Health-Related Quality of Life in Common Variable Immunodeficiency Italian Patients Switched to Remote Assistance During the COVID-19 Pandemic.

BACKGROUND: A rapidly expanding pandemic of the new coronavirus has become the focus of global scientific attention. Data are lacking on the impact of the pandemic caused by the severe acute respiratory syndrome coronavirus 2 on health-related quality of life among patients affected by primary antibody deficiencies (PADs). OBJECTIVE: To identify factors impacting the health-related-quality of life (HRQOL) among Italian patients affected by PADs switched to remote assistance at the time of the coronavirus disease 2019 pandemic. METHODS: The quality of life was surveyed in 158 patients with PADs by the Common Variable Immune Deficiency Quality of Life questionnaire, a disease-specific tool, and by the 12-item General Health Questionnaire, a generic tool to assess the risk of anxiety/depression. Since the beginning of the coronavirus disease 2019 epidemic, we shifted all patients with PADs to home therapy, and activated remote visits. Questionnaires were sent by email 4 weeks later. Common Variable Immune Deficiency Quality of Life questionnaire and 12-item General Health Questionnaire data scores were compared with the same set of data from a survey done in 2017. RESULTS: Of 210 patients, 158 (75%) agreed to participate. The quality of life was worse in the group of patients who were at risk of anxiety/depression at the study time. HRQOL was similar in patients forced to shift from hospital-based to home-based immunoglobulin treatment and in patients who continued their usual home-based replacement. The risk of anxiety/depression is associated with pandemia caused by the severe acute respiratory syndrome coronavirus 2 and with patients' fragility, and not with related clinical conditions associated with common variable immune deficiencies. Anxiety about running out of medications is a major new issue. CONCLUSIONS: The coronavirus disease 2019 epidemic impacted HRQOL and the risk of anxiety/depression of patients with PADs. The remote assistance program was a useful possibility to limit personal contacts without influencing the HRQOL.

A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial.

OBJECTIVE: To test the effectiveness of an educational intervention including "face to face" training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. DESIGN: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. SETTING: Hospital wards of a large Italian dermatological reference center. SUBJECTS: Female inpatients with diagnosis of systemic sclerosis. INTERVENTIONS: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific "face-to-face" interventions, repeated at each follow-up visit. MAIN MEASURES: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. RESULTS: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13-0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01-0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant (P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). CONCLUSION: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials.

Double-blind, placebo-controlled, randomized trial on low-dose azithromycin prophylaxis in patients with primary antibody deficiencies.

BACKGROUND: Lacking protective antibodies, patients with primary antibody deficiencies (PADs) experience frequent respiratory tract infections, leading to chronic pulmonary damage. Macrolide prophylaxis has proved effective in patients with chronic respiratory diseases. OBJECTIVE: We aimed to test the efficacy and safety of orally administered low-dose azithromycin prophylaxis in patients with PADs. METHODS: We designed a 3-year, double-blind, placebo-controlled, randomized clinical trial to test whether oral azithromycin (250 mg administered once daily 3 times a week for 2 years) would reduce respiratory exacerbations in patients with PADs and chronic infection-related pulmonary diseases. The primary end point was the number of annual respiratory exacerbations. Secondary end points included time to first exacerbation, additional antibiotic courses, number of hospitalizations, and safety. RESULTS: Eighty-nine patients received azithromycin (n = 44) or placebo (n = 45). The number of exacerbations was 3.6 (95% CI, 2.5-4.7) per patient-year in the azithromycin arm and 5.2 (95% CI, 4.1-6.4) per patient-year in the placebo arm (P = .02). In the azithromycin group the hazard risk for having an acute exacerbation was 0.5 (95% CI, 0.3-0.9; P = .03), and the hazard risk for hospitalization was 0.5 (95% CI, 0.2-1.1; P = .04). The rate of additional antibiotic treatment per patient-year was 2.3 (95% CI, 2.1-3.4) in the intervention group and 3.6 (95% CI, 2.9-4.3) in the placebo group (P = .004). Haemophilus influenzae and Streptococcus pneumoniae were the prevalent isolates, and they were not susceptible to macrolides in 25% of patients of both arms. Azithromycin's safety profile was comparable with that of placebo. CONCLUSION: The study reached the main outcome centered on the reduction of exacerbation episodes per patient-year, with a consequent reduction in additional courses of antibiotics and risk of hospitalization.

