Of patients screened, low-value testing was rare for 3 cancers, with receipt of a low-value test in 633 of 21 930 of women screened for breast cancer (2.9%), 630 of 65 511 of women screened for cervical cancer (1.0%), and 6790 of 299 765 of patients screened for colorectal cancer (2.3%). However, 350 705 of 4 647 479 of screened men (7.5%) received a low-value prostate cancer test. Patient race and ethnicity, sociodemographic factors, and illness burden were significantly associated with likelihood of receipt of low-value tests among screened patients. No single patient-, clinician-, or clinic-level factor explained the receipt of a low-value test across cancer screening cohorts. This large cohort study found that low-value breast, cervical, and colorectal cancer screenings were rare in the Veterans Health Administration, but more than one-third of patients screened for prostate cancer were tested outside of clinical practice guidelines. Guideline-discordant care has quality implications and is not consistently explained by associated multilevel factors.

Traditional healer-delivered point-of-care HIV testing versus referral to clinical facilities for adults of unknown serostatus in rural Uganda: a mixed-methods, cluster-randomised trial

SummaryBackgroundHIV counselling and testing are essential to control the HIV epidemic. However, HIV testing uptake is low in sub-Saharan Africa, where many people use informal health-care resources such as traditional healers. We hypothesised that uptake of HIV tests would increase if provided by traditional healers. We aimed to determine the effectiveness of traditional healers delivering HIV testing at point of care compared with referral to local clinics for HIV testing in rural southwestern Uganda.MethodsWe did a mixed-methods study that included a cluster-randomised trial followed by individual qualitative interviews among a sample of participants in Mbarara, Uganda. Traditional healers aged 18 years or older who were located within 8 km of the Mbarara District HIV clinic, were identified in the 2018 population-level census of traditional healers in Mbarara District, and delivered care to at least seven clients per week were randomly assigned (1:1) as clusters to an intervention or a control group. Healers screened their clients for eligibility, and research assistants confirmed eligibility and enrolled clients who were aged 18 years or older, were receiving care from a participating healer, were sexually active (ever had intercourse), self-reported not having received an HIV test in the previous 12 months (and therefore considered to be of unknown serostatus), and had not previously been diagnosed with HIV infection. Intervention group healers provided counselling and offered point-of-care HIV tests to adult clients. Control group healers provided referral for HIV testing at nearby clinics. The primary outcome was the individual receipt of an HIV test within 90 days of study enrolment. Safety and adverse events were recorded and defined on the basis of prespecified criteria. This study is registered with ClinicalTrials.gov, NCT03718871.FindingsBetween Aug 2, 2019, and Feb 7, 2020, 17 traditional healers were randomly assigned as clusters (nine to intervention and eight to control), with 500 clients of unknown HIV serostatus enrolled (250 per group). In the intervention group, 250 clients (100%) received an HIV test compared with 57 (23%) in the control group, a 77% (95% CI 73–82) increase in testing uptake, after adjusting for the effect of clustering (p<0·0001). Ten (4%) of 250 clients in the intervention group tested HIV positive, seven of whom self-reported linkage to HIV care. No new HIV cases were identified in the control group. Qualitative interviews revealed that HIV testing delivered by traditional healers was highly acceptable among both providers and clients. No safety or adverse events were reported.InterpretationDelivery of point-of-care HIV tests by traditional healers to adults of unknown serostatus significantly increased rates of HIV testing in rural Uganda. Given the ubiquity of healers in Africa, this approach holds promise as a new pathway to provide community-based HIV testing, and could have a dramatic effect on uptake of HIV testing in sub-Saharan Africa.FundingUS National Institute of Mental Health, National Institutes of Health.

