Effectiveness of different booster vaccine combinations against SARS-CoV-2 during a six-month follow-up in Mexico and Argentina.

Introduction: Given the limited number of patients in Latin America who have received a booster dose against the COVID-19, it remains crucial to comprehend the effectiveness of different vaccine combinations as boosters in real-world scenarios. This study aimed to assess the real-life efficacy of seven different vaccine schemes against COVID-19, including BNT162b2, ChAdOx1-S, Gam-COVID-Vac, and CoronaVac as primary schemes with either BNT162b2 or ChAdOx1-S as booster vaccines. Methods: In this multicentric longitudinal observational study, participants from Mexico and Argentina were followed for infection and SARS-CoV-2 Spike 1-2 IgG antibodies during their primary vaccination course and for 185 days after the booster dose. Results: A total of 491 patients were included, and the booster dose led to an overall increase in the humoral response for all groups. Patients who received BNT162b2 exhibited the highest antibody levels after the third dose, while those with primary Gam-COVID-Vac maintained a higher level of antibodies after six months. Infection both before vaccination and after the booster dose, and Gam-COVIDVac + BNT162b2 combination correlated with higher antibody titers. Discussion: The sole predictor of infection in the six-month follow-up was a prior COVID-19 infection before the vaccination scheme, which decreased the risk of infection, and all booster vaccine combinations conveyed the same amount of protection.

Effect of the SARS-CoV-2 pandemic on metabolic control in patients with type 2 diabetes: a 5-year cohort follow-up managed by a dynamic multidisciplinary team in Northeastern Mexico.

BACKGROUND: The SARS-CoV-2 pandemic brought a radical shift in the healthcare system and suboptimal care for vulnerable patients, such as those with Type 2 Diabetes Mellitus (T2D). Therefore, we compared metabolic control and macro/microvascular complications of patients with T2D before and throughout the three-year SARS-CoV-2 pandemic. RESEARCH DESIGN AND METHODS: A retrospective observational cohort of subjects with T2D studied from 2018 to 2022 in Northern Mexico was treated by a dynamic multidisciplinary team. Levels of Glycated hemoglobin (HbA1c), fasting serum glucose (FG), LDL-Cholesterol (LDL-C), blood pressure (BP), albuminuria, triglycerides, Body Mass Index (BMI), and FIB-4 score, micro and macrovascular complications were evaluated. RESULTS: A total of 999 patients were studied, 51.7% males with a mean (SD) age of 60.1 (12.7) years. Adequate glycemic control based on HbA1c increased by 15.2% and 42.3% in FSG (p < 0.001) between the beginning 2018 and the end of 2022. LDL-C control decreased by 5.1% between 2018 and 2022 (p < 0.001). Systolic BP control decreased by 2.6% (p < 0.001), whereas diastolic BP control increased by 1.8% (p = 0.01) between 2018 and 2022. Albuminuria control increased by 8.5% (p = 0.002). When comparing the Area Under the Curve (AUC) of metabolic parameters between patients who developed SARS-CoV-2 vs. those who did not, AUC was statistically higher in those who developed SARS-CoV-2 (p < 0.05). Diabetic neuropathy was the most prevalent microvascular complication (n = 35; 3.6%); ischemic heart disease was the most frequent macrovascular complication (n = 11;1.1%). CONCLUSIONS: A multidisciplinary dynamic team that adapts to the pandemic SARS-CoV-2 maintains and increases metabolic control in subjects with type 2 diabetes in Mexico. This represents a low percentage of chronic complications. The AUC of metabolic parameters of subjects with SARS-CoV-2 infection is higher, reflecting more variability in metabolic control.

Risk factors for intubation and mortality in patients treated with high flow nasal cannula due to COVID-19 infection. Survival Analysis Study in a Northern Mexican Population.

