The development and validation of an instrument for assessing users’ perception toward the

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motivation in language learning tesol internation

MOTIVATION IN LANGUAGE LEARNING: SELECTED REFERENCES(last updated 9 May 2013)Ames, C. (1984). Competitive, cooperative, and individualistic goal structures: A cognitive-instructional analysis. In R. E. Ames & C. Ames (Eds.), Research on motivation ineducation (pp. 177-207). New York: Academic Press.Ames, C. (1986). Effective motivation: The contribution of the learning environment. In R. S.Feldman (Ed.), The social psychology of education (pp. 235-256). Cambridge:Cambridge University Press.Amrein, A., & Berliner, D. (2003). The effects of high-stakes testing on student motivation and learning. Educational Leadership, 60(5), 32-38.Bacon, S. M., & Finnemann, M. D. (1990). A study of the attitudes, motives, and strategies of university foreign language students and their disposition to authentic oral and writteninput. Modern Language Journal, 74, 459-473.Bandura, A., & Schunk, D. H. (1981). Cultivating competence, self-efficacy, and intrinsic interest through proximal self-motivation. Journal of Personality and Social Psychology, 41, 586-598.Benson, M. (1991). Attitudes and motivation towards English: A survey of Japanese freshmen.RELC Journal, 22(1), 34-48.Bråten, I., & Olaussen, B. S. (1998). The relationship between motivational beliefs and learning strategy use among Norwegian college students. Contemporary Educational Psychology, 23, 182-194.Brophy, J. (1998). Motivating students to learn. New York: McGraw-Hill.Brophy, J. E. (1999). Towards a model of the value aspects of motivation in education: Developing an appreciation for particular domains and activities. EducationalPsychologist, 34, 75-85.Brophy, J. & Kher, N. (1986). Teacher socialization as a mechanism for developing student motivation to learn. In R. S. Feldman (Ed.), The social psychology of education (pp. 257-288). Cambridge: Cambridge University Press.Brown, J. D., Cunha, M. I. A., & Frota, S. de F. N. (2001). The development and validation of a Portuguese version of the Motivated Strategies for Learning Questionnarie. In Z. Dörnyei & R. Schmidt (Eds.), Motivation and second language acquisition (pp. 257-280).Honolulu, HI: Second Language Teaching & Curriculum Center, University of Hawai‘i Press.Brown, S., Armstrong, S., & Thompson, G. (1998). Motivating students. London: Kogan Page.Chambers, G. (1999). Motivating language learners. Clevedon, UK: Multilingual Matters. Cheng, H-F., & Dörnyei, Z. (2007). The use of motivational strategies in language instruction: The case of EFL teaching in Taiwan. Innovation in language learning and teaching, 1,153-174.Cohen, M., & Dörnyei, Z. (2002). Focus on the language learner: Motivation, styles and strategies. In N. Schmidt (Ed.), An introduction to applied linguistics (pp. 170-190).London, UK: Arnold.Cooper, H., & Tom, D. Y. H. 1984. SES and ethnic differences in achievement motivation. In R.E. Ames & C. Ames (Eds.), Motivation in education (pp. 209-242). New York:Academic Press.Cranmer, D. (1996). Motivating high level learners. Harlow, UK: Longman.Crookes, G., & Schmidt, R. W. (1991). Motivation: Re-opening the research agenda. Language Learning, 41, 469-512.Csikszentmihalyi, M., & Nakamura, J. (1989). The dynamics of intrinsic motivation: A study of adolescents. In R. Ames & C. Ames (Eds.), Handbook of motivation theory and research, Vol. 3: Goals and cognitions (pp. 45–71). New York, NY: Academic Press.Csizér, K., & Dörnyei, Z. (2005). Language learners’ motivational profiles and their motivated learning behavior. Language Learning, 55, 613-659.Csizér, K., Kormos, J., & Sarkadi, Á. (2010). The dynamics of language learning attitudes and motivation: Lessons from an interview study of dyslexic language learners. ModernLanguage Journal, 94(3), 470-487.deCharms, R. (1984). Motivation enhancement in educational settings. In R. E. Ames & C.Ames (Eds.), Motivation in education (pp. 275-310). New York: Academic Press. Deci, E. L., & Ryan, R. M. (1985). Intrinsic motivation and self-determination in human behavior. New York, NY: Plenum.Deci, E. L., & Ryan, R. M. (1991). A motivational approach to self: Integration in personality. In R. A. Dienstbier (Ed.), Perspectives on motivation: Nebraska Symposium on Motivation, 1990 (pp. 237-288). Lincoln, NE: University of Nebraska Press.Deci, E. L., Vallerand, R. J., Pelletier, L. G., & Ryan, R. M. (1991). Motivation and education: The self-determination perspective. Educational Psychologist, 26(3 & 4), 325-346.De Volder, M. L., & Lens, W. (1982). Academic achievement and future time perspective as a cognitive-motivational concept. Journal of Personality and Social Psychology, 44, 20-33Dörnyei, Z. (1990). Conceptualizing motivation in foreign language learning. Language Learning, 40, 45-78.Dörnyei, Z. (1994). Motivation and motivating in the foreign language classroom. Modern Language Journal,78, 273-284.Dörnyei, Z. (1998). Motivation in second and foreign language learning. Language Teaching, 31, 117-135.Dörnyei, Z. (2001). Motivational strategies in the language classroom. Cambridge, UK: Cambridge University Press.Dörnyei, Z. (2001). Teaching and researching motivation. Harlow, UK: Longman.Dörnyei, Z. (2002). The motivational basis of language learning tasks. In P. Robinson (Ed.), Individual differences and instructed language learning (pp. 137-158). Philadelphia, PA: John Benjamins.Dörnyei, Z. (2003). Attitudes, orientations, and motivations in language learning: Advances in theory, research, and applications. Language Learning, 53(Supplement 1), 3-32.Dörnyei, Z. (2007). Creating a motivating classroom environment. In J. Cummins & C. Davison (Eds.), International Handbook of English Language Teaching (Vol. 2) (pp. 719-731).New York, NY: Springer.Dörnyei, Z. (2008). New ways of motivating foreign language learners: Generating vision. Links, 38(Winter), 3-4.Dörnyei, Z. (2009). The L2 motivational self system. In Z. Dörnyei & E. Ushioda (Eds.), Motivation, language identity and the L2 self (pp. 9-42).Tonawanda, NY: MultilingualMatters.Dörnyei, Z., & Csizér, K. (1998). Ten commandments for motivating language learners: Results of an empirical study. Language Teaching Research, 2, 203-229.Dörnyei, Z., & Csizér, K. (2002). Some dynamics of language attitudes and motivation: Results of a longitudinal nationwide survey. Applied Linguistics, 23, 421-462.Dörnyei, Z., & K. Csizér. (2002). Some dynamics of language attitudes and motivation: Results of a longitudinal nationwide survey. Applied Linguistics, 23, 421–462.Dörnyei, Z., Csizér, K., & Németh, N. (2006). Motivation, language attitudes, and globalization:A Hungarian perspective. Clevedon, UK: Multilingual Matters.Dörnyei, Z., & Ottó, I. (1998). Motivation in action: A process model of L2 motivation. Working Papers in Applied Linguistics, 4, 43-69.Dörnyei, Z., & Schmidt, R. (Eds.). (2001). Motivation and second language acquisition.Honolulu: National Foreign Language Resource Center/ University of Hawai'i Press.Dörnyei, Z., & Skehan, P. (2003). Individual differences in second language learning. In C. J.Doughty & M. H. Long (Eds.), The handbook of second language acquisition (pp. 589-630). Malden, MA: Blackwell.Dweck, C. S. (1986). Motivational processes affecting learning. American Psychologist, 41, 1040-1048.Ehrman, M. (1996). An exploration of adult language learner motivation, self-efficacy, and anxiety. In R. Oxford (Ed.), Language learning motivation: Pathways to the new century (pp. 81-103). Honolulu, HI: University of Hawai’i Press.Gao, Y., Zhao, Y., Cheng, Y., & Zhou, Y. (2004). Motivation types of Chinese university undergraduates. Asian Journal of English Language Teaching, 14, 45-64.Gardner, R. (1985). Social psychology and second language learning: The role of attitude and motivation. London, UK: Edward Arnold.Gardner, R. (2001). Integrative motivation and second language acquisition. In Z. Dörnyei & R.Schmidt (Eds.), Motivation and language acquisition (pp. 1-19). Honolulu, HI:University of Hawai’i Press.Gardner, R. C. (2000). Correlation, causation, motivation, and second language acquisition.Canadian Psychology, 41, 10-24.Gardner, R. C. (2001). Integrative motivation: Past, present and future. Retrieved from ://publish.uwo.ca/~gardner/docs/GardnerPublicLecture1.pdfGardner, R. (2001). Integrative motivation and second language acquisition. In Z. Dörnyei & R.Schmidt (Eds.), Motivation and language acquisition (pp. 1-19). Honolulu: University of Hawai’i Press.Gardner, R. C. (2005). Integrative motivation and second language acquisition. Retrieved from ://publish.uwo.ca/~gardner/docs/caaltalk5final.pdfGardner, R. C. (2009). Gardner and Lambert (1959): Fifty years and counting. Retrieved from ://publish.uwo.ca/~gardner/docs/CAALOttawa2009talkc.pdfGardner, R. C., & Lambert, W. E. (1959). Motivational variables in second language acquisition.Canadian Journal of Psychology, 13, 266-272.Gardner, R. C., & Lambert, W. E. (1972). Attitudes and motivation in second language learning. Rowley, MA: Newbury House.Gardner, R. C., Masgoret, A.-M., Tennant, J., & Mihic, L. (2004). Integrative motivation: Changes during a year-long intermediate-level language course. Language Learning, 54, 1-34.Gardner, R. C., & Smythe, P. C. (1981). On the development of the attitude/ motivation test battery. The Canadian Modern Language Review, 37, 510-525.Gardner, R. C., & Tremblay, P. F. (1994). On motivation, research agendas, and theoretical frameworks. The Modern Language Journal, 78, 359-368.Grabe, W. (2009). Motivation and reading. In W. Grabe (Ed.), Reading in a second language: Moving from theory to practice (pp. 175-193). New York, NY: Cambridge UniversityPress.Graham, S. (1994). Classroom motivation from an attitudinal perspective. In H. F. J. O'Neil and M. Drillings (Eds.), Motivation: Theory and research (pp. 31-48). Hillsdale, NJ:Lawrence Erlbaum.Guilloteaux, M. J., & Dörnyei, Z. (2008). Motivating language learners: A classroom-oriented investigation of the effects of motivational strategies on student motivation. TESOLQuarterly, 42, 55-77.Hadfield, J. (2013). A second self: Translating motivation theory into practice. In T. Pattison (Ed.), IATEFL 2012: Glasgow Conference Selections (pp. 44-47). Canterbury, UK:IATEFL.Hao, M., Liu, M., & Hao, R. (2004). An empirical study on anxiety and motivation in English asa Foreign Language. Asian Journal of English Language Teaching, 14, 89-104.Hara, C., & Sarver, W. T. (2010). Magic in ESL: An observation of student motivation in an ESL class. In G. Park, H. P. Widodo, & A. Cirocki (Eds.), Observation of teaching:Bridging theory and practice through research on teaching (pp. 141-153). Munich,Germany: LINCOM EUROPA.Hashimoto, Y. (2002). Motivation and willingness to communicate as predictors of reported L2 use: The Japanese ESL context. Retrieved from :///sls/uhwpesl/20(2)/Hashimoto.pdf.Hawkins, J. N. (1994). Issues of motivation in Asian education. In H. F. O’Neill & M. Drillings (Eds.), Motivation—theory and research (pp. 101-115). Hillsdale, NJ: Erlbaum. Hsieh, P. (2008). Why are college foreign language students' self-efficacy, attitude, and motivation so different? International Education, 38(1), 76-94.Huang, S. (2010). Convergent vs. divergent assessment: Impact on college EFL students’ motivation and self-regulated learning strategies. Language Testing, 28(2), 251-270.Keller, J. M. (1983). Motivational design of instruction. In C. M. Reigeluth (Ed.), Instructional design theories and models (pp. 386-433). Hillsdale, NJ: Erlbaum.Kim, S. (2009). Questioning the stability of foreign language classroom anxiety and motivation across different classroom contexts. Foreign Language Annals, 42(1), 138-157. Komiyama, R. (2009). CAR: A means for motivating students to read. English Teaching Forum, 47(3), 32-37.Kondo-Brown, K. (2001). Bilingual heritage students’ language contact and motivation. In Z.Dörnyei & R. Schmidt (Eds.), Motivation and language acquisition (pp. 433-460).Honolulu, HI: University of Hawai’i Press.Koromilas, K. (2011). Obligation and motivation. Cambridge ESOL Research Notes, 44, 12-20.Lamb, M. (2004). Integrative motivation in a globalizing world. System, 32, 3-19.Lamb, T. (2009). Controlling learning: Learners’ voices and relationships between motivation and learner autonomy. In R. Pemberton, S. Toogood, & A. Barfield (Eds.), Maintaining control: Autonomy and language learning (pp. 67-86). Hong Kong: Hong KongUniversity Press.Lau, K.-l., & Chan, D. W. (2003). Reading strategy use and motivation among Chinese good and poor readers in Hong Kong. Journal of Research in Reading, 26, 177-190.Lepper, M. R. (1983). Extrinsic reward and intrinsic motivation: implications for the classroom.In J. M. Levine & M. C. Wang (eds.), Teacher and student perceptions: implications for learning (pp. 281-317). Hillsdale, NJ; Erlbaum.Li, J. (2009). Motivational force and imagined community in ‘Crazy English.’ In J. Lo Bianco, J.Orton, & Y. Gao (Eds.), China and English: Globalisation and the dilemmas of identity(pp. 211-223). Clevedon, UK: Multilingual Matters.Lopez., F. (2010).Identity and motivation among Hispanic ELLs. Education Policy Analysis Archives, 18(16), 1-29.MacIntyre, P. D. (2002). Motivation, anxiety and emotion in second language acquisition. In P.Robinson (Ed.), Individual differences and instructed language learning (pp. 45-68).Amsterdam, The Netherlands: John Benjamins.MacIntyre, P. D., MacMaster, K., & Baker, S. C. (2001). The convergence of multiple models of motivation for second language learning: Gardner, Pintrich, Kuhl, and McCroskey. In Z.Dörnyei & R. Schmidt (Eds.), Motivation and language acquisition (pp. 461-492).Honolulu, HI: University of Hawai’i Press.Maehr, M. L. & Archer, J. (1987). Motivation and school achievement. In L. G. Katz (ed.), Current topics in early childhood education (pp. 85-107). Norwood, NJ: Ablex.Manderlink, G., & Harackiewicz, J. M. 1984. Proximal versus distal goal setting and intrinsic motivation. Journal of Personality and Social Psychology, 47, 918-928.Markus, H. R., & Kitayama, S. (1991). Culture and self: Implications for cognition, emotion, and motivation. Psychological Review, 98(2), 224-253.Maslow, A. H. (1970). Motivation and personality. New York, NY: Harper & Row.McCombs, B. L. (1984). Processes and skills underlying continued motivation to learn.Educational Psychologist, 19(4), 199-218.McCombs, B. L. (1988). Motivational skills training: combining metacognitive, cognitive, and affective learning strategies. In C. E. Weinstein, E. T. Goetz & P. A. Alexander (Eds.),Learning and study strategies (pp.141-169). New York: Academic Press.McCombs, B. L. (1994). Strategies for assessing and enhancing motivation: keys to promoting self-regulated learning and performance. In H. F. O’Neill & M. Drillings (Eds.),Motivation: theory and research (pp. 49-69). Hillsdale, NJ: Erlbaum.McCombs, B. L., & Whisler, J. S. (1997). The learner-centered classroom and school: Strategies for increasing student motivation and achievement. San Francisco. CA:Jossey-Bass.McCrossan, L. (2011). Progress, motivation and high-level learners. Cambridge ESOL Research Notes, 44, 6-12.Melvin, B. S., & Stout, D. S. (1987). Motivating language learners through authentic materials.In W. Rivers (Ed.), Interactive language teaching (pp. 44–56). New York, NY:Cambridge University Press.Midraj, S., Midraj, J., O’Neil, G., Sellami, A., & El-Temtamy, O. (2007). UAE grade 12 students’ motivation & language learning. In S. Midraj, A. Jendli, & A. Sellami (Eds.), Research in ELT contexts (pp. 47-62). Dubai: TESOL Arabia.Molden, D. C., & Dweck, C. S. (2000). Meaning and motivation. In C. Sansone & J.Harackiewicz (Eds.), Intrinsic and extrinsic motivation: The search for optimalmotivation and performance (pp. 131-159). San Diego, CA: Academic Press.Mori, S. (2002). Redefining motivation to read in a foreign language. Reading in a Foreign Language, 14, 91-110.Noels, K. A., Clément, R., & Pelletier, L. G. (1999). Perceptions of teachers’ communicative style and students’ intrinsic and extrinsic motivation.Modern Language Journal,83, 23-34.Noels, K. A., Pelletier, L. G., Clément, R., & Vallerand, R. J. (2000). Why are you learning a second language?: Motivational orientations and self-determination theory. LanguageLearning, 50, 57-85.Oxford, R. L. (Ed.). (1996). Language learning motivation: pathways to the new century.Hono lulu: Second Language Teaching & Curriculum Center, University of Hawai’i.Oxford, R., & Shearin, J. (1994). Language learning motivation: Expanding the theoretical framework. Modern Language Journal, 78, 12-28.Papadimitriou, A. D. (2011). The impact of an extensive reading programme on vocabulary development and motivation. Cambridge ESOL Research Notes, 44, 39-47.Paris, S. C., & Turner, J. C. (1994). Situated motivation. In P. R. Pintrich, D. R. Brown, & C. E.Weinstein (Eds.), Student motivation, cognition, and learning (pp. 213-237). Hillsdale,NJ: Erlbaum.Peacock, M. (1997). The effect of authentic materials on the motivation of EFL learners. ELT Journal, 51(2), 144-156.Pedraza, P., & Ayala, J. (1996). Motivation as an emergent issue in an after-school program in El Barrio. In L. Schauble & R. Glaser (Eds.), Innovations in learning (pp. 75-91). Mahwah, NJ: Erlbaum.Pintrich, P. R. (1999). The role of motivation in promoting and sustaining self-regulated learning.International Journal of Educational Research, 31(6), 459-470.Pintrich, P. R., & De Groot, E. V. (1990). Motivational and self-regulated learning components of classroom academic performance. Journal of educational psychology, 82(1), 33.Pintrich, P. R., & Schunk, D. H. (1996). Motivation in education: Theory, research and applications. Englewood Cliffs: NJ: Prentice-Hall.Ramage, K. (1991). Motivational factors and persistence in second language learning. Language Learning, 40(2), 189-219.Rueda, R., & Moll, L. (1994). A sociocultural perspective on motivation. In H. F. O’Neill & M.Drillings (Eds.), Motivation: theory and research (pp. 117-137). Hillsdale, NJ: Erlbaum.Ryan, R. M., & Deci, E. L. (2000). Intrinsic and extrinsic motivations: Classic definitions and new directions. Contemporary Educational Psychology,25, 54-67.Ryan, R. M., & Deci, E. L. (2000). Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. American Psychologist, 55, 68-78. Schmidt, R., Boraie, D., & Kassabgy, O. (1996). Foreign language motivation: Internal structure and external connections. In R. Oxford (Ed.), Language learning motivation:Pathways to the new century (pp. 9-70). Honolulu: Second Language Teaching &Curriculum Center, University of Hawaii Press.Schutz, P. A. (1994). Goals as the transaction point between motivation and cognition. In P. R.Pintrich, D. R. Brown, & C. E. Weinstein (Eds.), Student motivation, cognition, andlearning (pp. 135-156). Hillsdale, NJ: Erlbaum.Scott, K. (2006). Gender differences in motivation to learn French. The Canadian Modern Language Review, 62, 401-422.Syed, Z. (2001). Notions of self in foreign language learning: A qualitative analysis. In Z.Dörnyei & R. Schmidt (Eds.), Motivation and second language acquisition (pp. 127-147).Honolulu, HI: University of Hawaii Press.Schmidt, R., Boraie, D., & Kassabgy, O. (1996). Foreign language motivation: Internal structure and external connections. In R. 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Schmidt, (Eds.), Motivation and second language acquisition (pp. 127-148).Honolulu: National Foreign Language Resource Center/ University of Hawai'iPress.Ushioda, E. (2003). Motivation as a socially mediated process. In D. Little, J. Ridley, & E.Ushioda (Eds.), Learner autonomy in the language classroom (pp. 90-102). Dublin,Ireland: Authentik.Ushioda, E. (2008). Motivation and good language learners. In C. Griffiths (Ed.), Lessons from good language learners (pp. 19-34). Cambridge, UK: Cambridge University Press. Ushioda, E. (2009). A person-in-context relational view of emergent motivation, self and identity.In Z. Dörnyei & E. Ushioda (Eds.), Motivation, language identity and the L2 self (pp.215-228). Tonawanda, NY: Multilingual Matters.Ushioda, E. (2012). Motivation. In A. Burns & J. C. Richards (Eds.), The Cambridge guide to pedagogy and practice in language teahcing (pp. 77-85). Cambridge, UK: CambridgeUniversity Press.Verhoeven, L., & Snow, C. E. (Eds.). (2001). Literacy and motivation: Reading engagement in individuals and groups. Mahwah, NJ: Lawrence Erlbaum.Wachob, P. (2006). Methods and materials for motivation and learner autonomy. Reflections on English Language Teaching, 5(1), 93-122.Walker, C. J., & Quinn, J. W. (1996). Fostering instructional vitality and motivation. In R. J.Menges and associates, Teaching on solid ground (pp. 315-336). San Francisco, SF:Jossey-Bass.Warden, C. A., & Lin, H. J. (2000). Existence of integrative motivation in an Asian EFL setting.Foreign Language Annals, 33, 535-547.Weiner, B. (1984). Principles for a theory of student motivation and their application within an attributional framework. In R. Ames & C. Ames (Eds.), Research on motivation ineducation (pp. 15-38). New York: Academic Press.Weiner, B. (1992). Human motivation: Metaphors, theories and research. Newbury Park, CA: Sage.Weiner, B. (1994). Integrating social and personal theories of achievement motivation. 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制药工程专业英语--5单元

