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S17.1: Sample size calculations in controlled clinical trials with clustered data - a SAS-Program

✍ Scribed by Gerlinde Dahmen; Andreas Ziegler


Publisher
John Wiley and Sons
Year
2004
Tongue
English
Weight
71 KB
Volume
46
Category
Article
ISSN
0323-3847

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✦ Synopsis


Venous thromboembolism, particularly deep vein thrombosis (DVT), is a significant complication following surgical interventions. The TOCA (Thrombosis Prophylaxis: Outcomes and Care Assessment) study evaluated prevention and treatment strategies of DVT, costs, health care utilisation, as well as patient quality of life (QoL) associated with thrombosis prophylaxis (TP) following joint replacement surgery. Preoperative QoL was assessed with the SF-36, the hospital course of TP documented, followed by patient questionnaires at 1 and 3-month intervals post-surgery which identified the typical treatment pattern in TP, associated costs, as well as quality of life and treatment satisfaction. 309 patients participated in this prospective cohort study in 17 hospitals. 59% of the patients were female, mean age was 66±10 years. Mean length of hospital stay was 17±6 days and rehabilitation stay was 22±5 days. Patients received parenteral anticoagulation for a mean of 38±16 days. 25 (10%) of these patients received subsequent oral anticoagulation for an additional 38±21 days. Symptomatic DVT was reported by 4 patients (1.3%). Clinical guidelines for TP were followed in over 90% of cases. The physical component summary score (PCS) of the SF-36 improved over the 3-month study period, however remained below the German norm. The mental component summary score (MCS) decreased slightly after 1 month but approached the German norm after 3 months. 90% of the patients were satisfied with their treatment. Total mean costs were €11,926±2,481. Hospital and rehabilitation accounted for 92% of total costs, productivity loss 5%, medications, physical therapy and physician visits for 3%. Mean cost of anticoagulation was €60.71±20.31 during hospitalisation and €127.80±124.31 after discharge. 95% of total costs incurred by joint replacement surgery and the 3-month post-operative period are direct costs. Only 1-2% of these costs are attributable to thrombosis prophylaxis.


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