Daily versus every other day oral iron supplementation in patients with iron deficiency anemia (DEODO): study protocol for a phase 3 multicentered, pragmatic, open-label, pilot randomized controlled trial.

BACKGROUND: Iron deficiency anemia (IDA) accounts for the majority of anemia cases across the globe and can lead to impairments in both physical and cognitive functioning. Oral iron supplementation is the first line of treatment to improve the hemoglobin level for IDA patients. However, gaps still exist in understanding the appropriate dosing regimen of oral iron. The current trial proposes to evaluate the feasibility of performing this study to examine the effectiveness and side-effect profile of oral iron once daily versus every other day. METHODS: In this open-label, pilot, feasibility, randomized controlled trial, 52 outpatients over 16 years of age with IDA (defined as hemoglobin < 12.0 g/dL in females and < 13.0 g/dL in males and ferritin < 30 mcg/L) will be enrolled across two large academic hospitals. Participants are randomized in a 1:1 ratio to receive 300 mg oral ferrous sulfate (60 mg of elemental iron) either every day or every other day for 12 weeks. Participants are excluded if they are as follows: (1) pregnant and/or currently breastfeeding, (2) have a disease history that would impair response to oral iron (e.g., thalassemia, celiac disease), (3) intolerant and/or have an allergy to oral iron or vitamin C, (4) on new anticoagulants in the past 6 months, (5) received IV iron therapy in the past 12 weeks, (6) have surgery, chemotherapy, or blood donation planned in upcoming 12 weeks, (7) a creatinine clearance < 30 mL/min, or (8) hemoglobin less than 8.0 g/dL with active bleeding. The primary outcome is feasibility to enroll 52 participants in this trial over a 2-year period to determine the effectiveness of daily versus every other day oral iron supplementation on hemoglobin at 12 weeks post-initiation and side-effect profile. DISCUSSION: The results of this trial will provide additional evidence for an appropriate dosing schedule for treating patients with IDA with oral iron supplementation. Additional knowledge will be gained on how the dosing regimen of oral iron impacts quality of life and hemoglobin repletion in IDA patients. If this trial is deemed feasible, it will inform the development and implementation of a larger multicenter definitive trial. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03725384 . Registered 31 October 2018.

Patient values and preferences in pulmonary embolism testing in the emergency department.

INTRODUCTION: Patient-centered care is concordant with patient values and preferences. There is a lack of research on patient values and preferences for pulmonary embolism (PE) testing in the emergency department (ED), and a poor physician understanding of patient-specific goals. Our aim was to map patient-specific values, preferences, and expectations regarding PE testing in the ED. METHOD: This qualitative study used constructivist grounded theory to identify patient values and expectations around PE testing in the ED. We conducted semi-structured interviews with ED patients who were being tested for PE in two EDs. Patients who were waiting for PE imaging or D-dimer results were approached and consented to take part in a 30-minute audio-recorded interview. Each interview was transcribed verbatim and analyzed using constant comparative coding. The interview script was modified to maximize information on emerging themes. Major themes and subthemes were derived, each representing an opportunity, barrier, or value to address with patient-centered PE testing. RESULTS: From 30 patient interviews, we mapped four major themes: patient satisfaction comes from addressing the patient's primary concern (for example, their pain); patients expect individualized care; patients prefer imaging over clinical examination for PE testing; and patients expect 100% confidence from their emergency physician when given a diagnosis. Subthemes included symptomatic relief, finding a diagnosis, receiving tests, rapid progression through their care, perception of highly accurate CT scans, willingness to seek a second opinion, direct physician communication, and expectation of case-specific testing with cognitive reassurance. CONCLUSION: Addressing each of these four themes by realigning ED processes could provide patient-centered PE testing.

Risk of venous and arterial thrombosis in non-surgical patients receiving systemic tranexamic acid: A systematic review and meta-analysis.

BACKGROUND: Antifibrinolytic agents such as tranexamic acid (TXA) are commonly used as adjunctive therapies to prevent and treat excessive bleeding. In non-surgical settings, TXA is known to reduce bleeding related mortality. However, impact of TXA use on thrombosis is uncertain. METHODS: We systematically searched the MEDLINE, EMBASE, and CENTRAL databases from January 1985 to August 2018. Studies with the following characteristics were included: (i) RCT design; (ii) compared systemic (oral or intravenous) TXA for prevention or treatment of bleeding for non-surgical indications and placebo or no TXA, and (iii) reported thrombotic events or mortality. A Mantel-Haenzel, random-effects model was used to calculate risk ratios, and risk of bias was assessed using the Cochrane risk of bias tool. RESULTS: Our search identified 22 studies representing 49,538 patients. Those receiving TXA had a significantly lower risk of death from any cause (RR = 0.92; 95% CI = 0.87-0.98; I2 = 0%). There was no significant increase in the risk of stroke (RR = 1.10; 95% CI = 0.68-1.78; I2 = 31%), myocardial infarction (RR = 0.88; 95% CI = 0.43-1.84; I2 = 46%), pulmonary embolism (RR = 0.97; 95% CI = 0.75-1.26; I2 = 0%), or deep vein thrombosis (RR = 0.99; 95% CI = 0.70-1.41; I2 = 0%) from use of TXA. The results were similar when restricted to studies at low risk of bias. CONCLUSIONS: In our systematic review and meta-analysis, the use of tranexamic acid reduced all-cause mortality without increased risk of venous or arterial thrombotic complications.