Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2013 Jul 6;2013(7):CD009445.
doi: 10.1002/14651858.CD009445.pub2.

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

Paul Kinnersley  1 , Katie Phillips, Katherine Savage, Mark J Kelly, Elinor Farrell, Ben Morgan, Robert Whistance, Vicky Lewis, Mala K Mann, Bethan L Stephens, Jane Blazeby, Glyn Elwyn, Adrian G K Edwards
Affiliations
Meta-Analysis

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

Paul Kinnersley et al. Cochrane Database Syst Rev. .

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.

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.

Search 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.

Selection criteria: 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.

Data collection and analysis: 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.

Main 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.

Authors' 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.

PubMed Disclaimer

Conflict of interest statement

Glyn Elwyn, Adrian Edwards, Paul Kinnersley have been involved in the evaluation of decision aids. None of the authors have any financial interest in the results of the review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Funnel plot of comparison: 2 All studies: interventions that promote informed consent, outcome: 2.7 Knowledge/retention/recall ‐ Immediate.
4
4
Funnel plot of comparison: 2 All studies: interventions that promote informed consent, outcome: 2.8 Knowledge/Retention/Recall ‐ Short term.
5
5
Funnel plot of comparison: 2 All studies: interventions that promote informed consent, outcome: 2.9 Knowledge/Retention/Recall ‐ Long term.
6
6
Funnel plot of comparison: 2 All studies: interventions that promote informed consent, outcome: 2.16 General or procedural‐related anxiety.
7
7
Funnel plot of comparison: 2 All studies: interventions that promote informed consent, outcome: 2.22 Satisfaction with consent process.
1.1
1.1. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 1 Informed consent: continuous data.
1.2
1.2. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 2 Patient understanding: continuous data.
1.3
1.3. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 3 Patient self‐report of understanding: continuous data.
1.4
1.4. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 4 Patient self‐report of understanding: dichotomous data.
1.5
1.5. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 5 Knowledge/retention/recall ‐ immediate: continuous data.
1.6
1.6. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 6 Knowledge/retention/recall ‐ short term: continuous data.
1.7
1.7. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 7 Knowledge/retention/recall ‐ long term: continuous data.
1.8
1.8. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 8 Knowledge/retention/recall ‐ immediate: dichotomous data.
1.9
1.9. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 9 Knowledge/retention/recall ‐ short term: dichotomous data.
1.10
1.10. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 10 Knowledge/retention/recall ‐ long term: dichotomous data.
1.12
1.12. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 12 Deliberation: continuous data.
1.13
1.13. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 13 Decisional conflict: continuous data.
1.14
1.14. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 14 General or procedural‐related anxiety: continuous data.
1.15
1.15. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 15 General or procedure‐related anxiety: dichotomous data.
1.16
1.16. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 16 Anxiety (or other psychological stress) with consent process: continuous data.
1.17
1.17. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 17 Anxiety (or other psychological stress) with consent process: dichotomous data.
1.19
1.19. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 19 Anxiety (or other psychological stress) with decision‐making: continuous data.
1.20
1.20. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 20 Satisfaction with consent process: continuous data.
1.21
1.21. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 21 Satisfaction with consent process: dichotomous data.
1.23
1.23. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 23 Satisfaction with decision making: continuous data.
1.24
1.24. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 24 Satisfaction with decision making: dichotomous data.
1.25
1.25. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 25 Pain levels: continuous data.
1.26
1.26. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 26 Pain levels: dichotomous data.
1.28
1.28. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 28 Desire for further information: dichotomous data.
1.29
1.29. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 29 Sense of control ‐ locus of control or perception of who made the decision: continuous data.
1.30
1.30. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 30 Sense of control ‐ locus of control or perception of who made the decision: dichotomous data.
1.31
1.31. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 31 Clinician outcome: satisfaction with the consent consultation: continuous data.
1.32
1.32. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 32 Clinician outcome: satisfaction with the consent consultation: dichotomous data.
1.33
1.33. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 33 Systems outcome: rates of uptake (or refusal) of clinical interventions/procedures: dichotomous data.
1.34
1.34. Analysis
Comparison 1 All studies: Interventions that promote informed consent, Outcome 34 Systems outcome: length of consultations: continuous data.
2.1
2.1. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 1 Distant interventions: knowledge/retention/recall ‐ immediate.
2.2
2.2. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 2 Distant interventions: knowledge/retention/recall ‐ short term.
2.3
2.3. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 3 Distant interventions: anxiety (or other psychological stress) with consent process.
2.4
2.4. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 4 Distant interventions: systems outcome: length of consultations.
2.5
2.5. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 5 Face to face interventions: knowledge/retention/recall ‐ immediate.
2.6
2.6. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 6 Face to face interventions: knowledge/retention/recall ‐ short term.
2.7
2.7. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 7 Face to face interventions: anxiety (or other psychological stress) with consent process.
2.8
2.8. Analysis
Comparison 2 Interventions that promote informed consent: Face‐to‐face interventions and distant interventions, Outcome 8 Face to face interventions: systems outcome: length of consultations.
3.1
3.1. Analysis
Comparison 3 Interventions to promote informed consent: consent on behalf of a minor and self consent, Outcome 1 Consent on behalf of a minor: knowledge/retention/recall ‐ immediate.
3.2
3.2. Analysis
Comparison 3 Interventions to promote informed consent: consent on behalf of a minor and self consent, Outcome 2 Consent on behalf of a minor: anxiety (or other psychological stress) with consent process.
3.3
3.3. Analysis
Comparison 3 Interventions to promote informed consent: consent on behalf of a minor and self consent, Outcome 3 Self‐consent: knowledge/retention/recall ‐ immediate.
3.4
3.4. Analysis
Comparison 3 Interventions to promote informed consent: consent on behalf of a minor and self consent, Outcome 4 Self‐consent: anxiety (or other psychological stress) with consent process.
4.1
4.1. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 1 Written: knowledge/retention/recall ‐ immediate.
4.2
4.2. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 2 Written: knowledge/retention/recall ‐ short term.
4.3
4.3. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 3 Written: knowledge/retention/recall ‐ long term.
4.4
4.4. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 4 Written: general or procedural‐related anxiety.
4.5
4.5. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 5 Written: anxiety (or other psychological stress) with consent process.
4.6
4.6. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 6 Written: satisfaction with consent process.
4.7
4.7. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 7 Audiovisual: knowledge/retention/recall ‐ immediate.
4.8
4.8. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 8 Audiovisual: knowledge/retention/recall ‐ short term.
4.9
4.9. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 9 Audiovisual: general or procedural‐related anxiety.
4.10
4.10. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 10 Audiovisual: anxiety (or other psychological stress) with consent process.
4.11
4.11. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 11 Audiovisual: satisfaction with consent process.
4.12
4.12. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 12 Audiovisual: satisfaction with consent process (dichotomous).
4.13
4.13. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 13 Interactive multimedia: knowledge/retention/recall ‐ short term.
4.14
4.14. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 14 Interactive multimedia: satisfaction with consent process.
4.15
4.15. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 15 Structured: knowledge/retention/recall ‐ immediate.
4.16
4.16. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 16 Decision aid: knowledge/retention/recall ‐ immediate.
4.17
4.17. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 17 Decision aid: knowledge/retention/recall ‐ short term.
4.18
4.18. Analysis
Comparison 4 Interventions that promote informed consent : Classification of interventions, Outcome 18 Decision aids: satisfaction with decision making.
5.1
5.1. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 1 Before admission: knowledge/retention/recall ‐ immediate.
5.2
5.2. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 2 Before admission: anxiety (or other psychological stress) with consent process.
5.3
5.3. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 3 Before admission: satisfaction with consent process.
5.4
5.4. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 4 Before admission: satisfaction with consent process (dichotomous).
5.5
5.5. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 5 After admission: knowledge/retention/recall ‐ immediate.
5.6
5.6. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 6 After admission: anxiety (or other psychological stress) with consent process.
5.7
5.7. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 7 After admission: satisfaction with consent process.
5.8
5.8. Analysis
Comparison 5 Interventions that promote informed consent: Timing of intervention, Outcome 8 After admission: satisfaction with consent process (dichotomous).
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

