scholarly journals Efficacy and safety of aliskiren combination therapy: a protocol for an umbrella review

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043807
Author(s):  
Jiantong Shen ◽  
Wenming Feng ◽  
Yike Wang ◽  
Qiyuan Zhao ◽  
Billong Laura Flavorta ◽  
...  

IntroductionEfficacy of aliskiren combination therapy with other antihypertensive has been evaluated in the treatment of patients with hypertension in recent systematic reviews. However, most previous reviews only focused on one single health outcome or one setting, none of them made a full summary that assessed the impact of aliskiren combination treatment comprehensively. As such, this umbrella review based on systematic reviews and meta-analyses is aimed to synthesise the evidences on efficacy, safety and tolerability of aliskiren-based therapy for hypertension and related comorbid patients.Methods and analysisA comprehensive search of PubMed, EMBASE, Cochrane Library, CNKI published from inception to August 2020 will be conducted. The selected articles are systematic reviews which evaluated efficacy, safety and tolerability of aliskiren combination therapy. Two reviewers will screen eligible articles, extract data and evaluate quality independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the Assessment of Multiple Systematic Reviews V.2 tool tool. We will take a mixed-methods approach to synthesising the review literatures, reporting summary of findings tables and iteratively mapping the results.Ethics and disseminationEthical approval is not required for the study, as we would only collect data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.PROSPERO registration numberCRD42020192131.

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e033448
Author(s):  
Qiyuan Zhao ◽  
Jiantong Shen ◽  
Jingya Lu ◽  
Fan Li ◽  
Qi Jiang ◽  
...  

IntroductionAliskiren is a newly developed medicine. As one of the effective renin–angiotensin–aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy.Methods and analysisA comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger’s test to evaluate if the reporting bias existed.Ethics and disseminationEthical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.PROSPERO registration numberCRD42019142141.


BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e035287
Author(s):  
Min Chen ◽  
Tai-Chun Tang ◽  
Tao-Hong He ◽  
Yong-Jun Du ◽  
Di Qin ◽  
...  

IntroductionThe prevalence of haemorrhoidal diseases was high in general population, and many treatments are proposed for the management of haemorrhoids. The treatments include conservative and surgical interventions; the credibility and strength of current evidence of their effectiveness are not comprehensively evaluated. We aim to evaluate the credibility of systematic reviews and meta-analyses that assess the effectiveness of the treatments for haemorrhoidal diseases through an umbrella review.Methods and analysisWe will search Ovid Medline, Embase, Cochrane library and Web of Science from inception to March 2020 without any language restriction. We will include meta-analyses that examine the effectiveness of treatments in the management of haemorrhoids. Two reviewers will independently screen the titles and abstracts of retrieved articles, and they will extract data from the included meta-analyses. For each meta-analysis, we will estimate the effect size of a treatment through the random-effect model and the fixed-effect model, and we will evaluate between-study heterogeneity (Cochrane’s Q and I2statistics) and small-study effect (Egger’s test); we will also estimate the evidence of excess significance bias. Evidence of each treatment will be graded according to prespecified criteria. Methodological quality of each meta-analysis will be evaluated by using Assessment of Multiple Systematic Reviews 2. The corrected cover area method will be used to assess the impact of overlap in reviews on the findings of the umbrella review.Ethics and disseminationWe will present the results of the umbrella review at conferences and publish the final report in a peer-reviewed journal. The umbrella review does not require ethical approval.PROSPERO registration numberCRD42019140702.


2021 ◽  
Author(s):  
Xu Tian ◽  
Yan-Fei Jin ◽  
Zhao-Li Zhang ◽  
Hui Chen ◽  
Wei-Qing Chen ◽  
...  

