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Nevin Manimala Statistics

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study

Sao Paulo Med J. 2022 Apr 29:S1516-31802022005007206. doi: 10.1590/1516-3180.2021.0492.R1.15092021. Online ahead of print.

ABSTRACT

BACKGROUND: Epidemiological studies involving large samples usually face financial and operational challenges.

OBJECTIVES: To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found.

DESIGN AND SETTING: Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers.

METHODS: Actions developed in each phase of implementation were described, with emphasis on innovations used within the logistics of this study, aimed at estimating the prevalence of nonadherence to treatment.

RESULTS: Coordination of activities was divided into four areas: general, regulatory, data collection and statistics. Weekly meetings were held for action planning. The general coordination team was in charge of project elaboration, choice of participating centers, definition of publication policy and monitoring other coordination teams. The regulatory team provided support to centers for submitting the project to ethics committees. The data collection team prepared a manual on the electronic collection system, scheduled web meetings and was available to respond to queries. It also monitored the data quality and reported any inadequacies found. Communication with the centers was through monthly reports via e-mail and distribution of exclusive material. The statistical team acted in all phases of the study, especially in creating the data analysis plan and data bank, generation of randomization lists and data extraction.

CONCLUSIONS: Through these logistics, we collected high-quality data and built a local research infrastructure for further studies. We present supporting alternatives for conducting similar studies.

CLINICAL TRIAL ANNOTATION: http://clinicaltrials.gov/ on October 10, 2013; NCT02066935.

PMID:35507993 | DOI:10.1590/1516-3180.2021.0492.R1.15092021

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Nevin Manimala Statistics

A new biomarker in severe pneumonia associated with coronavirus disease 2019: hypoalbuminemia. A prospective study

Sao Paulo Med J. 2022 May 2:S1516-31802022005009201. doi: 10.1590/1516-3180.2021.0066.R2.16082021. Online ahead of print.

ABSTRACT

BACKGROUND: Effective triage and early detection are very important for controlling and treating coronavirus disease 2019 (COVID-19). Thus, the relationships between hypoalbuminemia and other acute-phase reactants in such cases need to be evaluated.

OBJECTIVES: To investigate the importance of albumin levels in cases of severe pneumonia due to COVID-19.

DESIGN AND SETTING: Prospective study conducted in Ankara City Hospital (a stage 3 hospital), Turkey.

METHODS: Data from 122 patients diagnosed with pneumonia due to COVID-19 who were admitted to this hospital were analyzed statistically in comparison with date from 60 healthy controls. Three groups were established: healthy controls, intubated patients and non-intubated patients. Lung tomography scans from the patients were examined one-by-one. Real-time polymerase chain reaction (RT-PCR) test results were recorded.

RESULTS: Albumin levels were statistically significantly lower in the intubated and non-intubated groups than in the control group, in comparing the three groups (P < 0.01). The other acute-phase reactants, i.e. neutrophil-to-lymphocyte ratio and C-reactive protein levels, were significantly higher in the intubated and non-intubated groups than in the control group (P < 0.05). Albumin levels were also significantly lower in the intubated group than in the non-intubated group (P = 0.02). No differences were detected with regard to other parameters (P > 0.05).

CONCLUSIONS: Hypoalbuminemia may constitute a biomarker indicating the severity of pneumonia due to COVID-19.

PMID:35507997 | DOI:10.1590/1516-3180.2021.0066.R2.16082021

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Nevin Manimala Statistics

Effect of liberal or conservative oxygen therapy on the prognosis for mechanically ventilated intensive care unit patients: a meta-analysis

Sao Paulo Med J. 2022 Apr 29:S1516-31802022005007201. doi: 10.1590/1516-3180.2021.0062.21092021. Online ahead of print.

ABSTRACT

BACKGROUND: For critically ill patients, physicians tend to administer sufficient or even excessive oxygen to maintain oxygen saturation at a high level. However, the credibility of the evidence for this practice is unclear.

OBJECTIVE: To determine the effects of different oxygen therapy strategies on the outcomes of mechanically ventilated intensive care unit (ICU) patients.

DESIGN AND SETTING: Systematic review of the literature and meta-analysis conducted at Jiangxi Provincial People’s Hospital, Affiliated to Nanchang University, Nanchang, China.

