A good practice guide for translating and adapting hearing-related questionnaires for different languages and cultures

Objectives: To raise awareness and propose a good practice guide for translating and adapting any hearing-related questionnaire to be used for comparisons across populations divided by language or culture, and to encourage investigators to publish detailed steps. Design: From a synthesis of existing guidelines, we propose important considerations for getting started, followed by six early steps: (1) Preparation, (2, 3) Translation steps, (4) Committee Review, (5) Field testing and (6) Reviewing and finalising the translation. Study sample: Not applicable. Results: Across these six steps, 22 different items are specified for creating a questionnaire that promotes equivalence to the original by accounting for any cultural differences. Published examples illustrate how these steps have been implemented and reported, with shared experiences from the authors, members of the International Collegium of Rehabilitative Audiology and TINnitus research NETwork. Conclusions: A checklist of the preferred reporting items is included to help researchers and clinicians make informed choices about conducting or omitting any items. We also recommend using the checklist to document these decisions in any resulting report or publication. Following this step-by-step guide would promote quality assurance in multinational trials and outcome evaluations but, to confirm functional equivalence, large-scale evaluation of psychometric properties should follow

Ten millennia of hepatitis B virus evolution

Hepatitis B virus (HBV) has been infecting humans for millennia and remains a global health problem, but its past diversity and dispersal routes are largely unknown. We generated HBV genomic data from 137 Eurasians and Native Americans dated between ~10,500 and ~400 years ago. We date the most recent common ancestor of all HBV lineages to between ~20,000 and 12,000 years ago, with the virus present in European and South American hunter-gatherers during the early Holocene. After the European Neolithic transition, Mesolithic HBV strains were replaced by a lineage likely disseminated by early farmers that prevailed throughout western Eurasia for ~4000 years, declining around the end of the 2nd millennium BCE. The only remnant of this prehistoric HBV diversity is the rare genotype G, which appears to have reemerged during the HIV pandemic

Estudio epidemiológico en pacientes con esquizofrenia ambulatorios del estado cognitivo en àreas específicas relacionadas con resultados funcionales

En l’esquizofrenia no hi ha dades poblacionals disponibles sobre disfunció cognitiva que permetin descriure com és l’impacte de la malaltia sobre la cognició. També en l´esquizofrenia és necessari disposar de bateries cognitives breus que permetin predir l’impacte funcional de la malaltia a partir del dèficit cognitiu. Els objectius del treball foren; estimar la prevalença de disfunció cognitiva en una àmplia mostra de pacients amb esquizofrènia ambulatoris en tractament estable amb antipsicòtics, determinar la relació entre la capacitat cognitiva i la funcional, i en darrer lloc validar i conormalitzar la bateria breu derivada de l’estudi Epidemiològic del Dèficit Cognitiu en l’esquizofrènia (EPICOG-SCH). Amb aquesta idea, es va realitzar un estudi poblacional amb disseny transversal incloent pacients clínicament estables i en seguiment ambulatori. La bateria breu dissenyada per a l’estudi va incloure proves clàssiques en neuropsicologia, senzilles d’administrar i amb dades normatives a Espanya, i que a més avaluaven dominis cognitius relacionats amb l’estat funcional dels pacients: WAIS-III-Seqüència de Lletres-Xifres (LNS), Test de Fluència Semàntica de Categories (CFT), WMS-III Memoria Lògica Verbal-Record Immediat (LM), WAIS-III Codificació de Dígits (DSC); amb un temps total d’administració de menys de 20 minuts en funció del rendiment del pacient. També es va avaluar l’estat clínic dels pacients mitjançant escales d’Impressió Clínica de Gravetat (ICG-SCH) i la discapacitat funcional deguda a la malaltia mental mitjançant l’escala WHO-DAS-S. Es varen utilitzar tècniques de Receiver-Operating Characteristic (ROC), per identificar pacients amb diferents nivells de discapacitat funcional, a partir del resultat obtingut a la bateria EPICOG-SCH. Dels 672 pacients avaluables inclosos per 234 centres de totes les Comunitats Autònomes de constituïdes a Espanya, es va observar un 61,5% (n=413) de casos amb algun grau de disfunció cognitiva segons la ICG-SCH (>2). Les prevalences de disfunció basades en proves objectives per al punt de tall de ≤ 1,5 DE foren per CFT-Animals del 68,3% amb 95%IC de 67,8 a 68,8%; per DSC del 38,1% amb 95%IC de 37,5 a 38,3%; per LM – Unitats del 24,8% amb 95%IC de 24,1 a 25,5%; per LNS del 20,9% amb 95%IC de 20,2 a 21,6%; i per LM –Temes del 11,7% amb 95%IC 11,0 a 12,4%. Les prevalences ajustades per població a cada CCAA foren similars. La gravetat de la sistematologia Negativa, Positiva i Depressiva, així com la presencia del Síndrome Deficitari, varen estar inversament relacionades amb el rendiment cognitiu. El rendiment cognitiu també va estar inversament relacionat amb el grau de discapacitat funcional segons WHO DAS-S. El model de regressió per la predicció de discapacitat funcional segons la WHO-DAS-S, va estar compost per les variables ICG-SCH- Gravetat Global (β=1,34635, p<0,0001), ICG-SCH- Símptomes Negatius (β =0,75540, p<0,0001), Memoria de Treball (LNS) (β =-0,16442, p=0,0004) y del Temps d’Evolució de la Malaltia (β =0,05083, p=0,0094), explicant el 47% de la variabilitat observada. Es conclou que la disfunció cognitiva més prevalent a la mostra va ser la Funció Executiva (CFT), encara que la més relacionada amb la funcionalitat del pacient va ser la Memoria de Treball (LNS). La bateria mostrà una adequada consistència interna amb una Alfa de Cronbach de 0,78, la seva capacitat diagnòstica per a identificat pacients amb discapacitat moderada va mostrar una precisió acceptable amb AUC > 0,70, p<0,0001. Així, per a un diagnòstic de Funcionalitat Moderada, una puntuació mitjana de FWCS ≥ 100 mostrà un Quocient de Probabilitat (LR) de 4,7, amb LR+ de 2,3 i LR- de 0,5. La puntuació de tall FWCS ≥ 96 proporcionà el millor equilibri entre sensibilitat (0,74) i especificitat (0,62) en el diagnòstic de Funcionalitat Moderada. La bateria EPICOG-SCH ha demostrat ser una eina breu, útil en el cribatge de l’impacte cognitiu en l’esquizofrènia; la seva puntuació composta ajustada per regressió és un complement útil a l’entrevista clínica, eficient per confirmar el potencial funcional del pacient i útil també per monitoritzar la cognició de pacients ambulatoris durant les visites de rutina de seguiment.En esquizofrenia no se dispone de datos poblacionales sobre disfunción cognitiva que permitan describir como es el impacto de la enfermedad sobre la cognición. También es necesario disponer de baterías cognitivas breves que permitan predecir el impacto funcional de la enfermedad en base al déficit cognitivo. Los objetivo del trabajo fueron; estimar la prevalencia de disfunción cognitiva en una amplia muestra de pacientes con esquizofrenia ambulatorios bajo tratamiento estable con antipsicóticos, establecer la relación entre la capacidad cognitiva y la funcional, y por último como validar y co-normalizar la batería breve derivada del Estudio Epidemiológico del Déficit Cognitivo en la Esquizofrenia (EPICOG-SCH). Para ello, se realizó un estudio poblacional con diseño transversal incluyendo pacientes clínicamente estables y en seguimiento ambulatorio. La batería breve diseñada para tal fin, incluyó pruebas clásicas en neuropsicología, de fácil administración, con datos normativos en España, y que evaluaban dominios cognitivos relacionados con el estado funcional de los pacientes: WAIS-III-Secuencia de Letras-Números (LNS), Test de Fluencia Semántica de Categorías (CFT), WMS-III Memoria Lógica Verbal-Recuerdo Inmediato (LM), WAIS-III Codificación de Dígitos (DSC); con un tiempo total de administración de menos de 20 minutos según el rendimiento del paciente. También se evaluó el estado clínico de los pacientes mediante escalas de Impresión Clínica de Gravedad (ICG-SCH) y la discapacidad funcional debida a la enfermedad mental mediante la escala WHO-DAS-S. Se utilizaron técnicas Receiver-Operating Characteristic (ROC), para identificar pacientes con diferentes niveles de discapacidad funcional, a partir resultado en la batería EPICOG-SCH. De los 672 pacientes evaluables incluidos por 234 centros de todas las Comunidades Autónomas constituidas en España, se observó un 61,5% (n=413) con algún grado de disfunción cognitiva según la ICG-SCH (>2). Las prevalencias de disfunción cognitiva basadas en pruebas objetivas para el punto de corte de ≤ 1,5 DE fueron para CFT-Animales del 68,3% con 95%IC de 67,8 a 68,8%; para DSC del 38,1% con 95%IC de 37,5 a 38,3%; para LM – unidades del 24,8% con 95%IC de 24,1 a 25,5%; para LNS del 20,9% con 95%IC de 20,2 a 21,6%; y para LM –temas del 11,7% con 95%IC 11,0 a 12,4%. Las prevalencias ajustadas por población en cada CCAA fueron similares. La gravedad de la sintomatología Negativa, Positiva y Depresiva, así como la presencia de Síndrome Deficitario, estuvieron inversamente relacionados con el rendimiento cognitivo. El rendimiento cognitivo también estuvo inversamente relacionado con el nivel de discapacidad funcional según la WHO DAS-S. El modelo de regresión para la predicción de discapacidad funcional según WHO-DAS-S, estuvo compuesto por las variables ICG-SCH-Gravedad Global (β=1,34635, p<0,0001), ICG-SCH-Síntomas Negativos (β =0,75540, p<0,0001), memoria de trabajo (LNS) (β =-0,16442, p=0,0004) y del tiempo de evolución del trastorno (β =0,05083, p=0,0094), explicando el 47% de la variabilidad observada. Se concluye que la disfunción cognitiva más prevalente en la muestra fue la función Ejecutiva (CFT), aunque la más relacionada con la funcionalidad del paciente fue la de Memoria de Trabajo (LNS). La batería mostró una adecuada consistencia interna con alfa de Cronbach de 0,78, su capacidad diagnostica para identificar a pacientes con una discapacidad moderada mostró una precisión aceptable con AUC>0,70, p<0,0001. Así, para un diagnóstico de Funcionalidad Moderada una puntuación media de FWCS ≥ 100 mostró un Cociente de Probabilidad de (LR) 4,7, con LR+ de 2,3 y LR- de 0,5. La puntuación de corte FWCS ≥ 96 proporcionó el mejor balance entre sensibilidad (0,74) y especificidad (0,62) en el diagnóstico de Funcionalidad moderada. La batería EPICOG-SCH ha demostrado ser una herramienta breve, útil para el cribaje del impacto cognitivo en la esquizofrenia, su puntuación compuesta ajustada por regresión es un complemento a la entrevista clínica, eficiente para confirmar el potencial funcional del paciente y útil en la monitorización de la cognición de pacientes ambulatorio durante las visitas de rutina de seguimiento.In schizophrenia, there are no population-based data documenting cognitive impairment and describing the cognitive impact of the disease. Consequently, brief batteries are needed to support the prediction of functional outcomes of the disease based on its related cognitive disturbances. The study objectives were to ascertain the prevalence of cognitive impairment in a large sample of outpatients with schizophrenia under stable treatment with antipsychotic agents, to establish the relationship between cognitive and functional status and eventually to validate and co-norm the Epidemiological Study of Cognitive Impairment in Schizophrenia (EPICOG-SCH) derived brief cognitive battery. With this aim, a cross-sectional study was conducted with clinically stable outpatients in maintenance follow-up programs. The brief battery was designed ad hoc and included classical neuropsychological subtests that are easy to administer, have normative data available for Spain, and measure cognitive domains related to patient functional status: WAIS-III-Letter-Number-Sequencing (LNS), Category Fluency Test (CFT), Logical-Memory Immediate Recall (LM), and Digit-Symbol-Coding (DSC). The overall administration time was less than 20 minutes depending on the patient’s performance. Clinical status was also evaluated using Clinical Severity Impression-based scales (CGI-SCH), and functional disability due to mental disorder was evaluated using the WHO-DAS-S . Receiver-operating characteristic (ROC) techniques were used to identify patients whose functional disability differed in severity from the results obtained with the EPICOG-SCH battery. Among 672 evaluable patients recruited from 234 centers in all constituted autonomous communities in Spain, 61.5% (n=413) had cognitive impairment according to the CGI-SCH (score>2 ). The prevalence of cognitive impairment based on objective testing and cut-off score of ≤ 1.5 SD was 68.3% for CFT-Animals, with 95%CI 67.8 to 68.8%; 38.1% for DSC, with 95%CI 37.5 to 38.3%; 24.8% for LM-Units, with 95%CI 24.1 to 25.5%; 20.9% for LNS, with 95%CI 20.2 to 21.6%; and 11.7% for LM-Issues, with 95%CI 11.0 to 12.4%. The adjusted prevalences for CCAA inhabitants were similar. The severity of negative, positive and depressive symptoms and the presence of deficit syndrome were inversely related to cognitive performance. Cognitive performance was also inversely related to the severity of functional disability according to the WHO DAS-S. A linear regression model for predicting the presence of functional disability according to the WHO DAS-S included the following factors: CGI-SCH-Global Severity (β=1.34635, p<0.0001), CGI-SCH-Negative Symptoms (β=0.75540, p<0.0001), Working Memory (LNS) (β=-0.16442, p=0.0004) and Time of Disease Evolution (β=0.05083, p=0.0094), which explained 47% of the observed variability. It was concluded that the most prevalent impaired cognitive domain was Executive Functioning (CFT), although the domain most related to a patient’s functionality was Working Memory (LNS). The battery showed good internal consistency, Cronbach's alpha=0.78, and its diagnostic capacity to identify patients with moderate disability showed acceptable accuracy, with AUC>0.70, p<0.0001. To diagnose moderate functionality, a mean cut-off score of FWCS≥100 showed likelihood ratios (LR) up to 4.7, with an LR+ of 2.3 and an LR- of 0.5. An FWCS cut-off ≥96 provided the best balance between sensitivity (0.74) and specificity (0.62). The EPICOG-SCH proved to be a useful brief tool to screen for the cognitive impact of schizophrenia, and its regression-weighted composite score is an efficient complement to clinical interviews for confirming patients’ potential functional outcomes and is useful for monitoring cognition during routine outpatient follow-up visits

EPICOG-SCH : A brief battery to screen cognitive impact of schizophrenia in stable outpatients

Brief batteries in schizophrenia, are needed to screen for the cognitive impact of schizophrenia. We aimed to validate and co-norm the Epidemiological Study of Cognitive Impairment in Schizophrenia (EPICOG-SCH) derived brief cognitive battery. A cross-sectional outpatient evaluation was conducted of six-hundred-seventy-two patients recruited from 234 centers. The brief battery included well-known subtests available worldwide that cover cognitive domains related to functional outcomes: WAIS-III-Letter-Number-Sequencing-LNS, Category Fluency Test-CFT, Logical-Memory Immediate Recall-LM, and Digit-Symbol-Coding-DSC. CGI-SCH Severity and WHO-DAS-S were used to assess clinical severity and functional impairment, respectively. Unit Composite Score (UCS) and functional regression-weighted Composite Scores (FWCS) were obtained; discriminant properties of FWCS to identify patients with different levels of functional disability were analyzed using receiver-operating characteristic (ROC) technique. The battery showed good internal consistency, Cronbach's alpha = 0.78. The differences between cognitive performance across CGI-SCH severity level subscales ranged from 0.5 to 1 SD. Discriminant capacity of the battery in identifying patients with up to moderate disability levels showed fair discriminant accuracy with areas under the curve (AUC) > 0.70, p < 0.0001. An FWCS mean cut-off score ≥ 100 showed likelihood ratios (LR) up to 4.7, with an LR + of 2.3 and a LR − of 0.5. An FWCS cut-off ≥ 96 provided the best balance between sensitivity (0.74) and specificity (0.62). The EPICOG-SCH proved to be a useful brief tool to screen for the cognitive impact of schizophrenia, and its regression-weighted Composite Score was an efficient complement to clinical interviews for confirming patients' potential functional outcomes and can be useful for monitoring cognition during routine outpatient follow-up visits

A good practice guide for translating and adapting hearing-related questionnaires for use in different languages and cultures: Preferred reporting items with explanations and examples

Objective To raise awareness and propose a good practice guide for translating and adapting any questionnaire to be used for comparisons across populations divided by language or culture. Design Relevant methodological literature across ENT/Audiology and other healthcare fields was reviewed. The collective experience from the authors, members of the International Collegium of Rehabilitative Audiology and TINNET were also incorporated in this recommendation. Results Criteria for selecting an appropriate questionnaire were considered, followed by a set of guidelines for cross-cultural adaptation. Six steps promote a good-quality translation that is functionally equivalent to the original questionnaire and account for any cultural differences: 1) Preparation for translating a questionnaire, 2) The translation process – forward translation, 3) The translation process – back translation, 4) Committee review, 5) Field testing, and 6) Review and finalisation of the translation. Published examples illustrate how these steps have been implemented and reported. Conclusions Following this step-by-step guide can improve functional equivalence with the target-language version and promote quality assurance in multinational trials and outcome evaluations. A checklist of the preferred reporting items is included to help investigators make informed choices about conducting or omitting any items. We recommend using the checklist to document these decisions in any resulting publication

Cognitive Performance associated to functional outcomes in stable outpatients with schizophrenia

Background–objective: Prevalence data of cognitive impairment in Schizophrenia based on large population samples are scarce. Our goal is to relate cognition and functional outcomes, and estimate prevalence of cognitive impairment in a large sample of schizophrenia outpatients treated with second-generation antipsychotics. Method: A cross-sectional outpatient evaluation conducted during follow-up visits. Selection criteria included six-months stable treatment. The brief battery, EPICOG-SCH, covered four cognitive domains related to functional outcomes: working memory (WAIS-III-Letter-Number-Sequencing), executive function (Category Fluency Test; CFT), verbal memory (WMS-III-Logical-Memory), and information processing speed (Digit-Symbol-Coding and CFT). Clinical severity and functional impairment were assessed with CGI-SCH and WHO DAS-S. Impairment prevalence was calculated at ≤1.5 SD. Results: Among patients recruited (n = 848) in 234 participating centers, 672 were under 6-month treatment. 61.5% (n = 413) reported cognitive impairment according to CGI-SCH Cognitive Subscale. Estimated prevalences were 85.9% (95% CI 85.6–86.2%) CFT-Fruits; 68.3% (95% CI 67.8–68.8%) CFT-Animals; 38.1% (95% CI 37.5–38.3%) Digit-Symbol-Coding; 24.8% (95% CI 24.1–25.5%) Verbal Memory-Units; 20.9% (95% CI 20.2–21.6%) Letter-Number Sequencing; 11.7% (95% CI 11.0–12.4%) Verbal Memory-Items. Negative and Depressive symptoms, Deficit Syndrome, and functional disability were related to poor performance. Functional disability was predicted by CGI-SCH-Overall severity (OR = 1.34635, p < 0.0001), CGI-SCH-Negative Symptoms (OR = 0.75540, p < 0.0001), working memory (Letter-Number-Sequencing) (OR = −0.16442, p = 0.0004) and the time-course (OR = 0.05083, p = 0.0094), explaining 47% of the observed variability. Conclusion: Most prevalent impairments were on executive function and processing speed domains; however, working memory showed the strongest relationship to functional disability. Monitoring cognitive function during follow up is critical to understand patient’s everyday functional capacity

New approaches in psychiatric drug development

Stress-related psychiatric disorders across the life spa

Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials

Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate outcomes selection in early clinical trials is key to maximizing the likelihood of identifying new treatments in psychiatry and neurology. The field lacks good standards for designing outcome strategies, therefore The Outcomes Research Group was formed to develop and promote good practices in outcome selection. This article describes the first published guidance on the standardization of the process for clinical outcomes in neuroscience. A minimal step process is defined starting as early as possible, covering key activities for evidence generation in support of content validity, patient-centricity, validity requirements and considerations for regulatory acceptance. Feedback from expert members is provided, regarding the risks of shortening the process and examples supporting the recommended process are summarized. This methodology is now available to researchers in industry, academia or clinics aiming to implement consensus-based standard practices for clinical outcome selection, contributing to maximizing the efficiency of clinical research