Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience (PROMISE)-protocol for a randomised controlled trial of electronic self-reporting of symptoms versus usual care during and following treatment in patients with cancer

Introduction
Routine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. PROM scores can be tracked over time allowing more timely identification of problems and more appropriate intervention. Studies have reported clear benefits in patient–clinician communication when PROMs are used and trials in the USA and France found patients randomised to complete regular ePROMs reported better health-related quality of life, had fewer unplanned hospital visits and, importantly, significantly better survival than those randomised to usual care. However, information about the effects on health outcomes and, particularly, the cost-effectiveness of incorporating this information into practice is limited.

Methods and analysis
PROMISE (Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience) is a multicentre, randomised hybrid effectiveness/implementation trial to evaluate the clinical and cost-effectiveness of using ePROMs in routine cancer care to improve patient outcomes. Participants (target sample=572; randomised 1:1 to intervention and control) are adults aged 18 years or older diagnosed with a solid cancer and starting treatment at one of the four study hospitals. The primary outcomes are unplanned hospital presentations and physical/functional well-being at 6 months. We hypothesise that, compared with usual care, patients randomised to use an ePROM tool will have fewer unplanned hospital presentations, report better health-related quality of life and greater satisfaction with their care and that the ePROM tool will be cost-effective. We will also assess implementation and process outcomes consistent with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework.

Ethics and dissemination
This trial has been approved by the Metro South Human Research Ethics Committee (HREC/2020/QMS/67441). Participants provide written informed consent, including consent for record linkage, prior to completing the baseline questionnaire. Study results will be disseminated via peer-reviewed journals and presentations at scientific conferences and clinical meetings.

Trial registration number
ACTRN12620001290987.

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Novembre 2024

Characteristics of urinary stone composition among patients with urolithiasis: a retrospective study in China

Objective
To present the most recent data on urinary calculi characteristics in the southern region of China and explore the effects of sociodemographic, clinical and laboratory characteristics on stone composition to fill the research gap.

Setting
A retrospective observational study was performed in Shenzhen between December 2019 and August 2022.

Participants
A total of 858 calculi samples from patients with urolithiasis were analysed via infrared spectroscopy.

Methods
The stone was classified by the European Association of Urology guidelines and the Mayo Clinic stone classification practices. Multivariate logistic regression models were conducted to evaluate the association between different characteristics and urinary stone composition.

Results
We found that the majority of these patients with urolithiasis were under 60. Almost half of the stone samples (49.4%) were single constitute, and calcium oxalate stone accounted for the highest proportion (80.0%), followed by infection stone (10.0%) and uric acid stone (4.9%). Of these, 78.0% were collected from males, with a male-to-female ratio of 3.54:1; the majority (95.0%) of calculi localisation was in the upper urinary tract. Multivariate analysis found that age, gender, history of urolithiasis, kidney disease, anatomical location and urinary pH influenced urinary stone composition.

Conclusions
The effective prevention of urolithiasis is the key to this working-age population. These findings may supply significant evidence for understanding the underlying aetiology of urolithiasis and offer clues for effectively preventing and treating urinary calculi.

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Novembre 2024

What are the barriers and facilitators to help-seeking behaviour for symptoms in patients with ovarian cancer in China? A qualitative study

Objectives
To explore the barriers and facilitators to help-seeking behaviour for symptoms among patients with ovarian cancer in China.

Design
This semistructured interview-based study used a descriptive phenomenological research method.

Setting
The study was conducted in China.

Participants
17 patients with ovarian cancer were selected based on the principle of maximum differentiation.

Outcome measures and analysis
The study followed the consolidated criteria for reporting qualitative research. Data were analysed using the Colaizzi’s seven-step method.

Results
Three main themes were identified: (1) low level of symptom perception and cancer risk awareness: unawareness of early non-specific symptoms, mistaken attribution of symptoms and delay caused by a previous diagnosis of benign tumours; (2) cognitive factors influencing help-seeking behaviour: positive health beliefs, perceived benefits of help-seeking, previous adverse medical experiences, stigma and restrained self-disclosure and medical treatment accompanied by distress and (3) practical factors affecting help-seeking behaviour: time pressure caused by social role burden, financial burden, lack of informal carers and mismatch between medical resources and patients’ needs.

Conclusion
This study shows that help-seeking behaviour for symptoms among patients with ovarian cancer is not valued. The importance of early symptom recognition, the psychosocial needs of patients and practical barriers must be considered to develop interventions to promote help-seeking behaviour.

