Safety and performance of oropharyngeal muscle strength training in the treatment of post-stroke dysphagia during oral feeding: protocol for a systematic review and meta-analysis

Introduction
Dysphagia is a common functional disorder after stroke. Most patients post-stroke are incapable of oral feeding, which often leads to complications such as malnutrition, aspiration pneumonia and dehydration that seriously affect the quality of life of patients. Oropharyngeal muscle strength training is a major method of swallowing training, and recent studies have focused on healthy adults, elderly persons, and patients with head and neck cancer or neurodegenerative diseases; but there have been few studies on such training in patients with post-stroke dysphagia. Our study aims to systematically review the safety and performance of oropharyngeal muscle strength training in the treatment of post-stroke dysphagia during oral feeding.

Methods and analysis
The Cochrane Library, Web of Science, PubMed, Embase and ClinicalTrials.gov databases will be systematically searched, and all relevant articles in English from the establishment of the databases to January 2022 will be reviewed. The study will be conducted in accordance with the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines. The primary outcome measures include the Penetration–Aspiration Scale and the Functional Oral Intake Scale. Two authors will independently screen the articles, extract the data and assess the study quality. Any disagreements during this process will be resolved by discussion or by consultation with a third author. Next, quantitative or qualitative, subgroup and sensitivity analyses of the included literature data will be performed as appropriate.

Ethics and dissemination
Ethical approval is not required for this systematic review as no primary data collection will be required. The results of the present study will be published in a peer-reviewed journal in the field of deglutition disorders.

PROSPERO registration number
CRD42022302471.

Leggi
Giugno 2022

Steroid use for established bronchopulmonary dysplasia: study protocol for a systematic review and meta-analysis

Introduction
Postnatal steroids during the first few weeks of life have been demonstrated to be effective in decreasing the incidence of bronchopulmonary dysplasia (BPD), a serious chronic respiratory condition affecting preterm infants. However, this preventive option is limited by the concern of neurological side effects. Steroids are used to treat established BPD in an attempt to reduce mortality, and length of stay and home oxygen therapy, both of which associated with high levels of parental stress and healthcare costs. Moreover, a late timing for steroid treatment may show a more favourable safety profile in terms of neurodevelopment outcomes, considering the added postnatal brain maturation of these infants. Here, we report a protocol for a systematic review, which aims to determine the efficacy and long-term safety of postnatal steroids for the treatment of established BPD in preterm infants.

Methods and analysis
MEDLINE, Embase, Cochrane databases and sources of grey literature for conference abstracts and trial registrations will be searched with no time or language restriction. We will include case–control studies, cohort studies and non-randomised or randomised trials that evaluate postnatal steroids for infants diagnosed with moderate or severe established BPD at 36 weeks’ postmenstrual age. We will pool data from studies that are sufficiently similar to make this appropriate. Data extraction forms will be developed a priori. Observational studies and non-randomised and randomised clinical trials will be analysed separately. We will combine OR with 95% CI for dichotomous outcomes and the mean difference (95% CI) for continuous outcomes. We will account for the expected heterogeneity by using a random-effects model. We will perform subgroup analysis based on the a priori determined covariate of interest.

Ethics and dissemination
Systematic reviews are exempted from approval by an ethics committee. Attempts will be sought to publish all results.

PROSPERO registration number
CRD42021218881.

Leggi
Giugno 2022

Effectiveness of interventions for middle-aged and ageing population with neck pain: a systematic review and network meta-analysis protocol

Introduction
Neck pain (NP) is a common musculoskeletal complaint and is increasing in prevalence. Current clinical practice guidelines and systematic reviews recommended conservative, pharmacological and invasive interventions for individuals with NP. However, optimal management specifically for those who are middle-aged or older adults (≥45 years) is not available; and important considering our ageing population.

Methods and analysis
A systematic review with network meta-analysis (NMA) will be conducted following the Cochrane guidelines. Eligibility criteria include randomised controlled/clinical trials evaluating any of acute (

Leggi
Giugno 2022

Availability, accessibility and activation of mental health services among university students in Africa: a protocol of a mixed-methods systematic review with meta-analysis and meta-synthesis

Introduction
In Africa, the prevalence of mental health problems is higher among university students than in the general population. A number of systematic reviews and recent prevalence studies have focused on prevalence of mental health issues among college. This mixed-methods systematic review, including meta-analysis and meta-synthesis, will explore: what mental health services are available to university students; the extent to which students access available services and factors associated with service access; and the degree to which students activate (use) accessible services and factors associated with service activation.

