ABSTRACT
Background: Inclusion of historically underrepresented populations in research has been a problem existing for many years. The recent Covid pandemic has exposed the significant cost of gaps in access to care. There remains a need to reevaluate current research paradigm frameworks to consider tailored approaches that accommodate any location that would ease participant burden and maintain retention. Current decentralized research models include home and mobile options. However, barriers exist, and certain demographics remain elusive to recruitment into research studies. Aim(s): In this paper, we aim to identify a theoretical framework that will allow for more inclusivity in research. Methodology: Current utilized community-based decentralized research models are compared, barriers in recruitment and retention of interested participants are examined, and a framework individualized to study participants is offered. Result(s): The proposed framework expands upon the complex adaptive systems theory to incorporate community-based research which considers dividing studies into individual study visit components that may differ in location. It allows for ease of research participant access to care and mutual collaboration among providers and institutions. This new theoretical model expansion outlines a novel approach to communitybased participatory research for increased representation and inclusion. Conclusion(s): Investigators should carefully consider creative and effective solutions to overcome barriers to research participation access, increase diversity and representation, and provide tailored public health interventions. Minimally risk study intervention visits may occur in multiple community-driven locations such as: community resource centers, local physician offices, mobile research units, remote electronic visits, home settings, and a combination of the above (hybrid model). Breaking studies into individual study visit components expands the reach of science into the communities that have long been difficult to reach.
ABSTRACT
Background and Aim: Multi-system inflammatory syndrome in chil-dren (MIS-C) causes widespread systemic inflammation including a pancarditis in the weeks following a COVID infection. Further coronavirus surges appear inevitable and with vaccination rates lower in young people an understanding of the medium-term car-diac impacts of this condition is important for planning further treatment and understanding the impacts on their health. Method(s): A retrospective single-center study of 67 consecutive patients with MIS-C was performed. Three time points were determined as the point of worst cardiac dysfunction during the acute admission, then at intervals of 6-8 weeks and 6-8 months. Echocardiographic findings were used to evaluate both 2D and 3D measures of cardiac function. Coronary artery measurements were recorded. Corresponding serial ECG findings were evaluated. Result(s): The worst cardiac function arose 6.8 +/- 2.4 days after the onset of fever. The mean M mode-derived FS was 30.9 +/- 8.1% during the acute phase. The mean 3D left ventricle (LV) ejection fraction (EF) was borderline at 50.5 +/- 9.8%. A pancarditis was typ-ically present: 46.3% showed cardiac impairment;31.3% had some pericardial effusion;26.8% had moderate (or worse) valvar regur-gitation and;26.8% had coronary dilatation. Cardiac function returned to normal in all patients by 6-8 weeks (mean 3D LV EF 61.3 +/- 4.4%, plt;0.001 compared to admission). Coronary dila-tation normalized in all but one patient who initially developed large aneurysms at presentation;these continued 6 months later. ECG findings mainly featured T-wave changes resolving at fol-low-up. There were a small number of adverse events: need for ECMO (2), death as an ECMO-related complication (1), suben-docardial infarction (1), LV thrombus formation (1). Conclusion(s): MIS-C causes a pancarditis with decreased cardiac function and almost a quarter of patients showing coronary changes. In most, discharge from long-term follow-up can be con-sidered as full cardiac recovery is expected by 8 weeks. The excep-tion includes patients with medium sized aneurysms or greater or those with more of a Kawasaki disease phenotype as these require on-going surveillance for persistence of coronary changes.