Adoption of New Risk Stratification Technologies Within US Hospital Referral Regions and Association With Prostate Cancer Management

The clinical decisions that arise from prostate magnetic resonance imaging (MRI) and genomic testing in patients with prostate cancer are not well understood. To evaluate the association between regional uptake of prostate MRI and genomic testing and observation vs treatment for prostate cancer. This retrospective cohort study of commercial insurance claims for prostate MRI and genomic testing included 65 530 patients 40 to 89 years of age newly diagnosed with prostate cancer from July 1, 2012, through June 30, 2019. Patient- and regional-level use of prostate MRI and genomic testing. Observation vs definitive treatment for prostate cancer. Patient-level analyses examined the association between receipt of testing or residing in a hospital referral region (HRR) that adopted testing and observation. In regional-level analyses, the dependent variable was the change in the proportion of patients observed for prostate cancer at the HRR level between 2 periods: July 1, 2012, to June 30, 2014, and July 1, 2017, to June 20, 2019. The independent study variables included HRR-level changes in the proportion of men undergoing prostate MRI and genomic testing between these periods, and the models were adjusted for contextual factors associated with prostate cancer care and socioeconomic status. This study identified 65 530 patients, including 27 679 in the early period (mean [SD] age, 58.0 [5.9] years) and 37 851 in the late period (mean [SD] age, 59.0 [5.7] years). Use of prostate MRI increased significantly from 7.2% (95% CI, 6.9%-7.5%) to 16.7% (95% CI, 16.3%-17.1%) from the early to late period. Use of genomic testing increased significantly from 1.3% (95% CI, 1.1%-1.4%) to 12.7% (95% CI, 12.3%-13.0%) from the early to late period. Compared with the lowest, the highest HRR quartiles of prostate MRI and genomic testing uptake were associated with an adjusted 4.1% (SE, 1.1%; P < .001) and 2.5% (SE, 1.1%; P = .03) absolute increase in the proportion of patients receiving observation, respectively. In this cohort study, uptake of prostate MRI and genomic testing was associated with increased use of initial observation vs treatment for prostate cancer. Marked geographic variation supports the need for further patient-level research to optimize the dissemination and outcome of testing.

MP60-09 GERMLINE TESTING FOR PROSTATE CANCER: WHICH REFERRAL METHOD IS BEST?

You have accessJournal of UrologyProstate Cancer: Markers (MP60)1 Sep 2021MP60-09 GERMLINE TESTING FOR PROSTATE CANCER: WHICH REFERRAL METHOD IS BEST? David Ahlborn, Ilene Staff, Tara McLaughlin, and Joseph Wagner David AhlbornDavid Ahlborn More articles by this author , Ilene StaffIlene Staff More articles by this author , Tara McLaughlinTara McLaughlin More articles by this author , and Joseph WagnerJoseph Wagner More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002095.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Emerging evidence supports the importance of germline genetic counseling and testing as a key component of prostate cancer (PCa) management. However, there is little guidance for urologists on how to implement practice guidelines. We explored the relationships between referral method, reason for testing, completion of testing, and time to testing in PCa patients and aimed to identify the most effective referral method. METHODS: With IRB approval, we queried the electronic medical record (EMR) for patients who were counseled and offered germline testing per NCCN guidelines from 1/29/19 – 2/3/21. Patients qualified for testing due to pathologic high risk (HR), family history (FH), or both. As referral methods evolved over time, we compared three cohorts of patients referred for testing through one of three methods. Patients were offered either 1) telephone number for a genetic counselor (TN); 2) EMR referral to a genetic counselor who calls the patient (ER); 3) same-day in-office testing (IO). The proportions of patients in each cohort who received testing were compared using chi square. Time to testing for each cohort was compared using Kaplan Meier. Multivariate logistic regression and Cox regression evaluated the independent influence of referral method and reason for referral on these outcomes. All analyses used SPSSv26. RESULTS: 177 patients were offered germline testing (47 TN, 70 ER, and 60 IO.) The cohorts did not differ in age, race, PSA, or clinical stage. The percentage of patients referred for both HR and FH was lower in the TN group compared to the ER and IO groups (6% vs 21% vs 27%, respectively, p<.025). Time to testing (Fig. 1) and receipt of testing was significantly associated with the referral method. Testing was obtained in 8 (17%) of TN, 39 (56%) of ER referrals and 39 (65%) of IO (p<0.001). 47/96 (49%) of men with family history, 16/47 (34%) of those with high risk and 23/34 (68%) of those with both risk factors obtained testing (p=0.012). Multivariate analyses indicated that referral method was independently associated with receipt of test and time to test (p < .001) while reason for testing was not significant. CONCLUSIONS: In-office germline testing is the most effective and expedient method to obtain germline testing results. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1044-e1045 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Ahlborn More articles by this author Ilene Staff More articles by this author Tara McLaughlin More articles by this author Joseph Wagner More articles by this author Expand All Advertisement Loading ...