Methods and analysis
We will conduct electronic literature search of the following databases: PubMed, Cochrane Library, Semantic Scholar, ERIC, Trip Database, Medline and PsycINFO. Disagreement, if any, will be resolved by a third reviewer. Two reviewers will independently assess the methodological quality of included studies using relevant tools. For cross-sectional studies, we will use the Joanna Briggs Institute Checklist for Analytical Cross Sectional Studies whereas qualitative or mixed-methods studies will be assessed using the Critical Appraisal Skills Programme. OR, risk ratio or mean difference with 95% CI will be considered as the effect size. We will assess heterogeneity between studies by appropriate subgroup analyses. Publication bias will be detected using funnel plots.

Ethics and dissemination
Ethical clearance is not required as we are not collecting primary data. Findings will be disseminated via relevant scientific conferences and peer-reviewed publications.

PROSPERO registration number
CRD42022296870.

Leggi
Giugno 2022

Comparison of Hydrus and iStent microinvasive glaucoma surgery implants in combination with phacoemulsification for treatment of open-angle glaucoma: systematic review and network meta-analysis

Objectives
To compare the efficacy and safety of two Schlemm’s canal-based microinvasive glaucoma surgery (MIGS) devices, the Hydrus Microstent and the iStent Trabecular Bypass combined with phacoemulsification for treatment of open-angle glaucoma.

Design
Systematic review and network meta-analysis.

Methods
Literature searches were conducted on PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov to identify randomised controlled trials (RCTs) assessing the Hydrus or the iStent implantation combined with phacoemulsification for treatment of open-angle glaucoma until September 2020. Risk of bias was assessed using a six-item modified Jadad scale. Effects were estimated using the intraocular pressure (IOP) reduction (IOPR), the percentage of IOPR and the proportion of medication-free patients at follow-up end. Safety was estimated using the proportions of adverse events. The network meta-analysis was conducted within a Bayesian framework using the Markov Chain Monte Carlo method in ADDIS software.

Results
Six prospective RCTs comprising 1397 patients were identified. Regarding the absolute value and the percentage of IOPR, the Hydrus and 2-iStent implantation combined with phacoemulsification were significantly more effective than phacoemulsification alone. Rank probability analysis revealed the Hydrus might be the best choice to lower IOP. There was no significant difference in the proportion of medication-free patients among groups. The Hydrus and 2-iStent implantation had a higher probability to achieve the medication-free status versus the 1-iStent implantation and phacoemulsification alone. Overall safety profiles were good for each device with the focal peripheral anterior synechiae more frequently reported in Hydrus eyes.

Conclusions
The Hydrus implantation may have a slight advantage over the 1-iStent or 2-iStent implantation in combination with phacoemulsification to treat open-angle glaucoma. Our findings might be of some uncertainty due to the limited included data. Further studies are needed to investigate whether our findings are robust, including high-quality RCTs to directly compare these MIGS devices.

Leggi
Giugno 2022

Relationship between serum insulin-like growth factor 1 levels and ischaemic stroke: a systematic review and meta-analysis

Objective
To assess the association of insulin-like growth factor 1 (IGF-1) with the risk of incident ischaemic stroke and outcome after ischaemic stroke.

Design
A systematic review of primary studies.

Setting
Hospitals in Western Sweden, Italy, China and Denmark.

Methods
A search was carried out in eligible studies in electronic databases (PubMed, Scopus, Embase, China National Knowledge Infrastructure and Web of Science) updated to 29 December 2020. The relevant data were extracted in order to conduct the meta-analysis. Review Manager V.5.2 was used to pool data and calculate the mean difference (MD) and its 95% CI. Heterogeneity, subgroup analysis, sensitivity analysis and publication bias were also performed in this meta-analysis.

