ArticleAlimentary pharmacology & therapeutics2017
The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference.
Article in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 39 papers.
What it found
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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.
A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.
A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation
A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation
A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation
A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation
A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation
Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
A Randomised Controlled Trial to Evaluate Effectiveness and Cost-Effectiveness of Intermittent Colonic Exoperistalsis Treatment With MOWOOT Medical Device in Adults With Chronic Constipation Using Trans-Anal Irrigation.
Who cites it
39 citing papers in PubMed, 84 citations in OpenAlex.
- Establishing the minimal important change for Patient Assessment of Constipation Quality of Life questionnaire for the prevention of opioid-induced constipation in patients with cancer pain.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Trial
- Inulin-induced improvements on bowel habit and gut microbiota in adults with functional constipation: findings of a randomized, double-blind, placebo-controlled study.BMC gastroenterology · 2025Trial
- Effects of konjac glucomannan on gastrointestinal symptoms and gut microbiota in athletes with functional constipation: a double-blind randomized controlled trial.European journal of nutrition · 2025Trial
- Tai Chi's synergistic modulation on autonomic nervous activity and central autonomic networks in functional constipation patients: a randomized controlled trial.Scientific reports · 2025Trial
- Trial
- Effect of oral naloxone on opioid-induced constipation in methadone maintenance treatment patients, a double-blind, placebo-control, clinical trial.Irish journal of medical science · 2024Trial
- Acacia fiber or probiotic supplements to relieve gastrointestinal complaints in patients with constipation-predominant IBS: a 4-week randomized double-blinded placebo-controlled intervention trial.European journal of nutrition · 2024Trial
- Trial
- Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation.Techniques in coloproctology · 2022Trial
- Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.United European gastroenterology journal · 2020Trial
- Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial.International urogynecology journal · 2020Trial
- Short-Term Daily Intake of Polydextrose Fiber Does Not Shorten Intestinal Transit Time in Constipated Adults: A Randomized Controlled Trial.Nutrients · 2018Trial
- Abbreviated anorectal biofeedback therapy is beneficial in symptomatic improvement of functional defecatory disorder.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026Article
- Study Design Considerations for the Evaluation of Pancreatic Enzyme Replacement Therapy (PERT) Products in People with Cystic Fibrosis: An Update.Clinical therapeutics · 2026Review
- Beyond a single threshold: deepening the methodology for minimal important change in OIC prevention.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Roseburia intestinalis-derived inosine improves intestinal motility by activating TGF-β1/p-Smad3/Transgelin signaling axis.Journal of translational medicine · 2025Article
- Prophylactic laxative use for postoperative constipation in urological cancer: a real-world cohort study.World journal of urology · 2025Article
- Deep phenotyping of patient lived experience in functional bowel disorders using machine learning.Scientific reports · 2025Article
- Article
- Opioid-induced Constipation: Old and New Concepts in Diagnosis and Treatment.Journal of neurogastroenterology and motility · 2024Review
Corrections and comments
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Authors and funding
9 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC-SYM score used to define a clinical response on this 0-4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.
aimTo determine the minimal important difference in PAC-SYM score, and the optimum cut-off value for defining responders.
methodsThe minimal important difference was estimated using data from six international phase 3/4, double-blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), with anchor- and distribution-based approaches. Five appropriate patient-reported outcomes were selected as anchors. In addition, receiver operating characteristics (ROC) curve analyses were used to investigate responder discrimination for each anchor.
resultsData from 2884 patients were included. Minimal important difference estimates ranged from -0.52 to -0.63 across the five anchors. Estimates were not affected by study location but were consistently lower for rectal symptoms than for abdominal and stool symptoms. Distribution-based estimates were considerably lower than anchor-based estimates. ROC curve analyses showed optimum cut-off scores for discriminating responders to be similar to anchor-based minimal important difference estimates.
conclusionsAnchor-based methods gave consistent results for the minimal important difference, at approximately -0.6, and this value was close to the ROC-determined optimal cut-off scores for responder discrimination. This value could be considered in clinical practice. A slightly more conservative threshold (eg -0.75) could be used in clinical trials to reduce the placebo response rate.
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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.