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High Risk Surgery What is Best for the Patient? Hypothetical Scenario The following is a hypothetical scenario for discussion purposes only and does not represent any real persons, places, dates or events. Mr. Smith, 78, was seen by his orthopedic surgeon, Dr. White, because of knee pain. He was diagnosed with severe osteoarthritis and a total knee replacement was recommended to relieve the pain and improve his functional status. In addition to suffering from his afflicted joint, Mr. Smith is also morbidly obese. Dr. White subsequently met with Mr. Smith and his wife to discuss the surgery at length. He laid out all the risks involved, going over details of the knee replacement, as well as the anesthesia and surgery in general. The doctor also advised his patient that there were other, non-surgical options available. In the end, however, Mr. Smith signed the consent form and underwent a total knee replacement. The surgery itself was without complication. There was minimal blood loss and Mr. Smith was taken to the recovery room in stable condition. However, it became very difficult to extubate him, so he was taken to the ICU to be closely monitored. Once extubated, Mr. Smith was moved to the regular floor until he was stable enough to be discharged to an extended care facility. He remained at this facility for several weeks, but had to be readmitted to the hospital because of post-operative complications. The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 01 Mrs. Smith wondered why her husband’s hospital course was so much different than her brother Bill’s, who is also 78 and underwent the exact surgery. Bill did not have to go to the ICU and had no difficulty with his breathing. In fact, his breathing tube was removed before he left the recovery room. Her brother was in the hospital for a much shorter time, was discharged home and is now walking without any pain. One other key difference is that Mrs. Smith’s brother is not obese. Although the couple was told of the risk, benefits and alternatives to knee replacement surgery, they weren’t told of the risks individualized to Mr. Smith’s medical condition. In all likelihood, he still would have undergone the surgery, but now the two face medical bills they had never anticipated. Moreover, they would have made different arrangements to bring him home and to support Mrs. Smith while her husband was hospitalized. They were never told that Mr. Smith’s obesity placed him in a different category than brother Bill’s. “The good physician treats the disease; the great physician treats the patient who has the disease.” Sir William Osler Audience This white paper is designed not only for physicians, but also for other stakeholders within a healthcare organization. Those individuals are affected by the decision process surrounding high-risk surgeries and realize the need to change the culture to deal with this important issue with an eye toward overall patient care goals. Specifically, healthcare providers, healthcare educators, organizational leaders, ethics committees, risk managers and patient financial advocates can use the ideas and tools presented in this paper to help better deliver safe, effective and comprehensive care by recognizing the importance of a team approach that includes the patient and family when deciding on high risk surgery. The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 02 This paper recognizes that healthcare is delivered under different structures, including but not limited to: private practice, county clinics, academic facilities, long term care facilities, military institutions and physician employment models. Each delivery system will need to tailor the recommendations to fit its specific needs, similar to the healthcare team who must individualize the approach to each patient. Basic Definitions The first step in defining high risk or heroic surgery, as it is sometimes referred to, is defining what it is not. It is not futile surgery. Futile surgery can be differentiated from high risk surgery based on the idea that futile surgery is of no benefit to the patient. It is medically ineffective. There is no obligation to offer or continue interventions that are medically ineffective, even if the patient or surrogate decision maker demands it. High risk surgery is also not any heroic measure such as a code blue. High risk surgery may best be considered on a spectrum of procedures that MAY make a difference and intend to improve the quality of life/decrease pain in a frail or terminal patient. Therefore, families, patients and healthcare providers may push for the procedure without full evaluation of the value to the patient from a physical, emotional or financial standpoint. Additionally, the cost to the organization in terms of hard dollars as well as ICU beds needs to be taken into consideration, as resources are limited. From a practical standpoint, high risk surgery can be defined in two ways: the first is relevant to the patient and suggests that the risk to him or her is higher than for a population; the second compares the risk of the proposed surgery to the risk of surgical procedures in general.1 High Risk Patient The first category to be considered is the high risk patient having a routine procedure. While not typically thought of as undergoing high risk surgery, this group of patients should be approached from a collaborative standpoint when making decisions for surgery. High risk patients can include: (1) the elderly; (2) the disabled; (3) the morbidly obese; (4) transplant patients; (5) multiple co-morbidities; (6) chronically ill children; (7) patients admitted from nursing homes, institutionalized or so-called “hand-off” patients; (8) cancer patients in general; (9) those dealing with substance abuse including tobacco; and (10) patients without