Abstract Background: Enteral immunonutrition (EIN) has been extensively applied in cancer patients, however its role in esophageal cancer (EC) patients receiving esophagectomy remains unclear. We performed this network meta-analysis to investigate the impact of EIN on patients undergoing surgery for EC and further determine the optimal time of applying EIN.Methods: We searched PubMed, EMBASE, Cochrane library, and China National Knowledgement Infrastructure (CNKI) to identify eligible studies. Categorical data was expressed as the odds ratio with 95% confidence interval (CI), and continuous data was expressed as mean difference (MD) with 95% CI. Pair-wise and network meta-analysis was performed to evaluate the impact of EIN on clinical outcomes using RevMan 5.3 and ADDIS V.1.16.8 softwares. The surface under the cumulative ranking curve (SUCRA) was calculated to rank all nutritional regimes.Results: Total 14 studies involving 1071 patients were included. Pair-wise meta-analysis indicated no difference between EIN regardless of the application time and standard EN (SEN), however subgroup analyses found that postoperative EIN was associated with decreased incidence of total infectious complications (OR=0.47; 95%CI=0.26 to 0.84; p=0.01) and pneumonia (OR=0.47; 95%CI=0.25 to 0.90; p=0.02) and shortened LOH (MD=-1.01; 95%CI=-1.44 to -0.57; p<0.001) compared to SEN, which were all supported by network meta-analyses. Ranking probability analysis further indicated that postoperative EIN has the highest probability of being the optimal option in terms of these three outcomes.Conclusions: Postoperative EIN should be preferentially utilized in EC patients undergoing esophagectomy because it has optimal potential of decreasing the risk of total infectious complications and pneumonia and shortening LOH.OSF registration number: 10.17605/OSF.IO/KJ9UY.


Author(s):  
Alexandro Andrade ◽  
Thais Cristina Siqueira ◽  
Anderson D’Oliveira ◽  
Fábio Hech Dominski

The authors aimed to provide an overview of the evidence on the effects of exercise in people with Alzheimer’s disease through a comprehensive review of the existing systematic reviews and meta-analyses. A literature search was performed in CINAHL, Cochrane Library, EMBASE, PubMed, SPORTDiscus, Scopus, and Web of Science databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The AMSTAR-2-Tool was used for the quality assessment. Twenty-three reviews fulfilled the criteria. Most of the reviews investigated the effects of aerobic exercise on Alzheimer’s disease symptoms. The largest effects of exercise were seen in terms of improved cognition by multiple exercises. The majority of the reviews were rated as being of moderate quality and none were classified as having high quality. Exercise is an effective way to treat Alzheimer’s disease symptoms and has a low incidence of related adverse events. As most reviews were evaluated as low-moderate quality, caution is needed in the interpretation of the results.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
T. Paolucci ◽  
S. Sbardella ◽  
C. La Russa ◽  
F. Agostini ◽  
M. Mangone ◽  
...  

Parkinson disease (PD) is a chronic neurodegenerative condition that leads to progressive disability. PD-related reductions in muscle strength have been reported to be associated with lower functional performance and balance confidence with an increased risk of falls. Progressive resistance training (PRT) improves strength, balance, and functional abilities. This umbrella review examines the efficacy of PRT regarding muscular strength in PD patients. The PubMed, PEDro, Scopus, and Cochrane Library databases were searched from January 2009 to August 2019 for systematic reviews and meta-analyses conducted in English. The populations included had diagnoses of PD and consisted of males and females aged >18 years old. Outcomes measured were muscle strength and enhanced physical function. Eight papers (six systematic reviews and meta-analyses and two systematic reviews) were considered relevant for qualitative analysis. In six of the eight studies, the reported severity of PD was mild to moderate. Each study analyzed how PRT elicited positive effects on muscle strength in PD patients, suggesting 10 weeks on average of progressive resistance exercises for the upper and lower limbs two to three times per week. However, none of the studies considered the postworkout follow-up, and there was no detailed evidence about the value of PRT in preventing falls. The possibility of PRT exercises being effective for increasing muscle strength in patients with PD, but without comorbidities or severe disability, is discussed. Overall, this review suggests that PRT should be included in rehabilitation programs for PD patients, in combination with balance training for postural control and other types of exercise, in order to preserve cardiorespiratory fitness and improve endurance in daily life activities.


BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e031951
Author(s):  
Liqun Li ◽  
Jinjing Tan ◽  
Lijian Liu ◽  
Jianfeng Li ◽  
Guangwen Chen ◽  
...  

