RATIONALE AND BACKGROUND: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Abrocitinib received marketing authorization for the European Union (EU) on 09 December 2021 and is indicated for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. To mitigate the risks associated with abrocitinib, required routine RMMs including the SmPC and package leaflet are being employed. In addition to the routine RMMs, additional RMMs (aRMMs) inclulding prescriber’s brochure and patient card, are being implemented in the EU.
RESEARCH QUESTION AND OBJECTIVES: The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of HCPs’ adherence to the RMMs in accordance with the abrocitinib SmPC and prescriber’s brochure, assessed by:
– indicators of adherence to performing laboratory tests of CBC, lipid panel, hepatitis B/C, and TB screening prior to initiation of abrocitinib treatment,
– indicators of adherence to performing laboratory tests of CBC and lipid panel at week 4 (±2 weeks) after initiation of abrocitinib treatment,
– indicators of adherence to consideration of risk factors for VTE, MACE, malignancy and serious infection prior to treatment with abrocitinib,
– indicators of adherence to avoid live attenuated vaccines immediately prior to and during treatment with abrocitinib,
– indicators of adherence to contrainidcations for use during pregnancy,
– indicators of adherence to contraindications for use amog patients with severe hepatic impairment,
– indicators of adherence to no use in patients aged < 18 years, and - indicators of adherence to recommended posology (estimated average daily dose). STUDY DESIGN: This will be a descriptive drug utilization study using secondary data from healthcare databases in Denmark, France, Sweden, Spain and Hungary. POPULATION: The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic healthcare data in Denmark, France, Sweden, Spain and Hungary during the study period (study start: country-specific aRMM distribution [01 March 2022, Sweden; 09 March 2022, Denmark; 31 July 2022, France; 30 Jan 2023, Spain; September 2023 (estimated), Hungary]; study end: December 2026). These countries have universal healthcare. VARIABLES: The study will collect all relevant data including patient demographics, comorbidities, prescription medications, vaccine administration, and laboratory testing prior to the initiation of abrocitinib and during treatment with abrocitinib to address the study objectives. DATA SOURCES: This study will utilize routinely collected electronic healthcare data from national or regional population-based electronic healthcare registers in Denmark, Sweden and Spain and an administrative healthcare databases in France and Hungary. STUDY SIZE: All patients initiating abrocitinib during the study period will be included. DATA ANALYSIS: Data will be analysed in each country separately using a common protocol, database-specific definitions of the study variable, and common analysis strategy. The main indicators will be proportions of abrocitinib users with a given indicator of aRMM adherence.

RATIONALE AND BACKGROUND: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Abrocitinib received marketing authorization for the European Union (EU) on 09 December 2021 and is indicated for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. To mitigate the risks associated with abrocitinib, required routine RMMs including the SmPC and package leaflet are being employed. In addition to the routine RMMs, additional RMMs (aRMMs) inclulding prescriber’s brochure and patient card, are being implemented in the EU.
RESEARCH QUESTION AND OBJECTIVES: The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of HCPs’ adherence to the RMMs in accordance with the abrocitinib SmPC and prescriber’s brochure, assessed by:
– indicators of adherence to performing laboratory tests of CBC, lipid panel, hepatitis B/C, and TB screening prior to initiation of abrocitinib treatment,
– indicators of adherence to performing laboratory tests of CBC and lipid panel at week 4 (±2 weeks) after initiation of abrocitinib treatment,
– indicators of adherence to consideration of risk factors for VTE, MACE, malignancy and serious infection prior to treatment with abrocitinib,
– indicators of adherence to avoid live attenuated vaccines immediately prior to and during treatment with abrocitinib,
– indicators of adherence to contrainidcations for use during pregnancy,
– indicators of adherence to contraindications for use amog patients with severe hepatic impairment,
– indicators of adherence to no use in patients aged < 18 years, and - indicators of adherence to recommended posology (estimated average daily dose). STUDY DESIGN: This will be a descriptive drug utilization study using secondary data from healthcare databases in Denmark, France, Sweden, Spain and Hungary. POPULATION: The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic healthcare data in Denmark, France, Sweden, Spain and Hungary during the study period (study start: country-specific aRMM distribution [01 March 2022, Sweden; 09 March 2022, Denmark; 31 July 2022, France; 30 Jan 2023, Spain; September 2023 (estimated), Hungary]; study end: December 2026). These countries have universal healthcare. VARIABLES: The study will collect all relevant data including patient demographics, comorbidities, prescription medications, vaccine administration, and laboratory testing prior to the initiation of abrocitinib and during treatment with abrocitinib to address the study objectives. DATA SOURCES: This study will utilize routinely collected electronic healthcare data from national or regional population-based electronic healthcare registers in Denmark, Sweden and Spain and an administrative healthcare databases in France and Hungary. STUDY SIZE: All patients initiating abrocitinib during the study period will be included. DATA ANALYSIS: Data will be analysed in each country separately using a common protocol, database-specific definitions of the study variable, and common analysis strategy. The main indicators will be proportions of abrocitinib users with a given indicator of aRMM adherence.

