Cited by 244Psychometric Methodologies and TestingHealth Systems, Economic Evaluations, Quality of LifeHealth Education and Validation

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Advances in Patient Reported Outcomes: The NIH PROMIS Measures

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Broderick, Joan, DeWit, Esi Morgan, Rothrock, Nan, Crane, Paul, Forrest, Christopher B.·2013·eGEMs (Generating Evidence & Methods to improve patient outcomes)

DOI 10.13063/2327-9214.1015PMC PMC4371419

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Abstract

Patient reported outcomes (PROs) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed using contemporary psychometric methods, yielding rapid, accurate measurement. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. There is potential for use of PROs to improve quality of care and disease outcomes, to provide patient-centered assessment for comparative effectiveness research, and to enable a common metric for tracking outcomes across providers and medical systems.

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Figure 1. PROMIS Adult Domains Available as of 2013CC BY-NC-ND · PubMed Central

Figure 2. PROMIS Pediatric (8 to 17 years old) and Parent-Proxy Report (5 to 17 years old) Domains Available as of 2013CC BY-NC-ND · PubMed Central

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The Patient-Reported Outcomes Measurement Information System (PROMIS): Progress of an NIH Roadmap Cooperative Group During its First Two Years
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Why the nation needs a policy push on patient-centered health care
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Self-citation
Notices
Ellwood, P. M. (1988) · New England Journal of Medicine · doi:10.1056/nejm198806093182327 · Cited by 698