Health-Related Quality of Life in Patients with CVID Under Different Schedules of Immunoglobulin Administration: Prospective Multicenter Study.

OBJECTIVE: We assessed the health-related quality of life (HRQoL) in CVID adults receiving different schedules of immunoglobulin replacement therapy (IgRT) by intravenous (IVIG), subcutaneous (SCIG), and facilitated (fSCIG) preparations. For these patients, IgRT schedule was chosen after a period focused on identifying the most suitable individual option. METHODS: Three hundred twenty-seven participants were enrolled in a prospective, observational, 18-month study. Participants received IgRT for at least 2 years. The first 6 months were devoted to the educational process during which the choices related to IgRT were regularly re-assessed, and the shift to alternative regimen was permitted. During the following 12 months, clinical data were prospectively collected, and only patients who did not further modify their IgRT schedule were included in the analysis of HRQoL measured by CVID_QoL, a specific instrument, and by GHQ-12, a tool to assess minor psychiatric nonpsychotic disorders. RESULTS: Three hundred four patients were included in the analysis. CVID_QoL global score and its dimensions (emotional functioning, relational functioning, gastrointestinal symptoms) were similar in IVIG, SCIG, and fSCIG recipients. Patients receiving IgRT by different routes of administration reported similar capacity to make long-term plans, discomfort due to therapy, and concern to run out of medications. Multivariate analysis revealed the GHQ-12 status, but not the IgRT mode of administration, as the major factor impacting on treatment-related QoL items, and a significant impact of age on discomfort related to IgRT. CONCLUSIONS: IgRT schedules do not impact the HRQoL in CVID if the treatment is established after an extensive educational period focused on individualizing the best therapeutic regimen.

Gastric Cancer Is the Leading Cause of Death in Italian Adult Patients With Common Variable Immunodeficiency.

An increased prevalence of malignant lymphoma and of gastric cancer has been observed in large cohorts of patients with common variable immunodeficiency (CVID), the most frequently symptomatic primary immunodeficiency. Surveillance strategies for cancers in CVID should be defined based on epidemiological data. Risks and mortality for cancers among 455 Italian patients with CVID were compared to cancer incidence data from the Italian Cancer Registry database. CVID patients showed an increased cancer incidence for all sites combined (Obs = 133, SIR = 2.4; 95%CI = 1.7-3.5), due to an excess of non-Hodgkin lymphoma (Obs = 33, SIR = 14.3; 95%CI = 8.4-22.6) and of gastric cancer (Obs = 25; SIR = 6.4; 95%CI = 3.2-12.5). CVID patients with gastric cancer and lymphoma had a worse survival in comparison to cancer-free CVID (HR: 4.8, 95%CI: 4.2-44.4 and HR: 4.2, 95%CI: 2.8-44.4). Similar to what observed in other series, CVID-associated lymphomas were more likely to be of B cell origin and often occurred at extra-nodal sites. We collected the largest case-series of gastric cancers in CVID subjects. In contrast to other reports, gastric cancer was the leading cause of death in CVID. Standardized mortality ratio indicated a 10.1-fold excess mortality among CVID patients with gastric cancer. CVID developed gastric cancer 15 years earlier than the normative population, but they had a similar overall survival. Only CVID diagnosed at early stage gastric cancer survived >24 months. Stomach histology from upper endoscopy performed before cancer onset showed areas of atrophic gastritis, intestinal metaplasia or dysplasia. CVID patients might progress rapidly to an advanced cancer stage as shown by patients developing a III-IV stage gastric cancer within 1 year from an endoscopy without signs of dysplasia. Based on high rate of mortality due to gastric cancer in Italian CVID patients, we hereby suggest a strategy aimed at early diagnosis, based on regular upper endoscopy and on Helicobacter pylori infection treatment, recommending an implementation of national guidelines.

Reduced frequency of non-melanoma skin cancer in 72,739 patients with psoriasis: a retrospective study.

