Translation and validation of patient-oriented eczema measure in the Greek language.

Translating and validating the Greek version of the Patient Oriented Eczema Measure (POEM) was our goal. A parallel backtranslation process was used to translate POEM. A total of fifty-nine adult atopic dermatitis patients were enlisted to assess validity and reliability. Through patient interviews with physicians, a questionnaire comprising demographics, POEM, and the dermatology life quality index (DLQI) was filled out. 3-7 days after the first visit, a second POEM completion was conducted. The POEM items conducted with study participants demonstrated a good level of internal consistency (Cronbach's alpha = 0.88), and no overall floor and ceiling effects were found. There was a significant correlation between the DLQI and POEM scores (Spearman rho =0.71; p<0.001). The POEM score between interviews showed an average intraclass correlation coefficient (95% confidence interval) of 0.89 (0.80, 0.94), indicating good to excellent test-retest reliability. Patient-reported outcome measures are becoming more and more common in Greece, so it's critical to have access to Greek translations of validated instruments that are frequently used in literature.

Prevalence of adult self-reported atopic dermatitis in Greece: results from a nationwide survey

Background: Atopic dermatitis (AD) is a common chronic inflammatory skin disorder. In Greece, there is a lack of data on AD epidemiology. Objectives: The objective of the present study was to estimate the self-reported prevalence of AD and the prevalence of moderate/severe AD in the adult population in Greece. Materials & Methods: A nationwide cross-sectional survey with a structured questionnaire was conducted, between June 17th, 2021 and July 12th, 2021, using Computer Assisted Telephone Interviewing (CATI) and Computer Assisted web Interviewing (CAWI) data collection methods. Several different self-reported AD definitions, as extracted from the literature, were used. Self-reported moderate/severe atopic dermatitis was estimated using the Patient Oriented Eczema Measure (POEM). Results: More than 30,500 persons were invited to participate; among them, 3,001 were recruited for the survey. The 12-month self-reported AD prevalence in Greece ranged from 1.7% to 6.4%, while lifetime prevalence reached 11.4%. At least half of the responders who identified with AD during the last 12 months had moderate to very severe eczema. The multivariate analysis confirmed that age, atopy-related comorbidities (asthma, allergies, and rhinitis), a family history of AD, rhinitis, and asthma were factors that are independently associated with AD, irrespective of the definition used. Conclusion: The 12-month and lifetime prevalence of AD in adults in Greece ranges from 1.7% to 6.4% and 3.7% to 11.4%, respectively. At least half of the adults with AD suffer from moderate-to-severe disease. Our study is a first step in understanding AD epidemiology in Greece and may provide useful insights for healthcare decision makers.

Burden of Atopic Dermatitis in Adults in Greece: Results from a Nationwide Survey.

The objective was to describe the AD burden in terms of quality of life (QoL), sleep, social life, work productivity, and resource utilization in Greece and assess the impact of disease severity. A nationwide cross-sectional survey was conducted. The questionnaire consisted of socioeconomic factors, medical history, AD screening, AD severity, QoL, sleep difficulties, social activities, and work productivity questions. AD was defined using the UK Working Party criteria (UKWP cohort) and a patient-reported AD diagnosis from a physician (Expert Diagnosis cohort). Self-reported moderate/severe AD was estimated using the Patient-Oriented Eczema Measure (POEM). In the UKWP cohort, the AD effect on QoL was moderate/extremely large in 84.3% of moderate/severe AD (vs. 55.7% in mild; p = 0.016), while in the Expert Diagnosis cohort, it was 72.2% (vs. 22.8%; p < 0.001). Disease severity was associated with a higher impact on sleep and social activities. Overall work impairment was high in both mild (32.7%) and moderate/severe (48.5%) AD of the UKWP cohort, while among the Expert Diagnosis cohort, it was significantly higher among those with moderate/severe (31.2%) versus mild AD (11.9%; p < 0.001). The AD burden in Greece is significant, especially for those in moderate/severe AD stages. Acknowledging this burden is the first step toward applying healthcare decisions that will benefit patients and the community.

Cost-utility analysis of treatment with olanzapine compared with other antipsychotic treatments in patients with schizophrenia in the pan-European SOHO study.

