Best Practice Guidelines on Informed Consent ... - Wiley Online Library

Best Practice Guidelines on Informed Consent for Weight Loss Surgery Patients James Sabin,* Robert Fanelli,† Helen Flaherty,‡ Nawfal Istfan,§ Wendy Mariner,¶ Janet Nally Barnes,** Janey S.A. Pratt,†† Laura Rossi,** and Patricia Samour‡‡

Abstract SABIN, JAMES, ROBERT FANELLI, HELEN FLAHERTY, NAWFAL ISTFAN, WENDY MARINER, JANET NALLY BARNES, JANEY S.A. PRATT, LAURA ROSSI, AND PATRICIA SAMOUR. Best practice guidelines on informed consent for weight loss surgery patients. Obes Res. 2005;13:250 –253. Objective: To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. Research Methods and Procedures: We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. Results: This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed

The costs of publication of this article were defrayed, in part, by the payment of page charges. This article must, therefore, be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. *Harvard Pilgrim Health Care, Department of Psychiatry, Boston, Massachusetts; †Department of Surgery, Berkshire Medical Center, Pittsfield, Massachusetts; ‡Division of Nutrition, Boston University Medical Center, Boston, Massachusetts; §Boston University School of Public Health, Boston, Massachusetts; ¶Department of Risk Management, Brigham and Women’s Hospital, Boston, Massachusetts; **Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts; ††Department of Nursing, Brigham and Women’s Hospital, Boston, Massachusetts; ‡‡Division of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Address correspondence to James Sabin, Harvard Pilgrim Health Care, 133 Brookline Avenue, Sixth Floor, Boston, MA 02215. E-mail: [email protected] Copyright © 2005 NAASO

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consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Discussion: Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making. Key words: informed consent, competence, comprehension, patient education, content

Introduction To give informed consent on whether to undergo weight loss surgery (WLS),1 patients need information about the types of surgery available (restrictive and/or malabsorptive, laparoscopic), associated risks and complications, resulting dietary and lifestyle modifications, anticipated outcomes, and long-term effects (1). Patients require all of the information necessary for a reasonable person to make a decision (2). The legal requirements for informed consent in Massachusetts, as in other states, are limited (3,4). Legal doctrine does not oblige a physician to tell a patient everything he or she might want to know, nor does it require that the patient actually understand the information provided or the implications of their decision. It merely provides the minimum standards for making an informed decision possible (5). This report examines the process of informed consent, the content and presentation of educational materials, and the assessment of patient understanding, as they affect the safety of WLS patients. We assess the ethics of informed consent and make evidence-based recommendations for the

1

WLS, weight loss surgery.

Informed Consent Obesity Surgery, Sabin et al.

content and execution of best practice education as it pertains to informed consent by WLS patients.

Research Methods and Procedures We conducted a systematic review of the scientific literature published in MEDLINE between 1984 and 2004. We found three review articles focused on informed consent for WLS but no empirical data on the informed consent process for WLS. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models (6). We also relied on informed consent and educational materials from six WLS programs in Massachusetts. Recommendations were based on the three review articles, informed consent materials from the six Massachusetts WLS programs, discussions with WLS program leaders, and the consensus of Task Group leaders. All evidence is ranked Category D (Table 1).

Results Patient Safety: Understanding vs. Disclosure Legal precedent (4) sets a standard of disclosure that extends to significant medical information disclosed in a reasonable manner. Professional ethics suggest that physicians go beyond their legal obligations to ensure that patients understand the implications of medical decisions (7). Those suggestions are echoed by others who espouse reasonable efforts to assure patient comprehension and assess understanding (8 –11). Recommendation: ●

An informed consent process that includes assessment of the patient’s understanding of the material.

turn to it, clinicians may often need to spend time not only educating patients, but also reeducating them (12). However, education is the key to helping patients achieve optimal health and a better overall quality of life after WLS (1). Mason and Hesson (2) suggest that patient education about the operation and its effects should be documented throughout the work-up and into the follow-up. Recommendations. This Task Group recommends that educational objectives of the informed consent process should: ● ● ●

Appropriate Content At a minimum, informed consent materials need to explain changes in anatomy, function, and risk for available surgical options (2). Garza (1) extends that list to include rationales for and goals of WLS, associated risks and complications, dietary and lifestyle modifications that will result from the surgery, anticipated outcomes, and long-term effects of the surgery. Recommendations. WLS programs should include information on the following topics as part of their informed consent process: ● ● ● ● ●

Educational Resources and Objectives The Internet is not a dependable source of accurate information for patients. As more and more WLS candidates

Maximize patient participation in preoperative programs. Help patients make informed decisions about surgery. Improve each patient’s short- and long-term well-being.

●

Health risks associated with obesity. Alternatives to WLS for treatment of obesity. Alternative forms of WLS and our current understanding of respective risks and benefits. Potential complications in the postoperative period and beyond. Presurgical strategies to reduce surgical risks, including preoperative weight loss. Potential impact of WLS on family, friends, and relationships.

Table 1. Summary of literature review First author

Year of publication

Reference

Major recommendations

Mason

1998

2

Garza

2003

1

Madan

2003

12

Informed consent is a duty and good practice. Teaching about anatomical change is important. Robust education, using multiple approaches, should be offered first. Only after “patients have demonstrated an acceptable level of understanding” should they be assessed for suitability for surgery. A good proportion of information on the Internet is biased or inaccurate. “. . . bariatric surgeons often may need to spend time not only to educate, but also to reeducate their patients . . .”

Evidence grade


D D

D

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● ● ●

Common psychological adjustment issues after WLS. Postsurgical requirements, especially those related to diet and medications. Aftercare programs and sources of support.

