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Elodie Hurel,1,2 Marie Grall-Bronnec,1,2 Elsa Thiabaud,1 Anaïs Saillard,1 Jean-Benoît Hardouin,2 Gaëlle Challet-Bouju1,2 1CHU Nantes, Addictology and Psychiatry Department, Nantes, France; 2INSERM U1246 SPHERE (methodS in Patient-centered outcomes & HEalth ResEarch), University of Nantes, University of Tours, Nantes, FranceCorrespondence: Gaëlle Challet-Bouju Email gaelle.bouju@chu-nantes.frIntroduction: Only two behavioral addictions (BAs) are currently recognized in international classifications (gambling disorder: GbD; gaming disorder: GmD), while some of them await further investigation (food addiction: FA; sexual addiction: SA). Neurocognitive functioning is considered a risk factor for BAs. Research is quite abundant for GbD and highlights specific deficits in several cognitive functions. Nevertheless, grey areas still exist. The aim of this research programme is to investigate the neurocognitive profiles of patients presenting with various BAs and to establish parallels between different forms of BA to achieve a common addiction concept.Methods and Analysis: This research program is composed of two studies sharing the same methodology but focusing on different samples: the BANCO study aims to include 30 individuals with a GbD, whereas the BANCO2 study aims to include 30 individuals with a GmD, 30 with a SA, and 30 with a FA. Moreover, for each BA group, 30 healthy controls will be recruited, matched by sex, age and education level. Several cognitive tasks will be completed by participants. Cue reactivity and physiological responses, as well as clinical data regarding addiction characteristics and personality, will also be investigated. A composite score based on the cognitive tasks will be computed using principal component analysis (PCA). Overall cognitive performance and detailed performance on the different cognitive tasks will be compared between individuals with BAs and their matched healthy controls using linear models with random effects. Comparisons will also be made between BA groups to investigate specific alterations associated with each disorder.Discussion: The results of this research programme will impact both research and clinical areas by (i) providing new knowledge for discussions regarding the inclusion of BAs under the spectrum of addictive disorders; (ii) improving understanding of addiction mechanisms in general; (iii) providing clarity in the grey areas in neurocognitive research on BAs and improving the understanding of less studied BAs, (iv) guiding clinicians to propose therapeutic alternatives and complementary programmes.Trial Registration: BANCO study (ClinicalTrials.gov NCT03202290); BANCO2 study (ClinicalTrials.gov NCT03967418).Keywords: behavioral addiction, neurocognition, neuropsychology, gaming disorder, gambling disorder, sexual addiction, food addiction

Background: Patients-Reported Outcomes (PRO) are increasingly used in clinical and epidemiological research. Two main types of analytical strategies can be found for these data: classical test theory (CTT) based on the observed scores and models coming from Item Response Theory (IRT). However, whether IRT or CTT would be the most appropriate method to analyse PRO data remains unknown. The statistical properties of CTT and IRT, regarding power and corresponding effect sizes, were compared.Methods: Two-group cross-sectional studies were simulated for the comparison of PRO data using IRT or CTT-based analysis. For IRT, different scenarios were investigated according to whether items or person parameters were assumed to be known, to a certain extent for item parameters, from good to poor precision, or unknown and therefore had to be estimated. The powers obtained with IRT or CTT were compared and parameters having the strongest impact on them were identified.Results: When person parameters were assumed to be unknown and items parameters to be either known or not, the power achieved using IRT or CTT were similar and always lower than the expected power using the well-known sample size formula for normally distributed endpoints. The number of items had a substantial impact on power for both methods.Conclusion: Without any missing data, IRT and CTT seem to provide comparable power. The classical sample size formula for CTT seems to be adequate under some conditions but is not appropriate for IRT. In IRT, it seems important to take account of the number of items to obtain an accurate formula. [ABSTRACT FROM AUTHOR]

Introduction: Polypharmacy in patients with advanced cancer represents a major public health problem, leading to risk of iatrogenesis, decrease of quality of life and increase of healthcare costs. In the field of geriatrics, health policies have been developed to address polypharmacy through the use of deprescribing tools. Recently, palliative care initiatives have been introduced, yet these have not fully considered the specificities of this population, particularly their perceptions. It is therefore important to better understand patients' perceptions of deprescribing in order to adapt tools and actions to make these approaches more effective., Objectives: The aim is to investigate patients' perceptions of deprescribing in palliative oncology care, and to explore factors that may influence patients' attitudes and beliefs about deprescribing and to validate a specific questionnaire (rPATD) in this population. An ancillary study will investigate the relationship between patients' health literacy and their perception of deprescribing., Method: A prospective, observational, multicenter study will be conducted using a sequential mixed exploratory design in a population of patients living with advanced cancer and with a physician-estimated life expectancy of less than 1 year. The study will include an initial qualitative phase. Individual semi-structured interviews using a descriptive approach (thematic analysis) will be conducted (upon saturation). Following analysis of the qualitative data, a quantitative study including 300 patients will be realized to meet secondary objectives. Several data will be collected and 2 self-questionnaires will be administered: the BMQ (beliefs about medicine) and rPATD (perception of deprescribing) possibly supplemented by additional items if required by the qualitative analysis. The auxiliary study will be conducted during this second phase, using a validated self-questionnaire to assess patients' level of literacy., Conclusion: The disparate outcomes will facilitate the understanding of the perception of deprescribing in palliative oncology care, enabling the development of tailored approaches adapted to this population., Trial Registration: ClinicalTrials Identifier: NCT06193083., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Evin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: To compare the efficacy of treatment of optic neuritis (ON) with corticosteroids (CTC) alone, CTC+plasmapheresis (PLP), and CTC+intravenous immunoglobulin (IVIG)., Design: After an episode of ON, although visual recovery is usually good, some patients may have significant visual sequelae. While the efficacy of first-line CTC is now indisputable, there is no consensus on the nature of second-line treatment. To date, no systematic review has compared the efficacy of treatment of ON with CTC alone, CTC+plasmapheresis (PLP), and CTC+intravenous immunoglobulin (IVIG). A meta-analysis is needed to compare the efficacy of PLP and IVIG in steroid-resistant ON., Methods: This systematic review included all studies comparing at least two of the three treatments for steroid-resistant ON (CTC alone, CTC+PLP, and CTC+IVIG). From all articles published on PubMed between January 2000 and June 2022, two independent ophthalmologists selected studies of interest using the PRISMA method. Methodology, patient characteristics, and outcomes were identified. A network metaanalysis was then performed to compare the efficacy of the three treatments., Results: Six comparative studies were included, representing 209 patients. The percentage of significant visual recovery after CTC alone, CTC+PLP, and CTC+IVIG in the acute treatment of steroid-resistant ON was 30 %, 45 %, and 77 %, respectively. Comparison of CTC+IVIG vs CTC alone, CTC+PLP vs CTC only, and CTC+PLP vs CTC+IVIG yielded odds ratios of 12.81, 2.47, and 0.19 respectively., Conclusion: Treatment of steroid-resistant ON with CTC+PLP or CTC+IVIG is more effective than treatment with CTC alone. Although no study has directly compared the two treatments, IVIG may be more effective than PLP., Competing Interests: Declaration of competing interest None, (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objectives: To develop a simple, practical methodology to equate or link equivalent domains of the 36-item Short-Form Health Survey (SF-36) and the Patient-Reported Outcomes Measurement Information System 29-item questionnaire (PROMIS-29) using the Rasch framework., Study Design and Setting: In April 2016, the PROMIS-29 and SF-36 were completed by 1501 individuals selected to be representative of the French population. For each domain common to the two questionnaires, a Partial Credit Model was fitted to the items related to that dimension in the two questionnaires. These items were then calibrated on the same metric, which enabled the scores from one questionnaire to be associated with the scores from the other., Results: Six of the seven PROMIS-29 scales and five of the six SF-36 subscales (physical, pain, social, vitality, depression and anxiety domains) were equated or linked. Correspondence tables between scores, with a 95% confidence interval, were established for each domain. A freely available Stata macro program was developed to automatize the equating or linking process., Conclusion: These results should facilitate comparisons across studies using the SF-36 and the PROMIS-29 in France. The equating or linking process developed is simple to implement and can be used in other countries and for other instruments., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) questionnaire evaluates manual therapists' biomedical and biopsychosocial beliefs regarding the management of chronic low back pain. Its usage in clinical settings is an important step in the implementation of national guidelines and policies to improve patient management., Objectives: The objective of this study was to translate the PABS-PT questionnaire into French, to adapt it culturally, and to conduct a psychometric analysis., Design: Qualitative and cross-sectional study., Method: The translation process followed published guidelines with cross-cultural validation by an expert committee. We followed a forward and backward translation procedure and an expert committee, including the original author of the questionnaire and a linguistics expert ensuring good cultural adaptation, issued a finalised version. Psychometric analysis of the French version of the questionnaire was conducted among 390 French manual therapists in two phases. The first phase evaluated structural validity as well as external validity compared with the TSK and BBQ questionnaires. Then, reliability and scalability were analysed. The second phase evaluated test-retest reproducibility by sending the same questionnaire 3 months later., Results: The validity study revealed three subscales: the classic biomedical subscale and two subscales for biopsychosocial beliefs (aetiology of pain and physical activity). With 21 items in total for the PABS-PT-FR, the structural validity scores were good (BM: alpha = 0.82, H = 0.38; Physical Activity: alpha = 0.62, H = 0.32; Aetiology of Pain: alpha = 0.55, H = 0.29)., Conclusions: This study provides a validated tool to assess French physiotherapists' and, more generally, healthcare providers' beliefs about chronic low back pain, with a new insight into the BPS subscale internal construct., (© 2024 John Wiley & Sons Ltd.)