Chronic inflammatory conditions, such as psoriasis, may pose an increased risk of cancer due to impaired immunosurveillance resulting from chronic inflammation and immunosuppressive medications. To compare the risk of non-melanoma skin cancer (NMSC) in a retrospective cohort of 72,739 psoriasis patients and 25,956 non-dermatological patients. A record linkage was performed for data on hospitalizations, and the occurrence of NMSC was compared by computing the relative risk (RR) and modelled using multiple logistic regression. Overall, the occurrence of NMSC was 9.6‰ (95% CI: 8.9-10.3‰) in psoriasis patients and 19.6‰ (95% CI: 18.0-21.4‰) in non-dermatological patients (RR = 0.49; 95% CI: 0.44-0.55). The simultaneous adjustment for gender, age, and phototherapy yielded a RR of 0.84 (95% CI: 0.75-0.95). With regards to phototherapy, the occurrence of NMSC was significantly higher among psoriasis patients who underwent phototherapy relative to those who did not (27.0‰ vs. 9.3‰). In this large retrospective study, we found that patients with psoriasis had a 16% lower probability of having NMSC when compared to a group of non-dermatological patients. Further studies, preferably with a prospective longitudinal design to collect more precise data, are needed to corroborate our findings.

Development and Initial Validation of a Questionnaire to Measure Health-Related Quality of Life of Adults with Common Variable Immune Deficiency: The CVID_QoL Questionnaire.

BACKGROUND: Generic health status quality of life (QoL) instruments have been used in patients with common variable immune deficiency (CVID). However, by their nature, these tools may over- or underestimate the impact of diseases on an individual's QoL. OBJECTIVE: The objective of this study was to develop and validate a questionnaire to measure specific-health-related QoL for adults with CVID (CVID_QoL). METHODS: The 32-item content of the CVID_QoL questionnaire was developed using focus groups and individual patient interviews. Validation studies included 118 adults with CVID who completed Short Form-36, Saint George Respiratory Questionnaire, General Health Questionnaire-12, and EuroQol-5D questionnaire in a single session. Principal component and factor analysis solutions identified 3 scores to be similar in number and content for each solution. Validation of 3 factor scores was performed by construct validity. Reproducibility, reliability, convergent validity, and discriminant validity were evaluated. Matrices consisting of correlations between the 32 items in the CVID_QOL were calculated. RESULTS: Factor analysis identified 3 dimensions: emotional functioning (EF), relational functioning (RF), and gastrointestinal and skin symptoms (GSS). The instrument had good internal consistency (Cronbach's alpha, min. 0.74 for GSS, max. 0.84 for RF, n = 118) and high reproducibility (intraclass correlation coefficient, min. 0.79 for RF, max 0.90 for EF, n = 27). EF and RF scores showed good convergent validity correlating with conceptually similar dimensions of other study scales. Acute and relapsing infections had a significant impact on EF and RF. CONCLUSIONS: This study provides evidence of the reliability and construct validity of the CVID_QoL to identify QoL issues in patients with CVID that may not be addressed by generic instruments.

Relationship Between Psychosocial Burden of Skin Conditions and Symptoms: Measuring the Attributable Fraction.

Skin conditions often have a severe impact on the physical and psychosocial domains of patients' quality of life, but the relationship between these domains has been studied little. This study estimated the fraction of psychosocial burden that may be attributable to symptoms, using the Skindex-17 quality of life questionnaire (symptoms and psychosocial scales) in 2,487 outpatients. The excess proportion of psychosocial burden for each skin condition was computed. Overall, 79.8% of the psychosocial burden of patients with severe symptoms may be attributable to the symptoms. For patients with mild symptoms this figure is 49.7%. A great heterogeneity was observed, from -0.9% for patients with scars, up to more than 90% for conditions such as lichen planus and psoriasis. While these results will have to be confirmed in longitudinal studies, they seem to indicate that, by targeting specific symptoms, a substantial portion of the psychosocial burden of skin diseases could be spared.

Measuring disability of women with systemic sclerosis: validation of the italian version of the systemic sclerosis questionnaire.