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Background
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“The PF-CAT is based on modern psychometric techniques using item response theory, which has been used in the educational field to optimize test administration for decades by reducing time constraints to the participant, test length, data entry errors, and organizational cost while preserving data efficacy [3, 4].”
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Background
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“By using sophisticated algorithms, item selection is automatically matched to the health level of respondents, and the number of questions is reduced to a minimum.(1) 5–7 35 36 Available PROMIS instruments are useful for patients in the field of orthopaedics and traumatology (eg, the physical function CAT and pain int…”
BackgroundMethodInfluential
Major adverse renal events (MARE): a proposal to unify renal endpoints
Prischl, F. C., Rossing, P. R., Bakris, G. L., Mayer, G. J., & Wanner, C. (2019) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfz212 · Cited by 35
NIH HEAL Common Data Elements (CDE) implementation: NIH HEAL Initiative IDEA-CC
Adams, M. C. B., Hurley, R. W., Siddons, A., Topaloĝlu, Ü., Wandner, L. D., ICDEWG, Adams, M. C. B., Arnsten, J. H., Bao, Y., Barry, D. T., et al. (2023) · Pain Medicine · doi:10.1093/pm/pnad018 · Cited by 34
Performance of Pediatric PROMIS CATs in Children With Upper Extremity Fractures
Gerull, W. D., Okoroafor, U. C., Guattery, J. M., Goldfarb, C. A., Wall, L. B., & Calfee, R. P. (2018) · Hand · doi:10.1177/1558944718793195 · Cited by 33
“The pediatric PROMIS Physical Function assessment is comprised of individual mobility and upper extremity (UE) assessments that produce separate component scores.(4,9,14,20) In the pediatric population, a selfreport version can be completed by the child (8-17 years old) or a parent-proxy version can be completed by a…”
BackgroundMethod
Patient Reported Outcomes as Indicators of Pediatric Health Care Quality
Bevans, K. B., Moon, J., Carle, A. C., Mara, C. A., Lai, J., DiMarco, L., Müller, N., & Woods, D. M. (2014) · Academic Pediatrics · doi:10.1016/j.acap.2014.06.002 · Cited by 32
Sleep Quality and Emotion Regulation Interact to Predict Anxiety in Veterans with PTSD
Mantua, J., Helms, S. M., Weymann, K. B., Capaldi, V. F., & Lim, M. M. (2018) · Behavioural Neurology · doi:10.1155/2018/7940832 · Cited by 31
“The main analyses were conducted using several self-reported questionnaires: (1) Emotion Regulation Questionnaire (ERQ) [12], (2) National Institutes of Health Patient-Reported Outcomes Measurement Information System (NIH PROMIS) anxiety items [13], and (3) Insomnia Severity Index (ISI) [14].”
Method
Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial
Bossche, D. V., Lagaert, S., Willems, S. J. T., & Decat, P. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18063097 · Cited by 31
“Sample sizes were based on detecting a between-arm difference in mean change from baseline in PROMIS emotional support, social isolation, ability to participate in social roles and activities and anxiety T-scores at 8 weeks of 5 points, the meaningful change for this instrument [46,47].”
Method
Implementing PROMs in routine clinical care: a qualitative exploration of GP perspectives
Litchfield, I. J., Greenfield, S., Turner, G., Finnikin, S., & Calvert, M. (2020) · BJGP Open · doi:10.3399/bjgpopen20x101135 · Cited by 30
Psychosocial Effects of a Holistic Ayurvedic Approach to Well-being in Health and Wellness Courses
Patel, S., Klagholz, S., Peterson, C. T., Weiss, L., Chopra, D., & Mills, P. J. (2019) · Global Advances In Health and Medicine · doi:10.1177/2164956119843814 · Cited by 29
“Institutes of Health research initiative, the PROMIS, and Assessment Center, assessing a range of anxiety symptoms.(28) Additionally, data on age, gender, and number of months practicing meditation and/or number of months practicing yoga were obtained (Table 1).”
Method
Integrating remote monitoring into heart failure patients’ care regimen: A pilot study
Sohn, A., Speier, W. F., Lan, E. H., Aoki, K., Fonarow, G. C., Ong, M. K., & Arnold, C. W. (2020) · PLoS ONE · doi:10.1371/journal.pone.0242210 · Cited by 27
Patient reported outcome measures (PROMs) in amyotrophic lateral sclerosis
Marchi, F. D., Berry, J. D., Chan, J. G. M., Caldwell, S., Ellrodt, A. S., Scalia, J., Burke, K. M., Fang, T., Sisodia, R. C., Schwamm, L. H., et al. (2020) · Journal of Neurology · doi:10.1007/s00415-020-09774-8 · Cited by 28
“Two PROM questionnaires were administered: the PROMIS-10 and the Quality of Life in Neurological Disorders-fatigue subscale (NeuroQoL-fatigue) [18].”
Method
Movement pattern training compared with standard strengthening and flexibility among patients with hip-related groin pain: results of a pilot multicentre randomised clinical trial
Harris‐Hayes, M., Steger-May, K., Bove, A. M., Foster, S. N., Mueller, M. J., Clohisy, J. C. F., & Fitzgerald, G. K. (2020) · BMJ Open Sport & Exercise Medicine · doi:10.1136/bmjsem-2019-000707 · Cited by 32
The promise of computer adaptive testing in collection of orthopaedic outcomes: an evaluation of PROMIS utilization
Wong, L. H., & Meeker, J. E. (2022) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-021-00407-w · Cited by 28
“…Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) was developed to deliver standardized, precise, quantitative values for individual domains of health and well-being [4], and has great potential to improve understandings of PROs in orthopaedic cases.”
