Development of a PROMIS multidimensional cancer-related fatigue (mCRF) form using modern psychometric techniques.

PURPOSE: To develop a PRO assessment of multidimensional cancer-related fatigue based on the PROMIS fatigue assessments. METHOD: Cancer patients reporting fatigue were recruited from a comprehensive cancer care center and completed a survey including 39 items from the PROMIS Cancer Item Bank-Fatigue. Component and factor structures of the fatigue items were explored with Monte Carlo parallel factor and Mokken analyses, respectively. Psychometric properties were determined using item response theory, ensuring unidimensionality, scalability, and item independence. RESULTS: Fatigue scores from a sample of 333 fatigued cancer patients (mean age = 59.50, SD = 11.62, 67% women) were used in all scale development analyses. Psychometric analyses yielded 3 dimensions: motivational fatigue (15 items), cognitive fatigue (9 items), and physical fatigue (9 items). The subscales showed strong unidimensionality, were scalable, and were free of differential item function. Confirmatory factor analyses in a new sample of 182 patients confirmed the findings. CONCLUSION: The resulting 33-item PROMIS multidimensional cancer-related fatigue (mCRF) form provides a novel measure for the assessment of the different dimensions of cancer-related fatigue. It is the only multidimensional scale specific for cancer patients that has been developed using modern psychometric approaches. With its 3 dimensions (motivational, cognitive, and physical fatigue), this scale accurately captures the fatigue experienced by cancer patients, allowing clinicians to optimize fatigue management and improve patient care. The scale could also advance research on the nature and experience of cancer-related fatigue.

Introduction and validation of the open symptom framework: a public domain modular framework for patient-reported measurement of symptoms related to cancer and its treatment.

PURPOSE: We provide an initial description and validation of some public domain patient-reported outcome (PRO) items to assess cancer symptom burden to address immediate barriers to symptom assessment use in clinical practice and facilitate future research. METHODS: We created the Open Symptom Framework (OSF), a flexible tool for clinical cancer-related symptom assessment. The items comprise six components: recall period, concept, symptom, qualifier(s), a definition, and a 5-point Likert-type response. We recruited patients receiving cancer therapy in the United States and United Kingdom. We assessed external construct validity by comparing OSF scores to the PRO-CTCAE measure and assessed reliability, scalability, dimensionality, and item ordering within a non-parametric item response theory framework. We tested differential item functioning for country, age, gender, and level of education. RESULTS: We developed a framework alongside clinical and psychometric experts and debrieifed with 10 patients. For validation, we recruited 331patients. All items correlated with the PRO-CTCAE equivalents (r = 0.55-0.96, all p < 0.01). Mokken analysis confirmed the scalability and unidimensionality of all symptom scales with multiple items at the scale (Ho = 0.61-0.75) and item level (Hi = 0.60-0.76). Items are interpreted consistently between demographic groups (Crit = 0 for all groups). CONCLUSION: The public domain OSF has excellent psychometric properties including face, content, and criterion validity and can facilitate the development of flexible, robust measurements to fulfil stakeholder need. The OSF was designed specifically to support clinical assessment but will function well for research. Further work is planned to increase the number of symptoms and number of questions per symptom within the framework.

FACE-Q for Measuring Patient-reported Outcomes after Facial Skin Cancer Surgery: Cross-cultural Validation.

Background: Facial skin cancer and its surgical treatment can affect health-related quality of life. The FACE-Q Skin Cancer Module is a patient-reported outcome measure that measures different aspects of health-related quality of life and has recently been translated into Dutch. This study aimed to evaluate the performance of the translated version in a Dutch cohort using modern psychometric measurement theory (Rasch). Methods: Dutch participants with facial skin cancer were prospectively recruited and asked to complete the translated FACE-Q Skin Cancer Module. The following assumptions of the Rasch model were tested: unidimensionality, local independence, and monotonicity. Response thresholds, fit statistics, internal consistency, floor and ceiling effects, and targeting were assessed for all scales and items within the scales. Responsiveness was tested for the "cancer worry" scale. Results: In total, 259 patients completed the preoperative questionnaire and were included in the analysis. All five scales assessed showed a good or sufficient fit to the Rasch model. Unidimensionality and monotonicity were present for all scales. Some items showed a local dependency. Most of the scales demonstrate ordered item thresholds and appropriate fit statistics. Conclusions: The FACE-Q Skin Cancer Module is a well-designed patient-reported outcome measure that shows psychometric validity for the translated version in a Dutch cohort, using classical and modern test theory.