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Novembre 2024

Abstract 4144554: Revascularization of Patients with Low-Density Non-Calcified Plaque was Associated with Lower Occurrence of Acute Coronary Syndrome

Circulation, Volume 150, Issue Suppl_1, Page A4144554-A4144554, November 12, 2024. INTRODUCTION:Coronary CT angiography (CCTA) is a powerful noninvasive tool for identifying high-risk plaque, such as low-density non-calcified plaque (LD-NCP). Though, the optimal treatment of patients with LD-NCP remains unclear. This study explored the association of revascularization in the setting of LD-NCP with the occurrence of acute coronary syndrome (ACS).Methods:This was a post-hoc analysis of the ICONIC study. A subset of 234 patients that underwent CCTA with subsequent ACS were matched to 234 control patients who also underwent CCTA but did not have ACS during follow-up. Patients were also followed for occurrence of revascularization, either coronary artery bypass graft or percutaneous coronary intervention. Atherosclerosis imaging-enabled quantitative CT (AI-QCT) was used to measure diameter stenosis, and LD-NCP, non-calcified plaque, and calcified plaque volumes from each CCTA. LD-NCP was defined as plaque with -190 to 30 Hounsfield Units. Patients were stratified based on the presence of LD-NCP. Subgroup analysis was conducted to compare the occurrence of ACS with the rate of revascularization. Kaplan-Meier survival curves and extended Cox regression analysis were used to evaluate the effect size of revascularization and LD-NCP on occurrence of ACS.Results:AI-QCT was completed in 448/468 subjects (follow-up time [MEAN±SD] 2.44±2.48 years). The median of LD-NCP was 1.2 mm3for patients with >0 mm3LD-NCP. There were 85 patients with LD-NCP >1.2 mm3and 363 patients with LD-NCP ≤1.2 mm3. In patients with LD-NCP >1.2 mm3, the rate of revascularization in patients with and without ACS was 3/52 (5.8%) versus 14/33 (42.4%) (p1.2 mm3and revascularization were less likely to have ACS during follow-up (adjusted HR: 0.20 [0.07, 0.61]; p=0.005). Additionally, patients with LD-NCP >1.2 mm3who did not undergo revascularization were more likely to have ACS (adjusted HR: 1.47 [1.03, 2.12]; p=0.036). Hazard ratios were adjusted for diameter stenosis, and non-calcified and calcified plaque volume. Time-dependent coefficients were included for diameter stenosis.Conclusion:Revascularization of patients with LD-NCP >1.2 mm3identified on CCTA with AI-QCT was associated with less risk for ACS.

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Novembre 2024

Abstract 4122350: Most Diabetes Mellitus Patients Had Right Lower Pulmonary Vein Thrombi; Additionally, Many Patients Had Extended Large Rod-Like Thrombi in the Left Atrium

Circulation, Volume 150, Issue Suppl_1, Page A4122350-A4122350, November 12, 2024. Background:Retrieved thrombus studies have shown that retrieved thrombi have calcifications, indicating that the thrombi are old. Left atrium diverticula (LADs) are common; however, the mechanisms of LAD formation are poorly understood. Pulmonary vein thrombi (PVTs) are common and are underestimated. In 2022, we reported that 98.6% of senior patients with age-related diseases such as hypertension, dyslipidemia and atrial fibrillation had PVTs, as estimated by cardiac computed tomography (CT) and transesophageal echocardiography (TEE). Additionally, we reported a case in which a malignant lymphoma patient had ATs in the right lower pulmonary vein, in which extended large rod-like thrombi in the left atrium (LA) were found, as determined by TEE. Patients with type 2 diabetes mellitus (T2DM) must have PVTs. The characteristics of extended LA thrombi in patients with T2DM are unclear.Methods:Thirty-one patients with T2DM (73.5 +/- 8.9 y.o., from 50 y.o. to 88 y.o.; male, 24) were examined for PVTs, as estimated via TEE and cardiac CT.Results:Thirty (97%) patients with T2DM had PVTs in the right lower pulmonary vein (RLPV) and connected LA thrombi, as estimated using TEE. Among them, 27 (87%) patients had large white rod-like LA thrombi extending from RLPV thrombi, and the diameter of the thin part of the rod-like LA thrombi was approximately 5 mm. The end of the LA thrombi was mainly attached to the left side of the anterior wall or the posterior side of left side wall of the LA. Additionally, there were left atrium diverticula (LADs) around the attachment regions. Three patients had RLPV thrombi and connected shorter LA thrombi. A 79-year-old male patient did not have detectable PVTs. The patient had taken apixaban (2.5 mg, twice daily) for six years due to atrial fibrillation and stroke.Conclusions:Most (97%) elderly T2DM patients had RLPV thrombi. Additionally, many (87%) patients had extended large rod-like thrombi in the LA. The diameter of the thin part of the large rod-like LA thrombi was approximately 5 mm. There were LADs around the attachment regions where the ends of the LA thrombi from the RLPV thrombi were attached.

