Development of ACRODAT®, a new software medical device to assess disease activity in patients with acromegaly

Van Der Lely AJ, Gomez R, Pleil A, Badia X, Brue T, Buchfelder M, Burman P, Clemmons D, Ghigo E, Jorgensen JOL, Luger A, Van Der Lans-Bussemaker J, Webb SM, Strasburger CJ (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Pituitary Springer Verlag (Germany)

Book Volume: 20

Pages Range: 692-701

Journal Issue: 6

DOI: 10.1007/s11102-017-0835-5

Abstract

PURPOSE: Despite availability of multimodal treatment options for acromegaly, achievement of long-term disease control is suboptimal in a significant number of patients. Furthermore, disease control as defined by biochemical normalization may not always show concordance with disease-related symptoms or patient's perceived quality of life. We developed and validated a tool to measure disease activity in acromegaly to support decision-making in clinical practice. METHODS: An international expert panel (n = 10) convened to define the most critical indicators of disease activity. Patient scenarios were constructed based on these chosen parameters. Subsequently, a panel of 21 renowned endocrinologists at pituitary centers (Europe and Canada) categorized each scenario as stable, mild, or significant disease activity in an online validation study. RESULTS: From expert opinion, five parameters emerged as the best overall indicators to evaluate disease activity: insulin-like growth factor I (IGF-I) level, tumor status, presence of comorbidities (cardiovascular disease, diabetes, sleep apnea), symptoms, and health-related quality of life. In the validation study, IGF-I and tumor status became the predominant parameters selected for classification of patients with moderate or severe disease activity. If IGF-I level was ≤1.2x upper limit of normal and tumor size not significantly increased, the remaining three parameters contributed to the decision in a compensatory manner. CONCLUSION: The validation study underlined IGF-I and tumor status for routine clinical decision-making, whereas patient-oriented outcome measures received less medical attention. An Acromegaly Disease Activity Tool (ACRODAT) is in development that might assist clinicians towards a more holistic approach to patient management in acromegaly.

Authors with CRIS profile

Michael Buchfelder Lehrstuhl für Neurochirurgie

Involved external institutions

Erasmus University Rotterdam (EUR) / Erasmus Universiteit Rotterdam NL Netherlands (NL) Pfizer, Inc. US United States (USA) (US) Universitat de Barcelona (UB) / University of Barcelona ES Spain (ES) Aix-Marseille University / Aix-Marseille Université FR France (FR) Lund University / Lunds universitet SE Sweden (SE) UNC Hospitals Diabetes and Endocrinology Clinic at Meadowmont US United States (USA) (US) Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino IT Italy (IT) Aarhus University DK Denmark (DK) Vienna General Hospital / Allgemeines Krankenhaus der Stadt Wien (AKH) AT Austria (AT) Autonomous University of Barcelona (UAB) / Universitat Autònoma de Barcelona ES Spain (ES) Charité - Universitätsmedizin Berlin DE Germany (DE)

How to cite

APA:

Van Der Lely, A.J., Gomez, R., Pleil, A., Badia, X., Brue, T., Buchfelder, M.,... Strasburger, C.J. (2017). Development of ACRODAT®, a new software medical device to assess disease activity in patients with acromegaly. Pituitary, 20(6), 692-701. https://dx.doi.org/10.1007/s11102-017-0835-5

MLA:

Van Der Lely, Aart J., et al. "Development of ACRODAT®, a new software medical device to assess disease activity in patients with acromegaly." Pituitary 20.6 (2017): 692-701.

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