RATIONALE AND BACKGROUND: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Abrocitinib received marketing authorization for the European Union (EU) on 09 December 2021 and is indicated for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. To mitigate the risks associated with abrocitinib, required routine RMMs including the SmPC and package leaflet are being employed. In addition to the routine RMMs, additional RMMs (aRMMs) inclulding prescriber’s brochure and patient card, are being implemented in the EU.
RESEARCH QUESTION AND OBJECTIVES: The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of HCPs’ adherence to the RMMs in accordance with the abrocitinib SmPC and prescriber’s brochure, assessed by:
– indicators of adherence to performing laboratory tests of CBC, lipid panel, hepatitis B/C, and TB screening prior to initiation of abrocitinib treatment,
– indicators of adherence to performing laboratory tests of CBC and lipid panel at week 4 (±2 weeks) after initiation of abrocitinib treatment,
– indicators of adherence to consideration of risk factors for VTE, MACE, malignancy and serious infection prior to treatment with abrocitinib,
– indicators of adherence to avoid live attenuated vaccines immediately prior to and during treatment with abrocitinib,
– indicators of adherence to contrainidcations for use during pregnancy,
– indicators of adherence to contraindications for use amog patients with severe hepatic impairment,
– indicators of adherence to no use in patients aged < 18 years, and - indicators of adherence to recommended posology (estimated average daily dose). STUDY DESIGN: This will be a descriptive drug utilization study using secondary data from healthcare databases in Denmark, France, Sweden, Spain and Hungary. POPULATION: The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic healthcare data in Denmark, France, Sweden, Spain and Hungary during the study period (study start: country-specific aRMM distribution [01 March 2022, Sweden; 09 March 2022, Denmark; 31 July 2022, France; 30 Jan 2023, Spain; September 2023 (estimated), Hungary]; study end: December 2026). These countries have universal healthcare. VARIABLES: The study will collect all relevant data including patient demographics, comorbidities, prescription medications, vaccine administration, and laboratory testing prior to the initiation of abrocitinib and during treatment with abrocitinib to address the study objectives. DATA SOURCES: This study will utilize routinely collected electronic healthcare data from national or regional population-based electronic healthcare registers in Denmark, Sweden and Spain and an administrative healthcare databases in France and Hungary. STUDY SIZE: All patients initiating abrocitinib during the study period will be included. DATA ANALYSIS: Data will be analysed in each country separately using a common protocol, database-specific definitions of the study variable, and common analysis strategy. The main indicators will be proportions of abrocitinib users with a given indicator of aRMM adherence.

