Epidemiological studies are essential in medicine and public health as they help identify risk factors and causes of diseases. Additionally, they are key to planning, implementing, and evaluating health interventions aimed at preventing and controlling the spread of diseases. Among these studies, analytical observational studies, such as cross-sectional, case–control, and cohort studies, are the most used. The validity of their results largely depends on the robustness of the design, execution, and statistical analysis. Objective: The objective of this study is to examine the most common errors in the selection of methodological design and statistical tests in analytical observational studies and to provide recommendations to correct them. Methodology: A comprehensive review of the available literature on methodology in epidemiological observational studies was conducted, focusing on cross-sectional, case–control, and cohort studies. Common errors in the selection of designs and statistical tests were identified and analyzed. Results and Conclusions: Errors in the selection of methodological design and statistical tests are common in epidemiological observational studies. Based on the identified errors, a series of recommendations is provided to improve the selection of methodological design and statistical tests, thereby increasing the reliability of the results in cross-sectional, case–control, and cohort studies.
Background: The immunomodulatory effects of vitamin D are known to be beneficial in viral infections; it is also known that its deficiency is associated with a prognosis more critical of Coronavirus Disease 2019. This study aimed to determine baseline vitamin D serum concentrations and the effects of its supplementation in asymptomatic or mildly symptomatic Coronavirus Disease 2019 outpatients. Methods: 42 outpatients were included, 22 of which received a supplement of 10,000 IU of vitamin D3 for 14 days; the remaining 20 outpatients were designated as a control group. Serum levels of transferrin, ferritin, vitamin D, and D-dimer were measured at baseline in both groups. After 14 days, serum levels of total vitamin D were determined in the supplemented group. Results: At baseline, only 19% of infected outpatients had vitamin D levels corresponding to sufficiency. All outpatients with vitamin D insufficiency had at least one symptom associated with the disease, while only 75% of patients with symptoms presented sufficiency. On the seventh and fourteenth day of follow-up, the supplemented group presented fewer symptoms with respect to those non-supplemented. A vitamin D3 dose of 10,000 IU/daily for 14 days was sufficient to raise vitamin D serum concentrations. Conclusions: Immunomodulatory effects of vitamin D appear to be linked to the development of symptoms in positive outpatients. Vitamin D supplementation could have significant benefits in the Western Mexican population.
Macrophage migration inhibitory factor (MIF) significantly contributes to rheumatoid arthritis (RA) pathogenesis. We aimed to evaluate the canonical (CD74/CD44) and non-canonical MIF receptors (CXCR2,4 and 7) expression and sCD74 to establish their association with RA clinical activity according to DAS28-ESR. Methodology: 101 RA patients with different clinical activities (remission (n = 27), low (n = 16), moderate (n = 35) and high (n = 23)) and 9 control subjects (CS) were included. Expression was evaluated by flow cytometry and levels of soluble CD74 (sCD74) by ELISA. Data analysis was performed with FlowJov10.0, STATAv12.0, and GraphPad Prism v7.0. Results: According to disease activity, CXCR7 expression (percentage of expression and mean fluorescence intensity (MFI)) was higher in granulocytes from patients in remission, while the expression of CXCR4 was higher in patients with high disease activity (p < 0.05). The expression of CD74 was higher in B cells (p < 0.05) and monocytes (p < 0.01) from patients in remission. Regarding sCD74 levels these were higher in patients with high disease activity when compared to those in remission (p <0.05). Conclusions: The results support the need for further study of the role of sCD74 as a soluble MIF decoy receptor, sequestering it to negatively regulate MIF signaling though its membrane receptors. The expression patterns of CXCR4 and CXCR7 show that the latter is a scavenger-type receptor that prevents endocytosis and even degradation of CXCR4 under inflammatory conditions.
There are controversial results about the role of serum leptin and adiponectin levels as biomarkers of the severity of proteinuria in lupus nephritis. The aim of this study was to evaluate the relationship between serum leptin and adiponectin levels with severity of proteinuria secondary to lupus nephritis (LN). In a cross-sectional study, 103 women with systemic lupus erythematosus (SLE) were evaluated for kidney involvement. We compared 30 SLE patients with LN, all of them with proteinuria, versus 73 SLE patients without renal involvement (no LN). A comprehensive set of clinical and laboratory variables was assessed, including serum levels of leptin and adiponectin by ELISA. Multivariate analyses were used to adjust for potential confounders associated with proteinuria in LN. We found higher adiponectin levels in the LN group compared with the no LN group (20.4 ± 10.3 vs 15.6 ± 7.8 μg/mL; p = 0.02), whereas no differences were observed in leptin levels (33.3 ± 31.4 vs 22.5 ± 25.5 ng/mL; p = 0.07). Severity of proteinuria correlated with an increase in adiponectin levels (r = 0.31; p = 0.001), but no correlation was observed with leptin. Adiponectin levels were not related to anti-dsDNA or anti-nucleosome antibodies. In the logistic regression, adiponectin levels were associated with a high risk of proteinuria in SLE (OR = 1.06; 95% CI 1.01–1.12; p = 0.02). Instead, leptin was not associated with LN. These findings indicate that adiponectin levels are useful markers associated with proteinuria in LN. Further longitudinal studies are required to identify if these levels are predictive of renal relapse.
Nutrition is an essential component when promoting human health. Without a doubt, improving the quality of one’s diet can improve one’s quality of life as a whole and help postpone the onset or control of many chronic diseases. The volume of publications in this field has increased in recent years, in line with increased awareness of the importance of nutrition in health; however, the quality of the evidence on which most nutritional guidelines are based remains low, due to errors in conducting nutritional interventions or because the information is primarily derived from observational studies. To enhance the evidence supporting clinical guidelines in nutrition, the quality of randomized clinical trials (RCT) based on nutritional interventions must be improved; nevertheless, due to their heterogeneous nature and a lack of specific guidelines for designing, performing, documenting, and reporting on this type of intervention, conducting a nutritional intervention is a real challenge. Following a review of the literature on the methodological and ethical standards, as well as four extensions of the CONSORT (Consolidated Standards of Reporting Trials) guidelines that should be considered when implementing a nutritional intervention, seven essential aspects were identified. The current narrative review includes definitions, examples, diagrams, and algorithms regarding aspects of the appropriate study design, the intervention of the control group, the randomization and blinding processes, the study population selection, as well as a description of the type of intervention and the personnel involved in carrying out the study in order to make the implementation of a nutritional intervention easier.