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A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010
4 references·2 citing·23 second hop
A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010 (2012)A Review of Patient-Reported Outcome Labe…FDA guidance on patient reported outcomes (2010)FDA guidance on patient repor…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…Assessing Quality of Life in Clinical Research (1999)Assessing Quality of Life in …A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016) (2019)A Review of Patient-Reported …Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010) (2013)Assessment of PRO Label Claim…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)A 12-Item Short-Form Health Survey (1996)Comparing Alternative Rasch-Based Methods vs Raw Scores in Measuring Change in Health (2003)Benchmarks for evaluating socially assistive robotics (2007)Defining Quality of Life: A Wild-Goose Chase? (2013)Patient reported outcomes: looking beyond the label claim (2010)A technique for measurement of attitudes (1932)Construct validity in psychological tests. (1955)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)Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments (2006)Development of EMPRO: A Tool for the Standardized Assessment of Patient-Reported Outcome Measures (2008)Developing a Valid Patient-Reported Outcome Measure (2011)Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology. (1996)A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (2015)Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received (2016)Fundamentals of randomized clinical trials in wound care: Reporting standards (2013)Translation of Questionnaires Measuring Health Related Quality of Life Is Not Standardized: A Literature Based Research Study (2015)Montreal Accord on Patient-Reported Outcomes (PROs) use series – Paper 4: patient-reported outcomes can inform clinical decision making in chronic care (2017)
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References

  • 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
  • 2004Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels304 cited
  • 1999Assessing Quality of Life in Clinical Research283 cited
  • 2010FDA guidance on patient reported outcomes173 cited

Cited by

  • 2019A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)129 cited
  • 2013Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010)79 cited

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