Validación de la versión española del cuestionario Wound-QoL / Validation of the Spanish Wound-QoL Questionnaire

ANTECEDENTES Y OBJETIVOS: El Wound-QoL es un cuestionario validado para medir la calidad de vida en pacientes con heridas crónicas, que fue desarrollado originalmente para su uso en alemán. El objetivo de este estudio fue traducir el cuestionario Wound-QoL para su uso en la práctica clínica y estudios de investigación en España, así como validar esta versión. MATERIALES Y MÉTODOS: Se realizaron dos traducciones independientes del Wound-QoL, directa e inversa, a partir de la versión original en alemán, seguidas de un consenso de expertos sobre las versiones resultantes. Después de su perfeccionamiento se realizó un estudio piloto y posteriormente el estudio de validación. RESULTADOS: Se incluyó un total de 115 pacientes. La edad media fue de 69,5 (DE 14,5) años, y el 60,0% eran mujeres. La versión española del Wound-QoL mostró una excelente consistencia interna (índice alfa de Cronbach > 0,8 en todas las escalas). El análisis factorial dio como resultado las mismas escalas que la versión original. Se objetivaron características satisfactorias de la distribución de la puntuación global y de las subescalas. La validez de constructo y la validez convergente con otros resultados (calidad de vida genérica, tasa de curación) fueron satisfactorias. La gran mayoría de los pacientes consideraron que el cuestionario era una herramienta sencilla y factible. El tiempo medio necesario para completar el cuestionario fue de 5 minutos. El 99,1% de los participantes consideraron que las preguntas eran fáciles de entender y el 94,7% declaró que personal. CONCLUSIONES: La versión española del Wound-QoL muestra una excelente validez en la práctica clínica. Por lo tanto, puede ser recomendada para su uso tanto en la rutina clínica como en los ensayos

BACKGROUND AND AIMS: The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds, originally developed for use in German. The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version. MATERIALS AND METHODS: Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted, followed by an expert consensus of the resulting versions. After refinement, the final tool was piloted in N = 10 patients and then used in the validation study. RESULTS: A total of 115 patients were recruited. Mean age was 69.5 (SD 14.5) years, 60.0% were female. The Spanish version of Wound-QoL showed high internal consistency (Cronbach's alpha > 0.8 in all scales). Factor analysis resulted in the same scales as the original version. There were satisfactory distribution characteristics of the global score and the subscales. Construct validity and convergent validity with other outcomes (generic QoL, healing rate) were satisfactory. The vast majority of patients considered the Wound-QoL a simple and feasible tool. Mean time needed for completing the questionnaire was 5 minutes. Overall, 99.1% of the participants found it easy to understand the questions and 94.7% stated that the questionnaire suits the personal situation. CONCLUSIONS. The Spanish version of the Wound-QoL shows good validity in clinical practice. It can be recommended for use in clinical routine and trials

Validation of the Spanish Wound-QoL Questionnaire. / Validación de la versión española del cuestionario Wound-QoL.

BACKGROUND AND AIMS: The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds, originally developed for use in German. The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version. MATERIALS AND METHODS: Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted, followed by an expert consensus of the resulting versions. After refinement, the final tool was piloted in N=10 patients and then used in the validation study. RESULTS: A total of 115 patients were recruited. Mean age was 69.5 (SD 14.5) years, 60.0% were female. The Spanish version of Wound-QoL showed high internal consistency (Cronbach's alpha>0.8 in all scales). Factor analysis resulted in the same scales as the original version. There were satisfactory distribution characteristics of the global score and the subscales. Construct validity and convergent validity with other outcomes (generic QoL, healing rate) were satisfactory. The vast majority of patients considered the Wound-QoL a simple and feasible tool. Mean time needed for completing the questionnaire was 5minutes. Overall, 99.1% of the participants found it easy to understand the questions and 94.7% stated that the questionnaire suits the personal situation. CONCLUSIONS: The Spanish version of the Wound-QoL shows good validity in clinical practice. It can be recommended for use in clinical routine and trials.

