Development of ACRODAT®, a new software medical device to assess disease activity in patients with acromegaly
(2017) In Pituitary 20(6). p.692-701- 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)... (More)
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.
(Less)
- author
- organization
- publishing date
- 2017-09-08
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- ACRODAT, Acromegaly, AcroQoL, Patient-reported outcomes
- in
- Pituitary
- volume
- 20
- issue
- 6
- pages
- 692 - 701
- publisher
- Springer
- external identifiers
-
- pmid:28887782
- pmid:28887782
- wos:000413803200011
- scopus:85028977299
- ISSN
- 1386-341X
- DOI
- 10.1007/s11102-017-0835-5
- language
- English
- LU publication?
- yes
- id
- 55da938c-7f67-4eb7-b8ee-a6d03e20087e
- date added to LUP
- 2017-10-09 10:25:28
- date last changed
- 2025-03-18 02:49:53
@article{55da938c-7f67-4eb7-b8ee-a6d03e20087e,
abstract = {{<p>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.</p>}},
author = {{van der Lely, Aart Jan and Gomez, Roy and Pleil, Andreas and Badia, Xavier and Brue, Thierry and Buchfelder, Michael and Burman, Pia and Clemmons, David and Ghigo, Ezio and Jørgensen, Jens Otto Lunde and Luger, Anton and van der Lans-Bussemaker, Joli and Webb, Susan M. and Strasburger, Christian J}},
issn = {{1386-341X}},
keywords = {{ACRODAT; Acromegaly; AcroQoL; Patient-reported outcomes}},
language = {{eng}},
month = {{09}},
number = {{6}},
pages = {{692--701}},
publisher = {{Springer}},
series = {{Pituitary}},
title = {{Development of ACRODAT<sup>®</sup>, a new software medical device to assess disease activity in patients with acromegaly}},
url = {{http://dx.doi.org/10.1007/s11102-017-0835-5}},
doi = {{10.1007/s11102-017-0835-5}},
volume = {{20}},
year = {{2017}},
}