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Acetyl-L-carnitine is a substance that occurs naturally during the course of metabolism within the mitochondria. The substance plays a role in a variety of biochemical reactions within cells, including reactions that produce phospholipids necessary for cell membranes. The substance also appears to promote the uptake of choline by cells, the synthesis of acetylcholine, and the release of acetylcholine. Since there is considerable evidence that acetylcholine systems (as well as other systems) are deficient in patients with Alzheimer's disease, there is some rationale for attempting to use acetyl-L-carnitine to treat Alzheimer's disease. Such a study was conducted with 130 Alzheimer's disease patients who were randomly assigned to receive either acetyl-L-carnitine or a placebo for one year. The patients were tested before and after the study period for performance on 14 different measures of intellectual performance. At the end of the study, both the treated group and the placebo group had deteriorated in cognitive function. However, in 13 of the 14 measures, the patients treated with acetyl-L-carnitine had deteriorated less than the patients who received only placebo treatment. In four of these performance measures, the decreased rate of decline among the treated patients was statistically significant. Furthermore, when only the patients with indications of good compliance in taking the drug were considered, less decline was observed compared with the overall group. The side effects of acetyl-L-carnitine were generally mild. (Consumer Summary produced by Reliance Medical Information, Inc.)

Purpose.To report on the preliminary results of an Italian project on the implementation of an ICF-based protocol for providing public services and benefits for persons with disabilities. Methods.The UN Convention on the Rights of persons with disabilities (UNC) was mapped to the ICF, and core elements were implemented in an ICF-based evaluation protocol. A person-environment interaction classification (PEIC) tree was also developed for defining evaluation outputs. Results.The PEIC and the ICF-based protocol are the guideline and the data interpretation source, respectively, for providing public services and benefits. They enable to assign persons to different services, from surveillance and monitoring to facilitator provision or sustain over time, to barrier removal or to the reorganisation of environmental factors provision. A detailed description of the target intervention is made available through the implementation of a protocol, which points out the effect of personal support and other environmental factors. Conclusions.The detailed description of functioning and disability provided by our methodology can help policy makers and administrators in decision making, on the basis of a description of real needs, and in targeting person-tailored interventions. [ABSTRACT FROM AUTHOR]

The International Classification of Functioning Disability and Health (ICF) was approved in 2001 and, since then, several studies reported the increased interest about its use in different sectors. A recent overview that summarizes its applications is lacking. This study aims to provide an updated overview about 20 years of ICF application through an international online questionnaire, developed by the byline authors, and sent to each World Health Organization Collaborating Centers of the Family of International Classifications (WHO-FIC CCs). Data was collected during October 2020 and December 2021 and descriptive content analyses were used to report main results. Results show how, in most of the respondent countries represented by WHO-FIC CCs, ICF was mainly used in clinical practice, policy development and social policy, and in education areas. Despite its applications in different sectors, ICF use is not mandatory in most countries but, where used, it provides a biopsychosocial framework for policy development in health, functioning and disability. The study provides information about the needs related to ICF applications, that can be useful to organize targeted intervention plans. Furthermore, this survey methodology can be re-proposed periodically to monitor the use of the ICF in the future.

An overarching WHO-FIC Content Model will allow uniform modeling of classifications in the WHO Family of International Classifications (WHO-FIC) and promote their joint use. We provide an initial conceptualization of such a model.

The COVID-19 pandemic provides the opportunity to re-think health policies and health systems approaches by the adoption of a biopsychosocial perspective, thus acting on environmental factors so as to increase facilitators and diminish barriers. Specifically, vulnerable people should not face discrimination because of their vulnerability in the allocation of care or life-sustaining treatments. Adoption of biopsychosocial model helps to identify key elements where to act to diminish effects of the pandemics. The pandemic showed us that barriers in health care organization affect mostly those that are vulnerable and can suffer discrimination not because of severity of diseases but just because of their vulnerability, be this age or disability and this can be avoided by biopsychosocial planning in health and social policies. It is possible to avoid the banality of evil, intended as lack of thinking on what we do when we do, by using the emergence of the emergency of COVID-19 as a Trojan horse to achieve some of the sustainable development goals such as universal health coverage and equity in access, thus acting on environmental factors is the key for global health improvement., Competing Interests: Conflict of InterestThe authors declare that they have no conflict of interests., (© The Author(s) 2020.)

