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PURPOSE Despite evidence of diagnostic accuracy but unclear long-term clinical benefit, national utilization patterns of prostate-specific membrane antigen positron emission tomography (PSMA-PET) are undefined. METHODS We conducted a serial cross-sectional study to evaluate the use of PET imaging among commercial insurance beneficiaries with prostate cancer using administrative claims from deidentified Blue Cross Blue Shield Axis database. Eligible patients included prevalent and incident prostate cancer cases. We calculated the proportions undergoing PET imaging in semiannual periods from January 1, 2016, through December 31, 2024. We examined the association between regional-level contextual sociodemographic and health care characteristics, and regional use of PSMA-PET imaging in 2024. RESULTS A total of 514,750 male beneficiaries age 40-89 years with prostate cancer were identified between 2016 and 2024. The proportion of individuals with prostate cancer undergoing PET imaging increased from 4.5 [95% CI, 4.1 to 4.9] per 1,000 in the first half of 2016 to 77.6 (95% CI, 76.2 to 79.1) per 1,000 in the second half of 2024, P < .001. Increases in PET were driven by uptake of PSMA-PET following approval in 2021, which increased from 0.8 (95% CI, 0.6 to 0.9) per 1,000 in the second half of 2021 to 77.0 (95% CI, 75.5 to 78.5) per 1,000 in the second half of 2024, P < .001. PSMA-PET use in 2024 was higher in regions with greater education (99.3 v 114.6 per 1,000 in lowest [Q1] v highest [Q4] educated) and income (95.4 v 112.3 per 1,000 in Q1 v Q4 income) measures, P < .001. CONCLUSION PSMA-PET was rapidly incorporated into clinical practice among commercial insurance beneficiaries with prostate cancer with higher adoption in geographic regions with higher income and education.

Introduction Many clinical practice guidelines (CPGs) claim to use Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, but its implementation varies. This suggests that CPG developers, methodologists and users would benefit from an instrument to evaluate the extent to which CPGs adhere to GRADE approach. Such a structured instrument is currently unavailable. Accordingly, this study will develop an evaluation instrument for assessing guideline adherence to the GRADE approach, which we have named ‘GRADE-Check’. The goal is to target items to which CPGs fail to adhere and that potentially have serious consequences resulting in inaccuracies in certainty of evidence and inappropriate direction or strength of recommendations, thereby discriminating across CPGs in issues of importance. Methods and analysis The panel will include up to 25 individuals with specific knowledge and expertise, including experienced authors, educators and methodologists on CPGs methodology and GRADE approach from relevant organisations. The instrument will focus on the key elements of GRADE, aiming for clarity for GRADE experts and non-GRADE experts to apply. The development process for GRADE-Check will consist of the following five phases: (1) recruitment of a panel of GRADE experts; (2) development of objectives and scope for the development of GRADE-Check and criteria for item selection; (3) generation of candidate items through a literature review and panel consultation; (4) panellist discussion to construct the initial draft and extended explanation manual and (5) user testing. Ethics and dissemination This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no. (2025047K)). Our research findings will be published in peer-reviewed journal articles and presented at academic conferences. Additionally, the dissemination plan will include considerations for the development of implementation manuals, a dedicated project website and training tools.

