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Prostate MRI versus PSA screening for prostate cancer detection (the MVP Study): a randomised clinical trial
Objectives
Our objective was to compare prostate cancer detection rates between patients undergoing serum prostate-specific antigen (PSA) vs magnetic resonance imaging (MRI) for prostate cancer screening.
Design
Phase III open-label randomised controlled trial.
Setting
Single tertiary cancer centre in Toronto, Canada.
Participants
Men 50 years of age and older with no history of PSA screening for ≥3 years, a negative digital rectal exam and no prior prostate biopsy.
Interventions
Patients were recommended to undergo a prostate biopsy if their PSA was ≥2.6 ng/mL (PSA arm) or if they had a PIRADS score of 4 or 5 (MRI arm). Patients underwent an end-of-study PSA in the MRI arm.
Primary and secondary outcome measures
Adenocarcinoma on prostate biopsy. Prostate biopsy rates and the presence of clinically significant prostate cancer were also compared.
Results
A total of 525 patients were randomised, with 266 in the PSA arm and 248 in the MRI arm. Due to challenges with accrual and study execution during the COVID-19 pandemic, the study was terminated early. In the PSA arm, 48 patients had an abnormal PSA and 28 (58%) agreed to undergo a prostate biopsy. In the MRI arm, 25 patients had a PIRADS score of 4 or 5 and 24 (96%) agreed to undergo a biopsy. The relative risk for MRI to recommend a prostate biopsy was 0.52 (95% CI 0.33 to 0.82, p=0.005), compared with PSA. The cancer detection rate for patients in the PSA arm was 29% (8 of 28) vs 63% (15 of 24, p=0.019) in the MRI arm, with a higher proportion of clinically significant cancer detected in the MRI arm (73% vs 50%). The relative risk for detecting cancer and clinically significant with MRI compared with PSA was 1.89 (95% CI 0.82 to 4.38, p=0.14) and 2.77 (95% CI 0.89 to 8.59, p=0.07), respectively.
Conclusions
Prostate MRI as a stand-alone screening test reduced the rate of prostate biopsy. The number of clinically significant cancers detected was higher in the MRI arm, but this did not reach statistical significance. Due to early termination, the study was underpowered. More patients were willing to follow recommendations for prostate biopsy based on MRI results.
Trial registration number
NCT02799303.
Womens preference to apply shared decision-making in breast cancer screening: a discrete choice experiment
Objective
To analyse women’s stated preferences for establishing the relative importance of each attribute of shared decision-making (SDM) and their willingness to pay (WTP) for more participatory care in breast cancer screening programmes (BCSP).
Design
A discrete choice experiment was designed with 12 questions (choice tasks). It included three attributes: ‘How the information is obtained’, regarding benefits and harms; whether there is a ‘Dialogue for scheduled mammography’ between the healthcare professional and the woman; and, ‘Who makes the decision’, regarding participation in BCSP. Data were obtained using a survey that included 12 choice tasks, 1 question on WTP and 7 socioeconomic-related questions. The analysis was performed using conditional mixed-effect logit regression and stratification according to WTP.
Setting
Data collection related to BCSP was conducted between June and November 2021 in Catalonia, Spain.
Participants
Sixty-five women aged between 50 and 60.
Main outcome measures
Women’s perceived utility of each attribute, trade-off on these attributes and WTP for SDM in BCSP.
Result
The only significant attribute was ‘Who makes the decision’. The decision made alone (coefficient=2.879; 95% CI=2.297 to 3.461) and the decision made together with a healthcare professional (2.375; 95% CI=1.573 to 3.177) were the options preferred by women. The former contributes 21% more utility than the latter. Moreover, 52.3% of the women stated a WTP of 10 or more for SDM. Women’s preferences regarding attributes did not influence their WTP.
Conclusions
The participant women refused a current paternalistic model and preferred either SDM or informed decision-making in BCSP.