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Novembre 2024

Abstract 4139141: Predicted efficacy of inclisiran on cardiovascular outcomes in lower extremity peripheral artery disease: results of the In Silico Sirius study

Circulation, Volume 150, Issue Suppl_1, Page A4139141-A4139141, November 12, 2024. Introduction:Symptomatic lower extremity peripheral artery disease (PAD) patients have the highest risk of cardiovascular (CV) outcomes among patients with established atherosclerotic cardiovascular disease (ASCVD). Inclisiran, an siRNA targeting PCSK9 mRNA, reduces LDL-C levels. In SIRIUS in silico trial (NCT05974345), inclisiran was predicted to lower CV events in ASCVD patients.Research question/Hypothesis:SIRIUS in silico study aims to predict the efficacy of inclisiran on CV outcomes in subgroups of patients with or without PAD.Methods:The SIRIUS in silico trial was conducted using a knowledge-based mechanistic computational model of ASCVD applied to a virtual ASCVD population with LDL-C ≥ 70 mg/dL. Each virtual patient is its own control. This model was previously calibrated and validated before running the trial. SIRIUS compared the efficacy of inclisiran vs placebo on top of High Intensity (HI) statins with or without ezetimibe on 3-Point-MACE defined as a composite of time to first occurrence of CV death, nonfatal myocardial infarction (MI) or nonfatal ischemic stroke (IS) over 5 years. Occurrence of major acute limb events (MALE) was also individually assessed in time-to-first-event analyses.Results:Among 204, 691 virtual SIRIUS ASCVD patients, 28,072 (13.7%) had PAD. At 5 years, the mean predicted percentage reduction in LDL-C with inclisiran as compared to placebo was -49.3% and -49.8% in patients with or without PAD, respectively. The predicted rate of 3P-MACE in the inclisiran arm was consistently lower than in the placebo arm in patients with PAD (17.62% vs 22.88%; Hazard Ratio (HR): 0.75 medium uncertainty) and in patients without PAD (10.33% vs 13.64%; HR: 0.75 low uncertainty). Compared to placebo, inclisiran was also predicted to consistently reduce MALE in patients with or without PAD (2.71% vs 4.11%; HR: 0.65 medium uncertainty and 0.19% vs 0.29%; HR: 0.66 high uncertainty respectively).Conclusion:Pending the results of ORION-4 and VICTORION-2-P, this first In Silico trial in virtual PAD patients predicted a potential effect of inclisiran on 3P-MACE and MALE reductions over 5 years follow-up.

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Novembre 2024

Abstract 4140089: Lower low-lipoprotein cholesterol level at the time of acute myocardial infarction is associated with increased cardiovascular events

Circulation, Volume 150, Issue Suppl_1, Page A4140089-A4140089, November 12, 2024. Background:Lipid-lowering therapy for patients with acute myocardial infarction (AMI) is highly recommended, however, a paradox may exist where lower low-density lipoprotein cholesterol (LDL-C) levels at myocardial infarction (MI) are associated with poorer prognoses.Aim:To evaluate the association between baseline LDL-C levels and cardiovascular events after MI.Methods:We studied 1,987 consecutive AMI patients who underwent primary percutaneous coronary intervention and who had available data on preprocedural LDL-C between 1999-2015 at Juntendo University Shizuoka Hospital. Patients were divided into quartiles based on their LDL-C levels. The incidence of major adverse cardiac events (MACE), including all-cause death and recurrent MI up to 5-year, were evaluated.Results:Patients in the lowest LDL-C group were older and had higher prevalence of hypertension, diabetes mellitus and chronic kidney disease. During follow-up, 455 (20.9%) MACE were identified. Cumulative incidence of MACE was significantly higher in the lowest LDL-C group than in other groups (p

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Novembre 2024

Abstract 4140995: Ultrasonic Vaping Devices Heat at Lower Temperatures than Coiled E-Cigarettes, but can Cause Comparable Levels of Cardiac Fibrosis