BACKGROUND: The aim of this study was to validate the Italian version of Systemic Sclerosis Questionnaire (SySQ) and to evaluate its psychometric characteristics on a sample of inpatient and outpatient women with systemic sclerosis (SSc). METHODS: Internal and external validity of the Italian version of SySQ were analyzed. Internal validity included: 1) construct validity by means of factor analysis; 2) internal consistency for each category of SySQ through Cronbach's alpha; and 3) reproducibility over time with test-retest using both Pearson's correlation and Intraclass Correlation Coefficient. External validity included: 1) concurrent validity, i.e. correlation with Skindex-17; and 2) discriminant validity, through comparison of scores for different groups of patients. RESULTS: We obtained data on 115 patients with SSc: 68 had the limited clinical form (lSSc) and 47 had the diffuse clinical form (dSSc). The structure of SySQ was confirmed by factor analysis. The questionnaire showed optimal internal consistency for all SySQ categories (Cronbach's alpha >0.84) and very good reproducibility over time (0.79-0.93, P<0.001). Regarding external validity, SySQ showed good correlation with Skindex-17 (P<0.01) and a satisfactory power of discrimination between groups affected by different clinical conditions. CONCLUSIONS: The study confirmed that the SySQ maintains good psychometric properties also in a language different from the original. It is a disease-specific tool that can be routinely used in clinical practice for the evaluation of the level of disability in patients with SSc.

Reduced frequency of melanoma in 72,739 patients with psoriasis: A retrospective study.

BACKGROUND: Chronic inflammatory conditions such as psoriasis may pose an increased risk of cancer due to impaired immunosurveillance resulting from the chronic inflammation and immunosuppressive medications. However, the relationship between psoriasis and the risk of melanoma is still controversial. OBJECTIVE: To compare the occurrence of melanoma in a cohort of 72,739 psoriasis patients and in 25,956 non-dermatological patients. METHODS: A record-linkage was performed between records of hospitalizations and access to day-hospital and day-surgery clinics and outpatient clinics. The frequency of melanoma was compared between psoriasis patients and vascular surgery patients. Occurrence of melanoma was compared by computing the relative risk (RR) and modelled using multiple logistic regression. RESULTS: Overall, occurrence of melanoma was 1.8% (95% CI 1.5-2.2%) in psoriasis patients and 4.5% (95% CI 3.8-5.4%) in non-dermatological patients (RR = 0.40, 95% CI 0.31-0.51). The simultaneous adjustment for gender, age, and phototherapy yielded a RRadj = 0.54(95% CI 0.41-0.70. For patients who underwent phototherapy, vs. those who did not, the RRadj was 1.50 (95% CI 0.56-4.15). CONCLUSIONS: In this large retrospective study, patients with psoriasis had a significantly lower probability of having melanoma when compared to a group of non-dermatological patients. Further studies, preferably with a concurrent longitudinal design to estimate incidence with more complete information, are needed to corroborate our findings.

Factors associated with the prescription of "traditional" or "biological" systemic treatment in psoriasis.

Abstract The choice of an adequate psoriasis treatment is critical to good disease management and to overall patient health. It is estimated that about 20-30% of patients requires systemic treatment: "traditional" (methotrexate, acitretina and cyclosporin) or "biological" (etanercept, adalimumab and infliximab). Clinical records of 784 outpatients with psoriasis were analyzed. 51.5% received traditional treatments and 48.5% a biological treatment. Males were 67.8% of patients. Psoriatic arthritis was observed in 37.3%. Females and younger patients were more likely to receive biological treatments. No differences were observed for Body Mass Index or for presence of comorbidities. Patients with psoriatic arthritis were also more frequently prescribed biological drug treatment. In a multivariate logistic regression model, only the older age-group (≥60 years) had a statistically significant OR (p=0.001) with a reduction of about 80% the likelihood of receiving biological treatment compared to the younger age-group (<40 years). Patients with a PASI score ≥20 and patients with arthritis have a probability to be prescribed biologics about five times higher than the other patients. In conclusion, younger age, psoriatic arthritis and the previous use of systemic drugs are factors associated with the use of biological treatment rather than the traditional systemic drugs.

Longitudinal study on health-related quality of life in a cohort of 96 patients with common variable immune deficiencies.

