Véronique Sébille

• PhD
• Professor at Nantes Université

Purpose Our objectives were to identify characteristics of response shift studies using patient-reported outcomes (PROMs) that explain variability in (1) the detection and (2) the magnitude of response shift effects. Methods We conducted a systematic review of quantitative studies published before June 2023. First, two-level multivariable logistic...

Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Randomized controlled trials (RCTs) are the cornerstone to evaluate the efficacy of an intervention. To assess the methodology of clinical research, we performed a systematic review that evaluated the different outcomes used in RCTs targeting the early phase of moder...

Purpose We aimed to describe the psychosocial adjustments according to return to work (RTW) trajectories in breast cancer survivors (BCS) using a sequential and temporal approach. Methods We used BCS data included from February 2015 to April 2016 in the Longitudinal Study on Behavioural, Economic and Sociological Changes after Cancer (ELCCA) cohor...

Purpose Anxiety and depression are common psychiatric comorbidities in cancer patients that may vary depending on cancer type. Differential item functioning (DIF) and response shift (RS) may impact self-reported outcomes when patients don’t interpret items about their experience in the same way between groups and over time, respectively. Objectives...

Purpose We aimed to describe the psychosocial adjustments according to return-to-work (RTW) trajectories in breast cancer survivors (BCS) using a sequential and temporal approach. Methods We used BCS data included from February 2015 to April 2016 in the Longitudinal Study on Behavioural, Economic and Sociological Changes after Cancer (ELCCA) cohor...

Purpose Unsupervised item-response theory (IRT) models such as polytomous IRT based on recursive partitioning (IRTrees) and mixture IRT (MixIRT) models can be used to assess differential item functioning (DIF) in patient-reported outcome measures (PROMs) when the covariates associated with DIF are unknown a priori. This study examines the consisten...

BACKGROUND With more than 60 million new cases around the world each year, traumatic brain injury (TBI) holds substantial mortality and morbidity. The management of TBI is a major human, social and economic burden. In the last 20 years, there has been an increase of clinical trials in neuro-trauma, leading mostly to negative results. The evaluation...

Background : With more than 60 million new cases around the world each year, traumatic brain injury (TBI) causes substantial mortality and morbidity. Managing TBI is a major human, social, and economic concern. In the last 20 years, there has been an increase in clinical trials in neurocritical care, leading mostly to negative results. The evaluati...

Purpose The objective of this systematic review was to describe the prevalence and magnitude of response shift effects, for different response shift methods, populations, study designs, and patient-reported outcome measures (PROM)s. Methods A literature search was performed in MEDLINE, PSYCINFO, CINAHL, EMBASE, Social Science Citation Index, and D...

When analyzing patient-reported outcome (PRO) data, sources of differential item functioning (DIF) can be multiple and there may be more than one covariate of interest. Hence, it could be of great interest to disentangle their effects. Yet, in the literature on PRO measures, there are many studies where DIF detection is applied separately and indep...

PurposeWe aimed to determine whether interferon gamma-1b prevents hospital-acquired pneumonia in mechanically ventilated patients.Methods In a multicenter, placebo-controlled, randomized trial conducted in 11 European hospitals, we randomly assigned critically ill adults, with one or more acute organ failures, under mechanical ventilation to receiv...

Introduction: The prevalence and risk factors of anxiety and depression symptoms in relatives of moderate to severe traumatic brain injury (TBI) survivors have not been thoroughly investigated. Methods: Ancillary study of a multicentric prospective randomized-controlled trial in nine university hospitals in 370 moderate-to-severe TBI patients. T...

Background Health-related quality of life (HRQoL) is clearly recognized as a patient-important outcome in patients with traumatic brain injury (TBI). Patient-reported outcomes are therefore often used and supposed to be directly reported by the patients without interpretation of their responses by a physician or anyone else. However, patients with...

Purpose Our aim is to advance response shift research by explicating the implications of published syntheses by the Response Shift – in Sync Working Group in an integrative way and suggesting ways for improving the quality of future response shift studies. Methods Members of the Working Group further discussed the syntheses of the literature on de...

Purpose: Patient-Reported Outcomes are essential to properly assess treatment effectiveness in randomized clinical trial (RCT) for Major Depressive Disorder (MDD). MDD self-assessment may vary over time depending on change in the meaning of patients' self-evaluation of depression, i.e. Response Shift (RS). Our aim was to investigate RS and its imp...

