Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. The role of estrogen in the treatment of Alzheimer's disease. Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial. Lavender oil as a treatment for agitated behaviour in severe dementia: a placebo controlled study. Randomized controlled trials in pediatric surgery: could we do better? A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia. Care management, dementia care and specialist mental health services: an evaluation. Pharmacist-led medication review in patients over 65: a randomized, controlled trial in primary care. Appraising the evidence: applying sex- and gender-based analysis (SGBA) to Cochrane systematic reviews on cardiovascular diseases. Randomized controlled trials in surgery. A controlled clinical trial on the effects of motor intervention on balance and cognition in institutionalized elderly patients with dementia.
A recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials.
                To test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.
                A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures.
                One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) (P=0.014) and Quality of Life - Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group.
                The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia. Multiple factors appear to contribute to the expression of Alzheimer's disease (AD). About 30 percent of cases of dementia of the Alzheimer's type can be attributed to genetic factors. These observations raise the possibility of identifying multiple interventions that may modify the disease process and, therefore, the clinical expression of the dementia. Prominent among factors that may contribute to dementia and, specifically, to dementia of the Alzheimer's type is cerebral vascular disease. Estrogen is a potent factor that not only prevents vascular disease but also improves blood flow in diseased vessels, including blood flow in regions on the brain affected by AD. Estrogen also has direct effects on neuronal function that may play an important role not only in the preservation of neurons but in repair of neurons damaged by disease process. These effects of estrogen on the CNS suggest that the hormone may be effective not only in the prevention of dementia but also in its treatment. The results of clinical trials, reviewed in this presentation, are very promising but are limited by the paucity of subjects and often the lack of adequate controls. Larger, randomized, placebo-controlled trials are needed to definitively establish the efficacy of estrogen in the treatment of dementia of the Alzheimer's type. Dementia is a highly invalidating condition and, given the progressive aging of the population, one of the major issues that health systems will have to face in future years. Recently there has been an increase in the potential of diagnostic tools and pharmacological treatments for dementia; moreover, considerable interest has been expressed regarding non pharmacological interventions. However, the current evidence in support of non pharmacological treatments in patients affected by dementia still does not allow to draw definitive conclusions on what is the most effective treatment to apply, largely because of methodological difficulties and limitations of the studies so far carried out due to the complex nature of the disease. To address this need, we carried out a single blind randomized controlled study on the efficacy of computer cognitive rehabilitation in patients with mild cognitive decline. We here present preliminary data on 11 patients with diagnosis of Alzheimer's Disease (AD) and mild cognitive decline randomly assigned to treatment (a) or control (b) condition (i.e. specific vs. aspecific treatment). The specific treatment (a) consisted in a cycle of 12 individual sessions of computer exercises, while the control condition (b) consisted in sessions of semi-structured interviews with patients, conducted with the same frequency and time period as (a). Cognitive, behavioural and functional assessment was performed by an expert evaluator, blinded to the patients' group allocation. Preliminary results show a significant performance decline only in the control group at the 9-month follow-up compared to both baseline and the 3-month follow-up. Our results suggest that computer based cognitive training in patients with AD and mild cognitive decline is effective at least in delaying the continuous progression of cognitive impairment in AD. To determine whether aromatherapy with lavender oil is effective in the treatment of agitated behaviour in patients with severe dementia.
                A placebo controlled trial with blinded observer rater.
                A long-stay psychogeriatric ward.
                Fifteen patients meeting ICD-10 diagnostic criteria for severe dementia and suffering from agitated behaviour defined as a minimum score of three points on the Pittsburgh Agitation Scale (PAS).
                A 2% lavender oil aromatherapy stream was administered on the ward for a two hour period alternated with placebo (water) every other day for a total of ten treatment sessions.
                For each subject 10 total PAS scores were obtained. Five during treatment and five during placebo periods.