BACKGROUND: COVID-19-related acute hypoxic respiratory failure patients often use high-flow nasal cannula (HFNO) oxygen therapy. COVID-19 HFNO intubation and mortality risk factors are understudied in the Mexican population, so the aim was to study them. METHODS: This retrospective study searched electronic medical records from March 2020 to June 2022 for patients with COVID-19 who required hospitalization and HFNO. Descriptive statistics, a survival curve analysis, and Cox proportional hazard models were used to determine predictor factors for intubation and mortality in patients with HFNO and COVID-19, respectively. RESULTS: A total of 134 patients received HFNO treatment. Ninety-one (67.9%) were men with a mean (SD) age of 54.5 (17.9) years. Common medical history included obesity (n = 89, 66.4%) with a Body Mass Index (BMI) mean (SD) of 31.8 (5.9), hypertension (n = 67, 50.0%), type 2 diabetes (n = 55, 41.0%), and dyslipidemias (n = 43, 32.1%). The variables associated with a greater risk of requiring intubation after high-flow therapy were age (HR = 1.018, 95% CI 1.003-1.034, p = 0.022) and BMI (HR = 1.071, 95% CI 1.024-1.120, p = 0.003). No variables were associated with lower risk. Increased mortality was associated with increasing age (HR = 1.151, 95% CI 1.102-1.201, p = <0.001), hypertension (HR = 4.092, 95% CI 1.369-12.236, p = 0.012), and dyslipidemia (HR = 3.954, 95% CI 1.395-11.209, p = 0.010). Patients with type 2 diabetes had a lower risk of mortality (HR = 0.235, 95% CI 0.080-0.688, p = 0.008). CONCLUSIONS: A higher age and BMI were associated with an increased risk of intubation in patients with HFNO and COVID-19. Hypertension and dyslipidemias were associated with a higher risk of mortality.

Association of vaccine status, reinfections, and risk factors with Long COVID syndrome.

The COVID-19 pandemic had a profound global impact, characterized by a high fatality rate and the emergence of enduring consequences known as Long COVID. Our study sought to determine the prevalence of Long COVID syndrome within a population of Northeastern Mexico, correlating it with patients' comorbidities, number of COVID-19 reinfection, and vaccination status. Employing an observational cross-sectional approach, we administered a comprehensive questionnaire covering medical history, demographics, vaccination status, COVID-related symptoms, and treatment. Our participant cohort included 807 patients, with an average age of 41.5 (SD 13.6) years, and women accounting 59.3% of the cohort. The follow-up was 488 (IQR 456) days. One hundred sixty-eight subjects (20.9%) met Long COVID criteria. Long COVID-19 was more prevalent when subjects had reinfections (p = 0.02) and less frequent when they had a complete vaccination scheme (p = 0.05). Through logistic regression, we found that male gender (OR 0.5, p ≤ 0.001), blood types of AB- (OR 0.48, p = 0.003) and O- (OR 0.27, p ≤ 0.001) in comparison with A+ and two doses of vaccines (OR 0.5, p = 006) to be protective factors against Long COVID; while higher BMI (OR 1.04, p = 0.005) was a risk factor. We saw that the prevalence of Long COVID was different within vaccinated patients and specific blood types, while being female and a higher BMI were associated with an increased risk of having long-COVID.

Development, validation and measurement of patient satisfaction questionnaire in Spanish in drive thru services adapted to hospital pharmacies during COVID-19 pandemic.

Background: There are no validation studies on patient satisfaction surveys in Spanish that can evaluate a hospital pharmacy drive-thru service. Objective: To develop and apply a pharmacy drive-thru satisfaction survey in Spanish during the COVID-19 pandemic with an analysis of the instrument validation. Methods: This was a qualitative study for developing, validating, and measuring patient satisfaction who used the drive-thru pharmacy during the COVID-19 pandemic. Content validity was obtained by a two-round Delphi and patient interview for apparent validity. The questionnaire was administered to 110 patients. The researchers made an item reduction by inter-item and item-total correlation analysis, stability validation by a test-retest, a test of reliability by Cronbach's alpha, and extraction of factors by an exploratory factorial analysis. Likewise, confirmatory factor analysis was developed to obtain a structural equation model based on generating an instrument of two sub-models of latent factors (service and place) with ten observed variables (items). Results: A questionnaire was developed that relates six observable variables to the latent factor service and four observable variables to the latent factor place which are ten items based on a Likert scale from 1 to 5, obtaining a Cronbach's alpha = 0.901. The mean population satisfaction score was 4.523. The model presented a Root Mean Square Error of Approximation (RMSEA) of 0.026 (0.000-0.098), and standardized beta values greater than 0.2 according to the confirmatory factor analysis. Therefore, the goodness-of-fit of our model is consistent and the instrument of patient satisfaction with the use of drive-thru has been validated. Patient satisfaction had a mean of 4.9 points. Conclusions: This study developed and validated a reliable scale that evaluates satisfaction in a hospital pharmacy drive-thru service during COVID-19 pandemic that can be applied in other Spanish speaking countries. A great percentage of the patients that were evaluated had good satisfaction.