Sífilis maligna, una presentación de sífilis a tener en cuenta / Syphilis Maligna: A Presentation to Bear in Mind

La sífilis maligna es una forma infrecuente de sífilis secundaria asociada a la infección por el VIH, caracterizada clínicamente por nódulos necróticos y lesiones ulceradas generalizadas. Presentamos 4 pacientes diagnosticados de sífilis maligna tras revisar los casos de sífilis diagnosticados en nuestro centro entre 2012 y 2016. Describimos los aspectos epidemiológicos, clínicos, histopatológicos y serológicos, así como su relación con el VIH y la respuesta al tratamiento. Aunque se trate de una forma de sífilis poco frecuente, en los últimos años ha aumentado el número de casos publicados, principalmente pacientes jóvenes infectados por el VIH. Es necesario incluir la sífilis maligna en el diagnóstico diferencial de pacientes infectados por el VIH con lesiones ulceradas y necróticas

Malignant syphilis is an uncommon form of secondary syphilis associated with HIV infection. Clinically, it is characterized by necrotic nodules and generalized ulcerated lesions. We present 4 cases of malignant syphilis diagnosed after evaluating syphilis cases diagnosed at our hospital between 2012 and 2016. We describe the epidemiologic, clinical, histiopathologic, and serologic characteristics of malignant syphilis and explore its response to treatment and association with HIV infection. Although malignant syphilis is uncommon, there has been an increase in the number of cases published in recent years, particularly in young HIV-positive patients. Malignant syphilis must be contemplated in the differential diagnosis of HIV patients with ulcerated, necrotic lesions

Syphilis Maligna: A Presentation to Bear in Mind. / Sífilis maligna, una presentación de sífilis a tener en cuenta.

Malignant syphilis is an uncommon form of secondary syphilis associated with HIV infection. Clinically, it is characterized by necrotic nodules and generalized ulcerated lesions. We present 4 cases of malignant syphilis diagnosed after evaluating syphilis cases diagnosed at our hospital between 2012 and 2016. We describe the epidemiologic, clinical, histiopathologic, and serologic characteristics of malignant syphilis and explore its response to treatment and association with HIV infection. Although malignant syphilis is uncommon, there has been an increase in the number of cases published in recent years, particularly in young HIV-positive patients. Malignant syphilis must be contemplated in the differential diagnosis of HIV patients with ulcerated, necrotic lesions.

Descripción de los pacientes que reciben biológicos como primer tratamiento sistémico en el registro BIOBADADERM durante el periodo 2008-2016 / Description of Patients Treated with Biologic Drugs as First-Line Systemic Therapy in the BIOBADADERM Registry Between 2008 and 2016

INTRODUCCIÓN Y OBJETIVOS: La utilización clínica habitual de los fármacos biológicos en el tratamiento de la psoriasis es en segunda línea, es decir, tras el uso previo de un fármaco clásico. Sin embargo, en casos particulares -particularidades del paciente o criterio médico- se realiza la indicación en primera línea. No existen estudios sobre las características demográficas, clínicas y de seguridad de los pacientes que reciben fármaco biológico en primera línea. Como objetivo primario se pretende determinar dichas características de acuerdo con la iniciación de la terapia biológica en primera o segunda línea. MATERIAL Y MÉTODO: Se realizó un estudio descriptivo, multicéntrico, de 181 pacientes que iniciaron tratamiento biológico como primer fármaco sistémico para control de su psoriasis moderada-grave, y que forman parte del Registro Español de Acontecimientos Adversos Asociados con Medicamentos Biológicos en Dermatología, entre enero de 2008 y noviembre de 2016. RESULTADOS: Los pacientes de ambos grupos son muy similares, si bien se evidencia que el grupo que recibe el biológico en primera línea presenta una edad más avanzada, sin que se justifique por gravedad de la enfermedad (PASI) ni por el tiempo de evolución de esta desde el diagnóstico. En este grupo de pacientes es más frecuente la presencia de hipertensión, diabetes y hepatopatía. No hemos encontrado diferencias en motivos de suspensión ni seguridad entre ambos grupos. CONCLUSIONES: No se han encontrado diferencias relevantes entre los 2 grupos, lo cual refuerza la seguridad de los fármacos biológicos en este contexto

