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Authors = Roger R. Dmochowski

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13 pages, 1098 KiB  
Review
Blinding in Clinical Trials: Seeing the Big Picture
by Thomas F. Monaghan, Christina W. Agudelo, Syed N. Rahman, Alan J. Wein, Jason M. Lazar, Karel Everaert and Roger R. Dmochowski
Medicina 2021, 57(7), 647; https://doi.org/10.3390/medicina57070647 - 24 Jun 2021
Cited by 63 | Viewed by 23805
Abstract
Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to [...] Read more.
Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to eliminate bias, blinding does also pose some inherent limitations, and it behooves clinicians and researchers to be aware of such caveats. This article will review general principles for blinding in clinical trials, including examples of useful blinding techniques for both pharmaceutical and non-pharmaceutical trials, while also highlighting the limitations and potential consequences of blinding. Appropriate reporting on blinding in trial protocols and manuscripts, as well as future directions for blinding research, will also be discussed. Full article
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11 pages, 312 KiB  
Review
Foundational Statistical Principles in Medical Research: A Tutorial on Odds Ratios, Relative Risk, Absolute Risk, and Number Needed to Treat
by Thomas F. Monaghan, Syed N. Rahman, Christina W. Agudelo, Alan J. Wein, Jason M. Lazar, Karel Everaert and Roger R. Dmochowski
Int. J. Environ. Res. Public Health 2021, 18(11), 5669; https://doi.org/10.3390/ijerph18115669 - 25 May 2021
Cited by 20 | Viewed by 11538
Abstract
Evidence-based medicine is predicated on the integration of best available research evidence with clinical expertise and patient values to inform care. In medical research, several distinct measures are commonly used to describe the associations between variables, and a sound understanding of these pervasive [...] Read more.
Evidence-based medicine is predicated on the integration of best available research evidence with clinical expertise and patient values to inform care. In medical research, several distinct measures are commonly used to describe the associations between variables, and a sound understanding of these pervasive measures is foundational in the clinician’s ability to interpret, synthesize, and apply available evidence from the medical literature. Accordingly, this article aims to provide an educational tutorial/topic primer on some of the most ubiquitous measures of association and risk quantification in medical research, including odds ratios, relative risk, absolute risk, and number needed to treat, using several real-world examples from the medical literature. Full article
7 pages, 261 KiB  
Review
Foundational Statistical Principles in Medical Research: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value
by Thomas F. Monaghan, Syed N. Rahman, Christina W. Agudelo, Alan J. Wein, Jason M. Lazar, Karel Everaert and Roger R. Dmochowski
Medicina 2021, 57(5), 503; https://doi.org/10.3390/medicina57050503 - 16 May 2021
Cited by 266 | Viewed by 19577
Abstract
Sensitivity, which denotes the proportion of subjects correctly given a positive assignment out of all subjects who are actually positive for the outcome, indicates how well a test can classify subjects who truly have the outcome of interest. Specificity, which denotes the proportion [...] Read more.
Sensitivity, which denotes the proportion of subjects correctly given a positive assignment out of all subjects who are actually positive for the outcome, indicates how well a test can classify subjects who truly have the outcome of interest. Specificity, which denotes the proportion of subjects correctly given a negative assignment out of all subjects who are actually negative for the outcome, indicates how well a test can classify subjects who truly do not have the outcome of interest. Positive predictive value reflects the proportion of subjects with a positive test result who truly have the outcome of interest. Negative predictive value reflects the proportion of subjects with a negative test result who truly do not have the outcome of interest. Sensitivity and specificity are inversely related, wherein one increases as the other decreases, but are generally considered stable for a given test, whereas positive and negative predictive values do inherently vary with pre-test probability (e.g., changes in population disease prevalence). This article will further detail the concepts of sensitivity, specificity, and predictive values using a recent real-world example from the medical literature. Full article
(This article belongs to the Section Epidemiology & Public Health)
17 pages, 684 KiB  
Article
Why Do Women Not Use the Bathroom? Women’s Attitudes and Beliefs on Using Public Restrooms
by Siobhan M. Hartigan, Kemberlee Bonnet, Leah Chisholm, Casey Kowalik, Roger R. Dmochowski, David Schlundt and W. Stuart Reynolds
Int. J. Environ. Res. Public Health 2020, 17(6), 2053; https://doi.org/10.3390/ijerph17062053 - 20 Mar 2020
Cited by 31 | Viewed by 10772
Abstract
There are a variety of factors and influences, both internal and external, that may impact an individual’s public toileting experience and may ultimately have repercussions for bladder health. This study sought to identify predominant constructs underlying a women’s attitude towards using restrooms at [...] Read more.
There are a variety of factors and influences, both internal and external, that may impact an individual’s public toileting experience and may ultimately have repercussions for bladder health. This study sought to identify predominant constructs underlying a women’s attitude towards using restrooms at work, at school, and in public in order to develop a conceptual model incorporating these themes. We performed a secondary analysis of a cross-sectional, survey-based study that included open-ended questions about limitations to restroom use using a mixed-methods approach. Qualitative data coding and analysis was performed on 12,583 quotes and, using an iterative inductive-deductive approach, was used to construct the conceptual framework. Our conceptual framework reveals a complicated interplay of personal contexts, situational influences, and behavioral strategies used by women to manage their bladder and bowel habits away from home. These findings can inform future research and public policy related to bladder health awareness related to toilet access in the workplace and in public. Full article
(This article belongs to the Special Issue Bladder Health in Women)
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15 pages, 262 KiB  
Review
Use of Botulinum Toxin A in the Treatment of Lower Urinary Tract Disorders: A Review of the Literature
by David C. Moore, Joshua A. Cohn and Roger R. Dmochowski
Toxins 2016, 8(4), 88; https://doi.org/10.3390/toxins8040088 - 23 Mar 2016
Cited by 25 | Viewed by 5711
Abstract
Botulinum neurotoxin (BoNT) is used to treat a variety of ailments, and its therapeutic application in lower urinary tract disorders (LUTDs) is well studied. Robust evidence supporting the efficacy and tolerability of BoNT in the treatment of neurogenic detrusor overactivity (NDO) and non-neurogenic [...] Read more.
Botulinum neurotoxin (BoNT) is used to treat a variety of ailments, and its therapeutic application in lower urinary tract disorders (LUTDs) is well studied. Robust evidence supporting the efficacy and tolerability of BoNT in the treatment of neurogenic detrusor overactivity (NDO) and non-neurogenic overactive bladder (OAB) has led to regulatory approval for these conditions. Use of BoNT in the treatment of interstitial cystitis/bladder pain syndrome, chronic pelvic pain, and detrusor sphincter dyssynergia has demonstrated some promise, but is still evolving and off-label for these indications. Trials to date do not support the use of BoNT for benign prostatic hyperplasia. This comprehensive review outlines the mechanisms of BoNT in the treatment of LUTDs in adults and presents background and updated data examining the efficacy and adverse events associated with the use of BoNT in common urologic applications. Full article
(This article belongs to the Special Issue Botulinum Toxin A on Lower Urinary Tract Dysfunction)
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