A Randomized Controlled Trial Evaluating the Impact of Pre-Consultation Information on Patients' Perception of Information Conveyed and Satisfaction with the Decision-Making Process.

BACKGROUND: Patient participation in treatment decision-making is a health care priority. This study hypothesized that providing a decision aid before surgical consultation would better prepare patients for decision-making. The objective was to examine the impact of a decision aid versus high-quality websites on patients' perceptions of information conveyed during surgical consultation and satisfaction with the decision process. METHODS: Patients with stages 0 to 3 breast cancer were randomized. Surveys assessed perceptions of information conveyed, being asked surgical preference, and satisfaction with the decision process. Multivariable logistic regression assessed associations between outcomes and randomization arm, patient factors, and surgeon. Change in Pseudo-R2 assessed the comparative effect of these factors on perceptions of the information conveyed. RESULTS: The median patient age was 59 years. Most of the patients (98%) were white, and 62% were college educated (n = 201). The findings showed no association between randomization arm and perceptions of information conveyed, being asked surgical preference, or satisfaction with the decision process. Most of the patients reported discussing both breast-conserving therapy and mastectomy (69%) and being asked their surgical preference (65%). The surgeon seen was more important than the randomization arm or the patient factors in predicting patients' perceptions of information conveyed (explained 64-69% of the variation), and 63% of the patients were satisfied with the decision process. CONCLUSION: Use of a decision aid compared with high-quality websites did not increase patients' perceptions of information conveyed or satisfaction with the decision process. Although the surgeon seen influenced aspects of the patient experience, the surgeon was not associated with satisfaction. Understanding the factors driving low satisfaction is critical because this is increasingly used as a marker of health care quality.

Barriers to Goal-concordant Care for Older Patients With Acute Surgical Illness: Communication Patterns Extrinsic to Decision Aids.

OBJECTIVE: We sought to characterize patterns of communication extrinsic to a decision aid that may impede goal-concordant care. BACKGROUND: Decision aids are designed to facilitate difficult clinical decisions by providing better treatment information. However, these interventions may not be sufficient to effectively reveal patient values and promote preference-aligned decisions for seriously ill, older adults. METHODS: We conducted a secondary analysis of 31 decision-making conversations between surgeons and frail, older inpatients with acute surgical problems at a single tertiary care hospital. Conversations occurred before and after surgeons were trained to use a decision aid. We used directed qualitative content analysis to characterize patterns within 3 communication elements: disclosure of prognosis, elicitation of patient preferences, and integration of preferences into a treatment recommendation. RESULTS: First, surgeons missed an opportunity to break bad news. By focusing on the acute surgical problem and need to make a treatment decision, surgeons failed to expose the life-limiting nature of the patient's illness. Second, surgeons asked patients to express preference for a specific treatment without gaining knowledge about the patient's priorities or exploring how patients might value specific health states or disabilities. Third, many surgeons struggled to integrate patients' goals and values to make a treatment recommendation. Instead, they presented options and noted, "It's your decision." CONCLUSIONS: A decision aid alone may be insufficient to facilitate a decision that is truly shared. Attention to elements beyond provision of treatment information has the potential to improve communication and promote goal-concordant care for seriously ill older patients.

Feasibility of Providing Web-Based Information to Breast Cancer Patients Prior to a Surgical Consult.

Patients facing decisions for breast cancer surgery commonly search the internet. Directing patients to high-quality websites prior to the surgeon consultation may be one way of supporting patients' informational needs. The objective was to test an approach for delivering web-based information to breast cancer patients. The implementation strategy was developed using the Replicating Effective Programs framework. Pilot testing measured the proportion that accepted the web-based information. A pre-consultation survey assessed whether the information was reviewed and the acceptability to stakeholders. Reasons for declining guided refinement to the implementation package. Eighty-two percent (309/377) accepted the web-based information. Of the 309 that accepted, 244 completed the pre-consultation survey. Participants were a median 59 years, white (98%), and highly educated (>50% with a college degree). Most patients who completed the questionnaire reported reviewing the website (85%), and nearly all found it helpful. Surgeons thought implementation increased visit efficiency (5/6) and would result in patients making more informed decisions (6/6). The most common reasons patients declined information were limited internet comfort or access (n = 36), emotional distress (n = 14), and preference to receive information directly from the surgeon (n = 7). Routine delivery of web-based information to breast cancer patients prior to the surgeon consultation is feasible. High stakeholder acceptability combined with the low implementation burden means that these findings have immediate relevance for improving care quality.

