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Introduction Women undergoing radical cystectomy (RC) followed by urinary diversion (UD) for bladder cancer experience a substantial reduction in health-related quality of life (HRQOL). At present, studies comparing long-term QOL outcomes for different UD methods, needed to inform evidence-based choices of bladder reconstruction for female patients, are sparse. Our objective was to compare two common UD methods in terms of their HRQOL outcomes in women. Materials and methods We retrospectively analysed HRQOL in 73 consecutive female bladder cancer patients having undergone orthotopic ileal neobladder (IONB, N = 24) or ileal conduit (IC, N = 49) following RC between 2007 and 2013 in six Italian academic urological centres. Patients had no evidence of tumour recurrence and were actively followed up. Validated Italian versions of the European Organisation for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder-cancer-specific (QLQ-BLM30) questionnaires were used to evaluate HRQOL. Results Patients in the IONB group were significantly younger than those in the IC group (median age: 67 and 73 years, respectively, p = 0.02). Barring that, the two groups did not present statistically significant differences in median length of follow-up (43 vs 54 months), pathological stage, grading of the neoplasm, or adjuvant chemo - or radiotherapy. No significant differences in QOL were found between the groups, with the exception of financial difficulties, affecting IONB patients significantly more than IC patients (mean score on a scale of 0–100: 33.3 ± 29.5 vs 18.4 ± 19.3, respectively; p = 0.05). Conclusion Financial difficulties was the only HRQOL item to differ between the two UD groups.

Background Benign prostatic hyperplasia (BPH), a progressive condition and common cause of lower urinary tract symptoms (LUTS), is underdiagnosed in primary care, impacting patient outcomes. Here, we evaluate the utility of a BPH screening tool in general practice, to identify men confirmed to have BPH after urologist assessment of diagnostic test results. Methods A 3-item questionnaire was developed to discriminate between LUTS due to BPH versus other conditions, and was translated and validated cross-culturally. Its utility was assessed in a cohort study (FDC116114/NCT02757963) conducted in 47 centers across France, Germany, Italy, Russia, and Spain. The study enrolled men ≥50 years of age presenting to general practice clinics with a score of ≥3 on the BPH screening tool or ≥8 on the International Prostate Symptom Score (IPSS). In total, 561 men completed the study. The primary endpoint was the proportion of patients with a urologist-confirmed BPH diagnosis among those with a positive result on the BPH screening tool (score ≥3) and serum prostate specific antigen (PSA) ≥2ng/mL. Results The primary endpoint was fulfilled; 88.3% (95% CI: 84.9, 91.2) of patients had urologistconfirmed BPH diagnoses among those with positive results on the BPH screening tool and serum PSA ≥2ng/mL, similar to the proportion seen with IPSS ≥8 and serum PSA ≥2ng/mL (87.7%; 95% CI 84.6, 90.4). Conclusions The BPH screening tool, in conjunction with serum PSA, demonstrated adequate predictive value by allowing general practitioners to quickly screen men presenting with different medical conditions but identified as having urological symptoms.

Background/Aim: Studies comparing health-related quality of life (HR-QoL) between patients who underwent radical cystectomy (RC) and those who underwent a different form of urinary diversion has not reached yet univocal and reliable conclusions. The aim of our study was to evaluate bladder-specific long-term HR-QoL after radical cystectomy and ileal conduit. Patients and Methods: A multicenter study was carried out on 145 consecutive patients (112 males and 33 females) undergoing RC and ileal conduit (IC). HR-QoL assessment was conducted using Italian versions of European Organisation for Research and Treatment of Cancer QLQ-C30 and EORTC BLM-30 questionnaires. Results: Our data showed that women who underwent IC presented greater problems than men in cognitive functioning (mean score±SD: 77.3±27.9 vs. 87.8±18.6) as well in future perspective (score: 42.4±34.4 vs. 21.9±24.6). Nevertheless, men undergoing IC had more problems in sexual functioning than women (score: 23.3±24.5 vs. 7.0±20.3) (all p