Understanding the barriers to quality care in ovarian cancer: results from a needs assessment and quality improvement initiative

Objectives: The Association of Community Cancer Centers (ACCC) launched an initiative to improve care for patients with ovarian cancer (OVCA) in the United States. The project was designed to identify areas of greatest need for quality improvement (QI) initiatives aimed at improving OVCA care. Methods: A needs assessment survey and workshop application was designed by a multidisciplinary committee and was administered online using Qualtrics. A full day onsite workshop was conducted with the care teams at each site which included a lecture by an OVCA expert, a guided discussion to identify problems and barriers to optimal care delivery, and development of a problem statement for the resulting project. A 6-month QI project utilizing Plan-Do-Study-Act Cycles was developed by each site with data benchmarks. Project specific data was collected and analyzed. Results: 26 programs submitted workshop applications. Program types varied, with the majority being Comprehensive Community Cancer Programs (n=6, 26.1%); Academic Comprehensive Cancer Programs (n=5, 21.7%); or NCI-Designated Comprehensive Cancer Programs (n=5, 21.7%). The median number of annual OVCA patients diagnosed per site was 50.5 (range 22-190). The median numbers of clinical trials per site were 0 Phase I, 1.5 Phase II, and 2 Phase III. Eighty-five percent of sites reported having OVCA multidisciplinary care teams. Genetic testing and counseling (GTC) was the most frequently requested topic for QI (see Table). Three sites were chosen for QI projects. Site 1 chose to improve GTC rates for patients with newly diagnosed OVCA by implementing an electronic medical record (EMR) notification. During the 6-month project, receipt of any genetic testing within 60 days of an initial encounter improved from 68% to 77% of patients. Site 2 also chose to improve the receipt and efficiency of GTC through the development and application of an EMR smartset. During the QI period, GTC improved from 4/27 (15%) retrospectively to 14/14 (100%) with time from diagnosis to GTC decreasing from 1-8 months to 0.5-2 months. The QI project at Site 3 was to improve enrollment onto clinical trials though insertion of an EMR phrase in the template relating to clinical trial eligibility. No change in clinical trials enrollment was identified during the QI period which spanned the initial phase of the COVID-19 pandemic. Download : Download high-res image (146KB) Download : Download full-size image Conclusions: Significant needs for the improvement of quality care delivery for patients with OVCA were identified across varied cancer care programs. Improved access to genetic testing and counseling was the most commonly identified need, followed by enhanced clinical trial enrollment. Using EMR tools, sites were able to rapidly increase rates of GTC. Increasing clinical trial enrollment using an EMR trigger was unsuccessful, largely due to effects of the COVID-19 pandemic. Ongoing work to improve the implementation of best practices in OVCA treatment is needed.

Healthcare workers\u2019 perspectives on coronavirus testing availability: a cross sectional survey

