Simulated presence therapy for dementia.

BACKGROUND: Dementia is a common and serious neuropsychiatric syndrome, characterised by progressive cognitive and functional decline. The majority of people with dementia develop behavioural disturbances, also known as behavioural and psychological symptoms of dementia (BPSD). Several non-pharmacological interventions have been evaluated to treat BPSD in people with dementia. Simulated presence therapy (SPT), an intervention that uses video or audiotape recordings of family members played to the person with dementia, is a possible approach to treat BPSD. OBJECTIVES: To assess the effects of SPT on behavioural and psychological symptoms and quality of life in people with dementia. SEARCH METHODS: We searched ALOIS (the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group), CENTRAL (The Cochrane Library) (9 April 2020), MEDLINE Ovid SP (1946 to 9 April 2020), Embase Ovid SP (1972 to 9 April 2020), PsycINFO Ovid SP (1806 to 9 April 2020), CINAHL via EBSCOhost (1980 to 9 April 2020), LILACS via BIREME (all dates to 9 April 2020), ClinicalTrials.gov (ClinicalTrials.gov) (all dates to 9 April 2020), and the World Health Organization (WHO) Portal (apps.who.int/trialsearch) (all dates to 9 April 2020). We also checked the reference lists of relevant articles to identify any additional studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials, including cross-over studies, that evaluated the efficacy of SPT, consisting of personalised audio or videotape recordings of family members, in people with any form of dementia. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed risk of bias and extracted data. No meta-analyses were conducted because of substantial heterogeneity among the included studies. MAIN RESULTS: Three trials with 144 participants met the inclusion criteria. Two of the trials had a randomised cross-over design, one was a cross-over trial which we classified as quasi-randomised. Participants in the included studies were people with dementia living in nursing homes. They were predominantly women and had a mean age of over 80 years. SPT was performed using an audio or video recording prepared by family members or surrogates. It varied in its content, frequency of administration and duration. All the studies compared multiple treatments. In one study, SPT was compared with two other interventions; in the other two studies, it was compared with three other interventions. Specifically, SPT was compared to usual care, personalised music (two studies), a 'placebo' audiotape containing the voice of a person (two studies), and one-to-one social interaction performed by trained research assistants (one study). In terms of outcomes evaluated, one study considered agitation and withdrawn behaviour (both assessed with three methods); the second study evaluated verbal disruptive behaviour (assessed with three methods); and the third study evaluated physically agitated behaviour and verbally agitated behaviour (the method used was not clearly described). According to the GRADE criteria, the overall quality of the evidence was very low due to very small numbers of participants and risk of bias in the included studies; (none of the trials was at low risk of selection bias; all the trials were at high risk of performance bias; one trial was at high risk of attrition bias; and all had unclear selective reporting). Because of variation in the participants, the format of SPT, the comparison interventions, and the measures used to assess outcomes, we judged the results unsuitable for a meta-analysis. Within each trial, the effect of SPT on behaviour, compared to usual care, was mixed and depended on the measure used. Two trials which included a personalised music intervention reported no significant differences between simulated presence and music on behavioural outcomes. Because the overall quality of the evidence was very low, we were very uncertain regarding all the results None of the studies evaluated quality of life or any of our secondary outcome measures (performance of activities of daily living, dropout and carer burden). AUTHORS' CONCLUSIONS: We were unable to draw any conclusions about the efficacy of SPT for treating behavioural and psychological symptoms and improving quality of life of people with dementia. New high-quality studies are needed to investigate the effect of SPT.

Ageism and surgical treatment of breast cancer in Italian hospitals.

AIM: To determine if age is a factor influencing the type of breast cancer surgery (radical versus conservative) in Italy and to investigate the regional differences in breast cancer surgery clinical practice. METHODS: Retrospective study is based on national hospital discharge records. The study draws on routinely collected data from hospital discharge records in Italy in 2010. The following exclusion criteria were applied: day hospital stays, patients younger than 17 years, males, patients without an ICD-9CM code indicating breast cancer and breast surgery, and repeated hospital admission of the same patient. Overall, 49,058 patient records were selected for the analysis. RESULTS: The proportion of conservative breast cancer operations was 70.9%. A greater number of women younger than 70 had undergone a breast-conserving operation compared to older women. There were regional variations ranging from a minimum in Basilicata to a maximum in Val d'Aosta. Multivariate analysis revealed that older patients with lower clinical severity were more likely to have undergone a radical operation than younger women. In addition, radical surgery was approximately twice as likely to occur in a private hospital that performed at least 50 breast cancer operations annually than in a public hospital that performed <50 breast surgeries. CONCLUSION: Notwithstanding increases in life expectancy and the lack of clinical evidence to support the use of age as a surrogate for co-morbid conditions and frailty, our data on breast cancer operations in Italy are consistent with the hypothesis suggesting the persistence of ageistic practice in the healthcare system.