Objective: To evaluate health-related quality of life (HR-QoL) outcomes in elderly patients with different type of urinary diversion (UD), ileal conduit (IC) and ileal orthotopic neobladder (IONB), after radical cystectomy (RC) for bladder cancer, by using validated self-reported cancer-specific instruments. Patients and Methods: We retrospectively reviewed 77 patients who received an IC or an IONB after RC. HR-QoL was assessed with specific and validated disease questionnaires, administered at last follow-up. Result: At univariate analysis, at a mean follow-up of 60.91 ± 5.63 months, IONB results were favourable with regard to the following HR-QoL aspects: nausea and vomiting (p = 0.045), pain (p = 0.049), appetite loss (p = 0.03), constipation (p = 0.000), financial impact (p = 0.012) and cognitive functioning (p = 0.000). This last functional aspect was significantly worse in female patients (p = 0.029). Emotional functioning was significantly better in patients without long-term complications (p = 0.016). At multivariate analysis, male gender and IONB were independent predictors of better cognitive functioning, while long-term complications negatively affected emotional functioning. Conclusions: Obtained results suggest that an IONB can also be suitable for elderly patients compared with an IC with few and selected advantages in favour of the former UD. Preoperative patient’s selection, counselling, education and active participation in the decision-making process lead to a more suitable choice of treatment.

To examine the different and health-related quality of life (HR-QoL) outcomes between ileal conduit (IC) and ileal orthotopic neobladder (IONB) in patients who underwent radical cystectomy (RC), by using validated self-reported cancer-specific instruments.This retrospective, cross-sectional, multicenter cohort study included 148 and 171 patients with either IC or IONB. HR-QoL was evaluated with Quality of Life Core Questionnaire and bladder module (BLM)-30 European Organisation for Research and Treatment of Cancer questionnaires. Baseline HR-QoL scores were dichotomized at the median to give "good" or "poor" score profiles. A matched-pair analysis compared HR-QoL aspects between 79 IC patients and 79 IONB patients.At univariate analysis IONB resulted favorable for physical functioning, emotional functioning, cognitive functioning (CF), fatigue, dyspnea, appetite loss, constipation (CO), and abdominal bloating flatulence (AB). At multivariate analyses, IONB showed better scores for emotional functioning (85 vs 79, P = .023), CF (93 vs 85, P .001), CO (16 vs 31, P .001), and AB (12 vs 25, P .001). A significant worsening of sexual and urinary function was observed for IONB patients in the long-term. At matched-pair analysis, global health status was similar (65 vs 62, P = .385). Significantly better scores were observed in the IONB group for the following items: CF (P = .007), fatigue (P = .003), pain (P = .019), dyspnea (P = .016), CO (P = .001), and AB (P = .00).IONB and IC after RC were similar in terms of global health status. IONB provides better results in some aspects of HR-QoL related to bowel function, but a worsening of urinary and sexual functions. Further randomized controlled trials are needed to confirm these data.

Introduction: From the most recent systematic revision of the literature, an orthotopic neobladder would seem to show marginally better health related quality of life (HR-QoL) scores compared with an ileal conduit. The aim of this study was to review all relevant published studies about the comparison between ileal orthotopic neobladder (IONB) and ileal conduit using validated HR-QoL questionnaires. Materials and Methods: Studies were identified by searching multiple literature databases. Data were synthesized using meta-analytic methods conformed to the PRISMA statement. Results: The literature search identified 10 papers; pooled effect sizes of combined quality of life outcomes for ileal conduit versus IONB showed a significantly better HR-QoL in patients with IONB (Hedges' g = 0.278; p = 0.000);. The present study has an important limitation due to the type of the analyzed comparative studies, all retrospective and not randomized. Conclusion: This meta-analysis of not-randomized, retrospective comparative studies on the impact of ileal conduit versus IONB on HR-QoL showed a significant advantage of IONB subgroups.