a clear primary admitting provider. To simplify the discussion, this paper will use obesity as an example since the epidemic of obesity in America continues to increase, and now extends to the elderly population.2 A study The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 03 by Silber et al. suggests that the condition may require an increase in general and orthopedic surgery in the obese elderly but, unfortunately, administrative claims do not collect Body Mass Index (BMI) information, making it somewhat difficult to study. Furthermore, since BMI information is not collected, it is not used for severity adjustments in Medicare payment algorithms. This suggests that doctors and hospitals are not being reimbursed appropriately for taking care of such high risk patients. Medicare payments from 2002-2006 were 3% greater for the obese than the non-obese, but it cost almost 10% more to care for these patients.2 More significant was the medical outcomes in this group of patients. While there was no significant difference in mortality for obese patients, complications such as wound infection, sepsis, respiratory system complication, cardiac events and longer lengths of stay were observed, as compared to their matched non-obese counterparts.2 Additionally, the odds of being re-admitted were between 40% and 50% greater in the obese than the non-obese. This paper does not suggest that an obese patient should not undergo surgery. Instead, this individual needs to be informed that in addition to the risk of the surgery itself, he or she has a higher likelihood of certain complications, including a longer length of stay and increased rates of readmission. Arming our patients with this information and properly educating them will allow the healthcare team to better manage the individual patient’s overall expectations. High Risk Surgical Procedures In 2011, the New England Journal of Medicine (NEJM) listed eight cancer and cardiovascular surgeries to be considered high risk. They include: (1) cancer resection of the lung, esophagus, pancreas and bladder; (2) repair of an abdominal aortic aneurysm; (3) A-V valve replacement; (4) carotid artery bypass graft (CABG); (5) carotid endarterectomy; and (6) previous gastric bypass.3 In an effort to reduce mortality in these procedures, minimum volume standards were established in 2000 for several of the procedures as part of a broader, value-based purchasing initiative.3,4 Operative mortality is defined by the Medicare eligibility file as death before discharge or within 30 days after the operation.3 Additionally, professional organizations such as the American College of Surgeons have established minimum volumes as part of Centers of Excellence accreditation programs.3,5 While these efforts have improved the mortality when a few of the aforementioned procedures are done in high volume hospitals, the studies tend to focus on mortality as the end outcome.3 Minimal focus has been placed on quality of life following the procedures. One could argue that as improvement in mortality improves in high risk procedures, does that necessarily correlate to improved quality of life? If the World Health Organization (WHO) in 1948 defined health as “a state of complete physical, mental and social well-being, not merely the absence of disease or infirmary,” are we taking this comprehensive definition into account when we counsel our patients facing high risk surgery?6 The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 04 Health Literacy and Decision Making Studies on patients with colon cancer, the third highest cause of cancer-related morality, have demonstrated that optimal oncologic outcomes and long-term survival requires a multidisciplinary approach.7 In addition to the multidisciplinary approach, advances in chemotherapy agents have led to significant improvements in colorectal cancer outcomes in recent years.7–9 In the same study, emphasis was placed on the health literacy of patients and how adequate health literacy enables them to be informed and make appropriate treatment decisions.7,10 The U.S. Department of Health and Human Services 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.”11 Included in this definition is the ability to understand doctors’ directions and consent forms, as well as the ability to negotiate complex health care systems. Health literacy is not merely the ability to read the instructions, but the ability to listen, analyze and apply decision-making skills to healthcare situations.12 Numerically, health literacy can be characterized as Level 1, which is less than a grade 4 education. Patients with a Level 1 understanding can’t read signs, medication bottles, poison warnings or the city bus schedule. Approximately 40-44 million Americans are categorized as Level 1.13 An additional 50 million fall under the Level 2 category, with a reading comprehension of grade 4-8. They have difficulties with executive functions such as simple forms and reading USA Today. For reference, the average reading level is 8th grade. Medicaid patients and the elderly typically read at 5th grade levels. These are our patients, but do they really understand what we are telling them? People with limited literacy skills not only have problems with reading, they are more likely to have difficulties with oral communication, short term memory, carrying out medical instructions or learning new skills.11 Health Literacy and Understanding Quality of Life The requirement for adequate health literacy can be demonstrated in the evaluation of Quality of Life (QOL) measures. When patients and family members are trying to make difficult decisions on whether to proceed with a treatment, in addition to the inherent and immediate risks of surgery, also included in the discussion must be an evaluation of quality of life. QOL is a multifaceted ideal that incorporates physical, mental, social and emotional health as well as pre and post levels of functioning.14 It can be an abstract idea that depends on the individual’s circumstances. Measuring QOL is both a subjective and objective task based on the underlying disease, previous level of function and planned treatment.14 This paper is not meant to evaluate the numerous QOL measurement tools available, but instead to emphasize the need for a discussion regarding QOL prior to undertaking a treatment, in a proactive manner, rather than waiting until after the treatment. Assessing how treatments affect patients’ health from their understanding/viewpoint is one way to provide a more complete understanding of a proposed The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 05 intervention and is a useful supplement to traditional endpoints such as survival rates.15 Physicians take an oath to “first do no harm,” but how is that harm quantified? What may be considered harm to one patient may be an acceptable outcome to another. Unless we are having complete discussions with our patients, healthcare providers will not be able to optimize treatment choices and manage expectations. When discussing high risk surgery with a patient and his/her family, it becomes the duty of the healthcare team to understand the health literacy level of the individual making the decision. When evaluating whether to proceed with surgery, the patient will be hopeful that the planned procedure will confer a range of benefits including improved survival, symptom improvement and improvements in quality of life.16 We know from the principles of informed consent that the risks must also be discussed, and the prospect that the proposed surgery may result in post-operative mortality, morbidity, worsening quality of life and financial burden. Advanced surgical techniques, coupled with the greater focus on patient centered care, requires a completed discussion at the patient’s level of understanding. For most high risk surgery, survival is the primary endpoint when treatment is curative, potentially curative or when long-term survival is expected.16,17 However, when considering high risk surgery with a focus on palliative intent, the healthcare team should also discuss the challenges faced during the postoperative period that can result in both long term and short term problems. Therefore, any survival benefits must be considered in the context of the patient’s quality of life, as this may be the actual endpoint of concern.16,18,19 A less discussed or considered factor when deciding on high risk surgery is the financial implication to the patient, his/her family and the institution. For example, in cardiac surgery, studies have been done that demonstrate the difference in outcomes of patients with identified pre-operative risks related to length of intensive care unit (ICU) and hospital stay, and minimizing cost without compromising a patient’s clinical outcomes.20 In Rajakaruna, et al., the direct burden on hospital resources of patients requiring a prolonged ICU stay was recognized, demonstrating 12.2% of bed occupancy costs used to care for only 2.6% of patients, with indirect implications such as cancellations of surgery because of lack of ICU beds.20 The study concluded that there may be a benefit in optimizing the patient’s risk factors preoperatively and that predicting the likelihood of complications would optimize the preoperative patient information and consent process. The study could also prompt the question, if the patient could not be optimized and the risk of a lengthy stay in the ICU were known, would that information help the patient? A slippery slope to be avoided would be that of basing the decision on the cost to the institution, but is there a point where the financial impact to the organization, including lack of ICU beds, should be considered in the discussion with the patient? The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 06 Conclusion In order to optimize healthcare decision making, a complete evaluation of all aspects of care must be done, including the less often talked about financial implications. High risk surgery needs to be approached from the procedural standpoint, individualizing each surgery to a complex portrait of all the factors a patient brings to the operating suite. Surgeons must be aware of the importance the patient places on the desired outcome, not just survival alone. Patients are not a “one size fits all” and it becomes incumbent on the healthcare team to evaluate the patient’s level of understanding before attempting any discussion related to surgical outcomes. Any surgery carries an inherent amount of risk. Being able to appropriately evaluate our patient’s level of understanding, his/her co-morbid conditions prior to surgery and focus on post-op quality of life, will improve overall communication and ultimately align the goals of the surgeon and the high risk patient. The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 07 Bibliography 1 Boyd O, Jackson N. How is risk defined in high-risk surgical patient management? Crit Care. 2005;9(4):390–396. doi:10.1186/cc3057. 2 Silber JH, Rosenbaum PR, Kelz RR, et al. Medical and financial risks associated with surgery in the elderly obese. Ann. Surg. 2012;256(1):79–86. doi:10.1097/SLA.0b013e31825375ef. 3 Finks JF, Osborne NH, Birkmeyer JD. Trends in Hospital Volume and Operative Mortality for High-Risk Surgery. New England Journal of Medicine. 2011;364(22):2128–2137. doi:10.1056/NEJMsa1010705. Milstein A, Galvin RS, Delbanco SF, Salber P, Buck CR Jr. Improving the safety of health care: the leapfrog initiative. Eff Clin Pract. 2000;3(6):313–316. 4 The American College of Surgeons. Bariatric Surgery Center Network Accreditation Program. 2010. Available at: http://www.acsbscn.org/Public/index.jsp. Accessed January 10, 2013. 