Quantitative assessment of baseline imbalances in evolocumab and alirocumab trials: a meta-epidemiological study.

BACKGROUND: Baseline imbalances have been identified in randomized trials of evolocumab and alirocumab. Our aim was to quantitatively assess (1) the presence of systematic baseline differences, and (2) the relationship of baseline differences with effects on low-density lipoprotein-cholesterol (LDL-c) and clinical outcomes in the trials. METHODS: We performed a meta-epidemiological study. PubMed, Embase, regulatory reports, ClinicalTrials.gov and company websites were searched for trials. Seven baseline characteristics (mean age, LDL-c, BMI, percentage males, diabetics, smokers, and hypertensives) and five outcomes (LDL-c, major adverse cardiac events, serious adverse events, any adverse events, all-cause mortality) were extracted. We calculated (1) range and distribution of baseline imbalances (sign-test), (2) pooled baseline differences and heterogeneity (meta-analysis), (3) differences in SDs around continuous variables (sign-test and pooling), and (4) the relationship of baseline differences with outcomes (meta-regression). The comparisons of PCSK9-inhibitor groups with either placebo or ezetimibe were analysed separately and combined. RESULTS: We identified 43 trials with 63,193 participants. Baseline characteristics were frequently missing. Many trials showed small baseline imbalances, but some large imbalances. Only baseline BMI showed a statistically significant lower pooled mean for the drug versus placebo groups (MD -0.16; 95% CI -0.24 to -0.09). Heterogeneity in baseline imbalances was present in six placebo- and five ezetimibe-comparisons. Heterogeneity was statistically significant for BMI, males, diabetics and hypertensives in the combined comparisons. There was a statistically significant preponderance for larger SDs in the PCSK9-inhibitor versus control groups (sign-test age 0.014; LDL-c 0.014; BMI 0.049). Meta-regression showed clinically relevant relationships of baseline imbalances in age, BMI and diabetics with the risk of any adverse events and the risk of mortality. Two relationships were statistically significant: A higher mean BMI in the drug versus control group with a decreased risk of mortality (beta - 0.56; 95% CI -1.10 to -0.02), and a higher proportion of diabetics with an increased risk of any adverse events (beta 0.02; 95% 0.01 to 0.04). CONCLUSIONS: Heterogeneous baseline imbalances and systematically different SDs were present in evolocumab and alirocumab trials, so study groups cannot be assumed to be comparable. These findings raise concerns about the design and conduct of the randomization procedures.

Can the PROPER intervention reduce psychotropic drug prescription in nursing home residents with dementia? Results of a cluster-randomized controlled trial.

OBJECTIVES: To evaluate the effect of the PROPER intervention in nursing home residents with dementia on the prevalence of psychotropic drug use and neuropsychiatric symptoms. DESIGN: A cluster-randomized controlled design with two parallel groups (intervention versus usual care) and assessments at 0, 6, 12, and 18 months. SETTING: Thirty-one dementia special care units within 13 long-term care organizations in the Netherlands. PARTICIPANTS: Three hundred eighty nursing home residents with dementia. INTERVENTION: The PROPER intervention consisted of a structured and repeated multidisciplinary medication review, supported by education and continuous evaluation. MEASUREMENTS: Prescriptions of antipsychotics, antidepressants, anxiolytics, and hypnotics, and occurrence of neuropsychiatric symptoms. RESULTS: The prescription of any type of psychotropic drugs increased in the intervention group, and decreased in the control group, with an estimated difference of 3.9 percentage points per 6 months (p = 0.01). Effects for the individual drug groups were minor (differences of 1.6 percentage points and below per 6 months) and not statistically significant. The occurrence of neuropsychiatric symptoms remained stable in both the intervention and control groups during the follow-up of 18 months. CONCLUSIONS: The PROPER intervention failed to demonstrate effectiveness in reducing the prevalence of psychotropic drugs. It may be interesting to enrich the intervention with components that address personal attitudes and communication between nursing home professionals, not only with respect to the prescription of psychotropic drugs, but also to neuropsychiatric symptoms.The study has been registered in The Netherlands Trial Register (NTR3569).

Serious adverse events and deaths in PCSK9 inhibitor trials reported on ClinicalTrials.gov: a systematic review.