A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options.

BACKGROUND: Previous research suggests that providing information to women newly diagnosed with breast cancer, during the gap between cancer diagnosis and their first surgeon consultation, may support decision making. Our objective was to compare patients' knowledge after the pre-consultation delivery of standard websites vs a web-based decision aid (DA). STUDY DESIGN: We randomized women with stage 0 to III breast cancer, within an academic and community breast clinic, to be emailed a link to selected standard websites (National Cancer Institute, American Cancer Society, Breastcancer.org,) vs the Health Dialog DA (Clinicaltrials.govNCT03116035). Patients seeking second opinions, diagnosed by excisional biopsy, or without an email address, were ineligible. Pre-consultation knowledge was assessed using the Breast Cancer Surgery Decision Quality Instrument. We compared differences in knowledge using t-test. RESULTS: Median patient age was 59 years, 99% were white, and 65% had a college degree or higher, with no differences in demographics between study arms. Knowledge was higher in patients who received the DA (median 80% vs 66% correct, p = 0.01). Decision-aid patients were more likely to know that waiting a few weeks to make a treatment decision would not affect survival (72% vs 54%, p < 0.01). Patients in both arms found the information helpful (median score 8 of 10). CONCLUSIONS: Although patients found receipt of any pre-consultation information helpful, the DA resulted in improved knowledge over standard websites and effectively conveyed that there is time to make a breast cancer surgery decision. Decreasing the urgency patients feel may improve the quality of patient-surgeon interactions and lead to more informed decision-making.

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions.

INTRODUCTION: Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. METHODS AND ANALYSIS: This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings. TRIAL REGISTRATION NUMBER: NCT02623335.

A Framework to Improve Surgeon Communication in High-Stakes Surgical Decisions: Best Case/Worst Case.

Importance: Although many older adults prefer to avoid burdensome interventions with limited ability to preserve their functional status, aggressive treatments, including surgery, are common near the end of life. Shared decision making is critical to achieve value-concordant treatment decisions and minimize unwanted care. However, communication in the acute inpatient setting is challenging. Objective: To evaluate the proof of concept of an intervention to teach surgeons to use the Best Case/Worst Case framework as a strategy to change surgeon communication and promote shared decision making during high-stakes surgical decisions. Design, Setting, and Participants: Our prospective pre-post study was conducted from June 2014 to August 2015, and data were analyzed using a mixed methods approach. The data were drawn from decision-making conversations between 32 older inpatients with an acute nonemergent surgical problem, 30 family members, and 25 surgeons at 1 tertiary care hospital in Madison, Wisconsin. Interventions: A 2-hour training session to teach each study-enrolled surgeon to use the Best Case/Worst Case communication framework. Main Outcomes and Measures: We scored conversation transcripts using OPTION 5, an observer measure of shared decision making, and used qualitative content analysis to characterize patterns in conversation structure, description of outcomes, and deliberation over treatment alternatives. Results: The study participants were patients aged 68 to 95 years (n = 32), 44% of whom had 5 or more comorbid conditions; family members of patients (n = 30); and surgeons (n = 17). The median OPTION 5 score improved from 41 preintervention (interquartile range, 26-66) to 74 after Best Case/Worst Case training (interquartile range, 60-81). Before training, surgeons described the patient's problem in conjunction with an operative solution, directed deliberation over options, listed discrete procedural risks, and did not integrate preferences into a treatment recommendation. After training, surgeons using Best Case/Worst Case clearly presented a choice between treatments, described a range of postoperative trajectories including functional decline, and involved patients and families in deliberation. Conclusions and Relevance: Using the Best Case/Worst Case framework changed surgeon communication by shifting the focus of decision-making conversations from an isolated surgical problem to a discussion about treatment alternatives and outcomes. This intervention can help surgeons structure challenging conversations to promote shared decision making in the acute setting.

"Best Case/Worst Case": Training Surgeons to Use a Novel Communication Tool for High-Risk Acute Surgical Problems.

