Context.– Myocarditis in adolescents has been diagnosed clinically following the administration of the second dose of an mRNA vaccine for coronavirus disease 2019 (COVID-19).
Objective.– To examine the autopsy microscopic cardiac findings in adolescent deaths that occurred shortly following administration of the second Pfizer-BioNTech COVID-19 dose to determine if the “myocarditis” described in these instances has the typical histopathology of myocarditis.
Design.– Clinical and autopsy investigation of two teenage boys who died shortly following administration of the second Pfizer-BioNTech COVID-19 dose.
Results.– The microscopic examination revealed features resembling a catecholamine-induced injury, not typical myocarditis pathology.
Conclusions.– The myocardial injury seen in these post-vaccine hearts is different from typical myocarditis and has an appearance most closely resembling a catecholamine-mediated stress (toxic) cardiomyopathy. Understanding that these instances are different from typical myocarditis and that cytokine storm has a known feedback loop with catecholamines may help guide screening and therapy.
Background
Slow recruitment and poor retention jeopardize the reliability and statistical power of clinical trials, delaying access to effective interventions and increasing costs, as commonly observed in nephrology trials. Involving patients in trial design, recruitment and retention is infrequent but potentially transformational.
Methods
We conducted three workshops involving 105 patients/caregivers and 43 health professionals discussing patient recruitment and retention in clinical trials in chronic kidney disease.
Results
We identified four themes. ‘Navigating the unknown’—patients described being unaware of the research question, confused by technical terms, sceptical about findings and feared the risk of harm. ‘Wary of added burden’—patients voiced reluctance to attend additional appointments, were unsure of the commitment required or at times felt too unwell and without capacity to participate. ‘Disillusioned and disconnected’—some patients felt they were taken for granted, particularly if they did not receive trial results. Participants believed there was no culture of trial participation in kidney disease and an overall lack of awareness about opportunities to participate. To improve recruitment and retention, participants addressed ‘Building motivation and interest’.
Conclusions
Investigators should establish research consciousness from the time of diagnosis, consider optimal timing for approaching patients, provide comprehensive information in an accessible manner, emphasize current and future relevance to them and their illness, involve trusted clinicians in recruitment and minimize the burden of trial participation. Participation in clinical trials was seen as an opportunity for people to give back to the health system and for future people in their predicament.
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