Building a validity argument for the listening component of the Test de connaissance du français in the context of Quebec immigration

L’évaluation linguistique est une pratique omniprésente dans les contextes d’immigration, utilisée comme une méthode de collecte de données pour évaluer la capacité des immigrants à communiquer dans la langue du pays d’accueil afin de promouvoir l’intégration sociale et économique ainsi que la productivité au travail (McNamara & Shohamy, 2008). Contrairement aux tests d’anglais, peu d’attention est accordée à l’interprétation et à l’utilisation des scores aux tests en français, ce qui incite - et demande – de la validation des scores pour justifier l’utilisation des tests. Cette étude, qui fait appel aux avancées de la théorie de la validité des tests (Kane, 2006, 2013), construit un argumentaire de validité pour la composante de la compréhension orale du Test de connaissance du français (TCF) dans le contexte de l’immigration au Québec. La théorie de la validité des tests a évolué considérablement depuis le modèle tripartite traditionnel de contenu, de prédiction et de construit (Cronbach et Meehl, 1955), a été conceptualisée comme un construit unitaire (Messick, 1989) et, plus récemment, a été théorisée en termes d’argumentation (Kane, 2006, 2013), empruntant des concepts de modèles d’inférence (Toulmin [1958], 2003), qui englobent des inférences de score, de généralisation, d’explication, d’extrapolation et de décision, ayant des rôles importants dans un argumentaire de validité. Dans une approche de validité fondée sur l’argumentation, les affirmations relatives aux instruments de mesure sont composées de garanties qui doivent être étayées par des études empiriques, qui sont fondamentales pour les affirmations, mais qui appuient également les inférences qui autorisent chacune des affirmations de l’argumentaire. Plus précisément, cette étude a analysé des données empiriques pour appuyer les inférences de scores, de généralisation et d’explication, en proposant trois questions de recherche portant sur la représentativité du construit du TCF, le fonctionnement différentiel d’items et l’utilité de la technique de collecte de données. Les questions ont porté sur les sous-compétences de compréhension orale dont le TCF évalue, le fonctionnement différentiel des items (FDI) selon le genre, la langue maternelle, l’âge et l’emplacement géographique des candidats ainsi que le fonctionnement des items à choix multiples dans l’évaluation de la compréhension orale en langue seconde. Bien que de nombreux modèles statistiques et de mesure soient couramment disponibles pour analyser les données de réponse aux tests, cette étude a privilégié l’analyse factorielle confirmatoire (AFC) pour examiner les sous-compétences de compréhension orale opérationnalisées dans le TCF, en spécifiant des modèles suivant les suggestions d’un comité d’experts. Le modèle unidimensionnel de Rasch a permis de générer les paramètres de difficulté des items entre les sous-groupes d’intérêt pour effectuer les analyses FDI. Et le modèle à réponses nominales (MRN) a été utilisé pour modéliser les options des items à choix multiples. Les résultats issus de ces trois études ont permis d’étayer chacune des inférences retenues dans l’argumentaire de validité pour le TCF. Selon les modèles d’AFC recommandés par le comité d’experts, les résultats suggèrent que les deux versions analysées dans cette étude évaluent principalement la compréhension de l’information explicitement énoncée dans le discours oral, sous représentant ainsi le construit. Quelques items visaient l’habileté à inférer des idées implicites et la compréhension du sujet général ou de l’idée principale, mais cette dernière sous-compétence ne se retrouvait que dans une seule version du test, ce qui suggère que les versions ne sont pas comparables. L’analyse FDI a identifié de nombreux items dans les versions du test et entre les sous-groupes d’intérêt, mais très peu ont été associés à un biais potentiel, qui comprenait la perception de la voix, le genre littéraire et la familiarité du vocabulaire. Par conséquent, étant donné que de nombreux items signalés pour fonctionnement différentiel ne pouvaient pas être associés à un biais potentiel, la réponse à cette question est partiellement élaborée et atténue l’argumentaire de validité. Les résultats du MRN suggèrent que la plupart des items fonctionnaient bien, tandis que d’autres avaient potentiellement deux bonnes réponses. L’approche de la validité fondée sur l’argumentation s’avère utile pour regrouper des études empiriques dans un ensemble cohérent permettant d’étayer et de justifier l’interprétation et les utilisations du TCF dans un contexte d’immigration, qui peut à son tour servir à remédier les points faibles constatés, en fournissant un moyen d’atténuer les réfutations potentielles qui menacent la validité de l’argument. Certaines mises en garde dans le cadre de validation sont également soulignées et concernent l’accessibilité des données pour aborder les inférences d’extrapolation et de décision dans des contextes d’immigration, mais comme Newton et Shaw (2014, p. 142) le soulignent: « l’approche de validité fondée sur l’argumentation sous-tend le fait que la validation n’est pas simplement une étude isolée, mais un programme: potentiellement un programme très intensif ». Et ce programme peut inclure des parties prenantes importantes comme les représentants