Publication/Presentation Date
7-25-2014
Abstract
Abstract
This study presents the data gathered from surveying 187 individuals and compares the answers to two questions using religion and education as qualifiers. Individual patients were surveyed at four different Family Practice clinics and completed surveys were collected and data was analyzed. The mean, median, and mode were taken for two questions regarding possible available information sources during clinical trials questions 2L3 and 2L6 (Appendix 1). Each question allowed survey takers to select from 0 to 4. Further statistical analysis was done to see possible differences in choice based on religion and level of education from questions 3P and 3S (Appendix 1).Religious choices were summarized into two possibilities as was level of education. Student t-tests were done to ascertain whether or not significant differences were present. For question 2L3 the mean was found to be 3.49, the median was found to be 3 and the mode was found to be 4. For question 2L6 the mean was found to be 2.75, the median was 3 and the mode was 4. The t-tests found that there were no significant differences between Christian and non-Christian and between having less than four years or college and four years of college or more.
The Influence of Education and Religion on the Perceived Benefit of Two Resources for Enrollment in Clinical Trials
Background
As innovations in medicine become more and more common, the practice of conducting clinical trials does as well. There is however an imbalance in said studies regarding the diversity of enrollees (Ciuliano et al. 2000). Women as well as those of a minority race often do not participate in clinical trials in correct numbers to accurately represent the population. These disparities result from influences they may stem from the patient or the provider. Many studies have been done regarding how race and gender factor into recruitment for trials (Noah, 2003; Murphy, Krumholz, & Gross, 2004; Coakley, Fadiran, Parrish, Griffith, Weiss, & Carter 2012). Often patients are afraid of trials and prefer not to take part. Doctors have been found to select preferentially for their trials as well. However, much less attention has been placed on other demographic factors such as education and religious belief. This is what the study incorporates in part; to understand what previously ignored factors may be truly important.
An important factor in whether or not patients are willing to participate in clinical trials is availability of resources. After experiments such as the Tuskegee Syphilis study, there are many people who approach clinical trials warily especially African Americans (Corbie-Smith et al. 1997). Having different forms of resources available affects whether or not some people are willing to enroll in a clinical trial. Possible resources include brochures, DVDs, support groups, and translated materials. Learning more about the procedures involved in clinical research increases knowledge and often promote enrollment in trials (Butler, 2007). The study includes two other resources; the availability of a former clinical trial enrollee and whether or not there is a medical interpreter. From this, further steps are taken to utilize the previously mentioned demographics and compare their choices.
Methodology
Surveys were handed out by summer research scholars at 4 locations, Bethlehem Family Medicine, Community Health and Wellness Center, Lehigh Valley Family Center, and Lehigh Family Medicine Associates. The surveys were available in both English and Spanish. Chinese surveys in both traditional and simplified were also created but none were yet collected. Patients 18 years of age and older were asked to participate in this survey that also served as consent. Eligible participants were limited to patients of the practices. This survey was purely voluntary, refusal was permitted and acceptance or refusal was documented. In total, 198 surveys were collected from the four locations. Omitting surveys with too multiple incomplete portions, 187 were used for analysis. The mean, median, and mode were found for the questions regarding contact with a former participant and availability of a medical interpreter. The data for the questions was then further analyzed based on answers to the questions regarding level of education and religious beliefs. T-tests were done after categorizing the education choices into reaching less than 4 years of college and reaching 4 or more years of college. The religious beliefs were grouped into the broad categories of Christianity and Other. The T tests were then applied to determine if any significant differences existed when comparing the answers to the questions by the two different groups.
Results
The mean, median, and mode for the results of the 2L3 regarding the benefit of having the opportunity to speak to a past enrollee and 2L6 regarding the benefit of having a medical interpreter are shown below in Table 1. Figure 1 and Figure 2, show the level of education and religious beliefs held by participants respectively.
Table 1 Mean, Median, and Mode for Two Questions
Question Number
Question
Mean
Median
Mode
2L3
Opportunity to speak to a patient who has participated in a clinical research study
3.25
3
4
2L6
Access to a medical interpreter throughout the study
2.75
3
4
Figure 1 Distribution of answers to question 3P from 187 answers
Figure 2 Distribution of answers to question 3S from 187 answers
When the answers were analyzed they were categorized into two answer groups, less than two indicating that the topic would be of no help, and two or greater which indicates that it would help. The number of patients who took the survey and answered question 2L3 (Appendix 1) in the categories are tabulated below in Table 2. The data was further analyzed and separated into those who had reached less than 4 years of college education (8th grade or less, some high school, high school graduate or GED, and some college or 2 year degree) and those who had reached at least 4 years of college education (4 year college graduate, more than a four year college degree, masters degree, professional degree, or doctoral degree). Similarly the data was also looked at in terms of choices of religion. The religious groups were categorized into Christian covering Catholic, Evangelical, Pentecostal, Jehovah's Witness, and Protestant or Other covering Buddhist, Hindu, Jewish, Muslim, non religious, and other religions.