BACKGROUND: There is a lack of good data in the literature evaluating the Health-Related Quality of Life (HR- QoL) in patients with urinary diversions. The aim of this study was to examine the changes in expectation and needs in terms of human adaptation and behavioural profiles in patients with ileal conduit (IC) after radical cystectomy (RC) for bladder cancer (BC). MATERIALS AND METHODS: A qualitative, multicenter cross-sectional study using a "narrative based" approach was planned. We proceed with a sampling reasoned choice (purposive), selecting groups of patients with follow-up from one up to more than 7 years after surgery. Data were collected through individual interviews. RESULTS: Thirty patients participated in the study. The processing of the interviews allowed us to identify 2 major profiles: positive and negative. Patients with a positive profile resumed normal daily activities with no or limited restrictions both on the personal and the social level. This profile reflects a good HR-QoL. The negative profile reflects the patients for whom the ostomy has meant a worsening of HR-QoL. A positive profile was statistically more frequent in older patients (p = 0.023), with a longer follow-up (p = 0.042) and less complications rates (p = 0.0002). According to the length of follow-up and the occurrence of complitations, we identified further 5 intermediate profiles. CONCLUSIONS: Patients' satisfaction is related to the degree of adaptation to their new life with an urinary stoma and its correct management. Live "with urinary diversion" represents a new phase of life and not a deterioration.

Background: To evaluate the difference at different steps of follow-up of the postoperative quality of life (QoL) in patients who had undergone radical cystectomy and ileal orthotopic neobladder derivation. Patients and Methods: A multicentric, cross-qualitative study was performed in 5 Italian centers of reference for the treatment of bladder cancer. One hundred seventy one patients who underwent radical cystectomy and creation of ileal orthotopic neobladder according to ‘Vescica Ileale Padovana' between 2006 and 2011 have been analyzed. The validated and dedicated questionnaires EORTC QLQ-C30, IOB-PRO and EORTC QLQ-BLM30 were used. Results: All data gathered were then processed, specifically means ± SD were included for comparison during 4 periods of follow-up (quartile): the first ranging from 1 to 18 months; the second ranging from 19 to 36 months; the third from 37 to 72 months and the fourth >72 months. Cancer-specific and health-related factors were analyzed separately, and the change was determined during follow-up. Conclusions: The global QoL, highlighted by validated cancer-specific and health-related questionnaires, is certainly on a satisfactory level. Thus, the education of the patient, the exploration of the pros and cons of an orthotopic neobladder and the active participation in treatment decision seem to be the keys to better improve the post-operative QoL during the follow-up period.

Gender differences have been observed in the way males and females process cognitive stimuli coming from exposure to works of art and participation in leisure activities. For this reason, we designed a project to assess this issue, with a cross-sectional study in Milan, on a sample of the population consisting in 1,000 inhabitants. Our objective was to assess how cultural participation affects subjective well-being, measured with the Psychological General Well-being Scale, which gives a global index of psychological well-being ranging from 0 (lowest level of well-being) to 110 (highest level of well-being). The survey was conducted with the assistance of Doxa, an Italian pollster company, through telephone interviews, according to the Computer Aided Telephone Interview system. A significant statistical difference in variable distribution between the two genders was found for civil status (more males resulted as being single and more women widowed), income (higher income in males), cultural participation (higher in males) and psychological well-being (higher in males). As expected, state of health has the maximum impact on the level of psychological well-being. The increase in the number of concomitant diseases is in fact linearly associated with a progressive increase in psychological distress with average scores of around 60 (very low level of well-being), in the presence of 5 or more concomitant diseases, in both males and females. The impact profile of nine major determinants on subjective well-being resulted to be clearly different in the two genders. Health status dominates in both, but its impact is higher in females than in males. The obtained results remained substantially unchanged also when the two gender groups were matched according to civil status and income level distribution. Leisure activities play an important role in females (second place after health status), while in males they result as being less important (fourth place after health status, civil status and occupation). Education is quite important for females (third place), while it is given the least importance in males. This different profile probably reflects different social and environmental influences on the two genders. The social and psychological implications of these findings are discussed.

