| Title |
Methods for interpreting change over time in patient-reported outcome measures
|
|---|---|
| Published in |
Quality of Life Research, April 2012
|
| DOI | 10.1007/s11136-012-0175-x |
| Pubmed ID | |
| Authors |
K. W. Wyrwich, J. M. Norquist, W. R. Lenderking, S. Acaster, the Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL) |
| Abstract |
Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. |
Mendeley readers
The data shown below were compiled from readership statistics for 130 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Japan | 1 | <1% |
| United Kingdom | 1 | <1% |
| United States | 1 | <1% |
| Romania | 1 | <1% |
| Unknown | 126 | 97% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 23 | 18% |
| Student > Ph. D. Student | 16 | 12% |
| Student > Master | 15 | 12% |
| Professor > Associate Professor | 12 | 9% |
| Student > Bachelor | 10 | 8% |
| Other | 33 | 25% |
| Unknown | 21 | 16% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 45 | 35% |
| Psychology | 14 | 11% |
| Nursing and Health Professions | 11 | 8% |
| Social Sciences | 4 | 3% |
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 3% |
| Other | 19 | 15% |
| Unknown | 33 | 25% |