Background and Aims: While the concept of recovery is receiving increasing attention in the context of gambling disorder (GD), no consensus has yet been reached regarding its definition. This scoping review aims to map the literature on GD recovery, identify gaps, and provide insights for a more holistic and patient-centred perspective., Methods: A systematic search of three databases was conducted (PubMed, PsycINFO, and ScienceDirect). Based on the method by which the results of these studies were produced, the studies included were sorted into four categories (quantitative, instrument validation, qualitative, and mixed studies) and subsequently examined using conceptual analysis., Results: One hundred thirteen articles were included in this research after the screening process. In the quantitative and instrument validation studies, recovery was defined or operationalized in terms of abstinence, the absence of a GD diagnosis, or mild GD severity, or by reference to treatment outcomes or controlled gambling. A meta-synthesis of the results of the qualitative studies revealed four core features of recovery (insight, empowerment and commitment, wellbeing enhancement, and reconsideration of the issue of relapse)., Discussion: Discrepancies in definitions, outcomes, and variables used were evident across studies. Additionally, the quantitative and standardized approaches employed in most studies exhibited severe limitations with regard to defining recovery from the subjective and multidimensional perspectives of people recovering from GD., Conclusions: This lack of definitional clarity emphasizes the necessity for further qualitative research. This research should encompass multiple stakeholder perspectives to develop a working definition promoting recovery from a holistic, patient-centred, and tailored approach.

Objective: A large body of literature has examined the links between the use of dopamine replacement therapy (DRT) in Parkinson's disease (PD) and the development of "impulsive-compulsive behaviors (ICBs)." Little is known regarding the link between the development of ICBs and health-related quality of life (HRQOL). We aimed to explore the factors that are associated with poorer HRQOL, especially in relation to DRT-induced ICBs, in a sample of PD patients., Methods: This PARKADD (PARK: PARKinson's disease; ADD: behavioral ADDictions) study was a prospective case‒control study initially designed to assess the factors associated with ICBs in PD patients. A prospective clinical follow-up was added, aiming to capture the long-term evolution of HRQOL in relation to ICBs occurring or worsening after the beginning of PD. We focused on sociodemographic and PD characteristics and the history or presence of ICBs. HRQOL was measured using the Parkinson's Disease Questionnaire-8. A multivariate linear regression was performed to identify factors related to poorer HRQOL., Results: A total of 169 patients were eligible for the follow-up study. The presence of an ICB, a higher levodopa equivalent daily dose (LEDD) and a longer PD duration were significantly associated with poorer HRQOL, with an interaction between LEDD and PD duration., Conclusion: The presence of an ICB was related to poorer HRQOL and should be considered a crucial factor for the management of PD patients. Several studies were recently published that provide guidelines for the management of these patients, with recommendations based on two key principles: prevention and specific treatment.

Aim: This study aimed to evaluate the incidence of self-reported taste and smell alterations (TSA) in cancer paediatric patients and evaluate the impact of TSA on nutritional status in this population. We also developed and validated a composite score to detect TSA in children undergoing chemotherapy., Methods: Paediatric patients who were undergoing chemotherapy in a paediatric oncology unit were included. TSA were assessed from the Gustonco questionnaire from which a composite score was developed and internally validated, eating behaviour was assessed using Child Eating Behaviour Questionnaire, and major weight loss was defined from nutritional status. All data were calculated at 1, 3 and 6 months after chemotherapy start. Associations between nutritional status and scores were studied by using logistic models., Results: Among 49 patients included, TSA occurred in 71.7% of patients at 1 month after chemotherapy start and persisted at 3 and 6 months. TSA led to altered appetite since 1 month after chemotherapy start. The occurrence of a major weight loss at 6 months seemed to be associated with a high Gustonco score., Conclusion: Taste and smell alterations often occurred in paediatric cancer patients after chemotherapy start and seemed to be associated with impaired nutrition at 6 months after chemotherapy., (© 2023 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.)

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 independently for each covariate under examination. With such an approach, the covariates under investigation are not introduced together in the analysis, preventing from simultaneously studying their potential DIF effects on the questionnaire items. One issue, among others, is that it may lead to the detection of false-positive effects when covariates are correlated. To overcome this issue, we developed two new algorithms (namely ROSALI-DIF FORWARD and ROSALI-DIF BACKWARD). Our aim was to obtain an iterative item-by-item DIF detection method based on Rasch family models that enable to adjust group comparisons for DIF in presence of two binary covariates. Both algorithms were evaluated through a simulation study under various conditions aiming to be representative of health research contexts. The performance of the algorithms was assessed using: (i) the rates of false and correct detection of DIF, (ii) the DIF size and form recovery, and (iii) the bias in the latent variable level estimation. We compared the performance of the ROSALI-DIF algorithms to the one of another approach based on likelihood penalization. For both algorithms, the rate of false detection of DIF was close to 5%. The DIF size and form influenced the rates of correct detection of DIF. Rates of correct detection was higher with increasing DIF size. Besides, the algorithm fairly identified homogeneous differences in the item threshold parameters, but had more difficulties identifying non-homogeneous differences. Over all, the ROSALI-DIF algorithms performed better than the penalized likelihood approach. Integrating several covariates during the DIF detection process may allow a better assessment and understanding of DIF. This study provides valuable insights regarding the performance of different approaches that could be undertaken to fulfill this aim., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Dubuy, Hardouin, Blanchin and Sébille.)