Temperature Differences Between Controlled Primary Hypothyroidism and Healthy Patients: An Exploratory Study.

Introduction: Hypothyroidism is conventionally treated with replacement therapy through levothyroxine (LT4). Despite the improvement in symptoms, cold intolerance persists in some patients. The present study aims to determine whether there is a difference in temperature perception and skin temperature between patients with primary controlled hypothyroidism (PCH) and a group of healthy controls matched for body mass index and age. Secondarily we aimed to determine difference in quality of life. Methodology: Skin temperature measurements were performed in both groups, both in the central and peripheral regions of the body. In addition, subjects were asked about their perception of temperature in a temperature-controlled room; anthropometric measurements were taken, their quality of life was assessed using the ThyPRO-39, and a thyroid hormone profile was performed. Results: Eleven patients in the PCH group and 30 patients in the control group were studied. It was found that the group with PCH presented a significantly lower palmar temperature than the control group [mean (SD) of 32.05 (1.79) vs 33.10 (1.30) oC, P = .046]. A mediation model showed a direct effect. Temperature perception was equal between groups. The median (interquartile range) of ThyPRO was 8 (5.2) points in the control group vs 21.8 (13.5) in the group of controlled hypothyroidism, P < .001. Discussion: These results suggest that, despite LT4 treatment, patients continue to present abnormalities in thermogenesis-related thermogenesis, and this may be due to a lack of hormonal adaptation to environmental changes and physiological demands, leading to lower body temperatures and increased sensitivity to cold.

Risk of positive screening for anorexia nervosa, bulimia nervosa and night eating syndrome and associated risk factors in medical fellows in Northeastern Mexico: a multicenter study.

BACKGROUND: Eating disorders and food ingestion (EDs) are serious mental illnesses with a higher prevalence in young adults, with difficult diagnoses that cause serious morbidity and mortality problems. There is not much information about the risk of positive screening for EDs, specifically, anorexia nervosa (AN) and bulimia nervosa (BN) and night eating syndrome (NES) in undergraduate medical interns (UMI) and medical residents (MR) in Mexico. AIM: To determine the risk of AN, BN and NES and to determine the risk factors of such conditions such as age, body mass index (BMI) and gender of MR and UMI with AN/BN and NES at four private hospitals in northeastern Mexico. METHODS: A cross-sectional, descriptive, non-randomized survey in MR and UMI in four hospitals in Northeastern Mexico was conducted using an electronic questionnaire that included: informed consent signature, SCOFF questionnaire for AN and BN screening, NES questionnaire. Also, a survey on general sociodemographic data of each participant was included. Chi-square test and a logistic regression model were computed for analyses. RESULTS: The population included a total of 129 MR and UMI. It was observed that 48.8% were positive for AN or BN and 32.6% were positive for the NES. There was no difference between age, sex, BMI, or medical specialty (if they were MR); however, MR from the first year had a higher risk of AN or BN (OR 23.7, 95% CI 1.181-475.266). CONCLUSIONS: There was a higher risk of positive screening for AN or BN and NES in UMI and MR in our population. In the case of MR, those in first year have a higher risk of AN and BN. Timely diagnosis and treatment are mandatory in this population.

Eating disorders and food ingestion such as anorexia (AN) or bulimia (BN) nervosa and night eating syndrome (NES) are a group of mental illnesses that are frequently under diagnosed. Medical residents (MR) and undergraduate medical interns (UMI) are a high-risk population for such disorders due to their young age, stress environments, erratic eating patterns and long working hours. The aim of this study was to determine the risk of AN, BN and NES and to determine the risk factors of such conditions. One hundred twenty-nine UMI and MR were studied and showed that 48.8% were positive for AN or BN and 32.6% were positive for NES. MR in the first year of medical residency had a higher risk. Timely diagnosis and treatment are mandatory in this population.

Analyzing the Interplay between COVID-19 Viral Load, Inflammatory Markers, and Lymphocyte Subpopulations on the Development of Long COVID.