Consumer-Led Screening for Atrial Fibrillation: Frontier Review of the AF-SCREEN International Collaboration
Circulation, Volume 146, Issue 19, Page 1461-1474, November 8, 2022. The technological evolution and widespread availability of wearables and handheld ECG devices capable of screening for atrial fibrillation (AF), and their promotion directly to consumers, has focused attention of health care professionals and patient organizations on consumer-led AF screening. In this Frontiers review, members of the AF-SCREEN International Collaboration provide a critical appraisal of this rapidly evolving field to increase awareness of the complexities and uncertainties surrounding consumer-led AF screening. Although there are numerous commercially available devices directly marketed to consumers for AF monitoring and identification of unrecognized AF, health care professional–led randomized controlled studies using multiple ECG recordings or continuous ECG monitoring to detect AF have failed to demonstrate a significant reduction in stroke. Although it remains uncertain if consumer-led AF screening reduces stroke, it could increase early diagnosis of AF and facilitate an integrated approach, including appropriate anticoagulation, rate or rhythm management, and risk factor modification to reduce complications. Companies marketing AF screening devices should report the accuracy and performance of their products in high- and low-risk populations and avoid claims about clinical outcomes unless improvement is demonstrated in randomized clinical trials. Generally, the diagnostic yield of AF screening increases with the number, duration, and temporal dispersion of screening sessions, but the prognostic importance may be less than for AF detected by single–time point screening, which is largely permanent, persistent, or high-burden paroxysmal AF. Consumer-initiated ECG recordings suggesting possible AF always require confirmation by a health care professional experienced in ECG reading, whereas suspicion of AF on the basis of photoplethysmography must be confirmed with an ECG. Consumer-led AF screening is unlikely to be cost-effective for stroke prevention in the predominantly young, early adopters of this technology. Studies in older people at higher stroke risk are required to demonstrate both effectiveness and cost-effectiveness. The direct interaction between companies and consumers creates new regulatory gaps in relation to data privacy and the registration of consumer apps and devices. Although several barriers for optimal use of consumer-led screening exist, results of large, ongoing trials, powered to detect clinical outcomes, are required before health care professionals should support widespread adoption of consumer-led AF screening.
Incidental Coronary Artery Calcium: Opportunistic Screening of Prior Non-gated Chest CTs to Improve Statin Rates (NOTIFY-1 Project)
Circulation, Ahead of Print. Background: Coronary artery calcium (CAC) can be identified on non-gated chest CTs, but this finding is not consistently incorporated into care. A deep learning algorithm enables opportunistic CAC screening of non-gated chest CTs. Our objective was to evaluate the impact of notifying clinicians and patients of incidental CAC on statin initiation.Methods: NOTIFY-1 was a randomized quality improvement project in the Stanford healthcare system. Patients without known atherosclerotic cardiovascular disease (ASCVD) or prior statin prescription were screened for CAC on a prior non-gated chest CT from 2014-2019 using a validated deep learning algorithm with radiologist confirmation. Patients with incidental CAC were randomized to notification of the primary care clinician and patient versus usual care. Notification included a patient-specific image of CAC and guideline recommendations regarding statin use. The primary outcome was statin prescription within 6 months.Results: Among 2,113 patients who met initial clinical inclusion criteria, CAC was identified by the algorithm in 424 patients. After additional exclusions following chart review, a radiologist confirmed CAC among 173 of 194 patients (89.2%) who were randomized to notification or usual care. At 6 months, the statin prescription rate was 51.2% (44/86) in the notification arm versus 6.9% (6/87) with usual care (p
Melanoma Screening—Reply
In Reply I thank Elwood et al for highlighting their previous efforts to develop more robust evidence to guide melanoma screening efforts. However, their work found similar findings as Matsumoto et al, with increased thin melanoma ascertainment in patients who had undergone screening skin examinations. While they modeled possible associations with mortality based on thickness data, their work did not look at actual mortality, either all cause or melanoma related.
High-Quality Shared Decision-making for Lung Cancer Screening
This Viewpoint discusses the role of the International Patient Decision Aid Standards Collaboration in emphasizing the importance of shared decision-making facilitated by trained individuals and the use of decision aids that meet minimal quality standards when counseling patients for lung cancer screening.
Physician Attitudes About Using Life Expectancy to Inform Cancer Screening Cessation in Older Adults
This survey study assessed physicians’ attitudes about the use of life expectancy as a guide in the decision to stop cancer screening in older adults.
