Evidence map›Paper›PMID 40960406›Full record

ArticleStatistics in medicine2025

The Estimand Framework in Diagnostic Accuracy Studies.

Alexander Fierenz, Mouna Akacha, Norbert Benda, Mahnaz Badpa, Patrick M M Bossuyt, Nandini Dendukuri, Britta Rackow, Antonia Zapf

Abstract read
In one paragraph

Article in Statistics in medicine, 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.

Alexander FierenzInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0002-5233-215X
Mouna AkachaClinical Development and Analytics, Novartis Pharma AG, Basel, Switzerland.
Norbert BendaDepartment of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
Mahnaz BadpaInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Patrick M M BossuytDepartment of Epidemiology and Data Science, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Nandini DendukuriDepartment of Epidemiology and Biostatistics, McGill University, Montréal, Quebec, Canada.
Britta RackowInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Antonia ZapfInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0001-5339-2472

Funding

Deutsche Forschungsgemeinschaft ZA 687/6-1
6 · The paper itself

Abstract

Diagnostic accuracy studies evaluate how well a diagnostic test can detect or rule out a medical condition. Different events can interfere with the conduct of the test, affecting the test result. Before starting a diagnostic test accuracy study, the clinical question of interest should be precisely defined. Based on that, strategies can be chosen for dealing with the interfering event. We introduce six different strategies for how such events could be handled. We introduce the estimand concept for diagnostic accuracy studies, which consists of the attributes population, target condition, index test, accuracy measure, and the strategies for handling interfering events. The estimand determines which effect is estimated based on the study objective. To bridge the gap between the clinical study objective and the method for the estimation, we illustrate the necessary steps using a fictitious computed tomography scan study. The defined estimand improves the structure of the planning phase, enhances the interdisciplinary exchange, and supports the interpretation based on the study objective.

Indexed as

Diagnostic Tests, RoutineComputer SimulationData Interpretation, StatisticalHumansModels, StatisticalTomography, X-Ray Computeddiagnostic accuracy studyestimandICH E9 addendumindex testinterfering eventmissing values

Identifiers

PMID40960406
PMCPMC12442747

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.