Journal of the American College of Surgeons
Volume 210, Issue 6 , Pages 919-926 , June 2010

Predictors of Comprehension during Surgical Informed Consent

Presented at the American College of Surgeons 95th Annual Clinical Congress, Chicago, IL, October 2009.

  • Aaron S. Fink, MD, FACS

      Affiliations

    • Atlanta VAMC, Decatur, GA
    • Department of Surgery, Emory University School of Medicine, Atlanta, GA
    • Corresponding Author InformationCorrespondence address: Aaron S Fink, MD, VAMC Atlanta (112), 1670 Clairmont Rd, Decatur, GA 30033
    • ,
  • Allan V. Prochazka, MD, MSc

      Affiliations

    • Denver VAMC, Denver, CO
    • University of Colorado Health Outcomes Program, Denver, CO
    • ,
  • William G. Henderson, PhD

      Affiliations

    • University of Colorado Health Outcomes Program, Denver, CO
    • ,
  • Debra Bartenfeld, RN, MSN

      Affiliations

    • Atlanta VAMC, Decatur, GA
    • ,
  • Carsie Nyirenda, MB, ChB, MPH

      Affiliations

    • University of Colorado Health Outcomes Program, Denver, CO
    • ,
  • Alexandra Webb, MD, FACS

      Affiliations

    • Atlanta VAMC, Decatur, GA
    • Department of Surgery, Emory University School of Medicine, Atlanta, GA
    • ,
  • David H. Berger, MD, MHCM, FACS

      Affiliations

    • Michael DeBakey VAMC and Michael DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX
    • ,
  • Kamal Itani, MD, FACS

      Affiliations

    • Boston VAMC and Departments of Surgery, Boston University and Harvard Medical School, Boston, MA
    • ,
  • Thomas Whitehill, MD, FACS

      Affiliations

    • Denver VAMC and Department of Surgery, University of Colorado, Denver, CO
    • ,
  • James Edwards, MD, FACS

      Affiliations

    • Portland VAMC and Department of Surgery, Oregon Health & Science University, Portland, OR
    • ,
  • Mark Wilson, MD, PhD, FACS

      Affiliations

    • Pittsburgh VAMC and Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA
    • ,
  • Cynthia Karsonovich, MD, FACS

      Affiliations

    • Tampa VAMC and Department of Surgery, University of South Florida, Tampa, FL
    • ,
  • Patricia Parmelee, PhD

      Affiliations

    • Department of Psychology, University of Alabama, Tuscaloosa, AL

Received 17 December 2009 ,Revised 27 January 2010 ,Accepted 24 February 2010.

References 

  1. Byrne DJ, Napier A, Cuschieri A. How informed is signed consent?. Br Med J (Clin Res Ed). 1988;296:839–840
  2. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent – why are its goals imperfectly realized?. N Engl J Med. 1980;302:896–900
  3. Clark SK, Leighton BL, Seltzer JL. A risk-specific anesthesia consent form may hinder the informed consent process. J Clin Anesth. 1991;3:11–13
  4. Dawes PJ, O'Keefe L, Adcock S. Informed consent: the assessment of two structured interview approaches compared to the current approach. J Laryngol Otol. 1992;106:420–424
  5. Paling J. Strategies to help patients understand risks. BMJ. 2003;327:745–748
  6. Sugarman J, McCrory DC, Powell D, et al. Empirical research on informed consent (An annotated bibliography). Hastings Cent Rep. 1999;29:S1–S42
  7. Hekkenberg RJ, Irish JC, Rotstein LE, et al. Informed consent in head and neck surgery: how much do patients actually remember?. J Otolaryngol. 1997;26:155–159
  8. Herz DA, Looman JE, Lewis SK. Informed consent: is it a myth?. Neurosurgery. 1992;30:453–458
  9. Hutson MM, Blaha JD. Patients' recall of preoperative instruction for informed consent for an operation. J Bone Joint Surg. 1991;73:160–162
  10. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993;306:885–890
  11. Leeb D, Bowers DG, Lynch JB. Observations on the myth of “informed consent”. Plast Reconstr Surg. 1976;58:280–282
  12. Morgan LW, Schwab IR. Informed consent in senile cataract extraction. Arch Ophthalmol. 1986;104:42–45
  13. Reading AE. Psychological preparation for surgery: patient recall of information. J Psychosom Res. 1981;25:57–62
  14. Robinson G, Merav A. Informed consent: recall by patients tested postoperatively. Ann Thorac Surg. 1976;22:209–212
  15. Saw KC, Wood AM, Murphy K, et al. Informed consent: an evaluation of patients' understanding and opinion (with respect to the operation of transurethral resection of prostate). J R Soc Med. 1994;87:143–144
  16. Wade TC. Patients may not recall disclosure of risk of death: implications for informed consent. Med Sci Law. 1990;30:259–262
  17. Wadey V, Frank C. The effectiveness of patient verbalization on informed consent. Can J Surg. 1997;40:124–128
  18. Rothman RL, DeWalt DA, Malone R, et al. Influence of patient literacy on the effectiveness of a primary care-based diabetes disease management program. JAMA. 2004;292:1711–1716
  19. Williams MV, Davis T, Parker RM, Weiss BD. The role of health literacy in patient-physician communication. Fam Med. 2002;34:383–389
  20. Communicating with patients who have limited literacy skills (Report of the National Work Group on Literacy and Health). J Fam Pract. 1998;46:168–176
  21. Doak CC, Doak LG, Friedell GH, Meade CD. Improving comprehension for cancer patients with low literacy skills: strategies for clinicians. Cancer J Clin. 1998;48:151–162
  22. Meade CD. Improving understanding of the informed consent process and document. Semin Oncol Nurs. 1999;15:124–137
  23. Wilson FL, Baker LM, Nordstrom CK, Legwand C. Using the teach-back and Orem's Self-care Deficit Nursing theory to increase childhood immunization communication among low-income mothers. Issues Compr Pediatr Nurs. 2008;31:7–22
  24. Bertakis KD. The communication of information from physician to patient: a method for increasing patient retention and satisfaction. J Fam Pract. 1977;5:217–222
  25. White CS, Mason AC, Feehan M, Templeton PA. Informed consent for percutaneous lung biopsy: comparison of two consent protocols based on patient recall after the procedure. Am J Roentgenol. 1995;165:1139–1142
  26. Kripalani S, Bengtzen R, Henderson LE, Jacobson TA. Clinical research in low-literacy populations: using teach-back to assess comprehension of informed consent and privacy information. IRB. 2008;30:13–19
  27. Fink AS, Prochazka AV, Henderson WB, et al. Enhancement of surgical informed consent by addition of repeat back: a multi-center, randomized controlled clinical trial. Ann Surg, in press.
  28. Davis TC, Long SW, Jackson RH, et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993;25:391–395
  29. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–233
  30. VHA. VHA Handbook 1004.1. VHA Informed Consent for Clinical Treatments and Procedures. http://www.ethics.va.gov/docs/policy/VHA_Handbook_1004-01_Informed_Consent_Policy_20090814.pdf2003;Accessed April 15, 2010
  31. Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31:301–306
  32. Goldberger JJ, Kruse J, Parker MA, Kadish AH. Effect of informed consent on anxiety in patients undergoing diagnostic electrophysiology studies. Am Heart J. 1997;134:119–126
  33. Kindler CH, Harms C, Amsler F, et al. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000;90:706–712
  34. Lee A, Chui PT, Gin T. Educating patients about anesthesia: a systematic review of randomized controlled trials of media-based interventions. Anesth Analg. 2003;96:1424–1431
  35. Sudore RL, Landefeld CS, Williams BA, et al. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006;21:867–873
  36. Taub HA, Baker MT. The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Exp Aging Res. 1983;9:135–138
  37. Taub HA, Kline GE, Baker MT. The elderly and informed consent: effects of vocabulary level and corrected feedback. Exp Aging Res. 1981;7:137–146
  38. Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointest Endosc. 1994;40:271–276
  39. Taub HA. Comprehension of informed consent for research: issues and directions for future study. IRB. 1986;8:7–10
  40. Taub HA, Baker MT, Kline GE, Sturr JF. Comprehension of informed consent information by young-old through old-old volunteers. Exp Aging Res. 1987;13:173–178
  41. Aaronson NK, Visser-Pol E, Leenhouts GH, et al. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol. 1996;14:984–996
  42. Neptune SM, Hopper KD, Houts PS, et al. Take-home informed consent for intravenous contrast media: do patients learn more?. Invest Radiol. 1996;31:109–113
  43. Sorrell JM. Effects of writing/speaking on comprehension of information for informed consent. West J Nurs Res. 1991;13:110–122
  44. Greenley RN, Drotar D, Zyzanski SJ, Kodish E. Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent. J Clin Oncol. 2006;24:891–897
  45. Baker DW, Williams MV, Parker RM, et al. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999;38:33–42
  46. United States. Agency for Healthcare Research and Quality, University of California San Francisco-Stanford Evidence-Based Practice Center. Making health care safer: a critical analysis of patient safety practices. Rockville, MD: Agency for Healthcare Research and Quality, US Dept. of Health and Human Services; 2001;
  47. National Quality Forum. Safe practices for better healthcare : a consensus report. Washington, DC: National Quality Forum; 2003;
  48. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004;292:1593–1601

 The work was supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (Project no. IAF 05-308-01). The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

 Disclosure Information: Nothing to disclose.

PII: S1072-7515(10)00177-8

doi: 10.1016/j.jamcollsurg.2010.02.049

Journal of the American College of Surgeons
Volume 210, Issue 6 , Pages 919-926 , June 2010

Article Tools