INTRODUCTION AND OBJECTIVES: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. MATERIAL AND METHOD: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. RESULTS: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. CONCLUSIONS: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis

Respuesta a secukinumab tras fracaso terapéutico con ustekinumab en seis pacientes con psoriasis en placas / Response to Secukinumab after Treatment Failure with Ustekinumab in 6 Patients with Plaque Psoriasis

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Description of Patients Treated with Biologic Drugs as First-Line Systemic Therapy in the BIOBADADERM Registry Between 2008 and 2016. / Descripción de los pacientes que reciben biológicos como primer tratamiento sistémico en el registro BIOBADADERM durante el periodo 2008-2016.

INTRODUCTION AND OBJECTIVES: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. MATERIAL AND METHOD: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. RESULTS: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. CONCLUSIONS: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.

Determination of adalimumab and etanercept trough levels and drug antibodies in long-term psoriasis treatment: a single-centre cohort study.

BACKGROUND: An algorithm based on measurement of a serum tumour necrosis factor antagonists (anti-TNF) and antidrug antibodies (ADA) has been proposed previously to guide dose escalation or therapy switching in the early (i.e. the first months of) treatment of psoriasis by anti-TNF. In long-term treatment of responding patients with psoriasis, it is usual to empirically reduce standard doses of anti-TNF to reduce exposure while maintaining clinical response. The relationship between serum anti-TNF, ADA levels and clinical efficacy in long-term treated patients with psoriasis has not yet been determined, so the potential role of these parameters in guiding dose escalation in this scenario is unknown. AIMS: To evaluate the relationship between drug/ADA levels and clinical efficacy in a group of patients with psoriasis undergoing long-term treatment with adalimumab or etanercept. METHODS: This was a single-centre, prospective, cohort study of patients with psoriasis receiving adalimumab or etanercept for a minimum of 48 weeks. All patients were started on the standard dose, but some adalimumab users had a reduced frequency of administration. Clinical efficacy was measured using the Psoriasis Area and Severity Index. Serum concentrations were measured by ELISA. Clinical assessment and blood sample collection were carried out simultaneously within 24 h before the next drug administration. RESULTS: In total, 21 patients were enrolled (67 simultaneous clinical and serum determinations: 38 receiving adalimumab, 29 receiving etanercept). We did not find any association between serum anti-TNF levels and clinical response. None of the patients developed ADA. CONCLUSIONS: ADA and anti-TNF levels are not related to clinical effectiveness in patients with psoriasis undergoing long-term treatment with adalimumab or etanercept.

Infecciones de transmisión sexual: experiencia de una consulta multidisciplinar en un hospital terciario (2010-2013) / Sexually Transmitted Infections: Experience in a Multidisciplinary Clinic in a Tertiary Hospital (2010-2013)

INTRODUCCIÓN: Las infecciones de transmisión sexual son un motivo de consulta creciente en nuestro medio. El objetivo de este trabajo es describir y analizar las características epidemiológicas, conductuales, clínicas y microbiológicas de los pacientes registrados en una unidad de infecciones de transmisión sexual de un hospital terciario. MÉTODOS: Estudio descriptivo, retrospectivo y unicéntrico realizado en una unidad multidisciplinar especializada en infecciones de transmisión sexual de un hospital terciario entre 2010 y 2013. Se recogieron datos epidemiológicos, clínicos y conductuales mediante entrevista oral abierta y cuestionario estandarizado, y se llevó a cabo la obtención de muestras para estudio microbiológico. RESULTADOS: Se estudiaron 546 pacientes, de los cuales fueron 96% varones, 41% infectados por el VIH, 56% hombres que tienen sexo con hombres. Los motivos de consulta más prevalentes fueron: uretritis, úlceras genitales y/o anales/perianales, proctitis, úlceras orales, contacto sexual de persona con ITS conocida y contacto sexual de riesgo. Los diagnósticos microbiológicos más frecuentes fueron: Neisseria gonorrhoeae en uretritis, Treponema pallidum en úlceras genitales y/o anales/perianales y Chlamydia trachomatis serovares de linfogranuloma venéreo en proctitis. Las principales ITS estudiadas fueron más prevalentes en varones homosexuales e infectados por el VIH. CONCLUSIÓN: Se confirma el incremento en la incidencia de las infecciones de transmisión sexual en los últimos años y las características epidemiológicas de la epidemia VIH/ITS de nuestro entorno

