Accuracy of heart failure ascertainment using routinely collected healthcare data: a systematic review and meta-analysis.

BACKGROUND: Ascertainment of heart failure (HF) hospitalizations in cardiovascular trials is costly and complex, involving processes that could be streamlined by using routinely collected healthcare data (RCD). The utility of coded RCD for HF outcome ascertainment in randomized trials requires assessment. We systematically reviewed studies assessing RCD-based HF outcome ascertainment against "gold standard" (GS) methods to study the feasibility of using such methods in clinical trials. METHODS: Studies assessing International Classification of Disease (ICD) coded RCD-based HF outcome ascertainment against GS methods and reporting at least one agreement statistic were identified by searching MEDLINE and Embase from inception to May 2021. Data on study characteristics, details of RCD and GS data sources and definitions, and test statistics were reviewed. Summary sensitivities and specificities for studies ascertaining acute and prevalent HF were estimated using a bivariate random effects meta-analysis. Heterogeneity was evaluated using I2 statistics and hierarchical summary receiver operating characteristic (HSROC) curves. RESULTS: A total of 58 studies of 48,643 GS-adjudicated HF events were included in this review. Strategies used to improve case identification included the use of broader coding definitions, combining multiple data sources, and using machine learning algorithms to search free text data, but these methods were not always successful and at times reduced specificity in individual studies. Meta-analysis of 17 acute HF studies showed that RCD algorithms have high specificity (96.2%, 95% confidence interval [CI] 91.5-98.3), but lacked sensitivity (63.5%, 95% CI 51.3-74.1) with similar results for 21 prevalent HF studies. There was considerable heterogeneity between studies. CONCLUSIONS: RCD can correctly identify HF outcomes but may miss approximately one-third of events. Methods used to improve case identification should also focus on minimizing false positives.

Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial.

INTRODUCTION: ASCEND PLUS is a randomised controlled trial assessing the effects of oral semaglutide on the primary prevention of cardiovascular events in around 20,000 individuals with type 2 diabetes in the UK. The trial's innovative design includes a decentralised direct-to-participant invitation, recruitment, and follow-up model, relying on self-completion of online forms or telephone or video calls with research nurses, with no physical sites. Extensive patient and public involvement and engagement (PPIE) was essential to the design and conduct of ASCEND PLUS. AIM: To report the process and conduct of PPIE activity in ASCEND PLUS, evaluate effects on trial design, reflect critically on successes and aspects that could have been improved, and identify themes and learning relevant to implementation of PPIE in future trials. METHODS: PPIE activity was coordinated centrally and included six PPIE focus groups and creation of an ASCEND PLUS public advisory group (PAG) during the design phase. Recruitment to these groups was carefully considered to ensure diversity and inclusion, largely consisting of adults living with type 2 diabetes from across the UK. Two members of the PAG also joined the trial Steering Committee. Steering Committee meetings, focus groups, and PAG meetings were conducted online, with two hybrid workshops to discuss PPIE activity and aspects of the trial. RESULTS: PPIE activity was critical to shaping the design and conduct of ASCEND PLUS. Key examples included supporting choice for participants to either complete the screening/consent process independently online, or during a telephone or video call interview with a research nurse. A concise 'initial information leaflet' was developed to be sent with the initial invitations, with the 'full' information leaflet sent later to those interested in joining the trial. The PAG reviewed the content and format of participant- and public-facing materials, including written documents, online screening forms, animated videos, and the trial website, to aid clarity and accessibility, and provided input into the choice of instruments to assess quality of life. CONCLUSIONS: PPIE is integral in ASCEND PLUS and will continue throughout the trial. This involvement has been critical to optimising the trial design, successfully obtaining regulatory and ethical approval, and conducting the trial.

Complete heart block as a herald sign for cardiac lymphoma.

A previously well 48-year-old man presented with presyncope and was found to be in complete heart block. Blood tests, echocardiography and coronary angiography were reported as normal, and a dual chamber permanent pacemaker was inserted. Six months later he re-presented with breathlessness. His chest X-ray showed cardiomegaly and echocardiography revealed a 4.4 cm pericardial effusion. A CT thorax revealed a mass originating from the intra-atrial septum, extending into the right atrium and ventricle. There were multiple pulmonary lesions suspected to be metastases. Histology demonstrated high-grade B-cell lymphoma. He was treated with eight cycles of R-CHOP chemotherapy and showed good radiological and clinical improvement. Post-treatment echocardiography found severe left ventricular dysfunction with an ejection fraction of <20%. Heart failure medical therapy was optimised and the pacemaker was upgraded to a resynchronisation device. A repeat scan 6 months post device upgrade showed an improvement in ejection fraction to 45%-50%.

IgG4-mediated sclerosing fibroinflammatory disease presenting as inflammatory breast malignancy.

IgG4-mediated sclerosing fibroinflammatory disease is a rare systemic disease which has the ability to form masses in multiple organs and may mimic malignancy. In this case we describe a 53-year-old female who presented with clinical and imaging findings in her right breast consistent with inflammatory breast carcinoma and associated right axillary nodal mass. She underwent CT which also uncovered a left thyroid mass and suggested both masses were possibly malignancies. She proceeded to ultrasound-guided core biopsy of each, which showed an appearance characteristic of IgG4-mediated sclerosing fibroinflammatory disease. The patient was treated with steroids with good outcome. This is the first described case of this condition presenting in this way to our knowledge and this diagnosis should be considered in patients with similar presentations.