Introduction: There is an evidence-practice gap between guidelines for diagnosing pulmonary embolism (PE) and emergency physician practice. Computed tomography (CT) scanning is being overused to exclude PE in Canadian emergency departments (EDs) and current guidelines do not fit well with the ED model of patient care. There is a lack of research on patient opinions on PE testing, and a poor physician understanding of patient-specific goals in the ED. We are addressing this by conducting patient interviews to identify patient-specific values and opinions on PE testing in the ED. These will be used to develop patient-centered educational tools which physicians and patients can use to discuss the decision to order a CT PE scan. The aim of this study is to identify patient expectations and priorities on PE testing in the ED. Methods: This qualitative study uses constructivist grounded theory to analyze patient values and opinions on PE testing in ED patients from two hospitals. Participants are screened by monitoring the ED patient tracker. If a patient is being tested for PE, they are approached and consented by a researcher to take part in a 30-minute semi-structured interview. Each interview is transcribed verbatim and independently analyzed by four researchers using constant comparative coding. The researchers meet weekly to compare codes and agree on common coding terms. The codes are grouped into themes, and the interview script is modified to maximize information on emerging themes. From this, major themes with associated subthemes will be derived, each representing an opportunity, barrier or value which must be addressed in our new patient education tools. We have performed 23 interviews and expect to reach theme saturation at 30 interviews. Full results will be available by the 2019 CAEP conference. Results: From the patient interviews conducted so far, we have mapped four major themes: patient satisfaction comes from addressing their primary concern (for example, their pain); patients expect individualized care; patients prefer imaging over clinical examination when testing for PE; and patients expect 100% confidence from their ED physician when given a diagnosis. Conclusion: These four domains will be used to create a new patient-centered approach to PE testing in the ED which will include physician education, patient information and organizational changes to patient processing. This study incorporates evidence-based medicine with ethical and social implications to improve patient outcomes.
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.
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