Cochrane Database of Systematic Reviews最新文献

{"title":"Continuation versus discontinuation of intravenous oxytocin in the active phase of labour.","authors":"Sidsel Boie, Niels Uldbjerg, Pinar Bor, Jim G Thornton, Irene M de Graaf, Camille Le Ray, Julie Glavind, François Goffinet, Aude Girault","doi":"10.1002/14651858.CD015995","DOIUrl":"10.1002/14651858.CD015995","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of discontinuing intravenous oxytocin stimulation in pregnant women during the active phase of induced or augmented labour.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD015995"},"PeriodicalIF":8.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecular biomarkers for predicting complete response to preoperative chemoradiation in people with locally advanced rectal cancer.","authors":"Penelope A De Lacavalerie, Sarah J Lord, Matthew J Morgan, Catherine E Caldon, Maija Rj Kohonen-Corish","doi":"10.1002/14651858.CD014718","DOIUrl":"10.1002/14651858.CD014718","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: Primary objectives To identify and estimate the prognostic value of molecular biomarkers as predictors of pathological complete response to neoadjuvant chemoradiotherapy in people with locally advanced rectal cancer. summarises the review question in population, index prognostic factor, comparator prognostic factor(s), outcome, timing, and setting (PICOTS) format. [Table: see text] [Figure: see text] Secondary objectives To explore the following biomarker measurement, treatment, and study design factors as possible sources of heterogeneity in the association between the prognostic factor and pathological response: type of assay/measurement method, biomarker positivity criteria or cut-off point, chemotherapy regimen, and radiotherapy regimen.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD014718"},"PeriodicalIF":8.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early versus delayed timing of vitrectomy after open-globe injury.","authors":"David McMaster, Sophia Halliday, Syeda F Hussain, Theofilos Kempapidis, Lana S Bush, Marcus Colyer, Scott F McClellan, Sarah Miller, Grant Justin, Rupesh Agrawal, Annette K Hoskin, Kara Cavuoto, James Leong, Andrés Manuel Rousselot Ascarza, Fasika A Woreta, John Cason, Kyle Miller, Matthew C Caldwell, William Gensheimer, Tom H Williamson, Felipe Dhawahir-Scala, Peter Shah, Andrew Coombes, Gangadhara Sundar, Robert Mazzoli, Malcolm Woodcock, Stephanie L Watson, Ferenc Kuhn, Renata S M Gomes, Richard J Blanch","doi":"10.1002/14651858.CD016086","DOIUrl":"10.1002/14651858.CD016086","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of early versus delayed timing of vitrectomy after open-globe injury on visual outcomes.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD016086"},"PeriodicalIF":8.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Resistance training for fatigue in people with cancer.","authors":"Moritz Ernst, Carina Wagner, Annika Oeser, Sarah Messer, Andreas Wender, Nora Cryns, Paul J Bröckelmann, Ulrike Holtkamp, Freerk T Baumann, Joachim Wiskemann, Ina Monsef, Roberta W Scherer, Shiraz I Mishra, Nicole Skoetz","doi":"10.1002/14651858.CD015518","DOIUrl":"10.1002/14651858.CD015518","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Cancer-related fatigue (CRF) is one of the most common symptoms associated with cancer and its treatment. Different types of exercise have demonstrated beneficial effects on CRF. Previous evidence syntheses provided promising but inconclusive results when focusing on the effects of resistance training.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To evaluate the effects of resistance training on CRF in people with cancer and, specifically, to compare the effects of resistance training with no training on CRF at: different periods of treatment in relation to anticancer therapy (before, during, or after anticancer therapy); different periods of assessment (up to 12 weeks after the intervention, between more than 12 weeks and less than six months after the intervention, or six months or longer after the intervention). Moreover, we wanted to compare the effects of resistance training with no training on quality of life (QoL), adverse events, depression, and anxiety.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We performed an extensive literature search in eight databases including CENTRAL, Medline, and Embase in October 2023. We searched trial registries for ongoing studies, and we integrated results from update searches of previously published Cochrane reviews.