Objective To assess health-related quality of life (HRQoL) parameters in patients who received radical cystectomy (RC) with ileal orthotopic neobladder (IONB) reconstruction and to identify clinic-pathologic predictors of HRQoL. Patients and Methods From January 2010 to December 2013, a multicenter, retrospective on 174 RC-IONB patients was carried out. All patients completed the following questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer–specific instruments (QLQ-BLM30) and the IONB-Patient Reported Outcome (IONB-PRO). Univariate and multivariate analyses were computed to identify clinic-pathologic predictors of HRQoL. Results Median age was 66 years (range, 31-83), and 91.4% of patients were men. Median follow-up period was 37 months (range, 3-247). The EORTC QLQ-C30 revealed that age >65 years, absence of urinary incontinence, and absence of peripheral vascular disease were independent predictors of deteriorated body image. A follow-up > 36 months and the presence of urinary incontinence were independent predictors of worsened urinary symptoms, whereas the absence of urinary incontinence was an independent predictor of a worsened body image according to EORTC QLQ-BLM30 results. A follow-up >36 months and the absence of urinary incontinence were independent predictors of better functioning in terms of relational life, emotional life, and fatigue as revealed by the IONB-PRO. Conclusion Age, presence of urinary incontinence, length of follow-up, and comorbidity status may influence postoperative HRQoL and should all be taken into account when counseling RC-IONB patients.

Background/Aims: Liver biopsy represents the gold standard to establish a diagnosis in all liver patients, but its current position in chronic viral hepatitis is questioned. We aimed to create a consensus on best practice of use of liver biopsy in the management of chronic HCV infection. Methods: We applied the Delphi method to 12 clinical scenarios of chronic HCV infection, to assess the extent of agreement (consensus measurement) and to resolve disagreement (consensus development) on the appropriateness of liver biopsy. Results: Among 108 chosen hepatologists, 61 (56.5%) accepted to participate to the first-round survey. In four patients the majority of experts (from 61.4 to 86.2%) agreed not to perform liver biopsy; in two cases an equivalent opinion was found, and in the remaining six scenarios the majority of experts would have recommended a biopsy. No expert recommended liver biopsy in all cases, while most agreed for an histological evaluation of 4 to 8 cases. At the second round, 36 experts (59%) submitted ballots. Fifty-four out of 431 (12.6%) original judgments were changed with equal distribution among different scenarios. Conclusions: Our survey showed a great divergence of management of similar patients and should provide a stimulus for an evidence-based evaluation of liver histology in chronic HCV infection. (c) 2005 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

The methods employed in the development of needs-based quality of life (QoL) instruments have evolved with time as advances have been made in the field of psychometrics and as experience has grown. This paper illustrates the current instrument development methodology with reference to three needs-based QoL measures recently developed for use in dermatology: •The Quality of Life Index for Atopic Dermatitis (QoLIAD);•The Psoriasis Index of Quality of Life (PSORIQoL); and•The Parents' Index of Quality of Life—Atopic Dermatitis (PIQoL-AD).

Background: Being overweight or obese has substantial effects on individuals' perceptions of their health and quality of life (QoL). Generic measures often miss important QoL information, and existing obesity-specific instruments have shortcomings with respect to cross-cultural input, application to differing levels of severity, conceptual clarity, and patient burden. Objective: This study aimed to develop culturally sensitive measures of QoL and symptoms in overweight or obese persons, both those trying to lose weight and those not trying to lose weight. Methods: Currently accepted criteria and guidelines for questionnaire development were streamlined and augmented to include cross-cultural input from 5 European countries and the United States. The preliminary pool of items was created based on qualitative interviews conducted in the United States, followed by an early check of item translatability and preharmonization across all languages. Ten additional qualitative in-country interviews were then conducted to produce further culture-specific items. This was followed by 2 forward and 1 backward translation, plus cognitive debriefing interviews in each country. Finally, an expanded international harmonization meeting was held to ensure inclusion of appropriate new items and their acceptability across all 6 cultures. Results: The procedures described resulted in development of the 41-item Obesity and Weight Loss Quality of Life questionnaire and the 20-item Weight-Related Symptom Measure. These questionnaires are subject to further psychometric validation. Conclusions: Augmentation of the initial item-generation and international harmonization steps of questionnaire development through integration of cross-cultural input allowed greater validity of cross-cultural content while meeting time, budget, and resource constraints.