Objective: Cerebral amyloid angiopathy (CAA) is caused by cerebrovascular deposition of β -amyloid fragments leading to cerebrovascular dysfunction and other brain injuries. This phase 2, randomized, double-blind trial in patients with probable CAA assessed the efficacy and safety of ponezumab, a novel monoclonal antibody against A β 1-40 ., Methods: Thirty-six participants aged 55-80 years with probable CAA received intravenous placebo ( n  = 12) or ponezumab ( n  = 24). The change from baseline to Days 2 and 90 in cerebrovascular reactivity (CVR) was measured in the visual cortex as the natural log of the rising slope of the BOLD fMRI response to a visual stimulus. Safety and tolerability were also assessed., Results: The mean change from baseline to Day 90 was 0.817 (ponezumab) and 0.958 (placebo): a mean ratio of 0.852 (90% CI 0.735-0.989) representing a trend towards reduced CVR in the ponezumab group. This trend was not present at Day 2. There was one asymptomatic occurrence of amyloid-related imaging abnormality-edema in the ponezumab group. The total number of new cerebral microbleeds from baseline to day 90 did not differ between groups. The ponezumab group had a participant with nonfatal new cerebral hemorrhage with aphasia and a participant with subdural hemorrhage that site investigators deemed to be nondrug related. In the placebo group one participant had a fatal intracerebral hemorrhage and one participant had migraine with aura., Interpretation: Ponezumab was safe and well-tolerated. The ponezumab group showed a trend towards treatment effect at Day 90 that was opposite to the hypothesized direction. The prespecified efficacy criteria were thus not met., Competing Interests: Claire Leurent, James A. Goodman, Yao Zhang, Ping He, Monica Lindsay, Linda Frattura, U. S. Sohur, and Martin M. Bednar were employees of Pfizer. Steven M. Greenberg served as a consultant to Pfizer and GlaxoSmithKline and on safety monitoring committees for amyloid immunotherapy studies conducted by Roche, Biogen, and DIAN‐TU. Massachusetts General Hospital participated in this study under a Clinical Research Support Agreement with Pfizer. Anand Viswanathan served on safety monitoring committees for amyloid immunotherapy studies conducted by Roche.

In Italy, ICD-9-CM is currently used for coding health conditions at hospital discharge, but ICD-10 is being introduced thanks to the IT-DRG Project. In this project, one needed component is a set of transcoding rules and associated tools for easing coders work in the transition. The present paper illustrates design and development of those transcoding rules, and their preliminary testing on a subset of Italian hospital discharge data.

The collaborative research on ageing in Europe protocol was based on that of the World Health Organization Study on global AGEing and adult health (SAGE) project that investigated the relationship between health and well-being and provided a set of instruments that can be used across countries to monitor health and health-related outcomes of older populations as well as the strategies for addressing issues concerning the ageing process. To evaluate the degree to which SAGE protocol covered the spectrum of disability given the scope of the World Health Organization International Classification of Functioning, Disability and Health (ICF), a mapping exercise was performed with SAGE protocol. Results show that the SAGE protocol covers ICF domains in a non-uniform way, with environmental factors categories being underrepresented, whereas mental, cardiovascular, sensory functions and mobility were overrepresented. To overcome this partial coverage of ICF functioning categories, new assessment instruments have been developed. PRACTITIONER MESSAGE: Mapping exercises are valid procedures to understand the extent to which a survey protocol covers the spectrum of functioning. The mapping exercise with SAGE protocol shows that it provides only a partial representation of body functions and activities and participation domains, and the coverage of environmental factors is poor. New instruments are therefore needed for researchers to properly understand the health and disability of ageing populations., (Copyright © 2013 John Wiley & Sons, Ltd.)