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Selection criteria: &lt;/strong&gt;We included randomised controlled trials (RCTs) that compared resistance training with no training in adults with any type of cancer who received resistance training initiated before, during, or after anticancer therapy. Eligible RCTs needed to evaluate CRF or QoL. Resistance training had to be structured, last for at least five sessions, and include face-to-face instruction. We excluded studies that randomised fewer than 20 participants per group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data collection and analysis: &lt;/strong&gt;We used standard Cochrane methodology. For analyses, we pooled short-term, medium-term, and long-term effects (i.e. up to 12 weeks, between more than 12 weeks and less than six months, and six months or longer, after the intervention). We assessed risk of bias and certainty of the evidence using Cochrane's risk of bias tool (RoB 1), and the GRADE approach, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main results: &lt;/strong&gt;We included 21 RCTs with a total of 2221 participants, with diverse types of cancer, who received resistance training initiated during (14 studies), or after (7 studies) anticancer therapy. None of the studies investigated the effects of resistance training initiated before anticancer therapy. Here, we present the results on CRF, QoL, and adverse events. Results on depression and anxiety are reported in the full review. Resistance training during anticancer therapy Resistance training probably has a beneficial effect compared with no training on short-term CRF (mean difference (MD) on Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-Fatigue) 3.90, 95% confidence interval (CI) 1.30 to 6.51; scale from 0 to 52, hig","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD015518"},"PeriodicalIF":8.8,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum and urine nucleic acid screening tests for BK polyomavirus-associated nephropathy in kidney and kidney-pancreas transplant recipients.","authors":"Thida Maung Myint, Chanel H Chong, Amy von Huben, John Attia, Angela C Webster, Christopher D Blosser, Jonathan C Craig, Armando Teixeira-Pinto, Germaine Wong","doi":"10.1002/14651858.CD014839.pub2","DOIUrl":"10.1002/14651858.CD014839.pub2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;BK polyomavirus-associated nephropathy (BKPyVAN) occurs when BK polyomavirus (BKPyV) affects a transplanted kidney, leading to an initial injury characterised by cytopathic damage, inflammation, and fibrosis. BKPyVAN may cause permanent loss of graft function and premature graft loss. Early detection gives clinicians an opportunity to intervene by timely reduction in immunosuppression to reduce adverse graft outcomes. Quantitative nucleic acid testing (QNAT) for detection of BKPyV DNA in blood and urine is increasingly used as a screening test as diagnosis of BKPyVAN by kidney biopsy is invasive and associated with procedural risks. In this review, we assessed the sensitivity and specificity of QNAT tests in patients with BKPyVAN.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;We assessed the diagnostic test accuracy of blood/plasma/serum BKPyV QNAT and urine BKPyV QNAT for the diagnosis of BKPyVAN after transplantation. We also investigated the following sources of heterogeneity: types and quality of studies, era of publication, various thresholds of BKPyV-DNAemia/BKPyV viruria and variability between assays as secondary objectives.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We searched MEDLINE (OvidSP), EMBASE (OvidSP), and BIOSIS, and requested a search of the Cochrane Register of diagnostic test accuracy studies from inception to 13 June 2023. We also searched ClinicalTrials.com and the WHO International Clinical Trials Registry Platform for ongoing trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Selection criteria: &lt;/strong&gt;We included cross-sectional or cohort studies assessing the diagnostic accuracy of two index tests (blood/plasma/serum BKPyV QNAT or urine BKPyV QNAT) for the diagnosis of BKPyVAN, as verified by the reference standard (histopathology). Both retrospective and prospective cohort studies were included. We did not include case reports and case control studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data collection and analysis: &lt;/strong&gt;Two authors independently carried out data extraction from each study. We assessed the methodological quality of the included studies by using Quality Assessment of Diagnostic-Accuracy Studies (QUADAS-2) assessment criteria. We used the bivariate random-effects model to obtain summary estimates of sensitivity and specificity for the QNAT test with one positivity threshold. In cases where meta-analyses were not possible due to the small number of studies available, we detailed the descriptive evidence and used a summative approach. We explored possible sources of heterogeneity by adding covariates to meta-regression models.