Cochrane Collaboration

About: Cochrane Collaboration is a nonprofit organization based out in Oxford, United Kingdom. It is known for research contribution in the topics: Systematic review & Randomized controlled trial. The organization has 1995 authors who have published 3928 publications receiving 382695 citations.

ERS/ESTS/EACTS/ESTRO guidelines for the management of malignant pleural mesothelioma

Abstract: The European Respiratory Society (ERS)/European Society of Thoracic Surgeons (ESTS)/European Association for Cardio-Thoracic Surgery (EACTS)/European Society for Radiotherapy and Oncology (ESTRO) task force brought together experts to update previous 2009 ERS/ESTS guidelines on management of malignant pleural mesothelioma (MPM), a rare cancer with globally poor outcome, after a systematic review of the 2009-2018 literature. The evidence was appraised using the Grading of Recommendations, Assessment, Development and Evaluation approach. The evidence syntheses were discussed and recommendations formulated by this multidisciplinary group of experts. Diagnosis: pleural biopsies remain the gold standard to confirm the diagnosis, usually obtained by thoracoscopy but occasionally via image-guided percutaneous needle biopsy in cases of pleural symphysis or poor performance status. Pathology: standard staining procedures are insufficient in ∼10% of cases, justifying the use of specific markers, including BAP-1 and CDKN2A (p16) for the separation of atypical mesothelial proliferation from MPM. Staging: in the absence of a uniform, robust and validated staging system, we advise using the most recent 2016 8th TNM (tumour, node, metastasis) classification, with an algorithm for pre-therapeutic assessment. Monitoring: patient's performance status, histological subtype and tumour volume are the main prognostic factors of clinical importance in routine MPM management. Other potential parameters should be recorded at baseline and reported in clinical trials. Treatment: (chemo)therapy has limited efficacy in MPM patients and only selected patients are candidates for radical surgery. New promising targeted therapies, immunotherapies and strategies have been reviewed. Because of limited data on the best combination treatment, we emphasise that patients who are considered candidates for a multimodal approach, including radical surgery, should be treated as part of clinical trials in MPM-dedicated centres.

Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report.

Abstract: Objective Scientific and ethical justification for new clinical trials requires them to have been designed in the light of scientifically defensible assessments of relevant previous research. Reliable interpretation of the results of new clinical trials entails setting them in the context of updates of the reviews upon which they were deemed scientifically and ethically justifiable. We have shown previously that most reports of randomized trials published in five general medical journals in May 1997 and in May 2001 failed to set their results in the context of the findings from similar research. In the current study, we assess whether there had been progress in this respect in 2005 and also investigate the extent to which reports begin by referring to systematic reviews providing the justification for the new research reported. Design Assessment of the Introduction and Discussion sections in all reports of randomized trials published during May 2005 in five general medical journals. Setting Reports of randomized trials in five general medical journals. Participants Annals of Internal Medicine, BMJ, JAMA, Lancet and New England Journal of Medicine. Interventions None. Main outcome measures The inclusion or mention of one or more systematic reviews in the Introduction or Discussion section of each report assessed. Results We found 18 reports of randomized trials. The Introduction sections referred to systematic reviews in five (27%) of these reports. None of the Discussion sections of the 15 reports of trials that were not the first published trials to address the question studied placed the results of the new trial in the context of an updated systematic review of other research. Although reference was made to relevant systematic reviews in five of these 15 reports, there was no integration—quantitative or qualitative—of the results of the new trials in an update of these reviews. In the remaining ten reports there was no evidence that any systematic attempt had been made to set the new results in the context of previous trials. Conclusions There is no evidence of progress between 1997 and 2005 in the proportion of reports of trials published in general medical journals which discussed new results within the context of up-to-date systematic reviews of relevant evidence from other controlled trials. Although the proportion of trials referring to systematic reviews in Discussion sections has increased, the majority of reports continued to fail even to do this. Similarly, most researchers appear not to have considered a systematic review when designing their trial. Researchers and journal editors do a disservice to the interests of the public and others involved in healthcare decision-making by acquiescing in this situation.

