How much do children with disabilities participate in Clinical Trials? A Scoping review.

BACKGROUND: Children with disabilities (CWDs) are often excluded from scientific research, but no precise data are available on their participation in Clinical Trials. The aim of this study was to evaluate the rates of exclusion of CWDs from recent medical research. SUBJECTS AND METHODS: The protocol of the study was designed according to Prisma-ScR guidelines. All completed interventional Clinical Trials registered on Clinicaltrials.gov between 2010 and 2020 related to the Leading 10 Level 3 causes of global Disability-adjusted life years (DALYs) for both sexes combined for all ages of the updated Global Burden of Disease Study 2019 were analysed. The exclusion criteria were considered explicit if related to the following categories: disability, physical impairment, cognitive impairment, behavioural or psychiatric disorders, language and communication impairment, sensory impairment. Any generic or poorly specified exclusion criteria or statements that left wide discretion to researchers were considered "implicit exclusion criteria". We assessed the appropriateness of explicit exclusion criteria in relation to the primary objectives of the trials and labelled them as "absolute", "relative", or "questionable". RESULTS: The trials selected according to the inclusion criteria of the scoping review were 328; 166 (50.6%) were pediatric-only studies, and 162 (49.4%) trials comprising subjects of all ages. Explicit exclusion criteria were found in 82 trials (25%) and the disability category most frequently excluded was "Behavioural or psychiatric disorders" present in 46 trials (56.1%). Explicit exclusion criteria were considered "relative" in over 90% of the selected studies. Implicit exclusion criteria were present in 153 trials (46.6%) and the number and percentage of studies with at least one explicit or implicit exclusion criterion were 193 and 58.8% respectively. CONCLUSIONS: This study highlights a high rate of exclusion of CWDs from medical research and the need for an inclusive approach that comprises the study design and any necessary adaptations for specific needs.

Pain Assessment in People with Intellectual Disability: Improving Skills of Health and Educational Personnel at Istituto Serafico of Assisi, Italy.

BACKGROUND: Assessment of pain in people with intellectual disability (PWID) is a difficult clinical task. Poor knowledge and confidence in assessing pain in PWID result in underestimation and undertreatment. Available resources for healthcare personnel and caregivers on pain assessment in PWID are still very limited. The aim of the study was to measure the level of knowledge and confidence in assessing pain in PWID of health and education personnel at Istituto Serafico, before and after training. SUBJECTS AND METHODS: The Istituto Serafico is a neuro-rehabilitation center caring for people with complex disabilities. Nurses, rehabilitation therapists, social health workers (SHW) and educators were invited to participate in a 4-hours theoretical and practical training. Participants were assessed through a knowledge and confidence questionnaire on pain assessment in PWID, administered before and after the training. RESULTS: 123 participants attended both the theoretical and practical sessions. Median age was 43 years (range 23-67); 89 were females and 34 males. They were 10 (8%) nurses, 9 (7%) rehabilitation therapists, 77 (63%) SHW, 27 (22%) educators. Only 7 (6%) participants (5 nurses and 2 SHW) declared to have previously received formation on pain. Participants who felt "quite confident" in assessing pain increased from 28% to 73% after the training. The median score to the 24 knowledge questions raised from 15/24 correct answers (range 6-22, 62.5%) in the pre-test to 21/24 (range 11-24, 87.5%) in the post-tests (p=0.001) Conclusions: The study highlights the great need of education programs for health and educational personnel working with PWID on pain assessment and the potential to improve knowledge and confidence through theoretical and practical training. A greater awareness of pain causes, clinical manifestations and consequences of untreated pain, could improve patient care, quality of life and rehabilitation goals.

The Relationship Between Math Anxiety and Math Achievement: Differentiating the Role of Learning Math Anxiety and Math Evaluation Anxiety.

BACKGROUND: Math anxiety (MA) is considered one of the variables that cause poor performance in contexts where mathematical competence is required. SUBJECTS AND METHODS: The survey involved 28 Italian students in the first year of secondary school (corresponding to grade nine of English-speaking schools and of the Italian INVALSI evaluation system). The students, examined at the beginning of the school year, scored below the threshold of sufficiency in the calculation skills assessment test. This data analysis takes into consideration the development of their math performance; the hypothesis is that the level of MA may differentiate students who are able or not able to achieve the competencies expected by the course of study. RESULTS: Students who transitioned from an inadequate score to a sufficient one over the school year, exhibited significantly lower levels of MA compared to students who did not score sufficient on the math test at the end of the year. However, the significant difference primarily pertained to the "learning math" subscale, while the "math evaluation" subscale showed no significant differences between the two groups. CONCLUSIONS: Our results suggest the possibility of using the assessment of MA levels to identify the presence and type of emotional difficulties associated with the study of mathematics. Specifically, in individuals with difficulties in learning mathematics, the presence of a dissociation between the two AMAS subscales could suggest different approaches to educational intervention.

