Content validation of observer-reported sickle cell pain diaries (SCPD-CS and SCPD-CN): results from interviews with caregivers

Health and Quality of Life Outcomes

Patricia Stebbins¹  Danielle St. Pierre¹  Miranda Bailey²  Denise D’Alessio²  Michelle K. White³  Avery Rizio³  Cory Saucier³  April M. Foster³ 

[1]Formerly of Optum Patient Insights, 1301 Atwood Ave, Suite 311N, Johnston, RI, USA

[2]Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ, USA

[3]QualityMetric Incorporated, LLC (Formerly Known As Optum Patient Insights), 1301 Atwood Ave, Suite 216E, Johnston, RI, USA

关键词: Content validity;    Daily diary;    Sickle cell disease;    Caregivers;    Qualitative;   

DOI  :  10.1186/s12955-021-01888-5

来源: Springer

【 摘 要 】

BackgroundPatients with sickle cell disease (SCD) experience daily pain and acute episodes known as sickle cell pain crises (SCPCs). The Sickle Cell Pain Diary-Caregiver Report (SCPD-C) is an observer-reported diary for use by caregivers of children ages < 12 years with SCD. This study reports on the content validity of the SCPD-C.MethodsThe SCPD-C was developed based on a literature review, measurement expert input, and a patient advisory board including clinicians. Three rounds of interviews (including both concept elicitation and cognitive debriefing methodologies) were conducted with caregivers of children with SCD aged < 12 to evaluate the content validity of the SCPD-C.ResultsAcross three rounds of interviews, caregivers confirmed concepts in the SCPD-C and described observed impacts that were important and were added. Overall, caregivers evaluated the SCPD-C as easy to understand, with some minor adaptations for clarity. Additionally, the diary was split into two versions based on the child’s age and school enrollment status (SCPD-CS for school-aged and SCPD-CN for non-school age children).ConclusionsCaregivers provided valuable input that led to important additions and changes to the measures. The SCPD-CS and SCPD-CN are appropriate and fit-for-purpose observer-reported outcome measures of SCPC-related pain frequency and severity, and impacts on health-related quality of life.

【 授权许可】

CC BY