Abstract
BackgroundThe 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 health-related 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.MethodsFollowing 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.ResultsThe 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 0.91 for Part A and 0.76 for Part B, suggesting high internal consistency, and ICC of 0.91 for Part A and 0.76 for Part B. The recall period of “today” for Part-A and “last 3 days” for Part-B were the patients’ preferred “recall period.” Furthermore, the patients expressed preference to the HM-PRO items as statements.ConclusionThe findings of this study confirm that the HM-PRO possesses a strong content validity, includes all the issues important to patients and is easy to read, understand and respond to spontaneously.
Highlights
Hematological malignancies (HM) are type of cancers which affect the blood, bone marrow, lymphatic system, and production and function of the blood cells (American Society of Haematology, 2018)
This study investigated the content validity and face validity of the hematological malignancy specific patient reported outcome measure (HM-patient-reported outcomes (PRO)) which were carried out between September and November 2016 in the United Kingdom
58 Items including quality of life (QoL) issues as well as signs and symptoms were selected to be included in the prototype instrument
Summary
Hematological malignancies (HM) are type of cancers which affect the blood, bone marrow, lymphatic system, and production and function of the blood cells (American Society of Haematology, 2018). Considering the high number of instruments which are currently used in hematology and the gaps in their measurement properties, there is a need for a generic instrument possessing strong validity for use in clinical practice that could be applied to all HMs (Goswami et al, 2019). 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
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