Italian Questionnaire Research Articles

Translation and pre-validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in Italian.

Translation and pre-validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) in Italian.

Future acceptance of automated insulin delivery systems in youths with type 1 diabetes: validation of the Italian artificial pancreas-acceptance measure.

The purpose of this study was to develop a questionnaire to examine the future acceptance of Automatic insulin delivery systems (AIDs), their perceived usefulness, ease of use, and trust in the device in subjects with type 1 diabetes (T1D). A questionnaire in Italian, based on the Technology Acceptance Model, was developed to examine intention to use AIDs, considered as a measure of future acceptance, and its determinants to use the system. A total of 43 questions for children and 46 for parents were included, and a 5-point Likert scale was used. 239 subjects with T1D using multiple daily injections (MDI) or sensor-augmented pump (SAP) and their parents completed the questionnaire. The completion rate was excellent, with almost 100% of items answered. The overall Cronbach's coefficient for children and adolescents was 0.92 and 0.93 for parents, indicating excellent internal consistency in both groups. Parent-youth agreement was 0.699 (95% confidence interval: 0.689-0.709), indicating a good agreement between the two evaluations. Factor analysis identified measurement factors for the "artificial pancreas (AP)-acceptance labeled benefits and hassles of AIDs, and the internal consistency of the total scale was alpha = 0.94 for subjects with T1D and 0.95 for parents. The level of AP acceptance was more than neutral: 3.91 ± 0.47 and 3.99 ± 0.43 (p = 0.07) for youths and parents, respectively (possible score range 1 to 5, neutral score is 3.0). Parents reported higher scores in the benefit items than children-adolescents (p = 0.04). We developed a new questionnaire based on the items available in the literature, and we demonstrated that the "AP-acceptance" reveals a meaningful factor structure, good internal reliability, and agreement between parent-young people evaluations. This measure could be a valuable resource for clinicians and researchers to assess AP acceptance in pediatric patients with T1D and their parents. This patient profiling approach could help to enroll candidates for AIDs with proper expectations and who most likely will benefit from the system.

Development and Validation of the Perceived Deepfake Trustworthiness Questionnaire (PDTQ) in Three Languages

Exposure to false information is becoming a common occurrence in our daily lives. New developments in artificial intelligence are now used to produce increasingly sophisticated multimedia false content, such as deepfakes, making false information even more challenging to detect and combat. This creates expansive opportunities to mislead individuals into believing fabricated claims and negatively influence their attitudes and behavior. Therefore, a better understanding of how individuals perceive such content and the variables related to the perceived trustworthiness of deepfakes is needed. In the present study, we developed and validated the Perceived Deepfake Trustworthiness Questionnaire (PDTQ) in English, Italian, and Slovene. This was done in three phases. First, we developed the initial pool of items by reviewing previous studies, generating items via interviews and surveys, and employing artificial intelligence. Second, we shortened and adapted the questionnaire according to experts’ evaluation of content validity and translated the questionnaire into Italian and Slovene. Lastly, we evaluated the psychometric characteristics via a cross-sectional study in three languages (N = 733). The exploratory factor analyses suggested a two-factor solution, with the first factor measuring the perceived trustworthiness of the content and the second measuring the perceived trustworthiness of the presentation. This factorial structure was replicated in confirmatory factor analyses. Moreover, our analyses provided support for PDTQ’s reliability, measurement invariance across all three languages, and its construct and incremental validity. As such, the PDTQ is a reliable, measurement invariant, and valid tool for comprehensive exploration of individuals’ perception of deepfake videos.

Euterpe music therapy method for children with cerebral palsy.

The main purpose of our study was to evaluate whether involvement in a personalized music therapy program (Euterpe method), could improve the condition of children with cerebral palsy and their parents, compared to a control group. It investigated whether it could positively affect children's sleep quality, temperament and quality of life, quality of family life, and parental stress. A prospective single-center experimental study was conducted at "Bambino Gesù" Children's Hospital (Rome, Italy). All subjects involved attended an intensive rehabilitation program in the Neurorehabilitation Unit. In a group of patients (n = 25), a music therapy treatment was applied to evaluate the effect before and after the intervention. This group was also compared with a control group (n = 10) undergoing a standard protocol without music therapy. In the experimental group, the analysis shows statistically significant effects in the Disorders of initiating and maintaining sleep (p = 0.050) and the Sleep wake transition disorders (p = 0.026) factors, and the total score (p = 0.031) of Sleep Disturbances Scale for Children; the Positive emotionality scale (p = 0.013) of Italian Questionnaires of Temperament (QUIT); the Emotional Functioning (p = 0.029), Social Functioning (p = 0.012), Worry (p = 0.032), Daily Activities (p = 0.032), Total Score (p = 0.039) and Parent HRQL Summary Score (p = 0.035) dimensions of Pediatric Quality of Life for family. While in the control group, only the Attention scale of QUIT (p = 0.003) reaches statistical significance. Our study suggests that music therapy with the Euterpe Method has beneficial effects on fundamental aspects of the child's and his parents' lives, such as sleep, emotion control, and quality of family life.

Reliability and reproducibility of an Italian questionnaire on "Knowledge of high social impact Eye Diseases" (KED-IT).

Health literacy plays an important role in public health. Although this has been demonstrated in the field of ophthalmology, there are very few specific instruments available to assess eye health literacy. This work aims to develop an Italian questionnaire on knowledge of eye diseases (Knowledge on Eye Disease, Italian version; KED-IT) and to evaluate its reliability and reproducibility. The KED-IT focuses on diseases with high social impact, specifically glaucoma, macular degeneration, diabetic retinopathy and keratoconus, which is the main cause of corneal transplant in Italy. A cross-sectional study was conducted. The KED-IT was self-administered by the study participants twice. The interval between each administration (T0 and T1) was 5 to 8 days. Reliability was assessed using the KR-20 coefficient. The test-retest Cohen's Kappa coefficient was estimated to measure the stability and reproducibility of the results obtained between T0 and T1. A total of 60 subjects participated in the study. The response rate at T1 was 92%. The KR-20 reliability coefficient of the 14-item KED-IT questionnaire was good with a value of 0.878. The Cohen's kappa value for all 14 items of the KED-IT questionnaire was k=0.747, indicating good agreement. The KED-IT is the first specific ophthalmic knowledge questionnaire validated in the Italian language and we hope that it may be a starting point for the study of eye health literacy in the Italian population.

Psychometric properties and normative data of the Italian version of the Cognitive Function at Work Questionnaire: a screening tool for detecting subjective cognitive complaints at work.

Considering the extension of working life due to socioeconomic and political factors, many people may experience cognitive complaints (CC) at their workplace, with severe consequences on their quality of life. The identification of workers reporting significative SCC is crucial to eventually address them to an objective neuropsychological evaluation and implement cognitive interventions to guarantee workers' well-being. Since no Italian questionnaires for detecting CC were designed for occupational settings, the aim of the study was to validate the Italian version of the Cognitive Function at Work Questionnaire (CFWQ) and to provide its normative data. Internal consistency, convergent and divergent validity, and factorial structure of the CFWQ were evaluated. A regression-based procedure served to compute percentiles of CFWQ and its subscales. Four hundred twenty-one participants without psychiatric and/or neurological disorders completed the survey. We found that the Italian CFWQ included 26 items, with a good internal consistency (Cronbach's alpha = 0.897) and a six-factor structure (memory, language, processing speed, abstract thinking/behavioral control, behavioral inertia, planning ability). CFWQ score did not correlate with empathy but correlated strongly with memory scores and moderately with anxiety and depression scores. The Italian CFWQ showed good psychometric properties, in analogy with the original English scale. Therefore, it can be successfully employed in organizational contexts to possibly identify workers with CC and therefore with possible co-occurrent psychological, behavioral, and cognitive consequences.

Validation of an Italian Questionnaire of Adherence to the Ketogenic Dietary Therapies: iKetoCheck.

Ketogenic dietary therapies (KDTs) are an effective and safe non-pharmacological treatment for drug-resistant epilepsy, but adherence can be challenging for both patients and caregivers. In Europe, there are no adequate tools to measure it other than monitoring ketosis. This study aimed to adapt and validate the Brazilian adherence questionnaire, Keto-check, into the Italian version: iKetoCheck. Using the Delphi technique, 12 judges validated the contents through agreement rates and the Content Validity Index (CVI). The iKetocheck was self-completed electronically by 61 drug-resistant epilepsy or GLUT1 deficiency patients within an interval of 15 days to measure its reproducibility. The test-retest reliability was evaluated using Pearson's correlation and relative significance test. Exploratory and confirmatory factorial analyses were made using Factor software version 12.03.02. The final tool, iKetoCheck, consists of 10 questions with 5-point Likert scale answers. It evaluates various aspects such as informing caregivers about the diet, organization of meals, measurement of ketosis, weighing food consumed, diet negligence, use of carbohydrate-free medications, attending follow-up visits, reading food labels, consulting an expert for dietary concerns, and cooking at home. The factorial analysis resulted in three factors: "attention," "organization," and "precision," with satisfactory results for indices in exploratory and confirmatory analyses. Although higher mean values of ketonemia measurement were observed in patients with a higher adherence score, these values were not statistically significant (p = 0.284). In conclusion, despite the small sample size, iKetoCheck is a valid tool for evaluating KDTs' adherence in Italian drug-resistant epilepsy or GLUT1 deficiency patients. It can provide valuable information to improve patient management and optimize the effectiveness of KDTs.

SANReSP: A new Italian questionnaire to screen patients for obstructive sleep apnea.

PurposeObstructive sleep apnea (OSA) is a common, prevalent, and underdiagnosed disorder. Its lack of diagnosis and treatment is associated with increased morbidity and mortality. Previous screening questionnaires investigated parameters including body mass index, age, neck circumference, and sex, in addition to symptoms. This study aimed to validate a new Italian, self-administered, and easy-to-use six-item questionnaire that evaluates only subjective symptoms.Patients and methodsThe present study included 2622 patients (male, 2011; female, 611). Patients who were at least 18 years old, spoke Italian, referred to our sleep clinic for possible OSA, and completed the self-administered SANReSP questionnaire were recruited for the study. The predictive performance of the questionnaire was also evaluated.ResultsNocturnal study showed 89.9% of OSA patients had apnea-hypopnea index (AHI) ≥ 5/h; 68.7%, AHI ≥ 15/h; and 48.2%, AHI ≥ 30/h. The optimal SANReSP score for AHI ≥ 5/h was >3 with a sensitivity and specificity of 74.76% and 67.92%, respectively, and an area under receiver operating characteristic curve (ROC) of 0.76. For moderate–severe OSA, the optimal SANReSP score was >3 (sensitivity, 78.18%; specificity, 46.53%; ROC, 0.66). For severe OSA, the optimal SANReSP score was >4 (sensitivity, 59.10%; specificity, 64.73%; ROC, 0.65). The probability of OSA increased with higher SANReSP scores (98.7% and 97.9% in men and women, respectively).ConclusionThe SANReSP questionnaire is a short, easy-to-use, and self-administered screening tool for OSA. Its performance is similar to that of other widely used questionnaires; furthermore, it is advantageous in that it does not require anthropometric measurements.

WHODAS-Child: psychometric properties of the WHODAS 2.0 for children and youth among Italian children with autism spectrum disorder

Purpose A contribution to the Italian adaptation of the original English version of the World Health Organization Disability Assessment Schedule 2.0 for children and youth (WHODAS-Child), proxy-administered among children with autism spectrum disorder (ASD) without intellectual disability. Materials and methods Observational and retrospective study with within-dependent variables by cross-sectional sampling on psychometric properties (internal consistency and construct/criterion validity) of the 36- and 7-item versions of the Italian WHODAS-Child. The original English version was translated into Italian, also considering the Italian version of the WHODAS 2.0 for adults. The Italian questionnaire was then translated back into English. All authors compared the original and back-translated English versions. The sample was collected among parents and clinicians of 100 children with ASD. To assess convergent/divergent validity, the Autism Diagnostic Observational Schedule (ADOS) was also administered. Results Cronbach’s α for both versions’ total scores was good. WHODAS-Child also showed a positive correlation with the three DSM-5 levels of impairment. A pattern of correlations with the ADOS was found for all domains of the WHODAS-Child except for the mobility and self-care domains. Conclusions The WHODAS-Child Italian proxy-administered version has the potential to be a reliable and valid tool to measure functional impairment in children with ASD. Implications for rehabilitation World Health Organization Disability Assessment Schedule 2.0 for children and youth (WHODAS-Child) has shown to be sensitive in detecting children and youth functioning in the domains of activity and participation. WHODAS-Child Italian version seems to be a reliable and valid tool to measure the functional impairment in children with autism spectrum disorder. A critical issue for rehabilitation is that a single “minimal clinically important difference” score for the WHODAS-Child has not yet been established.

Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety, and Depression: A Multi-Arm Psychometric Study.

Mindfulness is a mental state that can be achieved through meditation. So far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. Mindfulness has recently begun to be used in the field of child development. The goal of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperamental characteristics. This multi-arm pre-post study included 41 subjects recruited in the fifth year of two primary school classes. Participants were randomly assigned to the experimental and control groups. The experimental group, but not the control group, underwent an eight-week mindfulness training. Every week, the program included 60-min group sessions. QUIT (Italian Questionnaires of Temperament) and TAD (Test for Anxiety and Depression in Childhood and Adolescence) were used to assess temperament, and anxiety and depression, respectively. Both groups were administered both instruments before and after mindfulness intervention. The mindfulness program lowered anxiety levels and was effective in changing temperament dimensions: there was an increase in social orientation (SO), positive emotionality (PE), and attention (AT), as well as a decrease in inhibition to novelty (IN) and negative emotionality. Path analysis revealed that AT may promote the improvement of both SO and IN. Similarly, PE may be promoted by the decrease of IN. Clinical implications are discussed.

Anxiety and depressive symptoms on continuous positive airway pressure: long-term adherence in patients with sleep apnea syndrome.

Obstructive sleep apnea (OSA) is often associated to mood disorders and anxiety symptoms that may influence negatively the treatment approach. However, the relationship between anxiety, depression and adherence to treatment is still unclear. We investigate the presence of anxiety and depressive symptoms in newly diagnosed OSA patients and the link between psychological symptoms and acceptance or adherence to CPAP after one year. A validated Italian questionnaire for anxiety and depressive symptoms was administered to 249 patients (69F) with a mean age of 57.2±12.2 and a mean AHI of 40.9±21.9 (ev*hr-1). The CPAP use in the first and last night of acclimatization and one year after prescription was 6.4±2.2, 6.9±1.4 and 5.3±2.2 hr, respectively. Anxiety symptoms were reported by 15.6% of patients, depressive symptoms by 6% while 12.5% reported both anxiety and depressive symptoms. Adherence to CPAP in the first night was not adequate in 19.7% of patients with relevant difference between groups: 16.4% in AD-,20.5% in A+,13.3% in D+ and 38.7% in AD+ (χ2=8.6; P=0.03). However, at the end of acclimatization period only 4.4% of patients utilized CPAP<5/h. One-year after prescription the adherence was adequate in 74.7% of patients without difference between groups. A Cox proportional hazard model demonstrated that AHI (OR=0.985, 95% CI: 0.97-0.99; P=0.03) and compliance to CPAP at the first night of use (OR=0.445; 95% CI: 0.246-0.8; P=0.007) are the only predictive factors of long-term compliance. Presence of anxiety and depressive symptoms should be checked before PAP titration since they may negatively influence the early acclimatization and adherence.

The 17-Item Computer Vision Symptom Scale Questionnaire (CVSS17): Translation, Validation and Reliability of the Italian Version.

Background. To validate the 17-item Computer Vision Symptom Scale questionnaire (CVSS17) in Italian. Methods. Cross-sectional validation study on video terminal (VDT) users and a reference sample of subjects not working at a VDT (control group), cognitively able to respond to a health status interview. The Italian self-administered version of the CVSS17 questionnaire was administered to all participants. The reliability and validity of the Italian translation of the CVSS17 were tested using standard statistical methods for questionnaire validation. The Rasch analysis was performed as well. Results. A total of 216 subjects were enrolled. Concerning the reliability, the Cronbach’s alpha coefficient was 0.925 (from 0.917 to 0.924), and the test–retest stability was 0.91 (<0.001). Concerning the validity, the control group had significantly better scores, and there were good correlations between responses to the CVSS17 and analogous domains of the GSS. Conclusion. The Italian version of the CVSS17 has shown psychometric properties comparable to those of the Spanish version, having good validity, discriminatory power, internal consistency and reliability. The questionnaire is a specific measure of vision-related quality of life in Italian-speaking VDT workers and can be used both in clinical practice and for research purposes.

Assessing validity and reliability of a new tool: the ECSQ (Endoscopy Customer Satisfaction Question-naire) in Italian for customer satisfaction in digestive endoscopy.

The European Society of Gastrointestinal Endoscopy and the American Society for Gastroin-testinal Endoscopy recommend the identification of quality indicators for endoscopy services, including patient satisfaction. Patients happy with the treatment received will be more willing to participate in screening programs and more adherent to the indications received from the doctor. The aim of this study is to validate the Endoscopy Customer Satisfaction Questionnaire in Italian, in order to have a valid and reliable tool that can allow each patient to fully describe their experience in digestive endoscopy services. The validation of the questionnaire was carried out through a a monocentric cross-sectional study, in the endoscopy service of the Campus Bio-Medico University Hospital in Rome between August and September 2020. A total of 155 patients underwent an endoscopy. The mean age of the sample was 56.21 years (SD ± 14.136) with 46.5% male and 53.5% female. The analysis of the validity and reliability of the question-naire was ensured through the finding of an average value of 0.944 for Cronbach's α. From the analysis of the results, we can therefore believe that the Italian version of the En-doscopy Customer Satisfaction Questionnaire is to be considered valid and reliable for measuring patient satisfaction, allowing them to express their point of view.

Placebo and hypnosis in the clinical setting: Contextual factors in hypnotic analgesia

ABSTRACT The assumption that hypnotic analgesia produces placebo effects is controversial. The cognitive dimension that can distinguish hypnosis from placebo analgesia has been suggested as hypnotic susceptibility. The aim of this study is to investigate the role of the relationship between patient and therapist, assumed to produce the placebo effect, in the clinical context of hypnotic treatment for pain. Seventy subjects were given hypnosis administered by the therapist in person (Group A) and 37 practiced self-hypnosis (Group B) for 8 weeks. The Somatosensory Amplification Scale (SSAS), Stanford hypnotic susceptibility scale type A, Cold pressor test (CPT) and SCL-90 were administered at baseline, and Italian Pain Questionnaire (IPQ) dimensions were used as outcome measures. The SSAS did appear to reflect the efficacy of hypnotic analgesia in all pain variables explored, but only in Group B. An improvement in pain intensity and all IPQ dimensions were found at 8 weeks. In particular, an improvement in the affective dimension of pain, with a medium–high effect size (η2 = .774), was recorded after hypnotic analgesia, with the outcome being better in Group A than in Group B (p = .001). This outcome was independent of hypnotic susceptibility in both groups. Considering our hypothesis that, given the administration of the same suggestions, the therapist could promote the placebo response, contributing to the improvement in the affective dimension of pain outcome, which exhibited a response to the hypnotic treatment independently of hypnotic susceptibility.

DEVELOPMENT AND VALIDATION OF A SCALE FOR MEASURING TEACHERS' DIGITAL CITIZENSHIP LITERACY.

