scholarly journals Meta-analyses in paediatric surgery are often fragile: implications and consequences

2021 ◽  
Vol 37 (3) ◽  
pp. 363-367
Author(s):  
Arne Schröder ◽  
Oliver J. Muensterer ◽  
Christina Oetzmann von Sochaczewski

Abstract Purpose Meta-analyses occupy the highest level of evidence and thereby guide clinical decision-making. Recently, randomised-controlled trials were evaluated for the robustness of their findings by calculating the fragility index. The fragility index is the number of events that needs to be added to one treatment arm until the statistical significance collapses. We, therefore, aimed to evaluate the robustness of paediatric surgical meta-analyses. Methods We searched MEDLINE for paediatric surgical meta-analyses in the last decade. All meta-analyses on a paediatric surgical condition were eligible for analysis if they based their conclusion on a statistically significant meta-analysis. Results We screened 303 records and conducted a full-text evaluation of 60 manuscripts. Of them, 39 were included in our analysis that conducted 79 individual meta-analyses with significant results. Median fragility index was 5 (Q25–Q75% 2–11). Median fragility in relation to included patients was 0.77% (Q25–Q75% 0.29–1.87%). Conclusion Paediatric surgical meta-analyses are often fragile. In almost 60% of results, the statistical significance depends on less than 1% of the included population. However, as the fragility index is just a transformation of the P value, it basically conveys the same information in a different format. It therefore should be avoided.

Author(s):  
Richard D Riley ◽  
Karel GM Moons ◽  
Thomas PA Debray ◽  
Douglas G Altman ◽  
Gary S Collins

Systematic reviews and meta-analyses identify, evaluate, and summarize prognosis research studies and their findings. The chapter provides a guide to the key components and methods for conducting a systematic review and meta-analysis for each of the four types of prognosis studies. The CHARMS checklist is introduced as a guide to identifying clear review objectives and design, and to extracting the relevant information from each included study. Many existing prognosis studies are at high risk of bias, because (for example) of selective recruitment and reporting. Tools for examining quality of studies are discussed—the QUIPS for prognostic factor research and PROBAST for prognostic model research. The statistical principles of meta-analysis are described, and the key statistics that can be synthesized are outlined. Challenges are identified, such as the potential for publication bias and substantial heterogeneity in published prognostic factor cut points and methods of prognostic factor measurement. Despite these challenges the chapter emphasizes the crucial importance of prognosis reviews for evidence-based guidelines and clinical decision making.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Georgios Maragkos ◽  
Efstathios Papavassiliou ◽  
Martina Stippler ◽  
Aristotelis Filippidis

Abstract INTRODUCTION There is currently no consensus regarding prognosis and management for gunshot wounds to the head (GSWH). To the author’' knowledge, this is the first meta-analysis to study functional outcomes in GSWH. METHODS Five online databases and the reference lists of relevant articles were queried for cohort studies of GSWH reporting factors associated with functional outcome. PRISMA guidelines were followed. Study quality was assessed using the Newcastle–Ottawa scale. Glasgow Outcome Scale (GOS) outcomes were divided into unfavorable (GOS 1-3) and favorable (GOS 4-5). Pooled estimates of odds ratios and 95% confidence intervals were derived using random-effects models. Heterogeneity was assessed with I-square and meta-regression. Funnel-plots were utilized to assess publication bias. RESULTS We identified 35 retrospective cohort studies encompassing 5508 GSWH patients. Out of the factors assessed, the ones significantly associated with unfavorable functional outcome were: postresuscitation GCS 3 to 8 (Odds Ratio 33.2, 95% Confidence Interval [10.1-108.6]), suicide attempt (3.6 [1.7-7.8]), penetration of the dura (10.3 [1.8-60.5]), bullet trajectory through both hemispheres (8.3 [4.1-17.2]), through the ventricles (8.8 [1.6-48.8]), and through multiple lobes (8.6 [2.2-33.5]). No statistical significance was found for unfavorable functional outcome regarding patient age, sex, pupillary response, and the existence of an exit wound. CONCLUSION This is the first systematic review and meta-analysis regarding prognostic factors for neurologic outcomes in patients sustaining GSWH. Such factors can inform clinical decision-making and assist in setting patient and physician expectations in the acute setting. Further research is required to properly incorporate this information into management guidelines.


