Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.

BACKGROUND: Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. METHODS: We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. RESULTS: For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). CONCLUSIONS: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

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.

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.

Potentially inappropriate prescribing detected by STOPP-START criteria: are they really inappropriate?

BACKGROUND: the STOPP-START criteria were developed to detect potentially inappropriate prescribing (PIP) in older people. The reasons why multidisciplinary geriatric teams decide not to follow STOPP-START criteria have not been studied. OBJECTIVE: to analyse compliance with the recommendations of the STOPP-START criteria in older inpatients. DESIGN: ambispective, non-randomised study. SUBJECTS SETTING: three hundred and eighty-eight consecutive patients aged 80 years or over admitted to the acute geriatric medicine unit of a University hospital. METHODS: STOPP-START criteria were systematically used by a pharmacist to assess pre-admission treatments, and the multidisciplinary geriatric team decided what drugs were recommended after discharge. Two researches independently assessed how many STOPP-START recommendations were accepted by the team, and if they were not accepted, why. RESULTS: two hundred and eighty-four PIPs were identified (0.8 per subject) according to STOPP criteria. Two hundred and forty-seven of these prescriptions (87.0%) were discontinued at discharge. STOPP recommendations were not accepted in 37 cases, mostly because the team considered other therapeutic priorities (lorazepam, n = 12; risperidone, n = 5; other, n = 18). Three hundred and ninety-seven PIPs were identified according to START criteria (1.1 per subject). START recommendations were not followed at discharge in 264 cases (66.5%). The most frequent reasons were as follows: severe disability (n = 90), the use of other effective treatments for the condition (n = 38) and high risk of severe adverse effects (n = 32). Not following START criteria was significantly associated with dependency for basic activities of daily living (ADLs) (odds ratio, OR: 0.66 for compliance with a recommendation; 0.49-0.89), dependency for instrumental ADLs (OR: 0.64; 0.48-0.85) or inability to walk (OR: 0.72; 0.54-0.98). CONCLUSIONS: potentially inappropriate drugs are usually discontinued, but many older hospitalised patients do not receive potentially recommended medications. More research on the reasons and consequences of this fact is needed.

Health impact on the elderly survivors of COVID-19: Six months follow up.

PURPOSE: To analyse factors associated with mortality at 6 months in survivors older than 70 years after hospital admission for SARS-CoV-2. METHODS: Descriptive observational study with follow-up at 6 months. All patients over 70 years of age, discharged from the Hospital Central de la Cruz Roja, after hospitalization for COVID-19 consecutively during the months March to May 2020 were included. The outcome at 6 months (mortality, readmissions) were collected. RESULTS: A total of 165 patients were included. Mean age 88.5±6.73, women 69.1%. High comorbidity 33.9%. Mean previous Barthel Index was 65.39±33.64 and at discharge 58.12±34.04. 24.2% had severe polypharmacy and 47.9% severe frailty. Six months after hospital discharge, 13% died and 23.8% required at least one readmission. More than half of the sample had some of the following sequelae: dyspnea 20%(33), functional impairment 41.7%(69), cognitive impairment 31.3%(52) or depressive symptoms 42.4%(70). Functional impairment at discharge was associated with an increased risk of mortality (OR 5.33; 95% CI 1.11-25.73). CONCLUSIONS: The functional status was a factor associated with risk of mortality at 6 months.

COVID-19 Mortality in Patients Aged 80 and over Residing in Nursing Homes-Six Pandemic Waves: OCTA-COVID Study.

During the first COVID-19 pandemic wave in Spain, 50% of deaths occurred in nursing homes, making it necessary for some hospitals to support these facilities with the care of infected patients. This study compares origin, characteristics, and mortality of patients admitted with COVID-19 during six pandemic waves in the Hospital Central de la Cruz Roja in Madrid. It is a retrospective observational study of patients ≥80 years old, admitted with an acute SARS-CoV-2 infection, with a total of 546 patients included, whose final outcome was death or discharge. During the first wave, those from nursing homes had a higher risk of death than those from home; during the two successive waves, the risk was higher for those from home; and in the last two waves, the risk equalized and decreased exponentially in both groups. Men had 72% higher risk of death than women. For each year of age, the risk increased by 4% (p = 0.036). For each Charlson index point, the risk increased by 14% (p = 0.019). Individuals in nursing homes, despite being older with higher comorbidity, did not show a higher overall lethality. The mortality decreased progressively in each successive wave due to high vaccination rates and COVID-19 control measures in this population.

Mortality risk factors in a Spanish cohort of oldest-old patients hospitalized with COVID-19 in an acute geriatric unit: the OCTA-COVID study.

