Evidence map›Paper›PMID 23857339›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2014

Assessment of abdominal pain through global outcomes and recent FDA recommendations in children: are we ready for change?

Saeed Mohammad, Carlo Di Lorenzo, Nader N Youssef, Adrian Miranda, Samuel Nurko, Paul Hyman, Miguel Saps

Abstract readMulticenter StudyRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
6.4field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Gastrointestinal symptoms predictors of health-related quality of life in pediatric patients with functional gastrointestinal disorders.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2017
    Article
  5. Article
  6. Article
  7. Article
  8. The Gastrointestinal Pain Pointer: A Valid and Innovative Method to Assess Gastrointestinal Symptoms.Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates
    Article
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

7 authors at 6 institutions in 1 country.

Saeed Mohammad*Division of Pediatric Gastroenterology, Hepatology and Nutrition, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University, Feinberg School of Medicine, Chicago, IL †Division of Gastroenterology, Nationwide Children's Hospital, Columbus, OH ‡Digestive Healthcare Center, Hillsborough, NJ §Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Medical College of Wisconsin, Milwaukee, WI ||Center for Motility and Functional Gastrointestinal Disorders, Children's Hospital Boston, Boston, MA ¶Division of Pediatric Gastroenterology, Children's Hospital of New Orleans, New Orleans, LA.
Carlo Di Lorenzo
Nader N Youssef
Adrian Miranda
Samuel Nurko
Paul Hyman
Miguel Saps
Northwestern University · USChildren's Hospital of New Orleans · USDigestive Care (United States) · USHarvard University Press · USMedical College of Wisconsin · USNationwide Children's Hospital · US

Funding

Clincal and Translational Science AwardUL1TR000055 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI SHAKER, REZA NONE · 2012 to 2015
$11.3M
NCATS NIH HHS UL1 TR000055
6 · The paper itself

Abstract

objectivesIrritable bowel syndrome is a multisymptom construct, with abdominal pain (AP) acting as the driving symptom of patient-reported severity. The Food and Drug Administration considers a >30% decrease in AP as satisfactory improvement, but this has not been validated in children. We investigated the correspondence of 2 measures for AP assessment, ≥30% improvement in AP and global assessment of improvement.

methodsSecondary analysis of data from 72 children who completed a randomized clinical trial for abdominal pain-associated functional gastrointestinal disorders. Children completed daily assessment of AP intensity, functional disability inventory (FDI), question regarding pain's interference with activities, and 2 global assessment questions. We measured the extent to which ≥30% improvement of AP and global assessment questions correlated with each other and with disability.

resultsThe global questions correlated with each other (r=0.74; P<0.0001) and with a ≥30% improvement in AP (P<0.01). Global outcomes were satisfaction with treatment was inversely related to the child's report of interference with activities (P<0.01) and symptom relief was positively associated with ≥30% improvement in FDI scores (P<0.009). A 30% change in FDI scores was associated with global questions of symptom relief (P=0.009) but not with satisfaction with treatment (P=0.07). The association of AP improvement with interference with activities (P=0.14) or change in FDI scores (P=0.27) did not reach significance.

conclusionsCurrently used global assessments are significantly associated with decreased pain intensity, decreased interference with daily activities, and a ≥30% change in FDI scores, whereas recommended 30% improvement in pain intensity is not as comprehensive.

Indexed as

Activities of Daily LivingDisability EvaluationPatient SatisfactionSeverity of Illness IndexAbdominal PainAdolescentAmitriptylineAnalgesics, Non-NarcoticChildFemaleHumansIrritable Bowel SyndromeMaleOutcome Assessment, Health CarePractice Guidelines as TopicSurveys and QuestionnairesAmitriptylineAnalgesics, Non-Narcotic

Identifiers

PMID23857339
PMCPMC4641447
OpenAlexW1974629481

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.