P54-专业英语作业1. Drug Development is a very complex process requiring a great deal of coordination and communication between a wide range of different functional groups.中文翻译:药物开发是一个十分复杂的过程，需要在广泛的不同功能性团队之间进行大量的协调与沟通。

2. It is expensive, particularly in the later phases of clinical development, where studies involve hundreds of patients这个过程（药物开发）这是昂贵的，特别是在临床开发的后期阶段，其中涉及到对数百名患者的研究。

3. It is currently estimated that the development of a new drug costs about $230 million and takes somewhere between7and10years form initiation of preclinical development to first marketing.目前估计,一种新药的开发成本约为2.3亿美元,并且从启动临床前的开发阶段到首次上市，需要花费7到10年4. Drug development is a high-risk business; although the rate is increasing, only about one out of every ten new chemical entities studied in human beings for the first time will ever become a product.药物开发是一个高风险的业务，尽管比率在不断上升，但是在完成了首次在人体研究中的每十个新化学实体中，大约只有一个能成为产品。

06应用WHO骨折风险因子评估工具_FRAX_诊断骨质疏松症的进展

自从 1994 年 ,WHO 推出 BMD 小于 - 215 SD 作为诊断骨质疏松症的时候 ,国内医疗机构开始大量装备骨密度仪 ,也采用这个诊断标准来诊断患者是否患有骨质疏松症 ,甚至很多区县医院也开始计划装备骨密度仪。就在国内眼光关注于单纯应用 BMD 结果来评估患者未来骨折可能的时候 ,国际上已经开始使用 BMD 联合一个或多个骨折风险因子 (clinical risk factors (CRFs) ) 来共同诊断和评估患者骨质疏松症的轻重。在 2002 年 ,这个方法作为主流认识[1] ,应用于很多西方国家的相关医疗机构中 ,甚至用来评估绝经后妇女绝对骨折风险程度[2] 。国内很多大的医疗机构也逐渐认识到这种评估方法比较适合于临床工作 ,对骨质疏松的患者筛选和治疗更
Japan. [6 ,7] ) 。该工具可以自动计算出患者 10 年内髋
美国的 B. Dawson2Hughes 教授[9] 在 2008 年也使
部骨质疏松性骨折的可能性 , (这个工具甚至还可以用了这个评估工具 ,对在美国的四个人种 (白人、亚
计算出脊柱、髋部、前臂和肱骨近端这些主要骨折的洲人、黑人和西班牙人) 进行大样本测试和随访。其
10 年内发生可能性) ,因此其可以用来评估出哪些得出的结果是对于白人妇女 ,患者的 10 年骨折可能
患者真正需要进行骨密度测量和进行骨质疏松干预性超过 3 %时 ,对所有年龄段的患者进行干预治疗
治疗。英国的 Kanis 教授是这个工具的主要推广者是值得的。这是因为在其研究中发现 ,白人随年龄
中 ,Kanis 教授发现在患者的 10 年骨折可能性超过 7 %时骨折风险因子评估工具发展到现在不止一种 ,

心愿科学家发明新药治疗癌症作文

心愿科学家发明新药治疗癌症作文英文回答：As a budding scientist, my heart yearns to revolutionize the medical world by pioneering a groundbreaking cure for cancer. This insidious disease has cast a dark shadow over countless lives, leaving an unfathomable void in families and communities across the globe. Fueled by an unyielding determination to alleviate human suffering, I embark on a scientific odyssey to unravel the enigmatic mechanisms of this formidable foe.Through meticulous research, I delved into theintricate complexities of cancer biology, deciphering its molecular intricacies and unraveling its Achilles' heels. This profound understanding served as the cornerstone for my unwavering belief that a cure is not merely a distant dream but a tangible reality within our grasp.Armed with knowledge and an unwavering resolve, Iembarked on a collaborative journey with fellow scientists, pooling our collective wisdom and expertise. We toiled tirelessly in state-of-the-art laboratories, utilizing cutting-edge technology to probe the depths of cancer's genetic code. Through countless experiments and countless hours of dedicated analysis, we isolated a promising compound that exhibited remarkable efficacy against a broad spectrum of cancer cells.The preclinical trials yielded astounding results, surpassing our wildest expectations. The compound not only eradicated cancer cells with unparalleled precision but also demonstrated minimal side effects, a testament to its safety and tolerability. Emboldened by these promising findings, we embarked on clinical trials, where hope flickered in the hearts of countless cancer patients and their loved ones.The initial clinical trials proved to be a resounding success, as the compound effectively shrank tumors, prolonged survival, and restored quality of life topatients who had previously been given a grim prognosis.The results sent shockwaves throughout the medical community, reigniting belief in the possibility of conquering this formidable disease.As the clinical trials progressed, the compound continued to demonstrate remarkable efficacy across a wide range of cancer types, offering hope to patients with even the most aggressive and treatment-resistant forms of the disease. The once-dreaded diagnosis of cancer was transformed into a manageable condition, offering patients a renewed sense of purpose and an extended horizon of life.The successful development and clinical validation of this groundbreaking cure marked a watershed moment in the annals of medical history. Cancer, once a relentless adversary, was finally brought to its knees. The scourge that had plagued humanity for centuries was vanquished, leaving behind a legacy of hope, triumph, and countless lives restored.In the wake of this scientific breakthrough, I felt an overwhelming sense of gratitude and humility. Therealization that my unwavering determination and the dedication of my fellow scientists had led to a cure for cancer filled me with an indescribable sense of fulfillment. The countless lives that would be saved and the immeasurable suffering that would be prevented served as a constant reminder of the profound impact that science can have on the human condition.As I reflect on this extraordinary journey, I am filled with an unwavering belief that the pursuit of scientific discovery holds the key to unlocking countless mysteriesand solving some of the most pressing challenges facing humanity. Through relentless dedication, collaboration, and an unwavering faith in the power of human ingenuity, we can continue to push the boundaries of medical knowledge and create a world where disease is a thing of the past.中文回答：作为一名年轻的科学家，我最大的心愿就是开创性地研制出一种治疗癌症的新药，从而彻底改变世界医学格局。

杨百寅简历---清华大学经济管理学院-CRM-系统

杨百寅通讯地址：清华大学经济管理学院人力资源与组织行为系中国北京清华园 100084电话：86-10-62796314传真：86-10-62772021电子信箱：1990－1992：（加拿大）萨斯卡彻温大学继续教育专业硕士1992－1996：（美国）佐治亚大学人力资源开发专业博士工程师（管理）1996-1998：（美国）奥本大学助理教授1998-2001：（美国）爱达荷大学助理教授、（终身）副教授2001-2006：（美国）明尼苏达大学助理教授、（终身）副教授、（终身）教授2006-至今：清华大学经济管理学院系主任教授•2010年：美国管理学会年会，最佳论文提名奖【Academy of Management, Carolyn Dexter Award Nominee】•2010年：中国管理学会，年会优秀论文《如何提高战略决策效果？TMT社会资本与冲突的作用》•2009年：长江学者奖励计划, 教育部长江学者特聘教授。

•2009年：中国管理学会，年会优秀论文《家长式领导，冲突与决策效果》•2008年：杰出人力资源开发学者奖，国际人力资源开发学会【Outstanding HRD Scholar Award, Academy of Human Resource Development (AHRD), 2008】。

•2007年：国家杰出青年科学基金获得者。

•2007年：友好全球人力资源最佳教授奖，(印度)友好大学【Amity Best Global HR Faculty Award, Amity University, India】。

•2004年：2003年度最佳论文奖，人力资源开发评论【Outstanding Article for 2003, Human Resource Development Review, 2004】。

•2000年：早期职业奖，美国成人教育教授协会【Early Career Award, Commission of Professors of Adult Education (CPAE), 2000】。

功能失调性态度问卷

功能失调性态度问卷（DAS）的记分方法DAS记分方法以及因子结构DAS 可归纳为八个因子结构, 分别为: 脆弱性(D1)3. 8. 15. 17.18 、吸引和排斥(D2)16. 31.32. 39. 40 、完美化(D3 )1. 11. 14. 20 .23. 、强制性(D4 )5. 13. 25. 30. 36. 、寻求赞许(D5 )19.27. 33. 34. 35. 、依赖性(D6 ) 7. 24. 26. 28. 38.、自主性态度(D7 ) 4. 9. 10. 21. 22.、认知哲学(D8) 2. 6. 12. 29. 37 。

正常人群中获得的DAS 均数( ≤ 130 分)作为标准采用反向记分的条目有2.6.12.18.24.29.30.35.37.40 共10个条目分数越高,认知障碍越严重。

药物治疗后患者DAS 的评分虽较治疗前有所降低,但仍较正常人高,故提示功能失调性状况是特征性表现。

功能失调性状况评定量表( DAS)在抑郁症中的初步应用中国神经精神疾病杂志1998 年第24 卷第5 期290-292陈远岭功能失调性状况评定量表信度和效度初步研究中国心理卫生杂志1998 年第12 卷第5 期265-2671)信度检验：DA S 各条目分与总分的一致性:以被试的全量表得分为效标, 求出了被试在各条目组的得分与全量表得分的Pearson 相关。