The global impact of the SARS-CoV-2 infection has been substantial, affecting millions of people. Long COVID, characterized by persistent or recurrent symptoms after acute infection, has been reported in over 40% of patients. Risk factors include age and female gender, and various mechanisms, including chronic inflammation and viral persistence, have been implicated in long COVID's pathogenesis. However, there are scarce studies in which multiple inflammatory markers and viral load are analyzed simultaneously in acute infection to determine how they predict for long COVID at long-term follow-up. This study explores the association between long COVID and inflammatory markers, viral load, and lymphocyte subpopulation during acute infection in hospitalized patients to better understand the risk factors of this disease. This longitudinal retrospective study was conducted in patients hospitalized with COVID-19 in northern Mexico. Inflammatory parameters, viral load, and lymphocyte subpopulation during the acute infection phase were analyzed, and long COVID symptoms were followed up depending on severity and persistence (weekly or monthly) and assessed 1.5 years after the acute infection. This study analyzed 79 patients, among them, 41.8% presented long COVID symptoms, with fatigue being the most common (45.5%). Patients with long COVID had higher lymphocyte levels during hospitalization, and NK cell subpopulation levels were also associated with long COVID. ICU admission during acute COVID-19 was also linked to the development of long COVID symptoms.

Efficacy of Six Different SARS-CoV-2 Vaccines during a Six-Month Follow-Up and Five COVID-19 Waves in Brazil and Mexico.

Comparisons among the different vaccines against SARS-CoV-2 are important to understand which type of vaccine provides more protection. This study aimed to evaluate the real-life efficacy through symptomatic infection and the humoral response of six different vaccines against SARS-CoV-2-BNT162b2, mRNA-1273, ChAdOx1-S, CoronaVac, Ad26.COV2, and Ad5-nCoV. This multicentric observational longitudinal study involved hospitals from Mexico and Brazil in which volunteers who received complete vaccination schemes were followed for 210 days after the last dose. SARS-CoV-2 Spike 1-2 IgG levels were taken before receiving the first vaccine, 21 days after each dose, and the last sample at six months (+/-1 month) after the last dose. A total of 1132 individuals exposed to five COVID-19 waves were included. All vaccines induced humoral responses, and mRNA vaccines had the highest antibody levels during follow-up. At six months, there was a decline in the SARS-CoV-2 Spike 1-2 IgG antibody titers of 69.5% and 36.4% in subjects with negative and positive history of infection respectively. Infection before vaccination and after complete vaccination scheme correlated with higher antibody titers. The predictors of infection were vaccination with CoronaVac compared to BNT162b2 and ChAdOx1-S. In the presence of comorbidities such as diabetes, rheumatoid arthritis, or dyslipidemia, CoronaVac lowered the risk of infection.

Effect of Vitamin D3 Supplementation vs. Dietary-Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL.

Background: There is scant information on the effect of supplementation with vitamin D3 in SARS-CoV-2 infection cases when patient 25-hydroxyvitamin D3 [25(OH)D3] levels are between 20-100 ng/mL. We aimed to evaluate the effect of supplementation with vitamin D3 vs. dietary-hygienic measures on the SARS-CoV-2 infection rate in participants with serum 25(OH)D3 levels ≥20 ng/mL. Methods: This study was quasi-experimental. We invited hospital workers with 25(OH)D3 levels between 20-100 ng/mL and no previous SARS-CoV-2 infection. They were randomized as follows: treatment options were a) vitamin D3 supplementation (52,000 IU monthly, G1) or b) dietary-hygienic measures (G2). We conducted a 3- to 6-month follow-up of SARS-CoV-2 infections. Participants with 25(OH)D3 levels <20 ng/mL were also analyzed. We divided these latter participants depending on whether they were supplemented (G3) or not (G4). Results: We analyzed 198 participants, with an average age of 44.4 (SD 9) years, and 130 (65.7%) were women. G1 had fewer cases of SARS-CoV-2 infection than G2 after a follow-up of 3- to 6-months (p < 0.05). There were no differences between G3 and G4 at the 3- and 6-month follow-up cutoff points (p > 0.05). Using a mixed effect Cox regression analysis in the 164 participants that completed six months of follow-up, vitamin D3 supplementation appeared to act as a protective factor against SARS-CoV-2 infection (HR 0.21, p = 0.008) in G1 and G2. None of the participants treated with the supplementation doses had serum 25(OH)D3 levels >100 ng/mL. Conclusions: Vitamin D3 supplementation in participants with 25(OH)D3 levels between 20-100 ng/mL have a lower rate of SARS-CoV-2 infection compared with the use of dietary-hygienic measures at six months follow-up.

