A systematic review protocol examining the effect of vitamin D supplementation on endothelial function Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review Interventions to reduce dependency in personal activities of daily living in community-dwelling adults who use homecare services: protocol for a systematic review Erectile dysfunction as a predictor of cardiovascular events and death in diabetic patients with angiographically proven asymptomatic coronary artery disease: a potential protective role for statins and 5-phosphodiesterase inhibitors. Prevention of cervical cancer in HIV-seropositive women from developing countries: a systematic review protocol Can atorvastatin improve the response to sildenafil in men with erectile dysfunction not initially responsive to sildenafil? Hypothesis and pilot trial results. Efficacy of vitamin D supplementation in depression in adults: a systematic review protocol The Effectiveness of Psychosocial Interventions as Adjuncts to Orthopaedic Surgery: A Systematic Review Protocol Impact of clinical registries on quality of patient care and health outcomes: protocol for a systematic review Protocol for an overview of systematic reviews of interventions to reduce unscheduled hospital admissions among adults Effect of vitamin D supplementation on inflammation: protocol for a systematic review Effectiveness of workplace interventions in rehabilitating musculoskeletal disorders and preventing its consequences among workers with physical and sedentary employment: systematic review protocol Effectiveness of female condom in preventing HIV and sexually transmitted infections: a systematic review protocol Reducing patient delay with symptoms of acute coronary syndrome: a research protocol for a systematic review of previous interventions to investigate which behaviour change techniques are associated with effective interventions What are the most effective behaviour change techniques to promote physical activity and/or reduce sedentary behaviour in inactive adults? A systematic review protocol Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review Effects of statins vs. non-statin lipid-lowering therapy on bone formation and bone mineral density biomarkers in patients with hyperlipidemia. Interventions in sports settings to reduce alcohol consumption and alcohol-related harm: a systematic review protocol Dietetic guidelines: diet in secondary prevention of cardiovascular disease. Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol Protocol for a systematic review of the diagnostic and prognostic utility of tests currently available for the detection of aspirin resistance in patients with established cardiovascular or cerebrovascular disease Statins for Primary Prevention: The Debate Is Intense, but the Data Are Weak. Peripheral vascular disease and erectile dysfunction as predictors of mortality in heart failure patients.
Introduction Vitamin D has potential benefits for extraskeletal health . These could include an anti-inflammatory effect as well as a reduction in endothelial dysfunction . We aim to provide quality evidence for the hypothesis that supplementation with vitamin D will improve endothelial function ( EF ) , possibly through the abrogation of systemic inflammation . Methods and analysis We will conduct a systematic review of all r and omised controlled trials on  vitamin D supplementation and EF lasting 12 weeks or more . The search will cover the period 2000–2015 and include studies that describe direct measures of EF  , markers of endothelial cell ( EC ) activation  and if concurrently reported , indicators of systemic inflammation  . Study selection will follow the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines and study quality will be assessed by the Jadad score in addition to an evaluation of allocation concealment and data analysis . If sufficient data are available , a meta- analysis will be conducted . The effect sizes will be generated using Hedges ’ g score , for both fixed and r and om effect models . I2 statistics and Galbraith plots will be used to assess heterogeneity and identify their potential sources . Potential publication and small sample size bias will be assessed by visual inspections of funnel plots and also Egger 's test . Meta-regression analysis ( if feasible ) will be conducted with restricted maximum likelihood ( REML ) estimation method , controlling for potential confounders ( demographics , study methods , location , etc ) . A backward elimination process will be applied in the regression modelling procedure . Subgroup analysis , conditional on number of studies retrieved and their sample size , will be stratified on participant disease category , total dose administered , degree of 25(OH)D change and type of supplement used . Ethics and dissemination Formal ethical approval is not required as primary data will not be collected . The results will be disseminated through a peer- review ed publication , conference presentation and the popular press . Trial registration number International Prospect i ve Register for Systematic Review s ( PROSPERO ) number CRD42014013523 Background Diabetic retinopathy ( DR ) is a common microvascular complication of diabetes mellitus , and more than 75 % of patients who have had diabetes for more than 20 years will have some degree of DR . This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age . The current mainstay of treatment is laser photocoagulation , which causes impairment of vision and discomfort to patients . Thus , finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable . Objective To assess the efficacy and safety of the drugs in the statin and /or fibrate groups for the prevention and treatment of DR . Methods In this systematic review , we will select r and omized controlled trials of fibrates or statins used for the treatment or prevention of DR . Our search strategy will include free text terms and controlled vocabulary ( eg , MeSH , Emtree ) for , “ diabetic retinopathy ” , “ statins ” , “ fibrates ” , “ hypolipidemic agents ” , and for drugs from both groups . Data bases that will be used include Medical Literature Analysis and Retrieval System/ PubMed , Embase , Cochrane Central Register of Controlled Trials , Latin American and Caribbean Center on Health Sciences Information , Clinical trials.gov , World Health Organization International Clinical Trials Registry Platform , and OpenGrey , and we will not have language or date limits . Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration ’s tool . We will report structured summaries of the included studies and , if possible , conduct meta-analyses . Results This is a protocol for a systematic review , therefore results are not available . We registered a short version of this protocol before progressing in the review and we are currently in the process of selecting the studies for inclusion . Conclusions Intensive glucose control and lowering blood pressure and lipids are mechanisms that protect macrocirculation in diabetic patients . Both macrovascular and microvascular events in diabetic patients appear to have a common pathway , starting with endothelial injury . Thus , prevention and treatment of microvascular events may benefit from the same interventions . In the review for which we have written this protocol , we will assess whether the use of lipid-lowering oral drugs of the statin and /or fibrate groups may prevent and /or retard progression of DR , with the added benefit of preserving visual acuity . Trial Registration PROSPERO Background There is a growing dem and for services whereby individuals receive assistance from care workers for personal care within the home . This has led to the development of re-ablement or restorative homecare services that provide time-limited input aim ed at reducing dependency in personal activities of daily living , and preventing or delaying the need for further homecare support . However , little is currently known about how such interventions are configured , or how they may affect individuals ’ ability to carry out personal care independently . Methods / Design We will seek to identify studies that compare an intervention design ed to reduce dependency in personal activities of daily living with routine input or usual care as the control . We will include r and omised controlled trials , nonr and omised controlled trials , and controlled before and after studies . We will also include interrupted time series studies .We shall search electronic data bases in addition to search ing for ongoing and unpublished studies , and where appropriate will contact key authors . Two review ers will independently screen articles for inclusion ; will assess risk of bias using quality assessment tools ; and will carry out data extraction using pre-prepared forms . Any disagreements , at any stage , will be resolved by discussion and the involvement of a third review er if needed . We will produce a narrative summary of the results . A meta- analysis will be conducted if sufficient data are available of appropriate quality and comparability . Discussion The findings from this review will inform future practice within homecare re-ablement services ; will inform policy decisions about the structure , organisation and content of such services ; and will identify areas where further research is warranted . Systematic review registration This review protocol has been registered on the PROSPERO data base ( CRD42013004163 ) OBJECTIVES We sought to investigate whether erectile dysfunction ( ED ) is a predictor of future cardiovascular events and death in diabetic patients with silent coronary artery disease ( CAD ) and whether there are predictors of cardiovascular events and death among CAD diabetic patients with ED . BACKGROUND Case-control studies showed that ED is associated with CAD in diabetic patients , but no prospect i ve study is available . METHODS Type 2 diabetic men ( n = 291 ) with silent CAD angiographically documented were recruited .  Erectile dysfunction  was assessed by the International Index Erectile Function-5 question naire .  RESULTS During a follow-up period of 47.2 + /- 21.8 months ( range 4 to 82 months ) , 49 patients experienced major adverse cardiac events ( MACE ) . The difference in ED prevalence between patients with and those without MACE was significant ( 61.2 % vs. 36.4 % ; p = 0.001 ) . Cox regression analysis showed that ED predicted MACE ( hazard ratio [ HR ] 2.1 ; 95 % confidence interval [ CI ] 1.6 to 2.6 ; p < 0.001 ) . Among patients with CAD and ED , the Kaplan-Meier method showed that the statin ( Mantel log-rank test : 3.921 ; p = 0.048 ) and 5-phosphodiesterase ( 5-PDE ) inhibitor use ( Mantel log-rank test : 4.608 ; p = 0.032 ) were associated with a lower rate of MACE . Cox regression analysis showed that statin use ( HR 0.66 ; 95 % CI 0.46 to 0.97 ; p = 0.036 ) reduced MACE . Treatment with 5-PDE inhibitors did not enter the model , but its p value was very near to the significant level ( HR 0.68 ; 95 % CI 0.46 to 1.01 ; p = 0.056 ) . CONCLUSIONS Our data first show that ED is a powerful predictor of cardiovascular morbidity and mortality in diabetic patients with silent CAD and that the treatment with statins and 5-PDE inhibitors might reduce the occurrence of MACE among CAD diabetic patients with ED Background Over 85 % of cervical cancer cases and deaths occur in developing countries . HIV-seropositive women are more likely to develop precancerous lesions that lead to cervical cancer than HIV-negative women . However , the literature on cervical cancer prevention in seropositive women in developing countries has not been review ed . The aim of this study is to systematic ally review cervical cancer prevention modalities available for HIV-seropositive women in developing countries . Methods / design This protocol was developed by following the Preferred Reporting Items for Systematic Review s and Meta-Analyses Protocol s ( PRISMA -P ) statement , and the systematic review will be reported in accordance with the PRISMA guidelines . Embase , MEDLINE , PubMed , CINAHL and Cochrane Library will be