Abstract

BackgroundThe European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is currently developing computerized adaptive testing measures for the Quality of Life Questionnaire Core-30 (QLQ-C30) scales. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ-C30.MethodsAccording to the EORTC guidelines on module development, the development of the EF item bank comprised four phases, of which the phases I–III are reported in the present paper.Phase I involved defining the theoretical framework for the EF item bank and a literature search. Phase II included pre-defined item selection steps and a multi-stage expert review process. In phase III, feedback from cancer patients from different countries was obtained.ResultsOn the basis of literature search in phase I, a list of 1750 items was generated. These were reviewed and further developed in phase II with a focus on relevance, redundancy, clarity, and difficulty. The development and selection steps led to a preliminary list of 41 items. In phase III, patient interviews (N = 41; Austria, Denmark, Italy, and the UK) were conducted with the preliminary item list, resulting in some minor changes to item wording. The final list comprised 38 items.DiscussionThe phases I–III of the developmental process have resulted in an EF item list that was well accepted by patients in several countries. The items will be subjected to larger-scale field testing in order to establish their psychometric characteristics and their fit to an item response theory model.

Highlights

  • Assessment of health-related quality of life (HRQOL) is a common practice in many cancer clinical trials, and emotional functioning (EF) is a common domain included in most HRQOL measures [1]

  • We describe the phases I–III of the development of the EORTC EF-computerized adaptive testing (CAT), that is, the development of an EF item list

  • The current paper describes the phases I–III of the development of an EF item bank as well as the preceding conceptualization of the theoretical framework on which the item bank will be based

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Summary

Introduction

Assessment of health-related quality of life (HRQOL) is a common practice in many cancer clinical trials, and emotional functioning (EF) is a common domain included in most HRQOL measures [1]. On the other hand, aiming at an accurate assessment usually requires a large number of questions, and many of these may lack relevance for the individual patient or a specific target population [4,6], resulting in considerable floor- and/or ceiling-effects. Modern measurement approaches, such as item banking and computerized adaptive testing (CAT) [7], have great potential for overcoming some limitations of traditional assessment methods. CAT tailors the item set to the condition of each subject, thereby increasing measurement precision and the relevance of the instrument for the individual person. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ-C30

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