Evaluation of Transplacental Antibody Transfer in Pregnant Women Immunized with Different SARS-CoV-2 Homologous or Heterologous Schemes.

There is scarce information related to transplacental antibody transfer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with different homologous and heterologous vaccination schemes. This study aimed to correlate the magnitude of transplacental transfer anti-SARS-CoV-2 antibodies in different homologous and heterologous schemes. An observational cross-sectional study was developed to identify pregnant women vaccinated against SARS-CoV-2. They were questioned about their immunization status; blood samples from the mother, umbilical cord during labor, and the newborn 72 h after birth were taken to measure anti-S1 and anti-S2 specific IgG antibodies for SARS-CoV-2. We recruited 104 women with a median age of 29 (SD 1.17). We found antibodies in all newborns with vaccinated mothers. Homologous BNT162b2 mRNA regimen had the highest mean (SD) antibody titers (AU/mL) in maternal (994.93 (3.08), p = 0.039), umbilical cord (1316.43 (2.79), p = 0.016), and newborn (1192.02 (3.55), p = 0.020) blood. The generalized linear model showed a positive effect over antibodies with at least one dose in maternal (ß = -1.1, p = 0.002) and newborn (ß= -0.717, p = 0.044) blood, and with two doses (ß = -0.684, p = 0.026) in umbilical cord blood. In conclusion, antibodies were detected in all vaccinated women and their newborns. Transfer of antibodies was found from the first dose, and the levels increased with the number of vaccine doses. Vaccination should be encouraged in pregnant women with any available scheme.

Analysis of immunization time, amplitude, and adverse events of seven different vaccines against SARS-CoV-2 across four different countries.

Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-CoV-2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI. Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers were measured at baseline, 21-28 days after the first and second dose (when applicable) of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models were performed. Results: We recruited 1867 individuals [52 (SD 16.8) years old, 52% men]. All vaccines enhanced anti-S1 and anti-S2 IgG antibodies over time (p<0.01). The highest increase after the first and second dose was observed in mRNA-1273 (p<0.001). There was an effect of previous SARS-CoV-2 infection; and an interaction of age with previous SARS-CoV-2 infection, Gam-COVID-Vac and ChAdOx1-S (p<0.01). There was a negative correlation of Severe or Systemic AEFI (AEs) of naïve SARS-CoV-2 subjects with age and sex (p<0.001); a positive interaction between the delta of antibodies with Gam-COVID-Vac (p=0.002). Coronavac, Gam-COVID-Vac and ChAdOx1-S had less AEs compared to BNT162b (p<0.01). mRNA-1273 had the highest number of AEFIs. The delta of the antibodies showed an association with AEFIs in previously infected individuals (p<0.001). Conclusions: The magnitude of seroconversion is predicted by age, vaccine type and SARS-CoV-2 exposure. AEs are correlated with age, sex, and vaccine type. The delta of the antibody response only correlates with AEs in patients previously exposed to SARS-CoV-2. Registration number: ClinicalTrials.gov, identifier NCT05228912.

Analysis of Immunization, Adverse Events, and Efficacy of a Fourth Dose of BNT162b2 Vaccine in Health Workers in Mexico, a Pilot Study.

There is scarce information on seroconversion and adverse events after immunization (AEFI) with the fourth dose of BNT162b2. Our aim was to correlate the magnitude of the antibody response to this vaccination regimen in terms of clinical conditions and AEFI. This was an observational pilot study in which SARS-CoV-2 S1−S2 IgG antibodies titers were measured 21−28 days after the first and second dose, three months after the second dose, 1−7 and 21−28 days after the third dose, before the fourth dose, and 21−28 days after the fourth dose. We recruited 112 subjects in a hospital in Mexico, 74% women, with an average age of 43 (SD 9) years. After the first dose, subjects had a median IgG AU/mL (IQR) of 122 (1904) that increased to 1875 (2095), 3020 (2330), and 4230 (3393) 21−28 days after the second, third, and fourth doses, respectively (p < 0.01). The number (%) who experienced any AEFI between the first and fourth doses was 90 (80.4), 89 (79), 65 (58), and 69 (61.5), respectively (p < 0.001). After the fourth dose, the most frequent of AEFI was pain at the injection site (87%). There was a correlation between AEFI and gender after the fourth dose, as well as with antibody levels (p < 0.05). During the Omicron outbreak, six (5.3%) had mild COVID-19 for 8−28 days after the fourth dose. The median increase in S1/S2 IgG was 30.8-fold after the fourth BNT162b2 dose when compared with the first dose and caused mild AEFI.