RATIONALE AND BACKGROUND: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Abrocitinib received marketing authorization for the European Union (EU) on 09 December 2021 and is indicated for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. To mitigate the risks associated with abrocitinib, required routine RMMs including the SmPC and package leaflet are being employed. In addition to the routine RMMs, additional RMMs (aRMMs) inclulding prescriber’s brochure and patient card, are being implemented in the EU.
RESEARCH QUESTION AND OBJECTIVES: The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of HCPs’ adherence to the RMMs in accordance with the abrocitinib SmPC and prescriber’s brochure, assessed by:
– indicators of adherence to performing laboratory tests of CBC, lipid panel, hepatitis B/C, and TB screening prior to initiation of abrocitinib treatment,
– indicators of adherence to performing laboratory tests of CBC and lipid panel at week 4 (±2 weeks) after initiation of abrocitinib treatment,
– indicators of adherence to consideration of risk factors for VTE, MACE, malignancy and serious infection prior to treatment with abrocitinib,
– indicators of adherence to avoid live attenuated vaccines immediately prior to and during treatment with abrocitinib,
– indicators of adherence to contrainidcations for use during pregnancy,
– indicators of adherence to contraindications for use amog patients with severe hepatic impairment,
– indicators of adherence to no use in patients aged < 18 years, and - indicators of adherence to recommended posology (estimated average daily dose). STUDY DESIGN: This will be a descriptive drug utilization study using secondary data from healthcare databases in Denmark, France, Sweden, Spain and Hungary. POPULATION: The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic healthcare data in Denmark, France, Sweden, Spain and Hungary during the study period (study start: country-specific aRMM distribution [01 March 2022, Sweden; 09 March 2022, Denmark; 31 July 2022, France; 30 Jan 2023, Spain; September 2023 (estimated), Hungary]; study end: December 2026). These countries have universal healthcare. VARIABLES: The study will collect all relevant data including patient demographics, comorbidities, prescription medications, vaccine administration, and laboratory testing prior to the initiation of abrocitinib and during treatment with abrocitinib to address the study objectives. DATA SOURCES: This study will utilize routinely collected electronic healthcare data from national or regional population-based electronic healthcare registers in Denmark, Sweden and Spain and an administrative healthcare databases in France and Hungary. STUDY SIZE: All patients initiating abrocitinib during the study period will be included. DATA ANALYSIS: Data will be analysed in each country separately using a common protocol, database-specific definitions of the study variable, and common analysis strategy. The main indicators will be proportions of abrocitinib users with a given indicator of aRMM adherence.

RATIONALE AND BACKGROUND: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Abrocitinib received marketing authorization for the European Union (EU) on 09 December 2021 and is indicated for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. To mitigate the risks associated with abrocitinib, required routine RMMs including the SmPC and package leaflet are being employed. In addition to the routine RMMs, additional RMMs (aRMMs) inclulding prescriber’s brochure and patient card, are being implemented in the EU.
RESEARCH QUESTION AND OBJECTIVES: The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of HCPs’ adherence to the RMMs in accordance with the abrocitinib SmPC and prescriber’s brochure, assessed by:
– indicators of adherence to performing laboratory tests of CBC, lipid panel, hepatitis B/C, and TB screening prior to initiation of abrocitinib treatment,
– indicators of adherence to performing laboratory tests of CBC and lipid panel at week 4 (±2 weeks) after initiation of abrocitinib treatment,
– indicators of adherence to consideration of risk factors for VTE, MACE, malignancy and serious infection prior to treatment with abrocitinib,
– indicators of adherence to avoid live attenuated vaccines immediately prior to and during treatment with abrocitinib,
– indicators of adherence to contrainidcations for use during pregnancy,
– indicators of adherence to contraindications for use amog patients with severe hepatic impairment,
– indicators of adherence to no use in patients aged < 18 years, and - indicators of adherence to recommended posology (estimated average daily dose). STUDY DESIGN: This will be a descriptive drug utilization study using secondary data from healthcare databases in Denmark, France, Sweden, Spain and Hungary. POPULATION: The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic healthcare data in Denmark, France, Sweden, Spain and Hungary during the study period (study start: country-specific aRMM distribution [01 March 2022, Sweden; 09 March 2022, Denmark; 31 July 2022, France; 30 Jan 2023, Spain; September 2023 (estimated), Hungary]; study end: December 2026). These countries have universal healthcare. VARIABLES: The study will collect all relevant data including patient demographics, comorbidities, prescription medications, vaccine administration, and laboratory testing prior to the initiation of abrocitinib and during treatment with abrocitinib to address the study objectives. DATA SOURCES: This study will utilize routinely collected electronic healthcare data from national or regional population-based electronic healthcare registers in Denmark, Sweden and Spain and an administrative healthcare databases in France and Hungary. STUDY SIZE: All patients initiating abrocitinib during the study period will be included. DATA ANALYSIS: Data will be analysed in each country separately using a common protocol, database-specific definitions of the study variable, and common analysis strategy. The main indicators will be proportions of abrocitinib users with a given indicator of aRMM adherence.

