FAQs

 

Is the Steritas GTI easy to use?

Adding patient data is quick. Most GTI data are collected routinely at patient visits. The clinic team enters basic data and the GTI handles the rest -  applying the weights and calculating the scores automatically.

Modules can be completed all at once or as patient data become available. The GTI lets you know what data may be missing. The GTI can also be integrated with EMR and EDC platforms to streamline data entry further.

 

How long does it take to get scores from the GTI?

GTI scores are in your hands as soon as you have entered all data at the first follow up visit – remember that the Steritas GTI measures change in steroid-toxicity so the second visit is when the patient’s SteriTox profile shows the scores.

 

What is the protocol for using the Steritas GTI in a clinic workflow?

The best practice is to share the work, to ensure efficient and accurate data capture.

 

Trial Coordinator/Study Nurse:

Step 1. Updates any changes in the patient’s Glucose, Blood Pressure and Lipid medications.
Step 2. Records Height, Weight and Vital Signs.
Step 3. Records laboratory test results relevant to the GTI: hemoglobin A1c (HbA1c) and low-density lipoprotein (LDL) measurements, and in come trials, bone mineral density BMD. Results of these tests may not be available at the time of the Trial Visit but should be entered as the results become available.


The Physician/Researcher:

Step 4. Examines the patient, gathering data required for the scoring of the remaining Domains, namely:
• Steroid Myopathy
• Skin Effects
• Neuropsychiatric Impact
• Infection
• Other Toxicities
The data can be captured easily over the course of a routine study visit, requiring only history-taking skills and a directed physical examination.

 

What is the cost to my organization to use the GTI?

Use of the Steritas GTI requires a use license. Each license and its fees are tailored to the design and size of the clinical trial. Contact licensing@steritas.com to learn more.

 

Is the Steritas GTI better than electronic CRFs?

The Steritas GTI integrates into trial databases to ensure standardized collection of data across each clinical trial, guards against errors in data entry, includes logic checks, guarantees data completeness, and ensures scoring accuracy. The algorithms account for nuances that a trial team cannot always capture.

Steritas helps trial teams integrate CRFs, scripted worksheets, and user manual content into a trial flow for use in any electronic environment.

 

Does the Physician Investigator need to complete all the data at every visit?

No. One of the many strengths of the Steritas GTI is that over half of the modules are completed by the Trial Coordinator/Study Nurse or may be populated automatically with data from the trial database: medications, vital signs, laboratory work, and bone mineral density study results.

 

Can data from a previous visit be changed or updated after the visit has been completed?

To maintain compliance with regulatory standards for data integrity, data collection is locked in most modules to maintain accuracy of scoring.

 

Why is no GTI Score calculated at the Baseline Visit?

The Steritas GTI measures CHANGE in glucocorticoid-toxicity over time. Therefore, a score can be derived only when comparing values from one visit to the next. Data related to steroid-toxicity are captured at Baseline, but the full SteriTox Profile scores are calculated at follow-up.

 

How do I know that the data I enter are accurate?

The Steritas GTI helps you. The generation of baseline data for most of the Steritas GTI Domains is straightforward and the app includes a knowledge base with images and standardized definitions to promote rigor and accuracy.

1) The input for medications, labs, vital signs, and bone mineral density are quantitative and must fall within a given numerical range.
2) The input for steroid myopathy, skin, neuropsychiatric, infections, and other toxicities – are semi-quantitative, and require evaluation by the physician-investigator.

 

Does the Steritas GTI improve the process of studying steroid-toxicity?

Yes. The Steritas GTI reinforces rigorous use by prompting both the Trial Coordinator/Study Nurse and Physician Investigator to complete the modules in an intuitive order.

How is the Steritas GTI Score calculated?

GTI data are calculated to deliver a toxicity profile that has two scores:


Cumulative Worsening Score (CWS)
The CWS assesses cumulative toxicity, both permanent and transient, thereby serving as a running total of all toxicity. For trials in some diseases, it may it is vital to that any and all toxicity be accounted for and thus, all toxicities are ADDED.

Aggregate Improvement Score (AIS)
The AIS establishes that the new therapy is effective at reducing baseline toxicity over time. The AIS is a running total but any toxicities that resolve are DELETED.

 

Which GTI Score do we use for our trial?

Both scores provide important information. Together, the CWS and AIS provide a nuanced and consistent judgment of how patients in one study arm fare compared to patients in another arm in terms of steroid-toxicity.