DEVELOPMENT AND SCORING OF THE SATISFACTION WITH IRON CHELATION THERAPY INSTRUMENT FOR PATIENTS WITH IRON OVERLOAD

Author(s)

Diana Rofail, BSc, (Hons), MSc, Project Manager1, Muriel Viala, MSc, Senior Research Analyst2, Linda Abetz, BA, MA, Director3, Claire Gait, BSc, MPhil, Research Associate41Mapi Values Limited, Macclesfield, United Kingdom; 2 Mapi Values France, Lyon, France; 3 Mapi Values Limited, Bollington, United Kingdom; 4 Mapi Values Ltd, Macclesfield, United Kingdom

OBJECTIVES: Patients with thalassemia, sickle cell disease (SCD), and myelodysplastic syndromes (MDS) require infusion iron chelation therapy (ICT) involving 8-12 hour infusions, 5 days per week, potentially limiting quality of life (QoL) and inhibiting adherence in patients already limited by their condition. Thus, satisfaction with ICT is an important treatment outcome. To date, there is no well-established measure to quantify patient satisfaction with ICT. The aim of this study is to describe the development and scoring of a treatment satisfaction instrument for patients taking ICT. METHODS: Based on a literature review, and patient and clinician interviews, a 28-item instrument was developed as funded by Novartis. This included an assessment of: satisfaction with prior experience with ICT; satisfaction with ICT characteristics; adherence to treatment; preferences; and behavioural intentions. U.S. and U.K. patients with thalassemia, SCD, or MDS (n=110) currently taking ICT completed the satisfaction instrument. The scoring of the instrument and the assessment of its reliability and validity was performed on the 19 satisfaction items. The 9 items related to past experience, intentions and preferences were scored separately. RESULTS: The Principal Component Analysis using a varimax rotation revealed a four dimensional structure that explained 63% of the total variance. The factors of the Satisfaction with ICT instrument were labelled: Perceived Effectiveness of ICT (6 items); Burden of ICT (5 items); Acceptance of ICT (5 items); and Side-effects of ICT (3 items). Internal consistency reliability for all subscales was good, with alpha coefficients ranging between 0.80 for Acceptance of ICT to 0.86 for Perceived Effectiveness. CONCLUSIONS: Preliminary analyses suggest that the Satisfaction with ICT instrument is reliable. Further validation of the instrument is required to assess its test-retest reliability, construct validity and responsiveness. The instrument could be used in routine clinical practice or in clinical trials to measure satisfaction with ICT.

Conference/Value in Health Info

2006-10, ISPOR Europe 2006, Copenhagen, Denmark

Value in Health, Vol. 9, No.6 (November/December 2006)

Code

PHM11

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction

Disease

Systemic Disorders/Conditions

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