Categories
Nevin Manimala Statistics

Autologous Fat Transfer Harvest-site Complications: Incidence, Risk Factors, and Management

Ophthalmic Plast Reconstr Surg. 2021 Apr 28. doi: 10.1097/IOP.0000000000001989. Online ahead of print.

ABSTRACT

PURPOSE: Autologous fat transfer is an effective tool for volume restoration to the aging face. Although numerous reports exist regarding injection site complications, there is limited data on donor-site morbidity in the cosmetic surgery literature.

METHODS: This study is a large-scale retrospective review to determine incidence of fat harvest-site complications, identify risk factors, and describe management strategies. Records of all patients who underwent autologous fat harvesting and facial grafting at a single oculofacial plastic surgery practice from 2010 to 2019 were reviewed. Patient demographics and clinical data were collected and assessed. A statistical analysis was performed using a two-tailed T-test with p values of <0.05 considered significant.

RESULTS: Four-hundred sixteen patients were followed for an average of 6.2 months postoperatively. There was an overall 5.5% harvest-site complication rate. There was no correlation of harvest-site complications with gender (p = 0.249) or age (p = 0.881). Harvest location did not significantly correlate with complication rate. The most common complications were contour irregularities, prolonged induration, and prolonged erythema. Low body mass index was associated with higher complication rate (p = 0.003), even when excluding those patients with contour irregularities (p = 0.001). Various treatment modalities were used to manage donor-site morbidity with consistent improvement.

CONCLUSIONS: Autologous fat transfer used for facial volume augmentation has low donor-site morbidity. Minor harvest-site complications occur more commonly in patients with low body mass index, irrespective of age, gender, or fat source.

PMID:33927171 | DOI:10.1097/IOP.0000000000001989

Categories
Nevin Manimala Statistics

COVID-19 and gender: certainties and uncertainties in monitoring the pandemic.

Rev Esp Salud Publica. 2021 Apr 30;95:e202104066.

ABSTRACT

OBJECTIVE: Highlighting gender inequalities during the pandemic and its relationship with other axes of social inequality will be decisive for its adequate monitoring. The aim of this study was to assess the differences between men and women in the main measures of infection and mortality by COVID-19, considering its temporal evolution, raising awareness about the weaknesses and contradictions between sources of information.

METHODS: Cross-sectional analysis based on the microdata on COVID cases notified by the National Epidemiological Surveillance Network (RENAVE), the Death Statistics of the National Statistical Institute (INE) and the estimates of excess mortality from the INE and the Daily Mortality Monitoring System (MoMo) microdata. Standardized rates, prevalences and and ratios by sex were calculated for each indicator. The percentage of excess mortality without COVID-19 diagnosis in each sex was calculated. Male/female ratios for symptoms and risk factors of COVID-19 were also calculated.

RESULTS: The rate of infection by COVID-19 was higher in women in the three waves of the pandemic, reaching 65% of infections during April and May 2020. Complications were between 1.5 and 2.5 times higher in men, especially in ICU admissions, which were 2.5 times more frequent than in women. Although mortality rates and excess mortality were also higher in men (around 1.8 times), the percentage of excess mortality without COVID-19 diagnosis was higher in women (44% in men vs. 52% in women the first wave). With regard to the symptoms of COVID-19, fever, cough, and dyspnoea were more frequent in men (20%, 10% and 19% more, respectively) compared to sore throat, vomiting or diarrhea that were more prevalent in women (90%, 40% and 10% more, respectively).

CONCLUSIONS: The analysis disaggregated by sex has made it possible to identify differences between men and women in the diagnosis, presentation and severity of the COVID-19 that can help a better clinical and epidemiological approach to the disease. However, official sources present important gaps when presenting information disaggregated by sex. It is therefore necessary to advance in the inclusion of a gender perspective in the statistics on COVID-19, starting with a necessary but not sufficient condition such as the disaggregation by sex of the data.