Results
A total of 2277 patients were included in 17 studies. This meta-analysis indicated that higher serum IGF-1 levels were significantly correlated with less risk of ischaemic stroke (MD=–45.32 95% CI –63.70 to –26.94], p < 0.00001, I2=99%) and better improvement of outcome after ischaemic stroke (MD=27.52, 95% CI 3.89 to 51.14, p=0.02, I2=96%). According to subgroup analysis, heterogeneity comes from country, sample size, male and the time from symptom onset to blood collection. Sensitivity analysis showed that there was no significant influence of any individual study on the pooled MD. The effect of high heterogeneity on result credibility was eliminated when four included studies were merged (MD=–30.32, 95% CI –36.52 to –24.11, p< 0.00001, I2=0%). Moreover, no potential publication bias was discovered in this meta-analysis. Conclusion Higher serum IGF-1 was significantly correlated with a lower risk of ischaemic stroke. In view of the high degree of heterogeneity, it may need more studies to confirm the prognostic value of serum IGF-1 levels in ischaemic stroke and explore the sources of heterogeneity.

Leggi
Giugno 2022

How and why do financial incentives contribute to helping people stop smoking? A realist review protocol

Introduction
Smoking is harmful to human health and programmes to help people stop smoking are key public health efforts that improve individual and population health outcomes. Research shows that financial incentives improve the success of stop smoking programmes. However, a better understanding of how they work is needed to better inform policy and to support building capability for implementation.
The aims of this study: (1) To review the international literature to understand: How, why, in what circumstances and for whom financial incentives improve the success of stop smoking interventions among general population groups and among pregnant women. (2) To provide recommendations for how to best use financial incentives in efforts to promote smoking cessation.

Methods and analysis
A realist review of published international literature will be undertaken to understand how, why, for whom and in which circumstances financial incentives contribute to success in stopping smoking for general population groups and among pregnant women. Systematic searches were undertaken on 16 February 2022 of five academic databases: MEDLINE (ovid), Embase.com, CIHAHL, Scopus and PsycINFO. Iterative searching using citation tracking and of grey literature will be undertaken as needed. Using Pawson and Tilley’s iterative realist review approach, data collected will be screened, selected, coded, analysed and synthesised into a set of explanatory theoretical findings.

Ethics and dissemination
Ethical approval is not required for this review as data sources to be included are previously published. The study will provide important findings for policy-makers and health system leaders to guide the development of stop smoking services which use incentives, for example, as part of the Health Service Executive’s Tobacco Free Programme in Ireland. Understanding how contextual factors impact implementation and programmatic success is key to developing a more effective public health approach to stop smoking. Our dissemination strategy will be developed with our stakeholders.

PROSPERO registration number
CRD42022298941.

Leggi
Giugno 2022

Acupuncture for patients with type 2 diabetes mellitus with dry eye: protocol for a systematic review and meta-analysis

Introduction
The global incidence of patients with type 2 diabetes mellitus (T2DM) with dry eye is increasing annually, which imposes additional healthcare costs and financial burden on families and societies. In clinical practice, artificial tears are often used for symptomatic treatment, but these can only relieve the symptoms of discomfort. Acupuncture is a widely used alternative therapy. Indeed, randomised trials have found that acupuncture confers a definite therapeutic effect on patients with T2DM with dry eye. However, systematic reviews on the effectiveness and safety of acupuncture are lacking, therefore this systematic review aims to evaluate the effectiveness and safety of acupuncture for T2DM with dry eye.

Methods and analysis
Four English databases (PubMed, Cochrane Library, Embase and Ovid), three Chinese databases (China National Knowledge Infrastructure, Wanfang, Chonqing VIP Information), three Japanese databases (Japan Science, Technology Agency and Japan Medical Abstracts Society) and three Korean databases (Korean Medical database, Oriental Medicine Advanced Searching Integrated System and Research Information Service System) will be searched for reports published between 1 January 2007 and 1 October 2021. Only randomised controlled trials will be included, and language or publication dates will not be restricted. Two researchers will independently extract, manage and analyse data. The primary outcomes will include Schirmer’s I test, breakup time, corneal fluorescein staining and ocular surface disease index scores. Secondary results will include visual analogue scale scores for ocular symptoms and any adverse events related to acupuncture. We will use Review Manager V.5.4 for the meta-analysis. The risk of bias will be independently assessed using Cochrane’s ‘risk of bias’ tool.