其相关系数高(P 均< 0.01, 见表1)。

其中有10 个条目分与总分呈负相关, 与DA S 量表40条项目中有10 条为反向记分项目相符(见表1)。

1:分半信度: 使用奇偶分半法,将DA S 条目组分为二半, 一半含20 个条目组, 分别求出每一被试在两半条目组上的得分和, 然后计算Pearson 相关。

结果表明, 分半相关系数rn=01731。

用Spearman-B row n 公式[6 ]校正, 得DA S 全量表分半信度指标r= 01835。

Development and Validation of a Liquid Chromatogra

J. Chem. Chem. Eng. 5 (2011) 1-6.Development and Validation of a LiquidChromatography–Tandem Mass Spectrometry Method for Determination of Artemisinin in Rat PlasmaElhassan Gamal1,2, Yuen Kah1, Wong Jiawoei1, Chitneni Mallikarjun1,3, Al-Dahli Samer1, Khan Jiyauddin1 and Javed Qureshi31. School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden 11800, Penang, Malaysia2. Local Pharmaceutical Manufacturing Department, General Pharmacy Directorate, MOH, 11111, Khartoum-Sudan3. School of Pharmacy and Health Sciences, International Medical University, 5700, Kula Lumpur, MalaysiaReceived: September 03, 2010 / Accepted: October 11, 2010 / Published: January 10, 2011.Abstract: Artemisinin is a potent anti-malarial drug isolated from traditional Chinese medicinal herb, Artemisia annua. The objective of this study was to develop and validate a sensitive and specific LC-MS/MS method for the determination of artemisinin in rat plasma using amlodipine as Internal Standard. The method consist of a simple liquid-liquid extraction with methyl tertiary butyl ether (MTBE) with subsequent evaporation of the supernatant to dryness followed by the analysis of the reconstituted sample by LC-MS/MS with a Z-spray atmospheric pressure ionization (API) interface in the positive ion-multiple reaction monitoring mode to monitor precursor→product ions of m/z 282.70→m/z 209.0 for artemisinin and m/z 408.9→m/z 237.0 for amlodipine respectively. The method was linear (0.999) over the concentration range of 7.8–2000 ng/mL in rat plasma. The intra and inter-day accuracy were measured to be within 94-104.2% and precision (CV) were all less than 5%. The extraction recovery means for internal standard and all the artemisinin concentrations used were between 82-85%.Key words: Artemisinin, LC-MS/MS, amlodipine, plasma, accuracy and precision.1. IntroductionArtemsinin is the name given to the active principle of qinghaosu, an extract of the Chinese medicinal plant qinghaosu or green Artemisia (Artemisinin annua L.) which has been used for many years centuries in Chinese traditional medicine for treatment of fever and malaria [1]. In 1972, Chinese researchers isolated artemisinin from Artemisia annua L. sweet wormwood) and its structure was elucidate in 1979 as show in Fig. 1.The determination of artemisinin and its derivatives in biological matrices have previously been characterized using several analytical techniques suchCorresponding author: Gamal Osman Elhassan Ph.D., research field: pharmaceutical technology. E-mail: ******************.as LC, HPLC, GC-MS etc [3-8]. However, some of these methods suffer from few drawbacks. In particulars, interference with endogenous constituents in the plasma at the absorption wave length of the derivatized compounds may render these techniques unsatisfactory and few of them lacked the required sensitivity to be used for measurement of drugFig. 1 The chemical structure of artemisinin [2].ll Rights Reserved.Development and Validation of a Liquid Chromatography–Tandem Mass Spectrometry Method forDetermination of Artemisinin in Rat Plasma2concentration in blood sample obtained from clinical investigation [9].To increase the specificity and sensitivity of HPLC-UV method, some workers combined it with a mass spectrometry (MS) and the total system is described as LC-MS technique [10, 11]. The development of LC-tandem mass spectrometry (LC-MS/MS) has made a more specific and sensitive analysis of artemisinin and its derivatives possible [12, 13]. The objective of this study was to develop a sensitive and specific LC-MS/MS method for the determination of artemisinin in rat plasma by simple liquid-liquid extraction procedure.2. Materials and Methods2.1 MaterialsArtemisinin was purchased from Kunming Pharmaceutical Corporation (Kunming, China). Amlodipine was obtained from Sigma Chemical (Louis, USA). Acetonitrile (ACN), formic acid and methyl tertiary butyl ether (MTBE) were purchased from J.T Baker (USA).3. Methods3.1 Instrumentation and ConditionsThe instrumentation comprised of Quattro-micro tandem mass spectrometer with Z-spray atomospheric pressure ionization (API) source (Micromass, Manchester, UK) using electrospray ionization (ESI) operated at positive mode. Chromatography was performed on an Alliance 2,695 separation module (Waters, M.A, USA). The delivery system consisted of an autosampler and a column heater. The chromatographic separation was obtained using an X Terra MS C8 encapped (5 μm) (150 × 2.1 mm) analytical column (Water, USA).3.2 Sample PreparationA 250 μL aliquot of plasma was pipetted into a screw-capped culture tube, followed by 100 μL of internal standard solution (50 ng/mL). To each tube, 5 mL (MTBE) extraction solvent was then added and the mixture was vortexed for 2.5 minutes followed by centrifuging for 15 minutes at 3,500 rpm. The upper layer was transferred to a reactive vial and dried under nitrogen flow at 40 °C. The residue was then reconstituted with 250 μL of mobile phase and 20 μL was injected into the LC-MS/MS system.3.3 Assay ValidationCalibration curve at a concentration range of 7.8–2,000 ng/mL were constructed by spiking blank human plasma with a known amount of artemisinin. Plasma sample spiked with artemisinin at these concentrations 7.8, 62.5, 250, 2,000 ng/mL were used to determine the within and between-day accuracy and precision. For within-day accuracy and precision, replicates analysis (n = 6) for each concentration were performed in a single day. For between-day evaluation, analysis was carried out with a single sample of each concentration daily over 6 days, with calibration curve constructed on each day of analysis. The extraction recovery of artemisinin was estimated by comparing the peak height obtained after extraction of the samples from plasma with that of aqueous artemisinin solution of the corresponding concentration.4. Results and DiscussionBoth electrospray (TIS) and atmospheric pressure chemical ionisation (APCI) methods have been reported previously for the quantification of artemisinin derivatives in biological fluids [11, 12, 14-16]. According to the previously reported methods TIS was found to be superior to APCI for the quantification of artesunate and dihydroartemisinin (DHA) mainly because of improved linearity [16]. Therefore in this method electrospray ionization was used. When artemisinin and amlodipine were injected directly into the mass spectrometer along with mobile phase in the positive mode, the protonated molecules of artemisinin and amlodipine were set as precursorll Rights Reserved.Development and Validation of a Liquid Chromatography–Tandem Mass Spectrometry Method forDetermination of Artemisinin in Rat Plasma3(a)(b)Fig. 2 (a) Positive-ionization electrospray mass spectra of precursor ion for artemisinin; (b) Positive-ionization electrospray mass spectra of product ion for artemisinin.ions with m/z of 282.7 and 408.7, respectively. The product ion that gave the highest intensity was m/z of 209.0 for artemisinin and 237.7 for amlodipine. Fig 2(a) shows the spectra precursor ion, 2(b) production for artemisinin.Artemisinin and amlodipine have retention time of approximately 6.9 and 1.65 minutes, respectively (Fig.3). The peak was well resolved and free from interference from endogenous compounds in rat plasma (Fig. 4).ll Rights Reserved.Development and Validation of a Liquid Chromatography–Tandem Mass Spectrometry Method forDetermination of Artemisinin in Rat Plasma4Fig. 3 Plasma spiked with 500 ng/ml artemisinin and amlodipine 50 ng/mL.Fig. 4 Chromatograms for analysis of artemisinin in plasma (Rat blank plasma).Calibration curve was linear over the entire range of calibration curves with a mean correlation coefficient greater than 0.9995 (Fig. 5).The limit of quantification (LOQ) of the assay method was 7.8 ng/mL being the lowest concentration used to construct the calibration curve whereas the limit of detection (LOD) was 3.9 ng/mL at a signal to noise ratio of 3. The validation data demonstrated a good precision, accuracy and recovery. The extraction recovery means for internal standard and all artemisinin concentrations used were 75-85% (Table 1). The within-day and between-day accuracy and precision values are given in Table 2.Neither artemisinin nor the internal standard producedll Rights Reserved.Development and Validation of a Liquid Chromatography–Tandem Mass Spectrometry Method forDetermination of Artemisinin in Rat Plasma5Fig. 5 Mean calibration curve of artemisinin (ng/mL).Table 1 Extraction recovery.Concentration (ng/mL) Mean recovery (%) CV (%)7.81 75.081.5062.50 82.161.94250.00 82.03 2.072000.00 85.23 1.48Table 2 Within-day and between-day precision andaccuracy.Added (ng/mL)Within-day Between-day Accuracy (%) C.V (%) Accuracy (%) C.V (%)7.81 96.00 4.60 104.11 2.30 62.50 98.10 1.60 94.10 2.20 250.00 98.10 1.50 98.10 1.60 2000.00 96.10 2.50 97.10 1.80any detectable carry-over after three injections of upper limit of quantification. Blank rat plasma showed no interference with artemisinin. Interfering signals from blank plasma contributed less than 20% of the artemisinin signal at LOQ. There was no interference of artemisinin on the internal standard or vice versa. A small enhancement for artemisinin and the internal standard could be detected when references in neat injection solvent were compared with references in extracted blank biological matrix. The normalized matrix effects (artemisinin/internal standard) were close to 1 with a low variation in accordance with international guidelines. Post-column infusion experiments confirmed the absence of regions with severe matrix effects (i.e., no sharp drops or increases in the response) for blank human plasma extracted with the developed method.Xing et al. used artmether as an internal standard for the analysis of artemisinin [17]while for the analysis of artemisinin derivatives; artemisinin was used as internal standard [14]. In the present study amlodipine was found to be suitable because it could be separated chromatographically, ionized and fragmented under the conditions that optimized the intensity of artemisinin peak (Fig. 3).The analysis of artemisinin and its derivatives with mass spectrometry are most often performed with a different mode of ionization. Xing et al. used ESI inletin the positive ion-multiple reaction monitoring mode which relatively producing a higher sensitivity than in the SIM mode. Therefore, the mass spectrometry was operated at positive ion-MRM mode.4. ConclusionThe LC-MS/MS method described in this work is suitable for the determination of artemisinin in plasma. The assay procedure is simple with a relatively shortll Rights Reserved.Development and Validation of a Liquid Chromatography–Tandem Mass Spectrometry Method forDetermination of Artemisinin in Rat Plasma6retention time allowing sufficient sample to beprocessed to be applied to pharmacokinetic and bioavailability studies of artemisinin. The accuracy and precision of the assay method, as well as the recovery of extraction procedure were found to be satisfactory.References[1] D.L. Klayman, Qinghasou (Artemisinin): An antimalaria drug from China, Science 228 (1985) 1049-1055.[2] X.D. Luo, C.C. Shen, The chemistry, pharmacology andclinical applications of Qinghaosu (artemisinin) and it’sderivatives, Med. Res. Rev. 7 (1987) 29-52.[3] K.T. Batty, M. Ashton, K.F. Llett, G . Edwards, T.M. Davis,Selective high-performance liquid chromatography ofartesunate and α-and β-dihydroartemisinin in patients withfalciparum malaria, J. Chromatog. B 677 (2-3) (1996)345-350.[4] J. Karbwang, K. Na-Bangchang, P. Molunto, V . Banmairuroi, Determination of artemisinin and its majormetabolite, dihydroartemisinin, in plasma usinghigh-performance liquid chromatography withelectrochemical detector, J. Chromatog. B 7 (1-2) (1997)259-265.[5] K.L. Chan, K.H. Yuen, H. Takayanki, S. Jinandasa, K.K. Peh, Polymorphism of artemisinin from Artemisia annua,Phytochemistry 46 (7) (1997) 1209-1214.[6] G .Q. Li, T.O. Peggins, L.L. Fleckenstein, K. Masonic,M.H. Heiffles, T.G . Brewer, The pharmacokinetics andbiovailability of dihydroartemisinin, arteether, artemether,artesunic acid and artelinic acid in rats, J. Pharm.Pharmacol 5 (1998) 173-182.[7] B.A. Avery, K.K. Venkatesh, M.A. Avery, Rapid determination of artemisinin and related analogues usinghigh-perfomance liquid chromatography and anevaporative light scattering detector, J. Chromat. B 730 (1)(1999) 71-80.[8] S.S. Mohamed, S.A. Khalid, S.A. Ward, T.S.M. Wan,H.P.O. Tang, M. Zheng, R.K. Haynes, G . Edwards,Simultaneous determination of artemether and its majormetabolite dihydroartemisinin in plasma by gaschromatography-mass spectrometry-selected ionmonitoring, J. Chromat. B 731(1999) 251-260.[9] K.T. Batty, M. Ashton, K.F. Llett, G . Edward, T.M. Davis,The pharmacokinetics of artemisinin (ART) and artesunate (ARTS) in healthy volunteers, Am J. Trop Med. Hyg. 58(2) (1998) 125-126.[10] C. Souppart, N. Gouducheau, N. Sandenan, F. Richard,Development and validation of a high-performance liquid chromatography-mass spectrometry assay for the determination of artemisinin and its metabolite dihydraartemisinin in human plasma, J. Chromat. B 774(2002) 195-203.[11] H. Naik, D.J. Murry, L.E. Kirsch, L. Fleckenstein,Development and validation of high-performance liquid chromatography-mass spectroscopy assay for determination of artesunate and dihydrroartemisinin in human plasma, J. Chromat. B 816 (1-2) (2005) 233-242. [12] J. Xing, H. Yan, S. Zhang, G . Ren, Y . Gao, A high-performance liquid chromatography/tandem mass spectrometry method for the determination of artemisinin in rat plasma, Rapid Commun in Mass Spectro. 20 (9) (2006) 1463-1468. [13] J. Xing, H.X. Yan, R.L. Wang, L.F. Zhang, S.Q. Zhang,Liquid chromatography-tandem mass spectrometry assay for the quantitation of β-dihydroartemisinin in rat plasma, J. Chromat. B 852 (1-2) (2007) 202-207. [14] M. Rajanikanth, K.P. Madhusudanan, R.C. Gupta, An HPLC-MS method for simultaneous estimation of alpha, beta-arteether and its metabolite dihydroartemisinin, in rat plasma for application to pharmacokinetic study, J Biomed. Chromat. 17 (7) (2003) 440-446. [15] Y . Gu, Q. Li, M.V . Elendez, P. Weina, Comparison of HPLC with electrochemical detection and LC–MS/for the separation and validation of artesunate and dihydroartemisinin in animal and human plasma, J. Chromatogr B 867 (2008) 213-218. [16] W. Hanpithakpong, B. Kamanikom, A.M. Dondorp, P.Singhasivanon, N.J. White, N.P. Day, N. Lindegardh, A liquid chromatographic-tandem mass spectrometric method for determination of artesunate and its metabolite dihydroartemisinin in human plasma, J. Chromatogr. B 876 (2008) 61-68. [17] Y . Xing, H. Yan, S. Zhang, G . Ren, Y . Gao, A high-performance liquid chromatography/tandem mass spectrometry method for the determination of artemisinin rat plasma, Rapid Communication in Mass Spectrometry 20 (9) (2006) 1463-1468.ll Rights Reserved.。

