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Making PROMIS meaningful to patients and providers in clinical practice
Investigator (PI): Bingham, Clifton
Performing Organization (PO): (Current): Johns Hopkins Medicine, Department of Medicine, Division of Rheumatology / (410) 955-6642
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2019
Record Source/Award ID: PCORI/ME-1402-10818
Funding: Total Award Amount: $767,229
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Patient-reported outcomes (PROs) provide information from an individual's perspective on the impact of a disease and its treatment on symptoms, function, and quality of life. When used in health care settings, PROS can target patient-valued symptoms, improve communication, help detect new problems, enhance monitoring, and prompt changes in patient management to optimize care. To facilitate uptake in clinical practice, PROs must be viewed as relevant by both patients and clinicians, with scores that are easily interpretable. NIH's PROMIS was developed and tested in the general population to compare aspects of health across chronic diseases. The precision, efficiency, and selection of PROMIS measures currently available to researchers has generated interest in moving PROMIS into health care to help inform treatment decisions. However, a new PROMIS report identifies key knowledge gaps, including the extent to which universal PROMIS measures are relevant to single conditions, perform similarly across subgroups, and are responsive to change. These gaps may hinder the widespread adoption of PROMIS in clinical settings. Rheumatoid arthritis (RA), a disease characterized by pain, disability, and fatigue, is an optimal model to explore whether PROMIS can improve care. RA affects individuals across the lifespan with debilitating symptoms that often fluctuate rapidly between high and low levels. In our ongoing PCORI project, we are evaluating the feasibility, validity, and impact of using PROMIS in arthritis care. Our preliminary results suggest PROMIS scales target patient-valued symptoms, are feasible to implement, and provide additional information to assess treatment adequacy. However, interviews with patients and providers have also identified important barriers to use. PROMIS scores are presented on a population-normalized metric (T-score); unfortunately normative scores for scales like physical function, pain, and fatigue convey little information about symptom severity or clinical meaning for people with RA, who often experience high levels of symptoms. Patients have asked: What do these results say about me? How do I compare with other people with RA? How much better or worse can I expect to get? Doctors asked: What are typical PROMIS scores in RA? What are clinically meaningful differences for improvement or worsening? What are the action values that should trigger concern? These issues reflect critical gaps between measurement and application that must be addressed to make PROMIS meaningful to patients and providers in clinical practice. Objectives: Our overall goal is to develop and test an approach to evaluate the Relevance, Responsiveness, and appropriate Reactions to PROMIS results all within the context of what is Right for the Patient. Our specific aims are to assemble and prospectively collect data from a well-characterized and representative group of RA patients to 1) confirm the relevance of items in selected PROMIS Short Forms in RA, 2) evaluate responsiveness and establish minimally important differences (MIDs), and 3) seek consensus among RA patients and providers for meaningful thresholds of severity and changes that would signal a need to react to the results. Methods: A mixed-methods approach will be used. Patient interviews (n=36) and online surveys (n=200) will help us confirm the relevance of selected PROMIS measures for people with RA through cognitive interviewing methods. We will assemble a cohort of patients (n=280) and follow them over three consecutive visits to establish the responsiveness and minimally important differences. Finally, we will extend a standard-setting method widely used in educational testing to develop a novel consensus-building process, where patients and clinicians work together to define meaningful cut-points for symptom severity and identify the appropriate change thresholds that would signal a need to react and re-evaluate the current treatment approach. We will test these methods in RA, but are confident they will be broadly applicable and therefore can serve as a template to establish relevance, responsiveness, and reaction thresholds in PROMIS across multiple chronic diseases. Patient and stakeholder engagement: This research addresses questions raised by the patients, patient research partners, clinicians, and stakeholders in our ongoing project. Our Patient Research Partners are essential members of our team and have helped write this application and refine study methods. They will be directly involved in all aspects of conducting the study including participating on the steering committee and in investigator and stakeholder teleconferences, monitoring recruitment, reviewing interim results, creating protocols and materials for patients, and disseminating findings to broader lay audiences. We have also engaged a diverse group of stakeholders from health care systems and payers, research networks, government, industry, patient advocacy groups, and other spheres. These individuals also helped us develop this application and will offer guidance throughout the study and help evaluate the broader implications of this work. Anticipated impact: The project will serve as an exemplar of applying proven methods to ensure the relevance and responsiveness of PROMIS SFs across chronic diseases. We will test the novel application of standard setting and consensus building approaches, drawn from education and business models and our own experience. This will be the first study to bring together patients and clinicians to establish thresholds for symptom severity and changes that would signal a need to react to PROMIS results. If these methods prove to be successful, this approach will be applicable to a wide range of health outcome measures to enhance use and value of PROMIS in clinical care.
MeSH Terms:
  • Arthritis, Rheumatoid /*therapy
  • Cohort Studies
  • Decision Making
  • Disabled Persons
  • Health Services Accessibility
  • Humans
  • Outcome Assessment, Health Care
  • Pain
  • Patient Participation
  • Patient-Centered Care /*organization & administration
  • Prospective Studies
  • Quality of Life
  • Research Design
Country: United States
State: Maryland
Zip Code: 21224
UI: 20152294
Project Status: Completed
Record History: ('2019: Project extended to 2019. 2018: Project extended to 2018. 2017: Project extended to 2017',)