Responsiveness of the Spanish Version of the "Skin Cancer Index".

Background. Skin Cancer Index (SCI) is a specific questionnaire measuring health related quality of life (HRQL) in patients with cervicofacial non-melanoma skin cancer (CFNMSC). The original scale has recently been adapted and validated into Spanish. Objectives. Evaluate the responsiveness of the Spanish version of SCI. Methods. Patients with CFNMSC candidate for surgical treatment were administered the questionnaire at time of diagnostic (t0), 7 days after surgery (t1), and 5 months after surgery (t2). The scale and subscales scores (C1: social/appearance, C2: emotional) were then evaluated. Differences between t0-t1, t1-t2, and t0-t2 were determined and a gender-and-age segmented analysis was performed. Results. 88 patients, 54.8% male, mean age 62.5 years, completed the study. Differences between t0-t1 and t1-t2 scores were statistically significant (p < 0.05). The lowest values were found at time of diagnosis and postsurgery. Women and patients under 65 years showed the lowest values at the three times. Limitations. Concrete geographic and cultural area. Clinical and histological variables are not analysed. Conclusions. Our results confirm responsiveness of the Spanish version of the SCI. Further development of the instrument in Spanish-speaking countries and populations will make it possible to extend worldwide research and knowledge horizons on skin cancer.

Quality of Life and Side Effects in Patients with Actinic Keratosis Treated With Ingenol Mebutate: A Pilot Study / Calidad de vida y efectos secundarios en los pacientes con queratosis actínica tratados con ingenol mebutato-estudio pilot

INTRODUCTION: Actinic keratosis (AK) lesions are in situ squamous cell carcinoma. These lesions have a low risk of progressing to invasive disease but significant impact on patients' quality of life (QoL). The aim of this study was to assess QoL and side effects in patients with AK receiving treatment with ingenol mebutate. MATERIAL AND METHODS: This was a prospective, non-randomized pilot study carried out in Spain. The target population was adults with a clinical diagnosis of AK affecting any part of the body. Outcomes were assessed on the basis of a QoL questionnaire (Skindex-29), local skin response, the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), and clinical response. RESULTS: A total of 19 patients were studied. Most of the participants were men (89.5%) and mean age was 76.2 years. After treatment with ingenol mebutate, significant improvement was observed in the Skindex-29 subscales relating to symptom severity (P=.041), the patients' emotional state (P=.026), and in the overall score (P=.014). Erythema, crusting, and flaking or scaling were the local skin responses with highest median score (2.0 in all 3 cases). Imiquimod 5% and ingenol mebutate achieved higher median scores for effectiveness and global satisfaction than any other previous treatments (as measured by TSQM 1.4). In the patients' assessment of convenience, ingenol mebutate had a higher median score than previous treatments. Over half of the patients (52.6%) had an improvement of at least 75% at month 3. CONCLUSIONS: QoL in patients with AK improves after treatment with ingenol mebutate. The presence of side effects did not affect QoL or patient satisfaction with treatment

INTRODUCCIÓN: Las queratosis actínicas (QA) se consideran carcinomas espinocelulares "in situ" con poca capacidad invasiva pero con un impacto significativo en la calidad de vida (CV). El objetivo fue evaluar la CV y los efectos secundarios de ingenol mebutato (IM) en pacientes con QA. MATERIAL Y MÉTODOS: Estudio piloto, prospectivo, no aleatorizado, en pacientes >18 años, con diagnóstico clínico de QA de cualquier localización. Se valoraron: la CV, mediante el cuestionario Skindex- 29; la satisfacción con el tratamiento mediante el cuestionario TSQM 1.4; la respuesta clínica, y la reacción cutánea local (RCL). RESULTADOS: Se incluyeron 19 pacientes, el 89,5% eran hombres, con una edad media 76,2 años. Después del tratamiento con IM, se observó una mejoría significativa en las subescalas del Skindex-29 (emocional y sintomática) y en la puntuación global (p = 0,026, p = 0,041 y p = 0,014), respectivamente). Al día 3-4, el eritema, la costra y la descamación fueron las RCLs con una mediana de puntuación más alta (2,0, en los 3 casos). La efectividad y la satisfacción global (según TSQM 1,4) presentaron puntuaciones medianas más altas con imiquimod 5% e IM comparado con los otros tratamientos previos. La valoración de la conveniencia mostró una puntuación más alta en IM comparado con los otros tratamientos previos. Más de la mitad de pacientes (52,6%) lograron una mejoría ≥75% al tercer mes. CONCLUSIONES: La CV en pacientes con QA mejora después del tratamiento con IM. La presencia de efectos secundarios no afecta ni a la CV ni a la satisfacción de los pacientes con el tratamiento

Quality of life and side effects in patients with actinic keratosis treated with ingenol mebutate: a pilot study.

