Evidence map›Paper›PMID 25199473›Full record

ArticleThe American journal of gastroenterology2014

Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales.

Brennan M R Spiegel, Ron D Hays, Roger Bolus, Gil Y Melmed, Lin Chang, Cynthia Whitman, Puja P Khanna, Sylvia H Paz, Tonya Hays, Steve Reise and 1 more

Erratum issued 2 registry-linked trialsAbstract read
In one paragraph

Article in The American journal of gastroenterology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 144 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
144citing papers in PubMed, 3 pooled it
12.0field-weighted citation impact, top 1% 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.

NCT04733456 unknown statusnot on this mapstarted 2021, after this paper: background citation

Evaluation of Brain Activity and Oxygenation Using Near-infrared Spectroscopy (NIRS) in Inflammatory Bowel Disease (IBD) Patients

TypeobservationalSponsorUniversity of CalgaryRan2021 to 2026Enrolled40ConditionsIBD, Maladaptive Behavior Associated With Physical IllnessArmsQuality of life questionnaires, NIRS, Stool Collection, Blood and urine collection
NCT07492134 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

TypeinterventionalSponsorVanderbilt University Medical CenterRan2026 to 2028Enrolled100ConditionsAcute Uncomplicated DiverticulitisArmsAmoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, Placebo, Metronidazole, Cefuroxime
3 · Its place in the literature

Who cites it

144 citing papers in PubMed, 3 syntheses or guidelines pooled it, 255 citations in OpenAlex.

  1. Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2017
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  18. Gut microbiome-dependent IL-1 signaling is a mediator of ACVR1bioRxiv : the preprint server for biology · 2026
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  20. Electrophysiological and Proteomic Evidence of Protease-Mediated Pro-nociceptive Signaling in Inflammatory Bowel Disease Patients.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2026
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84 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Brennan M R Spiegel1] Department of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA [2] Cedars-Sinai Center for Outcomes Research and Education, Los Angeles, California, USA [3] Department of Gastroenterology, VA Greater Los Angeles Healthcare System, Los Angeles, California, USA [4] Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.
Ron D Hays1] Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA [2] Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Roger BolusCedars-Sinai Center for Outcomes Research and Education, Los Angeles, California, USA.
Gil Y MelmedDepartment of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Lin Chang1] Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA [2] Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Cynthia WhitmanCedars-Sinai Center for Outcomes Research and Education, Los Angeles, California, USA.
Puja P KhannaDivision of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.
Sylvia H PazDepartment of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.
Tonya HaysDepartment of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.
Steve ReiseDepartment of Psychology, UCLA, Los Angeles, California, USA.
Dinesh KhannaDivision of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.
Cedars-Sinai Medical Center · USUCLA Health · USScleroderma Foundation · USUniversity of California, Los Angeles · USUniversity of Michigan–Ann Arbor · USVA Greater Los Angeles Healthcare System · US

Funding

The Center for Health Improvement of Minority ElderlyP30AG021684 · NIA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Homero Erwin del Pino · 2002 to 2026
$19.7M
Pilot and Feasibility ProgramP30DK041301 · NIDDK · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ROZENGURT, JUAN ENRIQUE · 1990 to 2019
$18.0M
Women's Health and Functional Visceral Disorders CenterP50DK064539 · NIDDK · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MAYER, EMERAN A · 2002 to 2017
$17.5M
TRAINING COREP20MD000182 · NIMHD · CHARLES R. DREW UNIVERSITY OF MED &SCI · PI CUNNINGHAM, WILLIAM EMERY, SHAPIRO, MARTIN F. · 2002 to 2016
$16.5M
NIH PROMIS Statistical Coordinating Center(RMI)U01AR052177 · NIAMS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI CELLA, DAVID · 2004 to 2010
$10.6M
UCLA OLDER AMERICANS INDEPENDENCE CENTERP30AG028748 · NIA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MOORE, ALISON AHERN · 2006 to 2017
$9.8M
Development and Initial Validation of PROMIS GI Distress ScaleU01AR057936 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI KHANNA, DINESH, SPIEGEL, BRENNAN · 2009 to 2013
$2.2M
Outcomes Research in Rheumatic DiseasesK24AR063120 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2012 to 2022
$1.6M
Academic Training in RheumatologyT32AR053463 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SINGH, RAM RAJ · 2007 to 2011
$1.1M
NIAMS NIH HHS 1 T32 AR053463NIAMS NIH HHS AR052177NIAMS NIH HHS K24 AR063120NIAMS NIH HHS T32 AR053463NIAMS NIH HHS U01 AR052177NIAMS NIH HHS U01 AR057936NIAMS NIH HHS U01AR057936ANIA NIH HHS P30 AG021684NIA NIH HHS P30-AG021684NIA NIH HHS P30 AG028748NIA NIH HHS P30-AG028748NIDDK NIH HHS P30 DK041301NIDDK NIH HHS P50 DK064539NIDDK NIH HHS P50 DK64539NIMHD NIH HHS 2P20MD000182NIMHD NIH HHS P20 MD000182
6 · The paper itself

Abstract

objectivesThe National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS gastrointestinal (GI) symptom measures.

methodsWe first conducted a systematic literature review to develop a broad conceptual model of GI symptoms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive debriefing in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on confirmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity.

resultsA total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). The scales correlated significantly with both generic and disease-targeted legacy instruments, and demonstrate evidence of reliability.

conclusionsUsing the NIH PROMIS framework, we developed eight GI symptom scales that can now be used for clinical care and research across the full range of GI disorders.

Indexed as

Information SystemsPatient Outcome AssessmentAdultAgedAged, 80 and overFemaleFocus GroupsGastrointestinal DiseasesHumansMaleMiddle AgedNational Institutes of Health (U.S.)PsychometricsUnited States

Identifiers

PMID25199473
PMCPMC4285435
OpenAlexW2151194216

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.