INTRODUCTION: The number of consultations for sexually transmitted infections (STIs) is increasing in Spain. The aim of this study was to describe and analyze the epidemiological, behavioral, clinical, and microbiological characteristics of patients registered at the STI unit of a tertiary hospital. METHODS: This was a retrospective, single-center descriptive study carried out between 2010 and 2013 in a multidisciplinary unit specialized in STIs, situated in a tertiary hospital. Epidemiological, clinical, and behavioral data were gathered using a face-to-face interview and a standardized questionnaire. Samples were collected for microbiology analysis. RESULTS: The study included 546 patients: 96% were men, 41% had human immunodeficiency virus (HIV) infection, and 56% were men who have sex with men. The reasons for consultation were the following: urethritis; genital, anal, or perianal ulcers; proctitis; oral ulcers; sexual contact with a person with a known STI; and high-risk sexual contact. The most common microbiological diagnoses were Neisseria gonorrhoeae in urethritis, Treponema pallidum in genital and anal or perianal ulcers, and Chlamydia trachomatis lymphogranuloma venereum serovars in proctitis. The highest prevalences of the main STIs studied occurred in homosexual men with HIV infection. CONCLUSION: This study confirms the increase in the incidence of STIs in recent years and the epidemiological characteristics of the HIV/STI epidemic in Spain

Sexually Transmitted Infections: Experience in a Multidisciplinary Clinic in a Tertiary Hospital (2010-2013).

INTRODUCTION: The number of consultations for sexually transmitted infections (STIs) is increasing in Spain. The aim of this study was to describe and analyze the epidemiological, behavioral, clinical, and microbiological characteristics of patients registered at the STI unit of a tertiary hospital. METHODS: This was a retrospective, single-center descriptive study carried out between 2010 and 2013 in a multidisciplinary unit specialized in STIs, situated in a tertiary hospital. Epidemiological, clinical, and behavioral data were gathered using a face-to-face interview and a standardized questionnaire. Samples were collected for microbiology analysis. RESULTS: The study included 546 patients: 96% were men, 41% had human immunodeficiency virus (HIV) infection, and 56% were men who have sex with men. The reasons for consultation were the following: urethritis; genital, anal, or perianal ulcers; proctitis; oral ulcers; sexual contact with a person with a known STI; and high-risk sexual contact. The most common microbiological diagnoses were Neisseria gonorrhoeae in urethritis, Treponema pallidum in genital and anal or perianal ulcers, and Chlamydia trachomatis lymphogranuloma venereum serovars in proctitis. The highest prevalences of the main STIs studied occurred in homosexual men with HIV infection. CONCLUSION: This study confirms the increase in the incidence of STIs in recent years and the epidemiological characteristics of the HIV/STI epidemic in Spain.

Leishmaniasis cutánea. Experiencia de 20 años en un hospital español de tercer nivel / Cutaneous Leishmaniasis: 20 years’ experience in a Spanish tertiary care hospital