search ed from inception up to date of final search , and additional studies will be located through citation and reference list tracking . Eligible studies will be r and omised controlled trials , prospect i ve and retrospective cohort studies , case-control and cross-sectional studies carried out in developing countries . Studies will be included if they are published in English and examine cervical cancer prevention modalities in HIV-seropositive women . Results will be summarised in tables and , where appropriate , combined using meta- analysis . Discussion This review will address the gap in evidence by systematic ally review ing the published literature on the different prevention modalities being used to prevent  cervical cancer in HIV-seropositive women in developing countries . The findings may be used to inform evidence -based guidelines for prevention of cervical cancer in seropositive women as well as future research . Systematic review registration PROSPERO CRD42017054678 BACKGROUND Erectile dysfunction ( ED ) may be one manifestation of a generalized vascular disorder characterized by endothelial dysfunction . Statin drugs may improve endothelial function , even before altering the lipid profile . OBJECTIVE We sought to determine whether the addition of a statin with sildenafil would improve ED in men who initially responded poorly to sildenafil .  METHODS Men with moderate-to-severe ED despite an adequate sildenafil trial were enrolled in this r and omized , double-blind , placebo-controlled pilot study . ED was defined using a vali date d self-administered question naire as a score of < or=16 on the International Index of Erectile Function ( erectile function domain score range of 6 - 30 ) . Improvement in ED score with sildenafil was reassessed at 6 and 12 weeks of treatment with atorvastatin ( 80 mg daily ) or matching placebo . RESULTS Twelve men ( mean age 58 + /- 13 years ) with a mean domain score of 8.2 + /- 6.9 and a mean duration of ED of 3.7 years were enrolled in the study . Treatment with atorvastatin decreased mean low-density lipoprotein cholesterol by 43 % and result ed in an improvement with  sildenafil in domain score of 7.8 ( P = 0.036 ) ; an effect was apparent by 6 weeks . The increase in domain score in placebo patients was not statistically significant . CONCLUSIONS Treatment with atorvastatin improved sexual function and the response to oral sildenafil  in men who did not initially respond to treatment with sildenafil .  The results of this pilot study support the hypothesis that vascular endothelial dysfunction contributes to ED in sildenafil nonresponders and deserves further testing in a large clinical trial Background The role of vitamin D in management of depression is unclear . Results from observational and emerging r and omized controlled trials ( RCTs ) investigating the efficacy of vitamin D in depression lack consistency - with some suggesting a positive association while others show a negative or inconclusive association . Methods / Design The primary aim of this study is to conduct a systematic review of RCTs to assess the effect of oral vitamin D supplementation versus placebo on depression symptoms measured by scales and the proportion of patients with symptomatic improvement according to the authors ’ original definition . Secondary aims include assessing the change in quality of life , adverse events and treatment discontinuation . We will conduct the systematic review and meta- analysis according to the recommendations of the Cochrane H and book for Systematic Review s of Interventions . We will search the Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE ( 1966 to present ) , EMBASE ( 1980 to present ) , CINAHL ( 1982 to present ) , PsychINFO ( 1967 to present ) and Clinical Trials.gov . Unpublished work will be identified by search ing two major conferences : the International Vitamin Conference , the Anxiety Disorders and Depression Conference , while grey literature will be acquired by contacting authors of included studies . We will use the r and om-effects meta- analysis to synthesize the data by pooling the results of included studies . Discussion The results of this systematic review will be helpful in clarifying the efficacy of vitamin D supplementation and providing evidence to establish guidelines for implementation of vitamin D for depression in general practice and other relevant setting s. Study registration Unique identifier : CRD42013003849 AIMS Pain and anxiety are commonly reported among those undergoing orthopaedic surgery . Improvement in anxiety and pain control might be achieved by supplementing st and ard care with psychological interventions . However , the effectiveness of adjunctive psychosocial interventions in anxiety and pain control have not been addressed sufficiently by previous systematic review s in orthopaedic surgeries . The present study aim ed to assess the effectiveness of adjunctive psychosocial techniques to improve perioperative clinical care in orthopaedic surgery , to identify the most effective intervention types and to evaluate potential moderators . METHODS We will perform a systematic review and meta- analysis to address the study aims . PubMed , PsycINFO , CINAHL and ProQuest Dissertations & Theses will be search ed between 1980 and 2015 . Prospect i ve controlled clinical trials completed in adults , contrasting st and ard care and st and ard care supplemented with psychosocial methods  , will be eligible for inclusion . Effectiveness will be assessed through the outcomes of postoperative pain intensity , analgesic requirement , perioperative anxiety , quality of life and postoperative recovery . The results of a r and om-effect meta- analysis will be reported . To aid implementation of best practice , moderating effects of the type and timing of psychosocial intervention , type of surgical intervention and type of anaesthesia will be evaluated through meta-regression . Sensitivity analyses and subgroup contrasts will follow as necessary . DISCUSSION Recommendations will be made to improve medical care in orthopaedic procedures . The quality of evidence will be rated using GRADE criteria . Copyright © 2016 John Wiley & Sons , Introduction Many developed countries have regional and national clinical registries aim ed at improving health outcomes of patients diagnosed with particular diseases or cared for in particular healthcare setting s.  