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Intravenous immunoglobulin for treatment of hospitalized COVID-19 patients: an evidence mapping and meta-analysis
Background: The clinical efficacy and safety of intravenous immunoglobulin (IVIg) treatment for COVID-19 remain controversial. This study aimed to map the current status and gaps of available evidence, and conduct a meta-analysis to further investigate the benefit of IVIg in COVID-19 patients. Methods: Electronic databases were searched for systematic reviews/meta-analyses (SR/MAs), primary studies with control groups, reporting on the use of IVIg in patients with COVID-19. A random-effects meta-analysis with subgroup analyses regarding study design and patient disease severity was performed. Our outcomes of interest determined by the evidence mapping, were mortality, length of hospitalization (days), length of intensive care unit (ICU) stay (days), number of patients requiring mechanical ventilation, and adverse events. Results: We included 34 studies (12 SR/MAs, 8 prospective and 14 retrospective studies). A total of 5571 hospitalized patients were involved in 22 primary studies. Random-effects meta-analyses of very low to moderate evidence showed that there was little or no difference between IVIg and standard care or placebo in reducing mortality (relative risk [RR] 0.91; 95% CI 0.78-1.06; risk difference [RD] 3.3% fewer), length of hospital (mean difference [MD] 0.37; 95% CI - 2.56, 3.31) and ICU (MD 0.36; 95% CI - 0.81, 1.53) stays, mechanical ventilation use (RR 0.92; 95% CI 0.68-1.24; RD 2.8% fewer), and adverse events (RR 0.98; 95% CI 0.84-1.14; RD 0.5% fewer) of patients with COVID-19. Sensitivity analysis using a fixed-effects model indicated that IVIg may reduce mortality (RR 0.76; 95% CI 0.60-0.97), and increase length of hospital stay (MD 0.68; 95% CI 0.09-1.28). Conclusion: Very low to moderate certainty of evidence indicated IVIg may not improve the clinical outcomes of hospitalized patients with COVID-19. Given the discrepancy between the random- and fixed-effects model results, further large-scale and well-designed RCTs are warranted
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Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair
Background Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. Therefore, it is critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graL is introduced to the aneurysm in this way. This Cochrane Review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. However, the technique may be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the previous Cochrane Review published in 2017. Objectives To evaluate the benefits and harms of totally percutaneous access compared to cut-down femoral artery access in people undergoing elective bifurcated abdominal endovascular aneurysm repair (EVAR). Search methods We used standard, extensive Cochrane search methods The latest search was 8 April 2022. Selection criteria We included randomised controlled trials in people diagnosed with an AAA comparing totally percutaneous versus surgical cut-down access endovascular repair. We considered all device types. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for ruptured AAAs and those reporting aorto-uni-iliac repairs. Data collection and analysis We used standard Cochrane methods. Our primary outcomes were 1. short-term mortality, 2. failure of aneurysm exclusion and 3. wound infection. Secondary outcomes were 4. major complications (30-day or in-hospital); 5. medium- to long-term (6 and 12 months) complications and mortality; 6. bleeding complications and haematoma; and 7. operating time, duration of intensive treatment unit (ITU) stay and hospital stay. We used GRADE to assess the certainty of evidence for the seven most clinically relevant primary and secondary outcomes. Main results Three studies with 318 participants met the inclusion criteria, 189 undergoing the percutaneous technique and 129 treated by cutdown femoral artery access. One study had a small sample size and did not adequately report the method of randomisation, allocation concealment or preselected outcomes. The other two larger studies had few sources of bias and good methodology; although one study had a high risk of bias in selective reporting. We observed no clear difference in short-term mortality between groups, with only one death occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.06 to 36.18; 2 studies, 181 participants; low-certainty evidence). One study reported failure of aneurysm exclusion. There was one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 1 study, 151 participants; moderate-certainty evidence). For wound infection, there was no clear difference between groups (RR 0.18, 95% CI 0.01 to 3.59; 3 studies, 318 participants; moderate-certainty evidence). There was no clear difference between percutaneous and cut-down femoral artery access groups in major complications (RR 1.21, 95% CI 0.61 to 2.41; 3 studies, 318 participants; moderate-certainty evidence), bleeding complications (RR 1.02, 95% CI 0.29 to 3.64; 2 studies, 181 participants; moderate-certainty evidence) or haematoma (RR 0.88, 95% CI 0.13 to 6.05; 2 studies, 288 participants). One study reported medium- to long-term complications at six months, with no clear differences between the percutaneous and cut-down femoral artery access groups (RR 0.82, 95% CI 0.25 to 2.65; 1 study, 135 participants; moderate-certainty evidence). We detected differences in operating time, with the percutaneous approach being faster than cut-down femoral artery access (mean difference (MD) -21.13 minutes, 95% CI -41.74 to -0.53 minutes; 3 studies, 318 participants; low-certainty evidence). One study reported the duration of ITU stay and hospital stay, with no clear difference between groups. Authors' conclusions Skin puncture may make little to no difference to short-term mortality. There is probably little or no difference in failure of aneurysm exclusion (failure to seal the aneurysms), wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications between the two groups. Compared with exposing the femoral artery, skin puncture may reduce the operating time slightly. We downgraded the certainty of the evidence to moderate and low as a result of imprecision due to the small number of participants, low event rates and wide CIs, and inconsistency due to clinical heterogeneity. As the number of included studies was limited, further research into this technique would be beneficial.
