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PURPOSE Three large, randomized trials of patients with bone metastases recently demonstrated that zoledronic acid reduces the risk of skeletal-related events. These trials provide an opportunity for investigating the correlation between bone metabolism and clinical outcome during bisphosphonate therapy. PATIENTS AND METHODS Urinary measurements of(More)
BACKGROUND Whether bone markers have prognostic value in patients with bone metastases is unknown. We investigated this question in patients with bone metastases secondary to prostate cancer and to non-small-cell lung cancer (NSCLC) and other solid tumors assigned to the placebo arms of two phase III trials of zoledronic acid. METHODS Levels of the(More)
PURPOSE Thromboprophylaxis with low-molecular-weight heparin (LMWH) may be more effective than unfractionated heparin but also more likely to bioaccumulate and potentially cause bleeding in patients with renal insufficiency. The objectives of this study were to assess, among medical-surgical patients in the intensive care unit receiving dalteparin 5,000 IU(More)
BACKGROUND Anemia may be an important factor contributing to an increased risk of bleeding, particularly in patients with thrombocytopenia. STUDY DESIGN AND METHODS A multicenter, single-blinded pilot randomized controlled trial (RCT) was performed to evaluate the feasibility of conducting a larger RCT to determine the effect of the hemoglobin (Hb)(More)
OBJECTIVE To establish the frequency and predictors of minimal disease activity in psoriatic arthritis (PsA) and to investigate the prognostic ability of minimal disease activity criteria to predict future joint damage. METHODS The study was conducted using an observational PsA cohort. Patients were classified as being in minimal disease activity if they(More)
OBJECTIVE To investigate the impact of physiotherapy (PT) and occupational therapy (OT) services on long-stay home care patients with musculoskeletal disorders. DESIGN Observational study. SETTING Home care programs. PARTICIPANTS All long-stay home care patients between 2003 and 2008 (N=99,764) with musculoskeletal disorders who received a baseline(More)
We describe methods for designing non-inferiority trials with recurrent event responses arising from mixed-Poisson models. Sample size formulae are derived for trials in which treatment effects are expressed as relative rates and as absolute differences in cumulative mean functions at a particular time. Simulation studies are conducted to provide empirical(More)
SUMMARY Interval-censored life-history data arise when the events of interest are only detectable at periodic assessments. When interest lies in the occurrence of two such events, bivariate-interval censored event time data are obtained. We describe how to fit a four-state Markov model useful for characterizing the association between two interval-censored(More)
Many chronic diseases feature recurring clinically important events. In addition, however, there often exists a random variable which is realized upon the occurrence of each event reflecting the severity of the event, a cost associated with it, or possibly a short term response indicating the effect of a therapeutic intervention. We describe a novel model(More)