CONTEXT: Older adults often have surgery in the months preceding death, which can initiate postoperative treatments inconsistent with end-of-life values. "Best Case/Worst Case" (BC/WC) is a communication tool designed to promote goal-concordant care during discussions about high-risk surgery. OBJECTIVE: The objective of this study was to evaluate a structured training program designed to teach surgeons how to use BC/WC. METHODS: Twenty-five surgeons from one tertiary care hospital completed a two-hour training session followed by individual coaching. We audio-recorded surgeons using BC/WC with standardized patients and 20 hospitalized patients. Hospitalized patients and their families participated in an open-ended interview 30 to 120 days after enrollment. We used a checklist of 11 BC/WC elements to measure tool fidelity and surgeons completed the Practitioner Opinion Survey to measure acceptability of the tool. We used qualitative analysis to evaluate variability in tool content and to characterize patient and family perceptions of the tool. RESULTS: Surgeons completed a median of 10 of 11 BC/WC elements with both standardized and hospitalized patients (range 5-11). We found moderate variability in presentation of treatment options and description of outcomes. Three months after training, 79% of surgeons reported BC/WC is better than their usual approach and 71% endorsed active use of BC/WC in clinical practice. Patients and families found that BC/WC established expectations, provided clarity, and facilitated deliberation. CONCLUSIONS: Surgeons can learn to use BC/WC with older patients considering acute high-risk surgical interventions. Surgeons, patients, and family members endorse BC/WC as a strategy to support complex decision making.

Patient-reported Limitations to Surgical Buy-in: A Qualitative Study of Patients Facing High-risk Surgery.

OBJECTIVE: To characterize how patients buy-in to treatments beyond the operating room and what limits they would place on additional life-supporting treatments. BACKGROUND: During a high-risk operation, surgeons generally assume that patients buy-in to life-supporting interventions that might be necessary postoperatively. How patients understand this agreement and their willingness to participate in additional treatment is unknown. METHODS: We purposively sampled surgeons in Toronto, Ontario, Boston, Massachusetts, and Madison, Wisconsin, who are good communicators and routinely perform high-risk operations. We audio-recorded their conversations with patients considering high-risk surgery. For patients who were then scheduled for surgery, we performed open-ended preoperative and postoperative interviews. We used directed qualitative content analysis to analyze the interviews and surgeon visits, specifically evaluating the content about the use of postoperative life support. RESULTS: We recorded 43 patients' conversations with surgeons, 34 preoperative, and 27 postoperative interviews. Patients expressed trust in their surgeon to make decisions about additional treatments if a serious complication occurred, yet expressed a preference for significant treatment limitations that were not discussed with their surgeon preoperatively. Patients valued the existence or creation of an advance directive preoperatively, but they did not discuss this directive with their surgeon. Instead they assumed it would be effective if needed and that family members knew their wishes. CONCLUSIONS: Patients implicitly trust their surgeons to treat postoperative complications as they arise. Although patients may buy-in to some additional postoperative interventions, they hold a broad range of preferences for treatment limitations that were not discussed with the surgeon preoperatively.

Engaging Patients, Health Care Professionals, and Community Members to Improve Preoperative Decision Making for Older Adults Facing High-Risk Surgery.

Importance: Older patients are at greater risk for postoperative complications, yet they are less likely than younger patients to ask questions about surgery. Objective: To design an intervention to improve preoperative decision making and manage postoperative expectations. Design, Setting, and Participants: A Patient and Family Advisory Council (PFAC) was created to help identify preoperative decisional needs. The PFAC included 4 men and women who had previous experience with high-risk surgery as older patients or their family members; the PFAC met monthly at a local library from May 2014 to April 2015 to examine findings from a prior qualitative study and to integrate themes with PFAC members' experiences. Patient observations included 91 recorded conversations between patients and surgeons and 61 patient interviews before and after surgery. The PFAC members and other stakeholders evaluated 118 publicly available questions and selected 12 corresponding to identified needs to generate a question prompt list (QPL). Three focus groups, including 31 community members from diverse backgrounds, were conducted at community centers in Madison and Milwaukee, Wisconsin, to refine the QPL. A clinical pilot with 42 patients considering surgery was conducted in one outpatient surgical clinic in Madison. Main Outcomes and Measures: Generation of a QPL to address patients' preoperative informational and decisional needs. Results: Through exploration of qualitative data, the PFAC noted 3 critical problems. Patients and family members believed surgery had to be done, were surprised that postoperative recovery was difficult, and lacked knowledge about the perioperative use of advance directives. The PFAC identified a need for more information and decisional support during preoperative conversations that included clarification of treatment options, setting postoperative expectations, and advance care planning. The following 3 question prompt categories arose: "Should I have surgery?" "What should I expect if everything goes well?" and "What happens if things go wrong?" The final list included 11 questions within these domains, was understandable in English and Spanish, and was acceptable to patients in the clinic. Conclusions and Relevance: Through direct engagement of stakeholders, a QPL was created to address core decisional and informational needs of surgical patients. Future testing will evaluate whether this list can be used to improve patient engagement and reduce postoperative regret and conflict about postoperative treatments.

