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Nevin Manimala Statistics

Effect of weight-loss diets prior to elective surgery on postoperative outcomes in obesity: A systematic review and meta-analysis

Clin Obes. 2021 Aug 31:e12485. doi: 10.1111/cob.12485. Online ahead of print.

ABSTRACT

This systematic review investigated the effects of weight-loss diets before elective surgery on preoperative weight loss and postoperative outcomes in people with obesity. Electronic databases were searched from inception to May 2021. Inclusion criteria were prospective cohort or randomised controlled studies that compared effects of weight-loss diets to standard care on postoperative outcomes in adults with obesity awaiting surgery. Participants with cancer or undergoing bariatric surgery were excluded. Data on preoperative weight change, length of stay, postoperative complications and patient-reported outcome measures were extracted and synthesised in meta-analyses. One randomised controlled trial involving total knee arthroplasty and two that investigated general surgery were eligible that included 173 participants overall. Each study compared low-calorie diets using meal replacement formulas to usual care. There is very-low-quality evidence of a statistically significant difference favouring the intervention for preoperative weight loss (mean difference [MD] -6.67 kg, 95% confidence interval [CI] -12.09 to -1.26 kg; p = 0.02) and low-quality evidence that preoperative weight-loss diets do not reduce postoperative complications to 30 days (odds ratio [OR] 0.34, 95% CI 0.08-1.42; p = 0.14) or length of stay (MD -3.72 h, 95% CI -10.76 to 3.32; p = 0.30). From the limited data that is of low quality, weight loss diets before elective surgery do not reduce postoperative complications.

PMID:34463422 | DOI:10.1111/cob.12485

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Nevin Manimala Statistics

Conditional uncertainty: Misinterpretations of “significant” p values

J Card Surg. 2021 Aug 31. doi: 10.1111/jocs.15963. Online ahead of print.

ABSTRACT

Misapplication of p values can lead to very misleading conclusions. The frequent insignificance of a “significant” p value 1 provides examples illustrating situations where p values are misused in interpretation and describes alternatives to p values to consider. The concern about p values, and their potential shortcomings and misinterpretations, has been widely discussed and has received a lot of debate from the statistical community. While we agree with much of the content presented in the article, the issue fundamentally represents a misinterpretation of conditional probability, misapplication of measures regarding diagnostic accuracy, and consequently violations of assumptions inherent in experimental design and the validity of many approaches to statistical analysis and inference. One way this can be remedied is through team science, and collaboration between clinical and biostatistical scientists in research.

PMID:34463384 | DOI:10.1111/jocs.15963

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Physical and psychosocial comorbidities of pediatric hidradenitis suppurativa: A retrospective analysis

Pediatr Dermatol. 2021 Aug 31. doi: 10.1111/pde.14765. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVES: Hidradenitis suppurativa (HS) is understudied in the pediatric population. Adult HS patients are known to have a high comorbidity burden. We aimed to describe physical and psychosocial comorbidities in a cohort of pediatric HS patients.

METHODS: A retrospective chart review of pediatric HS patients at a single academic institution was conducted. Data on patient demographics, disease characteristics, and physical and psychosocial comorbidities in pediatric patients with HS were collected and analyzed.

RESULTS: Seventy-three pediatric patients were included in this study, 81% female. Mean (SD) age of HS disease onset was 12.6 (2.9) years. Comorbid conditions were reported in 68 of 73 (93%) patients. Significantly increased rates of several comorbidities were seen in our cohort as compared to the general US pediatric population. Metabolic and endocrine abnormalities were prevalent, with 52% (22/42) patients with obesity and 10% (6/59) with polycystic ovary syndrome. The most common cutaneous comorbidity was acne vulgaris, seen in 37% (27/73) of patients. Over one quarter (21/73, 29%) of patients had either an anxiety or depression disorder. Almost one-fifth (14/73, 19%) of our cohort had a diagnosis of asthma and other reactive airway diseases. Only one-third (24/73, 33%) of patients had documentation regarding impact of HS on their daily life. Overall, comorbidities largely did not significantly differ based on race, gender, or disease severity.

CONCLUSIONS: Pediatric patients with HS face a high-comorbidity burden, especially with psychiatric conditions. Early identification, including routine mental health screening, and management of comorbidities is warranted in the pediatric HS population.

PMID:34463372 | DOI:10.1111/pde.14765

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Quantitative evaluation of prospective motion correction in healthy subjects at 7T MRI

Magn Reson Med. 2021 Aug 31. doi: 10.1002/mrm.28998. Online ahead of print.