2010 ◽  
Vol 21 (04) ◽  
pp. 274-286 ◽  
Author(s):  
Jeffrey L. Danhauer ◽  
Carole E. Johnson ◽  
Melissa Mixon

Purpose: To determine if the evidence supports the recommendation of Baha implant systems (Bahas) over unaided conditions in persons with conductive hearing loss due to congenital unilateral aural atresia (CUAA), and if laboratory measures predict patient benefit and satisfaction. Research Design: A systematic review. Methods: The authors constructed and submitted search strings to PubMed and other electronic databases to identify studies in peer-reviewed journals that were at an appropriate level of evidence (systematic reviews, randomized controlled trials, or nonrandomized intervention studies); used outcome measures assessing audibility, localization, or speech-recognition in noise; included patients with CUAA using Bahas; and had intrepretable data. References of all retrieved articles were also hand searched for relevant studies. Evaluation forms were completed by the authors for each of the included studies at all phases of the review including quality assessment and data extraction. Results: The authors reviewed 88 retrieved titles and excluded four that had no relevance to the topic and 67 that were duplicates. Abstracts were reviewed for the remaining 17, and six nonrelevant studies were excluded. The remaining 11 articles were retrieved for full-text review; only three studies met inclusion criteria and were analyzed further. The three studies were not appropriate for a meta-analysis due to limited data, too few participants, and insufficient presentations of results. Qualitative analysis revealed inconsistent findings across audiometric measures, and few significant differences were noted with and without Bahas, yet most participants believed that Bahas improved their quality of life. Laboratory measures did not always predict patient benefit and satisfaction with Bahas. Conclusions: Results were limited for this narrow population having CUAA and the specific criteria used for this review. Audiologic measures generally failed to predict patients' success and/or satisfaction with their Bahas, but most of the included studies showed that patients perceived some benefits. Ideally, clinical decision making should include the highest levels of scientific evidence. However, when evidence is unavailable or does not support a clear-cut recommendation for a particular treatment across patients, as seems to be the case for the use of Bahas with CUAA, then clinicians must rely more heavily on clinical expertise and individual patient preferences in guiding clinical decision making.


Author(s):  
Niels Jonker ◽  
Berna Aslan ◽  
Beatriz Boned ◽  
Fernando Marqués-García ◽  
Carmen Ricós ◽  
...  

AbstractObjectiveKidney markers are some of the most frequently used laboratory tests in patient care, and correct clinical decision making depends upon knowledge and correct application of biological variation (BV) data. The aim of this study was to review available BV data and to provide updated BV estimates for the following kidney markers in serum and plasma; albumin, creatinine, cystatin C, chloride, potassium, sodium and urea.ContentRelevant studies were identified from a historical BV database as well as by systematic literature searches. Retrieved publications were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Meta-analyses of BIVAC compliant studies with similar design were performed to deliver global estimates of within-subject (CVI) and between-subject (CVG) BV estimates. Out of the 61 identified papers, three received a BIVAC grade A, four grade B, 48 grade C, five grade D grade and one was not appraised as it did not report numerical BV estimates. Most studies were identified for creatinine (n=48). BV estimates derived from the meta-analysis were in general lower than previously reported estimates for all analytes except urea. For some measurands, BV estimates may be influenced by age or states of health, but further data are required.SummaryThis review provides updated global BV estimates for kidney related measurands. For all measurands except for urea, these estimates were lower than previously reported.OutlookFor the measurands analyzed in this review, there are sufficient well-designed studies available to publish a trustworthy estimate of BV. However, for a number of newly appearing kidney markers no suitable data is available and additional studies are required.


