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Frontiers in Neurology 2022To investigate the available evidence on early supported discharge (ESD) and transitional care (TC) delivery service in patients with cerebrovascular disease.
OBJECTIVE
To investigate the available evidence on early supported discharge (ESD) and transitional care (TC) delivery service in patients with cerebrovascular disease.
METHODS
A systematic literature search was conducted to collect all available evidence on the use of ESD and TC services. We included cluster-randomized pragmatic trials or randomized controlled trials (RCTs) that recruited patients with stroke or transient ischemic attack to receive either conventional care or any care service intervention that included rehabilitation or support provided by professional medical personnel with the aim of accelerating and supporting home discharge. Relevant data were electronically searched through international databases (Cochrane Library, EMBASE, and PubMed) and incorporated into a summary grid to investigate research outcomes and provide a narrative synthesis. Furthermore, we compared the outcomes in terms of length of hospital stay, patient and caregiver outcomes, and mortality through meta-analysis.
RESULTS
We identified and included a total of 20 publications of various original randomized studies. There were 18 studies conducted in western countries and 2 in eastern countries. The meta-analysis revealed a tendency that ESD or TC could decrease the length of hospital stay more than the usual care [standardized mean difference (SMD) -0.13; 95% confidence interval (CI) -0.31 to 0.04 days; = 0.14]. Moreover, there was a tendency that ESD resulted in better activities of daily living (ADL) than usual care (SMD 0.29; 95% CI -0.04 to 0.61; = 0.08). Patient outcome based on modified Rankin scale (mRS) score (SMD -0.11; 95% CI -0.38 to 0.17; = 0.45] and mortality (odds ratio 0.80; 95% CI 0.56-1.17; = 0.25) did not reveal any significant difference. The Caregiver Strain Index revealed no difference.
CONCLUSION
We did not find a large effect size for the use of TC and ESD. When implementing the TC and ESD model from western to Asian countries, services should be prepared and implemented in accordance with national medical rehabilitation pathways for cerebrovascular disease.
PubMed: 35370909
DOI: 10.3389/fneur.2022.755316 -
The Cochrane Database of Systematic... Aug 2011First generation 'typical' antipsychotics such as chlorpromazine and haloperidol have been the mainstay of treatment up until the introduction of the second generation... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
First generation 'typical' antipsychotics such as chlorpromazine and haloperidol have been the mainstay of treatment up until the introduction of the second generation 'atypical' antipsychotics such as risperidone and olanzapine. Typical and atypical antipsychotics do provide a treatment response for most people with schizophrenia, whether a reduction in psychotic episodes or a lessening in the severity of their illness. However, a proportion of people still do not respond adequately to antipsychotic medication. Additionally, atypical and especially typical antipsychotics are associated with serious adverse effects, which can often compromise compliance with medication and therefore increase the incidences of relapse. In this review we examine the effects of aripiprazole compared with placebo.
OBJECTIVES
To evaluate the effects of aripiprazole compared with placebo for people with schizophrenia and schizophrenia-like psychoses.
SEARCH STRATEGY
We searched the Cochrane Schizophrenia Group Trials Register (January 2008) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. For this update, we carried out an initial search in May 2007 and a second search in August 2008.
SELECTION CRITERIA
We included all randomised trials comparing aripiprazole with placebo in people with schizophrenia or schizophrenia-like psychosis.
DATA COLLECTION AND ANALYSIS
We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a fixed-effect model. We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. For continuous data, we calculated mean differences (MD) again based on a fixed-effect model.
MAIN RESULTS
Despite the fact that 2585 people participated in nine randomised aripiprazole studies, we were unable to extract any usable data on death, service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment; economic outcomes or cognitive functioning. In general, study attrition was very large for all studies over four weeks' duration. There was high attrition in most of the included studies. Fewer people left the aripiprazole group compared with those in the placebo group (n = 2585, 9 RCTs, RR 0.73 CI 0.60 to 0.87). Compared with placebo, aripiprazole significantly decreased relapse in both the short (n = 310, 1 RCT, RR 0.59 CI 0.45 to 0.77) and medium term (n = 310, 1 RCT, RR 0.66 CI 0.53 to 0.81). It also produced better compliance with study protocol (n = 2275, 8 RCTs, RR 0.74 CI 0.59 to 0.93). Aripiprazole may decrease prolactin levels below those expected from placebo (n = 305, 2 RCT, RR 0.21 CI 0.11 to 0.37). Insomnia (˜23%) and headaches (˜15%) were commonly reported in both groups, with no significant difference.