References to studies included in this review

Agre 1994a {published data only}
    1. Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointestinal Endoscopy 1994;40(3):271‐6. - PubMed
Agre 1994b {published data only}
    1. Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointestinal Endoscopy 1994;40(3):271‐6. - PubMed
Armstrong 1997 {published data only (unpublished sought but not used)}
    1. Armstrong AP, Cole AA, Page RE. Informed consent: Are we doing enough?. British Journal of Plastic Surgery 1997;50(8):637‐40. - PubMed
Armstrong 2010 {published and unpublished data}
    1. Armstrong AW, Alikhan A, Cheng LS, Schupp C, Kurlinkus C, Eisen DB. Portable video media for presenting informed consent and wound care instructions for skin biopsies: a randomized controlled trial. British Journal of Dermatology 2010;163(5):1014‐9. - PubMed
Ashraff 2006 {published data only (unpublished sought but not used)}
    1. Ashraff S, Malawa G, Dolan T, Khanduja V. Prospective randomised controlled trial on the role of patient information leaflets in obtaining informed consent. ANZ Journal of Surgery 2006;76(3):139‐41. - PubMed
Astley 2008a {published data only}
    1. Astley CM, Chew DP, Aylward PE, Molloy DA, Pasquale CG. A randomised study of three different Informational aids prior to coronary angiography, measuring patient recall, satisfaction and anxiety. Heart Lung and Circulation 2008;17(1):25‐32. - PubMed
Astley 2008b {published data only}
    1. Astley CM, Chew DP, Aylward PE, Molloy DA, Pasquale CG. A randomised study of three different informational aids prior to coronary angiography, measuring patient recall, satisfaction and anxiety. Heart Lung and Circulation 2008;17(1):25‐32. - PubMed
Bekker 2004 {published and unpublished data}
    1. Bekker HL, Hewison J, Thornton JG. Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Prenatal Diagnosis 2004;24(4):265‐75. - PubMed
Bennett 2009a {published data only (unpublished sought but not used)}
    1. Bennett DL, Dharia CV, Ferguson KJ, Okon AE. Patient‐physician communication: informed consent for imaging‐guided spinal injections. Journal of the American College of Radiology 2009;6(1):38‐44. - PMC - PubMed
Bennett 2009b {published data only (unpublished sought but not used)}
    1. Bennett DL, Dharia CV, Ferguson KJ, Okon AE. Patient‐physician communication: informed consent for imaging‐guided spinal injections. Journal of the American College of Radiology 2009;6(1):38‐44. - PMC - PubMed
Bollschweiler 2008 {published data only (unpublished sought but not used)}
    1. Bollschweiler E, Apitzsch J, Obliers R. Results of a prospective randomized multicenter study of patients before cholecystectomy. Annals of Surgery 2008;248(4):694. - PubMed
Chan 2002 {published data only (unpublished sought but not used)}
    1. Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, et al. Patient education and informed consent in head and neck surgery. Archives of Otolaryngology ‐ Head and Neck Surgery 2002;128(11):1269‐74. - PubMed
Chantry 2010 {published data only}
    1. Chantry CJ, Byrd RS, Sage AC, Calvert EE. Video versus traditional informed consent for neonatal circumcision. Acta Paediatrica 2010;99(9):1418‐24. - PubMed
Cornoiu 2010a {published and unpublished data}
    1. Cornoiu A, Beischer AD, Donnan L, Graves S, Steiger R. Multimedia patient education to assist the informed consent process for knee arthroscopy. ANZ Journal of Surgery 2010;81(3):176‐80. - PubMed
Cornoiu 2010b {published and unpublished data}
    1. Cornoiu A, Beischer AD, Donnan L, Graves S, Steiger R. Multimedia patient education to assist the informed consent process for knee arthroscopy. ANZ Journal of Surgery 2010;81(3):176‐80. - PubMed
Cowan 2007 {published and unpublished data}
    1. Cowan EA, Calderon Y, Gennis P, Macklin R, Ortiz C, Wall SP. Spanish and English video‐assisted informed consent for intravenous contrast administration in the emergency department: a randomized controlled trial. Annals of Emergency Medicine 2007;49(2):221‐30. - PubMed
Danino 2006 {published data only}
    1. Danino AM, Sultan SD, Weber ID, Herve C, Malka G. Effect of information by images on patients' anxiety and comprehension before esthetic surgery on the abdominal wall: a prospective randomised trial with 60 patients [Impact de l'introduction d'images sur l'anxiete et la connaissance des patientes avant une abdominoplastie esthetique: Une etude prospective randomisee incluant 60 patientes]. Annales de Chirurgie Plastique et Esthetique 2006;51(6):517‐24. - PubMed
Deyo 2000 {published data only (unpublished sought but not used)}
    1. Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley Jr AG. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Medical Care 2000;38(9):959‐69. - PubMed
Elfant 1995 {published data only (unpublished sought but not used)}
