Comparison between Physical Activity and Stress-Related Lifestyle between Orthorexic and Non-Orthorexic University Students: A Case-Control Study.

(1) Background: The literature regarding orthorexia nervosa (ON) has well documented the association with other mental disorders, such as obsessive-compulsive and eating disorders. However, the research has not taken into account stress-related behavior and the conduction of physical activity (PA), both structured and unstructured. (2) Methods: In this cross-sectional study, 165 students of the University of Parma (92 females and 74 males) aged between 18 and 49 years old (mean = 24.62 ± 4.81) were consecutively recruited. The ORTO-15 questionnaire was used to divide the total sample into a group without orthorexia (score > 40) and a group with orthorexia (score < 40). All subjects completed the P Stress Questionnaire, and specific items were extrapolated from the Eating Habits Structured Interview (EHSI) to investigate lifestyle, including structured and unstructured PA. (3) Results: Subjects with orthorexia represented 83% of the total sample and reported higher levels of stress-related risk behaviors (i.e., sense of responsibility (t = -1.99, p = 0.02), precision (t = -1.99, p = 0.03), stress disorders (t = -1.38, p = 0.05), reduced spare time (t = -1.97, p = 0.03), and hyperactivity (t = -1.68, p = 0.04)) and a higher frequency of PA (i.e., hours spent training in structured PA, daily (t = -1.68, p = 0.05), weekly (t = -1.91, p = 0.03), and monthly (t = -1.91, p = 0.03), the tendency to carry out physical exercise even if tired (t = -1.97, p = 0.02), and to adhere to unstructured PA (i.e., moving on foot or by bike rather than using transport (t = 1.27, p = 0.04)). (4) Conclusions: The results confirmed the presence of hyperactivity at a motor and behavioral level in people with orthorexia. Further studies are necessary to highlight the causality between ON, stress, and physical activity but it may be possible to hypothesize that "obsessive" physical exercise may not generate the benefits generally known by the literature.

Introversion, Alexithymia, and Hostility: A Path Analysis From Personality to Suicidal Ideation Among University Students.

PURPOSE: The aim of the current study was to investigate the relationship between state (i.e., hostility) and trait (i.e., social detachment, alexithymia) psychological constructs associated with suicidal ideation among university students. METHODS: A group of 190 university students was consecutively recruited in the period between September 2022 and March 2023. After a clinical interview, a series of psychological tests were administered: the Cattell's 16-Personality Factors Questionnaire (16PF), the Toronto Alexithymia Scale (TAS-20), the Symptom Checklist-90-R (SCL-90-R), and the anamnestic form of the Cognitive Behavioral Assessment (CBA2.0), which contains a specific question regarding the suicidal ideation. RESULTS: The analyses demonstrated that alexithymia fully mediated the relationship between a particular aspect of introversion (social detachment or low warmth) and hostility which, in turn, seemed to be a significant predictor of suicidal ideation. CONCLUSIONS: The path analysis conducted seemed to highlight the importance of personality traits, such as social detachment and the ability to recognize and express one's internal states, on the mental health of university students in terms of hostility and suicidal ideation. Considering that the reduction of suicide mortality has been prioritized as a global target in the 15-19 age group, identifying the psychological factors associated with it is fundamental.

Evaluation of the effectiveness of behavioral interventions for autism spectrum disorders: A systematic review of randomized controlled trials and quasi-experimental studies.

The objective of this research was to assess the efficacy of behavioral therapy interventions in the treatment of autism spectrum disorders (ASD). The study utilized the PubMed and Embase databases to locate randomized controlled trials, quasi-experimental treatment studies, and randomized clinical trial comparisons. The experimental group received treatment based on an applied behavioral approach, such as PECS, DTT, PRT, TEACCH, ESDM, and EIBI. After examining seventeen studies, the researchers found that each type of behavioral intervention had a positive impact. Naturalistic protocols that employed PRT and PECS improved ASD symptoms in general, despite their targeting of particular cognitive domains such as language. ESDM enhanced receptive language, particularly in preschool-aged children. Structured and integrated interventions, like EIBI and TEACCH, improved overall adaptive functioning. Combining DTT with a TEACCH program produced greater benefits in linguistic, affective-social, and personal autonomy domains. However, there is a scarcity of high-quality research available on behavioral interventions for ASD. Further comparative studies are necessary to identify cost-efficient interventions. For example, PRT and PECS significantly improved social communication skills in only 15-40 hours over six months. The authors emphasized the need for continued research and the application of evidence-based interventions in specialized settings.

