Health Qual Life Out
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Health Qual Life Out · Jun 2013
ReviewThe development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease.
The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument. ⋯ A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content validity. The NiSCI is ready for empirical testing, including item reduction and evaluation of psychometric properties.
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Health Qual Life Out · May 2013
Potential of patient-reported outcomes as nonprimary endpoints in clinical trials.
The purpose of this research was to fully explore the impact of endpoint type (primary vs. nonprimary) on decisions related to patient-reported outcome (PRO) labeling claims supported by PRO measures and to determine if nonprimary PRO endpoints are being fully optimized.This review examines the use of PROs as both primary and nonprimary endpoints in support of demonstration of treatment benefit of new molecular entities (NMEs) and biologic license applications (BLAs) in the United States in the years 2000 to 2012. ⋯ Successful PRO labeling claims are typically based on primary endpoints assessing signs and symptoms. Based on this research, studies with PROs as primary endpoints are far more likely to facilitate positive regulatory review and acceptance of PROs in support of labeling claims. Although inclusion of PROs as nonprimary endpoints in clinical trials has its challenges, recent PRO labels granted by the FDA show that they can indeed be candidates for PRO labeling claims as long as they are supported by evidence.
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Health Qual Life Out · Mar 2013
Comparative StudyHealth-related quality of life and life satisfaction in colorectal cancer survivors: trajectories of adjustment.
This longitudinal study describes the five year trajectories of health-related quality of life (HR-QOL) and life satisfaction in long term colorectal cancer survivors. ⋯ Although HR-QOL and subjective cognitive QOL share similar antecedents their trajectory patterns suggested they are distinct adjustment outcomes; with life satisfaction emerging as temporally stable phenomenon. Unique patterns of risk support suggest the need to account for heterogeneity in adjustment in longitudinal QOL studies with cancer survivors.
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Health Qual Life Out · Feb 2013
Cross-cultural adaptation and psychometric properties of the Brazilian version of the scale of oral health outcomes for 5-year-old children (SOHO-5).
Most of the instruments available to measure the oral health-related quality of life (OHRQoL) in paediatric populations focus on older children, whereas parental reports are used for very young children. The scale of oral health outcomes for 5-year-old children (SOHO-5) assesses the OHRQoL of very young children through self-reports and parental proxy reports. We aimed to cross-culturally adapt the SOHO-5 to the Brazilian Portuguese language and to assess its reliability and validity. ⋯ The present study demonstrated that the SOHO-5 exhibits satisfactory psychometric properties and is applicable to 5- to 6-year-old children in Brazil.
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Health Qual Life Out · Jan 2013
Randomized Controlled Trial Multicenter StudyImprovements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study.
Apremilast, a specific inhibitor of phosphodiesterase 4, modulates pro-inflammatory and anti-inflammatory cytokine production. ⋯ Apremilast treatment resulted in improved HRQOL, including DLQI and pruritus VAS over 16 weeks of treatment, in patients with moderate to severe psoriasis.