Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)

Catalan healthcare; Decision-making; Multi-criteria decision analysis; Orphan drugsSanitat catalana; Presa de decisions; Anàlisi de decisions multicriteri; Medicaments orfesSanidad catalana; Toma de decisiones; Análisis de decisiones multicriteria; Medicamentos huérfanosBACKGROUND: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. METHODS: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. RESULTS: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. CONCLUSIONS: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access

Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)

Background: orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. Methods: the assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. Results: the final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. Conclusions: the study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access

Manual fes-t'ho tu mateix! : l'experiment de la muntanya russa. El principi de la conservació de l'energia

En aquest document es presenta un manual tipus fes-t’ho tu mateix (en anglès do it yourself, sovint abreujat DIY) per a la construcció d’una maqueta d’una muntanya russa. Aquesta maqueta serveix per: i) conèixer com es tracta el concepte d’energia en l’àmbit de l’Enginyeria Mecànica; ii) demostrar mitjançant l’experimentació, el principi de la conservació de l’energia, que és equivalent al teorema de l’energia en l’àmbit de les màquines i els mecanismes. La maqueta es basa en una joguina amb un cost d’uns 70 € per facilitar que es pugui repetir l’experiment. S’han muntat dos tipus de sensors de velocitat. El primer model de sensors de velocitat són més cars i s’han utilitzat per establir els valors de referència. El segon model de sensors de velocitat, molt més econòmics es basen en components electrònics basats en la plataforma Arduino que segueix una filosofia de codi obert, per compartir tot el que es desenvolupa de forma senzilla. S’ha optat per prioritzar reduir el cost de desenvolupament de la maqueta i utilitzar processos de fabricació basats en impressió 3D que cada vegada són més utilitzats en centres educatius. Aquest document s’emmarca dins el projecte ECOMEC, atorgat al grup de recerca Centre de Disseny d’Equips Industrials–Dinàmica de Màquines (CDEI-DM) en la convocatòria dels ajuts Joan Oró 2022 de la Fundació Catalana per a la Recerca i la Innovació. Per ampliar l’abast formatiu de la proposta es recomana visualitzar els vídeos del projecte ECOMEC penjats a la Zona UPC vídeos [1]. Els vídeos s’han de buscar filtrant pel títol Objectius de Desenvolupament Sostenible. Una mirada des de l’Enginyeria Mecànica. En la primera part del document s’explica la construcció de la maqueta de la muntanya russa. En la segona part es fa la descripció de l’experiment per demostrar el principi de la conservació de l’energia. L’Annex 1 conté el llistat de material necessari per a la construcció de la maqueta. L’Annex 2 conté el recull de les taules per recopilar les dades de l’experiment. L’Annex 3 conté les plantilles amb els circuits proposats en l’experiment.2022/202

Under-diagnosis of mental disorder in people with intellectual disabilities: study of prevalence in population with different degrees of intellectual disability

There are a few studies in the literature analyzing the prevalence of mental illness in people with intellectual disabilities (ID). This study explores the prevalence of mental disorders in adults without previous mental disorder and different degrees of ID. We assessed 142 individuals with varying degrees of ID and with unknown previous psychiatric disorder. We applied the diagnostic battery PAS-ADD based on criteria ICD-10 and DSM-IV TR to analyzed the prevalence of mental disorders in people with mild / moderate ID. We applied the Spanish version of the scale DASH-II to analyze the prevalence of mental disorders in people with severe and profound ID. We found a psychiatric disorder previously undiagnosed in 29.57% of our sample. In people with mild/ moderate ID the most common psychiatric disorder was depressive disorder (33.3%), but in people with severe and profound ID was the anxiety disorder. The most prevalent medical comorbidity was epilepsy (22.5% of the total sample and 39.2% in the population with severe / profound intellectual disabilities). Psychiatric disorders seem to be more common in the population with ID than in the general population, increasing their prevalence and medical comorbidity in severe and profound ID.Introducción: Existen pocos estudios en la literatura que hayan analizado la prevalencia de enfermedades mentales en las personas con discapacidad intelectual (DI). Se presenta un estudio de identificación de enfermedad mental en población adulta sin trastorno mental previo conocido y con diferentes grados de DI./nMetodología: El presente estudio describe la comorbilidad psiquiátrica y médica de una muestra de 142 individuos con diferentes grados de DI. Para el estudio de enfermedad mental en la población con DI Leve/Moderada se utilizó la batería diagnóstica PAS-ADD, basada en criterios CIE-10 y DSM-IV TR y en la población con DI grave/severa la escala DASH-II/nResultados: El 29,57% de los participantes presentaron un trastorno psiquiátrico previamente no diagnosticado. En el grupo DI leve/moderada la patología más prevalente fue el trastorno depresivo mayor, en cambio en el grupo DI grave/profunda fue el trastorno de ansiedad. La comorbilidad médica más prevalente fue la epilepsia, con un 22,5% de la muestra global y un 39,2% en la población con discapacidad intelectual grave o severa./nConclusión: Los trastornos psiquiátricos parecen ser más frecuentes en la población con DI que en población general, aumentando su prevalencia, así como su comorbilidad médica, en la DI severa/profunda.