OBJECTIVE: To determine the cost utility of treating schizophrenic patients with olanzapine compared with other antipsychotics in a naturalistic outpatient setting. METHODS: The pan-European SOHO study is a 3-year, prospective, outpatient, observational study of outcomes associated with antipsychotic treatment, focusing on olanzapine, in ten European countries. For the cost-utility analysis, healthcare resource use (inpatient care, day care, outpatient psychiatric consultations and antipsychotic and concomitant medication use) and EQ-5D data were collected at baseline and at 3, 6 and 12 months. The perspective was that of the health service payer. UK healthcare unit costs (year 2004 values) were applied to the resource use data for the ten countries. UK population tariffs were applied to the EQ-5D data to determine utility values.An Epoch analysis was used to analyze the longitudinal data. Multivariate regression analyses that adjusted for baseline covariates were used to estimate the incremental cost and utility gains for patients treated with olanzapine compared with each of the other antipsychotics (risperidone, quetiapine, amisulpride, clozapine and oral or depot typical antipsychotics). RESULTS: A total of 10 972 patients were enrolled at baseline, of which 9107 completed the 12-month study period. Treatment with olanzapine was more effective in terms of QALYs gained than all of the other antipsychotic treatments. Treatment with olanzapine dominated quetiapine and amisulpride. The incremental cost for olanzapine compared with risperidone was pound sterling 226 per patient over 12 months and the incremental cost per QALY gained was pound 5156, with bootstrap analyses showing 100% of the replications falling below a pound sterling 30 000 per QALY gained threshold. Compared with treatment with clozapine, olanzapine was found to be marginally more effective, at an additional cost of pound sterling 13 per patient over 12 months and to have an incremental cost per QALY gained of pound sterling 775. Bootstrap analyses showed that 81% of replications fell below a pound sterling 30 000 per QALY gained threshold. Comparing olanzapine with oral and depot typical antipsychotics, the incremental cost was pound sterling 849 and pound sterling 1106 per patient over 12 months and the incremental cost per QALY gained was pound sterling 15 696 and pound sterling 23 331, respectively. Bootstrap analyses showed that 98% of the replications fell below a pound sterling 30 000 per QALY gained threshold for the comparison with oral typical antipsychotics, and 79% of replications for the comparison with depot preparations. CONCLUSIONS: Among SOHO patients, if a funding threshold of pound sterling 30 000 per QALY gained is assumed, this analysis suggests that olanzapine has a high probability of being the most cost-effective treatment compared with other antipsychotic treatments. However, comparison of olanzapine with clozapine and typical depot antipsychotics should be viewed with caution because clozapine is a second-line treatment and depot treatment is used for patients who do not adhere to their oral medication.

Assessment of the psychometric properties of the EQ-5D-3L and EQ-5D-5L instruments in psoriasis.

The aim of this study was to assess the psychometric properties of the five-level (EQ-5D-5L) in comparison with the standard three-level (EQ-5D-3L) classification systems of the EQ-5D in a sample of psoriatic patients. Psoriatic subjects (n = 396) recruited from 16 private practicing centers from various areas of Greece self-completed the two EQ-5D versions and the Dermatology Life Quality Index, while information was also collected on socio-demographics, clinical characteristics and comorbidities. The EQ-5D-5L and EQ-5D-3L were evaluated in terms of agreement, feasibility, ceiling effects, redistribution properties, inconsistency, informativity, and convergent and known-groups validity. Missing values were negligible in both versions. The agreement between the EQ-5D-5L and the EQ-5D-3L was very high (ICC = 0.94), while the largest differences were identified for subjects with moderate health status. Ceiling effects decreased in the EQ-5D-5L system by 14.08% (p < 0.05), with "anxiety/depression" showing the highest relative reduction (-10.31%; p < 0.05). Overall inconsistency was rather low (1.7%) and respondents preferred to report milder problems in the EQ-5D-5L. Absolute informativity improved by 56.42% in the EQ-5D-5L, while relative informativity declined by 9.24%, with only "anxiety/depression" demonstrating a small increase (6.77%). Both instruments demonstrated good convergent and known-groups validity, with evidence of a slightly better convergent performance and discriminatory efficiency of the EQ-5D-5L. In conclusion, both instruments demonstrated consistency, valid redistribution and good construct validity. The EQ-5D-5L system may be preferable to the EQ-5D-3L in psoriatic patients, as it demonstrated a marginally better performance in terms of reduced ceiling effects, increased informativity, and improved convergent and known-groups validity efficiency, particularly in the domain of "anxiety/depression".

Cost-effectiveness of Ingenol Mebutate Gel for the Treatment of Actinic Keratosis in Greece.

