Table 2.
Five selected parameters and their level of severity
| Health status parameter | Parameter levels |
|---|---|
| IGF-I | 1 = IGF-I is within normal limits 2 = IGF-I exceeds the ULN but not >1.2 × ULN, or is below LLN 3 = IGF-I is significantly elevated, >1.2 × ULN |
| Tumor status | Based on the most current MRI: 1 = Tumor is not visible or has not changed since prior MRI 2 = A slight increase in tumor size (≤20%) is observed 3 = A clinically significant increase in tumor size (>20%) and/or invasiveness is observed since prior MRI and/or a worsening in vision is observed |
| Comorbidities | 1 = No diabetes diagnosis, complaints of sleep apnea are absent, and cardiac disease, if present, is well controlled 2 = Diabetes controlled by therapy, with no concomitant complaints of sleep apnea, and cardiac disease, if present, is controlled with therapy or no diabetes diagnosis but complaints of sleep apnea and/or cardiac disease that is not well controlled with therapy 3 = Diabetes is not well controlled by therapy or diabetes is well controlled, with complaints of moderate to severe sleep apnea and/or uncontrolled cardiac disease |
| Symptoms | 1 = Mild: patient reports no or only mild symptoms on SSS (all symptoms rated ≤2) 2 = Moderate: patient reports presence of some symptoms on SSS but no single symptom exceeds a score of 6 (mild to moderate) and mean score is ≤4 overall 3 = Severe: patient reports significant symptoms on SSS, with mean score >4 or one or more symptoms rated >6 |
| Health-related QoL impairmenta | 1 = Patient reports no or minimal impairment in QoL (score ≥60) 2 = Patient reports mild to moderate impairment in QoL (40 ≤ score <60) 3 = Patient reports significant impairment in QoL (score <40) |
IGF-I insulin-like growth factor I, ULN upper limit of normal, LLN lower limit of normal, MRI magnetic resonance imaging, SSS Signs and Symptoms Score, QoL quality of life, AcroQoL Acromegaly Quality of Life Questionnaire
aThe endocrinology experts selected AcroQoL as the most suitable currently available tool to address disease-specific QoL assessment. In order to avoid response bias, the term “health-related quality of life” was used in the validation study