A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions

Wouter K G Leclercq, Bram J Keulers, Marc R M Scheltinga, Paul H M Spauwen, Gert-Jan van der Wilt, Wouter K G Leclercq, Bram J Keulers, Marc R M Scheltinga, Paul H M Spauwen, Gert-Jan van der Wilt

Abstract

Background: Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process.

Methods: Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed.

Results: The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose.

Conclusions: IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.

Figures

Fig. 1
Fig. 1
Landmarks in the history of the IC process: a timetable
Fig. 2
Fig. 2
American Review: A Whig Journal of Politics, Literature, Art, and Science (December 1845); publication of Edgar Allen Poe’s “The fact in the case of M. Valdemar.” Available at http://digital.library.cornell.edu/cgi/t/text/text-idx?c=amwh;idno=amwh0002-6
Fig. 3
Fig. 3
Cardozo, Benjamin Nathan. Online photograph from the Encyclopædia Britannica. Available at http://www.britannica.com/eb/art-96738
Fig. 4
Fig. 4
Nuremberg Trial: the 23 defendants in dock during the doctors’ trial. Available at http://www.law.umkc.edu/faculty/projects/ftrials/nuremberg/docdef.jpg
Fig. 5
Fig. 5
The elements of IC

References

    1. Ajlouni KM. History of informed medical consent. Lancet. 1995;346(8980):980. doi: 10.1016/S0140-6736(95)91608-3.
    1. Baron JH. History of informed medical consent. Lancet. 1996;347(8998):410.
    1. Rothman DJ. History of informed medical consent. Lancet. 1995;346(8990):1633. doi: 10.1016/S0140-6736(95)91970-8.
    1. Eng Rep. Slater vs. Baker and Stapleton, 1767 (Slater vs. Baker and Stapleton 95 Eng Rep. 860 (k.b. 1767))
    1. Curran WJ, Hall MA, Kaye DH (1990) Health care law, forensic science, and public policy, 4th edn. Little, Brown and Company, Boston
    1. Altschuler EL. Informed consent in an Edgar Allen Poe tale. Lancet. 2003;362(9394):1504. doi: 10.1016/S0140-6736(03)14710-1.
    1. Poe EA (1845) The fact in the case of M. Valdemar. Am Rev: Whig J Polit Lit Art Sci II(VI).
    1. Supreme Court of Minnesota (1905) Mohr v. Williams (104 N.W. 12 Supreme Court of Minnesota)
    1. Recent Decisions: Tort. assault and battery. Unauthorized surgical operation constitutes “assault and battery.” (1927) Virginia Law Rev 13(6):505.
    1. N.E. Schoendorff v. Society of New York Hospital, 1914 (106N.E. 93 (N.Y. 1914))
    1. Armstrong AP, Cole AA, Page RE. Informed consent: are we doing enough? Br J Plast Surg. 1997;50(8):637–640. doi: 10.1016/S0007-1226(97)90510-5.
    1. Katz J. Reflections on informed consent: 40 years after its birth. J Am Coll Surg. 1998;186(4):466–474. doi: 10.1016/S1072-7515(98)00045-3.
    1. Langdon IJ, Hardin R, Learmonth ID. Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Ann R Coll Surg Engl. 2002;84(6):404–408. doi: 10.1308/003588402760978201.
    1. Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996;313(7070):1445–1449.
    1. P. Salgo v. Leland Stanford Jr. University Board of Trustees, 1957 (317 P.2d 170)
    1. P. Natanson vs. Kline, 1960 (350 P.2d 1093)
    1. WLR Bolam vs. Friern Hospital Management Committee, 1957 (1 WLR 583)
    1. F. Canterbury vs. Spence, 1972 (464 F.2d 772 (d.c. 1972))
    1. Issa MM, Setzer E, Charaf C, et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. J Urol. 2006;176(2):694–699. doi: 10.1016/j.juro.2006.03.037.
    1. Skene L, Smallwood R. Informed consent: lessons from Australia. BMJ. 2002;324(7328):39–41. doi: 10.1136/bmj.324.7328.39.