Interhemispheric Communication in Down Syndrome.

BACKGROUND: Within the domain of intellectual disability, evidence suggests a potential association with changes in the developmental pathways governing the maturation of interhemispheric communication mechanisms. SUBJECTS AND METHOD: Through this study, our objective was to identify potential anomalies in interhemispheric transfer among individuals with Down syndrome (DS). Specifically, we investigated whether a significant difference exists in interhemispheric communication efficiency between DS and control participants of similar chronological age. For our analysis, 11 participants with DS and 13 from the control group were evaluated. A fingertip cross-localization test was used to quantify the efficiency of interhemispheric information transfer. RESULTS: The data revealed a significantly reduced efficiency of interhemispheric communication in participants diagnosed with DS compared to the control group. CONCLUSIONS: These findings suggest a potential dysfunction in the corpus callosum of DS individuals. It is plausible to suggest that this functional disconnection might influence the development of cognitive anomalies.

'Being disabled' as an exclusion criterion for clinical trials: a scoping review.

BACKGROUND: People with disabilities (PWDs) are often excluded from biomedical research, but comprehensive data regarding their participation in clinical trials are not available. The objective of this study was to assess the rates of exclusion of PWDs from recent medical scientific research. METHODS: The protocol of the study was designed according to PRISMA-ScR (PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) extension for Scoping Reviews) guidelines. All completed interventional clinical trials registered on ClinicalTrials.gov between 2010 and 2020 regarding the 10 leading causes of global disability-adjusted life-years according to the Global Burden of Disease Study were analysed. An exclusion criterion from the study was considered explicit if it could be associated with one of the following seven categories: disability, physical impairment, cognitive impairment, behavioural or psychiatric disorders, language and communication impairment, sensory impairment. Comorbidities not more clearly defined and researcher discretion regarding exclusion of study participants were considered to be 'implicit exclusion criteria'. We assessed the appropriateness of explicit exclusion criteria in relation to the primary objectives of the trials and labelled them as 'absolute', 'relative' or 'questionable'. RESULTS: The total number of trials analysed was 2710; 170 were paediatric trials (6.3%), 2374 were adult trials (87.6%) and 166 were trials including subjects of all ages (6.1%). Explicit exclusion criteria were found in 958 trials (35.3%). The disability category most frequently excluded was behavioural or psychiatric disorders, present in 588 trials (61.4%). In only 3% and 1% of the trials, the exclusion criteria were considered either 'absolute' or 'questionable', while in 96% the exclusion criteria were judged as 'relative'. Implicit exclusion criteria were present in 1205 trials (44.5%). CONCLUSIONS: This study highlights the high rate of exclusion of PWDs from biomedical research and the widespread use of ill-defined exclusion criteria in clinical trials. It underscores the importance of more inclusive study designs so that PWDs can become active participants in research.

Anxiety Disorders in People with Intellectual Disabilities: the Best Treatment for Properly Modulate Activities of Daily Living.

The article explores the correlation between intellectual disability and anxiety and how much they occur together. People with intellectual disability have comorbidity disorders of all types 3 to 4 times higher than the general population and the anxiety, can create difficulties in the context of social inclusion caused by insecurity and worries felt from who is affected by this pathology.

Assessment of math anxiety as a potential tool to identify students at risk of poor acquisition of new math skills: longitudinal study of grade 9 Italian students.

Introduction: Numerous international educational institutions have sounded the alarm about the gradual increase in the number of students failing to achieve a sufficient level of proficiency in mathematical abilities. Thus, the growing interest in identifying possible solutions and factors interfering with learning seems justified. In recent years, special attention has accrued to the possible role played by emotional factors. Methods: In the present investigation, students in the first grade of a technical vocational secondary school are followed to assess the influence of math anxiety (MA) on the development of skill acquisition in calculus. A math skills assessment test is administered on two occasions, at the beginning and end of the school year. Results: Results highlighted that the score on the anxiety scale, administered at the beginning of the year, negatively correlated with the score obtained on the mathematics test, administered at the end of the school year: the higher the level of anxiety, the worse the performance. Furthermore, the score obtained in the second administration makes it possible to divide the students tested into two groups: students who improved their performance and students who did not benefit at all from repeating the test. In these two groups, an analysis of the relationships between the outcome of the end-of-year mathematics test and the level of MA at the beginning of the year showed that MA correlates negatively with performance only in students who will fail to acquire new expertise in mathematics over the course of the school year. Discussion: The results suggest that MA may interfere with the smooth development of math skills. Assessing the level of MA at the beginning of the school year could prove to be a useful tool in identifying which and how many students are at risk of failing to achieve the skills expected from the usual course of instruction. A consideration of anxiety as one of the variables at play in the genesis of learning difficulties may prompt educators to modify teaching methodology and strategies by increasing focus on the impact of the emotional dimension on learning.