PURPOSE: To determine predictors of in-hospital mortality related to COVID-19 in oldest-old patients. DESIGN: Single-center observational study. SETTING AND PARTICIPANTS: Patients ≥ 75 years admitted to an Acute Geriatric Unit with COVID-19. METHODS: Data from hospital admission were retrieved from the electronic medical records: demographics, geriatric syndromes (delirium, falls, polypharmacy, functional and cognitive status) co-morbidities, previous treatments, clinical, laboratory, and radiographic characteristics. Cox proportional hazard models were used to evaluate in-hospital mortality. RESULTS: Three hundred patients were consecutively included (62.7% females, mean age of 86.3 ± 6.6 years). Barthel Index (BI) was < 60 in 127 patients (42.8%) and 126 (42.0%) had Charlson Index CI ≥ 3. Most patients (216; 72.7%) were frail (Clinical Frailty Scale ≥ 5) and 134 patients (45.1%) had dementia of some degree. The overall in-hospital mortality rate was 37%. The following factors were associated with higher in-hospital mortality in a multi-variant analysis: CURB-65 score = 3-5 (HR 7.99, 95% CI 3.55-19.96, p < 0.001), incident delirium (HR 1.72, 1.10-2.70, p = 0.017) and dementia (HR 3.01, 95% CI 1.37-6.705, p = 0.017). Protective factors were concurrent use of angiotensin-converting enzyme inhibitors (HR 0.42, 95% CI 0.25-0.72, p = 0.002) or prescription of hydroxychloroquine (HC 0.37 95% CI 0.22-0.62, p < 0.001) treatment during admission. CONCLUSIONS AND IMPLICATIONS: Our findings suggest that recognition of geriatric syndromes together with the CURB-65 score may be useful tools to help clinicians establish the prognosis of oldest-old patients admitted to hospital with COVID-19.

Elderly Population with COVID-19 and the Accuracy of Clinical Scales and D-Dimer for Pulmonary Embolism: The OCTA-COVID Study.

BACKGROUND: Elderly COVID-19 patients have a high risk of pulmonary embolism (PE), but factors that predict PE are unknown in this population. This study assessed the Wells and revised Geneva scoring systems as predictors of PE and their relationships with D-dimer (DD) in this population. METHODS: This was a longitudinal, observational study that included patients ≥75 years old with COVID-19 and suspected PE. The performances of the Wells score, revised Geneva score and DD levels were assessed. The combinations of the DD level and the clinical scales were evaluated using positive rules for higher specificity. RESULTS: Among 305 patients included in the OCTA-COVID study cohort, 50 had suspected PE based on computed tomography pulmonary arteriography (CTPA), and the prevalence was 5.6%. The frequencies of PE in the low-, intermediate- and high-probability categories were 5.9%, 88.2% and 5.9% for the Geneva model and 35.3%, 58.8% and 5.9% for the Wells model, respectively. The DD median was higher in the PE group (4.33 mg/L; interquartile range (IQR) 2.40-7.17) than in the no PE group (1.39 mg/L; IQR 1.01-2.75) (p < 0.001). The area under the curve (AUC) for DD was 0.789 (0.652-0.927). After changing the cutoff point for DD to 4.33 mg/L, the specificity increased from 42.5% to 93.9%. CONCLUSIONS: The cutoff point DD > 4.33 mg/L has an increased specificity, which can discriminate false positives. The addition of the DD and the clinical probability scales increases the specificity and negative predictive value, which helps to avoid unnecessary invasive tests in this population.

Prevalence of potentially inappropriate prescription in community-dwelling patients with advanced dementia and palliative care needs.

OBJECTIVE: To establish the prevalence of potentially inappropriate prescription (PIP) in older people with advanced dementia, monitored by a Geriatric Home Care Unit (GHC), as well as the associated risk factors and costs. METHODS: Community-dwelling patients ≥65 years with an advanced dementia diagnosis (GDS-FAST≥7a) and poor 1-year vital prognosis (Frail-VIG≥0.6) were included. Pharmacotherapy history was reviewed retrospectively, collecting functional and cognitive status, on the first GHC visit, of patients assessed January 2016-January 2019. Potentially inappropriate medication was defined following STOPP-Frail criteria. RESULTS: 100 patients included (76% women, 89.15±5.8 years). Total medications prescribed 760 (7.63±3.4 drugs per patient). 85% patients were given at least one drug considered to be PIP. 26% (196) of the total drugs registered were PIPs. Patients who were prescribed an inappropriate drug showed a higher number of total prescribed drugs (7.92±3.42 vs 6.00±2.24; p 0.04) and a higher frequency of polypharmacy (84.7% vs 60%; p 0.025). Risk of receiving inappropriate medication increased by 24% for each additional drug prescribed (OR 1.24; 95% CI 1.01-1.52; p 0.04). The costs associated with PIP were 113.99 euros per 100 patients/day; 41,606.35 euros per 100 patients/year. CONCLUSIONS: Prescription of PIP to community-dwelling patients with severe dementia and poor vital prognosis is common and is associated with high economic impact in this population group.