METHODS: We systematically searched electronic databases such as PubMed and Embase for relevant articles and performed meta-analyses on the effects of different oxygen therapy strategies on the outcomes of mechanically ventilated ICU patients.

RESULTS: A total of 1802 patients from five studies were included. There were equal numbers of patients in the conservative and liberal groups (n = 910 in each group). There was no significant difference between the conservative and liberal groups with regard to 28-day mortality (risk ratio, RR = 0.88; 95% confidence interval, CI = 0.59-1.32; P = 0.55; I2 = 63%). Ninety-day mortality, infection rates, ICU length of stay, mechanical ventilation-free days up to day 28 and vasopressor-free days up to day 28 were comparable between the two strategies.

CONCLUSIONS: It is not necessary to use liberal oxygen therapy strategies to pursue a higher level of peripheral oxygen saturation for mechanically ventilated ICU patients. Conservative oxygen therapy was not associated with any statistically significant reduction in mortality.

PMID:35507988 | DOI:10.1590/1516-3180.2021.0062.21092021

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Nevin Manimala Statistics

In-vitro evaluation of the anti-cariogenic effect of a hybrid coating associated with encapsulated sodium fluoride and stannous chloride in nanoclays on enamel

J Appl Oral Sci. 2022 May 2;30:e20210643. doi: 10.1590/1678-7757-2021-0643. eCollection 2022.

ABSTRACT

OBJECTIVE: The aim of this study is to test, in vitro, the anti-cariogenic effect of experimental hybrid coatings, with nano clays of halloysite or bentonite, loaded with sodium fluoride or with a combination of sodium fluoride and stannous chloride, respectively.

METHODOLOGY: The varnish Fluor Protector (1,000 ppm of F-) was used as positive control and no treatment was the negative control. Enamel specimens (5 mm × 5 mm) were obtained from bovine teeth. The specimens (n=10) had their surfaces divided into two halves (5 mm × 2.5 mm each), in which one half received one of the treatments (Hybrid; Hybrid + NaF; Hybrid + NaF + SnCl2; Hybrid + NaF Loaded; Hybrid + NaF + SnCl2 Loaded). The specimens were submitted to a cariogenic challenge using a biofilm model (S. mutans UA159, for 5 days). Enamel surfaces both under and adjacent to the treated area were analyzed for mineral loss and lesion depth, by transverse microradiography. The pH of the medium was measured twice a day, and the fluoride release was analyzed. Additional specimens were submitted to confocal analysis.

RESULTS: Data were statistically analyzed by two-way ANOVA followed by Tukey test (α=0.05). None of hybrid groups were able to reduce the lesion depth; the Hybrid + NaF group, however, was able to reduce mineral loss differing from the negative control (p=0.008). The groups showed no significant difference in the pH measurement and fluoride release. Confocal analysis confirmed that for all groups the biofilm growth was similar.

CONCLUSION: None of the hybrid groups reduced lesion depth, but the Hybrid + NaF group was able to promote protection against mineral loss.

PMID:35507984 | DOI:10.1590/1678-7757-2021-0643

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Nevin Manimala Statistics

Analysis of the number of deaths in Brazil between 2003 and 2020 and possible inferences about the COVID-19 pandemic and history of other diseases

An Acad Bras Cienc. 2022 May 2;94(2):e20210205. doi: 10.1590/0001-3765202220210205. eCollection 2022.

ABSTRACT

The historical number of yearly deaths in Brazil has a growing tendency since always. In recent years were observed increases in this number beyond the tendency, probably associated to epidemics. In this work it was implemented an analysis on public data, using the total number of deaths from violence, respiratory diseases, and deaths in hospitals. The historical series of deaths in Brazil from 2003 to 2019 was used to estimate the number of deaths in 2020 by a statistical projection, and this estimate value was compared with the number of deaths recorded as “Deaths with suspicion or confirmation of COVID-19”. It was verified that deaths attributed to COVID-19 far exceed the statistical projections but this result was interpreted together with the numbers of deaths by respiratory diseases. Increasing of deaths between 2019 and 2020 can be partially explained by a lowering in the deaths of violence in 2019. In this paper it was verified that despite de pandemic the difference between number of deaths between 2020 and 2019 remained in the same order of magnitude as the difference in the past, in periods which can be associated to other infectious diseases as H1N1 and dengue, for example.

