The Promise of Patient-Reported Outcomes Measurement Information System—Turning Theory into Reality: A Uniform Approach to Patient-Reported Outcomes Across Rheumatic Diseases

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Key points

  • The Patient-Reported Outcomes Measurement Information System (PROMIS) implements modern measurement theory and techniques to advance self- and proxy assessment of symptoms and health-related quality-of-life concepts.

  • PROMIS enables improved measurement precision with less respondent burden by embracing item-response theory and computer-adaptive testing.

  • PROMIS focuses on measuring universally relevant domains of health and disease to allow agnostic assessments across diseases and clinical

New science of patient-reported outcomes

Robust qualitative and quantitative studies, using a “mixed methods approach,” are essential components for PRO development and validation according to modern measurement principles and current standards.3, 4, 5 Despite this, few of the legacy or traditional PROs currently used in clinical medicine, including rheumatology, have been developed with this degree of rigor and attention, especially the inclusion of input from those living with and impacted by the conditions under study during the

Content of Patient-Reported Outcomes Measurement Information System measures

Over the years, investigators from the PROMIS Cooperative Group have developed a robust and evolving library of psychometrically validated scales, short forms, profiles, and item banks that assess key domains/subdomains of patient-reported physical, mental, and social health. PROMIS is based on the observation that there are universally common, core domains that can help describe a person’s health and disease and that these core domains can be measured in a clinically meaningful way across

Pediatric patient-reported outcomes measures

In the second phase of PROMIS (eg, 2009–2014), there was a special emphasis8 on developing and validating new pediatric (including their parent proxy) domains. The PROMIS pediatric framework was developed and additional measures were validated to include additional pediatric and parent or proxy domains (Fig. 8). Many of the domains within the pediatric framework also are measured with the PROMIS’ adult framework; this is reflective of one of the goals of PROMIS, to measure across the lifespan

Psychometric testing of Patient-Reported Outcomes Measurement Information System measures

Validation of outcome measures is a journey, not a destination. Fig. 9 depicts this rigorous validation journey for PROMIS measures. Foremost is ensuring that the psychometric aspects of PRO validation are adequately addressed early with psychometrically focused testing in the development of a PROMIS instrument as outlined in the FDA guidance.4 Items can be tested using qualitative techniques, such as focus groups and cognitive interviews designed to explicate the domain of interest under

Rheumatology applications of Patient-Reported Outcomes Measurement Information System

The PROMIS PF instrument has a unique heritage emerging from the Health Assessment Questionnaire Disability Index (HAQ-DI).10 The PROMIS PF item bank assesses one's ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. This definition is inclusive of the term disability and covers the full spectrum of PF from severe impairment to

Patient-Reported Outcomes Measurement Information System and the Food and Drug Administration

From an FDA perspective, the term qualification is a regulatory term that means the “tool” has undergone critical FDA review through the Center for Drug Evaluation and Research’s Drug development Tools Qualification program.27 Once this process is satisfied, FDA publishes these clinical outcome assessments. They are intended, as appropriate, for wider use because the process of qualification is best envisioned to occur in the precompetitive space. The FDA, NIH, and PROMIS investigators have had

International scope

PROMIS items have been translated into more than 40 languages (http://www.nihpromis.org/measures/translations); thus, international studies are emerging as additional exciting options to advance PRO science and create unique opportunities for collaboration. An expanding PROMIS international working group (http://www.nihpromis.org/science/PROMISInternational) has developed and is executing a strategic action plan for the international spread of PROMIS. The vision for PROMIS-International is to

Future opportunities

PROs provide important insights into individuals’ health and well-being, including the major role symptoms play in the onset and progression of disease, day-to-day function, and response to treatments. In clinical research and health care settings, robust, accurate, and feasible assessment of symptoms has the potential to greatly improve research and patient care. The current adoption and incorporation of PROMIS into large electronic health records systems such as EPIC and through projects,

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    Disclosure Statement: The author has nothing to disclose. Opinions in this article are those of the author and not the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases.

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