Evidence map›Paper›PMID 41740648›Full record

ArticleOsteoarthritis and cartilage2026

Evaluating the utility of prognostic enrichment in clinical trials: Applications to clinical trial design in osteoarthritis.

Jamie E Collins, Karen Smith, Faith Selzer, Jeffrey N Katz, Elena Losina

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Osteoarthritis and cartilage, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Jamie E CollinsOrthopaedic and Arthritis Center for Outcomes Research (OrACORe), Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: jcollins13@bwh.harvard.edu.
Karen SmithOrthopaedic and Arthritis Center for Outcomes Research (OrACORe), Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: ksmith81@bwh.harvard.edu.
Faith SelzerOrthopaedic and Arthritis Center for Outcomes Research (OrACORe), Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: fselzer@bwh.harvard.edu.
Jeffrey N KatzOrthopaedic and Arthritis Center for Outcomes Research (OrACORe), Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Departments of Epidemiology and Environmental Health, Harvard T. H. Chan School of Public Health, Boston, MA, USA. Electronic address: jnkatz@bwh.harvard.edu.
Elena LosinaOrthopaedic and Arthritis Center for Outcomes Research (OrACORe), Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Policy and Innovation eValuation in Orthopaedic Treatments (PIVOT) Center, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA. Electronic address: elosina@bwh.harvard.edu.

Funding

VERITY: Value and Evidence in Rheumatology using bioInformaTics, and advanced analYticsP30AR072577 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Elena Losina · 2017 to 2026
$9.8M
Data-driven approaches in defining knee osteoarthritis phenotypes and factorsassociated with fast progressionK01AR075879 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COLLINS, JAMIE E. · 2020 to 2023
$524k
NIAMS NIH HHS K01 AR075879NIAMS NIH HHS P30 AR072577
6 · The paper itself

Abstract

objectivePrognostic enrichment in clinical trials aims to target potential participants at high risk for events of interest, such as disease progression or incident osteoarthritis (OA). The objective of this work is to describe and investigate key parameters that should inform the decision to implement an enrichment strategy.

designWe apply the framework of the Biomarker Prognostic Enrichment Tool (BioPET) to develop the Research-Based Enrichment for Arthritis Clinical Trials (REACT) tool. REACT takes into consideration the cost of screening and enrichment accuracy to determine whether an enrichment strategy is cost- and time-saving as compared with no enrichment.

resultsModestly accurate prognostic enrichment can yield cost-savings if the costs of enrichment are low; we show cost-savings for a scenario with a prognostic enrichment algorithm with an area under the curve (AUC) of 0.6 and a cost of enrichment of $25 per potential participant screened. The increased number of potential participants needed to screen in order to enroll an enriched sample may present logistical and/or feasibility challenges. While the example with a prognostic enrichment algorithm AUC of 0.6 is indeed cost-saving from a monetary perspective, enrichment in this scenario requires screening 1.7 times more potential participants than a strategy with no enrichment.

conclusionsREACT is a user-friendly tool to assess the value of incorporating an enrichment algorithm into clinical trial design. It could assist investigators in evaluating enrollment strategies to critically evaluate enrichment trade-offs, consider operational feasibility, in addition to qualitative factors such as generalizability and acceptability by participants.

Indexed as

Clinical Trials as TopicOsteoarthritisPatient SelectionResearch DesignAlgorithmsArea Under CurveBiomarkersCost-Benefit AnalysisDisease ProgressionHumansPrediction AlgorithmsPrognosisBiomarkersBiomarkersEnrichmentPrognostic modelingRandomized controlled trials

Identifiers

PMID41740648
PMCPMC12961611

What OpenQuestion holds

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LicenceTDM
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Registered trials

None linked

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.