    1. Elfant AB, Korn C, Mendez L, Pello MJ, Peikin SR. Recall of informed consent after endoscopic procedures. Diseases of the Colon and Rectum 1995;38(1):1‐3. - PubMed
Enzenhofer 2004 {published data only}
    1. Enzenhofer M, Bludau HB, Komm N, Wild B, Mueller K, Herzog W, et al. Improvement of the educational process by computer‐based visualization of procedures: randomized controlled trial. Journal of Medical Internet Research 2004;6(2):e16. - PMC - PubMed
Felley 2008 {published data only}
    1. Felley C, Perneger TV, Goulet I, Rouillard C, Azar‐Pey N, Dorta G, et al. Combined written and oral information prior to gastrointestinal endoscopy compared with oral information alone: a randomized trial. BMC Gastroenterology 2008;8(22):n.p. [DOI: 10.1186/1471-230X-8-22] - DOI - PMC - PubMed
Fink 2010 {published and unpublished data}
    1. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, et al. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Annals of Surgery 2010;252(1):27‐36. - PubMed
Friedlander 2011 {published data only}
    1. Friedlander JA, Loeben GS, Finnegan PK, Puma AE, Zhang X, Zoeten EF, et al. A novel method to enhance informed consent: a prospective and randomised trial of form‐based versus electronic assisted informed consent in paediatric endoscopy. Journal of Medical Ethics 2011;37(4):194‐200. - PubMed
Garden 1996 {published and unpublished data}
    1. Garden AL, Merry AF, Holland RL, Petrie KJ. Anaesthesia information ‐ what patients want to know. Anaesthesia and Intensive Care 1996;24(5):594‐8. - PubMed
Garrud 2001 {published data only (unpublished sought but not used)}
    1. Garrud P, Wood M, Stainsby L. Impact of risk information in a patient education leaflet. Patient Education and Counseling 2001;43(3):301‐4. - PubMed
Gerancher 2000 {published data only (unpublished sought but not used)}
    1. Gerancher JC, Grice SC, Dewan DM, Eisenach J. An evaluation of informed consent prior to epidural analgesia for labor and delivery. International Journal of Obstetric Anesthesia 2000;9(3):168‐73. - PubMed
Goel 2001 {published data only (unpublished sought but not used)}
    1. Goel V, Sawka CA, Thiel EC, Gort EH, O'Connor AM. Randomized trial of a patient decision aid for choice of surgical treatment for breast cancer. Medical Decision Making 2001;21:1‐6. - PubMed
Greening 1999 {published data only (unpublished sought but not used)}
    1. Greening J, Bentham P, Stemman J, Staples V, Ambegaokar S, Upthegrove R, et al. The effect of structured consent on recall of information pre‐ and post‐electroconvulsive therapy: a pilot study. Psychiatric Bulletin 1999;23(8):471‐4.
Heller 2008 {published data only (unpublished sought but not used)}
    1. Heller L, Parker PA, Youssef A, Miller MJ. Interactive digital education aid in breast reconstruction?. Plastic and Reconstructive Surgery 2008;122(3):717‐24. - PubMed
Henry 2008 {published data only (unpublished sought but not used)}
    1. Henry E, Brown T, Bartlett C, Massoud E, Bance M. Informed consent in otologic surgery: Prospective randomized study comparing risk recall with an illustrated handout and a nonillustrated handout. Journal of Otolaryngology ‐ Head and Neck Surgery 2008;37(2):273‐8. - PubMed
Hermann 2002 {published data only}
    1. Hermann M. 3‐dimensional computer animation‐‐a new medium for supporting patient education before surgery Acceptance and assessment of patients based on a prospective randomized study‐‐picture versus text [Dreidimensionale Computeranimation‐‐neues Medium zur Unterstutzung des Aufklarungsgesprachs vor Operationen Akzeptanz und Bewertung der Patienten anhand einer prospektiv randomisierten Studie‐‐Bild versus Text]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 2002;73(5):500‐7. - PubMed
Hong 2009 {published data only}
    1. Hong P, Makdessian AS, Ellis DAF, Taylor SM. Informed consent in rhinoplasty: prospective randomized study of risk recall in patients who are given written disclosure of risks versus traditional oral discussion groups. Journal of Otolaryngology ‐ Head and Neck Surgery 2009;38(3):369‐74. - PubMed
Hopper 1994 {published data only}
    1. Hopper KD, Zajdel M, Hulse SF, Yoanidis NR, TenHave TR, Labuski MR, et al. Interactive method of informing patients of the risks of intravenous contrast media. Radiology 1994;192(1):67‐71. - PubMed
Johnson 2006 {published data only (unpublished sought but not used)}
    1. Johnson BR, Schartz A, Goldberg J, Koerber A. A chairside aid for shared decision making in dentistry: a randomized controlled trial. Journal of Dental Education 2006 Feb;70(2):133‐41. - PubMed
Kain 1997 {published and unpublished data}
    1. Kain ZN, Wang SM, Caramico LA, Hofstadter M, Mayes LC. Parental desire for perioperative information and informed consent: a two‐phase study. Anesthesia and Analgesia 1997;84(2):299‐306. - PubMed
Kang 2009a {published and unpublished data}