PMID:35507980 | DOI:10.1590/0001-3765202220210205

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Nevin Manimala Statistics

Population dynamics of pelagic rotifers in Marala Headworks (Pakistan)

Braz J Biol. 2022 Apr 29;84:e250134. doi: 10.1590/1519-6984.250134. eCollection 2022.

ABSTRACT

Research work was designed to investigate the density and diversity of pelagic rotifers in a Lake near Marala Headworks. The physico-chemical parameters of water such as pH, dissolved oxygen, temperature, electrical conductivity, transparency and turbidity were evaluated. Correlation between rotifers and these parameters was also studied. Plankton sampling was done on monthly basis in order to check the population density of rotifers. In total, 18 species of rotifers were identified which belonged to 11 genera. The highest number of rotifers and their diversity was shown by genera namely Brachionus, Keratella, and Filinia. The Brachionus calyciflorus was dominant species in all the samples with mean population density (41%). Analysis of variance of physico-chemical parameters presented that the air and water temperature, electrical conductivity, transparency, dissolved oxygen and oxygen saturation were statistically significant in all the months. While pH was statistically non-significant (p≥0.05. Pearson correlation showed that oxygen and transparency were negatively correlated with rotifers density and diversity. Air and water temperature, concentration of hydrogen ions (pH), electrical conductivity and salinity showed positive relationship with density and diversity of rotifers.

PMID:35507960 | DOI:10.1590/1519-6984.250134

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Nevin Manimala Statistics

Intersections between rural women’s resilience and quality of life: a mixed-methods study

Rev Lat Am Enfermagem. 2022;30:e3559. doi: 10.1590/1518-8345.5671.3559.

ABSTRACT

OBJECTIVE: to analyze the intersections between rural women’s quality of life and resilience.

METHOD: convergent mixed methods design in which a cross-sectional quantitative study is triangulated with a qualitative study guided by Oral History. Data were collected concomitantly, using a socio-demographic form, Resilience Scale, Medical Outcomes Study 36-Item Short-Form Health Survey, and open-ended interviews. The analysis was based on descriptive and inferential statistics and inductive thematic analysis, which was integrated later.

RESULTS: an association was found between the social aspects domain of quality of life and a moderate level of resilience related to the characteristics of life in rural areas. The integration of results enabled verifying that these two constructs (which mutually influence each other) are mediated by protective factors, resilience developed by the rural women, such as spirituality and the formation of social support, enchantment, and a feeling of belonging to their context.

CONCLUSION: by developing protective factors, rural women develop a resilient behavior that favors their quality of life. Identifying these factors enables the development of psychosocial interventions to promote rural women’s health.

PMID:35507957 | DOI:10.1590/1518-8345.5671.3559

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Nevin Manimala Statistics

Impact of long-term care facilities’ size on adherence to COVID-19′ infection prevention guidance

Rev Lat Am Enfermagem. 2022;30:e3557. doi: 10.1590/1518-8345.5581.3557.

ABSTRACT

OBJECTIVE: to evaluate the adherence of Brazilian long-term care facilities to the World Health Organization Infection Prevention and Control guidance, and assess the association of their size with the adherence to these recommendations.

METHOD: cross-sectional study conducted with facilities’ managers. Authors developed a 20-item questionnaire based on this guidance, and a global score of adherence, based on the adoption of these recommendations. Adherence was classified as (1) excellent for those who attended ≥14 out of 20 recommendations; (2) good for 10 to 13 items; and (3) low for those with less than ten items. Facilities’ sizes were established as small, intermediate, and large according to a two-step cluster analysis. Descriptive statistics and chi-square tests were used at a 5% significance level.

RESULTS: among 362 included facilities, 308 (85.1%) adhered to 14 or more recommendations. Regarding its size, adherence to screening COVID-19 symptoms of visitors (p=0.037) and isolating patients until they have had two negative laboratory tests (p=0.032) were lower on larger ones compared to medium and small facilities.

CONCLUSION: adherence to COVID-19 mitigation measures in Brazilian facilities was considered excellent for most of the recommendations, regardless of the size of the units.

