articles
nature publishing group
Intervention and Prevention
Best Practice Updates for Informed Consent and Patient Education in Weight Loss Surgery Christina C. Wee1, Janey S. Pratt2, Robert Fanelli3,4, Patricia Q. Samour5, Linda S. Trainor6 and Michael K. Paasche-Orlow7 To update evidence-based best practice guidelines for obtaining informed consent from weight loss surgery (WLS) patients, with an emphasis on appropriate content and communications approaches that might enhance patient understanding of the information, we performed a systematic search of English-language literature published between April 2004 and May 2007 in MEDLINE and the Cochrane database. Keywords included WLS and informed consent, comprehension, health literacy, and patient education; and WLS and outcomes, risk, patient safety management, and effectiveness. Recommendations are based on the most current literature and the consensus of the expert panel; they were graded according to systems used in established evidence-based models. We identified over 120 titles, 38 of which were reviewed in detail. Evidence suggests that WLS outcomes, including long-term rates of relapse, vary by procedure. For some weight loss surgeries, long-term outcomes may not be known. Risks also vary by patient and provider characteristics. Informed consent should incorporate realistic projections of the short- and long-term risks, benefits, and consequences of surgery, as well as alternatives to WLS. For consent to be informed, the education process should continue until the patient demonstrates comprehension of all relevant material and concepts. Confirmation of comprehension can protect patients engaged in the process of consent for WLS. Future research should focus on the outcomes and consequences of WLS, and different approaches that facilitate patient understanding of, and decision making about, WLS. Obesity (2009) 17, 885–888. doi:10.1038/oby.2008.567
Introduction
Evidence-based best practice guidelines for informed consent in weight loss surgery (WLS) have been previously described (1). Previous recommendations focused on understanding vs. disclosure, appropriate content, teaching and learning, and promoting realistic expectations (1). The 2004 task group found no studies on informed consent and WLS. Recommendations were based on three review articles, standard practice at six WLS centers in Massachusetts, and the consensus of the expert panel (1). No studies on WLS and informed consent have been published since that time. Recommendations are, therefore, based on related articles identified through our search strategy. This report adds recommendations to those in the 2005 guidelines, and describes the supporting evidence. To make sound medical decisions, patients must not only receive adequate and appropriate information, but also understand it (2). Poor comprehension of the risks, benefits, and
consequences of surgery can contribute to unrealistic expectations, suboptimal decision making, and potential litigation (3). The previous report cited a need for studies that assess the effect of different forms of education on patient understanding (1). This update draws on the evolving literature on patient safety and WLS outcomes to make recommendations on informed consent content. It also reviews the literature on patient comprehension in informed consent, including studies on health literacy and on clinical areas (e.g., cardiac surgery) that might apply to WLS. Methods and Procedures We searched MEDLINE and the Cochrane database for articles on bariatric or elective surgery and informed consent, comprehension, health literacy, and patient education published between April 2004 and May 2007. We also conducted searches on bariatric surgery and outcomes, risk, patient safety management, and effectiveness. In addition, we reviewed WLS guidelines and other potentially relevant articles recommended by the expert panel or cited in the initial articles we identified.