                Nine patients (60%) showed an improvement, five (33%) showed no change and one patient (7%) showed a worsening of agitated behaviour during aromatherapy compared with placebo. A comparison of the group median PAS scores during aromatherapy showed a significant improvement in agitated behaviour during aromatherapy compared with placebo (median PAS scores 3 c.f. 4; Wilcoxon Signed-Ranks test p = 0.016 (one-tailed)).
                Lavender oil administered in an aroma stream shows modest efficacy in the treatment of agitated behaviour in patients with severe dementia.
                Copyright 2002 John Wiley & Sons, Ltd. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.
                A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n = 36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p = .014), but not for the other groups.
                Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group. To evaluate a model of intensive case management for people with dementia based in a community-based mental health service for older people.
                Quasi-experimental design. Individuals in one community team setting received case management and were compared with those in a similar team without such a service. Forty-three matched pairs were identified. Eligible older people and their carers were interviewed at uptake and again at 6 and 12 months.
                The impact of the scheme upon placement occurred in the second year at the end of which 51% of the experimental group remained at home compared with 33% of the comparison group. For the experimental group significant improvements in the social contacts of older people were noted; a decrease in the stress of their carers was observed, together with a reduction in their input to the care of the client; and there were significant improvements on ratings of overall need reduction, aspects of daily living and level of risk. Differences between the two groups based on service receipt showed higher costs for the experimental group.
                The benefits to older people and their carers confirms previous findings that the most effective case management interventions are those targeted on a highly specific client group. Issues which influence the cost-effectiveness of intensive case management are discussed. The benefits of locating this service within a specialist mental health team are explored in the context of current initiatives to promote greater service integration between health and social services.
                Copyright 2002 John Wiley & Sons, Ltd. regular medication review has been recommended for those over 75 and those on multiple drug therapy. Pharmacists are a potential source of assistance in reviewing medication. Evidence of the benefits of this process is needed.
                to study the effect of medication review led by a pharmacist on resolution of pharmaceutical care issues, medicine costs, use of health and social services and health-related quality of life.
                randomized, controlled trial.
                general medical practices in the Grampian region of Scotland.
                patients aged at least 65 years, with at least two chronic disease states who were taking at least four prescribed medicines regularly.
                pharmacists reviewed the drug therapy of 332 patients, using information obtained from the practice computer, medical records and patient interviews. In 168 patients, a pharmaceutical care plan was then drawn up and implemented. The 164 control patients continued to receive normal care. All outcome measures were assessed at baseline and after 3 months.
                all patients had at least two pharmaceutical care issues at baseline. Half of these were identified from the prescription record, the rest from notes and patient interview. Of all the issues, 21% were resolved by information found in notes and 8.5% by patient interview. General practitioners agreed with 96% of all care issues documented on the care plans in the intervention group. At the time of follow-up, 70% of the remaining care issues had been resolved in the intervention group, while only 14% had been resolved in the control group. There were no changes in medicine costs or health-related quality of life in either group. There were small increases in contacts with health-care professionals and slightly fewer hospital admissions among the intervention group than the control group.
                pharmacist-led medication review has the capacity to identify and resolve pharmaceutical care issues and may have some impact on the use of other health services. To examine the use of sex- and gender-based analysis (SGBA) in systematic reviews of cardiovascular health in order to strengthen the evidence base for clinical practice and policy.
                To determine the current status of SGBA in systematic reviews, an appraisal tool was developed by the research team and applied by an independent reviewer to a random sample of 38 Cochrane systematic reviews. The sample was drawn from reviews addressing interventions for cardiovascular diseases (CVD). A random sample of Cochrane reviews in cardiovascular health was selected from the Cochrane Library, Issue 3, 2001, to Issue 3, 2007. The main outcome measure was the number of reviews that included analysis of sex or gender or both.
                Our findings showed that SGBA was generally absent in the sampled reviews. Data were rarely disaggregated by sex; only 2 of 38 reviews reported any sex or gender research gaps. Only one quarter of the reviews included a rationale as to why any subgroup analyses by sex were or were not completed. None of the 38 reviews met all of the appraisal tool criteria. As well, we found that where sex or gender was mentioned, the terms were used interchangeably.