BackgroundStudies on the impact of the novel SARS-CoV-2 virus (COVID) for healthcare workers (HCWs) rarely include the full spectrum of hospital workers, including less visible patient support roles. In the early days of the pandemic, COVID testing was preferentially available to HCWs. The objective of this study was to understand how individual experiences for all HCWs during the pandemic were associated with perceptions of access to, and receipt of COVID testing .MethodsAll hospital employees (n = 6736) in a single academic medical center in Boston, Massachusetts were invited to participate in a cross-sectional survey regarding perceived access to, and receipt of COVID testing during the first wave of the pandemic (March – August 2020). Responses were linked to human resources data. Log binomial univariate and multivariable models were used to estimate associations between individual and employment variables and COVID testing.ResultsA total of 2543 employees responded to the survey (38 %). The mean age was 40 years (± 14). Respondents were female (76 %), white (55 %), worked as nurses (27 %), administrators (22 %) and patient support roles (22 %); 56 % of respondents wanted COVID testing. Age (RR 0.91, CI 0.88–0.93), full time status (RR 0.85, CI 0.79–0.92), employment tenure (RR 0.96, CI 0.94–0.98), changes in quality of life (RR 0.94, CI 0.91–0.96), changes in job duties (RR 1.19, CI 1.03–1.37), and worry about enough paid sick leave (RR 1.21, CI 1.12–1.30) were associated with interest in testing. Administrators (RR 0.64, CI 0.58–0.72) and patient support staff (RR 0.85, CI 0.78–0.92) were less likely than nurses to want testing. Age (RR 1.04, CI 1.01–1.07), material hardships (RR 0.87, CI 0.79–0.96), and employer sponsored insurance (RR 1.10, CI 1.00-1.22) were associated with receiving a COVID test. Among all employees, only administrative/facilities staff were less likely to receive COVID testing (RR 0.69, CI 0.59–0.79).ConclusionsThis study adds to our understanding of how hospital employees view availability of COVID testing. Hazard pay or other supports for hospital workers may increase COVID testing rates. These findings may be applicable to perceived barriers towards vaccination receipt.

Challenges and Opportunities to Bolster the Effectiveness of Childhood Screening.

Challenges and Opportunities to Bolster the Effectiveness of Childhood Screening.

Use of COVID-19 Serologic Testing in Healthcare Workers with Acute Respiratory Tract Infection

Background: Diagnostic tests for COVID-19 are in high demand. Serologic assays are of interest as diagnostic adjuncts to SARS-CoV-2 quantitative polymerase chain reaction (PCR); however, many of the commercially available assays have limited validation data and clinical utility is unknown. We describe the utilization of SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) for healthcare workers with acute respiratory tract infection (ARTI) who underwent SARS-CoV-2 PCR testing. Methods: The MetroHealth System is the largest public hospital system in Ohio, employing ~8,000 staff. COVID-19 detection began in early March 2020. EDI novel coronavirus COVID-19 IgG ELISA (KT-1032) targeting antibody response to viral nucleocapsid was obtained for diagnostic and seroprevalence analyses. Manufacturer reports of sensitivity and specificity of the assay are 100% and 99%, respectively. A 2-part test strategy for employees with symptoms of ARTI was implemented. Qualifying symptoms for SARS-CoV-2 PCR testing included fever and either cough or shortness of breath. Additional symptoms were included to reflect expanding knowledge of COVID-19. Employees who underwent SARS-CoV-2 PCR testing (Luminex ARIES) were offered serologic testing on day 14 following PCR result. Education accompanied the offer for serologic testing as well as the receipt of test result to aide interpretation. Results: From April 16, 2020, through July 6, 2020, 588 employees underwent PCR testing. Overall, 70 cases of COVID-19 were detected. Of the 197 employees who opted for serologic testing, IgG positivity was 12.6%. The mean time to IgG collection following PCR result was 30 days (range, 10–79). Using PCR results obtained in the clinical setting of ARTI as the diagnostic gold standard, IgG was 84.6% sensitive and 98.2% specific (Figure 1). Conclusions: In a population of symptomatic healthcare workers, SARS-CoV2 IgG testing was specific for COVID-19 diagnosis. Sensitivity was inadequate compared to the positive predictive agreement of 90% or greater required for US Food and Drug Administration emergency use authorization. In a low-prevalence environment for COVID-19 (&lt;5%), a positive SARS-CoV-2 IgG has a low positive predictive value, which may falsely imply immunity and may negatively affect infection prevention practices.Funding: NoDisclosures: None

Real-World Testing and Treatment Patterns in Chronic Lymphocytic Leukemia (CLL) in the United States during the Modern Era: A SEER Patterns of Care Analysis