Division of General Medicine and Primary Care and Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; 2Department of Surgery and MGH Weight Center, Massachusetts General Hospital, Boston, Massachusetts, USA; 3Department of Surgery, Berkshire Medical Center, Pittsfield, Massachusetts, USA; 4Department of Surgery, University of Massachusetts Medical School, Pittsfield, Massachusetts, USA; 5Department of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; 6Minimally Invasive Surgery and Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; 7General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA. Correspondence: Christina C. Wee (
[email protected]) 1
Received 21 June 2007; accepted 6 September 2007; published online 19 February 2009. doi:10.1038/oby.2008.567
obesity | VOLUME 17 NUMBER 5 | MAY 2009
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articles Intervention and Prevention The system used to grade the quality of the evidence has already been described (4). We identified >120 titles; 38 of the most relevant were reviewed in detail. These included randomized controlled trials, prospective and retrospective cohort studies, meta-analyses, case reports, prior systematic reviews, and expert opinion. The focus of the recommendations and the process used to develop them are reported elsewhere (4). Results Content Risks/complications. WLS centers are ethically obligated to pro-
vide patients with adequate information on the risks, benefits, consequences, and alternatives to treatment (2). A recent systematic review of randomized controlled trials and observational studies suggests that risks of mortality and complications associated with WLS vary depending on the type of procedure (5). Several observational studies also indicate that risks vary depending on patient characteristics, e.g., older adults, men, and those with greater comorbidity have higher risks of mortality and complications (6–10). Risks can vary by as much as 20-fold across patient populations (6). Moreover, risks are higher in unselected and more generalizable populations (5,6,8) than in studies of selected patients seen primarily at tertiary surgical centers. The same applies to participants in studies where follow-up rates were low (5). One small single-site study found that patients who do not follow-up after surgery had poorer outcomes (10). Emerging evidence suggests that health provider characteristics, e.g., surgeon training, and hospital and surgeon volume of specific WLS procedures performed, may correlate with actual risk (11–13). Recommendations
• Provide realistic risk estimates that take into account patient factors (category C) and relevant institutional and health provider characteristics that might affect risk (e.g., experience and outcomes for specific WLS procedures) (category B). • Discuss short- and long-term risks and complications, and the potential for unknown or unforeseeable long-term risks (category D). Benefits/effectiveness. Obesity is associated with premature mor-
tality and other adverse health consequences, some of which are improved or reversed with weight loss (14). Controlled trials and observational studies demonstrate that WLS produces significant and sustained weight loss compared with alternative forms of treatment (5,15). In addition, two recent observational studies found that mortality rates of severely obese patients who had WLS were lower than those of severely obese patients who did not (16,17). Both studies were limited, however, by inadequate control for baseline BMI, illness burden, and potential selection bias. Studies document substantial weight loss and health benefits from WLS at 1 year; longer-term studies suggest that some, but not all, of the short-term weight loss and medical benefits are sustained over time (18). Magnitude and sustainability of weight loss and benefits vary by type of WLS procedure and 886
patient characteristics (5,18). One recent nonrandomized controlled study found that of 1,703 Swedish subjects enrolled for at least 10 years, 74% of gastric bypass and 35% of gastric banding patients, sustained at least a 20% weight loss; however, 9 and 25%, respectively sustained 5 years) are unavailable (category D). • Advise patients on the long-term health benefits of weight loss produced by WLS (category B). • Make them aware that not all preexisting medical and psychosocial consequences of obesity, including eating disorders, will improve with WLS (category C). • Give realistic estimates for health outcomes if patients decline surgical treatment (categories B and C), and advise them of known factors and interventions that might optimize benefits (category D). • Consider patient expectations, the value placed on different outcomes, and the risks each candidate is willing to accept; address unrealistic expectations or other misconceptions patients might have (category C). Consequences. In addition to risks and benefits, WLS is asso-
ciated with physiological changes that may have an adverse impact on patient quality of life; these include gastrointestinal side-effects, nutritional deficiencies, and excess skin (20). Recommendation
• Advise patients on required behavioral and dietary changes and other reasonable and foreseeable consequences of WLS that could affect health or quality of life in a substantive way, e.g., gastrointestinal symptoms, cosmetic effects, nutritional restrictions (category D). Alternative treatments
WLS is currently the most effective treatment for moderate to severe obesity, patients, but patients vary in the value they place on weight loss and the risks and tradeoffs they are willing to make to lose weight (19,21). Risks, benefits, and tradeoffs vary among different WLS procedures and nonsurgical treatments (5,15,18,22). Recommendations
• Advise patients about alternative WLS procedures and nonsurgical treatment options (e.g., medical and behavioral) (category C). • Inform them about alternatives even if they are not available through the consenting health provider or institution (category C). VOLUME 17 NUMBER 5 | MAY 2009 | www.obesityjournal.org
articles Intervention and Prevention Comprehension of informed consent