Clinical-Psychological Aspects Involved in Gynecological Surgery: Description of Peri-Operative Psychopathological Symptoms and Illness Behavior.

Background: Within the current literature concerning the gynecological surgery, there are only a few studies that focus on the psychological aspects that characterize the peri-operative period. In this research, the psychopathological symptoms and the illness behavior were assessed in order to confirm previous results about clinical variables such as the type and method of intervention, as well as psychological aspects regarding the positive anamnesis for mental disorders. Moreover, other factors including the desire for maternity and previous surgical interventions and pregnancies were also investigated. Methods: In this observational research, 58 women (age = 41.5±8.8), that undergone gynecological surgery (conservative and non-conservative) for benign pathologies, were consecutively recruited. Information on psychopathological symptoms was collected 15 days (T0) and one day before surgery (T1), and at the time of discharge (T2) through the Symptom Questionnaire (SQ). At T2, the Illness Behavior Questionnaire (IBQ) was also administered. Results: The descriptive analyzes conducted on the total sample demonstrated that while anxious activation and irritable mood decrease from T0 to T1, somatizations and depression mood increase between T1 and T2. Moreover, the comparisons between groups, dividing the sample according to the clinical-medical and psychological variables, highlighted that the type and modality of the intervention, as well as a positive history for the presence of psychological disorders, the desire for maternity, and previous surgical interventions and pregnancies, can influence the course of psychopathological symptoms. Conclusion: This study highlights the need to include a clinical-psychological evaluation and to pay attention to specific clinical variables regarding women that are undergoing a conservative or non-conservative gynecological surgery. Considering the psychological impact of these type of interventions, the clinical history of these women, as well as their fears and desires, could facilitate a better management of the patients in terms of well-being, adherence to treatment, and recovery.

Fundamento: Dentro de la literatura actual referente a la cirugía ginecológica, existen pocos estudios que se centren en los aspectos psicológicos que caracterizan el perioperatorio. En esta investigación se evaluaron los síntomas psicopatológicos y la conducta de enfermedad con el fin de confirmar resultados previos sobre variables clínicas como el tipo y método de intervención así como aspectos psicológicos en cuanto a la anamnesis positiva para trastornos mentales. Además, también se investigaron otros factores, como el deseo de maternidad y las intervenciones quirúrgicas y embarazos previos. Métodos: En esta investigación observacional, se reclutaron consecutivamente 58 mujeres (edad=41.5±8.8), sometidas a cirugía ginecológica (conservadora y no conservadora) por patologías benignas. La información relativa a los síntomas psicopatológicos se ha recogido durante 15 días (T0) y un día antes de la cirugía (T1), y en el momento del alta (T2) a través del Cuestionario de Síntomas (SQ). En T2 también se administró el Cuestionario de Conducta de Enfermedad (IBQ). Resultados: Los análisis descriptivos realizados sobre la muestra total demostraron que mientras la activación ansiosa y el estado de ánimo irritable disminuyen de T0 a T1, las somatizaciones y el estado de ánimo depresivo aumentan entre T1 y T2. Además, las comparaciones entre grupos, dividiendo la muestra de acuerdo con las variables clínico-médicas y psicológicas, destacaron que el tipologia y modalidad de la intervención, así como una historia positiva para la presencia de trastornos psicológicos, deseo de maternidad y antecedentes quirúrgicos, las intervenciones y los embarazos pueden influir en el curso de los síntomas psicopatológicos. Conclusión: Este estudio pone de relieve la necesidad de incluir una evaluación clínico-psicológica y prestar atención a variables clínicas específicas en mujeres que se someten a una cirugía ginecológica conservadora o no conservadora. Considerando el impacto psicológico de este tipo de intervenciones, la historia clínica de estas mujeres, sus miedos y deseos podría facilitar un mejor manejo de las pacientes en términos de bienestar, adherencia al tratamiento y recuperación.

