ISCTM Autumn 2018
HarmResearch gave the following presentations at the 2018 Autumn Conference of the International Society for CNS Clinical Trials and Methodology (ISCTM):
Monday, October 15th, 2018, 6 to 7:30 pm Poster
Monday, October 15th, 2018 Poster
The Graphic Display of Quantitative Suicidality Data: S-Plots
David V Sheehan MD, MBA, DLFAPA 1, 2, 3
Jennifer M Giddens BA 1, 2
1 Harm Research Institute, Tampa, FL, USA
2 Tampa Center for Research on Suicidality, Tampa, FL, USA
3 University of South Florida College of Medicine, Tampa, FL, USA
Click here to view or download a copy of this poster
Date: Monday, October 15th, 2018
Time: 6 pm to 7:30 pm
Location: The Ritz-Carlton, Marina del Rey, CA
Abstract:
Background: Regulatory agencies, pharmaceutical companies, clinical research organizations, data safety monitoring boards, medical directors of health care organizations, and medical safety officers are challenged with the difficulty of summarizing the suicidality status of patients under their care in a simple, clear manner. Currently, data collected using a dimensional scale are reduced to the categorical system at the completion of a study. Suicidality data is currently organized and reviewed in complex tables, reflecting these categories, with a resultant loss of sensitivity and the risk of delayed detection, or of detection errors. Linking such data to study stopping rules is a complex multistep series of tasks, fraught with potential errors. In the interest of reducing error, speeding detection, protection of patients, clarity of data presentation and display, there is a need for a more efficient, clear, and simple system to display suicidality data.
Methods: We explored and reviewed graphic displays of quantitative data in other medical and scientific disciplines to find suitable models. The selection criteria included simplicity, clarity, the ease of interpretation of the data, and how appropriate the displays would be for suicidality data, collected using a dimensional suicidality tracking scale. We applied a variety of graphic displays to a prospectively collected dataset using the Sheehan-Suicidality Tracking Scale (S-STS). The final displays are the result of this iterative process.
Results: Suicidality-Plots (S-Plots) display the data for groups of patients and for individual patients over time. Interpretation of these S-Plots can quickly identify patients at higher risk, and provide a method to monitor the status of patients within a large sample over time. Interpretation of S-Plots can quickly identify the overall status of suicidality in the study over time in relation to the study stopping rules. Graphic display of quantitative suicidality data can be used to quickly visually identify individual patients at high risk, the disposition of all patients in a healthcare setting or clinical trial, and whether a clinical trial should be halted because of treatment-emergent suicidality. These S-Plots are customizable for the needs of different clinical trials and settings. A computer-generated version of these S-Plots is in development. It is designed to generate e-mails or phone alerts to site investigators and sponsors for subjects deemed at imminent risk, and who need immediate attention.
Conclusion: Use of S-Plots may reduce the potential medico-legal hazards from either the delayed analysis or delayed detection of suicidality in safety data, and the risk to patients in research trials and clinical settings.
Learning Objectives:
Following this presentation, participants will be:
1. Be familiar with graphical approaches to the display of quantitative suicidality data in clinical research trials and clinical settings
2. Better able to understand, interpret, and analyze suicidality data displayed in S-Plots
Literature References:
1. Tufte E, Graves-Morris P. The visual display of quantitative information.; 1983.
2. Amit O, Heiberger RM, Lane PW. Graphical approaches to the analysis of safety data from clinical trials. Pharmaceutical Statistics. 2008 Jan 1;7(1):20-35.
How to Cite:
Sheehan DV, Giddens JM. The Graphic Display of Quantitative Suicidality Data: S-Plots. Poster. Autumn Conference, International Society for CNS Clinical Trials and Methodology (ISCTM), Marina del Rey, CA, October, 15, 2018.