The role of cardiac registries in evidence-based medicine. Evidence-based public health: moving beyond randomized trials. A systematic review of online interventions for mental health in low and middle income countries: a neglected field Bias due to withdrawal in long‐term randomised trials in COPD: Evidence from the TORCH study Feasibility of evidence-based diagnosis and management of heart failure in older people in care: a pilot randomised controlled trial A simplified search strategy for identifying randomised controlled trials for systematic reviews of health care interventions: a comparison with more exhaustive strategies A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review protocol The Treatment of cardiovascular Risk in Primary care using Electronic Decision suppOrt (TORPEDO) study: intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT A systematic review of randomized controlled trials on curative and health enhancement effects of forest therapy Effectiveness of workplace interventions in rehabilitating musculoskeletal disorders and preventing its consequences among workers with physical and sedentary employment: systematic review protocol Assessing the Quality of Randomized Controlled Trials Published in the Journal of Korean Medical Science from 1986 to 2011 Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Increasing participation of cancer patients in randomised controlled trials: a systematic review
Cardiovascular disease remains the primary cause of mortality , and a major cause of disability in the developed world.1 This significant burden necessitates ongoing improvements in patient management , to minimize the impact of cardiovascular conditions on both patients and healthcare systems . These improvements in cardiovascular care are promoted by an evidence -based approach , shaped by comprehensive clinical guidelines . The scientific basis of recommendations is an important feature of clinical guidelines , and influences the degree to which they are followed in clinical practice .2 Recent studies have assigned the highest evidence grading to r and omized controlled trials ( RCTs ) that are clinical ly important , and representative of the clinical population covered by the guideline recommendation .3 For example , this highest grading was assigned to a recommendation based on a meta- analysis of RCTs showing low-dose diuretics to be the most effective first-line treatment for cardiovascular event prevention in hypertensive patients . This study review ed data from 42 RCTs which were , crucially , representative of the population that the recommendation was made for ( i.e. hypertensive patients ) .3,4 The importance of the applicability of evidence to recommendations highlights the need to consider evidence from clinical ly relevant situations , not all of which have been assessed by RCTs . This evidence can originate from expert consensus , as well as non-r and omized prospect i ve studies . Although generally providing a lower evidence -level than RCTs , 3,5 observational studies can make an important contribution to the evidence base when the study outcomes are clinical ly important , and the population s involved are representative . Indeed , information from several registries was considered in the recent American Heart Association Acute Coronary Care in the Elderly Scientific Statement.6 Non-r and omized prospect i ve registries document the treatment and outcomes for consecutive patients in clinical practice . Therefore , data are gained from a ‘ real-world ’ selection of patients , many of whom would be excluded from RCTs , R and omized controlled trials ( RCTs ) are essential for evaluating the efficacy of clinical interventions , where the causal chain between the agent and the outcome is relatively short and simple and where results may be safely extrapolated to other setting s. However , causal chains in public health interventions are complex , making RCT results subject to effect modification in different population s. Both the internal and external validity of RCT findings can be greatly enhanced by observational studies using adequacy or plausibility design s. For evaluating large-scale interventions , studies with plausibility design s are often the only feasible option and may provide valid evidence of impact . There is an urgent need to develop evaluation st and ards and protocol s for use in circumstances where RCTs are not appropriate Background . Low and middle income countries ( LMICs ) are facing an increase of the impact of mental health problems while confronted with limited re sources and limited access to mental health care , known as the ‘ mental health gap ’ . One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care . We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs . Methods . We systematic ally search ed the data -bases PubMed , PsycINFO , JMIR , and additional sources . MeSH terms , Thesaurus , and free text keywords were used . We included all r and omized controlled trials ( RCTs ) of online interventions in LMICs . Results . We found only three articles reported results of RCTs on  online interventions for mental health conditions in LMICs , but none of these interventions was compared with an active control condition . Also , the mental health conditions were diverse across the three studies . Conclusions . There is a dearth of studies examining the effect of online interventions  in LMICs , so we can not draw a firm conclusion on its effectiveness . However , given the effectiveness of  online interventions in high income countries and sharp increase of internet access in LMICs , online interventions may offer a potential to help reduce the ‘ mental health gap ’ . More studies are urgently needed in LMICs Introduction : R and omised controlled trials ( RCTs ) are considered the least biased method for evaluating drug efficacy and several large long‐term RCTs in chronic obstructive pulmonary disease have been published . These usually include drugs with symptomatic benefits and have significant withdrawal rates Background Many older people in long-term care do not receive evidence -based diagnosis or management for heart failure ; it is not known whether this can be achieved for this population . We initiated an onsite heart failure service , compared with ‘ usual care ’ with the aim of establishing the feasibility of accurate diagnosis and appropriate management . Methods A pilot r and omised controlled trial which r and omised residents from 33 care facilities in North-East Engl and with left ventricular systolic dysfunction ( LVSD ) to usual care or an onsite heart failure service . The primary outcome was the optimum prescription of angiotensin-converting enzyme inhibitors and beta-adrenergic antagonists  at 6 months . Results Of 399 echocardiographically-screened residents aged 65–100 years , 30 subjects with LVSD were eligible ; 28 ( 93 % ) consented and were r and omised ( HF service : 16 ; routine care : 12 ) . Groups were similar at baseline ; six month follow-up was completed for 25 patients ( 89 % ) ; 3 ( 11 % ) patients died . Results for the primary outcome were not statistically significant but there was a consistent pattern of increased drug use and titration to optimum dose in the intervention group ( 21 % compared to 0 % receiving routine care , p=0.250 ) . Hospitalisation rates , quality of life and mortality at 6 months were similar between groups . Conclusions This study demonstrated the feasibility of an on-site heart failure service for older long-term care population s. Optimisation of medication appeared possible without adversely affecting quality of life ; this questions clinicians ’ concerns about adverse effects in this group . This has international implication s for managing such patients . These methods should be replicated in a large-scale study to quantify the scale of benefit . Trial registration IS RCT N19781227 http://www.controlled-trials.com/IS RCT Background It is generally believed that exhaustive search es of bibliographic data bases are needed for systematic review s of health care interventions . The CENTRAL data base of controlled trials ( RCTs ) has been built up by exhaustive search ing . The CONSORT statement aims to encourage better reporting , and hence indexing , of RCTs . Our aim was to assess whether developments in the CENTRAL data base , and the CONSORT statement , mean that a simplified RCT search strategy for identifying RCTs now suffices for systematic review s of health care interventions . Methods RCTs used in the Cochrane review s were identified . A brief RCT search strategy ( BRSS ) , consisting of a search of CENTRAL , and then for variants of the word r and om across all fields ( r and om$.af . ) in MEDLINE and EMBASE , was devised and run . Any trials included in the meta-analyses , but missed by the BRSS , were identified . The meta-analyses were then re-run , with and without the missed RCTs , and the differences quantified . The proportion of trials with variants of the word r and om in the title or abstract was calculated for each year . The number of RCTs retrieved by search ing with " r and om$.af . " was compared to the highly sensitive search strategy ( HSSS ) . Results The BRSS had a sensitivity of 94 % . It found all journal RCTs in 47 of the 57 review s. The missing RCTs made some significant differences to a small proportion of the total outcomes in only five review s , but no important differences in conclusions result ed . In the post-CONSORT years , 1997–2003 , the percentage of RCTs with r and om in the title or abstract was 85 % , a mean increase of 17 % compared to the seven years pre-CONSORT ( 95 % CI , 8.3 % to 25.9 % ) . The search using r and om$.af . reduced the MEDLINE retrieval by 84 % , compared to the HSSS , thereby reducing the workload of checking retrievals . Conclusion A brief RCT search strategy is now sufficient to locate RCTs for systematic review s in most cases . Exhaustive search ing is no longer cost-effective , because in effect it has already been done for CENTRAL Background The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease ( COPD ) is unsustainable , and focus is needed on self-management and prevention of hospital admissions . Telehealth monitoring of patients ’ vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health . This paper reports the results of a pilot r and omised controlled trial ( RCT ) of Telehealth-supported care within a community-based COPD supported-discharge service . Methods A two-arm pragmatic pilot RCT was conducted comparing the st and ard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT . The co- primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients ’ self-reported quality of life . The objectives were to assess the suitability of the methodology , produce a sample size calculation for a full RCT , and to give an indication of cost-effectiveness for both pathways . Results Sixty three participants were recruited ( n = 31 St and ard ; n = 32 Telehealth ) ; 15 participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm . Recruitment was slow with significant gaps in data collection , due predominantly to an unanticipated 60 % reduction of staff capacity within the clinical team . The sample size calculation was guided by estimates of clinical ly important effects and COPD readmission rates derived from the literature . Descriptive analyses showed that the st and ard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group . Telehealth was cost-effective only if hospital admissions data were excluded . Conclusions Slow recruitment rates and service reconfigurations prevented progression to a full RCT . Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team , in this case , challenges arose when re sources within the team were reduced by external events . Gaps in data collection were resolved by recruiting a research nurse . This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions , and provides recommendations for the introduction and evaluation of complex interventions within clinical setting s , such as prioritisation of research within the clinical remit . Trial registration Current Controlled Trials IS RCT N68856013 , registered Nov 2010 Background Cluster r and omised trials ( CRTs ) are a key instrument to evaluate public health interventions , particularly in low- and middle-income countries ( LMICs ) . Fidelity assessment examines study processes to gauge whether an intervention was delivered as initially planned . Evaluation of implementation fidelity ( IF ) is required to establish whether the measured effects of a trial are due to the intervention itself and may be particularly important for CRTs of complex interventions . Current CRT reporting guidelines offer no guidance on IF assessment . We will systematic ally review the scientific literature to study current practice s concerning the assessment of IF in CRTs of public health interventions in LMICs . Methods We will include  CRTs of public health interventions in LMICs that planned or assessed IF in either the trial protocol or the main trial report ( or an associated document ) . Search strategies use Medical Subject Headings ( MESH ) and text words related to CRTs , developing countries , and public health interventions . The electronic data base search was developed first for MEDLINE and adapted for the following data bases : EMBASE , CINAHL , PubMed , and EMB Review s , to identify CRT reports in English , Spanish , or French published on or after January 1 , 2012 . To ensure availability of a study protocol , we will include CRTs reporting a registration number in the abstract . For each included study , we will compare planned versus reported assessment of IF , and consider the dimensions of IF studied , and data collection methods used to evaluate each dimension . Data will be synthesis ed using quantitative and narrative techniques . Risk of bias for individual studies will be assessed using the Cochrane Collaboration Risk of Bias Tool criteria and additional criteria related to CRT methods . We will investigate possible sources of heterogeneity by performing subgroup analysis . This review was not eligible for inclusion in the PROSPERO registry . Discussion Fidelity assessment may be a key tool for making studies more reliable , internally valid , and externally generalizable . This review will provide a portrait of current practice s related to the assessment of intervention fidelity in CRTs and offer suggestions for improvement . Results will be relevant to research ers , those who finance health interventions , and for decision-makers who seek the best evidence on public health interventions Background Large gaps exist in the implementation of guideline recommendations for cardiovascular disease ( CVD ) risk management .  Electronic decision support ( EDS ) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia . We have developed HealthTracker , a multifaceted EDS and quality improvement intervention to improve the management of CVD risk . Methods / design It is hypothesised that the use of HealthTracker over a 12-month period will result in : ( 1 ) an increased proportion of patients receiving guideline -indicated measurements of CVD risk factors and ( 2 ) an increased proportion of patients at high risk will receive guideline -indicated prescriptions for lowering their CVD risk . Sixty health services ( 40 general practice s and 20 Aboriginal Community Controlled Health Services ( ACCHSs ) will be r and omised in a 1:1 allocation to receive either the intervention package or continue with usual care , stratified by service type , size and participation in existing quality improvement initiatives . The intervention consists of point-of-care decision support ; a risk communication interface ; a clinical audit tool to assess performance on CVD-related indicators ; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance .  The control arm will continue with usual care without access to these intervention components . Quantitative data will be derived from cross-sectional sample s at baseline and end of study via automated data extraction . Detailed process and economic evaluations will also be conducted . Ethics and dissemination The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee ( HREC ) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC . Formal agreements with each of the participating sites have been signed . In addition to the usual scientific forums , results will be disseminated via newsletters , study websites , face-to-face feedback forums and workshops . Trial registration The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910 Background Of all workers in Dutch construction industry , 20 % has an elevated risk of cardiovascular disease ( CVD ) . A major risk factor for CVD risk is an unhealthy lifestyle . The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk , and to evaluate its ( cost- ) effectiveness . Methods / Design In a RCT , 692 participants will be r and omised to either the control or the intervention group . The control group will receive usual care . For the