Interventions to reduce hospital readmissions in the elderly: in‐hospital or home care. A systematic review

Rationale, aims and objectives Unplanned hospital readmissions of elderly people represent an increasing burden on health care systems. This burden could theoretically be reduced by adequate preventive interventions, although there is uncertainty about the effectiveness of different types of interventions. The objective of this systematic review was to identify interventions that effectively reduce the risk of hospital readmissions in patients of 75 years and older, and to assess the role of home follow‐up. Methods We searched studies in MEDLINE, CINAHL, CENTRAL and seven other electronic databases up to October 2007, and we updated the MEDLINE search in October 2009. Clinical trials (randomized or controlled) evaluating the effectiveness of an intervention aimed at reducing readmissions in elderly patients were selected. Quality was assessed using the SIGN tool and the information extracted is presented in text and tables. Results Thirty‐two clinical trials were included and they were divided into two groups: in‐hospital interventions (17 studies) and interventions with home follow‐up (15 studies). A positive effect of the intervention evaluated on the readmission outcome was found in three studies from the first group and in seven from the second group. Conclusions Most of the interventions evaluated did not have any effect on the readmission of elderly patients. However, those interventions that included home care components seem to be more likely to reduce readmissions in the elderly.     

The Treatment of Auto‐erotic Asphyxiation in a Man with Severe Intellectual Disabilities: the Effectiveness of a Behavioural and Educational Programme

Background The treatment of individuals with severe intellectual disabilities who engage in self‐injurious sexual practices and are incapable of giving consent poses a significant challenge to health care services. Treatment options can be highly personal and intrusive, and potentially pose a risk of litigation. However, there is also a risk of being prosecuted for negligence if necessary treatment is not pursued. This paper discusses the treatment of an individual engaged in such a behaviour – auto‐erotic asphyxiation. It describes how the legal aspects of the design and implementation of the treatment approach were handled. Methods The treatment approach involved a behavioural and psycho‐educational programme. A single case study methodology was utilized in order to assess the effectiveness of the intervention. Results The intervention led to the learning of new adaptive behaviour. Auto‐erotic asphyxiation ceased and the individual's masturbatory behaviour changed sufficiently to reduce the threat of mortality. Qualitatively, a significant reduction in the level of stress experienced by the individual's family was reported. Conclusions It is concluded that behavioural and educational techniques may be effective in the management of such cases. Further research replicating such techniques with similar cases is required prior to the efficacy of this treatment becoming established.     

Motivation for physical activity and exercise in severe mental illness: A systematic review of intervention studies

There has been increasing interest for research on motivation for physical activity (PA) and exercise among individuals with severe mental illness (SMI). The aim of this systematic review is to summarize findings from all intervention studies on PA or exercise that either include empirical data on motivational constructs or apply motivational techniques/theories in their intervention. Systematic searches of seven databases were conducted from database inception to February 2015. Studies were eligible if they: (i) included participants with SMI, (ii) had PA as part of the intervention, and (iii) reported empirical data on motivational constructs related to PA or incorporated motivational techniques/theory in their intervention. Of the 79 studies that met the inclusion criteria only one had motivation for PA as its main outcome. Nine additional interventions reported empirical data on motivational constructs. Altogether these studies yielded mixed results with respect to change in motivational constructs. Only one of those examined the association between motivation and PA, but found none. Sixty‐four studies reported using motivational techniques/theory in their intervention. Motivational interviewing and goal‐setting were the most popular techniques. Due to the exploratory nature of most of these studies, findings from intervention studies do not so far give very clear directions for motivational work with the patients. There is an urgent need for a more systematic theory based approach when developing strategies that target to increase engagement in PA among people with SMI.     

