scholarly journals Clinical trials—meta-analysis, confidence limits and ‘intention to treat” analysis

1990 ◽  
Vol 10 (4) ◽  
pp. 259-260 ◽  
Author(s):  
Denis F. Hawkins
Keyword(s):  
Clinical Trials ◽  
Meta Analysis ◽  
Confidence Limits ◽  
Intention To Treat ◽  
Treat Analysis

scholarly journals Preventing Respiratory Tract Infections by Synbiotic Interventions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 11 (4) ◽  
pp. 979-988 ◽  
Author(s):  
Carty K Y Chan ◽  
Jun Tao ◽  
Olivia S Chan ◽  
Hua-Bin Li ◽  
Herbert Pang
Keyword(s):  
Clinical Trials ◽  
Respiratory Tract ◽  
Respiratory Tract Infections ◽  
Meta Analysis ◽  
Clinical Effects ◽  
Primary Analysis ◽  
Intention To Treat ◽  
The Times ◽  
Tract Infections ◽  
Alternative Nutrition

ABSTRACT Dysbiosis of the human gut microbiome has been linked to various health conditions, including respiratory tract infections (RTIs) through the gut–lung axis. Several trials have reported that synbiotic therapy could help prevent RTIs or relieve symptoms of some diseases. This meta-analysis comprehensively evaluates the clinical effects of synbiotic supplements for preventing RTIs. PubMed and Google Scholar were searched by keywords for eligible clinical trials until April 2019. Sixty-two studies were retrieved, and 16 studies were selected for meta-analysis. The primary outcomes were defined as the proportion of participants with RTIs at least once or the times of RTI episodes during follow-up based on the intention-to-treat approach. Overall, synbiotic interventions reduced the incidence rate of RTIs by 16% (95% CI: 4%, 27%) and the proportion of participants experiencing RTIs by 16% (95% CI: 5%, 26%). There was no significant evidence of publication bias. A subgroup analysis suggested more prominent effects of synbiotics among adults than infants and children for RTI prevention. The sensitivity analysis excluding trials with prebiotics or probiotics as controls was consistent with our primary analysis. This meta-analysis of clinical trials involving >10,000 individuals showed that synbiotic interventions could be an alternative nutrition strategy for conferring human health and preventing RTIs. Future investigations on the clinical efficacy and safety of synbiotic interventions are warranted with strain-specific and dose-specific approaches.

Intention-to-Treat Analysis and Accounting for Missing Data in Orthopaedic Randomized Clinical Trials

2009 ◽  
Vol 91 (9) ◽  
pp. 2137-2143 ◽  
Author(s):  
Amir Herman ◽  
Itamar Busheri Botser ◽  
Shay Tenenbaum ◽  
Ahron Chechick
Keyword(s):  
Clinical Trials ◽  
Missing Data ◽  
Randomized Clinical Trials ◽  
Intention To Treat ◽  
Treat Analysis

The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

2004 ◽  
Vol 29 (6) ◽  
pp. 621-624 ◽  
Author(s):  
S. SAUERLAND ◽  
T. R. C. DAVIS
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Scientific Validity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Study Results ◽  
Methodological Aspects ◽  
Treat Analysis

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of report ed clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

scholarly journals A Method to Estimate the Efficacy vs Effectiveness in Meta-Analysis of Clinical Trials with Different Adherence Scenarios: A Monte Carlo Simulation Study in Nutrition

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2352
Author(s):  
Miguel Ángel López-Espinoza ◽  
José Antonio Lozano-Lozano ◽  
David Prieto-Merino
Keyword(s):  
Clinical Trials ◽  
Monte Carlo ◽  
Randomized Clinical Trials ◽  
Expert Knowledge ◽  
Meta Analysis ◽  
Specific Effect ◽  
Cochrane Systematic Review ◽  
Monte Carlo Simulation Study ◽  
Intention To Treat ◽  
Meta Analyses

Randomized clinical trials (RCTs) evaluating the effectiveness of interventions to promote fruit and vegetable (FV) consumption usually report intention-to-treat (ITT) analysis as the main outcome. These analyses compare the randomly assigned groups and accept that some individuals may not follow the recommendations received in their group. The ITT analysis is useful to quantify the global effect of promoting the consumption of FV in a population (effectiveness) but, if non-adherence is significant in the RCT, they cannot estimate the specific effect in the individuals that increased their FV consumption (efficacy). To calculate the efficacy of FV consumption, a per protocol analysis (PP) would have to be carried out, in which groups of individuals are compared according to their actual adherence to FV consumption, regardless of the group to which they were assigned; unfortunately, many RCTs do not report the PP analysis. The objective of this article is to apply a new method to estimate the efficacy of Meta-analysis (MA) PP which include RCTs of effectiveness by ITT, without estimates of adherence. The method is based on generating Monte Carlo simulations of percentages of adherence in each allocation group from prior distributions informed by expert knowledge. We illustrate the method reanalyzing a Cochrane Systematic Review (SR) of RCTs on increased FV consumption reported with ITT, simulating 1000 times the estimation of a PP meta-analyses, and obtaining means and ranges of the potential PP effects. In some cases, the range of estimated PP effects was clearly more favourable than the effect calculated with the original ITT assumption, and therefore this corrected analysis must be considered when estimating the true effect of the consumption of a certain food.

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