Italian Validation Research Articles

Daphne European Research Project: Italian Validation of Hypothesis Model (SAI-R, CORE-OM and BDI-II)

Daphne European Research Project: Italian Validation of Hypothesis Model (SAI-R, CORE-OM and BDI-II)

The Myleloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Derived Total Symptom Score (TSS): An International Trial of 1433 Patients with Myeloproliferative Neoplasms (MPNs),

Abstract 3839▪▪This icon denotes a clinically relevant abstract BACKGROUND:We have previously reported on the validation of the 18 item Myeloproliferative Neoplasm Assessment Form (MPN-SAF) (Blood 2011;118:401–408) given in conjunction with the 9 item Brief Fatigue Inventory (BFI) (Cancer 1999;85:1186–1196) to assess symptomatic burden in an international sample of MPN patients (pts), including validation in English, Italian, Swedish, German, French, Spanish, and Dutch. We desired to assess the utility of an average total symptom score (TSS) from the most pertinent and representative MPN symptoms for purposes of assessing the burden of symptoms in MPN pts, and subsequent tracking in response to therapy. METHODS:Data was collected among an international cohort of MPN pts and their physicians, including patient demographics and disease features and completion the BFI, MPN-SAF and the EORTC-QLQ-C30. Among pts who completed at least 5 of 10 specific items on the BFI and MPN-SAF, an average score was calculated as the TSS. TSS items included “worst” fatigue from the BFI and 9 items from the MPN-SAF including concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss and fever. The TSS thus had a possible range of 0–10 with 10 representing the highest level of symptom severity. Data was then analyzed for internal consistency, and divergent, convergent validity, and construct validity. RESULTS:Patient Demographic and Disease Characteristics:1433 MPN pts were prospectively enrolled (Argentina 22, France 482, Germany 59, Italy 186, Netherlands 236, Puerto Rico 10, United Kingdom 57, United States 102, Spain 157, Sweden 114, Uruguay 8) including 594 ET, 538 PV and 293 MF pts (8 missing; MF: 61% Primary MF, 23% post-ET MF, 15% post-PV MF). 1408 pts completed at least 5 of the 10 items necessary to calculate a TSS. Pts were of characteristic age (mean 62, range 20–94) and gender (54% female) common to disease. TSS Burden of MPN Symptoms: Consistent with prior studies, the majority of pts (>50%) were symptomatic in each TSS item except for items associated with high disease severity, namely bone pain (48.6%), weight loss (30.6%) and fever (18.4%). Fatigue carried the highest symptom intensity (4.4, SD=2.8), followed by problems with concentration (2.5, SD=2.8) and early satiety (2.5, SD=2.7). Overall mean TSS was 2.1 (SD=1.6). Divergent Validity: TSS significantly differed among MPN disease subtypes (p<0.001) with means of 1.9 (SD=1.5), 2.2 (SD=1.6), and 2.5 (SD=1.7) for ET, PV, and MF pts, respectively. Statistically significant differences in TSS were also observed between pts with clinically deficient (>4, n=480) versus non-clinically deficient QOL (<4, n=894; mean 3.3 versus 1.5; p<0.001). When comparing to MD perceptions, TSS was significantly higher when MDs rated >2 of 6 common MPN-related symptoms as clinically significant (2.8, n=400) versus <2 symptoms (1.6, n=726; p<0.001). No significant trends were observed when comparing disease type by the presence of a current medical therapy. Convergent Validity: The TSS was strongly correlated with patient-reported QOL (r=0.59, p<0.001). Overall excellent correlations existed between the TSS and EORTC-QLQ-C30 functional subscales (all p<0.001 and r>0.50 except social functioning [r=0.48]). Additionally, excellent correlations were observed between the TSS and EORTC-QLQ-C30 fatigue and pain symptom scales (r>0.5, p<0.001). Internal Consistency and Construct Validity: The TSS had excellent internal consistency (Cronbach’s alpha=0.83). Factor analysis identified a single underlying construct among the 10 TSS items (significant eigenvalues being >1). Factor loadings ranged from 0.43 for fever and weight loss to 0.71 for inactivity. The single factor suggests that the arithmetic mean of the 10 items is an appropriate global TSS score. CONCLUSION:The TSS demonstrated excellent psychometric properties. Overall, results of validity and internal consistency indicate that the TSS is a concise, valid, and accurate assessment of symptom burden among MPN pts. This new scoring will facilitate ease of implementation of the MPN-SAF into larger clinical trials and reduce ambiguity associated with interpreting response outcomes. Future analyses to investigate the impact of therapies on TSS are ongoing. Disclosures:No relevant conflicts of interest to declare.

