Mauro Niero

International development of the Parents' Index of Quality of Life in Atopic Dermatitis (PIQoL-AD)

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.

International development of the Quality of Life in Depression Scale (QLDS)

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.

Validity of the International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms: A Screening Questionnaire for Children

PURPOSE 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. MATERIALS AND METHODS 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. RESULTS 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 (Cronbachs 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. CONCLUSIONS 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.

Validity and reliability of the Italian version of the Quality-of-Life in Epilepsy Inventory (QOLIE-31).

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).

Quality of Life Assessment With Orthotopic Ileal Neobladder Reconstruction After Radical Cystectomy: Results From a Prospective Italian Multicenter Observational Study.

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.

Development of a questionnaire specifically for patients with Ileal Orthotopic Neobladder (IONB)

BackgroundThe 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.MethodsA) 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.ResultsThe 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.ConclusionsThe IONB-PRO long and short-forms demonstrated a high level of internal consistency and reliability with an excellent discriminanting validity.

Variability in Malaria Prophylaxis Prescribing Across Europe: A Delphi Method Analysis

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.

Integrating the patient's views into the measurement of quality of life: Examples from the peri- and post-menopausal periods

This paper focuses on patients 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.

Health-Related Quality of Life after Radical Cystectomy for Bladder Cancer in Elderly Patients with Ileal Orthotopic Neobladder or Ileal Conduit: Results from a Multicentre Cross-Sectional Study Using Validated Questionnaires

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.

Quality of life following urinary diversion: Orthotopic ileal neobladder versus ileal conduit. A multicentre study among long-term, female bladder cancer survivors

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.