Method
Finding ikigai: How robots can support meaning in later life
Randall, N., Joshi, S., Kamino, W., Hsu, L.-J., Agnihotri, A., Li, G., Williamson, D. S., Tsui, K., & Šabanović, S. (2022) · Frontiers in Robotics and AI · doi:10.3389/frobt.2022.1011327 · Cited by 27
Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder
Santiago, J., Akeman, E., Kirlić, N., Clausen, A. N., Cosgrove, K. T., McDermott, T. J., Mathis, B. K., Paulus, M. P., Craske, M. G., Abelson, J. L., et al. (2020) · Trials · doi:10.1186/s13063-019-3802-9 · Cited by 26
“NIH PROMIS® [64] and Toolbox® [65] measures Table 2 Diagnostic, demographic, self-report, behavioral, and neuroimaging assessments (Continued)”
Method
A novel application of SMART on FHIR architecture for interoperable and scalable integration of patient-reported outcome data with electronic health records
Wesley, D. B., Blumenthal, J., Shah, S., Littlejohn, R., Pruitt, Z. M., Dixit, R. A., Hsiao, C., Dymek, C., & Ratwani, R. M. (2021) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocab110 · Cited by 26
Patient-centred outcomes of imaging tests: recommendations for patients, clinicians and researchers
Thompson, M. J., Suchsland, M. Z., Hardy, V., Lavallee, D. C., Lord, S. J., Devine, E. B., Jarvik, J. G., Findlay, S. D., Trikalinos, T. A., Walter, F. M., et al. (2021) · BMJ Quality & Safety · doi:10.1136/bmjqs-2021-013311 · Cited by 26
Self-Reported Health Outcomes of Children and Youth with 10 Chronic Diseases
Forrest, C. B., Schuchard, J., Bruno, C., Amaral, S. G., COX, E. D., Flynn, K. E., Hinds, P. S., Huang, I., Kappelman, M. D., Krishnan, J. A., et al. (2022) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2022.02.052 · Cited by 29
Self-citation
Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial
Ellison, J. S., Lorenzo, M., Beck, H., Beck, R., Chu, D. I., Forrest, C. B., Huang, J. Y., Kratchman, A. L., Kurth, A., Kurth, L., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-056789 · Cited by 26
Self-citation
User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care
Tsangaris, E., Edelen, M. O., Means, J., Gregorowitsch, M. L., O’Gorman, J., Pattanaik, R., Dominici, L. S., Hassett, M. J., Witkowski, M. L., Schrieber, K., et al. (2022) · BMJ Surgery Interventions & Health Technologies · doi:10.1136/bmjsit-2021-000119 · Cited by 32
“32 33 Seamless integration with the EHR, including the ability for providers to easily make direct referrals (eg, to physical therapy or social work) based on PRO scores, is generally lacking.”
Background
Barriers to treatment optimization and achievement of patients’ goals: perspectives from people living with rheumatoid arthritis enrolled in the ArthritisPower registry
Gavigan, K., Nowell, W. B., Serna, M. S., Stark, J. L., Yassine, M., & Curtis, J. R. (2020) · Arthritis Research & Therapy · doi:10.1186/s13075-019-2076-7 · Cited by 24
“Participants completed four patientreported outcome (PRO) measures included in the Patient-Reported Outcomes Measurement Information System – Computerized Adaptive Tests (PROMIS-CATs): Pain Interference, Fatigue, Sleep Disturbance, and Physical Function [10].”
Method
Association Between Patient Experience With Patient-Reported Outcome Measurements and Overall Satisfaction With Care in Neurology
Lapin, B. R., Honomichl, R. D., Thompson, N. R., Rose, S. L., Sugano, D., Udeh, B. L., & Katzan, I. L. (2019) · Value in Health · doi:10.1016/j.jval.2019.02.007 · Cited by 25
Idio Scale Judgment: evaluation of a new method for estimating responder thresholds
Cook, K. F., Kallen, M. A., Coon, C. D., Victorson, D. E., & Miller, D. M. (2017) · Quality of Life Research · doi:10.1007/s11136-017-1625-2 · Cited by 23
mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial
Miyamoto, S., Dharmar, M., Fazio, S., Tang-Feldman, Y. J., & Young, H. M. (2018) · JMIR Research Protocols · doi:10.2196/resprot.9168 · Cited by 24
Large-scale momentary brain co-activation patterns are associated with hyperalgesia and mediate focal neurochemistry and cross-network functional connectivity in fibromyalgia
Mawla, I., Huang, Z., Kaplan, C. M., Ichesco, E., Waller, N., Larkin, T. E., Zöllner, H. J., Edden, R. A. E., Harte, S. E., Clauw, D. J., et al. (2023) · Pain · doi:10.1097/j.pain.0000000000002973 · Cited by 27
Understanding the Connection Among Ikigai, Well-Being, and Home Robot Acceptance in Japanese Older Adults: Mixed Methods Study
Randall, N., Kamino, W., Joshi, S., Chen, W.-C., Hsu, L.-J., Tsui, K. M., & Šabanović, S. (2023) · JMIR Aging · doi:10.2196/45442 · Cited by 24
An Overview of the Traumatic Brain Injury–Quality of Life (TBI-QOL) Measurement System
Tulsky, D. S., & Kisala, P. A. (2019) · Journal of Head Trauma Rehabilitation · doi:10.1097/htr.0000000000000531 · Cited by 24
A Systematic Review of the Outcomes Used to Assess Upper Body Lymphedema
Sierla, R., Dylke, E. S., & Kilbreath, S. L. (2018) · Cancer Investigation · doi:10.1080/07357907.2018.1517362 · Cited by 22
“Patientreported outcomes are gaining recognition for their importance in health-related research (70), particularly for chronic disease management (71).”
Background
Being Present 2.0 : Online Mindfulness-Based Program for Metastatic Gastrointestinal Cancer Patients and Caregivers
Dragomanovich, H. M., Dhruva, A., Ekman, E., Schoenbeck, K. L., Kubo, A., Van Blarigan, E. L., Borno, H. T., Esquivel, M., Chee, B., Campanella, M., et al. (2021) · Global Advances in Health and Medicine · doi:10.1177/21649561211044693 · Cited by 20
“0) Time to death, months (median, range) 6 (1-13) Distance from home to UCSF, miles (median, range) 25 (1-2340) Lives outside San Francisco (N, %) 36 (78.”