ABSTRACT

PURPOSE: Quantitative assessment of prospective motion correction (PMC) capability at 7T MRI for compliant healthy subjects to improve high-resolution images in the absence of intentional motion.

METHODS: Twenty-one healthy subjects were imaged at 7 T. They were asked not to move, to consider only unintentional motion. An in-bore optical tracking system was used to monitor head motion and consequently update the imaging volume. For all subjects, high-resolution T1 (3D-MPRAGE), T2 (2D turbo spin echo), proton density (2D turbo spin echo), and T2 (2D gradient echo) weighted images were acquired with and without PMC. The images were evaluated through subjective and objective analysis.

RESULTS: Subjective evaluation overall has shown a statistically significant improvement (5.5%) in terms of image quality with PMC ON. In a separate evaluation of every contrast, three of the four contrasts (T1 , T2 , and proton density) have shown a statistically significant improvement (9.62%, 9.85%, and 9.26%), whereas the fourth one ( T2 ) has shown improvement, although not statistically significant. In the evaluation with objective metrics, average edge strength has shown an overall improvement of 6% with PMC ON, which was statistically significant; and gradient entropy has shown an overall improvement of 2%, which did not reach statistical significance.

CONCLUSION: Based on subjective assessment, PMC improved image quality in high-resolution images of healthy compliant subjects in the absence of intentional motion for all contrasts except T2 , in which no significant differences were observed. Quantitative metrics showed an overall trend for an improvement with PMC, but not all differences were significant.

PMID:34463376 | DOI:10.1002/mrm.28998

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Mortality associated with non-melanoma skin cancer in Spain from 1979 to 2018: trends and age-adjusted rates

Eur J Dermatol. 2021 Aug 26. doi: 10.1684/ejd.2021.4110. Online ahead of print.

ABSTRACT

Non-melanoma skin cancers (NMSCs) are the most frequent group of malignant tumours worldwide. Objectives: The aim of the present research was to analyse mortality associated with NMSC in Spain between 1979 and 2018 and highlight changes regarding trend in mortality and differences according to age groups and gender. Death records and mid-year population data were collected from the National Statistics Institute. Age-standardized mortality rates were calculated. Significant changes in mortality trends were identified using Joinpoint regression. The independent effects of age, period and cohort and potential years of life lost due to NMSC were also analysed. Mortality rates associated with NMSC in Spain were reported as 2.49 per 100,000 inhabitants in 1979 (95% CI: 2.24-2.77) and 1.27 per 100,000 inhabitants in 2018 (95% CI; 1.16-1.39) for the overall population. Women who were born after the 70 s showed a significant increase in relative risk of death due to NMSC. Mortality associated with NMSC in Spain shows a decreasing overall trend that appears to have stabilized since 2005, with the exception of women between 35 and 64 years old.

PMID:34463287 | DOI:10.1684/ejd.2021.4110

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Comparison of Anti-SARS-CoV-2 S1 Receptor-Binding Domain Antibody Immunoassays in Health Care Workers Before and After the BNT162b2 mRNA Vaccine

Am J Clin Pathol. 2021 Aug 31:aqab107. doi: 10.1093/ajcp/aqab107. Online ahead of print.

ABSTRACT

OBJECTIVES: The Pfizer-BioNTech BNT162b2 vaccine against SARS-CoV-2 infection is now available. This vaccine induces antibody production against the receptor-binding domain (RBD) of the spike glycoprotein S1 (S1-RBD). This study evaluated the performance of new immunoassays to measure this type of antibody.

METHODS: Blood samples were collected at t0 (prime dose), after 21 days (t1, booster dose), and then after another 15 days (t2) from 70 health care professionals who had tested negative for previous SARS-CoV-2 infection and underwent vaccination with BNT162b2.

RESULTS: Antibodies against S1-RBD were measured using 4 commercial assays. At t0, t1, and t2, the median antibody concentrations (interquartile range) were, respectively, 0.2 (0.1-0.4), 49.5 (19.1-95.7), and 888.0 (603.6-1,345.8) U/mL by Maglumi SARS-CoV-2 S-RBD immunoglobulin G (IgG) (Shenzen New Industries Biomedical Engineering, Snibe Diagnostics); 0.0 (0.0-0.0), 7.9 (4.2-15.6), and 112.3 (76.4-205.6) U/mL by Atellica IM SARS-CoV-2 IgG assay (Siemens Healthineers); 0.0 (0.0-0.0), 59.9 (18.3-122.0), and 2,646.0 (1,351.2-4,124.0) U/mL by Elecsys Anti-SARS-CoV-2 S assay (Roche Diagnostics); and 1.8 (1.8-1.8), 184 (94-294), and 1,841.0 (1,080.0-2,900.0) AU/mL by LIAISON SARS-CoV-2 TrimericS IgG assay (DiaSorin). The differences between medians at t0, t1, and t2 were all statistically significant (P < .001).