PMID:33927179

Categories
Nevin Manimala Statistics

Pericarditis in patients with coronavirus disease 2019: a systematic review

J Cardiovasc Med (Hagerstown). 2021 Apr 28. doi: 10.2459/JCM.0000000000001202. Online ahead of print.

ABSTRACT

AIMS: We performed a systematic review to summarize the clinical features, diagnostic methods, treatment, and outcomes of coronavirus disease 2019 (COVID-19) patients with pericarditis.

METHODS: We searched electronic databases from inception to 17 December 2020. Studies that reported clinical data on patients with COVID-19 and pericarditis were included. Descriptive statistics were used for categorical and continuous variables [mean ± standard deviation or median (interquartile range)]. As an exploratory analysis, differences between patients with acute pericarditis and myopericarditis were compared.

RESULTS: A total of 33 studies (32 case reports and 1 case series) involving 34 patients were included. The mean age was 51.6 ± 19.5 years and 62% of patients were men. Sixty-two percentage of patients were diagnosed with myopericarditis. The most frequent electrocardiographic pattern (56%) was diffuse ST-elevation and PR depression. Pericardial effusion and cardiac tamponade were reported in 76 and 35% of cases, respectively. The median values of C-reactive protein [77 mg/dl (12-177)] and white blood cells [12 335 cells/μl (5625-16 500)] were above the normal range. Thirty-eight percent and 53% of patients were treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine, respectively. These drugs were more frequently used in patients with acute pericarditis compared with myopericarditis. The in-hospital mortality was 6% without a significant difference between both groups.

CONCLUSION: Our review shows that COVID-19 patients with pericarditis had similar clinical features to other viral cardiotropic infections. However, NSAIDs and colchicine were used in half or less of the cases. Overall, the short-term prognosis was good across groups.

PMID:33927144 | DOI:10.2459/JCM.0000000000001202

Categories
Nevin Manimala Statistics

Predictors of Peripapillary and Macular Optical Microangiography Measurements in Healthy Eyes

J Glaucoma. 2021 Apr 28. doi: 10.1097/IJG.0000000000001857. Online ahead of print.

ABSTRACT

PRCIS: The vessel density and perfusion density generated by optical microangiography is significantly affected by the signal strength. Gender, hypertension, diabetes and axial length did not have any statistically significant effect on these measurements.

PURPOSE: To assess the effect of subject-related factors (age, gender, systemic hypertension, diabetes and axial length) and machine related factor (signal strength) on vessel density (VD) and perfusion density (PD) generated by optical microangiography (OMAG) in peripapillary and macular regions.

METHODS: In an observational, cross-sectional study of 200 eyes of 100 healthy individuals (age: 18-80▒y), mean and sectoral VD and PD were calculated on disc and macular scans. Effect of subject-related and machine-related factors on VD and PD parameters were evaluated using multivariate mixed effect models.

RESULTS: Mean (±standard deviation) peripapillary and macular VD of the study population was 18.56±1.11▒mm-1 and 20.59±1.85▒mm-1 respectively. Mean peripapillary and macular PD was 46.43±3.22% and 37.61±3.26% respectively. Sex, hypertension, diabetes and axial length did not have any statistically significant effect on the OMAG measurements (P>0.05 for all associations). However, the signal strength (SS) had significant effect on the OMAG measurements. Mean peripapillary and macular VD on scans with SS of 10 was 1.4▒mm-1 and 3.79▒mm-1 greater respectively than that on scans with SS of 7. Mean peripapillary and macular PD on scans with SS of 10 was 4.43% and 7.85% greater respectively than that on scans with SS of 7.

CONCLUSION: Significant association exists between SS of the scan and the optical coherence tomography angiography (OCT-A) measurements generated by OMAG even when the scans had acceptable SS as recommended by the manufacturer (≥7). This needs to be considered while interpreting OCT-A measurements.

