Development of a Novel Hematological Malignancy Specific Patient-Reported Outcome Measure (HM-PRO): Content Validity

Area of Science:

• Oncology
• Patient-Reported Outcomes
• Health Services Research

Background:

• Hematological malignancies significantly impact patients' quality of life.
• Existing measures may not fully capture the unique HRQoL issues for these patients.
• Content validity is crucial for instruments measuring patient-reported outcomes.

Purpose of the Study:

• To examine the content validity of a novel hematological malignancy-specific patient-reported outcome measure (HM-PRO).
• To ensure the HM-PRO items are relevant and comprehensive for patients with hematological malignancies.
• To assess the suitability of the HM-PRO for routine clinical practice.

Main Methods:

• A 4-step content validation process was employed, including literature review, semi-structured interviews, item rating by experts and patients, and cognitive interviewing.
• Themes from 129 patient interviews informed the prototype development of the HM-PRO.
• Patient preferences for recall period and item format (question vs. statement) were investigated.

Main Results:

• The prototype HM-PRO comprised 58 items across two parts: impact/HRQoL and signs/symptoms.
• Content validity index for scales averaged >0.8 for both parts, indicating strong relevance and clarity.
• High internal consistency (Cronbach's alpha) and intra-class correlation coefficients (ICC) were observed, with preferred recall periods identified.

Conclusions:

• The HM-PRO demonstrates robust content validity, encompassing key patient concerns.
• The instrument is deemed easy to read, understand, and respond to spontaneously.
• The HM-PRO is suitable for assessing the health-related quality of life in patients with hematological malignancies in clinical settings.