5 World Health Organization. Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19-22 June, 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948. Retrieved March. 1948;16:2011. 6 Pendlimari R, Holubar SD, Hassinger JP, Cima RR. Assessment of Colon Cancer Literacy in screening colonoscopy patients: a validation study. J. Surg. Res. 2012;175(2):221–226. doi:10.1016/j.jss.2011.04.036. 7 Tsikitis VL, Holubar SD, Dozois EJ, Cima RR, Pemberton JH, Larson DW. Advantages of fast-track recovery after laparoscopic right hemicolectomy for colon cancer. Surg Endosc. 2010;24(8):1911–1916. doi:10.1007/s00464-009-0871-y. 8 9 Boostrom SY, Nagorney DM, Donohue JH, et al. Impact of neoadjuvant chemotherapy with FOLFOX/FOLFIRI on disease-free and overall survival of patients with colorectal metastases. J. Gastrointest. Surg. 2009;13(11):2003–2009; discussion 2009–2010. doi:10.1007/s11605-009-1007-3. Office of Disease Prevention and Health Promotion. Healthy People 2010. United States Department of Health and Human Services NAS Newsletter. 2000;15(3). 10 11 Lynn Nielsen-Bohlman, Allison M. Panzer, David A. Kindig, Editors, Committee on Health Literacy. Health Literacy: A Prescription to End Confusion. Washington, D.C.: The National Academies Press; 2004. National Network of Libraries of Medicine. Health Literacy. 2012. Available at: http://nnlm.gov/outreach/consumer/hlthlit.html. Accessed January 10, 2013. 12 Institute of Education Sciences National Center for Education Statistics. National Assessment of Adult Literacy (NAAL). 2013. Available at: http://nces.ed.gov/naal/. Accessed January 10, 2013. 13 Kasparek MS, Hassan I, Cima RR, Larson DR, Gullerud RE, Wolff BG. Long-term quality of life and sexual and urinary function after abdominoperineal resection for distal rectal cancer. Dis. Colon Rectum. 2012;55(2):147–154. doi:10.1097/DCR.0b013e31823d2606. 14 McNair AG, Blazeby JM. Health-related quality-of-life assessment in GI cancer randomized trials: improving the impact on clinical practice. Expert Rev Pharmacoecon Outcomes Res. 2009;9(6):559–567. doi:10.1586/erp.09.68. 15 Fitzsimmons D, Wheelwright S, Johnson CD. Quality of life in pulmonary surgery: choosing, using, and developing assessment tools. THORAC SURG CLIN. 22(4):457–470. 16 Davis K, Yount S, Wagner L, Cella D. Measurement and management of health-related quality of life in lung cancer. Clin Adv Hematol Oncol. 2004;2(8):533–540. 17 The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 08 18 Yusen RD. Technology and outcomes assessment in lung transplantation. Proc Am Thorac Soc. 2009;6(1):128–136. doi:10.1513/pats.200809-102GO. 19 Brunelli A. Risk Assessment for Pulmonary Resection. Seminars in Thoracic and Cardiovascular Surgery. 2010;22(1):2–13. doi:10.1053/j.semtcvs.2010.04.002. Rajakaruna C, Rogers CA, Angelini GD, Ascione R. Risk factors for and economic implications of prolonged ventilation after cardiac surgery. J. Thorac. Cardiovasc. Surg. 2005;130(5):1270–1277. doi:10.1016/j.jtcvs.2005.06.050 20 The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 09 About the Authors Dr. Dana Welle has more than 16 years of clinical experience as an obstetrician-gynecologist. After completing her residency in a large tertiary academic medical center, she began private practice, where she continued to manage high risk obstetric cases as well as perform complicated gynecological surgery. She is a fellow in the American College of Obstetrics and Gynecology (ACOG) and also a fellow in the American College of Surgeons (ACS). Although she is no longer directly involved in patient care, she continues her pursuit of medical knowledge and remains active in both ACOG and ACS. Dr. Welle currently serves as the physician risk consultant for Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. Her responsibilities include conducting risk assessments, consulting with and educating healthcare providers and staff, and investigating potential claims at both facilities. She serves on the Committee for Professionalism and the Physician Wellness Committee at Stanford Hospital & Clinics, as well as on the Care Improvement Committee for both hospitals, and the Patient Safety Oversight Committee for Lucile Packard Children’s Hospital. Dr. Welle’s combined educational degrees, coupled with her clinical background, places her in a unique position. She is able to use both her medical and legal insight to strengthen the relationship between the medical staff and the risk management team and bring a different perspective to addressing risk management issues. Dr. Welle received her BS in Kinesiology from the University of California at Los Angeles, her DO degree from the Western University of Health Sciences and her JD degree from Santa Clara University School of Law. She is a member of the state bar of California. This white paper is not intended to be and should not be taken as legal advice. It is for educational purposes only, and does not provide all available information on the subject, nor establish the statutory, legal or medical standard of care on any particular subject. Federal and State law may have different standards on the subject matter; any question on a particular jurisdiction’s legal standards/requirements should be presented to legal counsel familiar with that jurisdiction. The opinions expressed, discussions undertaken, and materials provided do not represent any official position of Stanford University or any of its affiliates including Stanford University Medical Center, its faculty, staff or employees. The Risk Authority of The Stanford University Medical Network / January 2013 High Risk Surgery I 10 Learn more about The Risk Authority of The Stanford University Medical Network. http://src.stanfordhospital.org 300 Pasteur Drive, MC: 5713 Stanford, CA 94305 T: (650) 723-6824 [email protected] Board of Trustees of The Leland Stanford Jr. University 2013 ©