Evidence mapPaperPMID 41296240Full record

ReviewJournal of patient-reported outcomes2025

Defining score interpretation thresholds for clinical outcome assessments: a review of terminology and reporting recommendations.

E Flood, N Clarke, B L King-Kallimanis, J Musoro, S Eremenco, C L Ward, J C Cappelleri, S Nolte

Abstract readReview
In one paragraph

Review in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

E FloodPatient Centered Science, AstraZeneca, Gaithersburg, MD, USA.ORCID https://orcid.org/0000-0002-3526-9670
N ClarkePatient Centered Science, AstraZeneca, Gaithersburg, MD, USA.
B L King-KallimanisLUNGevity Foundation Institution, Bethesda, MD, USA.ORCID https://orcid.org/0000-0001-9418-9374
J MusoroEuropean Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.ORCID https://orcid.org/0000-0002-6228-3531
S EremencoCritical Path Institute, Tucson, AZ, USA.ORCID https://orcid.org/0000-0003-3956-0235
C L WardOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, MD, USA.ORCID https://orcid.org/0000-0003-4857-7397
J C CappelleriStatistical Research and Data Science Center, Pfizer Inc., New York, NY, USA.ORCID https://orcid.org/0000-0001-9586-0748
S NoltePerson-Centred Research, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia. sandra.nolte@monash.edu.ORCID http://orcid.org/0000-0001-6185-9423

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe concept of 'score interpretation threshold' for understanding score differences of clinical outcome assessments (COAs) and terminology around this topic have evolved over several decades. Yet, considerable confusion regarding terminology remains, leading to potentially erroneous interpretation of COA results. This article sought to provide an updated overview of terminology and an assessment of trends to explore opportunities for harmonizing the field.

methodsA targeted literature review was conducted for review articles published 2016-September 2024 discussing terminology related to COA score interpretation thresholds, followed by a review of guidance by regulatory and reimbursement/payer stakeholders for specific terminology in this context. A targeted review of original research articles that were aimed at deriving interpretation thresholds was undertaken, spanning a five-year period (2016- Apr 2021) to explore potential trends regarding use of terms, acronyms, and definitions.

resultsAs expected, vast heterogeneity in terminology and definitions was observed across review articles and regulatory/reimbursement/payer guidelines. Across 318 original research articles, 39 different terms were identified, with 'minimal clinically important difference' (MCID) most frequently used (mentioned in 163 articles), which was more than twice as often as the next term ('minimal important difference'; MID), mentioned in 76 articles, followed by 'minimal important change' (MIC), mentioned in 54 articles. Articles also showed great variation in how thresholds were defined, derived, and applied. Frequently, authors failed to provide sufficient details on methods and application, making it difficult to interpret derived thresholds.

conclusionsCOA score interpretation threshold terminology is far from harmonized. Evidence is insufficient to derive specific recommendations on which terms to use. Instead, we present minimum reporting standards for defining thresholds to ensure that they are comprehensible and reproducible, regardless of the specific terms and acronyms used.

Indexed as

Outcome Assessment, Health CareTerminology as TopicHumansClinical outcome assessmentMCIDMeaningful changeMIDMinimal clinically important differenceMinimal important differencePatient-reported outcomesSelf-Report

Identifiers

PMID41296240
PMCPMC12657697

What Socratic holds

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Registered trials

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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.