Evidence map›Paper›PMID 28116591›Full record

SynthesisDigestive diseases and sciences2017

PRISM, a Patient-Reported Outcome Instrument, Accurately Measures Symptom Change in Refractory Gastroesophageal Reflux Disease.

Garth Fuller, Roger Bolus, Cynthia Whitman, Jennifer Talley, M Haim Erder, Alain Joseph, Debra G Silberg, Brennan Spiegel

Abstract readSystematic ReviewValidation Study
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In one paragraph

Synthesis in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

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

4 citing papers in PubMed.

  1. Article
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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

8 authors.

Garth FullerCedars-Sinai Center for Outcomes Research and Education (CS-CORE), 116 N. Robertson Blvd.Suite 400, Los Angeles, CA, 90048, USA.
Roger BolusCedars-Sinai Center for Outcomes Research and Education (CS-CORE), 116 N. Robertson Blvd.Suite 400, Los Angeles, CA, 90048, USA.
Cynthia WhitmanCedars-Sinai Center for Outcomes Research and Education (CS-CORE), 116 N. Robertson Blvd.Suite 400, Los Angeles, CA, 90048, USA.
Jennifer TalleyCedars-Sinai Center for Outcomes Research and Education (CS-CORE), 116 N. Robertson Blvd.Suite 400, Los Angeles, CA, 90048, USA.
M Haim ErderM. H. Erder Health Economics, Inc, Livingston, NJ, USA.
Alain JosephShire, Zählerweg 10, 6300, Zug, Switzerland.
Debra G SilbergM. H. Erder Health Economics, Inc, Livingston, NJ, USA.
Brennan SpiegelCedars-Sinai Center for Outcomes Research and Education (CS-CORE), 116 N. Robertson Blvd.Suite 400, Los Angeles, CA, 90048, USA. brennan.spiegel@cshs.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al. in Cochrane Database Syst Rev 18:CD002095, 2004; El-Serag et al. in Aliment Pharmacol Ther 32:720-737, 2010).

aimTo develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial responders.

methodsWe prepared a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy, and scored at least 8 points on the GerdQ [6]. Qualitative data guided development of 26 draft items. Items were reviewed by expert panels and debriefed with patients. The resulting 21-item instrument underwent psychometric evaluation during a Phase IIB trial.

resultsDuring the trial, confirmatory factor analysis (n = 220) resulted in a four-factor model displaying the highest goodness of fit. All domains had a high inter-item correlation (Cronbach's α > 0.8). Test-retest reliability and convergent validity were strong, with highly significant (p < 0.01) correlations between average weekly PRISM scores and severity anchors and significant (p < 0.05) correlations with anchor subscales. Cumulative distribution functions revealed significant differences between responders and non-responders.

conclusionsAnalysis in a clinical trial setting demonstrated strong psychometric properties suggesting validity of PRISM. Developed in line with FDA guidance on PROs, PRISM represents an important new outcome measure for patients with GERD with a partial response to PPI therapy.

Indexed as

Gastroesophageal RefluxPatient Reported Outcome MeasuresPsychometricsQuality of LifeSymptom AssessmentAdultClinical Trials as TopicData AccuracyDrug ResistanceFactor Analysis, StatisticalFemaleHumansMaleMiddle AgedProton Pump InhibitorsQualitative ResearchProton Pump InhibitorsGastroesophageal refluxPatient-reported outcomesProton pump inhibitorsPsychometricsQualitative researchUS Food and Drug AdministrationValidation studies

Identifiers

PMID28116591

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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.