Unlabelled: COURAGE in Europe was a 3-year project involving 12 partners from four European countries and the World Health Organization. It was inspired by the pressing need to integrate international studies on disability and ageing in light of an innovative perspective based on a validated data-collection protocol. COURAGE in Europe Project collected data on the determinants of health and disability in an ageing population, with specific tools for the evaluation of the role of the built environment and social networks on health, disability, quality of life and well-being. The main survey was conducted by partners in Finland, Poland and Spain where the survey has been administered to a sample of 10,800 persons, which was completed in March 2012. The newly developed and validated COURAGE Protocol for Ageing Studies has proven to be a valid tool for collecting comparable data in ageing population, and the COURAGE in Europe Project has created valid and reliable scientific evidence, demonstrating cross-country comparability, for disability and ageing research and policy development. It is therefore recommended that future studies exploring determinants of health and disability in ageing use the COURAGE-derived methodology., Key Practitioner Message: COURAGE in Europe Project collected data on the determinants of health and disability in an ageing population, with specific tools for the evaluation of the role of built environment and social networks on health, disability quality of life and well-being. The COURAGE Protocol for Ageing Studies has proven to be a valid tool for collecting comparable data in the ageing population. The COURAGE in Europe Consortium recommends that future studies exploring determinants of health and disability in ageing use COURAGE-derived methodology., (Copyright © 2013 John Wiley & Sons, Ltd.)

Under the ARCHITRAVE programme aimed at redesigning the regional health and social information system, the alpha version of a new web application was developed using the International Classification of Functioning, Disability and Health (ICF) and other medical terminology systems as a basis for a flexible electronic standards-based bio-psycho-social record. The web application was developed in order to collect information according to a multiaxial assessment framework consistent with the model of functioning adopted by the ICF. The web application translates information collected in natural language into ICF and releases outputs at different stages of the assessment process useful in evaluating clinical and social outcomes, distinguishing between functioning and disability in the same functioning profile and planning reasonable adaptations to overcome disability. The alpha version works in Italian and was adapted to the Italian welfare system/services/policies, but an international version working in other languages/welfare systems can be designed. The first field trial is ongoing in the Friuli Venezia Giulia Region, implementing the regional Health and Social Action Plan 2010-2012.

Background: There is a connection between the definition of disability in a person-environment framework, the development of appropriate assessment strategies and instruments, and the logic underpinning the organization of benefits and services to confront disability., Methods: The Italian Ministry of Health and Ministry of Labor and Social Policies supported a three-year project for the definition of a common framework and a standardised protocol for disability evaluation based on ICF. The research agenda of the project identified 6 phases: 1) adoption of a definition of disability; 2) analytical breakdown of the contents of disability definition, so as to indicate as clearly as possible the core information essential to guide the evaluation process; 3) definition of a data collection protocol; 4) national implementation of the protocol and collection of approximately 1,000 profiles; 5) proposal of a profile analysis and definition of groups of cases with similar functioning profiles; 6) trial of the proposal with the collected data. The data was analyzed in different ways: descriptive analysis, application of the person-environment interactions classification tree, and cluster analysis., Results: A sample of 1,051 persons from 8 Italian regions was collected that represented different functioning conditions in all the phases of the life cycle. The aggregate result of the person-environment interactions was summarized. The majority of activities resulted with no problems in all of the A&P chapters. Nearly 50.000 facilitators codes were opened. The main frequent facilitators were family members, health and social professionals, assistive devices and both health and social systems, services and politics. The focus of the person-environment interaction evaluation was on the A&P domains, differentiating those in which performance presented limitations and restrictions from those in which performance had no or light limitations and restrictions. Communication(d3) and Learning and Applying Knowledge(d1) appeared as the more problematic A&P areas. Self Care(d5) was the domain in which facilitators were more effective in supporting functioning, suggesting that the Italian welfare system is mainly focused on providing care services for activities of daily living, jointly with the family. The cluster analysis was limited to those categories that were common to all age classes (38 categories out of 55). For a final representation, a solution with 6 clusters was chosen., Conclusions: An example is provided of how it is possible to plan empirical studies in which theoretical advances and operative goals on disability in a person-environment framework can support the definition of a research design, measurement strategies, and data analysis. The description of functioning and disability at population level is no more based on individual deficits or limitations. Personal profiles may be elaborated and groups created based on the characteristics of the person-environment interactions. Personal profiles may also be used as a "rationale" for defining personalized intervention programs.