Introduction: The use of fluorescence in situ hybridization (FISH) and IgVH mutation analyses were initially used to help prognosticate CLL patients in clinical trials. In the modern era of Bruton tyrosine kinase inhibitors and improved response rates in patients with deletion 17p, and demonstrated long-term remissions among mutated IgVH patients treated with fludarabine, cyclophosphamide and rituximab (FCR), the use of testing prior to treatment is now considered standard of care to determine appropriate therapy. Several therapies were FDA approved for CLL since 2008 through 2014, including bendamustine and novel therapeutics (obinutuzumab, ibrutinib, and idelalisib). We aimed to look at patterns of real-world testing frequencies and treatment patterns by comparing two United States population based samples of untreated and treated CLL patients in 2008 and 2014.Methods: The National Cancer Institute sponsored Patterns of Care (POC) study was conducted in a population of CLL patients, randomly sampled from 13 Surveillance, Epidemiology, and End Results (SEER) program registries, diagnosed in 2008 and again in 2014. Trained abstractors collected data on demographics, diagnostics, testing, and treatments from patient medical records within 24 months post-diagnosis (along with a physician verification survey). Patient characteristics were described by age, sex, race, Charlson comorbidity index, area-based socioeconomic status, insurance status, receipt of systemic therapy, and type of treatments by diagnosis year. Patient characteristics and frequency of testing (FISH and IgVH mutation analyses) in 2008 and 2014 were compared using Rao-Scott chi-square tests. Logistic regression taking into account sampling weights was used to estimate odd ratios and 95% confidence intervals for receipt of FISH testing, both unadjusted and adjusted for age, sex, race, insurance status, and receipt of systemic treatment. Adjusted models were run overall and stratified by age at diagnosis (<65 and ≥65).Results: This study included 1,008 CLL patients diagnosed in 2008 and 1,367 CLL patients diagnosed in 2014. The mean age was 69.6 years in 2008, and 68.0 years in 2014. Among those with a known status for FISH testing, the proportion of patients who underwent testing was 51.3% in 2008, which increased to 59.6% in 2014 (p<0.01). Among those with a known status for IgVH mutation analyses, 8.5% underwent testing in 2008, which increased to 15.1% in 2014 (p<0.01). Older age was a strong predictor for not receiving FISH testing in both 2008 and 2014 (adjusted p-trend <0.01 for both years). In 2014, Hispanic patients were less likely to undergo testing (aOR 0.68, 95% CI: 0.48-0.96) compared to non-Hispanic whites, but no significant difference was found among non-Hispanic blacks. Among patients 65 or older, those with Medicare without private insurance were less likely to receive testing compared to Medicare patients with private insurance (aOR 0.49, CI: 0.32-0.74).Most CLL patients were untreated within the first two years from diagnosis (74.3% in 2008, and 70.6% in 2014). FISH testing occurred in a majority but not all patients who received therapy (64.5% of treated patients in 2008, increased to 74.7% in 2014). In 2008, the four most frequently used regimens for first treatment were 1) FCR, 2) rituximab monotherapy, 3) FR, and 4) chlorambucil based regimens. This is in contrast to 2014, where the regimens were 1) bendamustine and rituximab (BR), 2) rituximab monotherapy, 3) FCR, and 4) ibrutinib. When evaluating the use of novel therapies (obinutuzumab, ibrutinib, and idelalisib) for those diagnosed in 2014, there were no significant differences in distribution by age, race/ethnicity, comorbid conditions, SES, or insurance type.Conclusions: There has been an increase in frequency of FISH testing and IgVH mutation analyses from 2008 to 2014. FISH testing is more common compared to IgVH mutation analyses which was modest in both years. Patients of older age, Hispanic ethnicity, and Medicare with no private insurance were also less likely to receive FISH testing in 2014. There are significant differences in the treatment patterns of patients in 2008 compared to 2014, with the use of bendamustine being more common at the expense of FCR. These results highlight rapidly changing practices within CLL in the modern era. DisclosuresNo relevant conflicts of interest to declare.

Management of patients presenting with low back pain to a private hospital emergency department in Melbourne, Australia.