Resurgence of Syphilis in the US—USPSTF Reaffirms Screening Guidelines
Since its modern-day nadir of 5979 cases per year, or 2.1 cases per 100 000 population, in 2001, primary and secondary (PS) syphilis incidence has rapidly increased. In 2019, 38 992 cases, or 11.9 cases per 100 000, were reported, more than a 5-fold increase. The United States Preventive Services Task Force (USPSTF) currently “recommends screening for syphilis infection in persons who are at increased risk for infection (A recommendation).” The recommendation applies to asymptomatic, nonpregnant adolescents and adults who have ever been sexually active and is based on findings that the benefits of screening outweigh the harms. Because dermatologists are among the frontline health care professionals in the fight against syphilis, the USPSTF recommendation, supported by an updated evidence report and systematic review, presents an opportunity to update the dermatology community regarding recent trends in syphilis epidemiology, clinical presentation, testing, and treatment.
Melanoma Screening
To the Editor We agree with the title of the Editorial by Swerlick, but it omits the considerable efforts to mount a randomized clinical trial in Australia. We assessed melanoma screening in 1992, recommending a randomized clinical trial at ages 45 to 69 years to assess mortality. Subsequently, a similar trial based on whole-body examinations by primary care practitioners (PCPs) was proposed. A pilot phase showing that screening increased enough to allow detection of a 20% reduction in mortality over 15 years was reported in 2002. The trial cost approximately $8.4 million; after national and international peer review, the research costs were approved, which were approximately half the total. However, the other costs, including payments to PCPs for the screening examinations, were not funded. Thus, the full trial was not conducted.
Performance of HPV testing, Pap smear and VIA in women attending cervical cancer screening in Kilimanjaro region, Northern Tanzania: a cross-sectional study nested in a cohort
Objective
There is a concern about performance of the screening approaches, where information on the quality of novel and affordable screening approaches that will perform well in remote areas is warranted. This lack of information makes it difficult to prioritise resource use in efforts to improve cervical cancer outcomes. We aimed to compare the diagnostic value of human papillomavirus (HPV) testing on self-collected samples, Pap smear and visual inspection of the cervix with acetic acid (VIA) tests for detection of high-grade cervical intraepithelial neoplasia or worse (CIN2+).
Design
A combined cross-sectional and cohort study.
Setting
Three primary healthcare centres in Kilimanjaro region, Tanzania.
Participants
1620 women undergoing cervical cancer screening from December 2018 to September 2021. Inclusion criteria were being aged 25–60 years, and no history of premalignant or cervical cancer. Exclusion criteria were overt signs of cancer and previous hysterectomy.
Interventions
Participants underwent HPV self-sampling with Evalyn Brush and Care HPV kit assay was used to determine prevalence of high-risk HPV infection. Women with positive HPV test were together with a random sample of HPV negative women scheduled for follow-up where VIA was performed, and Pap smear and cervical biopsies obtained.
Results
Of 1620 women enrolled, 229 (14.1%) were HPV positive and 222 of these attended follow-up together with 290 (20.8%) women with negative HPV test. On VIA, 17.6% were positive. On Pap smear, 8.0% were classified as high-grade squamous intraepithelial lesion. The sensitivity and specificity, respectively, of the various tests, compared with histopathology for the detection of CIN2+ were: HPV test 62.5%, 59.3%; Pap smear 82.8%, 82.1% and; VIA 48.4%, 56.8%. When combined, the sensitivity and specificity for HPV and Pap smear were 90.6%, 70.6% while HPV and VIA were 65.6% and 75.5% for the detection of CIN2+.
Conclusions
The performance of care HPV testing on self-collected samples opens the possibility of increasing coverage and early detection in resource-constrained settings.
