ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2018
Moving from significance to real-world meaning: methods for interpreting change in clinical outcome assessment scores.
Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 2 of them syntheses that pooled it.
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
76 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021Pooled it
- Supporting the Primary Outcomes of the Mirai Trial for the Adjunctive Digital Therapeutic Rejoyn (CT-152) in the Treatment of Major Depressive Disorder: Meaningful Change Analysis in the Montgomery-Åsberg Depression Rating Scale.JMIR formative research · 2026Trial
- Is training speed an accurate predictor of who attains a minimal clinically important difference in the six-minute walk test in people with chronic stroke?Topics in stroke rehabilitation · 2025Trial
- Psychometric analysis of the Neuro-QoL Fatigue in generalized Myasthenia Gravis (gMG) using data from a phase 3 trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Trial
- Psychometric validation of the severity of chronic cough diary, leicester cough questionnaire, and a cough severity visual analogue scale in patients with refractory chronic cough.Journal of patient-reported outcomes · 2025Trial
- Patient-reported outcomes in non-small cell lung cancer: psychometric evaluation of the PROMIS PF-SF 8c and NSCLC-SAQ in two phase 3 clinical trials.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Trial
- Validity, reliability, responsiveness, and clinically meaningful change threshold estimates of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16).Journal of patient-reported outcomes · 2024Trial
- GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale (GODDESSQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Trial
- Establishing the minimal clinically important difference of the EQ-5D-3L in older adults with a history of falls.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Trial
- Trial
- Reliability and Validity of an Instrument of COVID-19 Patient-Reported Symptoms in Outpatients.JAMA network open · 2022Trial
- Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Trial
- Defining changes in physical limitation from the patient perspective: insights from the VITALITY-HFpEF randomized trial.European journal of heart failure · 2022Trial
- Modifying the quality-adjusted life year calculation to account for meaningful change in health-related quality of life: insights from a pragmatic clinical trial.The European journal of health economics : HEPAC : health economics in prevention and care · 2021Trial
- Validity and Clinically Meaningful Changes in the Psychosexual Daily Questionnaire and Derogatis Interview for Sexual Function Assessment: Results From the Testosterone Trials.The journal of sexual medicine · 2018Trial
- Trial
- Establishing meaningful score differences for the observer-reported communication ability (ORCA) measure using the scale judgment approach with caregivers of individuals with Angelman syndrome.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Article
- Meaningful Improvement Thresholds for Pruritus and Sleep Disturbance in PBC Using the Worst Itch and Sleep Interference Numerical Rating Scales.Advances in therapy · 2026Article
16 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeClinical outcome assessments (COAs) require evidence not only of reliability, validity, and ability to detect change, but also a definition of what constitutes a meaningful change on the instrument. The responder definition specifies the amount of change on the COA that may be interpreted as a treatment benefit and is critical for interpreting what constitutes a meaningful change on the COA scores. However, the literature that describes methods for developing and applying responder definitions can be difficult to navigate. Clear and concise guidelines regarding which methods to apply under what circumstances and how to interpret the results are lacking. This article provides a guide to the variety of available methods and issues that should be considered when establishing responder definitions for interpreting meaningful changes in COA scores.
methodsAn overview is provided for selecting anchors, developing study designs, planning psychometric analyses, using psychometric results to set responder thresholds, and applying responder thresholds in demonstrating treatment efficacy.
resultsThere are a variety of anchor-based methods for consideration, but they all rely on a preference for strongly related and easily interpretable anchors. The benefits of applying multiple anchors and multiple analytic methods are discussed. The process of triangulation can synthesize results across multiple sources to gain confidence in a proposed responder definition. Though a link to meaningfulness from the patient's perspective is absent, distribution-based methods provide lower bound estimates of score precision and have a role in triangulation. Responder definitions are typically required within regulatory review, but their application may differ across clinical trial programs.
conclusionsBy careful planning of anchor selection, study design, and psychometric methods, COA researchers can establish defensible responder thresholds that ultimately aid patients and clinicians in making informed treatment decisions.
Indexed as
Identifiers
28620874What 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.