Quality of life assessment in core outcome sets: A position statement of the EADV Task Force on Quality of Life and Patient Oriented Outcomes.

Core outcome sets (COSs) are an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. Tsekhe aim of our position paper by the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life and Patient Oriented Outcomes was to identify the challenges and Patient Oriented Outcomes advantages in the development of COSs within dermatological QoL research. Twelve EADV Task Force multidisciplinary team members presented a total of 101 items (51 advantages and 50 disadvantages). All participants considered that COS are beneficial for comparison between different studies, treatments, dermatological diseases, geographical location and ethnicities. In conclusion, the EADV Task Force on Quality of Life and Patient Oriented Outcomes has recognized the primacy of advantages of COS and deliberated that the disadvantages in COS are related to development process and use of COS.

Reversibility of alexithymia with effective treatment of moderate-to-severe psoriasis: longitudinal data from EPIDEPSO.

BACKGROUND: Alexithymia refers to difficulty in identifying and expressing emotions. Alexithymia is associated with high burden of disease in patients with psoriasis. OBJECTIVES: To investigate whether alexithymia was reversible in patients with psoriasis following real-life therapeutic intervention. METHODS: The Epidemiological Study in Patients with Recently Diagnosed Psoriasis (EPIDEPSO; NCT01964443) was a 1-year multicentre observational study investigating the prevalence of alexithymia and other psychosocial comorbidities in patients with psoriasis with ≤ 10 years' disease duration and eligible for systemic treatment. Alexithymia was assessed using the Toronto Alexithymia Scale (TAS-20) at baseline, 6 months and 1 year. RESULTS: There was a statistically significant decrease in the prevalence of alexithymia in the follow-up cohort, from 26·7% at baseline to 21·2% at 6 months and 18·8% at 1 year. More than half of the patients (n = 77, 53·8%) who were alexithymic at baseline experienced reversion of their alexithymia. Reversion of alexithymia was higher in patients who reached a high level of disease control, defined as ≥ 75% or ≥ 90% improvement in Psoriasis Area and Severity Index. Reversion of alexithymia was associated with dramatic improvement in quality of life, anxiety and depression. Moreover, hazardous alcohol use, highly prevalent in patients with alexithymia, was reduced almost threefold at 1 year. CONCLUSIONS: Alexithymia and associated high disease burden may be reversible in patients with effective treatment of psoriasis. Proactive recognition of patients who are unable to identify and express their feelings is important.

Prevalence of alexithymia in patients with psoriasis and its association with disease burden: a multicentre observational study.

BACKGROUND: Single-centre studies show that alexithymia, defined as difficulty in recognizing and describing emotions, is more prevalent among patients with psoriasis than in the general population. However, its prevalence and the consequences of the association between alexithymia and psoriasis are unclear. OBJECTIVES: The primary objective of this study was to determine the prevalence of alexithymia, as defined by a score ≥ 61 in the 20-item Toronto Alexithymia Scale, in a large sample of patients who had plaque psoriasis for ≤ 10 years and were eligible for phototherapy or systemic treatment. The secondary objectives were to investigate the relationship between alexithymia and the clinical and psychological aspects of psoriasis. METHODS: Data were collected in the framework of an observational, multicentre, international study, the EPidemiological Study In Patients With Recently DiagnosEd PSOriasis (EPIDEPSO), aiming at investigating the prevalence of alexithymia and other psychosocial comorbidities in patients with psoriasis of ≤ 10 years' disease duration. RESULTS: The prevalence of alexithymia within a cohort of 670 patients was 24·8% (95% confidence interval 21·7-28·2). Patients with alexithymia had a higher burden of psoriasis, including significant impairment of quality of life, higher levels of anxiety and depression, a higher risk of alcohol dependency and impairment of work productivity, compared with patients without alexithymia. CONCLUSIONS: It is important to identify alexithymic patients with psoriasis in clinical practice as they experience a higher disease burden and have a lower ability to express their feelings.

The burden of common skin diseases assessed with the EQ5D™: a European multicentre study in 13 countries.

