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

Christina Theodore-Oklota, Louise Humphrey, Christof Wiesner, Gabriel Schnetzler, Stacie Hudgens, Alicyn Campbell, Christina Theodore-Oklota, Louise Humphrey, Christof Wiesner, Gabriel Schnetzler, Stacie Hudgens, Alicyn Campbell

Abstract

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 and satisfaction with rituximab SC (RASQ-SC) or rituximab intravenous (RASQ-IV). We assessed the content validity and psychometric properties of RASQ in patients with non-Hodgkin lymphoma.

Methods: Face and content validity of RASQ-SC and RASQ-IV were qualitatively assessed using 60-minute combined concept elicitation and cognitive debriefing interviews. Psychometric validation of RASQ (item performance and reliability) was assessed quantitatively against the established Cancer Therapy Satisfaction Questionnaire (CTSQ), using questionnaire data from the PrefMab (NCT01724021) and MabCute (NCT01461928) clinical studies.

Results: RASQ-IV demonstrated excellent coverage of concepts relevant to patients' (n=10) own treatment experiences and no new concepts were identified. Patients' expectations of rituximab SC were conceptually consistent with items included in the RASQ-SC, suggesting that the tool is also conceptually adequate. In 1,051 patients from PrefMab and MabCute, correlations with domains such as "RASQ: Physical Impacts" and "CTSQ: Feelings About Side Effects", "RASQ: Physical Impacts" and "CTSQ: Satisfaction With Therapy", and "RASQ: Satisfaction" and "CTSQ: Satisfaction With Therapy", achieved moderate-to-high correlations (>0.4) for convergent domains and <0.3 for divergent domains.

Conclusion: This study supports the qualitative face and content validity and psychometric validity of RASQ-IV and RASQ-SC. Minor revisions were made to the questionnaires to enhance clarity and aid consistent reporting.

Keywords: MabCute; PrefMab; RASQ; cognitive interview; non-Hodgkin lymphoma; patient-reported outcome measure; questionnaire.

Figures

Figure 1
Figure 1
Core concept is rituximab IV/SC treatment satisfaction. Abbreviations: CTSQ, Cancer Therapy Satisfaction Questionnaire; IV, intravenous; SC, subcutaneous; TSQM, Treatment Satisfaction Questionnaire for Medication.
Figure 2
Figure 2
Core concept is impact of rituximab IV/SC administration. Abbreviations: CTSQ, Cancer Therapy Satisfaction Questionnaire; FACT-G, functional assessment of cancer therapy; IV, intravenous; PRO-CTCAE, patient-reported outcomes version of the common terminology criteria for adverse events; SC, subcutaneous.
Figure 3
Figure 3
Outline of interview methodology. Abbreviations: IV, intravenous; min, minutes; NHL, non-Hodgkin lymphoma; RASQ-IV, Rituximab Administration Satisfaction Questionnaire-intravenous; RASQ-SC, Rituximab Administration Satisfaction Questionnaire-subcutaneous; SC, subcutaneous.

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Source: PubMed

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