Oncologists' perceived barriers to an expanded role for primary care in breast cancer survivorship care.

Concern exists about the sustainability of traditional, oncologist-led models of breast cancer survivorship care. However, many oncologists are hesitant about deferring survivorship care to primary care providers (PCPs). Our objective was to examine oncologists' perceptions of the role PCPs play in breast cancer survivorship and the rationale underlying these perceptions. One-on-one interviews with medical, radiation, and surgical oncologists in Wisconsin were conducted (n = 35) and transcribed. Data analysis was performed using an inductive approach to content analysis. Oncologist-perceived barriers included: PCP's level of experience with cancer care; Lack of PCP comfort in providing survivorship care; Existing demands on PCPs' time; Patient preference for oncology-led survivorship care. Oncologists described familiarity and trust in individual PCPs as factors that could mitigate barriers and lead to increased PCP involvement in survivorship care. Although a number of perceived barriers to PCP participation in survivorship were identified by Wisconsin oncologists, our findings support the direction of ongoing initiatives to facilitate PCP involvement. Our findings also suggest that early PCP involvement in survivorship may increase PCP comfort and patients' trust in PCPs in this role. The identified barrier most challenging to address may be the limited capacity of the current primary care system to manage follow-up for breast cancer survivors.

Oncologists' Perspectives of Their Roles and Responsibilities During Multi-disciplinary Breast Cancer Follow-Up.

BACKGROUND: Improving the quality of follow-up provided to the 3 million U.S. breast cancer survivors is a high priority. Current guidelines do not provide guidance regarding who should participate in follow-up or what providers' specific responsibilities should be. Given the multidisciplinary nature of breast cancer care, this results in significant variation and creates the potential for redundancy and/or gaps. Our objective was to provide insight into why different types of oncologists believe their participation in follow-up is necessary. METHODS: A purposeful sample of breast medical, radiation, and surgical oncologists was identified (n = 35) and in-depth one-on-one interviews were conducted. Data were analyzed using content analysis. RESULTS: Medical oncologists were driven by a sense of Responsibility for Ongoing Therapy, perceived Strong Patient Relationship, and belief that their systemic approach to follow-up represented a Specific Skillset beneficial to patients. In contrast, surgical and radiation oncologists were selective about which patients they followed, participating when they perceived their Specific Skillset of enhanced local-regional assessments would be valuable. Additionally, they endorsed participating to Ensure Follow-up is Received or not participating to Minimize Redundancy. These individual decisions led to either a Complementary Oncologist Team or Primary Oncologist follow-up approach. CONCLUSIONS: Oncologists' feel responsible for the cancer-related components of follow-up. Differences amongst oncology specialists' perceived responsibilities influenced decisions to provide ongoing follow-up. Based on these individual decisions, a Complementary Oncologist Team or Primary Oncologist model of care evolves organically. Guidelines that explicitly direct patients into a care model have the potential to significantly improve care quality and efficiency.

Constructing High-stakes Surgical Decisions: It's Better to Die Trying.