CONCLUSIONS: Antibodies against nucleocapsid proteins (N) were also measured using Maglumi 2019-nCoV IgG assay, which showed all negative results. All the considered anti-RBD methods detected response to the vaccine, while the method directed against anti-N failed to show response.

PMID:34463321 | DOI:10.1093/ajcp/aqab107

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A new approach to the regenerative medicine in gynecology

Int J Gynaecol Obstet. 2021 Aug 31. doi: 10.1002/ijgo.13906. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to evaluate the efficacy of the injection of microfragmented adipose tissue in the treatment of women with genitourinary syndrome of menopause (GSM).

METHODS: This observational cohort study included 12 women who received one session of multiple injections of microfragmented adipose tissue using the SEFFIGYN medical device (SEFFILINE S.r.l. Bologna – Italy). Symptoms such as burning, itching, dryness, pain on penetration, pain during deep intercourse, and pain on urination were assessed before the patient’s treatment (T0), after 15 days (T15), and after five months (5Mo) using the Numerical Rating Scale (NRS).

RESULTS: An improvement of vulvar trophism was clinically evident already after two weeks from treatment; all symptoms were notably attenuated compared to the initial visit, as demonstrated by statistically significant reductions of the NRS scores (P=0.003 for hitching, P=0.008 for pain on urination, and P<0.001 for the other symptoms, Sign test). Moreover, all symptoms continued to improve over time. All patients reported a positive change in their quality of life and a resumption of sexual life.

CONCLUSION: The use of microfragmented adipose tissue in GSM is promising. Nevertheless, more studies will be fundamental to exclude a potential placebo effect and better understand the underlying molecular mechanism of action.

PMID:34463351 | DOI:10.1002/ijgo.13906

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General anaesthesia versus other types of anaesthesia in patients undergoing surgery for treatment of cutaneous melanoma: a systematic review and meta-analysis

Eur J Dermatol. 2021 Aug 26. doi: 10.1684/ejd.2021.4109. Online ahead of print.

ABSTRACT

General and local anaesthetics alter tumour behaviour in experimental models. Objectives: To investigate the relationship between general anaesthesia and recurrence or survival in patients who received surgery for malignant melanoma. A meta-analysis was performed based on a comprehensive literature search. Controlled and observational studies of patients undergoing surgery for melanoma under general anaesthesia, compared with other types of anaesthesia, were included. The primary outcomes were overall survival and disease-free survival. The secondary outcomes included cancer-specific survival, cost analysis, and adverse events. Risk of bias was assessed. Individual study information was summarized. The meta-analysis was performed using a random-effects model. The GRADE approach was used to summarise the certainty of evidence. Eight studies were included (n = 5,832). The use of general anaesthesia was not associated with any statistical difference in overall survival (p = 0.087; 1 NRS; n= 104; very low certainty of evidence) or disease-free survival (HR: 1.266; 95% CI: 0.904-1.773; p = 0.169; 1 NRS; n = 281; very low certainty of evidence). However, general anaesthesia was associated with worse melanoma-specific survival (HR: 1.46; 95% CI: 1.22-1.68: p < 0.00001; 3 NRS; n = 4654; low certainty of evidence). Three studies reported increased intraoperative costs associated with the use of general anaesthesia (3 NRT; n = 513; very low certainty of evidence). No study adequately reported other primary or secondary outcomes. General anaesthesia may reduce melanoma-specific survival in patients undergoing surgery for treatment of cutaneous melanoma. We are uncertain whether general anaesthesia impacts the other reported outcomes.

PMID:34463285 | DOI:10.1684/ejd.2021.4109

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Lower limb lymphedema staging based on magnetic resonance lymphangiography

J Vasc Surg Venous Lymphat Disord. 2021 Jul 8:S2213-333X(21)00301-2. doi: 10.1016/j.jvsv.2021.06.006. Online ahead of print.