Background: The Quality of Life in Depression Scale (QLDS) employs the needs-based model of quality of life (QoL) and was developed in the UK and The Netherlands as an outcome measure for clinical trials. This paper describes the production and psychometric assessment of nine new language versions for Canada (French and English), Denmark, France, Germany, Italy, Morocco, Spain and the US. Methods: Three adaptation stages were employed; production of conceptually equivalent translations, field-test interviews and assessment of reliability and construct validity by survey of patients with major depression. Results: Few problems were experienced with producing conceptually equivalent translations, except in Morocco. Patients in the field-test interviews found the instrument to have appropriate content and to be easy to complete. Internal consistency and test–retest reliability were excellent for all language versions and scores were found to relate appropriately to measures of depression severity and health status. Limitations: Further investigation is required of the ability of the measure to assess individuals at the extremes of the QoL continuum. Data collected with the Arabic QLDS should not be combined with those from other countries. Conclusions: The QLDS is the first instrument designed to assess QoL in depression based on a coherent model of the construct. Each language version has been shown to be well accepted by respondents and to have excellent psychometric properties. As the instrument is now available in a large number of languages, the QLDS is the QoL instrument of choice for inclusion in clinical trials of interventions for depression.

This paper focuses on patient's views and how they are addressed in current approaches to the measurement of health related quality of life (QOL) during the peri-and post-menopausal periods. Although all QOL questionnaires are meant to be subjective as they ask for self-reported assessments, they do differ in their rationale, particularly the standards against which patient QOL is assessed. These standards can be defined either by the researchers, the doctors, the community or the patients themselves. Approaches to measurement include the assessment of symptoms, physical function, the ability to perform daily activities, the achievement of personal expectations and motivational needs, well-being and utility theory. The contribution that each approach can make to the measurement of quality of life is examined and instruments such as those used during the peri- and post-menopausal periods are given as examples. The different underlying rationales have resulted in instruments that serve different purposes. The rationale therefore should be used as a guide for choosing the most appropriate measure according to whether the information is required to inform decision making by payers, clinicians or individuals. Further research is required to assess interventions for peri- and post-menopausal women in the context of their needs and expectations.

Several studies have shown that growth hormone deficiency in adults leads to poor well-being and other clinical consequences, and that these improve when the hormone is replaced. However, the studies employed generic measures of health status that miss important aspects of the patients' experience and that have inadequate reliability and responsiveness. This paper describes the European development and testing of the Quality of Life–Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), a condition-specific quality of life measure for use in clinical trials and for the routine monitoring of patients. The instrument was produced in five languages; English, Swedish, Italian, German and Spanish. Each language version is shown to have good reliability, internal consistency and construct validity. The QoL-AGHDA is currently included in an international database monitoring the long-term efficacy and safety of growth hormone replacement therapy and in clinical trials in a number of countries.

Nei primi anni’ 60, dopo uno straordinario trend di crescita economica, le amministrazioni democratiche americane (seguite presto anche dalle altre dell’Occidente) inaugurarono una stagione di politiche redistributive indirizzate alle problematiche del mondo civile. Le prospettive di benessere che si aprivano richiedevano misure adatte a seguire le nuove visioni del mondo. Fino ad allora, la misura chiave piu rappresentativa delle grandezze economiche dello stato era il Prodotto Interno Lordo (PIL), che aveva conosciuto una lunga parabola iniziata dopo la crisi del 1929, che rappresentava il parametro comune del benessere di un Paese.