    1. Kang EY, Fields HW, Kiyak A, Beck FM, Firestone AR. Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods. American Journal of Orthodontics and Dentofacial Orthopedics 2009;136(4):488.e1‐e13. - PubMed
Kang 2009b {published and unpublished data}
    1. Kang EY, Fields HW, Kiyak A, Beck FM, Firestone AR. Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods. American Journal of Orthodontics and Dentofacial Orthopedics 2009;136(4):488.e1‐e13. - PubMed
Langdon 2002 {published data only}
    1. Langdon IJ, Hardin R, Learmonth ID. Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients?. Annals of the Royal College of Surgeons of England 2002;84(6):404‐8. - PMC - PubMed
Lavelle‐Jones 1993 {published data only (unpublished sought but not used)}
    1. Lavelle‐Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993;306(6882):885‐90. - PMC - PubMed
Luck 1999 {published and unpublished data}
    1. Luck A, Pearson S, Maddern G, Hewett P. Effects of video information on precolonoscopy anxiety and knowledge: a randomised trial. Lancet 1999;354(9195):2032‐5. - PubMed
Makdessian 2004 {published data only}
    1. Makdessian AS, Ellis DA, Irish JC. Informed consent in facial plastic surgery: effectiveness of a simple educational intervention. Archives of Facial Plastic Surgery 2004;6(1):26‐30. - PubMed
Mason 2003 {published data only}
    1. Mason V, McEwan A, Walker D, Barrett S, James D. The use of video information in obtaining consent for female sterilisation: a randomised study. British Journal of Obstetrics and Gynaecology 2003;110(12):1062‐71. - PubMed
Masood 2007 {published data only (unpublished sought but not used)}
    1. Masood J, Hafeez A, Wiseman O, Hill JT. Informed consent: are we deluding ourselves? A randomized controlled trial. British Journal of Urology International 2007;99(1):4‐5. - PubMed
Mauffrey 2008 {published and unpublished data}
    1. Mauffrey C, Prempeh EM, John J, Vasario G. The influence of written information during the consenting process on patients' recall of operative risks: a prospective randomised study. International Orthopaedics 2008;32(4):425‐9. - PMC - PubMed
Mishra 2010a {published and unpublished data}
    1. Mishra PK, Mathias H, Millar K, Nagrajan K, Murday A. A randomized controlled trial to assess the effect of audiotaped consultations on the quality of informed consent in cardiac surgery. Archives of Surgery 2010;145(4):383‐8. - PubMed
Mishra 2010b {published and unpublished data}
    1. Mishra PK, Mathias H, Millar K, Nagrajan K, Murday A. A randomized controlled trial to assess the effect of audiotaped consultations on the quality of informed consent in cardiac surgery. Archives of Surgery 2010;145(4):383‐8. - PubMed
Morgan 2000 {published and unpublished data}
    1. Morgan MW, Deber RB, Llewellyn‐Thomas HA, Gladstone P, Cusimano RJ, O'Rourke K, et al. Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease. Journal of General Internal Medicine 2000;15(10):685‐93. - PMC - PubMed
Nadeau 2010 {published and unpublished data}
    1. Nadeau DP, Rich JN, Brietzke SE. Informed consent in pediatric surgery: do parents understand the risks?. Archives of Otolaryngology ‐ Head and Neck Surgery 2010;136(3):265‐9. - PubMed
Neary 2010 {published data only}
    1. Neary PM, Sung R, Corrigan M, O'Donovan M, Cahill RA, Redmond HP. The benefits of an interactive, individualized online patient pathway for patients undergoing minimally invasive radioguided parathyroidectomy: a prospective, double‐blinded, randomized clinical trial. Surgical Innovation 2010;17(3):236‐41. - PubMed
Neptune 1996 {published data only (unpublished sought but not used)}
    1. Neptune SM, Hopper KD, Houts PS, Hartzel JS, Have TR, Loges IRJ. Take‐home informed consent for intravenous contrast media. Investigative Radiology 1996;31(2):109‐13. - PubMed
O'Neill 1996a {published data only}
    1. O'Neill P, Humphris GM, Field EA. The use of an information leaflet for patients undergoing wisdom tooth removal. British Journal of Oral and Maxillofacial Surgery 1996;34(4):331‐4. - PubMed
O'Neill 1996b {published data only}
    1. O'Neill P, Humphris GM, Field EA. The use of an information leaflet for patients undergoing wisdom tooth removal. British Journal of Oral and Maxillofacial Surgery 1996;34(4):331‐4. - PubMed
Olver 2009 {published and unpublished data}
    1. Olver IN, Whitford HS, Denson LA, Peterson MJ, Olver SI. Improving informed consent to chemotherapy: a randomized controlled trial of written information versus an interactive multimedia CD‐ROM. Patient Education and Counseling 2009;74(2):197‐204. - PubMed
Paci 1999 {published data only}
    1. Paci E, Barneschi MG, Miccinesi G, Falchi S, Metrangolo L, Novelli GP. Informed consent and patient participation in the medical encounter: a list of questions for an informed choice about the type of anaesthesia. European Journal of Anaesthesiology 1999;16(3):160‐5. - PubMed
Pesudovs 2006 {published data only (unpublished sought but not used)}