Background The Posttraumatic growth inventory (PTGI) aims to assess the positive psychological changes that individuals can perceive after a traumatic life event such as a cancer diagnosis. Several French translations of the PTGI have been proposed, but comprehensive data on their psychometric properties are lacking. This study aimed to provide a m...

Background Meaningfully interpreting patient-reported outcomes (PRO) results from randomized clinical trials requires that the PRO scores obtained in the trial have the same meaning across patients and previous applications of the PRO instrument. Calibration of PRO instruments warrants this property. In the Rasch measurement theory (RMT) framework,...

Introduction Le trouble dépressif majeur est le plus prévalent de tous les troubles psychiatriques et peut affecter la référence à soi. La plupart des stratégies thérapeutiques de la dépression visent à modifier le processus de référence à soi pour rectifier le biais cognitif négatif du patient. L'efficacité de ces traitements est souvent mesurée a...

Introduction Le cancer est un événement traumatique ayant de nombreuses répercussions négatives sur les patients. Parallèlement, il peut aussi résulter en des changements psychologiques positifs perçus chez les individus qui en sont atteints, tels que la modification de leur philosophie de la vie, de leur perception d'eux-mêmes ou encore de leurs r...

Background Recently intermittent theta burst stimulation (iTBS) proved to be non-inferior to conventional repetitive transcranial magnetic stimulation (10 Hz rTMS) in unipolar depression after failure of one antidepressant trial, but to date no randomized control trial assessed the ability of iTBS to improve depression level and quality of life in...

Introduction : ll n'y a pas de données récentes sur la prévalence des infections nosocomiales (IN) en réanimation dans notre pays. Le but de cette étude était d’évaluer cette prévalence dans les services de réanimations du centre hospitalier universitaire (CHU) de Rabat Méthodes : Etude multicentrique de prévalence d'un jour donné en Mars 2021 mené...

Introduction Expanded-criteria donors (ECDs) are used to reduce the shortage of kidneys for transplantation. However, kidneys from ECDs are associated with an increased risk of delayed graft function (DGF), a risk factor for allograft loss and mortality. HYPOREME will be a multicentre randomised controlled trial (RCT) comparing targeted hypothermia...

PurposeKidney transplantation (KT) can impact patients’ evaluation of health-related quality of life (HRQoL) as they adapt to their new life with a graft and its changes. Patients may adapt to KT in a different way, depending on whether they were on dialysis prior to transplantation or not (i.e. preemptive group). This may result in lack of measure...

Item Response Theory (IRT) models have received growing interest in health science for analyzing latent constructs such as depression, anxiety, quality of life or cognitive functioning from the information provided by each individual’s items responses. However, in the presence of repeated item measures, IRT methods usually assume that the measureme...

Background: Transcranial Direct Current Stimulation (tDCS) and Virtual Reality Exposure Therapy (VRET) are individually increasingly used in psychiatric research. Objective/hypothesis: Our study aimed to investigate the feasibility of combining tDCS and wireless 360° full immersive active and embodied VRET to reduce height-induced anxiety. Meth...

The growing interest in patient perception and experience in healthcare has led to an increase in the use of patient-reported outcomes (PRO) data. However, chronically ill patients may regularly adapt to their disease and, as a consequence, might change their perception of the PRO being measured. This phenomenon named response shift (RS) may occur...

PurposeMethods for response shift (RS) detection at the individual level could be of great interest when analyzing changes in patient-reported outcome data. Guttman errors (GEs), which measure discrepancies in respondents’ answers compared to the average sample responses, might be useful for detecting RS at the individual level between two time poi...

Background In the analysis of clinical trial endpoints, calibration of patient-reported outcomes (PRO) instruments ensures that resulting “scores” represent the same quantity of the measured concept between applications. Rasch measurement theory (RMT) is a psychometric approach that guarantees algebraic separation of person and item parameter estim...

Purpose The Working Group undertook a critical, comprehensive synthesis of the response shift work to date. We aimed to (1) describe the rationale for this initiative; (2) outline how the Working Group operated; (3) summarize the papers that comprise this initiative; and (4) discuss the way forward. Methods Four interdisciplinary teams, consisting...

