SynthesisGastroenterology2009
Psychometric evaluation of patient-reported outcomes in irritable bowel syndrome randomized controlled trials: a Rome Foundation report.
Synthesis in Gastroenterology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.
- Physical activity for treatment of irritable bowel syndrome.The Cochrane database of systematic reviews · 2022Pooled it
- Evidence-based clinical practice guidelines for irritable bowel syndrome.Journal of gastroenterology · 2015Guideline
- Trial
- Trial
- A Microbial Signature of Psychological Distress in Irritable Bowel Syndrome.Psychosomatic medicine · 2018Trial
- Trial
- Trial
- Lubiprostone does not influence visceral pain thresholds in patients with irritable bowel syndrome.Neurogastroenterology and motility · 2011Trial
- A cognitive-behavioral treatment for irritable bowel syndrome using interoceptive exposure to visceral sensations.Behaviour research and therapy · 2011Trial
- Initiating multi-strain probiotics is associated with clinically meaningful symptom relief, better quality of life, and fewer treatment escalations in IBS-D/IBS-M: a Chinese real-world propensity-matched cohort study.Frontiers in medicine · 2026Article
- Impact of HADS Anxiety and Depression Scores on the Efficacy of Dietary Interventions for Irritable Bowel Syndrome.Alimentary pharmacology & therapeutics · 2025Article
- Patients' perceptions on non-specific effects of acupuncture: Qualitative comparison between responders and non-responders.Integrative medicine research · 2022Article
- Validity and Reliability of the Malay Versions of Bloating Severity (BSQ-M) and Quality of Life (BLQoL-M) Questionnaires.International journal of environmental research and public health · 2021Article
- Intestinal Microbiome in Irritable Bowel Syndrome before and after Gut-Directed Hypnotherapy.International journal of molecular sciences · 2018Article
- Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics.Integrative medicine research · 2018Article
- Cost Effectiveness of Biomarker Tests for Irritable Bowel Syndrome With Diarrhea: A Framework for Payers.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018Article
- Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms.World journal of gastroenterology · 2017Observational
- Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea.BioPsychoSocial medicine · 2017Article
- Factors affecting response to proton pump inhibitor therapy in patients with gastroesophageal reflux disease: a multicenter prospective observational study.Journal of gastroenterology · 2015Observational
- [Visceral pain].Schmerz (Berlin, Germany) · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 1 country.
Funding
Abstract
BACKGROUND &
aimsThere is debate about how best to measure patient-reported outcomes (PROs) in irritable bowel syndrome (IBS). We pooled data to measure the psychometric properties of IBS end points, including binary responses (eg, "adequate relief") and 50% improvement in symptom severity.
methodsWe pooled data from 12 IBS drug trials involving 10,066 participants. We tested the properties of binary response and 50% improvement end points, including the impact of baseline severity on performance, and measured construct validity using clinical anchors.
resultsThere were 9044 evaluable subjects (age, 44 years; 85% female; 58% IBS constipation-prominent [IBS-C]; 31% IBS diarrhea-prominent [IBS-D]). Using the binary end point, the proportion responding in the mild, moderate, and severe groups was 42%, 40%, and 38%, respectively (P = .0008). There was no effect of baseline severity on binary response (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.99-1.0; P = .07). The proportions reaching 50% improvement in pain were 45%, 41%, and 41%, respectively; there was a small, yet significant, impact of baseline severity (OR, 1.04; 95% CI, 1.03-1.05; P < .0001) that did not meet clinical relevance criteria. Both end points revealed strong construct validity and detected "minimally clinically important differences" in symptoms. Both provided better discriminant spread in IBS-D than IBS-C.
conclusionsBoth the traditional binary and 50% improvement end points are equivalent in their psychometric properties. Neither is impacted by baseline severity, and both demonstrate excellent construct validity. They are optimized for the IBS-D population but also appear valid in IBS-C.
Indexed as
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What OpenQuestion holds
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.