October 1998 | Ray Fitzpatrick, Claire Davey, Martin J Buxton, David R Jones
The report "Evaluating Patient-Based Outcome Measures for Use in Clinical Trials" by Ray Fitzpatrick, Claire Davey, Martin J Buxton, and David R Jones, published in October 1998, aims to guide researchers in selecting appropriate patient-based outcome measures for clinical trials. The authors identify seven major types of instruments: disease-specific, site-specific, dimension-specific, generic, summary item, individualised, and utility. They highlight the lack of consistency in definitions and the diverse purposes of these instruments, emphasizing the need for clear criteria when selecting a measure.
The report outlines eight key criteria for evaluating patient-based outcome measures: appropriateness, reliability, validity, responsiveness, precision, interpretability, acceptability, and feasibility. Each criterion is discussed in detail, with the authors noting that these criteria are not consistently defined and that there is no clear ranking of their relative importance. The report emphasizes that investigators must consider the specific purpose and questions of the trial when choosing a measure, ensuring that the instrument is reproducible, valid, sensitive to changes, precise, interpretable, acceptable, and feasible.
The authors also address the challenges in selecting patient-based outcome measures, such as the lack of consensus on definitions and the need for trade-offs between criteria. They recommend that researchers make explicit decisions about these criteria when choosing a measure and that developers provide evidence under the same headings to support their instruments.
The report concludes with recommendations for both trialists and developers, emphasizing the importance of clear criteria and evidence-based choices. It suggests that further primary research and consensus processes are needed to evaluate leading instruments across different fields and specialties, improving their use in research.The report "Evaluating Patient-Based Outcome Measures for Use in Clinical Trials" by Ray Fitzpatrick, Claire Davey, Martin J Buxton, and David R Jones, published in October 1998, aims to guide researchers in selecting appropriate patient-based outcome measures for clinical trials. The authors identify seven major types of instruments: disease-specific, site-specific, dimension-specific, generic, summary item, individualised, and utility. They highlight the lack of consistency in definitions and the diverse purposes of these instruments, emphasizing the need for clear criteria when selecting a measure.
The report outlines eight key criteria for evaluating patient-based outcome measures: appropriateness, reliability, validity, responsiveness, precision, interpretability, acceptability, and feasibility. Each criterion is discussed in detail, with the authors noting that these criteria are not consistently defined and that there is no clear ranking of their relative importance. The report emphasizes that investigators must consider the specific purpose and questions of the trial when choosing a measure, ensuring that the instrument is reproducible, valid, sensitive to changes, precise, interpretable, acceptable, and feasible.
The authors also address the challenges in selecting patient-based outcome measures, such as the lack of consensus on definitions and the need for trade-offs between criteria. They recommend that researchers make explicit decisions about these criteria when choosing a measure and that developers provide evidence under the same headings to support their instruments.
The report concludes with recommendations for both trialists and developers, emphasizing the importance of clear criteria and evidence-based choices. It suggests that further primary research and consensus processes are needed to evaluate leading instruments across different fields and specialties, improving their use in research.