Simulated presence therapy for dementia.

BACKGROUND: Dementia is a common and serious neuropsychiatric syndrome, characterised by progressive cognitive and functional decline. The majority of people with dementia develop behavioural disturbances, also known as behavioural and psychological symptoms of dementia (BPSD). Several non-pharmacological interventions have been evaluated to treat BPSD in people with dementia. Simulated presence therapy (SPT), an intervention that uses video or audiotape recordings of family members played to the person with dementia, is a possible approach to treat BPSD. OBJECTIVES: To assess the effects of SPT on behavioural and psychological symptoms and quality of life in people with dementia. SEARCH METHODS: We searched ALOIS (the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group), CENTRAL (The Cochrane Library) (9 February 2016), MEDLINE Ovid SP (1946 to 6 January 2017), Embase Ovid SP (1972 to 6 January 2017), PsycINFO Ovid SP (1806 to 6 January 2017), CINAHL via EBSCOhost (1980 to 6 January 2017), LILACS via BIREME (all dates to 6 January 2017), ClinicalTrials.gov (ClinicalTrials.gov) (all dates to 6 January 2017), and the World Health Organization (WHO) Portal (apps.who.int/trialsearch) (all dates to 6 January 2017). We also checked the reference lists of relevant articles to identify any additional studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials, including cross-over studies, that evaluated the efficacy of SPT, consisting of personalised audio or videotape recordings of family members, in people with any form of dementia. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed risk of bias and extracted data. No meta-analyses were conducted because of substantial heterogeneity among the included studies. MAIN RESULTS: Three trials with 144 participants met the inclusion criteria. Two of the trials had a randomised cross-over design, one was a cross-over trial which we classified as quasi-randomised.Participants in the included studies were people with dementia living in nursing homes. They were predominantly women and had a mean age of over 80 years. SPT was performed using an audio or video recording prepared by family members or surrogates. It varied in its content, frequency of administration and duration. All the studies compared multiple treatments. In one study, SPT was compared with two other interventions; in the other two studies, it was compared with three other interventions. Specifically, SPT was compared to usual care, personalised music (two studies), a 'placebo' audiotape containing the voice of a person (two studies), and one-to-one social interaction performed by trained research assistants (one study). In terms of outcomes evaluated, one study considered agitation and withdrawn behaviour (both assessed with three methods); the second study evaluated verbal disruptive behaviour (assessed with three methods); and the third study evaluated physically agitated behaviour and verbally agitated behaviour (the method used was not clearly described).According to the GRADE criteria, the overall quality of the evidence was very low due to very small numbers of participants and risk of bias in the included studies; (none of the trials was at low risk of selection bias; all the trials were at high risk of performance bias; one trial was at high risk of attrition bias; and all had unclear selective reporting).Because of variation in the participants, the format of SPT, the comparison interventions, and the measures used to assess outcomes, we judged the results unsuitable for a meta-analysis.Within each trial, the effect of SPT on behaviour, compared to usual care, was mixed and depended on the measure used. Two trials which included a personalised music intervention reported no significant differences between simulated presence and music on behavioural outcomes. Because the overall quality of the evidence was very low, we were very uncertain regarding all the resultsNone of the studies evaluated quality of life or any of our secondary outcome measures (performance of activities of daily living, dropout and carer burden). AUTHORS' CONCLUSIONS: We were unable to draw any conclusions about the efficacy of SPT for treating behavioural and psychological symptoms and improving quality of life of people with dementia. New high-quality studies are needed to investigate the effect of SPT.

Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series.