    1. Kastelein WR (1998) [Informed consent and medical liability: jurisprudence 1994–1998. Tijdschr Gezondhd 22:134-146 [in Dutch]
    1. P. Truman vs. Thomas, 1980 (611 P.2d 902 (Cal 1980))
    1. World Health Organization Staff (1995) Promotion of the Rights of Patients in Europe. In: Proceedings of a WHO Consultation
    1. Ashraff S, Malawa G, Dolan T, et al. Prospective randomised controlled trial on the role of patient information leaflets in obtaining informed consent. ANZ J Surg. 2006;76(3):139–141. doi: 10.1111/j.1445-2197.2006.03671.x.
    1. Pleat JM, Dunkin CS, Davies CE, et al. Prospective survey of factors affecting risk discussion during consent in a surgical specialty. Br J Surg. 2004;91(10):1377–1380. doi: 10.1002/bjs.4590.
    1. Verbogt S (2003) Hoofdstukken over gezondheidsrecht (chapters in health law), 9th edn. Wolters-Noordhoff, Groningen, The Netherlands. ISBN:9068905759
    1. Bernat JL, Peterson LM. Patient-centered informed consent in surgical practice. Arch Surg. 2006;141(1):86–92. doi: 10.1001/archsurg.141.1.86.
    1. Appelbaum PS. Clinical practice. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834–1840. doi: 10.1056/NEJMcp074045.
    1. Akkad A, Jackson C, Kenyon S, et al. Patients’ perceptions of written consent: questionnaire study. BMJ. 2006;333(7567):528. doi: 10.1136/bmj.38922.516204.55.
    1. Schouten B, Hoogstraten J, Eijkman M. Dutch dental patients on informed consent: knowledge, attitudes, self-efficacy and behaviour. Patient Educ Couns. 2002;46(1):47–54. doi: 10.1016/S0738-3991(01)00158-6.
    1. Ghulam AT, Kessler M, Bachmann LM, et al. Patients’ satisfaction with the preoperative informed consent procedure: a multicenter questionnaire survey in Switzerland. Mayo Clin Proc. 2006;81(3):307–312. doi: 10.4065/81.3.307.
    1. Godwin Y. Do they listen? A review of information retained by patients following consent for reduction mammoplasty. Br J Plast Surg. 2000;53(2):121–125. doi: 10.1054/bjps.1999.3220.
    1. Kriwanek S, Armbruster C, Beckerhinn P, et al. Patients’ assessment and recall of surgical information after laparoscopic cholecystectomy. Dig Surg. 1998;15(6):669–673. doi: 10.1159/000018675.
    1. Pesudovs K, Luscombe CK, Coster DJ. Recall from informed consent counselling for cataract surgery. J Law Med. 2006;13(4):496–504.
    1. Shamsian N, Southern SJ, Wilkinson S, et al. What is the medicolegal implication of a Web-based three-dimensional interactive virtual reality plastic surgery package? Plast Reconstr Surg. 2005;116(6):1839–1840. doi: 10.1097/01.prs.0000189024.65541.d0.
    1. Keulers BJ, Scheltinga MR, Houterman S, et al. Surgeons underestimate their patients’ desire for preoperative information. World J Surg. 2008;32(6):964–970. doi: 10.1007/s00268-008-9581-1.
    1. Angelos P, Darosa DA, Bentram D, et al. Residents seeking informed consent: are they adequately knowledgeable? Curr Surg. 2002;59(1):115–118. doi: 10.1016/S0149-7944(01)00591-8.
    1. Leeper-Majors K, Veale JR, Westbrook TS, et al. The effect of standardized patient feedback in teaching surgical residents informed consent: results of a pilot study. Curr Surg. 2003;60(6):615–622. doi: 10.1016/S0149-7944(03)00157-0.
    1. Soin B, Smellie WA, Thomson HJ. Informed consent: a case for more education of the surgical team. Ann R Coll Surg Engl. 1993;75(1):62–65.