Italian validation of the Brief Rcope scale for religious coping

Interest in the relevance of religion and spirituality to medicine has grown in the last decades in sight of possible association with well being. The so-called religious coping is a further step which has prompted by a growing awareness of beneficial effect on stress and outcome of many disabling diseases. A measure of this kind of coping is “The Brief RCOPE” which has gained a wide application. We translated “The Brief RCOPE” into Italian and validated the version. There are two main reasons why an Italian translation of a religious coping scale was deemed useful: (i) Italian population reached 60 millions of inhabitants but Italians and their families who live abroad considerably increase that amount and (ii) Italy has a large aging population and thus a high prevalence of disabled patients. The translation was accomplished in several steps, including the back translation. Altogether, the translated scale was applied to 211 participants. One hundred and sixteen healthy volunteers were the control group. Thirty-five frail elderly (FE) in residence, twenty-three participants from nursing homes (NHs), twenty members of religious orders, and seventeen cancer (K) patients were also enrolled in the study. The Brief RCOPE consists of two sub-scales ranging from 7 (low) to 28 (high). They measure positive and negative coping. Each one of the 14 items is scored on a 4-point Likert scale with response options from 1 (strongly disagreement) to 4 (strongly agreement). The positive scoring values outlined differences among groups, whereas negative coping values had a smoothing effect. Religious people have a high median value (25) at positive coping sub-scale. They outscore lay-people and the finding could be expected. By contrast, FE, NH, and K participants do not score differently from religious people. The scale has internal validity. The Cronbach’s Alpha coefficient was 0.90 (positive coping scale) and 0.78 (negative coping scale) in the whole sample. The ranges of values in the sub-groups were 0.69–0.90 and 0.59–0.83, respectively, for the positive and the negative Brief RCOPE. The Spearman coefficient for test–retest reliability was calculated in 12 clergy members and in 12 healthy volunteers. In both cases, the value was 0.9, P < 0.0001. The scale has also external validity. The difference between the positive and the negative sub-scales is confirmed by the Kruskal–Wallis test. The 5-group comparison is highly significant. The Mann–Whitney test was then used for a post-hoc comparison. It was found that religious members, FE, NH, and K participants outscore healthy volunteers. In conclusion, a reliable tool is available to health and social science Italian researchers for integrating religious dimensions into models of health, stress, and coping. The scale can be useful for identifying those patients who can exploit religious coping.

Italian Validation of the English Prom-Uss-Q Questionnaire in Patients Undergoing Anterior Urethroplasty

The aim of this study was to translate and validate in Italian the condition-specific patient-reported outcome measure for urethral stricture surgery (PROM-USS-Q) and evaluate its psychometric properties to determine whether it was suitable for routine use. We translated the English version; 52 men scheduled for bulbar urethroplasty at our high volume center agreed to self-complete PROM-USS-Q pre-operatively, and between four and six months post-operatively. We undertook an in-depth psychometric assessment of the questionnaire constructs. There was excellent correlation between change in voiding symptom score and change in Qmax (ρ=0.746) with parallel improvements in EQ-5D visual analogue and time trade-off scores demonstrating criterion validity. Test-retest reliability and internal consistency statistics were similarly robust: intra-class correlation coefficients ranged from 0.81 to 0.90 for the individual voiding questions. Cronbach's alpha was 0.79 for the overall score and ranged between 0.74 and 0.81. These indices exceeded our predefined reliability thresholds for inclusion. Statistically highly significant improvements in construct scores occurred following urethroplasty, demonstrating responsiveness to change. The PROM-USS-Q is a practical and robust instrument for assessing voiding symptoms and health-related quality of life following urethral stricture surgery.

