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Purpose: There is increasing interest in using administrative data to examine treatment-related complications that lead to emergency department (ED) visits or hospitalizations (H). The purpose of this study was to evaluate the reliability of billing codes for identifying chemotherapy-related acute care visits (CRVs) among women with early-stage breast cancer. Materials and Methods: The cohort was identified by using deterministically linked health databases and consisted of women who were diagnosed with early-stage breast cancer who started adjuvant chemotherapy between 2007 and 2009 in Ontario, Canada. A random sample of 496 patient cases was chosen as the validation cohort. Sensitivity (SN) and specificity (SP) were calculated for three scenarios: chemotherapy-related ED visit, chemotherapy-related H, and febrile neutropenia (FN)–related visit. For FN-related visits, three definitions were considered: general, moderate, and strict. Results: The administrative cohort consisted of 8,359 patients, 43.4% of whom had at least one ED or H, including 1,496 women who had multiple visits that resulted in 6,293 unique visits. Of these, 73.1% were considered CRVs. The algorithm performed well in identifying CRVs that included H either from ED (SN, 90%; SP, 100%) or directly from home (SN, 91%; SP, 93%), but less well for ED visits that did not result in H (SN, 65%; SP, 80%). Depending on which FN algorithm was used, 4.8% to 24% of visits were considered related. The moderate FN algorithm provided the best tradeoff between SN (69% to 97%) and SP (83% to 98%). Conclusion: Administrative data can be valuable in evaluating chemotherapy-related serious events. Algorithm validation in other cohorts is needed.

To determine if early recovery from severe post-operative anemia is accelerated by iv iron therapy alone or in combination with recombinant erythropoietin (EPO).In this double-blinded, placebo-controlled randomized study, consenting adult patients without preoperative anemia whose hemoglobin concentration (Hb) was 70 to 90 g x L(-1) on the first day after cardiac or orthopedic surgery (POD 1) were assigned to one of three groups: control, iv iron alone (200 mg of iron sucrose on POD 1, 2, and 3) or in combination with EPO (600 U x kg(-1) on POD 1 and 3). The primary outcome was increase in Hb (adjusted for red blood cell transfusions) from POD 1 to 7. Analysis was by intention-to-treat in patients for whom the primary outcome was available. Group effect was analyzed by the ANOVA test, and between-group differences were specified with a Duncan multiple-range test.The primary outcome was available in 31 of 38 randomized patients. The average POD 1 Hb was 84 +/- 4 g x L(-1). There were no between-group differences in outcomes except for higher reticulocyte counts on POD-7 in the combination group. The average adjusted one-week increases in Hb were 7 +/- 8 g x L(-1) in the control group (n = 10), 9 +/- 9 g x L(-1) in the iv iron group (n = 11), and 10 +/- 14 g x L(-1) in the combination group (n = 10). The average adjusted six-week increases in Hb were 37 +/- 14 g x L(-1) in the control group, 40 +/- 7 g x L(-1) in the iv iron group, and 45 +/- 12 g x L(-1) in the combination group.Early postoperative treatment with iv iron alone or in combination with EPO does not appear to accelerate early recovery from postoperative anemia.

BACKGROUND: Cardiac surgery is occasionally complicated by massive blood loss that is refractory to standard hemostatic interventions. Recombinant factor VIIa (rF-VIIa) is being increasingly used as rescue therapy in such cases, but little information is available on its safety and efficacy for this indication. STUDY DESIGN AND METHODS: The outcomes of the first 51 cardiac surgery patients who received rF-VIIa for intractable blood loss (from November 2002 to February 2004) at a single institution according to a standardized clinical guideline were compared to 51 matched control patients, with the control patients identified from a large database and matched based on the propensity for massive blood loss. RESULTS: Blood loss and blood product usage were significantly decreased after 2.4 to 4.8 mg of rF-VIIa. In those treated after sternal closure (n = 32), there was a significant reduction in blood loss from the hour before to the hour after treatment: 100 (70, 285) mL (median [25th, 75th percentiles]; p < 0.0001). Except for a slower postoperative recovery and higher incidence of acute renal dysfunction, the adverse event rates were similar between the rF-VIIa-treated patients and their matched controls. CONCLUSIONS: These results suggest that rF-VIIa may be an effective rescue therapy for patients with intractable hemorrhage after cardiac surgery. A clinically important risk of stroke or other major thrombotic complications could not be ruled out by our study. Controlled clinical trials with adequate power to detect the impact of rF-VIIa therapy on morbidity and mortality therefore are necessary before one can recommend its routine use in patients undergoing cardiac surgery who have excessive bleeding. assive blood loss is a serious complication of cardiac surgery that occurs when standard hemostatic interventions, which include surgical intervention, local hemostatic agents, and transfusion of blood products, fail to stop hemorrhage after surgery. There has recently been a great deal of interest in the use of recombinant factor VIIa (rF-VIIa)—a novel hemostatic agent that is currently approved only for patients with hemophilia with antibodies against specific coagulation factors (anti-FVIII or antiF IX)—for control of refractory hemorrhage after cardiac surgery. There are now multiple case reports and small case series that have described the successful use of rFVIIa in cardiac surgery. 1-10 Owing to their small sample sizes and lack of comparison groups, however, these reports can confirm neither the efficacy nor the safety of rF-VIIa for this indication. The high rate of serious adverse events in these reports has raised concerns about the safety of rF-VIIa in cardiac surgery.