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main results: &lt;/strong&gt;We included 31 relevant studies with a total of 6559 participants in this review. Twenty-six studies included kidney transplant recipients, four studies included kidney and kidney-pancreas transplant recipients, and one study included kidney, kidney-pancreas and kidney-liver transplant recipients. Studies were carried out in South Asia and the Asia-Pacific region (12 stud","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD014839"},"PeriodicalIF":8.8,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fenoldopam for preventing and treating acute kidney injury.","authors":"Christopher I Esezobor, Girish C Bhatt, Emmanuel E Effa, Elisabeth M Hodson","doi":"10.1002/14651858.CD012905.pub2","DOIUrl":"10.1002/14651858.CD012905.pub2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Fenoldopam is a short-acting benzazepine selective dopaminergic A1 (DA1) receptor agonist with increased activity at the D1 receptor compared with dopamine. Activation of the DA1 receptors increases kidney blood flow because of dilatation of the afferent and efferent arterioles. Previous reviews have been published on the efficacy and safety of fenoldopam for acute kidney injury (AKI); however, they either combined data on its effect on both prevention and treatment of AKI, focused on only those undergoing cardiac surgery and/or excluded children.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This review aimed to assess the benefits and harms of fenoldopam for the prevention or treatment of AKI in children and adults.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We searched the Cochrane Kidney and Transplant Register of Studies up to 12 November 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Selection criteria: &lt;/strong&gt;We included randomised controlled trials (RCTs) evaluating fenoldopam for the prevention or treatment of AKI in children and adults following surgery, radiocontrast exposure or sepsis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data collection and analysis: &lt;/strong&gt;Two authors independently assessed studies for eligibility, assessed the studies for risk of bias and extracted data from the studies. Dichotomous outcomes were presented as relative risk (RR) with 95% confidence intervals (CI). For continuous outcomes, the mean difference (MD) with 95% CI was used. Statistical analysis was performed using the random-effects model. We assessed the certainty of the evidence using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main results: &lt;/strong&gt;We identified 25 RCTs, including 3339 randomised participants. Twenty-three studies used fenoldopam for preventing AKI and two for the treatment of AKI. Nine studies included participants undergoing cardiac surgery, and one included children. The risks of bias for sequence generation and concealment were low in 11 and 13 studies, respectively. Only 13 and 18 studies were at low risk of performance bias and detection bias, respectively. The risk of attrition bias and selective reporting were judged to be at low risk of bias in 17 and 10 studies, respectively. We included data in the meta-analyses from eight of the 14 studies comparing fenoldopam with placebo or saline, all six studies comparing fenoldopam with dopamine, all five studies comparing fenoldopam with N-acetylcysteine (NAC) for the prevention of AKI and from the two studies comparing fenoldopam with placebo or saline for the treatment of AKI. Compared with placebo or saline fenoldopam probably results in fewer participa","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD012905"},"PeriodicalIF":8.8,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosimilar monoclonal antibodies for cancer treatment in adults.","authors":"Tais F Galvao, Annemeri Livinalli, Luciane C Lopes, Ivan R Zimmermann, Marcus Tolentino Silva","doi":"10.1002/14651858.CD013539.pub2","DOIUrl":"10.1002/14651858.CD013539.pub2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Biosimilars are products containing an approved biological medicine. They are similar, but not identical, to an originator medicine. In cancer, biosimilars have been developed from the monoclonal antibodies, bevacizumab, rituximab, and trastuzumab. They have become available for the treatment of lung, colorectal, non-Hodkin's lymphoma, and breast cancers. As these biological products are not identical, synthesis of evidence of the clinical effects of biosimilars compared to their originators is needed to understand their comparative effectiveness and harms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To evaluate the benefits and harms of biosimilar monoclonal antibodies versus their originator drugs for adults with cancer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We searched bibliographic (CENTRAL, MEDLINE, Embase, Web of Science) and clinical trials databases to February 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Selection criteria: &lt;/strong&gt;We included head-to-head randomised controlled trials conducted in adults with cancer treated with biosimilar or originator monoclonal antibodies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data collection and analysis: &lt;/strong&gt;We followed standard