Need for Multidimensional and Multidisciplinary Management of Depressed Preadolescents and Adolescents: A Review of Randomized Controlled Trials on Oral Supplementations (Omega-3, Fish Oil, Vitamin D3).

(1) Background: Depression is a serious health problem with a high cost for public administration. Epidemiological studies report that one in five children have a mental disorder and about 50% of mental health problems exacerbate in childhood and adolescence. Moreover, the antidepressant efficacy in children and adolescents is poorly demonstrated and can cause severe behavioral adverse events such as suicidal ideation. (2) Methods: This systematic literature review examined oral supplementations (Omega-3, fish oil, Vitamin D3) to treat depressed children, preadolescents, and adolescents. MEDLINE, Scopus, Embase, and PsycInfo were searched for articles published in the last five years. Six studies met the eligibility criteria. The inclusion criteria encompassed children, preadolescents, and adolescents, a diagnosis of depression, and an intervention of oral supplementations such as Omega-3, fish oil, and Vitamin D3. (3) Results: Most of the studies demonstrated that dietary intervention provides positive outcomes in terms of depression symptoms. (4) Conclusions: Overall, the results demonstrate a positive effect for oral supplementation suggesting an increase intake of Omega-3, fish oil, and Vitamin D3. However, only a few studies assess the effectiveness of diet recommendations, as a monotherapy or combined treatment, for the management of depression at developmental ages. Thus, there is still a need to further investigate these aspects and to look more specifically at adolescents and preadolescents.

A Systematic Review of Clinical Psychophysiology of Obsessive-Compulsive Disorders: Does the Obsession with Diet Also Alter the Autonomic Imbalance of Orthorexic Patients?

(1) Background: A new mental illness is attracting the attention of researchers and mental health professionals. Orthorexia nervosa (ON) is a possible new mental disorder, the main symptom of which is an obsessive and insecure focus on healthy foods and consequent compulsive behaviors. There is a common consensus among researchers that ON is considered partly overlapping with obsessive-compulsive disorders (OCDs). (2) Methods: MEDLINE and Scopus were searched for articles published in the last 10 years regarding the psychophysiological aspects of OCD and ON. Eight studies met the eligibility criteria. The inclusion criteria encompassed adults diagnosed with OCD and/or ON. However, only studies involving OCD patients were found. (3) Results: Some research groups have shown that OCD disorders can be considered among anxiety disorders because they are characterized by anxious hyper activation. Other research, however, has shown profiles characterized by low psychophysiological reactivity to stressful stimuli. Despite this, there seems to be a consensus on the poor inhibition abilities, even when activation is low, and the dissociation between cognitive and psychophysiological activation emerged. (4) Conclusions: However discordant, some points seem to bring the researchers to agreement. In fact, there is consensus on conducting a multidimensional assessment that can measure all of the aspects of suffering (cognition, emotion, and behavior) and highlight the poor body-mind integration. This clinical approach would make it possible to propose interventions aimed at treating some mental illnesses such as food obsession that can paradoxically impair the psychophysical balance. Nevertheless, the applied systematizing approach to existing studies on ON is very much needed for better understanding of the psychophysical nature of this new mental illness and its implications for prevention and treatment.

Health Related Quality of Life and Psychopathological Symptoms in People with Hemophilia, Bloodborne Co-Infections and Comorbidities: An Italian Multicenter Observational Study.

