Hospital Alemão Oswaldo Cruz

Long COVID is a complex condition with diverse symptoms, lacking specific diagnostic or therapeutic tools. Although vaccination reduces the risk of severe COVID-19, its role in preventing long COVID, particularly through booster doses, remains limited. This study assessed the impact of first and second booster doses and identified long COVID risk factors.

We conducted a multicenter observational study with a cross-sectional analysis of participants previously infected with SARS-CoV-2 during the pre-Omicron and Omicron epidemiological periods. Both periods included mixed populations of healthcare workers (HCWs) and non-HCWs, with HCWs representing 86% of all participants. The study included five medical centers in São Paulo and Rio de Janeiro. Clinical data and long COVID symptoms were collected through a single standardized electronic questionnaire sent to all eligible participants. Predictors of long COVID were evaluated using multivariable logistic regression. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated.

A total of 2033 participants were included, and 67% (1370) reported long COVID symptoms. Independent risk factors included female sex (OR 2.25, 95% CI 1.81-2.79, p < 0.001), the presence of one, two, or three or more comorbidities (OR 1.74, 95% CI 1.36-2.23, p < 0.001; OR 2.14, 95% CI 1.43-3.20, p < 0.001; and OR 3.10, CI 1.55-6.19, p = 0.001, respectively); the occurrence of one or more reinfections (OR 2.35, 95% CI 1.84-3.01, p < 0.001; and OR 4.22, 95% CI 2.043-7.91, p < 0.001, respectively), and a severe acute illness (OR: 1.91; 95%CI 1.09-3.35; p = 0.02). Vaccination was protective, with the strongest effect observed among those receiving two booster doses (OR: 0.18; 95% CI 0.07-0.46; p < 0.001). In the Omicron period sub-analysis, only the second booster dose was associated with reduced risk compared with a complete primary series (OR 0.50, CI 0.34-0.74, p < 0.001), whereas one booster dose showed no significant effect.

COVID-19 vaccination, especially two booster doses, reduced long COVID risk. Female sex, comorbidities, reinfections, and severe acute illness were independent risk factors for developing long-lasting symptoms.

Regulatory agencies are increasingly incorporating real-world data (RWD) and real-world evidence (RWE) into decision-making frameworks to complement randomized clinical trials. While some regions, such as the U.S. and EU, have developed structured approaches for RWE use, Brazil's regulatory environment remains comparatively limited. This study examines the status of RWE regulatory integration in Brazil through an analysis of normative documents, institutional publications, and selected case studies, using a comparative policy perspective. Although advances have been made in data standardization and the publication of technical guidelines, such as ANVISA's Guidance No. 64/2023, the practical use of RWE in regulatory processes is still nascent. Key challenges include fragmented data infrastructure, and limited intersectoral coordination. Addressing these gaps will require improved interoperability across health information systems, convergence of methodological standards, and sustained collaboration among regulatory authorities, academia, and data holders to enable consistent and scientifically robust use of RWE in the Brazilian context and, potentially, in other low- and middle-income countries.

To systematically assess whether MRI-based measurements of glenoid bone loss (GBL) are comparable to CT in patients with shoulder instability.

We searched PubMed, Cochrane Library, Web of Science, and Embase for studies comparing GBL measurements between CT and MRI through May 16, 2024. We performed subgroup analyses based on 2D versus 3D imaging and linear versus area measurement methods. We conducted statistical analysis using Review Manager (RevMan) version 5.4.1, applying a random-effects model to calculate the mean difference.

Eleven studies were included, totaling 492 shoulders. Of these, 119 shoulders were evaluated using 3D MRI versus 3D CT, 126 using 2D MRI versus 2D CT, 292 using the linear method, and 149 using the area method. The pooled analysis showed no significant difference in GBL measurements between MRI and CT (mean difference -0.05; 95% CI: -0.26 to 0.15; p = 0.61). Subgroup analyses also showed no significant differences (p = 0.94 for 3D, p = 0.14 for 2D, p = 0.67 for linear, p = 0.46 for area, and p = 0.51 comparing linear vs area methods).

MRI provides GBL measurements comparable to CT across various imaging protocols including 2D and 3D approaches and the linear and area methods. MRI may be sufficient as the sole imaging modality for comprehensive preoperative evaluation in patients with shoulder instability.