Intervention Review

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

  1. Paul Kinnersley1,*,
  2. Katie Phillips1,
  3. Katherine Savage1,
  4. Mark J Kelly2,
  5. Elinor Farrell1,
  6. Ben Morgan1,
  7. Robert Whistance3,
  8. Vicky Lewis4,
  9. Mala K Mann5,
  10. Bethan L Stephens1,
  11. Jane Blazeby6,
  12. Glyn Elwyn1,
  13. Adrian GK Edwards1

Editorial Group: Cochrane Consumers and Communication Group

Published Online: 6 JUL 2013

Assessed as up-to-date: 17 JUL 2012

DOI: 10.1002/14651858.CD009445.pub2

How to Cite

Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AGK. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD009445. DOI: 10.1002/14651858.CD009445.pub2.

Author Information

  1. 1

    Cardiff University, Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff, Wales, UK

  2. 2

    Cardiff University, South East Wales Trials Unit, Institute of Translation, Innovation, Methodology and Engagement, Cardiff, Wales, UK

  3. 3

    University of Bristol, Academic Unit of Surgical Research, School of Social and Community Medicine, Bristol, UK

  4. 4

    Wales Deanery for Postgraduate Medical and Dental Education, Cardiff, Wales, UK

  5. 5

    Information Services, Cardiff University, Support Unit for Research Evidence (SURE), Cardiff, Wales, UK

  6. 6

    University of Bristol, Section of Healthcare Research, The School of Social and Community Medicine, Bristol, UK

*Paul Kinnersley, Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff University, 3rd Floor, Neuadd Meirionnydd, Heath Park, Cardiff, Wales, CF14 4XN, UK. kinnersley@cf.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 6 JUL 2013

