ABSTRACT
Background: A severe multisystem inflammatory syndrome in children (MIS-C) related to SARS-CoV-2 has been described after infection. A limited number of reports have analyzed the long-term complications related to pro-inflammatory status in MIS-C. We evaluated multiorgan impairment at the 6-month follow-up in MIS-C. Methods: We enrolled 33 pediatric patients consecutively hospitalized for MIS-C and monitored for almost 6 months. The inter-relationship of patient's features and disease severity at admission with long term complications was studied by multivariate analysis. Results: Endo-metabolic derangement, cardiac injury, respiratory, renal and gastrointestinal manifestations and neurological involvement are part of the initial presentation. The most abnormalities appear to resolve within the first few weeks, without significant long term dysfunction at the 6-months follow-up, except for endocrine (non-thyroidal illness syndrome in 12.1%, insulin resistance in 21.2%) and neurological system (27.3% cognitive or psychological, behavioral, adaptive difficulties). Endocrine and heart involvement at admission represent a significant factor on the long term sequelae; however no association between severity score and long-term outcome was noted. Conclusions: The severity of initial clinical presentation may be associated to organ domain, however it is not related to long term sequelae. The prevalent organ restoration supports a predominant indirect immune-mediated injury triggered by a systemic inflammatory response; however a direct damage due to the viral entry could be not excluded. Eventhought our preliminary results seem to suggest that MIS-C is not a long-term risk condition for children health, a longer follow-up is mandatory to confirm this hypothesis.
ABSTRACT
Clinical practice guidelines (CPGs) on screening, surveillance, and treatment of several diseases recommend the selective use of biomarkers with central role in clinical decision-making and move towards including patients in this process. To this aim we will clarify the multidisciplinary interactions required to properly measure the cost-effectiveness of biomarkers with regard to the risk-benefit of the patients and how Health Technology Assessment (HTA) approach may assess value of biomarkers integrated within the decision-making process. HTA through the interaction of different skills provides high-quality research information on the effectiveness, costs, and impact of health technologies, including biomarkers. The biostatistical methodology is relevant to HTA but only meta-analysis is covered in depth, whereas proper approaches are needed to estimate the benefit-risk balance ratio. Several biomarkers underwent HTA evaluation and the final reports have pragmatically addressed: 1) a redesign of the screening based on biomarker; 2) a de-implementation/replacement of the test in clinical practice; 3) a selection of biomarkers with potential predictive ability and prognostic value; and 4) a stronger monitoring of the appropriateness of test request. The COVID-19 pandemic has disclosed the need to create a robust and sustainable system to urgently deal with global health concerns and the HTA methodology enables rapid cost-effective implementation of diagnostic tests allowing healthcare providers to make critical patient-management decisions.