Impact of Race Versus Education and Race Versus Income on Patients' Motivation to Participate in Clinical Trials.

Our study investigates whether levels of motivation and barriers to participation in clinical trials vary with patients' education and income. A self-administered survey asked outpatients to rank potential influential factors on a "0" to "4" significance scale for their motivation to participate in clinical trials. Principal component analysis (PCA), analysis of variance (ANOVA), Kruskal-Wallis, and Mann-Whitney U tests analyzed the impact of race, education, and income on their motivation to participate. Analysis included 1841 surveys; most respondents had a high school education or some college, and listed annual income < $30,000. There was a significant interaction between race and income on our motivation scale 1 scores (p = .0261). Compared with their counterparts, subjects with less education/lower income ranked monetary compensation (p = .0420 and p < .0001, respectively) as a higher motivator. Minorities and patients with less education and lower income appear to be more influenced by their desire to please the doctor, the race and sex of the doctor, and the language spoken by the doctor being the same as theirs. For all races, education appeared to have a direct relationship with motivation to participate, except for African-Americans, whose motivation appeared to decline with more education. Income appeared to have an inverse relationship with motivation to participate for all races.

Factors Influencing Participation in Clinical Trials: Emergency Medicine vs. Other Specialties.

INTRODUCTION: This study investigated factors that influence emergency medicine (EM) patients' decisions to participate in clinical trials and whether the impact of these factors differs from those of other medical specialties. METHODS: A survey was distributed in EM, family medicine (FM), infectious disease (ID), and obstetrics/gynecology (OB/GYN) outpatient waiting areas. Eligibility criteria included those who were 18 years of age or older, active patients on the day of the survey, and able to complete the survey without assistance. We used the Kruskal-Wallis test and ordinal logistic regression analyses to identify differences in participants' responses. RESULTS: A total of 2,893 eligible subjects were approached, and we included 1,841 surveys in the final analysis. Statistically significant differences (p≤0.009) were found for eight of the ten motivating factors between EM and one or more of the other specialties. Regardless of a patient's gender, race, and education, the relationship with their doctor was more motivating to patients seen in other specialties than to EM patients (FM [odds ratio {OR}:1.752, 95% confidence interval {CI}{1.285-2.389}], ID [OR:3.281, 95% CI{2.293-4.695}], and OB/GYN [OR:2.408, 95% CI{1.741-3.330}]). EM's rankings of "how well the research was explained" and whether "the knowledge learned would benefit others" as their top two motivating factors were similar across other specialties. All nine barriers showed statistically significant differences (p≤0.008) between EM and one or more other specialties. Participants from all specialties indicated "risk of unknown side effects" as their strongest barrier. Regardless of the patients' race, "time commitment" was considered to be more of a barrier to other specialties when compared to EM (FM [OR:1.613, 95% CI{1.218-2.136}], ID [OR:1.340, 95% CI{1.006-1.784}], or OB/GYN [OR:1.901, 95% CI{1.431-2.526}]). Among the six resources assessed that help patients decide whether to participate in a clinical trial, only one scored statistically significantly different for EM (p<0.001). EM patients ranked "having all material provided in my own language" as the most helpful resource. CONCLUSION: There are significant differences between EM patients and those of other specialties in the factors that influence their participation in clinical trials. Providing material in the patient's own language, explaining the study well, and elucidating how their participation might benefit others in the future may help to improve enrollment in EM-based clinical trials.

Gender Differences in CDC Guideline Compliance for STIs in Emergency Departments.

INTRODUCTION: Sexually transmitted infections (STIs) are a common reason for emergency department (ED) visits. The objective of this study was to determine if there were gender differences in adherence to Centers for Disease Control and Prevention (CDC) STI diagnosis and treatment guidelines, as documented by emergency providers. METHODS: We performed a retrospective chart review to identify patients treated for urethritis, cervicitis, and pelvic inflammatory disease (PID) in the EDs of three hospitals in a Pennsylvania network during a calendar year. Cases were reviewed to assess for compliance with CDC guidelines. We used descriptive statistics to assess the distributions of study variables by patient sex. In the analysis we used Student's t-tests, chi-square tests, and logistic regression. Statistical significance was set at p ≤ 0.05. RESULTS: We identified 286 patient records. Of these, we excluded 39 for the following reasons: incorrect disease coding; the patient was admitted and treated as an inpatient for his/her disease; or the patient left the ED after refusing care. Of the 247 participants, 159 (64.4%) were female. Females were significantly younger (26.6 years, SD=8.0) than males (31.2, SD=11.5%), (95% confidence interval [CI] [2.0- 7.0], p=0.0003). All of the males (n=88) in the cohort presented with urethritis; 25.8% of females presented with cervicitis, and 74.2% with PID. Physician compliance for the five CDC criteria ranged from 68.8% for patient history to 93.5% for patient diagnostic testing, including urine pregnancy and gonorrhea/chlamydia cultures. We observed significant differences by patient sex. Fifty-four percent of the charts had symptoms recorded for female patients that were consistent with CDC characteristics for diagnostic criteria compared to over 95% for males, OR=16.9; 95% CI [5.9-48.4], p<0.001. Similar results were observed for patient discharge instructions, with physicians completely documenting delivery of discharge instructions to 51.6% of females compared to 97.7% of complete documentation in males, OR=42.3; 95% CI [10.0-178.6] p<0.001). We observed no significant sex differences in physician documentation for physical exam or for therapeutic antibiotic treatment. CONCLUSION: This retrospective study found patient gender differences in how emergency providers complied with documenting with regard to the 2010 CDC guidelines for the diagnosis and treatment of urethritis, cervicitis, and PID. Specifically medical records of men were more likely to have complete documentation of symptoms recorded (95% CI 5.9-48.4) and to have discharge instruction documentation (95% CI 10.0-178.6) than records of women.

