Risultati per: Infezione da Helicobacter pylori: review

The SPIRIT-iNeurostim extension will help to promote increased transparency, clarity, and completeness of reporting trial protocols evaluating implantable neurostimulation devices. It will assist journal editors, peer-reviewers, and readers to better interpret the appropriateness and generalisability of the methods used for a planned clinical trial.

Introduction
Post-intensive care syndrome (PICS) seriously affects the quality of life of intensive care unit (ICU) survivors, their ability to return to work and society and the quality of life of their families, increasing overall care costs and healthcare expenditures. ICU follow-up services have important potential to improve PICS. However, the best clinical practice model of ICU follow-up service has not been fully defined and its benefits for ICU survivors are not clear. This review will synthesise and map the current types of follow-up services for ICU survivors and summarise the impact of follow-up services on PICS.

Methods and analysis
This scoping review will be conducted by applying the five-stage protocol proposed by Arksey and O’Malley in an updated version of the Joanna Briggs Institute. Eight academic databases including the Cochrane Library, MEDLINE, Web of Science, Embase, EBSCO Academic, CINAHL, PsycInfo and SinoMed (China Biology Medicine) will be systematically searched from inception to the present. Peer-reviewed literature and grey literature will be included. Qualitative, quantitative and mixed methods studies will be included. Studies published in English or Chinese will be included. There will be no time restriction. Two reviewers will screen and select the articles independently and if there is any disagreement, the two reviewers will discuss or invite a third reviewer to make decisions together. Descriptive analysis will be used to conduct an overview of the literature. The results will be presented in a descriptive format in response to the review questions accompanied by the necessary tables or charts.

Ethics and dissemination
Ethical approval is not required for this scoping review because data could be obtained by reviewing published primary study results and do not involve human participants. Findings should be disseminated at scientific meetings and published in peer-reviewed journals.

Background
A decrease in obtaining quality healthcare is a major cause of maternal and newborn deaths in low-income and middle-income countries. Ethiopia has one of the highest neonatal mortality rates. Increasing mothers’ health-seeking practices related to neonatal danger signs is an essential strategy for reducing the death rate of newborns. However, the pooled prevalence of mothers’ health-seeking practices related to neonatal danger signs is not well known in Ethiopia.

Objective
The main aim of this systematic review and meta-analysis is to assess the mothers’ health-seeking practices and associated factors towards neonatal danger signs in Ethiopia.

Design
Systematic review and meta-analysis.

Primary and secondary outcomes
The primary outcome was to assess the mothers’ health-seeking practices towards neonatal danger signs and the secondary outcome was to identify factors associated with health-seeking practices.

Methods
In total, comprehensive literature was searched in the PubMed, Google Scholar, HINARI, Embase and CINAHL databases published up to 30 December 2023. A random effect model was used to estimate the pooled prevalence and adjusted OR (AOR). Stata (V.17.0) was used to analyse the data. I2 statistics were computed to assess heterogeneity among studies. To minimise the underlying heterogeneity, a subgroup analysis was conducted based on the study region and year of publication. To assess publication bias, Egger’s test and funnel plots were used.

Results
Overall, 1011 articles were retrieved, and 11 cross-sectional studies, with a total of 5066 study participants, were included in this systematic review. The overall pooled prevalence of mothers’ health-seeking practices for neonatal danger signs in Ethiopia was 52.15%. Postnatal care follow-up (AOR 2.72; 95% CI 1.62 to 4.56), good maternal knowledge (AOR 3.20, 95% CI 2.24 to 4.56), educational status of secondary school and above (AOR 4.17, 95% CI 2.04 to 8.55), women’s decision-making autonomy (AOR 3.59, 95% CI 1.60 to 8.06) and place of delivery (AOR 2.71, 95% CI 1.21 to 6.04) were significantly associated with mothers’ health-seeking practices for neonatal danger signs.

Conclusion
The maternal health-seeking practices of women towards neonatal danger signs were found to be low in Ethiopia. When barriers to seeking care for newborn danger signs are successfully removed, women’s practices for seeking care for neonatal danger signs could decrease perinatal mortality.

Objectives
Target trial emulation is an approach that is increasingly used to improve transparency in observational studies and help mitigate biases. For studies declaring that they emulated a target trial, we aimed to evaluate the specification of the target trial, examine its consistency with the observational emulation and assess the risk of bias in the observational analysis.

Design
Methodological systematic review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Data sources
The database MEDLINE (Medical Literature Analysis and Retrieval System Online) was interrogated for all studies published from 1 January 2021 to 3 July 2022. We performed an additional manual search of 20 general medical and specialised journals that spanned the same period.

Eligibility criteria
All studies that declared emulating a hypothetical or real randomised trial were eligible.

Data extraction and synthesis
Two independent reviewers performed the whole systematic review process (screening and selection of studies, data extraction and risk of bias assessment). The main outcomes were the definition of the key protocol components of the target trial and its emulation, consistency between the target trial and its emulation and risk of bias according to the ROBINS-I (Risk Of Bias In Non-randomised Studies – of Interventions) tool.

Results
Among the selected sample of 100 studies, 24 (24%) did not specify the target trial. Only 40 studies (40%) provided detailed information on all components of the target trial protocol. Eligibility criteria, intervention strategies and outcomes were consistent between the target trial and its emulation in 35 studies (46% of those specifying the target trial). Overall, 28 studies (28%) exhibited serious risk of bias and 41 (41%) had misalignments in the timing of eligibility assessment, treatment assignment and the start of follow-up (time-zero). As compared with studies that did not specify the target trial, those that did specify the trial less frequently seemed to have both time-zero issues (39% vs 52%) and serious risk of bias (26% vs 33%).

Conclusions
One-quarter of studies declaring that they emulated a target trial did not specify the trial. Target trials and their emulations were particularly inconsistent for studies emulating a real randomised trial. Risk of methodological issues seemed lower in observational analyses that specified versus did not specify the target trial.

Introduction
Asthma exacerbations or ‘attacks’ can vary in severity from mild worsening of symptoms to life-threatening changes that require urgent hospital care. Understanding these exacerbations is crucial to improving treatment and support for patients. Electronic health records (EHR) using anonymised data from people with asthma in primary and secondary care can be used to understand exacerbations and outcomes. However, previous studies found significant heterogeneity in the algorithms used to define asthma exacerbations. Validating definitions of asthma exacerbations in EHR will lead to more robust and comparable evidence in future research.

Methods and analysis
Medline and Embase will be searched for the key concepts relating to asthma exacerbations, EHR and validation. All studies that validate exacerbations of asthma in EHR and administrative claims databases published before 30 May 2024 and written in English will be considered. Validated algorithms for asthma exacerbations or attacks must be compared against a reference or gold standard definition, and a measure of validity must be included. Articles will be screened for inclusion by two independent reviewers with any disagreements resolved by consensus or arbitration by a third reviewer. Study details will be extracted, and the risk of bias will be assessed using a QUADAS-2 tailored to this review.

Ethics & dissemination
No ethical approval is required as this is a review of previously published literature. Results will be disseminated in a peer-reviewed journal with the aim of being used in future research to help identify asthma exacerbation in EHR.

PROSPERO registration number
CRD42024545081

Objectives
Optimising postoperative pain following knee replacement is important for patients, healthcare professionals and healthcare funders. Adductor canal blocks (ACB) are widely used but there is uncertainty about their efficacy when combined with local infiltration analgesia (LIA) compared with either LIA or ACB alone.

Design
A systematic review and meta-analyses of randomised controlled. The primary outcome was pain over the first 72 hours. Secondary outcomes included morphine use, range of movement, distance walked, length of hospital stay, health economic outcomes and reported adverse events.

