TY - JOUR
T1 - An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures
T2 - data from two large multicenter international studies
AU - Fleseriu, Maria
AU - Fogelfeld, Leon
AU - Gordon, Murray B.
AU - Sisco, Jill
AU - Crosby, Ross D.
AU - Ludlam, William H.
AU - Haviv, Asi
AU - Mathias, Susan D.
N1 - Funding Information:
MF has received research grants to her institution from Chiasma, Crinetics, Ionis, Novartis and Pfizer and she has been a scientific consultant to Chiasma, Crinetics, Ionis, Novartis and Pfizer. LF has received research grants and has been a scientific consultant to Chiasma, Inc. MG has received research support from Chiasma, Corcept, Crinetics, Ipsen, Novartis, OPKO, Pfizer, Strongbridge, Teva, and has been a scientific consultant to Novo Nordisk. JS has received an advisory consulting and speaking honorarium from Pfizer. RC is a consultant to Health Outcomes Solutions which received funding for conducting this research study. WL and AH are employees of Chiasma, Inc. SM is an employee of Health Outcomes Solutions which received funding for conducting this research study.
Funding Information:
This study was funded by Chiasma, Inc. Acknowledgements
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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.
AB - 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.
KW - Acro-TSQ
KW - Acromegaly
KW - Measurement properties
KW - Patient reported outcomes
KW - Quality of life
KW - Questionnaire
KW - Validation
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U2 - 10.1007/s11102-020-01038-y
DO - 10.1007/s11102-020-01038-y
M3 - Article
C2 - 32221764
AN - SCOPUS:85082946963
SN - 1386-341X
VL - 23
SP - 347
EP - 358
JO - Pituitary
JF - Pituitary
IS - 4
ER -