BACKGROUND: Generic instruments measuring health-related quality of life (HRQoL), like EQ5D™, enable comparison of skin diseases with healthy populations and nondermatological medical conditions, as well as calculation of utility data. OBJECTIVES: To measure HRQoL in patients with common skin diseases and healthy controls across Europe using the EQ5D. METHODS: This multicentre observational cross-sectional study was conducted in 13 European countries. Each dermatology clinic recruited at least 250 consecutive adult outpatients to complete questionnaires, including the EQ5D. RESULTS: There were 5369 participants (4010 patients and 1359 controls). Mean ± SD self-rated health state reported by patients was 69·9 ± 19·7; for controls it was 82·2 ± 15·5. When adjusted for confounding factors, including comorbidity, mean patient EQ visual analogue scores were 10·5 points lower than for controls (standardized ß = -0·23). Odds ratio with 95% confidence interval for impairment in all five dimensions of EQ5D adjusted for confounders was doubled for patients compared with controls. Patients with hidradenitis suppurativa (HS), blistering conditions, leg ulcers, psoriasis and eczemas had the highest risk for reduction in HRQoL in most dimensions (2-10-fold). Data on differences of impairment by dimensions offer new insights. CONCLUSIONS: This study confirms the large impact skin conditions have on patients' well-being, differentiating between aspects of HRQoL. Patients with HS, blistering diseases, leg ulcers, infections and most chronic skin diseases reported reduced HRQoL compared with patients with chronic obstructive lung disease, diabetes mellitus, cardiovascular disease and cancers. These findings are important in the prioritization of resource allocation between medical fields and within dermatological subspecialities.

Results of the validation study of the Psodisk instrument, and determination of the cut-off scores for varying degrees of impairment.

BACKGROUND: The Psodisk is a 10-item visual instrument, aimed at measuring the burden of psoriasis on patients. OBJECTIVES: To validate the Psodisk in a large sample of patients with psoriasis, and to define categories for the interpretation of the scores. METHODS: Data were collected in 21 dermatological centres. The Psodisk was administered at baseline (t0), after 2 or 3 days (t1) and about 3 months (t2) after baseline, and data were used to assess validity and reliability of the instrument. The cut-off scores were determined using the perception of the severity of the disease by the patient as anchor point. RESULTS: The evaluable population consisted of 320 patients at baseline, with a mean Psodisk score of 36.9. The concurrent validity of the instrument was confirmed by the high correlation with Skindex-29 and DLQI. Factor analyses selected a single factor, which alone explained almost 60% of the variance. Cronbach's coefficient alpha was 0.927, suggesting a good reliability. Test-retest reliability was verified by a Pearson's correlation coefficient between the Psodisk scores at baseline and t1 of 0.924. Five categories of disease burden were defined: 1. minimal (<9); 2. mild (9-15); 3. moderate (16-30); 4. marked (31-50); 5. severe (>50). CONCLUSION: The Psodisk showed good psychometric properties. The definition of the cut-off scores will be useful to evaluate the burden of psoriasis on patients.

The evaluation of family impact of recessive dystrophic epidermolysis bullosa using the Italian version of the Family Dermatology Life Quality Index.

BACKGROUND: Severe skin diseases, such as epidermolysis bullosa (EB), may have a strong impact not only on patients but also on caregivers. A specific questionnaire evaluating the family impact of dermatological conditions has been created, the Family Dermatology Life Quality Index (FDLQI), but it has not yet been translated in Italian and validated. OBJECTIVE: To evaluate the burden of recessive dystrophic EB on family caregivers, using for the first time the Italian version of the FDLQI, and to validate the instrument. METHODS: Patients with recessive dystrophic EB participated in a postal survey enquiring about the burden of EB on family caregivers. They completed the Family Strain Questionnaire and the FDLQI and they marked on a silhouette of the human body the skin lesion distribution. RESULTS: Data on 62 family caregivers were collected. The overall mean FDLQI score was 9.8. The most frequently reported problems were the time spent on looking after the patient, emotional distress, physical well-being, and increased household expenditure. FDLQI scores were higher in family caregivers of patients between 10 and 20 years. The Italian FDLQI showed high internal consistency, construct and convergent validity. Factor analysis revealed the presence of one factor structure underlying the items of the FDLQI, which explained 51.5% of the total variance, very similar to the original questionnaire (55.8%). CONCLUSION: The Italian version of the FDLQI seems to be a useful tool to evaluate the impact of EB on family caregivers. Further studies are necessary to test this instrument in other dermatological conditions.

Assessment of the health status of 2,499 dermatological outpatients using the 12-item Medical Outcomes Study Short Form (SF-12) questionnaire.

BACKGROUND: In dermatological research and clinical practice it is important to evaluate the burden of the disease. OBJECTIVE: To assess whether the 12-item Short Form of the Medical Outcomes Study (SF-12) could yield a valid description of the health status of a large number of dermatological outpatients. METHODS: The SF-12 and the 12-item General Health Questionnaire (GHQ-12) were utilized. Questionnaires were self-completed by the outpatients in the waiting rooms. At the end of the visit the dermatologists recorded the diagnosis and the evaluation of the clinical severity. RESULTS: Data were complete for 2499 patients. We observed a reduction in the Physical Component Summary score (PCS-12) with increasing age, while the Mental Component Summary score (MCS-12) was stable. PCS-12 and MCS-12 scores were worse in women. Twenty-three per cent of patients were identified as GHQ-12 positive. GHQ-12-positive patients ('cases') had lower PCS-12 and MCS-12 scores compared with GHQ-12-negative patients (mean ± SD, PCS-12: 47·9 ± 10·8 vs. 52·2 ± 6·6; MCS-12: 35·2 ± 10·2 vs. 50·9 ± 78·3, respectively). High correlations between the MCS-12 score and the GHQ-12 were documented overall (-0·690, P < 0·001) and for single skin diseases. CONCLUSIONS: The impact of dermatological diseases is high for the mental components of health status; the mean scores for MCS-12 were low, and lower in patients identified as GHQ-12 'cases'. The picture of the general health status of patients with skin diseases given by the SF-12 allows meaningful comparisons both within dermatological conditions and with diseases in other specialties, as well as within categories of clinical severity and psychological well-being in single skin conditions.