Physiotherapy‐provided operant conditioning in the management of low back pain disability: A systematic review

Background and Purpose. Non‐specific low back pain (LBP) is a leading cause of disability in developed countries. Behavioural interventions have been found efficacious in reducing disability in LBP. Operant conditioning is one type of behavioural intervention being employed by physiotherapists; however, the effectiveness of physiotherapist‐provided operant conditioning (POC) in the management of LBP disability is unknown. This review aims to answer the question: is POC more effective than comparison interventions in reducing LBP disability? Method. A systematic review of randomized controlled trials was conducted using a qualitative analysis of effect. Participants were adults ≥18 years with non‐specific LBP. The intervention was defined as a time contingent, graduated increase in activity including goal setting and the education and reinforcement of positive pain behaviours with the aim of decreasing disability. The primary outcome measure was back pain specific disability. Secondary outcomes included generic functional status, pain intensity, sick leave, fear avoidance beliefs or behaviour and adverse effects. Results. Fifteen trials involving 3737 people were included. Eight studies reported a clinically significant difference. The POC intervention was not found to be inferior to any of the comparison interventions in reducing disability. Moderate evidence was found that POC is more effective than other behavioural interventions in reducing long term disability in chronic LBP. Moderate evidence showed POC may be more effective than other treatments in reducing post‐treatment fear avoidance beliefs in a sub‐acute population but less effective in reducing short term fear avoidance beliefs in a population with mixed LBP. Moderate evidence showed POC is more effective than a placebo intervention in reducing short term pain in sub‐acute LBP. Conclusion. POC may be considered efficacious in the treatment of LBP. Physiotherapists may also consider POC for its additional effect of reducing long term disability in chronic LBP. Copyright © 2010 John Wiley & Sons, Ltd.     

Psychosocial treatments for people with co-occurring severe mental illness and substance misuse: systematic review

Title. Psychosocial treatments for people with co‐occurring severe mental illness and substance misuse: systematic review. Aim. This study is a report of a systematic review to assess current evidence for the efficacy of psychosocial interventions for reducing substance use, as well as improving mental state and encouraging treatment retention, among people with dual diagnosis. Background. Substance misuse by people with a severe mental illness is common and of concern because of its many adverse consequences and lack of evidence for effective psychosocial interventions. Data sources. Several electronic databases were searched to identify studies published between January 1990 and February 2008. Additional searches were conducted by means of reference lists and contact with authors. Review methods. Results from studies using meta‐analysis, randomized and non‐randomized trials assessing any psychosocial intervention for people with a severe mental illness and substance misuse were included. Results. Fifty‐four studies were included: one systematic review with meta‐analysis, 30 randomized controlled trials and 23 non‐experimental studies. Although some inconsistencies were apparent, results showed that motivational interviewing had the most quality evidence for reducing substance use over the short term and, when combined with cognitive behavioural therapy, improvements in mental state were also apparent. Cognitive behavioural therapy alone showed little consistent support. Support was found for long‐term integrated residential programmes; however, the evidence is of lesser quality. Contingency management shows promise, but there were few studies assessing this intervention. Conclusion. These results indicate the importance of motivational interviewing in psychiatric settings for the reduction of substance use, at least in the short term. Further quality research should target particular diagnoses and substance use, as some interventions may work better for some subgroups.     

Peer support interventions seeking to improve physical health and lifestyle behaviours among people with serious mental illness: A systematic review

People with serious mental illness (SMI) experience a premature mortality gap of between 10 and 20 years. Interest is growing in the potential for peer support interventions (PSI) to improve the physical health of people with SMI. We conducted a systematic review investigating if PSI can improve the physical health, lifestyle factors, and physical health appointment attendance among people with SMI. A systematic search of major electronic databases was conducted from inception until February 2016 for any article investigating PSI seeking to improve physical health, lifestyle, or physical health appointment attendance. From 1347 initial hits, seven articles were eligible, including three pilot randomized, control trials (interventions: n = 85, controls: n = 81), and four pretest and post‐test studies (n = 54). There was considerable heterogeneity in the type of PSI, and the role of the peer support workers (PSW) varied considerably. Three studies found that PSI resulted in insignificant reductions in weight. Evidence from three studies considering the impact of PSI on lifestyle changes was equivocal, with only one study demonstrating that PSI improved self‐report physical activity and diet. Evidence regarding physical health appointment attendance was also unclear across four studies. In conclusion, there is inconsistent evidence to support the use of PSW to improve the physical health and promote lifestyle change among people with SMI. The small sample sizes, heterogeneity of interventions, outcome measures, and lack of clarity about the unique contribution of PSW means no definitive conclusions can be made about the benefits of PSW and physical health in SMI.     