    1. Pesudovs K, Luscombe CK, Coster DJ. Recall from informed consent counselling for cataract surgery. Journal of Law and Medicine 2006;13(4):496‐504. - PubMed
Phatouros 1995 {published data only (unpublished sought but not used)}
    1. Phatouros CC, Blake MP. Patients' attitudes to an information sheet prior to angiography and angioplasty. Australasian Radiology 1995;39(2):135‐9. - PubMed
Raynes‐Greenow 2010 {published data only}
    1. Raynes‐Greenow CH, Nassar N, Torvaldsen S, Trevena L, Roberts CL. Assisting informed decision making for labour analgesia: a randomised controlled trial of a decision aid for labour analgesia versus a pamphlet. BMC Pregnancy and Childbirth 2010;10(15). [DOI: 10.1186/1471-2393-10-15] - DOI - PMC - PubMed
Rossi 2004 {published data only (unpublished sought but not used)}
    1. Rossi M, McClellan R, Chou L, Davis K. Informed consent for ankle fracture surgery: patient comprehension of verbal and videotaped information. Foot and Ankle International 2004;25(10):756‐62. - PubMed
Rossi 2005 {published data only (unpublished sought but not used)}
    1. Rossi MJ, Guttmann D, MacLennan MJ, Lubowitz JH. Video informed consent improves knee arthroscopy patient comprehension. Arthroscopy 2005;21(6):739‐43. - PubMed
Rymeski 2010 {published data only}
    1. Rymeski B, Marchildon M, Katz DA, Vinocur CD, Dunn SP, Reichard KW, et al. Pilot study using an Internet‐based program in informed consent. Journal of Pediatric Surgery 2010;45(6):1137‐41. - PubMed
Shorten 2005 {published data only}
    1. Shorten A, Shorten B, Keogh J, West S, Morris J. Making choices for childbirth: a randomized controlled trial of a decision‐aid for informed birth after cesarean. Birth 2005;32(4):252‐61. - PubMed
Solberg 2010 {published data only}
    1. Solberg LI, Asche SE, Sepucha K, Thygeson NM, Madden JE, Morrissey L, et al. Informed choice assistance for women making uterine fibroid treatment decisions: a practical clinical trial. Medical Decision Making 2010;30(4):444‐52. - PubMed
Tait 2009 {published and unpublished data}
    1. Tait AR, Voepel‐Lewis T, Moscucci M, Brennan‐Martinez CM, Levine R. Patient comprehension of an interactive, computer‐based information program for cardiac catheterization: a comparison with standard information. Archives of Internal Medicine 2009;169(20):1907‐14. - PMC - PubMed
Thomas 2000 {published data only}
    1. Thomas R, Daly M, Perryman B, Stockton D. Forewarned is forearmed ‐ benefits of preparatory information on video cassette for patients receiving chemotherapy or radiotherapy ‐ a randomised controlled trial. European Journal of Cancer 2000;36(12):1536‐43. - PubMed
Uzbeck 2009 {published data only (unpublished sought but not used)}
    1. Uzbeck M, Quinn C, Saleem I, Cotter P, Gilmartin JJ, O'Keeffe ST. Randomised controlled trial of the effect of standard and detailed risk disclosure prior to bronchoscopy on peri‐procedure anxiety and satisfaction. Thorax 2009;64(3):224‐7. - PubMed
Wadey 1997 {published data only}
    1. Wadey V, Frank C. The effectiveness of patient verbalization on informed consent. Canadian Journal of Surgery 1997;40(2):124‐8. - PMC - PubMed
Walker 2007 {published data only}
    1. Walker MS, Farria D, Schmidt M, Monsees B, Wiele K, Bokern J, et al. Educational intervention for women undergoing image‐guided breast biopsy: results of a randomized clinical trial. Cancer Control 2007;14(4):380‐7. - PubMed
Whelan 2003 {published data only (unpublished sought but not used)}
    1. Whelan T, Sawka C, Levine M, Gafni A, Reyno L, Willan A, et al. Helping patients make informed choices: a randomized trial of a decision aid for adjuvant chemotherapy in lymph node‐negative breast cancer. Journal of the National Cancer Institute 2003;95(8):581‐7. - PubMed
Wilhelm 2009 {published and unpublished data}
    1. Wilhelm D, Gillen S, Wirnhier H, Kranzfelder M, Schneider A, Schmidt A, et al. Extended preoperative patient education using a multimedia DVD‐impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial. Langenbeck's Archives of Surgery 2009;394(2):227‐33. - PubMed
Wong 2006 {published data only}
    1. Wong SSM, Thornton JG, Gbolade B, Bekker HL. A randomised controlled trial of a decision‐aid leaflet to facilitate women's choice between pregnancy termination methods. British Journal of Obstetrics and Gynaecology 2006;113(6):688‐94. - PubMed
Yucel 2005 {published data only}
    1. Yucel A, Gecici O, Emul M, Oyar O, Gulsoy UK, Dayanir YO, et al. Effect of informed consent for intravascular contrast material on the level of anxiety: how much information should be given?. Acta Radiologica 2005;46(7):701‐7. - PubMed
Zite 2011 {published data only}
    1. Zite NB, Wallace LS. Use of a low‐literacy informed consent form to improve women's understanding of tubal sterilization: a randomized controlled trial. Obstetrics and Gynecology 2011;117(5):1160‐6. - PubMed

