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

Abstract

Background: The quality of life of patients at all stages of hematological malignancy is greatly affected by the disease and its treatment. There is a wide range of healthrelated quality of life (HRQoL) issues important to these patients. Any new instrument developed to measure HRQoL of such patients should be content valid, i.e., the items should be comprehensively relevant to the patients and their health condition. The aim of the present study was to examine content validity of a hematological malignancy specific patient reported outcome measure (HM-PRO) developed for use in routine clinical practice. Methods: Following literature review and semi-structured interviews, the generated themes and sub-themes were discussed to develop the prototype version of the HM-PRO. A 4-step approach was used for content validation: initial testing and cognitive interviewing; item rating; content validity panel meeting; final field testing and cognitive interviewing. Additional questions related to patients' perception of recall period and preferred sentence structure (i.e., question or statement) of the items were also asked during cognitive interviews. Results: The content analysis of 129 transcribed semi-structured interviews resulted in the prototype version of the instrument consisting of 58 items grouped into two parts: Part A (impact/HRQoL-34 items) and Part B (signs and symptoms-24 items). The initial testing showed intra-class correlation coefficient (ICC) of >0.8 for both Part A and Part B. Item rating for language clarity, completeness, relevance, and response scale by experts and patients showed content validity index for scales average >0.8 for both Part A and Part B, except 0.64 for relevance for Part A by the patient panel. The final testing of the revised version of the instrument showed the Cronbach's alpha value of

Hematological Malignancy Specific Patient-Reported Outcome Measure (HM-PRO): Construct Validity Study

“…The HM-PRO has been developed in accordance to FDA PRO guidlines. It has shown evidence of good content validity, meaning that it captures what is important to patients with different hematological malignancies (Goswami et al, 2020). The evidence on the construct validity presented in this research is a testimony of the HM-PRO's ability to measure HRQoL issues which it intends to measure.…”

“…"My drinking habits have changed," and ninth item of Part B related to "skin problems" are not included in the scoring system but collected for additional information. The HM-PRO has shown good reliability with Cronbach's alpha and ICC with coefficient greater than 0.8 for all four domains of Part A and for Part B (Goswami et al, 2016;Goswami et al, 2017;Goswami et al, 2020).…”

“…The hematological malignancy-patient reported outcome measure (HM-PRO) is a newly developed composite measure consisting of two scales: Part A (Impact); and Part B (Signs and Symptoms). Part A measures the impact of the HM and its treatment on a patient's HRQoL, and Part B captures the severity of disease or treatment related signs and symptoms (Goswami et al, 2016;Goswami et al, 2017;Goswami et al, 2020). Part A has a total of 24 items in four domains: physical behavior (7); social behavior (3); emotional behavior (11); and eating and drinking habits (3).…”

“…The hematological malignancy specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use in daily clinical practice as well as in research (Goswami et al, 2016;Goswami et al, 2018a;Goswami et al, 2018b;Goswami et al, 2019a;Goswami et al, 2019b;Goswami et al, 2020). The HM-PRO is undergoing all necessary assessments to meet the minimum standards set out by regulatory authorities such as the FDA.…”

Reliability of a Novel Hematological Malignancy Specific Patient-Reported Outcome Measure: HM-PRO

“…Similar finiding were reported by another systematic reviwer which focused on patients with multiple myeloma (Osborne et al, 2012;Goswami et al, 2019a). A new PRO measure, HM-PRO (hematological malignancy specific patient-reported outcome measure), has been recently developed to evaluate the HRQoL of patients with HMs in daily clinical practice as well as in research (Goswami et al, 2017;Goswami et al, 2020b;Goswami et al, 2020c).…”