Whether you’re a clinician, CRO, or study coordinator, we have answers to your concerns.
Is the GTI difficult to use?
Loading data is easy - and quick. Completing the 9 modules can be done all at
once or as patient data become available. The GTI app handles all
calculations as data are entered and lets you know if you are missing any
data. Although the timing of data collection will vary according to the
specific trial or study, with the GTI app each patient visit can be recorded
in a minute or two.
How long does it take to get scores from the GTI?
GTI scores are in your hands as soon all required data are complete.
What is the cost to my organization to use the GTI?
The GTI requires the purchase of a license. Each license and its fees are tailored to the design and size of the clinical trial. The GTI App saves hundreds of hours of staff time and data calculation.
Why is there no GTI score calculated at the Baseline Visit?
The GTI measures change in glucocorticoid (GC) toxicity. Therefore, a score can be derived only when comparing values from one visit to the next. Data related to GC toxicity are captured at Baseline, but GTI scores are calculated at designated follow-up visits, when GTI data are required by the protocol.
Does the GTI improve the process of studying steroid toxicity?
Yes. The App reinforces rigorous use by prompting both the study coordinator and physician investigator to complete the modules in an intuitive order. The GTI app incorporates the GTI Domains and the Additional Manifestations List logically and thoroughly.
Does the Physician Investigator need to complete all the data at every visit?
No. One of the strengths of the GTI is that more than half of the modules can be completed by the study coordinators. The study coordinators enter all the GTI data pertaining to the subject’s medications, vital signs, routine laboratory work, and bone mineral density study results; in short, five of the GTI’s nine domains.
How do I know that the data I enter is accurate?
The generation of baseline data for most of the GTI Domains is
straightforward and data fields protect against inaccurate:
1) The numerical values for medications, labs, vital signs, and bone mineral
density are quantitative.
2) The other modules - steroid myopathy, skin, neuropsychiatric, infections,
and other toxicities - are semi-quantitative, relying upon an evaluation by
What is the protocol for use of the GTI?
The best practice is to share the work, to ensure efficient and
accurate data capture.
Trial Coordinator or Nurse:
Step 1. Updates any changes in the subject’s medications for the
treatment of hyperglycemia, hyperlipidemia, and hypertension.
Step 2. Weighs the subject, records the subject’s height (at only the
first visit), and measures the subject’s vital signs.
Step 3. Records the results of laboratory tests that are relevant to
the GTI, specifically the hemoglobin A1c (HgbA1c) and low-density
lipoprotein (LDL) measurements, as well as the results of bone mineral
density studies. Results of these tests may not be available at the
time of the Trial Visit but should be completed by the Study
Coordinator as the results become available.
Step 4. The physician investigator examines the subject, gathering data required for the scoring
of the remaining Domains, namely:
· Steroid Myopathy
· Skin Effects
· Neuropsychiatric Impact
· Other Toxicities
The data can be captured easily over the course of a routine study
visit, requiring only focused history-taking skills and a directed
Can data from a previous visit be changed or updated after the visit has been completed?
Yes - with exceptions designed into the coding to maintain integrity of each trial across the calculations and protect the accuracy of the scoring.
How is GTI Score calculated?
GTI data are analyzed in two ways:
1: Cumulative Worsening Score (CWS)
For trials in some diseases, it may be most important to document ANY cumulative GC toxicity that occurs. The CWS assesses cumulative toxicity, both permanent and transient, thereby serving as a record of toxicity.
2: Aggregate Improvement Score (AIS)
With the AIS, GC toxicities are DELETED if they resolve - leading to an improvement in the score - and are ADDED if they worsen.
In a trial anticipating that many patients will have some GC toxicity at baseline , the AIS establishes that the new therapy is
effective at reducing baseline toxicity over time.
Which GTI Score do we use for our trial?
Together, the CWS and AIS provide a granular and consistent assessment of GC toxicity in subjects in one treatment arm compared to subjects in another treatment arm. Both scores are useful and together provide a complete picture of steroid toxicity.