OBJECTIVE: To explore high-stakes surgical decision making from the perspective of seniors and surgeons. BACKGROUND: A majority of older chronically ill patients would decline a low-risk procedure if the outcome was severe functional impairment. However, 25% of Medicare beneficiaries have surgery in their last 3 months of life, which may be inconsistent with their preferences. How patients make decisions to have surgery may contribute to this problem of unwanted care. METHODS: We convened 4 focus groups at senior centers and 2 groups of surgeons in Madison and Milwaukee, Wisconsin, where we showed a video about a decision regarding a choice between surgery and palliative care. We used qualitative content analysis to identify themes about communication and explanatory models for end-of-life treatment decisions. RESULTS: Seniors (n = 37) and surgeons (n = 17) agreed that maximizing quality of life should guide treatment decisions for older patients. However, when faced with an acute choice between surgery and palliative care, seniors viewed this either as a choice between life and death or a decision about how to die. Although surgeons agreed that very frail patients should not have surgery, they held conflicting views about presenting treatment options. CONCLUSIONS: Seniors and surgeons highly value quality of life, but this notion is difficult to incorporate in acute surgical decisions. Some seniors use these values to consider a choice between surgery and palliative care, whereas others view this as a simple choice between life and death. Surgeons acknowledge challenges framing decisions and describe a clinical momentum that promotes surgical intervention.

Quality of online information to support patient decision-making in breast cancer surgery.

BACKGROUND: Breast cancer patients commonly use the internet as an information resource. Our objective was to evaluate the quality of online information available to support patients facing a decision for breast surgery. METHODS: Breast cancer surgery-related queries were performed (Google and Bing), and reviewed for content pertinent to breast cancer surgery. The DISCERN instrument was used to evaluate websites' structural components that influence publication reliability and ability of information to support treatment decision-making. Scores of 4/5 were considered "good." RESULTS: 45 unique websites were identified. Websites satisfied a median 5/9 content questions. Commonly omitted topics included: having a choice between breast conservation and mastectomy (67%) and potential for 2nd surgery to obtain negative margins after breast conservation (60%). Websites had a median DISCERN score of 2.9 (range 2.0-4.5). Websites achieved higher scores on structural criteria (median 3.6 [2.1-4.7]), with 24% rated as "good." Scores on supporting decision-making questions were lower (2.6 [1.3-4.4]), with only 7% scoring "good." CONCLUSION: Although numerous breast cancer-related websites exist, most do a poor job providing women with essential information necessary to actively participate in decision-making for breast cancer surgery. Providing easily- accessible, high-quality online information has the potential to significantly improve patients' experiences with decision-making.

"Best Case/Worst Case": Qualitative Evaluation of a Novel Communication Tool for Difficult in-the-Moment Surgical Decisions.

OBJECTIVES: To evaluate a communication tool called "Best Case/Worst Case" (BC/WC) based on an established conceptual model of shared decision-making. DESIGN: Focus group study. SETTING: Older adults (four focus groups) and surgeons (two focus groups) using modified questions from the Decision Aid Acceptability Scale and the Decisional Conflict Scale to evaluate and revise the communication tool. PARTICIPANTS: Individuals aged 60 and older recruited from senior centers (n = 37) and surgeons from academic and private practices in Wisconsin (n = 17). MEASUREMENTS: Qualitative content analysis was used to explore themes and concepts that focus group respondents identified. RESULTS: Seniors and surgeons praised the tool for the unambiguous illustration of multiple treatment options and the clarity gained from presentation of an array of treatment outcomes. Participants noted that the tool provides an opportunity for in-the-moment, preference-based deliberation about options and a platform for further discussion with other clinicians and loved ones. Older adults worried that the format of the tool was not universally accessible for people with different educational backgrounds, and surgeons had concerns that the tool was vulnerable to physicians' subjective biases. CONCLUSION: The BC/WC tool is a novel decision support intervention that may help facilitate difficult decision-making for older adults and their physicians when considering invasive, acute medical treatments such as surgery.

"And I think that we can fix it": mental models used in high-risk surgical decision making.