Table 2 Answers to question 2L3 separated by category
Category
Education
Category
Religion
Answer
<2
>2
Answer
<2
>2
Did not reach four years of college
31
103
Christian
27
113
Had at least four years of college
6
47
Other Religion
10
37
Total
37
150
Total
37
150
Table 3 shows the results for question 2L6 (Appendix 1) analyzed in similar fashion to question 2L3.
Table 3 Answers to question 2L6 separated by category
Category
Education
Category
Religion
Answer
<2
>2
Answer
<2
>2
Did not reach four years of college
50
82
Christian
42
97
Had at least four years of college
18
37
Other Religion
16
22
Total
68
119
Total
37
150
Tabulated below in Table 4 are the results of a T-Test done on answers for question 2L3 chosen by those who had reached than 4 years of college education and those who had at least 4 years of college education. Whether or not there is significance between the two sets of data is shown below. Also included are the answers of those who are Christian or belong to the Other category evaluated in the same fashion. T-tests were unpaired, two tailed, with unequal variance, and utilized a 95 percent confidence value.
Table 4 T-Tests for comparison of answers for two different subcategories of two categories for question 2L3
Categories for comparison
T-Test p value
Significance
Categories for comparison
T-Test p value
Significance
Less than 4 years of college education
0.185
No significant difference
Christian
0.533
No significant difference
Had at least four years of college
Other Religion
Table 5 T-Tests for comparison of answers for two different subcategories of two categories for question 2L6
Categories for comparison
T-Test p value
Significance
Categories for comparison
T-Test p value
Significance
Less than 4 years of college education
0.746
No significant difference
Christian
0.599
No significant difference
Had at least four years of college
Other Religion
Conclusion
The results show that on average people feel that having the chance to meet a person who had taken part in a clinical trial would be more influential in helping them decide to take part in a clinical trial when compared with having the aid of a medical interpreter.
Though the study is limited to the population of the four clinics, the data shows that in general people feel more comfortable talking about the experience with someone who was inside the clinical research trial process than having someone trained to interpret the medical data. This depicts the distrust that still exists between the enrollee and the medical professionals. As mentioned before Tuskegee remains a firm memory, particularly in the minority population. Increasing the number of opportunities to interact with past enrollees would help increase recruitment numbers as the prospective participants become more confident and comfortable with clinical trials. While having a medical interpreter was ranked below meeting a past participant in ability to help decide patients to enroll in clinical trials, it was still rated as beneficial in helping decide whether or not to participate. Again, a deeper understanding of the trial fosters comfort and willingness to join. It should be noted that the majority of people chose 4 for both questions indicating that the resource in the inquiry would play a large part in helping the participant join a clinical trial. Furthermore, the T-Tests show that although they are considered factors in clinical trial enrollment, religious beliefs and education have no significant differences when comparing the answers found by separating each category into two different groups.
While this data seems to contradict the idea that these two factors are in fact influential to choosing whether or not a person will enroll, it must be taken into consideration that these two questions in general do not rely on religion or education. The acceptance or desire for information is not affected by what level your education is. While it is possible that religious beliefs may stop a person from taking part in a trial, unless their religion prohibited obtaining information it is unlikely that it will factor into a person’s opinion on what is helpful in convincing them of joining a trial. Similarly, a basic understanding of the trial is needed, which can be obtained with increased learning. However, it is also unlikely that a person’s level of education will influence whether or not they wish to obtain further information. While this particular sample did not show the influence of education level and religion, the willingness to enroll is very often affected.
A limitation to this study can be seen in the fact that only four clinics were selected to participate and were located in close vicinity to each other. While a total of 400 surveys were desired, the goal has not yet been reached thus limiting the population further. The limited population may have skewed the results as less opportunity was available for trends to become significant. Another limitation is that not all surveys were answered completely, further changing the results. The study looked at religion and education but missing answers from minority groups in both categories cause even less distinction to appear when analyzed using a T-test. Because this study is a subdivision of another broader study there are many parts that will be covered. Future research could add an additional question such as whether or not having a contract explicitly stating the processes that will occur will help participants decide to enroll. The contract would serve to hold the doctors to standards and allay issues that the patient may have towards possible deviations from what they had signed up for. Yet another opportunity for further research lies in location, specifically by increasing the number of clinics all over the United States from the east to west coast. The different areas with different populations to pull from would give a chance for any underlying trends to be seen.
