Search

To investigate reporting and methodological characteristics of overviews on adverse (drug-associated) events (AEs) of pharmacological interventions.We searched MEDLINE, Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews from inception to May 17, 2021 for overviews exclusively investigating AEs of pharmacological interventions. We extracted general, reporting, and methodological characteristics and analyzed data descriptively.We included 27 overviews, 70% of which were published in 2016 or later. The most common nomenclature in the title was "overview" (56%), followed by "umbrella review" (26%). The median number of included systematic reviews (SRs) in each overview was 15 (interquartile range 7-34). Study selection methods were reported in 52%, methods for data extraction in 67%, and methods for critical appraisal in 63% of overviews. An assessment of methodological quality of included SRs was performed in 70% of overviews. Only 22% of overviews reported strategies for dealing with overlapping SRs. An assessment of the certainty of the evidence was performed in 33% of overviews.To ensure methodological rigor, authors of overviews on AEs should follow available guidance for the conduct and reporting of overviews.

Aim The aim of this meta-analysis was to evaluate the impact of continuous glucose monitoring (CGM) systems on short- and long-term glycemic control in children and adolescents diagnosed with diabetes type 1. Methods The review was registered in PROSPERO (CRD42019135152). We partly updated a formerly published systematic review and searched several databases (Ovid MEDLINE, Embase, CENTRAL, and Clinicaltrials.gov) in May 2019. Summary measures were estimated as relative risks (RR) and standardized mean differences (SMD). The primary endpoint of our analysis was frequency of hypoglycemic events. Quality of evidence was evaluated using the GRADE approach. Results Eleven studies with a total number of 818 patients were included in our review. Meta-analyses indicated a potential benefit of CGM systems regarding the relative risk of a severe hypoglycemic event (RR 0.78; 95% CI 0.29 to 2.04) and mean level of HbA1c at end of study (SMD -0.23; 95% CI -0.46 to 0.00). Certainty of evidence for effect estimates of these meta-analyses was low due to risk of selection bias and imprecision of the included studies. Qualitative analyses of the secondary outcomes of user satisfaction and long-term development of blood glucose supported these findings. Conclusion CGM systems may improve glycemic control in children and adolescents diagnosed with diabetes type 1, but the imprecision of effects is still a problem. Only a few studies examined and reported data for pediatric populations in sufficient detail. Further research is needed to clarify advantages and disadvantages of CGM systems in children and adolescents.

BACKGROUND: The development of severe coronavirus disease 2019 (COVID-19) and poor clinical outcomes are associated with hyperinflammation and a complex dysregulation of the immune response. Colchicine is an anti-inflammatory medicine and is thought to improve disease outcomes in COVID-19 through a wide range of anti-inflammatory mechanisms. Patients and healthcare systems need more and better treatment options for COVID-19 and a thorough understanding of the current body of evidence. OBJECTIVES: To assess the effectiveness and safety of Colchicine as a treatment option for COVID-19 in comparison to an active comparator, placebo, or standard care alone in any setting, and to maintain the currency of the evidence, using a living systematic review approach. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register (comprising CENTRAL, MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv), Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index), and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 21 May 2021. SELECTION CRITERIA: We included randomised controlled trials evaluating colchicine for the treatment of people with COVID-19, irrespective of disease severity, age, sex, or ethnicity. We excluded studies investigating the prophylactic effects of colchicine for people without severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but at high risk of SARS-CoV-2 exposure. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. We used the Cochrane risk of bias tool (ROB 2) to assess bias in included studies and GRADE to rate the certainty of evidence for the following prioritised outcome categories considering people with moderate or severe COVID-19: all-cause mortality, worsening and improvement of clinical status, quality of life, adverse events, and serious adverse events and for people with asymptomatic infection or mild disease: all-cause mortality, admission to hospital or death, symptom resolution, duration to symptom resolution, quality of life, adverse events, serious adverse events. MAIN RESULTS: We included three RCTs with 11,525 hospitalised participants (8002 male) and one RCT with 4488 (2067 male) non-hospitalised participants. Mean age of people treated in hospital was about 64 years, and was 55 years in the study with non-hospitalised participants. Further, we identified 17 ongoing studies and 11 studies completed or terminated, but without published results. Colchicine plus standard care versus standard care (plus/minus placebo) Treatment of hospitalised people with moderate to severe COVID-19 All-cause mortality: colchicine plus standard care probably results in little to no difference in all-cause mortality up to 28 days compared to standard care alone (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93 to 1.08; 2 RCTs, 11,445 participants; moderate-certainty evidence). Worsening of clinical status: colchicine plus standard care probably results in little to no difference in worsening of clinical status assessed as new need for invasive mechanical ventilation or death compared to standard care alone (RR 1.02, 95% CI 0.96 to 1.09; 2 RCTs, 10,916 participants; moderate-certainty evidence). Improvement of clinical status: colchicine plus standard care probably results in little to no difference in improvement of clinical status, assessed as number of participants discharged alive up to day 28 without clinical deterioration or death compared to standard care alone (RR 0.99, 95% CI 0.96 to 1.01; 1 RCT, 11,340 participants; moderate-certainty evidence). Quality of life, including fatigue and neurological status: we identified no studies reporting this outcome. Adverse events: the evidence is very uncertain about the effect of colchicine on adverse events compared to placebo (RR 1.00, 95% CI 0.56 to 1.78; 1 RCT, 72 participants; very low-certainty evidence). Serious adverse events: the evidence is very uncertain about the effect of colchicine plus standard care on serious adverse events compared to standard care alone (0 events observed in 1 RCT of 105 participants; very low-certainty evidence). Treatment of non-hospitalised people with asymptomatic SARS-CoV-2 infection or mild COVID-19 All-cause mortality: the evidence is uncertain about the effect of colchicine on all-cause mortality at 28 days (Peto odds ratio (OR) 0.57, 95% CI 0.20 to 1.62; 1 RCT, 4488 participants; low-certainty evidence). Admission to hospital or death within 28 days: colchicine probably slightly reduces the need for hospitalisation or death within 28 days compared to placebo (RR 0.80, 95% CI 0.62 to 1.03; 1 RCT, 4488 participants; moderate-certainty evidence). Symptom resolution: we identified no studies reporting this outcome. Quality of life, including fatigue and neurological status: we identified no studies reporting this outcome. Adverse events: the evidence is uncertain about the effect of colchicine on adverse events compared to placebo . Results are from one RCT reporting treatment-related events only in 4412 participants (low-certainty evidence). Serious adverse events: colchicine probably slightly reduces serious adverse events (RR 0.78, 95% CI 0.61 to 1.00; 1 RCT, 4412 participants; moderate-certainty evidence). Colchicine versus another active treatment (e.g. corticosteroids, anti-viral drugs, monoclonal antibodies) No studies evaluated this comparison. Different formulations, doses, or schedules of colchicine No studies assessed this. AUTHORS' CONCLUSIONS: Based on the current evidence, in people hospitalised with moderate to severe COVID-19 the use of colchicine probably has little to no influence on mortality or clinical progression in comparison to placebo or standard care alone. We do not know whether colchicine increases the risk of (serious) adverse events. We are uncertain about the evidence of the effect of colchicine on all-cause mortality for people with asymptomatic infection or mild disease. However, colchicine probably results in a slight reduction of hospital admissions or deaths within 28 days, and the rate of serious adverse events compared with placebo. None of the studies reported data on quality of life or compared the benefits and harms of colchicine versus other drugs, or different dosages of colchicine. We identified 17 ongoing and 11 completed but not published RCTs, which we expect to incorporate in future versions of this review as their results become available. Editorial note: due to the living approach of this work, we monitor newly published results of RCTs on colchicine on a weekly basis and will update the review when the evidence or our certainty in the evidence changes.

Background: The living systematic review (LSR) approach is based on an ongoing surveillance of the literature and continual updating. A few guidance documents address the conduct, reporting, publishing and appraisal of systematic reviews (SRs), but the methodology described is either not up-to date or not suitable for LSRs and misses additional LSR-specific considerations. The objective of this scoping review is to systematically collate methodological literature and guidance on how to conduct, report, publish and appraise the quality of LSRs. The scoping review will allow the mapping of the existing evidence on the topic to support LSRs authors seeking guidance and identify related gaps. Methods: To achieve our objectives, we will conduct a scoping review to survey and evaluate existing evidence, using the standard scoping review methodology. We will search MEDLINE, EMBASE, and Cochrane using the OVID interface. The search strategy was developed by a researcher experienced in developing literature search strategies with the help of an information specialist. As for searching grey literature, we will seek existing guidelines and handbooks on LSRs from organizations that conduct evidence syntheses using the Lens.org website. Two review authors will extract and catalogue the study data on LSR methodological aspects into a standardized and pilot-tested data extraction form. The main categories will reflect proposed methods for (i) conducting LSRs, (ii) reporting of LSRs, (iii) publishing and (iv) appraising the quality of LSRs. Data synthesis and conclusion: By collecting these data from methodological surveys and papers, as well as existing guidance documents and handbooks on LSRs, we might identify specific issues and components lacking within current LSR methodology. Thus, the systematically obtained findings of the scoping review could be used as basis for the revision of existing methods tools on LSR, for instance a PRISMA statement extension for LSRs.

Aim The aim of this meta-analysis was to evaluate the impact of continuous glucose monitoring (CGM) systems on short- and long-term glycemic control in children and adolescents diagnosed with diabetes type 1. Methods The review was registered in PROSPERO (CRD42019135152). We partly updated a formerly published systematic review and searched several databases (Ovid MEDLINE, Embase, CENTRAL, and Clinicaltrials.gov) in May 2019. Summary measures were estimated as relative risks (RR) and standardized mean differences (SMD). The primary endpoint of our analysis was frequency of hypoglycemic events. Quality of evidence was evaluated using the GRADE approach. Results Eleven studies with a total number of 818 patients were included in our review. Meta-analyses indicated a potential benefit of CGM systems regarding the relative risk of a severe hypoglycemic event (RR 0.78; 95% CI 0.29 to 2.04) and mean level of HbA1c at end of study (SMD -0.23; 95% CI -0.46 to 0.00). Certainty of evidence for effect estimates of these meta-analyses was low due to risk of selection bias and imprecision of the included studies. Qualitative analyses of the secondary outcomes of user satisfaction and long-term development of blood glucose supported these findings. Conclusion CGM systems may improve glycemic control in children and adolescents diagnosed with diabetes type 1, but the imprecision of effects is still a problem. Only a few studies examined and reported data for pediatric populations in sufficient detail. Further research is needed to clarify advantages and disadvantages of CGM systems in children and adolescents.

Background A living systematic review (LSR) is an emerging review type that makes use of continual updating. In the COVID-19 pandemic, we were confronted with a shifting epidemiological landscape, clinical uncertainties and evolving evidence. These unexpected challenges compelled us to amend standard LSR methodology. Objective and outline Our primary objective is to discuss some challenges faced when conducting LSRs in the context of the COVID-19 pandemic, and to provide methodological guidance for others doing similar work. Based on our experience and lessons learned from two Cochrane LSRs and challenges identified in several non-Cochrane LSRs, we highlight methodological considerations, particularly with regards to the study design, interventions and comparators, changes in outcome measure, and the search strategy. We discuss when to update, or rather when not to update the review, and the importance of transparency when reporting changes. Lessons learned and conclusion We learned that a LSR is a very suitable review type for the pandemic context, even in the face of new methodological and clinical challenges. Our experience showed that the decision for updating a LSR depends not only on the evolving disease or emerging evidence, but also on the individual review question and the review teams’ resources.

Background: While the PRISMA 2020 statement is intended to guide the reporting of original systematic reviews, updated systematic reviews, and living systematic reviews (LSRs), its explanation and elaboration document notes that additional considerations for updated systematic reviews and LSRs may need to be addressed. This paper reports the protocol for developing an extension of the PRISMA 2020 statement for LSRs. Methods: We will follow the EQUATOR Network’s guidance for developing health research reporting guidelines. We will review the literature to identify possible items of the PRISMA 2020 checklist that need modification, as well as new items that need to be added. Then, we will survey representatives of different stakeholder groups for their views on the proposed modifications of the PRISMA 2020 checklist. We will summarize, present, and discuss the results of the survey in an online meeting, aiming to reach consensus on the content of the LSR extension. We will then draft the checklist, explanation and elaboration for each item, and flow diagram for the PRISMA 2020 extension. Then, we will share these initial documents with stakeholder representatives for final feedback and approval. Discussion: We anticipate that the PRISMA 2020 extension for LSRs will benefit LSR authors, editors, and peer reviewers of LSRs, as well as different users of LSRs, including guideline developers, policy makers, healthcare providers, patients, and other stakeholders.

Please find detailed information on our protocol in the attached PDF file.