问题解决外文文献

The Chinese Version of the Social Problem-SolvingInventory:Some Initial Results on Reliabilityand ValidityᮢAndrew M.H.SiuHong Kong Polytechnic UniversityᮢDaniel T.L.ShekThe Chinese University of Hong KongThe development of an instrument that measures social problem solvingof Chinese adolescents is reported.The Social Problem-Solving InventoryRevised(SPSI-R)was translated to Chinese,and content validity,culturalrelevance,and reading level of the translated measure were reviewed bypanels of experts.The Chinese version of the scale(C-SPSI-R)was thenadministered to a sample of352junior secondary-school students.Explor-atory factor analyses revealed a5-factor structure that was largely consis-tent with the structure of the original English-language SPSI-R.The C-SPSI-Rand its subscales were found to be internally consistent and temporallystable over time.The scores of the subscales were also correlated withdepression scores,a correlation that supported the convergent validity ofthe subscales.Adolescents with high and low Chinese Beck DepressionInventory scores had significant differences in four out of five subscales ofthe C-SPSI-R(except Rational Problem-Solving).On the whole,the resultssupported that the C-SPSI-R is a reliable and valid instrument in the assess-ment of social problem solving in Chinese adolescents.©2004WileyPeriodicals,Inc.J Clin Psychol61:347–360,2005.Keywords:social problem-solving;Chinese;validation;measurementThe work described in this paper was financially supported by the Central Research Grant of the Hong Kong Polytechnic University(Project No.G-S838).Correspondence concerning this article should be addressed to:Andrew M.H.Siu,Department of Rehabilita-tion Sciences,Hong Kong Polytechnic University,Hunghom,Hong Kong,P.R.C.;e-mail:rsandsiu@.hk. JOURNAL OF CLINICAL PSYCHOLOGY,Vol.61(3),347–360(2005)©2005Wiley Periodicals,Inc. Published online in Wiley InterScience().DOI:10.1002/jclp.20023348Journal of Clinical Psychology,March2005This study aims to develop a Chinese version of the Social Problem-Solving Inventory Revised(SPSI-R),which is one of the most widely used measures of social problem solving(D’Zurilla,Nezu,&Maydeu-Olivares,1996).This paper reports a validation study in which the content validity,reliability,discriminant validity,and factor structure of the Chinese version of this instrument were examined.The following review has sev-eral objectives.First,the authors of the current study review evidence of the effect of social problem solving on the reduction of life stress and clinical practice.Second,the authors review the theoretical model of social problem st,the authors review the psychometric properties of the SPSI-R.Social problem solving is the cognitive-affective-behavioral process by which peo-ple attempt to resolve problems they experience in real-life social environments(D’Zurilla, Nezu,&Maydeu-Olivares,1996).Real-life problem solving follows a social learning process and requires timely application of social skills.A number of studies have shown that social problem-solving ability itself,or together with social support,can reduce or minimize the impact of life stress on individuals(Dubow&Tisak,1989;Dubow,Tisak, Causey,&Hryshko,1991;D’Zurilla&Sheedy,1991;Goodman,Gravitt,&Kaslow, 1995).Social problem-solving abilities have also been found to moderate the relation between negative life stress and measures of distress,such as hopelessness(Bonner& Rich,1988),anxiety(Nezu,1986b),depressive symptoms(Nezu,1986c),as well as behavioral and academic adjustment(Kang&Lee,1992).Social problem-solving training is commonly used in remedial programs in the school context and in the treatment of a wide variety of psychiatric disorders.Social problem-solving training programs have been used to reduce the stress of urban living among young children(Cowen,Wyman,Work,&Iker,1995),to help children cope with their academic stress(Elias,Gara,Ubriaco,&Rothbaum,1986),and to treat aggression prob-lems in adolescent offenders and conduct-disordered adolescents(Guerra&Slaby,1990; Tisdelle&wrence,1988).Social problem-solving skills training has also been used in the treatment of anxiety disorders(Albano,Marten,Holt,&Heimberg,1995),depres-sion(Nezu,1986a;Nezu,Nezu,&Perri,1989),and suicide ideation(Clum,Yang,Feb-braro,&Canfield,1996;Lerner&Clum,1990;Marx,Williams,&Claridge,1992,1994). One of the most comprehensive models of social problem solving was presented by D’Zurilla(1986)who proposed that the effectiveness of the social problem-solving pro-cess is determined by three components:a general motivational component called prob-lem orientation,a set of rational problem-solving skills,and behavioral styles in problem solving.Problem orientation is a relatively stable cognitive-affective response set that is pri-marily based on past experience with life problems and problem solving and affects an individual’s motivation in problem solving.The cognitive subcomponent of problem ori-entation consists of a set of attributions,appraisals,expectancies,and commitments con-cerning problems and problem solving.This cognitive response set has a major influence on an individual’s sensitivity to problems,and his or her perception of a problem as challenging or threatening.The affective subcomponent of problem orientation is the group of emotions associated with problems and problem solving.Such emotions can be negative(like anxiety,anger,and depression),as well as positive(such as hope and enthusiasm),and can alter the effectiveness and willingness of a person to solve a problem.The rational problem-solving skills consist of four cognitive-skill components that are required in the problem-solving process:(a)problem definition and formulation, (b)goal setting,(c)generation of alternative solutions,and(d)solution implementation and verification.These specific problem-solving skills are essential in the process of creating an effective solution,and problem-solving performance focuses on the outcomeChinese Social Problem-Solving Inventory349 of this process.The final component is the behavioral style of problem solving,which is whether one tends to approach or avoid problem solving and whether one is impulsive or careful in problem solving.The avoidance style and impulsiveness/carelessness style represent two common behavioral tendencies in ineffective problem solving.The Social Problem-Solving Inventory(SPSI)was developed to assess the above-mentioned components of social problem solving.The first version of the SPSI had70items, and its reliability and validity were demonstrated in a series of validation studies using clin-ical and nonclinical samples(D’Zurilla,1986).Based on a detailed evaluation of the factor structure of the SPSI(Maydeu-Olivares&D’Zurilla,1995,1996),the70-item SPSI was revised to the52-item SPSI-R in1996.There are5subscales of the52-item SPSI-R.The first subscale is Positive Problem Orientation(PPO),which assesses a constructive problem-solving set with the following characteristics:general disposition to appraise problems as challenging,an optimism that problems can be solved,a belief in one’s own personal ability to solve problems success-fully,and a willingness to commit oneself to solving problems.The second subscale is Negative Problem Orientation(NPO),which assesses a dysfunctional or inhibitive cognitive-emotional set that involves the general tendency to view problems as signifi-cant threats,pessimism about one’s ability to solve problems,and nearly immediate frus-tration and upset when confronted with problems.The third subscale is Rational Problem Solving(RPS),which assesses the degree of rational,deliberate,systematic,and skilful application of effective problem-solving principles and strategies.The fourth subscale is Impulsivity/Carelessness Style(ICS),which is a deficient problem-solving pattern char-acterized by active problem-solving attempts that are narrow,impulsive,careless,hur-ried,and incomplete.The final subscale is Avoidance style(AS),which assesses another defective problem-solving pattern characterized by procrastination,passivity,inaction,or dependency.For each of the52items,the respondents were requested to choose an answer on a5-point Likert scale ranging from“Not at all true of me”to“Extremely true of me.”Half of the test items indicate a constructive orientation toward problem solving,while the other half indicate a dysfunctional or inhibitive orientation.The items are presented in a random order.D’Zurilla et al.(1996)conducted a series of validation studies on the SPSI-R,which demonstrated that it is a reliable and valid assessment instrument for research and clinical purposes.In four samples of different age groups,the SPSI-R consistently demonstrated high internal consistency(rϭ.69to.95),and adequate to high test–retest reliability(rϭ.68to .91).A study of the concurrent validity showed that the subscales of the SPSI-R had mod-erate to high correlation with the Problem-Solving Inventory(PSI)—a measure of an individual’s appraisal of his or her own problem-solving attitude and behavior(Heppner& Peterson,1982).Several studies have also provided evidence on the convergent validity of the English and Spanish versions of the SPSI-R(Al-Abdulla,1996;Calero,Luna-Serano, Vera-Villarroell,&Gonzalez-Trujillo,2001;D’Zurilla&Chang,1995;D’Zurilla&Maydeu-Olivares,1995).On the whole,these studies showed that four of the five SPSI-R subscales (except RPS)were significantly related to measures of distress(including stress,somatic symptoms,anxiety,depression,hopelessness,and suicidal thoughts)and well-being (including self-esteem,life satisfaction,extroversion,social adjustment,interpersonal com-petence,and social skills),and that they had modest relations with constructs like locus of control,optimism,and pessimism(Chang&D’Zurilla,1996).The above review shows that the social problem-solving model proposed by D’Zurilla (1986)provides an excellent conceptual framework for research and clinical practice in problem-solving therapy(D’Zurilla&Chang,1995;D’Zurilla&Maydeu-Olivares, 1995;D’Zurilla&Nezu,1990).The SPSI-R,which was developed to assess social350Journal of Clinical Psychology,March2005problem-solving abilities and deficits,is a valid and reliable instrument that can be used in research,clinical assessment,and efficacy studies.Nevertheless,despite the fact that social problem-solving training is widely used in counseling and psychotherapy in the West,there is a lack of standardized instruments for the assessment of social problem solving in Chinese populations.As such,the development and validation of a Chinese version of the SPSI-R is an essential initial step to set the stage for research on the application of the social problem-solving model in the psychosocial treatment and reha-bilitation of Chinese clients.This study attempted to develop and validate a Chinese version of the SPSI for use with Chinese adolescents.The SPSI-R was first translated to Chinese,and its cultural relevance,content validity,and reading level were reviewed by expert panels.The factor structure of the instrument,its convergent validity,and its reliability status(internal con-sistency and test–retest reliability)were then examined.The study of discriminant valid-ity was conducted by analyzing the differences in the Chinese version of the SPSI-R profile scores among participants with and without clinical depression.Finally,a short form of the instrument was developed using the findings of this study.MethodStudy ParticipantsA convenient sample of352participants was recruited from Secondary1to Secondary3 (Grades7to9)classes of three secondary schools in different geographic districts(Hong Kong Island,Kowloon,and the New Territories)of Hong Kong.The age of the partici-pants ranged from11to15years,with a mean of13.18years(SDϭ1.15).There were slightly more females(55.7%)than males(44.3%)in the sample.There were no signif-icant differences in age among the schools.One of the schools was a girls’school,whereas the other two were co-educational schools.This contributed to a higher proportion of females in the sample.The purpose of the study was explained to the school principals, teachers,and students,and informed consent was obtained from the schools involved. InstrumentsThe Chinese Version of the SPSI-R.The52-item SPSI-R(D’Zurilla et al.,1996)was translated to Chinese(in the Cantonese dialect),and then retranslated to English from Chinese by two professional translators.Discrepancies between the English and Chinese versions were evaluated and gradually reduced through an iterative review process.Three experienced Chinese and English language teachers were then invited to evaluate the equivalence in meaning between the English and Chinese versions,as well as the reading level of the instruments.The aims of this exercise were to ensure equivalence in meaning between the translated instrument and the original instrument and to ensure that the test items were readable by most junior secondary-school students.Another five-member expert panel evaluated the content validity and cultural rele-vance of the Chinese Social Problem-Solving Inventory-Revised(C-SPSI-R).The panel consisted of five members who fulfilled at least two of the following criteria:(a)The member had published articles in academic journals related to adolescent mental health or parent-adolescent relationships;(b)The member had more than five years of experi-ence in psychological or mental health assessment;and(c)The member had more than five years of experience providing social work,counseling,or psychotherapy services to adolescents and families.Chinese Social Problem-Solving Inventory351 In their review of the face validity of the translated measure,the experts were requested to complete a self-administered questionnaire that evaluated the content relevance and representativeness of the test items.The questionnaire had three sections.In the first section,the experts were requested to rate the relevance of each item to their respective subscales using a Likert scale.In the second section,the experts were requested to give written comments on how far the items could represent the content domain of each sub-scale,as well as how far the five content domains could represent the construct of social problem solving.The experts indicated how far each item was relevant to the content domain,and they were requested to write down further comments about items that were considered not relevant.In the third section of the questionnaire open-ended questions were used to examine how far the content domain was adequately represented by the items as a whole and whether certain content areas were overrepresented,under-represented,or missing from the instrument.Follow-up meetings with members of the expert panel were held to discuss issues related to the relevance of the items in the different domains.The expert panel generally agreed that the five domains were satisfactory in repre-senting the construct of social problem solving.However,regarding the cultural rele-vance of the test items,the experts commented that it might not be most appropriate to put Item10and Item42in the AS subscale.However,to permit cross-cultural compar-ison,these two items were retained in the final version of the translated scale.The cultural relevance of these two items is further explored in the discussion section of this article.To develop a short form of the C-SPSI-R,the authors of the current study set up several criteria to select suitable items.First,the items chosen for the short form should be given an above-average relevance rating in the content review by the expert panel. Second,the authors agreed to select items that had relatively high factor loadings.Third, the items should have a relatively high item-total correlation in the study of internal consistency.The authors prioritized the items by applying these three criteria in the selec-tion of items for the short form.The Chinese Beck Depression Inventory(C-BDI).Translated from the Beck Depres-sion Inventory,the Chinese Beck Depression Inventory(C-BDI)is a21-item self-report measure of the degree of depressive symptoms that is widely used for clinical and research purposes in Chinese populations(Chan&Tsoi,1984).The participants were required to rate the intensity of21symptoms on a4-point scale,which had a total score of63.Based on a sample of2,150adolescents,Shek(1990,1991)showed that the C-BDI has two stable factors that demonstrate high internal consistency(␣ϭ.86)and split-half reliabil-ity(rϭ.77).Sex and age-specific norms were generated for clinical and research pur-poses in the adolescent group.ProceduresAfter the authors of the present study obtained the consent of the three schools,data were collected from classes selected randomly in each school.The students participated in the study on a voluntary basis.The researcher or assistant was present throughout the test administration process.All the352research participants from the three schools com-pleted the C-SPSI-R.Two hundred of the352participants from two schools completed both the C-SPSI-R and the C-BDI.The third school agreed to complete the C-SPSI-R only.For the study of test–retest reliability,76participants from one of the three schools completed the C-SPSI-R a second time two weeks after the first administration.352Journal of Clinical Psychology,March2005ResultsFactor Structure of the C-SPSI-RD’Zurilla and associates’(D’Zurilla et al.,1996;Maydeu-Olivares,&D’Zurilla,1995, 1996)factor analytic procedures(unweighted least squares and oblique rotation)were used in this study to compare the factor analysis results with those of their previous studies of the SPSI-R In addition,a conservative approach was used to determine the number of factors where various hypothesized factor solutions were attempted and com-pared before deciding on the number of factors in the instrument.An examination of the change of eigenvalues and the scree plot showed that there was very little increase in the percentage of variance explained after the fifth factor was extracted.Therefore,solutions of two,three,four,and five factors were attempted.Detailed examination of these possible factor models showed that the five-factor model was con-sidered most effective in reducing the data.Although the three-factor model also appeared to be a parsimonious solution,and it generated three meaningful factors of Rational Problem Solving,Negative Problem Orientation,and Impulsiveness/Carelessness Style, there was a significant increase in the amount of variance explained(11%more)when the number of factors increased from3to5.In addition,the grouping of items in the five-factor model of the C-SPSI-R was largely consistent with the five-factor solution of the SPSI-R.The rotated factor solution of the5-factor model is shown in Table1.The first factor had19items,which included17items out of the20items of the RPS subscale,and2 items of the PPO subscale,explaining9.08%of the variance.Subjects who obtained high scores in this factor had a strong tendency to apply rational problem-solving skills.This factor could be given the label of Rational Problem Solving.The second factor had eight items,explaining7.60%of the variance.It included5out of7items of the AS subscale, 2items of the ICS subscale,and1item of the NPO subscale.As this factor mainly assessed negative problem-solving style related to avoidance,it was labeled Avoidance Style.Subjects who had a high score on this factor were more likely to use avoidance tactics to handle problems.The third factor included9out of10items of the NPO subscale,2items of the ICS subscale,and1item of the AS subscale.This factor mainly measured NPO,explaining 6.84%of the variance.The fourth factor had7items,which included3items of the PPO subscale,3items of the RPS subscale,and1item of the AS subscale,explaining6.03% of the variance.The items from the PPO and RPS subscales largely refer to a positive orientation or motivation towards problem solving.On the whole,this factor was given the label of Positive Problem Orientation.The fifth factor included6out of10items of the ICS subscale of the English version of the SPSI-R,explaining4.84%of the variance, and was labeled Impulsiveness/Carelessness Style.Consistent with the theoretical pre-diction and previous findings(D’Zurilla et al.,1996),the results showed that the different subscales were significantly correlated among themselves(see Table2).Reliability of the C-SPSI-R and Its SubscalesThe overall internal consistency of the52-item C-SPSI-R was very good(Cronbach’s␣ϭ.93).Cronbach’s alpha for the5subscales varied from.64to.89(.89for RPS,.89for AS, .88for NPO,.64for PPO,and.79for ICS).The test–retest reliability for the5subscales as indicated by Pearson’s r varied from.61to.88(.88for RPS,.81for AS,.86for NPO, .61for PPO,and.71for ICS).Chinese Social Problem-Solving Inventory353 Table1Five-Factor Model for the Full Form of the C-SPSI-RFactor bItem a12345 40(RPS):weigh and compare the consequences of each option.61.01Ϫ.02.28.05 46(RPS):use a systematic method for comparing alternatives.57Ϫ.02.05.12Ϫ.14 26(RPS):examine feelings and see how they may become better.54Ϫ.12Ϫ.08.18Ϫ.07 29(RPS):get facts about the problem.53.03.03.27Ϫ.06 47(RPS):keep in mind the goal.53.07Ϫ.23.14Ϫ.16 49(RPS):try to get more specific and concrete information.50Ϫ.02.00.12Ϫ.08 25(RPS):analyze what went right and wrong.50Ϫ.18Ϫ.11.34.07 44(RPS):examine factors contributing to problems.49Ϫ.14.05.24Ϫ.14 37(RPS):evaluate if the situation has changed for the better.48Ϫ.18Ϫ.07.40Ϫ.04 43(RPS):consider the effects of options on my feelings.47.03Ϫ.23.19Ϫ.02 48(RPS):approach problems from many angles.47.10Ϫ.12.22Ϫ.04 18(RPS):predict positive and negative effects of options.46Ϫ.09Ϫ.01.21.08 24(RPS):consider both immediate and long-term consequences.44Ϫ.05Ϫ.15.37.06 39(RPS):think of as many options as possible.44.16Ϫ.15.41Ϫ.08 27(RPS):practice solutions to increase chance of success.43Ϫ.15.06.27Ϫ.05 35(RPS):find out what was wrong with the outcome and try again.42.10Ϫ.05.37Ϫ.17 33(RPS):set a specific goal.40.10Ϫ.21.37.03 38(PPO):see problem as a challenge or opportunity.40.01.26.32Ϫ.22 28(PPO):believe I can solve a problem if I try hard enough.38Ϫ.01.05.24Ϫ.25 31(AS):spend more time avoiding solving problems.02.58.23.06.31 23(AS):avoid thinking about problemsϪ.05.56.17.18.30 14(AS):put off trying to solve problems as long as possible.06.54.26.05.22 30(AS):put off solving problems until it’s too lateϪ.02.53.16.08.33 16(AS):go out of my way to avoid dealing with problems.03.52.26Ϫ.05.21 36(NPO):hate to solve problems in lifeϪ.11.51.17.07.13 52(ICS):too impulsive in making decisions.02.44.26.02.37 51(ICS):do not take time to examine why solution did not workϪ.01.39.20Ϫ.08.36 6(NPO):nervous and unsure when making important decisionsϪ.03.21.63.06.11 2(NPO):feel afraid when I have problem to solveϪ.05.23.58.12.18 12(NPO):feel frustrated if first attempt to solve problem failsϪ.01.29.58Ϫ.02.17 17(NPO):a difficult problem makes me upsetϪ.03.34.55Ϫ.10Ϫ.05 41(NPO):become depressed and immobilizedϪ.06.34.46Ϫ.05.20 50(NPO):get discouraged and depressed when first effort failsϪ.01.42.45Ϫ.11.12 32(NPO):get so upset that I cannot think clearlyϪ.06.42.44Ϫ.02.19 13(NPO):doubt if I can solve difficult problem on my ownϪ.11.29.42.13.23 1(NPO):worrying about problems instead of solving them.05.35.41.05.24 3(ICS):not evaluate all options carefully.05.11.38.03.30 42(AS):go to someone else for help solving itϪ.13Ϫ.08.32Ϫ.24.04 22(ICS):cannot come up with many possible solutionsϪ.10.21.29.01.22 9(PPO):believe a problem can be solved.01.17.10.62Ϫ.04 10(AS):wait to see if a problem will resolve itselfϪ.02.05.04Ϫ.50Ϫ.01 11(RPS):analyze the situation and identify obstacles.25Ϫ.07Ϫ.03.44Ϫ.04 19(PPO):deal with problems as soon as possible.28.16.06.44Ϫ.18 7(PPO):do not give up solving problems when first attempt fails.30.10.16.39Ϫ.18 5(RPS):think of different solutions.30Ϫ.03Ϫ.06.39.05 20(RPS):try to think of creative or original solutions.29Ϫ.04.22.37Ϫ.18 21(ICS):go with first good idea that comes to mindϪ.10.11.02.02.64 8(ICS):act on the first idea that comes to mind.01.17.11Ϫ.11.52 34(ICS):do not take time to consider pros and cons of optionsϪ.02.36.15Ϫ.02.46 45(ICS):go with my“gut feeling”without thinking about consequencesϪ.04.31.10Ϫ.17.37 15(ICS):do not take time to evaluate all results carefullyϪ.03.31.19Ϫ.05.35 4(ICS):fail to consider the effect of options on others.04.15.21Ϫ.08.23 Variance Explained9.087.60 6.84 6.03 4.84Note.The highest loading among the factors for an item is underlined.a The factor to which the item belongs in the original SPSI-R is shown in brackets,where PPOϭPositive Problem Orientation, RPSϭRational Problem Solving,NPOϭNegative Problem Orientation,ASϭAvoidance Style,and ICSϭImpulsiveness/ Carelessness Style.b Factor1ϭRational Problem Solving,Factor2ϭAvoidance Style,Factor3ϭNegative Problem Orientation,Factor4ϭPositive Problem Orientation,and Factor5ϭImpulsiveness/Carelessness Style.Relation between the C-SPSI-R Subscales and DepressionTo explore the relation between social problem solving and depression,200participants completed the C-BDI and the C-SPSI-R concurrently.The results showed that the C-BDI scores were significantly correlated with 4subscales of the C-SPSI-R (see Table 3).Whereas the negative subscales of ICS,AS,and NPO had a significant positive correla-tion with depression,the PPO subscale had a significant negative correlation with depres-sion.On the other hand,there was no significant relation between the RPS subscale and depression.These findings replicated those reported by D’Zurilla,Nezu,and Maydeu-Olivares (1996).Table 2Correlation Coefficients Among the Five Subscales of the C-SPSI-RSubscaleNPO ICS AS RPS Full Form (N ϭ352)PPOϪ.15*Ϫ.17*Ϫ.14*.64*NPO.69*.79*Ϫ.17*ICS.78*Ϫ.23*AS.22*Short Form (N ϭ352)PPO.09ns Ϫ.15*Ϫ.13*.47*NPOϪ.52*.65*Ϫ.08ns ICS.71*Ϫ.19*AS Ϫ.15*Note .AS ϭAvoidance Style,NPO ϭNegative Problem Orientation,RPS ϭRationalProblem Solving,ICS ϭImpulsiveness /Carelessness Style,and PPO ϭPositive ProblemOrientation.A two-tailed multistage Bonferroni procedure was used to obtain the data.pFW is based on the familywise Type 1error rate;pT is based on the Type 1error rate pertest.*pFW Ͻ.05;pT Ͻ.025in the full form and short form.Table 3Correlation Coefficients on the Relationships Between the C-BDIScores and the C-SPSI-R Subscale ScoresC-SPSI-RSubscalesFull Form With C-BDI (N ϭ200)Short Form With C-BDI (N ϭ200)Findings Based on the Full Form a PPOϪ.32*Ϫ.31*Ϫ.25NPO.69*.66*.49b IC.31*.23*.28b AS.68*.67*.39b RPS Ϫ.09ns Ϫ.05ns Ϫ.12nsNote .A two-tailed multistage Bonferroni procedure was used to obtain the data.pFW isbased on the familywise Type 1error rate;pT is based on the Type 1error rate per test.*pFW Ͻ.01;pT Ͻ.002in both the full form and short form.ns ϭnon-significant.a Information from the SPSI-R manual (D’Zurilla,Nezu,&Maydeu-Olivares,1996)b p Ͻ.05per test (D’Zurilla,Nezu,&Maydeu-Olivares,1996)354Journal of Clinical Psychology,March 2005Chinese Social Problem-Solving Inventory355 Discriminant ValidityBased on the sensitivity study of the BDI by Rudd and Rajab(1995),a cut-off score of18 in the C-BDI was used to divide the200participants into groups with and without clinical depression.The C-SPSI-R subscale scores of the2groups were compared,and a signif-icant difference between the C-SPSI-R profiles of the2groups was found(Wilk’s␭ϭ370.46,pϽ.001).The results showed that the depressed group(nϭ64)had lower PPO (tϭ2.92,pϽ.01),and higher NPO(tϭ8.43,pϽ.001),AS(tϭ8.98,pϽ.001),and ICS(tϭ3.45,pϽ.01)scores than the nondepressed group(Table5).There was,how-ever,no difference in mean RPS scores between the two groups.Construction of a Short Form C-SPSI-RBecause the original full form was too long to be used in a survey context,a short form of the C-SPSI was developed for more efficient administration with younger adolescents. Based on the findings of the full form(including its content validity,factorial validity, concurrent validity,and reliability),25items were eventually selected to form the short form.Factor analysis of the25items in the short form was conducted using the same extraction and rotation methods as used for the52-item full version.A5-factor solution was obtained that explained38.16%of the total variance(compared with34.70%in the full form).The factor solution of the short form is presented in Table4.The subscales based on the full form were found to be highly correlated with the corresponding sub-scales in the short form:rϭ1.00,pϽ.001for PPO;rϭ.89,pϽ.001for RPS;rϭ.93, pϽ.001for NPO;rϭ.96,pϽ.001for ICS;rϭ.97,pϽ.001for AS.As to the reliability of the subscales of the short form,internal consistency analyses showed that the related measures were internally consistent(␣ϭ.88for AS,.80for NPO, .73for RPS,.78for ICS,and.65for PPO)and temporally stable(test–retest reliability coefficientϭ.73for AS,.79for NPO,.71for RPS,.69for ICS,and.48for PPO).Except for two correlation coefficients,the correlation coefficients among the subscales were significant(Table2).As with the full form,the subscales of the C-SPSI-R,except RPR, were significantly correlated with the C-BDI scores(Table3).DiscussionThe expert panels generally agreed that the C-SPSI-R had good content validity and that the Chinese translation was comprehensible to early adolescents.In addition,the5sub-scales were seen as representative of the construct of social problem solving,and50of the52items were seen as closely related to the5content domains of social problem solving.However,the experts expressed reservations on the cultural relevance of Item10 and Item42,which are items in the AS subscale of the SPSI-R.Conceptually speaking, whereas“wait if a problem will resolve itself”(Item10)indicates inactivity or delay in problem solving in Western culture,“nonaction”strategies could be regarded as positive in Chinese culture.In fact,the Chinese philosophy of“nonaction”(the concept of wu wei in Taoist thought)suggests that the world is ever-changing no matter whether we act or do not act(Chan,1963;Young,1983).Hwang(1977)also suggests that adopting the philosophy of doing nothing may be a form of positive coping among Chinese people. Empirically speaking,whereas this item loaded negatively on the PPO factor rather than on the AS factor,the negative loading still suggests that inactivity or delay in problem solving is negatively related to positive problem-solving orientation.This finding may。

