The Patient Centered Outcomes Research Institute (PCORI) released its Preliminary Draft Methodology Report, entitled “Our Questions, Our Decisions: Standards for Patient-centered Outcomes Research” on June 4, 2012. Among other things, the report sets forth 60 standards to guide the process of patient-centered outcomes research. This initial list of standards, set forth in Appendix A of the report, was selected to reflect areas in which PCORI’s Methodology Committee believed that there were “either substantial deficiencies or inconsistencies in how the methods were applied in practice, or for which there was specialized knowledge in how to conduct research that had not been effectively disseminated.” These standards fall into the following 11 categories:
- Standards for formulating research questions
- Patient-centeredness
- Research prioritization
- General and cross-cutting methods for all patient-centered outcomes research
- Causal inference
- Heterogeneity of Treatment Effects
- Missing data
- Data networks
- Adaptive trials
- Data registries
- Diagnostic tests