Fecal blood loss: A quantitative method of evaluating hemostasis in patients with thrombocytopenia.

BACKGROUND: The purpose of our studies was to determine if fecal blood loss can provide a quantitative measure of bleeding at platelet counts of 20 000/µL or less in patients with hypoproliferative thrombocytopenia and to document the effects of different prophylactic platelet transfusion triggers on fecal blood loss. METHODS AND MATERIALS: Patients had an aliquot of their autologous red blood cells (RBCs) labeled with 51 Cr. Following reinjection of their radiolabeled RBCs, all feces and a daily blood sample were collected to determine fecal blood loss per day. Three different studies were performed in patients with thrombocytopenia: The first was in patients with thrombocytopenia with aplastic anemia who were not receiving platelet transfusions, and the other two trials involved thrombocytopenic patients with cancer who were receiving prophylactic platelet transfusions at platelet transfusion triggers of 5000/µL, 10 000/µL, or 20 000/µL. RESULTS: In patients with thrombocytopenia not receiving platelet transfusions, fecal blood loss does not increase substantially until platelet counts are 5000/µL or less. When platelet transfusions are given prophylactically to patients with cancer with chemotherapy-induced thrombocytopenia at platelet counts of 5000/µL or less, fecal blood loss and red cell transfusion requirements are the same as those for patients transfused prophylactically at higher transfusion triggers of 10 000 platelets/µL or 20 000 platelets/µL. However, the total number of platelet transfusions needed increases significantly, and the duration of the patient's thrombocytopenia tends to be longer at the higher platelet transfusion thresholds. CONCLUSION: A prophylactic platelet transfusion threshold of 5000/µL or greater is sufficient to maintain hemostasis in patients with thrombocytopenia.

A MULTICENTER, LONGITUDINAL, INTERVENTIONAL, DOUBLE BLIND RANDOMIZED CLINICAL TRIAL IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS RESIDING IN REMOTE AREAS: LESSONS LEARNED FROM THE LATE CYTOMEGALOVIRUS PREVENTION TRIAL.

PURPOSE: The logistics of conducting double-blinded phase III clinical trials with participants residing in remote locations are complex. Here we describe the implementation of an interventional trial for the prevention of late cytomegalovirus (CMV) disease in hematopoietic cell transplantation (HCT) subjects in a long-term follow-up environment. METHODS: A total of 184 subjects at risk for late CMV disease surviving 80 days following allogeneic HCT were randomized to receive six months of valganciclovir or placebo. Subjects were followed through day 270 post-transplant at their local physician's office within the United States. Anti-viral treatment interventions were based on CMV DNAemia as measured by polymerase chain reaction (PCR) (>1000 copies/mL) and granulocyte colony stimulating factor (G-CSF) was prescribed for neutropenia (absolute neutrophil count (ANC <1.0 × 109 cells/L). Blood samples for viral testing and safety monitoring were shipped to a central laboratory by overnight carrier. Real-time communication was established between the coordinating center and study sites, primary care physicians, and study participants to facilitate starting, stopping and dose adjustments of antiviral drugs and G-CSF. The time required to make these interventions was analyzed. RESULTS: Of the 4169 scheduled blood specimens, 3832 (92%) were received and analyzed; the majority (97%) arriving at the central site within 2 days. Among subjects with positive CMV DNAemia (N=46), over 50% received open label antiviral medication within one day. The median time to start G-CSF for neutropenia was <1 day after posting of laboratory results (range 0-6; N=38). Study drug dose adjustments for abnormal renal function were implemented 203 times; within one day for 48% of cases and within 2 days for 80% of cases. CONCLUSION: Complex randomized, double-blind, multicenter interventional trials with treatment decisions made at a central coordinating site can be conducted safely and effectively according to Good Clinical Practice (GCP) guidelines over a large geographic area.

A randomized clinical trial of cognitive-behavioral therapy and applied relaxation for adults with generalized anxiety disorder.

This randomized clinical trial compared cognitive-behavioral therapy (CBT), applied relaxation (AR), and wait-list control (WL) in a sample of 65 adults with a primary diagnosis of generalized anxiety disorder (GAD). The CBT condition was based on the intolerance of uncertainty model of GAD, whereas the AR condition was based on general theories of anxiety. Both manualized treatments were administered over 12 weekly 1-hour sessions. Standardized clinician ratings and self-report questionnaires were used to assess GAD and related symptoms at pretest, posttest, and at 6-, 12-, and 24-month follow-ups. At posttest, CBT was clearly superior to WL, AR was marginally superior to WL, and CBT was marginally superior to AR. Over follow-up, CBT and AR were equivalent, but only CBT led to continued improvement. Thus, direct comparisons of CBT and AR indicated that the treatments were comparable; however, comparisons of each treatment with another point of reference (either waiting list or no change over follow-up) provided greater support for the efficacy of CBT than AR.

Comparative psychometric properties of the BACS and RBANS in patients with schizophrenia and schizoaffective disorder.

OBJECTIVES: There has been a recent impetus to develop short and portable instruments for the cognitive assessment of patients with schizophrenia in clinical settings, but direct comparative data are lacking. The objectives of the present study were to compare the psychometric properties of two such batteries, the BACS (Brief Assessment of Cognition in Schizophrenia) and the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status). METHODS: The French version of the BACS and the RBANS was administered to 36 patients with schizophrenia and schizoaffective disorder, and 14 healthy controls. A subgroup of patients was also tested with a standard battery (WAIS-III). RESULTS: Both instruments were easily administrable. Internal consistency was satisfying (global scale reliability alphas of 0.90 for the BACS, and 0.87 for the RBANS), although some sub-scores from the RBANS decreased the overall consistency of the instrument. BACS and RBANS composite scores were highly correlated to verbal, non-verbal and total WAIS-III scores (BACS: r=0.727, 0.865 and 0.857, respectively; RBANS: r=0.843, 0.747 and 0.875, respectively). Patients underperformed controls by a magnitude of 1.81 SD (BACS), and 0.78 SD (RBANS), after adjusting for education. Both batteries showed good test-retest reliability, except for three sub-scores from the RBANS. CONCLUSION: The psychometric properties and ease of use of the BACS and the RBANS were overall satisfying. The BACS demonstrated better internal consistency and test-retest reliability than the RBANS and was nominally more sensitive to diagnosis.