Health-related quality of life (HRQoL) in common variable immunodeficiency diseases (CVID) was evaluated by different tools, which were mainly used to compare different schedules of immunoglobulins administration in cross-sectional or short-term longitudinal studies. We assessed the HRQoL and psychological status of CVID patients in a longitudinal study over a 6-year period by a generic, non-disease-specific instrument (SF-36), and by a General Health Questionnaire (GHQ-12) for the risk of depression/anxiety. At baseline, 96 patients were enrolled. After 1 year, a second assessment was performed on 92 patients and, after 6 years, a third assessment was performed on 66 patients. Eighteen patients died during the study time. HRQoL was low, with mental health scales less affected than physical scales. A decline in the score on SF-36 scales was observed between the first and the third assessment for the Physical Functioning, Body Pain, General Health, Social Functioning, and Role-Emotional scales. The General Health scale showed a lower score in these patients, when compared to patients with other chronic diseases. Approximately one-third of the patients were at risk of anxiety/depression at all observation times, a percentage that reached two thirds of the patients, considering only the group of females. Over the 6 years of the study, the health condition of 11/66 patients worsened, passing from "GHQ-negative" to "GHQ-positive"; their score on SF-36 scales also decreased. A decrement of one point in each of the Physical Functioning, Vitality, Social Functioning, and Mental Health SF-36 scales increased the risk of developing anxiety/depression from three to five percent. A negative variation of the Physical Functioning score increased the risk of psychological distress. In a survival analysis with dichotomized variables, Physical Functioning scores <50 were associated with a relative risk (RR) of 4.4, whereas Social Functioning scores <37.5 were associated with a RR of 10.0. In our study, it was the clinical condition, as opposed to the different treatment strategies with immunoglobulins, which had a major role on the deterioration of HRQoL. Moreover, in a quality-of-life evaluation, disorders such as anxiety/depression should be assessed, as they yet often go unrecognized. Our results might be helpful in the interpretation of currently available data on quality of life in CVID patients.

Markedly reduced incidence of melanoma and nonmelanoma skin cancer in a nonconcurrent cohort of 10,040 patients with vitiligo.

BACKGROUND: Genetic findings suggesting a lower susceptibility to melanoma in patients with vitiligo are supported by recent clinical studies. Nonmelanoma skin cancer (NMSC) has also been studied, but mainly in small samples, and with conflicting results. OBJECTIVE: We sought to study the relative risk (RR) of melanoma and NMSC in patients with vitiligo compared with that in patients seen for vascular surgery. METHODS: The frequency of melanoma and NMSC was compared between patients with vitiligo and patients seen for vascular surgery. Occurrence of skin cancer was compared by computing RR and modeled using multiple logistic regression. RESULTS: Overall, the crude RR for melanoma was 0.24 (95% confidence interval [CI] 0.13-0.45) in patients with vitiligo compared with those with a nondermatologic condition (occurrence 1.1‰, 95% CI 0.5‰-2.0‰ in patients with vitiligo and occurrence 4.5‰, 95% CI 3.8‰-5.4‰ in the control cohort). The crude RR for NMSC was 0.19 (95% CI 0.14-0.17) and the occurrence was 3.8‰ (95% CI 2.7‰-5.2‰) among patients with vitiligo and 19.6‰ (95% CI 18.0‰-21.4‰) in control subjects. Patients with vitiligo who underwent phototherapy had a markedly higher risk of both cancers. CONCLUSIONS: In our large study, patients with vitiligo have a decreased risk of developing skin neoplasms, even considering that a larger proportion in this patient group is exposed to higher levels of ultraviolet radiation.

Intra-erythrocyte infusion of dexamethasone reduces neurological symptoms in ataxia teleangiectasia patients: results of a phase 2 trial.

BACKGROUND: Ataxia Teleangiectasia [AT] is a rare neurodegenerative disease characterized by early onset ataxia, oculocutaneous teleangiectasias, immunodeficiency, recurrent infections, radiosensitivity and proneness to cancer. No therapies are available for this devastating disease. Recent observational studies in few patients showed beneficial effects of short term treatment with betamethasone. To avoid the characteristic side effects of long-term administration of steroids we developed a method for encapsulation of dexamethasone sodium phosphate (DSP) into autologous erythrocytes (EryDex) allowing slow release of dexamethasone for up to one month after dosing. Aims of the study were: the assessment of the effect of EryDex in improving neurological symptoms and adaptive behaviour of AT patients; the safety and tolerability of the therapy. METHODS: Twenty two patients (F:M=1; mean age 11.2 ± 3.5) with a confirmed diagnosis of AT and a preserved or partially supported gait were enrolled for the study. The subjects underwent for six months a monthly infusion of EryDex. Ataxia was assessed by the International Cooperative Ataxia Rating Scale (ICARS) and the adaptive behavior by Vineland Adaptive Behavior Scales (VABS). Clinical evaluations were performed at baseline and 1, 3, and 6 months. RESULTS: An improvement in ICARS (reduction of the score) was detected in the intention-to-treat (ITT) population (n=22; p=0.02) as well as in patients completing the study (per protocol PP) (n=18; p=0.01), with a mean reduction of 4 points (ITT) or 5.2 points (PP). When compared to baseline, a significant improvement were also found in VABS (increase of the score) (p<0.0001, ITT, RMANOVA), with statistically significant increases at 3 and 6 months (p<0.0001). A large inter-patient variability in the incorporation of DSP into erythrocytes was observed, with an evident positive effect of higher infusion dose on ICARS score decline. Moreover a more marked improvement was found in less neurologically impaired patients. Finally, a 19 month-extension study involving a subgroup of patients suggested that Erydex treatment can possibly delay the natural progression of the disease.EryDex was well tolerated; the most frequent side effects were common AT pathologies. CONCLUSIONS: EryDex treatment led to a significant improvement in neurological symptoms, without association with the typical steroid side effects. TRIAL REGISTRATION: Current Controlled Trial 2010-022315-19SpA.