The trauma symptom inventory: Italian validation of an instrument for the assessment of post-traumatic symptoms

The trauma symptom inventory (TSI; Briere, 1995) is a useful instrument for the assessment of post-traumatic and common trauma-related mental health symptoms. The purpose of the study was to validate the Italian version of the original TSI. Participants from non-clinical (n = 285), clinical (n = 110) and post-traumatic (n = 30) samples completed the TSI as part of a battery that included self-report measures of trauma exposure [MMPI-2 PK scale and Impact of Event Scale-Revised (IES-R)] and of psychological symptoms [brief symptom inventory (BSI) and symptom questionnaire (SQ)]. TSI validity scales were compared with MMPI-2 validity scales in order to assess convergent validity. The TSI Italian version showed adequate internal consistency reliability and a good convergent validity. Discriminant function analysis indicates a classification accuracy of TSI scales of 90% for true-positive and 91.4% for true-negative post-traumatic stress disorder (PTSD) cases. A revised three-factor structural model, which demonstrated an adequate and the best fit for the data, was proposed. The study extended the generalization and validity of TSI and provided some suggestions for eventually revisiting factorial structure of the questionnaire.

Self-Rating Scale of Self-Directed Learning (SRSSDL): preliminary results from the Italian validation process

Self-directed learning is considered a key feature in the learning process. Despite the emerging debate regarding continuing education strategies and the effectiveness and pertinence of the learning needs of adult learners, little evidence is available on the measurement of the self-directed learning competence of nurses. The main aim of the study was to evaluate the validity and reliability of the Self-rating Scale of Self-directed Learning (SRSSDL) in an Italian sample of nurses. The forward—backward translation process of the original SRSSDL was adopted. Forty-one nurses were involved in the test—retest reliability. Internal consistency was evaluated in a convenience sample of 334 nurses working in Northeast Italy. The Italian version of the SRSSDL has demonstrated good reliability (Pearson coefficient 0.73) and internal consistency (Cronbach’s alpha coefficient 0.94). The SRSSDL was found to be a valid and reliable instrument in the Italian context. This study has implemented the external validity of the scale by its application to a different population and context in its first validation process.

Review: Self-Rating Scale of Self-Directed Learning (SRSSDL): preliminary results from the Italian validation process

Review: Self-Rating Scale of Self-Directed Learning (SRSSDL): preliminary results from the Italian validation process

Italian validation of the drinking motives questionnaire revised short form (DMQ-R SF)

The aim of the study is to validate the four-dimensional structure of the Drinking Motive Questionnaire Revised Short Form (DMQ-R SF) in a sample of Italian adolescents and to investigate associations of these motives with frequency of alcohol use and sensation seeking. The data were gathered through self-administered questionnaires in classrooms. The questionnaires were filled out by a representative sample of 2725 (56.4% males; mean age = 16.2) 8th to 13th grade alcohol-using students. Confirmatory factor analysis and structural equation models were applied. The four-dimensional structure of the DMQ-R SF was confirmed in the general sample and among subgroups defined by gender and age. Furthermore, enhancement, social and coping motives were found to be positively related to sensation seeking and frequency of alcohol use. Conformity motives were negatively related to sensation seeking and frequency of alcohol use. The results are consistent with previous studies from other countries and indicate that the DMQ-R SF is a valid instrument to assess drinking motives among Italian adolescents and possibly among those from other Mediterranean countries.

Italian validation of INQoL, a quality of life questionnaire for adults with muscle diseases

