Guidelines for Reporting of Figures and Tables for Clinical Research in Urology

Assel, Melissa; Sjoberg, Daniel D.; Qin, Rui; Zhao, Zhiguo; Koyama, Tatsuki; Botchway, Albert; Wang, Xuemei; Huo, Dezheng; Kattan, Michael W.; Zabor, Emily C.; Harrell, Frank E.

doi:10.1097/ju.0000000000001096

Cited by 13 publications

(19 citation statements)

References 4 publications

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“…P values were not estimated because of a lack of a null hypothesis that men treated with GnRH agonists and not treated with GnRH agonists should be equal given matching. [16][17][18]…”

Section: Study Populationmentioning

confidence: 99%

Association of Gonadotropin-Releasing Hormone Agonists for Prostate Cancer With Cardiovascular Disease Risk and Hypertension in Men With Diabetes

et al. 2022

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IMPORTANCEMen with type 2 diabetes have an increased risk of cardiovascular disease (CVD). Meanwhile, gonadotropin-releasing hormone (GnRH) agonists used in prostate cancer (PCa) are associated with increased risk of CVD. OBJECTIVE To evaluate the association between GnRH agonist use, PCa diagnosis per se, and CVD risk in men with type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS This nationwide population-based cohort study identified men with type 2 diabetes by use of data in the Prostate Cancer Data Base Sweden version 4.1 and the Swedish National Diabetes Register, with longitudinal data from 2006 to 2016. These data were used to create 2 cohorts, 1 including men with and without PCa and the other including men with PCa who received and did not receive GnRH agonists. Data analysis was conducted from January 2006 to December 2016. EXPOSURES Treatment with GnRH agonists and PCa diagnosis were the primary exposures. MAIN OUTCOMES AND MEASURES Primary outcome was a 10% increase in predicted 5-year CVD risk score. Secondary outcome was worsening hypertension as defined by the European Society of Hypertension Guidelines. Cox proportional hazards regression models were used to analyze the association. RESULTS The PCa exposure cohort included 5714 men (median [IQR] age, 72.0 [11.0]), and the non-PCa cohort included 28 445 men without PCa (median [IQR] age, 72.0 [11.0]). The GnRH agonist-exposure cohort included 692 men with PCa who received a GnRH agonist, compared with 3460 men with PCa who did not receive a GnRH agonist. Men with PCa receiving GnRH agonists had an increased estimated 5-year CVD risk score compared with men without PCa (hazard ratio [HR],1.25; 95% CI, 1.16-1.36) and compared with men with PCa not receiving GnRH agonists (HR, 1.53; 95% CI, 1.35-1.74). Men receiving GnRH agonists had decreased blood pressure compared with men without PCa (HR, 0.70; 95% CI, 0.61-0.80) and compared with men with PCa not receiving GnRH agonists (HR, 0.68; 95% CI, 0.56-0.82). CONCLUSIONS AND RELEVANCEIn this population-based cohort study, there was an increased risk of CVD in men with type 2 diabetes who received a GnRH agonist for PCa. These findings highlight the need to closely control CVD risk factors in men with type 2 diabetes treated with GnRH agonists. The association between GnRH agonist use and decreased blood pressure levels warrants further study.

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“…P values were not estimated because of a lack of a null hypothesis that men treated with GnRH agonists and not treated with GnRH agonists should be equal given matching. [16][17][18]…”

Section: Study Populationmentioning

confidence: 99%

Association of Gonadotropin-Releasing Hormone Agonists for Prostate Cancer With Cardiovascular Disease Risk and Hypertension in Men With Diabetes

et al. 2022

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“…Our findings were reported based on the CONSORT statement. 9,10 All individuals were recruited from June 2018 to January 2021 and their final followup results were obtained in July 2021.…”

Section: Methodsmentioning

confidence: 99%

The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial

et al. 2022

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“…Remember, tables and figures should have a function for your article and improve the reader’s ability to understand the study. Additional important considerations for reporting tables and figures are elaborated elsewhere 12,13 …”

Section: Considerations For Tables and Figuresmentioning

confidence: 99%

“…Additional important considerations for reporting tables and figures are elaborated elsewhere. 12,13 Tables Table 1 traditionally contains the baseline characteristics and demographics of the trial subjects (Table 1).…”

Section: Considerations For Tables and Figuresmentioning

confidence: 99%

Tutorial: Statistical analysis and reporting of clinical pharmacokinetic studies

Dunvald

Iversen

Svendsen

et al. 2022

Clinical Translational Sci

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Pharmacokinetics is the cornerstone of understanding drug absorption, distribution, metabolism, and elimination. It is also the key to describing variability in drug response caused by drug‐drug interactions (DDIs), pharmacogenetics, impaired kidney and liver function, etc. This tutorial aims to provide a guideline and step‐by‐step tutorial on essential considerations when designing clinical pharmacokinetic studies and reporting results. This includes a comprehensive guide on how to conduct the statistical analysis and a complete code for the statistical software R. As an example, we created a mock dataset simulating a clinical pharmacokinetic DDI study with 12 subjects who were administered 2 mg oral midazolam with and without an inducer of cytochrome P450 3A. We provide a step‐by‐step guide to the statistical analysis of this clinical pharmacokinetic study, including sample size/power calculation, descriptive statistics, noncompartmental analyses, and hypothesis testing. The different analyses and parameters are described in detail, and we provide a complete R code ready to use in supplementary files . Finally, we discuss important considerations when designing and reporting clinical pharmacokinetic studies. The scope of this tutorial is not limited to DDI studies, and with minor adjustments, it applies to all types of clinical pharmacokinetic studies. This work was done by early career researchers for early career researchers. We hope this tutorial may help early career researchers when getting started on their own pharmacokinetic studies. We encourage you to use this as an inspiration and starting point and continuously evolve your statistical skills.

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Guidelines for Reporting of Figures and Tables for Clinical Research in Urology

Cited by 13 publications

References 4 publications

Association of Gonadotropin-Releasing Hormone Agonists for Prostate Cancer With Cardiovascular Disease Risk and Hypertension in Men With Diabetes

Association of Gonadotropin-Releasing Hormone Agonists for Prostate Cancer With Cardiovascular Disease Risk and Hypertension in Men With Diabetes

The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial

Tutorial: Statistical analysis and reporting of clinical pharmacokinetic studies

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