The evolution that has taken place in the last thirty years concerning technology has led to important changes in everyday life (Piceci, 2020). These changes moved the attention to the concept of digital technologies, in particular the tools daily used. The European Union has implemented various interventions to promote the dissemination of digital culture through the European Digital Agenda with its emanations in the individual states of the Union, focusing on the availability of IT resources both from an infrastructural and information points of view. Concerning the concept of digital skills, EU created a first document in 2013 (Ferrari, 2013) then updated in 2017 with digiCom 2.1 (Carretero, Vuorikari & Punie, 2017) with the purpose of making a clear enumeration and definition. This study, starting from DigiComp 2.1, presents the process of creation and validation of the Italian Questionnaire on Digital Citizenship Skills for Teachers (Questionario sulle Competenze della Cittadinanza Digitale - QCCD). The sample used is made up of 351 teachers or student training to become teachers. Confirmatory Factor Analysis was performed to study the replicability of the factor structure obtained by EFA and it showed satisfactory goodness of fit indices for the hypothesized one-factor structure. Chi square ( = 388.8, df = 189, p < .001) value and very positive goodness of fit indices (CFI = .988, TLI = .0987 SRMR = 0.069, RMSEA = 0.055). Results of content and construct validity were also adequate and complemented a very strong internal consistence of the measurement tool.

Children’s Right to Health: Theory versus Practice

Introduction A research was conducted from 2014 to 2018 to understand the reasons behind the gap between the theoretical affirmation of children’s right to health and its practical realization. Hospitals and healthcare services were chosen as possible settings to understand these reasons and identify the gap. Methods Questionnaires (open-ended questions) were completed throughout the year 2017 with experts working at International level in the field of children’s rights. A survey was set up using a structured multiple-choice questionnaire in Italian, English, and French. The survey was addressed to hospital staff (professionals; managers and administrative staff). All the results from the experts’ questionnaires and from the survey were elaborated using Excel. Result Experts concluded that professionals still have to understand the full value of implementing children’s rights in hospitals and that the United Nations should empower their own action in order to push states towards the respect and full realization of the Convention on the Rights of the Child. The survey results seem to confirm that in healthcare settings professionals’ have difficulties in understanding how to relate to children in order to facilitate the full realization of their right to health. Conclusion The investigation confirmed the existence of a ‘perceptive astigmatism’ as guiding factor for professionals’ behaviour towards children.

Influence of Oral Health Care Systems on Future Career Environment of Dental Students in Europe.

Oral healthcare is organized subsidiarily and independently by nation states in Europe and also within the EU and consequently, major differences between the nation states and the various oral healthcare systems in Europe are present. The socialization in the respective catchment area can have an impact on the job choice and the perception of employment opportunities of different professional groups. Therefore, the purpose of this survey was to elucidate the influence of different oral healthcare systems on students living or studying in the respective catchment area. A questionnaire (in English, French, German, Italian, and Spanish) with 18 different components was administered. Data on gender, age, country of origin, university, semester, nationality, expected time of graduation, and forecast for future professional practices were gathered. In addition, 3851 students participated (2863 f/988 m). The sample distribution was uneven with predominantly Bismarckian and Southern European System participants. The National oral health care system was statistically significantly linked (p < 0.01) to the ownership period of a dental practice. Students in Bismarckian and Nordic systems tended to find their own practice earlier than in the Beverdigian system or Southern European and Transitional—East European systems. An association between the oral health care system and vocational training was inhomogeneous, but also significantly different (p < 0.01). The majority (47.51%, n = 1555) would like to work in their own practice, 18.95% (n = 621) want to establish a practice with two or more owners. It was striking that no student would like to work in the investor practice/practice chain of both Nordic, Beveridgian and Transitional—East European countries systems (p < 0.01). The oral health care system in which a dental student grows up/resides/studies influences the career choice/perception of future professional practice.

Validation of the Italian HeartQoL: a short health-related quality of life questionnaire for patients with ischemic heart disease

The psychometric properties of the core disease-specific 14-item Italian HeartQoL health-related quality of life questionnaire have been evaluated in this study. The Italian version of the HeartQoL, the MacNew questionnaire, and the Hospital Anxiety and Depression Scale were completed by 472 patients (angina, N = 183; myocardial infarction, N = 167; or ischemic heart failure, N = 122) who were recruited in five Italian centers (Florence, Veruno, Turin, Udine, and Naples) between 2015 and 2017. Patients with myocardial infarction reported significantly higher HeartQoL scores than patients with angina or ischemic heart failure. Floor and ceiling effects were always minor on the HeartQoL global scale and physical subscale with moderate ceiling effects on the emotional subscale in the total group and in patients with myocardial infarction. The bifactorial structure of the original HeartQoL questionnaire was confirmed with strong physical, emotional, and global scale H coefficients (> 0.50). The HeartQoL scales demonstrated optimal internal consistency (Cronbach’s alpha > 0.84). Convergent and divergent validity were confirmed. Discriminative validity was not confirmed for age, largely confirmed for sex, and fully confirmed for anxiety, depression, and distress. The Italian HeartQoL questionnaire demonstrated adequate key psychometric attributes of internal consistency reliability and validity in Italian-speaking patients with ischemic heart disease.