Introduction: Malignant tumors of the extremities are uncommon. Their surgical treatment, whether conservative or not, may cause sequelae. Functional assessment of patients is essential for research purposes, but also follow-ups and adaptation of treatments. The Musculoskeletal Tumor Society Rating Scale (MSTS) is a disease-specific functional scoring system often used in English literature. Currently, no studies have been published on a valid French translation of the MSTS, whether for the lower or upper extremities. We, therefore, conducted a prospective study to answer the following questions: (1) Are the proposed adapted French versions of the MSTS valid? (2) Do the psychometric properties of the two versions obtained make their use relevant?, Materials and Methods: The translation and cross-cultural adaptation were carried out following the recommendations of Beaton and Guillemin to obtain two versions: one for patients who had undergone upper extremity surgery (MSTS-UE) and one for those who had undergone lower extremity surgery (MSTS-LE). A prospective multicenter cohort study was then carried out to analyze the psychometric properties of these two versions., Results: A total of 250 patients from 3 referral centers were enrolled in this study. A confirmatory factor analysis (CFA) demonstrated that the two French versions of the MSTS (MSTS-LE and MSTS-UE) were a good fit with a root mean square error of approximation (RMSEA)<0.08 and a comparative fit index (CFI)>0.90. The psychometric properties of the two versions were validated with internal consistency (Cronbach alpha>0.7), convergent validity of each item with its score (> 0.4), and sufficient criterion validity (Pearson correlation coefficient>0.4). The discriminant validity analysis showed that there was a significant correlation between each version and the performance status (PS) (p<0.05)., Conclusion: This study produced a French version of the MSTS scoring system and validated the psychometric properties of the two versions obtained (MSTS-UE and MSTS-LE). Therefore, the French MSTS scoring system is a valid measurement that can be used in international studies., Level of Evidence: I., (Copyright © 2023. Published by Elsevier Masson SAS.)

Background: In emergency medicine, pain is a frequent reason for consultation. However, there is a great variation in its management which is often insufficient. The use intravenous morphine alone or multimodal analgesia with paracetamol is recommended for severe pain. But robust data are lacking to justify the association of paracetamol with morphine versus morphine alone for pain management in the emergency room (ER). The aim of our study is therefore to assess if in patients with acute pain of moderate to severe intensity with a numerical verbal scale (NVS) ≥5 in the ER, the intravenous administration of morphine alone is not inferior to the administration of intravenous morphine combined with paracetamol at 30 min from the first administration of the study drug., Methods: ADAMOPA is a prospective, non-inferiority, multicenter, placebo-controlled, parallel-group, randomized (1:1), double-blind trial. Subjects will be enrolled in the ER if they experience moderate to severe, acute, non-traumatic, and traumatic pain, defined as an NVS ≥5. The primary endpoint will be the between-group difference in mean change in NVS pain scores among patients receiving the combination of intravenous morphine plus paracetamol or intravenous morphine given alone, measured from the time before administration of the study medication to 30 min later., Discussion: This trial will determine the clinical utility of the association of paracetamol with morphine for pain management in the emergency room. The ADAMOPA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices., Trial Registration: EudraCT number: 2019-002149-39., Clinicaltrials: gov identifier: NCT04148495. Date of trial registration: November 1, 2019., (© 2022. The Author(s).)

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 more complete assessment of the psychometric properties of one of the most used PTGI translations in early-stage breast cancer and melanoma patients., Methods: A sample of 379 patients completed the PTGI two years after their cancer diagnosis. A confirmatory analysis was first performed to determine whether the initial five-factor structure of the PTGI was adequate for this French version. As issues were identified in the translation and in the questionnaire structure, we performed an exploratory analysis to determine the most suitable structure for this questionnaire. Validity and reliability of the evidenced structured were then assessed., Results: The exploratory analysis evidenced a four-factor structure close to the initial structure: four of the five initial domains were recovered, and items from the unrecovered domain were split into the other domains. This new structure showed good internal consistency and acceptable validity., Conclusions: This study highlights that the process of translation and cross-cultural validation of questionnaires is crucial to obtain valid and reliable psychometric instruments. We advise French psycho-oncology researchers and psychotherapists to (i) use the revised translation of Lelorain et al. (2010) proposed in this manuscript and (ii) use the four scores newly evidenced with a grouping of two response categories., (© 2022. The Author(s).)

Background and Aims: Gambling disorder is characterized by problematic gambling behavior that causes significant problems and distress. This study aimed to develop and validate a predictive model for screening online problem gamblers based on players' account data., Methods: Two random samples of French online gamblers in skill-based (poker, horse race betting and sports betting, n = 8,172) and pure chance games (scratch games and lotteries, n = 5,404) answered an online survey and gambling tracking data were retrospectively collected for the participants. The survey included age and gender, gambling habits, and the Problem Gambling Severity Index (PGSI). We used machine learning algorithms to predict the PGSI categories with gambling tracking data. We internally validated the prediction models in a leave-out sample., Results: When predicting gambling problems binary based on each PGSI threshold (1 for low-risk gambling, 5 for moderate-risk gambling and 8 for problem gambling), the predictive performances were good for the model for skill-based games (AUROCs from 0.72 to 0.82), but moderate for the model for pure chance games (AUROCs from 0.63 to 0.76, with wide confidence intervals) due to the lower frequency of problem gambling in this sample. When predicting the four PGSI categories altogether, performances were good for identifying extreme categories (non-problem and problem gamblers) but poorer for intermediate categories (low-risk and moderate-risk gamblers), whatever the type of game., Conclusions: We developed an algorithm for screening online problem gamblers, excluding online casino gamblers, that could enable the setting of prevention measures for the most vulnerable gamblers.

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, calibration is performed by fixing the item parameter estimates when measuring the targeted concept for each individual of the trial. The item parameter estimates used for this purpose are typically obtained from a previous "calibration" study. But imposing this constraint on item parameters, instead of freely estimating them directly in the specific sample of the trial, may hamper the ability to detect a treatment effect. The objective of this simulation study was to explore the potential negative impact of calibration of PRO instruments that were developed using RMT on the comparison of results between treatment groups, using different analysis methods., Methods: PRO results were simulated following a polytomous Rasch model, for a calibration and a trial sample. Scenarios included varying sample sizes, with instrument of varying number of items and modalities, and varying item parameters distributions. Different treatment effect sizes and distributions of the two patient samples were also explored. Cross-sectional comparison of treatment groups was performed using different methods based on a random effect Rasch model. Calibrated and non-calibrated approaches were compared based on type-I error, power, bias, and variance of the estimates for the difference between groups., Results: There was no impact of the calibration approach on type-I error, power, bias, and dispersion of the estimates. Among other findings, mistargeting between the PRO instrument and patients from the trial sample (regarding the level of measured concept) resulted in a lower power and higher position bias than appropriate targeting., Conclusions: Calibration does not compromise the ability to accurately assess a treatment effect using a PRO instrument developed within the RMT paradigm in randomized clinical trials. Thus, given its essential role in producing interpretable results, calibration should always be performed when using a PRO instrument developed using RMT as an endpoint in a randomized clinical trial., (© 2022. The Author(s).)

Background and Aims: Parkinson's disease (PD) is one of the most prevalent neurodegenerative diseases. First-line medications consist of drugs that act by counteracting dopamine deficiency in the basal ganglia. Unfortunately, iatrogenic impulsive-compulsive behaviors (ICBs) can occur in up to 20% of PD patients over the course of their illness. ICBs must be considered multifactorial disorders that reflect the interactions of the medication with an individual's vulnerability and the underlying neurobiology of PD. We aimed to explore the predictive genetic, psychopathological and neurological factors involved in the development of ICBs in PD patients by building a complete model of individual vulnerability., Methods: The PARKADD study was a case/non-case study. A total of 225 patients were enrolled ("ICB" group, N = 75; "no ICB" group, N = 150), and 163 agreed to provide saliva samples for genetic analysis. Sociodemographic, neurological and psychiatric characteristics were assessed, and genotyping for the characterization of polymorphisms related to dopaminergic and opioid systems was performed., Results: Factors associated with "ICBs" were younger age of PD onset, personal history of ICB prior to PD onset and higher scores on the urgency and sensation seeking facets of impulsivity. No gene variant was significantly associated, but the association with the opioid receptor mu 1 (OPRM1) rs1799971 polymorphism was close to significance., Discussion and Conclusions: The influence of gene-environment interactions probably exists, and additional studies are needed to decipher the possible role of the opioid system in the development of ICBs in PD patients.