BackgroundMethod
Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study
Hirten, R. P., Danieletto, M., Landell, K., Zweig, M., Golden, E., Pyzik, R., Kaur, S., Chang, H. L., Helmus, D. S., Sands, B. E., et al. (2024) · JMIR Mental Health · doi:10.2196/55552 · Cited by 23
“Higher scores reflect higher degrees of positive affect and well-being [63].”
Background
High prevalence of unmet healthcare need among people who use illicit drugs in a Canadian setting with publicly-funded interdisciplinary primary care clinics
Moallef, S., Homayra, F., Milloy, M., Bird, L., Nosyk, B., & Hayashi, K. (2020) · Substance Abuse · doi:10.1080/08897077.2020.1846667 · Cited by 19
Patient-reported outcomes for measuring sleep disturbance in pediatric atopic dermatitis: Cross-sectional study of the Patient Reported Outcomes Measurement Information System pediatric sleep measures and actigraphy
Fishbein, A. B., Lor, J., Penedo, F. J., Forrest, C. B., Griffith, J. W., & Paller, A. S. (2020) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2020.05.138 · Cited by 19
Self-citation
Value-based health care in Western countries: a scoping review on the implementation of patient-reported-outcomes sets for hospital-based interventions
Eijsink, J. F. H., Fabian, A., Vervoort, J. P. M., Khayat, M. N. M. T. A., Boersma, C., & Postma, M. J. (2022) · Expert Review of Pharmacoeconomics & Outcomes Research · doi:10.1080/14737167.2023.2136168 · Cited by 18
Determining the Effectiveness of Using Patient-Reported Outcomes in Pediatric Clinical Practices
Cheng, L., Kang, Q., Wang, Y., & Hinds, P. S. (2020) · Journal of Pediatric Nursing · doi:10.1016/j.pedn.2020.07.005 · Cited by 18
The use of the Core Outcome Measures Index (COMI) in patients undergoing total knee replacement
Impellizzeri, F. M., Leunig, M., Preiß, S., Guggi, T., & Mannion, A. F. (2016) · The Knee · doi:10.1016/j.knee.2016.11.016 · Cited by 17
When Dialysis “Becomes Life”: Pediatric Caregivers' Lived Experiences Obtained From Patient-Reported Outcomes Measures
Erez, D. L., Meyers, M. R., Raman, S., Thomas, M. J., Furth, S. L., Forrest, C. B., & Denburg, M. (2022) · Frontiers in Pediatrics · doi:10.3389/fped.2022.864134 · Cited by 17
Self-citation
Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System
Harle, C. A., Lipori, G. P., & Hurley, R. W. (2016) · eGEMs (Generating Evidence & Methods to improve patient outcomes) · doi:10.13063/2327-9214.1240 · Cited by 17
Using REDCap and Apple ResearchKit to integrate patient questionnaires and clinical decision support into the electronic health record to improve sexually transmitted infection testing in the emergency department
Ahmad, F. A., Payne, P., Lackey, I. T., Komeshak, R., Kenney, K., Magnusen, B., Metts, C. L., & Bailey, T. C. (2019) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocz182 · Cited by 17
How to Integrate Lived Experience Into Quality-of-Life Assessment in Patients Considering Facial Transplantation
Kimberly, L. L., Alfonso, A. R., Ramly, E. P., Kantar, R. S., Caplan, A. L., & Rodriguez, E. D. (2019) · The AMA Journal of Ethic · doi:10.1001/amajethics.2019.980 · Cited by 17
Teaching Health versus Treating Illness: The Efficacy of Three Principles Correctional Counseling with People in an English Prison
Kelley, T. M., Hollows, J., Lambert, E. G., Savard, D. M., & Pransky, J. B. (2017) · International Journal of Offender Therapy and Comparative Criminology · doi:10.1177/0306624x17735253 · Cited by 16
Concept and Measurement of Pediatric Value
Forrest, C. B., & Silber, J. H. (2014) · Academic Pediatrics · doi:10.1016/j.acap.2014.03.013 · Cited by 16
Self-citation
The effect of EHR-integrated patient-reported outcomes on satisfaction with chronic pain care.
Harle, C. A., Marlow, N. M., Schmidt, S. O., Shuster, J. J., Listhaus, A., Fillingim, R. B., & Hurley, R. W. (2016) · PubMed · Cited by 16
Detecting Non-cognitive Features of Prodromal Neurodegenerative Diseases
Seifan, A., Ganzer, C. A., Ryon, K. A., Lin, M. K., Mahmudur, R., Henriquez, A. M., Shih, C., Jacobs, A. R., Greenwald, M., & Isaacson, R. (2019) · Current Aging Science · doi:10.2174/1874609812666190204094233 · Cited by 16
“The standardized assessment included National Institutes of Health Patient Reported Outcomes Measurement & Information System (NIH PROMIS) scales assessing depression, anxiety, alcohol use, and sleep [19], as well as other validated scales measuring sleep and perceived stress [20, 21].”
Method
Interpreting Patient-Reported Outcome Scores: Pediatric Inflammatory Bowel Disease as a Use Case
Schuchard, J., Carle, A. C., Kappelman, M. D., Tucker, C. A., & Forrest, C. B. (2022) · Academic Pediatrics · doi:10.1016/j.acap.2021.12.029 · Cited by 16
Self-citation
Measuring subjective quality of life in autistic adults with the PROMIS global–10: Psychometric study and development of an autism-specific scoring method
Williams, Z. J., Cascio, C. J., & Woynaroski, T. G. (2022) · Autism · doi:10.1177/13623613221085364 · Cited by 18
“The PROMIS Global–10 (short form version 1.2; Hays et al., 2009) is a 10-item measure of general QoL developed as a part of the National Institutes of Health PROMIS initiative (Broderick et al., 2013; Cella et al., 2010).”
MethodInfluential
Behavioral activation therapy for depression is associated with a reduction in the concentration of circulating quinolinic acid
Savitz, J. B., Ford, B. N., Yeh, H., Akeman, E., Cosgrove, K. T., Clausen, A. N., Martell, C. R., Kirlić, N., Santiago, J., Teague, T. K., et al. (2020) · Psychological Medicine · doi:10.1017/s0033291720004389 · Cited by 15

