PubMed · 10232248
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J Walters. Shared care provides postoperative help.. https://pubmed.ncbi.nlm.nih.gov/10232248/
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CONTEXT: Hip fracture is a common clinical problem that leads to considerable mortality and disability. A need exists for a practical means to monitor and improve outcomes, including function, for patients with hip fracture. OBJECTIVES: To identify and compare the importance of significant prefracture predictors of functional status and mortality at 6 months for patients hospitalized with hip fracture and to compare risk-adjusted outcomes for hospitals providing initial care. DESIGN: Prospective study with data obtained from medical records and through structured interviews with patients and proxies. SETTING AND PARTICIPANTS: A total of 571 adults aged 50 years or older with hip fracture who were admitted to 4 New York, NY, metropolitan hospitals between August 1997 and August 1998. MAIN OUTCOME MEASURES: In-hospital and 6-month mortality; locomotion at 6 months; and adverse outcomes at 6 months, defined as death or needing assistance to ambulate, compared by hospital, adjusting for patient risk factors. RESULTS: The in-hospital mortality rate was 1.6%. At 6 months, the mortality rate was 13.5%, and another 12.8% needed total assistance to ambulate. Laboratory values were strong predictors of mortality but were not significantly associated with locomotion. Age and prefracture residence at a nursing home were significant predictors of locomotion (P =.02 for both) but were not significantly associated with mortality. Adjustment for baseline characteristics either substantially augmented or diminished interhospital differences in outcomes. Two hospitals had 1 outcome (functional status or mortality) that was significantly worse than the overall mean while the other outcome was nonsignificantly better than average. CONCLUSIONS: Mortality and functional status ideally should be considered both together and individually to distinguish effects limited to one or the other outcome. Hospital performance for these 2 measures may differ substantially after adjustment, probably because different processes of care are important to each outcome.
PURPOSE: This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival. PATIENTS AND METHODS: Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels < or = 10.5 g/dL, or greater than 10.5 g/dL but < or = 12.0 g/dL after a hemoglobin decrease of > or = 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study. RESULTS: Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P =.0057) and increased hemoglobin (P <.001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P <.01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P =.13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P =.052) favoring epoetin alfa. Adverse events were comparable between groups. CONCLUSION: Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings.
PURPOSE: To prospectively evaluate the effectiveness, safety, and clinical benefits of once-weekly epoetin alfa therapy as an adjunct to chemotherapy in anemic cancer patients. PATIENTS AND METHODS: A total of 3,012 patients with nonmyeloid malignancies who received chemotherapy were enrolled onto this multicenter, open-label, nonrandomized study conducted in 600 United States community-based practices. Patients received epoetin alfa 40,000 U once weekly, which could be increased to 60,000 U once weekly after 4 weeks dependent on hemoglobin response. Treatment was continued for a maximum of 16 weeks. RESULTS: Among the 2,964 patients assessable for efficacy, epoetin alfa therapy resulted in significant increases in hemoglobin levels, decreases in transfusion requirements, and improvements in functional status and fatigue as assessed by the linear analog scale assessment (energy level, ability to perform daily activities, and overall quality of life) and the anemia subscale of the Functional Assessment of Cancer Therapy-Anemia questionnaire. Improvements in quality-of-life parameters correlated significantly (P <.001) with increased hemoglobin levels. The direct relationship between hemoglobin and quality-of-life improvement was sustained during the 16-week study period, which is similar to findings of large community-based trials of three-times-weekly dosing. Once-weekly epoetin alfa was well tolerated, with most adverse events attributed to the underlying disease or concomitant chemotherapy. CONCLUSION: The results from this large, prospective, community-based trial suggest that once-weekly epoetin alfa therapy increases hemoglobin levels, decreases transfusion requirements, and improves quality of life in patients with cancer and anemia who undergo concomitant chemotherapy. Based on the results of this study, the clinical benefits and the adverse event profile of once-weekly epoetin alfa therapy in community-based practice are similar to those observed in the historical experience with the three-times-weekly dosage schedule.