Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab

• DOI: 10.2147/ppa.s108489
• Publication Date: 2016-09-14T03:50:56Z
• Authors: Christina Theodor...; Louise Humphrey; Christof Wiesner; Gabriel Schnetzler; Stacie Hudgens; Alicyn Campbell
• Keywords: Face validity; Content Validity; Concordance; Debriefing; Convergent validity

Background: A subcutaneous (SC) formulation of rituximab (MabThera ® /Rituxan ) has been developed that could reduce administration time and improve patient satisfaction with treatment. The Rituximab Administration Satisfaction Questionnaire (RASQ) was created to assess patients' perceptions SC (RASQ-SC) or intravenous (RASQ-IV). We assessed the content validity psychometric properties RASQ in patients non-Hodgkin lymphoma. Methods: Face RASQ-SC RASQ-IV were qualitatively using 60-minute combined concept elicitation cognitive debriefing interviews. Psychometric validation (item performance reliability) quantitatively against established Cancer Therapy (CTSQ), questionnaire data from PrefMab (NCT01724021) MabCute (NCT01461928) clinical studies. Results: demonstrated excellent coverage concepts relevant (n=10) own treatment experiences no new identified. Patients' expectations conceptually consistent items included RASQ-SC, suggesting tool is also adequate. In 1,051 MabCute, correlations domains such as "RASQ: Physical Impacts" "CTSQ: Feelings About Side Effects", With Therapy", Satisfaction" achieved moderate-to-high (>0.4) for convergent <0.3 divergent domains. Conclusion: This study supports qualitative face RASQ-SC. Minor revisions made questionnaires enhance clarity aid reporting. Keywords: RASQ, PrefMab, interview, lymphoma, patient-reported outcome measure,