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• W1990679290 abstract "In his comments on our recent publication (Singh et al, 2012), Dr. Blann states that ‘they have measured 12 laboratory indices in a sample size of only 43 subjects, leading to fears of false positives and false negatives, pertinent in a study with no clear original hypothesis or power calculations.' We argue that power considerations are most pertinent for confirmatory studies where exact alternative hypotheses can permit power calculations. This was a ‘proof of concept’ study to identify potentially meaningful association between biomarkers and obesity. This was done in two ways: we compared distributions of biomarkers between healthy and obese groups and ran correlations with body mass index (BMI) combined over both groups. Admittedly, with 12 biomarkers under consideration there is potential for alpha inflation. However, we assure the reader that we did not collect 100 biomarkers and reported only the 5 significant ones. These studies showed that circulating tissue factor procoagulant activity (TF-PCA), factor VII (FVII) and plasminogen activator inhibitor-1 (PAI-1) were positively related to the BMI. Furthermore, at this early stage in this research, we felt the benefits of detecting potentially meaningful associations far outweighed the potential for false positives. In his first observation, Dr Blann points to the non-normal distribution of the PAI-1 and soluble vascular adhesion molecule 1 (sVCAM1) data and takes issue with the data analyses. The key to statistical inference for means is not the shape of the sample or even the population, but the normality of the theoretical sampling distribution of means. With relatively small sample sizes and unknown population distributions, we chose not to invoke the Central Limit Theorem to justify normality, and thus used Wilcoxon rank sums tests for p-values (see Statistical Analysis section, Singh et al, 2012). We disagree with Dr. Blann's comment that ‘…analysis by the Mann-Whitney U test would give a different P value.’ Wilcoxon rank sums test is numerically equivalent to the Mann-Whitney U-test (In fact, SAS calls it the ‘Wilcoxon-Mann-Whitney test’); therefore, the P-values would have been identical. Nonetheless, we tabulated means and standard deviations (instead of medians and ranges) as an aid to researchers who want to power their own inquiries into biomarkers and obesity. Dr. Blann's second observation relates to the significance of VCAM1 and PAI-1 measurements. Our suggestion that childhood obesity is associated with endothelial dysfunction is based on increased plasma sVCAM1, which has been used in multiple studies as a marker of endothelial perturbation and dysfunction. Because sVCAM1 can come also from other cells, including tumour cells, some caution may be necessary in making the connection, but we disagree that the use of sVCAM1 as biomarker for endothelial dysfunction is unsound. The same applies for other markers in plasma, including soluble cell adhesion molecules (CAMS). Irrespective of the cellular source of sVCAM1, more important is the evidence from other studies (described in Singh et al, 2012) linking elevated plasma sVCAM1 to adverse cardiovascular events and diabetes mellitus. Our findings in children with obesity are, therefore, particularly concerning. Regarding PAI-1, we indicate in our paper that the plasma levels are increased in mouse models of obesity. Our primary reason for suggesting endothelial dysfunction is based on sVCAM-1 levels. Dr Blann alludes to the well-recognized effect of blood groups on plasma von Willebrand factor (VWF) levels. Future larger studies may need to take into account the impact of blood groups in examining the differences in plasma VWF between healthy weight and obese children. In his third observation, Dr. Blann states: ‘the correlation coefficients in their Figure 1 of 0·36, 0·38 are all less than 0·4.’ This is based purely on power considerations. We are concerned over the use of power considerations to argue that an observed significant P-value is not significant. Once data are collected and properly analysed, the results are either statistically significant or not, regardless of how much power was initially infused by design. Our studies demonstrated that TF-PCA and FVII levels are elevated in obese children (Singh et al, 2012); and as pointed out in our discussion, the TF-PCA levels are comparable to those we have reported in patients with type 2 diabetes mellitus, well known to be predisposed to cardiovascular events. These support our conclusion regarding the procoagulant state. We concur with Dr. Blann when he states ‘…this conclusion is not unreasonable.’ Our pilot studies lay the basis for future larger studies on the procoagulant state in childhood obesity, which is a major health issue worldwide." @default.
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• W1990679290 date "2012-12-11" @default.
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• W1990679290 title "A procoagulant state and endothelial dysfunction in obese children - response to Blann" @default.
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• W1990679290 doi "https://doi.org/10.1111/bjh.12159" @default.
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