Not only randomized controlled trials, but also case series should be considered in systematic reviews of rapidly developing technologies

Chambers, Duncan; Rodgers, Mark; Woolacott, Nerys

doi:10.1016/j.jclinepi.2008.12.010

Cited by 107 publications

(83 citation statements)

References 32 publications

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“…These items were rated as low (e.g., the study was double-blind and an identical placebo was used), high (e.g., study was open label), or unclear risk of bias (e.g., procedures for blinding were not adequately described). As no validated tool for the assessment of risk of bias in observational studies was available, we used the eight criteria for quality assessment of case series, published by Chambers et al [16] . These criteria address both quality of reporting as risk of bias.…”

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review

Rossen

MacDonald

Vries

et al. 2015

WJG

215

131

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AIM:To study the clinical efficacy and safety of Fecal microbiota transplantation (FMT). We systematically reviewed FMT used as clinical therapy. METHODS:We searched MEDLINE, EMBASE, the Cochrane Library and Conference proceedings from inception to July, 2013. Treatment effect of FMT was calculated as the percentage of patients who achieved clinical improvement per patient category, on an intention-to-treat basis. RESULTS:We included 45 studies; 34 on Clostridium difficile -infection (CDI), 7 on inflammatory bowel disease, 1 on metabolic syndrome, 1 on constipation, 1 on pouchitis and 1 on irritable bowel syndrome (IBS). In CDI 90% resolution of diarrhea in 33 case series (n = 867) was reported, and 94% resolution of diarrhea after repeated FMT in a randomized controlled trial (RCT) (n = 16). In ulcerative colitis (UC) remission rates of 0% to 68% were found (n = 106). In Crohn's disease (CD) (n = 6), no benefit was observed. In IBS, 70% improvement of symptoms was found (n = 13). 100% Reversal of symptoms was observed in constipation (n = 3). In pouchitis, none of the patients (n = 8) achieved remission. One RCT showed significant improvement of insulin sensitivity in metabolic syndrome (n = 10). Serious adverse events were rare. SYSTEMATIC REVIEWS CONCLUSION:FMT is highly effective in CDI, and holds promise in UC. As for CD, chronic constipation, pouchitis and IBS data are too limited to draw conclusions. FMT increases insulin sensitivity in metabolic syndrome.

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Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review

Rossen

MacDonald

Vries

et al. 2015

WJG

215

131

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“…Meta-regression was used to examine the impact of several clinical covariates on the effect size of both primary outcomes. Study quality and risk of bias within studies were assessed using a modified version of published criteria 1,19 for measuring the quality of case series (Supplemental Table 3). Risk of publication bias across studies was assessed using Funnel plots and Eggers' test.…”

Section: Methodsmentioning

confidence: 99%

“…Moreover, prior meta-analyses of case series in the field of ablation for AF have given results consistent with RCTs. 19 As the data were not sourced from RCTs there are inevitable differences in the demographics between study groups. Hybrid studies included more patients with longstanding persistent AF, which may underestimate the relative efficacy of hybrid ablation.…”

Section: Limitationsmentioning

confidence: 99%

Minimally Invasive Epicardial Surgical Ablation Alone Versus Hybrid Ablation for Atrial Fibrillation: A Systematic Review and Meta-Analysis

Pearman

Poon

Bonnett

et al. 2017

Arrhythmia &Amp; Electrophysiology Review

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The goal of arrhythmia eradication in AF continues to be elusive for cardiac electrophysiologists. Although endocardial radiofrequency (RF) catheter ablation is more effective than pharmacological management at maintaining sinus rhythm, 1 it is far from perfect, especially in patients with non-paroxysmal AF. 2 In an attempt to address this, attention has turned back to the surgical ablation that preceded catheterbased approaches. While the initial open-chest Cox-Maze procedure generated high success rates, the complexity and invasiveness of this procedure limited its widespread adoption. AbstractMaintaining sinus rhythm in patients with non-paroxysmal AF is an elusive goal. Some suggest that hybrid ablation, combining minimally invasive epicardial surgical ablation with endocardial catheter ablation, may be more effective than either modality alone.However, randomised trials are lacking. We investigated whether hybrid ablation is more effective than epicardial ablation alone at preventing recurrent AF by performing a systematic review and meta-analysis. The review was prospectively registered with PROSPERO (CRD42016043389). MEDLINE and EMBASE were searched for studies of standalone minimally invasive epicardial ablation of AF and/or hybrid ablation, identifying 41 non-overlapping studies comprising 2737 patients. A random-effects meta-analysis, meta-regression and sensitivity analysis were performed. Single-procedure survival free from atrial arrhythmias without antiarrhythmic drugs was similar between epicardial-alone and hybrid approaches at 12 months (epicardial alone 71. . Meta-regression suggested that bipolar radiofrequency energy and thoracoscopic access were associated with greater efficacy, but adjusting for these factors did not unmask any difference between epicardial-alone and hybrid ablation. Hybrid and epicardial ablation alone appear to be equally effective treatments for AF, although hybrid ablation may be associated with higher complication rates. These data derived from observational studies should be verified with randomised data.

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“…It was proposed to assess the methodological and reporting quality of case series studies which met the inclusion criteria using a customised quality tool that combined generic criteria proposed by the NHS CRD 8 and Chambers et al 10 with review-specific criteria, as follows: Meta-analysis strategy It was intended that, where appropriate, meta-analysis would be used to pool results, summary statistics would be derived for each study and a weighted average of the summary statistics would be computed across the studies. In the event, this was not possible because of the diversity of outcome measures used in the different studies.…”

Section: Quality Assessment Strategymentioning

confidence: 99%

“…We will assess the methodological and reporting quality of case series studies which meet the inclusion criteria using a customised quality tool combining generic criteria proposed by the NHS Centre for Reviews and Dissemination 8 and Chambers et al 10 with review-specific criteria, as follows: ■ Generic criteria: -Were patients recruited prospectively? -Were patients recruited consecutively?…”

Section: Quality Assessment Strategymentioning

confidence: 99%

What is the value of routinely testing full blood count, electrolytes and urea, and pulmonary function tests before elective surgery in patients with no apparent clinical indication and in subgroups of patients with common comorbidities: a systematic review of the clinical and cost-effective literature

Czoski-Murray

Jones²,

McCabe³

et al. 2012

Health Technol Assess

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Not only randomized controlled trials, but also case series should be considered in systematic reviews of rapidly developing technologies

Cited by 107 publications

References 32 publications

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review

Minimally Invasive Epicardial Surgical Ablation Alone Versus Hybrid Ablation for Atrial Fibrillation: A Systematic Review and Meta-Analysis

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