    1. Bollschweiler E, Apitzsch J, Obliers R, et al. Improving informed consent of surgical patients using a multimedia-based program? Results of a prospective randomized multicenter study of patients before cholecystectomy. Ann Surg. 2008;248(2):205–211. doi: 10.1097/SLA.0b013e318180a3a7.
    1. Brezis M, Israel S, Weinstein-Birenshtock A, et al. Quality of informed consent for invasive procedures. Int J Qual Health Care. 2008;20(5):352–357. doi: 10.1093/intqhc/mzn025.
    1. Eggers C, Obliers R, Koerfer A, et al. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity (Silver Spring) 2007;15(11):2866–2873. doi: 10.1038/oby.2007.340.
    1. McGaughey I. Informed consent and knee arthroscopies: an evaluation of patient understanding and satisfaction. Knee. 2004;11(3):237–242. doi: 10.1016/S0968-0160(03)00107-8.
    1. Lavelle-Jones C, Byrne DJ, Rice P, et al. Factors affecting quality of informed consent. BMJ. 1993;306(6882):885–890. doi: 10.1136/bmj.306.6882.885.
    1. Keating NL, Weeks JC, Borbas C, et al. Treatment of early stage breast cancer: do surgeons and patients agree regarding whether treatment alternatives were discussed? Breast Cancer Res Treat. 2003;79(2):225–231. doi: 10.1023/A:1023903701674.
    1. Kessler TM, Nachbur BH, Kessler W. Patients’ perception of preoperative information by interactive computer program—exemplified by cholecystectomy. Patient Educ Couns. 2005;59(2):135–140. doi: 10.1016/j.pec.2004.10.009.
    1. Braddock CH, III, Edwards KA, Hasenberg NM, et al. Informed decision making in outpatient practice: time to get back to basics. JAMA. 1999;282(24):2313–2320. doi: 10.1001/jama.282.24.2313.
    1. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Arch Surg. 2000;135(1):26–33. doi: 10.1001/archsurg.135.1.26.
    1. Hopper KD, TenHave TR, Tully DA, et al. The readability of currently used surgical/procedure consent forms in the United States. Surgery. 1998;123(5):496–503. doi: 10.1067/msy.1998.87236.
    1. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348(8):721–726. doi: 10.1056/NEJMsa021212.
    1. Edwards AG, Weale AR, Morgan JD. Informed consent in renal transplantation. Postgrad Med J. 2005;81(953):188–190. doi: 10.1136/pgmj.2004.024760.
    1. Krause HR, Bremerich A, Rustemeyer J. Reasons for patients’ discontent and litigation. J Craniomaxillofac Surg. 2001;29(3):181–183.
    1. Baum N. Informed consent—more than a form. J Med Pract Manag. 2006;22(3):145–148.
    1. Guadagnoli E, Soumerai SB, Gurwitz JH, et al. Improving discussion of surgical treatment options for patients with breast cancer: local medical opinion leaders versus audit and performance feedback. Breast Cancer Res Treat. 2000;61(2):171–175. doi: 10.1023/A:1006475012861.
    1. Steinemann S, Furoy D, Yost F, et al. Marriage of professional and technical tasks: a strategy to improve obtaining informed consent. Am J Surg. 2006;191(5):696–700. doi: 10.1016/j.amjsurg.2006.02.003.
    1. Dimond B. Legal aspects of consent 22: nurses’ position when obtaining consent. Br J Nurs. 2002;11(4):281–283.
    1. Stalmeier PF, Roosmalen MS, Verhoef LC, et al. The decision evaluation scales. Patient Educ Couns. 2005;57(3):286–293. doi: 10.1016/j.pec.2004.07.010.
    1. Edwards MH. Satisfying patients’ needs for surgical information. Br J Surg. 1990;77(4):463–465. doi: 10.1002/bjs.1800770431.
    1. Askew G, Pearson KW, Cryer D. Informed consent: can we educate patients? J R Coll Surg Edinb. 1990;35(5):308–310.
    1. Brown TF, Massoud E, Bance M. Informed consent in otologic surgery: prospective study of risk recall by patients and impact of written summaries of risk. J Otolaryngol. 2003;32(6):368–372. doi: 10.2310/7070.2003.13987.
