Development of a novel patient-reported measure for acromegaly: the Acro-TSQ

Abstract

PurposeSomatostatin analogs (SSAs) represent a mainstay of medical treatment for acromegaly, currently available as either intramuscular or deep subcutaneous injections. Patient-reported outcomes (PROs) are increasingly common as relevant outcomes in studies of acromegaly and its treatment, but there are no validated PRO measures available that focus on the disease burden and the impact of treatment, specifically designed for use in patients with acromegaly. We sought to develop a new and unique PRO measure, the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ).MethodsConcept elicitation (CE) interviews were conducted with acromegaly patients in the United States receiving SSA injections at a stable dose for ≥ 6 months. A questionnaire was drafted based on these interviews; combined CE and cognitive debriefing (CE/CD) interviews were then conducted to confirm the content, clarity, and relevance of the questionnaire.ResultsNineteen subjects completed interviews [n = 9 CE, n = 10 CE/CD; n = 15 Lanreotide Depot/Autogel (Somatuline), n = 4 Octreotide LAR (Sandostatin LAR)]. Most subjects responded positively when asked about the effectiveness of their current treatment; however, breakthrough symptoms, injection site reactions, and side effects were commonly reported and had negative impacts on social and emotional well-being and daily activities. All 10 subjects involved in debriefing interviews found the questionnaire to be relevant, easy to complete, and found the response options to be clear. The resulting 26-item Acro-TSQ covers symptoms and symptom control, gastrointestinal side effects and their impact on daily activities, the emotional impact of treatment, convenience and ease of use, and overall satisfaction.ConclusionsThe Acro-TSQ is a novel PRO, focused on both disease burden and impact of treatment; it was found to be comprehensive, clear, and relevant for patients with acromegaly receiving injectable SSA treatment.

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 ].…”

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].…”

Updates in rare and not-so-rare complications of acromegaly: focus on respiratory function and quality of life in acromegaly

“…It can be measured with questionnaires designed for use in the general population or aimed at specific disease dimension conditions, such as disease-generated or -specific questionnaires like the Acromegaly Quality of Life (AcroQoL) questionnaire 75 , 82 . Table 2 presents brief details of the following questionnaires: the Symptom Questionnaire 83 , 84 , Signs and Symptoms Score 85 , 86 , the Patient-Assessed Acromegaly Symptom Questionnaire 85 , 86 , Short-Form Health Survey (SF-36) 87 – 89 , the Multidimensional Fatigue Inventory (MFI-20) 90 , 91 , the Nottingham Health Profile 92 , 93 , Health-Related Quality of Life 12 , 94 , Psychological General Well-Being 82 , 95 , the Hospital Anxiety and Depression Scale 96 , 97 , the AcroQoL Questionnaire 75 , 82 , 96 , 98 , and the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) 99 , 100 .…”

“…In that study, gastrointestinal disturbances were very frequent (73%); this was possibly related to SRL side effects or disease activity itself 127 . A new questionnaire, Acro-TSQ, was developed to evaluate QoL specifically in patients who received injectable SRLs and provides further insight 99 .…”