[Translated article] Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study. / Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Spanish Version of Teenagers’ Quality of Life (T-QoL) for Adolescents with Skin Diseases: Translation, Cultural Adaptation and Validation / Adaptación cultural y validación de la versión española del Teenagers’ Quality of Life (T-QoL): cuestionario para adolescentes con enfermedades de la piel

Background Teenagers’ Quality of Life (T-QoL) is an age-specific measure to assess QoL of teenagers suffering from different skin diseases. A validated Spanish language version is lacking. We present the translation, cultural adaptation and validation of the T-QoL into Spanish. Methods A prospective study with 133 patients (between 12 and 19 years old), attended at the dermatology department of Toledo University Hospital, Spain (September 2019–May 2020), was carried out for the validation study. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were used for the translation and cultural adaptation. We evaluated the convergent validity with the Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI) and with a Global Question (GQ) on self-assessed disease severity. We also analysed internal consistency and reliability of the T-QoL tool and confirmed its structure with a factor analysis. Results Global T-QoL scores significantly correlated with the DLQI and the CDLQI (r=0.75) and with the GQ (r=0.63). The confirmatory factor analysis showed optimal fit for the bi-factor model and an adequate fit for the correlated three-factor model. Reliability indicators were high (Cronbach's α=0.89; Guttman's Lambda 6 index=0.91; Omega ω=0.91) and test–retest showed a high stability (ICC=0.85). The results were consistent with those found by the authors of the original test. Conclusion Our Spanish version of the T-QoL tool is valid and reliable to assess QoL of Spanish-speaking adolescents with skin diseases (AU)

Antecedentes Teenagers’ Quality of Life (T-QoL) es un cuestionario de calidad de vida específico para adolescentes con enfermedades cutáneas. Hasta el momento, no existe ningún método validado para este fin en español, por lo que presentamos la traducción, adaptación cultural y validación del T-QoL al español. Método Se diseñó un estudio prospectivo con 133 pacientes (entre 12-19 años), atendidos en el Servicio de Dermatología del Hospital Universitario de Toledo, España (septiembre 2019-mayo 2020). Para la traducción y adaptación cultural se utilizaron las guías de la Sociedad Internacional de Farmacoeconomía e Investigación de Resultados (ISPOR). Se evaluó la validez convergente con el Índice de Calidad de Vida en Dermatología (DLQI), el Índice de Calidad de Vida en Dermatología Infantil (CDLQI) y con una Pregunta Global (GQ) sobre la gravedad de la enfermedad autoevaluada. También se analizó la consistencia interna y la fiabilidad de la herramienta T-QoL, y se confirmó su estructura con un análisis factorial. Resultados Las puntuaciones globales de T-QoL se correlacionaron significativamente con el DLQI y el CDLQI (r=0,75) y con la GQ (r=0,63). El análisis factorial mostró un ajuste óptimo para el modelo bifactorial y un ajuste adecuado para el modelo de 3 factores correlacionado. Los indicadores de fiabilidad fueron altos (α de Cronbach=0,89; índice Lambda 6 de Guttman=0,91; Omega ω=0,91) y el test-retest mostró una alta estabilidad (ICC=0,85). Los resultados fueron consistentes con los encontrados por los autores de la prueba original. Conclusiones La versión española del T-QoL es un cuestionario válido y fiable para evaluar la calidad de vida de adolescentes hispanohablantes con enfermedades cutáneas (AU)

[Artículo Traducido] Traducción, adaptación cultural y validación de la versión española del Teenagers’ Quality of Life (T-QoL): cuestionario para adolescentes con enfermedades de la piel / Spanish Version of Teenagers’ Quality of Life (T-QoL) for Adolescents with Skin Diseases: Translation, Cultural Adaptation and Validation

Antecedentes Teenagers’ Quality of Life (T-QoL) es un cuestionario de calidad de vida específico para adolescentes con enfermedades cutáneas. Hasta el momento, no existe ningún método validado para este fin en español, por lo que presentamos la traducción, adaptación cultural y validación del T-QoL al español. Método Se diseñó un estudio prospectivo con 133 pacientes (entre 12-19 años), atendidos en el Servicio de Dermatología del Hospital Universitario de Toledo, España (septiembre 2019-mayo 2020). Para la traducción y adaptación cultural se utilizaron las guías de la Sociedad Internacional de Farmacoeconomía e Investigación de Resultados (ISPOR). Se evaluó la validez convergente con el Índice de Calidad de Vida en Dermatología (DLQI), el Índice de Calidad de Vida en Dermatología Infantil (CDLQI) y con una Pregunta Global (GQ) sobre la gravedad de la enfermedad autoevaluada. También se analizó la consistencia interna y la fiabilidad de la herramienta T-QoL, y se confirmó su estructura con un análisis factorial. Resultados Las puntuaciones globales de T-QoL se correlacionaron significativamente con el DLQI y el CDLQI (r=0,75) y con la GQ (r=0,63). El análisis factorial mostró un ajuste óptimo para el modelo bifactorial y un ajuste adecuado para el modelo de 3 factores correlacionado. Los indicadores de fiabilidad fueron altos (α de Cronbach=0,89; índice Lambda 6 de Guttman=0,91; Omega ω=0,91) y el test-retest mostró una alta estabilidad (ICC=0,85). Los resultados fueron consistentes con los encontrados por los autores de la prueba original. Conclusiones La versión española del T-QoL es un cuestionario válido y fiable para evaluar la calidad de vida de adolescentes hispanohablantes con enfermedades cutáneas (AU)