PMID:33927147 | DOI:10.1097/IJG.0000000000001857

Categories
Nevin Manimala Statistics

Effectiveness of Buffered Lidocaine for Local Anesthesia During Liver Biopsy

Gastroenterol Nurs. 2021 Apr 26. doi: 10.1097/SGA.0000000000000542. Online ahead of print.

ABSTRACT

The aim of this research study was to evaluate the effectiveness of lidocaine versus lidocaine with sodium bicarbonate in reducing anxiety and pain, using visual analog scales, in subjects receiving local anesthetic during liver biopsies. The project included 199 subjects presenting for percutaneous liver biopsy using local anesthesia. Subjects were randomized into 2 groups: the control group, which received lidocaine alone, and the experimental group, which received lidocaine buffered with sodium bicarbonate. Immediately after they received the lidocaine injection, both groups were asked to rate their preprocedure anxiety and pain using a 0-10 visual analog scale. Mean postprocedure pain was statistically significantly different between the two arms with the intervention group reporting less pain (1.65 vs. 2.27, p = .037). Change in pain scores between the two groups were also statistically significantly different with the intervention group reporting a mean change in pain score of 0.93 compared to 1.63 in the control group (p = .021). However, no differences were found for reported anxiety. This study has shown that using sodium bicarbonate with lidocaine significantly decreased pain sensation at the injection site when used for deep visceral anesthesia during percutaneous liver biopsy.

PMID:33927155 | DOI:10.1097/SGA.0000000000000542

Categories
Nevin Manimala Statistics

Estimating the Effectiveness of Rotavirus Vaccine Schedules

Epidemiology. 2021 Apr 12. doi: 10.1097/EDE.0000000000001363. Online ahead of print.

ABSTRACT

BACKGROUND: Important questions exist regarding the comparative effectiveness of alternative childhood vaccine schedules; however, optimal approaches to studying this complex issue are unclear.

METHODS: We applied methods for studying dynamic treatment regimens to estimate the comparative effectiveness of different rotavirus vaccine (RV) schedules for preventing acute gastroenteritis-related emergency department visits or hospitalization. We studied the effectiveness of six separate protocols: one- and two-dose monovalent rotavirus vaccine (RV1); one-, two-, and three-dose pentavalent rotavirus vaccine (RV5); and no RV vaccine. We used data on all infants to estimate the counterfactual cumulative risk for each protocol. Infants were censored when vaccine receipt deviated from the protocol. Inverse probability of censoring-weighted estimation addressed potentially informative censoring by protocol deviations. A non-parametric group-based bootstrap procedure provided statistical inference.

RESULTS: The method yielded similar 2-year effectiveness estimates for the full-series protocols; weighted risk difference estimates comparing unvaccinated children to those adherent to either full-series (two-dose RV1, three-dose RV5) corresponded to four fewer hospitalizations and 12 fewer emergency department visits over the 2-year period per 1,000 children. We observed dose-response relationships, such that additional doses further reduced risk of acute gastroenteritis. Under a theoretical intervention to fully vaccinate all children, the 2-year risk differences comparing full to observed adherence were 0.04% (95% CI: 0.03%, 0.05%) for hospitalizations and 0.17% (95% CI: 0.14%, 0.19%) for emergency department visits.

CONCLUSIONS: The proposed approach can generate important evidence about the consequences of delaying or skipping vaccine doses, and the impact of interventions to improve vaccine schedule adherence.

PMID:33927157 | DOI:10.1097/EDE.0000000000001363

Categories
Nevin Manimala Statistics

Association Between Lack of Blinding and Mortality Results in Critical Care Randomized Controlled Trials: A Meta-Epidemiological Study

Crit Care Med. 2021 Apr 30. doi: 10.1097/CCM.0000000000005065. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate whether intervention effect estimates for mortality differ between blinded and nonblinded randomized controlled trials conducted in critical care. We used a meta-epidemiological approach, comparing effect estimates between blinded and nonblinded randomized controlled trials for the same research question.