Abstract 10105: Health Disparities in Cholesterol Screening Among Older Americans: Longitudinal Analysis of the Health and Retirement Study (2008-2018)
Circulation, Volume 146, Issue Suppl_1, Page A10105-A10105, November 8, 2022. Introduction:Hypercholesterolemia is often asymptomatic and requires cholesterol screening to be identified. Current guidelines recommend adults at low risk for cardiovascular disease (CVD) to receive cholesterol screening at least every 5 years with more frequent screenings in older adults and/or at higher CVD risk. Yet, currently, about 25% of Americans do not meet the every-5-year screening recommendations. While disparities in the prevention and treatment of hypercholesterolemia continue to rise, little is known regarding factors influencing cholesterol screening among older Americans in the past 10 years.Methods:This longitudinal analysis used data from the Health and Retirement Study (HRS). HRS is a nationally representative survey of older adults in the U.S. The current study focused on data collected from 2008 (Wave 9) to 2018 (Wave 14). Participants who passed away by 2019, ever had CVD or stroke, were under age 55 at baseline, had more than 3 waves of missing data in self-reported cholesterol screening, or any missing data in covariates were excluded from the current analysis. In total, 7643 participants were included. Meeting cholesterol screening recommendations was defined as those reporting more than two cholesterol screenings between waves 9-14. Poisson regression and logistic regression were used for data analysis.Results:Compared to Black, Indigenous, and People of Color (BIPOC), White older Americans were more likely to meet cholesterol screening recommendations (odds ratio= 1.60; p
Abstract 11770: Cost-Effectiveness Analysis of Coronary Artery Disease Screening in Patients With Breast Cancer
Circulation, Volume 146, Issue Suppl_1, Page A11770-A11770, November 8, 2022. Background:Association of cardiovascular disease with cancer is caused by an increased risk of coronary artery disease (CAD), in part attributable to the association of standard risk factors with both coronary disease and cancer. In addition to these drivers of accelerated plaque formation, treatment used in breast cancer therapy is associated with CAD.Purpose:Cancer patients require an individualised approach for managing CAD and there is an unmet need to define the benefit of CAD screening on outcomes in cancer survivors and the cost-effectiveness of this approach is unknown.Methods:A Markov model was assembled using three states; well, myocardial infarction and death. Base case scenario was a 55 year old female treated for breast cancer, followed up 10 years post treatment. Costs, utilities, and transition probabilities were derived from published literature. Costs are in 2021 AUD$ and calculated from a societal perspective. Costs and utilities were discounted at 3% per annum. Sensitivity analyses were performed on key inputs including transition probabilities of well state and MI, costs of CAD and screening test. Willing-to-pay threshold of AUD$50,000 was selected.Results:Screening cancer survivors for CAD dominated no screening, providing cost savings of $1916 and QALY savings of 5.9 QALYs per-patient. Major determinants were probabilities of MI, death and costs of screening and MI. There was no change in life expectancy.Conclusion:Screening for CAD provided an increase in long-term QALY and reduction in healthcare costs in breast cancer survivors at least 10 years post treatment.
Abstract 10137: Area Deprivation Index Predicts Annual Chronic Kidney Disease Screening and Chronic Kidney Disease Development Among Newly Diagnosed Hypertensive and Type 2 Diabetic Patients in a Large Midwestern Health System
Circulation, Volume 146, Issue Suppl_1, Page A10137-A10137, November 8, 2022. Introduction:Clinical practice guidelines recommend regular chronic kidney disease (CKD) screening after a diagnosis of hypertension (HTN) or type 2 diabetes (T2DM). Annual monitoring of kidney function increases early detection of CKD and improves quality of life. However, disparities in neighborhood characteristics can impact access to routine care, including CKD screening.Hypothesis:We hypothesize area deprivation index (ADI), a national ranking of neighborhood sociodemographic disadvantage would predict annual CKD screening and CKD development among newly diagnosed HTN or T2DM patients.Methods:Electronic health records of patients (n=235,208) with an new HTN or T2DM diagnosis between 2015-2018 were abstracted using International Classification Codes. Patients were followed for three years to assess annual CKD screening (one estimated glomerular filtration rate and urinary albumin-to-creatine ratio) and CKD development (CKD or end stage renal disease). ADI ranks (1-100) were divided into quintiles (Q1=least deprived, Q5=most deprived). Multivariable logistic regression models evaluated associations between ADI quintiles with CKD screening and CKD development.Results:Most patients were White (57%) females (55%) with solely HTN (65%). Few with only T2DM (9%) and 26% had both. Screening was highest for patients who developed HTN and T2DM during the study (44%) compared to only T2DM (38%) or HTN (4%). CKD developed for 9% of patients with HTN and T2DM, but 0% for only HTN or T2DM. Compared to the least deprived patients, the most deprived were less likely to not be screened in the first year of HTN or T2DM diagnosis (Odds Ratio (OR)= 0.77; 95% confidence interval (CI): 0.73, 0.80). The most deprived patients were more likely to develop CKD compared to the least deprived patents (OR=1.98, 95%CI: 1.75, 2.23).Conclusions:The most deprived patients were more likely to be screened annually and almost twice as likely to develop CKD compared to the least deprived. Although an increase in deprivation is associated with poor lifestyle choices which can lead to an increase in CKD, it’s possible early diagnosis is due to an increase in screening, thus leading to an increase in quality of life through monitoring kidney function.
