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The FDA guidance for industry on PROs: the point of view of a pharmaceutical company
10 references·0 citing·47 second hopsampled
The FDA guidance for industry on PROs: the point of view of a pharmaceutical company (2006)The FDA guidance for industry on PROs: th…Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change (2006)Minimal changes in health sta…The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory? (2004)The use of patient reported o…Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels (2004)Measuring treatment impact: a…Incorporating the Patient's Perspective into Drug Development and Communication: An Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001 (2003)Incorporating the Patient's P…Methods to Explain the Clinical Significance of Health Status Measures (2002)Methods to Explain the Clinic…Health-Related Quality of Life (HR-QOL) and Regulatory Issues (2001)Health-Related Quality of Lif…Recommendations on health-related quality of life research to support labeling and promotional claims in the United States (2000)Recommendations on health-rel…Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion (1999)Recommendations for Evaluatin…The Problem of Quality of Life in Medicine (1997)The Problem of Quality of Lif…Measuring change over time: Assessing the usefulness of evaluative instruments (1987)Measuring change over time: A…The American Psychological Association (1919)Construct validity in psychological tests. (1955)Measurement of health status (1989)Core outcome domains for chronic pain clinical trials: IMMPACT recommendations (2003)Defining clinically meaningful change in health-related quality of life (2003)Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes (2007)The Sickness Impact Profile: Development and Final Revision of a Health Status Measure (1981)Measuring Health-Related Quality of Life (1993)Interpretation of Changes in Health-related Quality of Life (2003)Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial (2010)Review of Psychometric theory (2nd ed.). (1979)Linking Clinical Variables With Health-Related Quality of Life (1995)Effects of cognitive–behavioural therapy on health-related quality of life in obese subjects with and without binge eating disorder (2002)SF-36 health survey: Manual and interpretation guide (2003)Health-Related Quality of Life and Other Patient-Reported Outcomes in the European Centralized Drug Regulatory Process: A Review of Guidance Documents and Performed Authorizations of Medicinal Products 1995 to 2003 (2005)Instrumentos de medida de calidad de vida relacionada con la salud y de otros resultados percibidos por los pacientes (2005)A Critical Appraisal of the Quality of Quality-of-Life Measurements (1994)Using quality of life measures in the clinical setting (2001)Quality of life in older people: A structured review of generic self-assessed health instruments (2005)Routine outcome monitoring and feedback on physical or mental health status: evidence and theory (2010)Coproduction of healthcare service (2015)Foundations of Cost-Effectiveness Analysis for Health and Medical Practices (1977)Judgment Under Uncertainty: Heuristics and Biases. (1984)A taxonomy for responsiveness (2001)Health, Health-Related Quality of Life, and Quality of Life: What is the Difference? (2016)Statistical principles in experimental design. (1962)Reliability and Validity Assessment (1979)QUANTIFYING TEST-RETEST RELIABILITY USING THE INTRACLASS CORRELATION COEFFICIENT AND THE SEM (2005)Quality criteria were proposed for measurement properties of health status questionnaires (2006)Reliability and Validity Assessment (2011)A technique for measurement of attitudes (1932)The Pediatric Quality of Life Inventory: Measuring Pediatric Health-Related Quality of Life from the Perspective of Children and Their Parents (2009)PRO development: rigorous qualitative research as the crucial foundation (2010)Cross-cultural adaptation of the Health Education Impact Questionnaire: experimental study showed expert committee, not back-translation, added value (2013)Theory of games and economic behavior (2019)A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale (1991)The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. (1992)The MOS 36-ltem Short-Form Health Survey (SF-36) (1992)Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments (2006)An Introduction to Item Response Theory for Patient-Reported Outcome Measurement (2014)Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. (1991)Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. (1991)A methodological review of resilience measurement scales (2011)A point of minimal important difference (MID): a critique of terminology and methods (2011)COSMIN guideline for systematic reviews of patient-reported outcome measures (2018)Generic Health-Related Quality-of-Life Assessment in Children and Adolescents (2006)Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (2018)
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References

  • 1987Measuring change over time: Assessing the usefulness of evaluative instruments1,882 cited
  • 2002Methods to Explain the Clinical Significance of Health Status Measures1,525 cited
  • 2006Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change830 cited
  • 1997The Problem of Quality of Life in Medicine640 cited
  • 2000Recommendations on health-related quality of life research to support labeling and promotional claims in the United States577 cited
  • 2003Incorporating the Patient's Perspective into Drug Development and Communication: An Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001515 cited
  • 2004The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory?436 cited
  • 1999Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion387 cited
  • 2004Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels304 cited
  • 2001Health-Related Quality of Life (HR-QOL) and Regulatory Issues87 cited

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