ABSTRACT

OBJECTIVE: Dermal backflow (DBF) and reduced lymphatic visualization are common findings of lymphedema on various imaging modalities. However, there is a lack of knowledge about how these findings vary with the anatomic location and severity of lymphedema, and previous reports using indocyanine green lymphography or lymphoscintigraphy show variable results. Magnetic resonance lymphangiography (MRL) is expected to clarify this clinical question due to its superior ability for lymphatic visualization. This retrospective study aimed to investigate the following: (1) Are there any characteristic patterns for DBF and lymphatics’ visualization, depending on the anatomic location within lower limbs and severity of lymphedema? (2) Is it possible to classify the severity of lymphedema based on MRL findings?

METHODS: Two radiologists performed consensus readings of MRL of 56 patients (112 limbs) with lower-limb lymphedema. The frequency of visualized DBF and lymphatics was analyzed in six regions in each lower limb. The results were compared with the International Society of Lymphology clinical stages and etiology of lymphedema. Characteristic findings were categorized and compared with the clinical stage and duration of lymphedema.

RESULTS: DBF and lymphatics were observed more frequently in the distal regions than the proximal regions of lower limbs. DBF appeared more frequently as the clinical stage increased, reaching statistical significance (P < 10-3) between stages 0 or I and II. DBF above the knee joint was rarely observed (0.48%) in early stages (0 and I) but appeared more frequently (13.5%, P < 10-5) in stage II. Lymphatics appeared less frequently as the stage progressed, with significant differences (P < .05) between stages I and II and between II and III. The frequency of lymphatics above the knee joint decreased significantly (P < .05) between stages I and II and between II and III as the stage progressed, reaching 0% in stage III. An MRL staging was proposed and showed significant positive correlations with the clinical stage (r = 0.79, P < .01) and the duration of lymphedema (r = 0.57, P < .01).

CONCLUSIONS: MRL-specific patterns of DBF and lymphatics that depended on the site within the lower limb and clinical stage were shown. The DBF pattern differed from those observed in previous studies with other imaging techniques. The proposed MRL staging based on these characteristic findings allows new stratification of patients with lymphedema. Combined with its excellent ability to visualize lymphatic anatomy, MRL could enable a more detailed understanding of individual patient’s pathology, useful for determining the most appropriate treatment.

PMID:34463259 | DOI:10.1016/j.jvsv.2021.06.006

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Evaluation of the Validity of a Food Frequency Questionnaire and 24-Hour Dietary Recall to Assess Dietary Iron Intake in Children and Adolescents from the South American Youth/Child Cardiovascular and Environmental Study

J Acad Nutr Diet. 2021 Aug 24:S2212-2672(21)00831-5. doi: 10.1016/j.jand.2021.07.005. Online ahead of print.

ABSTRACT

BACKGROUND: A food frequency questionnaire (FFQ) for South American children and adolescents was developed, but its validity for assessing dietary iron intake has not been evaluated.

OBJECTIVE: To evaluate the validity of the FFQ and 24-hour dietary recalls (24h-DR) for assessing dietary iron intake in children and adolescents.

DESIGN: The South American Youth/Child Cardiovascular and Environmental study is a multicenter observational study, conducted in five South American cities: Buenos Aires (Argentina), Lima (Peru), Medellin (Colombia), Sao Paulo, and Teresina (Brazil). The FFQ assessed dietary intake over the previous 3 months, and the 24h-DR was completed three times (2 weekdays and 1 weekend day) with a minimum 5-day interval between recalls. Blood samples were collected to assess serum iron, ferritin, and hemoglobin levels.

PARTICIPANTS AND SETTING: Data of 99 children (aged 3 to 10 years) and 50 adolescents (aged 11 to 17 years) from public and private schools were collected during 2015 to 2017.

MAIN OUTCOME MEASURES: Dietary iron intake calculated from the FFQ (using the sum of daily iron intake in all food/food groups) and 24h-DR (mean of 3 days using the multiple source method).

STATISTICAL ANALYSES PERFORMED: Dietary iron intake in relation to blood biomarkers were assessed using Spearman rank correlations adjusted for sex, age, and total energy intake, and the quadratic weighted κ coefficients for agreement.

RESULTS: Spearman correlations showed very good coefficients (range = 0.78 to 0.85) for the FFQ in both age groups; for the 24h-DR, the coefficients were weak in children and adolescents (range = 0.23 to 0.28). The agreement ranged from 59.9% to 72.9% for the FFQ and from 63.9% to 81.9% for the 24h-DR.

CONCLUSION: The South American Youth/Child Cardiovascular and Environmental study FFQ exhibited good validity to rank total dietary iron intake in children and adolescents, and as well as the 24h-DR, presented good strength of agreements when compared with serum iron and ferritin levels.

PMID:34463258 | DOI:10.1016/j.jand.2021.07.005