Purpose This work is part of an international, interdisciplinary initiative to synthesize research on response shift in results of patient-reported outcome measures. The objective is to critically examine current response shift methods. We additionally propose advancing new methods that address the limitations of extant methods. Methods Based on l...

Purpose The extant response shift definitions and theoretical response shift models, while helpful, also introduce predicaments and theoretical debates continue. To address these predicaments and stimulate empirical research, we propose a more specific formal definition of response shift and a revised theoretical model. Methods This work is an int...

A correction to this paper has been published: https://doi.org/10.1007/s11136-021-02890-6

Item Response Theory (IRT) models have received growing interest in health science for analyzing latent constructs such as depression, anxiety, quality of life or cognitive functioning from the information provided by each individual's items responses. However, in the presence of repeated item measures, IRT methods usually assume that the measureme...

AimsProxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations.Methods We...

Background Patient-Reported Outcomes (PROs) are standardized questionnaires used to measure subjective outcomes such as quality of life in healthcare. They are considered paramount to assess the results of therapeutic interventions. However, because their calibration is relative to internal standards in people’s mind, changes in PRO scores are diff...

Introduction L’enquête nationale VICAN (Vie après le CANcer) a pour but de mieux connaître l’impact social du cancer et les conséquences physiques et psychologiques de la maladie sur le long terme chez des patients adultes deux et cinq ans après leur diagnostic. La santé perçue des patients a été mesurée avec le questionnaire SF12 dont les 12 items...

Introduction Le trouble dépressif majeur est le plus prévalent de tous les troubles psychiatriques et peut affecter la référence à soi. La plupart des stratégies thérapeutiques de la dépression visent à modifier le processus de référence à soi pour rectifier le biais cognitif négatif du patient. L’efficacité de ces traitements est souvent mesurée a...

Background: One of the most important issues for opiate maintenance therapy efficacy is the involvement of primary care physicians (PCPs) in opiate use disorder treatment, especially after referral from specialized units. This study aimed to analyze the progress of subjects in a specialized center and after referral to PCPs. Methods: This study was...

Objective: The aim of the study was to identify clinical variables associated with changes in specific domains of self-reported depression during treatment by antidepressant and/or repetitive Transcranial Magnetic Stimulation (rTMS) in patients with Major Depressive Disorder (MDD). Methods: Data from a trial involving 170 patients with MDD receivin...

ABO blood groups appear to be associated with the risk of SARS-CoV-2 infection, but the underlying mechanisms and their real importance remain unclear. Two hypotheses have been proposed: ABO compatibility-dependence (neutralization by anti-ABO antibodies) and ABO-dependent intrinsic susceptibility (spike protein attachment to histo-blood group glyc...

In order to investigate patients’ experience of healthcare, repeated assessments of patient-reported outcomes (PRO) are increasingly performed in observational studies and clinical trials. Changes in PRO can however be difficult to interpret in longitudinal settings as patients’ perception of the concept being measured may change over time, leading...

Background: We determined whether an audit on the adherence to guidelines for hospital-acquired pneumonia (HAP) for can improve the outcomes of patients in intensive care units (ICUs). Methods: This study was conducted at 35 ICUs in 30 hospitals. We included consecutive adult patients hospitalized in ICUs for three days or more. After a three-mo...

Introduction L’étalonnage d’un instrument de mesure permet d’assurer la validité du mesurage et l’estimation de son incertitude. Si cette approche est bien établie pour la mesure de grandeurs physiques, sa pertinence reste à être étudiée pour des grandeurs non physiques. L’évaluation de l’effet d’un nouveau traitement dans le cadre d’un essai clini...

Introduction L’analyse longitudinale des données rapportées par les patients (PRO) suppose souvent que la perception du concept mesuré (qualité de vie, anxiété…), des items et des modalités de réponses reste la même au cours du temps. Cette hypothèse peut être remise en question, notamment lorsque les patients ont une maladie avec des conséquences...

Introduction La transplantation rénale peut avoir un impact sur la santé physique et psychologique des patients y compris leur qualité de vie (QdV). Les patients doivent s’adapter à leur nouvelle vie avec un greffon et aux changements qui en résultent. Du fait de cette adaptation ou non, les patients peuvent percevoir et interpréter différemment le...