Clinical quality registries ( CQRs ) are clinical registries established with the purpose of monitoring quality of care and providing feedback to improve health outcomes . The aim of this systematic review is to underst and the impact of CQRs on ( 1 ) mortality/survival ; ( 2 ) measures of outcome that reflect a process or outcome of healthcare ; ( 3 ) healthcare utilisation and ( 4 ) costs . Methods and analysis The PRISMA -P methodology , checklist and st and ard strategy using predefined inclusion and exclusion criteria and structured data abstract ion tools will be followed . A search of the electronic data bases MEDLINE , EMBASE , Cochrane Central Register of Controlled Trials ( CENTRAL ) and CINAHL will be undertaken , in addition to Google Scholar and grey literature , to identify studies in English covering the period January 1980 to December 2014 . Case – control , cohort , r and omised controlled trials and controlled clinical trials which describe the registry as an intervention will be eligible for inclusion . Narrative synthesis of study findings will be conducted , guided by a conceptual framework developed to analyse the outcome measure of the registry using defined criteria . If sufficient studies are identified with a similar outcome of interest and measure using the same comparator and time of interval , results will be pooled for r and om-effects meta- analysis . Test for heterogeneity and sensitivity analysis will be conducted . To identify reporting bias , forest plots and funnel plots will be created and , if required , Egger 's test will be conducted . Ethics and dissemination Ethical approval is not required as primary data will not be collected . Review results will be published as a part of thesis , peer- review ed journal and conferences . Trial registration number CRD42015017319 Introduction Unscheduled hospital admissions are an increasing burden on health systems worldwide . To date , initiatives to reduce admissions have had limited success as it is unclear which strategies effectively reduce admissions and are supported by a strong evidence -base . Therefore , we will conduct an overview to find , assess and summarise all published peer- review ed systematic review s of r and omised controlled trials that examine the effect of an intervention on  unplanned admissions among adults . Methods and analysis This is a protocol for a systematic overview of review s. We will search four data bases : Ovid MEDLINE , PubMed , Cochrane Data base of Systematic Review s and the Cochrane Data base of Abstract s of Review s of Effects . We will consider systematic review s and meta-analyses of r and omised controlled trials in adults ( ≥16 years old ) evaluating the effect of any intervention on unscheduled hospital admissions including those to treat , monitor , diagnose or prevent a health problem . We will only include review s that identified unscheduled hospitalisations as a prespecified outcome . Two authors will independently screen articles for inclusion using a priori criteria . We will assess the quality of included review s and extract ratings of the quality of evidence from within each review . We will create a hierarchical list of interventions based on estimates of absolute admission reductions and the quality of the evidence . Presentation of results will align with guidelines in the Cochrane H and book of Systematic Review s of Interventions and the Preferred Reporting Items for Systematic Review s and Meta- Analysis statement . Ethics and dissemination Ethics approval is not required . We will su bmi t the results of this study for peer- review publication . The results will inform future research and could be used by healthcare managers , administrators and policymakers to guide re source allocation decisions and inform local implementation and optimisation of interventions to reduce unscheduled hospital admissions Introduction The extraskeletal role of vitamin D is being increasingly recognised . This has important clinical implication s , as vitamin D deficiency has reached epidemic proportions worldwide . Vitamin D has proposed anti-inflammatory properties , yet the role of vitamin D supplementation in reducing inflammation remains largely unknown . The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation , and to identify relevant knowledge gaps in the field . Methods and analysis Medline , CINAHL , EMBASE and All EBM will be systematic ally search ed for r and omised controlled trials ( RCTs ) and systematic review s of RCTs , comparing vitamin D supplementation with placebo , usual care or other pharmacological or non-pharmacological interventions . One review er will assess articles for eligibility according to prespecified selection criteria , after which 2 independent review ers will perform data extraction and quality appraisal . Meta-analyses will be conducted where appropriate . Ethics and dissemination Formal ethical approval is not required as no primary data is collected . This systematic review will identify potential clinical implication s of vitamin D deficiency and supplementation , and will be disseminated through a peer- review ed publication and at conference meetings , to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases . PROSPERO registration number CRD42016037104 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 Introduction The HIV p and emic continues to evolve with young women being the most vulnerable group to acquire infection . The presence of sexually transmitted infections ( STIs ) further enhances HIV susceptibility and also leads to long-term complications such as infertility and cervical cancer . The female condom is a self-initiated method for STI and