Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study.

Background: The purpose of this study was to evaluate the real-world use, efficacy, and safety of one or more dexamethasone intravitreal implant(s) 0.7 mg (DEX implant) in patients with macular edema (ME).

Methods: This was a retrospective cohort study of patients with ME secondary to retinal disease treated at ten Canadian retina practices, including one uveitis center.

An observational study of bimatoprost 0.01% in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan(®) RC Early Analysis Review (CLEAR) trial.

Purpose: To evaluate the ocular hyperemia and intraocular pressure (IOP)-lowering efficacy of bimatoprost 0.01% in subjects with elevated IOP due to primary open-angle glaucoma (POAG) or ocular hypertension (OHT) in a real-world clinical setting.

Subjects And Methods: This open-label, 12-week, observational study was conducted at 67 centers in Canada.

Power to negotiate spatial barriers to breastfeeding in a western context: when motherhood meets poverty.

Although breastfeeding is beneficial to the health of babies born into poverty, rates have remained consistently low among this group. This paper presents findings from a study conducted with poor French Canadian women, who were exposed to breastfeeding promotion. Analysis of 31 qualitative interviews suggests that the 'good mother' imperative in context of poverty and the western hypersexualization of breasts acted as major deterrents to breastfeeding.

An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial.

Background: This study was designed to evaluate the occurrence and severity of ocular hyperemia in subjects with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) following treatment with bimatoprost 0.01% in a real-world clinical setting.

Methods: This was an open-label, observational study conducted at 67 centers in Canada.

Documentation of daily sit-to-stands performed by community-dwelling adults.

No information exists about how many sit-to-stands (STSs) are performed daily by community-dwelling adults. We, therefore, examined the feasibility of using a tally counter to document daily STSs, documented the number of daily STSs performed, and determined if the number of STSs was influenced by demographic or health variables. Ninety-eight community-dwelling adults (19-84 years) agreed to participate.

Quantitative interpretation of optical density measurements using PF4-dependent enzyme-immunoassays.

Background: Many laboratories test for heparin-induced thrombocytopenia (HIT) using a PF4-dependent enzyme-immunoassay (EIA). An advantage of the EIA is its simplicity; a disadvantage is that it only indirectly detects heparin-dependent, platelet-activating antibodies ('HIT antibodies').

Objectives: To determine whether the magnitude of a positive EIA result, expressed in optical density (OD) units, predicts risk of HIT antibodies, defined as a strong-positive platelet serotonin-release assay (SRA) result (>or=50% serotonin release).

A randomized controlled trial to assess the efficacy of tiotropium in Canadian patients with chronic obstructive pulmonary disease.

Background: Patients with chronic obstructive pulmonary disease (COPD) who smoke have a greater annual rate of decline in forced expiratory volume in 1 s (FEV(1)) than those patients who have stopped smoking.

Objectives: To assess the effect of tiotropium on pre-dose (trough) FEV(1) in patients with COPD followed in Canada.

Methods: A total of 913 patients were randomly assigned to receive either tiotropium 18 mug once daily (n=608) or placebo (usual care minus inhaled anticholinergics) (n=305) for 48 weeks in the present randomized, double-blind, parallel-group study.

What is the potential for overdiagnosis of heparin-induced thrombocytopenia?

Heparin-induced thrombocytopenia (HIT) is caused by platelet-activating antibodies that recognize platelet factor 4//heparin (PF4/H) complexes. According to the "iceberg model," only a subset of anti-PF4/heparin antibodies of IgG class evincing strong platelet-activating properties cause clinical HIT. Since many centers rely predominantly on an anti-PF4/polyanion enzyme-immunoassay (EIA) to diagnose HIT, we estimated the potential for overdiagnosis when only this single test is available.

Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura.

Background: Rituximab, a monoclonal anti-CD20 antibody, is increasingly used to treat idiopathic thrombocytopenic purpura (ITP).

Purpose: To systematically review the literature on the efficacy and safety of rituximab for the treatment of adults with ITP.

Data Sources: MEDLINE, EMBASE, the Cochrane Library, abstracts from the American Societies of Hematology and Clinical Oncology annual meetings, and bibliographies of relevant articles and reviews were searched in duplicate until April 2006.