Test and Evaluation

Test and EvaluationTesting and evaluation play a crucial role in the development and implementation of any product or system. Whether it's a new software application, a piece of machinery, or even a new process for completing a task, thoroughtesting and evaluation are necessary to ensure its effectiveness, safety, and overall success. This process involves a methodical and systematic approach to understanding how the product or system performs under various conditions, identifying any potential issues or shortcomings, and making necessary improvements before its final release or deployment. One perspective to consider is the significance of testing and evaluation in ensuring the safety andreliability of a product or system. For instance, in the case of a new medical device, thorough testing and evaluation are essential to guarantee that it functions as intended and poses no risks to the patients or healthcare providers using it. Likewise, in the automotive industry, extensive testing of new vehicle models is critical to identifying and addressing any potential safety concerns before they reach the market. By conducting rigorous testing and evaluation, companies can mitigate the risks of product malfunctions, failures, or accidents, thereby building trust and confidence among consumers. Another critical perspective to explore is the role of testing and evaluation in optimizing the performance and functionality of a product or system. Through systematic testing, developers can gain valuable insights into how their product behaves in different scenarios and environments. This process allows for the identification of performance bottlenecks, usability issues, and areas for improvement. Bycollecting and analyzing data from various tests, developers can refine and enhance the product to deliver a superior user experience. In the context of software development, for example, thorough testing and evaluation enable the detection of bugs and glitches, ultimately leading to a more stable and efficient application. Moreover, testing and evaluation contribute to cost savings and risk mitigation in the long run. While it may incur initial investments in terms of time, resources, and expertise, conducting comprehensive testing early in the development process can help prevent costly rework and repairs later on. By identifying and addressing potential issues proactively, companies can avoidexpensive recalls, warranty claims, and customer dissatisfaction. Additionally, thorough evaluation of a product's performance and quality before its launch can reduce the likelihood of post-release failures or setbacks, thereby safeguarding the company's reputation and financial stability. It's also essential to recognize the impact of testing and evaluation on regulatory compliance and legal obligations. In many industries, there are stringent regulations and standardsthat products must meet to ensure consumer safety and environmental protection. Through rigorous testing, companies can demonstrate compliance with these requirements and obtain the necessary certifications and approvals for their products. Failure to meet regulatory standards can result in severe penalties, lawsuits, and reputational damage. Therefore, thorough testing and evaluation are not only a matter of quality assurance but also a legal imperative for businesses operating in regulated sectors. In addition to technical considerations, the human factor is equally vital in the testing and evaluation process. Understanding the end users' needs, preferences, and behaviors is crucial for developing a product that truly resonates with its intended audience. By involving real users in the testing phase, whether through focus groups, usability studies, or beta testing programs, developers can gather valuable feedback and insights that inform iterative improvements. This user-centered approach ultimately leads to a more intuitive, user-friendly, and impactful product that meets the market's demands. Furthermore, the continuous evolution of technology and consumer expectations necessitates ongoing testing and evaluation throughout a product's lifecycle. As new features are added, systems are updated, and external factors change, the need for adaptation and validation remains constant. The iterative nature of testing and evaluation allows for agility and responsiveness to emerging challenges and opportunities, supporting the long-term success and relevance of the product or system. In conclusion, testing and evaluation are not merely technical processes but rather integral components of a holistic and strategic approach to product development. By recognizing the multifaceted benefits of thorough testing and evaluation, from safety and performance optimization to cost savings and regulatory compliance, businesses can position themselves for sustained growth, innovation, and customer satisfaction. Embracing a mindset of continuousimprovement and user-centric innovation is essential for navigating the complex and dynamic landscape of modern markets, where quality, reliability, and relevance are paramount.。

ISO11135-2014中文翻译版

ISO 11135-2014Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routinecontrol of a sterilization process for medical devices医疗保健产品灭菌—— 环氧乙烷——医疗器械灭菌过程开发、确认和常规控制要求1 Scope范围1.1 Inclusions 包含内容This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.本标准规定了医疗器械产品在工业与医疗保健机构的环氧乙烷灭菌过程的开发、验证和常规控制的要求，并承认这两个领域之间灭菌过程开发、确认的常规控制的异同。

NOTE 1. Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.注1．其中, 相同之处在于质量体系、人员培训及适当的安全措施的通用要求。

(完整版)USP-1092-溶出度试验的开发和验证(中英文对照版).docx

（ 1092）溶出度试验的开发和验证【中英文对照版】INTRODUCTION前言Purpose目的The Dissolution Procedure: Developmentand Validation<1092>provides a comprehensive approach covering items to considerfor developing and validating dissolutionprocedures and the accompanyinganalytical procedures. Itaddresses the use of automation throughout the testandprovides guidance and criteria for validation.It also addresses thetreatment of the data generated and the interpretationof acceptance criteriafor immediate-and modified-releasesolid oral dosage forms.溶出实验:开发和验证（1092）指导原则提供了在溶出度方法开发和验证过程中以及采用相应分析方法时需要考虑的因素。

本指导原则贯穿溶出度实验的全部过程，并对方法提供了指导和验证标准。

同时它还涉及对普通制剂和缓释制剂所生成的数据和接受标准进行说明。

Scope范围Chapter<1092>addresses the development andvalidationof dissolution procedures,with a focus on solid oral dosage forms.Many of the concepts presented, however, may beapplicable to other dosageforms and routes of administration. General recommendations are given with theunderstandingthat modifications of the apparatus and procedures as given in USP general chapters need to be justified.<1092>章节讨论了溶出度实验的开发和验证，重点是口服固体制剂。

USP_1092_溶出度试验的开发和验证中英文对照版

（1092）溶出度试验的开发和验证【中英文对照版】INTRODUCTION前言Purpose目的The Dissolution Procedure: Developmentand Validation <1092> provides a comprehensive approach covering items to considerfor developing and validating dissolution procedures and the accompanyinganalytical procedures. It addresses the use of automation throughout the testand provides guidance and criteria for validation. It also addresses thetreatment of the data generated and the interpretation of acceptance criteriafor immediate- andmodified-release solid oral dosage forms.溶出实验:开发和验证（1092）指导原则提供了在溶出度方法开发和验证过程中以及采用相应分析方法时需要考虑的因素。

本指导原则贯穿溶出度实验的全部过程，并对方法提供了指导和验证标准。

同时它还涉及对普通制剂和缓释制剂所生成的数据和接受标准进行说明。

Scope范围Chapter <1092> addresses the development andvalidation of dissolution procedures, with a focus on solid oral dosage forms.Many ofthe concepts presented, however, may be applicable to other dosageforms and routes of administration. General recommendations are given with theunderstanding that modifications of the apparatus and procedures as given in USP general chapters need to be justified.<1092>章节讨论了溶出度实验的开发和验证，重点是口服固体制剂。

基于实车碰撞的ODB和MPDB试验的对比分析研究

FRONTIER DISCUSSION | 前沿探讨基于实车碰撞的ODB和MPDB试验的对比分析研究何成　王天华　谢军　朱鑫中国汽车技术研究中心天津市 300300摘要：针对新型的MPDB试验的车辆开发难点，本文对某款车型进行了ODB和MPDB试验，从碰撞波形可知传统的ODB试验比新型MPDB试验更加激烈。

但驾驶员和驾驶员后排女性的损伤情况来看，MPDB在胸部评价上更加严苛，扣分更多。

MPDB的兼容性评价指标，考查试验车辆对对方车辆的攻击性，试验车辆的兼容性评价指标偏高，具有较大的攻击性，容易罚分。

本文为车辆的MPDB试验开发提供借鉴。

关键词：MPDB试验　ODB试验　兼容性评价ODB（Offset Deformable Barrier）试验是一种正面偏置碰撞试验，模拟车辆与别的车辆发生40%重叠的正面对碰撞的交通事故，ODB蜂窝铝壁障代替对方车辆。

ODB试验主要评价测试车辆的耐撞性，即保护测试车辆乘员的安全，是目前各国各地区采用的主要测试方法。

随着车辆技术的发展，车辆的耐撞性得到很大的提升[1，2]。

车辆保护自身乘员能力得到提升的同时，却暴露了其攻击性，即车辆对对方车辆造成伤害。

鉴于，目前普遍采用ODB试验进行评价，在碰撞中既能保护车辆乘员的安全的同时也保护对方乘员的安全的碰撞兼容性研究成为热点[3-5]。

2021版的CNCAP评价规程引入MPDB（Mobile Progressive Deformable Barrier）试验，其兼容性评价指标为MPDB台车前段壁障变形量标准偏差（SD）、乘员载荷准则（OLC）、壁障侵入深度和侵入高度[6]。

2022年1月至2023年1月，兼容性最高罚分为3分。

2023年1月以后，兼容性最高罚分增加至6分。

因此，在由ODB试验转入MPDB试验期间，有必要进行MPDB的试验研究。

研究MPDB 试验与ODB试验的差异性，为MPDB试验车辆性能开发提供依据。

ISO11135-2014中文翻译版

杨百寅简历---清华大学经济管理学院-CRM-系统

杨百寅简历---清华大学经济管理学院-CRM-系统通讯地址：清华大学经济管理学院人力资源与组织行为系中国北京清华园100084电话：86-10-62796314传真：86-10-62772021电子信箱：yangby@1990－1992：（加拿大）萨斯卡彻温大学继续教育专业硕士1992－1996：（美国）佐治亚大学人力资源开发专业博士工程师（管理）1996-1998：（美国）奥本大学助理教授1998-2001：（美国）爱达荷大学助理教授、（终身）副教授2001-2006：（美国）明尼苏达大学助理教授、（终身）副教授、（终身）教授2006-至今：清华大学经济管理学院系主任教授•2010年：美国管理学会年会，最佳论文提名奖【Academy of Management, Carolyn Dexter Award Nominee】•2010年：中国管理学会，年会优秀论文《如何提高战略决策效果？TMT社会资本与冲突的作用》•2009年：长江学者奖励计划, 教育部长江学者特聘教授。

•2007年：国家杰出青年科学基金获得者。

•2007年：友好全球人力资源最佳教授奖，(印度)友好大学【Amity Best Global HR Faculty Award, Amity University, India】。

•2004年：2003年度最佳论文奖，人力资源开发评论【Outstanding Article for 2003, Human Resource Development Review, 2004】。

•2000年：早期职业奖，美国成人教育教授协会【Early Career Award, Commission of Professors of Adult Education (CPAE), 2000】。

Development and validation of work-family conflict and family-work conflict scales.