Mood Disorders in People with Intellectual Disabilities: Diagnosis and Treatment.

Discriminating mood disorders from symptoms of intellectual disability is still a challenge for clinicians. We need standardized tools to apply right diagnoses without confusing signs and symptoms and specially to standardize psychological techniques to treat mood disorders without the use of drugs even in people with intellectual disability.

Intellectual Disability and Psychiatric Disorders as Exclusion Criteria in Randomized Controlled Trials (RCT).

People with intellectual disability or psychiatric disorders are commonly excluded from Randomized Controlled Trials (RCTs) because of explicit exclusion to the trials or because of inaccessible research protocols. We analyzed the exclusion rate of persons with cognitive impairment, psychiatric disorders and inability to give informed consent in interventional RCTs about the first 10 causes of global DALYs (disability- adjusted life-years) according to the Global Burden of Disease Study (GBD) utilizing the website Clinicaltrials.gov. A total of 2809 studies in the 10 selected categories were reviewed. "Cognitive impairment" was present in 488 (17.4%) studies, "Behavioural and psychiatric disorders" was present in 616 (21.9%) studies, "Inability to grant informed consent" was present in 498 (17.7%) studies and the three explicit criteria were present, alone or in combination, in 1076 studies (38.3%). Other disability-related exclusion criteria were considered to be implicit exclusion criteria and were present in 1233 (43.9%) studies. A judgement was made on the correlation between the exclusion criteria and the primary objectives of the studies analyzed. The low level of representation of people with disabilities in RCTs, in addition to being an ethical problem, is a limitation of scientific knowledge because it considerably reduces the external validity of a significant part of medical research. There is a need to review the way scientific research designs are constructed, seeking to promote greater inclusiveness of people with disabilities.

Music Training as a Potential Neuroprotective Agent.

A substantial amount of evidence suggest that music training is a powerful means of plastic reorganization of brain structures. Musical training is accompanied by plastic rearrangement of the central nervous system and numerous studies converge in disclosing that the brain differs significantly between musicians and non-musicians. Music-dependent brain changes concern both the grey and the white matter so that musicians possess a neuronal network shaped by type and degree of individual expertise as well as a different connectome than non-musicians. It is reasonable to assume that these plastic changes can provide a more efficient configuration of the neural network and justify an impact on cognition and behaviour in all ages of life. Furthermore, a number of studies suggest the effectiveness of "neurological music therapy" in clinical practice. Based on available literature, music should be considered one of the main activity that can preserve the brain efficiency and can be proposed as a primary non pharmachological agent in promoting a neuroprotective lifestyle. Understanding the variables of musical training that can positively influence brain plasticity might be one of the most exciting and promising areas of future research.

The D.A.M.A. Project at Terni Hospital, Italy.

Experience shows how difficult it is for a person with disabilities to cope with the reality of a hospital, especially if he or she has an intellectual disability. The difficulty in carrying out even simple diagnostic and therapeutic manoeuvres, the complexity of the pathologies, the difficulty in relating to the patient all make it a real risk that many medical problems of patients with disabilities are overlooked or denied altogether. The person with a disability has the right to all care, not only that related to his or her particular pathology, but also that required for other specialist or general pathologies. The UN Convention clearly states the rights of persons with disabilities. The Italian Republic has implemented the UN's declaration with Law 18/2009. The rights enshrined in Article 25 of the UN Convention are also concretely applied in the European Charter of Patients' Rights. The right of people with disabilities to be treated on an equal and non-discriminatory basis is also recalled by His Holiness Pope Francis in his latest encyclical. The DAMA (Disabled Advanced Medical Assistance) Hospital project was created to guarantee the right to health and care of people with disabilities, always, by remodelling its diagnostic and care procedures. The CAD/DAMA Service of the Terni Hospital since 2018 has adopted the DAMA project and also since 2018 has been collaborating with the Seraficio Institute of Assisi. The aim of the CAD/DAMA Service is also to promote and implement research in this area of care and training for healthcare professionals on disability and related issues.

