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Updated: Oct 26, 2025
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Content validation of a self-report daily diary in patients with sickle cell disease
Michelle K White1, Cory Saucier2, Miranda Bailey3
1Optum, 1301 Atwood Ave, Suite 311N, Johnston, RI, USA. mwhite@qualitymetric.com.
Insights
The Sickle Cell Pain Diary- Self Report (SCPD-S) was validated for content, confirming its suitability for measuring pain frequency, severity, and quality of life impacts in Sickle Cell Disease (SCD) patients. This patient-reported outcome measure effectively captures the patient experience during pain crises.
Area of Science:
- Medical research
- Patient-reported outcomes
- Health psychology
Background:
- Sickle Cell Disease (SCD) is a genetic disorder causing significant pain crises (SCPCs) and impacting patient quality of life.
- Sickle-cell pain crises (SCPCs) are a major cause of morbidity and mortality in SCD patients.
- The Sickle Cell Pain Diary- Self Report (SCPD-S) was developed to capture pain and its effects on quality of life.
Purpose of the Study:
- To investigate the content validity of the SCPD-S.
- To ensure the SCPD-S accurately reflects the patient experience of SCD and SCPC-related pain.
- To confirm the SCPD-S measures the impact of pain on health-related quality of life.
Main Methods:
- Conducted 18 hybrid concept elicitation and cognitive debriefing interviews with US-based SCD patients (aged 12+).
- Utilized a semi-structured interview guide and a think-aloud approach for cognitive debriefing.
- Analyzed interview data through recording, transcription, coding, and analysis.
Main Results:
- Initial interviews (n=12) led to expanding the SCPD-S from 13 to 19 items, adding impacts on social, recreational, sleep, and emotional well-being.
- Significant revisions were made to five items and three response sets.
- Follow-up interviews (n=6) confirmed the revised diary's comprehensiveness, clarity, and appropriateness of recall periods and response sets, with saturation analysis indicating no further interviews were needed.
Conclusions:
- The study provides evidence supporting the content validity of the SCPD-S.
- The SCPD-S is a fit-for-purpose measure for assessing SCD and SCPC-related pain frequency, severity, and impact on quality of life, including fatigue and emotional health.
- The iterative refinement process underscores the importance of content validation in developing patient-reported outcome measures.
Background:
Sickle Cell Disease (SCD) is a genetic progressive vascular disease that impacts patients overall health and quality of life. Sickle-cell pain crises (SCPCs) are a hallmark clinical presentation of SCD and have been associated with increased morbidity and mortality. The Sickle Cell Pain Diary- Self Report (SCPD-S) was developed as a daily patient-reported outcome (PRO) measure primarily intended to capture the frequency and severity of SCD-related pain during and outside of a SCPC. The SCPD-S also examines the impact of the pain associated with an SCPC on other health-related quality of life concepts. The objective of this study was to investigate the content validity of the SCPD-S.
Methods:
The content validation testing included 18 in-depth hybrid concept elicitation and cognitive debriefing interviews conducted with SCD patients in the US aged 12 years and older. Interviewers used a semi-structured interview guide and a think-aloud approach for the cognitive debriefing portion. All interviews were recorded, transcribed, coded and analyzed.
Results:
Eighteen interviews across two rounds were conducted. Round 1 hybrid interviews (n = 12) resulted in the expansion of the SCPD-S from 13 to 19 items. Items on the impact of an SCPC on social and recreational activities, sleep, and emotional well-being were added. Five items were significantly revised, as were three response choice sets. Round 2 hybrid interviews (n = 6) confirmed the comprehensiveness of the revised diary, understandability of the wording, and appropriateness of the recall period and response sets. Saturation analyses specific to concept elicitation revealed that no additional interviews were needed.
Conclusions:
This study provided evidence to support the content validity of the SCPD-S, a self-report daily diary. Data gathered during patient interviews indicated that the SCPD-S is a fit for purpose measure of SCD and SCPC-related pain frequency and severity and the impact of this pain on other health-related quality of life concepts including fatigue and emotional health. The numerous changes to the SCPD-S as a result of the study findings highlight the importance of the content validation process when developing a PRO measure.
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