Evidence map›Paper›PMID 33166066›Full record

Observational studyArthritis care & research2022

Identifying Minimal and Meaningful Change in a Patient-Reported Outcomes Measurement Information System for Rheumatoid Arthritis: Use of Multiple Methods and Perspectives.

Susan J Bartlett, Anna Kristina Gutierrez, Kathleen M Andersen, Vivian P Bykerk, Jeffrey R Curtis, Uzma J Haque, Ana-Maria Orbai, Michelle R Jones, Clifton O Bingham

Registry-linked trialOpen access · greenAbstract readObservational Study
In one paragraph

Observational study in Arthritis care & research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06938399 (Motiva Implants® Post-Approval Study), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 6% of its field
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.

NCT06938399 narecruitingnot on this mapstarted 2025, after this paper: background citation

Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures

TypeinterventionalSponsorMotiva USA LLCRan2025 to 2037Enrolled2,400ConditionsBreast ImplantArmsSilicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
    Pooled it
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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

9 authors at 3 institutions in 2 countries.

Susan J BartlettMcGill University and McGill University Health Centre, Montreal, Quebec, Canada, and Johns Hopkins University, Baltimore, Maryland.
Anna Kristina GutierrezJohns Hopkins University, Baltimore, Maryland.
Kathleen M AndersenJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.ORCID 0000-0003-2670-800X
Vivian P BykerkHospital for Special Surgery, Weill Cornell Medical College, New York, New York.
Jeffrey R CurtisUniversity of Alabama at Birmingham.ORCID 0000-0002-8907-8976
Uzma J HaqueJohns Hopkins University, Baltimore, Maryland.
Ana-Maria OrbaiJohns Hopkins University, Baltimore, Maryland.ORCID 0000-0001-8644-8567
Michelle R JonesJohns Hopkins University, Baltimore, Maryland.
Clifton O BinghamJohns Hopkins University, Baltimore, Maryland.ORCID 0000-0002-4752-5029
Johns Hopkins University · USHospital for Special Surgery · USUniversity of Alabama at Birmingham · US

Funding

Sample Processing and Immunoassay Research CoreP30AR070254 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI CLIFTON O BINGHAM, Antony Rosen · 2016 to 2026
$8.9M
Phenotype-Specific Immune Responses in the Systemic VasculitidesP30AR053503 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI ROSEN, ANTONY · 2006 to 2015
$6.4M
NHLBI Training Program in PharmacoepidemiologyT32HL139426 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI G. Caleb Alexander, JODI B. SEGAL · 2018 to 2026
$2.5M
NHLBI NIH HHS T32 HL139426NIAMS NIH HHS P30 AR053503NIAMS NIH HHS P30 AR070254
6 · The paper itself

Abstract

objectiveRheumatoid arthritis (RA) is chronic, painful, disabling condition resulting in significant impairments in physical, emotional, and social health. Our objective was to use different methods and perspectives to evaluate the responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) short forms (SFs) and to identify minimal and meaningful score changes.

methodsAdults with RA who were enrolled in a multisite prospective observational cohort completed PROMIS physical function, pain interference, fatigue, and participation in social roles/activities SFs, the PROMIS 29-item form (PROMIS-29), and pain and patient global assessment, and rated change in specific symptoms and RA (a little versus lot better or worse) at the second visit. Physicians recorded joint counts, physician global assessment, and change in RA at visit 2. We compared mean score differences for minimal and meaningful improvement/worsening using patient and physician change ratings and distribution-based methods, and we visually inspected empirical cumulative distribution function curves by change categories.

resultsThe 348 adults were mostly female (81%) with longstanding RA. Using patient ratings, generally 1-3-point differences were observed for minimal change and 3-7 points for meaningful change. Larger differences were observed with patient versus physician ratings and for symptom-specific versus RA change. Mean differences were similar among SF versions. Prespecified hypotheses about change in PROMIS physical function, pain interference, fatigue, and participation and legacy scales were supported.

conclusionPROMIS SFs and the PROMIS-29 profiles are responsive to change and generally distinguish between minimal and meaningful improvement and worsening in key RA domains. These data add to a growing body of evidence demonstrating the robust psychometric properties of PROMIS and supporting its use in RA care, research, and decision-making.

Indexed as

Arthritis, RheumatoidPatient Reported Outcome MeasuresAdultFatigueFemaleHumansInformation SystemsMalePain

Identifiers

PMID33166066
PMCPMC10360361
OpenAlexW3104574711

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.