ObjectiveSystematic reviews and meta-analyses have revealed the associations betweenH. pyloriinfection and various health outcomes. We aimed to evaluate the strength and breadth of evidence on the associations.DesignUmbrella review of systematic reviews and meta-analyses.SettingNo settings.ParticipantsNo patients involved.Data sourcesEmbase, PubMed, Web of Science, Cochrane Library Databases, CNKI, VIP database and Wangfang database from inception to February 1, 2019.Outcomes measuresDiverse diseases (such as cancer and ischaemic heart disease).ResultsSixty articles reporting 88 unique outcomes met the eligible criteria. 74 unique outcomes had nominal significance (p<0.05). Of the outcomes with significance, 61 had harmful associations and 13 had beneficial associations. Furthermore, 73% (64) of the outcomes exhibited significant heterogeneity . Of the these meta-analyses, 32 had moderate to high heterogeneity (I2=50%–75%) and 24 had high heterogeneity (I2>75%). Moreover, 20% exhibited publication bias (p<0.1). In addition, 97% of the methodological qualities were rated ‘critically low’. 36% of the evidence qualities of outcomes were rated ‘low’, 56% of the evidence qualities were rated ‘very low’ and 8% of the evidence qualities were rated ‘moderate’.H. pyloriinfection may be associated with an increased risk of five diseases and a decreased risk of irritable bowel syndrome.ConclusionAlthough 60 meta-analyses explored 88 unique outcomes, moderate quality evidence only existed for six outcomes with statistical significance.H. pyloriinfection may be associated with a decreased risk of irritable bowel syndrome and an increased risk of hypertriglyceridemia, chronic cholecystitis and cholelithiasis, gestational diabetes mellitus, gastric cancer and systemic sclerosis.Trial registrationCRD42019124680.


10.2196/16791 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e16791 ◽  
Author(s):  
Patrick Timpel ◽  
Sarah Oswald ◽  
Peter E H Schwarz ◽  
Lorenz Harst

Background Telemedicine is defined by three characteristics: (1) using information and communication technologies, (2) covering a geographical distance, and (3) involving professionals who deliver care directly to a patient or a group of patients. It is said to improve chronic care management and self-management in patients with chronic diseases. However, currently available guidelines for the care of patients with diabetes, hypertension, or dyslipidemia do not include evidence-based guidance on which components of telemedicine are most effective for which patient populations. Objective The primary aim of this study was to identify, synthesize, and critically appraise evidence on the effectiveness of telemedicine solutions and their components on clinical outcomes in patients with diabetes, hypertension, or dyslipidemia. Methods We conducted an umbrella review of high-level evidence, including systematic reviews and meta-analyses of randomized controlled trials. On the basis of predefined eligibility criteria, extensive automated and manual searches of the databases PubMed, EMBASE, and Cochrane Library were conducted. Two authors independently screened the studies, extracted data, and carried out the quality assessments. Extracted data were presented according to intervention components and patient characteristics using defined thresholds of clinical relevance. Overall certainty of outcomes was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Results Overall, 3564 references were identified, of which 46 records were included after applying eligibility criteria. The majority of included studies were published after 2015. Significant and clinically relevant reduction rates for glycated hemoglobin (HbA1c; ≤−0.5%) were found in patients with diabetes. Higher reduction rates were found for recently diagnosed patients and those with higher baseline HbA1c (>8%). Telemedicine was not found to have a significant and clinically meaningful impact on blood pressure. Only reviews or meta-analyses reporting lipid outcomes in patients with diabetes were found. GRADE assessment revealed that the overall quality of the evidence was low to very low. Conclusions The results of this umbrella review indicate that telemedicine has the potential to improve clinical outcomes in patients with diabetes. Although subgroup-specific effectiveness rates favoring certain intervention and population characteristics were found, the low GRADE ratings indicate that evidence can be considered as limited. Future updates of clinical care and practice guidelines should carefully assess the methodological quality of studies and the overall certainty of subgroup-specific outcomes before recommending telemedicine interventions for certain patient populations.