Effect of the third dose of BNT162b2 vaccine on quantitative SARS-CoV-2 spike 1-2 IgG antibody titers in healthcare personnel.

BACKGROUND: Vaccination is our main strategy to control SARS-CoV-2 infection. Given the decrease in quantitative SARS-CoV-2 spike 1-2 IgG antibody titers three months after the second BNT162b2 dose, healthcare workers received a third booster six months after completing the original protocol. This study aimed to analyze the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers and the safety of the third dose. MATERIAL AND METHODS: A prospective longitudinal cohort study included healthcare workers who received a third booster six months after completing the BNT162b2 regimen. We assessed the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers 21-28 days after the first and second dose, three months after the completed protocol, 1-7 days following the third dose, and 21-28 days after booster administration. RESULTS: The cohort comprised 168 participants aged 41(10) years old, 67% of whom were female. The third dose was associated with an increase in quantitative antibody titers, regardless of previous SARS-CoV-2 history. In cases with a negative SARS-CoV-2 history, the median (IQR) antibody titer values increased from 379 (645.4) to 2960 (2010) AU/ml, whereas in cases with a positive SARS-CoV-2 history, from 590 (1262) to 3090 (2080) AU/ml (p<0.001). The third dose caused a lower number of total (local and systemic) adverse events following immunization (AEFI) compared with the first two vaccines. However, in terms of specific symptoms such as fatigue, myalgia, arthralgia, fever, and adenopathy, the proportion was higher in comparison with the first and second doses (p<0.05). The most common AEFI after the third BNT162b2 vaccine was pain at the injection site (n = 82, 84.5%), followed by fatigue (n = 45, 46.4%) of mild severity (n = 36, 37.1%). CONCLUSION: The third dose applied six months after the original BNT162b2 regimen increased the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers. The booster dose was well tolerated and caused no severe AEFI.

Effect of Heterologous Vaccination Regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers.

The efficacy of one dose Ad5-nCoV has been concerning. This study aimed to evaluate the effect of a single dose BNT162b2 in individuals after a completed Ad5-nCoV vaccination regiment compared to a group without this boost measuring SARS-CoV-2 Spike 1−2 IgG antibodies in plasma. This observational study included a subgroup analysis of patients who were immunized with Ad5-nCoV in a northern city of Mexico. During follow-up, some patients self-reported having received a BNT162b2 booster. We report baseline IgG levels, 21−28 days after the Ad5-nCoV dose, three months, and an additional 21−28 days after BNT162b2 (four months after Ad5-nCoV). Seventeen patients, age 40 (16), 52.9% men, were analyzed. We created four groups: G1 and G2 refer to patients without a history of SARS-CoV-2 infection, vaccinated with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 4 and n = 6), respectively; G3 and G4 included patients with a history of SARS-CoV-2 infection and immunized with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 5 and n = 2), respectively. The Ad5-nCoV/BNT162b2 protocol reported higher antibody titers after 21−28 days. Median (IQR) values were: G1 46.7 (-), G2 1077.5 (1901), G3 1158.5 (2673.5), and G4 2090 (-) (p < 0.05). Headache and pain at injection site were the most frequent adverse reactions associated with Ad5-nCoV (n = 10, 83%) and BNT162b2 (n = 5, 83.3%), respectively. Patients receiving BNT162b2 after Ad5-nCoV had higher SARS-CoV-2 spike 1−2 IgG antibody titers and had no severe adverse reactions.

Effect of Digital-Tool-Supported Basal Insulin Titration Algorithm in Reaching Glycemic Control in Patients with Type 2 Diabetes in Mexico.