Data sources
MEDLINE, Embase, EB Health – KSR Evidence, Cochrane Central Register of Controlled Trials, CINAHL, International HTA database, ClinicalTrials.gov and the International Clinical Trials Registry Platform (WHO) were searched up to June 2023.

Eligibility criteria
Randomised controlled trials involving patients undergoing primary total knee replacement comparing LIA combined with ACB to either LIA or ACB alone.

Data extraction and synthesis
All eligible studies were data extracted independently by two reviewers. Studies were pooled for each outcome at each timepoint in a random effects meta-analysis.

Results
We identified 13 completed studies including 1154 participants. 12 studies compared LIA vs combination and 5 compared ACB vs combination. We identified that participants receiving the combination had lower pain scores at rest at 24 hours compared with LIA alone (SMD 0.42, 95% CI 0.20 to 0.64) or ACB alone (SMD 0.63, 95% CI 0.42 to 0.83). Pain on movement at 24 hours was also lower for patients with combination vs LIA alone (SMD 0.37, 95% CI 0.01 to 0.73) or ACB alone (SMD 0.81, 95% CI 0.35 to 1.26). We also identified that patients on combination used less morphine than on LIA alone (MD 1.06, 95% CI –0.09 to 2.20) or ACB alone (MD 5.94, 95% CI –2.41 to 14.29). The same was seen with range of motion at 24 hours with combination having a larger improvement than LIA alone (MD –5.19, 95% CI –5.55 to –4.83) or ACB alone (MD –3.80, 95% CI –4.37 to –3.23). These findings were consistent across all time points; however, there were no studies deemed to be at a low risk of bias.

Conclusions
Further well-designed and conducted randomised controlled trials are needed to confirm if a combination of LIA and ACB is superior to either option alone for patients undergoing primary total knee arthroplasty.

PROSPERO registration number
CRD42023436895.

Introduction
Micropapillary serous borderline ovarian tumours (MP-SBOTs) are an aggressive subtype of serous borderline ovarian tumours (SBOTs). Surgery is the mainstay of treatment. Radical surgery (RS, including debulking) is an alternative. However, for patients who are of reproductive age, another treatment option is fertility-sparing surgery (FSS). Up to now, the best surgical approach for MP-SBOTs and whether different procedures will have an impact on postoperative recurrence are still up for debate. This protocol outlines a systematic review and meta-analysis to investigate whether FSS adversely affected outcomes compared with RS in patients with MP-SBOTs. Additionally, we will do a prognosis analysis of BOTs with no microcapillary pattern and MP-SOBTs, if possible.

Methods and analysis
This protocol will consider non-randomised studies comparing outcomes in patients with MP-SBOTs treated with RS or FSS. The following databases will be searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, MEDLINE, Embase Medline, PubMed, Web of Science, China Biological Medicine Database, China National Knowledge Infrastructure and Wan Fang database. We will try our best to search the grey literature to avoid missing crucial research. Data collection and extraction will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Risk of Bias in Non-randomised Studies of intervention will be used to assess non-randomized studies. We will assess the certainty of the evidence using the GRADEpro methodology and describe the degree of certainty of our results using suggested wording based on the GRADEpro assessment. We will conduct a meta-analysis and offer summary statistics for each result if there is enough data available. Instead, we will report the findings narratively where the data do not permit a statistical assessment.

Ethics and dissemination
Ethics approval was not required for this study. Results will be published through a peer-reviewed publication and communicated at scientific events once complete.

PROSPERO registration number
CRD42023439136.

Introduction
Traumatic brain injury (TBI) is one of the prevalent critical illnesses encountered in clinical practice, often resulting in a spectrum of consciousness disorders among survivors. Prolonged states of impaired consciousness can significantly elevate the susceptibility to complications such as urinary tract infections and pulmonary issues, consequently leading to a compromised prognosis and substantially impacting the quality of life for affected individuals. Clinical studies have reported that median nerve electrical stimulation (MNES) may have a therapeutic effect in the treatment of disorders of consciousness (DOC). We plan to conduct a systematic review and meta-analysis to evaluate the efficacy and safety of MNES in the management of DOC subsequent to TBI.

