Abstract


Background The Acro-TSQ is a novel tool, assessing acromegaly-specific patient-reported outcomes (PRO) related to medical treatment, including mode of administration. Six items focus on acromegaly symptoms including symptom bother and interference. Results from these symptom items using data from a recent validation study were examined to more fully understand the unmet needs of patients with acromegaly. view more

Background The Acro-TSQ is a novel tool, assessing acromegaly-specific patient-reported outcomes (PRO) related to medical treatment, including mode of administration. Six items focus on acromegaly symptoms including symptom bother and interference. Results from these symptom items using data from a recent validation study were examined to more fully understand the unmet needs of patients with acromegaly.
Methods 79 patients with acromegaly on a stable dose of SRL injections (lanreotide and octreotide LAR) for > 6 months from 14 sites in the US, UK and the Netherlands were enrolled and completed the Acro-TSQ and other PRO tools at enrollment (Baseline), Day 7, and Month 3, following IRB approval. Descriptive analyses at the item and scale level were conducted.
Results Item-level results indicated that 61% (48/79) of patients reported acromegaly symptoms at baseline. Thirty-nine patients (81% of those reporting symptoms), experience symptoms all the time; 41 patients (85%) report some degree of bother by these symptoms. Patients who reported symptoms also report that symptoms interfere with daily activities (90%), with leisure activities (82%) and with work (68% of those who work), while an additional 12 patients (25%) do not work because of acromegaly. When examining scale-level results at baseline, the Acromegaly Symptom scale displayed acceptable internal consistency reliability (Cronbach’s alpha coefficient = 0.711) and high test-retest reliability (intra-class correlation coefficient = 0.957). Correlations of the Acro-TSQ Symptom scale were highest with the Physical scale of the Acro-QoL (0.579; p < 0.01). Significant differences (p<0.001) were found for the Acro-TSQ Symptom scale when categorized by patient’s global assessment of symptom severity (PGA) scores, with lower scores representing more symptom interference (absent/mild: 73 + 20, moderate: 58 + 17, severe/very severe: 33 + 18).
Conclusions Patients with acromegaly continue to experience symptoms despite receiving SRL injections. The Acro-TSQ is currently being used in the Mpowered phase 3 study, assessing octreotide capsules vs. injectable SRLs in patients with acromegaly. This tool can be used by clinicians to monitor patients’ satisfaction with various modes of administration for acromegaly treatments and, in addition, can specifically allow clinicians to track the extent to which symptoms may be alleviated with efficacious treatment.

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