Evidence map›Paper›PMID 36115002›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2023

Flexible modeling of longitudinal health-related quality of life data accounting for informative dropout in a cancer clinical trial.

Audrey Winter, Benjamin Cuer, Thierry Conroy, Beata Juzyna, Sophie Gourgou, Caroline Mollevi, Célia Touraine

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00861094 (Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT00861094 phase2 / phase3completednot on this map

Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.

TypeinterventionalSponsorUNICANCERRan2008 to 2012Enrolled266ConditionsEsophageal CancerArmscisplatin, 5-FU, oxaliplatin, radiation therapy, Folinic Acid
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

7 authors.

Audrey WinterBiometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Parc Euromédecine, 208 Avenue des Apothicaires, 34090, Montpellier, France. audrey.winter@icm.unicancer.fr.ORCID http://orcid.org/0000-0002-6161-8037
Benjamin CuerDesbrest Institute of Epidemiology and Public Health, University of Montpellier, INSERM, 641 Avenue du Doyen Gaston Giraud, Montpellier, France.
Thierry ConroyDepartment of Medical Oncology, Institut de Cancérologie de Lorraine, 6 Av. de Bourgogne, Vandoeuvre-lès-Nancy, France.
Beata JuzynaR&D Unicancer, Paris, France.
Sophie GourgouBiometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Parc Euromédecine, 208 Avenue des Apothicaires, 34090, Montpellier, France.
Caroline MolleviBiometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Parc Euromédecine, 208 Avenue des Apothicaires, 34090, Montpellier, France.
Célia TouraineBiometrics Unit, Cancer Institute of Montpellier, University of Montpellier, Parc Euromédecine, 208 Avenue des Apothicaires, 34090, Montpellier, France.

Funding

Ligue Contre le Cancer ("Projet de Recherche en Epidémiologie Ligue" 2019SIRIC Montpellier Cancer Grant INCa_Inserm_DGOS_12553
6 · The paper itself

Abstract

purposeA joint modeling approach is recommended for analysis of longitudinal health-related quality of life (HRQoL) data in the presence of potentially informative dropouts. However, the linear mixed model modeling the longitudinal HRQoL outcome in a joint model often assumes a linear trajectory over time, an oversimplification that can lead to incorrect results. Our aim was to demonstrate that a more flexible model gives more reliable and complete results without complicating their interpretation.

methodsFive dimensions of HRQoL in patients with esophageal cancer from the randomized clinical trial PRODIGE 5/ACCORD 17 were analyzed. Joint models assuming linear or spline-based HRQoL trajectories were applied and compared in terms of interpretation of results, graphical representation, and goodness of fit.

resultsSpline-based models allowed arm-by-time interaction effects to be highlighted and led to a more precise and consistent representation of the HRQoL over time; this was supported by the martingale residuals and the Akaike information criterion.

conclusionLinear relationships between continuous outcomes (such as HRQoL scores) and time are usually the default choice. However, the functional form turns out to be important by affecting both the validity of the model and the statistical significance.

trial registrationThis study is registered with ClinicalTrials.gov, number NCT00861094.

Indexed as

Esophageal NeoplasmsQuality of LifeHumansLinear ModelsCancerClinical trialsHealth-related quality of lifeJoint modelLinear mixed modelSpline

Identifiers

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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 OpenQuestion graph.