Methods and analysis
We will conduct a comprehensive literature search in the following electronic databases: Web of Science, Embase, PubMed, Cochrane Library, China Biology Medicine, China National Knowledge Infrastructure, Wan Fang Database and Chinese Scientific Journal Database. The search will be performed from the inception of the databases until 30 September 2024. Furthermore, we will search for relevant ongoing trials in the International Clinical Trial Registry Platform, ClinicalTrials.gov and China Clinical Trial Registry. Grey literature will also be sourced from reputable sources like GreyNet International, Open Grey and Google Scholar. We will include eligible randomised controlled trials. The primary outcome of interest will be the assessment of consciousness disorder severity. To ensure rigour and consistency, two independent reviewers will screen the studies for inclusion, extract relevant data and assess the risk of bias. Any discrepancies will be resolved through discussion or consultation with a third reviewer. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Data synthesis and meta-analysis will be conducted using STATA 15.1 software.

Ethics and dissemination
This systematic review and meta-analysis do not involve the collection or use of any individual patient data, thereby obviating the necessity for ethical review. The research findings will be disseminated through publication in peer-reviewed scientific journals.

PROSPERO registration number
CRD42024533359.

Introduction
Olfactory dysfunction (OD) is a prevalent nasal affliction that has detrimental effects on the patients’ quality of life and safety. Conventional therapeutic strategies have various limitations such as high costs, prolonged treatment durations and adverse side effects. Intranasal insulin is a novel intervention for the management of OD. To date, few systematic reviews have been conducted to evaluate the efficacy of this intervention. This study aims to critically assess the therapeutic efficacy and safety profile of intranasal insulin administration in patients with OD.

Methods and analysis
A systematic literature search will be performed on several databases, including PubMed, the Cochrane Central Register of Controlled Trials, Embase, SinoMed and China National Knowledge Infrastructure (CNKI), to identify studies investigating the efficacy of intranasal insulin in treating OD. The search will span from database inception to 1 April 2024, including publication in Chinese and English languages. Data will be retrieved from the literature by two independent investigators. Subsequently, the data will be processed using RevMan V.5.3.5. The meta-analysis will be performed in line with the Cochrane Handbook guidelines. The clinical efficacy and safety of intranasal insulin for OD will be appraised based on various outcomes, including overall symptom improvement, the Connecticut Chemosensory Clinical Research Center score, variations in serum glucose levels, body mass index variations and the incidence of adverse events.

Ethics and dissemination
This will be a systematic review of available literature; thus, no ethical clearance is required. The results of this study will be shared through journal publication or presented at an academic conference.

Trial registration number
According to the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 16 May 2024 (registration number CRD42024543438).

Objectives
To evaluate the association between drinking water pollutants and non-syndromic birth defects.

Design
Systematic review and meta-analysis synthesis.

Data sources
A search of MEDLINE, EMBASE and Google Scholar was performed to review relevant citations reporting on birth defects in pregnancies exposed to water pollutants between January 1962 and April 2023.

Eligibility criteria
Prospective or retrospective cohort, population studies and case–control studies that provided data on exposure to drinking water pollutants around conception or during pregnancy and non-syndromic birth defects. We included studies published in the English language after the Minamata Bay disaster to reflect on contemporary concerns about the effect of environmental pollution and obstetric outcomes.

Data extraction and synthesis
Two reviewers independently read the retrieved articles for content, data extraction and analysis. The methodological quality of studies was assessed using the Newcastle-Ottawa Scale. Included studies were assessed for comparability when considered for meta-analysis.