Importance Prostate-specific membrane antigen positron emission tomography (PSMA-PET), a form of molecular imaging, increases detection of advanced and metastatic prostate cancer, but its potential to increase treatment costs due to increased detection is poorly defined. Objective To estimate lifetime health and cost outcomes and evaluate the cost-effectiveness associated with implementing PSMA-PET in the clinical evaluation of a patient with a biochemical recurrence (BCR) of prostate cancer, with evaluation of sources of uncertainty in the underlying evidence and assessment of the need and focus of additional data collection. Design, Setting, and Participants This economic evaluation developed a decision-analytic model consisting of a decision tree and a Markov model informed by published literature and a study of patients with BCR prostate cancer undergoing PSMA-PET after definitive surgery or radiation therapy at 2 high-volume US academic centers. The analysis was performed between August 1, 2024, and May 1, 2025. Interventions Patients underwent (1) PSMA-PET, (2) PSMA-PET imaging as a reflex test if computed tomography plus bone scan (CTBS) was negative or equivocal (CTBS + PSMA-PET), and (3) CTBS alone. Main Outcomes and Measures Lifetime quality-adjusted life-years (QALYs) and costs, incremental cost-effectiveness ratio (ICER), and value of information estimates were assessed, with 95% uncertainty intervals (UIs). We assumed a willingness-to-pay threshold of $150 000 per QALY. Results The model simulated 1000 patients with BCR (median age, 66 years) and estimated that up-front PSMA-PET is expected to have the highest mean QALYs (7.12 QALYs [95% UI, 6.71-7.51 QALYs]) compared with 6.55 QALYs (95% UI, 6.08-7.03 QALYs) for CTBS; it was also estimated to have higher mean costs ($451 000 [95% UI, $336 000-$577 000]) compared with $351 000 (95% UI, $263 000-$455 000]) for CTBS; consequently, PSMA-PET had mean increments of $99 000 (95% UI, $55 000-153,000) in costs and 0.58 QALYs (95% UI, 0.35-0.82 QALYs) compared with CTBS, leading to an ICER of $172 000 per QALY, which exceeded the assumed $150 000/QALY willingness-to-pay threshold. In patients with lower prostate-specific antigen levels (&amp;lt;2 ng/mL), PSMA had mean increments of $61 000 (95% UI, $21 000-$104 000) in costs and 0.54 QALYs (95% UI, 0.34-0.77 QALYs) compared with CTBS, leading to an ICER of $113 000/QALY, suggesting it had the potential to be cost-effective. Because of high decisional uncertainty, additional information regarding outcomes and diagnostic characteristics may be associated with reduced uncertainty and a gain of 15 747 QALYs. Conclusions and Relevance This study found that PSMA-PET may be associated with improved disease detection but may not be cost-effective due to high treatment costs offsetting moderate improvements in QALYs. Further research is needed to identify patient subsets and clinical scenarios in which molecular imaging provides the greatest value.

Purpose: Prostate-specific membrane antigen positron emission tomography (PSMA-PET) improves prostate cancer (PCa) localization, particularly in biochemical recurrence (BCR). The primary objective was to assess management patterns after PSMA-PET for BCR at 2 academic centers. Methods: This study evaluated clinical management within 6 months after first PSMA-PET for patients with BCR after local therapy. Management categories included no treatment, local therapy, systemic therapy, and metastasis-directed therapy (MDT). We also evaluated clinical management decision variation across strata of PSMA-PET results PSA levels (<2.0, 2.0-4.99, and ≥5.0 ng/mL) at time of imaging. Results: We identified 581 patients who received PSMA-PET from February 2021 to June 2023. PSMA-PET findings were negative in 142 (24%) and demonstrated localized recurrence in 86 (15%), regional nodal disease in 60 (10%), and distant metastasis in 293 (50%). Distant metastasis was identified in 105 (35%) patients with PSA < 2.0, 67 (60%) with PSA 2.0 to 4.99, and 115 (71%) with PSA ≥ 5.0. In patients with negative PSMA-PET, 63 (44%) received treatment. Conversely, 92% with detected metastases were treated (systemic therapy in 189 [64%], MDT in 75 [26%], and local therapy in 7 [2%]). Treatments differed by the PSA level within strata of PSMA-PET findings. Among 293 patients with metastases, MDT was used more commonly in patients with PSA < 2.0 (37%) than PSA 2.0 to 4.99 (30%) or PSA ≥ 5.0 (13%). Conclusions: Most patients undergoing PSMA-PET for BCR had identifiable disease and initiated therapy within 6 months. Identification of distant metastases and treatment choices differed by the PSA level at imaging. Prospective research is needed to determine whether earlier detection and treatment initiation improve clinical outcomes.

