title: Impact of oral cyclophosphamide on health-related quality of life in patients with active scleroderma lung disease: results from the scleroderma lung study.
abstract: OBJECTIVE
  To assess the impact of cyclophosphamide (CYC) on the health-related quality of life (HRQOL) of patients with scleroderma after 12 months of treatment.
  
  
  METHODS
  One hundred fifty-eight subjects participated in the Scleroderma Lung Study, with 79 each randomized to CYC and placebo arms. The study evaluated the results of 3 measures of health status: the Short Form 36 (SF-36), the Health Assessment Questionnaire (HAQ) disability index (DI), and Mahler's dyspnea index, and the results of 1 preference-based measure, the SF-6D. The differences in the HRQOL between the 2 groups at 12 months were calculated using a linear mixed model. Responsiveness was evaluated using the effect size. The proportion of subjects in each treatment group whose scores improved at least as much as or more than the minimum clinically important difference (MCID) in HRQOL measures was assessed.
  
  
  RESULTS
  After adjustment for baseline scores, differences in the HAQ DI, SF-36 role physical, general health, vitality, role emotional, mental health scales, and SF-36 mental component summary (MCS) score were statistically significant for CYC versus placebo (P < 0.05). Effect sizes were negligible (<0.20) for all of the scales of the SF-36, HAQ DI, and SF-6D at 12 months. In contrast, a higher proportion of patients who received CYC achieved the MCID compared with placebo in the HAQ DI score (30.9% versus 14.8%), transitional dyspnea index score (46.4% versus 12.7%), SF-36 MCS score (33.3% versus 18.5%), and SF-6D score (21.3% versus 3.8%).
  
  
  CONCLUSIONS
  One year of treatment with CYC leads to an improvement in HRQOL in patients with scleroderma lung disease.
authors.affiliation: University of Cincinnati, Cincinnati, Ohio 45267-0563, USA. Dinesh.Khanna@uc.edu
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
authors.forename: Xiaohong
authors.initials: X
authors.lastname: Yan
authors.forename: Donald P
authors.initials: DP
authors.lastname: Tashkin
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.forename: Robert
authors.initials: R
authors.lastname: Elashoff
authors.forename: Michael D
authors.initials: MD
authors.lastname: Roth
authors.forename: Richard
authors.initials: R
authors.lastname: Silver
authors.forename: Charlie
authors.initials: C
authors.lastname: Strange
authors.forename: Marcy
authors.initials: M
authors.lastname: Bolster
authors.forename: James R
authors.initials: JR
authors.lastname: Seibold
authors.forename: David J
authors.initials: DJ
authors.lastname: Riley
authors.forename: Vivien M
authors.initials: VM
authors.lastname: Hsu
authors.forename: John
authors.initials: J
authors.lastname: Varga
authors.forename: Dean E
authors.initials: DE
authors.lastname: Schraufnagel
authors.forename: Arthur
authors.initials: A
authors.lastname: Theodore
authors.forename: Robert
authors.initials: R
authors.lastname: Simms
authors.forename: Robert
authors.initials: R
authors.lastname: Wise
authors.forename: Fredrick
authors.initials: F
authors.lastname: Wigley
authors.forename: Barbara
authors.initials: B
authors.lastname: White
authors.forename: Virginia
authors.initials: V
authors.lastname: Steen
authors.forename: Charles
authors.initials: C
authors.lastname: Read
authors.forename: Maureen
authors.initials: M
authors.lastname: Mayes
authors.forename: Ed
authors.initials: E
authors.lastname: Parsley
authors.forename: Kamal
authors.initials: K
authors.lastname: Mubarak
authors.forename: M Kari
authors.initials: MK
authors.lastname: Connolly
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Golden
authors.forename: Mitchell
authors.initials: M
authors.lastname: Olman
authors.forename: Barri
authors.initials: B
authors.lastname: Fessler
authors.forename: Naomi
authors.initials: N
authors.lastname: Rothfield
authors.forename: Mark
authors.initials: M
authors.lastname: Metersky
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Clements
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008137:Longitudinal Studies; D008171:Lung Diseases / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D015203:Reproducibility of Results; D012595:Scleroderma, Systemic / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D003520:Cyclophosphamide