AUTHORS' CONCLUSIONS
Aripiprazole may be effective for the treatment of schizophrenia. Aripiprazole has a lower risk of raised prolactin and prolongation of the QTc interval. Clearly reported pragmatic short-, medium- and long-term randomised controlled trials should be undertaken to determine its position in everyday clinical practice.
Topics: Antipsychotic Agents; Aripiprazole; Humans; Patient Dropouts; Piperazines; Placebos; Quinolones; Randomized Controlled Trials as Topic; Schizophrenia
PubMed: 21833956
DOI: 10.1002/14651858.CD006622.pub2 -
Pain Physician 2008Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and... (Review)
Review
Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence for treatment alternatives. However, in practical clinical trials, interventions compared in the trial are clinically relevant alternatives, participants reflect the underlying affected population with the disease, participants come from a heterogeneous group of practice settings and geographic locations, and endpoints of the trial reflect a broad range of meaningful clinical outcomes.
Topics: Bias; Clinical Protocols; Data Interpretation, Statistical; Evidence-Based Medicine; Guidelines as Topic; Humans; Pain; Placebos; Random Allocation; Randomized Controlled Trials as Topic
PubMed: 19057624
DOI: No ID Found -
Journal of Neurotrauma Oct 2020Therapeutic hypothermia was a mainstay of severe traumatic brain injury (TBI) management for half a century. Recent trials have suggested that its effect on long-term... (Meta-Analysis)
Meta-Analysis
A Systematic Review and Meta-Analysis of Hypothermia in Experimental Traumatic Brain Injury: Why Have Promising Animal Studies Not Been Replicated in Pragmatic Clinical Trials?
Therapeutic hypothermia was a mainstay of severe traumatic brain injury (TBI) management for half a century. Recent trials have suggested that its effect on long-term functional outcome is neutral or negative, despite apparently promising pre-clinical data. Systematic review and meta-analysis is a useful tool to collate experimental data and investigate the basis of its conclusions. We searched three online databases to identify studies testing systemic hypothermia as monotherapy for treatment of animals subjected to a TBI. Data pertaining to TBI paradigm, animal subjects, and hypothermia management were extracted as well as those relating to risk of bias. We pooled outcome data where sufficient numbers allowed and investigated heterogeneity in neurobehavioral outcomes using multi-variate meta-regression. We identified 90 publications reporting 272 experiments testing hypothermia in animals subject to TBI. The subjects were mostly small animals, with well-established models predominating. Target temperature was comparable to clinical trial data but treatment was initiated very early. Study quality was low and there was some evidence of publication bias. Delay to treatment, comorbidity, and blinded outcome assessment appeared to predict neurobehavioral outcome on multi-variate meta-regression. Therapeutic hypothermia appears to be an efficacious treatment in experimental TBI, which differs from the clinical evidence. The pre-clinical literature showed limitations in quality and design and these both appeared to affect neurobehavioral experiment outcome. These should be acknowledged when designing and interpreting pre-clinical TBI studies in the future.
Topics: Animals; Brain Injuries, Traumatic; Disease Models, Animal; Humans; Hypothermia, Induced; Outcome Assessment, Health Care; Pragmatic Clinical Trials as Topic
PubMed: 32394804
DOI: 10.1089/neu.2019.6923 -
Journal of the American Medical... Feb 2020Older age is associated with multimorbidity and polypharmacy with high anticholinergic burden (ACB). High ACB is linked to adverse events such as poor physical... (Review)
Review
INTRODUCTION
Older age is associated with multimorbidity and polypharmacy with high anticholinergic burden (ACB). High ACB is linked to adverse events such as poor physical functioning, dementia, cardiovascular disease, and falls. Interventions are needed to reduce this burden.
AIMS/OBJECTIVES
The aim was to systematically review the literature to identify and describe studies of clinical and cost-effectiveness of interventions designed to reduce ACB in adults (≥65 years) on polypharmacy regimes, compared with usual care. The objective was to answer the following questions: What are the contents of the interventions? Were these interventions clinically effective? Were these interventions cost effective?.
DESIGN, SETTING, AND PARTICIPANTS
Systematic review of interventions to reduce anticholinergic burden in adults aged 65 and older in any clinical setting.
