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Preoperative anxiety is a very common phenomenon that adversely affects a patient's physical and psychological outcome. To evaluate subjective complaints such as anxiety, use of a validated psychological instrument is essential. In this study, we translated, culturally adapted and validated the Amsterdam preoperative anxiety and information scale (APAIS) for use in Japan. One hundred and twenty-six preoperative patients participated in this cross-sectional study. The psychometric properties of the APAIS evaluated by factor analysis, correlation with the state-trait anxiety inventory (STAI) and Cronbach's were very similar to those of the original Dutch and English versions. Female gender and a high information requirement were associated with high preoperative anxiety. In conclusion, the Japanese version of the APAIS is a valid and reliable instrument for screening Japanese patients for preoperative anxiety and information requirements. Female gender and high information requirement may be associated with high preoperative anxiety.  相似文献   

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In this study, we have translated and cross-culturally adapted the Functional Assessment of Cancer Therapy-Lung (FACT-L) version 4 into Korean, and we have evaluated its reliability and validity. The FACT-L version 4 was translated into Korean following the standard Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology. The psychometric properties of the FACT-L were evaluated in 122 lung cancer patients (mean age, 60.88 years). Pre-testing was performed in 22 patients, and these results indicated good content coverage and overall comprehensibility. In validating the FACT-L version 4, our results indicated high internal consistency of the FACT-L scales, with Cronbach’s α coefficients ranging from 0.52 to 0.84. The FACT-L also demonstrated good convergent and divergent validity when correlated with the Functional Living Index-Cancer (FLIC) and the shortened forms of the Profile of Mood States (POMS). This reliable and valid instrument can now be used to properly evaluate the quality of life of Korean lung cancer patients.  相似文献   

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目的:为完善我国新药审评制度提供参考。方法:分析美国《处方药付费法案》各阶段侧重点、监管措施及实施成效,进而针对我国新药审评实际提出相关建议。结果:PDUFA在显著缩短新药审评时间、改善研制效率、提高首轮审评通过率和助力极具创新性药物产出方面发挥了重要作用。结论:建议我国在确保药品安全有效前提下,通过加强新药研发指导、优化上市申请审评过程管理以及加快药品监管科学发展与应用等进一步完善新药审评制度。  相似文献   

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Diane Wild  MSc    Alyson Grove  MSc    Mona Martin  MPA    Sonya Eremenco  MA    Sandra McElroy  BA    Aneesa Verjee-Lorenz  MSc    Pennifer Erikson  PhD 《Value in health》2005,8(2):94-104
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 published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.  相似文献   

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The objective of this study was to assess the psychometric properties of the Thai version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0. The questionnaire was completed by 310 cancer patients during their follow-up at 2 teaching hospital oncology clinics. About 70% of participants had advanced stage of cancer and 72% had been receiving chemotherapy. Cronbach’s α coefficients of the six scales were above 0.7, except for cognitive and social function scales. All test–retest reliability coefficients were high. Multitrait scaling analysis showed that all item-scale correlation coefficients met the standards of convergent and discriminant validity. Most scales and items could discriminate between subgroups of patients with different clinical status assessed with the Eastern Cooperative Oncology Group (ECOG) scale. The results suggested that the EORTC QLQ-C30 and the Functional Assessment of Cancer Therapy – General (FACT-G) measured different aspects of quality of life and should be independently used. Testing psychometric properties of the EORTC QLQ-C30 in heterogeneous diagnostic group yield similar results as found in homogeneous group. These results support that the EORTC QLQ-C30 (version 3.0) has proven to be a reliable and valid measure of the quality of life in Thai patients with various types of cancer.  相似文献   

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