DATA SOURCES: Systematic reviews and meta-analyses of randomized controlled trials evaluating a therapeutic intervention on mortality in critical care, published between January 2009 and March 2019 in high impact factor general medical or critical care journals and by Cochrane.

DATA EXTRACTION: For each randomized controlled trial included in eligible meta-analyses, we evaluated whether the trial was blinded (i.e., double-blinded and/or reporting adequate methods) or not (i.e., open-label, single-blinded, or unclear). We collected risk of bias evaluated by the review authors and extracted trial results.

DATA SYNTHESIS: Within each meta-analysis, we compared intervention effect estimates between blinded and nonblinded randomized controlled trials by using a ratio of odds ratio (< 1 indicates larger estimates in nonblinded than blinded randomized controlled trials). We then combined ratio of odds ratios across meta-analyses to obtain the average relative difference between nonblinded and blinded trials. Among 467 randomized controlled trials included in 36 meta-analyses, 267 (57%) were considered blinded and 200 (43%) nonblinded. Intervention effect estimates were statistically significantly larger in nonblinded than blinded trials (combined ratio of odds ratio, 0.91; 95% CI, 0.84-0.99). We found no heterogeneity across meta-analyses (p = 0.72; I2 = 0%; τ2 = 0). Sensitivity analyses adjusting the main analysis on risk of bias items yielded consistent results.

CONCLUSIONS: Intervention effect estimates of mortality were slightly larger in nonblinded than blinded randomized controlled trials conducted in critical care, but confounding cannot be excluded. Blinding of both patients and personnel is important to consider when possible in critical care trials, even when evaluating mortality.

PMID:33927122 | DOI:10.1097/CCM.0000000000005065

Categories
Nevin Manimala Statistics

Effect of Vitamin D Supplementation on Vitamin D Level and Bone Mineral Density in Patients With Cirrhosis: A Randomized Clinical Trial

Am J Gastroenterol. 2021 Apr 29. doi: 10.14309/ajg.0000000000001272. Online ahead of print.

ABSTRACT

INTRODUCTION: In patients with cirrhosis, highly prevalent vitamin D deficiency and low bone mineral density (BMD) increase the burden of disease, and role of vitamin D supplementation is not clear. So, our aim was to determine the effect of vitamin D supplementation on vitamin D level and BMD in patients with cirrhosis.

METHODS: Patients with cirrhosis (18-60 years) of any etiology were enrolled. We measured serum 25(OH)D, parathyroid hormone, thyroid-stimulating hormone, free T4, bone-specific alkaline phosphatase, insulin-like growth factor (IGF)-1, and health-related quality of life at entry and at 1 year; however, serum calcium was measured at 3-month interval. BMD was measured by dual-energy x-ray absorptiometry at lumbar spine and left hip neck at entry and after 1 year. Statistical analysis was performed according to intention-to-treat analysis.

RESULTS: Of 390 screened patients with cirrhosis, 164 participants (82 in each group) were randomized. There was significant increase in 25(OH)D levels in intervention group after 1 year (33.7 [24.3-45.7] ng/mL vs 23.1 [17-28.2] ng/mL; P < 0.001) when compared with placebo. The mean difference in BMD at lumbar spine and left hip neck was not significantly changed after 1 year of intervention with vitamin D between both groups. There was no significant change in both the groups in levels of calcium, thyroid-stimulating hormone, parathyroid hormone, free T4, IGF-1, and bone-specific alkaline phosphatase and quality of life.

DISCUSSION: Supplementation with vitamin D for 1 year improves vitamin D levels but did not result in improvement in BMD at lumbar spine and left hip neck in patients with cirrhosis.

