There are two significant barriers to including these PROs in comparative effectiveness research (CER): Lack of standardization of PRO scores required to make interpretable comparisons, and feasibility (including acceptability and cost to providers). We propose to address these barriers by developing improved methods and research tools, enabling CER research to include PROs. This will be accomplished through the application and extension of our nationally-recognized expertise on the measurement of health-related quality of life (HRQL) and other PROs, as well as our six-year history of central involvement and leadership of the NIH Roadmap Patient-Reported Outcomes Measurement Information System (PROMIS) and other national efforts to standardize self-reported health and function for clinical research. In our primary and organizing aim of this proposed project, we will develop and apply methods to link PROMIS measures with other related scales to expand the range of PRO assessment options within a common, standardized metric and to aid interpretation of results obtained in future CER studies. We will develop and apply three test scaling and linking methods: Linking separate calibrations (LSC), fixed parameter calibration (FPC), and Equipercentile linking (EQP). This will allow scores on a range of assessment instruments to be expressed as standardized T-score metrics linked to PROMIS. We will use two approaches to support the proposed methods development activity. One approach is to thoroughly analyze the vast amount of available PRO data we have on hand from 20 years of PRO research. The other approach is to conduct six targeted waves of data collection (n=700/wave) from the US general population (n=2,800) and cancer patients (n=1,400), to enable formal linking in measures of social health (2 waves;n=1,400), to bridge pediatric and adult PRO measures (2 waves;n=1,400), and to test the invariance of the linking relationships we form with general population, in people with cancer (2 waves;n=1,400). This will enable us to produce a comprehensive """"""""PRO Rosetta Stone"""""""" for children and adults, including efforts to bridge concepts and measures from childhood into adulthood, and to test the invariance of linking relationships in people with cancer. In addition, as a secondary, supporting aim, we will compile these many linked scales and measures into a """"""""PRO Rosetta Stone"""""""" that will be loaded into our Assessment Center to enable CER to include and report on PRO data, based upon carefully-gathered input and usability testing from external stakeholders and clinical researchers. This will establish the feasibility of integrating PROMIS and other PRO measures available on Assessment Center, to enable a standardized PRO measurement approach in CER. This work will enable a fully comprehensive CER capacity (i.e., inclusive of PROs) across multiple cooperating health care delivery groups.
We propose to address two barriers to including patient-reported outcomes (PROs) in comparative effectiveness research (CER): lack of standardization of PRO scores to aid in their interpretation, and lack of feasibility of incorporating PROs in CER. We will develop and apply methods to link measures developed in the Patient-Reported Outcomes Measurement Information System (PROMIS) and other national efforts to standardize self-reported health and function with other existing related scales. This will expand the range of PRO assessment options and provide a common, standardized scoring system to aid interpretation of results obtained in future CER studies. We will also contribute our Assessment Center web-based survey administration platform. The linked measures will also be loaded into Assessment Center to allow researchers to include and report on PRO data.