References
Butler, K. L. (2007) African Americans’ participation in clinical research: importance, barriers,
and solutions. The American Journal of Surgery, 32-39.
Coakley, M., Fadiran, EO., Parrish, L.J., Griffith, R. A., Weiss, E., &Carter, C. (2012).
Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trial. Journal of Women’s Health, 21 (2), 713-716
Corbie-Smith, G., Thomas, S. B., Williams, M. V., & Moody-Ayers, S. (1999). Attitudes and
beliefs of african americans toward participation in medical research. Journal of General Internal Medicine, 14(9), 537-546.
Giuliano, A., MoKuau, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R., & McDCaskill-
Stevens, W. (2000). Participation of minorities in cancer research: the influence of structural, andlinguistic factors. Annals of Epidemiology, 10(8 Supply), S22-S34
Noah, B.A. (2003). The participation of underrepresented minorities in clinical research.
American Journal of Law & Medicine, 29:221-245
Murthy, V.H., Krumholz, H.M. & Gross, C..P. (2004) Participation in cancer clinical trials:
Race-, sex-, and age-based disparities. JAMA. 291 (22), 2720-2726
Appendix
PARTICIPANT INFORMED CONSENT, AUTHORIZATION AND SURVEY
Title of Study: Factors Influencing Participation in Clinical Research
Principal Investigator: Anita Kurt, PhD, RN
Address: Lehigh Valley Health Network
1240 South Cedar Crest Boulevard, Suite #212
Allentown, Pennsylvania 18103
Telephone: 610-402-7666
You are being asked to participate in a survey which will help us understand the factors that influence participation in clinical research (for example: doctors testing a new medication or device and collecting data to see whether the new medication or device is working).
If you are 18 years of age or older, you are eligible to take the survey. This survey is completely anonymous; in other words, any personal identifying information or your signature will not be collected. Also, your participation in this survey is completely voluntary; it is up to you to decide whether or not you want to participate.
Completing the survey should take no more than 8 to 10 minutes of your time. If you start the survey and change your mind about participating, you may stop at any time. If any of the questions make you uncomfortable, feel free to skip them.
This project is funded by the Anne and Carl Anderson Trust, a non-profit philanthropic trust. If you would like to discuss any issues, have complaints, and/or address concerns or questions, you may contact the Research Participant Protection Office at Lehigh Valley Health Network, 1255 South Cedar Crest Boulevard, Suite #3500, Allentown, Pennsylvania, 18103, telephone, 610-402-2760.
If you were asked to participate before and completed this survey at another location, please do not fill out another survey. If you wish to know the results of this survey after the data are analyzed (likely by the end of 2016), please call Anita Kurt, PhD, Principal Investigator, at 610-402-7666.
Please take this page with you for future inquiries.
Thank you for taking the time to complete this survey
Section 1: General questions about your health and previous participation in clinical research studies:
Are you here today as a patient?
A1. Yes
A2. No
In general, compared to other people your age, how would you rate your overall health?
Excellent
Very Good
Good
Fair
Poor
About how often would you say you make decisions about obtaining the medical care you need (as opposed to someone else making the decision for you)?
All of the time
Most of the time
Some of the time
Rarely
Never
Have you ever participated in a clinical research study (a study where a doctor tests a new medication or device to see how it improves your health)?
Yes
No
Which family member would play the MOST important role in deciding whether another member of your family can participate in a clinical research study? (Please select one)
My mother
My father
My spouse or significant other
My brother
My sister
Other; please specify_______
How many clinical research studies have you participated in within the last FIVE years?
F1. None
F2. One
F3. More than one
Please list the health condition that was the focus of the MOST RECENT study you participated in.
G1. ____________
G2. ___ I did not participate in any.
Using any number from 0 to 10, where 0 was the worst experience possible and 10 was the best experience possible what number would you use to rate the MOST RECENT study you participated in?
H1. ______________
H2. _____ I did not participate in any.
Some studies are able to offer participants money to participate. Would you prefer to participate if you are paid?