Measuring the health status of patients with vascular leg ulcers and the burden for their caregivers.

OBJECTIVES: To assess the health status of patients with leg ulcers and the impact and consequences of such chronic disease on the life of their caregivers. DESIGN: Observational study in a "day care" setting. MATERIAL: Administration of the Short Form-12 questionnaire and of Visual Analogue Scales for pain to patients; of the Family Strain Questionnaire to caregivers. METHODS: Eighty consecutive patients with leg ulcers and their principal caregivers were observed in the period January-August 2006. RESULTS: The emotional burden and problem in social involvement were statistically significantly higher in caregivers for patients with worse SF-12 scores on the physical scale. Values of emotional burden were lower than those observed for cancer patients and for patients in a persistent vegetative state; however, they were higher than those observed for patients with neurological, respiratory, or renal conditions. The score for social involvement was significantly higher for caregivers of patient with vascular leg ulcers compared to other diseases, with the single exception of the persistent vegetative state. CONCLUSIONS: Leg ulcers alter the relationship between family members, and the physical impairment causes significant strain on the caregiver. The improvement of physical health status in patients with leg ulcers may induce a reduction in the emotional burden and an improvement in the social involvement for caregivers.

Financial systems' impact on dental care; a review of fee-for-service and capitation systems.

OBJECTIVE: This review covers the impact of financial systems on dental care. BACKGROUND: Remuneration in fee-for-service (FFS) is done per service provided and in capitation (CAP) per patient enrolled. It may be expected that dentists' incentive in CAP is to keep the number of services provided at a minimum, while in FFS it is to keep the number of services at a maximum. This should lead to a different impact on care, with the dentists in CAP focusing more on prevention and dentists in FFS more on restorative treatment. Six questions were put: Does CAP increase or decrease caries incidence? Does CAP increase or decrease restorative treatments? Does CAP increase preventive care? Does CAP increase or decrease productivity? Does CAP increase or decrease the dentist's satisfaction with his/her work? Does CAP increase or decrease the patients' satisfaction with the oral care provided? METHODS: Literature was obtained through searches in databases. A format was developed to define the literature of interest. RESULTS: CAP decreases restorative treatment and there is a tendency of decreased caries incidence. "Supervised neglect" cannot be established. CAP increases preventive care. A conclusion regarding productivity was not possible. The results on dentist's satisfaction with work were inconclusive, as were the results regarding patient satisfaction. CONCLUSIONS: CAP has a different impact on provided care than FFS. More research is needed in this area and focus on efficiency is of importance.

Sensitivity of the Dermatology Life Quality Index to clinical change in patients with psoriasis.

BACKGROUND: Quality of life is increasingly recognized as an important outcome measure in dermatology. The Dermatology Life Quality Index (DLQI) is a self-administered questionnaire designed to measure the impact of skin diseases on patients' quality of life. OBJECTIVES: To assess the responsiveness of the DLQI to variations in clinical status as measured by the Self-Administered Psoriasis Area and Severity Index (SAPASI) in a large sample of in-patients with psoriasis. METHODS: The SAPASI and the DLQI were completed by 359 in-patients with psoriasis at hospital admission and 4 weeks after discharge. Changes in SAPASI scores were used to categorize patients as improved, unchanged or worsened. Next, these groups were compared with one another with regard to the change in DLQI scores. RESULTS: Four weeks after discharge, both mean SAPASI scores and mean DLQI scores were significantly lower than at admission (P < 0.001). In improved patients, the DLQI score decreased significantly more than in worsened patients (P < 0.001), and tended to decrease more than in unchanged patients (P = 0.07). The difference in DLQI score change between improved patients and unchanged or worsened patients grouped together was highly significant (P < 0.001); also, it remained significant or nearly significant when the analysis was performed on subsets of patients based on gender and age range. CONCLUSIONS: This study contributes to building evidence of validity for the DLQI, because the instrument demonstrated the ability to detect small but meaningful changes in clinical status over time in a large sample of patients with psoriasis.