BACKGROUND: Previous reviews of PCSK9 inhibitor trials are limited by a focus on composite cardiovascular outcomes. ClinicalTrials.gov provides trial results for individual clinical outcomes. Aim of this systematic review was to assess the effect of PCSK9 inhibitors on the risk of myocardial infarction, stroke/TIA, heart failure, diabetes mellitus, neurocognitive events, all-cause serious adverse events (SAE), and all-cause deaths as registered on ClinicalTrials.gov. METHODS: PubMed, regulatory reports, ClinicalTrials.gov, and company websites were used to search studies. Randomized trials comparing PCSK9 inhibitor with placebo in participants with hypercholesterolemia were eligible. Study characteristics, risk of bias, and numbers of participants with the outcomes of interest were collected. RESULTS: We identified 33 lipid-lowering and 4 clinical outcomes trials with results on ClinicalTrials.gov (n = 16,958 and n = 73,836, respectively). Risk of bias was generally high. PCSK9 inhibitors did not affect the risk of any of the investigated outcomes in either type of trial. However, in clinical outcomes studies, alirocumab decreased the risk of all-cause SAE (OR 0.92; 95% CI 0.86-0.98), and evolocumab probably increased the risk of mortality (OR 1.12; 95% CI 1.00-1.25). CONCLUSIONS: Our meta-analysis of clinical events registered on ClinicalTrials.gov did not show that PCSK9 inhibitors improve cardiovascular health. Evolocumab increased the risk of all-cause mortality.

Effects Of Increasing The Involvement Of Community-Dwelling Frail Older Adults In A Proactive Assessment Service: A Pragmatic Trial.

BACKGROUND: Older adults and care professionals advocate a more integrated and proactive care approach. This can be achieved by proactive outpatient assessment services that offer comprehensive geriatric assessments to better understand the needs of older adults and deliver person-centered and preventive care. However, the effects of these services are inconsistent. Increased involvement of the older adult during the assessment service could increase the effects on older adult's well-being. METHODS: We studied the effect of an assessment service (Sage-atAge) for community-dwelling frail adults aged ≥65 years. After studying the local experiences, this service was adapted with the aim to increase participant involvement through individual goal setting and using motivational interviewing techniques by health-care professionals (Sage-atAge+). Within Sage-atAge+, when finishing the assessment, a "goal card" was written together with the older adult: a summary of the assessment, including goals and recommendations. We measured well-being with a composite endpoint consisting of health, psychological, quality of life, and social components. With regression analysis, we compared the effects of the Sage-atAge and Sage-atAge+ services on the well-being of participants. RESULTS: In total, 453 older adults were eligible for analysis with a mean age of 77 (± 7.0) years of whom 62% were women. We found no significant difference in the change in well-being scores between the Sage-atAge+ service and the original Sage-atAge service (B, 0.037; 95% CI, -0.188 to 0.263). Also, no change in well-being scores was found even when selecting only those participants for the Sage-atAge+ group who received a goal card. CONCLUSION: Efforts to increase the involvement of older adults through motivational interviewing and goal setting showed no additional effect on well-being. Further research is needed to explore the relationship between increased participant involvement and well-being to further develop person-centered care for older adults.

Efficacy of antipsychotics in dementia depended on the definition of patients and outcomes: a meta-epidemiological study.

OBJECTIVES: Postulating that efficacy of antipsychotics for agitation and psychosis in dementia is best estimated in trials among patients with these symptoms and with symptom-specific outcomes, we investigated whether clinically broader definitions affected the pooled efficacy. STUDY DESIGN AND SETTING: Trials were searched in multiple databases and categorized according to patient population (agitated, psychotic, and mixed) and outcome scale (agitation, psychosis, and generic). Standardized mean differences with 95% confidence intervals were calculated for conventional and atypical antipsychotics separately. RESULTS: Thirty trials met our inclusion criteria. Conventional antipsychotics might have a small effect in agitated patients on agitation scales (-0.44, -0.88, 0.01) and in psychotic patients on psychosis scales (-0.31, -0.61, -0.02). There was no effect on generic scales. Efficacy of atypical antipsychotics was not established in agitated patients on agitation scales (-0.15, -0.43, 0.13) and in psychotic patients on psychosis scales (-0.11, -0.20, -0.03) but was small in mixed patients on agitation scales (-0.29, -0.40, -0.18). CONCLUSION: Pooled efficacy of antipsychotics for agitation and psychosis in dementia is biased when based on trials that included patients without these target symptoms or on results measured with generic scales. This finding is important for reviewers and guideline developers who select trials for reviews.

