Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA).

Background: Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain. Methods: (Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation. Discussion: This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation. Trial registration number TRN and date of registration: ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.

Perfil de efectividad y seguridad de la colchicina en pacientes con diagnóstico de COVID-19 en un área sanitaria / Efficacy and safety profile of colchsicine in patients diagnosed with COVID-19 in a healthcare area

Objetivo: describir la evolución y la seguridad de la utilización de colchicina en pacientes no ingresados con diagnóstico de COVID-19 leve-moderado en la Gerencia de Atención Integrada (GAI) de Albacete. Métodos: estudio observacional retrospectivo. De los 389 participantes incluidos en el primer reclutamiento, se seleccionaron 315 con datos válidos. La variable principal del estudio ha sido el fallecimiento o ingreso hospitalario en pacientes con diagnóstico de COVID-19 y tratamiento con colchicina. Se registraron variables sociodemográficas, clínicas y tratamientos y comorbilidades concomitantes. Resultados: fallecieron 6 (1,90%) pacientes y 49 (15,5%) requirieron ingreso hospitalario. A un 58,4% se les prescribió un antibiótico, siendo la azitromicina el más utilizado y el responsable en un 32,7% de las posibles interacciones. Un 34,5% y un 43% de pacientes recibieron heparinas de bajo peso molecular (HBPM) y corticosteroides respectivamente. En el 42,3% de pacientes no se tuvo en cuenta el valor del aclaramiento de creatinina al dosificar la colchicina. La edad elevada muestra una relación estadísticamente significativa con la gravedad de la clínica (68,5 versus 58,9) y con la variable recaída (ingreso + urgencias) (63,25 versus 58,54). Conclusiones: en nuestra muestra, la utilización de colchicina en pacientes ambulatorios no ha modificado el curso de la enfermedad en pacientes diagnosticados de COVID-19.(AU)

Objective: to describe the evolution and safety of the use of colchicine in outpatients with a diagnosis of mild-moderate COVID-19 in the Integrated Care Management of Albacete. Methods: retrospective observational study. Of the 389 participants included in the first recruitment, 315 subjects with valid data were selected. The main variable of the study has been death or hospital admission in patients diagnosed with COVID-19 and treatment with colchicine. Sociodemographic, clinical and treatment variables and concomitant comorbidities were recorded. Results: 6 (1.90%) patients died and 49 (15.5%) required hospital admission. 58.4% of the patients were prescribed an antibiotic, azithromycin being the most used and responsible for 32.7% of the interactions detected. 34.5% and 43% of the patients received LMWH and corticosteroids, respectively. In 42.3% of the patients, the value of creatinine clearance was not taken into account when dosing colchicine. High age shows a statistically significant relationship with the severity of the symptoms (68.5 vs 58.9) and with the variable relapse (admission + emergency room) (63.25 vs 58.54). Conclusions: in our sample, the use of colchicine in outpatients has not modified the course of the disease in patients diagnosed with COVID-19.(AU)

Incidence of COVID-19 in patients under chronic treatment with hydroxychloroquine.

OBJECTIVE: To analyze the incidence of Covid-19 in patients who are chronic users of hydroxychloroquine. PATIENTS AND METHODS: Cross-sectional retrospective observational multicenter study in health areas and districts from Castilla La-Mancha and Andalucia. Of the 4451 participants included in the first recruitment, 3817 with valid data were selected. The main variable of the study is the presence or absence of Covid-19 infection by clinical, serological or polymerase chain reaction diagnosis. Sociodemographic and clinical variables and treatment and concomitant comorbidities were recorded. RESULTS: 169 (4,45%) patients had Covid-19 infection, of which 12 (7.1 %) died and 32 (18.9%) required hospital admission. Previous respiratory pathology was related to Covid-19 infection (P < .05). Maculopathy appears in 5.3% of patients and is significantly related to the dose of hydroxychloroquine consumed (P < .05). CONCLUSION: There is no relationship between chronic use of hydroxychloroquine and the incidence of Covid-19.

