Surgery News - March 2008 - (Page 12) SURGERY NEWS • M A R C H 2 0 0 8 NEWS new book for surgical patients and their families—I Need an Operation . . . Now What? A Patient’s Guide to a Safe and Successful Outcome— has been published by the ACS in conjunction with Thomson Healthcare. Written by ACS Executive Director Thomas R. Russell, M.D., FACS, the book lays out the key things patients should consider before consenting to an operation, the questions they should ask their surgeon, and helpful pre- and postoperative tips. How to find a qualified surgeon; what to ask before an operation; how to prepare for your operation, from what to pack and what to wear to when to stop eating; and how to ensure a comfortable recovery period are just a few of the questions addressed. Checklists at the end of several chapters pose additional questions patients and their families should ask their surgeon. Publication of the book follows the release of the results of the College’s latest “On the Table” consumer survey, which indicates that typical patients FROM prepare more thoroughly to go on vacation or to buy a new car than they do to have surgery. The survey finds that patients are significantly less proactive in learning about the surgical procedure they will undergo, yet obtaining additional information prior to surgery could improve their overall experience and outcome. According to the survey, one in three Americans (32%) has had a surgical procedure within the past 5 years; one of two (51%) has bought or leased a new car; and three of five (62%) have spent more than $1,000 on something for their home. And while surgical patients spend an average of just one hour researching their surgical procedure or their surgeon, they spend significantly more time researching any of the following: Changing jobs (10 hours) Buying/leasing a new car (8 hours) Buying a big ticket item for their home = $1,000 (5 hours) Planning a vacation = $1,000 (4 hours) Even more shocking, more than onethird of Americans who had an opera- THE COLLEGE of the National Business Group on Health, said. “Most importantly, this book urges you, the patient, to take control and become fully informed about your options.” Margaret E. O’Kane, president of the National Committee for Quality Assurance, said, “In clear English, this book allows people to undergo surgery with all of the information they need to help make it a safe and successful operation.” And Arnold Milstein, M.D., medical director of the Pacific Business Group on Health, commented, “Practical suggestions embed great sensitivity to the public’s right to know about a surgeon’s prior results, to be told when unexpected events occur, and how difficult it is for many patients to advocate for themselves. Buy this book for your parents . . . and be prepared to borrow it back from them.” More information can be found at www.facs.org/public_info/patientguidebook.html. The cover price is $19.95, but the book is available to ACS members for $14.95 and to nonmembers for $15.95. Quantity discounts are also available. The book can also be purchased through national Web retailers at the cover price. ■ New Book Steers Patients Through the Surgical Experience tion in the last 5 years (36%) did not check their surgeons’ credentials before having the procedure. “Being an informed consumer is important, but being an informed patient is even more so. A surgical procedure should not be something that is done to you while you passively sit by—patients should know that they can improve their odds for a good outcome if they do their homework up front,” Dr. Russell said. “This book provides patients with the basic strategies and information necessary to help them gain peace of mind about how to prepare and what to expect when they have an operation.” “I Need An Operation . . . Now What? is not only practical, but also highly respectful and educational. Patients can use this book to navigate through their surgical experience while we all push for a better organized health care delivery system,” said Richard J. Umbdenstock, president and CEO of the American Hospital Association. “This book gives excellent advice on how to ask good questions and become an informed, empowered consumer,” Helen Darling, president Survey Respondents Favor Phase III Clinical Trial Idea B Y D A V I D M . O TA , M . D . , F A C S A N D H E I D I N E L S O N , M . D. , FA C S n important topic for many hospital tumor boards is management of the primary tumor for patients with stage IV breast cancer. Because metastatic disease precludes the possibility of cure, surgery is generally reserved for symptom control. Recent retrospective studies have shown a potential benefit of removing the primary tumor to prolong overall survival (Ann. Surg. Oncol. 2007;14:3345-51; Ann. Surg. Oncol. 2007;14:3285-7). Such results are confounded by potential patient selection bias, and only a prospective phase III clinical trial can detect a benefit from the procedure. Although enthusiasm is increasing for a phase III trial design to answer the question of primary tumor management in stage IV breast cancers, there are important questions about the feasibility and equipoise in the medical community. There is a strong perception that randomized trials comparing surgery versus no surgery are difficult to complete because of inherent physician and patient preferences. The American College of Surgeons Oncology Group (ACOSOG) asked the ACS to conduct a Webbased survey to measure equipoise in the medical community. Seema Khan, M.D., FACS, drafted the trial design and the survey at right. It was decided that if there were fewer than 50 positive responders, the trial idea would not move forward, but if there were more than 150 positive responders, the trial idea would advance toward a national trial. The 822 survey respondents included ACS general surgeons in the U.S. and Canada and members of the Cancer and Leukemia Group B (CALGB). By specialty, 86% of responders were surgeons and 13% were medical oncologists. In response to the enrollment question, 92% said that they would enroll patients into the trial and 8% said no. By the threshold set before the survey, there is evidence of equipoise in the medical community. The survey did not address equipoise in the patient community. The cost of developing and launching a phase III trial is approximately $500,000. There is also immeasurable value to patient expectations and sponsors. Survey responses from ACS and CALGB members provide evidence that the trial is feasible, and there is a likely return on investing resources into such a trial. ACOSOG will work with the National Cancer Institute and medical oncologists to advance this trial idea and with ACS staff to create new survey methods to measure national opinion from all stakeholders regarding the potential of a clinical trial idea. ■ Dr. Ota and Dr. Nelson are ACOSOG co-chairs. American College of Surgeons Oncology Group Trial Design and Survey The conventional therapeutic approach to women presenting with stage IV breast cancer and an intact primary tumor has been systemic therapy, with primary tumor resection reserved for palliation of symptoms. However, 30%-50% of these women undergo resection of the primary tumor, presumably with the intent of avoiding uncontrolled chest wall disease. Several large retrospective studies have suggested that resection of the primary tumor may offer a survival advantage for women with de novo stage IV breast cancer, but selection bias remains a very plausible explanation for these findings. The American College of Surgeons Oncology Group (ACOSOG) is considering the feasibility of a randomized trial to address the question of whether or not local therapy for the primary tumor is beneficial in this patient group, from the perspective of local control and overall survival. The proposed schema is shown here. The primary end point would be overall survival. 800 women with stage IV disease and intact primary tumors (exclude sites with very poor prognosis, like meningeal or lymphangitic lung) ↓ Optimal systemic therapy at discretion of treating physician (provide guidelines) Randomize women who respond to systemic therapy (n = 600) Stratified by soft tissue/skeletal mets vs. visceral mets ↓ Early local therapy following response to systemic therapy (excision with free margins and XRT, or mastectomy +/– XRT) Delayed local therapy only if local tumor progresses (extent of local therapy at physician discretion) Please respond to the following questions: 1. Would you enroll stage IV breast cancer patients with intact primary tumors into a clinical trial with the above design? Yes No 2. Indicate your oncologic specialty: Medical Surgical/breast Radiation ↓ ↓ ↓ http://www.facs.org/public_info/patientguidebook.html http://www.facs.org/public_info/patientguidebook.html
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