Ethics and dissemination
Ethical approval will not be required since raw data will not be collected or generated. Our findings will be disseminated through peer-reviewed journal.

PROSPERO registration number
CRD42021271891.

Leggi
Giugno 2022

Aetiological research on the health of migrants living in Germany: a systematic literature review

Background
Germany has become an important immigration country and health services need to adopt to meet the needs of an increasingly multicultural population. For public health planning, it is essential to understand the aetiology of health problems among migrant populations. The main objective was to systematically identify, evaluate and synthesise population-based studies that investigated exposure–outcome relationships among migrant groups in Germany.

Methods
In November 2019, we searched PubMed and LIVIVO, and updated this search in November 2020, to identify peer-reviewed publications that fulfilled our eligibility criteria: English or German language; study on disease aetiology among major migrant groups in Germany, according to the latest microcensus; publication date from inception to 01 November 2020 and observational or experimental study designs. For quality appraisal, we used the Critical Appraisal Skills Programme checklists. Outcomes under investigation were categorised according to the WHO major disease groups, and their associations with risk factors were synthesised as a heat map.

Results
Out of 2407 articles retrieved, we included 68 publications with a total number of 864 518 participants. These publications reported on cross-sectional data (n=56), cohort studies (n=11) and one intervention study. The population groups most frequently studied were from the Middle East (n=28), Turkey (n=24), sub-Saharan Africa (n=24), Eastern Europe (n=15) and the former Soviet Union (n=11). The outcomes under study were population group specific. There were consistent associations of demographic and socioeconomic factors with ill health among migrants in Germany.

Discussion
In this systematic review, we observed low risk of bias in two-thirds of the studies. There is an increasing body of evidence for aetiological research on migrants’ health in Germany. Still, the directions of associations between a wide range of risk factors and major disease groups seem only partially understood.

PROSPERO registration number
CRD42018085074.

Leggi
Giugno 2022

Value of robotic surgery simulation for training surgical residents and attendings: a systematic review protocol

Introduction
Robotic surgery is a method of minimally invasive surgery performed through small incisions using a remote robotic console. Surgical residents and attendings participate in simulation training to be able to effectively perform robotic surgery using wet labs, dry labs and virtual reality platforms. Our objective is to identify the effectiveness of robotic simulation on novice robotic surgeons. This review will answer our review question: To what extent are robotic simulations for training novice robotic general surgery residents and attendings associated with improved outcomes in comparison with no simulation training?

Methods and analysis
A comprehensive search of PubMed, Embase, the Cochrane Library and Web of Science was performed. The studies were then determined to meet initial screening criteria by one individual for abstract and title with full text screening performed by two authors independently and in duplicate. Narrative themes will be collected, analysed and summarised where possible.

Ethics and dissemination
There is no Institutional Review Board approval required given that the work is carried out on previously published papers. The final manuscript and results will be presented and published at an academic conference and peer -reviewed journal.

PROSPERO registration number
CRD42021274090.

Leggi
Giugno 2022

Patient-centered outcomes for gastrointestinal cancer care: a scoping review protocol

Introduction
Following a cancer diagnosis, patients and their caregivers face crucial decisions regarding goals of care and treatment, which have consequences that can persist throughout their cancer journey. To foster informed and value-driven treatment choices, evidence-based information on outcomes relevant to patients is needed. Traditionally, clinical studies have largely focused on a few concrete and easily measurable outcomes such as survival, disease progression and immediate treatment toxicities. These outcomes do not capture other important factors that patients consider when making treatment decisions. Patient-centred outcomes (PCOs) reflect the patients’ individual values, preferences, needs and circumstances that are essential to directing meaningful and informed healthcare discussions. Often, however, these outcomes are not included in research protocols in a standardised and practical fashion. This scoping review will summarise the existing literature on PCOs in gastrointestinal (GI) cancer care as well as the tools used to assess these outcomes. A comprehensive list of these PCOs will be generated for future efforts to develop a core outcome set.