OBJECTIVE: To examine how surgeons use the "fix-it" model to communicate with patients before high-risk operations. BACKGROUND: The "fix-it" model characterizes disease as an isolated abnormality that can be restored to normal form and function through medical intervention. This mental model is familiar to patients and physicians, but it is ineffective for chronic conditions and treatments that cannot achieve normalcy. Overuse may lead to permissive decision making favoring intervention. Efforts to improve surgical decision making will need to consider how mental models function in clinical practice, including "fix-it." METHODS: We observed surgeons who routinely perform high-risk surgery during preoperative discussions with patients. We used qualitative content analysis to explore the use of "fix-it" in 48 audio-recorded conversations. RESULTS: Surgeons used the "fix-it" model for 2 separate purposes during preoperative conversations: (1) as an explanatory tool to facilitate patient understanding of disease and surgery, and (2) as a deliberation framework to assist in decision making. Although surgeons commonly used "fix-it" as an explanatory model, surgeons explicitly discussed limitations of the "fix-it" model as an independent rationale for operating as they deliberated about the value of surgery. CONCLUSIONS: Although the use of "fix-it" is familiar for explaining medical information to patients, surgeons recognize that the model can be problematic for determining the value of an operation. Whether patients can transition between understanding how their disease is fixed with surgery to a subsequent deliberation about whether they should have surgery is unclear and may have broader implications for surgical decision making.

It's big surgery: preoperative expressions of risk, responsibility, and commitment to treatment after high-risk operations.

OBJECTIVE: To identify the processes, surgeons use to establish patient buy-in to postoperative treatments. BACKGROUND: Surgeons generally believe they confirm the patient's commitment to an operation and all ensuing postoperative care, before surgery. How surgeons get buy-in and whether patients participate in this agreement is unknown. METHODS: We used purposive sampling to identify 3 surgeons from different subspecialties who routinely perform high-risk operations at each of 3 distinct medical centers (Toronto, Ontario; Boston, Massachusetts; Madison, Wisconsin). We recorded preoperative conversations with 3 to 7 patients facing high-risk surgery with each surgeon (n = 48) and used content analysis to analyze each preoperative conversation inductively. RESULTS: Surgeons conveyed the gravity of high-risk operations to patients by emphasizing the operation is "big surgery" and that a decision to proceed invoked a serious commitment for both the surgeon and the patient. Surgeons were frank about the potential for serious complications and the need for intensive care. They rarely discussed the use of prolonged life-supporting treatment, and patients' questions were primarily confined to logistic or technical concerns. Surgeons regularly proceeded through the conversation in a manner that suggested they believed buy-in was achieved, but this agreement was rarely forged explicitly. CONCLUSIONS: Surgeons who perform high-risk operations communicate the risks of surgery and express their commitment to the patient's survival. However, they rarely discuss prolonged life-supporting treatments explicitly and patients do not discuss their preferences. It is not possible to determine patients' desires for prolonged postoperative life support on the basis of these preoperative conversations alone.

Impact of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial on clinical management of the axilla in older breast cancer patients: a SEER-medicare analysis.

BACKGROUND: American College of Surgeons Oncology Group (ACOSOG) Z0011 demonstrated that eligible breast cancer patients with positive sentinel lymph nodes (SLN) could be spared an axillary lymph node dissection (ALND) without sacrificing survival or local control. Although heralded as a ''practice-changing trial,'' some argue that the stringent inclusion criteria limit the trial's clinical significance. The objective was to assess the potential impact of ACOSOG Z0011 on axillary surgical management of Medicare patients and examine current practice patterns. METHODS: Medicare beneficiaries aged C66 years with nonmetastatic invasive breast cancer diagnosed from 2001 to 2007 were identified from the Surveillance, Epidemiology and End Results-Medicare database (n = 59,431). Eligibility for ACOSOG Z0011 was determined: SLN mapping, tumor\5 cm, no neoadjuvant treatment, breast conservation; number of positive nodes was determined. Actual surgical axillary management for eligible patients was assessed. RESULTS: Twelve percent (6,942/59,431) underwent SLN mapping and were node positive. Overall, 2,637 patients (4.4 % (2,637/59,431) of the total cohort, but 38 % (2,637/6,942) of patients with SLN mapping and positive nodes) met inclusion criteria for ACOSOG Z0011, had 1 or 2 positive lymph nodes, and could have been spared an ALND. Of these 2,637 patients, 46 % received a completion ALND and 54 % received only SLN biopsy. CONCLUSIONS: Widespread implementation of ACOSOG Z0011 trial results could potentially spare 38 % of older breast cancer patients who undergo SLN mapping with positive lymph nodes an ALND. However, 54 % of these patients are already managed with SLN biopsy alone, lessening the impact of this trial on clinical practice in older breast cancer patients.