HIV prevention but there are controversies on its effects . We aim to assess the effectiveness , safety and acceptability of the use of female condoms for prevention of STI and HIV acquisition among women . Methods and analysis We will search Cochrane Central Register of Controlled Trials , PubMed , EMBASE , Scopus , WHO International Clinical Trials Registry and reference lists of relevant publications for potentially eligible studies . We will screen search outputs , select eligible studies , extract data and assess risk of bias in duplicate ; resolving discrepancies through discussion and consensus or arbitration . We will combine data from clinical ly homogenous studies in a fixed effect meta- analysis and assess the certainty of the evidence using the method for Grading of Recommendations Assessment , Development and Evaluation . We registered the planned systematic review with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) in March 2018 and will finalise the search strategy in August 2018 ; conduct the search es and select eligible studies between August and October 2018 ; and collect data , conduct statistical analyses and prepare and su bmi t the manuscript for consideration by a peer- review ed journal between November 2018 and April 2019 . Ethics and dissemination We will use publicly available data ; hence no formal ethical approval is required for this review . We will disseminate the findings of this review through conference presentations and publication in an open-access peer- review ed journal . PROSPERO registration number CRD42018090710 Introduction Delay to presentation with symptoms of acute coronary syndrome ( ACS ) is common meaning many fail to achieve optimal benefit from treatments . Interventions have had variable success in reducing delay . Evidence suggests inclusion of behaviour change techniques ( BCTs ) may improve effectiveness of interventions but this has not yet been systematic ally evaluated . Data from other time-critical conditions may be relevant . Methods and analysis A systematic review will be undertaken to identify which BCTs are associated with effective interventions to reduce patient delay ( or prompt rapid help-seeking ) among people with time-critical conditions ( eg , chest pain , ACS , lumps , stroke , cancer and meningitis ) . A systematic search of a wide range of data bases ( including Cochrane Library , MEDLINE , EMBASE , CINAHL , PsycInfo ) and grey literature will be undertaken to identify all relevant intervention studies ( r and omised controlled trials , controlled clinical trials and cohort studies ) . Two independent review ers will screen abstract s to identify relevant studies , apply inclusion criteria to full papers , assess method ological quality and extract data . Primary outcome measure Change in patient decision time BCTs reported in each of the included studies will be categorised and presented according to the latest reliable taxonomy . Results of included studies will be synthesis ed , exploring relationships between inclusion of each BCT and effectiveness of the overall intervention . Where possible , means and SDs for differences in delay time will be calculated and combined within meta-analyses to derive a st and ardised mean difference and 95 % CI . Analysis of ( 1 ) all time-critical and ( 2 ) ACS-only interventions will be undertaken . Ethics and dissemination No ethical issues are anticipated . Results will be su bmi tted for publication in a relevant peer- review ed journal Introduction Large proportions of the population are not meeting recommended levels of physical activity and have increasingly sedentary lifestyles . Low levels of physical activity are predictive of poor health outcomes and time spent sedentary is related to a host of risk factors independently of physical activity levels . Building an evidence base of the best approaches to intervene in the lifestyles of inactive individuals is crucial in preventing long-term disease , disability and higher mortality rates . Methods and analysis Systematic search es will be conducted on all relevant data bases ( eg , PubMed , Scopus , CINAHL , PsycINFO ) . Studies will be included if they assess interventions aim ed at changing physical activity or sedentary behaviour levels in adults ( over 18 ) who are inactive and do not suffer from chronic conditions . Studies must also be r and omised controlled trials ( RCTs ) , have a primary outcome of physical activity or sedentary behaviour , and measure outcomes at least 6 months after intervention completion . Studies will be coded using the Behaviour Change Technique ( BCT ) taxonomy v1 and Template for Intervention Description and Replication ( TIDieR ) guidelines . 2 review ers will independently screen full-text articles and extract data on study characteristics , participants , BCTs , intervention features and outcome measures . Study quality will also be assessed independently by 2 review ers using the Cochrane risk of bias tool . A meta- analysis will be considered if there is sufficient homogeneity across outcomes . GRADE criteria will be used to assess quality of evidence . Dissemination This will be the first review to systematic ally appraise interventions aim ed at changing the physical activity or sedentary behaviour of inactive individuals using RCT design s with a 6-month follow-up post-intervention . This review will better inform intervention design ers targeting inactive population s and inform the design of a future complex intervention . Review registration number This protocol was registered with the International Prospect i ve Register of Systematic Review s ( PROSPERO ) on 17 October 2014 ( registration number : CRD42014014321 ) Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 INTRODUCTION The 3-hydroxy-3-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitors , named statins , are well-established cholesterol-lowering drugs able to reduce cardiovascular risk in hypercholesterolemic patients . The possible effect of statin on bone tissue , so-called pleiotropic effects has