Improving Health Care Accessibility for People with Complex Disabilities.

For many people with disabilities in health care even the simplest actions such as performing an examination or a test can be extremely difficult, just as a hospitalization or an access to the emergency room can be complex experiences. The issue of access to health services is felt to be particularly critical and unresolved by users, families and operators, who still report significant difficulties. The solutions to the problems of accessibility to care cannot be sought only at the clinical and professional level, but must rely on organizational and managerial innovations. The Seraphic Institute has promoted a project to ensure a better response to the health needs of people with complex disabilities to adapt the health care offer to the needs of people with disabilities, activating a proximity service aimed at reducing the inconvenience and costs related to the fragmentation of services and to improve and extend access to care of people with complex disabilities through the activation of a regional reference pole and a network of specialized multicenter and multidisciplinary assistance (Hub & Spoke model).

Learning and Participation of People with Multiple Disabilities through Rite and Rhythm: Description of the Catechetical and Liturgical Experience of the Serafico Institute of Assisi.

Through the description of the catechetical and liturgical experience of persons with multiple disabilities at the Serafico Institute of Assisi, we intend to initiate a discussion on the specific value that Rite and Rhythm have for learning and social participation of persons with severe physical, Psychic and sensory disabilities, from an integral educational and rehabilitative prospective. In summary, our attempt is to focus on elements such as the enhancement of non-verbal language within the Eucharistic liturgy, the ritual (in its characteristic of repetition) as an opportunity for learning, rhythm as an opportunity for spatial-temporal and social-relational movement.

Affective Disorders in Complex Disabilities: Strategies Empowerment for Improving the Lifestyle of the Disabled Person.

The concept of physical and intellectual disability has experienced a series of changes and evolutions over time with regard to approach, classification and rehabilitation-therapeutic programs, since it contemplates a heterogeneous clinical phenomenology in terms of severity, complexity, pervasiveness and severity of the diagnosis. The significant repercussions on the quality of life mean that a comprehensive approach is required with attention to the physical, social, emotional, sensory and cognitive profile, and that there is a need for the adoption of classification systems and assessment tools that are different and in some ways pioneering, so as to guarantee the surpassing of the concept of disability as a "mere defect" physical and/or impairment and/or loss of psychological, physiological or anatomical function (Holden & Gitlesen 2003, Linden 2017, WHO 2001). It is exactly in contemplation of a bio-psycho-social model, that the International Classification of Functioning, Disability and Health (ICF) arises, which possesses a neutral position with respect to etiology and a complementarity with the ICD-10 classification (WHO 2001), since it allows the functional diagnosis (i.e. a specialized analytical description of the potential and deficits in relation to the pathology) proposing a detailed analysis of the possible social consequences of disability by evaluating the residual capacities and measuring the "social skills" (WHO 2001).

A New Rating Scale (SAVE-9) to Demonstrate the Stress and Anxiety in the Healthcare Workers During the COVID-19 Viral Epidemic.

The COVID-19 epidemic has been a major global public health problem during past months in Italy and in several other Countries and on the date of publication of this article, is still a serious public health problem. The health staff, engaged in the care of the sick and in the prevention of the spread of the infection have been subjected to a further increase in psychological difficulties and work-related stress, related to the workload for the continuous influx of sick and intense and close working shifts for the viral emergency. The SAVE-9 (Stress and Anxiety to Viral Epidemics - 9 items) scale has been developed as a tool for assessing work anxiety and stress in response to the viral epidemic of health professionals working to prevent the spread of the virus and to treat infected people.

Factors affecting the relationship between adaptive behavior and challenging behaviors in individuals with intellectual disability and co-occurring disorders.

Previous studies have reported an inverse relationship between adaptive behavior and challenging behaviors in individuals with ID. However, it is unclear which characteristics might influence this relationship in individuals with ID and co-occurring conditions. We found a positive correlation between adaptive behavior (Vineland-II) and challenging behaviors (Nisonger Child Behavior Rating Form) in a study of 105 individuals who presented with mostly severe to profound ID and comorbid physical and mental health conditions. These results might be the consequence of the individual participant characteristics. Therefore, participants were separated out into two groups representing the top (n = 24) and bottom quartiles (n = 28) for presence of challenging behaviors. The participants with the highest levels of challenging behaviors had higher levels of adaptive behavior, higher frequency of intermittent explosive/conduct disorder, but lower frequency of epilepsy and cerebral palsy. All participants with the highest levels of challenging behaviors lived in an institutional setting; whereas, those with the lowest level of challenging behaviors lived in either an institutional setting or with their family. In participants with severe/profound ID and multiple co-occurring disorders, a minimum level of adaptive behavior seems to be necessary for the expression of challenging behaviors.

