Abstract
Research participation by patients is critical to the improvement of medical care. Prior work has suggested that treatment for pain may influence patient participation in research, although this has not been studied in a rigorous quantitative way. We hypothesized that receiving prior treatment for pain would not independently increase the participation rate for patients approached for cardiac biomarker research studies. DESIGN-Retrospective observational cohort study. SETTING–academic urban tertiary care emergency department (ED) with annual census of approximately 70,000 visits. PARTICIPANTS–Patients who were approached for enrollment into 1 of 2 IRB approved, cardiac biomarker research studies between 12/2010 and 11/2011. To be eligible, patients had to be 18 years of age, present with chief complaint of chest pain, and have experienced chest pain within 12 hours of presentation. Trained clinical research coordinators approached eligible patients from 8 am-10 pm on weekdays with intermittent sampling on weekends. OBSERVATIONS–Pain treatment data was abstracted from electronic medical records by a single reviewer who was blinded to study hypothesis. Patient demographics and participation outcomes were recorded from a research screening log. DATA ANALYSIS-Simple descriptive statistics were calculated and a multivariate logistic regression model was created with participation as outcome, pain treatment as a binary predictor variable, and age, race, gender, and self-reported pain score as confounding variables. All analyses were performed using JMP (Version 9.0, SAS Institute, Cary, NC).A total of 396 patients were approached, with 3 excluded patients for missing data. Median age was 55 years, 39.2% Black, and 50.1 % male. Eighty percent of patients participated in the research studies. A total of 67.3% of patients had been provided pain treatment prior to approach; only 10% of those patients received opiates. Treated patients had an 80.8% participation rate versus 78.3% for those not receiving treatment. After adjusting for confounding variables, treated patients had odds ratio of 1.14 (95%CI 0.66-1.94) of participating.Treatment for pain does not seem to affect participation ED research studies. This study is limited by being restricted to one type of pain and research study. Other factors that do influence participation should be explored.
Highlights
Each year, almost 6 million people present to emergency departments (ED) with chest pain.[1]
396 patients were approached to participate in the two cardiac biomarker studies
There have been no evidence-based methods proposed for increasing the likelihood of patient participation
Summary
Almost 6 million people present to emergency departments (ED) with chest pain.[1]. Advances in ACS diagnostics are dependent on the willingness of chest pain patients to participate in research. In previous qualitative studies patients cited pain in general as a reason for refusal of research participation.[5, 6] Pain has been cited as a cause of a compromised informed consent process by interfering with patients’ ability to understand what is involved in participating in research.[7, 8] It is possible that prior studies in patients with chest pain may have been systematically biased. If level of pain influences participation, it would suggest that addressing a patient’s pain prior to approaching them for research would improve enrollment rates for research studies. No prior study has quantitatively explored the relationship between pain treatment and research study refusal rates in a sample of ED patients
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