References to studies excluded from this review

Ader 1992 {published data only}
    1. Ader DN, Seibring AR, Bhaskar P, Melamed BG. Information seeking and interactive videodisc preparation for third molar extraction. Journal of Oral & Maxillofacial Surgery 1992;50(1):27‐31; discussion ‐2. - PubMed
Altaie 2011 {published data only}
    1. Altaie RR, Ku JJ, Mora JJ. Informed consent in strabismus surgery. Journal of American Association of Pediatric Ophthalmology and Strabismus 2011;15(1):e12. - PubMed
Broyles 1992 {published data only}
    1. Broyles S, Sharp C, Tyson J, Sadler J. An exploratory trial in the neonatal period. Early Human Development 1992;31(1):67‐75. - PubMed
Clark 2011 {published data only}
    1. Clark S, Mangram A, Ernest D, Lebron R, Peralta L. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. Journal of Surgical Education 2011;68(2):143‐7. - PubMed
Dawes 1992 {published data only}
    1. Dawes PJ, O'Keefe L, Adcock S. Informed consent: the assessment of two structured interview approaches compared to the current approach. Journal of Laryngology & Otology 1992;106(5):420‐4. - PubMed
Dawes 1993 {published data only}
    1. Dawes PJD, O'Keefe L, Adcock S. Informed consent: using a structured interview changes patients' attitudes towards informed consent. Journal of Laryngology and Otology 1993;107(9):775‐9. - PubMed
Eggers 2007 {published data only}
    1. Eggers C, Obliers R, Koerfer A, Thomas W, Koehle K, Hoelscher AH, et al. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity 2007;15(11):2866‐73. - PubMed
Finch 2009 {published data only}
    1. Finch WJG, Rochester MA, Mills RD. A randomised trial of conventional versus BAUS procedure‐specific consent forms for transurethral resection of prostate. Annals of the Royal College of Surgeons of England 2009;91(3):232‐8. - PMC - PubMed
Fink 2010a {published data only}
    1. Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, et al. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Annals of Surgery 2010;252(1):27‐36. - PubMed
Graham 2000 {published data only}
    1. Graham W, Smith P, Kamil A, Fitzmaurice A, Smith N, Hamilton N. Randomised controlled trial comparing effectiveness of touchscreen system with leaflet for providing women with information on prenatal tests. BMJ 2000;320:155‐60. - PMC - PubMed
Grawe 2010 {published data only}
    1. Grawe JS, Mirow L, Bouchard R, Lindig M, Huppe M. [Impact of preoperative patient education on postoperative pain in consideration of the individual coping style]. Der Schmerz 2010;24(6):575‐86. - PubMed
Gyomber 2010 {published data only}
    1. Gyomber D, Lawrentschuk N, Wong P, Parker F, Bolton DM. Improving informed consent for patients undergoing radical prostatectomy using multimedia techniques: a prospective randomized crossover study. British Journal of Urology International 2010;106(8):1152‐6. - PubMed
Hewison 2001 {published data only}
    1. Hewison J, Cuckle H, Baillie C, Sehmi I, Lindow S, Jackson F, et al. Use of videotapes for viewing at home to inform choice in Down syndrome screening: a randomised controlled trial. Prenatal Diagnosis 2001;21(2):146‐9. - PubMed
Hilzenrat 2006 {published data only}
    1. Hilzenrat N, Yesovitch R, Shrier I, Stavrakis M, Deschenes M. The effect of information level and coping style on pain and anxiety in needle liver biopsy. Canadian Journal of Gastroenterology 2006;20(9):597‐600. - PMC - PubMed
Jlala 2010 {published data only}
    1. Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. British Journal of Anaesthesia 2010;104(3):369‐74. - PubMed
Johnson 2011 {published data only}
    1. Johnson MR, Singh JA, Stewart T, Terance JG. Patient understanding and satisfaction in informed consent for total knee arthroplasty: a randomized study. American College of Rheumatology July 2011;63(7):1048‐54. - PubMed
Kasper 2008 {published data only}
    1. Kasper J, Kopke S, Muhlhauser I, Nubling M, Heesen C. Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial. European Journal of Neurology 2008;15(12):1345‐52. - PubMed
Lembcke 1998 {published data only}
    1. Lembcke B, Specht J, Nippel G, Caspary WF. Prospective randomized investigation of three printed information forms for upper GI‐endoscopy [Struktur‐ und ergebnisqualitat deutschsprachiger gastroskopie‐ aufkdarungsbogen aus Patientensicht]. Zeitschrift fur Gastroenterologie 1998;36(9):829‐38. - PubMed
Lipp 1991 {published data only}
    1. Lipp M, Dick W, Daublander M, Bertram M. Different information patterns and their influence on patient anxiety prior to dental local anesthesia [Beeinflussung der Patientenangst vor der zahnarztlichen Lokalanasthesie mit verschiedenen Aufklarungsformen]. Deutsche Zeitschrift fur Mund‐, Kiefer‐ und Gesichts‐Chirurgie 1991;15(6):449‐57. - PubMed
Migden 2008 {published data only}
    1. Migden M, Chavez‐Frazier A, Nguyen T. The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit. Seminars in Cutaneous Medicine and Surgery 2008;27(1):89‐93. - PubMed
Nagle 2008 {published data only}
    1. Nagle C, Gunn J, Bell R, Lewis S, Meiser B, Metcalfe S, et al. Use of a decision aid for prenatal testing of fetal abnormalities to improve women’s informed decision making: a cluster randomised controlled trial. BJOG An International Journal of Obstetrics and Gynaecology 2008;115:339‐47. - PubMed
O'Cathain 2002 {published data only}
    1. O'Cathain A, Walters SJ, Nicholl JP, Thomas KJ, Kirkham M. Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice. BMJ 2002;324(7338):643‐6. - PMC - PubMed
Roth‐Isigkeit 2001a {published data only}
    1. Roth‐Isigkeit A, Brechmann J, Schwarzenberger J, Bruckner S, Schmucker P. Preoperative preparation of patients undergoing cardiac surgery and satisfaction ratings [Auswirkungen praoperativer vorbereitung auf zufriedenheitseinschatzungen kardiochirurgischer patienten]. Zeitschrift fur Herz‐, Thorax‐ und Gefasschirurgie 2001;15(2):62‐7.
Scanlan 2003 {published data only}
    1. Scanlan D, Siddiqui F, Perry G, Hutnik CML. Informed consent for cataract surgery: what patients do and do not understand. Journal of Cataract and Refractive Surgery 2003;29(10):1904‐12. - PubMed
Schenker 2010 {published data only}
    1. Schenker Y. Computer information program improves patient understanding in informed consent for cardiac catheterization. Journal of Clinical Outcomes Management 2010;17(1):10‐2.
Shurnas 2003 {published data only}
    1. Shurnas PS, Coughlin MJ. Recall of the risks of forefoot surgery after informed consent. Foot and Ankle International 2003;24(12):904‐8. - PubMed
Stanley 1998 {published data only}
    1. Stanley BM, Walters DJ, Maddern GJ. Informed consent: how much information is enough?. Australian & New Zealand Journal of Surgery 1998;68(11):788‐91. - PubMed
Steckelberg 2011 {published data only}
    1. Steckelberg A, Hulfenhaus C, Haastert B, Muhlhauser I. Effect of evidence based risk information on "informed choice" in colorectal cancer screening: randomised controlled trial. BMJ 2011;342(7810):d3193. - PMC - PubMed
Taylor 2010 {published data only}
    1. Taylor KL, Davis KM, Lamond T, Williams RM, Schwartz MD, Lawrence W, et al. Use and evaluation of a CD‐ROM‐based decision aid for prostate cancer treatment decisions. Behavioral Medicine 2010;36(4):130‐40. - PubMed
Wright 2010 {published data only}
    1. Wright NS, Fleming PS, Sharma PK, Battagel J. Influence of supplemental written information on adolescent anxiety, motivation and compliance in early orthodontic treatment. Angle Orthodontist 2010;80(2):329‐35. - PMC - PubMed