Beyond the Disease: "...Am I My Brother's Keeper?"

Today, the concepts of health and illness require a global vision of man; the suffering of the person places the entire environment in great difficulty: health professionals, family, society. It is important not to simplify the response to a purely health-focused view of the disorder, because fragile people possess a deep need to feel welcomed, listened to, understood and accepted. Service provision that is respectful of the dignity of the person is an important challenge both for those who are responsible for providing services to individuals and their families as well as for the entire community. Therefore in providing care the human qualities of the health professional and not only his technical skills come into play: blending together science and humanitarian ethos. The provision of care therefore "forces" us to broaden our horizons and requires us to face the challenge of responsibility towards the Other, the human condition of being-for. However, ethical capacity cannot be born solely out of sharing standards or adhering to regulations and respecting prohibitions: it stems from high and unconditional moral values and meanings. The ME-YOU relationship represents the primary ethical factor of the human being: my responsibility towards the Other is unconditional. In the book of Genesis when the Lord asks Cain: "... where is Abel, your brother?" He responds with another question: "Am I my brother's keeper?" In this biblical passage Cain kills Abel: the rejection of brotherhood and the care of the other only leads to the death of the Other. "Where is your brother?" This question is crucial in today's day and age and must be taken seriously: it is the decisive question that forces us to decide how to place ourselves in relationship with the other and with the world: do we choose proximity or distance, connection or indifference?

Evaluation of the Quality of Rehabilitation Treatment in Neurodevelopmental Disorder.

Complex disability is very difficult to manage. It usually subtends very serious clinical pictures, because it affect several body systems, or because it is associated with intellectual disability and behavioral disorders. Often affected patients are unable to communicate their basic needs. All these factors combine to make the management of these patients very complex, and those who care for them realize how important it is to find a way to detect their state and to identify their potential capabilities. Developing appropriate rehabilitation programs for these patients requires additional effort and an assessment capacity that is as objective as possible. Few scales cited in the literature are capable of evaluating these aspects in patients with complex disabilities, among them the Barthel Index (Mahoney & Barthel 1965) and the Vineland Adaptive Behavior scale II (Sparrow et al. 2005). The majority of these scales often tend to depict the data regarding the disease to a degree of severity that precludes adequate individual rehabilitation program development. There is a dire need for a more appropriate instrument, an observational grid that is capable of identifying the potential of this patient population and evaluate the effectiveness of rehabilitation interventions provided. The aim of the study is to evaluate the efficacy of rehabilitation interventions in a group of patients with IQ <32 (determined by the Vineland II scale) using an evaluation tool created ad hoc called D-Rubrics, designed with the intent to identify "micro-differences" between baseline (T0) and post-rehabilitation (T1). The goal is part of a more long term-term objective which involves developing an effective assessment tool for patients with complex disabilities. Such an assessment tool should be practical, easy to administer and useful in both clinical and research settings.

New technologies for art therapy interventions tailored to severe disabilities.

Individuals with multiple disabilities can have a wide range of characteristics depending on the combination and severity of the disabilities, such as intellectual disability, mobility issues, sensorial impairment, language issues and brain injury. New technologies can help therapists find an alternative way to engage and interact with clients by opening a communication window and starting to build the therapeutic relationship. The need to use more customized technological tools led us to develop the Painteraction system, an intuitive tool based on Augmented Reality that allows clients to be immersed in their own images. Just by moving their bodies individuals are able to make drawings and receive visual feedback, both from themselves and their therapists, as it appears on the screen. The pilot testing of Painteraction was performed on 21 inpatients at Istituto Serafico (Assisi, Italy) with severe/multiple disabilities in order to explore and assess reaction and responsiveness in a semi-structured art therapy setting. The sample was formed by 14 males and 7 females (N=21) between the ages of 7 and 35. All participants attended three twenty-minute individual art therapy sessions which were approximately one week apart. Through direct and indirect (video recordings) observation of the sessions, it appeared that the specific Augmented Reality tool introduced in the art therapy setting was easily accepted by most of the clients involved and generally allowed the development of an interpersonal therapist-client relationship. The present study therefore gave us the opportunity to test new digital tools in the challenging setting of severe/multiple disabilities and observe the huge potential of new media to empower clients to express themselves and their creativity, and ultimately overcome mental and physical barriers. We propose that Augmented Reality tools are particularly well-suited to art therapy and create an equally suitable therapeutic environment to address specific client needs.