PMID:33927126 | DOI:10.14309/ajg.0000000000001272

Categories
Nevin Manimala Statistics

Effect of painting intervention based on Mandala-self theory on mood and physiological state in patients in preoperative waiting room

Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2021 Mar 28;46(3):293-299. doi: 10.11817/j.issn.1672-7347.2021.190795.

ABSTRACT

OBJECTIVES: The waiting room for surgery is an area set up to improve the surgical turnover rate, but the waiting time for surgery is uncertain. Patients are prone to negative emotions that affect their physiological state during waiting time. This study aims to explore the effect of Mandala painting intervention based on Mandala-self theory on the emotion and physiological state of patients waiting before operation.

METHODS: The patients in the control group (n=30) were given routine nursing before operation in the waiting room, and the patients in the intervention group (n=30) were given Mandala painting intervention on the basis of routine nursing. Repeated measurement analysis of variance was used to compare patients’ mood, pressure, heart rate, and waiting time of perception after intervention via SPSS 21.0.

RESULTS: Diastolic pressure, heart rate, and happiness and excitement showed no statistical significance in the time effect, intervention effect, and interaction between the 2 factors (all P>0.05). Systolic pressure, fidgety, and pain and sadness showed interaction between the time effect and intervention effect (P<0.05 or P<0.01). The waiting time of perception in the intervention group was significantly shorter than that in the control group (P<0.01).

CONCLUSIONS: The application of Mandala painting in the operation waiting room is feasible and can effectively regulate the patients’ negative mood and systolic pressure, as well as shorten the waiting time of perception.

PMID:33927077 | DOI:10.11817/j.issn.1672-7347.2021.190795

Categories
Nevin Manimala Statistics

Implications of weight gain with newer antiretrovirals: 10-year predictions of cardiovascular disease and diabetes

AIDS. 2021 Apr 28. doi: 10.1097/QAD.0000000000002930. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the long-term risks of type 2 diabetes mellitus (T2DM) and cardiovascular disease secondary to weight gain and clinical obesity associated with the initiation of integrase strand transfer inhibitors (INSTIs) and tenofovir alafenamide (TAF) in the ADVANCE trial using validated risk equation tools.

DESIGN: Retrospective data analysis.

METHODS: In ADVANCE, 1,053 treatment-naïve participants in South Africa (99% black, 59% female) were randomized to 96 weeks of tenofovir alafenamide/ emtricitabine + dolutegravir (TAF/FTC+DTG), tenofovir disoproxil fumarate/ emtricitabine + dolutegravir (TDF/FTC+DTG), or tenofovir disoproxil fumarate/ emtricitabine + efavirenz (TDF/FTC/EFV). The 5- and 10-year risks of CVD were calculated using D:AD, QRISK and Framingham, and T2DM risk using QDiabetes, Cambridge Diabetes and Leicester Practice Risk scores. Participants were included in this analysis if they were above 30 years old at baseline.

RESULTS: 217 (TAF/FTC+DTG), 218 (TDF/FTC+DTG), and 215 (TDF/FTC/EFV) participants had 96-week data available. Weight gain was +8.1 kg, +4.2 kg, and +2.4 kg on TAF/FTC+DTG, TDF/FTC+DTG, and TDF/FTC/EFV, respectively. Participants on TAF/FTC+DTG had greatest risk scores for CVD (using QRISK) and T2DM, driven by weight changes. Differences were statistically significant between TAF/FTC+DTG and TDF/FTC/EFV for CVD risk using the QRISK equation, equivalent to 1 extra case per 1,000 people treated over 10 years, and between all treatment groups for T2DM risk. Six extra T2DM cases were predicted on TAF/FTC+DTG vs TDF/FTC+DTG using QDiabetes.

CONCLUSION: Obesity, especially with TAF/FTC+DTG, drove increased risk of T2DM, with some evidence of greater CVD risk. However, predictive tools have not been validated in the HIV-positive and black African population.

PMID:33927086 | DOI:10.1097/QAD.0000000000002930