2020 ◽  
Vol 7 (1) ◽  
pp. e000557 ◽  
Author(s):  
Christopher N Schmickl ◽  
Robert L Owens ◽  
Jeremy E Orr ◽  
Bradley A Edwards ◽  
Atul Malhotra

IntroductionAcetazolamide (AZM) is used for various conditions (eg, altitude sickness, sleep apnoea, glaucoma), but therapy is often limited by its side effect profile. Our objective was to estimate the risk of commonly reported side effects based on meta-analyses. We hypothesised that these risks are dose-dependent.MethodsWe queried MEDLINE/EMBASE (Medical Literature Analysis and Retrieval System Online/Excerpta Medica dataBASE) up until 04/10/2019, including any randomised placebo-controlled trial in which adults received oral AZM versus placebo reporting side effects. Eligibility assessment was performed by two independent reviewers. Data were abstracted by one reviewer who verified key entries at a second time point. For side effects reported by >3 studies a pooled effect estimate was calculated, and heterogeneity assessed via I2; for outcomes reported by >5 studies effect modification by total daily dose (EMbyTDD; <400 mg/d, 400–600 mg/d, >600 mg/d) was assessed via meta-regression. For pre-specified, primary outcomes (paraesthesias, taste disturbances, polyuria and fatigue) additional subgroup analyses were performed using demographics, intervention details, laboratory changes and risk of bias.ResultsWe included 42 studies in the meta-analyses (Nsubjects=1274/1211 in AZM/placebo groups). AZM increased the risk of all primary outcomes (p<0.01, I2 ≤16% and low-to-moderate quality of evidence for all)—the numbers needed to harm (95% CI; nStudies) for each were: paraesthesias 2.3 (95% CI 2 to 2.7; n=39), dysgeusia 18 (95% CI 10 to 38, n=22), polyuria 17 (95% CI 9 to 49; n=22), fatigue 11 (95% CI 6 to 24; n=14). The risk for paraesthesias (beta=1.8 (95% CI 1.1 to 2.9); PEMbyTDD=0.01) and dysgeusia (beta=3.1 (95% CI 1.2 to 8.2); PEMbyTDD=0.02) increased with higher AZM doses; the risk of fatigue also increased with higher dose but non-significantly (beta=2.6 (95% CI 0.7 to 9.4); PEMbyTDD=0.14).DiscussionThis comprehensive meta-analysis of low-to-moderate quality evidence defines risk of common AZM side effects and corroborates dose dependence of some side effects. These results may inform clinical decision making and support efforts to establish the lowest effective dose of AZM for various conditions.


2019 ◽  
Vol 34 (1) ◽  
pp. 3-78 ◽  
Author(s):  
Thomas RE Barnes ◽  
Richard Drake ◽  
Carol Paton ◽  
Stephen J Cooper ◽  
Bill Deakin ◽  
...  

These updated guidelines from the British Association for Psychopharmacology replace the original version published in 2011. They address the scope and targets of pharmacological treatment for schizophrenia. A consensus meeting was held in 2017, involving experts in schizophrenia and its treatment. They were asked to review key areas and consider the strength of the evidence on the risk-benefit balance of pharmacological interventions and the clinical implications, with an emphasis on meta-analyses, systematic reviews and randomised controlled trials where available, plus updates on current clinical practice. The guidelines cover the pharmacological management and treatment of schizophrenia across the various stages of the illness, including first-episode, relapse prevention, and illness that has proved refractory to standard treatment. It is hoped that the practice recommendations presented will support clinical decision making for practitioners, serve as a source of information for patients and carers, and inform quality improvement.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stefano Granieri ◽  
Francesco Sessa ◽  
Alessandro Bonomi ◽  
Sissi Paleino ◽  
Federica Bruno ◽  
...  