Come mostrano i precedenti capitoli di questo volume, che riflettono a loro volta una folta letteratura [1–6], la partecipazione culturale avrebbe ricadute positive molto importanti sul benessere e la percezione dello stato di salute. Il presente approfondimento risponde all’esigenza di valutare questa relazione anche su sottogruppi di popolazione nelle loro segmentazioni tipiche, fra cui la piu suggestiva e quella di genere. Lo studio ambientato nel 2009 nella citta di Milano, descritto al capitolo 16, si e prestato particolarmente all’approfondimento di questa tematica, grazie alle tradizioni civili e culturali della citta. Il focus di questo capitolo e quello di valutare la ricaduta sul benessere di genere delle attivita di tempo libero, in particolare di quelle culturali, cogliendone le evidenze empiriche e offrendo alcune spiegazioni sulle differenze tra genere maschile e femminile.

Boundary lines between medicine and social sciences have often been crossed in either direction during the course of their history. Lately the re-discovery of social determinants in health inequalities recalls the tradition of the socio-medical inquiries that that characterized the XIX and the XX century, while the epidemiological scenario of the latter has long included social daily life functioning in the evaluation, prevention and care of most important chronic diseases. Vulnerability is a new concept for the explanation of health inequalities. It is not a causal but a dispositional concept so it triggers events under certain environmental circumstances; it is systemic in its essence, being complementary to resilience; it was first applied to the socio-ecological environments of the third world. It was recently regarded as suitable for the western post-modern risk societies in health sociology in particular by describing both systems undergoing fatal shocks (i.e. pandemic/epidemic risk fatalities) as well as vulnerable trajectories throughout individual course of lives. By including basic factors such as social determinants of inequality vulnerability contends with frailty its importance in medical sciences, while, as a disposition, it is increased or decreased by socio-structural as well as individual action. Its inclusion in health sociology studies requires middle range theories such as those on coping and on social capital both at the individual and community level.

Lower urinary tract symptoms are common in pediatric patients. To our knowledge no validated instruments properly designed to screen lower urinary tract symptoms in the pediatric population have been published to date. In the International Consultation on Incontinence Questionnaire Committee the psychometric properties of a screening questionnaire for pediatric lower urinary tract symptoms were assessed.The 12-item International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms was developed in child and parent self-administered versions, and produced in English, Italian and German using a standard cross-cultural adaptation process. The questionnaire was self-administered to children 5 to 18 years old and their parents presenting for lower urinary tract symptoms (cases) or to pediatric/urological clinics for other reasons (controls). A case report form included history, urinalysis, bladder diary, flowmetry/post-void residual urine volume and clinician judgment on whether each child did or did not have lower urinary tract symptoms. Questionnaire psychometric properties were evaluated and data were stratified into 3 age groups, including 5 to 9, 10 to 13 and 14 to 18 years.A total of 345 questionnaires were completed, of which 147 were negative and 198 were positive for lower urinary tract symptoms. A mean of 1.67% and 2.10% of items were missing in the child and parent versions, respectively. Reliability (Cronbach's α) was unacceptable in only the 5 to 9-year-old group. The high ICC of 0.847 suggested fair child/parent equivalence. Sensitivity and specificity were 89% and 76% in the child version, and 91% and 73.5% in the parent version, respectively.The questionnaire is an acceptable, reliable tool with high sensitivity and specificity to screen for lower urinary tract symptoms in pediatric practice. Problems related to literacy suggest use of the child versions for patients older than 9 years. In research this questionnaire could be used to recalibrate the prevalence of lower urinary tract symptoms in children.