Author(s):  
Yu-Fen Chen ◽  
Mei-Yu Chang ◽  
Lok-Hi Chow ◽  
Wei-Fen Ma

Background: Intensive care unit (ICU) patients experience multiple uncomfortable symptoms, which may be alleviated using music-based intervention, a nondrug treatment. This umbrella review aims to combine the data of systematic reviews and/or meta-analyses to evaluate the effectiveness of music-based intervention in improving uncomfortable symptoms in ICU patients. Methods: A comprehensive literature search was performed on the PubMed, Embase, Cochrane Library, Airiti Library, CINAHL, ProQuest, and Web of Science databases, and Epistemonikos. The search had no language restrictions, and articles on the improvement of symptoms using music-based intervention in adult ICU patients were included. This review protocol was registered on PROSPERO (CRD42021240327). Results: This umbrella review retrieved 5 systematic reviews and 41 original studies, including 39 randomized controlled trials, and 2 nonrandomized controlled trials. Diverse music was the most common music type used for music-based intervention, the intervention music was typically decided by the study participants (61%), and most subjects underwent one intervention session (78%). Furthermore, most music intervention sessions lasted for 30 min (44%). The positive results included decreased anxiety, decreased pain, decreased agitation, decreased anesthesia dose and sedative use, decreased chances of delirium, decreased feelings of uncomfort, and improved sleep quality. Conclusions: A systematic review on the effectiveness of music-based intervention in improving uncomfortable symptoms in ICU patients revealed that 20–30 min intervention sessions showed the best improvement in the uncomfortable symptoms in patients. This study provides a basis for using music-based intervention to relieve the uncomfortable symptoms in critically ill ICU patients, and a reference for empirical clinical practice.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042525
Author(s):  
Michail Arvanitidis ◽  
Deborah Falla ◽  
Andy Sanderson ◽  
Eduardo Martinez-Valdes

IntroductionPerforming contractions with minimum force fluctuations is essential for everyday life as reduced force steadiness impacts on the precision of voluntary movements and functional ability. Several studies have investigated the effect of experimental or clinical musculoskeletal pain on force steadiness but with conflicting findings. The aim of this systematic review is to summarise the current literature to determine whether pain, whether it be clinical or experimental, influences force steadiness.Methods and analysisThis protocol for a systematic review was informed and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Cochrane Handbook for Systematic Reviews of Interventions. Key databases will be searched from inception to 31 August 2020, including MEDLINE, EMBASE, PubMed, CINAHL Plus, ZETOC and Web of Science. Grey literature and key journals will be also reviewed. Risk of bias will be assessed with the Newcastle-Ottawa tool, and the quality of the cumulative evidence assessed with the Grading of Recommendations, Assessment, Development and Evaluation guidelines. If homogeneity exists between groups of studies, meta-analysis will be conducted. Otherwise, a narrative synthesis approach and a vote-counting method will be used, while the results will be presented as net increases or decreases of force steadiness.Ethics and disseminationThe findings will be presented at conferences and the review will be also submitted for publication in a refereed journal. No ethical approval was required.PROSPERO registration numberCRD42020196479


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052831
Author(s):  
Marta Chmielowska ◽  
Yaara Zisman-Ilani ◽  
Rob Saunders ◽  
Stephen Pilling

IntroductionSocial networks (SNs) can play a crucial role in the process of recovery from mental illness. Yet there is no standard best practice for involving SNs to optimise patient recovery. It is therefore critical to explore the diversity of SN approaches in mental health, highlight gaps in the evidence and suggest future directions for research and practice. This protocol describes the methods for an umbrella review of SN interventions for the care and/or treatment of mental illness.Methods and analysisNine electronic databases will be searched for the relevant journal articles: CINAHL, PubMed, Scopus, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Library, Web of Science, Scopus and Ovid PsycINFO. We will include reviews which extracted information about the quantity, structure and quality of patient’s SNs as well as frequency of contact. The range of publication dates of the included articles will be from 2010 and 2021, as recommended by Joanna Briggs Institute guidelines. The Assessment of Multiple Systematic Reviews 2 tool and ratings of the quality of evidence will be used to assess the quality of the included reviews. The results will be presented in accordance with guidelines in the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement. Findings will inform the development of an SN framework to guide the design and evaluation of psychosocial interventions.Ethics and disseminationThis umbrella review will involve secondary data analysis and ethical approval is not required. The target audience includes clinicians, researchers and service users, who will be reached with tailored materials through journal publications, conference presentations and social media. The presentation of the results will provide a more complete picture of relevant evidence and explicit basis from which to improve psychosocial well-being for people diagnosed with a mental illness.PROSPERO registration numberThis protocol was registered with the International Prospective Register of Systematic Reviews (http:/ /www.crd.york.ac.uk/PROSPERO), registration number CRD42020192873.


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