Purpose: A diagnosis of breast cancer or melanoma is a traumatic life event that patients have to face. However, their locus-of-control (LOC) beliefs and coping strategies as well as the associations with health-related quality of life (HRQoL) changes over time are still not well known and rarely compared by cancer site. Methods: The objective o...

Purpose The waiting list period for kidney transplantation can be lengthy and associated with a deteriorated health-related quality of life (HRQoL). It might also be experienced differently depending on the experience of renal replacement therapy (preemptive or dialyzed patients), and the type of dialysis. The main objective of this study is to mea...

When assessing change in patient-reported outcomes, the meaning in patients’ self-evaluations of the target construct is likely to change over time. Therefore, methods evaluating longitudinal measurement non-invariance or response shift at item-level were proposed, based on structural equation modelling or on item response theory. Methods coming fr...

Introduction La transplantation rénale peut avoir un impact sur la santé physique et psychologique des patients y compris leur qualité de vie (QdV). Les patients doivent s’adapter à leur nouvelle vie avec un greffon et aux changements qui en résultent. Les patients pourront interpréter et répondre différemment aux questionnaires de QdV avant et apr...

High dosages of ceftriaxone are used to treat central nervous system infections (CNSI). Dosage adaptation according to the glomerular filtration rate is currently not recommended. Ceftriaxone pharmacokinetics (PK) was investigated by a population approach in patients enrolled in a French multicenter, prospective cohort study who received high-dose...

Objective: This article presents a comparison of the changes of Posttraumatic Growth (PTG) in breast cancer and melanoma patients over a 2-year follow-up period and investigates the associations between coping strategies, anxiety, depression, emotional functioning, and PTG over time. Method: Seventy-eight early stage melanoma patients from Nante...

Addiction is correlated with the dysfunction of definite neural circuitry involving deep as well as superficial brain regions. Among the deep structures are the midbrain ventral tegmental area (VTA) and the nucleus accumbens of the ventral striatum, connected to each other by means of dopaminergic fibers. This pathway is the neural correlate of nor...

Introduction Les données rapportées par les patients (PRO) sont utilisées pour mesurer des concepts non observables directement, tels que la qualité de vie ou la douleur. Lors de l’analyse longitudinale de PRO, il peut se produire un phénomène, appelé « response shift ». Ce phénomène reflète une modification de la perception du questionnaire au cou...

Introduction Les données rapportées par les patients (« Patient Reported Outcomes », PRO) sont souvent collectées de façon longitudinale mais sont difficiles à analyser/interpréter. Pourtant, mieux appréhender le vécu et le ressenti des patients atteints d’une maladie chronique est indispensable pour évaluer les conséquences des traitements et pris...

Objective The aims were to review practices concerning Differential Item Functioning (DIF) detection in composite measurement scales, particularly those used in health research, and to provide guidance on how to proceed if statistically significant DIF is detected. Methods This work specifically addressed the Rasch model which is the subject of gr...

Median of the rating (from 1-“strongly disagree” to 7-“strongly agree”) by the seven reviewers to each items of the Appraisal of Guidelines for Research & Evaluation II (AGREE II) adapted for the evaluation of methodological recommendations and score to each of the six domains. (DOCX)

List of the references of the 285 articles included in the literature review. References with 2015 as year of publication were published online during the search period: November 11, 2013 and November 10, 2014. (DOCX)

Median of the rating (from 1-“strongly disagree” to 7-“strongly agree”) by the seven reviewers to each items of the Appraisal of Guidelines for Research & Evaluation II (AGREE II) adapted for the evaluation of methodological recommendations and score to each of the six domains. (DOCX)

Evaluation of the effects of the presence of DIF and practices and/or recommendation produced for its management in practice. N = 71 articles in which statistically significant DIF was found. (DOCX)

Background: Ceftriaxone is widely used to treat community-acquired CNS bacterial infections. French guidelines for meningitis in adults promote 75-100 mg/kg/day ceftriaxone without an upper limit for dosage, yet little is known about the pharmacology and tolerability of such regimens. Patients and methods: A multicentre prospective cohort study...

Purpose: Severe combined immunodeficiency (SCID) refers to a group of genetic disorders characterized by greatly compromised cellular and humoral immunity. Children with SCID are asymptomatic at birth, but they die from infections within the first months of life if not treated. Quantification of T-cell receptor excision circles is an extremely sen...

