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Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys
Background: Neurogenic bladder (NGB) is a chronic and disabling condition with a high prevalence rate, which can cause economic burden on patients and their families and reduce the quality of life of patients. Researchers have carried out a large number of clinical trials on the effectiveness and safety of different interventions for the treatment of NGB. The published clinical trials of NGB generally suffered from inconsistent and irregular reporting of outcome indicators. To facilitate future research studies of NGB, a core outcome set (COS) is required, which helps translate the results into high-quality evidence. Methods and analysis: This mixed-method project has four phases instrument: in phase 1, a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of clinical trials of interventions for NCB; in phase 2, a qualitative component using interviews to obtain the views of NGB patients, families, and their caregivers; in phase 3, Delphi survey among stakeholders to prioritize the core outcomes; and in phase 4, a face-to-face consensus meeting to discuss and agree on the final NBG COS. Conclusions: We will develop a COS that should be reported in future clinical trials of NGB.
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Antimicrobial stewardship for surgical antibiotic prophylaxis and surgical site infections: A systematic review
BACKGROUND: Surgical site infections account for 14–17% of all healthcare-associated infections. Antimicrobial stewardship (AMS) are complementary strategies developed to optimize the use of antimicrobials. AIM: to evaluate the effectiveness of AMS in promoting adherence to surgical antibiotic prophylaxis protocols in hospitalized patients, reducing surgical site infection rate and cost–benefit ratio. METHOD: This systematic review of randomized clinical trials, non-randomized clinical trials and before and after studies was performed using Pubmed, Cochrane, Web of Science, Scopus, Embase, Google Scholar and ClinicalTrials.gov, in addition to reference lists of included studies. The risk of bias of studies was measured by the ROBINS-I checklist and the quality of the evidence synthesis by GRADE. RESULTS: Fourteen before and after design studies were included. In 85.7% of the studies, AMS was effective in increasing adherence to surgical antibiotic prophylaxis protocols and in 28.5%, there was reduction in surgical site infection rate. Three studies evaluated cost–benefit ratio and found a favorable impact. Eight (57%) studies were at risk of moderate bias and six had severe bias. The evaluation of the synthesis of evidence showed quality ranging from low to very low. CONCLUSION: AMS, such as audit, feedback, education, implementation of a protocol, and a computer-assisted decision support methodology, appear to be effective in promoting adherence to surgical antibiotic prophylaxis protocols, reducing surgical site infection rate with a positive economic impact. However, more studies, particularly randomized clinical trials, are needed to improve the level of evidence of available information on AMS in order to favor decision-making.
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End of life care pathways in the Emergency Department and their effects on patient and health service outcomes: An integrative review.
Introduction: End of life (EOL) care in the Emergency Department (ED) requires focused, person-centred care to meet the needs of this vulnerable cohort of patients. Methods: An integrative review of the literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was conducted. Studies were included if they were primary research relating to patients in the ED at the EOL, and/or evaluated EOL care pathways in the ED. Databases OVID Emcare, OVID Medline, and Scopus were searched from 1966-September 2021; followed by screening and appraisal. Articles were compared and data grouped into categories. Results: Eleven research articles were included generating three categories for EOL care in ED. 1) tools/criteria to identify patients who may require EOL care in ED; 2) processes for providing EOL care, and 3) implementation methods/frameworks to support the uptake of EOL care processes. Conclusion: There were some commonalities in the criteria used to identify patients who may be at their EOL and the interventions implemented thereafter. There was no standardised process for screening for or treating EOL care needs in the ED. Further research is required to determine the impact that EOL care pathways have on patient and health service outcomes to inform strategies for future policy development.
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Sjogren's syndrome in clinical trials of traditional Chinese medicine: protocol for the development of a core outcome set
Background: Sjogren's syndrome (SS) is a chronic autoimmune rheumatic disease with an incidence of 0.03 to 0.3%. In recent years, there are an increasing number of randomized controlled trials of traditional Chinese medicine (TCM) for SS. However, there are generally some problems in these published clinical trials: lack of reporting primary or long-term outcomes and the heterogeneous in different clinical trials' outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders and reach agreement on the COS and syndromes to be measured and reported in all future TCM trials in patients with SS. Methods and analysis: A phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (I-a) identifying of a long initial list of outcomes through systematic literature review and semi-structured qualitative interviews and (I-b) identifying an initial list of TCM syndromes through (1) systematic literature review, (2) referencing ancient Chinese medical books, and (3) retrospective studies of medical records; (II) prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients; and (III) through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes. Discussion: We summarized the actions of COS into three points: direct action, indirect action, and final action. After the final COSs is completed, we will publish this research in a journal to promote communication.
