Evidence map›Paper›PMID 26952842›Full record

ArticleJournal of clinical epidemiology2016

PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions.

Karon F Cook, Sally E Jensen, Benjamin D Schalet, Jennifer L Beaumont, Dagmar Amtmann, Susan Czajkowski, Darren A Dewalt, James F Fries, Paul A Pilkonis, Bryce B Reeve and 3 more

5 registry-linked trialsAbstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 288 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
288citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06101849 nacompletednot on this mapstarted 2024, after this paper: background citation

Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2024 to 2025Enrolled23ConditionsBreast Cancer, Cancer, Treatment-Related, Pain CancerArmsI-Can-Manage-Pain after cancer (Pain Management Program)
NCT06543355 nacompletednot on this mapstarted 2025, after this paper: background citation

The Acupuncture for Pain, Opioid Use Disorder and Mood (AcuPOM) Study: A Pilot Trial

TypeinterventionalSponsorAlbert Einstein College of MedicineRan2025 to 2025Enrolled17ConditionsChronic Pain, Opioid Use Disorder, Mood Change, Opioid MisuseArmsModified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol
NCT06953648 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Remotely Monitored, Mobile Health-supported, High Intensity Interval Training Before Hematopoietic Stem Cell Transplantation (REMM-HIIT-HCT)

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2025 to 2030Enrolled126ConditionsHematopoietic Stem Cell Transplantation, Cardiorespiratory FitnessArmsHigh Intensity Interval Training
NCT07102914 naenrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Building Effective Evidence-Based Services at New Haven Adult Education

TypeinterventionalSponsorYale UniversityRan2025 to 2028Enrolled340ConditionsBehavioral Health ChallengesArmsScreening, Brief Intervention and Referral for Treatment (SBIRT)
NCT07516314 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients (ACTivate)

TypeinterventionalSponsorAnthony Sung, MDRan2026 to 2031Enrolled476ConditionsStem Cell Transplant PatientsArmsACTivate sessions
3 · Its place in the literature

Who cites it

288 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Utility of the Patient-Reported Outcomes Measurement Information System (PROMIS) to measure primary health outcomes in cancer patients: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Pooled it
  4. Trial
  5. Determining the feasibility of self-administered relaxing acupressure for fatigue among adolescent and young adult cancer survivors.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Trial
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  15. Preliminary effects of a yoga intervention for lung cancer dyads: benefits for care partners.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Trial
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228 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Karon F CookDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA. Electronic address: karon.cook@northwestern.edu.
Sally E JensenDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA; Department of Surgery (Division of Organ Transplant), Northwestern University Feinberg School of Medicine, 251 E. Huron, Galter 3-150, Chicago, IL, USA.
Benjamin D SchaletDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA.
Jennifer L BeaumontDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA.
Dagmar AmtmannDepartment of Rehabilitation Medicine, University of Washington School of Medicine, 4907 25th Ave NE, Seattle, WA 98105, USA.
Susan CzajkowskiNational Heart Lung and Blood Institute (NHLBI), Building 31, Room 5A52, 31 Center Drive MSC 2486, Bethesda, MD 20892, USA.
Darren A DewaltDivision of General Internal Medicine and Cecil G. Sheps Center for Health Services Research, University of North Carolina School of Medicine, CB# 7590, 725 Martin Luther King Jr. Blvd., Chapel Hill, NC 27599-7590, USA.
James F FriesDepartment of Medicine, Stanford University School of Medicine, 300 Pasteur Dr H3580, Stanford, CA 94305, USA.
Paul A PilkonisDepartment of Psychiatry, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.
Bryce B ReeveDepartment of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB# 7590, 725 Martin Luther King Jr. Blvd., Chapel Hill, NC 27599-7590, USA.
Arthur A StoneUniversity of Southern California, 635 Downey Way, Los Angeles, CA 9008, USA.
Kevin P WeinfurtDepartment of Psychiatry, Duke University School of Medicine, 2400 Pratt Street, Durham, NC 27705, USA.
David CellaDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA.