PURPOSE: The present study aimed to perform a cost-effectiveness analysis of ingenol mebutate (IM) versus other topical alternatives for the treatment of actinic keratosis (AK). METHODS: The analysis used a decision tree to calculate the clinical effects and costs of AK first-line treatments, IM (2-3 days), diclofenac 3% (for 8 or 12 weeks), imiquimod 5% (for 4 or 8 weeks), during a 24-month horizon, using discrete intervals of 6 months. A hypothetical cohort of immunocompetent adult patients with clinically confirmed AK on the face and scalp or trunk and extremities was considered. Clinical data on the relative efficacy were obtained from a network meta-analysis. Inputs concerning resource use derived from an expert panel. All costs were calculated from a Greek third-party payer perspective. FINDINGS: IM 0.015% and 0.05% were both cost-effective compared with diclofenac and below a willingness-to-pay threshold of €30,000 per quality-adjusted life-year (QALY) (€199 and €167 per QALY, respectively). Comparing IM on the face and scalp AK lesions for 3 days versus imiquimod for 4 weeks resulted in an incremental cost-effectiveness ratio of €10,868 per QALY. IM was dominant during the 8-week imiquimod period. IM use on the trunk and extremities compared with diclofenac (8 or 12 weeks) led to incremental cost-effectiveness ratios estimated at €1584 and €1316 per QALY accordingly. Results remained robust to deterministic and probabilistic sensitivity analyses. IMPLICATIONS: From a social insurance perspective in Greece, IM 0.015% and IM 0.05% could be the most cost-effective first-line topical field treatment options in all cases for AK treatment.

Methodological aspects in the assessment of treatment effects in observational health outcomes studies.

Prospective observational studies, which provide information on the effectiveness of interventions in natural settings, may complement results from randomised clinical trials in the evaluation of health technologies. However, observational studies are subject to a number of potential methodological weaknesses, mainly selection and observer bias. This paper reviews and applies various methods to control for selection bias in the estimation of treatment effects and proposes novel ways to assess the presence of observer bias. We also address the issues of estimation and inference in a multilevel setting. We describe and compare the use of regression methods, propensity score matching, fixed-effects models incorporating investigator characteristics, and a multilevel, hierarchical model using Bayesian estimation techniques in the control of selection bias. We also propose to assess the existence of observer bias in observational studies by comparing patient- and investigator-reported outcomes. To illustrate these methods, we have used data from the SOHO (Schizophrenia Outpatient Health Outcomes) study, a large, prospective, observational study of health outcomes associated with the treatment of schizophrenia. The methods used to adjust for differences between treatment groups that could cause selection bias yielded comparable results, reinforcing the validity of the findings. Also, the assessment of observer bias did not show that it existed in the SOHO study. Observational studies, when properly conducted and when using adequate statistical methods, can provide valid information on the evaluation of health technologies.

A systematic review and meta-analysis of the epidemiology and burden of venous thromboembolism among pregnant women.

BACKGROUND: Pregnancy-related venous thromboembolism (VTE) is one of the leading causes of maternal morbidity and mortality. OBJECTIVES: To review the epidemiology, and humanistic and economic burden of pregnancy-related VTE. SEARCH STRATEGY: Medline, the Cochrane Central Register of Controlled Trials, Econlit, Science Direct, JSTOR, Oxford Journals, and Cambridge Journals were searched for reports published between January 2000 and December 2012. Keywords related to VTE, pregnancy, and epidemiology and the humanistic and economic burdens were combined. SELECTION CRITERIA: Eligible studies evaluated the incidence, mortality, recurrence, complications, quality-of-life, and economic burden of VTE among pregnant women, and had been published in English. DATA COLLECTION AND ANALYSIS: Background information of the study, participants' characteristics, and study outcomes were collected. Meta-analyses of data were performed. MAIN RESULTS: Twenty studies were included, none of which investigated the economic burden. The pooled overall incidence of pregnancy-related VTE was 1.2 per 1000 deliveries. The pooled VTE case fatality rate was 0.68% and the recurrence rate was 4.27%. The pooled risk of major bleeding was 1.05%. Post-thrombotic syndrome seemed to have a negative effect on quality of life. CONCLUSIONS: Although the incidence of VTE was found to be relatively low during pregnancy and the postpartum period, the clinical burden is high. Further research is required to assess the economic burden of pregnancy-relate VTE.

The humanistic and economic burden of venous thromboembolism in cancer patients: a systematic review.

The objective of this study was to present evidence on the epidemiology, health outcomes and economic burden of cancer-related venous thromboembolism (VTE). Medline, Cochrane Central Register of Controlled Trials, Econlit, Science Direct, JSTOR, Oxford Journals and Cambridge Journals were searched. The systematic literature search was limited to manuscripts published from January 2000 to December 2012. On the basis of the literature, cancer patients experience between two-fold and 20-fold higher risk of developing VTE than noncancer patients. They are more likely to experience a VTE event during the first 3-6 months after cancer diagnosis. In addition, an increased risk of VTE in patients with distant metastases and certain types of cancer (i.e. pancreatic or lung) was revealed. VTE was found to be a leading cause of mortality in cancer patients. The annual average total cost for cancer patients with VTE was found to be almost 50% higher than that of cancer patients without VTE. Inpatient care costs accounted for more than 60% of total cost. The existing evidence assessed in the present review demonstrated the significant health and economic consequences of cancer-related VTE, which make a strong case for the importance of its proper and efficient prevention and management.