Evidence map›Paper›PMID 15651544›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2004

Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders.

A M Rentz, P Kahrilas, V Stanghellini, J Tack, N J Talley, C de la Loge, E Trudeau, D Dubois, D A Revicki

5 registry-linked trialsAbstract readMulticenter StudyValidation Study
PubMed Publisher
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2004. 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 194 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
194citing papers in PubMed, 8 pooled it
1.2field-weighted citation impact, top 23% 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.

NCT01269788 phase2 / phase3completednot on this mapstarted 2010, after this paper: background citation

Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial

TypeinterventionalSponsorTehran University of Medical SciencesRan2010 to 2011Enrolled144ConditionsNon-erosive Reflux DiseaseArmsFluoxetine, Omeprazole, placebo
NCT03012594 phase2completednot on this mapstarted 2017, after this paper: background citation

A Pilot Study to Evaluate Safety and Effectiveness of Lanreotide in the Treatment of Patients With Small Bowel Motility Disorders (SBMD): a Prospective, Non-randomized, Single-center Study of 20 Participants

TypeinterventionalSponsorNorthwell HealthRan2017 to 2019Enrolled12ConditionsGastrointestinal Motility Disorder, Intestinal DiseaseArmsLanreotide
NCT03884270 nacompletednot on this mapstarted 2019, after this paper: background citation

Self-Administered Hypnotherapy for Functional Dyspepsia

TypeinterventionalSponsorSarah KinsingerRan2019 to 2020Enrolled23ConditionsFunctional DyspepsiaArmsHypnotherapy
NCT04844190 nawithdrawnnot on this mapstarted 2021, after this paper: background citation

Use of Endoscopic Functional Lumen Imaging Probe (EndoFLIP) and Antroduodenal Manometry (ADM) in Predicting Clinical Response to Gastric Peroral Endoscopic Myotomy (G-POEM): A Pilot Study

TypeinterventionalSponsorNorthwestern UniversityRan2021 to 2024Enrolled0ConditionsGastroparesisArmsEndoFLIP, Antroduodenal Manometry
NCT07697352 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Randomised, Double-Blind, Non-Inferiority Trial Comparing Microbial and Porcine Pancreatic Enzyme Replacement Therapy in Chronic Pancreatitis

TypeinterventionalSponsorAsian Institute of Gastroenterology, IndiaRan2026 to 2027Enrolled134ConditionsPancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)ArmsDietary Supplement: Pancreatic enzyme preparation from microbial source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC)., Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)
3 · Its place in the literature

Who cites it

194 citing papers in PubMed, 8 syntheses or guidelines pooled it, 395 citations in OpenAlex.

  1. Pooled it
  2. A pilot genome-wide association study meta-analysis of gastroparesis.United European gastroenterology journal · 2023
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  4. Dietary Interventions for Gastroparesis: A Systematic Review.Advances in nutrition (Bethesda, Md.) · 2022
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  5. Systematic review of health-related quality of life (HRQoL) issues associated with gastric cancer: capturing cross-cultural differences.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2022
    Pooled it
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  7. Acupuncture for symptomatic gastroparesis.The Cochrane database of systematic reviews · 2018
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134 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

9 authors at 7 institutions in 6 countries.

A M RentzMEDTAP International, Inc, Sindelfingen, Germany. rentz@medtap.com
P Kahrilas
V Stanghellini
J Tack
N J Talley
C de la Loge
E Trudeau
D Dubois
D A Revicki
Mapi Research Trust · FRJohnson & Johnson (United States) · USKlinikum Sindelfingen-Böblingen · DEKU Leuven · BENorthwestern University · USUniversity of Bologna · ITUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDescribe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis.

methodsRecruited subjects with GERD (n=810), dyspepsia (n = 767), or gastroparesis (n = 169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores.

resultsThe final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=0.60-0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p < 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days.

conclusionsResults suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.

Indexed as

PsychometricsQuality of LifeSeverity of Illness IndexAnalysis of VarianceDyspepsiaEuropeFemaleGastroesophageal RefluxGastroparesisHealth Status IndicatorsHumansMaleMiddle AgedSelf DisclosureSurveys and Questionnaires

Identifiers

PMID15651544
OpenAlexW2011934653

What OpenQuestion holds

Textmetadata
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.