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 acce ss to health services is felt to be particularly critical and unresolved by users, families and operators, who still report significa nt difficulties. The solutions to the problems of accessibility to care cannot be sought only at the clinical and professional lev el, but must rely on organizational and managerial innovations. The Seraphic Institute has promoted a project to ensure a better respon se 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 im prove 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

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 biopsycho- 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)

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 biopsycho- 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)

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 acce ss to health services is felt to be particularly critical and unresolved by users, families and operators, who still report significa nt difficulties. The solutions to the problems of accessibility to care cannot be sought only at the clinical and professional lev el, but must rely on organizational and managerial innovations. The Seraphic Institute has promoted a project to ensure a better respon se 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 im prove 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

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

‘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

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