ReviewTherapeutic innovation & regulatory science2025
A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Group Literature Review and Survey.
Review in Therapeutic innovation & regulatory science, 2025. 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.
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Who cites it
3 citing papers in PubMed.
- Recommendations for the use of clinical outcome assessments in rare disease drug development.EClinicalMedicine · 2026Review
- Asthma daytime and nighttime symptom diaries: content validity and qualitative exploration of meaningful change in patients with moderate-to-severe asthma.Journal of patient-reported outcomes · 2026Article
- Defining score interpretation thresholds for clinical outcome assessments: a review of terminology and reporting recommendations.Journal of patient-reported outcomes · 2025Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical outcome assessments (COAs) measure how patients feel or function and can be used to understand which patients experience benefits of treatment and which do not. Interpretation of COA data is influenced by how meaningful change is defined. We aimed to compare how different stakeholders define, assess, and use meaningful change for decisions that impact patients.
methodsA targeted literature review was undertaken in July 2021 using Medline, Embase, online grey literature search engines, and stakeholder organization websites. Additionally, a stakeholder survey on meaningful change was fielded between March and June 2023. Both quantitative and qualitative methods were used to analyze responses and identify key themes.
resultsThe literature review resulted in 86 references. These revealed different approaches to define, measure and validate meaningful change. There were 248 survey responses. Many respondents felt the terminology and methods for defining meaningful change are confusing. Respondents also emphasized the importance of distinguishing within-patient and between-group change, and defining meaningfulness from the patient perspective (most patients and caregivers do not share a similar definition of meaningfulness as their healthcare professionals).
conclusionFour key recommendations for defining, establishing, and interpreting meaningful change estimates for COAs are: (1) Be clear on the type of "meaningful change" that is discussed or needed for a COA, (2) Ensure the "patient voice" is informing meaningful change estimates/definitions, (3) Acknowledge that a meaningful change estimate for a COA may differ between populations, diseases, and disease states, and (4) Disseminate data in a way that reduces ambiguity.
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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 Socratic graph.