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Agre 1994a {published data only}
  • Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointestinal Endoscopy 1994;40(3):271-6.
Agre 1994b {published data only}
  • Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointestinal Endoscopy 1994;40(3):271-6.
Armstrong 1997 {published data only (unpublished sought but not used)}
Armstrong 2010 {published and unpublished data}
Ashraff 2006 {published data only (unpublished sought but not used)}
Astley 2008a {published data only}
  • Astley CM, Chew DP, Aylward PE, Molloy DA, De 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.
Astley 2008b {published data only}
  • Astley CM, Chew DP, Aylward PE, Molloy DA, De 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.
Bekker 2004 {published and unpublished data}
Bennett 2009a {published data only (unpublished sought but not used)}
  • 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.
Bennett 2009b {published data only (unpublished sought but not used)}
  • 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.
Bollschweiler 2008 {published data only (unpublished sought but not used)}
  • Bollschweiler E, Apitzsch J, Obliers R. Results of a prospective randomized multicenter study of patients before cholecystectomy. Annals of Surgery 2008;248(4):694.
Chan 2002 {published data only (unpublished sought but not used)}
  • 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.
Chantry 2010 {published data only}
Cornoiu 2010a {published and unpublished data}
Cornoiu 2010b {published and unpublished data}
Cowan 2007 {published and unpublished data}
  • 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.
Danino 2006 {published data only}
  • 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.
Deyo 2000 {published data only (unpublished sought but not used)}
  • 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.
Elfant 1995 {published data only (unpublished sought but not used)}
Enzenhofer 2004 {published data only}
  • 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.
Felley 2008 {published data only}
  • 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]
Fink 2010 {published and unpublished data}
  • 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.
Friedlander 2011 {published data only}
  • Friedlander JA, Loeben GS, Finnegan PK, Puma AE, Zhang X, de 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.
Garden 1996 {published and unpublished data}
  • Garden AL, Merry AF, Holland RL, Petrie KJ. Anaesthesia information - what patients want to know. Anaesthesia and Intensive Care 1996;24(5):594-8.
Garrud 2001 {published data only (unpublished sought but not used)}
  • Garrud P, Wood M, Stainsby L. Impact of risk information in a patient education leaflet. Patient Education and Counseling 2001;43(3):301-4.
Gerancher 2000 {published data only (unpublished sought but not used)}
  • 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.
Goel 2001 {published data only (unpublished sought but not used)}
  • 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.
Greening 1999 {published data only (unpublished sought but not used)}
  • 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)}
Henry 2008 {published data only (unpublished sought but not used)}
  • 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.
Hermann 2002 {published data only}
  • 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.
Hong 2009 {published data only}
  • 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.
Hopper 1994 {published data only}
  • 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.
Johnson 2006 {published data only (unpublished sought but not used)}
  • 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.
Kain 1997 {published and unpublished data}
  • 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.
Kang 2009a {published and unpublished data}
  • 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.
Kang 2009b {published and unpublished data}
  • 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.
Langdon 2002 {published data only}
  • 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.
Lavelle-Jones 1993 {published data only (unpublished sought but not used)}
  • Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993;306(6882):885-90.
Luck 1999 {published and unpublished data}
Makdessian 2004 {published data only}
  • 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.
Mason 2003 {published data only}
  • 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.
Masood 2007 {published data only (unpublished sought but not used)}
Mauffrey 2008 {published and unpublished data}
  • 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.
Mishra 2010a {published and unpublished data}
  • 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.
Mishra 2010b {published and unpublished data}
  • 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.
Morgan 2000 {published and unpublished data}
  • 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.
Nadeau 2010 {published and unpublished data}
  • 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.
Neary 2010 {published data only}
  • 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.
Neptune 1996 {published data only (unpublished sought but not used)}
O'Neill 1996a {published data only}
O'Neill 1996b {published data only}
Olver 2009 {published and unpublished data}
  • 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.
Paci 1999 {published data only}
  • 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.
Pesudovs 2006 {published data only (unpublished sought but not used)}
  • Pesudovs K, Luscombe CK, Coster DJ. Recall from informed consent counselling for cataract surgery. Journal of Law and Medicine 2006;13(4):496-504.
Phatouros 1995 {published data only (unpublished sought but not used)}
  • Phatouros CC, Blake MP. Patients' attitudes to an information sheet prior to angiography and angioplasty. Australasian Radiology 1995;39(2):135-9.
Raynes-Greenow 2010 {published data only}
  • 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]
Rossi 2004 {published data only (unpublished sought but not used)}
  • 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.
Rossi 2005 {published data only (unpublished sought but not used)}
Rymeski 2010 {published data only}
  • 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.
Shorten 2005 {published data only}
Solberg 2010 {published data only}
  • 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.
Tait 2009 {published and unpublished data}
  • 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.
Thomas 2000 {published data only}
  • 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.
Uzbeck 2009 {published data only (unpublished sought but not used)}
  • 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.
Wadey 1997 {published data only}
Walker 2007 {published data only}
  • 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.
Whelan 2003 {published data only (unpublished sought but not used)}
