caa a22 4500 475847458 CHVBK 20180406123918.0 cr unu---uuuuu 170329e20000901xx s 000 0 eng 10.1023/A:1008996223999 doi (NATIONALLICENCE)springer-10.1023/A:1008996223999 Recommendations on health-related quality of life research to support labeling and promotional claims in the United States [Elektronische Daten] [D.A. Revicki, D. Osoba, D. Fairclough, I. Barofsky, R. Berzon, N.K. Leidy, M. Rothman] Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers. Kluwer Academic Publishers, 2000 Clinical trials nationallicence Health-related quality of life nationallicence Labeling and promotional claims nationallicence Psychometrics nationallicence Regulatory agencies nationallicence Statistical analysis nationallicence Revicki D.A. MEDTAP International, Bethesda, Maryland, USA aut Osoba D. QOL Consulting, Vancouver, British Columbia, Canada aut Fairclough D. AMC Cancer Research Center, Denver, Colorado aut Barofsky I. Johns Hopkins University, Baltimore, Maryland aut Berzon R. Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut aut Leidy N.K. MEDTAP International, Bethesda, Maryland, USA aut Rothman M. Janssen Pharmaceuticals, Titusville, New Jersey, USA aut Quality of Life Research Kluwer Academic Publishers 9/8(2000-09-01), 887-900 0962-9343 9:8<887 2000 9 11136 https://doi.org/10.1023/A:1008996223999 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1023/A:1008996223999 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Revicki D.A. MEDTAP International, Bethesda, Maryland, USA aut NATIONALLICENCE 700 1- Osoba D. QOL Consulting, Vancouver, British Columbia, Canada aut NATIONALLICENCE 700 1- Fairclough D. AMC Cancer Research Center, Denver, Colorado aut NATIONALLICENCE 700 1- Barofsky I. Johns Hopkins University, Baltimore, Maryland aut NATIONALLICENCE 700 1- Berzon R. Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut aut NATIONALLICENCE 700 1- Leidy N.K. MEDTAP International, Bethesda, Maryland, USA aut NATIONALLICENCE 700 1- Rothman M. Janssen Pharmaceuticals, Titusville, New Jersey, USA aut NATIONALLICENCE 773 0- Quality of Life Research Kluwer Academic Publishers 9/8(2000-09-01), 887-900 0962-9343 9:8<887 2000 9 11136 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer