Utilidad diagnóstica y validez predictiva del uso conjunto de Fototest y Mini-Cog en deterioro cognitivo / Diagnostic accuracy and predictive validity of associated use of Fototest and Mini-Cog in cognitive impairment

Introducción: El Fototest y el Mini-Cog incluyen todos los dominios que debieran formar parte de una evaluación cognitiva. Nuestro objetivo es evaluar la utilidad diagnóstica del uso conjunto de ambos instrumentos para el diagnóstico de deterioro cognitivo (DC). Métodos: Estudio fase iii de evaluación de pruebas diagnósticas con 2 muestras independientes, estudio (448 sujetos), dividida aleatoriamente en 2 dataset (Base 80%, Test 20%), y Externa (61 sujetos). Prueba index: Fototest y Mini-Cog aplicados consecutivamente; prueba de referencia: evaluación cognitiva formal. Se evalúa la UD del uso combinado y escalonado de los modelos simple (Comb-Simple), regresión logística (Comb-RL) y árbol aleatorio (Comb-AA) para identificar DC (GDS ≥ 3). Se realiza un análisis exploratorio en Base seleccionando los criterios que maximizan la exactitud; la evaluación se realiza en las muestras Test y externa mediante un análisis preespecificado con los criterios seleccionados. Resultados: La UD de los modelos combinados en Base (Comb-Simple 88,3 [(88,5-91,4] [exactitud, LI95%-LS95%], Comb-RL 91.6 [88,2-94,3] y Comb-AA 95,2 [92,5-97,2])) es significativamente superior a la de Mini-Cog y Fototest (81,6 [77,1-85,4] y 84,9 [80,8-88,5], respectivamente); estos resultados son replicados en Test (Comb-Simple 88,9 [exactitud], Comb-RL 95,6 y Comb-AA 92,2) y externa (Comb-Simple 91,8, Comb-RL 90,2 y Comb-AA 88,5). La aplicación escalonada mantiene la misma UD pero requiere menos tiempo (197,3 ± 56,7 vs. 233,9 ± 45,2, p < 0,0001). Conclusiones: El uso conjunto del Fototest y el Mini-Cog requiere menos de 4 min y mejora la UD de ambos instrumentos. El uso escalonado es más eficiente porque manteniendo la misma UD requiere menos tiempo de aplicación.(AU)

Introduction: The Fototest and Mini-Cog include all the domains that are necessary in a cognitive assessment. This study aims to evaluate the diagnostic accuracy of the combined use of both instruments for detecting cognitive impairment. Methods: We performed a phase iii diagnostic accuracy study with 2 independent samples: STUDY, which included 448 participants randomly allocated to 2 datasets (BASE [80%] and TEST [20%]); and EXTERNAL, which included 61 participants. The index test was consecutive administration of the Fototest and Mini-Cog, and the reference test was formal cognitive assessment. We evaluated the diagnostic accuracy of two-step vs. consecutive application of the tests and simple (Comb-Simple), logistic regression (Comb-LR), and random decision tree (Comb-RDT) models of their combined use for detecting cognitive impairment (Global Deterioration Scale score ≥ 3). We performed an exploratory analysis of the BASE dataset, selecting criteria that maximise accuracy; a pre-specified analysis was used to evaluate the selected criteria in the TEST and EXTERNAL datasets. Results: The diagnostic accuracy (95% confidence interval) of the combined models in the BASE dataset (Comb-Simple: 88.3 [88.5-91.4]; Comb-LR: 91.6 [88.2-94.3]; Comb-RDT 95.2 [92.5-97.2]) was significantly higher than the individual values observed for the Mini-Cog and Fototest (81.6 [77.1-85.4] and 84.9 [80.8-88.5], respectively). These results were replicated in the TEST (Comb-Simple: 88.9; Comb-LR: 95.6; Comb-RDT: 92.2) and EXTERNAL datasets (Comb-Simple: 91.8; Comb-LR: 90.2; Comb-RDT: 88.5). Two-step application had the same diagnostic accuracy than consecutive application but required less time (mean [SD] of 197.3 s [56.7] vs. 233.9 s [45.2]; P<.0001). Conclusions: Combined application of the Fototest and Mini-Cog takes less than 4 minutes and improves the diagnostic accuracy of both instruments. Two-step application is more efficient as it requires less...(AU)

Análisis coste-utilidad del modelo de unidad de terapia intravítrea (UTI) frente a la administración tradicional de terapia intravítrea / Cost-utility model of new intravítreous units vs. current patient journey model in Spain

Objetivo Comparar la efectividad y los costes de la implantación del Modelo de Unidad de Terapia Intravítrea (UTI), avalado por la Sociedad Española de Retina y Vítreo (SERV), Sociedad Española de Calidad Asistencial (SECA), Sociedad Española de Oftalmología (SEO) y Sociedad Española de Directivos Sanitarios (SEDISA) vs. el procedimiento habitual. Método Modelo de decisión analítico que compara una organización asistencial tipo UTI con cuatro escenarios de práctica habitual en España, en cuanto al resultado en la calidad de vida por pérdida de agudeza visual y la utilización de recursos. Se estimó la probabilidad, el coste y los años de vida ajustados por calidad (AVAC) para cada escenario planteado. Se realizó un análisis de sensibilidad univariante para cada uno de los parámetros empleados. Resultado Se observó que la implantación del modelo UTI mejora la calidad de vida de los pacientes y presenta un menor coste frente a la práctica habitual. Se produjo ahorro de costes y ganancia de AVAC. El análisis de sensibilidad mostró que el resultado no cambiaría de signo con la modificación de ninguna variable de partida. Conclusiones En las patologías oculares con indicación de tratamiento intravítreo, cualquier reducción en el tiempo que transcurre desde la sospecha diagnóstica hasta la primera inyección intravítrea disminuye la pérdida de agudeza visual. Así, actuar para acortar los tiempos sospecha-aguja es clave para mantener la visión funcional de los pacientes. La mejora de la eficiencia de los servicios de oftalmología que se organizan siguiendo el modelo UTI puede generar ahorros que varían entre los 175 € y 85 € por paciente atendido y año (AU)

Aim To compare the effectiveness and costs of the implementation of the intravitreal therapy unit model, endorsed by the SERV, SECA, SEO and SEDISA, compared to the usual procedure. Method Analytical decision model that compares an UTI-type healthcare organization with four usual practice scenarios in Spain, in terms of quality-of-life results due to loss of visual acuity and the use of resources. The probability, cost, and quality-adjusted life years (QALYs) were estimated for each scenario proposed. A univariate sensitivity analysis was performed for each of the parameters used in the model. Result The model showed that from any of the initial scenarios of the usual practice, transitioning to the UTI-type implementation improves the quality of life of patients and requires lower cost. UTI-type is dominant respect usual practice. The sensitivity analysis showed that the results would not change sign with the variation of any starting variable. Conclusions Shorten suspicion-needle times is key to maintaining functional vision in patients requiring intravitreal treatment. The UTI-type model seeks the efficiency of ophthalmology services and can produce savings that vary between €175 and €85 per patient attended per year (AU)

Diagnostic accuracy and predictive validity of combined use of Fototest and Mini-Cog in cognitive impairment.

INTRODUCTION: The Fototest and Mini-Cog include all the domains that are necessary in a cognitive assessment. This study aims to evaluate the diagnostic accuracy of the combined use of both instruments for detecting cognitive impairment. METHODS: We performed a phase III diagnostic accuracy study with 2 independent samples: STUDY, which included 448 participants randomly allocated to 2 datasets (BASE [80%] and TEST [20%]); and EXTERNAL, which included 61 participants. The index test was consecutive administration of the Fototest and Mini-Cog, and the reference test was formal cognitive assessment. We evaluated the diagnostic accuracy of two-step vs consecutive application of the tests and simple (Comb-Simple), logistic regression (Comb-LR), and random decision tree (Comb-RDT) models of their combined use for detecting cognitive impairment (Global Deterioration Scale score ≥ 3). We performed an exploratory analysis of the BASE dataset, selecting criteria that maximise accuracy; a pre-specified analysis was used to evaluate the selected criteria in the TEST and EXTERNAL datasets. RESULTS: The diagnostic accuracy (95% confidence interval) of the combined models in the BASE dataset (Comb-Simple: 88.3 [88.5-91.4]; Comb-LR: 91.6 [88.2-94.3]; Comb-RDT 95.2 [92.5-97.2]) was significantly higher than the individual values observed for the Mini-Cog and Fototest (81.6 [77.1-85.4] and 84.9 [80.8-88.5], respectively). These results were replicated in the TEST (Comb-Simple: 88.9; Comb-LR: 95.6; Comb-RDT: 92.2) and EXTERNAL datasets (Comb-Simple: 91.8; Comb-LR: 90.2; Comb-RDT: 88.5). Two-step application had the same diagnostic accuracy than consecutive application but required less time (mean [SD] of 197.3 s [56.7] vs 233.9 s [45.2]; P < .0001). CONCLUSIONS: Combined application of the Fototest and Mini-Cog takes less than 4 minutes and improves the diagnostic accuracy of both instruments. Two-step application is more efficient as it requires less time while maintaining the same diagnostic accuracy.

¿Es precisa la ecografía para el diagnóstico de pólipos vesiculares? Revisión de las piezas de colecistectomía de pacientes diagnosticados de pólipo vesicular durante un periodo de 14 años / Is ultrasonography accurate for the diagnosis of gallbladder polyps? A review of cholecystectomy specimens from patients diagnosed with gallbladder polyps over a 14 years period

Introducción: La incidencia de pólipos vesiculares es del 0,3-12%. Es importante diferenciar los seudopólipos (pólipos de colesterol, adenomiomatosis o pólipos inflamatorios) de los pólipos verdaderos (adenomas y adenocarcinomas). Los principales factores de riesgo de malignización son el tamaño superior a 6-10mm, crecimiento rápido del mismo, morfología sésil, etnia india y colangitis esclerosante primaria. La ecografía es el gold standard para su diagnóstico. Sin embargo, la mayoría de los pólipos diagnosticados por ecografía son seudopólipos. El objetivo del estudio es analizar si la ecografía es precisa para diagnosticar los pólipos verdaderos en los pacientes cuya indicación quirúrgica ha sido este diagnóstico ecográfico. Métodos: Estudio observacional retrospectivo de los pacientes intervenidos en nuestro centro, desde el año 2007 al 2019, de colecistectomía electiva por presentar pólipos vesiculares. La cirugía se indicó en pacientes sintomáticos y/o con factores de riesgo. El estudio fue aprobado por el Comité Ético de Investigación Clínica de nuestro hospital. Resultados: Se han incluido 124 pacientes. En todos ellos se ha realizado colecistectomía laparoscópica. La edad media fue de 55,4 años y el 61% eran mujeres. El 65% tenían síntomas biliares. En nuestro estudio, solo 3 pacientes presentaron pólipos verdaderos (2,4%). Todos ellos, fueron adenomas tubulares. El resto de los pacientes resultaron falsos positivos (97,6%). El tamaño de los adenomas fue de 11, 6 y 5mm. La cirugía se indicó por tamaño o por clínica asociada. Conclusiones: La ecografía no es precisa para el diagnóstico de pólipos vesiculares verdaderos. La validación de otras pruebas complementarias para el diagnóstico de pólipos en pacientes asintomáticos podría ser relevante para evitar cirugías innecesarias. (AU)

Introduction: The incidence of gallbladder polyps is 0,3-12%. It is important to differentiate pseudopolyps (cholesterol polyps, adenomyomatosis, inflammatory polyps), which do not have the potential to become malignant, and true polyps (adenomas and adenocarcinomas). The main risk factors for malignancy are size>6-10mm, rapid growth, sessile morphology, Indian ethnicity and primary sclerosing cholangitis. Ultrasound is the gold standard for diagnosis. However, most polyps diagnosed by ultrasound are pseudopolyps. The main objective of this study is to analyze whether ultrasound is accurate for diagnosing true polyps in patients undergoing surgery for this reason. Methods: We conducted a retrospective observational study with prospective data entry of patients undergoing elective cholecystectomy for gallbladder polyps from 2007 to 2021. Surgery was indicated in symptomatic patients and in those with risk factors. The study was approved by the Clinical Research Ethics Committee of our hospital. Results: Our study included 124 patients who had undergone elective laparoscopic cholecystectomy. Mean age was 55.4 years, and 61% were women. In total, 65% were symptomatic at diagnosis. Only 3 patients had true polyps (2.4%), all of which were tubular adenomas. The remainig patients were false positives (97.6%). The adenoma sizes were 11, 6 and 5mm, respectively. The surgical indication was due to polyp size or due to associated biliary symptoms. Conclusion: Ultrasonography is not accurate for the diagnosis of gallbladder polyps. The validation of other complementary tests for the diagnose gallbladder polyps in asymptomatic patients could be relevant to avoid unnecessary surgeries. (AU)

Cost-utility model of new intravitreous units vs. current patient journey model in Spain.

AIM: To compare the effectiveness and costs of the implementation of the Intravitreal Therapy Unit Model, endorsed by the SERV, SECA, SEO and SEDISA, compared to the usual procedure. METHOD: Analytical decision model that compares an UTI-type healthcare organization with 4 usual practice scenarios in Spain, in terms of quality-of-life results due to loss of visual acuity and the use of resources. The probability, cost, and quality-adjusted life years (QALYs) were estimated for each scenario proposed. A univariate sensitivity analysis was performed for each of the parameters used in the model. RESULT: The model showed that from any of the initial scenarios of the usual practice, transitioning to the UTI-type implementation improves the quality of life of patients and requires lower cost. UTI-type is dominant respect usual practice. The sensitivity analysis showed that the results would not change sign with the variation of any starting variable. CONCLUSIONS: Shorten suspicion-needle times is key to maintaining functional vision in patients requiring intravitreal treatment. The UTI-type model seeks the efficiency of ophthalmology services and can produce savings that vary between Є175 and Є85 per patient attended per year.

Is ultrasonography accurate for the diagnosis of gallbladder polyps? A review of cholecystectomy specimens from patients diagnosed with gallbladder polyps over a 14-years period.

INTRODUCTION: Incidence of gallbladder polyps is 0,3-12%. It is important to differentiate pseudopolyps (cholesterol polyps, adenomyomatosis, inflammatory polyps), which do not have the capacity to become malignant, from true polyps (adenomas and adenocarcinomas). The main risk factors for malignancy are >6-10 mm, growth, sessile morphology, Indian ethnicity and primary sclerosing cholangitis. Ultrasound is the gold standard for diagnosis. Most polyps diagnosed by ultrasound are pseudopolyps. The main objective of this study is to analyse whether ultrasound is accurate for diagnosing true polyps in patients undergoing surgery for this reason. METHODS: Retrospective observational study with prospective data entry of patients undergoing elective cholecystectomy for gallbladder polyps from 2007 to 2021. Surgery was indicated in symptomatic patients and in those with risk factors. The study has been approved by the Clinical Research Ethics Committee of our hospital. RESULTS: We included 124 patients in our study. An elective laparoscopic cholecystectomy was performed in all of them. The mean age was 55,4 years and 61% were women. Of all patients, 65% were symptomatic at diagnosis. Only 3 patients had true polyps (2,4%). All of them were tubular adenomas. The rest of patients were false positives (97,6%). The adenoma size was 11, 6 and 5 mm, respectively. The surgical indication was due to polyp size or due to associated biliary symptoms. CONCLUSION: Ultrasonography is not accurate for the diagnosis of gallbladder polyps. Validation of other complementary tests for the diagnosis of gallbladder polyps in asymptomatic patients could be relevant to avoid unnecessary surgeries.

Amapola, lindísima amapola: de los opiáceos y los opioides, utilidad y riesgos / Poppy, beautiful poppy: opiates and opioids, utility and risks

Resumen El opio y sus derivados, y recientemente los opioides, han acompañado a la humanidad desde las civilizaciones más antiguas hasta la actualidad. Sus efectos analgésicos, hipnóticos y placenteros no pasaron desapercibidos para los antiguos, los consideraron de utilidad médica y beneficiosa para el estado de ánimo. Hoy en día no existe otro tipo de medicamentos que puedan tratar el dolor más intenso tan eficientemente como estos potentes analgésicos. Sin embargo, el uso médico y recreativo de los opiáceos y los opioides conlleva riesgos para la salud, como la tolerancia, la hiperalgesia y la adicción. Actualmente, además de ser indiscutiblemente el tratamiento médico más poderoso para mitigar el sufrimiento ocasionado por el dolor, se ha convertido también en un problema de salud pública debido a la alta cantidad de personas con trastorno por uso de opioides y por las muertes ocasionadas por sobredosis. En esta revisión se hará mención de las bondades de los opiáceos y opioides, y también de los efectos no deseados que estos producen.

Abstract Opium and its derivatives, and recently the opioids have accompanied the humankind since the ancient civilizations to the present day. Its analgesic, hypnotic and pleasant effects did not go unnoticed by ancient people, which considered most of these effects of medical utility and noticed that they had remarkable mood benefits. Currently, there are no other kind of drugs that can palliate intense pain as efficiently as these powerful analgesics. However, the medical and recreational use of opiates and opioids may carry health risks such as tolerance, hyperalgesia, and addiction. Nowadays, in addition to being indisputably the most powerful medical treatment to alleviate the suffering caused by pain, it has also become a public health problem due to the high number of people with opioid use disorder that have facilitated deaths caused by opioids overdose. In this review we will discuss the medical benefits of opiates and opioids, as much as the unwanted effects they produce.

La innovación incremental en salud en España durante la pandemia de la COVID-19 / Incremental innovation in healthcare in Spain during the COVID-19 pandemic

Fundamentos: Es importante comprender cómo la pandemia de COVID-19 ha afectado a la innovación incremental y su protección mediante derechos de propiedad industrial, con el fin de obtener información valiosa para desarrollar políticas públicas yestrategias empresariales. El objetivo de este estudio fue analizar las innovaciones incrementales como respuesta a la pandemia quehan sido protegidas por derechos de propiedad industrial, y examinar si la pandemia de la COVID-19 había tenido un efecto positivo onegativo en la innovación incremental, fomentándola o inhibiéndola. Métodos: Se emplearon como indicadores los modelos de utilidad de la clase de patentes del ámbito salud en el periodo entreel 1 de enero de 2020 y el 31 de diciembre de 2021, puesto que la información que proporcionan y sus características (requisitos desolicitud y publicación) permitían extraer algunas conclusiones incipientes en el corto plazo. Se analizó su frecuencia de solicituddurante los meses de pandemia y se comparó con un periodo temporal equivalente inmediatamente anterior (1 de enero de 2018 a31 de diciembre de 2019). Resultados: El análisis mostró que hubo una mayor actividad de innovación sanitaria por parte de todos los agentes (particulares, empresas y sector público). En el período de la pandemia de 2020-2021, se solicitaron 754 modelos de utilidad, lo que representóun aumento de casi el 40% en comparación con el período equivalente de 2018-2019, de los cuales se identificaron 284 como innovaciones relacionadas con la pandemia, con el 59,7% de los titulares de los derechos siendo personas individuales, el 36,4% siendoempresas y solo el 3,9% siendo entidades públicas. Conclusiones: En general, las innovaciones incrementales requieren menor inversión y plazos de maduración de la tecnologíamás cortos, lo que permitía responder, en algunos casos exitosamente, a las situaciones de desabastecimiento inicial de...(AU)

Background: It is important to understand the impact of the COVID-19 pandemic on incremental innovation and its protectionthrough industrial property rights, in order to acquiring valuable insights to develop effective public policies and corporate strategies. Theobjective was to analyze incremental innovations in response to the pandemic that have been protected by industrial property rights,and to examine whether the COVID-19 pandemic had a positive or negative effect on incremental innovation, promoting or inhibiting it.Methods: Utility models in the health patent class have been used as indicators (01.01.20 to 31.12.21), since the information theyprovide and their characteristics (requirements of applications and publication) allowed us to obtain preliminary conclusions in the shortterm. Their frequency of application during the pandemic months was analyzed and compared with an equivalent period immediatelybefore (01.01.18 to 31.12.19).Results: The analysis showed that there had been greater activity in healthcare innovation by all agents (individuals, companiesand the public sector). In the pandemic period of 2020-2021, 754 utility models were requested, representing a nearly 40% increasecompared to the equivalent period of 2018-2019, of which 284 were identified as pandemic-related innovations, with 59.7% of rightsholders being individuals, 36.4% being companies, and only 3.9% being public entities.Conclusions: In general, incremental innovations require less investment and shorter technology maturation times, which hadmade it possible to respond, in some cases successfully, to situations of initial shortages of many medical devices, such as ventilatorsand protective equipment.(AU)

Patentes otorgadas a las universidades peruanas en el campo de la biomedicina. 2010 a 2020

Introducción: La patente es un título de propiedad industrial otorgado por el Estado al inventor de un nuevo producto o tecnología, susceptible de ser comercializado para obtener ganancias de forma exclusiva a un plazo de tiempo determinado. Objetivo: Determinar el número de patentes otorgadas a las universidades peruanas en el campo biomédico de 2010 a 2020, en comparación con la producción de otros inventores. Material y método: Este estudio descriptivo, observacional, retrospectivo y transversal analizó 73 patentes provenientes de un universo de 759, obtenidas de la base de datos del Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual en el Perú, de 2010 a 2020. Para comparar el número de patentes otorgadas a las universidades respecto a otros inventores, se aplicó la prueba del Chi Cuadrado de Pearson con la corrección de continuidad de Yates. Resultados: En el Perú, durante 2010 a 2020 se han otorgado 759 patentes, de las cuales 73 pertenecen al campo biomédico (9,61 %), de los cuales las universidades han generado 24,66 %; es decir 2,47 % del total. Además, las universidades presentaron diferencias significativas de producción de patentes (p = 0,019) en comparación a otros autores. Conclusiones: En el campo biomédico, la producción de patentes en las universidades peruanas ha sido muy limitadas desde 2010 a 2020. Además, las universidades presentaron significativamente menor producción de patentes en comparación a otros inventores, observándose que desde 2016, no se les ha otorgado ninguna patente de invención en el campo biomédico.

Introduction: A patent is an industrial property title granted by the State to the inventor of a new product or technology, susceptible of being marketed for profit on an exclusive basis for a determined period of time. Objective: To determine the number of patents granted to Peruvian universities in the biomedical field from 2010 to 2020, in comparison with the production of other inventors. Material and Methods: This descriptive, observational, retrospective and cross-sectional study analyzed 73 patents from a universe of 759 patents obtained from the database of the National Institute for the Defense of Competition and Protection of Intellectual Property in Peru, from 2010 to 2020. To compare the number of patents granted to universities with respect to other inventors, Pearson's chi-square test with Yates' continuity correction was applied. Results: In Peru, during the years 2010 to 2020, 759 patents have been granted, of which 73 belong to the biomedical field (9.61 %), of which universities have generated 24.66 %, i.e. 2.47 % of the total. Furthermore, universities showed significant differences in patent production (p = 0.019) compared to other authors. Conclusions: In the biomedical field, patent production in Peruvian universities has been very limited from 2010 to 2020. In addition, universities presented significantly lower patent production compared to other inventors, noting that since 2016, they have not been granted any invention patents in the biomedical field.

Revisiones sistemáticas en cinco pasos: V. Cómo interpretar la evidencia / Systematic reviews in five steps: V. Interpreting the findings

El último paso en una revisión sistemática es interpretar la evidencia de forma que pueda ser útil para sustentar la toma de resultados. Es importante presentar los resultados de forma claramente diferenciada, asignar el nivel de fuerza de la evidencia que respalda cada uno de ellos teniendo en cuenta factores como el diseño de los estudios, su calidad metodológica y el sesgo de publicación. También es necesario considerar las variaciones en la fuerza de la asociación. El objetivo es detectar en qué tipo de pacientes la intervención analizada será más o menos efectiva, tendrá mayor o menor impacto una exposición determinada, o será de mayor utilidad una prueba diagnóstica. En esta fase, para facilitar la interpretación de los resultados, se puede añadir una estimación de la magnitud de la asociación, bien global o bien estratificada en función de las características de los participantes. Toda esta información ayudará a la hora de formular recomendaciones prácticas con utilidad clínica. (AU)

The last step in a systematic review is the interpretation of the findings. The important findings need to be explicitly identified. A level of strength of evidence should be assigned to support each key finding, based on factors such as study design, methodological quality and risk of publication bias. Variations in the magnitude of associations observed also need to be explored. The aim of this analysis is to determine in which clinical groups the intervention is more or less effective, the impact of exposure is greater or lesser, or a diagnostic test is more useful. At this stage, for better interpretation of the findings, the magnitude of the association can be estimated either globally or stratified according to the characteristics of the participants. All this is helpful in formulating recommendations for clinical practice and policy. (AU)

[Systematic reviews in five steps: V. Interpreting the findings]. / Revisiones sistemáticas en cinco pasos: V. Cómo interpretar la evidencia.

The last step in a systematic review is the interpretation of the findings. The important findings need to be explicitly identified. A level of strength of evidence should be assigned to support each key finding, based on factors such as study design, methodological quality and risk of publication bias. Variations in the magnitude of associations observed also need to be explored. The aim of this analysis is to determine in which clinical groups the intervention is more or less effective, the impact of exposure is greater or lesser, or a diagnostic test is more useful. At this stage, for better interpretation of the findings, the magnitude of the association can be estimated either globally or stratified according to the characteristics of the participants. All this is helpful in formulating recommendations for clinical practice and policy.

Brief cognitive tests as a decision-making tool in primary care. A population and validation study.

INTRODUCTION AND OBJECTIVES: Brief cognitive tests (BCT) are used in primary care (PC) for the detection of cognitive impairment (CI). Still, there are little data on their diagnostic utility (DU) in a community setting. This work evaluates the DU at the population level of Fototest, T@M, AD8 questionnaire and MMSE. It provides new cut-off points (CoP) validated in a CI early detection program. MATERIAL AND METHODS: In the population and validation samples, the evaluation was carried out in two phases, a first of screening and administration of BCT and a second of clinical diagnosis, blinded to the results of the BCT, applying the current NIA-AA criteria. The DU of BCT in the population sample was evaluated with the area under the ROC curve (aROC). Youden index and the CoP with the best specificity that ensured a sensitivity of 80% were used to decide on the most appropriate CoP. The sensitivity, specificity, and predictive values for these CoP were calculated in the validation sample. RESULTS: 260 participants (23.1% with CI) from the population sample and 177 (42.4% with CI) from the validation sample were included. The Fototest has the best UD at the population level (aROC 0.851), which improves with the combination of Fototest and AD8 (aROC 0.875). The proposed CoP are AD8 ≥ 1, Fototest ≤ 35, T@M ≤ 40, and MMSE ≤ 26. CONCLUSION: BCT are helpful in detecting CI in PC. This work supports the use of more demanding PoC.

Utilidad diagnóstica de test cognitivos breves en el cribado de deterioro cognitivo / Diagnostic performance of brief cognitive tests in cognitive impairment screening

Introducción y objetivos: Evaluar y comparar la utilidad diagnóstica (UD) para el cribado de deterioro cognitivo (DC) de los test cognitivos breves (TCB) recomendados por la Guía de práctica clínica sobre la atención integral a las personas con enfermedad de Alzheimer y otras demencias. Material y métodos: Estudio de fase iii de evaluación de pruebas diagnósticas en el que se ha incluido en Atención Primaria a sujetos con sospecha de DC. A todos se les ha aplicado Mini-Mental State Examination (Mini-Mental), Mini Examen Cognoscitivo (MEC), Short Portable Mental Status Questionnaire (SPMSQ), Memory Impairment Screen (MIS), test del reloj (TdR), Eurotest, Fototest y test de alteración de memoria (T@M). El diagnóstico de DC se ha realizado de forma independiente y cegada con respecto a los resultados de los TCB. La UD se ha evaluado mediante el área bajo la curva ROC (aROC). Resultados: Se ha incluido a 141 sujetos (86 con DC). El Eurotest y el T@M (0,91 ± 0,02 [aROC ± EE] y 0,90 ± 0,02, respectivamente), los instrumentos que requieren más tiempo (7,1 ± 1,8 [media ± DE] y 6,8 ± 2,2 min, respectivamente) tienen una UD significativamente superior a la del Mini-Mental, MEC, SPMSQ y TdR, pero no a la del MIS y Fototest (0,87 ± 0,03 ambas), requiriendo este último menos de la mitad del tiempo (2,8 ± 0,8 min). T@M y MIS solo evalúan memoria y el último no es aplicable a analfabetos. Conclusiones: Los instrumentos más recomendables para el cribado de DC en Atención Primaria son Eurotest, T@M y Fototest, siendo el último más eficiente por requerir la mitad de tiempo. (AU)

Introduction and objectives: This study aims to assess and compare the diagnostic performance of brief cognitive tests for cognitive impairment (CI) screening recommended by the Spanish guidelines for the integral care of people with Alzheimer's disease and other dementias. Material and methods: We performed a phase iii study into the accuracy of diagnostic tests, including patients with suspected CI in a primary care setting. All patients completed the Mini–Mental State Examination (MMSE), the Mini Examen Cognoscitivo (MEC), the Short Portable Mental Status Questionnaire (SPMSQ), the Memory Impairment Screen (MIS), the Clock Drawing Test (CDT), the Eurotest, the Fototest, and the Memory Alteration Test (M@T). CI was diagnosed independently by researchers blinded to scores on these tests. Diagnostic performance was evaluated by calculating the area under the receiver operating characteristic curve (AUC). Results: The study included 141 individuals (86 with CI). The Eurotest and M@T (AUC ± SE: 0.91 ± 0.02 and 0.90 ± 0.02, respectively) took longer to administer (mean [SD]: 7.1 [1.8] and 6.8 [2.2] min, respectively) and have significantly better diagnostic performance compared to the MMSE, MEC, SPMSQ, and CDT, but not compared to MIS or Fototest (both with an AUC of 0.87 ± 0.03), with the latter taking less than half as long to administer (2.8 [0.8] min). The M@T and MIS only evaluate memory, and the latter cannot be administered to illiterate people. Conclusion: The most advisable tests for CI screening in primary care are the Eurotest, M@T, and Fototest, with the latter being the most efficient as it takes half as long to administer. (AU)

Diagnostic performance of brief cognitive tests in cognitive impairment screening.

INTRODUCTION AND OBJECTIVES: This study aims to assess and compare the diagnostic performance of brief cognitive tests for cognitive impairment (CI) screening recommended by the Spanish guidelines for the integral care of people with Alzheimer's disease and other dementias. MATERIAL AND METHODS: We performed a phase iii study into the accuracy of diagnostic tests, including patients with suspected CI in a primary care setting. All patients completed the Mini-Mental State Examination (MMSE), the Mini Examen Cognoscitivo (MEC), the Short Portable Mental Status Questionnaire (SPMSQ), the Memory Impairment Screen (MIS), the Clock Drawing Test (CDT), the Eurotest, the Fototest, and the Memory Alteration Test (M@T). CI was diagnosed independently by researchers blinded to scores on these tests. Diagnostic performance was evaluated by calculating the area under the receiver operating characteristic curve (AUC). RESULTS: The study included 141 individuals (86 with CI). The Eurotest and M@T (AUC±SE: 0.91±0.02 and 0.90±0.02, respectively) took longer to administer (mean [SD]: 7.1 [1.8] and 6.8 [2.2]min, respectively) and have significantly better diagnostic performance compared to the MMSE, MEC, SPMSQ, and CDT, but not compared to MIS or Fototest (both with an AUC of 0.87±0.03), with the latter taking less than half as long to administer (2.8 [0.8]min). The M@T and MIS only evaluate memory, and the latter cannot be administered to illiterate people. CONCLUSION: The most advisable tests for CI screening in primary care are the Eurotest, M@T, and Fototest, with the latter being the most efficient as it takes half as long to administer.

Preliminary analysis of a shortened picture version of the Free and Cued Selective Reminding Test.

INTRODUCTION: A picture version of the Free and Cued Selective Reminding Test (FCSRT) would assist in the assessment of memory function in patients with low levels of schooling. A shortened version would improve the test's applicability. OBJECTIVES: To analyse the diagnostic usefulness of a shortened picture version of the FCSRT for distinguishing patients with amnestic mild cognitive impairment (aMCI) from controls, without excluding participants with a low level of schooling. METHODS: Phase I study of a diagnostic evaluation (convenience sampling; pre-test prevalence 50%). A blinded researcher independently administered the FCSRT to 30 patients with aMCI and 30 controls matched for age, sex, level of schooling and literacy, using images and omitting the usual 30-minutes delayed recall item. Three variables were recorded: free recall, total recall, and cue efficiency. Diagnostic accuracy was calculated using receiver operating characteristic curves and the area under the curve. The Youden index was used to identify optimal cut-off points. RESULTS: Of all participants, 41.7% had not completed primary education. There were no differences between groups as regards sociodemographic variables. Area under the curve was excellent for free recall (0.99), total recall (0.95), and cue efficiency (0.93). The optimal cut-off points were 21/22, 43/44, and < 0.77, respectively. CONCLUSIONS: This preliminary analysis shows that a shortened picture version of the FCSRT may be useful and applicable for the diagnosis of aMCI without excluding individuals with a low level of schooling.

Statistical characterization of a good biomarker in oncology. / Características bioestadísticas de un buen biomarcador en Oncología.

OBJECTIVE: The  aim of this article is to review and illustrate the attributes that analyze the performance of a predictive model, suchas discrimination, calibration and clinical utility. MATERIAL AND METHODS: To illustrate a biomarkervalidation process, we analyzed 216 patientsrecruited in the Miguel Servet University Hospital Zaragoza, Spain. The outcome of the study was clinicallysignificant prostate cancer (Gleason ≥ 7). A newbiomarker was built using logistic regression modelfrom age, prostate-specific antigen, prostate volumeand digital rectal exam variables. To analyze the discriminationability, the receiver operating characteristiccurve, its area under the curve (AUC), and Youdenindex were estimated. In addition, the calibration wasanalyzed through calibration curve, intercept and slope;and the clinical utility was studied by means of decisionand clinical utility curves. RESULTS: The discrimination ability was good:AUC 0.790 (0.127-0.853 95% C.I.), Youden index cutoffpoint 0.431 (specificity 0.811, sensitivity 0.697).The Intercept was 0 and Slope 1 showing a perfect calibration.Decision curve showed good net benefit in athreshold probability range 25%-80%. Clinical utilitycurve showed that for a 18% cutoff point, a minimum4.5% of CsPCa patients are wrongly classified belowthe cutoff point, saving 18.5% biopsies. CONCLUSIONS: A complete validation process isnecessary to analyze the performance of a biomarkerin oncology, based on their discrimination ability, theconcordance between predicted and actual occurrenceof the outcome, and its applicability in clinical practice.

OBJETIVO: El objetivo principal de esteartículo es revisar e ilustrar las propiedades para analizarel desempeño de un modelo predictivo, que sonla discriminación, calibración y utilidad clínica.MATERIAL Y MÉTODOS: Para ilustrar un procesode validación de biomarcadores, analizamos 216 pacientesreclutados en el Hospital Universitario MiguelServet, Zaragoza, España. El objetivo a predecir en elestudio fue un cáncer de próstata clínicamente significativo(Gleason ≥ 7). Se construyó un nuevo biomarcadorutilizando un modelo de regresión logísticausando la edad, el antígeno prostático específico, elvolumen de la próstata y el tacto rectal como variablespredictoras. Para analizar la capacidad de discriminaciónse estimó la curva característica de funcionamientodel receptor, su área bajo la curva (AUC) y elíndice de Youden. Además, la calibración se analizómediante curva de calibración, intersección y pendiente;y la utilidad clínica se estudió mediante curvasde decisión y utilidad clínica. RESULTADOS: La capacidad de discriminación fuebuena: AUC 0,790 (0,127-0,853 IC del 95%), punto decorte del índice de Youden 0,431 (especificidad 0,811,sensibilidad 0,697). La intersección fue 0 y la pendiente1, mostrando una calibración perfecta. La curva dedecisión muestra un buen beneficio neto en un rangode probabilidad del 25% al 80%. La curva de utilidadclínica mostró que para un punto de corte del 18%, seproduce un mínimo del 4,5% de los pacientes con CsPCaclasificados incorrectamente por debajo del puntode corte, ahorrando un 18,5% de biopsias. CONCLUSIONES: Es necesario un proceso de validacióncompleto para analizar el desempeño de un biomarcadoren oncología, en función de su capacidad dediscriminación, la concordancia entre las prediccionesque proporciona el marcador y la ocurrencia real delevento, y su aplicabilidad en la práctica clínica.

Características bioestadísticas de un buen biomarcador en oncología / Statistical characterization of a good biomarker in oncology

OBJETIVO: El objetivo principal de esteartículo es revisar e ilustrar las propiedades para analizar el desempeño de un modelo predictivo, que sonla discriminación, calibración y utilidad clínica.MATERIAL Y MÉTODOS: Para ilustrar un procesode validación de biomarcadores, analizamos 216 pacientes reclutados en el Hospital Universitario MiguelServet, Zaragoza, España. El objetivo a predecir en elestudio fue un cáncer de próstata clínicamente significativo (Gleason ≥ 7). Se construyó un nuevo biomarcador utilizando un modelo de regresión logísticausando la edad, el antígeno prostático específico, elvolumen de la próstata y el tacto rectal como variablespredictoras. Para analizar la capacidad de discriminación se estimó la curva característica de funcionamiento del receptor, su área bajo la curva (AUC) y elíndice de Youden. Además, la calibración se analizómediante curva de calibración, intersección y pendiente; y la utilidad clínica se estudió mediante curvasde decisión y utilidad clínica. RESULTADOS: La capacidad de discriminación fuebuena: AUC 0,790 (0,127-0,853 IC del 95%), punto decorte del índice de Youden 0,431 (especificidad 0,811,sensibilidad 0,697). La intersección fue 0 y la pendiente 1, mostrando una calibración perfecta. La curva dedecisión muestra un buen beneficio neto en un rangode probabilidad del 25% al 80%. La curva de utilidadclínica mostró que para un punto de corte del 18%, seproduce un mínimo del 4,5% de los pacientes con CsPCa clasificados incorrectamente por debajo del puntode corte, ahorrando un 18,5% de biopsias.CONCLUSIONES: Es necesario un proceso de validación completo para analizar el desempeño de un biomarcador en oncología, en función de su capacidad dediscriminación, la concordancia entre las prediccionesque proporciona el marcador y la ocurrencia real delevento, y su aplicabilidad en la práctica clínica. (AU)

lustrate the attributes that analyze theperformance of a predictive model, such as discrimination, calibration and clinical utility.MATERIAL AND METHODS: To illustrate a biomarker validation process, we analyzed 216 patientsrecruited in the Miguel Servet University Hospital, Zaragoza, Spain. The outcome of the study was clinically significant prostate cancer (Gleason ≥ 7). A newbiomarker was built using logistic regression modelfrom age, prostate-specific antigen, prostate volumeand digital rectal exam variables. To analyze the discrimination ability, the receiver operating characteristic curve, its area under the curve (AUC), and Youdenindex were estimated. In addition, the calibration wasanalyzed through calibration curve, intercept and slope; and the clinical utility was studied by means of decision and clinical utility curves.RESULTS: The discrimination ability was good:AUC 0.790 (0.127-0.853 95% C.I.), Youden index cutoff point 0.431 (specificity 0.811, sensitivity 0.697).The Intercept was 0 and Slope 1 showing a perfect calibration. Decision curve showed good net benefit in athreshold probability range 25%-80%. Clinical utilitycurve showed that for a 18% cutoff point, a minimum4.5% of CsPCa patients are wrongly classified belowthe cutoff point, saving 18.5% biopsies.CONCLUSIONS: A complete validation process isnecessary to analyze the performance of a biomarkerin oncology, based on their discrimination ability, theconcordance between predicted and actual occurrenceof the outcome, and its applicability in clinical practice. (AU)

Validez, confiabilidad y utilidad clínica de los trastornos mentales: el caso de la esquizofrenia de la CIE-11 / Validity, Reliability and Clinical Utility of Mental Disorders: The Case of ICD-11 Schizophrenia

RESUMEN Los sistemas de clasificación diagnóstica categorizan la psicopatología en trastornos mentales. Aunque estas entidades son constructos clínicos elaborados por consenso, se ha señalado que en la práctica se suele tratarlas como entidades naturales y sin valorar aspectos relacionados con su construcción nosológica. Los objetivos del estudio son revisar: a) la conceptualización de los trastornos mentales; b) los indicadores de validez, confiabilidad y utilidad clínica, y c) los valores de estos indicadores en la esquizofrenia de la CIE-11. Los resultados muestran que los trastornos mentales están conceptualizados como entidades discretas, al igual que las enfermedades de otras áreas de la medicina; sin embargo, se observan diferencias entre ambas categorías diagnósticas en la práctica clínica. La confiabilidad y la utilidad clínica de los trastornos mentales son adecuadas; no obstante, la validez aún no está esclarecida. De modo similar, la esquizofrenia de la CIE-11 presenta adecuadas confiabilidad y utilidad clínica, pero su validez permanece incierta. La conceptualización de la psicopatología mental en entidades discretas puede resultar inadecuada para su estudio, por lo que se han propuesto modelos dimensionales y mixtos. Los indicadores de validez, confiabilidad y utilidad clínica permiten tener una visión precisa del estado nosológico de los trastornos mentales al valorar distintos aspectos de su construcción nosológica.

ABSTRACT Diagnostic classification systems categorize mental psychopathology in mental disorders. Although these entities are clinical constructs developed by consensus, it has been pointed out that in practice they are usually managed as natural entities and without evaluating aspects related to their nosological construction. The objectives of the study are to review a) the conceptualization of mental disorders, b) the indicators of validity, reliability and clinical utility, and c) the values of these indicators in ICD-11 schizophrenia. The results show that mental disorders are conceptualized as discrete entities, like the diseases of other areas of medicine; however, differences are observed between these diagnostic categories in clinical practice. The reliability and clinical utility of mental disorders are adequate; however, the validity is not yet clarified. Similarly, ICD-11 schizophrenia demonstrates adequate reliability and clinical utility, but its validity remains uncertain. The conceptualization of psychopathology in discrete entities may be inadequate for its study, therefore dimensional and mixed models have been proposed. The indicators of validity, reliability and clinical utility enable us to obtain an accurate view of the nosological state of mental disorders when evaluating different aspects of their nosological construction.