Additional references

Akkad 2004
    1. Akkad A, Jackson C, Kenyon S, Dixon‐Woods M, Taub N, Habiba M. Informed consent for elective and emergency surgery: questionnaire study. British Journal of Obstetrics and Gynaecology 2004;111(10):1133‐8. - PubMed
Akkad 2006
    1. Akkad A, Jackson C, Kenyon S, Dixon‐Woods M, Taub N, Habiba M. Patients' perceptions of written consent: questionnaire study. BMJ 2006;333:528. - PMC - PubMed
AMA 2009
    1. American Medical Association. Informed Consent. Code of Medical Ethics. Revised. American Medical Association, 2009:438.
AMC 2009
    1. Australian Medical Council Ltd. Good Medical Practice: A Code of Conduct for Doctors in Australia. http://www.amc.org.au/images/Final_Code.pdf 2009 (accessed 9 Sep 2011).
Barkin 2009
    1. Barkin JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM. Evaluation and stages of surgical innovations. Lancet 2009;374:1089‐96. - PubMed
Beisecker 1990
    1. Beisecker AE, Beisecker TD. Patient information‐seeking behaviors when communicating with doctors. Medical Care 1990;28(1):19‐28. - PubMed
BMA 2009
    1. British Medical Association. Consent Tool Kit. http://www.bma.org.uk/images/consenttoolkitdec2009_tcm41‐193139.pdf 2009 (accessed 9 Sep 2011).
Brezis 2008
    1. Brezis M, Israel S, Weinstein‐Birenshtock A, Pogoda P, Sharon A, Tauber R. Quality of informed consent for invasive procedures. International Journal of Quality in Health Care 2008;20(5):352‐7. - PubMed
Canterbury v Spence 1972
    1. United States Court of Appeals for the District of Columbia Circuit. Canterbury v Spence. Federal Reporter 1972; Vol. 464.
CCCRG 2008
    1. Cochrane Communication and Consumers Review Group. Outcomes of interest to the Cochrane Communication and Consumers Review Group. (http://www.latrobe.edu.au/chcp/assets/downloads/Outcomes.pdf) 2008, accessed 12 September 2011.
Chester v Afshar 2004
    1. House of Lords. Chester v Afshar. House of Lords opinions of the Lords of Appeal for Judgement 2004; Vol. UKHL41.
Cohn 2007
    1. Cohn E, Larson E. Improving participant comprehension in the informed consent process. Journal of Nursing Scholarship 2007;39:273‐80. - PubMed
Dixon‐Woods 2006
    1. Dixon‐Woods M, Williams SJ, Jackson CJ, Akkad A, Kenyon S, Habiba M. Why women consent to surgery, even when they don't want to: a qualitative study. Clinical Ethics 2006;1(3):153.
DoH 2001
    1. Department of Health (UK). Reference Guide to Consent for Examination or Treatment. London: Department of Health (UK), 2001.
DoH 2009
    1. Department of Health (UK). Reference Guide to Consent for Examination or Treatment. 2nd Edition. London: Department of Health (UK), 2009.
Doust 2007
    1. Doust J, Mannes P, Bastian H, Edwards AGK. Interventions for improving understanding and minimising the psychological impact of screening. Cochrane Database of Systematic Reviews 2007, Issue 4. [DOI: 10.1002/14651858.CD001212.pub2] - DOI
Duncan 2010
    1. Duncan E, Best C, Hagen S. Shared decision making interventions for people with mental health conditions. Cochrane Database of Systematic Reviews 2010, Issue 1. [DOI: 10.1002/14651858.CD007297.pub2] - DOI - PMC - PubMed
Edwards 2002
    1. Edwards A, Elwyn G, Mulley A. Explaining risks: turning numerical data into meaningful pictures. BMJ 2002;324(7341):827‐30. - PMC - PubMed
Egbert 1964
    1. Egbert LD, Battit GE, Welch CE, Bartlett MK. Reduction of postoperative pain by encouragement and instruction of patients. a study of doctor‐patient rapport. New England Journal of Medicine 1964;270:825‐7. - PubMed
Elwyn 2008
    1. Elwyn G. Patient consent: decision or assumption?. BMJ 2008;336(7656):1259. - PMC - PubMed
Elwyn 2010
    1. Elwyn G, Miron‐Shatz T. Deliberation before determination: the definition and evaluation of good decision making. Health Expectations June 2010;13(2):139‐47. - PMC - PubMed
Elwyn 2012
    1. Elwyn G, Frosch D, Thomson R, Joseph‐Williams N, Lloyd A, Kinnersley P, et al. Shared decision making: a model for clinical practice. Journal of General Internal Medicine 2012;May 23. [DOI: 10.1007/s11606-012-2077-6] - DOI - PMC - PubMed
Ergina 2009
    1. Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien P, Reeves BC, et al. Challenges in evaluating surgical innovations. Lancet 2009;374:1097‐104. - PMC - PubMed
Evans 2007
    1. Evans R, Elwyn G, Edwards A, Newcombe R, Kinnersley P, Wright P, et al. A randomised controlled trial of the effects of a web‐based PSA decision aid, Prosdex. Protocol. BMC Family Practice 2007;8(1):58. [DOI: 10.1186/1471-2296-8-58] - DOI - PMC - PubMed
GMC 2008
    1. General Medical Council. Consent: Patients and Doctors Making Decisions Together. General Medical Council 2008. [ISBN 978‐0‐901458‐31‐5]
Gøtzsche 2013
    1. Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2013, Issue 6. [DOI: 10.1002/14651858.CD001877.pub5] - DOI - PMC - PubMed
Habiba 2004
    1. Habiba M, Jackson C, Akkad A, Kenyon S, Dixon‐Woods M. Women's accounts of consenting to surgery: is consent a quality problem?. Quality & Safety in Health Care 2004;13(6):422. - PMC - PubMed
Hall 1988
    1. Hall JA, Dornan MC. What patients like about their medical care and how often they are asked: a meta‐analysis of the satisfaction literature. Social Science in Medicine 1988;27(9):935‐9. - PubMed