    1. Chan Y, Irish JC, Wood SJ, et al. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002;128(11):1269–1274.
    1. Danino AM, Lile A, Moutel G, et al. Visual documentation of oral consent: a new method of informed consent before major gigantomastia reduction for an illiterate population. Plast Reconstr Surg. 2006;117(4):1370–1371. doi: 10.1097/01.prs.0000205583.85178.26.
    1. Dawes PJ, O’Keefe L, Adcock S. Informed consent: using a structured interview changes patients’ attitudes towards informed consent. J Laryngol Otol. 1993;107(9):775–779. doi: 10.1017/S0022215100124417.
    1. Deyo RA, Cherkin DC, Weinstein J, et al. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care. 2000;38(9):959–969. doi: 10.1097/00005650-200009000-00009.
    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. Chirurg. 2002;73(5):500–507. doi: 10.1007/s00104-001-0416-y.
    1. Keulers BJ, Welters CF, Spauwen PH, et al. Can face-to-face patient education be replaced by computer-based patient education? A randomised trial. Patient Educ Couns. 2007;67(1–2):176–182. doi: 10.1016/j.pec.2007.03.012.
    1. Layton S, Korsen J. Informed consent in oral and maxillofacial surgery: a study of the value of written warnings. Br J Oral Maxillofac Surg. 1994;32(1):34–36. doi: 10.1016/0266-4356(94)90170-8.
    1. Makdessian AS, Ellis DA, Irish JC. Informed consent in facial plastic surgery: effectiveness of a simple educational intervention. Arch Facial Plast Surg. 2004;6(1):26–30. doi: 10.1001/archfaci.6.1.26.
    1. Mason V, McEwan A, Walker D, et al. The use of video information in obtaining consent for female sterilisation: a randomised study. BJOG. 2003;110(12):1062–1071. doi: 10.1111/j.1471-0528.2003.03041.x.
    1. Masood J, Hafeez A, Wiseman O, et al. Informed consent: are we deluding ourselves? A randomized controlled study. BJU Int. 2007;99(1):4–5. doi: 10.1111/j.1464-410X.2007.06516.x.
    1. Moseley TH, Wiggins MN, O’Sullivan P. Effects of presentation method on the understanding of informed consent. Br J Ophthalmol. 2006;90(8):990–993. doi: 10.1136/bjo.2006.092650.
    1. O’Neill P, Humphris GM, Field EA. The use of an information leaflet for patients undergoing wisdom tooth removal. Br J Oral Maxillofac Surg. 1996;34(4):331–334. doi: 10.1016/S0266-4356(96)90014-5.
    1. Rossi MJ, Guttmann D, MacLennan MJ, et al. Video informed consent improves knee arthroscopy patient comprehension. Arthroscopy. 2005;21(6):739–743.
    1. Shurnas PS, Coughlin MJ. Recall of the risks of forefoot surgery after informed consent. Foot Ankle Int. 2003;24(12):904–908.
    1. Stanley BM, Walters DJ, Maddern GJ. Informed consent: how much information is enough? Aust N Z J Surg. 1998;68(11):788–791. doi: 10.1111/j.1445-2197.1998.tb04678.x.
    1. Wadey V, Frank C. The effectiveness of patient verbalization on informed consent. Can J Surg. 1997;40(2):124–128.
    1. Hopper KD, Zajdel M, Hulse SF, et al. Interactive method of informing patients of the risks of intravenous contrast media. Radiology. 1994;192(1):67–71.
    1. Jimison HB, Sher PP, Appleyard R, et al. The use of multimedia in the informed consent process. J Am Med Inform Assoc. 1998;5(3):245–256.
    1. Klima S, Hein W, Hube A, et al. Multimedia preoperative patient information. Chirurg. 2005;76(4):398–403. doi: 10.1007/s00104-004-0917-6.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する