PMID:35507956 | DOI:10.1590/1518-8345.5581.3557

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Nevin Manimala Statistics

Effect of Momordica charantia Administration on Anthropometric Measures and Metabolic Profile in Patients with Obesity: A Pilot Clinical Trial

J Med Food. 2022 May 4. doi: 10.1089/jmf.2021.0164. Online ahead of print.

ABSTRACT

The aim of this study was to evaluate the effect of Momordica charantia (MC) administration on anthropometric measures in patients with obesity. A randomized, double-blind, placebo-controlled pilot clinical trial was carried out in 24 patients with obesity. Twelve patients randomly received MC (2000 mg/day) for 12 weeks, and 12 patients received placebo. Body weight (BW), body mass index (BMI), waist circumference (WC), body fat percentage, as well as clinical and laboratory determinations, were evaluated before and after the intervention. Results showed that while reductions in BW, BMI, WC, and body fat percentage were observed in the MC group, these differences did not reach statistical significance. Significant decreases in triglycerides (TG) (1.9 ± 0.6 mM vs. 1.7 ± 0.7 mM, P ≤ .05) and very low-density lipoprotein (VLDL) (0.4 ± 0.1 mM vs. 0.3 ± 0.1 mM, P ≤ .05) levels were found after the intervention with MC. In contrast, significant increases in BW (83.0 ± 10.7 kg vs. 84.6 ± 9.1 kg, P ≤ .05) and BMI (31.9 ± 1.5 kg/m2 vs. 33.0 ± 1.3 kg/m2, P ≤ .05) were observed in the placebo group. In conclusion, no significant reductions in BW, BMI, WC, and body fat percentage were observed after MC administration; however, MC significantly decreased TG and VLDL levels. The protocol was registered at ClinicalTrials.gov with the identifier NCT04916379.

PMID:35507955 | DOI:10.1089/jmf.2021.0164

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Nevin Manimala Statistics

Cervical Disc Replacement for Radiculopathy Versus Myeloradiculopathy: An MCID Analysis

Clin Spine Surg. 2022 May 1;35(4):170-175. doi: 10.1097/BSD.0000000000001313. Epub 2022 Apr 18.

ABSTRACT

STUDY DESIGN: Retrospective cohort study.

OBJECTIVES: The aim was to compare the minimally clinically important difference (MCID) across multiple patient-reported outcomes (PROs) in patients undergoing cervical disc replacement (CDR) for cervical spondylotic radiculopathy versus myeloradiculopathy.

SUMMARY OF BACKGROUND DATA: To date, a limited number of studies have demonstrated mostly similar results in patients with cervical spondylotic radiculopathy or myeloradiculopathy undergoing CDR. However, each of these previous studies have focused on statistically significant differences, which may not correlate with patient perceived improvements in outcomes or success.

METHODS: Patients who underwent 1 or 2-level CDR with radiculopathy versus myeloradiculopathy were identified, and prospectively collected data was retrospectively reviewed. Demographic variables, preoperative diagnosis, and operative variables were collected for each patient. The following PROs were prospectively collected: Neck Disability Index (NDI), visual analog scale (VAS)-Neck, VAS-Arm, Short Form-12 Health Survey (SF-12) Physical Component Score (PCS), SF-12 Mental Component Score (MCS), PROMIS Physical Function (PF). An MCID analysis of PROs for each diagnosis group was performed and the percentage of patients achieving the MCID was compared between the two diagnosis groups.

RESULTS: Eight-five patients, of which 56% had radiculopathy and 44% had myeloradiculopathy. MCID analysis demonstrated that at 6-week, 12-week, and final postoperative follow-up there was no significant difference in the percentage of patients with radiculopathy or myeloradiculopathy achieving the MCID for each PRO assessed. In both diagnosis groups the percentage of patients achieving the MCID for each PRO continued to increase from the 6-week to final postoperative follow-up except for the SF-12 MCS in patients with myeloradiculopathy.

CONCLUSIONS: The percentage of patients achieving the MCID was not significantly different at each postoperative period assessed in the radiculopathy and myeloradiculopathy groups treated with CDR. In addition, the percentage of patients achieving the MCID continued to increase from 6 weeks to final follow-up in both groups for almost all PROs assessed.

PMID:35507951 | DOI:10.1097/BSD.0000000000001313