Henderson 2010
    1. Henderson A, Henderson S. Provision of a surgeon's performance data for people considering elective surgery. Cochrane Database of Systematic Reviews 2010, Issue 11. [DOI: 10.1002/14651858.CD006327.pub2] - DOI - PubMed
Higgins 2003
    1. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327(7414):557‐60. - PMC - PubMed
Higgins 2011
    1. Higgins JPT, Altman DG, Sterne JAC (eds). Chapter 8: Assessing the risk of bias in included studies. In: Higgins JPT, Greene S editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. The Cochrane Collaboration, 2011.
Hon 2012
    1. Hon YK, Narayanan P, Goh PP. Extended discussion of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2012, Issue 5. [DOI: 10.1002/14651858.CD009835] - DOI
Jefford 2002
    1. Jefford M, Tattersall MH. Informing and involving cancer patients in their own care. Lancet Oncology 2002;3(10):629‐37. - PubMed
Jenkins 1999
    1. Jenkins VA, Fallowfield LJ, Souhami A, Sawtell M. How do doctors explain randomised clinical trials to their patients?. European Journal of Cancer 1999;35(8):1187‐93. - PubMed
Kennedy 2002
    1. Kennedy AD, Sculpher MJ, Coulter A, Dwyer N, Rees M, Abrams KR, et al. Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs: a randomized controlled trial. Journal of the American Medical Association 2002;288(21):2701‐8. - PubMed
Kinnersley 2007
    1. Kinnersley P, Edwards AGK, Hood K, Cadbury N, Ryan R, Prout H, et al. Interventions before consultations for helping patients address their information needs. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD004565.pub2] - DOI - PMC - PubMed
Légaré 2010
    1. Légaré F, Ratte S, Stacey D, Kryworuchko J, Gravel K, Graham ID, et al. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database of Systematic Reviews 2010, Issue 5. [DOI: 10.1002/14651858.CD006732.pub2] - DOI - PubMed
Makoul 1995
    1. Makoul G, Arntson P, Schofield T. Health promotion in primary care: physician‐patient communication and decision making about prescription medications. Social Science and Medicine 1995;41(9):1241‐54. - PubMed
Marteau 2001
    1. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expectations 2001;4(2):99‐108. - PMC - PubMed
Mazur 2009
    1. Mazur DJ. Medical‐legal aspects of evidence‐based choice and shared decision making. In: Edwards A, Elwyn G editor(s). Shared Decision‐Making in Healthcare: Achieving Evidence‐Based Patient Choice. 2nd Edition. Oxford: OUP, 2009:165‐70.
Oxman 2004
    1. Oxman A. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490‐4. - PMC - PubMed
Picano 2004
    1. Picano E. Informed consent and communication of risk from radiological and nuclear medicine examinations: how to escape from a communication inferno. BMJ 2004;329(7470):849‐51. - PMC - PubMed
RevMan [Computer program]
    1. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
Rogers v Whitaker 1992
    1. High Court of Australia. Rogers v Whitaker. High Court of Australia, Canberra 1992; Vol. 58:175 CLR 479.
Roter 2006
    1. Roter DL, Hall JA. Doctors Talking to Patients/Patients Talking to Doctors: Improving Communication in Medical Visits. 2nd Edition. Westport, CT: Praeger Publishing, 2006.
Royal College of Surgeons of England 2011
    1. Royal College of Surgeons of England. Surgery and the NHS in numbers. http://www.rcseng.ac.uk/media/media‐background‐briefings‐and‐statistics/... 2011.
Ryan 2009
    1. Ryan R, Prictor M, McLaughlin KJ, Hill S. Audio‐visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD003717.pub2] - DOI - PubMed
Ryan 2011
    1. Ryan R, Hill S, Prictor M, McKenzie J. Study Quality Guide. Cochrane Consumers and Communication Review Group. May 2011 (accessed 12 Sep 2011).
Schattner 2006
    1. Schattner A, Bronstein A, Jellin N. Information and shared decision‐making are top patients' priorities. BMC Health Services Research 2006;6(1):21. [DOI: 10.1186/1472-6963-6-21] - DOI - PMC - PubMed
Schenker 2011
    1. Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Medical Decision Making 2011;31(1):151‐73. - PMC - PubMed
Silverman 2005
    1. Silverman J, Kurtz S, Draper J. Skills for Communicating with Patients. Oxford: Radcliffe, 2005.
Stacey 2011
    1. Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes‐Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database of Systematic Reviews 2011, Issue 10. [DOI: 10.1002/14651858.CD001431.pub2] - DOI - PubMed
Treadwell 2006
    1. Treadwell JR, Tregear SJ, Reston JT, Turkelson CM. A system for rating the stability and strength of medical evidence. BMC Medical Research Methodologies 2006;6:52. - PMC - PubMed
Woodrow 2006
    1. Woodrow SR, Jenkins AP. How thorough is the process of informed consent prior to outpatient gastroscopy? A study of practice in a United Kingdom District Hospital. Digestion 2006;73(2‐3):189‐97. - PubMed

References to other published versions of this review

Kinnersley 2011
    1. Kinnersley P, Stephens BL, Elwyn GJ, Blazeby J, Kelly MJ, Savage K, et al. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database of Systematic Reviews 2011, Issue 11. [DOI: 10.1002/14651858.CD009445] - DOI - PMC - PubMed

Publication types

LinkOut - more resources