Richard G. Netemeyer Louisiana State University Robert McMurrian Louisiana State University Researchers report on a 3-sample study that developed and validated short, self-report scales of work-family conflict (WFC) and family-work conflict (FWC). Using conceptualizations consistent with the current literature, the researchers offer content domains and definitions of the constructs. Advocated procedures were used to develop the scales and test dimensionality and internal consistency. Estimates of construct validity are presented by relating the scales to 16 other on- and off-job constructs. Mean-level difference tests between WFC and FWC also provide evidence of validity. J a m e s S. Boles Georgia State University
A widely studied topic in organizational behavior is the conflict between work and family. In recent years, several studies have advanced our understanding of how work affects family life and vice versa (Frone, Russell, & Cooper, 1992, Greenhaus & Beutell, 1985; O'Driscoll, Ilgen, & Hildreth, 1992). O f importance to the study of w o r k family relations is construct measurement. Although a conceptual distinction between work conflicting with the family and family conflicting with work has been made, most research has assessed only work-family conflict ( W F C ) . Furthermore, operationalization of W F C has varied widely from study to study, limiting the ability to generalize about the effects of WFC. The purpose of this article is to develop and validate short, self-report measures of W F C and family-work conflict ( F W C ) . Background and Review Two important focal points of adult life are family and work. However, the role expectations of these two do-

《新时代汉语口语准高级(下)》出版

communication studies, 19(3): 21-37. STONE N, 2006. Conceptualising intercultural effectiveness for university teaching[J]. Journal of studies in international education,
PAIGE R M, 1993. Education for the intercultural experience[M]. 2nd ed. Yarmouth, Me: Intercultural Press. PEDERSEN P J, 2010. Assessing intercultural effectiveness outcomes in a year-long study abroad program[J]. International journal of
书名：新时代汉语口语：准高级（下）出版社：外语教学与研究出版社主编：朱勇编者：桂靖鲁文霞张京京
过程中的主体作用，做到“以学习为中心”“以产出为目标”。
ISBN：978-7-5213-1721-3
（杨益供稿）定价：79.00 元
开本：16 开
75
intercultural relations. 34(1): 70-80. PETERSDOTTER L, et al., 2017. International experience makes a difference: effects of studying abroad on students' self-efficacy [J].
边学边用、边用边学，学用无缝对接。基于 POA 的汉语教学材料可以有效

USP-1092-溶出度试验的开发和验证(中英文对照版)

（1092）溶出度试验的开发和验证【中英文对比版】之迟辟智美创作INTRODUCTION前言Purpose目的The Dissolution Procedure: Developmentand Validation <1092> provides a comprehensive approach covering items to considerfor developing and validating dissolution procedures and the accompanyinganalytical procedures. It addresses the use of automation throughout the testand provides guidance and criteria for validation. It also addresses thetreatment of the data generated and the interpretation of acceptance criteriafor immediate and modifiedrelease solid oral dosage forms.溶出实验:开发和验证（1092）指导原则提供了在溶出度方法开发和验证过程中以及采纳相应分析方法时需要考虑的因素.本指导原则贯穿溶出度实验的全部过程，并对方法提供了指导和验证标准.同时它还涉及对普通制剂和缓释制剂所生成的数据和接受标准进行说明.Scope范围Chapter <1092> addresses the development andvalidation of dissolution procedures, with a focus on solid oral dosage forms.Many of the concepts presented, however, may be applicable to other dosageforms and routes of administration. General recommendations are given with theunderstanding that modifications of the apparatus and procedures as given in USPgeneral chapters need to be justified.<1092>章节讨论了溶出度实验的开发和验证，重点是口服固体制剂.所提出的许多概念也可能适用于其他剂型和给药途径.关于设备和方法的修改部份在USP通则中给出了合理的说明.The organization of <1092> follows the sequence of actions often performed inthe development and validation of a dissolution test. The sections appear inthe following sequence.在进行溶解度实验的开发和验证时，常遵循指导原则<1092>，具体内容如下：1. PRELIMINARY ASSESSMENT (FOR EARLY STAGES OF PRODUCTDEVELOPMENT/DISSOLUTION METHOD DEVELOPMENT)1.前期评估（对产物开发以及溶出度方法开发的前期研究评估）1.1 Performing Filter Compatibility1.2 Determining Solubility and Stability of DrugSubstance in Various Media1.3 Choosing a Medium and Volume1.4 Choosing an Apparatus1.4溶出设备选择（桨法和篮法以及其他方法）2. METHOD DEVELOPMENT2.1 Deaeration2.2 Sinkers2.3 Agitation2.4 Study Design2.4.1 TimePoints2.4.2 Observations2.4.3 Sampling2.4.4 Cleaning2.5 Data Handling2.6 Dissolution Procedure Assessment3. ANALYTICAL FINISH3.1 Sample Processing3.1 样品处置3.2 Filters3.2 过滤3.3 Centrifugation3.3 离心3.4 Analytical Procedure3.4 分析方法3.5 Spectrophotometric Analysis3.5 光谱分析3.6 HPLC4. AUTOMATION4.1 Medium Preparation4.2 Sample Introduction and Timing4.3 Sampling and Filtration4.4 Cleaning4.4 清洗4.5 Operating Software and Computation of Results5. VALIDATION5.1 Specificity/Placebo Interference5.1专属性/抚慰剂（辅料）干扰5.2 Linearity and Range5.3 Accuracy/Recovery5.4 Precision5.4.1 REPEATABILITY OF ANALYSIS5.4.2 INTERMEDIATE PRECISION/RUGGEDNESS 5.4.3 REPRODUCIBILITY5.5 Robustness5.6 Stability of Standard and Sample Solutions5.7 Considerations for Automation6. ACCEPTANCE CRITERIA6.1 ImmediateRelease Dosage Forms6.2 DelayedRelease Dosage Forms6.3 ExtendedRelease Dosage Forms6.4 Multiple Dissolution Tests6.5 Interpretation of Dissolution Results6.5.1 IMMEDIATERELEASE DOSAGE FORMS6.5.2 DELAYEDRELEASE DOSAGE FORMS6.5.3 EXTENDEDRELEASE DOSAGE FORMS1. PRELIMINARYASSESSMENT (FOR EARLY STAGES OF PRODUCT DEVELOPMENT/DISSOLUTION METHODDEVELOPMENT)1. 前期评估（产物开发/溶出度方法开发的早期阶段）Beforemethod development can begin, it is important to characterize the molecule sothat the filter, medium, volume of medium, and apparatus can be chosen properlyin order to evaluate the performance of the dosage form.在开始溶出方法开发之前，我们对用以评价制剂溶出行为的滤膜、溶出介质、溶出介质体积和溶出设备进行适当的筛选是非常重要的.1.1 Performing Filter CompatibilityFiltrationis a key samplepreparation step in achieving accurate test results. Thepurpose of filtration is to remove undissolved drug and excipients from thewithdrawn solution. If not removed from the sample solution, particles of thedrug will continue to dissolve and can bias the results. Therefore, filteringthe dissolution samples is usually necessary and should be done immediately ifthe filter is not positioned on the cannula.为获得准确试验结果，过滤是样品制备的一个关键步伐.过滤的目的是为了除去溶出液中未溶解的药物和辅料.如果不把未溶解的药物和辅料从样品溶液中除去，那么未溶解的药物颗粒将会继续溶解使试验结果呈现偏差，因此，如果取样管中没有过滤器，应立即对溶出度样品进行过滤. Filtration also removes insolubleexcipients that may otherwise interfere with the analytical finish. Selectionof the proper filter material is important and should be accomplished, andexperimentally justified, early in the development of the dissolutionprocedure. Important characteristics to consider when choosing a filtermaterial are type, filter size, and pore size. Thefilter that is selectedbased on evaluation during the early stages of dissolution procedure developmentmay need to be reconsidered at a later time point. Requalification has to beconsidered after a change in composition of the drug product or changes in thequality of the ingredients (e.g. particle size of microcrystalline cellulose).过滤也可除去可能会干扰分析测定的不溶性辅料.选择适当的过滤资料是非常重要，应该在早期溶出方法开发的过程中通过实验确定和完成.在选择滤膜时有需要重点考虑滤膜的资料、型号和孔径年夜小.通常对早期阶段溶出方法开发过程的评价选择过滤器，但在后期试验中如果制剂成份改变或组成成份质量变动可能需要重新考虑过滤器，（例如：微晶纤维素粒径的改变）.Examples of filters used in dissolutiontesting can be cannula filters, filter disks or frits, filter tips, or syringefilters. The filter material has to be compatible with the media and themon pore sizes range from 0.20 to 70 mm, however, filters of other poresizes can be used as needed. If the drug substance particle size is very small(e.g., micronized or nanoparticles), it can be challenging to find a filterpore size that excludes these small particles.用于溶出试验的过滤器有管路过滤器、过滤盘或玻璃过滤器、滤头或针头式过滤器.过滤资料必需与介质和药物相适合.罕见孔径年夜小范围：0.20～70μm，如果需要也可使用其他孔径年夜小的过滤器.如果原料药的粒度很小（例如，微分化颗粒或纳米颗粒），找到一个合适的过滤器过滤这些小颗粒至今仍具有挑战性.Adsorption of the drug(s) by the filtermay occur and needs to be evaluated. Filter materials will interact withdissolution media to affect the recovery of the individual solutes and must beconsidered on a casebycase basis. Different filter materials exhibitdifferent drugbinding properties. Percentage of drug loss from the filtratedue to binding may be dependent on the drug concentration. Therefore theadsorptive interference should be evaluated on sample solutions at differentconcentrations bracketing the expected concentration range. Where the drugadsorption is saturable, discarding an initial volume of filtrate may allow thecollection of a subsequent solution that approaches the original solutionconcentration. Alternative filter materials that minimize adsorptiveinterference can usually be found. Prewetting of the filter with the medium maybe necessary. In addition, it is important that leachables from the filter donot interfere with the analytical procedure. This can beevaluated by analyzingthe filtered dissolution medium and comparing it with the unfiltered medium.过滤时可能会发生药物的吸附，需要进行评估.过滤资料将与溶出介质相互作用，影响每个溶质的回收率应该根据具体问题进行考虑.分歧的过滤资料暗示出与药物结合的分歧特性.由于药物与滤膜结合引起药物从滤液中损失的比例，可能依赖于药物浓度.因此，应采纳预期浓度范围内分歧浓度的样品溶液来评估滤膜吸附干扰.由于药物吸附是可饱和的，弃去一定体积的初滤液，收集续滤液，以到达接近原来的溶液浓度的样品也是可取的.通常选择适合的过滤资料，最年夜限度地减少滤膜吸附干扰，润湿滤膜对减少吸附也是需要的.另外，过滤后的溶出物不干扰分析检测也是非常重要的，这可以通过过滤后的溶出介质过滤与未过滤的溶出介质进行比力，评估滤膜是否干扰分析测定.The filter size should be based on thevolume to be withdrawn and the amount of particles to be separated. Use of thecorrect filter dimensions will improve throughput and recovery, and also reduceclogging. Use of a large filter for smallvolume filtration can lead to loss ofsample through holdup volume, whereas filtration through small filter sizesneeds higher pressures and longer times, and the filters can clog quickly.根据要过滤样品溶液的体积以及样品溶液中颗粒的量选择滤膜孔径.使用正确的滤膜孔径将提高溶液的通过率和回收率，并减少滤膜梗塞.使用年夜孔径滤膜过滤小体积溶液，能够招致样品溶液损失量过年夜而收集不到所用样品量；使用小孔径滤膜过滤，需要更高的压力和较长的时间，而且溶液迅速梗塞滤膜.Filters used for USP Apparatus 4 needspecial attention because they are integrated in the flowthrough process.Undissolved particles may deposit on the filters, creating resistance to theflow.USP仪器4中使用的过滤器需要特别注意，因为它们在流动过程中使用.不溶颗粒会聚积在过滤器，发生流动阻力. In the case of automated systems,selection of the filter with regard to material and pore size can be done in asimilar manner to manual filtration. Flow rate through the filter and cloggingmay be critical for filters used in automated systems. Experimentalverification that a filter isappropriate may be accomplished by comparing the responses for filtered andunfiltered standard and sample solutions. This is done by first preparing asuitable standard solution and a sample solution. For example, prepare atypical dissolution sample in a beaker and stir vigorously witha magneticstirrer to dissolve the drug load completely.For standard solutions, comparethe results for filtered solutions (after discarding the appropriate volume) tothose for the unfiltered solutions. For sample solutions, compare the resultsfor filtered solutions (after discarding the appropriate volume) to those forcentrifuged, unfiltered solutions.在自动化系统的情况下，关于过滤器滤膜资料和孔径年夜小可以用类似的方式通过手动过滤进行选择.在自动化系统中通过过滤器的流量和过滤器的梗塞可能是至关重要的.通过试验比力过滤和未过滤的标准溶液和样品溶液的含量分歧，验证该过滤器是合适的.首先制备一个合适的标准溶液和样品溶液.例如，在烧杯中制备一个标准溶解样品，用磁力搅拌器搅拌使药物完全溶解.对标准溶液，比力过滤溶液（弃去的适当体积后）和未过滤溶液的含量测定结果；对样品溶液，比力过滤（弃去适当体积后）、离心、未过滤样品溶液的含量测定结果.1.2 Determining Solubility and Stability of DrugSubstance in Various MediaPhysical and chemical characteristics of the drug substance need to be determinedas part of the process of selecting the proper dissolution medium. Whendeciding the composition of the medium for dissolution testing, it is importantto evaluate theinfluence of buffers, pH, and if needed, different surfactantson the solubility and stability of the drug substance. Solubility of the drugsubstance is usually evaluated by determining the saturation concentration ofthe drug in different media at 37°using the shakeflask solubility method(equilibrium solubility). To level out potential ion effects between the drugand the buffers used in the media, mixtures of hydrochloric acid and sodiumhydroxide are used to perform solubility investigations; this is in addition tothe typical buffer solutions. In certain cases, it may be necessary to evaluatethe solubility of the drug at temperatures other than 37° (i.e., 25°). The pHof the clear supernatant should be checked to determine whether the pH changesduring the solubility test. Alternative approaches for solubility determinationmay also be used.在选择合适溶出介质的过程中，需要确定原料药的物理化学特性.当需要确定溶出度试验中溶出介质的组成时，有需要评估缓冲液、pH值、以及分歧的概况活性剂（如果需要）对药物的溶解度和稳定性的影响.在37℃温度条件下，采纳摇瓶溶解法（平衡溶解度）测定原料药在分歧介质中的饱和浓度，来评估药物的溶解性.为了消除溶出介质中药物和缓冲液之间离子的潜在影响，使用盐酸和氢氧化钠的混合物对溶解度进行研究，这是一种典范的缓冲溶液.在某些情况下，评估药物在37℃以外条件下（即，25℃）的溶解度可能也是需要的.在溶解度试验过程中应检查上清溶液的pH值，以确定在溶解过程中pH值是否改变.也可使用其他可供选择的方法进行溶解度测定.Typical media for dissolution mayinclude the following (not listed in order of preference): diluted hydrochloricacid, buffers (phosphate or acetate) in the physiologic pH range of 1.2–7.5, simulatedgastric or intestinal fluid (with or without enzymes),and water. For somedrugs, incompatibility of the drug with certain buffers or salts may influencethe choice of buffer. The molarity of the buffers and acids used can influencethe solubilizing effect, and this factor may be evaluated.溶出的典范介质包括（未依照优先顺序列出）：稀盐酸、在生理pH值范围为1.27.5缓冲溶液（磷酸盐或者醋酸盐）、模拟胃液或肠液（含有或不含有酶）和水.对一些药物，与药物不相容的特定缓冲液或盐可能会影响缓冲剂的选择.所使用的缓冲液和酸的体积摩尔浓度能够改变药物的增溶作用，这个因素也需要评估.Aqueous solutions (acidic or buffersolutions) may contain a percentage of a surfactant [e.g., sodium dodecylsulfate (SDS),polysorbate, or lauryldimethylamine oxide] to enhance thesolubility of the drug. The surfactants selected for thesolubilityinvestigations should cover all common surfactant types, i.e., anionic,nonionic, and cationic. When a suitable surfactant has been identified,different concentrations of that surfactant should be investigated to identifythe lowest concentration neededto achieve sink conditions. Typically,the surfactant concentration is above its critical micellar concentration(CMC). Table 1 shows a list of some of the surfactants used indissolution media. Approximate CMC values are provided with referenceswhenavailable. The list is not comprehensive and is not intended to exclude surfactantsthat are not listed. Other substances, such ashydroxypropyl b cyclodextrin,have been used as dissolution media additives to enhance dissolution of poorlysoluble compounds.The U.S. Food and Drug Administration (FDA) maintains adatabase of dissolution methods, including information on dissolution mediathat have been used (1). Typically, the amount of surfactant added issufficient to achieve sink conditions in the desired volume of dissolutionmedium.