  • 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.
Wilhelm 2009 {published and unpublished data}
  • 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.
Wong 2006 {published data only}
Yucel 2005 {published data only}
  • 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.
Zite 2011 {published data only}
  • 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.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Ader 1992 {published data only}
  • 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.
Altaie 2011 {published data only}
  • Altaie RR, Ku JJ, Mora JJ. Informed consent in strabismus surgery. Journal of American Association of Pediatric Ophthalmology and Strabismus 2011;15(1):e12.
Broyles 1992 {published data only}
Clark 2011 {published data only}
  • 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.
Dawes 1992 {published data only}
  • 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.
Dawes 1993 {published data only}
  • 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.
Eggers 2007 {published data only}
Finch 2009 {published data only}
  • 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.
Fink 2010a {published data only}
  • 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.
Graham 2000 {published data only}
  • 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.
Grawe 2010 {published data only}
  • 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.
Gyomber 2010 {published data only}
Hewison 2001 {published data only}
  • 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.
Hilzenrat 2006 {published data only}
  • 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.
Jlala 2010 {published data only}
  • 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.
Johnson 2011 {published data only}
  • 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.
Kasper 2008 {published data only}
Lembcke 1998 {published data only}
  • 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.
Lipp 1991 {published data only}
  • 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.
Migden 2008 {published data only}
  • 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.
Nagle 2008 {published data only}
O'Cathain 2002 {published data only}
  • 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.
Roth-Isigkeit 2001a {published data only}
  • 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}
  • 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.
Schenker 2010 {published data only}
  • 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}
  • Shurnas PS, Coughlin MJ. Recall of the risks of forefoot surgery after informed consent. Foot and Ankle International 2003;24(12):904-8.
Stanley 1998 {published data only}
Steckelberg 2011 {published data only}
  • 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.
Taylor 2010 {published data only}
  • 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.
Wright 2010 {published data only}
  • 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.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Akkad 2004
Akkad 2006
AMA 2009
  • American Medical Association. Informed Consent. Code of Medical Ethics. Revised. American Medical Association, 2009:438.
AMC 2009
  • 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
  • Barkin JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM. Evaluation and stages of surgical innovations. Lancet 2009;374:1089-96.
Beisecker 1990
  • Beisecker AE, Beisecker TD. Patient information-seeking behaviors when communicating with doctors. Medical Care 1990;28(1):19-28.
BMA 2009
  • British Medical Association. Consent Tool Kit. http://www.bma.org.uk/images/consenttoolkitdec2009_tcm41-193139.pdf 2009 (accessed 9 Sep 2011).
Brezis 2008
  • 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.
Canterbury v Spence 1972
  • United States Court of Appeals for the District of Columbia Circuit. Canterbury v Spence. Federal Reporter 1972; Vol. 464.
CCCRG 2008
  • 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
  • House of Lords. Chester v Afshar. House of Lords opinions of the Lords of Appeal for Judgement 2004; Vol. UKHL41.
Cohn 2007
Dixon-Woods 2006
  • 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
  • Department of Health (UK). Reference Guide to Consent for Examination or Treatment. London: Department of Health (UK), 2001.
DoH 2009
  • Department of Health (UK). Reference Guide to Consent for Examination or Treatment. 2nd Edition. London: Department of Health (UK), 2009.
Doust 2007
  • 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]
Duncan 2010
Edwards 2002
Egbert 1964
  • 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.
Elwyn 2008
  • Elwyn G. Patient consent: decision or assumption?. BMJ 2008;336(7656):1259.
Elwyn 2010
Elwyn 2012
  • 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]
Ergina 2009
  • Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien P, Reeves BC, et al. Challenges in evaluating surgical innovations. Lancet 2009;374:1097-104.
Evans 2007
  • 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]
GMC 2008
  • General Medical Council. Consent: Patients and Doctors Making Decisions Together. General Medical Council 2008. [: ISBN 978-0-901458-31-5]
Gøtzsche 2013
Habiba 2004
Hall 1988
Henderson 2010
  • 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]
Higgins 2003
Higgins 2011
  • 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
  • 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]
Jefford 2002
Jenkins 1999
Kennedy 2002
  • 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.
Kinnersley 2007
Légaré 2010
Makoul 1995
  • 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.
Marteau 2001
Mazur 2009
  • 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
  • Oxman A. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490-4.
Picano 2004
RevMan
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
Rogers v Whitaker 1992
  • High Court of Australia. Rogers v Whitaker. High Court of Australia, Canberra 1992; Vol. 58:175 CLR 479.
Roter 2006
  • 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
  • Royal College of Surgeons of England. Surgery and the NHS in numbers. http://www.rcseng.ac.uk/media/media-background-briefings-and-statistics/surgery-and-the-nhs-in-numbers 2011.
Ryan 2009
  • 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]
Ryan 2011
  • 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
Schenker 2011
  • 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.
Silverman 2005
  • Silverman J, Kurtz S, Draper J. Skills for Communicating with Patients. Oxford: Radcliffe, 2005.
Stacey 2011
  • 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]
Treadwell 2006
  • 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.
Woodrow 2006
  • 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.

References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Kinnersley 2011
  • 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]