title: Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.
abstract: 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 understand 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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies.
  
  
  METHODS
  Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided.
  
  
  METHODS
  Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data.
  
  
  RESULTS
  We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias.  More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process.  Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I(2) 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I(2) 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I(2) 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I(2) 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I(2) 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I(2) 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I(2) 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I(2) 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I(2) 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results.
  
  
  CONCLUSIONS
  Informed consent is an important ethical and practical part of patient care.  We have identified efforts by researchers 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. Only one study attempted to measure informed consent as a unified concept.
authors.affiliation: Cochrane Institute of Primary Care and Public Health, School ofMedicine, Cardiff University, Cardiff, UK. kinnersley@cf.ac.uk
authors.forename: Paul
authors.initials: P
authors.lastname: Kinnersley
authors.forename: Katie
authors.initials: K
authors.lastname: Phillips
authors.forename: Katherine
authors.initials: K
authors.lastname: Savage
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Kelly
authors.forename: Elinor
authors.initials: E
authors.lastname: Farrell
authors.forename: Ben
authors.initials: B
authors.lastname: Morgan
authors.forename: Robert
authors.initials: R
authors.lastname: Whistance
authors.forename: Vicky
authors.initials: V
authors.lastname: Lewis
authors.forename: Mala K
authors.initials: MK
authors.lastname: Mann
authors.forename: Bethan L
authors.initials: BL
authors.lastname: Stephens
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.forename: Glyn
authors.initials: G
authors.lastname: Elwyn
authors.forename: Adrian G K
authors.initials: AG
authors.lastname: Edwards
mesh_terms: D003661:Decision Support Techniques; D004724:Endoscopy; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D013514:Surgical Procedures, Operative; D013664:Teaching Materials