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In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and(More)
OBJECTIVES With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force(More)
OBJECTIVE To develop and validate a self-administered questionnaire to assess the 'severity' and 'bothersomeness' of the most frequently reported signs and symptoms of uncomplicated urinary tract infection (uUTI). SUBJECTS AND METHODS The UTI Symptoms Assessment questionnaire (UTISA) is a 14-item instrument asking about the severity and bothersomeness of(More)
BACKGROUND To validate a questionnaire to assess the activity impairment associated with uncomplicated urinary tract infection (uUTI). METHODS The Activity Impairment Assessment (AIA) assesses the amount of time an individual's work or regular activities have been impaired as a result of their UTI. The measure was completed by 276 women with uUTI who had(More)
OBJECTIVE To examine the impact of schizophrenia, its treatment and treatment-related adverse events related to antipsychotics, on quality of life from the perspective of schizophrenia patients and laypersons. METHODS Health state descriptions for stable schizophrenia, extra pyramidal symptoms (EPS), hyperprolactinemia, diabetes, weight gain and relapse(More)
OBJECTIVE To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patient reported outcome measures (PROMs) in studies conducted subsequent to those included in Gwaltney et al's 2008 review. METHODS A systematic literature review of PROM equivalence studies conducted between 2007 and 2013(More)
OBJECTIVE To describe the measurement properties of the Personal and Social Performance scale (PSP), a clinician-reported measure of severity of personal and social dysfunction, in subjects with acute symptoms of schizophrenia. METHODS Pooled data from three paliperidone extended-release clinical studies (n = 1665) and data from a separate(More)
BACKGROUND Being overweight or obese has substantial effects on individuals' perceptions of their health and quality of life (QoL). Generic measures often miss important QoL information, and existing obesity-specific instruments have shortcomings with respect to cross-cultural input, application to differing levels of severity, conceptual clarity, and(More)
A disease-specific measure was needed for use in an international clinical trial to evaluate an investigational drug for genital herpes. A new measure was developed initially in the UK and translated and adapted for use in France, Italy, Germany, Denmark, Spain and the USA. This paper describes the translation and adaptation of the USA measure. It also(More)
LGS is a severe form of childhood epilepsy which is characterized by multiple seizures and cognitive impairment. Semi-structured interviews were conducted with 40 parents of children with LGS in the US, UK, and Italy. Parents were asked to report on their perceptions of the HRQL of their child and also to describe the impact on their own HRQL. Thematic(More)