Teaching and Learning Teaching methods can vary from simple drawings used to explain what is planned, how the operation will determine body weight, side effects, and risk (2) to office-based, computer-generated educational information tailored to the specific needs of individual patients (13). Garza (1) notes that teaching methods may include a combination of written materials, videos, multimedia presentations, seminar-type lectures, and/or one-to-one patient discussions. Initial patient education can be done either in the physician’s office, at the clinic, through a structured class, or through the Internet. Recommendations. This Task Group recommends that WLS programs should use active teaching and learning techniques that may include:

Recommendations: ● ●

Future Research A public repository of educational materials and informed consent documents used by WLS programs statewide would promote the development of improved and more consistent patient education and informed consent materials. Recommendations: ● ● ●

● ●

●

Videotapes that prospective patients can take home and share with their family and friends. Participation of patients’ support network (family or friends) in education programs and discussions with the WLS clinical team. Practice with a mock postsurgical diet regimen to improve understanding of long-term implications.

Assessment of Learning Patients need to be comfortable with their decisions to pursue WLS and to base those decisions on accurate and reliable information. After completion of initial education, some patients may be required by their physicians to take a posttest to determine their level of understanding (1). Recommendations: ● ●

That assessment of learning be an integral part of the informed consent process. That WLS programs evaluate the effectiveness of their informed consent education programs using a variety of tools, including diet preparation and documentation exercises and oral or written tests and tools.

Promoting Realistic Expectations Herron (14) suggests that patient selection be performed very carefully, with the choice of procedure tailored to the individual patient’s physiological needs and desires for postoperative lifestyle. Patients need to understand that nutritional and metabolic follow-up will continue for the rest of their lives (14). WLS patients must be committed to the appropriate preoperative work-up and to continuing longterm postoperative medical management (15). 252


Emphasize that WLS is only one component of a lifetime weight management program. Offer an agreement, signed by the patient and a WLS clinician, to help reinforce commitment to long-term follow-up and self-management. (The agreement is not legally binding.)

Studies to assess the effect of different forms of education on levels of patient understanding. Studies to assess patient satisfaction with different informed consent processes. Operations research to increase the efficiency and reliability of the informed consent process.

Discussion WLS procedures are effective in producing long-term weight loss in appropriately selected morbidly obese patients (16), but they also carry substantial risks, including numerous complications and death (17). Patients frequently make decisions about the risks of medical treatments, but their understanding of such risks may not be completely objective (18). Risk perception is affected not only by individual factors, such as the patient’s sex, prior beliefs, and past experience (18 –20), but also by how the risk information itself is presented. By employing a mix of techniques that accommodate the varying preferences and abilities of different patients (18), providers of WLS procedures can satisfy the legal doctrine of disclosure (5) and the ethical obligation to assure comprehension (8) of informed consent materials.

Acknowledgments We thank George Blackburn and Frank Hu for manuscript preparation, Barbara Ainsley for administrative services, and Rita Buckley for editorial services. Manuscript preparation was supported in part by the Center for Healthy Living at Harvard Medical School and by the Boston Obesity Nutrition Research Center (Grant P30DK46200). This report on WLS was prepared for the Betsy Lehman Center for Patient Safety and Medical Error Reduction (Department of Public Health, Boston, MA). References 1. Garza SF. Bariatric weight loss surgery: patient education, preparation, and follow-up. Crit Care Nurs Q. 2003;26:101– 4.


2. Mason EE, Hesson WW. Informed consent for obesity surgery. Obes Surg. 1998;8:419 –28. 3. 429 Mass. 456; 709 N.E. 2d 58 (1999). Shine V. Vega. 4. 387 Mass 152; 439 N.E. 2d 240. Harnish v Children’s Hospital Medical Center. 1982. 5. Annas GJ. The Rights of Patients. 3rd ed. Carbondale, IL: Southern Illinois University Press; 2004. 6. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services. Baltimore, MD: Williams & Wilkins; 1996. 7. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions. Washington, DC: Government Printing Office; 1982. 8. Jonsen AR, Siegler M, Winslade JJ. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. New York: Macmillan Publishing Company; 1982. 9. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986. 10. Katz J. The Silent World of Doctor and Patient. New York: Free Press; 1984. 11. Lo B. Resolving Ethical Dilemmas: A Guide for Clinicians. Baltimore: Williams & Wilkins; 1995. 12. Madan AK, Frantzides CT, Pesce CE. The quality of information about laparoscopic bariatric surgery on the Internet. Surg Endosc. 2003;17:685–7.

13. Kreuter MW, Chheda SG, Bull FC. How does physician advice influence patient behavior? Evidence for a priming effect. Arch Fam Med. 2000;9:426 –33. 14. Herron DM. The surgical management of severe obesity. Mt Sinai J Med. 2004;71:63–71. 15. American College of Surgeons. [ST-34] Recommendations for Facilities Performing Bariatric Surgery. http://www.facs. org/fellows info/statements/st-34.html (accessed November 3, 2004). 16. NHLBI. The Practical Guide to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Bethesda, MD: National Institutes of Health; 2000. 17. Weight-Control Information Network. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): Longitudinal Assessment of Bariatric Surgery (LABS): August 2004. http://win.niddk.nih.gov/publications/labs.htm (accessed November 3, 2004). 18. Gordon-Lubitz RJ. MSJAMA. Risk communication: problems of presentation and understanding. JAMA. 2003;289:95. 19. Shilo S, Saxe L. Perception of risk in genetic counseling. Psychol Health. 1989;3:45– 61. 20. Hallowell N, Statham H, Murton F, Green JM, Richards MP. “Talking about chance”: the presentation of risk information during genetic counseling for breast and ovarian cancer. J Gen Counseling. 1997;6:269 – 85.


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