Attention, arousal and other rapid bedside screening instruments for delirium in older patients: a systematic review of test accuracy studies.

Objective: delirium occurs frequently in frail patients but is easily missed. Screening with a rapid, easy-to-use and highly sensitive instrument might help improve recognition. The aim of this study was to review attention, arousal and other rapid bedside screening instruments for delirium in older patients. Methods: a literature search was performed in PubMed, PsycINFO and Embase. We scrutinized forward citations in Google Scholar, and references of included articles and prior reviews. We included studies among older patients that investigated the sensitivity and specificity of delirium screening instruments that could be administered in 3 min or less, and did not require surrogate information. We extracted study characteristics, risk of bias, sensitivity and specificity. Results: we identified 27 studies among 4,766 patients in hospitals and nursing homes. They tested many different single and several combined screening instruments. Prevalence of delirium varied between 4% and 57%. Only one study scored a low risk of bias on all domains. Sensitivity varied between 17% and 100%, and specificity between 38% and 99%. Of the 22 tests with sensitivity ≥90%, seven also had specificity ≥80% in older patients in general. These results were approximately reproduced for the Observational Scale of Level of Arousal (OSLA) and Richmond Agitation and Sedation Scale (RASS): sensitivity and specificity were >80%. Conclusion: two arousal tests-OSLA and RASS-had reproduced high sensitivity and specificity in older patients. Nurses can administer these tests during daily interaction with patients. Test accuracy studies about rapid screening tools for delirium superimposed on dementia were scarce.

Behavior and Evolution of Young ONset Dementia part 2 (BEYOND-II) study: an intervention study aimed at improvement in the management of neuropsychiatric symptoms in institutionalized people with young onset dementia.

ABSTRACTBackground:Both neuropsychiatric symptoms (NPS) and psychotropic drug use (PDU) are common in institutionalized People with Young Onset Dementia (PwYOD) and can produce negative outcomes such as reduced quality of life and high workload. In community-dwelling PwYOD, NPS are found to be associated with unmet care needs. This emphasizes the importance of a care program for the management of NPS in institutionalized PwYOD that also addresses unmet care needs and PDU. The objectives of the Behavior and Evolution of Young ONset Dementia part 2 (BEYOND-II) study are to develop a care program for the management of NPS in institutionalized PwYOD and to evaluate its effectiveness. METHODS: The care program consists of an educational program combined with an intervention to manage NPS with the following five steps: the evaluation of psychotropic drug prescription, detection, analysis (including the detection of unmet needs), treatment and the evaluation of NPS. A stepped wedge design will be used to evaluate its effectiveness. The primary outcomes are agitation and aggression and other NPS. The secondary outcomes are PDU, quality of life, the workload of nursing staff and job satisfaction. Additionally, a process analysis and a cost-consequence analysis will be conducted. CONCLUSIONS: The study protocol of the Beyond-II study describes the development, implementation and evaluation of a care program for the management of NPS in institutionalized PwYOD. This care program provides a structured method for the management of NPS, in which unmet needs and PDU are also addressed.

Change in psychotropic drug use in Norwegian nursing homes between 2004 and 2011.

ABSTRACTBackground:We aimed to assess whether there were any changes in the use of psychotropic drugs in Norwegian nursing homes between 2004 and 2011. Also, we investigated whether the predictors of use of specific psychotropic drug groups have changed. METHODS: We conducted a secondary analysis of two cohort studies of two Norwegian nursing home samples (2004/05 and 2010/11). Multivariate models were applied. RESULTS: We found a significant decrease in the prescription of antipsychotic drugs between 2004 and 2011 (0.63 OR, 95%CI = 0.49-0.82, p < 0.001) even after adjusting for relevant demographic and clinical variables. There are only minor changes for the other psychotropic drugs. We found that (1) the use of specific psychotropic drug groups as well as the number of psychotropic drugs used was associated with more affective symptoms and (2) the use of specific psychotropic drug groups as well as the number of psychotropic drugs used was associated with lower scores on the Physical Self-Maintenance scale. CONCLUSION: This is the first study to show a robust decrease in antipsychotic drug use in nursing home patients with dementia unrelated to possible changes in case mix. The change might be explained by treatment recommendations against its use except in the most severe conditions of aggression or psychosis. Our findings indicate that it takes several years to implement scientific knowledge in clinical practice in nursing homes.

Characteristics of institutionalized young onset dementia patients--the BEYOnD study.

BACKGROUND: People with Young Onset Dementia (YOD) have specific needs for care. These people eventually require institutional care, usually delivered by institutions designed for the elderly. The Dutch network of care organizations delivering specialized YOD care offers a unique opportunity to obtain more knowledge of this special population. METHODS: Our cross-sectional study collected data from 230 people with YOD in eight care homes providing YOD specialized care. Data collected: demographic data, disease duration, dementia subtype, comorbidity, dementia severity (Global Deterioration Scale - GDS), neuropsychiatric symptoms (NPS; Neuropsychiatric Inventory - NPI, Cohen Mansfield Agitation Inventory - CMAI), disease awareness (Guidelines for the Rating of Awareness Deficits - GRAD), need for assistance (hierarchic Activities of Daily Living (ADL) scale - Resident Assessment Instrument - Minimum Data Set (RAI-MDS)). RESULTS: The mean age of the residents with YOD in care homes was 60 years and 53% of them were men. There is a large variety of etiologic diagnoses underlying the dementia. Dementia severity was very mild to mild in 18%, moderate in 25%, and severe or very severe in 58% of the participants. The prevalence of NPS was high with 90% exhibiting one or more clinically relevant NPS. Comorbidity was present in more than three quarters of the participants, most frequently psychiatric disorders. CONCLUSIONS: The institutionalized YOD population is heterogeneous. NPS occur in almost all institutionalized people with YOD, and frequency and severity of NPS are higher than in late onset dementia (LOD) and community-dwelling YOD patients. Care should be delivered in settings accommodating a mixed male and female population, with appropriate, meaningful activities for all individuals. Further research is needed on NPS in YOD, to enhance quality of life and work in specialized YOD-care.

Diagnostic accuracy of Parkinson's disease and atypical parkinsonism in nursing homes.

INTRODUCTION: Management of Parkinson's disease (PD) and atypical parkinsonism in nursing homes depends on a timely and accurate diagnosis. However, little is known about the diagnostic accuracy of these parkinsonian syndromes in nursing homes. We examined this issue in a large group of Dutch nursing home residents. METHODS: Twelve large nursing home organizations in the Netherlands accounting for 100 nursing homes with a total population of 5480 residents participated. Residents with PD or atypical parkinsonism were identified according to their nursing home medical chart diagnosis. Additionally, local pharmacists provided a list of all residents using antiparkinson medication. We compared the admission diagnosis to a clinical diagnosis made in the study, based upon interview and detailed neurological examination by movement disorders experts. Diagnoses were based on accepted clinical criteria for PD and atypical parkinsonism. RESULTS: In the total population of 5480 residents, 258 had previously been diagnosed with a form of parkinsonism according to their medical record. In 53 of these residents (20.5%) we changed or rejected the diagnosis. Specifically, we found no parkinsonism in 22 of these 53 residents (8.5% of all patients with suspected parkinsonism). In the remaining 31 residents (12%), we established a new diagnosis within the parkinsonian spectrum. CONCLUSIONS: In a large population of Dutch nursing home residents, 20% of diagnoses within the parkinsonian spectrum were inaccurate. Almost 9% of residents had inadvertently received a diagnosis of parkinsonism. Better recognition of parkinsonism in nursing homes is important, because of the consequences for management and prognosis.

Applause sign in advanced Parkinson's disease.