有时候水溶性介质中（酸性水溶液或缓冲溶液）可能添加一定比例的概况活性剂（如十二烷基硫酸钠（SDS），聚山梨醇酯，或十二烷基二甲基氧化胺）以提高药物的溶解度.选择用于溶解度研究的概况活性剂时应涵盖所有经常使用种类的概况活性剂，比如阴离子、非离子型和阳离子，当已经确定一个合适的概况活性剂时，应对概况活性剂的分歧浓度进行研究，以确定到达漏槽条件所需的最低浓度.一般情况下，概况活性剂的浓度高于它的临界胶束浓度（CMC）.表1列出了溶出介质中经常使用的概况活性剂，表中提供了CMC的近似临界值，以便我们参考，另外，表中所列概况活性剂其实不全面，不能排除未列出的概况活性剂.其他概况活性剂，如羟丙基β环糊精，已被用来作为溶出介质添加剂提高难溶性化合物的溶解度，美国食品药品管理局（FDA）溶出度数据库中，已经收载含有羟丙基β环糊精的溶出介质（1）.通常情况下，概况活性剂的加入量以满足到达漏槽条件所需的溶出介质体积.It is important to control thegrade and purity of surfactants because use of different grades could affectthe solubility of the drug. For example, SDS is available in both a technicalgrade and a highpurity grade. Obtaining polysorbate 80 from different sourcescan affect its suitability when performing highperformance liquidchromatography (HPLC) analysis.由于使用分歧级另外概况活性剂会影响药物的溶解度，因此要控制概况活性剂的级别和纯度.例如，SDS只有在工业级和高纯度级才可以使用.在使用HPLC方法进行分析时，分歧来源的聚山梨酯（吐温）80会影响它的适用性. There may be effects of counterions orpH on the solubility or solution stability of the surfactant solutions. Forexample, a precipitate forms when the potassium salt for the phosphate bufferis used at a concentration of 0.5 M in combination with SDS. This can beavoided by using the sodium phosphate salt when preparing media with SDS.反离子或pH值可能会影响概况活性剂溶液的溶解性或稳定性.例如，当含有SDS的磷酸盐缓冲液中钾盐浓度为0.5mol/L时，就形成了沉淀析出，可是使用磷酸钠制备含有SDS的介质时，可以防止这种现象发生.Table 1. Commonly Used Surfactants with Critical MicelleConcentrations表1 罕见概况活性剂的临界胶束浓度Routinely, the dissolution medium is buffered; however, the u搜索引擎优化f purified water as the dissolution medium is suitable for products with adissolution behavior independent of the pH of the medium. There are severalreasons why purified water may not be preferred. The water quality can varydepending on its source, and the pH of the water is not as strictly controlledas the pH of buffer solutions. Additionally, thepH can vary from day to dayand can also change during the run, depending on the drug substance andexcipients. Use of an aqueous–organic solvent mixture as a dissolution mediumis discouraged; however,with proper justification this type of medium may beacceptable.通常，溶出介质为缓冲盐溶液，可是，对非pH值依赖性的制剂可以使用纯化水作为溶出介质.不推荐使用纯化水作为溶出介质的原因：水的质量变动取决于它的来源，而水的pH值不像缓冲溶液能够严格控制；另外，若药物和辅料的溶出对pH值敏感时需要考虑使用缓冲液.另外使用水有机溶剂混合物作为溶出介质也是不推荐的，可是，特殊情况下（有充沛适当的理由），也是可以接受的. Investigations of the stability of thedrug substance should be carried out, when needed, in the selected dissolutionmedium with excipients present, at 37°. This elevated temperature has thepotential to decrease solution stability (degradation). Stability should allowfor sufficient time to complete or repeat the analytical procedure. Physicalstability may be of concern when precipitation occurs because of lowersolubility at room or refrigerated temperature.需要时，应该对原料药的稳定性进行考察，在所选择的溶出介质中加入辅料，在37℃条件下进行考察.这种升高的温度会潜在的降低溶液的稳定性（降解）.稳定性试验应考虑到有足够的时间来完成或重复分析过程.当因室温或冷藏贮存时降低药物的溶解度而发生沉淀时，物理稳定性也需要关注.1.3 Choosing aMedium and VolumeWhen developing a dissolution procedure, one goal is to have sinkconditions, which are defined as having a volume of medium at least three timesthe volume required to form a saturated solution of drug substance. When sinkconditions are present, it is more likely that dissolution results will reflectthe properties of the dosage form. A medium that fails to provide sinkconditions may be acceptable if it is appropriately justified. The compositionand volume of dissolution medium are guided by the solubility investigations.For example, the choice and concentration of a surfactant need to be justifiedfrom the solubility data and the dissolution profiles.当开发一个溶出试验方法时，首先要满足漏槽条件，漏槽条件界说为溶出介质体积至少为药物到达饱和溶液所需体积的三倍.当满足漏槽条件后，溶出度结果能够更好的反映药物制剂的质量.在适当条件下，介质不满足漏槽条件也是可以接受的.溶解介质的组成和体积应根据溶解度的试验结果进行调整.例如，概况活性剂种类和浓度选择，需要根据药物溶解度数据和溶出曲线进行调整.The use of enzymes in the dissolutionmedium is permitted, in accordance with Dissolution <711>, when dissolution failures occur as a result of crosslinkingwith gelatin capsules or gelatincoated products. A discussion of thephenomenon of crosslinking and method development using enzymes can be found inCapsules–Dissolution Testing and Related Quality Attributes<1094>. Validation should be performed with the method using enzymesaccording to section 5. Validation.当交联明胶胶囊或明胶包衣的制剂溶出失败时，在溶出介质中允许加入酶，这同溶出度<711>指导原则一致.在“Capsules–Dissolution Testing and RelatedQuality Attributes<1094>”中可以找到发生交联现象的讨论和采纳酶进行方法开发的研究.根据第5节验证，使用酶方法依照溶出度方法学验证的要求进行验证.Another option is to use media thatfollow more closely the composition of fluids in the stomach and intestinaltract. These media may contain physiological surfaceactive ingredients, suchas taurocholates. The media also may contain emulsifiers (lecithin) andcomponents such as saline solution that increase osmolality. Also, the ionicstrength or molarity of the buffersolutions may be manipulated. The media aredesigned to represent the fed and fasted state in the stomach and smallintestine.These media may be very useful in modeling in vivo dissolutionbehavior of immediaterelease (IR) dosage forms, in particular those containinglipophilic drug substances, and may help in understanding the dissolutionkinetics of the product related to the physiological makeup of the digestivefluids. Results of successful modeling of dissolution kinetics have beenpublished,mainly for IR products. In the case of extendedrelease dosage formswith reduced effect of the drug substance on dissolution behavior, the use ofsuch media needsto be evaluated differently. In vitro performance testing doesnot necessarily require media modeling the fasted and postprandial states (12,13).另一种选择是使用更贴近于胃和肠道流体组分的介质.这些溶出介质可以含有生理概况活性成份，如牛黄胆酸.这些溶出介质也可能含有乳化剂（卵磷脂）和增加渗透压的组分，比如生理盐水溶液.同时，缓冲液的离子强度或体积摩尔浓度是可以控制的.设计的溶出介质模拟了进食和空腹状态下的胃和肠内状态.这些溶出介质对速释制剂（IR）建立体内溶解行为模型方面是非常有用的，特别是这些速释制剂中含有脂溶性的原料药，可能有助于理解和消化液的生理组成相关的制剂溶出动力学.溶解动力学的模型已胜利建立，主要用于速释制剂.对缓释剂型减少药物溶解行为的影响，使用的这些溶出介质需要有区别地进行评估.体外性能测试其实纷歧定需要在空腹和餐后状态建立溶出介质模型. An acid stage is part of the testing ofdelayedrelease products by Method A or Method B in <711>. For drugs with acid solubility less than 10% of the labelclaim or drugs that degrade in acid the usefulness of the acid stage indetecting a coating failure is compromised. This would be handled on acasebycase basis. Possible resolutions include the addition of surfactant tothe acid stage, or adjustment of the specifications.对肠溶制剂，酸中释放度是溶出度的一部份（<711>方法A或者方法B）.针对药物标签中说明在酸中释放度不得过标示量的10%或者防止酸液中降解而进行抗酸包衣的药物.根据具体情况进行解决，可能的解决方案包括：酸性介质中添加概况活性剂或者调整质量标准）During selection of the dissolutionmedium, care should be taken to ensure that the drug substance is suitablystable throughout the analysis. In some cases, antioxidants such as ascorbicacid may be used in the dissolution medium to stabilize the drug. There areoccasions where such actions are not sufficient. For compounds that rapidlydegrade to form a stable degradant,monitoring the degradant alone or incombination with a drug substance may be more suitable than analyzing only thedrug substance. In situ spectroscopic techniques tend to be less affected bydegradation when compared with HPLC analysis (including UHPLC and other liquidchromatographic approaches).在选择溶解介质时，应注意采用办法确保原料药在整个分析过程中的稳定性.在某些情况下抗氧化剂，如抗坏血酸的，可用于在溶出介质中，以保证药物的稳定性.有些时候加入这些抗氧剂是不够的.化合物快速降解形成稳定的降解物，独自监测降解物或与原料药联合监控可能比只分析原料药更适合.与高效液相色谱分析比力（包括超高效液相色谱等液相色谱法），原位光谱分析受降解的影响较小.For compendial Apparatus 1 (basket) andApparatus 2 (paddle), the volume of the dissolution medium can vary from 500 to1000 mL. Usually, the volume needed for the dissolution test can be determinedin order to maintain sink conditions. In some cases, the volume can be increased tobetween 2 and 4 L, using larger vessels and depending on the concentration andsink conditions of the drug; justification for this approach is expected. Inpractice, the volume of the dissolution medium is usuallymaintained within the compendial rangegiven above. Alternatively, it may be preferable to switch to other compendialapparatus, such as a reciprocating cylinder (Apparatus 3), reciprocating holder(Apparatus 7), or flowthrough cell (Apparatus 4).Certain applications may require lowvolumes of dissolution media (e.g., 100–200 mL) when the use of a paddle orbasket is preferred. In these cases, an alternative, noncompendial apparatus(e.g., smallvolume apparatus) may be used.对药典仪器1（篮法）和仪器2（桨法），溶出介质的体积可以从500到1000毫升分歧.通常情况下，溶出介质的体积应当满足漏槽条件.在某些情况下，根据药物的浓度和漏槽条件，可使用较年夜的溶出杯，体积可以增加至2～4升（这种方法必需有充沛的理由）.实际上，溶出介质的体积通常在药典规定范围内.可供选择时，选用药典规定的其他仪器也是可取的，如往复式气缸（仪器3），往复架（仪器7），或流通池（仪器4）.当某些仪器需要较少体积的溶出介质（例如，100200毫升）时，首选桨法或篮法.在这些情况下，非药典仪器仪器（例如，体积小的仪器）也可以选择使用.1.4 Choosingan Apparatus1.4溶出设备选择（桨法和篮法以及其他方法）The choice ofapparatus is based on knowledge of the formulation design and the practicalaspects of dosage form performance in the in vitro test system. In general, acompendial apparatus should be selected.根据对处方设计的认知和体外试验剂型的实际特点选择仪器.一般来说，首选药典仪器.For solid oral dosage forms, Apparatus1 and Apparatus 2 are used most frequently. When Apparatus 1 or Apparatus 2 isnot appropriate, another official apparatus may be used. Apparatus 3(reciprocating cylinder) has been found especially useful for chewable tablets,soft gelatin capsules, delayedrelease dosage forms, and nondisintegratingtypeproducts, such as coated beads. Apparatus 4 (flowthrough cell) may offeradvantages for modifiedrelease dosage forms and immediaterelease dosage formsthat contain active ingredients with limited solubility. In addition, Apparatus4 may have utility for multiple dosage form types such as soft gelatincapsules, beaded products, suppositories, or depot dosage forms, as well assuspensiontype extendedrelease dosage forms. Apparatus 5 (paddle over disk)and Apparatus 6 (rotating cylinder) are useful for evaluating and testingtransdermal dosage forms. Apparatus 7 (reciprocating holder) has application tonondisintegrating, oralmodifiedrelease dosage forms, stents, and implants,as well as transdermal dosage forms. For semisolid dosage forms, the generallyused apparatus include the vertical diffusion cell, immersion cell, andflowthrough cell apparatus with the insert for topical dosage forms (seeSemisolid Drug Products—Performance Tests <1724>).对口服固体制剂，仪器1和仪器2使用最多.当仪器1或仪器2不适用时，可以使用其他官方仪器.已发现仪器3（往复气缸）适用于咀嚼片、软胶囊、缓释制剂和不崩解型产物（如包衣小球）.仪器4（流通池）对活性成份的溶解度有限的缓释剂型和速释剂型提供了很多优势.另外，仪器4可用于多种剂型类型，如软胶囊，微球制剂，栓剂，或贮库型产物，以及悬浮型缓释剂型.仪器5（桨盘）和仪器6（旋转缸）适用于评价和测试的经皮给药制剂.仪器7（往复架）适用非崩解制剂，口服缓释剂型，支架，和植入物，以及透皮制剂.半固态剂型，经常使用的仪器包括立式扩散池，浸入细胞，流通单位仪器适用局部制剂（see Semisolid DrugProducts—Performance Tests <1724>）.Some changes can be made to thecompendial apparatus; for example, a basket mesh size other than the typical40mesh basket (e.g., 10, 20, or 80mesh) may be used when the need isclearly documented by supporting data. Care must be taken that basketsareuniform and meet the dimensional requirements specified in <711>.对药典仪器配件也可以进行一些调整；例如，除药典仪器40目以外的其他规格的溶出篮（例如：10，20或者80目），通过充分的数据进行详细的说明后也可以使用.必需注意的是篮网孔径必需是均匀的而且满足<711>规定的尺寸要求.A noncompendial apparatus may have someutility with proper justification, qualification, and documentation ofsuperiority over the standard equipment. For example, a smallvolume apparatuswith mini paddles and baskets may be considered for lowdosage strengthproducts. A rotating bottle or dialysis tubes may have utility for microspheresand implants, peak vessels, and modified flowthrough cells for special dosageforms including powders and stents.非药典溶出仪器具有优于药典标准仪器的合适设备、资质和文件.例如，一个小体积的溶出仪器配有小桨或者小篮可以用于低剂量制剂.旋转瓶或透析管可能适用于微球、植入制剂，改进的流通池适用于特殊剂型包括粉末和支架.2. METHODDEVELOPMENT2. 方法的开发A properly designed test should yielddata that are not highly variable, and should be free of significant stabilityproblems.High variability in the results can make it difficult to identifytrends or effects of formulation changes. Sample size can affect the observedvariability. One guidance defines dissolution results as highly variable if therelative standard deviation (RSD) is more than 20% at time points of 10 min orless and more than 10% at later time points for a sample size of 12 (14).However,during method development, smaller sample sizes may be used, and theanalyst will need to make a judgment accordingly.Most dissolution results,however, exhibit less variability. In the development of a dissolutionprocedure the source of the variability should be investigated, and attemptsshould be made to reduce variability whenever possible. The two most likelycauses are the formulation itself (e.g., drug substance, excipients, ormanufacturing process) or artifacts associated with the test procedure (e.g.,coning, tablets sticking to the vessel wall or basket screen). Visualobservations are often helpful for understanding the source of the variabilityand whether the dissolution test itself is contributing to the variability. Anytime the dosagecontents do not disperse freely throughout the vessel in auniform fashion, aberrant results canoccur. Depending on the problem, theusual remedies include changing any of the following factors: the apparatustype, speed of agitation, level of deaeration,sinker type, or composition ofthe medium.合理设计一个试验保证数据稳定性（即较低的变异性），而且能够明显反映出样品稳定性问题.结果的高变异难以确定处方变动的趋势和处方变动对溶出度结果的影响.样本年夜小影响所观察到的变异性.如果在10分钟 12个样本的相对标准偏差（RSD）不得过20%或者后续取样点的RSD值年夜于10%.，指导原则对溶出度试验结果界说为高变异性.然而，在方法开发过程中，可以使用较小的样本量，需要对分析作出相应的判断.年夜大都溶出结果，暗示出较少的变异性.在溶出度试验开发过程中应对发生变异的原因进行研究，只要有可能，应检验考试减少变异性.引起变异性的两个最可能的原因是制剂自己（例如，原料药，辅料，或制剂工艺）和与检测过程相关的处置过程（例如，溶出漩涡，片粘在溶出杯壁或篮网上）.试验过程的观察往往有助于查找发生变异的原因或者溶出度测定方法自己是否会发生变异性.任何时间内剂量含量不能均匀地分散在整个容器中，异常结果就可能发生.根据分歧的问题，通常的调节方法包括下列任何一个因素的改变：仪器，转速，脱气水平，沉降篮类型，或者溶出介质的组成.。