Abstract Background Entero-colovesical fistula is a rare complication of various benign and malignant diseases. The diagnosis is prominently based on clinical symptoms; imaging studies are necessary not only to confirm the presence of the fistula, but more importantly to demonstrate the extent and the nature of the fistula. There is still a lack of consensus regarding the if, when and how to repair the fistula. The aim of the study is to review the different surgical treatment options, focus on surgical indications, and explore cumulative recurrence, morbidity, and mortality rates of entero-vesical and colo-vesical fistula patients. Methods A systematic review of the literature was conducted according to PRISMA guidelines. Random effects meta-analyses of proportions were developed to assess primary and secondary endpoints. I2 statistic and Cochran’s Q test were computed to assess inter-studies’ heterogeneity. Results Twenty-two studies were included in the analysis with a total of 861 patients. Meta-analyses of proportions pointed out 5, 22.2, and 4.9% rates for recurrence, complications, and mortality respectively. A single-stage procedure was performed in 75.5% of the cases, whereas a multi-stage operation in 15.5% of patients. Palliative surgery was performed in 6.2% of the cases. In 2.3% of the cases, the surgical procedure was not specified. Simple and advanced repair of the bladder was performed in 84.3% and 15.6% of the cases respectively. Conclusions Although burdened by a non-negligible rate of complications, surgical repair of entero-colovesical fistula leads to excellent results in terms of primary healing. Our review offers opportunities for significant further research in this field. Level of Evidence Level III according to ELIS (SR/MA with up to two negative criteria).


2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.


Author(s):  
Zaki Arshad ◽  
Henry David Maughan ◽  
Karadi Hari Sunil Kumar ◽  
Matthew Pettit ◽  
Arvind Arora ◽  
...  

Abstract Purpose The aim of this study was investigate the relationship between version and torsional abnormalities of the acetabulum, femur and tibia in patients with symptomatic FAI. Methods A systematic review was performed according to PRISMA guidelines using the EMBASE, MEDLINE, PubMed and Cochrane databases. Original research articles evaluating the described version and torsional parameters in FAI were included. The MINORS criteria were used to appraise study quality and risk of bias. Mean version and torsion values were displayed using forest plots and the estimated proportion of hips displaying abnormalities in version/torsion were calculated. Results A total of 1206 articles were identified from the initial search, with 43 articles, involving 8861 hips, meeting the inclusion criteria. All studies evaluating femoral or acetabular version in FAI reported ‘normal’ mean version values (10–25 °). However, distribution analysis revealed that an estimated 31% and 51% of patients with FAI displayed abnormal central acetabular and femoral version, respectively. Conclusion Up to 51% of patients presenting with symptomatic FAI show an abnormal femoral version, whilst up to 31% demonstrate abnormal acetabular version. This high percentage of version abnormalities highlights the importance of evaluating these parameters routinely during assessment of patients with FAI, to guide clinical decision-making. Level of evidence IV.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017868
Author(s):  
Joey S.W. Kwong ◽  
Sheyu Li ◽  
Wan-Jie Gu ◽  
Hao Chen ◽  
Chao Zhang ◽  
...  

IntroductionEffective selection of coronary lesions for revascularisation is pivotal in the management of symptoms and adverse outcomes in patients with coronary artery disease. Recently, instantaneous ‘wave-free’ ratio (iFR) has been proposed as a new diagnostic index for assessing the severity of coronary stenoses without the need of pharmacological vasodilation. Evidence of the effectiveness of iFR-guided revascularisation is emerging and a systematic review is warranted.Methods and analysisThis is a protocol for a systematic review of randomised controlled trials and controlled observational studies. Electronic sources including MEDLINE via Ovid, Embase, Cochrane databases and ClinicalTrials.gov will be searched for potentially eligible studies investigating the effects of iFR-guided strategy in patients undergoing coronary revascularisation. Studies will be selected against transparent eligibility criteria and data will be extracted using a prestandardised data collection form by two independent authors. Risk of bias in included studies and overall quality of evidence will be assessed using validated methodological tools. Meta-analysis will be performed using the Review Manager software. Our systematic review will be performed according to the guidance from the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Ethics and disseminationEthics approval is not required. Results of the systematic review will be disseminated as conference proceedings and peer-reviewed journal publication.Trial registration numberThis protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42017065460.


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