IN HER OWN WORDS: BARRIERS TO ENROLLMENT INTO SURGICAL TRIALS BY SOCIALLY DISADVANTAGED WOMEN: A PRELIMINARY STUDY
H. AKINGBA1, S. ROSE 2, K. ROARK 3;
1Urogynecology, Wayne State, Detroit, MI, 2OB/GYN, IUPUI, Indianapolis, IN, 3Sociology, Purdue Univ., Lafayette, IN.
Introduction: In the United States, many clinical trials lack ethnic and gender diversity. There are no questionnaires available that measure the barriers preventing under-represented women with pelvic floor dysfunction from enrolling into clinical trials.
Objective: The primary aim of this survey was to identify the barriers that prevent under-represented women from enrolling into clinical trials. We hypothesized that the women themselves would know better than researchers which barriers have the strongest negative impact on their enrollment.
Methods: We used a mixed-methods research methodology to interview our participants. Nineteen women identified with pelvic organ prolapse completed a 55 question survey during a one-hour cognitive interview. The interviews utilized think out-loud and verbal probing to explore concepts, to clarify questions, and increase the accuracy of answers. The interviews were analyzed using in vivo and interviewer interpretive coding to identify themes in responses. Behavioral coding was utilized to analyze the responses and to modify the survey.
Results: Our participants were 40% Caucasian, 25% African-American, 30% Hispanic, and 5% Asian women. Eighty-five percent of participants existed below the poverty line with an average household income less than $25,000 per year. The average number of school years attended was 10.5 grades. All of the women had symptomatic pelvic organ prolapse with an average POP-Q score of 2.6. Some of the identified barriers that the women identified are trust, prior poor experience with clinical research, resistance to randomization, fear of blinding, socio-economic pressures to extended follow-up, and lack of understanding of basic principles of research such as controlling for bias. The women were also able to identify positive influences to clinical trial enrollment. Those influences included altruism, relatability to the concept being studied and curiosity about the subject matter. This study did not reach saturation with low-literacy Spanish-speaking only women due to the low number of participants (three).
Conclusions: The study confirmed our hypothesis that underrepresented women are able to recognize their own barriers to clinical trial enrollment. They also identified positive influences for clinical trial enrollment. We feel this is an important start point from which to validate our survey instrument which we hope to utilize in screening potential study candidates who might need extra help with overcoming the barriers to trial enrollment. The Spanish version of the instrument was not fully saturated and will require further interviews to clarify the barriers low-literacy, immigrant women face.
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