The risk of bleeding in thrombocytopenic patients with acute myeloid leukemia.

Background And Objectives: Patients with acute myeloid leukemia are at risk of bleeding. The risk factors for different severities of bleeding are poorly studied.

Design And Methods: Data from Rebulla et al.

Multicenter retrospective analysis of cardiovascular risk factors affecting long-term outcome of de novo cardiac transplant recipients.

Background: Previous risk factor studies in cardiac transplant patients have analyzed pre-transplant risk factors as they relate to outcomes. This study is the first in-depth multicenter assessment of ongoing post-transplant risk factors in heart transplant patients and their impact on 5-year outcomes.

Methods: We reviewed 280 heart transplant patients who survived > 1 year for the impact of post-transplant risk factors (hyperlipidemia, hypertension, diabetes, body mass index [BMI] and renal dysfunction: 8 to 18 possible measurements over 5 years) on outcomes, including death, cardiac allograft vasculopathy (CAV) and non-fatal major adverse cardiac events (NF-MACE).

Utilization of platelet transfusions in the intensive care unit: indications, transfusion triggers, and platelet count responses.

Background: A description of current platelet (PLT) transfusion practice in the intensive care unit (ICU) is needed.

Study Design And Methods: All thrombocytopenic patients (PLT count, <150 x 10(9)/L) who received PLT transfusions were identified from a previous prospective study of consecutive medical-surgical ICU patients; trauma, orthopedic, and cardiac surgery were exclusions. Risk factors for ineffective transfusions were examined.

Effectiveness of preventive primary care outreach interventions aimed at older people: meta-analysis of randomized controlled trials.

Objective: To determine the effectiveness of preventive primary care outreach interventions aimed at older people. Knowing whether such interventions are effective could help busy family physicians make choices about which preventive care services to provide.

Data Sources: We searched MEDLINE, CINAHL, AgeLine, Cochrane Controlled Trials Register, and EMBASE databases and reviewed the reference lists of retrieved articles.

Gender imbalance and risk factor interactions in heparin-induced thrombocytopenia.

Heparin-induced thrombocytopenia (HIT) is caused by antibodies against a "self" protein-platelet factor 4-bound to heparin. We observed an overrepresentation of the female gender in 290 patients who developed HIT after cardiac or orthopedic surgery compared with the representation found in national databases (study 1). Therefore, we investigated gender imbalance in HIT by logistic regression analysis of a randomized controlled trial of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) (study 2), and we analyzed individual patient data from 7 prospective studies comparing HIT frequency between UFH and LMWH, evaluating effects of gender, heparin (UFH vs LMWH), and patient type (surgical vs medical) (study 3).

A descriptive analysis of international transfusion practice and bleeding outcomes in patients with acute leukemia.

Background: Recently, bleeding has been used in platelet (PLT) trials rather than surrogate outcomes. The purpose of this study was to provide a descriptive summary of data from PLT studies conducted in four countries and exploratory analyses to determine the relationship between bleeding and PLT count.

Study Design And Methods: A descriptive analysis was performed on original data from the Italian trigger study, the US TRAP study, the Canadian febrile reaction study, and a clinical chart review from one hospital site in the United Kingdom.

Evaluation of pretest clinical score (4 T's) for the diagnosis of heparin-induced thrombocytopenia in two clinical settings.

Background: Heparin-induced thrombocytopenia (HIT) is a prothrombotic adverse drug reaction caused by heparin. As thrombocytopenia is common in hospitalized patients receiving heparin, it would be useful to have a clinical scoring system that could differentiate patients with HIT from those with other reasons for thrombocytopenia.

Aim: To compare prospectively the diagnostic utility of a clinical score for HIT in two different clinical settings.

In vivo recovery and survival of apheresis and whole blood-derived platelets: a paired comparison in healthy volunteers.

Background: Methods of platelet preparation may alter the recovery and survival characteristics of platelets following transfusion. As suggested by a recent clinical trial, platelet recovery may be better preserved with apheresis platelet preparations than with platelets prepared from whole blood by the platelet-rich plasma (PRP) method.