METHODS
Eligible papers reported primary or secondary research describing any type of intervention including systematic reviews, randomized controlled trials (RCTs), controlled clinical trials, or nonrandomized pre-post intervention studies (PPIs) published in English from January 2010 to February 2019. Databases searched included CINAHL, Ovid MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL).
RESULTS
The search yielded 5862 records. Eight studies (4 RCTs, 4 PPIs) conducted in hospital (4), community (2), nursing homes (1), and retirement villages (1) met the inclusion criteria. Pharmacists, either individually or as part of a team, provided the intervention in the majority of studies (6/8). Most (7/8) involved individual patient medication review followed by feedback to the prescriber. Two of the 4 RCTs and all non-RCTs reported a decrease in ACB following the intervention. No study reported cost outcome.
CONCLUSIONS/IMPLICATIONS
Pharmacists may be well placed to implement an ACB reduction intervention. This is the first systematic review of interventions to reduce ACB in older adults, and it highlights the need for development and testing of high-quality pragmatic clinical and cost-effectiveness trials in community and specific patient populations at high risk of harm from ACB. [PROSPERO registration: CRD42018089764].
Topics: Aged; Cholinergic Antagonists; Cost-Benefit Analysis; Humans; Nursing Homes; Polypharmacy
PubMed: 31351858
DOI: 10.1016/j.jamda.2019.06.001 -
Obesity Reviews : An Official Journal... May 2016The review describes the effectiveness of physical activity interventions implemented in centre-based childcare services and (i) examines characteristics of... (Meta-Analysis)
Meta-Analysis Review
CONTEXT
The review describes the effectiveness of physical activity interventions implemented in centre-based childcare services and (i) examines characteristics of interventions that may influence intervention effects; (ii) describes the effects of pragmatic interventions and non-pragmatic interventions; (iii) assesses adverse effects; and (iv) describes cost-effectiveness of interventions
METHODS
Data sources were Cochrane Central Register of Controlled trials, MEDLINE, EMBASE, PsycINFO, ERIC, CINAHL, SCOPUS and SPORTDISCUS. Studies selected included randomized controlled trials conducted in centre-based childcare including an intervention to increase objectively measured physical activity in children aged less than 6 years. Data were converted into standardized mean difference (SMD) and analysed using a random effects model.
RESULTS
Overall interventions significantly improved child physical activity (SMD 0.44; 95% confidence interval [CI]: 0.12-0.76). Significant effects were found for interventions that included structured activity (SMD 0.53; 95% CI: 0.12-0.94), delivery by experts (SMD 1.26; 95% CI: 0.20-2.32) and used theory (SMD 0.76; 95% CI: 0.08-1.44). Non-pragmatic (SMD 0.80; 95% CI: 0.12-1.48) but not pragmatic interventions (SMD 0.10; 95% CI:-0.13-0.33) improved child physical activity. One trial reported adverse events, and no trials reported cost data.
CONCLUSIONS
Intervention effectiveness varied according to intervention and trial design characteristics. Pragmatic trials were not effective, and information on cost and adverse effects was lacking. Evidence gaps remain for policymakers and practitioners regarding the effectiveness and feasibility of childcare-based physical activity interventions.
Topics: Bias; Child; Exercise; Humans; Obesity; Risk Factors
PubMed: 27005942
DOI: 10.1111/obr.12392 -
The Journal of Asthma : Official... Jun 2014One of the most common reasons for medication non-adherence for asthma patients is forgetfulness. Daily medication reminder system interventions in the form of text... (Review)
Review
OBJECTIVE
One of the most common reasons for medication non-adherence for asthma patients is forgetfulness. Daily medication reminder system interventions in the form of text messages, automated phone calls and audiovisual reminder devices can potentially address this problem. The aim of this review was to assess the effectiveness of reminder systems on patient daily asthma medication adherence.
METHODS
We conducted a systematic review of the literature to identify randomized controlled trials (RCTs) which assessed the effect of reminder systems on daily asthma medication adherence. We searched all English-language articles in Pub Med (MEDLINE), CINAHL, EMBASE, PsychINFO and the Cochrane Library through May 2013. We abstracted data on the year of study publication, location, inclusion and exclusion criteria, patient characteristics, reminder system characteristics, effect on patient adherence rate and other outcomes measured. Descriptive statistics were used to summarize the characteristics and results of the studies.
