Test reliability and comparability of paper and Chinese electronic version of the western Ontario and McMaster University osteoarthritis index: protocol for a randomised controlled clinical trial

Introduction
The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.

Methods and analysis
A total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.

Ethics and dissemination
The protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number
ChiCTR2100050914.

Leggi
Novembre 2022

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.

Leggi
Novembre 2022

The Prevalence and Association of Exercise Test Abnormalities with Sudden Cardiac Death and Transplant-Free Survival in Childhood Hypertrophic Cardiomyopathy

Circulation, Ahead of Print. Background: Hypertrophic cardiomyopathy (HCM) can be associated with an abnormal exercise response. In adults with HCM, an abnormal exercise stress test is predictive of heart failure outcomes. Our goal was to determine if an abnormal exercise response is associated with adverse outcomes in pediatric HCM patients.Methods: In an international cohort study with 20 centers, phenotype-positive children with primary HCM

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Novembre 2022

Abstract 10285: Prognostic Value of Provocative Spasm Test in Patients With Myocardial Infarction With and Without Obstructive Coronary Arteries

Circulation, Volume 146, Issue Suppl_1, Page A10285-A10285, November 8, 2022. Introduction: Coronary spasm potentially contributes to the pathogenesis of acute myocardial infarction (MI) with obstructive coronary artery disease (MICAD) and particularly warrants close consideration in MI with non-obstructive coronary arteries (MINOCA). However, there are limited data concerning the impact of coronary spasm in acute myocardial infarction (AMI). We aimed to assess the prognostic impact of provocative coronary spasm in both MICAD and MINOCA.Methods:Of 1,101 AMI patients admitted to our hospital from January 2012 to December 2019, 267 AMI patients (MICAD: n=198, MINOCA: n=69) who underwent emergency CAG and invasive provocative spasm test were assessed. The primary endpoint was a composite of major adverse cardiac events (MACE), defined as cardiovascular death, acute coronary syndrome, or revascularization. The median follow-up duration was 48 months.Results:Provocative test was positive in 143 (72.2%) of MICAD group and 33 (47.8%) of MINOCA group. In MICAD group, spasm-positive patients had a significantly higher occurrence of both MACE [27 (18.9%) vs. 4 (7.3%); p=0.0413] and Revascularization [25 (17.5%) vs. 3 (5.5%); p=0.0296] compared to spasm-negative patients. In MINOCA group, MACE occurred only in patients with spasm-positive [4 (12.1%) vs. 0 (0%); p=0.0473]. Among the 4 groups based on the type of MI (MICAD or MINOCA) and the presence of provoked coronary spasm, there was a significant difference in the MACE-free survival rate, with the lowest rate observed for MICAD patients with spasm-positive (log rank P=0.0111). In a Multivariable analysis, provoked coronary spasm was significantly associated with MACE in MICAD group (hazard ratio, 3.37;95% CI, 1.20-12.10; P=0.0189).Conclusions:Provocative spasm test could provide prognostic stratification for AMI patients.

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Ottobre 2022

Abstract 15241: Mixed Meal Tolerance Test Elicits Distinct Metabolite Kinetics for Individuals With and Without Diabetes

Circulation, Volume 146, Issue Suppl_1, Page A15241-A15241, November 8, 2022. Introduction:Branched chain amino acids (BCAA) are strongly associated with incident diabetes and CVD, and drugs that target their metabolism, especially in the context of a meal, are emerging treatments for diabetes given supportive genetic data. However, little is known about how BCAA, their breakdown metabolites—branched chain ketoacids (BCKA), and other metabolites change after a meal.Hypothesis:BCAA and BCKA levels are higher in individuals with diabetes after a mixed meal tolerance test (MMTT) than in those without diabetes, and a MMTT will uncover additional metabolites involved in dysregulated metabolic pathways secondary to diabetes.Methods:We administered a MMTT to 13 adults with diabetes treated by metformin alone and 11 age and sex matched controls. We measured BCKA, BCAA, and 194 metabolites at 8 timepoints across 6 hours. We used a mixed model for repeated measurements to compare between group differences at each timepoint with adjustment for baseline levels.Results:Across the participants (57 ± 8 years, 71% female, BMI 28 ± 4 kg/m2), adjusted BCAA levels were similar at all timepoints between groups, but adjusted BCKA levels were higher in those with diabetes at 120 minutes (Figure). An additional 9 metabolites had 4 or more timepoints with significant between group differences (Figure). Acylcarnitine, palmitic acid, and linoleic acid showed slower rates of decrease and recovery in those with diabetes, altogether supportive of impaired fatty acid uptake and oxidation. Glycocholic acid showed no increase in those with diabetes, a finding that requires further study given growing recognition of bile acids’ paracrine effects on the liver.Conclusions:In contrast to BCAA, BCKA remained elevated after a MMTT in those with diabetes, suggesting that BCKA catabolism may be a key dysregulated process in the link between BCAA and diabetes. Other metabolites with different kinetics after a MMTT may be markers of dysmetabolism and impaired nutrient handling.

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Ottobre 2022

Abstract 11615: The Prevalence and Association of Exercise Test Abnormalities With Sudden Cardiac Death and Transplant-Free Survival in Childhood Hypertrophic Cardiomyopathy

Circulation, Volume 146, Issue Suppl_1, Page A11615-A11615, November 8, 2022. Introduction:Hypertrophic cardiomyopathy (HCM) can be associated with an abnormal exercise response. In adults with HCM, an abnormal exercise stress test (EST) is predictive of heart failure outcomes. Our goal was to determine if an abnormal exercise response is associated with adverse outcomes in pediatric HCM patients.Methods:: In an international cohort study with 20 centers (PRIMaCY), children

Leggi
Ottobre 2022