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Use of traditional Chinese medicine for the treatment and prevention of COVID-19 and rehabilitation of COVID-19 patients: An evidence mapping study
Background: The potential effectiveness of traditional Chinese medicine (TCM) against "epidemic diseases " has highlighted the knowledge gaps associated with TCM in COVID-19 management. This study aimed to map the matrix for rigorously assessing, organizing, and presenting evidence relevant to TCM in COVID-19 management.Methods: In this study, we used the methodology of evidence mapping (EM). Nine electronic databases, the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal, , gray literature, reference lists of articles, and relevant Chinese conference proceedings, were searched for articles published until 23 March 2022. The EndNote X9, Rayyan, EPPI, and R software were used for data entry and management.Results: In all, 126 studies, including 76 randomized controlled trials (RCTs) and 50 systematic reviews (SRs), met our inclusion criteria. Of these, only nine studies (7.14%) were designated as high quality: four RCTs were assessed as "low risk of bias " and five SRs as "high quality. " Based on the research objectives of these studies, the included studies were classified into treatment (53 RCTs and 50 SRs, 81.75%), rehabilitation (20 RCTs, 15.87%), and prevention (3 RCTs, 2.38%) groups. A total of 76 RCTs included 59 intervention categories and 57 efficacy outcomes. All relevant trials consistently demonstrated that TCM significantly improved 22 outcomes (i.e., consistent positive outcomes) without significantly affecting four (i.e., consistent negative outcomes). Further, 50 SRs included nine intervention categories and 27 efficacy outcomes, two of which reported consistent positive outcomes and two reported consistent negative outcomes. Moreover, 45 RCTs and 38 SRs investigated adverse events; 39 RCTs and 30 SRs showed no serious adverse events or significant differences between groups.Conclusion: This study provides evidence matrix mapping of TCM against COVID-19, demonstrating the potential efficacy and safety of TCM in the treatment and prevention of COVID-19 and rehabilitation of COVID-19 patients, and also addresses evidence gaps. Given the limited number and poor quality of available studies and potential concerns regarding the applicability of the current clinical evaluation standards to TCM, the effect of specific interventions on individual outcomes needs further evaluation.
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Extending the RIGHT statement for reporting adapted practice guidelines in healthcare: the RIGHT-Ad@pt Checklist protocol
Introduction The adaptation of guidelines is an increasingly used methodology for the efficient development of contextualised recommendations. Nevertheless, there is no specific reporting guidance. The essential Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement could be useful for reporting adapted guidelines, but it does not address all the important aspects of the adaptation process. The objective of our project is to develop an extension of the RIGHT statement for the reporting of adapted guidelines (RIGHT-Ad@pt Checklist). Methods and analysis To develop the RIGHT-Ad@pt Checklist, we will use a multistep process that includes: (1) establishment of a Working Group; (2) generation of an initial checklist based on the RIGHT statement; (3) optimisation of the checklist (an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review by guideline developers and users and a final assessment of adapted guidelines); and (4) approval of the final checklist. At each step of the process, we will calculate absolute frequencies and proportions, use content analysis to summarise and draw conclusions, discuss the results, draft a report and refine the checklist. Ethics and dissemination We have obtained a waiver of approval from the Clinical Research Ethics Committee at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain). We will disseminate the RIGHT-Ad@pt Checklist by publishing into a peer-reviewed journal, presenting to relevant stakeholders and translating into different languages. We will continuously seek feedback from stakeholders, surveil new relevant evidence and, if necessary, update the checklist. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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