Background: There is an increasing interest in beta-blockade as a therapeutic approach to sepsis following consistent experimental findings of attenuation of inflammation and improved survival with beta1 selective antagonist. However, the mechanism of these beneficial effects remains very uncertain. Thus, this study is aimed at investigating the e...

Following publication of the original article [1], the author reported these required corrections to Fig. 5 and Fig. 6.

Purpose: This study describes the characteristics and quality of reporting for published computer simulation studies about statistical methods to analyze complex longitudinal (i.e., repeated measures) patient-reported outcomes (PROs); we included methods for longitudinal latent variable measurement and growth models and response shift. Methods:...

Severe combined immunodeficiency (SCID) is characterized by a major T cell deficiency. Infants with SCID are asymptomatic at birth but die from infections in the first year of life if not treated. Survival rates are better for early treatment. SCID therefore meets criteria for newborn screening (NBS). T cell receptor excision circle (TREC) quantifi...

Introduction L’insuffisance rénale chronique terminale (IRCT) nécessite le recours à une technique de suppléance : la dialyse ou la transplantation rénale. Réduire la période de dialyse a de nombreux avantages en termes de qualité de vie (QdV), ainsi qu’au niveau médical, social et économique. Ainsi, lorsque cela est possible, la transplantation pr...

Introduction L’évaluation de la santé perçue des patients au moyen de « Patient-Reported Outcomes » (PRO) tels que la qualité de vie liée à la santé (QdV) ou la fatigue est devenue un des critères incontournables dans les essais cliniques et la surveillance des malades. Ces données PRO sont mesurées au moyen de questionnaires regroupant différents...

Introduction Les données collectées pour une étude clinique et non utilisées, par la suite, pour les analyses statistiques peuvent représenter une part importante de l’ensemble des données collectées. Le volume de données à recueillir dans les « Case Report Form » (CRFs) a un impact sur le temps passé par chacun des acteurs de la recherche dans le...

Background: Patients with prostate cancer (PC) may be ready to make trade-offs between their quantity and their quality of life. For instance, elderly patients may prefer the absence of treatment if it is associated with a low-risk of disease progression, compared to treatments aiming at preventing disease progression but with a substantial deteri...

Background Craving is a core symptom of addictive disorders, such as pathological gambling for example. Over the last decade, several studies have assessed the efficacy of repetitive transcranial magnetic stimulation (rTMS) in the addiction field, which triggers the dorsolateral prefrontal cortex (DLPFC) to decrease craving. The STIMJEU study inves...

Introduction Les recherches longitudinales étudiant l’évolution de la qualité de vie liée à la santé suite à un diagnostic de cancer portent principalement sur un seul type de cancer. Peu de données sont disponibles à propos de potentielles différences selon le type de tumeur. La présente étude vise à comparer les changements de la qualité de vie l...

Background: Intracranial hypertension (ICH) is a major cause of death after traumatic brain injury (TBI). Continuous hyperosmolar therapy (CHT) has been proposed for the treatment of ICH, but its effectiveness is controversial. We compared the mortality and outcomes in patients with TBI with ICH treated or not with CHT. Methods: We included pati...

Fatigue is the most prevalent symptom in breast cancer. It might be perceived differently among patients over time as a consequence of the differing patients’ adaptation and psychological adjustment to their cancer experience which can be related to response shift (RS). RS analyses can provide important insights on patients’ adaptation to cancer bu...

Background: Patients with brain injury are at high risk of extubation failure. Methods: We conducted a prospective observational cohort study in four intensive care units of three university hospitals. The aim of the study was to create a score that could predict extubation success in patients with brain injury. Results: A total of 437 consecu...

Purpose: We assessed outcomes in brain-injured patients after implementation of a multi-faceted approach to reduce respiratory complications in intensive care units. Methods: Prospective nationwide before-after trial. Consecutive adults with acute brain injury requiring mechanical ventilation for ≥24 h in 20 French intensive care units (ICUs) we...

AIM: Self-image is liable to deteriorate in a certain number of situations when a person has health problems and especially in the case of medical conditions needing a hospital stay. Socio-aesthetics is a field that was founded in the 1960s. It is starting to catch on in hospitals when the patient needs comprehensive care. The objective of this stu...