Authors: Broderick, J., DeWit, E. M., Rothrock, N., Crane, P., & Forrest, C. B.
Affiliations: Stony Brook University (US)
Northwestern University (US)
University of Washington (US)
University of Pennsylvania (US)
ORCID: Broderick, Joan
Rothrock, Nan
Crane, Paul
Forrest, Christopher B.
Venue: eGEMs (Generating Evidence & Methods to improve patient outcomes)
Publisher: Ubiquity Press, Ltd.
Published: 2013-02-08
Volume: 1
Issue: 1
Pages: 12
ISSN: 2327-9214 (ISSN-L)
DOI: 10.13063/2327-9214.1015
PMC: PMC4371419
OpenAlex: W1908118904
Cited by: 244
References: 54
Citations by year: 2026: 6 · 2025: 13 · 2024: 25 · 2023: 23 · 2022: 34 · 2021: 31 · 2020: 26 · 2019: 21 · 2018: 25 · 2017: 14 · 2016: 10 · 2015: 5 · 2014: 10
FWCI: 11.40
Type: journal article
Language: en
Open access: diamond
doi.org
Licence: cc-by-nc-nd
Locations: eGEMs (Generating Evidence & Methods to improve patient outcomes) (publishedVersion, cc-by-nc-nd)
Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders: Children's Hospital of Philadelphia (U01AR057956)
Northwestern University (U54AR057951, U54AR057943, U01AR052177)
University of Washington (U01AR052171, U01AR057954)
University of Pittsburgh (U01AR052155)
Georgetown University (U01AR057971)
Australian Government
National Institutes of Health (5u01ar057940-04, U01AR057940)
University of California, Los Angeles (U01AR057936)
University of North Carolina at Chapel Hill (U01AR052181)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01AR052171, U01AR057956, U01AR057967, U01AR052186, U01-AR-057940, U01AR057936, U54AR057943, U01AR057929, U01AR052170, U01AR052158, U01AR052155, U01AR052177, U01AR052181, U01AR057971, U01AR057954, U01AR057948, U54AR057926, U54AR057951)
Common Fund
Topics: Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Health Sciences › Nursing › Research and Theory › Health Education and Validation
Keywords: patient-reported outcomes, PROMIS, item bank, computerized adaptive testing, health-related quality of life, physical function, mental health, social health, shared decision-making, comparative effectiveness research, patient-centered outcomes, outcome measurement

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