Interpreting observed changes over time in Patient-Reported Outcomes (PRO) measures is still considered a challenge. Indeed, concluding an observed change at group level is statistically significant does not necessarily equate this change is meaningful from the perspective of the patient. To help interpret within and/or between group changes in the measure over time, the estimation of the Minimal Important Difference (MID) of the instrument - the smallest value that patients consider as a perceived change - is useful. In the last 30 years, a plethora of methods and estimators have been proposed to derive this MID value using clinical data from sample of patients. MIDs for hundreds of PROs have been estimated, with frequently a substantial variability in the results depending on the method used. Nonetheless, a rigorous assessment of the statistical performances of numerous proposed methods for estimating MIDs by experimental design such as Monte-Carlo study has never been performed. The purpose of this paper is to thoroughly depict a protocol for a large-scale simulation study designed to investigate the statistical performances, especially bias against a true populational value, of the common proposed estimators for MID. This paper depicts how investigated methods and estimators were retained after the conduct of a systematic review, the design of a conceptual model that formally defines what is the true populational MID value and the translation of the conceptual model into a model allowing the simulation of responses of items to a hypothetical PRO at two times of measurement along with the response to a Patient Global Rating of Change at the second time under the constraint of a known true MID value. A statistical analysis plan is depicted in order to conclude if working hypotheses on what could be appropriate MID estimators will be verified. Strengths, assumptions, and limits of the simulation model are exposed. Finally, we show how this protocol could be the basis for fostering future methodological research on the issue of interpreting changes in PRO measures., (Copyright © 2022. Published by Elsevier Inc.)

Aims: To estimate whether the use of wagering inducements has a significant impact on the gambling behaviors of on-line gamblers and describe this temporal relation under naturalistic conditions., Design: This longitudinal observational study is part of the second stage of the Screening for Excessive Gambling Behaviors on the Internet (EDEIN) research program., Setting: Gambling tracking data from the French national on-line gambling authority (poker, horse race betting and sports betting) and from the French national lottery operator (lotteries and scratch games)., Participants: A total of 9306 gamblers who played poker, horse race or sports betting and 5682 gamblers who played lotteries and scratch games completed an on-line survey. The gender ratio was largely male (between 87.1% and 92.9% for poker, horse race betting and sports betting, and equal to 65.1% for lotteries). Median age ranged from 35 (sports betting) to 53 (horse race betting and lotteries)., Measurements: The survey used the Problem Gambling Severity Index (PGSI) to determine the status of the gamblers (at-risk or not). Gambling tracking data included weekly gambling intensity (wagers, deposits), gambling frequency (number of gambling days), proxies of at-risk gambling behaviors (chasing and breadth of involvement) and use of wagering inducements., Findings: The use of wagering inducements was associated with an increase of gambling intensity [β between -0.06 (-0.08; -0.05) and 0.57 (0.54; 0.60)], gambling frequency [β between 0.12 (0.10; 0.18) and 0.29 (0.28; 0.31)] and at-risk gambling behaviors [odds ratio between 1.32 (1.16; 1.50) and 4.82 (4.61; 5.05)] at the same week of their use. This effect was stronger for at-risk gambling behaviors and at-risk gamblers., Conclusions: Wagering inducements may represent a risk factor for developing or exacerbating gambling problems., (© 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Background: The resurgence of heroin use and the misuse of pharmaceutical opioids are some of the reasons for a worldwide increase in opioid dependence. Opioid Medication Therapies (OMT) have amply demonstrated their efficacy. From a medical point of view, the main objectives of OMT concern medical and social outcomes, centred on risk reduction and the cessation of opioid use. But patient points of view can differ and few studies have explored opioid-dependent patient viewpoints on their OMT. This variable seems important to consider in a patient-centred approach. The aim of our study was to explore points of view of people who use drugs (PWUD) treated with OMT, in a large multicentre sample., Method: A cross-sectional multicentre study explored the points of view of PWUD with Opioid Use Disorder following OMT. Data regarding the patients' points of view were collected using a self-administered questionnaire developed by the scientific committee of the study. A descriptive analysis and an exploratory factor analysis were performed to explore the structure of items exploring patient viewpoints., Results: 263 opioid dependent PWUD were included, a majority were men consuming heroin prior to being prescribed OMT. 68% were on methadone, 32% were on buprenorphine. Most PWUD identified a positive impact on their lives, with 92.8% agreeing or strongly agreeing that OMT had changed a lot of things in their lives. The exploratory factor analysis identified three factors: (F1) items related to points of views concerning the objectives and efficacy of OMT; (F2) items related to the legitimacy of OMT as a treatment compared to a drug, (F3) items related to experiences and relationships with OMT., Conclusion: Patient viewpoints on efficacy were correlated with the pharmacological benefits of OMT and with the associated psychosocial measures. The implications of OMT in relationships, such as the feeling of being judged, concerned a majority. Points of view were ambivalent concerning the role of OMT as a treatment or as a drug. Involving patient points of view in therapeutic strategies decisions could help enhance positive views among PWUD on OMT and help PWUD towards their recovery., Trial Registration: OPAL study was registered: (NCT01847729)., (© 2022. The Author(s).)

Introduction: COVID-19 sequelae are numerous and multisystemic, and how to evaluate those symptomatic patients is a timely issue. Klok et al proposed the Post-COVID-19 Functional Status (PCFS) Scale as an easy tool to evaluate limitations related to persistent symptoms. Our aim was to analyse PCFS Scale ability to detect functional limitations and its correlation with quality of life in a cohort of patients, 2-9 months after hospitalisation for COVID-19 hypoxemic pneumonia., Methods: PCFS Scale was evaluated in 121 patients together with quality of life and dyspnoea questionnaires, pulmonary function tests and CT scans., Results: We observed a high correlation with multiple questionnaires (Short Form-36, Hospital Anxiety and Depression Scale, modified Medical Research Council, end Borg Six-Minute Walk Test), making the PCFS Scale a quick and global tool to evaluate functional limitations related to various persistent symptoms following COVID-19 pneumonia., Discussion: The PCFS Scale seems to be a suitable instrument to screen for patients who will require careful follow-up after COVID-19 hypoxemic pneumonia even in the absence of pulmonary sequelae., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Kidney 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 measurement invariance between these patients' groups and/or over time (i.e. response shift, RS) which may invalidate the between-group comparison of HRQoL change scores. The aim of this study was to investigate and compare RS before and after KT between these two patients' groups. Measurement invariance was investigated between groups and over time with three measurement occasions., Methods: Adult patients completed the SF-36 at the last visit before KT, and 3, 6 months after. A structural equation model-based procedure was used to (i) detect and take into account measurement non-invariance between groups and RS, if appropriate, (ii) identify the period of occurrence of RS, (iii) study the heterogeneity of RS between the two groups., Results: Before KT (i.e. baseline), measurement invariance was not rejected between dialyzed (n = 196) and preemptive (n = 178) patients' groups. Between baseline and 3 months after KT, similar uniform recalibration was detected on the general health domain in both groups. Uniform recalibration was found between 3- and 6 months after KT on the vitality domain for preemptive patients only., Conclusion: HRQoL, adjusted for RS, increased overall for preemptive and dialyzed kidney transplant patients after transplantation. RS may reflect differing adaptation processes following KT., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