Circulation, Volume 150, Issue Suppl_1, Page A4140995-A4140995, November 12, 2024. Background:Coil-less ultrasonic vaping devices like Surge use an ultrasonic chip that vibrates at several million Hz, aerosolizing the e-liquid. They are advertised as emitting significantly lower levels of toxins than coiled e-cigs by heating to lower temperatures that produce fewer chemical breakdown products. We tested the hypothesis that ultrasonic e-cigs cause less adverse cardiac effects than coiled e-cigs.Methods:We exposed 3 groups of conscious Sprague Dawley rats (n=8/group) to aerosol from JUUL (Virginia Tobacco 5% nicotine), Surge (Rich Tobacco 18 mg/ml nicotine), or air. Pulsatile exposure consisted of 10 consecutive cycles, each consisting of 2s exposure to aerosol followed by 28s of clean air, over 5 min, for 9 weeks using a Gram Research universal vaping machine. Hearts were then isolated, sectioned, and stained for left and right ventricular fibrosis with Sirius Red. Temperature profiles for the Surge ultrasonic vaping device were obtained at the California Department of Public Health (CDPH) via a single point thermocouple probe.Results:Temperature profiles of Surge during one session of aerosol production (with airflow) showed temperatures not exceeding 132 degrees Celsius. (We previously reported that the USONICIG Zip ultrasonic vaping device with air flow heated to ~77 degrees Celsius; reported temperatures of coiled e-cigs are up to 300 degrees Celsius.) Fibrosis was significantly increased in the JUUL group compared to air (p=0.04). Mean fibrosis in the Surge group was comparable to that in the JUUL group (p=0.84) and was higher than air fibrosis but did not reach significance (p=0.15), potentially due to high variability of Surge values.Conclusion:Temperature profiles of ultrasonic vaping devices are substantially lower than those of coiled vaping devices, with Surge being warmer than USONICIG Zip under airflow conditions. Despite lower temperatures, ultrasonic vaping devices cause a comparable level of cardiac fibrosis to conventional coiled vaping devices. Therefore, Surge does not avoid the increase in cardiac fibrosis that we have reported for coiled e-cigs and for smoke from tobacco or marijuana.

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Novembre 2024

Abstract 4139413: Free Testosterone is Associated with Lower Microvascular Function in Men with Prostate Cancer

Circulation, Volume 150, Issue Suppl_1, Page A4139413-A4139413, November 12, 2024. BACKGROUND:Cardiovascular disease (CVD) is the leading cause of death in men with prostate cancer (PC), and vascular function and arterial stiffness can predict CVD. High circulating free testosterone has been associated with increased arterial stiffness in PC, and higher circulating free testosterone early in prostate cancer diagnosis is associated with more aggressive disease. However, the role of circulating free testosterone and its influence on microvascular function in men with PC has yet to be elucidated. Thus, the present study sought to investigate the relationship between free testosterone and a comprehensive assessment of vascular health over time in men with PC.METHODS:Thirty-two men (Age: 67±1 years; BMI: 28.2±1.1 kg/m2) with PC participated in this study. Fasting blood samples were collected to assess both total and free testosterone. The flow-mediated dilation (FMD) test was used to assess conduit vessel function and microvascular function was assessed using local thermal heating (LTH). Arterial stiffness was assessed using augmentation index (AIx75). Blood samples and assessments of vascular health were conducted at baseline and every 3 months thereafter. Data are reported as mean±SEM.RESULTS:Free testosterone decreased (p=0.079) from baseline (5.0±0.5 pg/mL) to 3 months (4.6±1.1 pg/mL) and remained lower at 6 months (4.4±0.7 pg/mL), and 9 months (4.7±0.8 pg/mL). In addition, total testosterone was similar (p >0.05) from baseline (318±38 ng/dL) throughout the study. Free testosterone at baseline was inversely correlated with the change in LTH at 3 months (r=-0.601;p=0.030), 6 months (r=-0.638;p=0.035), and 9 months (r=-0.671;p=0.048). There was a positive correlation between free testosterone at baseline and the change in AIx75 from baseline to 3 months (r=0.668;p=0.013). No relationships between free testosterone and FMD over time were identified, nor were any relationships observed between total testosterone and indices of vascular health.DISCUSSION:Findings from this study demonstrate that a higher circulating free testosterone at baseline is associated with increased microvascular dysfunction and arterial stiffness over time. Future studies are needed to elucidate the precise mechanistic role of free testosterone on microvascular function in prostate cancer and whether therapeutic approaches can be used to mitigate the negative cardiovascular effects associated with lower concentrations of androgens.

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Novembre 2024