Development of a patient ‐reported outcomes symptom measure for patients with nontransfusion‐dependent thalassemia (NTDT‐PRO©)
This study aimed to develop a new, US Food and Drug Administration (FDA)‐compliant PRO of chronic anemia symptoms, the NTDT‐PRO© tool, for use in patients with NTDT. Participants had a median age of 36 years (range, 18‐47) and 60% were female. The initial development of the NTDT‐PRO tool involved concept‐elicitation interviews with 25 patients from 3 centers (in Lebanon, Greece, and Canada); subsequent interview discussions and clinical input resulted in the generation of 9 items for incl usion in the draft NTDT‐PRO. Following a round of cognitive interviews involving 21 patients from 2 centers (in Lebanon and Greece), 4 items (Pain, Headaches, Ability to Concentrate, and Paleness) were removed from the draft NTDT‐PRO. The final NTDT‐PRO comprises 6 items that measure Tiredness , Weakness, and Shortness of Breath, with or without Physical Activity. The NTDT‐PRO is a new disease‐specific HRQoL tool for patients with NTDT, developed using a thorough methodology based on FDA 2009 PRO development guidelines.
Source: American Journal of Hematology - Category: Hematology Authors: Ali Taher,
Vip Viprakasit,
Maria Domenica Cappellini,
Pranee Sutcharitchan,
Richard Ward,
Dalia Mahmoud,
Abderrahmane Laadem,
Anzalee Khan,
Chad Gwaltney,
Gale Harding,
Kenneth Attie,
Xiaosha Zhang,
Jun Zou,
Joseph Pariseau,
X. Henry Hu,
An Tags: RESEARCH ARTICLE Source Type: research
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