OBJECTIVE: To provide an overview of non-pharmacological interventions for behavioural and psychological symptoms in dementia (BPSD). DESIGN: Systematic overview of reviews. DATA SOURCES: PubMed, EMBASE, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO (2009-March 2015). ELIGIBILITY CRITERIA: Systematic reviews (SRs) that included at least one comparative study evaluating any non-pharmacological intervention, to treat BPSD. DATA EXTRACTION: Eligible studies were selected and data extracted independently by 2 reviewers.The AMSTAR checklist was used to assess the quality of the SRs. DATA ANALYSIS: Extracted data were synthesised using a narrative approach. RESULTS: 38 SRs and 129 primary studies were identified, comprising the following categories of non-pharmacological interventions: (1) sensory stimulation interventions (25 SRs, 66 primary studies) that encompassed: shiatsu and acupressure, aromatherapy, massage/touch therapy, light therapy, sensory garden and horticultural activities, music/dance therapy, dance therapy, snoezelen multisensory stimulation therapy, transcutaneous electrical nerve stimulation; (2) cognitive/emotion-oriented interventions (13 SRs; 26 primary studies) that included cognitive stimulation, reminiscence therapy, validation therapy, simulated presence therapy; (3) behaviour management techniques (6 SRs; 22 primary studies); (4) Multicomponent interventions (3 SR; four primary studies); (5) other therapies (5 SRs, 15 primary studies) comprising exercise therapy, animal-assisted therapy, special care unit and dining room environment-based interventions. CONCLUSIONS: A large number of non-pharmacological interventions for BPSD were identified. The majority of the studies had great variation in how the same type of intervention was defined and applied, the follow-up duration, the type of outcome measured, usually with modest sample size. Overall, music therapy and behavioural management techniques were effective for reducing BPSD.

Validity of peptic ulcer disease and upper gastrointestinal bleeding diagnoses in administrative databases: a systematic review protocol.

INTRODUCTION: Administrative healthcare databases are useful to investigate the epidemiology, health outcomes, quality indicators and healthcare utilisation concerning peptic ulcers and gastrointestinal bleeding, but the databases need to be validated in order to be a reliable source for research. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases, 9th Revision and 10th version (ICD-9 and ICD-10) codes for peptic ulcer and upper gastrointestinal bleeding diagnoses. METHODS AND ANALYSIS: MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched, using appropriate search strategies. We will include validation studies that used administrative data to identify peptic ulcer disease and upper gastrointestinal bleeding diagnoses or studies that evaluated the validity of peptic ulcer and upper gastrointestinal bleeding codes in administrative data. The following inclusion criteria will be used: (a) the presence of a reference standard case definition for the diseases of interest; (b) the presence of at least one test measure (eg, sensitivity, etc) and (c) the use of an administrative database as a source of data. Pairs of reviewers will independently abstract data using standardised forms and will evaluate quality using the checklist of the Standards for Reporting of Diagnostic Accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) 2015 statement. ETHICS AND DISSEMINATION: Ethics approval is not required given that this is a protocol for a systematic review. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide for researchers validating administrative healthcare databases to determine appropriate case definitions for peptic ulcer disease and upper gastrointestinal bleeding, as well as to perform outcome research using administrative healthcare databases of these conditions. TRIAL REGISTRATION NUMBER: CRD42015029216.

Effectiveness of Non-Pharmacological Interventions to Prevent Falls in Older People: A Systematic Overview. The SENATOR Project ONTOP Series.

BACKGROUND: Falls are common events in older people, which cause considerable morbidity and mortality. Non-pharmacological interventions are an important approach to prevent falls. There are a large number of systematic reviews of non-pharmacological interventions, whose evidence needs to be synthesized in order to facilitate evidence-based clinical decision making. OBJECTIVES: To systematically examine reviews and meta-analyses that evaluated non-pharmacological interventions to prevent falls in older adults in the community, care facilities and hospitals. METHODS: We searched the electronic databases Pubmed, the Cochrane Database of Systematic Reviews, EMBASE, CINAHL, PsycINFO, PEDRO and TRIP from January 2009 to March 2015, for systematic reviews that included at least one comparative study, evaluating any non-pharmacological intervention, to prevent falls amongst older adults. The quality of the reviews was assessed using AMSTAR and ProFaNE taxonomy was used to organize the interventions. RESULTS: Fifty-nine systematic reviews were identified which consisted of single, multiple and multifactorial non-pharmacological interventions to prevent falls in older people. The most frequent ProFaNE defined interventions were exercises either alone or combined with other interventions, followed by environment/assistive technology interventions comprising environmental modifications, assistive and protective aids, staff education and vision assessment/correction. Knowledge was the third principle class of interventions as patient education. Exercise and multifactorial interventions were the most effective treatments to reduce falls in older adults, although not all types of exercise were equally effective in all subjects and in all settings. Effective exercise programs combined balance and strength training. Reviews with a higher AMSTAR score were more likely to contain more primary studies, to be updated and to perform meta-analysis. CONCLUSIONS: The aim of this overview of reviews of non-pharmacological interventions to prevent falls in older people in different settings, is to support clinicians and other healthcare workers with clinical decision-making by providing a comprehensive perspective of findings.

