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ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025

Interpreting the meaningfulness of treatment effects estimated in parallel groups designs: comment on Trigg et al.

Kevin Weinfurt

Abstract read
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Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. The structural and moral integrity of our field.Journal of patient-reported outcomes · 2026
    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

1 author.

Kevin WeinfurtDepartment of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA. kevin.weinfurt@duke.edu.ORCID http://orcid.org/0000-0002-0624-7448

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Draft guidance from the U.S. Food and Drug Administration states that one can interpret a treatment effect on a clinical outcome assessment-based endpoint when expressed as some difference between group means. Recently, Trigg et al. examined different approaches for deriving thresholds for interpreting such between-group differences. In this commentary, I make several observations to advance further discussion around this issue. Some key points are (1) rather than "between-group difference," specify the level at which you wish to infer a treatment effect: population or individual; (2) points of reference may be different for interpreting individual- and population-level treatment effect estimates; (3) who provides input and what types of anchor variables are used to generate points of reference might differ for interpreting individual- versus population-level estimates of treatment effect; and (4) in a parallel groups design, meaningful within-patient change is not especially relevant for understanding the meaningfulness of a treatment effect.

Indexed as

Outcome Assessment, Health CareResearch DesignData Interpretation, StatisticalHumansTreatment OutcomeUnited States

Identifiers

What OpenQuestion 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 OpenQuestion graph.