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Background:Several instruments are widely used for assessing dependence, craving, withdrawal symptoms, and reinforcing effects in users of tobacco- and nicotine-containing products (TNP), including the Fagerström Test for Nicotine Dependence (FTND), Questionnaire of Smoking Urges, original (QSU) and brief (QSU-b) versions; Minnesota Nicotine Withdrawal Scale, original (MNWS) and revised (MNWS-R) versions; and Cigarette Evaluation Questionnaire, original (CEQ) and modified (mCEQ) versions. Although these instruments have been translated extensively, their translations and corresponding measurement properties have not been systematically assessed. This study aimed to (1) identify the translations of these instruments for which psychometric properties have been published, (2) describe the methods used for translation, and (3) describe the measurement properties and the context in which these translations were evaluated (e.g., target population and TNP used).Methods:Embase and MEDLINE databases were systematically searched.Results:While no information could be found for the CEQ/mCEQ, several translations were available for the remaining instruments: FTND, 25; QSU and QSU-b, 4 each; QSU (12-item version), 1; MNWS, 4; and MNWS-R, 1. Cigarette smokers represented the main target population in which the validation studies were conducted. Information about the translation process was reported for 25 translations. In most cases, the properties of the translations mirrored those of the originals. Differential item functioning was explored in only one case.Conclusions:There are few publications describing the measurement properties of the translations of the FTND, QSU/QSU-b, and MNWS/MNWS-R. None of these translations have been validated for TNPs other than cigarettes, which suggests the need for greater development and validation of instruments in this area.

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Background and Aims Anaemia is a common complication of CKD in children that is associated with adverse clinical outcomes, including poor physical functioning for patients and lower HRQoL for patients and caregivers.1 Given the subjective nature of the disease, instruments that measure patient- and/or observer-reported outcomes (PROs/ObsROs), by collecting information about symptom severity and HRQoL, could be of value to assess treatment benefit. We determined which aspects of anaemia of CKD and its treatments are important for paediatric patients and their caregivers, and examined which PRO/ObsRO instruments comprehensively capture patients’ and caregivers’ experiences. Method A targeted literature review and database search were performed to find a) qualitative and quantitative studies of symptoms and related health outcomes in paediatric patients with anaemia of CKD; b) related clinical practice guidelines; and c) HRQoL information in product labelling. Study outcomes were used to develop a structured representation of health outcomes concepts and issues (‘conceptual model’) capturing the symptoms, perceptions of treatment and impact on HRQoL of anaemia of CKD, from the perspective of both paediatric patients and their caregivers. PRO and ObsRO instruments were identified from published quantitative studies and ongoing clinical trials, and a selection was then critically assessed to determine their content validity and whether their psychometric properties adequately covered the conceptual model domains. Results The conceptual model captured shortness of breath, fatigue and headaches as the most important symptoms experienced by paediatric patients with anaemia of CKD. Concerns regarding disease management included medical interventions, fear associated with interventions and the need for information about the disease. Disease symptoms and their management impacted seven HRQoL domains, namely physical, emotional and social functioning; activities of daily living; and effects on family, work and caregivers (Figure). The quantitative search of published studies identified 20 unique instruments; of these, the most frequently used was Pediatric Quality of Life Inventory™ (PedsQL) Version 4.0. Ongoing clinical trials used 14 unique instruments, of which only EQ-5D-Y was used in more than one study. Two clinical practice guidelines (National Institute for Health and Care Excellence and Kidney Disease: Improving Global Outcomes) supported measurements of HRQoL, symptoms, patient preferences and school attendance/performance, but they did not advocate use of any specific instruments. No HRQoL product labelling information was identified. Based on the conceptual model, the literature review results and age group coverage, five instruments were selected for critical appraisal: PedsQL, PedsQL Infant Scales, PedsQL Multidimensional Fatigue Scale, PedsQL v3.0 End Stage Renal Disease module, and EQ-5D-Y. Between them, these instruments provided complete coverage of the impact of fatigue and headaches, and partial coverage of the effects on physical functioning, activities of daily living, emotional functioning and social functioning. None of these instruments measured the impact of shortness of breath, and there was no coverage of the consequences for work or the family’s/caregivers’ HRQoL. Conclusion Anaemia of CKD affects many HRQoL domains for paediatric patients and their caregivers. While current PRO/ObsRO instruments partially address these impacts, no single instrument in our assessment measured all symptoms and domains of interest to patients and caregivers. Multiple instruments should be included in clinical studies to capture symptoms and HRQoL important to patients, and adequate measurement of the effects of anaemia on work or the family’s/caregivers’ HRQoL might require development of a new instrument.

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