Cochrane methodology. Primary outcomes were progression-free survival, duration of response, overall survival, breast cancer's pathological complete response, serious adverse events, and health-related quality of life. If survival estimates were adjusted or provided as rates, we did not combine them. We used Cochrane's RoB 1 tool to assess the risk of bias and GRADE to evaluate the certainty of evidence of critical and important outcomes according to the relevance determined by consumers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main results: &lt;/strong&gt;We included 55 studies with 22,046 adults (23 of bevacizumab, 10,639 participants with colorectal or lung cancer; 17 of rituximab, 4412 participants with non-Hodgkin's lymphoma; and 15 of trastuzumab, 6995 participants with breast cancer). Studies were conducted in all continents, most were multicentre, and all were funded by the drug manufacturer. Participants' ages ranged from 47 (mean) to 62 (median) years and the proportion of women from 18% to 100%. Fifteen studies were conducted as non-inferiority and 40 as equivalence. The overall risk of bias was low; main biases were in the incomplete outcome data and selective reporting domains. Bevacizumab biosimilar versus bevacizumab originator in lung or colorectal cancer Progression-free survival is likely similar between bevacizumab biosimilar and the originator (per 1000: 380 in both groups at 12 months, hazard ratio (HR) 1.00, 95% confidence interval (CI) 0.91 to 1.09; 5 studies, 2660 participants; moderate-certainty evidence). There were no differences in lung or colorectal cancer subgroups. Bevacizumab biosimilar is likely similar to the originator in duration of response (per 1000: 219 participants who achieved response progressed with biosimilar versus 210 with originator at 12 months; HR 1.05, 95% CI 0.81 to 1.37; 1 ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD013539"},"PeriodicalIF":8.8,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Psychotherapeutic treatments for depression in older adults.","authors":"Lin Ang, Myeong Soo Lee, Eunhye Song, Hye Won Lee, Liujiao Cao, Jingyi Zhang, Qi Wang, Jeeyoun Jung, Soobin Jang, Chiara Gastaldon, Charles F Reynolds, Pim Cuijpers, Vikram Patel, Corrado Barbui, Liang Yao, Davide Papola","doi":"10.1002/14651858.CD015976","DOIUrl":"10.1002/14651858.CD015976","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of psychotherapeutic interventions in the treatment of older adults with depression and whether the effects of different types of psychotherapeutic treatments vary for older adults with depression.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD015976"},"PeriodicalIF":8.8,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600498/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prophylactic use of inotropic agents for the prevention of low cardiac output syndrome and mortality in adults undergoing cardiac surgery.","authors":"Dwi Gayatri, Jörn Tongers, Ljupcho Efremov, Rafael Mikolajczyk, Daniel Sedding, Julia Schumann","doi":"10.1002/14651858.CD013781.pub2","DOIUrl":"10.1002/14651858.CD013781.pub2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;As the burden of cardiovascular disease grows, so does the number of cardiac surgeries. Surgery is increasingly performed on older people with comorbidities who are at higher risk of developing perioperative complications such as low cardiac output state (LCOS). Surgery-associated LCOS represents a serious pathology responsible for substantial morbidity and mortality. Prevention of LCOS is a critical and worthwhile aim to further improve the outcome and effectiveness of cardiac surgery. However, guidelines consistently report a lack of evidence for pharmacological LCOS prophylaxis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To assess the benefits and harms of the prophylactic use of any inotropic agent to prevent low cardiac output and associated morbidity and mortality in adults undergoing cardiac surgery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We identified trials (without language restrictions) via systematic searches of CENTRAL, MEDLINE, Embase, and CPCI-S Web of Science in October 2022. We checked reference lists from primary studies and review articles for additional references. We also searched two registers of ongoing trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Selection criteria: &lt;/strong&gt;We included randomised controlled trials (RCTs) enrolling adults who underwent cardiac surgery and were prophylactically treated with one or multiple inotropic agent(s) in comparison to any type of control (i.e. standard cardiac care, placebo, other inotropic agents).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data collection and analysis: &lt;/strong&gt;We used established methodological procedures according to Cochrane standards. Two review authors independently extracted data and assessed risk of bias according to a pre-defined protocol. On request, we obtained a reply and additional information from only one of the included study authors. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the certainty of evidence from the studies that contributed data to the meta-analyses for the pre-specified outcomes. Based on the identified studies, there were seven comparison groups: amrinone versus placebo, dopamine versus placebo, milrinone versus placebo, levosimendan versus dobutamine, levosimendan versus milrinone, levosimendan versus standard cardiac care, and levosimendan versus placebo.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main results: &lt;/strong&gt;We identified 29 eligible studies, including 3307 individuals, and four ongoing studies. In general, confidence in the results of the analysed studies was reduced due to relevant study limitations, imprecision, or inconsistency. Domains of concern encompassed inadequate methods of sequence generation and lack of blinding. The majority of trials were small, with only a few included participants, and investigated the prophylactic use of levosimendan. Our meta-analyses showed that levosimendan as compared to placebo may reduce the risk of LCOS (risk ratio (RR) 0.43, 95% confidence i","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"CD013781"},"PeriodicalIF":8.8,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time to publication for results of clinical trials.","authors":"Marian G Showell, Sammy Cole, Mike J Clarke, Nicholas J DeVito, Cindy Farquhar, Vanessa Jordan","doi":"10.1002/14651858.MR000011.pub3","DOIUrl":"10.1002/14651858.MR000011.pub3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Researchers conducting trials have a responsibility to publish the results of their work in a peer-reviewed journal, and failure to do so may introduce bias that affects the accuracy of available evidence. Moreover, failure to publish results constitutes research waste.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To systematically review research reports that followed clinical trials from their inception and their investigated publication rates and time to publication. We also aimed to assess whether certain factors influenced publication and time to publication.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Search methods: &lt;/strong&gt;We identified studies by searching MEDLINE, Embase, Epistemonikos, the Cochrane Methodology Register (CMR) and the database of the US Agency for Healthcare Research and Quality (AHRQ), from inception to 23 August 2023. We also checked reference lists of relevant studies and contacted experts in the field for any additional studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Selection criteria: &lt;/strong&gt;Studies were eligible if they tracked the publication of a cohort of clinical trials and contained analyses of any aspect of the publication rate or time to publication of these trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Data collection and analysis: &lt;/strong&gt;Two review authors performed data extraction independently. We extracted data on the prevalence of publication and the time from the trial start date or completion date to publication. We also extracted data from the clinical trials included in the research reports, including country of the study's first author, area of health care, means by which the publication status of these trials were sought and the risk of bias in the trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main results: &lt;/strong&gt;A total of 204 research reports tracking 165,135 trials met the inclusion criteria. Just over half (53%) of these trials were published in full. The median time to publication was approximately 4.8 years from the enrolment of the first trial participant and 2.1 years from the trial completion date. Trials with positive results (i.e. statistically significant results favouring the experimental arm) were more likely to be published than those with negative or null results (OR 2.69, 95% CI 2.02 to 3.60; 19 studies), and they were published in a shorter time (adjusted HR 1.92, 95% CI 1.51 to 2.45; 4 studies). On average, trials with positive results took 2 years to publish, whereas trials with negative or null results took 2.6 years. Large trials were more likely to be published than smaller ones (adjusted OR 1.92, 95% CI 1.33 to 2.77; 11 studies), and they were published in a shorter time (adjusted HR 1.41, 95% CI 1.18 to 1.68; 7 studies). Multicentre trials were more likely to be published than single-centre trials (adjusted OR 1.20, 95% CI 1.03 to 1.40; 2 studies). We found no difference between multicentre and single-centre trials in time to publication. Trials funded by non-industry sources (e.g.governments or universities) were more likely to be published ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"11 ","pages":"MR000011"},"PeriodicalIF":8.8,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}