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., Methods: We carried out a pilot randomized, double-blind, controlled study associating VRET (two 20 min sessions with a 48 h interval, during which, participants had to cross a plank at rising heights in a building in construction) with online tDCS (targeting the ventromedial prefrontal cortex) in 28 participants. The primary outcomes were the sense of presence level and the tolerability. The secondary outcomes were the anxiety level (Subjective Unit of Discomfort) and the salivary cortisol concentration., Results: We confirmed the feasibility of the association between tDCS and fully embodied VRET associated with a good sense of presence without noticeable adverse effects. In both groups, a significant reduction in the fear of height was observed after two sessions, with only a small effect size of add-on tDCS (0.1) according to the SUD. The variations of cortisol concentration differed in the tDCS and sham groups., Conclusion: Our study confirmed the feasibility of the association between wireless online tDCS and active, fully embodied VRET. The optimal tDCS paradigm remains to be determined in this context to increase effect size and then adequately power future clinical studies assessing synergies between both techniques.

Background: Sterols are the main components of fungal membranes. Inhibiting their biosynthesis is the mode of action of azole antifungal drugs that are widely used to treat fungal disease including aspergillosis. Azole resistance has emerged as a matter of concern but little is known about sterols biosynthesis in azole resistant Aspergillus fumigatus ., Methods: We explored the sterol composition of 12 A. fumigatus isolates, including nine azole resistant isolates with TR 34 /L98H, TR 46 /Y121F/T289A or TR 53 alterations in the cyp51A gene and its promoter conferring azole resistance. Modifications in sterol composition were also investigated after exposure to two azole drugs, itraconazole and voriconazole., Results: Overall, under basal conditions, sterol compositions were qualitatively equivalent, whatever the alterations in the target of azole drugs with ergosterol as the main sterol detected. Azole exposure reduced ergosterol composition and the qualitative composition of sterols was similar in both susceptible and resistant isolates. Interestingly TR 53 strains behaved differently than other strains., Conclusions: Elucidating sterol composition in azole-susceptible and resistant isolates is of interest for a better understanding of the mechanism of action of these drugs and the mechanism of resistance of fungi.

Statement of Problem: Intraoral scanners have significantly improved over the last decade. Nevertheless, data comparing intraoral digital scans with conventional impressions are sparse., Purpose: The purpose of this systematic review and meta-analysis was to determine the impact of impression technique (digital scans versus conventional impressions) on the clinical time, patient comfort, and marginal fit of tooth-supported prostheses., Material and Methods: The authors conducted a literature search based on the Population, Intervention, Comparison, and Outcome (PICO) framework in 3 databases to identify clinical trials with no language or date restrictions. The mean clinical time, patient comfort, and marginal fit values of each study were independently extracted by 2 review authors and categorized according to the scanning or impression method. The authors assessed the study-level risk of bias., Results: A total of 16 clinical studies met the inclusion criteria. The mean clinical time was statistically similar for digital scan procedures (784 ±252 seconds) and for conventional impression methods (1125 ±159 seconds) (P>.05). The digital scan techniques were more comfortable for patients than conventional impressions; the mean visual analog scale score was 67.8 ±21.7 for digital scans and 39.6 ±9.3 for conventional impressions (P<.05). The mean marginal fit was 80.9 ±31.9 μm and 92.1 ±35.4 μm for digital scan and conventional impressions, respectively, with no statistically significant difference (P>.05)., Conclusions: Digital scan techniques are comparable with conventional impressions in terms of clinical time and marginal fit but are more comfortable for patients than conventional impression techniques., (Copyright © 2020 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.)

Purpose: Methods 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 points, as RS may induce an increase in the number of discrepancies over time. This study aims to establish the link between recalibration RS and the change in the number of GEs over time (denoted index [Formula: see text]) via simulations and explores the discriminating ability of this index., Methods: We simulated the responses of individuals affected or not affected by recalibration RS (defined as changes in the patients' standard of measurement) to determine whether simulated individuals with recalibration had a greater change in the number of GEs over time than individuals without recalibration. The effects of factors related to the sample, the questionnaire structure and recalibration were investigated. As an illustrative example, the change in the number of GEs was computed in patients suffering from eating disorders., Results: Within simulations, simulated individuals affected by recalibration had, on average, a greater change in the number of GEs over time than did individuals without RS. Some of the parameters related to the questionnaire structure and recalibration magnitude appeared to have substantial effects on the values of [Formula: see text]. Discriminating abilities appeared, however, globally low., Conclusion: Some evidence of the link between recalibration and the change in GEs was found in this study. GEs could be a valuable nonparametric tool for RS detection at a more individual level, but further investigation is needed., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Context: The PP Convergences criteria group together 10 of the most significant clinical criteria for sensitization in the context of chronic pelvic pain. They are the result of a consensus of experts and represent to date the only clinical evaluation guide to identify patients with pelvic perineal pain in whom a pelvic sensitization component can be evoked., Objective: This work concerns the psychometric validation of these criteria. The aim is to answer 3 questions: 1) is the instrument reliable (i.e., sensitive, specific and accurate)?; 2) can we define a screening score for pelvic-perineal pain by sensitization from the CPP criteria?; 3) can combinations of criteria be defined to predict pelvic-perineal sensitization from the CPP criteria?, Methodology and Subjects: In total, 308 patients with pelviperineal pain were recruited during their medical consultation., Procedure: Fifteen expert physicians were asked to judge the presence or absence of the 10 CPP criteria and to make a diagnosis of the presence or absence of pelviperineal sensitization in their patient., Results: ROC curve analysis indicated that a score of 5 was the closest to a perfect score with a sensitivity of 95% and a specificity of 87%. They also indicate that the CPP criteria have a very good sensitivity (97%) and specificity (91%) and present globally a good reproducibility on all the criteria (Kappa>0.6). Finally, the statistical analyses reveal that the most discriminating criterion for predicting sensitization is Q8 (pain persisting after sexual activity)., Conclusion: The CPP criteria represent a very good screening tool for pelvic sensitization. The score of 5 corresponds to the score at which the patient has sufficient clinical criteria to be classified as sensitized., Level of Evidence: 4., (Copyright © 2021. Published by Elsevier Masson SAS.)

Background and Aims: Since June 2018, gaming disorder (GD) has been recognized as a disease. It is frequently associated with attention deficit hyperactivity disorder (ADHD), as there are common vulnerability factors and bidirectional interactions between the two disorders. This study aims to evaluate the presence of ADHD symptoms and predictive factors of ADHD among patients with GD., Methods: Ninety-seven patients ≥16 years old referred to the University Hospital of Nantes between 2012 and 2020 for GD were included. The diagnosis of GD was given a posteriori in accordance with the new ICD-11 GD definition. ADHD was screened using the Adult-ADHD Self-Report Scale and the Wender-Utah Rating Scale. A multivariate logistic regression model was used to identify explanatory factors for ADHD-GD comorbidity., Results: The rate of GD patients who screened positive for ADHD was 39%. Predictive factors of ADHD-GD comorbidity were impulsivity (higher score on the negative urgency dimension) and low self-esteem., Discussion: The rate of ADHD found among patients with GD is consistent with that from the literature on internet GD but higher than that found for other behavioural addictions. The identification of a higher negative urgency score and low self-esteem as predictive factors of AHDH-GD comorbidity indicates that gaming could be considered a dysfunctional way to cope with emotional dysregulation in ADHD or to virtually escape., Conclusions: Comorbid ADHD must be taken into consideration to minimize its functional impact on GD patients and gaming-related damage. In contrast, the evaluation of gaming habits in patients with ADHD could be useful for both prevention and care.

