We have identified efforts by research ers to investigate interventions which seek to improve information delivery and consideration of information to enhance  informed consent .
The interventions used consistently improve patient knowledge , an important prerequisite for informed consent .
This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable .
Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions .
BACKGROUND Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken .
However , it is a complex process which requires patients be provided with information which they can underst and and retain , opportunity to consider their options , and to be able to express their opinions and ask questions .
There is evidence that at present some patients undergo procedures without informed consent being achieved .
OBJECTIVES To assess the effects on patients , clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures .
AUTHORS ' CONCLUSIONS Informed consent is an important ethical and practical part of patient care .
A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy
Objectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy . Methods The Consent-20 instrument was developed and piloted on 47 subjects . Subsequently , parents of 101 children undergoing first-time , diagnostic upper endoscopy performed under moderate IV sedation were prospect ively and consecutively , blinded , r and omised and enrolled into two groups that received either st and ard form-based informed consent or st and ard form-based informed consent plus a commercial ( Emmi Solutions , Inc , Chicago , Il ) , sixth grade level , interactive learning module ( electronic assisted consent ) . Anonymously and electronically , the subjects ' anxiety ( State Trait Anxiety Inventory ) , satisfaction ( Modified Group Health Association of America ) , number of questions asked , and attainment of informed consent were assessed ( Consent-20 ) . Statistics were calculated using t test , paired t test , and Mann Whitney tests . Results The ability to achieve informed consent , as measured by the new instrument , was 10 % in the control form-based consent group and 33 % in the electronic assisted consent group ( p<0.0001 ) . Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction , anxiety or number of questions asked in a paediatric endoscopy unit . Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy . It also shows that even when necessary information was repeated electronically in a comprehensive and st and ardised video , informed consent as measured by our instrument was incompletely achieved . The supplemental information did , however , significantly improve underst and ing in a manner that did not negatively impact workflow , subject anxiety or subject satisfaction . Additional study of informed consent is required . Clinical trial registration number Clinical Trials.gov Identifier NCT00899392
We have identified efforts by research ers to investigate interventions which seek to improve information delivery and consideration of information to enhance  informed consent .
The interventions used consistently improve patient knowledge , an important prerequisite for informed consent .
This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable .
Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions .
BACKGROUND Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken .
However , it is a complex process which requires patients be provided with information which they can underst and and retain , opportunity to consider their options , and to be able to express their opinions and ask questions .
There is evidence that at present some patients undergo procedures without informed consent being achieved .
OBJECTIVES To assess the effects on patients , clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures .
AUTHORS ' CONCLUSIONS Informed consent is an important ethical and practical part of patient care .