Study Design And Methods: In vivo platelet recovery and survival of autologous leukoreduced (LR) apheresis platelets and autologous filter-LR PRP platelets were compared in 22 healthy volunteers using a paired crossover design.

Laboratory testing for the antibodies that cause heparin-induced thrombocytopenia: how much class do we need?

Heparin-induced thrombocytopenia (HIT) is usually caused by platelet-activating antibodies of immunoglobulin G class that recognize platelet factor-4 (PF4) bound to heparin or certain other polyanions. Commercial enzyme immunoassays (EIAs) for PF4/polyanion-reactive antibodies detect two immunoglobulin classes (IgA and IgM) besides IgG. To investigate whether the additional detection of these antibody classes improves or worsens assay operating characteristics, we compared the sensitivity and specificity of EIAs that detect these 3 immunoglobulin classes individually with that of a commercial EIA (Genetic Testing Institute, GTI), as well as a platelet-activation assay, the serotonin-release assay (SRA).

In vitro evaluation of prestorage pooled leukoreduced whole blood-derived platelets stored for up to 7 days.

Background: Advantages to storing whole blood-derived platelets (PLTs) as a pool for 7 days would include operational efficiencies and facilitation of bacterial testing and pathogen inactivation. The in vitro quality of pre-storage pooled PLTs stored for up to 7 days was assessed.

Study Design And Methods: Leukoreduced PLTs were pooled before storage (5 units/pool) and stored for either 5 or 7 days.

Assessing the effectiveness of whole blood-derived platelets stored as a pool: a randomized block noninferiority trial.

Background: Prestorage pooling of whole blood-derived platelets (PLTs) would simplify bacterial detection. This study evaluated the in vivo effect of the prestorage pooling of PLTs stored for up to 5 days, by assessing the corrected count increment (CCI) 18 to 24 hours after transfusion of the product.

Study Design And Methods: A randomized block noninferiority design was used.

Comparing hand-held computers and paper diaries for haemophilia home therapy: a randomized trial.

Treatment of severe haemophilia with factor concentrates is by self-infusion in the home. Adherence to record keeping on paper diaries is poor. A randomized-controlled trial compared adherence with record keeping of paper diaries with hand-held computers.

Canadian multicenter pilot trial of haploidentical donor transplantation.

Background: Canadian multicenter pilot study of haploidentical donor.

Aims: To assess (1) ability to collect suitable graft (CD34+ > or = 5 x 10(6)/kg and CD3 < 1 x 10(5)/kg recipient body weight), (2) toxicity, (3) survival to day +100. ELIGIBILITY: All hematological malignancies and ages; accrual to end after 20 transplants of patients with AML in remission and age less than 55 years.

Methods for the analysis of bleeding outcomes in randomized trials of PLT transfusion triggers.

Background: A number of methodologic challenges arise in the analysis of bleeding data from clinical trials of PLT transfusion triggers. It is important to understand the assumptions and role of the various methods of analysis to interpret published trials and to design future studies appropriately.

Study Design And Methods: The methods of analysis used for testing the effectiveness and safety of transfusion strategies are reviewed from several recent PLT transfusion trigger trials.

Evaluation of the effectiveness of two clinical training procedures to elicit yes/no responses from patients with a severe acquired brain injury: a randomized single-subject design.

Primary Objective: Thirteen (10 males) participants with severe acquired brain injuries (ABI) were randomly assigned to two treatments, A or B (ABAB, BABA) in a crossover study to determine which treatment approach elicited more consistent and reliable yes/no responses.

Research Design: Treatment A consisted of an enriched stimulus environment, collaborative multidisciplinary interventions and additional yes/no response training, while Treatment B consisted of the standard hospital environment and interventions.

Main Outcomes: An ANOVA showed no order effect (AB vs BA; p=0.

A retrospective 11-year analysis of obstetric patients with idiopathic thrombocytopenic purpura.

Numerous studies have examined the outcomes of infants born to mothers with idiopathic thrombocytopenic purpura (ITP). Fewer studies have discussed the morbidity of obstetric patients with ITP. We describe a retrospective study of 92 women with ITP during 119 pregnancies over an 11-year period.