Background: Dementia with Lewy bodies remains underdiagnosed in clinical practice mainly because of the low sensitivity of existing diagnostic criteria and a strong overlap with Alzheimer's pathology that can mask the Lewy phenotype., Objective: The objective of this study was therefore to develop and validate a new clinical scale designed to detect signs of Lewy body disease, called LeSCoD for Lewy body Screening scale in Cognitive Disorders., Methods: 128 patients who fulfilled the clinical criteria of dementia with Lewy bodies (DLB; n = 32), Alzheimer's disease (AD; n = 77) or both (n = 19) was prospectively enrolled. 18 F-DOPA PET imaging and/or CSF biomarkers were available in some patients. LeSCoD scale was systematically administered and the potential correlation with 18 F-DOPA PET imaging was evaluated in a subgroup of patients., Results: LeSCoD scale showed robust internal and external validity. We determined a cut-off of 10 above which the sensitivity and specificity for Lewy body disease diagnosis were 86% and 95%, respectively. The LeSCoD scale correlated with striatal dopamine uptake in 18 F-DOPA PET., Conclusion: LeSCoD scale is a simple and reliable tool for the evaluation of Lewy body disease in routine clinical practice, with a higher sensitivity and specificity than the existing criteria. It might be an alternative to the use of dopamine-specific imaging., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Anorexia nervosa (AN) is a complex disease in which obsessive thoughts about body image, shape, or weight are expressed. The intensity of these concerns varies among individuals, and only a few studies have focused on their impact on patients' clinical course when patients are treated on an outpatient basis. Our study aimed to determine whether marked body concerns at inclusion were predictive of the one-year follow-up., Method: Participants (N = 72) were women seeking treatment for AN in a specialized unit for eating disorder management. All participants were assessed at inclusion and at the 1-year follow-up. Clinical outcome was assessed using the Morgan & Russel Outcome Average Score (MROAS), and body concerns were assessed using the Body Shape Questionnaires (BSQ)., Results: Marked body concerns (BSQ score >140) at inclusion were associated with a poorer outcome at the 12-month follow-up (lower MROAS "total score"). Other characteristics at inclusion that were predictive of a poorer outcome at 12 months were as follows: higher severity of ED at inclusion, longer hospitalization during follow-up, and experiencing a lower impact of the illness on school/work life., Discussion: The results confirmed the importance of a multifocal treatment that should address body concerns and motivation to change. Our results also highlighted the necessity of promoting the maintenance of school/work during the treatment course., (© 2021 The Authors. Brain and Behavior published by Wiley Periodicals LLC.)

Aims: To identify factors associated with vascular events in patients with giant cell arteritis (GCA)., Methods: We performed a retrospective study of GCA patients diagnosed over a 20-year-period, who all underwent vascular imaging evaluation at diagnosis. Symptomatic vascular events were defined as the occurrence of any aortic event (aortic dissection or symptomatic aortic aneurysm), stroke, myocardial infarction, limb or mesenteric ischemia and de novo lower limbs arteritis stage 3 or 4. Patients with symptomatic vascular event (VE+) and without were compared, and risk factors were identified in a multivariable analysis., Results: Thirty-nine (15.4%) of the 254 included patients experienced at least one symptomatic vascular event during follow-up, with a median time of 21.5 months. Arterial hypertension, diabetes, lower limbs arteritis or vascular complication at diagnosis were more frequent in VE+ patients ( p  < 0.05), as an abnormal computed tomography (CT)-scan at diagnosis ( p  = 0.04), aortitis ( p  = 0.01), particularly of the descending thoracic aorta ( p  = 0.03) and atheroma ( p  = 0.03). Deaths were more frequent in the VE+ group (37.1 versus 10.3%, p  = 0.0003). In multivariable analysis, aortic surgery [hazard ratio (HR): 10.46 (1.41-77.80), p  = 0.02], stroke [HR: 22.32 (3.69-135.05), p  < 0.001], upper limb ischemia [HR: 20.27 (2.05-200.12), p  = 0.01], lower limb ischemia [HR: 76.57 (2.89-2027.69), p  = 0.009], aortic atheroma [HR: 3.06 (1.06-8.82), p  = 0.04] and aortitis of the descending thoracic aorta on CT-scan at diagnosis [HR: 4.64 (1.56-13.75), p  = 0.006] were independent predictive factors of a vascular event., Conclusion: In this study on GCA cases with large vessels imaging at diagnosis, aortic surgery, stroke, upper or lower limb ischemia, aortic atheroma and aortitis of the descending thoracic aorta on CT-scan, at GCA diagnosis, were independent predictive factors of a vascular event., Plain Language Summary: Risk factors for symptomatic vascular events in giant cell arteritisThis study was performed to identify the risk factors for developing symptomatic vascular event during giant cell arteritis (GCA) because these are poorly known.We performed a retrospective study of GCA patients diagnosed over a 20-year-period, who all underwent vascular imaging evaluation at diagnosis.Patients with symptomatic vascular event (VE+) and without (VE-) were compared, and risk factors were identified in a multivariable analysis.Thirty-nine patients experienced at least one symptomatic vascular event during follow-up, with a median time of 21.5 months.Arterial hypertension, diabetes, lower limbs arteritis or vascular complication at diagnosis were significantly more frequent in VE+ patients, as an abnormal CT-scan at diagnosis, aortitis, particularly of the descending thoracic aorta and atheroma. Deaths were more frequent in the VE+ group.Among 254 GCA patients, 39 experienced at least one vascular event during follow-up.Aortic surgery, stroke, upper and lower limb ischemia were vascular event risk factors.Aortic atheroma and descending thoracic aorta aortitis on CT-scan were vascular event risk factors.This study on GCA cases with large vessels imaging at diagnosis, showed that aortic surgery, stroke, upper or lower limb ischemia, aortic atheroma and aortitis of the descending thoracic aorta on CT-scan, at GCA diagnosis, were independent predictive factors of a vascular event., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest., (© The Author(s), 2021.)

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 difficult to interpret. Knowing the smallest value in the score that the patient perceives as change can help. An estimator linking the answers to a Patient Global Rating of Change (PGRC: a question measuring the overall feeling of change) with change in PRO scores is frequently used to obtain this value. In the last 30 years, a plethora of methods have been used to obtain these estimates, but there is no consensus on the appropriate method and no formal definition of this value., Methods: We propose a model to explain changes in PRO scores and PGRC answers., Results: A PGRC measures a construct called the Perceived Change (PC), whose determinants are elicited. Answering a PGRC requires discretizing a continuous PC into a category using threshold values that are random variables. Therefore, the populational value of the Minimal Perceived Change (MPC) is the location parameter value of the threshold on the PC continuum defining the switch from the absence of change to change., Conclusions: We show how this model can help to hypothesize what are the appropriate methods to estimate the MPC and its potential to be a rigorous theoretical basis for future work on the interpretation of change in PRO scores.