Quality of life in patients with anogenital warts.

BACKGROUND: Anogenital warts (GW) are among the most common sexually transmitted diseases. Few studies have investigated the quality of life (QoL) of GW patients. OBJECTIVE: We undertook an exhaustive description of the health status of GW patients and assessed disease impact on QoL. METHODS: GW patients enrolled at the Sexually Transmitted Diseases service of Rome Catholic University were administered the SF-36 questionnaire to assess health status, the Skindex-29 to evaluate the impact of dermatological aspects and the GHQ-12 questionnaire to identify patients with probable minor psychiatric non-psychotic conditions. Clinical severity was assessed with the Physician Global Assessment (PGA) and through quantitative measures. RESULTS: There was a significant association between greater disease severity and lower SF-36 values (reflecting a worse QoL). The severity parameters showed no significant differences in any of the Skindex-29 scales except for Emotions, which showed higher values (reflecting a worse QoL) in patients with severe disease assessed by PGA. The GHQ-positive patients (23.7%) consistently showed worse QoL scores on all the SF-36 scales and on all the Skindex-29 scales compared to GHQ-negative patients. CONCLUSIONS: To the best of our knowledge, this is the first study of the impact of GW on QoL to use a range of validated tools, both generic and dermatology-specific. We observed a strong influence of GW on the mental and physical components of QoL in terms of general health status (SF-36). The effects in terms of specific dermatological aspects (Skindex-29) were less significant, but still reflected an impact on patients' emotional state.

Health status, coping strategies, and alexithymia in subjects with androgenetic alopecia: a questionnaire study.

BACKGROUND: Androgenic alopecia (AGA) is viewed as a relatively mild dermatologic condition; however, affected individuals feel that alopecia is a serious condition with major consequences in their life. OBJECTIVE: The objective of this study was to assess the health status, the risk of anxiety/depression, the coping strategies, and alexithymia in subjects with AGA. METHODS: Consecutive subjects referred to the outpatients department of the Istituto Dermopatico dell'Immacolata, Istituto di Ricovero e Cura a Carattere Scientifico (IDI IRCCS) dermatologic hospital with a diagnosis of AGA were enrolled. AGA was assessed using the Ludwig scale in female subjects and following Hamilton-Norwood's classification in male subjects. The questionnaires provided to the patient and collected before the visit were the Medical Outcomes Study Short Form-12 (SF-12), the 12-item General Health Questionnaire (GHQ-12), the Coping Orientations to Problems Experienced (COPE), and the Toronto Alexithymia Scale-20 (TAS-20). Multiple logistic regressions were performed to examine the relationship of sociodemographic variables and clinical characteristics with coping. RESULTS: 351 subjects were enrolled during the study period. Sixty percent of female subjects with AGA were GHQ-12 positive (values ≥4) compared with 32 % of male subjects with AGA. AGA male and AGA female subjects had a statistically worse score than non-AGA male subjects for the physical component summary (PCS) and the mental component summary (MCS) of the SF-12, and for the GHQ-12. Compared with male subjects, AGA female subjects were more likely to adopt an 'active emotional coping' strategy according to COPE scores, and less likely to have 'externally oriented thinking,' and more 'difficulty identifying feelings' according to the TAS-20 scores. In a logistic regression model, including sex, MCS, total TAS-20, and the COPE scores as independent variables and the AGA severity as a dependent variable, only sex had a significant odds ratio (OR) [13.32; 95 % CI 4.77-38.58, p < 0.001]. Female subjects were almost 13 times more likely to have more severe AGA than male subjects. In three other models (i.e., one for each coping category) which included sex, AGA severity, MCS, and TAS-20, the 'problem-focused coping' strategy was negatively associated with alexithymia (OR 0.48; 95 % CI 0.27-0.86, p = 0.01), the 'active emotional coping' strategy was associated with gender (women had an OR of 2.69; 95 % CI 1.5-4.8, p = 0.001), and the 'avoidant coping' strategy was associated with alexithymia (OR 4.12; 95 % CI 2.23-7.58, p < 0.001) and with lower MCS values (OR 0.37; 95 % CI 0.22-0.64, p < 0.001). CONCLUSION: The study confirmed the high prevalence of depression/anxiety in AGA subjects, with a significantly higher prevalence in AGA female than male subjects. It is interesting to observe that patients reactions to their AGA related more to the emotional and psychological states deriving from their alopecia than to the objective clinical rating. Avoidant coping strategies were selected more frequently by AGA subjects if they were GHQ-12 positive and had alexithymia. To have alexithymia modified all coping strategies in AGA female subjects but not in AGA male subjects. Physicians should be aware that the impact of AGA is not limited to symptoms, and should help people to deal with their emotional responses to alopecia, such as anger and worry, and their beliefs about the consequences of their condition, and how it will impact on their daily life.