Funding

Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Daniela E Matei · 1993 to 2026
$153.9M
NIH PROMIS Statistical Coordinating Center(RMI)U01AR052177 · NIAMS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI CELLA, DAVID · 2004 to 2010
$10.6M
Validating and Extending the PROMIS Sexual Function Measure for Clinical ResearchU01AR052186 · NIAMS · DUKE UNIVERSITY · PI WEINFURT, KEVIN P · 2004 to 2013
$9.5M
PROMIS Pediatrics: Longitudinal Validation and Linking Pediatric and Adult Item BU01AR052181 · NIAMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI REEVE, BRYCE B · 2004 to 2013
$9.1M
Patient reported outcomes in routine clinical care of patients infected with HIVU01AR057954 · NIAMS · UNIVERSITY OF WASHINGTON · PI CRANE, HEIDI M., CRANE, PAUL K · 2009 to 2013
$7.8M
Validation and domain development in mental health and sleep-wake functionU01AR052155 · NIAMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI PILKONIS, PAUL A · 2004 to 2013
$6.0M
Validation of PROMIS in Diverse Cancer PopulationsU01AR057971 · NIAMS · GEORGETOWN UNIVERSITY · PI MOINPOUR, CAROL M, POTOSKY, ARNOLD L · 2009 to 2013
$5.7M
Improving Assessment of Physical Function and Drug Safety in Health and DiseaseU01AR052158 · NIAMS · STANFORD UNIVERSITY · PI KRISHNAN, ESWAR · 2004 to 2013
$5.6M
PROMIS Technical CenterU54AR057943 · NIAMS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GERSHON, RICHARD · 2009 to 2013
$5.3M
UW Center on Outcomes Research in Rehabilitation(RMI)U01AR052171 · NIAMS · UNIVERSITY OF WASHINGTON · PI AMTMANN, DAGMAR · 2004 to 2008
$5.0M
Pediatric PROMIS: Advancing the Measurement and Conceptualizaiton of Child HealthU01AR057956 · NIAMS · CHILDREN'S HOSP OF PHILADELPHIA · PI FORREST, CHRISTOPHER B · 2009 to 2014
$4.9M
QUALITY OF LIFE EVALUATION IN ONCOLOGYR01CA060068 · NCI · RUSH UNIVERSITY MEDICAL CENTER · PI CELLA, DAVID · 1995 to 2008
$4.8M
NCI NIH HHS P30 CA060553NCI NIH HHS R01 CA060068NCI NIH HHS R01 CA160671NIAMS NIH HHS U01 AR052155NIAMS NIH HHS U01 AR052158NIAMS NIH HHS U01 AR052170NIAMS NIH HHS U01 AR052171NIAMS NIH HHS U01 AR052177NIAMS NIH HHS U01 AR052181NIAMS NIH HHS U01 AR052186NIAMS NIH HHS U01 AR057929NIAMS NIH HHS U01 AR057936NIAMS NIH HHS U01 AR057940NIAMS NIH HHS U01 AR057948NIAMS NIH HHS U01 AR057954NIAMS NIH HHS U01 AR057956NIAMS NIH HHS U01 AR057967NIAMS NIH HHS U01 AR057971NIAMS NIH HHS U54 AR057926NIAMS NIH HHS U54 AR057943NIAMS NIH HHS U54 AR057951
6 · The paper itself

Abstract

objectiveTo present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations. STUDY DESIGN AND

settingApproximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model.

resultsThe results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions.

conclusionThe cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions.

Indexed as

Activities of Daily LivingAffectSocial BehaviorAdolescentAdultAgedChronic DiseaseChronic PainComorbidityComparative Effectiveness ResearchFatigueFemaleFollow-Up StudiesHumansLongitudinal StudiesMaleOutcomes researchPatient-reported outcomesPsychometricsResponsivenessValidity

Identifiers

PMID26952842
PMCPMC5131708

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.