A quality of life (QoL) questionnaire for neuromuscular diseases was recently constructed and validated in the United Kingdom in a sample of adult patients with a variety of muscle disorders. Preliminary results suggested it could be a more relevant and practical measure of QoL in muscle diseases than generic health measures of QoL. The purpose of our work was: (i) To validate INQoL in Italy on a larger sample of adult patients with muscle diseases (ii) to compare INQoL to SF-36. We have translated into Italian and applied language adaptations to the original UK INQoL version. We studied 1092 patients with different muscle disorders and performed (i) test-retest reliability (n = 80); (ii) psychometric (n = 345), known-group (n = 1092), external criterion (n = 70), and concurrent validity with SF-36 (n = 183). We have translated and formally validated the Italian version of INQoL confirming and extending results obtained in the United Kingdom. In addition to good results in terms of reliability, known-group and criterion validity, a comparison with the SF-36 scales showed a stronger association between INQoL total index and SF-36 physical (r = -0.72) than mental (r = -0.38) summary health indexes. When considering comparable domains of INQoL and SF-36 with respect to an objective measure of muscle strength assessment (MMRC), regression analysis showed a stronger correlation using INQoL rather than SF-36 scores. INQoL is recommended to assess QoL in muscle diseases because of its ability to capture physical limitations that are specifically relevant to the muscle condition.

Quality of life and motor impairment in ALS: Italian validation of ALSAQ

Objectives: To evaluate the validity and reliability of the amyotrophic lateral sclerosis assessment questionnaire (ALSAQ) in an Italian cohort of ALS patients and to further characterize the relationship between motor impairment and quality of life (QoL) in ALS.Methods: Seventy-six patients completed the Italian version of ALSAQ-40 and ALSAQ-5. To verify test–retest reliability, 30 patients were revaluated after 3 months. The medical outcome study short form 36 (MOS SF-36) questionnaire and revised ALS functional rating scale (ALSFR-R) scale were used to assess Italian ALSAQ-40 construct validity. The limb muscles' Medical Research Council (MRC) score and forced vital capacity (FVC) were used to measure the degree of motor impairment.Results: The Italian ALSAQ-40 showed a very good internal consistency (all subscales Cronbach's alpha>0.86) and a good construct validity as shown by the patterns of correlation between the subscales and SF-36 (resp. ALSFRS-R) scores. ALSAQ-5 showed a positive correlation with the corresponding ALS patient total score and subscale scores of the ALSAQ-40 (Spearman's correlation coefficient>0.73). The emotional functioning subscale did not correlate with any motor impairment measures.Discussion: Italian ALSAQ-40 and ALSAQ-5 psychometric properties are reliable and similar to those showed by the original English version. We observed emotional aspects to be distinct from physical involvement.

Anhedonia and cognitive impairment in Parkinson's disease: Italian validation of the Snaith–Hamilton Pleasure Scale and its application in the clinical routine practice during the PRIAMO study

Objective To assess the psychometric properties of the Italian version of the Snaith–Hamilton Pleasure Scale (SHAPS) and to study the relationship between anhedonia, depression and cognitive impairment in patients with Parkinson's disease (PD). Methods The SHAPS (14 items) was translated into Italian and pre-tested in a pilot study. Two items evaluating physical anhedonia related to sexual issues were added. The Italian version of SHAPS was validated in 274 consecutive PD patients, divided into patients with major depression according to DSM-IV criteria (dPD) and patients without depression (nPD), and in healthy subjects. To test the feasibility of the instrument and to determine whether clinical data affect anhedonia, we also administered SHAPS to 1307 patients with different types of parkinsonism. Results The Italian SHAPS proved to be easy to understand as regards the question and answer modes. Intraclass coefficient for test–retest reliability was 0.65 for the total score. KR index was 0.61. ANOVA of the SHAPS total score revealed that scores were higher in dPD patients than in healthy controls and nPD ( p < 0.05). In the 1307 patients with various types of parkinsonism, the SHAPS data showed that anhedonia was related to age, type of parkinsonism, apathy, depression and cognitive impairment. Anhedonia was correlated with frontal dysfunctions in supranuclear palsy and PD patients ( r = -0.682 and −0.264 respectively, p < 0.05). Conclusion The Italian version of the SHAPS is a reliable tool with which to assess anhedonia in patients with PD and other forms of parkinsonism.