The NIH has defined health literacy as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions (23). Over 90 million American adults have inadequate health literacy skills (24). The prevalence of limited literacy is higher in older adults, in racial or ethnic minorities, and in those with limited education and chronic diseases (25). The association between limited literacy and adverse health outcomes has been well documented. Seminal reports about the problem of health literacy have been issued by the Institute of Medicine (24), the Agency for Healthcare Research and Quality (26), the American Medical Association (27), and the Joint Commission on the Accreditation of Hospital Organizations (28). However, no studies have examined the relation between limited literacy and the WLS informed consent process. Several lessons can still be drawn from related areas of research: limited literacy is a barrier to patient comprehension in the process of informed consent (29); clinicians are not able to discern which of their patients have limited literacy; and patients frequently fail to disclose that information due to concerns about shame (30–32). In addition, patients with limited literacy are less likely to ask questions than those with higher literacy skills (33). Data show that screening patients for limited literacy skills is neither beneficial nor necessary. Conversely, confirmation of comprehension promotes understanding regardless of health literacy level, and has been promoted as a patient safety measure (34). Simplification of informed consent materials and the use of multiple channels of communication can also be useful (35–37). In particular, care is needed with the presentation of numerical concepts; many people lack basic quantitative literacy skills (38). A recent study found that 66% of participants (174 of 264) were not able to answer a question relating to the odds of getting “heads” from flipping a coin (39). Moreover, clinicians are frequently unaware of the extent to which they communicate with jargon or use concepts that patients do not comprehend (40,41). In addition to consent forms and supporting brochures, websites, videos, and other materials and decision aids (35), patient participation in developing informed consent information can be helpful (42). A teach-to-goal educational approach, in which patient comprehension is evaluated and education continued until the patient exhibits mastery of the content, can help people with limited literacy (29). Recommendations
• Evaluate each patient’s comprehension of the risks, benefits, consequences, and alternatives to WLS (category C). • Confirm comprehension to protect patients engaged in the informed consent process (category C). Discussion
The demographics of WLS patients are changing; older patients and those with greater comorbidity are now undergoing surgery. As a result of these changes, historic estimates of risks and benefits extrapolated from earlier studies of WLS may obesity | VOLUME 17 NUMBER 5 | MAY 2009
not apply to the current WLS population. The disproportionate prevalence of obesity in many racial and minority groups requires modifications to how the informed consent process is conducted and communicated; low health literacy is more prevalent in ethnic and racial minorities, and can be a barrier to adequate informed consent (24,25). Our report is limited because of a lack of high-quality studies, particularly long-term, randomized trials on the risks, benefits, and consequences of various surgical and nonsurgical weight loss treatments. There are also few high-quality long-term observational studies on WLS outcomes in diverse populations. Future research is needed to better identify factors that affect WLS surgery outcomes in the long- and short-term so that patients can be cited appropriate and individualized outcomes information. WLS is a rapidly evolving field. New surgical techniques are being developed and evaluated. The current report addresses the process of informed consent for routine WLS. We have not presented recommendations for experimental procedures. These require an informed consent process that adheres to federal regulations for the protection of human subjects. We did not address informed consent in the pediatric population either. Data on the risks, benefits, consequences, and alternatives to WLS differ from those on adult populations, and are more limited. Informed consent in the pediatric/adolescent arena requires the assent of the patient and informed consent of the patient’s parents (43). This subject is covered in more detail in the Pediatric/Adolescent Task Group report (44). Our recommendations to ensure patient comprehension of informed consent materials are largely based on relevant research in other clinical areas. Future studies should examine whether these approaches will be effective in the WLS arena, and their potential impact on patient satisfaction and WLS outcomes. WLS is a high-risk procedure in a demographically diverse and clinically complex population. Rather than serve as a mere legal hurdle, informed consent should provide patients with easily understood and complete information needed to authorize the proposed surgery (2). Future research should focus on important gaps in knowledge on the outcomes and consequences of WLS, and different approaches to facilitate patient understanding of, and decision making about, WLS. SUPPLEMENTARY MATERIAL To review task group appendices, go to www.mass.gov/dph and search “Weight Loss Surgery.”
Acknowledgments We thank Frank Hu for advice in manuscript preparation, Leslie Kirle for administrative support, and Rita Buckley for research and editorial services. This report on WLS was prepared for the Betsy Lehman Center for Patient Safety and Medical Error Reduction (Commonwealth of Massachusetts Boston, MA). Manuscript preparation was supported, in part, by the Boston Obesity Nutrition Research Center Grant P30-DK-46200 and the Center for Healthy Living, Division of Nutrition, Harvard Medical School.
Disclosure The authors declared no conflict of interest. © 2009 The Obesity Society
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