Background The indications for prescribing malaria chemoprophylaxis lack a solid evidence base that results in subjectivity and wide variation of practice across countries and among professionals. Methods European experts in travel medicine, who are members of TropNetEurop, participated in a survey conducted using the Delphi method. This technique aims at evaluating and developing a consensus through iterations of questionnaires, controlled feedback, and statistical group responses. Results A first questionnaire, including questions about controversial issues in prescribing malaria prophylaxis, required responses on a visual scale between 1 and 10. The questionnaire included issues on problematic prescribing, characteristics of drugs, relevance of geography, and importance of insect bite prevention. The repeat questionnaire with the group response from the first round revealed an increasing consensus on most issues. A second survey considered 14 practical scenarios (including two internal standards) and investigated preferred choice of prophylaxis. A significant consensus was noted in 8 of 14 scenarios, which did not increase after a second round. The analysis revealed a wide variation in prescribing choices with preferences grouped by region of practice, and a greater willingness to prescribe in northern and southern Europe than in central Europe. The second round showed a 9.5% change of opinion. Conclusions The study shows that improving the evidence base on efficacy and tolerability and risk of malaria for prescribing chemoprophylaxis is needed as is further discussion across Europe to achieve harmonization of prescribing practice.

Objective: The international development of the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described. Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument. Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test–retest reliability (above 0.85), internal consistency and promising validity. Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials.

Summary Purpose : To develop an Italian adaptation of the shortened version of the Quality-of-Life in Epilepsy Inventory (QOLIE-31). Methods : The study population comprised 503 consecutive ambulatory patients with epilepsy from 44 centers. Internal validity was tested by factor analysis, to detect similarities to and differences from the original version, and by multitrait/multi-item analysis, to assess item convergent and discriminant validity. External validity testing included correlation to the SF-36 Inventory, to check the properties of the epilepsy-specific dimensions. Validity testing was completed by analysis of variance (ANOVA) of QOLIE-31 dimension scores against demographic and clinical variables, including age, sex, seizure frequency and number of drugs. Results : The domains showing the highest internal consistency and the best discriminant validity were Medication effect , and Seizure worry . Social functioning had the lower discriminant validity. With reference to the SF-36 scores, the study patients were slightly but constantly below the population values, mostly for General health and Role physical domains. All QOLIE-31 dimensions were sensitive to almost any demographic and clinical variable, except for Medication effects (sensitive to number of drugs) and Energy–fatigue (sensitive to age). Conclusions : Except for Social functioning , the psychometric properties of the Italian adaptation of the QOLIE-31 Inventory are fairly good and similar to the American version and the Spanish translation. Social functioning scale suffers shortcomings because of life constraints caused by epilepsy (with missing values for regular job and driving license).

Purpose To date no validated instruments are available to screen lower urinary tract symptoms (LUTS) in children, even if several questionnaires deal with clinical outcome. We developed and tested for validity a screener tool (ICIQ-CLUTS), to detect LUTS in children Material and Methods A 12-items questionnaire had been designed by experts, in a children's (ICIQ-CLUTSchildren) and parents' (ICIQ-CLUTSparents) version, and submitted to a standard cross-cultural adaptation process, simultaneously in English, Italian and German languages. Items investigated: age, gender, urinary tract infection, enuresis, daytime incontinence, daytime frequency, urgency, voiding postponement, straining to void, urge incontinence, feeling of incomplete emptying, bowel movements. Questionnaires have been administered, anonymously and blended, to children (age 10-18 years) and to parents of children aged 5-18 years presenting for LUTS (cases) or attending paediatric/urological clinics for reasons different that LUTS (controls); post-operative controls and uncontrolled insulin-dependent-diabetes being excluded.A Case-Report-Form comprehended history, urinalysis, bladder diary, flowmetry/PVR and a final clinician's judgment. Acceptability of ICIQ-CLUTS children and ICIQ-CLUTS parents were evaluated as percentage of missing items. ICIQ-CLUTS children and ICIQ-CLUTS parents scores were matched to clinician's judgement (taken as gold standard) in order to produce sensitivity and specificity (confidence interval 5-10%; level of confidence 95%). Results A total of 345 questionnaires were completed (267 by children and parents, 75 by parents and 3 by children). Final clinician's judgement identified 197 children as LUTS+ and the remaining 148 as LUTS-. Low percentage of missing items confirmed acceptability of ICIQ-CLUTS children (average missing items:1.7%) and ICIQ-CLUTSparents (average missing items:2.0).Sensitivity and specificity were, respectively,85% and 81% for ICIQ-CLUTS children and 87% and 70% for ICIQ-CLUTS parents. Conclusions Data analysis confirms ICIQ-CLUTS as valid and easy tool to screen LUTS in general paediatric population. ICIQ-CLUTS might be used to reconfigurate prevalence of LUTS in children, which was previously evaluated without validated instruments.