RESULTS
Five RCTs and one pragmatic RCT were included in the analysis. Median follow-up time was 16 weeks. All of the six studies suggested that the reminder system intervention was associated with greater levels of participant asthma medication adherence compared to those participants in the control group. None of the studies documented a change in asthma-related quality of life or clinical asthma outcomes.
CONCLUSION
All studies in our analysis suggest that reminder systems increase patient medication adherence, but none documented improved clinical outcomes. Further studies with longer intervention durations are needed to assess effects on clinical outcomes, as well as the sustainability of effects on patient adherence.
Topics: Asthma; Humans; Medication Adherence; Randomized Controlled Trials as Topic; Reminder Systems
PubMed: 24506699
DOI: 10.3109/02770903.2014.888572 -
Journal of General Internal Medicine Jan 2015The US Preventive Services Task Force recommends screening for and treating obesity. However, there are many barriers to successfully treating obesity in primary care... (Review)
Review
BACKGROUND
The US Preventive Services Task Force recommends screening for and treating obesity. However, there are many barriers to successfully treating obesity in primary care (PC). Technology-assisted weight loss interventions offer novel ways of improving treatment, but trials are overwhelmingly conducted outside of PC and may not translate well into this setting. We conducted a systematic review of technology-assisted weight loss interventions specifically tested in PC settings.
METHODS
We searched the literature from January 2000 to March 2014.
INCLUSION CRITERIA
(1) Randomized controlled trial; (2) trials that utilized the Internet, personal computer, and/or mobile device; and (3) occurred in an ambulatory PC setting. We applied the Cochrane Effective Practice and Organization of Care (EPOC) and Delphi criteria to assess bias and the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) criteria to assess pragmatism (whether trials occurred in the real world versus under ideal circumstances). Given heterogeneity, results were not pooled quantitatively.
RESULTS
Sixteen trials met inclusion criteria. Twelve (75 %) interventions achieved weight loss (range: 0.08 kg - 5.4 kg) compared to controls, while 5-45 % of patients lost at least 5 % of baseline weight. Trial duration and attrition ranged from 3-36 months and 6-80 %, respectively. Ten (63 %) studies reported results after at least 1 year of follow-up. Interventions used various forms of personnel, technology modalities, and behavior change elements; trials most frequently utilized medical doctors (MDs) (44 %), web-based applications (63 %), and self-monitoring (81 %), respectively. Interventions that included clinician-guiding software or feedback from personnel appeared to promote more weight loss than fully automated interventions. Only two (13 %) studies used publically available technologies. Many studies had fair pragmatism scores (mean: 2.8/4), despite occurring in primary care.
DISCUSSION
Compared to usual care, technology-assisted interventions in the PC setting help patients achieve weight loss, offering evidence-based options to PC providers. However, best practices remain undetermined. Despite occurring in PC, studies often fall short in utilizing pragmatic methodology and rarely provide publically available technology. Longitudinal, pragmatic, interdisciplinary, and open-source interventions are needed.
Topics: Biomedical Technology; Delivery of Health Care; Humans; Internet; Mobile Applications; Obesity; Primary Health Care; Weight Loss
PubMed: 25134692
DOI: 10.1007/s11606-014-2987-6 -
Health Technology Assessment... May 2004To undertake a systematic review of the long-term effects of obesity treatments on body weight, risk factors for disease, and disease. (Review)
Review
OBJECTIVES
To undertake a systematic review of the long-term effects of obesity treatments on body weight, risk factors for disease, and disease.
METHODS
The study encompassed three systematic reviews that examined different aspects of obesity treatments. (1) A systematic review of obesity treatments in adults where the methods of the Cochrane Collaboration were applied and randomised controlled trials (RCTs) with a follow-up of at least 1 year were evaluated. (2) A systematic epidemiological review, where studies were sought on long-term effects of weight loss on morbidity and/or mortality, and examined through epidemiological modelling. (3) A systematic economic review that sought reports with both costs and outcomes of treatment, including recent reports that assessed the cost-effectiveness of pharmaceutical and surgical interventions. A Markov model was also adopted to examine the cost-effectiveness of a low-fat diet and exercise intervention in adults with obesity and impaired glucose tolerance.
