The TRIM-AGHD: Measuring Response to Treatment

Adult Growth Hormone Deficiency. The incidence of adult growth hormone deficiency (AGHD) is estimated at 10 cases per million; in the US there are an estimated 50 000 cases with 6000 new cases diagnosed annually. AGHD has a significant negative impact on physical and psychological wellbeing which translates into overall reduced quality of life.

The TRIM-AGHD. The Treatment-Related Impact Measure-Adult Growth Hormone Deficiency is an FDA-approved measure of patient-reported outcomes in response to treatment. The tool measures the impact of AGHD on energy and psychological, cognitive, and physical domains. The current study evaluates minimal important difference (MID) and sensitivity to change as an additional step in TRIM-AGHD validation.

Study Methods. Inclusion criteria for the observational study included adults aged 23-79 years who were naive to hGH treatment. Exclusion criteria included prior hGH treatment within 6 months, a specified score on the Beck Depression Inventory, and pregnancy.

Baseline and Follow-up Visits. Initial measures used were the TRIM-AGHD and  Patient Global Impression of Severity (PGI-S) questionnaires; at follow up, an average of 6+ weeks later, patients again completed the TRIM-AGHD and PGI-S, plus the Patient Global Rating of Change (PGRC) questionnaire.

Effect Size, Minimal Important Difference Calculations. Effect size was used to detect sensitivity to change and MID assessment looked at the difference between improved/non-improved groups, 0.5 SD of change between measurements, plus standard error of measurement.

Results. The TRIM-AGHD was assessed as “highly responsive” to treatment (ES >0.80), with a total score effect size of 1.38; 0.5 SD for TRIM-AGHD total score was 8.09 and SEm was 2.66.

Anchor-based Scores for TRIM-AGHD. Using Patient Global Response to Change data, the patient-reported differences were greater -- nearly 60% reported they were "better" than at the study's beginning and nearly 35% reported being "about the same."  The difference between these 2 groups was 20.43.