The Italian validation of the Montreal Global definition and classification of gastroesophageal reflux disease

Recently, a Global definition and a classification of gastroesophageal reflux disease (GERD) were developed by Montreal Consensus Group, composed of international expert gastroenterologists. Guidelines and consensus documents are, however, infrequently accepted and adopted at a local level. The aim of this study was to measure the acceptance of Montreal Global definition of GERD consensus document by specialists in a single country (Italy) and to measure the linguistic, scientific, and practical differences between the international consensus document and the Italian version. A 2-day meeting was held in June 2007 in Rome, Italy, attended by 147 Italian physicians who were experts in gastroenterology. They reviewed the individual original statements in their Italian translation and then voted on the statement using the scoring system used by the Montreal Consensus Group (6-point Likert scale). Voting was performed at baseline and after an analytical discussion on each statement, led by six internationally renowned experts. Consensus was defined as an agreement with a statement by at least two-thirds of the group. Results were compared with the Montreal statements. The level of consensus was already extremely high at the first vote (>90% with the two-thirds threshold). The level of agreement at the second vote increased slightly. The maximum variation between two votes was 33% (of increase from first to second round, 59-92%). The high level of agreement could be because of both the general acceptance of Montreal Consensus by scientific community, and the new scientific evidences published after the Montreal report, which fit with the original statements. This study is the first national linguistic validation of the Montreal Global definition of GERD and is also proof of its scientific validity, based on the same methodology used to create the Montreal statements. It also suggests that evidence-based International disease classification systems can be applied to local settings after validation by local experts.

World Health Organisation Disability Assessment Schedule II: Contribution to the Italian validation

Introduction. The World Health Organisation Disability Assessment Schedule II (WHODAS II) is an instrument developed by the World Health Organisation in order to assess behavioural limitations and restrictions to participation experienced by an individual, independently from a medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability and Health: ICF. Specifically, the instrument is designed to evaluate the functioning of the individual in six activity domains: Understanding and communicating, Getting around, Self-care, Getting along with people, Life activities, Participation in society.Purposes. Considering the widespread consent about the usefulness of the WHODAS II, the general aim of the present study is to provide a contribution to the validation of the Italian version.Method. The WHODAS II Italian version has been administered to a sample of 500 participants subdivided in two groups: 271 normal adults and 229 disabled adults. The disabled participants group has been subdivided in three sub-groups, according to their disability: 111 motor disabled, 45 mental disabled, 73 sensory disabled.Results. The mean Total score of the WHODAS II is 12.95 for the normal adults and 22.93 for the disabled group. Either group obtains the least impairment in the Self-care domain. This could be probably due to the presence of social-health workers in everyday life for all Italian disabled people. For the three disabled participant groups separately computed the mean Total score is: 28.66 for the motor disabled, 24.60 for the mental disabled, and 14.97 for the sensory disabled, confirming that sensory disabled do not perceive their disability as a personal functioning problem but a socially constructed one. Some subscales of WHODAS II show relatively strong floor effects. The Cronbach's Alpha calculated for each of the subscales is found to be high. The correlations of the subscales show strong correlations in all subscales.Conclusions. The WHODAS II is a useful instrument for measuring disability and functioning in normal and disabled people. It shows high reliability and a stable factor structure; although an additional psychometric evaluation of a representative sample of Italian disabled should be carried out in order to reach standard scores for each macro-category of disability.

The assessment of empathy in adolescence: A contribution to the Italian validation of the “Basic Empathy Scale”

The present study examined the validity of the Basic Empathy Scale (BES) [Jolliffe, D., & Farrington, D. P. (2006a). Development and validation of the Basic Empathy Scale. Journal of Adolescence, 29, 589–611; Jolliffe, D., & Farrington, D. P. (2006b). Examining the relationship between low empathy and bullying. Aggressive Behavior, 32(6), 540–550.] and found further evidence for the scale's good psychometric properties. The BES was administered to a sample of 655 Italian adolescents to examine the generalizability and reliability of its factor structure. The results of the confirmatory factor analysis showed a reasonable data fit with the two hypothesized BES domains of Cognitive Empathy and Affective Empathy. Scale reliability was also satisfactory, showing good internal consistency. Lastly, BES scores were significantly associated with other empathy questionnaire scores (the Interpersonal Reactivity Index and Balanced Emotional Empathy Scale) and with a scale measuring prosocial behavior. Research and practice implications are discussed.