Review article: Effectiveness of ultra‐brief interventions in the emergency department to reduce alcohol consumption: A systematic review

To assess the effectiveness of ultra‐brief interventions (ultra‐BI) or technology‐involved preventive measures in the ED to reduce alcohol harm and risky drinking. Medline, Embase, PsycINFO, CINAHL and EBM reviews were searched for articles published between 1996 and 2015. Randomised controlled trials and quasi‐randomised trials, which compared an ultra‐BI with screening, standard care or minimal intervention for adults and adolescents at risk for alcohol‐related harm presenting to an ED, were included. Outcomes of interest were frequency of alcohol consumption, quantity of alcohol consumed, binge drinking and ED representation. Thirteen studies (nine single centre and four multicentre) were included. Six studies showed a significant reduction in the quantity consumed with intermediate effect size at 3 months (d = ?0.40) and small effect size at 12 months (d = ?0.15). Two studies showed a significant reduction in binge drinking with small effect size at 3 months (d = ?0.12) and 12 months (d = ?0.09). No studies showed an effect on frequency of alcohol consumption or ED representation. Heterogeneity in study design, definition of risky, harmful or hazardous alcohol use, intervention types, outcomes, outcome timeframes and outcome measures prevented the performance of quantitative meta‐analysis. Despite its limited effectiveness in reducing alcohol use in the short‐term, with the large number of people attending EDs with risky drinking, the use of an effective ultra‐BI would have the potential to have a measurable population effect.     

The effects of mindfulness‐based stress reduction on depression,anxiety, and stress in older adults: A systematic review and meta‐analysis

Mindfulness‐based stress reduction (MBSR) has been widely used to improve various physical and mental conditions. Studies show the intervention is particularly effective in alleviating depression, anxiety, and stress in working‐aged adults. No recent systematic review has focused on the use of MBSR in older adults. This study aims to examine the effects of MBSR intervention on depression, anxiety, and stress symptoms of older adults. Five electronic databases were searched for relevant randomized controlled trials (RCTs) published between 1990 and 2017. Six eligible studies were included and computed for meta‐analysis. The methodological quality and risk of biases across the included RCTs were assessed using the Cochrane risk of bias assessment tool. Overall, the amount of evidence is limited and of relatively low quality. The results of this review provide evidence that the MBSR is more effective than wait‐list‐control group to reduce depression in older adults with clinically significant symptoms immediately following the intervention. However, there is no clear evidence that the intervention reduced the perception of stress and anxiety, or that positive effects are maintained over the longer term. More robust studies involving larger sample sizes and using longer follow‐up measurements are required.     

The effectiveness of generic self‐management interventions for patients with chronic musculoskeletal pain on physical function,self‐efficacy,pain intensity and physical activity: A systematic review and meta‐analysis

Generic self‐management programs aim to facilitate behavioural adjustment and therefore have considerable potential for patients with chronic musculoskeletal pain. Our main objective was to collect and synthesize all data on the effectiveness of generic self‐management interventions for patients with chronic musculoskeletal pain in terms of physical function, self‐efficacy, pain intensity and physical activity. Our secondary objective was to describe the content of these interventions, by means of classification according to the Behaviour Change Technique Taxonomy. We searched PubMed, CENTRAL, Embase and Psycinfo for eligible studies. Study selection, data extraction and risk of bias were assessed by two researchers independently. Meta‐analyses were only performed if the studies were sufficiently homogeneous and GRADE was used to determine the quality of evidence. We identified 20 randomized controlled trials that compared a self‐management intervention to any type of control group. For post‐intervention results, there was moderate quality evidence of a statistically significant but clinically unimportant effect for physical function and pain intensity, both favouring the self‐management group. At follow‐up, there was moderate quality evidence of a small clinically insignificant effect for self‐efficacy, favouring the self‐management group. All other comparisons did not indicate an effect. Classification of the behaviour change techniques showed large heterogeneity across studies. These results indicate that generic self‐management interventions have a marginal benefit for patients with chronic musculoskeletal pain in the short‐term for physical function and pain intensity and for self‐efficacy in the long‐term, and vary considerably with respect to intervention content.