Article 38 above of the Italian Constitution of 1948 (Moss and Rogers, 1980, p. 161) reflected the welfare philosophy of the past rather than the new and more positive role of the state in welfare envisaged by such reports as those of Beveridge in the UK, Laroque in France, and so on. It talked about ‘maintenance’ for those ‘unable to work’ rather than national unity and social rights for all. For this reason, even though social expenditure in the 1960s and early 1970s as a proportion of GDP was high by OECD standards (see Table 1.2), the philosophy and the method of provision of welfare were dated. It was not until the late 1970s that Italy adopted a universalist approach in the area of health and also extended its social security system to most groups in society. Interestingly enough, this climax in the development of social policy in Italy was reached at a time when the welfare state was already under attack in many other West European countries.

There is increasing interest throughout Europe in measuring health needs in the general population and in the 'quality of life' of patients. This has led to a demand for questionnaires capable of measuring health status in a reliable and valid manner. Most existing measures have, however, been standardised only in the U.S.A. and, to a lesser extent, in the U.K. The issue of translation and retesting of questionnaires prepared in the English language for use in other countries has received surprisingly little attention. This paper describes some of the technical, linguistic and conceptual issues raised by translation and the processes involved in producing acceptable country-specific versions of the Nottingham Health Profile according to a systematic method.

Background The ileal orthotopic neobladder (IONB) is often used in patients undergoing radical cystectomy. The IONB allows to void avoiding the disadvantages of the external urinary diversion. In IONB patients the quality of life (QoL) appears compromised by the need to urinate voluntarily. The patients need to wake up at night interrupting the sleep-wake rhythm with consequences on social and emotional life. At present the QoL in IONB patients is evaluated by generic questionnaires. These are useful when IONB patients are compared with patients with different urinary diversions but they are less effective when only IONB patients are evaluated. To address this problem a specific questionnaire—the IONB-PRO—was developed. Methods A) Based on a conceptual framework, narrative-based interviews were conducted on 35 IONB patients. A basic pool of 43 items was produced and organized throughout two clinical and four QoL dimensions. An additional 15 IONB patients were interviewed for face validity testing. B) Psychometric testing was conducted on 145 IONB patients. Both classic test strategy and Rasch analysis were applied. Psychometric properties of the resulting scales were comparatively tested against other QoL-validated scales. Results The IONB-PRO questionnaire includes two sections: one on the QoL and a second section on the capability of the patient to manage the IONB. For evaluation of the QoL, three versions were delivered: 1) a basic 23-item QoL version (3 domains 23-items; alpha 0.86÷ 9.69), 2) a short-form 12-item QoL scale (alpha = 0.947), and 3) a short-form 15-item Rasch QoL scale (alpha = 0.967). Correlations of the long version scales with the corresponding dimensions of the EORTC-QLQ C30 and the EORTC-BLM30 were significant. The short forms exhibited significant correlations with the global health dimension of the EORTC-QLQ and with the urinary subscales of the EORTC-BLM30. The effect size was approximately 1.00 between patients at the 1-year follow-up period and those with 3, 5, and > 5-year follow-up periods for all scales. No relevant differences were observed between the 12-item short-form and the Rasch scale. Conclusions The IONB-PRO long and short-forms demonstrated a high level of internal consistency and reliability with an excellent discriminanting validity.