Bias in clinical intervention research.
@article{Gluud2006BiasIC,
title={Bias in clinical intervention research.},
author={Lise Lotte Gluud},
journal={American journal of epidemiology},
year={2006},
volume={163 6},
pages={
493-501
}
}Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical evidence is needed to evaluate their effects on the extent and direction of bias. This narrative review summarizes the findings of methodological studies on the influence of bias in clinical trials. A…
505 Citations
Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies.
- Psychology, MedicineHealth technology assessment
- 2012
Bias associated with specific reported study design characteristics leads to exaggeration of beneficial intervention effect estimates and increases in between-trial heterogeneity, and assessments of the risk of bias in RCTs should account for these findings.
Methodological characteristics and treatment effect sizes in oral health randomised controlled trials: Is there a relationship? Protocol for a meta-epidemiological study
- MedicineBMJ Open
- 2014
This study aims to examine the empirical evidence quantifying the extent of bias associated with methodological and non-methodological characteristics in oral health RCTs using a meta-meta-analytic approach with a random effects model.
SYSTEM research note on : initial observations of diagnostic accuracy concerning quantitative testing for selection bias in RCTs - II
- Psychology
- 2012
CONTEXT: Selection bias interferes with the internal validity of clinical trials and leads to favouring one clinical outcome over another. In order to limit the influence of selection bias on…
Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study
- Medicine, PsychologyBMJ Open
- 2014
This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias, as well as perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect.
Risk and Evidence of Bias in Randomized Controlled Trials in Economics
- Economics
- 2013
The randomized controlled trial (RCT) has been a heavily utilized research tool in medicine for over 60 years. Since the early 2000's, large-scale RCTs have been used in increasingly large numbers in…
Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials
- PsychologyAnnals of Internal Medicine
- 2012
For each characteristic, average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes.
Estimation and adjustment of bias in randomized evidence by using mixed treatment comparison meta-analysis
- Psychology
- 2010
There is good empirical evidence that specific flaws in the conduct of randomized controlled trials are associated with exaggeration of treatment effect estimates. Mixed treatment comparison…
Improving the completeness and transparency of reports of randomized trials in oral health: the CONSORT statement.
- MedicineAmerican journal of dentistry
- 2008
The quality of reporting of trials improves in journals that have adopted CONSORT, although with significant variation, most likely due to differing levels of editorial adherence to it.
Influence of Sponsorship Bias on Treatment Effect Size Estimates in Randomized Trials of Oral Health Interventions: A Meta-epidemiological Study.
- Psychology, MedicineThe journal of evidence-based dental practice
- 2021
Assessing the Validity of Clinical Trials
- Psychology, MedicineJournal of pediatric gastroenterology and nutrition
- 2008
Clinical trials use scientific methods to evaluate the effectiveness and safety of treatments or other interventions, and a well-conducted randomised controlled trial is considered to be the most powerful tool for evaluating interventions.
References
SHOWING 1-10 OF 158 REFERENCES
Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.
- PsychologyJAMA
- 1995
Empirical evidence is provided that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias.
Reported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses
- PsychologyAnnals of Internal Medicine
- 2001
The potential association between reported methodologic quality and intervention effects was studied to assess whether methodologicquality may explain discrepancies between the results of large and small randomized trials in meta-analyses.
Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?
- Medicine, PsychologyThe Lancet
- 1998
Evaluating non-randomised intervention studies.
- MedicineHealth technology assessment
- 2003
The inability of case-mix adjustment methods to compensate for selection bias and the inability to identify non- randomised studies that are free of selection bias indicate that non-randomised studies should only be undertaken when RCTs are infeasible or unethical.
Randomisation to protect against selection bias in healthcare trials.
- MedicineThe Cochrane database of systematic reviews
- 2007
Comparisons of adequately and inadequately concealed allocation in randomised trials of the same intervention provided high quality evidence that concealment can be crucial in achieving similar treatment groups and, therefore, unbiased estimates of treatment effects.
Assessing the quality of controlled clinical trials
- PsychologyBMJ : British Medical Journal
- 2001
The concept of study quality and the methods used to assess quality are discussed and the methodology for both the assessment of quality and its incorporation into systematic reviews and meta-analysis is discussed.
Statistics notes: Absence of evidence is not evidence of absence
- Psychology, MedicineBMJ
- 1995
It is wrong and unwise to interpret so many negative trials as providing evidence of the ineffectiveness of new treatments, and one must seriously question whether the absence of evidence is a valid justification for inaction.
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
- MedicineJAMA
- 2004
The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials.
- Psychology, MedicineJAMA
- 2002
Individual quality measures are not reliably associated with the strength of treatment effect across studies and medical areas, and findings of associations with treatment effect cannot be generalized to all clinical areas or meta-analyses.