INTRODUCTION: Actinic keratosis (AK) lesions are in situ squamous cell carcinoma. These lesions have a low risk of progressing to invasive disease but significant impact on patients' quality of life (QoL). The aim of this study was to assess QoL and side effects in patients with AK receiving treatment with ingenol mebutate. MATERIAL AND METHODS: This was a prospective, non-randomized pilot study carried out in Spain. The target population was adults with a clinical diagnosis of AK affecting any part of the body. Outcomes were assessed on the basis of a QoL questionnaire (Skindex-29), local skin response, the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), and clinical response. RESULTS: A total of 19 patients were studied. Most of the participants were men (89.5%) and mean age was 76.2 years. After treatment with ingenol mebutate, significant improvement was observed in the Skindex-29 subscales relating to symptom severity (P=.041), the patients' emotional state (P=.026), and in the overall score (P=.014). Erythema, crusting, and flaking or scaling were the local skin responses with highest median score (2.0 in all 3 cases). Imiquimod 5% and ingenol mebutate achieved higher median scores for effectiveness and global satisfaction than any other previous treatments (as measured by TSQM 1.4). In the patients' assessment of convenience, ingenol mebutate had a higher median score than previous treatments. Over half of the patients (52.6%) had an improvement of at least 75% at month 3. CONCLUSIONS: QoL in patients with AK improves after treatment with ingenol mebutate. The presence of side effects did not affect QoL or patient satisfaction with treatment.

A Spanish version of the Skin Cancer Index: a questionnaire for measuring quality of life in patients with cervicofacial nonmelanoma skin cancer.

INTRODUCTION: The Skin Cancer Index (SCI) is the first specific patient-reported outcome measure for patients with cervicofacial nonmelanoma skin cancer. To date, only the original English version has been published. OBJECTIVES: To develop a Spanish version of the SCI that is semantically and linguistically equivalent to the original, and to evaluate its measurement properties in this different cultural environment. MATERIAL AND METHODS: A cross-sectional study was conducted of the cultural adaptation and empirical validation of the questionnaire, analysing the psychometric properties of the new index at different stages. RESULTS: Of 440 patients recruited to the study, 431 (95%) completed the Spanish version of the SCI questionnaire, in a mean time of 6·3 min (SD 2·9). Factor analysis of the scale revealed commonality and loading values of < 0·5 for three of the 15 items. The remaining 12 items converged into two components: appearance/social aspects (seven items) and emotional aspects (five items). Both domains presented a high level of internal consistency, with Cronbach's alpha values above 0·8. The convergent-discriminant validity analysis produced correlations higher than 0·3 for the mental component of the Short Form Health Survey-12v2 Health Questionnaire (correlation coefficient 0·39) and the Dermatology Quality of Life Index (correlation coefficient -0·30). In the test-retest, nine of the 12 items produced a weighted kappa value exceeding 0·4, and for the remaining three items, the absolute agreement percentage exceeded 60%. CONCLUSIONS: The Spanish version of the SCI quality of life scale has been satisfactorily adapted and validated for use in Spanish-speaking countries and populations.

Comparison of Skindex-29, Dermatology Life Quality Index, Psoriasis Disability Index and Medical Outcome Study Short Form 36 in patients with mild to severe psoriasis.

BACKGROUND: Severity assessment of patients with psoriasis is a critical issue. Classical clinical assessment has recently been combined with quality of life (QoL) scores, but several instruments are used. Moreover, studies have focused on patients with moderate to severe psoriasis. OBJECTIVES: To compare the characteristics of QoL instruments in patients with the full range of psoriasis severity attending dermatology clinics. METHODS: Observational, prospective, multicentre study. Patients completed Skindex-29 (anchor) and a second instrument randomly selected from Dermatology Life Quality Index (DLQI), Psoriasis Disability Index (PDI) and Medical Outcome Study Short Form 36 (SF-36). RESULTS: Demographic data, Psoriasis Area and Severity Index and affected body surface area were not different between the three groups. Skindex-29 showed a weak but significant correlation with clinical severity; only PDI showed similar correlation. PDI, DLQI and SF-36 showed a substantial floor effect in patients with mild to severe psoriasis. Skindex-29 showed strong correlations with the other three QoL instruments. SF-36 was more sensitive than the other instruments in detecting worse QoL in male patients. CONCLUSIONS: Skindex-29 has better sensitivity to clinical severity with minimal floor effect, and covers the main domains explored by the other three QoL instruments in patients with mild to severe psoriasis.

Quality of life in mild to moderate acne: relationship to clinical severity and factors influencing change with treatment.

BACKGROUND: Because of its effects on quality of life, acne vulgaris is more than a merely physiological or cosmetic entity. OBJECTIVES: To describe the influence of mild to moderate acne on patients' quality of life, measured using Skindex-29, and to correlate changes in Skindex-29 scores with changes in objective and subjective indices in clinical severity after treatment with topical 4% erythromycin 0.2% zinc. Also, to evaluate efficacy and side-effects of the treatment. METHODS: Observational, prospective study of 1878 patients cared for by 252 clinicians in Spain. Data included epidemiological information and responses to Skindex-29, a subjective change and objective severity index. RESULTS: Baseline Skindex scale scores were worse in women, older patients, and those with more severe clinical disease. Skindex was sensitive to changes in objective severity but changes in Skindex scale scores were also related to other factors. Patients who reported their skin condition to be 'the same' or 'worse' at the end of the study had significantly worse baseline scores on the 'symptoms' and 'emotions' scales but 'functioning' scores were not worse than for those who reported their condition had improved. CONCLUSION: The effects of acne vulgaris on quality of life and changes in quality of life after treatment are not only explainable by objective severity of acne. Patients' and clinicians' judgements about acne severity are different.