Background: Giant cell arteritis (GCA) is the most common systemic vasculitis. Relapses are frequent. The aim of this study was to identify relapse risk factors in patients with GCA with complete large-vessel imaging at diagnosis., Methods: Patients with GCA followed in our institution between April 1998 and April 2018 were included retrospectively. We included only patients who had undergone large vascular imaging investigations at diagnosis by computed tomography (CT)-scan and/or positron emission tomography (PET)-scan and/or angio-magnetic resonance imaging (MRI). Clinical, biological, and radiological data were collected. Relapse was defined as the reappearance of GCA symptoms, with concomitant increase in inflammatory markers, requiring treatment adjustment. Relapsing patients (R) and non-relapsing patients (NR) were compared. Relapse and multiple relapses (>2) risk factors were identified in multivariable Cox analyses., Results: This study included 254 patients (73.2% women), with a median age of 72 years at diagnosis and a median follow up of 32.5 months. At diagnosis, 160 patients (63%) had an inflammatory large-vessel involvement on imaging, 46.1% (117 patients) relapsed at least once, and 21.3% (54 patients) had multiple relapses. The median delay of first relapse after diagnosis was 9 months. The second relapse delay was 21.5 months. NR patients had more stroke at diagnosis than R ( p  = 0.03) and the brachiocephalic trunk was involved more frequently on CT-scan ( p  = 0.046), as carotids ( p  = 0.02) in R patients. Multivariate Cox model identified male gender [hazard ratio (HR): 0.51, confidence interval (CI) (0.27-0.96), p  = 0.04] as a relapse protective factor, and peripheral musculoskeletal manifestations [HR: 1.74 (1.03-2.94), p  = 0.004] as a relapse risk factor. Peripheral musculoskeletal manifestations [HR: 2.78 (1.23-6.28), p  = 0.014], negative temporal artery biopsy [HR: 2.29 (1.18-4.45), p  = 0.015], large-vessel involvement like upper limb ischemia [HR: 8.84 (2.48-31.56), p  = 0.001] and inflammation of arm arteries on CT-scan [HR: 2.39 (1.02-5.58), p  = 0.04] at diagnosis were risk factors of multiple relapses., Conclusion: Male gender was a protective factor for GCA relapse and peripheral musculoskeletal manifestations appeared as a relapsing risk factor. Moreover, this study identified a particular clinical phenotype of multi-relapsing patients with GCA, characterized by peripheral musculoskeletal manifestations, negative temporal artery biopsy, and large-vessel involvement with upper limb ischemia or inflammation of arm arteries., Plain Language Summary: At giant cell arteritis diagnosis, large-vessel inflammatory involvement is predictive of multiple relapses 46.1% of patients with GCA relapse, and 21.3% undergo multiple relapses;Male gender appears as a protective factor for relapsing in GCA;Peripheral musculoskeletal manifestations are a relapse and multiple relapses risk factor;A negative temporal artery biopsy is predictive of multiple relapses;Large-vessel involvement is predictive of multiple relapses., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest., (© The Author(s), 2021.)

Background and Aims: Few studies have been conducted on the long-term evolution of gambling disorder (GD). The aim of this study was to identify factors that could predict GD relapse., Methods: Data were part of a dataset from a large 5-year cohort of gamblers who were assessed at inclusion and each year thereafter. Participants were recruited from an outpatient addiction treatment center, from various gambling places and through the press. For this specific study, inclusion criteria included (i) transitioning from GD to recovery at a follow-up time and (ii) undergoing at least one follow-up visit afterwards. Participants were evaluated using a structured clinical interview and self-report questionnaires assessing sociodemographic, gambling and clinical characteristics. "Relapse" was defined as the presence of GD (according to the DSM-5) at the N+1th visit following the absence of GD at the Nth visit. A Markov model-based approach was employed to examine predictive factors associated with relapse at a subsequent follow-up visit., Results: The sample consisted of 87 participants, aged 47.6 years (sd = 12.6), who were predominantly male (65%). Among the participants, 49 remained in recovery, whereas 38 relapsed. Participants who reported not having experienced at least one month of abstinence and those with a low level of self-directedness at the previous follow-up visit were more likely to relapse., Conclusions: Our findings suggest the existence of factors that are predictive of relapse in individuals with GD who had previously achieved recovery. These results can inspire the development of measures to promote long-term recovery.

Background: Lupus animal model has shown that arsenic trioxide (ATO), a treatment of acute promyelocytic leukaemia, could be effective in SLE. This is the first clinical study to determine the safety and efficacy of a short course of intravenous ATO in patients with active SLE., Methods: This phase IIa, open-label, dose-escalating study enrolled 11 adult SLE patients with a non-organ threatening disease, clinically active despite conventional therapy. Patients received 10 IV infusions of ATO within 24 days. The first group received 0.10 mg/kg per injection, with dose-escalating to 0.15 mg/kg in a second group, and to 0.20 mg/kg in a third group. The primary endpoint was the occurrence of adverse events (AEs) and secondary endpoints were the number of SLE Responder Index 4 (SRI-4) responders at week 24 and reduction of corticosteroid dosage. In an exploratory analysis, we collected long-term data for safety and attainment of lupus low disease activity state (LLDAS)., Results: Four serious AEs occurred (grade 3 neutropenia, osteitis, neuropathy), 2 of which were attributable to ATO (neutropenia in the 2 patients treated with mycophenolate). Two patients suffered a severe flare during the last 4 weeks of the trial. At W24, five patients among 10 were SRI-4 responders. Overall, mean corticosteroid dosage decreased from 11.25 mg/day at baseline to 6 mg/day at W24 (P < 0.01). In the long term, 6 patients attained LLDAS at W52, which continued at last follow-up (median LLDAS duration 3 years, range 2-4)., Conclusions: A short course of ATO has an acceptable safety profile in SLE patients and encouraging efficacy., Trial Registration: ClinicalTrials.gov, NCT01738360  registered 30 November 2012.

Background: The aim of this network meta-analysis (NMA) was to compare the clinical results obtained after primary reconstruction of orbital floor fractures (OFF) using different materials., Methods: PubMed, Cochrane, and Google Scholar databases were screened from 1989 to 2019. For a study to be eligible, it had to evaluate two or more materials and report the following clinical parameters: diplopia and/or enophthalmos and/or other complications., Results: Nine studies involving 946 patients presenting with an OFF were included. After the surgical procedure, 105 patients (11%) had diplopia, while 43 patients (4.5%) suffered from enophthalmos. The NMA revealed that less postoperative diplopia and enophthalmos were obtained either by using polydioxanone (PDS), or a polymer of l-lactic acid and dl-lactic acid (P[L/DL]LA), or porous polyethylene, or titanium mesh compared with the use of autologous bone grafts., Conclusion: P(L/DL)LA and PDS seem to be the best options for small and intermediate defects, whereas the association of porous polyethylene and titanium should be preferred for larger defects., (© 2020 Wiley Periodicals LLC.)

Background: The frontal variant of Alzheimer's disease (fAD) is poorly understood and poorly defined. The diagnosis remains challenging. The main differential diagnosis is the behavioral variant of frontotemporal degeneration (bvFTD). For fAD, there is some dissociation between the clinical frontal presentation and imaging and neuropathological studies, which do not always find a specific involvement of the frontal lobes. DAPHNE is a behavioral scale, which demonstrated excellent performance to distinguish between bvFTD and AD., Objective: The aim of the present study was to assess the reliability of this new tool to improve the clinical diagnosis of fAD., Methods: Twenty fAD patients and their caregivers were prospectively included and were compared with 36 bvFTD and 22 AD patients., Results: The three main behavioral disorders in the fAD patients were apathy, loss of empathy, and disinhibition. Three disorders were discriminant because they were less frequent and less severe in the fAD patients than in the bvFTD patients, namely hyperorality, neglect, and perseverations. This specific pattern of behavioral disorders was corroborated by SPECT or 18FDG PET-CT scan that showed that patients with fAD could have a medial frontal hypoperfusion, whereas in bvFTD patients the orbitofrontal cortex was the main involved region, with more diffuse hypoperfusion., Conclusion: We demonstrated that DAPHNE had good sensitivity and good specificity to discriminate between the three groups and in particular between fAD and bvFTD patients. DAPHNE is a quick tool that could help clinicians in memory clinics not only to differentiate bvFTD from typical AD but also from fAD.

