Assessing the outcomes of healthcare interventions on children and families from their point of view has long been a central goal of pediatric psychology. This approach to outcome assessment is now being embraced in many areas of healthcare under the aegis of patient reported outcomes (PROs)—that is, evaluating health from the perspectives of patients themselves. Their growing importance in clinical research is highlighted by the 2009 guidance issued by the Food and Drug Administration (U.S. DHHS, 2010) on necessary criteria for using PROs to support claims for medical product labeling, the federal government’s establishment of the Patient-Centered Outcomes Research Institute (Clancy & Collins, 2010) and their markedly increased use in clinical trials (Rahimi, Malhotra, Banning, & Jenkinson, 2010). Ample evidence has accrued in support of the validity and practicality of administering PROs to children (Bevans, Riley, Moon, & Forrest, 2010).
As the demand for pediatric participation in clinical trials has grown, the interest in trying to measure pediatric PROs has also increased. The validity and reliability of children as informants about their own states have been supported in large studies using instruments from Healthy Pathways (Bevans, Riley, Forrest, 2010), the Peds QL,(Varni et al., 2007), the Child Health and Illness Profile (Rebok et al., 2001; Riley et al., 2004), and the KIDSCREEN (Ravens-Sieberer et al., 2005, 2008).
The NIH launched in 2004 a program of research called the Patient Reported Outcome Measurement Information System (PROMIS®) (Cella, Yount et al., 2007). The goal of PROMIS is to provide clinicians and researchers access to efficient, precise, valid, and responsive adult- and child-reported measures of health (see www.nihpromis.org for more information). These measures are rapidly proliferating throughout clinical and behavioral research, epidemiology and population surveillance, and clinical practice.
PROMIS comprises a cooperative group of research sites and centers, a unique mixed-methods instrument development process, many measures of health and well-being, and an informatics platform that enables web-based static and dynamic administration (Cella, Yount et al., 2007; Cella et al., 2010; Gershon, Rothrock, Hanrahan, Bass, & Cella, 2010; Riley et al., 2010). This article presents the science of PROMIS and discusses how these methods and tools may solve some of the issues facing pediatric psychology in measuring health outcomes in children.
Source: Journal of Pediatric Psychology, 37(6), 614-621.
Author: Forrest, C. B., Bevans, K. B., Tucker, C., Riley, A. W., Ravens-Sieberer, U., Gardner, W., & Pajer, K. (2012).http://dx.doi.org/10.1093/jpepsy/jss038