gouvernementaux qui peuvent aider à compléter l’argumentaire de validité du TCF en matière d’immigration au Québec.Language testing is a ubiquitous practice in immigration contexts used as a data collection procedure to assess immigrants’ ability to communicate in the language of the host country to promote social as well as economic integration and productivity in the workplace (McNamara & Shohamy, 2008). Unlike English tests, little attention has been directed to the interpretation and uses of scores from French proficiency tests, which prompts – indeed, requires – validation research to justify test use. Drawing on advances in test validity theory (Kane, 2006, 2013), this study builds a validity argument for the listening component of the Test de connaissance du français (TCF) in the context of Quebec immigration. Test validity theory has evolved considerably since the traditional tripartite model of content, predictive and construct components (Cronbach & Meehl, 1955), have been conceptualized as a unitary construct (Messick, 1989) and more recently have been theorized in terms of argumentation (Kane, 2006, 2013), borrowing concepts from models of inference (Toulmin [1958], 2003), which include scoring, generalization, explanation, extrapolation and decision inferences that play key roles in a validity argument. In an argument-based approach to validity, claims about testing instruments are composed of warrants that must be supported by backings in the form of empirical studies, which are foundational for the claims, but also support the inferences that authorize each of the claims in the argument. More specifically, this study gathered empirical evidence to support the scoring, generalization and explanation inferences, proposing three research questions that addressed construct representation, potential bias and test method usefulness. The questions were concerned with the listening subskills that the TCF assesses, differential item functioning (DIF) across gender, first language, age, and geographical location as well as the option functioning of multiple choice (MC) items in the assessment of second language listening comprehension. Although multiple statistical and measurement models are readily available to analyze test response data, this study privileged confirmatory factor analysis (CFA) to examine the listening subskills operationalized in the TCF, specifying the models following suggestions from a panel of experts. The unidimensional Rasch model was used to generate the difficulty parameters across subgroups of interest to perform the DIF analyses. And the nominal response model (NRM) was used to model the response options of the MC items. The results from these three studies yielded backings for each of the selected inferences in the validity argument for the TCF. Based on the CFA models recommended by the panel of experts, the results suggested that the TCF test forms under study primarily assess examinees’ understanding of explicitly stated information in aural discourse, thereby underrepresenting the listening construct. A few items were found to target the ability to infer implicit ideas and understanding of the general topic or main idea, however, this latter subskill was only found in one test form, suggesting that the forms are not equivalent. The DIF analysis flagged multiple items across test forms and between the subgroups of interest, but very few were associated to potential bias, which included speech perception, literary genre and vocabulary familiarity. Thus, given that many items flagged for DIF could not be associated to a potential bias, this question was partially answered and attenuates the validity argument. The results from the NRM suggested that most items functioned well while others were potentially doubled keyed. The argument-based approached to validity proved helpful in putting together empirical evidence into a coherent whole to support and build a case for the interpretation and uses of the TCF in the context of immigration, which in turn can be used to address the identified weaknesses, providing a means to attenuate the potential rebuttals that threaten the validity of the argument. Some caveats in the validation framework were also outlined and relate to the accessibility of data to address the extrapolation and decision inferences in immigration contexts, but as Newton and Shaw (2014, p. 142) advocated “the argument-based approach underlies the fact that validation is not simply a one-off-study but a program: potentially a very intensive program”. And this program can include key stakeholders such as government officials that help complete the validity argument for the TCF in Quebec immigration

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Estudios sociales y administrativos en América Latina

Esta obra contiene la compilación de una serie de investigaciones latinoamericanas en las cuales se presenta los nuevos enfoques investigativos, metodológicos y cientificos. Para la generación de soluciones que contribuyan a la toma de decisiones en variables, sociales, economicas y administrativas en los diferentes contextos organizacionales. Además de estos elementos, en esta obra se presentan nuevas apuestas multidisciplinares cuanti-cualitativas en las cuales se destacan la ingeniería, derecho entre otros.

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure

BACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.)