Significance

This study contributes to a growing body of evidence that generic self‐management interventions have limited effectiveness for patients with chronic musculoskeletal pain. Furthermore, this study has identified substantial differences in both content and delivery mode across self‐management interventions.     

The treatment effect of exercise programmes for chronic low back pain

Rationale This paper summarizes evidence of long‐term effectiveness of physiotherapy exercise therapy for chronic low back pain (LBP). Methods A literature search was undertaken for experimental studies (2001–2007), which reported any post‐intervention (follow‐up) outcomes. Studies were critically appraised using the PEDro instrument. Comparative statistics were calculated, relative to the type of follow‐up outcome data. Results Fifteen moderate quality trials were included [mean PEDro score 7.7, SD 1.3 (range 5–10)]. Nine trials reported pain scales, and six reported LBP reoccurrence. Trials which reported on pain scales at 6‐month follow‐up found significant differences in favour of exercise [standardized mean differences ?0.57, 95%CI ?0.75 to ?0.39 (555 participants)]. At 12‐month follow‐up, a small pain scale benefit from exercise persisted [standardized mean differences ?0.25, 95%CI ?0.44 to 0.06 (434 participants)]. There was unconvincing evidence of exercise effectiveness on pain scales after this time. Three of the four trials which reported dichotomous outcomes at 6‐month follow‐up demonstrated large clinical benefits of exercise (relative risk reduction of reoccurrence 45–246%, absolute risk reduction of reoccurrence 36–42 for every 100 patients; and number needed to treat approximating 3, to prevent one patient suffering a LBP recurrence). The effect of exercise on LBP reoccurrence was variably reported beyond 6 months. Conclusion Exercise programmes are effective for chronic LBP up to 6 months after treatment cessation, evidenced by pain score reduction and reoccurrence rates. The way in which follow‐up data are reported assists clinical interpretation of research findings.     

Factors affecting behaviours that address HIV risk among black and white South Africans

The aim of this study was to identify factors affecting HIV risk reduction among 150 Black and 150 White South Africans chosen by systematic random sampling. Main outcome measures included sexual behavior and condom use, knowledge about correct condom use, intention of condom use, behavioural norms, attitudes, normative beliefs, and subjective norms about condoms, HIV/AIDS health beliefs, and HIV risk behaviour. Bivariate analysis gave positive significant relations among being single, age, HIV/AIDS perceived severity, HIV/AIDS prevention barriers and HIV risk behaviour. Further, bivariate analysis gave negative significant relations among age at onset of puberty, age at first vaginal intercourse, correct condom use knowledge, subjective norms, intention to use condoms and HIV risk behaviour. Regression analysis indicated that for subjective norm to use condoms, less intention for condom use, less condom use knowledge and younger age of first vaginal intercourse were predictive for HIV/AIDS risk behaviour. HIV prevention intervention programmes should include the identified factors and cultural diversity.     

Improving condom self‐efficacy and use among individuals living with HIV: The positive choices mapping intervention

Few interventions have been designed to improve behavioural outcomes and reduce risk of HIV transmission of individuals living with HIV, most focusing on preventative efforts directed at individuals who are HIV‐negative. However, people living with HIV present individual and public health risks (infection with a different strain of HIV, health complications from contracting STD's, continued sexual activity with individuals with unknown HIV status) that have become the focus of intervention efforts. The current paper explores a promising new intervention, The Positive Choices Mapping (PCM) intervention, designed to increase condom self‐efficacy and use among African American crack cocaine smokers who are living with HIV. The intervention was grounded in Social Cognitive Theory and incorporated an empirically backed visual representation strategy (node‐link mapping). The focus of the current paper is on the main components of the intervention.     

