Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review.

OBJECTIVE: To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline. DESIGN: Systematic review. DATA SOURCES: We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020. STUDY SELECTION: Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome. DATA ABSTRACTION AND SYNTHESIS: 4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials. RESULTS: We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005). CONCLUSIONS: Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials. PROSPERO REGISTRATION NUMBER: CRD42022282565.

[Epicardial adipose tissue: a novel cardiovascular risk factor]. / Tessuto adiposo epicardico quale nuovo fattore di rischio cardiovascolare.

Epicardial adipose tissue (EAT) has various metabolic functions aiming at heart protection. When abnormal, it is related to atherosclerotic plaque development and adverse cardiovascular outcome. Additionally, in recent years, several studies have demonstrated its role in other settings such as atrial fibrillation and heart failure with preserved ejection fraction. Future studies should aim to assess diagnostic role of EAT and the effect of medical therapy on EAT volume and attenuation.

Cholesterol efflux capacity is increased in subjects with familial hypercholesterolemia in a retrospective case-control study.

Familial Hypercholesterolemia (FH) is characterized by an increase in Low-Density Lipoprotein Cholesterol (LDL-C) and by premature Cardiovascular Disease (CVD). However, it remains to be fully elucidated if FH impairs cholesterol efflux capacity (CEC), and whether CEC is related to lipoprotein subfraction distribution. This study aimed at comparing FH patients and age, sex and BMI matched controls in terms of LDL and HDL subfraction distribution as well as CEC. Forty FH patients and 80 controls, matched for age, sex and BMI, were enrolled in this case-control study. LDL and HDL subfractions were analyzed using the Quantimetrix Lipoprint System. CEC was evaluated as aq-CEC and ABCA1-CEC. FH subjects showed a significantly higher concentration of all LDL subfractions, and a shift from large to small HDL subfraction pattern relative to controls. FH subjects with previous CVD event had smaller LDL lipoproteins than controls and FH subjects without previous CVD event. Both aq-CEC and ABCA1-CEC were increased in FH patients with respect to controls. To conclude, FH subjects had a metabolic profile characterized not only by higher LDL-C but also by shift from large to small HDL subfraction phenotype. However, FH subjects showed an increase CEC than controls.

COVID-19 and blood groups: A six-months observational study in Ferrara, Italy.

The current literature still gives a little information about the relationships between the ABO blood group system and the immune response to the virus or the different disease outcomes. Hypothesizing the presence of a predisposition by some blood groups to COVID-19, we searched for differences between patients towards the different outcomes of disease.We enrolled 330 inpatients with a diagnosis of COVID-19, determining both their ABO blood group system and Rh factor, collecting demographic, clinical and laboratory data. We searched for relationships with COVID-19 outcomes within an observation period of 180 days (Intensification of Care - IoC, Inhospital death, 180-days mortality). The most frequent ABO blood group was A (45.8%); a minor part was represented by group O (38.8%), B (11.5%), AB (3.9%). As for the Rh factor, 86.7% of patients were Rh-positive. There were no significant differences between blood groups and Rh factors as for age, length of hospital stays (LoS), or Charlson Comorbidity Index (CCI), nor we found significant relationships between the ABO groups and COVID-19 outcomes. A significant relation was found between AB group and IoC (p=0.03) while as for the Rh factor, the patients with Rh factor positive died with less frequency during the stay (p=0.03). Cox regression analyses showed substantial differences in the survival functions concerning the Rh factors. The Rh factor seems to be involved in the 180-day prognosis. The survival functions of patients with Rh factor positive show, in fact, significantly better curves when compared to those with Rh factor negative.

Rethinking of osteoporosis through a sex- and gender-informed approach in the COVID-19 era.

Standards and models of reference for osteoporosis (OP) have been developed for female individuals as they are more likely to be affected by the disease. Nonetheless, OP is also responsible for one-third of hip fractures in male individuals suggesting that a sex-blinded approach to OP may lead to miss opportunities for equity in bone health. OP-related fractures, especially hip fractures, are a matter of immediate concern as they are associated with limited mobility, chronic disability, loss of independence, and reduced quality of life in both sexes. When it comes to sociocultural gender, the effect of gender domains (i.e., identity, roles, relations, and institutionalized gender) on development and management of OP is largely overlooked despite risk factors or protective conditions are gendered. Clinical trials testing the efficacy and safety of anti-OP drugs as well as non-pharmacological interventions have been conducted mainly in female participants, limiting the generalizability of the findings. The present narrative review deals with the sex and gender-based challenges and drawbacks in OP knowledge and translation to clinical practice, also considering the impact of coronavirus disease 2019 pandemic.

Role of Statins in Coronavirus-Related Disease (COVID-19): A Retrospective Cohort Study in Northern Italy.

INTRODUCTION: The outbreak by SARS-CoV-2 has rapidly spread worldwide. The need for specific treatments to adequately stop the inflammatory response and its sequelae is day by day more urgent and many therapeutic strategies were performed since COVID-19 burst in the last months. Statins were thought to be effective against this novel coronavirus for their anti-inflammatory properties, even if the real effects on COVID patients are still partially unexplored. METHODS: We retrospectively evaluated 501 adult patients, consecutively admitted to the two COVID-hospitals of Ferrara's territory, and divided them into two groups: ST = patients on statin therapy on admission and NST=patients not on statin therapy on admission. We searched for differences between groups in terms of anamnestic, clinical and laboratory data and then in terms of COVID-19 outcomes. RESULTS: We found significant differences between groups in terms of age, comorbidities, procalcitonin and CPK serum levels: ST patients were older, more comorbid, with lower procalcitonin and higher CPK serum levels. Male sex was, together with the Charlson Comorbidity Index, an independent predictor of needing intensification of care, while age only was a good predictor of in-hospital and 100-day mortality. Differences were also found in the survival functions between the two groups. CONCLUSIONS: After a period of observation of 100 days, ST patients, despite their older age and their greater load of comorbidities, have similar survival functions to NST patients. If adjusted for age and CCI the survival functions of ST group are considerably more favourable than those of the second group.