intervention group , a lifestyle intervention has been design ed based on interviews and current literature . The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts , consisting of individual counselling aim ed at increasing daily physical activity ( PA ) and improving dietary behaviour , and /or smoking cessation . Counselling will take place at the Occupational Health Service ( OHS ) , and will be done according to motivational interviewing ( MI ) . Additional written information about healthy lifestyle will also be provided to those in the intervention group . At baseline , after 6 and after 12 months , measurements will take place . Primary outcome variables will be the lifestyle behaviours of concern , i.e. daily PA , dietary intake , and smoking status . Secondary outcome variables will be body mass index ( BMI ) , systolic and diastolic blood pressure , total and HDL blood cholesterol , Hba1c and cardio-respiratory fitness ( CRF ) . Sickness absenteeism and cost-effectiveness will be assessed as well . Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group . Discussion By improving lifestyle , CVD risk may be lowered , yielding benefits for both employee and employer . If proven effective , this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry . Trial registration Current Controlled Trials IS RCT Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015 Background A pilot project cardiovascular prevention was implemented in S and well ( West Midl and s , UK ) . This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice . Those found to be eligible for treatment were offered treatment . During the pilot a higher proportion of high risk patients were started on treatment in the intervention practice s than in control practice s. Following the apparent success of the prevention project , it was intended to extend the service to all practice s across the S and well area . However the pilot project was not a robust evaluation . There was a need for an efficient evaluation that would not disrupt the planned rollout of the project . Methods / design Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practice s , with the sequence of general practice s determined r and omly . This is a stepped wedge r and omised controlled trial design . The target population is patients aged 35 to 74 , without diabetes or cardiovascular disease whose ten-year cardiovascular risk , ( determined from data in their electronic records ) is ≥20 % . The primary outcome is the number of high risk patients started on treatment , because these data could be efficiently obtained from electronic primary care records . From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practice s before and after implementation of targeted case finding . Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs . Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians . Practical considerations meant that 26 practice s in S and well could be r and omised , including about 6,250 patients at high risk of cardiovascular disease . This gives sufficient power for evaluation . Discussion It is possible to design a stepped wedge r and omised controlled trial using routine data to determine the primary outcome to evaluate implementation of a cardiovascular prevention programme Objective To summarize the evidence for curative and health enhancement effects through  forest therapy  and to assess the quality of studies based on a review of r and omized controlled trials ( RCTs ) . Study design A systematic review based on RCTs . Methods Studies were eligible if they were RCTs . Studies included one treatment group in which forest therapy was applied .  The following data bases – from 1990 to November 9 , 2010 – were search ed : MEDLINE via PubMed , CINAHL , Web of Science , and Ichushi- Web . All Cochrane data bases and Campbell Systematic Review s were also search ed up to November 9 , 2010 . Results Two trials met all inclusion criteria . No specific diseases were evaluated , and both studies reported significant effectiveness in one or more outcomes for health enhancement . However , the results of evaluations with the CONSORT ( Consoli date d St and ards of Reporting Trials ) 2010 and CLEAR NPT ( A Checklist to Evaluate a Report of a Nonpharmacological Trial ) checklists generally showed a remarkable lack of description in the studies . Furthermore , there was a problem of heterogeneity , thus a meta- analysis was unable to be performed . Conclusion Because there was insufficient evidence on forest therapy due to poor method ological and reporting quality and heterogeneity of RCTs , it was not possible to offer any conclusions about the effects of this intervention . However , it was possible to identify problems with current RCTs of forest therapy , and to propose a strategy for strengthening study quality and stressing the importance of study feasibility and original check items based on characteristics of forest therapy as a future research agenda Background Musculoskeletal disorders ( MSDs ) are the leading cause of work disability and sickness absence worldwide . The prevalence of MSDs increases with age , consequently challenging sustainable employability among the growing ageing workforce . Knowledge of feasible and efficient workplace-based interventions to rehabilitate MSD or prevent its consequences is therefore warranted . This systematic review will evaluate the effectiveness of workplace-based interventions on MSDs and its consequences among adult workers with physical and sedentary work tasks , respectively . Methods We will search the following bibliographic data bases : PubMed ( including the data base ‘ MEDLINE ’ ) and Web of Science Core Collection ( including the