Objetivos

Objetivo Principal
Sintetizar toda la evidencia disponible sobre las distintas estrategias tanto dirigidas en ámbito cognitivo, referidas al comportamiento, en intervenciones centradas en los aspectos afectivos o intervenciones multicomponentes para aumentar la adherencia terapéutica en enfermedades crónicas

Objetivo secundario
– Describir la efectividad de las diferentes estrategias identificadas para incrementar la adherencia terapéutica en pacientes crónicos
– Priorizar las estrategias más efectivas en incrementar la adherencia terapéutica en pacientes crónicos
– Clasificar y describir las diferentes estrategias identificadas en el incremento de la adherencia terapéutica
– Sintetizar la evidencia sobre la efectividad de las estrategias para aplicar a pacientes crónicos.

2 – Estrategia de búsqueda
No se limitará por idioma ni por año de publicación
– Se realizará una búsqueda sistemática en Pubmed utilizando los términos MeSH y texto libre, no se pondrá límites en el tiempo ni en el idioma.
– PscycINF, CINHAL, SCOPUS, EMBASE
– Cochrane, Base de datos de Teseo de Tesis doctorales
– Uptodate
– Índice Médico Español.
– Búsqueda manual
– Consulta con expertos

OBJECTIU: Avaluar l´efectivitat d´una app per Smartwatch en disminuir el temps d´inici de les maniobres de reanimació cardio-pulmonar (RCP) en el cas d´aturada cardio-respiratòria extra-hospitalària (ACR-EH). Així com determinar les competències en RCP en una prova de simulació.

DISSENY: es desenvoluparà en dues fases: (a) disseny i desenvolupament d’una APP que permeti l´activació automàtica d´una alerta sanitària en cas de ACR-EH. (b) Es realitzaran simulacions d´episodis d´ACR-EH en via pública amb maniquis. La localització de les simulacions es determinarà a partir del registre d´episodis reals atesos al carrer pel Servei d’Emergències Mèdiques (SEM) en l’any previ (controls). Metge/ses d?atenció primària formaran una xarxa de voluntaris reanimadors (Xarxa RCP) estaran dispersos per la ciutat i connectats via Smartphone.

DESCRIPCIÓ DE LA INTERVENCIÓ: L´smartwatch disposarà de sensor de ritme cardíac i geo-localització (GPS). Aquesta alerta generada és derivada al SEM que activarà els recursos habituals i a la Xarxa RCP que rebran l’alerta al seu Smartphone.

VARIABLES D?ESTUDI: Variable resposta: diferència del temps d’inici de les maniobres de RCP entre el grup simulació i el grup control. Altres variables: Temps de resposta del SEM, Competència de les maniobres de RCP.

ANÀLISI ESTADÍSTIC: prova de la t-student per a dades aparellades es determinaran les diferències del temps d’inici de les maniobres de RCP.

RESULTATS ESPERATS: Esperem trobar un menor temps d’inici de les maniobres de RCP en el grup intervenció comparat amb el grup control.

LIMITACIONS: Possible aparició d´una alerta mèdica real durant el simulacre. Això motivaria la finalització del simulacre.

Justificació: La supervivència dels pacients amb aturada cardio-respiratoria (ACR) sobtada extra-hospitalària es pot augmentar mitjançant la formació en matèria de RCP dels cuidadors principals del pacients amb risc de ACR. Englobat dins d?un assaig clínic que vol determinar l´efectivitat d´una xarxa de voluntaris activats mitjançant una aplicació mòbil en la reducció del temps d´inici de les maniobres de RCP es realitzarà una formació en RCP i us del DEA a familiars o cuidadors principals de pacients amb malaltia cardíaca de reus.