Madelung's disease involving the tongue.

Madelung's disease or benign symmetric lipomatosis is rare. Symmetric lipomatosis of the tongue as an association of Madelung's disease is very rare; up to now only two cases of this association have been reported. We report the third case of Madelung's disease with involvement of the tongue in the form of macroglossia.

The Spanish version of Skindex-29.

BACKGROUND: Most currently available dermatologic quality-of-life measures were originally created in English, and must be translated and adapted for use in other cultures. Our purpose was to translate and adapt culturally into Spanish a skin-related quality-of-life measure, Skindex-29, and to begin preliminary assessments of its reliability and validity. METHODS: Transcultural adaptation and cross-sectional questionnaire studies were performed. One hundred and fourteen adult persons (patients and healthy people) responded to the Spanish version of Skindex-29. Evaluations of the semantic equivalence of back-translated items, reliability, construct validity, and content validity of the Spanish version were the main outcome measures. Comparison between Spanish and American responses was also performed. RESULTS: Six problematic items required a second translation and back-translation to achieve satisfactory agreement with the original instrument. The final Spanish version of Skindex-29 was internally reliable (range of Cronbach alpha for the scales, 0.70-0.87). The instrument demonstrated both construct and content validity. As hypothesized, scores for dermatologic patients were higher than those for healthy persons (mean global scores 21 vs. 5, P < 0.01) and scores for patients with inflammatory diseases were higher than those for persons with isolated skin lesions (mean global scores 32 vs. 11, P < 0.01), indicating a poorer quality of life. In addition, most patients' responses to an open-ended question about their skin disease were addressed by items in the instrument. Skindex scale scores of American and Spanish respondents were similar. CONCLUSIONS: We have developed a semantically equivalent translation of Skindex-29 into Spanish. Our preliminary evaluation of its measurement properties suggests that it is a reliable and valid measure of the effects of skin disease on the quality of life in Spanish patients.

Sclerodermatous graft-versus-host disease after donor leucocyte infusion.

Leucocyte infusion from the marrow donor is a new therapeutic option to avoid repeated bone marrow transplants in patients with recurrent leukaemia. The treatment is based on the fact that alloreactive donor immune cells may recognize and eliminate residual leukaemia cells. This phenomenon has been called graft-versus-leukaemia. We describe a patient who received donor leucocyte infusion for a relapsed chronic myeloid leukaemia after his second bone marrow transplant and developed sclerodermatous graft-versus-host disease.

Cutaneous metaplastic synovial cyst in an Ehlers-Danlos patient.

Metaplastic synovial cyst is a recently reorganized entity characterized by a cystic space lined by polygonal cells and villous structures resembling synovium pointing toward the lumen. It usually develops following trauma. We report a 15-year-old girl with Ehlers-Danlos syndrome who developed a nodular lesion of her elbow without previous trauma. Histopathological and immunohistochemical studies yielded results similar to those reported in cases of cutaneous metaplastic synovial cyst. This case appears to be the first one reported of cutaneous metaplastic synovial cyst associated with an Ehlers-Danlos syndrome. Cutaneous fragility and anomalous scarring typical of Ehlers-Danlos syndrome may be related to the development of this pseudocyst. If so, other connective-tissue diseases with increased skin fragility could be susceptible to development of such lesions.

Perforating granuloma annulare.

BACKGROUND: Perforating granuloma annulare (PGA) is considered an histologic subtype of granuloma annulare (GA) and it is described as a very rare disease, usually of children, affecting the dorsum of the hands. Mechanisms leading to perforation are unknown. Our experience suggested a different clinical presentation, so we decided to review our patients and the cases published. METHODS: We present six cases of PGA and review 52 PGA cases reported in the literature. Data regarding sex, age, time of evolution of disease, clinical features, laboratory findings, treatment, and follow-up were collected. The significance level was determined by the chi 2 or Student t test when appropriate. RESULTS: The prevalence of PGA could be up to 5% of GA. Pustular-like lesions can be found in 26% of cases, and scars in 37%; papular, umbilicated, and crusted lesions being the most common finding. While PGA appears as a single lesion in only 9% of cases, and half of the patients are older than 30 years. In GA 50% of cases present as a single lesion and 80% of patients are younger than 30 years. CONCLUSIONS: PGA is different to GA not only histologically but also clinically. It is a disseminated disease, affecting both children and adults, which is characterized by the presence of multiple papules, most of them umbilicated and/or crusted, and characteristically pustular lesions and scars. Histology suggests that the superficial localization of the necrobiotic granuloma leads to the epidermal perforation. Treatment is disappointing.