185 Background: Administrative data is increasingly being used to study treatment related complications that lead to acute care visits such as emergency department visits or hospitalizations (ED+H). We evaluated the accuracy of diagnosis codes for identifying chemotherapy related acute care visits (CRVs) among women with breast cancer. Methods: We prospectively developed algorithms to identify CRVs from administrative data in women receiving adjuvant chemotherapy for breast cancer in Ontario, Canada. Sensitivity (SN) and specificity (SP) were calculated for 3 scenarios: chemotherapy related ED visit, chemotherapy related H, and febrile neutropenia (FN) related visit using the chart as the gold standard. Since there is no specific diagnosis code for FN, three definitions of FN were considered: general (defined as fever or infection or neutropenia as main reason for visit), moderate (neutropenia as main reason for visit) or strict (fever or infection plus neutropenia). The population based cohort was generated by linking several health databases to identify women who had at least one ED+H during adjuvant chemotherapy for breast cancer between 2007-2009. The validation cohort consisted of 490 randomly selected cases from this cohort. Results: The population-based cohort consisted of 8,359 patients of whom 43.4% had at least one ED+H including 1,496 women who had multiple visits resulting in 6,293 unique ED+H. Of these, 73.1% were considered CRVs based on our algorithm. The algorithm performed well in identifying CRVs that included an H either from ED (SN 90%, SP 100%) or directly from home (SN 91%, SP 93%) but less well for ED visits that did not result in H (SN 65%, SP 80%). Depending on which FN algorithm was used, 1.4-24% of visits were considered FN related. The general FN algorithm had excellent SN regardless of whether the visit involved H (94-98%) but SP was moderate (66-80%). The strict FN algorithm had good SP (78-99%) but SN was highly variable (13-89%). The moderate FN algorithm provided the best tradeoff between SN (69-97%) and SP (76-98%). Conclusions: CRVs can be identified from administrative data with reasonable confidence, obviating the need for chart abstraction to evaluate chemotherapy related serious events.

The aim of the present study was to identify patients who were at particular risk of violent behaviour, over a period of one month in a psychiatric high dependency unit, and to examine whether particular patients could be identified at admission who would subsequently be violent. Medical records, and other documents for 52 inpatients were included. Demographic, historical and clinical data available at admission were noted. All violent incidents were recorded and classified. Seventeen of 52 patients committed physical violence, usually to the staff. Most incidents were carried out by a small number of individuals. Identifying the violent, using variables available at admission, was not possible. The ward admitted a group with a subsequent high rate of violence. Prediction within this high-risk group was not possible. Measures aimed at preventing violence on a local secure ward should apply to all patients and should not be targeted just at those that would appear to be the most likely to be violent.

115 Background: Over use of routine surveillance imaging to detect recurrence in women with EBC was recently identified as one of the top five opportunities to improve the quality of cancer care by the American Society of Clinical Oncology. We undertook a population level assessment of the current practice of surveillance imaging in EBC women treated in Ontario Canada. Methods: Incident EBC patients diagnosed 01/07 – 12/09 in Ontario, Canada were identified from the Ontario Cancer Registry. Patient records were linked deterministically to provincial health care databases to provide comprehensive medical follow-up. Basic (chest x-ray, abdominal x-ray and abdominal ultrasound) and advanced (computed tomography [CT] or bone scans) surveillance imaging scans completed during the first and second year of follow-up (starting 6 months after surgery or upon completion of chemotherapy) were identified. Logistic regression models were used to identify covariates associated with advanced surveillance imaging. Results: 16,981 EBC patients were included in the analysis of which 7,907(46.6%) received chemotherapy. In the first year of follow up care, 8,311 (48.9%) had at least 1 basic imaging test, while 4,916 (29.0%) had advanced imaging. This fell to 45.7% (basic) and 25.1% (advanced) in the second year of follow-up. Bone scans were the most common advanced imaging test (14.5%), followed by CT thorax (10.8%). On multivariable analysis age, stage, the use of chemotherapy and comorbidity were associated with increased use of advanced surveillance imaging (Table). Conclusions: Surveillance imaging was common in the first two years of follow-up for EBC patients. While appropriate for symptom driven investigation, the high rate of advanced imaging scans suggests an opportunity for improvement with the Ontario cancer system. [Table: see text]

6628 Background: Over use of routine surveillance imaging to detect recurrence in women with EBC was recently identified as one of the top five opportunities to improve the quality of cancer care by the American Society of Clinical Oncology. We undertook a population level assessment of the current practice of surveillance imaging in EBC women treated in Ontario Canada. Methods: Incident early breast cancer patients diagnosed 01/07 – 12/09 in Ontario, Canada were identified from the Ontario Cancer Registry. Patient records were linked deterministically to provincial health care databases to provide comprehensive medical follow-up. Basic (chest x-ray, abdominal x-ray and abdominal ultrasound) and advanced (computed tomography [CT] or bone scans) surveillance imaging scans completed during the first and second year of follow-up care (starting 6 months after surgery or upon completion of adjuvant chemotherapy) were identified. Logistic regression models were used to identify covariates associated with advanced surveillance imaging. Results: 16,981 EBC patients were included in the analysis of which 7,907(46.6%) received chemotherapy. In the first year of follow up care, 8,311 (48.9%) had at least 1 basic imaging test, while 4,916 (29.0%) had advanced imaging. This fell to 45.7% (basic) and 25.1% (advanced) in the second year of follow-up. Bone scans were the most common advanced imaging test (14.5%), followed by CT thorax (10.8%). On multivariable analysis age, stage, the use of chemotherapy and comorbidity were associated with increased use of advanced surveillance imaging (Table). Significant geographic variation was also demonstrated. Conclusions: Surveillance imaging was common in the first two years of follow-up for EBC patients. While appropriate for symptom driven investigation, attention should be paid to the routine use of surveillance imaging in EBC women during follow-up care. [Table: see text]