Recent studies suggest many patients with non-specific low back pain presenting to public hospital EDs receive low-value care. The primary aim was to describe management of patients presenting with low back pain to the ED of a private hospital in Melbourne, Australia, and received a final ED diagnosis of non-specific low back pain. We also determined predictors of hospital admission. Retrospective review of patients who presented with low back pain and received a final ED diagnosis of non-specific low back pain to Cabrini Malvern ED in 2015. Demographics, lumbar spinal imaging, pathology tests and medications were extracted from hospital records. Multivariate logistic regression was used to determine independent predictors of hospital admission. Four hundred and fifty presentations were included (60% female); 238 (52.9%) were admitted to hospital. One hundred and seventy-seven (39.3%) patients received lumbar spine imaging. Two hundred and eighty (62.2%) patients had pathology tests and 391 (86.9%) received medications, which included opioids (n = 298, 66.2%), paracetamol (n = 219, 48.7%), NSAIDs (n = 161, 35.8%), benzodiazepines (n = 118, 26.2%) and pregabalin (n = 26, 5.8%). Predictors of hospital admission included older age (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.02-1.05), arrival by ambulance (OR 2.03, 95% CI 1.06-3.90) and receipt of pathology tests (OR 3.32, 95% CI 2.01-5.49) or computed tomography scans (OR 1.86, 95% CI 1.12-3.11). We observed high rates of imaging, pathology tests and hospital admissions compared with previous public hospital studies, while medication use was similar. Implementation of strategies to optimise evidence-based ED care is needed to reduce low-value care and improve patient outcomes.

PIH14 Statewide Trends in Genetic Testing for Hereditary Cancers in Arkansas 2013-2018

To study the trends in genetic testing for hereditary breast and ovarian cancers (HBOC), lynch syndrome, and non-specific general genetic tests and receipt of any genetic test for Medicaid, commercial, state employee, and Medicare enrollees in Arkansas. Arkansas All Payers’ Claims Database (APCD) data from 2013 through 2018 was used for commercial, state employee and Medicaid enrollees and due to lags in access 2013-2016 data Medicare recipients. Individuals with at least one month of enrollment with both pharmacy and medical benefits in each quarter were included. Genetic tests were identified using Current Procedural Terminology (CPT-4) codes. Quarterly rates were calculated per 100,000 person-quarters. Age and gender stratified analyses were performed and scatter plots were used to visualize the trends. Time series models using ordinary least squares were estimated to identify trends. There were 1,516,850, 1,501,828, 154,529 and 519,955 individuals in Medicaid, commercial, state employee and Medicare plans respectively. The average age across the total sample was 38, and 54% were female. Across all years, rates of HBOC tests were 2, 22, 40 and 13 per 100,000 person-quarters respectively in Medicaid, commercial, state employee and Medicare. Likewise, the rates of lynch syndrome, general and any genetic tests were: 0.5, 7 and 10 (Medicaid); 2, 21 and 49 (commercial); 6, 77 and 134 (state employee); and 2, 114 and 133 (Medicare) per 100,000 persons-quarters. All measures had increasing linear trends in Medicaid, commercial and state employee (p<0.05), while only tests for HBOC (p=0.020) and lynch syndrome (p=0.004) had significant increasing linear trends in Medicare. HBOC and lynch syndrome test rates were highest among 18–64 females, while general and any genetic test rates were highest among 18–64 males. Genetic tests for hereditary cancers have increased linearly from 2013 to 2018, however the rates of testing to detect cancer remain low.

Association Between Medicare's National Coverage Determination and Utilization of Next-Generation Sequencing.