BACKGROUND: My Dose Coach (MDC) is a mobile application combined with a web portal that can suggest optimized basal insulin (BI) injection doses using Self-Measured Plasma Glucose (SMPG) and hypoglycemia data. This study aimed to evaluate its efficacy on patients reaching SMPG and Fasting blood glucose (FBG) target range 90-130 mg/dl (5-7.2 mmol/L) goals without severe hypoglycemic episodes. We also addressed the mean reduction in glycated hemoglobin (A1C), FBG, and SMPG and the improvement in the WHO's Five Well Being Index (WBI). METHODS: This prospective pilot study involved the use of MDC in outpatients with type 2 diabetes (T2DM) from a Hospital in Northern Mexico. Patients on treatment with any BI were included in the study. The follow-up was of 16 weeks. Student t-tests or McNemar test were used for effect comparisons. RESULTS: We included 158 patients (46.8% women), mean (SD) age 51 (10.3) years. We achieved SMPG target range in 58.9% [mean (95CI) reduction of 30.9 mg/dl (22.5-37.7; P < .001)] of the patients [66(28) days], with no severe hypoglycemia events. FBG goal was reached in 55.7% [mean (95CI) reduction of 63.4 mg/dl (49.6-77.2; P < .001)]. The mean (95CI) reduction of A1C was 1.78% (1.47-2, P < .01) with the last observation carried forward. There was a mean (95CI) increase of 2.23 (-3, -1.4, P < .01) points in WBI scale. CONCLUSIONS: MDC successfully helped to achieve FBG and SMPG goals, reduced A1C, and increased WBI with no severe hypoglycemia events.

Development and Validation of an Instrument in Spanish to Evaluate Patient Satisfaction in Telemedicine Consultation During COVID-19 Pandemic.

Background: The COVID-19 pandemic prompted health organizations to use telemedicine as an option to continue providing medical services. There is no telemedicine patient satisfaction survey validated in Spanish. Aim of the study: To develop and validate a telemedicine patient satisfaction survey and know the level of satisfaction with this type of consultation implemented at Hospital Clinica Nova during the COVID-19 pandemic. Methods: This was a qualitative study implemented in a private hospital in Monterrey, Mexico, of patients who attended telemedicine from April to August 2020. Content validity was obtained by a two-round Delphi study with the participation of 11 experts. We conducted six patient interviews for the apparent validity of the items. The questionnaire was administered to 120 patients for statistical analysis. We made an item reduction by interitem and item-total correlation analyses, stability validation by a test-retest, a test of reliability by Cronbach's alpha, and extraction of factors by a factorial analysis. Results: We obtained a validated nine-item questionnaire, eight items on a Likert scale (range 1-7), and one for a Net Promoter Score (NPS). Two factors explained the structure of the questionnaire and it had an Cronbach alpha = 0.86. The mean population satisfaction score was 6.35 and 43% in NPS. Discussion: In general, good satisfaction results were obtained, and most patients considered telemedicine as good as face-to-face consultation. Conclusions: The scale developed was valid and reliable for the hospital population. However, due to the characteristics of the items, it may apply to other Spanish-speaking health organizations that use telemedicine for patient care.

Viral load and its relationship with the inflammatory response and clinical outcomes in hospitalization of patients with COVID-19.

Background: The values of viral load in COVID-19 disease have gained relevance, seeking to understand its prognostic value and its behavior in the course of the disease, although there have been no conclusive results. In this study we sought to analyze serum viral load as a predictor of clinical outcome of the disease, as well as its association with inflammatory markers. Methods: An observational and retrospective study in a private hospital in North Mexico, patients with SARS-COV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) were followed through clinical outcome, viral load measurement, quantification of inflammatory markers and lymphocyte subpopulations. For the analysis, multiple regression models were performed. Results: We studied 105 patients [47 (SD 1.46) years old, 68.6% men]. After analysis with multiple regression models, there was an association between viral load at admission and vaccination schedule (ß-value=-0.279, p= 0.007), age (ß-value= 0.010, p = 0.050), mechanical ventilation (ß-value= 0.872, p = 0.007), lactate dehydrogenase (ß-value= 1.712, p= 0.004), D-dimer values at admission (ß-value= 0.847, p= 0.013) and subpopulation of B lymphocytes at admission (ß-value= -0.527, p= 0.042). There was no association with days of hospitalization, use of nasal prongs or high flux mask. Peak viral load (10 days after symptoms onset) was associated with peak IL-6 (ß-value= 0.470, p= 0.011). Peak viral load matched with peak procalcitonin and minimal lymphocyte values. C-reactive protein peak was before the peak of viral load. The minimum value viral load was documented on day 12 after symptom onset; it matched with the minimum values of IL-6 and ferritin, and the peak of D-dimer. Conclusions: SARS-COV-2 admission viral load is associated with vaccination status, mechanical ventilation, and different inflammatory markers.