Background: Psychiatric hospitals in Italy had to be closed under a law dated 1994., Aims: To investigate the discharge of patients from public psychiatric hospitals., Methods: A total of 4492 patients from 22 psychiatric hospitals were described at recruitment and followed during the period 1994-2000. Their characteristics were investigated as determinants of discharge to community residential facilities for psychiatric patients versus other settings., Results: All 22 psychiatric hospitals closed between 1994 and 2000; 678 patients had died, and the remainder were discharged. Of these, 39% went to nursing homes, 29% to community residential facilities for psychiatric patients, 2% joined their family, less than 1% were settled in private independent accommodation, and 29% remained in the psychiatric hospital, although defined as discharged. Ten patients were recorded as missing when still in the psychiatric hospitals, none after discharge. Younger, more educated patients and patients from two of the four regions studied were more likely to be discharged to community residential facilities., Conclusions: The majority of patients were discharged to highly supervised settings. The potential risk of abandonment due to deinstitutionalization was not observed in this population. The wide use of highly supervised settings can be explained by the patients' old age, but different local policies may have affected the discharge process.

Objective: This study describes the use of psychotropic drugs in a sample of eight Italian psychiatric hospitals., Methods: A cross-sectional approach was used to collect information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed. Prescribing behaviour in the hospitals was compared using three indicators: the number of patients taking psychotropic drugs, the use of high doses of neuroleptics and the use of multiple neuroleptics., Results: More than a thousand patients were resident in the eight hospitals on the census day, 56% of them males. Half the population had an ICD-X diagnosis of schizophrenia, one third of mental retardation. Sixty-nine percent of the sample was on neuroleptic therapy, nearly 47% on benzodiazepines and 4% on antidepressants. Twenty percent of the sample did not take any psychotropic drug on the census day. After adjustment for sociodemographic and clinical variables, setting-related variables resulted as determinants of psychotropic drug use., Conclusions: These data call for continuing education in psychopharmacology towards a more rational use of drugs; longitudinal audits of clinical practice should be implemented to guide clinicians toward a more rational use of psychotropic drugs., (Copyright 1999 John Wiley & Sons, Ltd.)

Objectives: Monitoring and evaluating the Italian psychiatric hospitals closure process, stated by the law to be concluded by 31 December 1996, and then postponed to 31 March 1998, identifying characteristics related to the possibility of discharge in 4493 patients living in twenty-two public psychiatric hospitals., Method: Sociodemographic and clinical data, information on impairment and functioning and plans for discharge in the subsequent twelve months of all patients were collected at baseline using a standard questionnaire., Results: Discharge was planned within twelve months for 11% of the patients: 4% to other psychiatric or non-psychiatric institutions and 7% to community settings. Severely disabled patients and patients with some behavioural problems were more frequently scheduled to go to institutional settings. For both types of discharge, an adequate network of social relationships was an important determinant. Patients were more frequently planned for discharge if they resided in hospitals with a higher care providers/patients ratio, and in Emilia Romagna and Rome, than in Lombardy and Liguria., Conclusion: Frequency of planned discharge depended partly on the patients' personal characteristics related to independence and functioning, but the effect of these factors on frequency of planned discharge was influenced by characteristics of the hospitals where the patients lived.

Objectives: To evaluate drug consumption in the elderly aged 75 years or more living at home., Design: Cross-sectional study., Setting: Old-old (i.e., > or = 75 y) people living in central Turin, a city in northern Italy., Participants: Thirty-four general practitioners (GPs), with 50 or more old-old people in their patient list, randomly chosen among the GPs working in the Unità Socio-Sanitaria Locale I (Local Health Unit I) of Turin; 261 old-old people (135 men and 126 women) randomly selected from the practice records., Methods: Data were collected by the GP through a structured questionnaire during an office visit and by a social worker in a home interview within 14 days of the GP visit. GPs were asked to record every diagnosis and drug currently taken by the patient; social workers were trained in the administration of a structured questionnaire exploring sociodemographic variables, drug use (following the medication inventory strategy), disability, cognitive functions, and depressive symptoms., Results: Nearly all subjects (95% of the women and 91% of the men) were taking at least 1 drug. The overall number of drugs recorded was 917 (47.1% for men and 52.9% for women), of which 172 (18.8%) were not reported by the GP but were recorded during the social worker's visit. The mean number of drugs was 3.2 for men and 3.8 for women, with a statistically significant difference (p = 0.02), while the mean number of diagnoses was 2.3 and 2.6, respectively. The study of correlates of drug consumption showed a strong association with number of diagnoses at univariate analysis (p < 0.0001, with a linear correlation coefficient of 0.64). No multivariate model showed a clear superiority over the simple one containing only the number of diagnoses in predicting the total number of drugs taken. Cardiovascular, nervous system, and alimentary tract drugs were the most frequently used. A total of 107 subjects (41%) were taking at least 1 unreported drug., Conclusions: Our study shows high drug consumption among old-old people, with nearly 20% of drugs taken not reported by the GP. These results emphasize the need for an essential therapeutic approach in old-old people, prescribing only drugs of scientifically proven efficacy. Furthermore, the GP must make more effort when collecting a drug history from old-old patients.