SPIRIT 2013 Statement: defining standard protocol items for clinical trials

Abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Celiac plexus neurolysis for abdominal cancer pain: a systematic review.

Abstract: Objective This systematic review assesses the effectiveness and side effects of celiac plexus neurolysis (CPN) in the treatment of upper abdominal cancer pain, and evaluates whether there are any differences between the percutaneous and endoscopic ultrasound-guided (EUS) denervation techniques. Methods Five databases were searched, expanded by assessing the reference lists of all retrieved papers. Sixty-six publications fulfilled the inclusion/exclusion criteria and were included in the systematic review. Randomized controlled trials were available for the percutaneous CPN, and therefore meta-analyses were performed for pain, opioid consumption, and specific side effects. The quality of life data were too heterogeneous to be assessed by a meta-analysis, and evidence for EUS CPN could only be evaluated by observational studies. Results Meta-analyses show that percutaneous CPN significantly improves pain in patients with upper abdominal cancer, with a decrease in opioid consumption and side effects. It is unclear whether there is any change in quality of life. Case series suggest that EUS CPN improves pain. No conclusion can be made about EUS CPN's influence on opioid consumption. Although CPN is a safe procedure, side effects and complications can occur with both the percutaneous and EUS techniques. Conclusions Following this review, evidence suggests that CPN should be considered in patients with upper abdominal cancer where the pain is not adequately controlled with systemic analgesics or when significant opioid-induced side effects are present. The percutaneous approach remains the standard technique as robust evidence for EUS CPN is lacking.

Artificial and bioartificial support systems for liver failure

Abstract: Background Artificial and bioartificial liver support systems may 'bridge' patients with acute or acute-on-chronic liver failure to liver transplantation or recovery. Objectives To evaluate beneficial and harmful effects of artificial and bioartificial support systems for acute and acute-on-chronic liver failure. Search strategy Trials were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register (September 2002), The Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 3, 2002), MEDLINE (1966 - September 2002), EMBASE (1985 - September 2002), and The Chinese Biomedical Database (September 2002), manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies. Selection criteria Randomised clinical trials on artificial or bioartificial support systems for acute or acute on-chronic liver failure were included irrespective of blinding, publication status, or language. Non-randomised studies were included in explorative analyses. Data collection and analysis Data were extracted independently by three reviewers. Results were presented as relative risks (RR) with 95% confidence intervals (CI). Sources of heterogeneity were explored through sensitivity analyses and meta-regression. The primary outcome was mortality. Main results Twelve trials on artificial or bioartificial support systems versus standard medical therapy (483 patients) and two trials comparing different artificial support systems (105 patients) were included. Most trials had unclear methodological quality. Compared to standard medical therapy, support systems had no significant effect on mortality (RR 0.86; 95% CI 0.65-1.12) or bridging to liver transplantation (RR 0.87; 95% CI 0.73-1.05), but a significant beneficial effect on hepatic encephalopathy (RR 0.67; 95% CI 0.52-0.86). Meta-regression indicated that the effect of support systems depended on the type of liver failure (P = 0.03). In subgroup analyses, artificial support systems appeared to reduce mortality by 33% in acute-on-chronic liver failure (RR 0.67; 95% CI 0.51-0.90), but not in acute liver failure (RR 0.95; 95% CI 0.71-1.29). Two trials comparing artificial support systems showed significant mortality reductions with intermittent versus continuous haemofiltration (RR 0.58; 95% CI 0.36-0.94) and no significant difference between five versus ten hours of charcoal haemoperfusion (RR 1.03; 95% CI 0.65-1.62). The incidence of adverse events was inconsistently reported. Reviewer's conclusions This Review indicates that artificial support systems may reduce mortality in acute-on-chronic liver failure. Artificial and bioartificial support systems did not appear to affect mortality in acute liver failure. However, considering the strength of the evidence additional randomised clinical trials are needed before any support system can be recommended for routine use.