Evidence map›Paper›PMID 26931296›Full record

ArticleJournal of clinical epidemiology2016

Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior.

Robert L Askew, Karon F Cook, Dennis A Revicki, David Cella, Dagmar Amtmann

3 registry-linked trialsAbstract readValidation Study
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 3 registered trials, which are not on this map. Cited by 118 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 5 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)
NCT06112093 phase1recruitingnot on this mapstarted 2023, after this paper: background citation

Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study

TypeinterventionalSponsorState University of New York - Upstate Medical UniversityRan2023 to 2027Enrolled60ConditionsBrain Concussion, Mild Traumatic Brain Injury, Headache, Post-Concussion SymptomsArmsRepetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
NCT07044583 narecruitingnot on this mapstarted 2025, after this paper: background citation

SAVE Trial: SAfe Opioid Use Video Education

TypeinterventionalSponsorUniversity of UtahRan2025 to 2027Enrolled68ConditionsBreast Reconstruction, Breast CancerArmsOpioid Educational Video
3 · Its place in the literature

Who cites it

118 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Pooled it
  2. Pooled it
  3. Pooled it
  4. 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
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  18. Defining substantial clinical benefits of PROMIS pain interference in adult spinal deformity patients.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Article
  19. Observational
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58 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

5 authors.

Robert L AskewDepartment of Rehabilitation Medicine, University of Washington School of Medicine, Box 357920, Seattle, WA 98195, USA.
Karon F CookDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, Suite 1900, Chicago IL 60611, USA.
Dennis A RevickiOutcomes Research, Evidera, 7101 Wisconsin Ave., Suite 1400, Bethesda, MD 208147, USA.
David CellaDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, Suite 1900, Chicago IL 60611, USA.
Dagmar AmtmannDepartment of Rehabilitation Medicine, University of Washington School of Medicine, Box 357920, Seattle, WA 98195, USA. Electronic address: dagmara@u.washington.edu.

Funding

Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LEONIDAS C. PLATANIAS · 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 CA060068NIAMS 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 evaluate clinical validity, including responsiveness, of Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PROMIS-PI) and pain behavior (PROMIS-PB) T-scores. STUDY DESIGN AND

settingData were aggregated from longitudinal studies of cancer, chronic low back pain (cLBP), rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and major depressive disorder (MDD). Linear mixed-effects models were used to compare baseline score differences and score changes over time. We calculated standardized response means (SRMs) for subgroups defined by self-reported change in general health and pain.

resultsA total of 1,357 individuals participated at baseline and 1,225 at follow-up. Hypotheses of significant change in PROMIS-PI and PROMIS-PB scores were supported in the intervention groups (cLBP and MDD). Differences in baseline scores for COPD exacerbators compared to stable COPD patients were in the hypothesized direction but were not statistically significant. Subgroups reporting better health showed corresponding negative SRM values supporting responsiveness of T-scores to improvement. Responsiveness to decrements was supported in some but not all clinical groups and varied by anchor. More congruent values were obtained when using a pain-specific anchor.

conclusionThis study provides evidence that PROMIS-PI and PROMIS-PB scores are sensitive to changes in pain in studies of interventions expected to impact pain. The results inform estimation of meaningful change and support power analyses for comparative effectiveness research.

Indexed as

Activities of Daily LivingSocial BehaviorAdolescentAdultAgedChronic DiseaseChronic PainComorbidityComparative Effectiveness ResearchFemaleFollow-Up StudiesHumansLongitudinal StudiesMaleMiddle AgedNational Institutes of Health (U.S.)Back painCancerChronic painPain behaviorPain interferencePROMIS

Identifiers

PMID26931296
PMCPMC4957699

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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.