Background Teenagers’ Quality of Life (T-QoL) is an age-specific measure to assess QoL of teenagers suffering from different skin diseases. A validated Spanish language version is lacking. We present the translation, cultural adaptation and validation of the T-QoL into Spanish. Methods A prospective study with 133 patients (between 12 and 19 years old), attended at the dermatology department of Toledo University Hospital, Spain (September 2019–May 2020), was carried out for the validation study. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were used for the translation and cultural adaptation. We evaluated the convergent validity with the Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI) and with a Global Question (GQ) on self-assessed disease severity. We also analysed internal consistency and reliability of the T-QoL tool and confirmed its structure with a factor analysis. Results Global T-QoL scores significantly correlated with the DLQI and the CDLQI (r=0.75) and with the GQ (r=0.63). The confirmatory factor analysis showed optimal fit for the bi-factor model and an adequate fit for the correlated three-factor model. Reliability indicators were high (Cronbach's α=0.89; Guttman's Lambda 6 index=0.91; Omega ω=0.91) and test–retest showed a high stability (ICC=0.85). The results were consistent with those found by the authors of the original test. Conclusion Our Spanish version of the T-QoL tool is valid and reliable to assess QoL of Spanish-speaking adolescents with skin diseases (AU)

Spanish Version of Teenagers' Quality of Life (T-QoL) for Adolescents with Skin Diseases: Translation, Cultural Adaptation and Validation. / [Artículo Traducido] Traducción, adaptación cultural y validación de la versión española del Teenagers' Quality of Life (T-QoL): cuestionario para adolescentes con enfermedades de la piel.

BACKGROUND: Teenagers' Quality of Life (T-QoL) is an age-specific measure to assess QoL of teenagers suffering from different skin diseases. A validated Spanish language version is lacking. We present the translation, cultural adaptation and validation of the T-QoL into Spanish. METHODS: A prospective study with 133 patients (between 12 and 19 years old), attended at the dermatology department of Toledo University Hospital, Spain (September 2019-May 2020), was carried out for the validation study. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were used for the translation and cultural adaptation. We evaluated the convergent validity with the Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI) and with a Global Question (GQ) on self-assessed disease severity. We also analysed internal consistency and reliability of the T-QoL tool and confirmed its structure with a factor analysis. RESULTS: Global T-QoL scores significantly correlated with the DLQI and the CDLQI (r = 0.75) and with the GQ (r = 0.63). The confirmatory factor analysis showed optimal fit for the bi-factor model and an adequate fit for the correlated three-factor model. Reliability indicators were high (Cronbach's α = 0.89; Guttman's Lambda 6 index = 0.91; Omega ω = 0.91) and test-retest showed a high stability (ICC = 0.85). The results were consistent with those found by the authors of the original test. CONCLUSION: Our Spanish version of the T-QoL tool is valid and reliable to assess QoL of Spanish-speaking adolescents with skin diseases.

Spanish Version of Teenagers' Quality of Life (T-QoL) for Adolescents with Skin Diseases: Translation, Cultural Adaptation and Validation.

BACKGROUND: Teenagers' Quality of Life (T-QoL) is an age-specific measure to assess QoL of teenagers suffering from different skin diseases. A validated Spanish language version is lacking. We present the translation, cultural adaptation and validation of the T-QoL into Spanish. METHODS: A prospective study with 133 patients (between 12 and 19 years old), attended at the dermatology department of Toledo University Hospital, Spain (September 2019-May 2020), was carried out for the validation study. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were used for the translation and cultural adaptation. We evaluated the convergent validity with the Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI) and with a Global Question (GQ) on self-assessed disease severity. We also analysed internal consistency and reliability of the T-QoL tool and confirmed its structure with a factor analysis. RESULTS: Global T-QoL scores significantly correlated with the DLQI and the CDLQI (r=0.75) and with the GQ (r=0.63). The confirmatory factor analysis showed optimal fit for the bi-factor model and an adequate fit for the correlated three-factor model. Reliability indicators were high (Cronbach's α=0.89; Guttman's Lambda 6 index=0.91; Omega ω=0.91) and test-retest showed a high stability (ICC=0.85). The results were consistent with those found by the authors of the original test. CONCLUSION: Our Spanish version of the T-QoL tool is valid and reliable to assess QoL of Spanish-speaking adolescents with skin diseases.

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