In 2018, Medicare issued a national coverage determination (NCD) providing reimbursement for next-generation sequencing (NGS) tests for beneficiaries with advanced or metastatic cancer and no previous NGS testing. We examined the association between NCD implementation and NGS utilization trends in Medicare beneficiaries versus commercially insured patients. This was a retrospective study of patients with advanced non-small-cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), metastatic breast cancer (mBC), or advanced melanoma with a de novo or recurrent advanced diagnosis from January 1, 2011, through December 30, 2019, using a nationwide US electronic health record-derived deidentified database. Patients were classified by insurance and by advanced diagnosis date. NGS testing was assessed by receipt of first NGS test result ≤ 60 days of advanced diagnosis. Interrupted time series analysis assessed NGS utilization pre- and post-NCD effective date by insurance type. The utilization and repeat NGS testing analysis included 70,290 and 4,295 patients, respectively. Use of NGS rose from < 1% in 2011 to > 45% in Q4 2019 in aNSCLC while remaining < 20% in mBC and advanced melanoma. Among patients with aNSCLC, mCRC, or mBC, NGS testing increased post-NCD versus pre-NCD (P < .05). There was no significant difference in trends pre- and post-NCD between Medicare beneficiaries and commercially insured patients in any tumor. Repeat NGS testing was similar before the NCD (Medicare v commercial: 24.8% v 28.5%). Post-NCD, fewer Medicare beneficiaries had repeat NGS testing (27.7% v 36.0%; P < .01). Trends in NGS utilization significantly changed post-NCD, although the magnitude of change was not significantly different by insurance type, indicating private insurers may also be incorporating NCD guidance. Implementation of the NCD may have limited use of repeat NGS testing in Medicare beneficiaries.

A Nationwide Survey of COVID-19 Testing in LGBTQ+ Populations in the United States.

Lesbian, gay, bisexual, transgender, or queer and questioning (LGBTQ+) people and populations face myriad health disparities that are likely to be evident during the COVID-19 pandemic. The objectives of our study were to describe patterns of COVID-19 testing among LGBTQ+ people and to differentiate rates of COVID-19 testing and test results by sociodemographic characteristics. Participants residing in the United States and US territories (N = 1090) aged ≥18 completed an internet-based survey from May through July 2020 that assessed COVID-19 testing and test results and sociodemographic characteristics, including sexual orientation and gender identity (SOGI). We analyzed data on receipt and results of polymerase chain reaction (PCR) and antibody testing for SARS-CoV-2 and symptoms of COVID-19 in relation to sociodemographic characteristics. Of the 1090 participants, 182 (16.7%) received a PCR test; of these, 16 (8.8%) had a positive test result. Of the 124 (11.4%) who received an antibody test, 45 (36.3%) had antibodies. Rates of PCR testing were higher among participants who were non-US-born (25.4%) versus US-born (16.3%) and employed full-time or part-time (18.5%) versus unemployed (10.8%). Antibody testing rates were higher among gay cisgender men (17.2%) versus other SOGI groups, non-US-born (25.4%) versus US-born participants, employed (12.6%) versus unemployed participants, and participants residing in the Northeast (20.0%) versus other regions. Among SOGI groups with sufficient cell sizes (n > 10), positive PCR results were highest among cisgender gay men (16.1%). The differential patterns of testing and positivity, particularly among gay men in our sample, confirm the need to create COVID-19 public health messaging and programming that attend to the LGBTQ+ population.

Disparities in post-operative surveillance testing for metastatic recurrence among colorectal cancer survivors.

Among colorectal cancer (CRC) survivors, treatment for metastatic recurrence is most effective when malignancies are detected early through surveillance with carcinoembryonic antigen (CEA) level test and computer tomography (CT) imaging. However, utilization of these tests is low, and many survivors fail to meet the recommended guidelines. This population-based study assesses individual- and neighborhood-level factors associated with receipt of CEA and CT surveillance testing. We used the Surveillance, Epidemiology and End Results (SEER)-Medicare data to identify Medicare beneficiaries diagnosed with CRC stages II-III between 2010 and 2013. We conducted multivariate logistic regression to estimate the effect of individual and neighborhood factors on receipt of CEA and CT tests within 18 months post-surgery. Overall, 78% and 58% of CRC survivors received CEA and CT testing, respectively. We found significant within racial/ethnic differences in receipt of these surveillance tests. Medicare-Medicaid dual coverage was associated with 39% lower odds of receipt of CEA tests among non-Hispanic Whites, and Blacks with dual coverage had almost two times the odds of receiving CEA tests compared to Blacks without dual coverage. Although this study did not find significant differences in receipt of initial CEA and CT surveillance testing across racial/ethnic groups, the assessment of the factors that measure access to care suggests differences in access to these procedures within racial/ethnic groups. Our findings have implications for developing targeted interventions focused on promoting surveillance for the early detection of metastatic recurrence among colorectal cancer survivors and improve their health outcomes.