scholarly journals Ethical considerations in placebo-controlled randomised clinical trials

BJPsych Open ◽  
2015 ◽  
Vol 1 (1) ◽  
pp. e3-e4 ◽  
Author(s):  
Kenneth R. Kaufman
Keyword(s):  
Informed Consent ◽  
Randomised Clinical Trial ◽  
Evidence Based ◽  
Ethical Considerations ◽  
Double Blind ◽  
Ethical Concerns ◽  
Placebo Controls ◽  
Ethics Research ◽  
Potential Impact ◽  
Based Medicine

SummaryEthical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raised by Chen et al's article ‘Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials' and serves as an invitation for further submissions to BJPsych Open on ethics, research design and informed consent.

Evidence-Based Medicine: Determining Quality of Randomized Controlled Trials

2014 ◽  
Vol 19 (4) ◽  
pp. 3-5
Author(s):  
Melissa Cheng
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Internal Validity ◽  
Cochrane Collaboration ◽  
Dropout Rate ◽  
Controlled Trials ◽  
Evidence Based ◽  
Double Blind ◽  
Randomized Controlled ◽  
Based Medicine

Abstract Evidence-based medicine is based on evidence gathered by randomized controlled trials (RCTs), which are considered the “gold standard” of research studies. Users of the medial literature must be able to read critically and evaluate RCTs. The present article uses the standards of the American College of Occupational and Environmental Medicine (ACOEM) practice guidelines in evaluating RCTs according to 11 criteria; these criteria follow those used by the Cochrane Collaboration in their evidence-based reviews. Well-written articles present their randomization schemes to create comparable groups, and studies must be controlled for co-interventions; in a double-blind trial, the co-interventions would be used equally in both groups, and treatment allocations should be concealed. Readers should ask if the study had acceptable compliance; that is, were patients doing what they were asked, and was the dropout rate acceptable (typically, less than 20%)? RCTs should be analyzed by an intention-to-treat analysis that includes all study subjects who were randomized, not just those who completed the study. Having high internal validity ensures a more accurate study that can be reproduced by others, so readers may ask if results are likely to be affected by observational bias, confounding, or chance variation. Readers can determine external validity by assessing study participants according to inclusion and exclusion criteria and baseline characteristics.

scholarly journals Assessment and certification of neurosurgery for mental disorder

1998 ◽  
Vol 22 (8) ◽  
pp. 497-500
Author(s):  
G. E. Langley
Keyword(s):  
Informed Consent ◽  
Mental Disorder ◽  
Evidence Based Medicine ◽  
Second Opinion ◽  
Evidence Based ◽  
Based Medicine ◽  
Made In

The views expressed are based on experiences of a second opinion appointed doctor and refer to neurosurgery for mental disorder. Here the general issues are sharpened by the necessity to certify informed consent and the likelihood of the alleviation or the prevention of deterioration. In an age of evidence-based medicine the criteria by which these issues are judged are critical and need to be generally agreed. The evidence needed in clinical reports and in certification is considered from theoretical and practical viewpoints and suggestions are made in reference to treatment at both new and established centres.

scholarly journals Catalogue of bias: attrition bias

2018 ◽  
Vol 23 (1) ◽  
pp. 21-22 ◽  
Author(s):  
David Nunan ◽  
Jeffrey Aronson ◽  
Clare Bankhead
Keyword(s):  
Gastrointestinal Bleeding ◽  
Upper Gastrointestinal Bleeding ◽  
Study Groups ◽  
Evidence Based ◽  
Sampling Weights ◽  
Attrition Bias ◽  
Potential Impact ◽  
Based Medicine ◽  
Upper Gastrointestinal ◽  
Unclear Risk

This article is part of a series of articles featuring the Catalogue of Bias introduced in this volume of BMJ Evidence-Based Medicine that describes attrition bias and outlines its potential impact on research studies and the preventive steps to minimise its risk. Attrition bias is a type of selection bias due to systematic differences between study groups in the number and the way participants are lost from a study. Differences between people who leave a study and those who continue, particularly between study groups, can be the reason for any observed effect and not the intervention itself. Associations for mortality in trials of tranexamic acid and upper gastrointestinal bleeding were no longer apparent after studies with high or unclear risk of attrition bias were removed. Over-recruitment can help prevent important attrition bias. Sampling weights and tailored replenishment samples can help to compensate for the effects of attrition bias when present.

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