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Inconsistencies in study eligibility criteria are common between non-Cochrane systematic reviews and their protocols registered in PROSPERO
The author should give careful consideration to the study eligibility criteria of systematic reviews (SRs) and follow it after review protocol development to reduce the possibility of manipulation of inclusion. Our aim was to investigate the prevalence of differences in study eligibility criteria between non-Cochrane SRs and their pre-registered protocols on PROSPERO, and determined what changes were involved as well as whether those changes were explained. We searched the protocols registered on PROSPERO platform in the year of 2018 and then selected these protocols which full-text have been published up to June 9, 2020. A random sample (n = 100) was included. Published full-texts were identified through the protocol's final publication citation. The following five key components of study eligibility criteria were compared: participants, intervention(s)/exposure(s), comparator(s), types of study design, and outcome(s). A total of 90% of included SRs exhibited differences in study eligibility criteria, and 59/90 altered in no less than two key components. Only one SR reported and explained the rationale for changes to the individual key component (the definition of exposure). The "Outcome(s)" exhibited the greatest variation, with changes in 61% of the SRs. The "Comparator(s)/control" exhibited the smallest variation, with changes in 20% of the SRs. Differences in study eligibility criteria between the non-Cochrane SRs and their protocols registered on PROSPERO were widespread but were seldom explained. Authors themselves, PROSPERO platform, as well as peer-review journals and their peer-reviewers should play a role in further improving transparency.
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A systematic review and network meta-analysis protocol of adjuvant chemotherapy regimens for resected gastric cancer
Background: Gastric cancer is the third leading cause of cancer death in the world. The benefit of adjuvant chemotherapy has been demonstrated by published individual patient data meta-analysis and Cochrane systematic review. However, there is no consensus on which is the optimal adjuvant chemotherapy regimens. Present network meta-analysis aims to compare the differences of effect between all available adjuvant chemotherapy regimens in improving overall survival and disease-free survival, and to rate the certainty of evidence from present network meta-analysis. Methods: We will conduct this systematic review and network meta-analysis using Bayesian method and according to Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. We will search PubMed, EMBASE.com, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese National Knowledge Infrastructure (CNKI), and Chinese Biological Medical Database (CBM), and ClinicalTrials.gov () to identify randomized controlled trials (RCTs) comparing adjuvant chemotherapy to surgery alone. We will assess the risk of bias of individual RCTs using a modified version of Cochrane tool. We will also use the advance of GRADE to rate the certainty of network meta-analysis. Data analysis will be performed with R-3.4.1 and WinBUGS software. Results: The results of this study will be published in a peer-reviewed journal. Discussion: To the best of our knowledge, this systematic review and network meta-analysis will firstly use both direct and indirect evidence to compare the differences of all available adjuvant chemotherapy regimens for resected gastric cancer patients. This is a protocol of systematic review and meta-analysis, so the ethical approval and patient consent are not required.
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Point-of-care ultrasound for pulmonary concerns in remote spaceflight triage environments
INTRODUCTION: With the development of the commercial space industry, growing numbers of spaceflight participants will engage in activities with a risk for pulmonary injuries, including pneumothorax, ebullism, and decompression sickness, as well as other concomitant trauma. Medical triage capabilities for mishaps involving pulmonary conditions have not been systematically reviewed. Recent studies have advocated the use of point-of-care ultrasound to screen for lung injury or illness. The operational utility of portable ultrasound systems in disaster relief and other austere settings may be relevant to commercial spaceflight. METHODS: A systematic review of published literature was conducted concerning the use of point-of-care pulmonary ultrasound techniques in austere environments, including suggested examination protocols for triage and diagnosis. RESULTS: Recent studies support the utility of pulmonary ultrasound examinations when performed by skilled operators, and comparability of the results to computed tomography and chest radiography for certain conditions, with important implications for trauma management in austere environments. DISCUSSION: Pulmonary injury and illness are among the potential health risks facing spaceflight participants. Implementation of point-of-care ultrasound protocols could aid in the rapid diagnosis, triage, and treatment of such conditions. Though operator-dependent, ultrasound, with proper training, experience, and equipment, could be a valuable tool in the hands of a first responder supporting remote spaceflight operations.