Manual fes-t'ho tu mateix : proposta de dues alternatives d'aixafa llaunes

En aquest document es presenta un manual tipus fes-t’ho tu mateix (en anglès do it yourself, sovint abreujat DIY) per a la construcció de dues alternatives d’aixafa llaunes automatitzades. La primera alternativa està basada en un mecanisme de pistó-biela-manovella. La segona alternativa està basada en un mecanisme de lleva d’excèntrica amb un palpador de corró de translació. Per al disseny i la construcció d’ambdues alternatives s’ha optat per prioritzar criteris de sostenibilitat, reduir el cost i utilitzar processos de fabricació que puguin ser més accessibles en centres educatius. Així, s’ha optat per reaprofitar material de rebuig: un motor d’un eixugaparabrises d’un vehicle de desballestament i una font d’alimentació d’un ordinador obsolet. D’aquesta forma es vol contribuir a assolir i conèixer l’Objectiu de Desenvolupament Sostenible 12 (ODS 12) que té a veure amb la reparació, la reutilització i el reciclatge. També s’ha optat per fer la major part de les peces en fusta, material amb menor impacte ambiental per assolir i conèixer l’ODS 9 que fomenta uns processos industrials més sostenibles. D’altres elements estan fets amb processos de fabricació basats en la impressió 3D. Es considera que aquest tipus de material educatiu basat en projectes aplicats, contribueix a l’ODS 4, relacionat amb una educació de qualitat, inclusiva i equitativa. En l’Annex 2 es faciliten els plànols de fabricació de totes les peces que no s’han fabricat amb una impressora 3D. Aquest document s’emmarca dins el projecte ECOMEC, atorgat al grup de recerca Centre de Disseny d’Equips Industrials–Dinàmica de Màquines (CDEI-DM) en la convocatòria dels ajuts Joan Oró 2022 de la Fundació Catalana per a la Recerca i la Innovació. Per ampliar l’abast formatiu de la proposta es recomana visualitzar els vídeos del projecte ECOMEC penjats a la Zona UPC vídeos [1]. Els vídeos s’han de buscar filtrant pel títol Objectius de Desenvolupament Sostenible. Una mirada des de l’Enginyeria Mecànica. L’estructura del document és la següent. Primer, s’expliquen les especificacions generals que s’han fixat en el disseny de l’aixafa llaunes, explicant com s’ha determinat la força necessària per aixafar una llauna. Segon, s’explica el muntatge dels elements comuns. Tercer, s’explica el muntatge del mecanisme de pistó-biela-manovella i del mecanisme de lleva d’excèntrica.2022/202

El infradiagnóstico del trastorno mental en la población con discapacidad intelectual: estudio de prevalencia en población con diferentes grados de discapacidad intelectual

Existen pocos estudios en la literatura que hayan analizado la prevalencia de enfermedades mentales en las personas con discapacidad intelectual (DI). Se presenta un estudio de identificación de enfermedad mental en población adulta sin trastorno mental previo conocido y con diferentes grados de DI. El presente estudio describe la comorbilidad psiquiátrica y médica de una muestra de 142 individuos con diferentes grados de DI. Para el estudio de enfermedad mental en la población con DI leve/moderada se utilizó la batería diagnóstica PAS-ADD, basada en criterios CIE-10 y DSM-IV TR y en la población con DI grave/severa la escala DASH-II. El 29,57% de los participantes presentaron un trastorno psiquiátrico previamente no diagnosticado. En el grupo DI leve/moderada la patología más prevalente fue el trastorno depresivo mayor; en cambio, en el grupo DI grave/profunda fue el trastorno de ansiedad. La comorbilidad médica más prevalente fue la epilepsia, con un 22,5% de la muestra global y un 39,2% en la población con discapacidad intelectual grave o severa. Existe un elevado porcentaje de trastornos psiquiátricos no diagnosticados en la población con DI, aumentando dicho porcentaje, así como su comorbilidad médica en la DI severa/profunda

Determinacions del perfil genètic de tumors sòlids de l’adult

Perfil genètic; Tumors sòlids; Adults; PrecisióPerfil genético; Tumores sólidos; Adultos; PrecisiónGenetic profile; Solid tumors; Adults; AccuracyEn aquest estudi s’ha definit la llista de gens per a cada patologia i tots ells han estat seleccionats atenent a; la seva utilitat diagnòstica per definir els subtipus tumorals en localitzacions tumorals molt concretes; la seva utilitat pronòstica i predictiva, sempre que això comporti un canvi d’actitud terapèutica; la seva utilitat terapèutica per a la indicació de l’ús de fàrmacs diana

Determinacions del perfil genètic de tumors sòlids de l’adult

Perfil genètic; Tumors sòlids; Adults; PrecisióPerfil genético; Tumores sólidos; Adultos; PrecisiónGenetic profile; Solid tumors; Adults; AccuracyEn aquest estudi s’ha definit la llista de gens per a cada patologia i tots ells han estat seleccionats atenent a; la seva utilitat diagnòstica per definir els subtipus tumorals en localitzacions tumorals molt concretes; la seva utilitat pronòstica i predictiva, sempre que això comporti un canvi d’actitud terapèutica; la seva utilitat terapèutica per a la indicació de l’ús de fàrmacs diana

Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)

Altres ajuts: CatSalut funded the development of this study.Background: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. Methods: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. Results: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. Conclusions: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access

Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)

Catalan healthcare; Decision-making; Multi-criteria decision analysis; Orphan drugsSanitat catalana; Presa de decisions; Anàlisi de decisions multicriteri; Medicaments orfesSanidad catalana; Toma de decisiones; Análisis de decisiones multicriteria; Medicamentos huérfanosBACKGROUND: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. METHODS: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. RESULTS: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. CONCLUSIONS: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access