Qualiveen Italian Validation: A Long and Short Form Quality of Life Questionnaire in Patients with Spinal Cord Injury and Urinary Disorders

Qualiveen Italian Validation: A Long and Short Form Quality of Life Questionnaire in Patients with Spinal Cord Injury and Urinary Disorders

The Outcome Questionnaire 45.2. Italian validation of an instrument for the assessment of phychological treatments

The Outcome Questionnaire (OQ-45.2; Lambert et al., 2004) was designed to measure important areas of functioning (symptoms, interpersonal problems and social role functioning) that are of central interest in mental health. The cross-cultural validity of the OQ-45.2 in the Italian population has been examined by comparing the psychometric properties and equivalence in factor structure and normative scores of the Italian OQ with the original American version. Data were collected at university (N = 461), in community (N = 61) and in three mental health care organisations (N = 301). Results showed that the psychometric properties of the Italian OQ were adequate and similar to the original instrument. The CFA supported the multidimentional construct system of the instrument. Furthermore, normative scores were different for the Italian and American samples and this resulted in different cutoff scores for estimating clinically significant change in the Italian population. The Italian version of the OQ-45.2 appears promising as a measure of general psychological distress, and it could be used to measure the psychotherapy outcome in routine clinical practice.

European Airport movement management: The Italian challenge

Goods and people mobility is a basic need in the age of sustainable growth and globalisation of the world economy. Air transport and aeronautics are seen as key assets for the future of Europe to meet needs of society and to win global leadership. Airports are identified as the future bottlenecks of air transport. Advanced surface movement guidance and control system (A-SMGCS) is seen as a key R&D topic the most promising way to achieve the necessary shift. This paper points out how Italy is addressing the challenge of A-SMGCS implementation and shows the first Italian A-SMGCS test-bed and validation process deployed at Milan-Malpensa.

Brief Form of the Social Phobia and Anxiety Inventory (SPAI-B) for Adolescents

Brief Form of the Social Phobia and Anxiety Inventory (SPAI-B) for Adolescents

A contribution to the Italian validation of the General Decision-making Style Inventory

The main purposes of the present study were to evaluate: the psychometric properties of the Italian version of the General Decision-Making Style Inventory (GDMS); the relationship among decision-making styles, as proposed by GDMS, and thinking styles, assessed by Style of Learning and Thinking (SOLAT). The psychometric properties of GDMS were evaluated on a sample of 422 students, while 230 students also completed the Italian version of the SOLAT. The reliability of the GDMS scales (rational, intuitive, dependent, avoidant and spontaneous) appeared to be satisfactory with good internal consistency. The pattern of inter-correlation between the different styles was in line with the results reported by the literature. Confirmatory and Exploratory factor analyses showed that the hypothesized 5-factor model provided an acceptable fit for the data. Furthermore, the patterns of relationship between the decision-making styles and the SOLAT scales provide concurrent validity of the GDMS.

Italian Validation of the Urogenital Distress Inventory and Its Application in LUTS Patients

ObjectivesThe objective of this study was to validate the Italian version of the Urogenital Distress Inventory (UDI) in a sample of women with lower urinary tract symptoms (LUTS). MethodsThe linguistic validation of the questionnaire was performed through a multistep process: backward and forward translations coordinated by clinical investigators, followed by a pretest. The final version was administered to a larger sample of female patients, aged 18 years or older who had been having LUTS for at least 3 months, numbering 53 subjects. To evaluate test-retest reliability, patients were re-rated after 1 week. To test the questionnaire’s capacity to discriminate women with or without LUTS (cases and controls, respectively), a sample of 53 healthy women was enrolled. A 72-h voiding diary was used as a gold standard and compared with the UDI. ResultsThe correlation coefficient between ratings was ≥0.80, and the discriminant power between cases and controls was confirmed. The UDI showed good internal consistency for all domains, except irritative symptoms (total score’s Cronbach alpha=0.86). Factor analytic structure revealed urinary incontinence to be opposite to the other urologic symptoms, with bed wetting being loaded separately. The average daily number of urgent micturitions was higher in patients who reported they “experience a strong feeling of urgency to empty bladder” in the UDI than those ones who did not (p<0.01). ConclusionsThe Italian version of the UDI is a valid and robust instrument, which can now be used reliably in daily practice and clinical research.