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
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
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 .