Trial reportChinese medical journal2026
Estimating minimal, moderate, and marked clinically important differences for patient reported outcome measure in randomised controlled trial.
Trial report in Chinese medical journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Combining electroacupuncture and transcutaneous electrical acupoint stimulation for psychiatric disorders in women victims of domestic violence: An assessor-blinded, randomised controlled trial.General psychiatry · 2026Article
- Enhancing clinical interpretation of patient-reported outcomes: A cross-platform toolkit for clinically important difference estimation using R Shiny and statistical analysis system.General psychiatry · 2026Article
- Establishing clinically important differences in adults with attention deficit/hyperactivity disorder.General psychiatry · 2026Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatient-reported outcome measures (PROMs) are increasingly used in clinical trials, yet thresholds that define clinically important difference (CID) within patients and treatment effects beyond placebo remain inconsistently reported, limiting its utility in clinical research and practice. Using chronic pelvic pain and its core PROM as a worked example, the study aims to present a structured framework for CID thresholds that separates within-group change from between-group difference in treatment effect, each further stratified as minimal, moderate, and marked.
methodsWe used data from a multicenter randomized controlled trial of acupuncture vs . sham acupuncture in 440 men with chronic prostatitis (CP)/chronic pelvic pain syndrome (CPPS) conducted from October 2017 to April 2019. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) served as the PROM and the Patient Global Impression of Change (PGI-C) as the anchor. CIDs were estimated using a linear mixed-effects model to assess changes in NIH-CPSI scores across PGI-C categories.
resultsAt the end of treatment, 12.3% (51/414) participants reported no change, 34.1% (141/414) slight improvement, 32.1% (133/414) moderate improvement, and 19.6% (81/414) marked improvement; and 1.9% (8/414) reported worsening. The estimated Clinically important within-group difference (CIDs within-group ) in NIH-CPSI total score was 4.6 points for minimal, 6.0 points for moderate, and 7.3 points for marked improvement. The corresponding Clinically important between-group difference (CIDs between-group ) were 1.4, 2.7, and 4.1 points, respectively.
conclusionsIn this methodological study, we proposed a pragmatic and scalable operational framework to derive thresholds for minimal, moderate, and marked CIDs. By explicitly distinguishing CIDs within-group and CIDs between-group , the approach clarifies two frequently conflated terms that serve distinct purposes in interpretation and decision-making. This framework offers benchmarks to strengthen inference on treatment response, trial design, and guideline decision thresholds.
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