Methods and analysis
This scoping review will follow Arksey and O’Malley’s expanded framework for scoping reviews. We will systematically search Medline, Embase, CINAHL, Cochrane Library and APA PsycINFO databases for studies examining PCOs in the context of GI cancer. We will include studies published in or after the year 2000 up to the date of the final searches, with no language restrictions. Studies involving adult patients with GI cancers and discussion of any PCOs will be included. Opinion pieces, protocols, case reports and abstracts will be excluded. Two authors will independently perform two rounds of screening to select studies for inclusion. The data from full texts will be extracted, charted and summarised both quantitatively and qualitatively.

Ethics and dissemination
No ethics approval is required for this scoping review. Results will be disseminated through scientific publication and presentation at relevant conferences.

Leggi
Giugno 2022

Severity and mortality of COVID-19 among people with disabilities: protocol for a systematic review and meta-analysis

Introduction
As the COVID-19 pandemic and the subsequent global healthcare crisis continue, people with disabilities may face greater health risks than their non-disabled peers. This systematic review and meta-analysis aims to determine the severity and mortality of COVID-19 among people with different types of disabilities.

Methods and analysis
We will search PubMed, HINARI, ScienceDirect, PEDro and Cochrane Library databases. Grey literature search will also be conducted on MedRxiv and Google Scholar. Searches will be without date restrictions. Cohort, case-control and cross-sectional studies assessing the severity and mortality of COVID-19 among people with disabilities will be included. Only full-text studies in the English language will be included. The outcomes of interest include the risk of COVID-19 infection, rate of hospitalisation, severity, hospital stay, mortality and others variables where data are available. Two reviewers will extract data and perform risk of bias assessment independently. The Newcastle-Ottawa Scale will be used to assess risk of bias. Review Manager V.5.4 and Stata V.16.0 software will be used for statistical analysis. Heterogeneity will be analysed using I² statistics. Pooled OR with 95% CI will be used to calculate the pooled results for outcome variables.

Ethics and dissemination
Ethical approval and informed consent are not required as this is a systematic review of existing publications. The final results will be published in a peer reviewed journal and presented at national and international conferences.

PROSPERO registration number
CRD42022306361.

Leggi
Giugno 2022

Systematic review of changed smoking behaviour, smoking cessation and psychological states of smokers according to cigarette type during the COVID-19 pandemic

Objectives
Although the global COVID-19 pandemic has increased interest in research involving high-risk smokers, studies examining changed smoking behaviours, cessation intentions and associated psychological states among smokers are still scarce. This study aimed to systematically review the literature related to this subject.

Design
A systematic review of published articles on cigarettes and COVID-19-related topics

Data sources
Our search was conducted in January 2021. We used the keywords COVID-19, cigarettes, electronic cigarettes (e-cigarettes) and psychological factors in PubMed and ScienceDirect and found papers published between January and December 2020.

Data selection
We included articles in full text, written in English, and that surveyed adults. The topics included smoking behaviour, smoking cessation, psychological state of smokers and COVID-19-related topics.

Data extraction and synthesis
Papers of low quality, based on quality assessment, were excluded. Thirteen papers were related to smoking behaviour, nine papers were related to smoking cessation and four papers were related to psychological states of smokers.

Results
Owing to the COVID-19 lockdown, cigarette users were habituated to purchasing large quantities of cigarettes in advance. Additionally, cigarette-only users increased their attempts and willingness to quit smoking, compared with e-cigarette-only users.

Conclusions
Owing to the COVID-19 outbreak, the intention to quit smoking was different among smokers, according to cigarette type (cigarette-only users, e-cigarette-only users and dual users). With the ongoing COVID-19 pandemic, policies and campaigns to increase smoking cessation intentions and attempts to quit smoking among smokers at high risk of COVID-19 should be implemented. Additionally, e-cigarette-only users with poor health-seeking behaviour require interventions to increase the intention to quit smoking.

Leggi
Giugno 2022

Examining endothelial function and carotid artery disease in patients with inflammatory bowel disease: a systematic review protocol

Introduction
Patients with inflammatory bowel disease (IBD) might be at an increased risk for the development of cardiovascular disease (CVD). The present protocol is developed to review and analyse published data to determine if patients with IBD have an increased CVD burden.