received particular attention . Studies reported a positive effect of statin on bone tissue in both of animal and human study by enhancing the expression of the bone morphogenetic proteins ( BMPs ) , in particular of BMP2 , which in turn leads to osteoblast differentiation and bone formation including interfering with osteoclastic activity . In a systematic review , the lipophilic statin as simvastatin had positive effect to bone mineral density ( BMD ) better than the more hydrophilic statin such as atorvastatin and fluvastatin . This study was aim ed to compare efficacy of medical therapy between HMG-CoA reductase inhibitor and non-HMG-CoA reductase inhibitor group to changing of bone mineral density and bone markers in the patients with hyperlipidemia . MATERIAL S AND METHODS A prospect i ve r and omized control trial study enrolled the 212 hyperlipidemia with osteopenia patients to study in year 2006 - 2008 . All subjects were r and omized to 2 groups between  statin and non-statin group ; the patients were screened by inclusion criteria and measured in bone mineral density ( BMD ) , bone marker and blood chemistry . All data were analyzed by difference of changing in bone marker and BMD between statin and non-statin groups using paired t test . RESULTS The present study showed 212 hyperlipidemia with osteopenia patients of which 106 patients in statin group had mean age ( 63.17+/-9.51 years ) and the same number of patients in non-statin group had mean age ( 60.96+/-8.9 years ) . All subjects were 63 patients in male and 149 patients in female . Difference of bone formation marker and BMD between after and before was significantly higher than in statin group and the difference of bone resorption marker was also significantly lower than in statin group . CONCLUSION The lipophilic statin as moderate to high dose of simvastatin had beneficial positive effect to increasing BMD and could be additive use for prevention of bone loss in hyperlipidemia patients Introduction Alcohol consumption is a primary cause of physical , psychological and social harm to both the user and others . At both the professional and non-professional level , sports players and fans report consuming alcohol at greater levels than people not involved in sports . Limited systematic review s have been conducted assessing interventions targeting alcohol consumption behaviour and related harms in the sporting context . Methods and analysis The review aims to determine if interventions implemented in the sport setting decrease alcohol consumption and related harms .  Participants may include all persons regardless of age or other characteristics . Studies will be included which have implemented interventions within the sport setting and have either measured : alcohol consumption , excessive alcohol consumption or intoxication or alcohol-related injury or violence . R and omised controlled trials , staggered enrolment trials , stepped-wedged trials , quasi-r and omised trials , quasi-experimental trials and natural experiments will be included . Studies without a parallel comparison group will be excluded . Data will be source d from a range of electronic data bases and sources of grey literature . Two authors will independently screen all titles and abstract s of papers identified through the search strategy . Two authors will independently examine the full text of all remaining papers to determine eligibility . Two authors will independently extract data from eligible studies and independently assess risk of bias by assessing the adequacy of study characteristics . Where studies are sufficiently homogeneous , trial results will be synthesis ed using a fixed-effects meta- analysis . St and ardised mean differences will be used for continuous outcomes and RRs will be used for binary outcomes . Dissemination The findings of this study will be disseminated widely through mechanisms including peer- review ed publications and conference presentations AIM To produce dietetic guidelines summarizing the systematic review evidence on dietary advice for secondary prevention of cardiovascular disease . METHODS The Cochrane Library , MEDLINE and EMBASE were comprehensively search ed for systematic review s on aspects of diet and heart health . Review s were included if they search ed systematic ally for r and omised controlled trials relating to diet and secondary prevention of cardiovascular disease . Two members of the UK Heart Health and Thoracic Dietitians Group critically appraised each review . The quality and results of each review were discussed and summarized in a whole group meeting . The guidelines were trialled in seven dietetic departments and modified where necessary . RESULTS Providing evidence -based dietary information ( including increasing omega-3 fat plus fruit and vegetable intake ) to all people after myocardial infa rct ion will save more lives than concentrating dietary advice on those in need of weight loss or lipid lowering . The practice of prioritizing dietetic time to those with raised lipids is out of date since the advent of statin therapy . CONCLUSION There is good systematic review evidence that dietary advice to those with cardiovascular disease can reduce mortality and morbidity as well as modify risk factors .  Dietary advice that does this most effectively should be prioritized Introduction Hearing loss is a major public health concern , affecting over 11 million people in the UK . While hearing aids are the most common clinical intervention for hearing loss , the majority of people that would benefit from using hearing aids do not take them up . Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids . These include hearing aids that can be customised using a smartphone , smartphone-based ‘ hearing aid ’ apps , personal sound amplification products and wireless hearing products . However , no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss . Methods and analysis The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss . Methods are reported according to the Preferred Reporting Items for Systematic review s and Meta-analyses Protocol s ( PRISMA -P ) 2015 checklist . Retrospective or prospect i ve studies , r and omised controlled trials , non-r and omised controlled trials , and before-after comparison studies will be eligible for inclusion . We will include studies with adult participants ( ≥18 years ) with a mild or moderate hearing loss . The intervention should be an alternative listening device to a conventional hearing aid ( comparison ) . Studies will be restricted to outcomes associated with the consequences of hearing loss . We will search relevant data bases to identify published , completed but unpublished and ongoing trials . The overall quality of included evidence will be evaluated using the GRADE system , and meta- analysis performed if appropriate . Ethics and dissemination No ethical issues are foreseen . The findings will be reported at national and international conferences , primarily audiology , and ear , nose and throat , and in a peer- review ed journal using the PRISMA guidelines . Review registration number PROSPERO CRD4201502958 Background The benefits of aspirin as an anti-platelet agent are well established ; however , there has been much debate about the lack of uniformity in the efficacy of aspirin to inhibit platelet function . In some patients , aspirin fails to inhibit platelets even where compliance has been verified , a phenomenon which has been termed “ aspirin resistance ” . These patients may in turn be at a higher risk of future vascular events . The proportion of “ resistant ” patients identified depends on the type of platelet function test . Therefore , the aim of this systematic review is to determine which , if any , platelet function test has utility in terms of identifying patients with a high risk of vascular events . The review has been registered with PROSPERO ( CRD42012002151 ) . Methods Relevant studies will be sought from bibliographic data bases . Trials registers will be search ed for ongoing studies . Reference lists will be checked and subject experts contacted . There will be no date or language restrictions . St and ard review ing methodology to minimise bias will be employed . Any prospect i ve studies in patients on aspirin therapy and assessing platelet function in relation to relevant clinical outcomes will be included , as will studies reporting prognostic models . Risk of bias assessment will be based on the Quality Assessment of Diagnostic Accuracy Studies guidelines , and suitable criteria for assessing quality of prognostic studies . Data on test accuracy measures , relative risks , odds or hazard ratios will be extracted and meta-analysed , where possible , using a r and om-effects model to account for between- study heterogeneity . Where appropriate , the causes of heterogeneity will be explored through meta-regression and sub-group or sensitivity analyses . If platelet function testing is demonstrated to have diagnostic/predictive utility in a specific population , the potential for a cost-effectiveness analysis will be considered and , if possible , an economic model constructed . This will be supported by a systematic review of existing economic evaluation studies . Discussion The results of the review could indicate if platelet function test(s ) could lead to a reliable prediction of the risk of clinical ly important events in a defined population , and thus support investigations into adjustments to therapy in order to compensate for a predicted poor response to st and ard aspirin This issue of JAMA contains the latest US Preventive Services Task Force ( USPSTF ) recommendation statement on statins for prevention of cardiovascular disease in adults,1 along with the accompanying evidence report and systematic review 2 on which the recommendations are based . The evidence report summarized data from 19 trials including a total of 71 344 patients and concluded that statin therapy was associated with reduced risk of all-cause and cardiovascular mortality and cardiovascular disease ( CVD ) events . Thus , the task force recommended “ initiating use of lowto moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 10 % or greater ( B recommendation ) ” or “ 7.5 % to 10 % ( C recommendation ) .”1 Although the task force did their usual careful job of review ing the evidence , the evidence for treating asymptomatic persons with statins does not appear to merit a grade B or even a grade C recommendation . The task force evidence report estimated an absolute benefit for use of statins of 0.40 % for all-cause mortality and 0.43 % for cardiovascular mortality and indicated that the absolute benefit was greater for patients at greater baseline risk.2 Notably , the evidence report did not exclude studies that included patients taking statins for secondary prevention , who have a higher baseline risk of cardiac events and death and thus are more likely to benefit from therapy that inflates the benefit attributed to a primary prevention population . The task force did perform a sensitivity analysis that excluded 3 trials with persons for whom there were prior “ hard ” cardiovascular events and obtained similar results of benefits ( eTable 5 in the article by Chou et al2 ) . This sensitivity analysis did not exclude WOSCOPS , which included patients receiving statins for secondary prevention—5 % had angina and 3 % had intermittent claudication,3 accounting for 15 % of the total weight in the meta- analysis . In contrast , a meta- analysis of 11 studies and 65 229 patients receiving statins for primary prevention , in which patients receiving statins for secondary prevention were excluded , found no benefit of statins for reducing all-cause mortality.4 The confidence intervals of these 2 analyses overlap , and the difference between these findings likely reflects differences in studies included . The USPSTF and authors of the evidence report did not have access to the primary data ( clinical study reports and anonymized patient-level data ) from the statin clinical trials . Rather , they had to rely on peer- review ed published