The Italian Questionnaire for Cancer Breakthrough Pain Diagnosis, a Multicenter Validation Study.

IntroductionThe literature lacks formally validated and reliable tools for the diagnosis of breakthrough cancer pain (BTcP). The Italian Questionnaire for BTcP diagnosis (IQ-BTP) is an 11-item questionnaire aimed at detecting potential-BTP and classifying it into three likelihood classes: high, intermediate, and low.MethodsA multicenter, prospective, and observational study was designed to validate the IQ-BTP. In three consecutive visits with each cancer patient, the demographic and clinical details of the patient, the Brief Pain Inventory (BPI) scores, IQ-BTP outcomes, and clinicians' autonomous BTcP diagnosis (gold standard) and the agreement of this diagnosis with IQ-BTP outcomes were recorded. The assessed domains for IQ-BTP validation were: Validity, including content and face validity, construct validity (hypothesis testing, and cross‐cultural validity\\measurement invariance), and criterion validity; Reliability (internal consistency, reliability, and measurement error); Interpretability, and Responsiveness.ResultsSeven palliative and pain management facilities in Italy recruited 280 patients, yielding 753 evaluations. Using the IQ-BTP, the rate of potential-BTcP was 27.2%, of which its likely presence was high in 52.7% of patients, intermediate in 38.5, and low in 8.8%. The BPI item scores differed significantly between the two IQ-BTP classes (no-BTcP and potential-BTcP classes). The correlation of the latter class with BPI items was significant but low. The IQ-BTcP showed two principal components, accounting for 66.6% of the variance. Cronbach’s α was 0.71. The agreement rate between the gold standard and IQ-BTP outcomes was 82%. Cohen's kappa was 0.535. The IQ-BTP showed sensitivity and specificity of 69 and 86%, respectively.ConclusionsThe IQ-BTP extensive formal validation showed satisfactory psychometric and validity properties. Its content, face, construct, and criterion validities and its reliability, interpretability, and responsiveness were shown. Its use enabled potential-BTcP to be identified and differentiated into three likelihood classes with direct therapeutic and epidemiological implications. The latter may be confirmed in future studies.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40122-021-00274-9.

Validation of the Italian Version of the Behavioral Inhibition Questionnaire (BIQ) for Preschool Children.

Behavioral Inhibition (BI) is a temperamental trait characterized by fear and wariness in reaction to new and unfamiliar stimuli, both social and non-social. BI has been recognized as possible forerunner of anxiety disorders, especially social anxiety and phobia; therefore, its assessment is clinically relevant. The present study aimed to examine the psychometric properties of the Italian adaptation of the Behavioral Inhibition Questionnaire (BIQ), which measures BI in preschool children. The BIQ was completed by 417 Italian parents (230 mothers, 187 fathers) of 270 preschoolers aged 3–5. Confirmatory factor analysis showed a good internal validity: the factorial structure was corresponding to the original six-factor version. Results showed excellent internal consistency, significant item-total correlations, good inter-rater reliability, convergent validity (by correlating the BIQ with the Italian Questionnaires of Temperament-QUIT, the Anxiety-Shy Conner’s Scale and the Laboratory Temperament Assessment Battery) and discriminant validity (i.e., no correlation with Conners’ ADHD scale). Significant correlations emerged between BI indexes and total BIQ scores of parents and maternal (but not paternal) versions of the questionnaire. Altogether, the results are promising and consistent with previous validation studies, suggesting the BIQ as a reliable and valid measure for evaluating parents’ perception of BI in Italian preschoolers.