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Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures


Kinnersley, P., et al

Subject Keywords: Patients, Clinicians, Healthcare system, Surgical procedures, Invasive healthcare treatments
Type: Article
Region: International (other)

Before patients have an operation or other invasive procedure (e.g. endoscopy) it is crucial for the healthcare professional to explain what the treatment involves, what alternatives exist and the risks and benefits of the different treatment options.  This process is known as ‘informed consent’ and aims to provide sufficient information to allow patients to understand their treatment options and to choose between them. 

Research suggests that when informed consent is obtained, the information provided by healthcare professionals is often unclear or insufficient, leading to misunderstanding, a worse treatment response and even litigation.  A number of interventions have been developed to improve the quality of information provided to patients, including written pamphlets, videos and websites.  It is unclear whether these interventions work in clinical practice. 

In this review we summarise studies of interventions designed to improve information delivery or to improve consideration of information for informed consent. 

We searched the scientific literature to identify randomised controlled trials (RCTs) of interventions designed to improve informed consent in clinical practice.  We wanted to determine primarily whether these interventions improved all components of ‘informed consent’ (understanding, deliberation and communication of decision).  Other individual outcomes of direct relevance to patients (e.g. recall/knowledge, understanding, satisfaction and anxiety), those related to healthcare professionals (e.g. ease of use of intervention, satisfaction) and system outcomes (e.g. cost, rates of procedural uptake) were also assessed. 

We included 65 studies involving a total of 9021 patients.  The studies varied according to the type of intervention, the procedure for which consent was sought, the clinical setting and the outcomes measured.  Most interventions were written or audio-visual.  Only one study assessed all the elements of informed consent, but the design was not robust; all other studies assessed only components of informed consent.  When the results of multiple studies were combined, we found that interventions improved knowledge of the planned procedure, immediately (up to 24 hours), in the short term (1 to 14 days) and the long term (more than 14 days).  Satisfaction with decision making was increased; decisional conflict was reduced; and consultation length may be increased. There were no differences between the intervention and control for the outcomes of generalised anxiety, and either anxiety or satisfaction associated with the consent process.

Limitations of the review include difficulties combining the results of studies due to variation in the procedures undergone by patients, the interventions used and outcomes measured.  This means that we are uncertain as to which specific interventions are most effective but pragmatic steps to improve information delivery and consideration of the information are likely to benefit patients. 



Rights: © The Cochrane Collaboration
Suggested citation:

Kinnersley, P., et al. (2013) Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures [Online]. Available from: [Accessed: 21st May 2019].


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