Design and Implementation of N-of-1 Trials: A User’s Guide – AHRQ – 12 February 2014

Posted on February 26, 2014. Filed under: Comparative Effectiveness Research, Research | Tags: |

Design and Implementation of N-of-1 Trials: A User’s Guide – AHRQ – 12 February 2014

AHRQ = US Agency for Healthcare Research and Quality

“Design and Implementation of N-of-1 Trials: A User’s Guide provides information on the design and implementation of n-of-1 trials (a.k.a. single-patient trials), a form of prospective research in which different treatments are evaluated in an individual patient over time. The apparent simplicity of this study design has caused it to be enthusiastically touted in some research fields and yet overlooked, underutilized, misunderstood, or erroneously implemented in other fields. With the advent of comparative effectiveness research and patient-centered outcomes research, there is a renewed interest in n-of-1 trials as an important research method for generating unique scientific evidence on patient health outcomes. A core aspect of this interest is that the n-of-1 approach may overcome some important limitations of other methodologies that involve larger samples of subjects. As a result, findings from n-of-1 trials may be especially useful in informing key health care decisions by patients and providers, particularly when combined with other scientific evidence. Likewise, the expansion of electronic health information technology into all areas of clinical care and the increasing recognition that new systems may also be deployed for research and quality improvement have further driven interest in conducting more n-of-1 trials as part of a learning health care system.

AHRQ commissioned this User’s Guide as an informational resource to researchers, health care providers, patients, and other stakeholders to improve general understanding of n-of-1 trials and strengthen the quality of evidence that is generated when an n-of-1 trial is conducted. The overarching aim of this User’s Guide is to guide readers by identifying key decisions and tradeoffs in the design and implementation of n-of-1 trials, particularly when used for patient-centered outcomes research. Patient-centered outcomes research includes investigations of a wide range of research problems, particularly studying the outcomes, effectiveness, benefits, and harms of diagnostic tests, treatments, procedures, or health care services. This User’s Guide identifies key elements to consider in applying the n-of-1 trial methodology to patient-centered outcomes research, describes some of the important complexities of the method, and provides readers with checklists to summarize the main points.”

… continues on the site


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