Results
32 studies met inclusion criteria including 17 cohorts (6 389 097 participants) and 15 case–control studies (47 914 cases and 685 712 controls). The most common pollutants investigated were trihalomethanes (11 studies), arsenic (5 studies) and nitrates (4 studies). The studies varied in design with different estimates of exposure, different stages of gestation age and different durations of exposure to pollutants. 21 articles reported data on any birth defects in their population or study groups and the others on specific birth defects including congenital heart defects, neural tube defects, orofacial defects and hypospadias. An increased risk or higher incidence of overall birth defects was reported by 9 studies and for specific birth defects by 14 studies. Eight studies compared the risk or incidence of birth defects with exposure to different concentrations of the pollutants. The analysis showed an association between higher levels of trihalomethanes (TTMs) and arsenic increase in major birth defects (lower vs higher exposure (OR 0.76, 95% CI 0.65 to 0.89; p

Objective
Pilot and feasibility studies are intended to ensure that subsequent randomised controlled trials (RCTs) are feasible, economical and rigorous, especially in a challenging research environment such as emergency medicine (EM). We aimed to evaluate the methodological quality in conducting and reporting randomised pilot and feasibility studies in the EM literature and propose recommendations to improve their quality.

Design
Methodological systematic review.

Data sources and eligibility
We searched MEDLINE and Embase (2018–29 September 2023) for pilot or feasibility RCTs published as full texts in the five top-ranked and other first-quartile EM journals according to Scimago.

Data extraction and analysis
We assessed their methodological features and reporting quality primarily based on the Consolidated Standards of Reporting Trials (CONSORT) extension.

Results
A total of 24 randomised trials identified as pilot (n=13), feasibility (n=3) or both (n=8) were included. At least one feasibility outcome was assessed in 9 trials (feasibility trials), while 15 others only focused on treatment efficacy (efficacy trials). Only three (12.5%) studies progressed to the main trials. Among 12 feasibility trials, 55.6% reported their outcomes with uncertainty estimates, and 33.3% had clear progression criteria. Efficacy trials tended to draw clinical implications on their results. Studies from the five top-ranked journals had better methodological and reporting quality than those from other first-quartile journals.

Conclusion
Main methodological concerns for pilot and feasibility studies in first-quartile EM literature include misconceptions, misuses and suboptimal design and reporting quality. These issues were more prominent in lower-ranked first-quartile journals. Our findings highlight the need for resources and training for researchers, journal editors and peer reviewers on the value, objectives and appropriate conduct of pilot and feasibility studies. The conceptual framework and standardised methodological components should be emphasised. EM journals should reinforce the reporting standards and support their publication. These actions can lead to more methodologically rigorous pilot and feasibility studies in EM.

PROSPERO registration number
CRD42023468437.

Objectives
This systematic review aims to identify, appraise and synthesise the findings of published qualitative research exploring the barriers and facilitators to self-management of chronic conditions reported by women.

Design
A systematic literature review and thematic synthesis of qualitative studies.

Data sources
A search of MEDLINE, CINAHL, Embase and PsycInfo was undertaken using the search terms ‘Women’, ‘Woman’ ‘Female,’ ‘Chronic’, ‘Long-term’, ‘Disease’, ‘Illness’, ‘Condition’ ‘Health,’ ‘Self-management,’ ‘Qualitative,’ ‘Barrier’ and ‘Facilitator’. A hand search for literature was also performed.

Eligibility criteria
Studies published before 2005 and those not in English were excluded.

Data extraction and synthesis
Extracted data were analysed thematically and emerging and recurring themes identified. Themes were mapped to the six components of the COM-B model. Critical appraisal of included publications was undertaken using the CASP (Critical Appraisal Skills Programme) qualitative checklist and finding weighted on quality.

Results
Eighty-four publications were identified and eligible for inclusion within the review. Studies were conducted in five continents, with a focus on 20 different chronic conditions and included a total of 1788 women. Barriers and facilitators to physical capability, psychological capability, physical opportunity, social opportunity, autonomic motivation and reflective motivation were identified with a number of recurring themes found. Self-prioritisation, support and culture all had a significant impact on whether women followed self-management recommendations. Certain groups of women such as those living remotely, those with financial difficulties, migrants and those who do not speak the predominant language appear to face additional barriers to self-management.