Objective: To describe structural features, attenders' characteristics and intervention habits in a large sample of Community Mental Health Departments (CMHDs) in Southern Italy., Design and Setting: 1) Survey of resources and organization features of collaborating CMHDs; 2) Unreplicated registration of all attenders and of therapeutic interventions during an index week., Results: A self-selected sample of 47 CMHDs in Southern Italy recruited 3845 patients during the last week of October 1992. Participating CMHDs were serving a socially deprived and severely ill population: 45.8% of attenders had 8 years or less of formal education; only 18.9% were employed, 30.9% of diagnoses were of the schizophrenia spectrum group and 23% of the affective disorders group. Sixty-eight per cent of patients were being treated with psychotropic drugs, while only 19% received rehabilitative interventions. The activity of CMHDs were oriented more towards the control of active symptomatology than towards rehabilitation. A significantly higher proportion of patients receiving a schizophrenia-spectrum disorder diagnosis were found in contact during the index week with those CMHDs providing both residential and semiresidential (day-hospital, community center) facilities.

A research protocol on the health and social situation of a sample of "very old" people seen in a setting of general practice. Besides its objective of defining the spectrum of problems presented by this group of patients, the investigation aims at evaluating the impact of an intervention which should include all the members of the care team (doctors, nurses, social and health assistants), to allow due attention also to the problems of relatives and of those who assure home assistance to the elderly.

A random sample of 46 general practitioners of the Unità Sanitaria Locale in Torino recruited 802 elderly outpatients and collected information about complaints and current drug treatment. Within a week each patient received a home interview and details were collected on drug compliance and use of drugs other than those reported by the GP. On average, each patient was taking 3.6 drugs of which 2.9 were correctly reported by the GP and 0.7 were un reported. Among the most prescribed therapeutic groups there were drugs with a narrow therapeutic index (cardiovascular drugs, diuretics, psychotropic agents) and substances whose efficacy has never been fully documented ("cerebroactive/vasoactive"). Age and number of compliants were positively and significantly correlated with number of prescribed drugs. The most common reason for non-compliance was fear of side-effects.

A group of 237 elderly patients with dementia of Alzheimer type (DAT) or multi-infarct dementia (MID) was randomly selected in a large geriatric institution in Milan. Mean age of the sample was 78.9 years, 160 (67.5%) were DAT patients and 77 (32.5%) were MID patients. Half of the sample had low levels of autonomy and after 4 years 183 (77.2%) patients were dead. Predictors of mortality, according to a univariate analysis, were age, level of autonomy and type of diagnosis (DAT vs. MID). Mortality rate after 4 years was significantly higher (p less than 0.001) in DAT (86.9%) than in MID (57.1%) patients.

Unlabelled: In ten Italian centers--hospitals and geriatric institutions--130 outpatients and inpatients with a diagnosis of Alzheimer's disease were recruited for a randomized, double blind, placebo controlled clinical trial with 1-acetylcarnitine. In planning the trial, we had to deal with some important and largely open issues., Diagnosis: we decided not to use neuropsychological tests (NPT) in the diagnostic process, both for the unknown risk of false positive and false negative rate and to improve the feasibility of the trial., Follow-Up: it must be representative of the disease and consequently we chose to follow the patients for one year (assessment at baseline, 3rd, 6th and 12th month) in spite of a possible high rate of drop-outs., Assessment: to assess the patients' outcome we used NPT and behavioural scales. However, the validity, reliability and feasibility of these instruments are rarely discussed and their usefulness as indicators of the relevant aspects of the disease needs a careful evaluation., Statistical Analysis: in this type of trial there is both a high risk of alpha-error, in view of the high number of NPT and behavioural scales used to assess the drug efficacy, and a high risk of beta-error connected with the usually small sample size. Thus, the role of small trials in defining the risk/benefit ratio of a treatment needs to be discussed.