scholarly journals The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review

BMJ ◽  
2011 ◽  
Vol 342 (mar28 1) ◽  
pp. d1569-d1569 ◽  
Author(s):  
X. Sun ◽  
M. Briel ◽  
J. W. Busse ◽  
J. J. You ◽  
E. A. Akl ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Subgroup Analyses ◽  
Study Characteristics ◽  
Randomised Controlled

scholarly journals Ginkgo biloba extract for prevention of acute mountain sickness: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e022005 ◽  
Author(s):  
Tou-Yuan Tsai ◽  
Shih-Hao Wang ◽  
Yi-Kung Lee ◽  
Yung-Cheng Su
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Acute Mountain Sickness ◽  
Study Groups ◽  
Ginkgo Biloba Extract ◽  
Controlled Trials ◽  
Subgroup Analyses ◽  
Mountain Sickness ◽  
Randomised Controlled

ObjectiveTrials of ginkgo biloba extract (GBE) for the prevention of acute mountain sickness (AMS) have been published since 1996. Because of their conflicting results, the efficacy of GBE remains unclear. We performed a systematic review and meta-analysis to assess whether GBE prevents AMS.MethodsThe Cochrane Library, EMBASE, Google Scholar and PubMed databases were searched for articles published up to 20 May 2017. Only randomised controlled trials were included. AMS was defined as an Environmental Symptom Questionnaire Acute Mountain Sickness-Cerebral score ≥0.7 or Lake Louise Score ≥3 with headache. The main outcome measure was the relative risk (RR) of AMS in participants receiving GBE for prophylaxis. Meta-analyses were conducted using random-effects models. Sensitivity analyses, subgroup analyses and tests for publication bias were conducted.ResultsSeven study groups in six published articles met all eligibility criteria, including the article published by Leadbetteret al, where two randomised controlled trials were conducted. Overall, 451 participants were enrolled. In the primary meta-analysis of all seven study groups, GBE showed trend of AMS prophylaxis, but it is not statistically significant (RR=0.68; 95% CI 0.45 to 1.04; p=0.08). The I2statistic was 58.7% (p=0.02), indicating substantial heterogeneity. The pooled risk difference (RD) revealed a significant risk reduction in participants who use GBE (RD=−25%; 95% CI, from a reduction of 45% to 6%; p=0.011) The results of subgroup analyses of studies with low risk of bias, low starting altitude (<2500 m), number of treatment days before ascending and dosage of GBE are not statistically significant.ConclusionThe currently available data suggest that although GBE may tend towards AMS prophylaxis, there are not enough data to show the statistically significant effect of GBE on preventing AMS. Further large randomised controlled studies are warranted.

scholarly journals Are orthodontic randomised controlled trials justified with a citation of an appropriate systematic review?

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kishan Patel ◽  
Martyn T. Cobourne ◽  
Nikolaos Pandis ◽  
Jadbinder Seehra
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Logistic Regression ◽  
Randomised Controlled Trials ◽  
Descriptive Statistics ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Study Characteristics ◽  
Randomised Controlled

Abstract Background A systematic review of the evidence should be undertaken to support the justification for undertaking a clinical trial. The aim of this study was to examine whether reports of orthodontic Randomised Clinical Trials (RCTs) cite prior systematic reviews (SR) to explain the rationale or justification of the trial. Study characteristics that predicated the citation of SR in the RCT report were also explored. Material and methods Orthodontic RCTs published between 1st January 2010 to 31st December 2020 in seven orthodontic journals were identified. All titles and abstracts were screened independently by two authors. Descriptive statistics and associations were assessed for the study characteristics. Logistic regression was used to identify predicators of SR inclusion in the trial report. Results 301 RCTs fulfilling the eligibility criteria were assessed. 220 SRs were available of which 74.5% (N = 164) were cited, and 24.5% (N = 56) were not included but were available in the literature within 12 months of trial commencement. When a SR was not included in the introduction or no SR was available within 12 months of trial commencement, interventional studies were commonly cited. The continent of the corresponding author predicated the possibility of inclusion of a SR in the introduction (OR 0.36; 95% CI 0.18–0.71; p = 0.003). Conclusions A quarter of orthodontic RCTs (24.5%) included in this study did not cite a SR in the introduction section to justify the rationale of the trial when a relevant SR was available. To reduce research waste and optimal usage of resources, researchers should identify or conduct a systematic review of the evidence to support the rationale and justification of the trial.

scholarly journals Perioperative liberal versus restrictive fluid strategies and postoperative outcomes: a systematic review and metanalysis on randomised-controlled trials in major abdominal elective surgery

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Antonio Messina ◽  
Chiara Robba ◽  
Lorenzo Calabrò ◽  
Daniel Zambelli ◽  
Francesca Iannuzzi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Postoperative Complications ◽  
Randomised Controlled Trials ◽  
Elective Surgery ◽  
Fluid Management ◽  
Risk Difference ◽  
Controlled Trials ◽  
Perioperative Fluid Management ◽  
Liberal Approach ◽  
Randomised Controlled

Abstract Background Postoperative complications impact on early and long-term patients’ outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. We conducted this trial to address the impact of restrictive vs. liberal fluid approaches on overall postoperative complications and mortality. Methods Systematic review and meta-analysis, including randomised controlled trials (RCTs). We performed a systematic literature search using MEDLINE (via Ovid), EMBASE (via Ovid) and the Cochrane Controlled Clinical trials register databases, published from 1 January 2000 to 31 December 2019. We included RCTs enrolling adult patients undergoing elective abdominal surgery and comparing the use of restrictive/liberal approaches enrolling at least 15 patients in each subgroup. Studies involving cardiac, non-elective surgery, paediatric or obstetric surgeries were excluded. Results After full-text examination, the metanalysis finally included 18 studies and 5567 patients randomised to restrictive (2786 patients; 50.0%) or liberal approaches (2780 patients; 50.0%). We found no difference in the occurrence of severe postoperative complications between restrictive and liberal subgroups [risk difference (95% CI) = 0.009 (− 0.02; 0.04); p value = 0.62; I2 (95% CI) = 38.6% (0–66.9%)]. This result was confirmed also in the subgroup of five studies having a low overall risk of bias. The liberal approach was associated with lower overall renal major events, as compared to the restrictive [risk difference (95% CI) = 0.06 (0.02–0.09); p value  = 0.001]. We found no difference in either early (p value  = 0.33) or late (p value  = 0.22) postoperative mortality between restrictive and liberal subgroups Conclusions In major abdominal elective surgery perioperative, the choice between liberal or restrictive approach did not affect overall major postoperative complications or mortality. In a subgroup analysis, a liberal as compared to a restrictive perioperative fluid policy was associated with lower overall complication renal major events, as compared to the restrictive. Trial Registration CRD42020218059; Registration: February 2020, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=218059.

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