The "Free from Housing Accessibility Problems" App.

The present study concerns the development of a computerized tool targeting housing accessibility issues. A user-centered approach involving professionals from the housing sector and senior citizens from four European countries resulted in a fully functional prototype of a mobile application (app) including an apartment database. The app raises awareness on housing accessibility and has the potential to support decision making and strengthen all citizens regardless of functional capacity to be more active in their endeavors for a satisfying housing solution. Further refinements and additional features are needed to enhance the potential benefits; they include addressing potential challenges facing senior citizens, developing interactive features that allow users to provide input and adapting to different national contexts to make the app applicable for the European market.

Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.

INTRODUCTION: Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases. METHODS AND ANALYSIS: MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. ETHICS AND DISSEMINATION: Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases. TRIAL REGISTRATION NUMBER: CRD42015029204.

Simulated presence therapy for dementia: a systematic review protocol.

INTRODUCTION: The majority of patients with dementia develop behavioural and psychological symptoms of dementia (BPSD). Non-pharmacological interventions are an appealing alternative for the treatment of BPSD in patients with dementia. Simulated presence therapy (SPT) is a simple and inexpensive non-pharmacological intervention that can be used to treat BPSD. We propose a Cochrane protocol for the collection and assessment of evidence concerning the efficacy of SPT to treat relevant outcomes in people with dementia. METHODS AND ANALYSIS: We will search the following electronic databases: the Cochrane Dementia and Cognitive Improvement Group's Specialised Register MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, CENTRAL and a number of trial registers as well as grey literature sources. We will include randomised and quasi-randomised controlled trials (including cross-over studies) that evaluated SPT in people with dementia. Comparators such as usual care with no additional activity, or any activity that differs in content and approach from SPT, but is additional to usual care, will be considered. The primary outcomes of interest will comprise behavioural and psychological symptoms, as measured by relevant scales, and quality of life. Two review authors working independently and in tandem will be involved in title and abstract screening, full-text screening and data abstraction. Where possible, quantitative data will be pooled, and relative risk and mean difference with 95% CI will be employed for dichotomous and continuous data, respectively. Assessment of risk of bias will be performed using the Cochrane risk-of-bias tool and the Grades of Recommendation, Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: Ethics approval is not required. The final results of this systematic review will be presented to the Cochrane Library and will also be disseminated at relevant conference presentations. TRIAL REGISTRATION NUMBER: CRD42015029778.

Socioeconomic Predictors of the Employment of Migrant Care Workers by Italian Families Assisting Older Alzheimer's Disease Patients: Evidence From the Up-Tech Study.

BACKGROUND: The availability of family caregivers of older people is decreasing in Italy as the number of migrant care workers (MCWs) hired by families increases. There is little evidence on the influence of socioeconomic factors in the employment of MCWs. METHOD: We analyzed baseline data from 438 older people with moderate Alzheimer's disease (AD), and their family caregivers enrolled in the Up-Tech trial. We used bivariate analysis and multilevel regressions to investigate the association between independent variables-education, social class, and the availability of a care allowance-and three outcomes-employment of a MCW, hours of care provided by the primary family caregiver, and by the family network (primary and other family caregivers). RESULTS: The availability of a care allowance and the educational level were independently associated with employing MCWs. A significant interaction between education and care allowance was found, suggesting that more educated families are more likely to spend the care allowance to hire a MCW. DISCUSSION: Socioeconomic inequalities negatively influenced access both to private care and to care allowance, leading disadvantaged families to directly provide more assistance to AD patients. Care allowance entitlement needs to be reformed in Italy and in countries with similar long-term care and migration systems.

Efficacy of Non-Pharmacological Interventions to Prevent and Treat Delirium in Older Patients: A Systematic Overview. The SENATOR project ONTOP Series.