Utility of the AIDS risk assessment for crack cocaine and sex risk behaviours among homeless persons addicted to crack undergoing behavioural day treatment

The primary aim of this study was to assess the impact of an HIV and drug addiction intervention on reported sexual transmission HIV risk and drug use among homeless persons in two treatments for cocaine addiction. The ARA‐C study (n=104) included 74 (71.2%) men and 30 (28.8%) women with an average age of 37.8 (SD=6.9) years. Most participants were African American (90, 86.5%) and the remainder were Caucasian (14, 13.5%). All participants met criteria for homelessness, nonpsychotic mental distress, and admitted to smoking crack cocaine within the 2 weeks prior to treatment. It appears that, overall, behavioural day treatment for cocaine disorders among homeless persons can have a short‐ and long‐term impact on the reduction of sexual transmission HIV risk among this population with a minimal sexual transmission HIV risk intervention. The causal factors of this outcome still remain unclear. Treatment group differences did not sufficiently explain sexual transmission risk reductions and the impact of the HIV risk education programme was impossible to explain because it was provided to all participants and was only a small part of the overall programme. There did seem to be a small contribution of drug abstinence in the reduction of sexually transmitted risk, but this was at one time point for the Sex and Crack subscale only. This study demonstrates that there may be promise in providing drug addiction treatment combined with sexual transmission HIV risk reduction prevention programming for this extremely vulnerable group, and that future interventions should be better designed and tested using more robust research.     

Changes in Attributions as a Consequence of Training for Challenging and Complex Behaviour for Carers of People with Learning Disabilities: A Systematic Review

Aim This paper reviews the evidence for changes in carers’ attributions regarding the behaviour of people with intellectual disabilities as a consequence of carer training in challenging and complex behaviour. Method Papers were included in the review if they reported outcomes for carer training on the behaviour of people with intellectual disabilities and used a measure of carer attribution of the behaviour of people with intellectual disabilities. The characteristics of the scales used and the content and length of training are considered as possible factors affecting changes in attribution. Results Eleven papers were reviewed, most studies using behavioural curricula for their training, and none explicitly set out to change attributions. Eight of the 11 papers reviewed reported changes in attribution although core characteristics of training did not distinguish those papers that reported such changes and those that did not. Conclusions Changes in beliefs and attributions occur even though these are not identified as a focus within the training provided. The present authors suggest that the formulation processes involved in behavioural training may play a key part in changing attributions as a consequence of this training. The present authors discuss the potential for more focussed intervention designed to change attributions and for better alignment of measures to specific attribution change expected as a result of specific training approaches.     

Reducing sexually-transmitted infection risk in young people with first-episode psychosis

There is emerging evidence that young people with first-episode psychosis are at greater risk of sexually-transmitted infections (STI) than their peers. Theoretical constructs central to behavioural change theories, broadly defined as sexual health-related knowledge, attitudes, and beliefs, have guided most sexual risk-reduction interventions in other at-risk populations. The role of these constructs in the sexual risk behaviour of young people with early psychosis remains unknown. A convenience sample of 67 young people with first-episode psychosis and 48 healthy controls matched on a number of sociodemographic characteristics was recruited. Participants completed a survey assessing their sexual behaviour and sexual health-related knowledge, attitudes, and beliefs. Group differences and the role of these constructs in the condom-use behaviour of these young people were examined. Although some differences emerged, group similarities were prominent. Inconsistent condom use was predicted by clinical status, unemployment, and the absence of peer support for condom use. These results support previous findings that young people with psychosis have greater needs for STI prevention due to increased rates of unprotected sex. Risk-reduction interventions that target peer influence are important. Inquiry into a broader range of psychosocial factors could further our understanding of STI infection risk in early psychosis.     