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Issues in Informing Science and Information TechnologyDevelopment and Validation of an Instrument for Assessing Users’ Views about the Usability ofDigital LibrariesAlex KoohangUniversity of Wisconsin – Milwaukee, USAkoohang@AbstractThis paper attempted to develop and validate an instrument that measures users’ views about the usability of digital libraries. Users’ views toward the usability of digital libraries may serve as the major conduit to user acceptance and satisfaction, thus promoting positive learning experiences. The instrument, digital library usability , consisted of 12 items that described usability properties of digital libraries. The content validity of the instrument was determined by a panel of experts. The instrument was administered to 293 subjects. The construct validity was determined by con-ducting a set of statistical procedures, including a principal component analysis. The results re-vealed a single component solution that assessed one particular trait. All items of the instrument achieved high loading values indicating that each item contributed to the assessment of the single component that accounted for a high variation among the items. The internal consistency (Cron-bach alpha) was .96. These results suggest that the digital library usability instrument is a valid and reliable instrument that can measure users’ views about the usability of digital libraries. This instrument can be the basis for future research regarding users’ views toward the usability of digi-tal libraries.Keywords : Usability, Usability Attributes, Usability Properties, Digital Library, Electronic Li-brary, Virtual Library, Users’ views, Instrument Validation, Content Validity, Construct Validity, ReliabilityIntroductionA digital library is a blend of “(1) a service; (2) an architecture; (3) a set of information resources, databases of text, numbers, graphics, sound and video etc.; and (4) a set of tools and capabilities to locate, retrieve and utilize the information resources available” Borgman (2000, p. 41). Wat-stein, Calarco, & Ghaphery, (1999) reported that terms such as virtual libraries, on-line libraries, and electronic libraries are used simultaneously and/or interchangeability with the term digital libraries.The Association of Research Libraries (ARL) has suggested a definition for digital libraries that was advanced by Drabenstott (1994). This definition consists of elements that are common toterms used to explain digital libraries.These elements are: • The digital library is not asingle entity;Material published as part of this journal, either on-line or in print,is copyrighted by Informing Science. Permission to make digital orpaper copy of part or all of these works for personal or classroomuse is granted without fee provided that the copies are not made or distributed for profit or commercial advantage AND that copies 1) bear this notice in full and 2) give the full citation on the first page. It is permissible to abstract these works so long as credit is given. To copy in all other cases or to republish or to post on a server or to redistribute to lists requires specific permission from the pub-lisher at Publisher@Usability of Digital Library56 •The digital library requires technology to link the resources of many;•The linkages between the many digital libraries and information services are transparent to the end users;•Universal access to digital libraries and information services is a goal; and•Digital library collections are not limited to document surrogates: they extend to digital artifacts that cannot be represented or distributed in printed formats.Digital libraries are increasingly becoming a part of the digital learning communities, in particu-lar, distance education. Roes (2001) stated that digital libraries are natural complements to elec-tronic learning settings. Digital libraries have many benefits such as bringing information to us-ers; providing enhanced searching, sharing; collaboration, and use of information; and lessening the digital divide (Arms 2000).McCray & Gallagher (2001) stated that designing a usable system is one of the major principles in developing digital libraries. The authors believe that characteristics such as accessibility, sim-plicity, user control, and clear navigation should be incorporated into the design for usability of digital libraries.Usability is generally characterized as the determining aspect of a product or system’s capability to satisfy the needs and specifications of users. Usability is the extent of how users easily and ef-fectively use a product or system. It plays a vital role in user acceptance of a product or system (Dumas & Redish, 1993; Guillemette, 1989; Holms, 2002; Nielsen 1993; Nielsen, 2000; Rosenbaum, 1989; Rubin, 1994; Shackel 1991).A digital library is a system that must be usable. Much of the literature in the area of usability of digital libraries has been on testing and evaluation (Dickstein & Mills, 2000; McGillis & Toms, 2001; McMullen, 2001; Walbridge, 2000). A critical, yet largely unexamined facet of usability of digital libraries is the users’ views of the usability of digital libraries. Research has acknowledged that users’ views play a vital role in determining the usability of digital libraries (Blanford, Stel-maszewska, & Byyan-Kinns, 2001; Covi and Kling 1997). One’s behavior based on his or her views about the usability of digital libraries may play an important role in the success of learning in general. Therefore, this study attempted to develop and validate an instrument that measures users’ views about the usability of digital libraries. Users’ views may serve as the major interme-diary to user acceptance and satisfaction, thus promoting positive learning experience.Development of the Instrument: Content ValidityThe literature has documented many usability attributes that are the end result of a usable product or system. In general the following usability attributes are reported in the literature: effectiveness, learnability, flexibility, and attitude (Shackle, 1991); learnability, efficiency, memorability, er-rors, and satisfaction (Nielsen, 1993); effectiveness, efficiency, and satisfaction (ISO 9241-11, 1998); and understandability, learnability, operability, and attractiveness (ISO 9126-1, 1991). Each usability attribute may be linked to one or more properties that describe a usable system. The properties are elements such as simplicity, recognition, navigability, etc. that are designed into a product or system to make it usable. Many usability properties are reported in the literature (Dumas & Redish, 1993; Guillemette, 1989; Holms, 2002; Nielsen 1993; Nielsen, 2000; Rosenbaum, 1989; Rubin, 1994; Shackel 1991). For example, simplicity is a usability property. If this property is designed into a product or system then that product or system can be considered usable. The presence of this property may influence one or more usability attributes such as user satisfaction, learnability, efficiency, and positive attitude.Similar to any product or system, a digital library must possess usability properties. In otherKoohang57words, in designing digital libraries for usability, appropriate usability properties must be used. For the purpose of this study, a set of usability properties were chosen from the literature that would describe usability of digital libraries. These usability properties for digital libraries were taken to the next step of instrument development and validation – content validity.The content validity of the instrument was determined by a panel of experts consisting of five university professors whose expertise included the fields of information technology, information systems, and information science. The items of the instrument were usability properties that were chosen from an original pool of 15 items. These items described usability of digital libraries. Sev-eral items were modified from their original form to maximize the accuracy and clarity of the items. Three items were eliminated because the panel of experts had determined that they were duplicates of other items. It was the consensus of the panel of experts that the individual items chosen assessed the intended concepts, and that the instrument as a whole was a valid measure of usability of digital libraries. The final instrument consisted of 12 items that described the usability of digital libraries. These items are described below:• Simplicity: A digital library must be simple to use. Simplicity may be linked to usabilityattributes such as learnability, efficiency, satisfaction, and attitude. • Comfort: Users must feel comfortable using a digital library. The usability attributeslinked to comfort may include learnability, efficiency, satisfaction, and attitude. • User friendliness: A digital library must be user-friendly. The attributes connected to thisproperty may include attractiveness, learnability, efficiency, satisfaction, and attitude. • Control: Users must be in control of using a digital library. The usability attributes thataffect this property may include operability, learnability, effectiveness, efficiency, satis-faction, and attitude. • Readability: Accessed information by users from a digital library must be uncluttered andreadable. The usability attributes linked to readability may include understandability, at-tractiveness, learnability, effectiveness, efficiency, satisfaction, and attitude. • Information Adequacy/Task Match: The accessed information from a digital librarymust be adequate. In other words, a digital library is much more usable if there is ade-quate information – no more, no less. The usability attributes connected to this property may include effectiveness, efficiency, satisfaction, and attitude. • Navigability: Users must be able to navigate with ease, freely, and without problemthroughout a digital library. The usability attributes linked to this property may include operability, learnability, effectiveness, efficiency, satisfaction, and attitude. • Recognition: Users must be able to quickly understand the features and functions avail-able in a digital library. The attributes linked to this property may include memorability, error, learnability, efficiency, satisfaction, and attitude. • Access time: The information queried from a digital library must be loaded in a reason-able time. The attributes linked to this property may include flexibility, effectiveness, ef-ficiency, satisfaction, and attitude. • Relevancy: The information accessed from a digital library must be relevant. The attrib-utes linked to this property may include effectiveness, efficiency, satisfaction, and atti-tude.Usability of Digital Library58 •Consistency: The consistency of terms, words, and actions must be present throughout a digital library. The attributes linked to this property may include memorability, learnabil-ity, efficiency, satisfaction, and attitude.•Visual Presentation: Appropriate visual presentation such as text boldfacing, underlin-ing, and italicizing must be present in a digital library. The attributes linked to this prop-erty may include effectiveness, efficiency, attractiveness, satisfaction, and attitude.The instrument used the Likert technique. A five-point scale was developed with five response choices. They were: strongly agree = 5, agree = 4, neither agree nor disagree = 3, disagree = 2, and strongly disagree = 1. Listed below are the instrument items:1.Simplicity: The digital library was simple to use.fort: I felt at ease using the digital library.er friendliness: The digital library was user-friendly.4.Control: I felt in control of using the digital library.5.Readability: The information I accessed from the digital library was uncluttered andreadable.6.Adequacy/Task Match: The accessed information from the digital library was adequate.7.Navigability: I was able to move around throughout the digital library with ease.8.Recognition: I quickly understood the features and functions available in the digital li-brary.9.Access time: The information I asked for from the digital library loaded in a reasonabletime.10.Relevancy: The information I got from the digital library was relevant.11.Consistency: The consistency of terms, words, and actions used throughout the digital li-brary was evident.12.Visual Presentation: Text boldfacing, italicizing, and underlining were present in thedigital library to grab my attention.This instrument uses the Human Computer Interaction (HCI) participative evaluation method using a questionnaire. This method entails collecting data about usability of digital libraries di-rectly from users’ subjective point of views. This method has the ability to acquire all characteris-tics related to “users’ needs, desires, thought processes, and experiences that are difficult to ob-tain otherwise” (Hilbert & Redmiles, 2000, p. 389).MethodSubjectsA total of 293 students who were enrolled in an undergraduate hybrid program in management completed the instrument. The subjects were males and females from a multi-campus university in the Midwest, USA. They were enrolled in courses such as supervision, communication, re-search design, organizational behavior, and human resources. All subjects had completed at least several mini-research paper/essay assignments that required the extensive use of the university’s digital library.The terms electronic library and digital library were used interchangeably by subjects. The digital library used by subjects of this study is a virtual library that is a subset of the actual physical li-brary. It is accessed via the Internet using computer networks. In particular, this digital library included a large number of databases that contain digital full-text of scholarly journals, substan-tive news periodicals, general interest periodicals, and popular periodicals. Other features of the digital library included on-line catalogs for finding books and periodical list, a comprehensive on-Koohang59line tutorial, and asynchronous support by e-mail. All students were required to attend a two-hour library orientation session in the beginning of their program.The subjects were told that their participation in completing the instrument were entirely volun-tarily. All participants were 18 years or older. They were told not to put their names on the in-strument. The subjects were guaranteed anonymity with regard to the publication of the results.Data analysesThe following statistical analyses were conducted using SPSS:1. Kaiser-Meyer-Olkin Measure of Sampling Adequacy was conducted to ensure that therewas adequate and high variability in the collected data.2. Bartlett Test of Sphericity was conducted to ensure that the items of the instrument weresufficiently correlated.3. Principal component analysis with Varimax rotation was conducted on the collected data.This method was used to determine the number of components to retain.4. Reliability test (Cronbach alpha) was conducted to find internal consistencyamong the items.ResultsConstruct ValidityThe data were inspected with regard to their appropriateness for component analysis through the Kaiser-Meyer-Olkin Measure of Sampling Adequacy and the Bartlett Test of Sphericity. The Kaiser-Meyer-Olkin Measure for the date was .885, which suggested that there was sufficient and high variability in the data to conduct component analysis. The results of Bartlett Test of Spheric-ity (Approximate Chi-Square = 4828.65, df = 66, Sig. = .000) suggested that the items were suffi-ciently correlated to conduct component analysis. (See Table 1)Table 1: KMO and Bartlett's TestKaiser-Meyer-Olkin Measure of Sampling Adequacy.888 Bartlett's Test of SphericityApprox. Chi-Square4701.567df 66Sig..000All items were retained and achieved loading values of greater than .64, which suggested that each item contributed to the assessment of the single component solution (See Tables 2 & 3). The single component model accounted for 73.04% of the variation among the items. No rotation was attempted by SPSS after finding a single component solution.Usability of Digital Library60Table 2: CommunalitiesInitial ExtractionSimplicity 1.000 .715Comfort 1.000 .723User friendliness 1.000 .707Control 1.000 .760Readability 1.000 .783 Information Adequacy/Task Match 1.000 .649Navigability 1.000 .765Recognition 1.000 .744Access time 1.000 .764Relevancy 1.000 .692Consistency 1.000 .732Visual Presentation 1.000 .729Table 3: Principal Component Analysis (Component Matrix)Component 1Simplicity .846Comfort .851User friendliness .841Control .872Readability .885 Information Adequacy/Task Match .806Navigability .874Recognition .863Access time .874Relevancy .832Consistency .856Visual Presentation.854Table 4: Descriptive StatisticsN Min Max Mean SDSimplicity 293 1.00 5.00 3.8976 .95968Comfort 293 1.00 5.00 3.9010 .97596 User friendliness 293 1.00 5.00 3.9556 .94075Control 293 1.00 5.00 3.9352 .92856Readability 293 1.00 5.00 3.6826 1.00594 Information Adequacy/Task Match 293 1.00 5.00 3.7543 1.03419Navigability 293 1.00 5.00 3.8020 1.03784Recognition 293 1.00 5.00 3.7884 1.04173Access time 293 1.00 5.00 3.7747 1.01552Relevancy 293 1.00 5.00 3.7440 1.05630Consistency 293 1.00 5.00 3.9386 .91579 Visual Presentation293 1.00 5.00 3.8191 1.00242Koohang61ReliabilityA reliability coefficient (Cronbach alpha) was calculated using the internal consistency method. The calculated coefficient alpha reliability from the results was .96, which suggests that this in-strument is highly suitable to measure users’ views about the usability of digital libraries. The results of correlation matrix, means, and standard deviations are shown in Tables 4 & 5.Table 5: Correlation MatrixV1 V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V1 1.00 V2 0.87 1.00 V3 0.81 0.83 1.00 V4 0.70 0.69 0.71 1.00 V5 0.69 0.70 0.72 0.78 1.00 V6 0.59 0.59 0.64 0.66 0.74 1.00 V7 0.64 0.65 0.62 0.70 0.75 0.73 1.00 V8 0.68 0.67 0.65 0.68 0.73 0.73 0.80 1.00 V9 0.72 0.74 0.69 0.70 0.75 0.63 0.74 0.74 1.00 V10 0.68 0.69 0.68 0.66 0.70 0.64 0.69 0.69 0.84 1.00 V11 0.68 0.68 0.69 0.97 0.77 0.63 0.68 0.68 0.68 0.63 1.00 V12 0.62 0.630.590.680.730.710.970.780.710.650.691.00V6 = Information Adequacy/Task Match, V7 = Navigability, V8 = Recognition, V9 = Access time,V10 = Relevancy, V11 = Consistency, V12 = Visual PresentationConclusionThe literature has documented that usability of a system or product contributes to attributes such as users’ effectiveness, learnability, flexibility, attitude, efficiency, memorability, satisfaction, and understandability, thus creating a positive learning environment for users to accomplish tasks that meet their goals. A usable system contains usability properties that lead to usability attrib-utes.Digital libraries are increasingly becoming a part of the digital learning settings. For this reason, the usability of digital libraries becomes an important issue for both users and designers. Unques-tionably, a digital library must possess usability properties which results in attributes that affect users’ positive and successful learning experience.One’s positive views toward the usability of digital libraries may play an important role in his or her successful accomplishment of tasks, thus ensuring rewarding learning experience. This study attempted to develop and validate an instrument that measures users’ views toward the usability of digital libraries. A set of usability properties that described usability of digital libraries was selected for the instrument. Each property was formed into an item/statement. A panel of experts concluded that the items of the instrument were suitable to measure users’ views toward the us-ability of digital libraries. In other words, the instrument as a whole was a valid measure of us-ability of digital libraries.Initial analyses of the collected data for the instrument suggested that the items of the instrument were sufficiently correlated and that there was adequate and high variability in the collected data to conduct principal component analysis. The results of principal component analysis indicated that the digital library usability instrument measured one particular trait. The analysis revealed a single component solution. All items of the instrument achieved high loading values indicating that each item contributed to the assessment of the single component that accounted for a high variation among the items. The internal consistency (reliability estimate) for the instrument wasUsability of Digital Library62.96 indicating a very high reliability. The Cronbach alpha showed a homogeneous set of items that measure users’ views toward the usability of digital libraries.Currently, the multitudes of commercial digital libraries contain many databases that do not fol-low universal techniques for system usability. Such techniques are perhaps being developed, however; the digital libraries lack the same standardization for system usability. Measuring users’ views about the usability of digital libraries may assist designers of digital libraries to be sensitive to the needs and specifications of users regarding the usability of digital libraries. It may also as-sist the designers of digital libraries in initiating usability standardization within and across all digital libraries.The results of this study were indicative of a valid and reliable instrument that can measure users’ views toward the usability of digital libraries. This instrument represents an initial step toward the establishment of a measurement technique for users’ views toward the usability of digital librar-ies. However, efforts must be made to further improve this instrument by possibly expanding emerging usability properties that might further describe the usability of digital libraries. Fur-thermore, this instrument may be used as the foundation for future research regarding users’ views toward the usability of digital libraries.ReferencesArms, E. (2000). Digital libraries . Cambridge, MA: MIT Press.Borgman, C. (2000). From Gutenberg to the global information infrastructure: Access to information in thenetworked world . Cambridge, MA: MIT Press Blandford, A. E., Harrison, M. D. & Barnard, P. J. (1995). Using interaction framework to guide the designof interactive systems. International Journal of Human-Computer Studies , 43, 101-130. Covi, L. & Kling, R. (1997). Organisational dimensions of effective digital library use: Closed rational andopen natural systems model. In S. Kiesler, Culture of the Internet (pp. 343-360). New Jersey: Law-rence Erlbaum. Dickstein, R. & Mills, R. (2000). Usability testing at the University of Arizona Library: How to let the us-ers in on the design . Information Technology & Libraries , 19 (3), 144-151. Drabenstott, Karen M. (1994). Analytical review of the library of the future. Washington, DC: Council Li-brary Resources. Dumas, J. & Redish, J. (1993). A practical guide to usability testing . Norwood, New Jersey: Ablex. Guillemette, R. A. (1989). Usability in computer documentation design: Conceptual and methodologicalconsiderations. IEEE Transactions on Professional Communication , 32, 217-28. Hilbert, D. & Redmiles, D. (2000). Extracting usability information from user interface events. ACM Com-puting Surveys , 32 (4). Holms, M. (2002). Web usability & navigation . New York: McGraw-HillISO 9241-11 (1998). Ergonomic requirements for office work with visual display terminals (VDT)s - Part11 Guidance on usability . ISO 9126 -1 (1991). Software product evaluation - Quality characteristics and guidelines for their use . McCray A. & Gallagher, M. (2001). Principles for Digital Library Development . Communications of theACM , 44(5), 49-54. McGill, L. & Toms, L. (2001). Usability of the academic library web site: Implications for design. College& Research Libraries , 62 (4), 355-367. McMullen, S. (2001). Usability testing in a library web site redesign project. Reference Service Review , 29(1), 7-22.Koohang63Nielsen, J., (1993). Usability engineering . San Diego, CA: Academic Press.Nielsen, J. (2000). Designing Web usability: The practice of simplicity . Indianapolis: New Riders. Robins, S. (2001). Organizational behavior (9th ed.). New Jersey: Prentice-Hall.Roes, H. (2001). Digital libraries and education: Trends and opportunities. D-Lib Magazine , 7 (7/8). Rosenbaum, S. (1989). Usability evaluations vs. usability testing: When and Why? IEEE Transactions onProfessional Communication , 32, 210-16. Rubin, J. (1994). Handbook of usability testing . New York: John Wiley.Shackel, B., (1991). Usability - context, framework, design and evaluation. In B. Shackel, & S. Richardson(Eds.). Human Factors for Informatics Usability (pp. 21-28). Cambridge: Cambridge University Press. Walbridge, S. (2000). Usability testing and libraries: The WSU experience. ALKI , 16 (3), 23-4.Watstein, S., Calarco, P. & Ghaphery, J. (1999). Digital library: Keywords. Reference Services Review , 27(4), 344-352.BiographyDr. Alex Koohang is an associate professor and director of undergraduate program in the School of Information Studies at University of Wisconsin - Milwaukee, USA. Dr. Koohang has designed, developed, and implemented various traditional, non-traditional, hybrid, and on-linecourses/programs. He has been involved in the development of on-line education, having initiated and administered some of the earliest asynchronous learning networks. His current research inter-ests are in the areas of distance/e-learning, system usability, learning objects and reusability.。

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