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 to response shift (longitudinal measurement non-invariance) and possibly to erroneous interpretation of the observed changes in PRO. Several statistical methods for response shift analysis have been proposed, but they usually assume that response shift occurs in the same way in all individuals within the sample regardless of their characteristics. Many studies aim at comparing the longitudinal change of PRO into two groups of patients (treatment arm, different pathologies, …). The group variable could have an effect on PRO change but also on response shift effect and the perception of the questionnaire at baseline. In this paper, we propose to enhance the ROSALI algorithm based on Rasch Measurement Theory for the analysis of longitudinal PRO data to simultaneously investigate the effects of group on item functioning at the first measurement occasion, on response shift and on changes in PRO over time. ROSALI is subsequently applied to a longitudinal dataset on change in emotional functioning in patients with breast cancer or melanoma during the year following diagnosis. The use of ROSALI provides new insights in the analysis of longitudinal PRO data., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Hammas, Sébille, Brisson, Hardouin and Blanchin.)

Background: Deep dermal suturing is critical for scar quality outcomes. The authors evaluated a new, fast medical device for dermal suturing, with the hypothesis of noninferiority with regard to clinical scar and cost-effectiveness., Methods: A prospective, patient-blind, randomized, multicenter noninferiority study in 26 French hospitals was conducted. Patients were randomized 1:1 to suturing with conventional thread or a semiautomatic stapler. The Patient Scar Assessment Scale was rated at 3 months for primary endpoint effectiveness. Secondary endpoints were cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale and Patient Scar Assessment Scale score, scar aesthetic quality 18 months after surgery, and occupational exposure to blood during surgery., Results: Six hundred sixty-four patients were enrolled, 660 were randomized, and 649 constituted the full analysis (stapler arm, n = 324; needle arm, n = 325). Primary endpoint Patient Scar Assessment Scale score in the stapler arm was not inferior to that in the needle arm at 3 months or after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 minutes in the needle arm (p = not significant). The mean suturing time was significantly lower in the stapler arm (p < 0.001). There were seven occupational exposures to blood in the needle arm and one in the stapler arm. The two arms did not differ significantly in terms of complications (p = 0.41). The additional cost of using the device was &OV0556;51.57 for the complete-case population., Conclusion: Wound healing outcome was no worse than with conventional suturing using a semiautomatic stapler and associated with less occupational exposure to blood., Clinical Question/level of Evidence: Therapeutic, I.

Introduction: Hyperkalaemia is a common electrolyte disorder and can be life-threatening. In the emergency room (ER), interventions aim to protect patients from the immediate dangers of elevated serum potassium by redistributing potassium ions from the bloodstream into the cells via intravenous insulin or nebulised beta2-agonists. However, to date, evidence for acute management of hyperkalaemia is limited. The aim of this randomised controlled trial is therefore to compare three strategies, namely insulin/glucose intravenous infusion, nebulised salbutamol or a combination of nebulised salbutamol and insulin/glucose intravenous infusion to reduce serum potassium concentration at 60 min as a first-line treatment in patients admitted to the ER with serum potassium concentrations superior or equal to 6 mmol/L., Methods and Analysis: INSAKA is a prospective, multicentre, controlled, open-label, parallel-group, randomised in a 1:1:1 ratio clinical trial. Patients will be eligible for randomisation if they have serum potassium concentrations superior or equal to 6 mmol/L measured in the ER. Patients will receive either: (1) 10 mg of nebulised salbutamol, (2) 10 units of short-acting insulin in an intravenous bolus with 500 mL of 10% glucose or (3) 10 units of short-acting insulin in an intravenous bolus with 500 mL of 10% glucose combined with 10 mg of nebulised salbutamol. The primary endpoint will be the mean change in the absolute serum potassium level from baseline to 60 min measured in mmol/L. We plan to include 525 patients., Ethics and Dissemination: The INSAKA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices. All trial documents and procedures have been reviewed and approved by the Ethics Committee Sud Méditerranée III (approval ID number: 19.07.16.36428). The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet., Trial Registration: EudraCT number: 2019-002710-39, Clinicaltrials.gov identifier: NCT04012138., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Individuals who gamble online may be at risk of gambling excessively, but internet gambling also provides a unique opportunity to monitor gambling behavior in real environments which may allow intervention for those who encounter difficulties., Objective: The objective of this study was to model the early gambling trajectories of individuals who play online lottery., Methods: Anonymized gambling-related records of the initial 6 months of 1152 clients of the French national lottery who created their internet gambling accounts between September 2015 and February 2016 were analyzed using a two-step approach that combined growth mixture modeling and latent class analysis. The analysis was based upon behavior indicators of gambling activity (money wagered and number of gambling days) and indicators of gambling problems (breadth of involvement and chasing). Profiles were described based upon the probabilities of following the trajectories that were identified for the four indicators, and upon several covariates (age, gender, deposits, type of play, net losses, voluntary self-exclusion, and Playscan classification-a responsible gambling tool that provides each player with a risk assessment: green for low risk, orange for medium risk and red for high risk). Net losses, voluntary self-exclusion, and Playscan classification were used as external verification of problem gambling., Results: We identified 5 distinct profiles of online lottery gambling. Classes 1 (56.8%), 2 (14.8%) and 3 (13.9%) were characterized by low to medium gambling activity and low values for markers of problem gambling. They displayed low net losses, did not use the voluntary self-exclusion measure, and were classified predominantly with green Playscan tags (range 90%-98%). Class 4 (9.7%) was characterized by medium to high gambling activity, played a higher breadth of game types (range 1-6), and had zero to few chasing episodes. They had high net losses but were classified with green (66%) or orange (25%) Playscan tags and did not use the voluntary self-exclusion measure. Class 5 (4.8%) was characterized by medium to very high gambling activity, played a higher breadth of game types (range 1-17), and had a high number of chasing episodes (range 0-5). They experienced the highest net losses, the highest proportion of orange (32%) and red (39%) tags within the Playscan classification system and represented the only class in which voluntary self-exclusion was present., Conclusions: Classes 1, 2, 3 may be considered to represent recreational gambling. Class 4 had higher gambling activity and higher breadth of involvement and may be representative of players at risk for future gambling problems. Class 5 stood out in terms of much higher gambling activity and breadth of involvement, and the presence of chasing behavior. Individuals in classes 4 and 5 may benefit from early preventive measures., (©Gaëlle Challet-Bouju, Jean-Benoit Hardouin, Elsa Thiabaud, Anaïs Saillard, Yann Donnio, Marie Grall-Bronnec, Bastien Perrot. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 12.08.2020.)

Purpose: While studies on patients' quality of life (QoL) are numerous, to date few have addressed the issue of what QoL means for doctors and how they use patient-reported QoL. This study aimed to explore how doctors define the concept of "patient QoL" and how they use QoL assessments in clinical practice., Methods: Focus group (FG) interviews were conducted with French hospital doctors and general practitioners. Transcripts of the FGs were explored using inductive thematic and lexical analyses., Results: Twenty-one clinicians participated in four FGs. They all agreed that QoL was a subjective and unstable concept, different from that of health status. In practice, the assessment of patient QoL was conducted using an intuitive and non-structured approach. Most participants thought that it would give them more confidence in making decisions and provide better patient care. But it was also seen in some cases as putting them in an uncomfortable position. The assessment of QoL requires a favourable work and organizational setting., Conclusions: Patient QoL provides useful data for clinicians. Yet assessments are made without standardized tools. The use of such tools could be very valuable for some practitioners or in some situations, and a real source of problems for others. These problems could, however, be easily overcome with experience-sharing and training clinicians.