title: Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia.
abstract: OBJECTIVE
  To assess the validity and reliability of the fatigue subscale of the Functional Assessment of Chronic Illness Therapy (FACIT-F), a 6-item subset from the thrombocytopenia subscale of the Functional Assessment of Cancer Therapy (FACT-Th6) and the Short Form-36 Version 2 (SF-36v2) in 2 clinical trials of the thrombopoietin receptor agonist eltrombopag in chronic immune thrombocytopenia (ITP) patients.
  
  
  METHODS
  In the 6-month, RAndomized placebo-controlled ITP Study with Eltrombopag (RAISE; n = 197), the FACIT-F, FACT-Th6, and SF-36v2 were administered at baseline, day 43, weeks 14 and 26, or early withdrawal. In the ongoing open-label extension study, Eltrombopag EXTENDed Dosing Study (EXTEND; n = 154), measures were administered at baseline, at the beginning of each stage, and at permanent discontinuation of study medication.
  
  
  RESULTS
  FACIT-F, FACT-Th6, and SF-36v2 demonstrated acceptable internal consistency reliability (i.e., all Cronbach's alphas >0.70) and test-retest reliability (all intraclass correlation coefficients >0.70). Construct validity was supported by moderate (0.35 < r < 0.50) to strong (r > 0.50) inter-measure correlations for baseline and change scores. A small to medium magnitude of effect was captured by the FACIT-F and FACT-Th6 among patients who experienced sustained platelet responses.
  
  
  CONCLUSIONS
  Results provide support for the validity, reliability, and responsiveness of the FACIT-F, FACT-Th6, and SF-36v2 in chronic ITP patients.
authors.affiliation: Analysis Group, Inc, Huntington Ave, Boston, MA, USA.
authors.forename: James
authors.initials: J
authors.lastname: Signorovitch
authors.forename: Andres
authors.initials: A
authors.lastname: Brainsky
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Grotzinger
mesh_terms: D001565:Benzoates / Q000008:administration & dosage* / Q000627:therapeutic use; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000188:drug therapy / Q000209:etiology / Q000523:psychology*; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control / Q000523:psychology; D006801:Humans; D006834:Hydrazines / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D053628:Receptors, Thrombopoietin / Q000008:administration & dosage / Q000819:agonists / Q000627:therapeutic use; D015203:Reproducibility of Results; D018434:Sickness Impact Profile; D013921:Thrombocytopenia / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D013995:Time
chemical_list: D001565:Benzoates; D006834:Hydrazines; D011720:Pyrazoles; D053628:Receptors, Thrombopoietin; C520809:eltrombopag