Conclusions
This review highlights that to self-manage chronic conditions women have to overcome various cultural, financial and social barriers. Self-management programmes should be designed taking into account these factors in order to ensure women are better supported and enabled to improve their health outcomes.

To the Editor In a recent Review about chronic pruritus, the authors did not mention transient receptor potential melastatin 8 (TRPM8) as a treatment option. Activation of TRPM8 induces a long-lasting cooling effect in the skin, and TRPM8 agonists such as icilin, menthoxypropanediol, and cryosim-1 can substantially improve recalcitrant pruritus associated with many conditions including eczema, urticaria, lichen sclerosus, and scalp itch.

In Reply We thank Drs Ben Salem and Ghariani for their comments about targeting TRMP8, the cold receptor, in the treatment of itch. We share an interest in this target, and our Review mentioned menthol, which is the prototype of TRMP8 agonists used for centuries to treat different types of itch. However, in our Review we decided to exclusively discuss treatments that are available in the US to treat itch. The TRMP8 agonists mentioned, icilin and cryosim-1, are not commercially available in the US. Although historically TRMP8 receptor activation has been considered to inhibit itch of different types, we have found that with psoriatic itch and, in particular, psoriatic scalp itch, TRMP8 is overexpressed in the skin and highly correlates with itch intensity. Additionally, a subpopulation of patients with atopic dermatitis report that cold exposure exacerbates their itch, and only 30% of patients with atopic dermatitis reported that cold reduces their itch. This highlights the need for studies to better understand which patients with pruritus (neuropathic, immunologic, or mixed etiology) may benefit from these agents. Moreover, in our clinical experience, the antipruritic effect of menthol and other currently available cooling agents is typically limited to minutes. We believe that additional studies using new TRMP8-specific agonists may help to identify the patients who will benefit the most from activation of cold receptors for the treatment of itch.

Objective
Potential coeliac disease (PCD) is characterised by positive serological and genetic markers of coeliac disease with architecturally preserved duodenal mucosa. The clinical outcomes and rates of progression to overt coeliac disease in patients with PCD remain uncertain. In this systematic review and meta-analysis, we aimed to evaluate the clinical outcomes of patients with PCD.

Design
We searched Medline, Embase, Scopus and Cochrane Library from 1991 through May 2024 to identify studies evaluating the clinical outcomes of patients with PCD. The progression rates to villous atrophy, seroconversion and response to a gluten-free diet (GFD) were analysed. A random-effect meta-analysis was performed, and the results were reported as pooled proportions with 95% CIs.

Results
Seventeen studies comprising 1010 patients with PCD were included in the final analyses. The pooled prevalence of PCD among patients with suspected coeliac disease was 16% (95% CI 10% to 22%). The duration of follow-up in most of the studies was at least 1 year, with follow-up periods within individual studies ranging from 5 months to 13 years. During follow-up, 33% (95% CI 18% to 48%; I2=96.4%) of patients with PCD on a gluten-containing diet developed villous atrophy, and 33% (95% CI 17% to 48%; I2=93.0%) had normalisation of serology. Among those who adhered to a GFD, 88% (95% CI 79% to 97%; I2=93.2%) reported symptomatic improvement.

Conclusion
Almost a third of patients with PCD develop villous atrophy over time, whereas a similar proportion experience normalisation of serology despite a gluten-containing diet. Most symptomatic patients benefit from a GFD. These findings highlight the importance of structured follow-up and individualised management for patients with PCD.

Dinis-Ribeiro M, Shah S, El-Serag H, et al. The road to a world-unified approach to the management of patients with gastric intestinal metaplasia: a review of current guidelines. Gut 2024;73:1607-17.
The affiliation for Ernst J Kuipers has been corrected in the online version only to:
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore