scholarly journals A comparison between two recommendations to conduct and report systematic reviews on drug’s safety

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Ana Penedones ◽  
Carlos Alves ◽  
Francisco Batel Marques
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Case Reports ◽  
Risk Of Bias ◽  
Drug Reactions ◽  
Post Marketing ◽  
Review Question ◽  
Marketing Data

Abstract Background Several recommendations are available to conduct and report a systematic review of adverse drug reactions. This study is aimed at identifying and comparing the methodologies of the two most commonly used recommendations to conduct and report systematic reviews on drug’s safety. Methods Two systematic reviews were conducted following the recommendations “Cochrane Handbook for Systematic Reviews of Interventions” and “Systematic Reviews’ Centre for Reviews and Dissemination guidance for undertaking reviews in healthcare.” The methods of each recommendation were characterized, and the results and the discussion of each systematic review were also evaluated. Results The methodologies of both recommendations are similar. The review question was structured. Both recommendations suggest to include pre- and post-marketing data. The recommended data sources differed and, consequently, the results of the systematic reviews (37 vs. 35 studies). Other aspects of search literature were identical. Different tools are suggested to evaluate the methodological quality of the included studies. For case reports, both recommendations only report some questions that may be helpful to assess risk of bias. The reporting of the results and discussion is also identical for both recommendations. Conclusions Few methodological differences were observed between the analyzed recommendations to conduct a systematic review on drug’s safety. Combining their methods into a single and recognized recommendation could be of great value.

P14.71 An assessment of the reporting and methodological quality of meningioma systematic reviews and meta-analyses

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii51-ii52
Author(s):  
A M George ◽  
S Gupta ◽  
S M Keshwara ◽  
M A Mustafa ◽  
C S Gillespie ◽  
...  
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Neurofibromatosis Type ◽  
Risk Of Bias ◽  
Measurement Tool ◽  
High Quality ◽  
Meta Analyses

Abstract BACKGROUND Systematic reviews and meta-analyses constitute the highest level of research evidence and for a disease with limited clinical trial activity, are often relied upon to help inform clinical practice. This review of reviews evaluates both the reporting & methodological quality of meningioma evidence syntheses. MATERIAL AND METHODS Potentially eligible meningioma reviews published between 1st January 1990 and 31st December 2020 were identified from eight electronic databases. Inclusion required the study to meet the Cochrane guideline definition of a systematic review or meta-analysis. Reviews concerning neurofibromatosis type 2, spinal and pediatric meningiomas were excluded. The reporting and methodological quality of articles were assessed against the following modified guidelines: Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), A MeaSurement Tool to Assess Systematic Reviews (AMSTAR2) and the Risk of Bias in Systematic Reviews (ROBIS) guidelines. RESULTS 117 systematic reviews were identified, 57 of which included meta-analysis (48.7%). The number of meningioma systematic reviews published each year has increased with 63 studies (53.9%) published between 01/2018 and 12/2020. A median of 17 studies (IQR 9–29) were included per review. Impact factor of journals publishing a systematic review with or without a meta-analysis was similar (median 2.3 vs 1.8, P=0.397). The mean PRISMA scores for systematic reviews with a meta-analysis was 21.11 (SD 4.1, 78% adherence) and without was 13.89 (SD 3.4, 63% adherence). Twenty-nine systematic reviews with meta-analysis (51%) and 11 without meta-analysis (18%) achieved greater than 80% adherence to PRISMA recommendations. Methodological quality assessment using AMSTAR2 revealed one study (0.9%) as high quality whilst 111 (94.8%) studies were graded as critically low. One hundred and two articles (87.2%) did not utilize a comprehensive search strategy as defined by the AMSTAR2 tool. Ninety-nine studies (84.6%) obtained a high level of concern for potential bias as per the ROBIS assessment. One hundred and eight articles (92.3%) failed to present information that a protocol had been established prior to study commencement and 76 articles (65.0%) did not conduct a risk of bias assessment. Across the three tools, domains relating to the establishment of a protocol prior to review commencement and conducting appropriate risk of bias assessments were frequently low scoring. CONCLUSION Overall reporting and methodological quality of meningioma systematic reviews was sub-optimal. Established critical appraisal tools and reporting guidelines should be utilized a priori to assist in producing high-quality systematic reviews.

scholarly journals The effectiveness and safety of low-level laser therapy on breast cancer–related lymphedema: An overview and update of systematic reviews

2021 ◽  
Author(s):  
Yuping Wang ◽  
Yonggui Ge ◽  
Wenting Xing ◽  
Junping Liu ◽  
Jiqi Wu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Risk Of Bias ◽  
Low Level Laser Therapy ◽  
Level Laser ◽  
Evidence Quality ◽  
Overview Of Systematic Reviews ◽  
Breast Cancer Related Lymphedema

AbstractThe objective of our overview of systematic reviews was to critically analyze the evidence from existing systematic reviews investigating the effectiveness and safety of low-level laser therapy (LLLT) in patients with breast cancer–related lymphedema (BCRL). In addition, an updated and comprehensive systematic review was conducted, which aimed to provide updated evidence about this topic. PubMed, EMBASE, and Cochrane Library databases were systematically searched for systematic reviews and randomized controlled trials (RCTs) investigating the effectiveness and safety of LLLT in patients with BCRL. The methodological quality for each of included systematic reviews or RCTs was assessed using the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR 2) tool or Cochrane risk of bias tool, respectively. The updated systematic review separately compared the effectiveness of LLLT to each of active or negative interventions. Data were pooled with random-effects models for each outcome per comparison. The evidence quality of outcomes was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) or GRADE-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) for quantitative studies and qualitative studies, respectively. Seven systematic reviews and ten RCTs met the eligibility criteria. Conflicting results regarding the effectiveness of LLLT were presented by the overview of systematic reviews. The AMSTAR 2 showed that the methodological quality of included systematic reviews was low or critically low quality due to one or more critical weaknesses. The GRADE and GRADE-CERQual showed that the evidence quality was low to very low for most outcomes. The updated systematic review showed that LLLT may offer additional benefits as compared to compression therapies (pneumatic compression or compression bandage), placebo laser, or no treatment for patients with BCRL. However, when compared to other types of active interventions, LLLT did not improve outcomes significantly. None of the treatment-related adverse event was reported. Many trials had a high or unclear risk of bias for two or more items, and our updated systematic review showed low quality of evidence per outcome using GRADE approach. Due to insufficient data and poor quality of evidence, there is uncertain to reach these conclusions that LLLT is superior to another active or negative intervention and is safe. More RCTs of high methodological quality, with large sample sizes and long-term follow-up, are needed to inform clinical guidelines and routine practice.

scholarly journals Methodological quality of systematic reviews on treatments for depression: a cross-sectional study

2017 ◽  
Vol 27 (6) ◽  
pp. 619-627 ◽  
Author(s):  
V. C. H. Chung ◽  
X. Y. Wu ◽  
Y. Feng ◽  
R. S. T. Ho ◽  
S. Y. S. Wong ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Methodological Quality ◽  
A Priori ◽  
Cross Sectional Study ◽  
Risk Of Bias ◽  
Sectional Study ◽  
Pharmacological Treatments ◽  
Cross Sectional ◽  
Depression Treatments

Aims.Depression is one of the most common mental disorders and identifying effective treatment strategies is crucial for the control of depression. Well-conducted systematic reviews (SRs) and meta-analyses can provide the best evidence for supporting treatment decision-making. Nevertheless, the trustworthiness of conclusions can be limited by lack of methodological rigour. This study aims to assess the methodological quality of a representative sample of SRs on depression treatments.Methods.A cross-sectional study on the bibliographical and methodological characteristics of SRs published on depression treatments trials was conducted. Two electronic databases (the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects) were searched for potential SRs. SRs with at least one meta-analysis on the effects of depression treatments were considered eligible. The methodological quality of included SRs was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. The associations between bibliographical characteristics and scoring on AMSTAR items were analysed using logistic regression analysis.Results.A total of 358 SRs were included and appraised. Over half of included SRs (n = 195) focused on non-pharmacological treatments and harms were reported in 45.5% (n = 163) of all studies. Studies varied in methods and reporting practices: only 112 (31.3%) took the risk of bias among primary studies into account when formulating conclusions; 245 (68.4%) did not fully declare conflict of interests; 93 (26.0%) reported an ‘a priori’ design and 104 (29.1%) provided lists of both included and excluded studies. Results from regression analyses showed: more recent publications were more likely to report ‘a priori’ designs [adjusted odds ratio (AOR) 1.31, 95% confidence interval (CI) 1.09–1.57], to describe study characteristics fully (AOR 1.16, 95% CI 1.06–1.28), and to assess presence of publication bias (AOR 1.13, 95% CI 1.06–1.19), but were less likely to list both included and excluded studies (AOR 0.86, 95% CI 0.81–0.92). SRs published in journals with higher impact factor (AOR 1.14, 95% CI 1.04–1.25), completed by more review authors (AOR 1.12, 95% CI 1.01–1.24) and SRs on non-pharmacological treatments (AOR 1.62, 95% CI 1.01–2.59) were associated with better performance in publication bias assessment.Conclusion.The methodological quality of included SRs is disappointing. Future SRs should strive to improve rigour by considering of risk of bias when formulating conclusions, reporting conflict of interests and authors should explicitly describe harms. SR authors should also use appropriate methods to combine the results, prevent language and publication biases, and ensure timely updates.

scholarly journals Rapid diagnostic test for antenatal syphilis screening in low-income and middle-income countries: a systematic review and meta-analysis

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018132 ◽  
Author(s):  
Carmen Phang Romero Casas ◽  
Marrissa Martyn-St James ◽  
Jean Hamilton ◽  
Daniel S Marinho ◽  
Rodolfo Castro ◽  
...  
Keyword(s):  
Systematic Review ◽  
High Risk ◽  
Diagnostic Accuracy ◽  
Pregnant Women ◽  
Sensitivity And Specificity ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Antenatal Clinics

ObjectivesTo undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women.MethodsFive electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot.ResultsThe methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively.ConclusionsThis review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.PROSPERO registration numberCRD42016036335.

scholarly journals Psychometric properties of the Jefferson Scale of Empathy: a COSMIN systematic review protocol

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Brett Williams ◽  
Bronwyn Beovich
Keyword(s):  
Systematic Review ◽  
Psychometric Properties ◽  
Methodological Quality ◽  
Grey Literature ◽  
Risk Of Bias ◽  
Measurement Properties ◽  
Future Research ◽  
Health Measurement ◽  
Jefferson Scale Of Empathy

Abstract Background Empathy is an important characteristic to possess for healthcare professionals. It has been found to improve communication between professionals and patients and to improve clinical health outcomes. The Jefferson Scale of Empathy (JSE) was developed to measure this quality and has been used extensively, and psychometrically appraised, with a variety of cohorts and in different cultural environments. However, no study has been undertaken to systematically examine the methodological quality of studies which have assessed psychometric factors of the JSE. This systematic review will examine the quality of published papers that have reported on psychometric factors of the JSE. Methods A systematic review of studies which report on the psychometric properties of the JSE will be conducted. We will use a predefined search strategy to identify studies meeting the following eligibility criteria: original data is reported on for at least one of the psychometric measurement properties described in the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist, examines the JSE in a healthcare cohort (using the student, physician or health profession versions of the JSE), and is published from January 2001 and in the English language. Conference abstracts, editorials and grey literature will be excluded. Six electronic databases (Medline, EMBASE, PsychInfo, PubMed, Web of Science and CINAHL) will be systematically searched for articles meeting these criteria and studies will be assessed for eligibility by two review authors. The methodological quality of included papers will be examined using the COSMIN Risk of Bias checklist. Discussion A narrative description of the findings will be presented along with summary tables. Recommendations for use of the JSE with various cohorts and circumstances will be offered which may inform future research in this field. Systematic review registration PROSPERO CRD42018111412

scholarly journals Systematic Reviews and Meta-Analysis in Spine Surgery—How Good Are They in Methodological Quality? A Systematic Review

2020 ◽  
pp. 219256822090681 ◽  
Author(s):  
Muthu Sathish ◽  
Ramakrishnan Eswar
Keyword(s):  
Systematic Review ◽  
Spine Surgery ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Eligibility Criteria ◽  
Cochrane Database ◽  
Critical Flaw ◽  
Meta Analyses

Study Design: Systematic review. Objectives: To assess the methodological quality of systematic reviews and meta-analyses in spine surgery over the past 2 decades. Materials and Methods: We conducted independent and in duplicate systematic review of the published systematic reviews and meta-analyses between 2000 and 2019 from PubMed Central and Cochrane Database pertaining to spine surgery involving surgical intervention. We searched bibliographies to identify additional relevant studies. Methodological quality was evaluated with AMSTAR score and graded with AMSTAR 2 criteria. Results: A total of 96 reviews met the eligibility criteria, with mean AMSTAR score of 7.51 (SD = 1.98). Based on AMSTAR 2 criteria, 13.5% (n = 13) and 18.7% (n = 18) of the studies had high and moderate level of confidence of results, respectively, without any critical flaws. A total of 29.1% (n = 28) of the studies had at least 1 critical flaw and 38.5% (n = 37) of the studies had more than 1 critical flaw, so that their results have low and critically low confidence, respectively. Failure to analyze the conflict of interest of authors of primary studies included in review and lack of list of excluded studies with justification were the most common critical flaw. Regression analysis demonstrated that studies with funding and studies published in recent years were significantly associated with higher methodological quality. Conclusion: Despite improvement in methodological quality of systematic reviews and meta-analyses in spine surgery in current decade, a substantial proportion continue to show critical flaws. With increasing number of review articles in spine surgery, stringent measures must be taken to adhere to methodological quality by following PRISMA and AMSTAR guidelines to attain higher standards of evidence in published literature.

scholarly journals A Protocol for the Use of Case Reports/Studies and Case Series in Systematic Reviews for Clinical Toxicology

2021 ◽  
Vol 8 ◽  
Author(s):  
Aboubakari Nambiema ◽  
Grace Sembajwe ◽  
Juleen Lam ◽  
Tracey Woodruff ◽  
Daniele Mandrioli ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Human Subjects ◽  
Case Reports ◽  
Case Series ◽  
Risk Of Bias ◽  
Clinical Toxicology ◽  
New Drugs ◽  
Control Group ◽  
Quality Of Evidence

Introduction: Systematic reviews are routinely used to synthesize current science and evaluate the evidential strength and quality of resulting recommendations. For specific events, such as rare acute poisonings or preliminary reports of new drugs, we posit that case reports/studies and case series (human subjects research with no control group) may provide important evidence for systematic reviews. Our aim, therefore, is to present a protocol that uses rigorous selection criteria, to distinguish high quality case reports/studies and case series for inclusion in systematic reviews.Methods: This protocol will adapt the existing Navigation Guide methodology for specific inclusion of case studies. The usual procedure for systematic reviews will be followed. Case reports/studies and case series will be specified in the search strategy and included in separate sections. Data from these sources will be extracted and where possible, quantitatively synthesized. Criteria for integrating cases reports/studies and case series into the overall body of evidence are that these studies will need to be well-documented, scientifically rigorous, and follow ethical practices. The instructions and standards for evaluating risk of bias will be based on the Navigation Guide. The risk of bias, quality of evidence and the strength of recommendations will be assessed by two independent review teams that are blinded to each other.Conclusion: This is a protocol specified for systematic reviews that use case reports/studies and case series to evaluate the quality of evidence and strength of recommendations in disciplines like clinical toxicology, where case reports/studies are the norm.

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