RESULTS
The addition of the drugs orlistat or sibutramine was associated with weight loss and generally improved risk factors, apart from diastolic blood pressure for sibutramine. Metformin was associated with decreased mortality after 10 years in obese people with type 2 diabetes. Low-fat diets were associated with continuing weight loss for 3 years and improvements in risk factors, as well as prevention of type 2 diabetes and improved control of hypertension. Insufficient evidence was available to demonstrate the benefits of low calorie or very low calorie diets. The addition of an exercise or behaviour programme to diet was associated with improved weight loss and risk factors for at least 1 year. Studies combining low-fat diets, exercise and behaviour therapy suggested improved hypertension and cardiovascular disease. Family therapy was associated with improved weight loss for 2 years compared to individual therapy. There was insufficient evidence to conclude that individual therapy was more beneficial than group therapy. Weight lost more quickly (within 1 year), from the epidemiology review, may be more beneficial with respect to the risk of mortality. The effects of intentional weight loss need further investigation. Weight loss from surgical and non-surgical interventions for people suffering from obesity was associated with decreased risk of development of diabetes, and a reduction in low-density lipoprotein cholesterol, total cholesterol and blood pressure, in the long term. Targeting high-risk individuals with drugs or surgery was likely to result in a cost per additional life-year or quality-adjusted life-year (QALY) of no more than 13,000 British pounds. There was also suggestive evidence of cost saving from treatment of people with type 2 diabetes with metformin. Targeting surgery on people with severe obesity and impaired glucose tolerance was likely to be more cost-effective at 2329 British pounds per additional life-year. Economic modelling over 6 years for diet and exercise for people with impaired glucose tolerance was associated with a high initial cost per additional QALY, but by the sixth year the cost per QALY was 13,389 British pounds. Results did not include cost savings from diseases other than diabetes, and therefore may be conservative.
CONCLUSIONS
The drugs orlistat and sibutramine appear beneficial for the treatment of adults with obesity, and metformin for obese patients with type 2 diabetes. Exercise and/or behaviour therapy appear to improve weight loss when added to diet. Low-fat diets with exercise, or with exercise and behaviour therapy are associated with the prevention of type 2 diabetes and hypertension. Long-term weight loss in epidemiological studies was associated with reduced risk of type 2 diabetes, and may be beneficial for cardiovascular disease. Low-fat diets and exercise interventions in individuals at risk of obesity-related illness are of comparable cost to drug treatments. Long-term pragmatic RCTs of obesity treatments in populations with obesity-related illness or at high risk of developing such illness are needed (to include an evaluation of risk factors, morbidity, quality of life and economic evaluations). Drug trials that include dietary advice, plus exercise and/or behaviour therapy are also needed. Research exploring effective types of exercise, diet or behaviour and also interventions to prevent obesity in adults is required.
Topics: Anti-Obesity Agents; Behavior Therapy; Caloric Restriction; Cost-Benefit Analysis; Cyclobutanes; Diet, Fat-Restricted; Humans; Hypoglycemic Agents; Lactones; Markov Chains; Metformin; Obesity; Orlistat; Physical Fitness; Randomized Controlled Trials as Topic; Risk Factors
PubMed: 15147610
DOI: 10.3310/hta8210 -
Journal of Psychiatric Research Jul 2017Essential criteria for the methodological quality and validity of randomized controlled trials are the drop-out rates from both the experimental intervention and the... (Meta-Analysis)
Meta-Analysis Review
Essential criteria for the methodological quality and validity of randomized controlled trials are the drop-out rates from both the experimental intervention and the study as a whole. This systematic review and meta-analysis assessed these drop-out rates in non-pharmacological schizophrenia trials. A systematic literature search was used to identify relevant trials with ≥100 sample size and to extract the drop-out data. The rates of drop-out from the experimental intervention and study were calculated with meta-analysis of proportions. Meta-regression was applied to explore the association between the study and sample characteristics and the drop-out rates. 43 RCTs were found, with drop-out from intervention ranging from 0% to 63% and study drop-out ranging from 4% to 71%. Meta-analyses of proportions showed an overall drop-out rate of 14% (95% CI: 13-15%) at the experimental intervention level and 20% (95% CI: 17-24%) at the study level. Meta-regression showed that the active intervention drop-out rates were predicted by the number of intervention sessions. In non-pharmacological schizophrenia trials, drop-out rates of less than 20% can be achieved for both the study and the experimental intervention. A high heterogeneity of drop-out rates across studies shows that even lower rates are achievable.
Topics: Antipyretics; Data Collection; Humans; Patient Dropouts; Randomized Controlled Trials as Topic; Schizophrenia
PubMed: 28231496
DOI: 10.1016/j.jpsychires.2017.02.009