Abstract 11554: Biochemical and Molecular Newborn Screening for Familial Hypercholesterolemia
Circulation, Volume 146, Issue Suppl_1, Page A11554-A11554, November 8, 2022. Introduction:Familial Hypercholesterolemia (FH) is a common genetic disorder resulting in elevated low-density lipoprotein cholesterol (LDL-C) causing premature atherosclerosis. Despite guidelines, universal screening rates remain low. Newborn screening could increase FH diagnostic rates.Hypothesis:Biochemical newborn screening for LDL-C, total cholesterol (TC), and apolipoprotein B (apoB) followed by selective molecular testing identifies pathogenic and likely pathogenic variants causing FH.Methods:De-identified, residual newborn screening bloodspots collected for routine screening at 24-48 hours of life were analyzed for LDL-C, TC, and apoB. Values are expressed as multiples of median (MoM). Mahalanobis distance, measuring how far MoM values differed positively from 1, was computed. Samples with the most extreme Mahalanobis distance were selected for molecular testing (panel includesLDLR,APOB,PCSK9,LDLRAP1,APOE,STAP1,LIPA,ABCG5, andABCG8).Results:Distributions of apoB, TC, and LDL-C from 5,248 samples are shown below (figure). ApoB followed a Gamma distribution; TC and LDL-C followed non-normal but symmetric distributions. ApoB and LDL-C accounted for 93% of variance among biomarkers. Of the first 2500 samples, 192 samples were selected for molecular testing; a pathogenic variant for monogenic FH was detected in 1 sample and risk factors for polygenic FH in 4 samples (table below).Conclusions:Pathogenic or likely pathogenic variants for FH were identified with an incidence of 1 in 500 in the first 2500 newborn specimens tested. Further study will determine if this two-tiered screening strategy adequately detects FH in newborns.
Abstract 10253: Integrating Mental Health Screening Into a Health System for Measurement-Based Care of Patients With Peripheral Artery Disease
Circulation, Volume 146, Issue Suppl_1, Page A10253-A10253, November 8, 2022. Introduction:Multi-dimensional assessments of patient reported outcomes (PROs) are becoming increasingly important in optimizing patient-centered care for chronic conditions such as peripheral artery disease (PAD). We aimed to demonstrate the feasibility of a health system integrated workflow to incorporate mental health screenings into the outpatient PAD clinic workflow.Methods:In a large academic center, we administered three validated psychological assessments to consecutive outpatients between March 3, 2021 and July 7, 2021. Assessments were administered as part of an in-person patient navigation system (Yale PRO-QI) and was supported by online data collection. Assessments included the Patient Health Questionnaire-8 (PHQ-8) for depression, the Generalized Anxiety Disorder-7 (GAD-7) for anxiety, and the Perceived Stress Scale-4 (PSS-4) for stress. Validated cutoffs were used to screen for depression and anxiety ( >10 = depression or anxiety, respectively) and stress ( >6 = high stress).Results:There were 104 assessments collected for 98 participants with a mean age of 68.6+12.0 years old, 38.8% female, 86.7% White, 9.1% Black and 2.0% Asian or American Indian. The majority (72.5%) were seen for a routine follow-up visit. Two participants (2.0%) screened positive for generalized anxiety disorder. For depression, 12.2% screened positive. Almost half of all participants (47.9%) had higher levels of stress compared with a normative population. There were no statistically significant associations between the risk of positive screening and visit type.Conclusions:Measurement-based care metrics are becoming a standard best practice in routine clinical operations. Psychosocial screening instruments can be integrated in PAD outpatient care and highlight opportunities to improve integrated behavioral care pathways to provide the best care for this vulnerable population.