Evaluation of a thromboprophylaxis quality improvement project in a palliative care unit.

CONTEXT: The benefits of anticoagulation treatment for primary prophylaxis in patients with advanced progressive diseases are unclear. Moreover, there are no empirically based guidelines on thromboprophylaxis for palliative care patients. OBJECTIVES: To prospectively evaluate a quality improvement protocol on the use of thromboprophylaxis on a 36-bed palliative care unit (PCU). METHODS: A protocol was developed to guide and standardize practice related to venous thromboembolic events (VTE) and anticoagulation medication use on the PCU in patients with a life expectancy of less than six months. Through a prospective audit, data were collected for consecutively admitted patients over a period of four months. RESULTS: Of the 127 patients admitted to the PCU, 41 (32.3%) were on thromboprophylaxis on admission. All but one of these patients had come from an acute care hospital. Thromboprophylaxis was discontinued in 36 (87.8%) of these patients; one patient went on to develop a VTE. Of the 71 patients admitted without thromboprophylaxis, none of the patients were started on thromboprophylaxis and six went on to develop a VTE. CONCLUSION: In this quality improvement study of patients admitted to a PCU largely for end-of-life care, thromboprophylaxis was discontinued in most patients without a significant increase in the incidence of symptomatic VTE. The validity of recommendations extrapolated from the general hospitalized cancer population supporting routine thromboprophylaxis and applied to these patients can be challenged. A policy that requires thromboprophylaxis in all hospitalized cancer patients may run the risk of indiscriminately including patients who are in the terminal phase of their lives.

Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer.

PURPOSE: The development of bone metastases depends on tumor-induced osteoclastic resorption of bone, which may be inhibited by the antiosteolytic bisphosphonate clodronate. Given to patients with primary breast cancer, clodronate might reduce the subsequent incidence of bone metastases. PATIENTS AND METHODS: This double-blind, multicenter trial accrued 1,069 assessable patients with operable breast cancer between 1989 and 1995. All patients received surgery, radiotherapy, chemotherapy, and tamoxifen as required. Patients were randomized to receive oral clodronate 1,600 mg/d or a placebo for 2 years starting within 6 months of primary treatment. The primary end point was relapse in bone, analyzed on an intent-to-treat basis, during the medication period and during the total follow-up period (median follow-up, 2,007 days). Secondary end points were relapse in other sites, mortality, and toxicity. RESULTS: During the total follow-up period, there was a nonsignificant reduction in occurrence of bone metastases (clodronate, n = 63; placebo, n = 80; hazards ratio [HR], 0.77; 95% confidence interval [CI], 0.56 to 1.08; P =.127). During the medication period there was a significant reduction in the occurrence of bone metastases (clodronate, n = 12; placebo, n = 28; HR, 0.44; 95% CI, 0.22 to 0.86; P =.016). The occurrence of nonosseous metastases was similar (clodronate, n = 112; placebo, n = 128; P =.257), but there was a significant reduction in mortality (clodronate, n = 98; placebo, n = 129; P =.047) during the total follow-up period. CONCLUSION: Clodronate, given to patients with primary operable breast cancer, may reduce the occurrence of bone metastases, although this reduction was only significant during this medication period. There was a significant reduction in mortality.