INTRODUCCIÓN Y OBJETIVOS: La leishmaniasis es endémica en España, siendo la leishmaniasis cutánea la forma más habitual de presentación. El objetivo del estudio fue valorar las características epidemiológicas y clínicas de la leishmaniasis cutánea en las últimas 2 décadas, haciendo hincapié en las diferencias clínicas según el estado inmunitario del paciente y el origen de la infección. MATERIALES Y MÉTODOS: Se revisaron retrospectivamente 67 historias clínicas de pacientes diagnosticados de leishmaniasis entre 1992 y 2012, de ellas 54 eran cutáneas, y con datos de seguimiento. RESULTADOS: Se incluyeron 54 pacientes: 26 diagnosticados entre 1992-2002 y 28 entre 2003-2012. La edad media fue de 49 años, con un predominio en varones y un tiempo medio de evolución previo a la consulta de 3 meses. Las manifestaciones clínicas más frecuentes fueron placas y úlceras. La mayoría de pacientes inmunodeprimidos y con leishmaniasis importada presentaron lesiones ulceradas y/o múltiples. El diagnóstico se basó en los hallazgos clínico-patológicos en la primera década, asociándose el diagnóstico por métodos moleculares en la segunda. El tratamiento de elección fue los antimoniales pentavalentes, con buenos resultados y escasos efectos adversos. CONCLUSIÓN: El número de casos y de pacientes inmunodeprimidos fueron similares en ambas décadas, diagnosticándose un mayor número de leishmaniasis importada en la segunda. En los pacientes con lesiones múltiples y/o ulceradas deberían descartarse la inmunosupresión del huésped y la infección por cepas importadas. El tratamiento con antimoniato de meglumina fue eficaz y seguro, tanto por vía sistémica como intralesional

INTRODUCTION AND OBJECTIVES: Cutaneous leishmaniasis is the most common form of leishmaniasis, which is endemic in Spain. The aim of this study was to evaluate the epidemiological and clinical characteristics of cutaneous leishmaniasis seen in our hospital over a period of 20 years, with a particular focus on clinical differences according to immune status and origin of infection MATERIALS AND METHODS: We performed a chart review of 67 cases of cutaneous leishmaniasis diagnosed between 1992 and 2012. Follow-up data were available for 54 patients. RESULTS: Fifty-four patients with cutaneous leishmaniasis were included in the study. Of these, 26 had been diagnosed between 1992 and 2002 and 28 between 2003 and 2012. The mean age at diagnosis was 49 years, there was a predominance of male patients, and the mean time from onset of symptoms to consultation was 3 months. The most common clinical manifestations were plaques and ulcers. Most of the immunodepressed patients and patients with imported leishmaniasis had skin ulcers and/or multiple lesions. During the first decade of the study, diagnosis was based on clinical and histologic findings. These were supported by molecular techniques in the second decade. Pentavalent antimonials were the treatment of choice, producing good results and very few adverse effects CONCLUSION: The number of patients with cutaneous leishmaniasis and with compromised immune status was similar in the periods 1992-2002 and 2003-2013, but more cases of imported leishmaniasis were diagnosed in the second period. Patients with ulcers and/or multiple lesions should be evaluated to rule out immunosuppression or infection by Leishmania species from other parts of the world. Both systemic and intralesional meglumine antimonate was effective and safe

Risk of Reactivation of Hepatitis B Virus Infection in Psoriasis Patients Treated With Biologics: A Retrospective Analysis of 20 Cases From the BIOBADADERM Database.

INTRODUCTION AND OBJECTIVES: A 5% risk of reactivation of hepatitis B virus (HBV) infection has been reported in patients with diseases other than psoriasis treated with tumor necrosis factor inhibitors. The aim of this study was to investigate the risk of HBV reactivation in patients with a past history of HBV infection who were receiving biologic therapy for psoriasis. MATERIAL AND METHODS: This was a multicenter study of 20 patients with psoriasis who were treated with at least 1 biologic agent. All the patients had serologic evidence of past HBV infection (positive total hepatitis B core antibody and negative hepatitis B surface antibody). We analyzed the clinical, serological, and liver function variables recorded before, during, and at the end of follow-up. The viral load at the end of follow-up was also analyzed for all patients. RESULTS: None of the patients fulfilled the criteria for HBV reactivation at the end of a median follow-up period of 40 months. Combining our data with data from other studies of psoriasis patients with a past history of HBV infection who were treated with a biologic, we calculated a maximum estimated risk of HBV reactivation for a mean follow-up period of 30 months of 2.7 reactivations per 100 patients. CONCLUSIONS: Biologic therapy did not cause HBV reactivation in our series of patients. Nonetheless, because of the potentially serious complications associated with HBV reactivation, it is important to measure viral load in patients with a history of HBV infection prior to initiation of biologic therapy to rule out occult carriage. These patients should also be monitored regularly in conjunction with a hepatologist.