An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures: data from two large multicenter international studies

Abstract

Purpose The Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) is a new patient-reported outcome (PRO) measure for patients with acromegaly receiving injectable somatostatin analogs (SSAs) to assess clinical symptoms and adverse drug reaction interference, treatment satisfaction, and convenience. We evaluated its scale structure, reliability, validity, responsiveness, and what constitutes clinically meaningful change. Methods Data from two longitudinal studies (N = 79 and 82) of patients receiving a stable injectable SSA dose for ≥ 6 months who completed the Acro-TSQ and other collateral measures (e.g., AcroQoL, AIS, WPAI:SHP, EQ-5D-5L) were analyzed. Results The first study demonstrated internal consistency of the Acro-TSQ. However, several items had high ceiling effects, responsiveness could not be established, and the minimally important difference (MID) was not estimable. In the second study, factor analysis revealed six scales: Symptom Interference, Treatment Convenience, Injection Site Interference, GI Interference, Treatment Satisfaction, and Emotional Reaction. Internal consistency and test-retest reliability were confirmed; most scales demonstrated significant differences in mean scores by disease severity. Correlations between Acro-TSQ scales and other collateral measures exceeded 0.30 in absolute value, confirming convergent validity. Responsiveness in Acro-TSQ scale scores reflected improved disease control. The MID was estimated for Symptom Interference (10-12 points), Treatment Convenience (9-11) and GI Interference (8-10). Conclusions The Acro-TSQ is a brief, yet comprehensive tool to monitor important outcomes associated with injectable acromegaly SSA treatments. Its content reflects both disease and treatment burden as well as patient satisfaction, and its relevant for use in clinical studies.

A Pituitary Society update to acromegaly management guidelines

“…Results of the longitudinal surveillance ACROSTUDY similarly showed improvement in QOL with pegvisomant using both AcroQoL and PASQ questionnaires [ 33 ]. A patient-centric approach for QOL assessment may allow a more personalized method of management [ 34 ], and tools such as the recently developed Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) also show improved QOL with disease control [ 11 ], specifically in patients treated with injectable SRL [ 35 ]. However, addressing the high discordance between patient- and medical provider-reported symptom severity, pattern of acromegaly symptoms, and treatment injection site reactions remains a challenge for treating physicians [ 12 ].…”

“…(HQ, SR) Rationale: In clinical trials, OOC was initiated at the time of the next SRL injection, i.e., at the end of the once-monthly injection period [ 4 , 9 ]. IGF-I levels may increase toward the end of the injection period with waning of injectable drug levels [ 10 ], and likely account for reported exacerbation of acromegaly symptoms [ 11 – 13 ] How should OOC dose be escalated? OOC can be up-titrated by an increment of 20 mg every 2–4 weeks based on IGF-I and clinical symptoms.…”

Patient reported outcome data from acromegaly patients treated with injectable somatostatin receptor ligands (SRLs) in routine clinical practice

“…Sample items from the survey are included in a supplemental file. The online survey also included the Acro-TSQ, an acromegaly-specific PRO assessing symptom and GI side effect interference, treatment satisfaction, treatment bother, and treatment convenience [16,17]. The Acro-TSQ contains 24 items and was developed in line with recommendations by the Food and Drug Administration in a published document containing guidelines for PRO development which included qualitative research with individuals with acromegaly [12].…”

Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide

“…However, these agents require deep tissue injection and can be associated with substantial treatment burden or deleterious long-term sequelae, including injection site pain, nodules, bruising, inflammation, and scarring ( 2 , 10 ). Injectable SRLs may also negatively affect patient quality of life; patients have reported anxiety, frustration, and loss of independence caused by the injections ( 10 , 11 ). Although some patients are able to safely and effectively receive injections at home, a recent study found that only 17% of patients with acromegaly are receiving injections in this manner ( 10 , 12 , 13 ).…”