Development of ACRODAT®, a new software medical device to assess disease activity in patients with acromegaly
van der Lely, Aart J. (Erasmus University Medical Center)
Gomez, Roy (Pfizer)
Pleil, Andreas (Pfizer Inc)
Badia, Xavier (Universitat de Barcelona)
Brue, Thierry (Centre de Référence des Maladies Rares de l'hypophyse HYPO)
Buchfelder, Michael (Universitätsklinikum Erlangen)
Burman, Pia (University of Lund)
Clemmons, David (UNC Hospitals Diabetes and Endocrinology Clinic)
Ghigo, Ezio (University Hospital Città Salute e Scienza)
Jorgensen, Jens Otto Lunde (Aarhus University)
Luger, Anton (Medizinische Universität und Allgemeines Krankenhaus Wien)
van der Lans-Bussemaker, Joli (Pfizer)
Webb, Susan 1952- (Institut d'Investigació Biomèdica Sant Pau)
Strasburger, Christian J. (Charité-Universitätsmedizin Berlin)
Universitat Autònoma de Barcelona

Data:	2017
Resum:	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. 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. 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	ACRODAT ; AcroQoL ; Acromegaly ; Patient-reported outcomes
Publicat a:	Pituitary, Vol. 20 Núm. 6 (january 2017) , p. 692-701, ISSN 1573-7403

DOI: 10.1007/s11102-017-0835-5
PMID: 28887782

10 p, 988.4 KB

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