Research Professionals' Perspectives, Barriers, and Recommendations Regarding Minority Participation in Clinical Trials.

OBJECTIVE: This study aims to investigate research professionals' perspectives regarding minority participation in clinical trials. METHODS: A web-based survey of research professionals at US institutions receiving NIH and/or AHRQ funding to conduct clinical research in 2013. Descriptive statistics, mean, standard deviation (SD), and the Wilcoxon rank-sum test were utilized for analysis. RESULTS: Distributed were 13,041 surveys with 967 (7.4%) responses. Overall and race-stratified analyses included 633 and 521 surveys, respectively. A majority agreed that patients' race (mean, 3.4; SD = 1.0) and primary language (mean, 4.0; SD = 0.9) have an effect on enrollment. They had more success in enrolling those whose primary language was the same as their own (mean, 3.8; SD = 1.0), and that a language barrier and time spent arranging for interpreters had prevented them from offering a study to potential candidates (mean, 3.2; SD = 1.2). Non-Caucasian respondents were more likely to agree that "fear of unknown side effects" was a deterrent for minorities (p < 0.01), "minorities are more likely to be unavailable for follow-up phone calls" (p = 0.07), and "the unavailability of translated material discourages non-English speakers from participation" (p = 0.08). They also were more likely to be neutral or agree with being discouraged from enrolling minorities because of the possibility of their withdrawal or being less likely to be available for phone follow-ups and follow-up visits (all p < 0.01). CONCLUSION: Despite a few subtle racial differences in research professionals' perspectives, a majority expressed no hesitation in enrolling minorities. Patients' race and primary language appeared to influence enrollment. A language barrier appeared to be the strongest barrier for research professionals.

Racial Differences Among Factors Associated with Participation in Clinical Research Trials.

OBJECTIVE: To identify whether racial differences exist among various factors associated with patients' decision to participate in clinical research trials. METHODS: A self-administered, IRB-approved survey was utilized with inclusion criteria requiring subjects to be 18 years of age or older, having active patient status and ability to complete the survey without assistance. Subjects were asked to rate potential influential motivators, barriers, and facilitators on a "no influence" (0) to "most influence" (4) scale for participation in research that tests a new drug or device. Kruskal-Wallis testing was used to identify factors significantly associated with race. RESULTS: Analysis included 1643 surveys: 949 (57.8 %) Caucasian; 217 (13.2 %) African-American; 317 (19.3 %) Hispanic; 62 (3.8 %) Multiracial; and 98 (6.0 %) "Other" minorities. Statistically significant differences (p ≤ .02) by race were found for five out of ten motivating factors. "How well the research study is explained to me" had the highest mean value for all races except other minorities, for whom "Knowledge learned from my participation will benefit someone in the future" scored highest. "Risk of unknown side-effects" was the greatest barrier for all races. CONCLUSION: Racial differences exist not only between Caucasians and Minorities for the factors associated with their clinical trial participation, but also among different minority races themselves. To promote diversity in research, recruitment strategies for each individual race should be customized based on what matters to the target population.

A Cross-Sectional Study of Medical Student Knowledge of Evidence-Based Medicine as Measured by the Fresno Test of Evidence-Based Medicine.

BACKGROUND: Evidence-based medicine (EBM) has been included in the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Emergency Medicine (ABEM) milestones project as a required component during emergency medicine (EM) residency training. Milestone Level One states that graduating medical students must be able to "describe basic principles of EBM." OBJECTIVE: We sought to identify the EBM skills of third- and fourth-year medical students. METHODS: Our institution, a network with 17 different residencies, hosts U.S. osteopathic and allopathic medical students. As a part of orientation, students are required to complete an entry Fresno Test of EBM (FTEBM). Retrospectively, medical student FTEBM scores from 2011 were assessed using descriptive statistics. RESULTS: Four hundred seventeen FTEBM scores were analyzed. Participants represented 40 medical schools, including 17 allopathic (MD) and 23 osteopathic (DO) schools. Fifty percent of participants (n = 210) were female, and 51.6% (n = 215) were from a DO medical school. Overall mean performance for the FTEBM was 47.2%. Exploring the results by individual question were (individual EBM question topics are in parentheses): 1A (study question), 62.0%; 1B (study question), 64.4%: 2 (sources of evidence), 67.6%; 3 (study design), 57.1%; 4 (search strategies), 53.2%; 5 (relevance), 41.2%; 6 (internal validity), 43.6%; 7 (magnitude), 37.8%; 8 (two-by-two grids), 30.0%; 9 (number needed to treat), 16.9%; 10 (confidence intervals), 34.3%; 11 (diagnosis), 5.0%; and 12 (prognosis), 43.4%. CONCLUSIONS: As measured by the FTEBM, senior medical students demonstrate understanding of about half of EBM. EM residencies can anticipate the need to instruct their residents in EBM concepts in order to meet ACGME/ABEM milestone requirements.