BACKGROUND: Non-pharmacological intervention (e.g. multidisciplinary interventions, music therapy, bright light therapy, educational interventions etc.) are alternative interventions that can be used in older subjects. There are plenty reviews of non-pharmacological interventions for the prevention and treatment of delirium in older patients and clinicians need a synthesized, methodologically sound document for their decision making. METHODS AND FINDINGS: We performed a systematic overview of systematic reviews (SRs) of comparative studies concerning non-pharmacological intervention to treat or prevent delirium in older patients. The PubMed, Cochrane Database of Systematic Reviews, EMBASE, CINHAL, and PsychINFO (April 28th, 2014) were searched for relevant articles. AMSTAR was used to assess the quality of the SRs. The GRADE approach was used to assess the quality of primary studies. The elements of the multicomponent interventions were identified and compared among different studies to explore the possibility of performing a meta-analysis. Risk ratios were estimated using a random-effects model. Twenty-four SRs with 31 primary studies satisfied the inclusion criteria. Based on the AMSTAR criteria twelve reviews resulted of moderate quality and three resulted of high quality. Overall, multicomponent non-pharmacological interventions significantly reduced the incidence of delirium in surgical wards [2 randomized trials (RCTs): relative risk (RR) 0.71, 95% Confidence Interval (CI) 0.59 to 0.86, I2=0%; (GRADE evidence: moderate)] and in medical wards [2 CCTs: RR 0.65, 95%CI 0.49 to 0.86, I2=0%; (GRADE evidence: moderate)]. There is no evidence supporting the efficacy of non-pharmacological interventions to prevent delirium in low risk populations (i.e. low rate of delirium in the control group)[1 RCT: RR 1.75, 95%CI 0.50 to 6.10 (GRADE evidence: very low)]. For patients who have developed delirium, the available evidence does not support the efficacy of multicomponent non-pharmacological interventions to treat delirium. Among single component interventions only staff education, reorientation protocol (GRADE evidence: very low)] and Geriatric Risk Assessment MedGuide software [hazard ratio 0.42, 95%CI 0.35 to 0.52, (GRADE evidence: moderate)] resulted effective in preventing delirium. CONCLUSIONS: In older patients multi-component non-pharmacological interventions as well as some single-components intervention were effective in preventing delirium but not to treat delirium.

Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study.

OBJECTIVE: To examine whether deviation from the standard intention to treat analysis has an influence on treatment effect estimates of randomised trials. DESIGN: Meta-epidemiological study. DATA SOURCES: Medline, via PubMed, searched between 2006 and 2010; 43 systematic reviews of interventions and 310 randomised trials were included. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: From each year searched, random selection of 5% of intervention reviews with a meta-analysis that included at least one trial that deviated from the standard intention to treat approach. Basic characteristics of the systematic reviews and randomised trials were extracted. Information on the reporting of intention to treat analysis, outcome data, risk of bias items, post-randomisation exclusions, and funding were extracted from each trial. Trials were classified as: ITT (reporting the standard intention to treat approach), mITT (reporting a deviation from the standard approach), and no ITT (reporting no approach). Within each meta-analysis, treatment effects were compared between mITT and ITT trials, and between mITT and no ITT trials. The ratio of odds ratios was calculated (value <1 indicated larger treatment effects in mITT trials than in other trial categories). RESULTS: 50 meta-analyses and 322 comparisons of randomised trials (from 84 ITT trials, 118 mITT trials, and 108 no ITT trials; 12 trials contributed twice to the analysis) were examined. Compared with ITT trials, mITT trials showed a larger intervention effect (pooled ratio of odds ratios 0.83 (95% confidence interval 0.71 to 0.96), P=0.01; between meta-analyses variance τ(2)=0.13). Adjustments for sample size, type of centre, funding, items of risk of bias, post-randomisation exclusions, and variance of log odds ratio yielded consistent results (0.80 (0.69 to 0.94), P=0.005; τ(2)=0.08). After exclusion of five influential studies, results remained consistent (0.85 (0.75 to 0.98); τ(2)=0.08). The comparison between mITT trials and no ITT trials showed no statistical difference between the two groups (adjusted ratio of odds ratios 0.92 (0.70 to 1.23); τ(2)=0.57). CONCLUSIONS: Trials that deviated from the intention to treat analysis showed larger intervention effects than trials that reported the standard approach. Where an intention to treat analysis is impossible to perform, authors should clearly report who is included in the analysis and attempt to perform multiple imputations.

The economic impact of moderate stage Alzheimer's disease in Italy: evidence from the UP-TECH randomized trial.

BACKGROUND: There is consensus that dementia is the most burdensome disease for modern societies. Few cost-of-illness studies examined the complexity of Alzheimer's disease (AD) burden, considering at the same time health and social care, cash allowances, informal care, and out-of-pocket expenditure by families. METHODS: This is a comprehensive cost-of-illness study based on the baseline data from a randomized controlled trial (UP-TECH) enrolling 438 patients with moderate AD and their primary caregiver living in the community. RESULTS: The societal burden of AD, composed of public, patient, and informal care costs, was about €20,000/yr. Out of this, the cost borne by the public sector was €4,534/yr. The main driver of public cost was the national cash-for-care allowance (€2,324/yr), followed by drug prescriptions (€1,402/yr). Out-of-pocket expenditure predominantly concerned the cost of private care workers. The value of informal care peaked at €13,590/yr. Socioeconomic factors do not influence AD public cost, but do affect the level of out-of-pocket expenditure. CONCLUSION: The burden of AD reflects the structure of Italian welfare. The families predominantly manage AD patients. The public expenditure is mostly for drugs and cash-for-care benefits. From a State perspective in the short term, the advantage of these care arrangements is clear, compared to the cost of residential care. However, if caregivers are not adequately supported, savings may be soon offset by higher risk of caregiver morbidity and mortality produced by high burden and stress. The study has been registered on the website www.clinicaltrials.org ( TRIAL REGISTRATION NUMBER: NCT01700556).

Cross-national user priorities for housing provision and accessibility--findings from the European innovAge Project.

To develop an innovative information and communication technology (ICT) tool intended to help older people in their search for optimal housing solutions, a first step in the development process is to gain knowledge from the intended users. Thus the aim of this study was to deepen the knowledge about needs and expectations about housing options as expressed and prioritized by older people, people ageing with disabilities and professionals. A participatory design focus was adopted; 26 people with a range of functional limitations representing the user perspective and 15 professionals with a variety of backgrounds, participated in research circles that were conducted in four European countries. An additional 20 experts were invited as guests to the different research circle meetings. Three themes illustrating cross-national user priorities for housing provision and accessibility were identified: "Information barrier: accessible housing", "Information barrier: housing adaptation benefits", and "Cost barrier: housing adaptations". In conclusion, early user involvement and identification of cross-national differences in priorities and housing options will strengthen the development of a user-friendly ICT tool that can empower older people and people with disabilities to be more active consumers regarding housing provision.

The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: preliminary findings on recruitment and caregiving burden in the baseline population.

OBJECTIVES: The paper describes recruitment results and characteristics of the UP-TECH clinical trial sample, including level of care services use, informal caregiver burden and its determinants. METHODS: UP-TECH is designed to test innovative care solutions for community-dwelling patients with moderate stage Alzheimer's disease and their caregivers in Italy. Four hundred and fifty patient-caregiver dyads were randomized into three arms receiving different combinations of services, composed of case management interventions, nurse visits, assistive technology and educational brochures. The research nurses administered a questionnaire comprising an in-depth socio-demographic assessment and several clinical scales, such as Novak's Caregiver Burden Inventory. Analyses of baseline data were conducted using uni- and bi-variate statistics. Linear regressions were computed to identify de-confounded correlates of caregiver burden. RESULTS: Four hundred and thirty-eight patient-caregiver dyads were recruited and randomized. In our sample, patients are predominantly women (71.5%), with an average age of 81.5 years and a mean Mini-Mental State Examination score of 16.2. Caregivers are mostly women (66.2%) and offspring (55.7%), with a mean caregiver burden score of 27.6. They provide more than 50 hours of care per week, while receiving an almost negligible support from public services. Factors associated with caregiver burden are female gender, kinship and the patient's behavioral disturbances. The most important factor associated with lower burden is the employment of a live-in care worker. CONCLUSION: The paper provides a comprehensive description of moderate stage Alzheimer's disease patients and their caregivers, suggesting useful markers of caregiver burden. The well-balanced randomization assures the reliability of the study data-set for prospective evaluation of care strategies.

The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial.

BACKGROUND: The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home. METHODS/DESIGN: A total of 450 dyads comprising AD patients and their caregivers in five health districts of the Marche region, Italy, will be randomized into three study arms. Participants in the first study arm will receive comprehensive care and support from a case manager (an ad hoc trained social worker) (UP group). Subjects in the second study arm will be similarly supported by a case manager, but in addition will receive a technological toolkit (UP-TECH group). Participants in the control arm will only receive brochures regarding available services. All subjects will be visited at home by a trained nurse who will assess them using a standardized questionnaire at enrollment (M0), 6 months (M6) and 12 months (M12). Follow-up telephone interviews are scheduled at 24 months (M24). The primary outcomes are: 1) caregiver burden, measured using the Caregiver Burden Inventory (CBI); and 2) the actual number of days spent at home during the study period, defined as the number of days free from institutionalizations, hospitalizations and stays in an observation unit of an emergency room. DISCUSSION: The UP-TECH project protocol integrates previous evidence on the effectiveness of strategies in dementia care, that is, the use of case management, new technologies, nurse home visits and efforts toward the integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01700556.

Migrant care workers as protective factor against caregiver burden: results from a longitudinal analysis of the EUROFAMCARE study in Italy.

OBJECTIVE: The aim of the analysis is to assess the impact of privately employed migrant care workers (MCWs) on the burden of Italian family members who care for a disabled older person. METHODS: EUROFAMCARE is a one-year prospective survey carried out to provide evidence on the availability and use of support services by family carers of older people in Europe. In Italy, 990 family caregivers were enrolled and successful follow-ups were completed for 863 subjects. The survey also assessed the level of caregiver burden using the COPE index, which has three sub-sections: 'Positive Value' (PV), 'Quality of Support' (QS) and 'Negative Impact' (NI). We used the one-year change of the COPE-NI as dependent variable and we realised multilevel regression models to estimate the longitudinal predictors of caregivers' burden increase. RESULTS: At a cross-sectional level, most burdened caregivers are those caring for a demented relative (COPE-NI = 13.6), with no educational title (14.5) and looking after their own spouses (15.1). Longitudinally those employing an MCW are significantly protected against burden increase (regression coefficient: -1.52; p < 0.01) while those who cannot rely on the support of other family members are exposed to the risk of burden increase (0.991; p < 0.05). Other formal services do not have any protective effect. CONCLUSION: Our study suggests that employing an MCW, rather than using formal services, is associated with a reduction of caregiving burden. Further research should assess whether the shift in care responsibilities to the MCWs also implies a transfer of care burden, and understand how these workers can be better supported by existing formal services.

Microarray analysis of cultured rat hippocampal neurons treated with brain derived neurotrophic factor.

Brain derived neurotrophic factor (BDNF) has been shown to exert multiple actions on neurons. It plays a role in neuronal growth and maintenance and use-dependent plasticity, such as long-term potentiation and learning. This neurotrophin is believed to regulate neuronal plasticity by modifying neuronal excitability and morphology. There is experimental evidence for both an acute and a long-term effect of BDNF on synaptic transmission and structure but the molecular mechanisms underlying these events have not been completely clarified. In order to study the BDNF-induced molecular changes, the set of genes modulated in cultured hippocampal neurons by BDNF treatment was investigated after subchronic treatment with the neurotrophin. Microarray analysis performed with these cells, revealed increased expression of mRNA encoding the neuropeptides neuropeptide Y and somatostatin, and of the secreted peptide VGF (non acronymic), all of which participate in neurotransmission. In addition, the expression of genes apolipoprotein E (ApoE), delta-6 fatty acid desaturase (Fads2) and matrix metalloproteinase 14 (Mmp14), which play a role in neuronal remodelling, was also enhanced. More studies are needed to investigate and confirm the role of these genes in synaptic plasticity, but the results reported in this paper show that microarray analysis of hippocampal cultures can be used to expand our current knowledge of the molecular events triggered by BDNF in the hippocampus.

Synthesis and pharmacological characterisation of 2,4-dicarboxy-pyrroles as selective non-competitive mGluR1 antagonists.

Metabotropic glutamate receptors (mGluRs) are an unusual family of G-protein coupled receptor (GPCR), and are characterised by a large extracellular N-terminal domain that contains the glutamate binding site. We have identified a new class of non-competitive metabotropic glutamate receptor 1 (mGluR1) antagonists, 2,4-dicarboxy-pyrroles which are endowed with nanomolar potency. They interact within the 7 transmembrane (7TM) domain of the receptor and show antinociceptive properties when tested in a number of different animal models.