data bases ‘ Science Citation Index Exp and ed ’ , ‘ Social Sciences Citation Index ’ and ‘ Arts & Humanities Citation Index ’ ) . Manual search es will also be performed . We will include r and omised controlled trials ( RCTs ) and non- RCTs reported in English in which ( 1 ) participants are adult workers with MSD , ( 2 ) interventions are aim ing at rehabilitating pain symptoms of MSD or preventing the consequences of MSD and ( 3 ) interventions are initiated and /or carried out at the workplace . The review will adhere to the ‘ Preferred Reporting Items for Systematic review s and Meta-Analyses ’ ( PRISMA ) guidelines for reporting systematic review s and the Institute for Work and Health ( IWH ) guidelines for workplace-based interventions . For the primary evaluation of the review , the quality assessment and evidence synthesis will conform to the IWH guidelines . Secondary evaluation will include a meta- analysis ( unless the included studies do not allow this due to heterogeneity ) and employ the risk of bias domains recommended by Cochrane along with the Grading of Recommendations , Assessment , Development and Evaluations ( GRADE ) approach on the studies with pain intensity as an outcome . Discussion This systematic review will provide knowledge on effective workplace-based interventions among physical and sedentary workers with MSD . RCTs are considered the most powerful experimental design in clinical trials , but solely including these may be too restrictive to underst and effective workplace-based interventions where r and omised and carefully controlled trials ( RCTs ) are not always possible . In order to maximize practical relevance , the selection process will , therefore , include both RCTs and non- RCTs and the quality assessment and evidence synthesis will conform to IWH guidelines focusing on developing practical guidelines for stakeholders . The result of this work will form the basis for industry-specific evidence -based recommendations on effective workplace-based interventions for rehabilitation of MSDs and its consequences that will later be operationalised into concrete and user-friendly practical tools for workplaces . Systematic review registration International Prospect i ve Register of Systematic Review s ( PROSPERO ) number CRD42018116752 Low quality clinical trials have a possibility to have errors in the process of deriving the results and therefore distort the study . Quality assessment of clinical trial is necessary in order to prevent any clinical application erroneous results is important . R and omized controlled trial ( RCT ) is a design for evaluate the effectiveness of medical procedure . This study was conducted by extracting the  RCTs from the original articles published in the Journal of Korean Medical Science ( JKMS ) from 1986 to 2011 and conducting a qualitative analysis using three types of analysis tools : Jadad scale , van Tulder scale and Cochrane Collaboration risk of bias Tool . To compare the quality of articles of JKMS , quality analysis of the RCTs published in Yonsei Medical Journal ( YMJ ) and Korean Journal of Internal Medicine was also conducted . In the JKMS , YMJ and Korean Journal of Internal Medicine , the quantitative increase of RCT presented over time was observed but no qualitative improvement of RCT was observed over time . From the results of this study , it is required for the research ers to plan for and perform higher quality studies AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 ) Background There are many barriers to patient participation in r and omised controlled trials of cancer treatments . To increase participation in trials , strategies need to be identified to overcome these barriers . Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in  r and omised controlled trials ( RCTs ) of cancer treatments . Methods A systematic review was conducted . Published and unpublished studies in any language were search ed for in fifteen electronic data bases , including MEDLINE , EMBASE , CINAHL and PsycINFO , from inception to the end of 2004 . Studies of any interventions to improve  cancer patient participation  in RCTs , which reported the change in recruitment rates , were eligible for inclusion . RCTs and non-r and omised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included . Data were extracted by one review er into structured summary tables and checked for accuracy by a second review er . Each included study was assessed against a checklist for method ological quality by one review er and checked by a second review er . A narrative synthesis was conducted . Results Eight studies were identified that met the inclusion criteria : three RCTs , two non-r and omised controlled trials and three observational studies . Six of the studies had an intervention that had some relevance to the UK . There was no robust evidence that any of the interventions investigated led to an increase in  cancer patient participation in RCTs , though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer . Although there was no evidence of an effect in any of the studies , the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work . Conclusion There is not a strong evidence -base for interventions that increase  cancer patient participation  in r and omised trials . Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials
Conclusions There is a dearth of evidence on the implementation of task-shifting strategies to reduce the burden of CVD in LMICs .
Objective To evaluate evidence from published r and omised controlled trials ( RCTs ) for the use of task-shifting strategies for cardiovascular disease ( CVD ) risk  reduction in low-income and middle-income countries ( LMICs ) .