Abstract
Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context.IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed.
Highlights
Elements of the US Patient-reported outcomes measurement information system (PROMIS) network PROMIS is a cooperative group of research sites and centers that employ mixed-methods development processes to create domain-specific measures of physical, mental and social health for use across diseases [5,6,7,8]
item response theory (IRT)-calibrated item banks are the methodological basis of the U.S National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS®)
Current categories of PROMIS measures for adults and pediatrics are shown in Figure 1; several new PROMIS pediatric and adult measures are scheduled for release in 2014
Summary
There is increasing recognition of the importance of integrating patients’ perspectives into clinical practice and research using tools that measure patients’ experiences of their health (i.e., patient-reported outcomes (PROs)). Well-known and internationally validated PRO measures, such as the SF-36 and EQ-5D, are used in clinical, economic and health services research, quality improvement, and clinical practice, as well as general population health assessment [3,4]. An exciting development in PROs has been the introduction of modern psychometric methods such as item response theory (IRT). IRT-calibrated item banks are the methodological basis of the U.S National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS®). One goal of PROMIS has been to standardize measurements in research and clinical practice, much like blood chemistry panels, facilitating comparability of data across studies and settings. We make the case for extending this PRO standardization internationally, building on the highly successful U.S PROMIS network initiative
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