I1. Yes
I2. No
I3. Does not matter
Section 2: Factors that relate to participating in clinical research studies:
What factors would motivate you to participate in a clinical research study? Please rate the following from NO MOTIVATION (0) to MOST (4) motivating factor.
Motivating factors
0
1
2
3
4
My relationship with my doctor
0
1
2
3
4
Doctor’s reputation in the community
0
1
2
3
4
How well the research study is explained to me
0
1
2
3
4
My desire to please the doctor
0
1
2
3
4
Money offered for my participation
0
1
2
3
4
A friend or family member participating in the same study
0
1
2
3
4
The doctor conducting the research is the same gender (sex) as me
0
1
2
3
4
The doctor conducting the research is the same race/ethnicity as me
0
1
2
3
4
The doctor conducting the research speaks the same language as I do
0
1
2
3
4
Knowledge learned from my participation will benefit someone in the future
0
1
2
3
4
What factors would prevent you from participating in a clinical research study? Please rate the following from NO BARRIER (0) to GREATEST (4) barrier.
Potential barriers
0
1
2
3
4
My distrust in doctors
0
1
2
3
4
Time commitment
0
1
2
3
4
My family’s concern
0
1
2
3
4
My religious beliefs
0
1
2
3
4
Clinical research studies are too hard to understand
0
1
2
3
4
Study related phone calls for follow-ups
0
1
2
3
4
Multiple follow-up visits related to the study
0
1
2
3
4
Risk of unknown side effects
0
1
2
3
4
Access to transportation
0
1
2
3
4
What would help you decide whether to or not to participate in a clinical research study? Please rate the following from NO HELP (0) to MOST (4) helpful resource.
Helpful Resources
0
1
2
3
4
Written material explaining the research study
0
1
2
3
4
DVDs or electronic material explaining the research study
0
1
2
3
4
Having opportunity to speak to a patient who has participated in a clinical research study
0
1
2
3
4
Having access to a support group of patients who have participated in clinical research
0
1
2
3
4
Having all material provided in my own language
0
1
2
3
4
Having access to a medical interpreter throughout the study
0
1
2
3
4
Section 3: Information about you:
What is your age?
M1. 18-24
M2. 25 to 34
M3. 35 to 44
M4. 45 to 54
M5. 55 to 64
M6. 65 to 74
M7 75 or older
What is your gender? _____Male ______Female
Do you have any children? _______Yes _______No
What is the highest grade or level of school you completed?
8th grade or less
Some high school, but did not graduate
High school graduate or GED
Some college or 2 year degree
4 year college graduate
More than a 4 year college degree
Masters degree (for example, MA, MS, MSN, MEng, Med, MBA)
Professional degree (for example, RN, MSW, MD, DDS, DVN, LLB, JD)
Doctoral Degree (for example,Ph.D, EdD, DSW, DNP)
Are you of Hispanic or Latino origin or descent?
Yes
No
What is your race (circle all that apply)?
White or Caucasian
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaska Native
Other: Please specify: ______________
What is your religious preference?
Buddhist
Catholic
Christian
Evangelical/Pentecostal
Hindu
Jehovah’s Witness
Jewish
Muslim
Not religious/None
S10. Protestant
S11. Other; please specify: __________
What language do you speak at home?
T1.English_____________
T2.Spanish
T3. Other: please specify: ___________________
How well do you speak and understand English?
Very well
Pretty good
Can understand English, but have a hard time speaking it
Cannot speak English
What category best describes your CURRENT employment status.
Employed Full-Time
Employed Part-Time
Unemployed and looking for work
Unemployed but not looking for work
Student
Retired
Other; please specify: _____________
If you said you are employed, what category best describes the industry you work in?
Not applicable (I am either unemployed or retired)
Military.
Education.
Transportation.
finance/banking
Service industry (for example, food services, retail, sales).
Health care/science.
Construction.
W9. I work in another industry (please list here :_____________________________)
What category best describes your TOTAL income in 2013?
Less than $30,000
$30,001-$50,000
$50,001-$75,000
$75,001-$100,000
$100,001 or more
I‘d rather not answer.
Thank you!!
Published In/Presented At
Chang, J., (2014, July, 25) The Influence of Education and Religion on the Perceived Benefit of Two Resources for Enrollment in Clinical Trials. Poster presented at LVHN Research Scholar Program Poster Session, Lehigh Valley Health Network, Allentown, PA.
Department(s)
Research Scholars, Research Scholars - Posters
Document Type
Poster
Comments
Mentor: Anita Kurt PhD, RN