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Lessons from a decade of individual-based models for infectious disease transmission: a systematic review (2006-2015).
Background: Individual-based models (IBMs) are useful to simulate events subject to stochasticity and/or heterogeneity, and have become well established to model the potential (re)emergence of pathogens (e.g., pandemic influenza, bioterrorism). Individual heterogeneity at the host and pathogen level is increasingly documented to influence transmission of endemic diseases and it is well understood that the final stages of elimination strategies for vaccine-preventable childhood diseases (e.g., polio, measles) are subject to stochasticity. Even so it appears IBMs for both these phenomena are not well established. We review a decade of IBM publications aiming to obtain insights in their advantages, pitfalls and rationale for use and to make recommendations facilitating knowledge transfer within and across disciplines. Methods: We systematically identified publications in Web of Science and PubMed from 2006-2015 based on title/abstract/keywords screening (and full-text if necessary) to retrieve topics, modeling purposes and general specifications. We extracted detailed modeling features from papers on established vaccine-preventable childhood diseases based on full-text screening. Results: We identified 698 papers, which applied an IBM for infectious disease transmission, and listed these in a reference database, describing their general characteristics. The diversity of disease-topics and overall publication frequency have increased over time (38 to 115 annual publications from 2006 to 2015). The inclusion of intervention strategies (8 to 52) and economic consequences (1 to 20) are increasing, to the detriment of purely theoretical explorations. Unfortunately, terminology used to describe IBMs is inconsistent and ambiguous. We retrieved 24 studies on a vaccine-preventable childhood disease (covering 7 different diseases), with publication frequency increasing from the first such study published in 2008. IBMs have been useful to explore heterogeneous between- and within-host interactions, but combined applications are still sparse. The amount of missing information on model characteristics and study design is remarkable. Conclusions: IBMs are suited to combine heterogeneous within- and between-host interactions, which offers many opportunities, especially to analyze targeted interventions for endemic infections. We advocate the exchange of (open-source) platforms and stress the need for consistent "branding". Using (existing) conventions and reporting protocols would stimulate cross-fertilization between research groups and fields, and ultimately policy making in decades to come.
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Integration of sexually transmitted infection (STI) services into HIV care and treatment services for women living with HIV: A systematic review
OBJECTIVE: To review and critically appraise the existing evidence on integration of sexually transmitted infection (STI) services into HIV care and treatment services for women living with HIV. DESIGN: Systematic review. DATA SOURCES: Four electronic databases were searched through 16February 2017 using keywords for HIV, STIs and integration. Reference lists of included articles and other reviews were also screened. REVIEW METHODS: We included studies that compared women living with HIV who received STI services integrated into HIV care and treatment services with those who received HIV care and treatment services without integrated STI services or standard of care. RESULTS: Of 170 articles identified, 3 studies reported in 4 articles were included. Two studies evaluated comprehensive care for people living with HIV in the UK; in both cases, quality and uptake of STI services seemed to improve following integration. The third study conducted a comparative case study across different models of care in Swaziland: two clinics integrated with sexual and reproductive health services (including STI services), and two stand-alone HIV clinics (without STI services). Coverage for Pap smears among women living with HIV was higher at the fully integrated site, but there was no significant difference in the prevalence of sexual health screening or advice on sexual health. Reported client satisfaction was generally higher at the stand-alone HIV clinic, and a diverse range of factors related to implementation of different care models challenged the notion that integrated services are always superior or desired. CONCLUSION: While there is a limited evidence base for integrating STI services into HIV care and treatment services, existing studies indicate that integration is feasible and has the potential for positive outcomes. However, diverse population needs and health system factors must be considered when designing models of care to provide STI services to women living with HIV.
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