Predictive Factors of Pulmonary Embolism in Older Patients with SARS-CoV-2: The OCTA-COVID-19 Study.

BACKGROUND: The risk of pulmonary embolism (PE) has not been studied in older patients affected by COVID-19. We aimed to assess PE incidence and risk factors in a population of older patients infected with SARS-CoV-2. METHODS: An ambispective, observational cohort study. A total of 305 patients ≥ 75 years old had the SARS-CoV-2 infection from March to May 2020. The incidence rate of PE was estimated as the proportion of new cases within the whole sample. Youden's index was used to assess the cutoff point of D-dimer. To select factors associated with the risk of PE, time-to-event analyses were performed using cause-specific hazard models. RESULTS: In total, 305 patients with a median age of 87 years (62.3% female) were studied; 67.9% were referred from nursing homes and 90.4% received any type of anticoagulation. A total of 64.9% showed frailty and 44% presented with dementia. The PE incidence was 5.6%. The cutoff value of a D-dimer level over 2.59 mg/L showed a sensitivity of 82.4% and specificity of 73.8% in discriminating a PE diagnosis. In the multivariate analysis, the factors associated with PE were previous oncological events and D-dimer levels. CONCLUSIONS: The PE incidence was 5.6%, and major risk factors for PE were oncological antecedents and increased plasma D-dimer levels.

Efficacy of non-pharmacological interventions to treat malnutrition in older persons: A systematic review and meta-analysis. The SENATOR project ONTOP series and MaNuEL knowledge hub project.

INTRODUCTION: We aimed to perform a review of SRs of non-pharmacological interventions in older patients with well-defined malnutrition using relevant outcomes agreed by a broad panel of experts. METHODS: PubMed, Cochrane, EMBASE, and CINHAL databases were searched for SRs. Primary studies from those SRs were included. Quality assessment was undertaken using Cochrane and GRADE criteria. RESULTS: Eighteen primary studies from seventeen SRs were included. Eleven RCTs compared oral nutritional supplementation (ONS) with usual care. No beneficial effects of ONS treatment, after performing two meta-analysis in body weight changes (six studies), mean difference: 0.59 (95%CI -0.08, 1.96) kg, and in body mass index changes (two studies), mean difference: 0.31 (95%CI -0.17, 0.79) kg/m2 were found. Neither in MNA scores, muscle strength, activities of daily living, timed Up&Go, quality of life and mortality. Results of other intervention studies (dietary counselling and ONS, ONS combined with exercise, nutrition delivery systems) were inconsistent. The overall quality of the evidence was very low due to risk of bias and small sample size. CONCLUSIONS: This review has highlighted the lack of high quality evidence to indicate which interventions are effective in treating malnutrition in older people. High quality research studies are urgently needed in this area.

Relevant outcomes for nutrition interventions to treat and prevent malnutrition in older people: a collaborative senator-ontop and manuel delphi study.

BACKGROUND AND AIMS: Research in malnutrition in older people is limited by the lack of consensus on relevant outcomes. Researchers of two European initiatives, the 'Malnutrition in the Elderly (MaNuEL) Knowledge Hub' (mostly experts in nutrition) and the Optimal Evidence-Based Non-drug Therapies in Older People (ONTOP) project (geriatricians) agreed to merge forces performing a systematic review of the effectiveness of nutritional interventions for the prevention and treatment of malnutrition in older persons. In a first step, we aimed to identify relevant outcomes for this review using a systematic approach and to explore if the rating of relevant outcomes differed depending on the researchers' professional background. METHODS: Following the ONTOP protocol, we searched all outcomes used in research of nutritional interventions for the prevention and treatment of malnutrition in older people. We carried out a web-based Delphi survey using a standardized list of 13 potentially relevant outcomes among 41 experts in geriatrics and nutrition who were asked to rate each outcome from 1 to 9 points: low importance (score 1-3), important but non-critical (score 4-6), and critical (score 7-9). Participants were informed that only those outcomes rated as critical (7-9 points) would be used in the literature review. After two rounds consultation, we compared the results from each group of experts: the ONTOP group formed by 13 geriatricians and the MaNuEL group formed by 28 experts in nutrition. Mean values were used for overall rating and the Mann-Whitney U test was used to see the differences on ratings between both groups. RESULTS: Mortality, morbidity, functional status, nutritional status and quality of life were considered critical outcomes by the whole group of experts. However, by analysing the ratings by the experts' professional background, geriatricians only rated mortality, morbidity and functional status as critical, while experts in nutrition (MaNuEL group) rated nutritional status, changes in dietary intake, compliance with the intervention, quality of life, and frailty status outcomes as critical too. Two outcomes, changes in dietary intake and compliance with the intervention, were rated with a significant different between the two professional groups (p < 0.05). CONCLUSIONS: Five outcomes were considered critical for research in nutritional interventions for the prevention and treatment of malnutrition in older persons: mortality, morbidity, functional status, nutritional status and quality of life by the whole panel of experts. However, more consensus is needed on the relevance of specific outcomes of nutritional interventions. Consensus processes within but also between relevant organizations are required to reach consensus and to contribute to this aim.

Incident adverse drug reactions in geriatric inpatients: a multicentred observational study.

BACKGROUND: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study's objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. METHODS: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. RESULTS: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4-6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions (r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5-25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. CONCLUSION: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

Nonpharmacological interventions to treat physical frailty and sarcopenia in older patients: a systematic overview - the SENATOR Project ONTOP Series.

BACKGROUND: Physical frailty (PF) and sarcopenia are predictors of negative health outcomes such as falls, disability, hospitalization, and death. Some systematic reviews (SRs) have been published on different nonpharmacological treatments of frailty and sarcopenia using heterogeneous definitions of them. OBJECTIVE: To critically appraise the evidence from SRs of the primary studies on nonpharmacological interventions to treat PF (defined by Fried's frailty phenotype) and sarcopenia (defined by the EWGSOP) in older patients. DESIGN: Overview of SRs and meta-analysis of comparative studies. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, EMBASE, and CINAHL were searched in October 2015. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: SRs that included at least one comparative study evaluating any nonpharmacological intervention to treat PF or sarcopenia in older patients in any health care setting. Any primary study described in these SRs with experimental design was included. DATA EXTRACTION AND MANAGEMENT: Two reviewers independently screened titles, abstracts, and full-texts of articles. Quality assessment was carried out by using criteria from the Cochrane Collaboration and the GRADE working group. RESULTS: Ten SRs with 5 primary studies satisfied the inclusion criteria. The most frequent interventions in the included studies were physical exercise (4) and nutritional supplementation (2). Muscle strength (MS; except for one study in a frail population) and physical performance (PP; except for another study in a frail population) improved with exercise and amino acid supplementation in frail and sarcopenic old adults. Falls and activities of daily living were assessed in two studies with opposite results. The overall quality of the evidence was low. CONCLUSION: This overview of SRs highlights the importance of exercise interventions with or without nutritional supplementation to improve the PP in community-dwelling patients aged >65 years with PF and sarcopenia. MS improved with multidisciplinary treatment and exercise interventions in this population.

Nonpharmacologic Interventions to Prevent Pressure Ulcers in Older Patients: An Overview of Systematic Reviews (The Software ENgine for the Assessment and optimization of drug and non-drug Therapy in Older peRsons [SENATOR] Definition of Optimal Evidence-Based Non-drug Therapies in Older People [ONTOP] Series).

BACKGROUND: Pressure ulcers (PUs) are frequent in older patients, and the healing process is usually challenging, therefore, prevention should be the first strategic line in PU management. Nonpharmacologic interventions may play a role in the prevention of PUs in older people, but most systematic reviews (SRs) have not addressed this specific population using convincing outcome measures. OBJECTIVE: To summarize and critically appraise the evidence from SRs of the primary studies on nonpharmacologic interventions to prevent PUs in older patients. DESIGN: SR and meta-analysis of comparative studies. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, EMBASE, and CINHAL (from inception to October 2013) were searched. A new search for updates in the Cochrane Database was launched in July 2014. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: SRs that included at least 1 comparative study evaluating any nonpharmacologic intervention to prevent PUs in older patients, in any healthcare setting, were selected. Any primary study with experimental design was then identified and included. DATA EXTRACTION: From each primary study, quality assessment was undertaken as specified by the Cochrane Collaboration and the Grading of Recommendations Assessment, Development and Evaluation working group. Interventions were identified and compared among different studies to explore the possibility of performing a meta-analysis, using the incidence of new pressure ulcers as the main outcome measure. RESULTS: One hundred ten SRs with 65 primary studies satisfied the inclusion criteria. The most frequent interventions explored in these trials were support surfaces (41 studies), repositioning (8), and nutrition interventions (5). High quality of evidence was not found for any intervention, mainly because of a high risk of bias and imprecision. There is moderate quality evidence to support the use of alternating pressure support mattresses over usual hospital mattresses in medical and surgical inpatients, low quality evidence to support constant low pressure devices and Australian medical sheepskin over usual mattresses, and very low quality evidence to support nutrition interventions in hospital settings. No recommendations on hydration, repositioning, standardized risk assessment, or multicomponent interventions can be done. CONCLUSIONS: In older patients at high risk to suffer PUs, high-technology and low- technology support surfaces can significantly reduce the incidence of PUs. Nutrition intervention may also have a role in preventing PUs in hospital settings. More evidence is needed to support other recommendations, which is specially lacking for repositioning.

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.