Training Staff to Manage Challenging Behaviour

Background A training package for staff working with clients presenting challenging behaviour was developed to (1) increase their knowledge regarding challenging behaviour, and (2) to improve the quality of physical intervention techniques. The latter aim was intended to reduce staff anxiety about dealing with incidents and limit physical risk of injury to both clients and themselves. Materials and Methods Sessions concerning theories of challenging behaviour were combined with physical intervention training. Effectiveness was assessed using knowledge questionnaires and observation of staff skills. Training effectiveness was tested in a pre–post‐test control group design. Results and Conclusions The training program proved to be effective. Staff knowledge of challenging behaviour and the quality of physical intervention techniques increased significantly. Scores remained above pre‐test levels at follow‐up. Staff members evaluated the training positively.     

Effectiveness of Group Cognitive‐Behavioural Treatment for Men with Intellectual Disabilities at Risk of Sexual Offending

Background For non‐disabled men, group cognitive‐behaviour therapy is a successful form of treatment when men have committed sexual offences. However, men with intellectual disabilities and sexually abusive behaviour are rarely offered treatment for their sexual behaviour and little research data on the effectiveness of such treatment has been collected. Method Nine collaborating sites ran 13, 1‐year long cognitive‐behavioural treatment groups for men with intellectual disabilities and sexually abusive behaviour. The men came from both community and secure provision and were assessed for sexual knowledge, victim empathy and cognitive distortions before and after the group treatment. Treatment was guided by a common treatment manual. Results Forty‐six men consented to take part in the research. Most men (83%) had engaged in more than one incident of sexually abusive behaviour but only 57% of the men who came for treatment were required by law to attend. Almost all the men (92%) who began treatment (and consented to take part in the research) completed treatment 1 year later, indicating considerable motivation amongst the men to get treatment for their difficulties. Over the period of treatment, the men showed statistically significant increases in sexual knowledge and victim empathy, as well as reductions in cognitive distortions. These changes were still significant at 6‐month follow‐up for sexual knowledge and cognitive distortions. Few men showed further sexually abusive behaviour during the 1‐year period when they were attending treatment (three men) or during the 6‐month follow‐up period (four men). Only the presence of autistic spectrum disorders appeared to be related to re‐offending (though this result should be treated with caution, given the small numbers who re‐offended). Conclusions This large treatment trial provides some evidence of the effectiveness of such treatment for men with intellectual disabilities but there remains a need for a longer follow‐up period and a randomized controlled trial.     

Aerobic exercise to improve cognitive function in adults with neurological disorders: a systematic review

McDonnell MN, Smith AE, Mackintosh SF. Aerobic exercise to improve cognitive function in adults with neurological disorders: a systematic review.

Objective

To evaluate whether aerobic exercise improves cognition in adults diagnosed with neurologic disorders.

Data Sources

The Cochrane Central Register of Controlled Clinical Trials, MEDLINE, CINAHL, PubMed, EMBASE, PEDro, AMED, SPORTDiscus, PsycINFO, ERIC, and Google Scholar, with the last search performed in December 2010.

Study Selection

We included controlled clinical trials and randomized controlled trials with adults diagnosed with a neurologic disorder. Studies were included if they compared a control group with a group involved in an aerobic exercise program to improve cardiorespiratory fitness and if they measured cognition as an outcome.

Data Extraction

Two reviewers independently extracted data and methodologic quality of the included trials.

Data Synthesis

From the 67 trials reviewed, a total of 7 trials, involving 249 participants, were included. Two trials compared the effectiveness of yoga and aerobic exercise in adults with multiple sclerosis. Two trials evaluated the effect of exercise on patients with dementia, and 2 trials evaluated the effectiveness of exercise to improve cognition after traumatic brain injury. One trial studied the effect of a cycling program in people with chronic stroke. Lack of commonality between measures of cognition limited meta-analyses. Results from individual studies show that aerobic exercise improved cognition in people with dementia, improved attention and cognitive flexibility in patients with traumatic brain injury, improved choice reaction time in people with multiple sclerosis, and enhanced motor learning in people with chronic stroke.