reports as the basis for these recommendations . Exacerbating the potential bias , all of the trials included in the task force evidence report2 were industry-sponsored except 1 trial,5 and that trial contributed 0.2 % of the weight to the mortality calculation . Industry-sponsored studies have been shown to report greater benefit and lesser adverse effects than noncommercially sponsored trials of the same drugs.6 Whether this is true for statins and primary prevention of CVD is unknown . Among the 19 r and omized clinical trials of statins vs placebo or no statin included in the evidence report for the task force recommendations , only 15 reported all-cause mortality , 10 reported cardiovascular mortality , 12 reported fatal and nonfatal myocardial infa rct ion  , and 13 reported fatal and nonfatal stroke.2,7  Reliance on selective reporting of the most important outcomes , which are likely included in the clinical trial data , makes reporting bias possible . Furthermore , after allcause mortality , the comparative incidence of serious adverse events between treatment and control groups is arguably the second most important measure of the effect of active therapy in r and omized clinical trials . Underst and ing the evidence base in evaluating harms of statin therapy is also critically important . Although the benefits of any preventive therapy accrue according to risk of disease ( greater benefit in higher-risk patients ) , the harms of therapy usually distribute equally over all risk levels . Thus , persons at low risk have little chance of benefit but equal chance of harms and thus are more likely to have a net harm . The evidence base for harms of statins , despite the introduction of these drugs more than 20 years ago , is incomplete . Many of the trials did not ask about commonly reported statin effects , such as muscle pains and weakness , and only recorded myopathy , for which an increase in creatine kinase levels was required . Because most muscle problems do not involve an increase in creatine kinase levels , this leads to a significant underestimate of muscle problems . Other studies have estimated that closer to 20 % of statin users have muscle problems.8 Additionally , the actual trial data are largely held by the Cholesterol Treatment Trialists ’ Collaboration on behalf of the industry sponsor and have not been made available to other research ers , despite multiple requests over many years.9 Although reported rates of adverse events in clinical trials are low , this does not reflect the experience of clinicians who see patients who are taking statins . For instance , the experience of an NPR reporter with a calculated 2.9 % risk of heart disease over 10 years using the recommended American College of Cardiology/American Heart Association ( ACC/AHA ) risk calculator,10 but still prescribed a statin , and experiencing adverse effects from the medication , is typical of what many Related articles at jama.com INTRODUCTION Seventy percent to 90 % of patients with heart failure ( HF ) report erectile problems . There are no published data on whether erectile dysfunction ( ED ) and peripheral vascular disease ( PVD ) correlate with mortality in HF patients . Also , little is known regarding the impact of HF etiology on mortality in patients with ED . AIMS Our aim was to investigate the relationship between ED and mortality in HF patients , to evaluate whether the etiology of HF carries a prognostic measure in patients with ED , and to assess the impact of PVD on mortality in optimally treated HF patients with ED . MAIN OUTCOME MEASURES The measures are : ( i ) mortality by presence or absence of ED ; ( ii ) mortality by HF etiology and presence or absence of ED ; and ( iii ) PVD and mortality in HF patients on optimal medical therapy with ED . METHODS This is a single-center , prospect i ve cohort study of 328 male HF patients ( ejection fraction < or = 40 % ) followed while being treated with optimal doses of beta blockers and angiotensin-converting enzyme inhibitors .  The  Sexual Health Inventory for Men survey  was used to assess ED ( no ED > or = 22 and ED < or = 21 ) . Ankle brachial index ( ABI ) was used to assess PVD ( normal ABI > or = 0.9 and abnormal ABI < 0.9 ) . RESULTS Kaplan-Meier curves were constructed to examine the relationship between the presence or absence of ED and PVD , and mortality in a HF population . Although not statistically significant , a trend for increased risk of death was demonstrated in the ischemic cardiomyopathy cohort with ED . CONCLUSIONS ED , highly prevalent in this cohort , did not identify HF patients on optimal medical therapy at increased risk for mortality . Among the HF patients with ED , HF type was not associated with increased risk for mortality whereas PVD was independently associated with a statistically significant increase in mortality
RESULTS For the comparison of statins ( + /- sildenafil ) with placebo ( + /- sildenafil ) , the mean International Index of Erectile Function ( IIEF-5 ) ( the st and ardized mean difference [ SMD ] = 3.23 , 95 % confidence interval [ CI ] = -1.65 to 4.80 , P < 0.0001 ) indicated that statins ( + /- sildenafil ) showed statistically significantly greater improvements in the mean IIEF-5 compared with placebo ( + /- sildenafil ) .
For the comparison of statins plus sildenafil with placebo plus sildenafil , the mean IIEF-5 ( SMD = 3.60 , 95 % CI = 2.64 to 4.56 , P < 0.00001 ) , the IIEF domain ( SMD = 4.88 , 95%CI = 3.01 to 6.74 , P < 0.00001 ) , and the global efficacy question ( odds ratio = 6.44 , 95 % CI = 2.92 to 14.23 , P < 0.00001 ) showed that compared with placebo plus sildenafil , statins plus sildenafil clearly improved erectile function .
CONCLUSIONS This meta- analysis indicates that statins ( + /- sildenafil ) may improve ED compared with placebo ( + /- sildenafil )
INTRODUCTION It is not known if statins will improve symptoms in patients with established erectile dysfunction ( ED ) .
AIM We carried out a systematic review and meta- analysis to assess the effect of statins on ED .