ImportanceAlthough prostate-specific membrane antigen positron emission tomography (PSMA-PET) has shown improved sensitivity and specificity compared with conventional imaging for the detection of biochemical recurrent (BCR) prostate cancer, the long-term outcomes of a widespread shift in imaging are unknown.ObjectiveTo estimate long-term outcomes of integrating PSMA-PET into the staging pathway for recurrent prostate cancer.Design, Setting, and ParticipantsThis decision analytic modeling study simulated outcomes for patients with BCR following initial definitive local therapy. Inputs used were from the literature and a retrospective cohort study conducted at 2 institutions. The base case analysis assumed modest benefits of earlier detection and treatment, and scenario analyses considered prostate-specific antigen (PSA) level at imaging and different outcomes of earlier vs delayed treatment. The analysis was performed between April 1, 2023, and May 1, 2024.Exposures(1) Immediate PSMA-PET imaging, (2) conventional imaging (computed tomography and bone scan [CTBS]) followed by PSMA-PET if CTBS findings were negative or equivocal, and (3) CTBS alone.Main Outcomes and MeasuresThe main outcomes were detection of metastases, deaths from prostate cancer, and life-years and quality-adjusted life-years (QALYs) gained.ResultsThe model estimated that per 1000 simulated patients with BCR (assumed median age, 66 years), PSMA-PET is expected to diagnose 611 (95% uncertainty interval [UI], 565-656) patients with metastasis compared with 630 (95% UI, 586-675) patients diagnosed using CTBS followed by PSMA-PET and 297 (95% UI, 202-410) patients diagnosed using CTBS alone. Moreover, the estimated number of prostate cancer deaths was 512 (95% UI, 472-552 deaths) with PSMA-PET, 520 (95% UI, 480-559 deaths) with CTBS followed by PSMA-PET, and 587 (95% UI, 538-632 deaths) with CTBS alone. Imaging with PSMA-PET yielded the highest number of QALYs, which were 824 (95% UI, 698-885) higher than CTBS. These results differed by PSA level at the time of testing, with the highest incremental life-years and QALYs and lowest number of deaths from prostate cancer among patients with PSA levels of at least 5.0 ng/mL. Finally, the estimates were sensitive to the expected benefit of initiating therapy for recurrent prostate cancer earlier in the disease course.Conclusions and RelevanceThe results of this decision-analytic model suggest that upfront PSMA-PET imaging for the evaluation of BCR is expected to be associated with reduced cancer mortality and gains in life-years and QALYs compared with the conventional imaging strategy, assuming modest benefits of earlier detection and treatment.

34 Background: Prostate specific membrane antigen positron emission tomography (PSMA-PET) imaging improves prostate cancer visualization and has been proposed as a tool to guide treatment decisions. As PSMA-PET imaging agents were not approved in the United States (US) until December 2020, little is known about national patterns of PET imaging utilization. Methods: We conducted a dynamic cohort study to evaluate use of PET imaging among insurance beneficiaries aged 40-89 years with a diagnosis of prostate cancer using deidentified administrative claims from Blue Cross Blue Shield Axis. We calculated the proportions of patients undergoing PET imaging in semiannual periods from January 1, 2016, through December 31, 2022, examining tracers specific to prostate cancer, including PSMA-targeted agents as well as fluciclovine, sodium fluoride, and choline tracers. Cochran-Armitage tests were used to evaluate trends in the proportion of individuals receiving PET imaging over time. We also assessed the association between regional [hospital referral region (HRR)] level contextual sociodemographic and healthcare characteristics and regional use of PSMA-PET imaging in 2022 using chi-square tests. Results: There were 410,505 beneficiaries with prostate cancer identified in the study period. The semiannual proportion of patients undergoing PET imaging increased from 4.5 [(95% confidence interval (CI) 4.1-5.0] per 1,000 in the first half of 2016 to 41.7 (95% CI 40.6-42.9) per 1,000 in the second half of 2022, p<0.001. Increases in PET imaging were driven by uptake of PSMA-PET imaging, which increased from 0.7 (95% CI 0.6-0.9) per 1000 in the second half of 2021 to 37.5 (95% CI 36.4-38.6) per 1,000 in the second half of 2022, p<0.001. Following approvals of PSMA-PET agents, other forms of PET imaging rapidly decreased – from 18.2 (95% CI 17.4-18.9) per 1000 in the second half of 2021 to 4.6 (95% CI 4.3-5.0) per 1,000 in the same period of 2022, p<0.001. Compared to HRRs in quartile 1 (Q1), HRRs in Q4 of PSMA-PET use in 2022 had higher levels of education (25.0% with college education or higher in Q1 versus 29.4% in Q4, p=0.005) and median household income ($50,200 in Q1 versus $60,900 in Q4, p<0.001). Conclusions: In this study from a large commercial US health insurer, PSMA-PET was rapidly incorporated into clinical practice and is now the dominant prostate cancer radiotracer. However, the initial uptake of PSMA-PET may be accompanied by disparity, as our data suggests less use in areas with lower income and education measures.

