Pharmacology and Statistics: Recommendations to Strengthen a Productive Partnership

Spector, Reynold; Vesell, Elliot S.

doi:10.1159/000095961

Cited by 11 publications

(4 citation statements)

References 47 publications

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“…The vast majority of these epidemiologic/observation studies suffer from multiple methodological deficiencies and the results are often ambiguous, misleading, or actually quantitatively incorrect, as pointed out by ourselves, and many others (Spector and Vesell, 2000, 2006aCampbell and Campbell 2006). These methodological deficiencies include poor validation of food questionnaires, infrequent or no assessment of change in diet, inattention to the Hill criteria for proving causality, improper use of statistics in nonrandomized studies, futile attempts to focus on one variable, "data dredging" (also termed data mining, i.e., looking for correlations in large data sets without a predetermined hypothesis, a procedure that leads to many false positive correlations), and many other errors (Spector and Vesell, 2000;, 2006aCampbell and Campbell 2006). Two important examples of false positives studies include those that concluded that HRT and mega-vitamin E prevented ASCVD (Spector and Vesell, 2002).…”

Section: The Role Of Dietmentioning

confidence: 98%

New Insight into the Dietary Cause of Atherosclerosis: Implications for Pharmacology

Spector¹

2016

Journal of Pharmacology and Experimental Therapeutics

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At present, the guideline approach to the medical treatment and prevention of atherosclerotic cardiovascular disease (ASCVD) is to classify patients by risk and treat the known risk factors (contributory causes), e.g., hypertension, diabetes, obesity, smoking, and poor diet, as appropriate. All high-risk patients should receive statins. This approach has had substantial success but ASCVD still remains the number one cause of death in the United States. Until recently, the underlying cause of ASCVD remained unknown, although a potential dietary cause was suggested by the fact that vegetarians, especially vegans, have a much lower incidence of ASCVD than animal flesh eaters. Recently, consistent with the vegetarian data, substantial evidence for a cause of ASCVD in animals and humans has been discovered. Trimethylamine (TMA)-containing dietary compounds in meat, milk, and other animal foods (e.g., lecithin, choline, and carnitine) are converted by closely related gut bacterial TMA lyases to TMA, which is absorbed and converted predominantly by flavin mono-oxygenase 3 to the toxic trimethylamine N-oxide (TMAO). TMAO causes atherosclerosis in animals and is elevated in patients with coronary heart disease. Inhibition of bacterial lyases in mice prevents TMA and secondarily TMAO formation and atherosclerosis, strong evidence for the TMAO hypothesis. At present, the challenge for the pharmaceutical industry is to discover and develop a potent "broad spectrum" bacterial lyase inhibitor that, along with diet and exercise, could, if the TMAO hypothesis is correct, revolutionize the preventive treatment of ASCVD.

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Section: The Role Of Dietmentioning

confidence: 98%

New Insight into the Dietary Cause of Atherosclerosis: Implications for Pharmacology

Spector¹

2016

Journal of Pharmacology and Experimental Therapeutics

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“…On the other hand, the utility of large doses of vitamin E in human brain diseases has been disappointing. In fact, there is actual increased morbidity/mortality in meta‐analyses of the large randomized vitamin E trials (Spector and Vesell 2002, 2006). We also know that giving humans massive does of vitamin E (e.g.…”

Section: Discussionmentioning

confidence: 99%

REVIEW: Vitamin transport and homeostasis in mammalian brain: focus on Vitamins B and E

Spector¹,

Johanson²

2007

Journal of Neurochemistry

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159

131

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With the application of genetic and molecular biology techniques, there has been substantial progress in understanding how vitamins are transferred across the mammalian bloodbrain barrier and choroid plexus into brain and CSF and how vitamin homeostasis in brain is achieved. In most cases (with the exception of the sodium-dependent multivitamin transporter for biotin, pantothenic acid, and lipoic acid), the vitamins are transported by separate carriers through the blood-brain barrier or choroid plexus. Then the vitamins are accumulated by brain cells by separate, specialized systems. This review focuses on six vitamins (B 1 , B 3 , B 6 , pantothenic acid, biotin, and E) and the newer genetic information including relevant 'knockdown' or 'knockout' models in mice and humans. The overall objective is to integrate this newer information with previous physiological and biochemical observations to achieve a better understanding of vitamin transport and homeostasis in brain. This is especially important in view of the newly described non-cofactor vitamin roles in brain (e.g. of B 1 , B 3 , B 6 , and E) and the potential roles of vitamins in the therapy of brain disorders.

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“…p-value cannot tell readers the strength or size of an effect, change, or relationship. In the end, patients and physicians want to know the magnitude of the benefit, change or association, not the statistical significance of individual studies [23,28].…”

Section: Item 4: Were Tables and Figures Well Prepared?mentioning

confidence: 99%

Ten Points for High-Quality Statistical Reporting and Data Presentation

Nieminen

2020

Applied Sciences

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Background: Data analysis methods have become an essential part of empirical research papers, especially in health sciences and medical research. It has previously been reported that a noteworthy percentage of articles have flaws in their statistical reporting. Reporting problems have been a long-term issue, and despite continued efforts to improve the situation, improvements have been far from satisfactory. One explanation is an inadequate assessment of statistical reporting during peer review. This communication proposes a short instrument to assess the quality of data analysis reporting in manuscripts and published papers. Method: A checklist-type instrument was developed by selecting and refining items from previous reports about the quality of statistical reporting in medical journals and from published guidelines for reporting and data presentation. Items were pretested and modified during pilot studies. A total of 160 original medical research articles that were published in 4 journals were evaluated to test the instrument. Interrater and intrarater agreements were examined by comparing quality scores assigned to 40 articles published in a psychiatric journal. Results: The data analysis reporting test consists of nine questions that assess the quality of health research from a reader’s perspective. The composed scale has a total score ranging from 0 to 10 and discriminated between journals and study designs. A high score suggested that an article had a good presentation of findings in tables and figures and that the description of analysis methods was helpful to readers. Interrater and intrarater agreements were high. Conclusion: An applicable checklist for quickly testing the statistical reporting quality of manuscripts and published research papers was developed. This instrument aims to improve the quality of empirical research in scientific fields where statistical methods play an important role.

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Pharmacology and Statistics: Recommendations to Strengthen a Productive Partnership

Cited by 11 publications

References 47 publications

New Insight into the Dietary Cause of Atherosclerosis: Implications for Pharmacology

New Insight into the Dietary Cause of Atherosclerosis: Implications for Pharmacology

REVIEW: Vitamin transport and homeostasis in mammalian brain: focus on Vitamins B and E

Ten Points for High-Quality Statistical Reporting and Data Presentation

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