Conclusions

There is limited evidence to support the use of aerobic exercise to improve cognition in adults with neurologic disorders. Of the 67 studies retrieved, less than half included cognition as an outcome, and few studies continued the aerobic exercise program long enough to be considered effective. Further studies investigating the effect of aerobic exercise interventions on cognition in people with neurologic conditions are required.     

The MEMA kwa Vijana project: design of a community randomised trial of an innovative adolescent sexual health intervention in rural Tanzania

BACKGROUND: Effective interventions to reduce the incidence of HIV, other sexually transmitted infections (STIs) and unwanted pregnancy among adolescents in sub-Saharan Africa are urgently needed. This paper describes the rationale and design of a randomised trial of the impact of an innovative sexual health intervention among adolescents in rural Mwanza Region, Tanzania. METHODS: The MEMA kwa Vijana intervention comprises a teacher-led, peer-assisted sexual health education programme for students in the last 3 years of primary school, training and supervision of health workers in the provision of youth-friendly health services, peer condom promotion and distribution, and wider community activities. Detailed process evaluation was conducted and the impact of the intervention was evaluated through a community-randomised trial in which a cohort of 9645 adolescents was followed up for 3 years. Both process and impact evaluation used multiple assessment methods. Impact measures included incidence and prevalence of HIV and other STIs, pregnancy rates, knowledge and reported attitudes and sexual behaviour, as well as qualitative assessments. RESULTS: Results of the baseline survey of the cohort have been presented previously. The outcome of the trial will be reported separately. CONCLUSIONS: Behaviour change interventions among adolescents have been widely advocated, but there have been few rigorously designed trials of their effectiveness, particularly in developing countries, and measurement of sexual behaviour is particularly problematic in this age group. The MEMA kwa Vijana trial was undertaken to address these problems and to collect rigorous evidence on the effectiveness of an innovative intervention, designed to be implemented on a very large scale.     

Effects of vitamin E on cardiovascular and microvascular outcomes in high-risk patients with diabetes: results of the HOPE study and MICRO-HOPE substudy

OBJECTIVES: Experimental and observational studies suggest that vitamin E may reduce the risk of cardiovascular (CV) events and of microvascular complications in people with diabetes. However, data from randomized clinical trials are limited. Therefore, we evaluated the effects of vitamin E supplementation on major CV outcomes and on the development of nephropathy in people with diabetes. RESEARCH DESIGN AND METHODS: The Heart Outcomes Prevention Evaluation (HOPE) trial is a randomized clinical trial with a 2 x 2 factorial design, which evaluated the effects of vitamin E and of ramipril in patients at high risk for CV events. Patients were eligible for the study if they were 55 years or older and if they had CV disease or diabetes with at least one additional coronary risk factor. The study was designed to recruit a large number of people with diabetes, and the analyses of the effects of vitamin E in this group were preplanned. Patients were randomly allocated to daily treatment with 400 IU vitamin E and with 10 mg ramipril or their respective placebos and were followed for an average of 4.5 years. The primary study outcome was the composite of myocardial infarction, stroke, or CV death. Secondary outcomes included total mortality, hospitalizations for heart failure, hospitalizations for unstable angina, revascularizations, and overt nephropathy. RESULTS: There were 3,654 people with diabetes. Vitamin E had a neutral effect on the primary study outcome (relative risk = 1.03, 95% CI 0.88-1.21; P = 0.70), on each component of the composite primary outcome, and on all predefined secondary outcomes. CONCLUSIONS: The daily administration of 400 IU vitamin E for an average of 4.5 years to middle-aged and elderly people with diabetes and CV disease and/or additional coronary risk factor(s) has no effect on CV outcomes or nephropathy.