Optimizing ECG to detect echocardiographic left ventricular hypertrophy with computer-based ECG data and machine learning.

BACKGROUND: Left ventricular hypertrophy detected by echocardiography (Echo-LVH) is an independent predictor of mortality. Integration of the Philips DXL-16 algorithm into the electrocardiogram (ECG) extensively analyses the electricity of the heart. Machine learning techniques such as the C5.0 could lead to a new decision tree criterion to detect Echo-LVH. OBJECTIVES: To search for a new combination of ECG parameters predictive of Echo-LVH. The final model is called the Cardiac Hypertrophy Computer-based model (CHCM). METHODS: We extracted the 458 ECG parameters provided by the Philips DXL-16 algorithm in patients with Echo-LVH and controls. We used the C5.0 ML algorithm to train, test, and validate the CHCM. We compared its diagnostic performance to validate state-of-the-art criteria in our patient cohort. RESULTS: We included 439 patients and considered an alpha value of 0.05 and a power of 99%. The CHCM includes T voltage in I (≤0.055 mV), peak-to-peak QRS distance in aVL (>1.235 mV), and peak-to-peak QRS distance in aVF (>0.178 mV). The CHCM had an accuracy of 70.5% (CI95%, 65.2-75.5), a sensitivity of 74.3%, and a specificity of 68.7%. In the external validation cohort (n = 156), the CHCM had an accuracy of 63.5% (CI95%, 55.4-71), a sensitivity of 42%, and a specificity of 82.9%. The accuracies of the most relevant state-of-the-art criteria were: Romhilt-Estes (57.4%, CI95% 49-65.5), VDP Cornell (55.7%, CI95%47.6-63.7), Cornell (59%, CI95%50.8-66.8), Dalfó (62.9%, CI95%54.7-70.6), Sokolow Lyon (53.9%, CI95%45.7-61.9), and Philips DXL-16 algorithm (54.5%, CI95%46.3-62.5). CONCLUSION: ECG computer-based data and the C5.0 determined a new set of ECG parameters to predict Echo-LVH. The CHCM classifies patients as Echo-LVH with repolarization abnormalities or LVH with increased voltage. The CHCM has a similar accuracy, and is slightly more sensitive than the state-of-the-art criteria.

Diagnostic utility of the electrocardiographic left ventricular hypertrophy criteria in specific populations.

BACKGROUND: Several electrocardiographic (ECG) criteria have been validated for the diagnosis of left ventricular hypertrophy (LVH); the majority in Caucasian subjects from Europe and North America. Diagnostic utility of ECG criteria to detect LVH has never been established in our population; nonetheless they are frequently used. OBJECTIVE: To evaluate the diagnostic utility of different LVH ECG criteria in a Northern Mexican population and to determine the effect of gender, age, body mass index (BMI), hypertension and ischaemic heart disease (IHD) on their performance. METHODS: We conducted an observational, case-control study in patients divided according to the presence of LVH in an echocardiogram (Echo). We calculated the accuracy, sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of 22 ECG criteria. RESULTS: Four hundred thirty-two patients were studied (202 had LVH). The Dalfó criterion (ECG18. SV3 + RaVL) had the best diagnostic performance with a Se of 56%, Sp of 71.3%, PPV 62.9%, NPV 65% and a diagnostic accuracy (95%CI) of 64.1% (59.5-68.6). This criterion had the highest accuracy in both genders, in all BMI, in older patients (>60 years) and in those with positive Echo ischaemic heart disease (IHD); it also performed well in patients with history of IHD and in hypertensive patients. VDP Cornell had the best accuracy in patients less than 60 years old, and in patients with non-ischaemic findings by Echo. CONCLUSIONS: The Dalfó criteria had the overall best accuracy in the detection of LVH, and specific populations.