Field performance of the Skindex-17 quality of life questionnaire: a comparison with the Skindex-29 in a large sample of dermatological outpatients.

The utilization of health-related quality of life (HRQoL) questionnaires in routine clinical practice is hampered by several factors, including their length and thus the time needed to complete and score them. For this reason, growing efforts are devoted both to create short questionnaires and to shorten existing ones. The Skindex-17 is a dermatological HRQoL instrument that was derived from the Skindex-29 using Rasch analysis. It consists of 17 items instead of 29, and answers are given on a three-point scale instead of a five-point scale. The aim of this study was to compare information obtained by the Skindex-29 and the Skindex-17 in a large sample of dermatological outpatients. We compared the Skindex-29 with the Skindex-17 scores in 2,487 patients with several dermatological conditions, using intraclass correlation coefficients. The overall correlation was 0.957 for the symptoms scale and 0.940 for the psychosocial scale. The values were very similar for all diseases. The concordance between the levels of severity of the Skindex subscales in the two instruments was also very high. In conclusion, the Skindex-17 provided very similar information compared with the Skindex-29, with the advantage of being shorter and including some important psychometric properties.

Information needs of patients with melanoma: a nursing challenge.

Evidence continues to suggest that patients with cancer require more information about their disease and its consequences. To evaluate the information needs of patients with advanced melanoma compared to patients with other malignancies, a cross-sectional study was conducted on 221 unselected patients from the oncology department of a dermatologic hospital In Italy. Patients completed the Edmonton Symptom Assessment System and the Need Evaluation Questionnaire, two standardized tools for symptoms and psychosocial needs assessment. Results highlight that patients with advanced melanoma have, in general, a higher need for information compared to patients with other cancers, even if they report fewer symptoms. Future studies on the needs of patients with melanoma may contribute to tailored and more satisfactory patient-centered care. Recommendations for clinical practice include that particular attention should be paid by the oncology team to the need for a strong therapeutic relationship.

Limited role of marital status in the impact of dermatological diseases on quality of life.

Health status, health services utilization and mortality differ by marital status for both sexes in most conditions, but little is known about dermatological diseases. We evaluated whether marital status is associated with the impact that dermatological diseases have on quality of life (QoL). Data from two surveys on dermatological outpatients were pooled. Marital status, sex, age, and educational level were analysed in relation to QoL (using the scales of the Skindex-29 questionnaire: emotions, symptoms, and functioning) and psychological well-being (using the GHQ-12 questionnaire). Data on 5,471 patients (59% females, 46% married) were obtained. Married patients in univariate analysis had lower mean values on the emotions scale and higher mean values in the symptoms scale of the Skindex-29 compared to singles. Statistically significant differences were identified only in men, for the emotions scale and for the GHQ-12. Females had significantly higher mean scores than males on each of the Skindex-29 scales and on the GHQ-12. Married patients had a lower disease impact on the emotions scale even if they suffered a higher impact on the symptoms scale. However, after multiple adjustment, gender seems to be more relevant than marital status in the evaluation of health status.