Validity, reliability and clinical utility of mental disorders: The case of ICD-11 schizophrenia.

Diagnostic classification systems categorise mental psychopathology in mental disorders. Although these entities are clinical constructs developed by consensus, it has been pointed out that in practice they are usually managed as natural entities and without evaluating aspects related to their nosological construction. The objectives of the study are to review a) the conceptualisation of mental disorders, b) the indicators of validity, reliability and clinical utility, and c) the values ​​of these indicators in ICD-11 schizophrenia. The results show that mental disorders are conceptualised as discrete entities, like the diseases of other areas of medicine; however, differences are observed between these diagnostic categories in clinical practice. The reliability and clinical utility of mental disorders are adequate; however, the validity is not yet clarified. Similarly, ICD-11 schizophrenia demonstrates adequate reliability and clinical utility, but its validity remains uncertain. The conceptualisation of psychopathology in discrete entities may be inadequate for its study, therefore dimensional and mixed models have been proposed. The indicators of validity, reliability and clinical utility enable us to obtain an accurate view of the nosological state of mental disorders when evaluating different aspects of their nosological construction.

Usefulness and acceptability of a Smart pH meter and mobile medical App as a monitoring tool in patients with urolithiasis: short-term prospective study. / Utilidad y aceptabilidad de un pH-metro inteligente y una aplicación móvil de salud como herramienta de monitorización en pacientes con urolitiasis: estudio prospectivo a corto plazo.

ORIGINAL ARTICLE: Usefulness and Acceptability of a Smart pH Meter and Mobile Medical App as a Monitoring Tool in Patients with Urolithiasis: Short-term Prospective Study. OBJECTIVE: An accurate strategy for regularly measuring urine pH is the use of portable electronic pH meters. This study evaluated the usefulness and acceptability of the smart Lit-Control® pH Meter connected with a companion mobile medical application (myLit-Control(R) App) used by patients with urolithiasis for home monitoring of urine pH. We also examined adherence and compliance rates, and users´ satisfaction levels. MATERIALS AND METHODS: This was a multicenter, prospective study conducted in 10 centers from Spain. Adult patients with a history of urolithiasis were recruited and instructed to carry out a pH measurement with the pH meter three times per day for two weeks. User tasks included turning on the device, registration and on boarding processes in the App, sync the device and the App, and data dumping. At the end of the trial, we evaluated the level of adherence and usage compliance. Participants' perceptions about the usefulness, acceptability, and satisfaction with the device/App were collected through the Computer System Usability Questionnaire (CSUQ) and subjective surveys. RESULTS: Participants were 27 men and 10 women. The mean age of participants was 48.7 (SD = 10.4) years, ranging from 25 to 66. The predominant type of stone was calcium oxalate. The mean pH of all readings was 5.83 (SD = 0.41). Seventy-three (73%) patients met the "good adherence" criterion (not being more than 2 days without recording any pH value). The compliance (actual vs. theoretical readings) was 87.6%. Participants rated the usability of the App 5.4 and above (on a 7-point scale) in all the items of CSUQ. Satisfaction was high, as indicated by the mean score of 6.0 in item 16. In the subjective questionnaire (0 to 3 scale), nearly all mean values were above 2. Patients scored their probability to recommend the App with an average of 8.2 on a 0 to 10 scale. CONCLUSION: The new smart Lit-Control® pH Meter and the accompanying medical App were deemed useful and acceptable by urolithiasis patients as a portable tool for urine pH monitoring at home. The usage compliance rates were high and the satisfaction with the products was good.

OBJETIVO: La utilización de pH-metroselectrónicos portátiles supone una estrategiaprecisa para medir regularmente el pH de la orina.Este estudio evaluó la utilidad y la aceptabilidad delpH-metro inteligente Lit-Control® conectado con unaaplicación móvil complementaria (myLit-Control(R)App) para la monitorización domiciliaria del pH de laorina por pacientes con nefrolitiasis. También examinamoslas tasas de adherencia y cumplimiento, y losniveles de satisfacción de los usuarios. MATERIALES Y MÉTODOS: Se trata de un estudioprospectivo y multicéntrico realizado en 10 centros deEspaña. Se reclutaron pacientes adultos con antecedentesde litiasis urinaria, a los que se les indicó querealizaran una medición del pH con el pH-metro tresveces al día durante un período de dos semanas. Lastareas del usuario incluyeron encender el dispositivo,instalación y registro en la aplicación, sincronizar ambossistemas y volcado de datos. Al final de la prueba,evaluamos el nivel de adherencia y cumplimiento dela monitorización. Las percepciones de los participantessobre la utilidad, aceptabilidad y satisfacción conel dispositivo/aplicación se obtuvieron a través delCuestionario de Usabilidad de Sistemas Informáticos(CSUQ) y encuestas subjetivas. RESULTADOS: Los participantes fueron 27 hombresy 10 mujeres. La edad media de los participantesfue 48,7 (DE = 10,4) años, con un rango de 25 a66. El tipo de cálculo predominante fue de oxalato decalcio. El pH promedio de todas las lecturas fue 5,83(DE = 0,41). Setenta y tres (73%) pacientes cumplieronel criterio de "buena adherencia" (no estar másde 2 días sin registrar ningún valor de pH). El cumplimiento(lecturas reales frente a lecturas teóricas) fuedel 87,6%. Los participantes calificaron la usabilidadde la aplicación en 5,4 o superior (en una escala de 7puntos) en todos los ítems de CSUQ. La satisfacciónfue alta, según la puntuación media de 6,0 en el ítem16. En el cuestionario subjetivo (escala de 0 a 3), casitodos los valores medios estaban por encima de 2. Lospacientes puntuaron su probabilidad de recomendarla aplicación a otros pacientes con un promedio de 8,2en una escala de 0 a 10. CONCLUSIÓN: El nuevo pH-metro inteligenteLit-Control(R) pH Meter y la aplicación médica vinculadase consideraron útiles y aceptables por los pacientescon urolitiasis como herramienta válida para  la monitorización del pH de la orina en el hogar. Lastasas de cumplimiento de uso fueron elevadas y la satisfaccióngeneral con los productos fue alta.