Background: The health-related quality of life (HRQoL) of people with hemophilia (PWH) is an important issue, especially considering people suffering from chronic diseases beyond hemophilia. The principal aim of this study was to investigate the presence and relevance of psychological symptoms, both internalizing and externalizing, lifestyle, and HRQoL in a group of Italian PWH with chronic bloodborne co-infections and comorbidities. Furthermore, the research describes the association between psychological aspects and the impact of disease-related characteristics (type of hemophilia, presence of co-infections, and comorbidities) on them. Methods: Seventy patients (mean age 46.77±11.3), 64 with severe hemophilia A (Factor VIII: C < 1 IU/dL) and 6 with severe hemophilia B (Factor IX <1 IU/dL), were consecutively recruited from seven Hemophilia Centers in Italy of Italian Association of Hemophilia Centers (AICE). In order to assess psychological symptoms, HRQoL, and lifestyle, three psychological questionnaires were administered (the SCL-90-R, SF-36, and PSQ, respectively). Results: A general decline in the quality of life and an increase in the tendency to adopt a lifestyle characterized by hyperactivity emerged. Inverse correlations were found between HRQoL and psychological distress. Although the SCL-90-R did not reveal symptoms above the clinical cut-off, co-infections significantly increased anxiety, depression, somatizations, paranoia, and social withdrawal. Lastly, HRQoL is impaired by co-infections as well as comorbidities. Conclusion: Our preliminary results must be confirmed to deepen the findings between mental health and hemophilia.

Clinical and psychological aspects in a group of allergic asthma patients and the impact on their health status perception.

BACKGROUND: The interplay between physical and psychological symptoms frequently affects the health-related quality of life of asthma patients. PARTICIPANTS AND PROCEDURE: This research aimed at assessing the psychological status of 60 patients attending their first/second doctor visit at which they were diagnosed with allergic asthma. Information on psychological distress was collected through the Symptom Questionnaire (SQ), personality traits were described through Cattell's 16-Personality Factor Questionnaire (16-PF), stress-related behavior was detected through the P Stress Questionnaire (PSQ), and the perceived quality of life was described with the Rhinasthma questionnaire. RESULTS: The SQ revealed anxiety levels above the clinical cut-off in 71.7% of patients, levels of depression in 46.7%, anger-hostility in 53.3%, and somatic symptoms in 65%. No significant differences were observed after three months. The 16-PF scores were also suggestive of specific personality traits associated with the predisposition towards psychosomatic disorders. However, no stress-related behaviors were observed with the PSQ. Rhinasthma highlighted a certain degree of the perceived quality of life. Additionally, the quality of life correlated with age, all psychological distress scales, a few personality traits, vigor, and stress disorders. CONCLUSIONS: Allergic asthma patients present a higher-than-average level of psychological distress and impaired perceived quality of life at the time of diagnosis. Therefore, it is important to assess the psychological status in addition to the respiratory function.

Cognition, Behavior, Sexuality, and Autonomic Responses of Women with Hypothalamic Amenorrhea.

(1) Background: Functional Hypothalamic Amenorrhea (FHA) can be caused by the hyper activation of neuro-endocrine responses to stress. Among other endocrine factors and hypothalamic dysfunctions, the psychophysiological stress response can very frequently lead to an inhibition of the gonadal-pituitary axis. The aim of this study was to investigate the level of neurovegetative activation in a group of young women affected by this condition. (2) Methods: Twenty-five women (mean age = 21.1 ± 4.34) with FHA were consecutively recruited. Information on psycho-physiological distress was collected through a Psychopathological assessment (with the administration of three psychometric tests) and the Psychophysiological Stress Profile (PSP). Their data were compared with a control group. (3) Results: In the PSP, the patients displayed significantly higher values compared to controls in terms of the parameters of muscle tension (sEMG), skin conductance (SCL/SCR), heart rate (HR), and peripheral temperature (PT). Furthermore, autonomic hyper-activation at rest, marked reactivity to stress, and reduced recovery were seen. Moreover, a condition characterized by psychological distress (anxiety and somatic complaints, depressed and irritable mood, obsessive-compulsive traits) emerged. (4) Conclusions: The results highlight autonomic hyper-activation in FHA, which is also associated with psychological distress. Considering that FHA is a condition that affects multiple systems between mind and body, a multimodal, multidimensional, and multidisciplinary assessment of stress is becoming an emerging need.

Oxidative Stress and Cognitive Decline: The Neuroprotective Role of Natural Antioxidants.

Free- radicals (Oxygen and Nitrogen species) are formed in mitochondria during the oxidative phosphorylation. Their high reactivity, due to not-engaged electrons, leads to an increase of the oxidative stress. This condition affects above all the brain, that usually needs a large oxygen amount and in which there is the major possibility to accumulate "Reacting Species." Antioxidant molecules are fundamental in limiting free-radical damage, in particular in the central nervous system: the oxidative stress, in fact, seems to worsen the course of neurodegenerative diseases. The aim of this review is to sum up natural antioxidant molecules with the greatest neuroprotective properties against free radical genesis, understanding their relationship with the Central Nervous System.

Unmasking selective path integration deficits in Alzheimer's disease risk carriers.

Alzheimer's disease (AD) manifests with progressive memory loss and spatial disorientation. Neuropathological studies suggest early AD pathology in the entorhinal cortex (EC) of young adults at genetic risk for AD (APOE ε4-carriers). Because the EC harbors grid cells, a likely neural substrate of path integration (PI), we examined PI performance in APOE ε4-carriers during a virtual navigation task. We report a selective impairment in APOE ε4-carriers specifically when recruitment of compensatory navigational strategies via supportive spatial cues was disabled. A separate fMRI study revealed that PI performance was associated with the strength of entorhinal grid-like representations when no compensatory strategies were available, suggesting grid cell dysfunction as a mechanistic explanation for PI deficits in APOE ε4-carriers. Furthermore, posterior cingulate/retrosplenial cortex was involved in the recruitment of compensatory navigational strategies via supportive spatial cues. Our results provide evidence for selective PI deficits in AD risk carriers, decades before potential disease onset.

Parkinson's Disease-Mild Cognitive Impairment (PD-MCI): A Useful Summary of Update Knowledge.

Mild cognitive impairment (MCI) is a common feature in Parkinson's Disease (PD), even at the time of diagnosis. Some levels of heterogeneity in nature and severity of cognitive impairment and risk of conversion to Parkinson's Disease Dementia (PDD) exist. This brief overview summarized the current understanding of MCI in PD, by considering the following major points: historical development of the clinical entity, evaluation, epidemiology, predictors and outcomes, neuroimaging findings, pathophysiology, treatment, and pharmacological and non-pharmacological intervention. MCI in PD represents a concept in evolution and plays a pivotal role in advancing our understanding of the disease mechanisms, with the ultimate goal of building effective strategies to prevent conversion into PDD. Challenges for future research are also discussed.

Psychophysiological Adjustment to Ovarian Cancer: Preliminary Study on Italian Women Condition.

This study aimed to evaluate the psychological and physiological adjustment in a sample of Ovarian Cancer survivors. For all we know, this is the first time that such analysis has been performed in Italy. We assessed psychological adjustment along with physiological adjustment, measured through the basal Heart Rate Variability at rest. We assessed 38 women overall, aged 29-80 years, in follow up for ovarian cancer. Each participant filled a psycho-oncological record, Multidimensional Scale of Perceived Social Support, Derridford Appearance Scale-59, Mental Adjustment to Cancer and EORTC Quality of Life Questionnaire LQ-30 Version 3.0. For each participant, we recorded Heart Rate Variability (5 min). These women have shown a high rate of perceived general social support (Me = 5.93) but they seem to have some general concern about their appearance (Me = 85.97, SD = 24.4). They have also shown a rather good total Quality of Life (QL2 Me = 66.32) with specific difficulties in emotional functioning (EF; Me = 69.19). Heart Rate Variability values, however, were lower of nearly 50% when compared to normative values. These women, then, seem to drag concerns and difficulties, in particular linked to the acceptance of their condition. Surprisingly enough, the best adjustment in these women seems to be related to the worst starting conditions. It is possible to suggest that the extremely negative conditions force these women to face cancer openly, as well as their condition of cancer survivors, pushing them "moving on" more than "trying to get back".

Multidimensional approach usefulness in early Alzheimer's disease: Advances in clinical practice.

BACKGROUND AND AIM: Improving quality of life of patients with early Alzheimer's Disease (AD) is a primary concern of health professionals involved in dementia treatment. The aim of this study is to reveal associations among psychiatric symptoms and wellbeing aspects, dysfunctional lifestyles and stress-related behaviors, illness perception, personality traits, and life quality satisfaction, in order to offer a comprehensive evaluation of psychological and behavioral aspects characterizing patients with early AD. METHODS: This is a cross-sectional study in which all the outpatients included were evaluated at the Dementia Clinic in Parma (Italy). 21 patients with probable AD were assessed by an overall cognitive screening (Milan Overall Dementia Assessment), the evaluation of personal and instrumental autonomy (Activities of Daily Living and Instrumental Activities of Daily Living), and of dementia severity (Clinical Dementia Rating Scale). After the neurocognitive assessment, a wide battery of clinical and psychological measures (Symptom Questionnaire, Pisa Stress Questionnaire, Illness Behavior Questionnaire, Sixteen Personality Factor Questionnaire and Satisfaction Profile) was administered to the patients. Spearman's rho correlations between clinical and psychological measures were performed. RESULTS: A tendency to deny anxiety, depressive and somatic symptoms might be present in patients with early AD. They also present with hypochondriasis, resulting in higher level of anxiety and depression. Reduced liveliness and self-reliance as personality traits may influence the intensity of such symptoms. CONCLUSIONS: A comprehensive assessment including psychological and clinical measures should be routinely integrated in clinical practice for the evaluation of patients with early AD.

Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the area of blood glucose and insulin concentrations.

Most requests for authorization to bear health claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate health claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of health claims.

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006.

Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function.

Claimed effects, outcome variables and methods of measurement for health claims on foods related to the gastrointestinal tract proposed under regulation (EC) 1924/2006.

Most of the requests of authorisation to the use of health claims pursuant to Regulation EC 1924/2006 related to the gastrointestinal (GI) tract have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of an insufficient substantiation of the claimed effect (CE). The present manuscript refers to the collection, collation and critical analysis of outcome variables (OVs) and methods of measurement (MMs) related to the GI tract compliant with Regulation 1924/2006. The critical evaluation of OVs and MMs was based on the literature review, with the final aim of defining their appropriateness in the context of a specific CE. The results obtained are relevant for the choice of the best OVs and MMs to be used in randomised controlled trials aimed to substantiate the claims on the GI tract. Moreover, the results can be used by EFSA for updating the guidance for the scientific requirements of such health claims.

Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management.

All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function.

Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims.

Contribution to the validation of Italian version of Fear-Avoidance Beliefs Questionnaire.

BACKGROUND AIM: Propose further evidence for reliability and validity of Italian translation and adaptation of Fear Avoidance Beliefs Questionnaire, (FABQ) originally built-up by Waddel et al. (1993) METHODS: 250 participants, inpatient and outpatient, suffering from acute or chronic back-pain have been consecutively recruited from various Italian physiotherapy and functional rehabilitation centres. All participants were administered FABQ and QUALEFFO, to evaluate if avoiding behaviors can provoke disability independently from experimented pain. RESULTS: Varimax rotation, point out a 4 factor structure: "Prognosis", "Work as cause", "Damage Expectancy", "Physical activity as cause". Statistical analysis underlined a good internal consistency. A good criterion validity resulted from correlation between FABQ scoring and QUALEFFO. The sample was splitted in "avoiders" (A) and "confronters" (C). Group A had no significant correlation between FABQ-W score and pain episode lasting, remission interval lasting, back-pain sick leave; no significant correlation emerged between beliefs and perceived pain. In group C a direct relation emerged between duration of sick leave, FABQ-W scores and FABQTOT scores, and an association between FABQ scores and reported pain. CONCLUSION: Pain-related fear and fear-avoidance beliefs are specific index which have to be considered in the first assessment phases, to prevent their effect on global functioning and on patients' quality of life. FABQ pointed out good reliability and validity propriety in Italian version. FABQ seems to be a brilliant instrument for multidisciplinary clinical practice in pain problem approach.