Methods and analysis
We will conduct a systematic review of all observational studies that examine endothelial function, arterial stiffness and carotid intima-media thickness in patients with IBD. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and study quality will be assessed using the Newcastle-Ottawa Scale. If sufficient data are available, a meta-analysis will be conducted. The overall effect sizes will be estimated using both fixed effects models and random effects models. Statistical heterogeneity will be calculated using Higgin’s (I2) tests. Subgroup analyses, conditional number of studies retrieved and their sample size, will be stratified according to participant disease category or gender or disease activity.

Ethics and dissemination
Formal ethics approval is not required as individual data will not be collected. The results will be disseminated through peer-reviewed publications, conference presentations and scientific news releases.

PROSPERO registration number
CRD42021274093.

Leggi
Giugno 2022

Diagnostic delay of myositis: protocol for an integrated systematic review

Introduction
Idiopathic inflammatory myopathies (IIM). described as ‘inflammatory myositis’, are a heterogeneous group of rare muscular autoimmune diseases characterised by skeletal muscle inflammation. Its complex characteristics with lack of accurate diagnostic tests, unified classification system and comprehensive widely used diagnostic criteria could lead to diagnostic delay. This study will review diagnostic delay in myositis and provide an overview and clearer insight of patients’ experiences, causes and consequences of diagnostic delay in myositis.

Methods and analysis
The literature source will be a systematic search of PubMed/MEDLINE, Scopus, ProQuest and sources of grey literature, conducted from database inception to December 2021 without restrictions on publication date. All study types (qualitative and quantitative) except review articles, examining diagnostic delay, incorrect diagnosis, missed diagnosis or slow diagnosis of all types of myositis in all ages will be included. Evidence of patients’ experiences associated with diagnostic delay will also be examined. Studies in languages other than English, German and Indonesian will be excluded. Outcomes will be diagnostic delay time, patients’ experiences, and causes and consequences associated with diagnostic delay in myositis. Two review authors will independently screen the titles and abstracts of search results against the inclusion criteria. The Mixed Methods Appraisal Tool (MMAT) will be used to appraise selected studies. Two independent authors will extract data using a prepiloted data extraction tool. If sufficient quantitative data is available, a meta-analysis will be conducted along with subgroup analysis including pooled diagnostic delay in each type of myositis. Qualitative data will be analysed in line with meta-aggregation methods. If data is insufficient, a narrative synthesis will be conducted.

Ethics and dissemination
As this work is a systematic review, ethical approval was not required. Findings of the study will be disseminated through publications in peer-reviewed journals, conferences and symposia.

PROSPERO registration number
CRD42022289830.

Leggi
Giugno 2022

Clinico-epidemiology and aetiopathogenesis of gallstone disease in the South Asian region: a scoping review protocol

Introduction
Pathogenesis of gallstones (GS) is multifactorial and is influenced by numerous environmental and genetic risk factors. As a result, clinico-epidemiology and aetiopathogenesis of GS vary in different populations. Understanding the aetiopathogenesis of GS for different populations is imperative in control and prevention of GS disease and its associated complications. This protocol describes the methodology of a scoping review which focuses on synthesising the most updated knowledge on GS disease in South Asia.

Methods and analysis
The scoping review proposed in this protocol will be guided by Arksey and O’Malley’s framework and the Joanna Briggs Institute Reviewers’ Manual. Accordingly, population, concept and context strategy will be used to formulate the scoping review question, eligibility criteria and search strategy. In the search, electronic databases, MEDLINE/PubMed, ScienceDirect, Scopus, Cochrane library, CINAHL, Trip, and Google scholar, as well as various grey literature sources will be used in synthesising and presenting the findings on clinico-epidemiology and aetiopathogenesis of GS disease in South Asia.

Ethics and dissemination
As secondary data will be used in the study, ethical approval will not be required. The scoping review proposed by this protocol will accurately summarise the current knowledge on GS disease in South Asia based on published and unpublished literature on the field. Thus, the evidence presented in the review will be important for healthcare providers to make decisions on the control and prevention of GS disease and as well as to identify future research priorities on GS disease in South Asia.

Leggi
Giugno 2022