SummaryBackgroundCrohn's disease has a substantial negative impact on health‐related quality of life (HRQoL).AimTo examine the effects of risankizumab on HRQoL in Crohn's diseaseMethodsWe analysed data from patients with Crohn's disease from 12‐week induction trials ADVANCE (N = 850) and MOTIVATE (N = 569) with risankizumab 600 mg or 1200 mg intravenous (IV) versus placebo IV and a 52‐week maintenance trial FORTIFY (N = 462) with risankizumab 180 or 360 mg subcutaneous (SC) versus placebo SC. Outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F), 36‐item Short Form Health Survey (SF‐36), EuroQol 5‐Dimension‐5‐Level (EQ‐5D‐5L) and work productivity. The mean change and percentages of patients achieving clinically meaningful improvement in all outcomes were determined at weeks 12 and 52.ResultsAt week 12, more patients in the risankizumab 600 or 1200 mg groups achieved IBDQ response than with placebo (ADVANCE: 70.2%, 75.5% vs. 47.8%, p ≤ 0.001; MOTIVATE: 61.7%, 68.5% vs. 48.2%, p ≤ 0.01) and FACIT‐F response (ADVANCE: 51.3%, 48.0% vs. 35.7%, p ≤ 0.01; MOTIVATE: 44.2%, 49.1% vs. 33.7%, p < 0.05). These improvements persisted at week 52 with risankizumab maintenance treatment. Similar trends were observed for SF‐36 physical and mental component summary scores, EQ‐5D‐5L and activity impairment within work productivity measures.ConclusionsRisankizumab induction therapy (600 or 1200 mg IV) led to clinically meaningful improvements in disease‐specific and general patient‐reported outcomes, including fatigue, in patients with moderate to severe Crohn's disease. These improvements were sustained after 52 weeks of risankizumab (180 or 360 mg SC) maintenance therapy.

Abstract Background Strategies to optimize antibiotic prescribing at discharge are not well understood. Methods In fall 2019, we surveyed 39 Michigan hospitals on their antibiotic stewardship strategies. The association of reported strategies with discharge antibiotic overuse (unnecessary, excess, suboptimal fluoroquinolones) for community-acquired pneumonia (CAP) and urinary tract infection (UTI) was evaluated in 2 ways: (1) all strategies assumed equal weight and (2) strategies were weighted based on the ROAD (Reducing Overuse of Antibiotics at Discharge) Home Framework (ie, Tier 1—Critical infrastructure, Tier 2—Broad inpatient interventions, Tier 3—Discharge-specific strategies) with Tier 3 strategies receiving the highest weight. Results Between 1 July 2017 and 30 July 2019, 39 hospitals with 20 444 patients (56.5% CAP; 43.5% UTI) were included. Survey response was 100%. Hospitals reported a median (interquartile range [IQR]) 12 (9–14) of 34 possible stewardship strategies. On analyses of individual stewardship strategies, the Tier 3 intervention, review of antibiotics prior to discharge, was the only strategy consistently associated with lower antibiotic overuse at discharge (adjusted incident rate ratio [aIRR] 0.543, 95% confidence interval [CI]: .335–.878). On multivariable analysis, weighting by ROAD Home tier predicted antibiotic overuse at discharge for both CAP and UTI. For diseases combined, having more weighted strategies was associated with lower antibiotic overuse at discharge (aIRR 0.957, 95% CI: .927–.987, per weighted intervention); discharge-specific stewardship strategies were associated with a 12.4% relative decrease in antibiotic overuse days at discharge. Conclusions The more stewardship strategies a hospital reported, the lower its antibiotic overuse at discharge. However, Tier 3, or discharge-specific strategies, appeared to have the largest effect on antibiotic prescribing at discharge.