BACKGROUND: The 'applause sign' a tendency to continue applauding in response to instructions to clap three times was described in 1995 and was considered specific to degenerative disease, especially to atypical parkinsonian disorders. In early phase Parkinson's disease (PD) the sign has been reported positive as well. In late stage PD it is unknown whether and to what extent the sign may be elicited and it remains unknown if and to what degree the sign correlates to cognitive impairment and PD related dementia. METHODS: Nursing home residents with PD (MMSE >17) were included. All patients underwent the clapping test and were tested for cognitive disturbance by making use of accepted clinimetrics (MMSE and Scopa-cog). T-testing was performed with the hypothesis that patients expressing the applause sign would score lower on the MMSE or Scopa-cog. RESULTS: Seventy three nursing home residents (mainly Hoehn and Yahr 4/5) with a mean disease duration of 10 years and a mean age of 78.7 years were included. The applause sign was found positive in 15 of 73 residents (20.5%). Residents expressing the applause sign had significantly lower mean scores on the MMSE (25.1 vs 22.9 points, p < 0.006) and Scopa-cog (14.8 vs 12.0 points, p < 0.039). CONCLUSIONS: The applause sign is present in late stage PD and correlates with a higher degree of cognitive impairment as established with accepted clinimetric tests. A higher degree of frontal lobe involvement explains the presence of the applause sign.

[Stroke rehabilitation in nursing homes: intensity of and motivation for physiotherapy]. / CVA-revalidatie in het verpleeghuis: therapie-intensiteit van en motivatie voor fysiotherapie.

INTRODUCTION: Stroke is a frequent and potential invalidating disease, of which recovery can be improved by rehabilitation. In The Netherlands old and frail stroke patients are rehabilitated in nursing homes. Probably, the intensity of and motivation for physiotherapy are important for successful discharge. The aim was to determine (1) therapy intensity of and motivation for physical therapy of geriatric stroke patients (2) its correlates and (3) the effect on discharge destination. METHODS: Data were obtained from the 'GRAMPS'-study, a longitudinal observational study of stroke rehabilitation in 15 Dutch nursing homes. Direct time spent on physiotherapy was registered during admission. Motivation was measured by the Pittsburgh Rehabilitation Participation Scale (PRPS). Data of 84 patients were analysed using uni- and multivariate regression analysis. RESULTS: Patients received an average 109 min of physiotherapy per week. 69 patients (82%) were good motivated for physiotherapy (had all PRPS scores 4 or higher). Therapy intensity was positively associated with the presence of a partner and good motivation. No significant independent variables of motivation were found. Therapy-intensity was positively related to discharge to prior living situation. CONCLUSION: Intensity of physiotherapy of stroke rehabilitation is an independent variable of successful discharge and is higher when the patient has a partner or is better motivated. These findings stress the importance of high motivation and therapy intensity in geriatric stroke rehabilitation.

Antipsychotic drug prescription rates among Dutch nursing homes: the influence of patient characteristics and the dementia special care unit.

OBJECTIVES: To assess the differences in antipsychotic drug prescription rates in residents with dementia in dementia special care units (SCUs) of Dutch nursing homes, considering the differences in patient characteristics. METHOD: As part of the Waalbed-II study, the data on antipsychotic drug use in 290 patients were collected and the Global Deterioration Scale (GDS) stage, type of dementia and behaviour (Cohen-Mansfield Agitation Inventory (CMAI)) were measured in 14 SCUs in nine nursing homes. A multilevel logistic regression model was used to assess the difference in antipsychotic drug prescription rates between dementia SCUs adjusted for age, gender, GDS stage, type of dementia and CMAI factor scores. RESULTS: Two hundred and ninety residents met the inclusion criteria. Thirty-two per cent were prescribed an antipsychotic drug. Antipsychotic drugs were more often prescribed in patients with physically aggressive and non-aggressive behaviour and in patients with mixed dementia (vascular/Alzheimer's) than in patients with other types of dementia. Antipsychotic drug prescriptions significantly differed among the dementia SCUs. The odds of antipsychotic drug use for patients in the SCU with the highest prevalence of drug use were 2.76 (95% confidence interval (CI) 1.14-6.69) times as high as for the SCU with the lowest prevalence of drug use, taking the patient characteristics into account. CONCLUSION: Antipsychotic drug use in nursing home residents with dementia is not only predicted by the type of dementia and patient behaviour, but it is independently associated with the dementia SCU at which the patient resides. This result indicates that antipsychotic drugs are not only prescribed for their clinical indications (agitation/aggression) but are associated with environmental factors that may reflect a specific nursing home prescribing culture.

The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia: a randomised controlled trial.

OBJECTIVE: This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. METHODS: In a randomised controlled design, residents with dementia (n = 94) were allocated to either music therapy or recreational activities. Both music therapy and general activities were offered twice weekly for 4 months. Changes in agitation were measured with a modified Cohen-Mansfield Agitation Inventory (CMAI) at four intervals on each intervention day. A mixed model analysis was used to evaluate the effectiveness of music therapy, compared with general activities, on CMAI scores at 4 h after the intervention, controlled for CMAI scores at 1 h before the session and session number. RESULTS: Data were analysed for 77 residents (43 randomised to music therapy and 34 to general activities). In both groups, the intervention resulted in a decrease in agitated behaviours from 1 h before to 4 h after each session. This decrease was somewhat greater in the music therapy group than in the general activities group, but this difference was statistically not significant (F = 2.885, p = 0.090) and disappeared completely after adjustment for Global Deterioration Scale stage (F = 1.500; p = 0.222). CONCLUSIONS: Both music therapy and recreational activities lead to a short-term decrease in agitation, but there was no additional beneficial effect of music therapy over general activities. More research is required to provide insight in the effects of music therapy in reducing agitation in demented older people.

Prescribing pattern of psychotropic drugs in nursing home residents with dementia.

BACKGROUND: The goal of this study is to determine patterns of psychotropic drug use (PDU), the association with neuropsychiatric symptoms (NPS), and the variability across dementia types in nursing home residents with dementia. In addition, PDU was analyzed across multiple indications. METHODS: This was a prospective cohort study over a two-year period from 2006 to 2008, which involved 14 dementia special care units in nine nursing homes. A total of 117 residents with dementia participated in the study, of whom 35% had Alzheimer's dementia (AD) and 11% vascular dementia (VaD). PDU was classified according to anatomical therapeutic chemical-classification as either "present" or "absent". RESULTS: The majority of residents had moderately severe to severe dementia. At all successive assessments, almost two-thirds of residents received any psychotropic drug (PD) and almost one-third continued to receive any PD. Of all PDs, antipsychotics (APs) were prescribed most frequently. Fewer residents started with antidepressants, but continued to receive antidepressants at higher percentages. Anxiolytics showed an intermittent course, but a subgroup of 9% showed two-year continuation. Once started on PDs at baseline, residents continued to use PDs at high percentages: three-quarters continued to receive APs for at least six months. Half of residents received at least one PD; one-fifth received at least two PDs simultaneously. Residents with AD received more hypnotics and antidementia drugs; residents with VaD received more antipsychotics, antidepressants, anxiolytics and anticonvulsants. CONCLUSIONS: PDs have different utilization patterns, but overall, consistently high continuation rates were found. These results warrant scrutiny of continuous PDU.

Determinants of quality of life in nursing home residents with dementia.

AIMS: The goal of this study is to assess the relationship between quality of life (QoL), neuropsychiatric symptoms (NPS), psychotropic drug use (PDU) and patient characteristics in a large group of nursing home residents with dementia. METHODS: This cross-sectional observational study included 288 individuals with dementia who reside in 14 special care units in 9 nursing homes. The following measures were used: the Qualidem scale to assess QoL, the Neuropsychiatric Inventory-Nursing Home version, the Global Deterioration Scale (GDS), the Severe Impairment Battery-short version, an Activities of Daily Living scale and PDU. Associations between QoL and NPS were examined using multivariate linear regression models with corrections for potential covariates. RESULTS: The average age of the residents was 84 years (SD = +/-7). Agitation, depression, psychosis, psychomotor agitation and psychotropic drugs were independently associated with poor QoL. In patients with mild to moderately severe dementia (GDS 4-6), NPS, PDU and cognitive impairment explained almost half of the variance in QoL scores. Agitation and depression were particularly strong predictors of poor QoL. In patients with severe dementia (GDS 7), agitation, depression, psychosis and cognitive impairment were associated with poor QoL. CONCLUSIONS: NPS, cognition and PDU independently impair QoL for patients in both the moderate and advanced stages of dementia. These results challenge existing pharmacological intervention strategies and highlight the need for psychosocial interventions in the treatment of NPS.

Validity of the Severe Impairment Battery Short Version.

BACKGROUND: Efficient neuropsychological tests are needed to measure cognitive impairment in moderate to severe dementia. OBJECTIVE: To examine construct validity of the Severe Impairment Battery Short Version (SIB-S) in nursing home patients with moderate to severe dementia, and to examine potential floor effects for the SIB-S. METHODS: Cross-sectional comparison of cognitive measures, dementia severity and functional dependency. RESULTS: A total of 290 patients were included 264 of whom had complete SIB-S protocols. Internal consistency of the SIB-S was very high (Cronbach alpha = 0.97). Principal-component analysis produced three factors, the first of which explained more than 50% of common score variance. Semantic memory items loaded highly on the first factor. Total SIB-S scores were associated with cognitive impairment (SIB-S--Mini Mental State Examination (MMSE) rho = 0.91, p<0.001), and with functional dependency (SIB-S--ADL scale rho = -0.61, p<0.001). SIB-S total scores differentiated between dementia stages as measured with the Global Deterioration Scale (F = 164.6; df 3,260, p<0.001). Comparisons of SIB-S total score variance across patients with moderate to severe dementia and patients with below or above average Mini Mental State Exam scores indicate an absence of large floor effects. CONCLUSION: In this first study examining an independently administered SIB-S, the scale proved to be a homogeneous and valid measure of cognitive impairment. The SIB short version can be used to assess moderately to severely demented patients, who may find it difficult to complete traditional, lengthier neuropsychological tests.

[Efficacy and adverse reactions of antipsychotics for neuropsychiatric symptoms in dementia: a systematic review]. / Werkzaamheid en bijwerkingen van antipsychotica voor neuropsychiatrische symptomen bij dementie; een systematische.

OBJECTIVE: To assess the efficacy and adverse reactions of typical and atypical antipsychotics in the treatment of neuropsychiatric symptoms in dementia, and to examine the evidence for the cerebrovascular events warning for atypical antipsychotics. DESIGN: Systematic review. METHOD: Using Medline, Cinahl, PsyclNFO, Embase and the Cochrane central register of controlled trials (1980-2005), double-blind randomized controlled trials with intention-to-treat analysis were selected, which evaluated efficacy and adverse reactions of antipsychotics in the treatment of neuropsychiatric symptoms in dementia. The studies underwent a standardised validity assessment. RESULTS: After screening 950 studies, 14 studies on the effect of haloperidol, risperidone, olanzapine, quetiapine, tiapride, loxapine and perphenazine were selected. In 7 out of 10 studies, haloperidol, risperidone and olanzapine appeared to be more effective than placebo in the treatment of aggression and psychosis. Direct comparison between typical and atypical antipsychotics revealed no statistically significant difference. The most common adverse reactions were extrapyramidal symptoms and somnolence. These adverse reactions were less frequent with low-dose risperidone than with haloperidol or olanzapine, but risperidone and olanzapine were found to be associated with a higher risk of cerebrovascular events in two studies. CONCLUSION: The efficacy of typical and atypical antipsychotics is comparable, but only low-dose risperidone seems to be associated with fewer (extrapyramidal) side effects. The adverse reactions are inadequately described in the published data and consequently the warning of an increased risk of mortality could not be confirmed.

[Prevalence of behavioural problems in a group of demented nursing home patients]. / Prevalentie van probleemgedrag bij een groep dementerende verpleeghuispatiënten.

Behavioural problems in dementia are a burden for patients and caregivers and are often the main reason for admission to a nursing home. Research on the prevalence of behavioural problems is scarce. In this study the prevalence of behavioural problems was estimated in nursing home patients with dementia. In 59 demented patients the Neuropsychiatric Inventory (NPI-NH) and the Cohen-Mansfield Agitation Inventory were used to measure behavioural problems over the last two weeks. Behavioural problems were present in about 85% of the study group. Using the NPI-NH aggression/agitation and apathy were present in almost 40% of the patients. Delusions, hallucinations, depression and anxiety were present in 10-15% of the patients. Using the CMAI cursing/verbal aggression, restlessness, complaining, negativism, and mannerisms were prevalent in 30%-50% of the patients. Larger studies on the prevalence of problem behaviour and possibly influencing factors are necessary.