OBJETIVO: Analizar la incidencia de la enfermedad del coronavirus 19 (COVID-19) en pacientes consumidores crónicos de hidroxicloroquina. PACIENTES Y MÉTODOS: Estudio multicéntrico observacional retrospectivo transversal en Áreas de Salud de Castilla La-Mancha y distritos sanitarios de Andalucía. De los 4.451 participantes incluidos en el primer reclutamiento se seleccionaron 3.817 sujetos con datos válidos. La variable principal del estudio ha sido la presencia o ausencia de infección por la COVID-19 por diagnóstico clínico, serológico o por reacción en cadena de la polimerasa. Se registraron variables sociodemográficas, clínicas y tratamientos y comorbilidades concomitantes. RESULTADOS: Ciento sesenta y nueve (4,45%) pacientes presentaron infección por la COVID-19, de los cuales fallecieron 12 (7,1%) y 32 (18,9%) requirieron ingreso hospitalario. La enfermedad respiratoria previa se relacionó con la infección por la COVID-19 (p < 0,05). La maculopatía aparece en un 5,3% de los pacientes y está relacionada significativamente con la dosis de hidroxicloroquina consumida (p < 0,05). CONCLUSIÓN: No existe relación entre consumo crónico de hidroxicloroquina e incidencia de la COVID-19.

Incidencia de la COVID-19 en pacientes en tratamiento crónico con hidroxicloroquina / Incidence of COVID-19 in patients under chronic treatment with hydroxychloroquine

Objetivo: Analizar la incidencia de la enfermedad del coronavirus 19 (COVID-19) en pacientes consumidores crónicos de hidroxicloroquina.Pacientes y métodosEstudio multicéntrico observacional retrospectivo transversal en Áreas de Salud de Castilla La-Mancha y distritos sanitarios de Andalucía. De los 4.451 participantes incluidos en el primer reclutamiento se seleccionaron 3.817 sujetos con datos válidos. La variable principal del estudio ha sido la presencia o ausencia de infección por la COVID-19 por diagnóstico clínico, serológico o por reacción en cadena de la polimerasa. Se registraron variables sociodemográficas, clínicas y tratamientos y comorbilidades concomitantes.ResultadosCiento sesenta y nueve (4,45%) pacientes presentaron infección por la COVID-19, de los cuales fallecieron 12 (7,1%) y 32 (18,9%) requirieron ingreso hospitalario. La enfermedad respiratoria previa se relacionó con la infección por la COVID-19 (p<0,05). La maculopatía aparece en un 5,3% de los pacientes y está relacionada significativamente con la dosis de hidroxicloroquina consumida (p<0,05).ConclusiónNo existe relación entre consumo crónico de hidroxicloroquina e incidencia de la COVID-19. (AU)

Objective: To analyze the incidence of Covid-19 in patients who are chronic users of hydroxychloroquine.Patients and methodsCross-sectional retrospective observational multicenter study in health areas and districts from Castilla La-Mancha and Andalucia. Of the 4451 participants included in the first recruitment, 3817 with valid data were selected. The main variable of the study is the presence or absence of Covid-19 infection by clinical, serological or polymerase chain reaction diagnosis. Sociodemographic and clinical variables and treatment and concomitant comorbidities were recorded.Results169 (4,45%) patients had Covid-19 infection, of which 12 (7.1%) died and 32 (18.9%) required hospital admission. Previous respiratory pathology was related to Covid-19 infection (P<.05). Maculopathy appears in 5.3% of patients and is significantly related to the dose of hydroxychloroquine consumed (P<.05).ConclusionThere is no relationship between chronic use of hydroxychloroquine and the incidence of Covid-19. (AU)

[Incidence of COVID-19 in patients under chronic treatment with hydroxychloroquine]. / Incidencia de la COVID-19 en pacientes en tratamiento crónico con hidroxicloroquina.

OBJECTIVE: To analyze the incidence of Covid-19 in patients who are chronic users of hydroxychloroquine. PATIENTS AND METHODS: Cross-sectional retrospective observational multicenter study in health areas and districts from Castilla La-Mancha and Andalucia. Of the 4451 participants included in the first recruitment, 3817 with valid data were selected. The main variable of the study is the presence or absence of Covid-19 infection by clinical, serological or polymerase chain reaction diagnosis. Sociodemographic and clinical variables and treatment and concomitant comorbidities were recorded. RESULTS: 169 (4,45%) patients had Covid-19 infection, of which 12 (7.1%) died and 32 (18.9%) required hospital admission. Previous respiratory pathology was related to Covid-19 infection (P<.05). Maculopathy appears in 5.3% of patients and is significantly related to the dose of hydroxychloroquine consumed (P<.05). CONCLUSION: There is no relationship between chronic use of hydroxychloroquine and the incidence of Covid-19.