                Despite increasing evidence over the past decade documenting that sex and gender frequently matter in CVD, this study demonstrated that SGBA was rarely considered in systematic reviews. We suggest this omission has important implications for assuring the quality of research and of evidence-based policy and practice and for achieving equitable health outcomes for women and men. To build a robust evidence base for future work in cardiovascular health, we propose that the methodologies of systematic reviews and of SGBA be refined and synchronized to enhance the collection, synthesis, and analysis of evidence for decision making. The objective was to determine the number of randomized controlled trials (RCT) performed by surgeons, published in surgical journals, or comprising a surgical arm and to assess their characteristics and overall quality.
                RCT in general surgery (including gastrointestinal, breast, surgical oncology, vascular, critical care, and trauma) published in 1990 were retrieved by MEDLINE and analyzed to determine the funding agency, type of therapy, area of surgery, journal published, country of origin, number of centers, and whether a surgeon was the principal author. The completeness of the MEDLINE search was compared to a manual search of the literature. All RCT were assessed with Chalmers' qualitative score.
                MEDLINE retrieved 202 surgical RCT (46% of those retrieved by a manual search) with a mean score of 0.40 +/- 0.13. However, surgical RCT were performed by surgeons in only one third of trials, compared surgical therapies in only one quarter of trials, and were published in surgical journals in less than one third of trials. Only 22% of surgical RCT were funded by peer reviewed granting agencies. The strongest variables determining the quality of surgical RCT were the type of therapy tested (p = 0.0001), the type of journal published (p = 0.006), and the area of general surgery (p = 0.007).
                Although surgical RCT are being performed, there are a relatively low proportion and standard of RCT performed by surgeons as the principal author, published in surgical journals, and comparing surgical therapies. This may reflect a lack of expertise by surgeons in clinical trials, lack of funding for surgical trials, methodologic problems peculiar to surgical trials, or a need for adoption of other research designs to assess surgical therapies. To analyse the effects of two interventions on the cognition and balance of institutionalized elderly people with mixed dementia.
                Fifty-four participants were allocated into three groups. Group 1 was assisted by an interdisciplinary programme comprising physiotherapy, occupational therapy and physical education. A physiotherapist alone carried out the intervention in group 2. Group 3 was considered as control. Assessors were blinded to guarantee the absence of bias. Cognitive functions were analysed with the Mini-Mental State Examination and the Brief Cognitive Screening Battery. Balance was assessed with the Berg Balance Scale and the Timed Get-Up-and-Go Test. Multiple analysis of variance (MANOVA) was used to test possible main effects of the interventions.
                The results showed benefits on the balance of subjects in both groups 1 (F=3.9, P<0.05) and 2 (F=3.1, P<0.05), compared with group 3. MANOVA did not indicate benefits on the cognitive functions between groups 1 and 3 (F=1.1, P>0.05) and groups 2 and 3 (F=1.6, P>0.05). However, univariate analysis indicated some benefits of the interdisciplinary intervention on two specific domains measured by the Brief Cognitive Screening Battery (F=26.5, P<0.05; F=4.4, P<0.05).
                Six months of multidisciplinary or physiotherapeutic intervention were able to improve a person's balance. Although global cognition did not improve through treatment, when the intervention was carried out on a multidisciplinary basis we observed an attenuation in the decline of global cognition on two specific cognitive domains. Exercises applied in different contexts may have positive outcomes for people with dementia.
Aroma therapy showed benefit for people with dementia in the only trial that contributed data to this review, but it is important to note there were several methodological difficulties with this study. More well designed large-scale RCTs are needed before clear conclusions can be drawn on the effectiveness of aroma therapy. Additionally, several issues need to be addressed, such as whether different aroma therapy interventions are comparable and the possibility that outcomes may vary for different types of dementia.