La formació es realitzarà a 430 persones i serà feta per formadors del Consell Català de Ressuscitació (CCR). Els voluntaris assistiran a unes sessions teòrico-pràctica (amb maniquí) amb una durada de dos hores, en grups de 15 voluntaris i dos docents acreditats pel CCR com a Formadors. Es faran en total 30 sessions per formar unes 430 persones. Un cop finalitzat cada curs formatiu en RCP-DEA s´oferirà la participació voluntària en la Xarxa-RCP. Esperem la captació d’unes 100 persones (25% dels formats).
També es convidarà a participar en la xarxa als estudiants de la Facultat de Medicina de a Universitat Rovira i Virgili de Reus, el personal sanitari dels Centres d´Atenció Primària de Reus i els membres del Cossos de Seguretat que reben una formació en RCP bàsica i ús de DEA.
Un cop finalitzada la formació en RCP es avaluarà les competències adquirides mitjançant una simulació al centre de la ciutat.

Justificació: La supervivència dels pacients amb aturada cardio-respiratoria (ACR) sobtada extra-hospitalària es pot augmentar mitjançant la formació en matèria de RCP dels cuidadors principals del pacients amb risc de ACR. Englobat dins d?un assaig clínic que vol determinar l´efectivitat d´una xarxa de voluntaris activats mitjançant una aplicació mòbil en la reducció del temps d´inici de les maniobres de RCP es realitzarà una formació en RCP i us del DEA a familiars o cuidadors principals de pacients amb malaltia cardíaca de reus.

La formació es realitzarà a 430 persones i serà feta per formadors del Consell Català de Ressuscitació (CCR). Els voluntaris assistiran a unes sessions teòrico-pràctica (amb maniquí) amb una durada de dos hores, en grups de 15 voluntaris i dos docents acreditats pel CCR com a Formadors. Es faran en total 30 sessions per formar unes 430 persones. Un cop finalitzat cada curs formatiu en RCP-DEA s´oferirà la participació voluntària en la Xarxa-RCP. Esperem la captació d’unes 100 persones (25% dels formats).
També es convidarà a participar en la xarxa als estudiants de la Facultat de Medicina de a Universitat Rovira i Virgili de Reus, el personal sanitari dels Centres d´Atenció Primària de Reus i els membres del Cossos de Seguretat que reben una formació en RCP bàsica i ús de DEA.
Un cop finalitzada la formació en RCP es avaluarà les competències adquirides mitjançant una simulació al centre de la ciutat.

Justificació: La supervivència dels pacients amb aturada cardio-respiratoria (ACR) sobtada extra-hospitalària es pot augmentar mitjançant la formació en matèria de RCP dels cuidadors principals del pacients amb risc de ACR. Englobat dins d?un assaig clínic que vol determinar l´efectivitat d´una xarxa de voluntaris activats mitjançant una aplicació mòbil en la reducció del temps d´inici de les maniobres de RCP es realitzarà una formació en RCP i us del DEA a familiars o cuidadors principals de pacients amb malaltia cardíaca de reus.

La formació es realitzarà a 430 persones i serà feta per formadors del Consell Català de Ressuscitació (CCR). Els voluntaris assistiran a unes sessions teòrico-pràctica (amb maniquí) amb una durada de dos hores, en grups de 15 voluntaris i dos docents acreditats pel CCR com a Formadors. Es faran en total 30 sessions per formar unes 430 persones. Un cop finalitzat cada curs formatiu en RCP-DEA s´oferirà la participació voluntària en la Xarxa-RCP. Esperem la captació d’unes 100 persones (25% dels formats).
També es convidarà a participar en la xarxa als estudiants de la Facultat de Medicina de a Universitat Rovira i Virgili de Reus, el personal sanitari dels Centres d´Atenció Primària de Reus i els membres del Cossos de Seguretat que reben una formació en RCP bàsica i ús de DEA.
Un cop finalitzada la formació en RCP es avaluarà les competències adquirides mitjançant una simulació al centre de la ciutat.