The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
Interpreting patient-reported outcome results: US FDA guidance and emerging methods
Open accessAbstract
In recent years, the US FDA has become more critical of instruments used to measure patient-reported outcomes (PROs) in clinical trials. To facilitate decisions related to the approval of drugs, labels and promotional claims based on PROs, the FDA created the Study Endpoints and Label Development (SEALD) group. SEALD has developed a PRO guidance related to the use of PRO measures used to support drug approvals and label claims, including recommendations for establishing thresholds for meaningful change at the individual level (i.e., defining a responder). This article examines in detail the FDA-recommended methodology for defining a responder and analyzing responder-based PRO measure results. We also present other responder analysis approaches for consideration in furthering the precision and interpretation of this methodology.
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Hanley, J. A., & McNeil, B. J. (1983) · Radiology · doi:10.1148/radiology.148.3.6878708 · Cited by 7,016
Farrar, J. T., Young, J. P., LaMoreaux, L., Werth, J. L., & Poole, M. R. (2001) · Pain · doi:10.1016/s0304-3959(01)00349-9 · Cited by 5,808
Determining a minimal important change in a disease-specific quality of life questionnaire
JUNIPER, E. (1994) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(94)90036-1 · Cited by 1,824
Wyrwich, K. W., Tierney, W. M., & Wolinsky, F. D. (1999) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(99)00071-2 · Cited by 862
Walters, S. J., & Brazier, J. E. (2003) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-1-4 · Cited by 405
Hays, R. D., Farivar, S. S., & Liu, H. (2005) · COPD: Journal of Chronic Obstructive Pulmonary Disease · doi:10.1081/copd-200050663 · Cited by 250
Self-citationFarrar, J. T., Dworkin, R. H., & Max, M. B. (2006) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2005.08.018 · Cited by 133
Hays, R. D., Brodsky, M., Johnston, M. F., Spritzer, K. L., & Hui, K.-K. P. (2005) · Evaluation & the Health Professions · doi:10.1177/0163278705275339 · Cited by 111
Self-citationConclusions About Frequently Studied Modified Angoff Standard-Setting Topics
Brandon, P. R. (2004) · Applied Measurement in Education · doi:10.1207/s15324818ame1701_4 · Cited by 73
McLeod, L., Fehnel, S. E., Brandman, J., & Symonds, T. L. (2003) · PharmacoEconomics · doi:10.2165/00019053-200321150-00001 · Cited by 30
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Guidelines for designing and evaluating feasibility pilot studies
Teresi, J. A., Yu, X., Stewart, A. L., & Hays, R. D. (2022) · Medical Care · doi:10.1097/mlr.0000000000001664 · Cited by 734
Report of the NIH Task Force on research standards for chronic low back pain.
Deyo, R. A., Dworkin, S. F., Amtmann, D., Andersson, G., Borenstein, D., Carragee, E., Carrino, J., Chou, R., Cook, K., DeLitto, A., et al. (2014) · The Journal of Pain · doi:10.1016/j.jpain.2014.03.005 · Cited by 533
Yosipovitch, G., Reaney, M., Mastey, V., Eckert, L., Abbé, A., Nelson, L., Clark, M., Williams, N., Chen, Z., Ardeleanu, M., et al. (2019) · British Journal of Dermatology · doi:10.1111/bjd.17744 · Cited by 394
Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy
Absolom, K., Warrington, L., Hudson, E., Hewison, J., Morris, C., Holch, P., Carter, R., Gibson, A., Holmes, M., Clayton, B., et al. (2021) · Journal of Clinical Oncology · doi:10.1200/jco.20.02015 · Cited by 311
Chen, C. X., Kroenke, K., Stump, T. E., Kean, J., Carpenter, J. S., Krebs, E. E., Bair, M. J., Damush, T. M., & Monahan, P. O. (2018) · Pain · doi:10.1097/j.pain.0000000000001121 · Cited by 199
Metadata
- Authors
- McLeod, L. D., Coon, C. D., Martin, S. A., Fehnel, S. E., & Hays, R. D.
- Venue
- Expert Review of Pharmacoeconomics & Outcomes Research
- Publisher
- Informa UK Limited
- Published
- 2011-04
- Volume
- 11
- Issue
- 2
- Pages
- 163-169
- ISSN
- 1473-7167 (ISSN-L)
- 1744-8379
- OpenAlex
- W2090233921
- Cited by
- 320
- References
- 10
- FWCI
- 12.80
- Type
- journal article
- Language
- en
- Open access
- green
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- The paper
- McLeod, L. D., Coon, C. D., Martin, S. A., Fehnel, S. E., & Hays, R. D. (2011). Interpreting patient-reported outcome results: US FDA guidance and emerging methods. Expert Review of Pharmacoeconomics & Outcomes Research. https://doi.org/10.1586/erp.11.12
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
