Background: Despite efforts to increase diversity in clinical trials, racial/ethnic minority grou... more Background: Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. Methods: The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan.
Background: Few research studies with non-English-Speaking audiences have been conducted to explo... more Background: Few research studies with non-English-Speaking audiences have been conducted to explore community members’ views on biospecimen donation and banking, and no validated Spanish-language multi-scale instruments exist to measure community perspectives on biobanking. This study describes the development and psychometric properties of the Biobanking Attitudes aNd Knowledge Survey-Spanish (BANKS-SP). Methods: The BANKS was translated into Spanish using the Brislin method of translation. Draft BANKS-SP items were refined through cognitive interviews, and psychometric properties were assessed in a sample of 85 Spanish-speaking individuals recruited at various community events in a three county area in Central West Florida, USA. Results: The final BANKS-SP includes 3 scales: Attitudes, Knowledge, and Self-Efficacy; as well as 3 single items, which evaluated receptivity and intention to donate a biospecimen for research. The final Cronbach’s alpha coefficients for the two scales that use Likert response format indicated adequate internal consistency (Attitudes: α=.79; Self-Efficacy: α=.91). Intention to donate blood and intention to donate urine were positively correlated with attitudes, self-efficacy, and receptivity to learning more about biobanking (all p’s <.001). BANKS-SP-Knowledge was not statistically significantly correlated with other BANKS-SP scales or single items measuring intention to donate a biospecimen for research and receptivity for learning more about biospecimen research. Conclusions: The BANKS-SP Attitudes and Self-Efficacy scales show evidence of satisfactory reliability and validity. Additional research should be conducted with larger samples to assess the BANKS-SP instrument’s reliability and validity. A valid and reliable Spanish-language instrument measuring Spanish-speaking community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation among this population.
Journal of Empirical Research on Human Research Ethics, 2016
This study developed and validated the Biomedical Research Trust Scale (BRTS), a 10-item measure ... more This study developed and validated the Biomedical Research Trust Scale (BRTS), a 10-item measure of global trust in biomedical research, in English and Spanish (BRTS-SP). Eighty-five English- and 85 Spanish-speaking participants completed the BRTS or BRTS-SP, as well as measures of biobanking attitudes, self-efficacy, receptivity, and intentions to donate blood or urine. Results indicated the BRTS and BRTS-SP showed adequate internal consistency in both English and Spanish. Additionally, greater levels of trust in biomedical research were significantly associated with greater self-efficacy, receptivity, attitudes, and intentions to donate blood and urine in English-speaking participants, and self-efficacy and intention to donate urine in Spanish-speaking participants. These results support the use of the BRTS and BRTS-SP among English- and Spanish-speaking community members.
Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; h... more Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128) stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1) knowledge and understanding of clinical trials, 2) fears and concerns about participating, 3) perceived benefits of participating, and 4) incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.
Background: This article describes community-engaged processes employed by two Community Network ... more Background: This article describes community-engaged processes employed by two Community Network Program Center (CNPC) sites located in Tampa, Florida, and Buffalo, New York, toward the development of Spanish/English educational products about biobanking and biospecimen research.
Methods: Each CNPC carried out a community-based participatory research (CBPR) approach that underscored six essential components that moved concepts to a final educational product in a highly participatory fashion. The similar CBPR processes at the two locations focused on the same topic, resulted in different engagement approaches and tools for their respective communities: 1) DVD and brochure toolkit and 2) PowerPoint, group program with audience response system (ARS).
Results: We detail a comparison of methods and applications for using these tools among diverse community groups to advance understandings about genetic and biomedical research technologies.
Conclusion: Ultimately, these tools and associated educational efforts emphasize the critical value of co-learning among academic and community members in biobanking and biospecimen research.
This paper recounts experiences, challenges, and lessons learned when implementing a lay patient ... more This paper recounts experiences, challenges, and lessons learned when implementing a lay patient navigator program to improve cancer care among medically underserved patients who presented in a primary care clinic with a breast or colorectal cancer abnormality. The program employed five lay navigators to navigate 588 patients. Central programmatic elements were the following: (1) use of bilingual lay navigators with familiarity of communities they served; (2) provision of training, education, and supportive activities; (3) multidisciplinary clinical oversight that factored in caseload intensity; and (4) well-developed partnerships with community clinics and social service entities. Deconstruction of healthcare system information was fundamental to navigation processes. We conclude that a lay model of navigation is well suited to assist patients through complex healthcare systems; however, a stepped care model that includes both lay and professional navigation may be optimal to help patients across the entire continuum.
Background: No validated multiscale instruments exist that measure community members’ views on bi... more Background: No validated multiscale instruments exist that measure community members’ views on biobanking and biospecimen donation. This study describes the development and psychometric properties of the English-language BANKS (Biobanking Attitudes and Knowledge Survey).
Methods: The BANKS was created by item generation through review of scientific literature, focus groups with community members, and input from a community advisory board. Items were refined through cognitive interviews. Content validity was assessed through an expert panel review. Psychometric properties of the BANKS were assessed in a sample of 85 community members.
Results: The final BANKS includes three scales: attitudes, knowledge, and self-efficacy; as well as three single items, which evaluated receptivity and intention to donate a biospecimen for research. Cronbach a coefficients for two scales that use Likert response format indicated high internal consistency (attitudes: a, 0.88; self-efficacy: a, 0.95). Content validity indices were moderate, ranging from 0.69 to 0.89. Intention to donate blood and intention to donate urine were positively correlated with attitudes, knowledge, self-efficacy, and receptivity to learning more about biobanking (P values range from 0.029 to <0.001).
Conclusions: The final BANKS shows evidence of satisfactory reliability and validity, is easy to administer, and is a promising tool to inform biospecimen research. Additional studies should be conducted with larger samples considering biospecimen donation to further assess the reliability and validity of the instrument.
Impact: A valid and reliable instrument measuring community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation. A Spanish-language BANKS is under development.
Preparing healthy community members with timely communications prior to engaging them in a reques... more Preparing healthy community members with timely communications prior to engaging them in a request to donate biospecimens promises to improve the experience of biobanking participation. To this end, a qualitative study was conducted to assess community member knowledge, attitudes, beliefs, and informational needs about cancer-related biospecimen collection in a large metropolitan area in southwest Florida. The study utilized purposive sampling techniques to recruit a total of 95 participants to participate in 12 focus groups, segmented by race/ethnicity and language preference (mixed race, African American only, and Spanish speaking) and age (18–29, 30–54, and 55 and older). Focus group interviews were analyzed using content analysis to identify emergent themes. Overall, participants in the 30 years and older groups were favorable toward participating in biobanking if their concerns were addressed, such as confidentiality and consent issues, in contrast to participants aged 18–29 who were more skeptical. For all participants, the desire to participate in research that seeks new cancer treatments outweighed mistrust. Moreover, many cited the potential scientific benefit for future generations as a primary motivator. Finally, in some groups a therapeutic misconception was expressed, where participants expressed a willingness to forego confidentiality of their health status in exchange for therapeutic benefit. This study contributes to the literature on community perceptions of the benefits and barriers of biobanking and adds to the development of meaningful education communication priming tools to advance understandings about biobanking.
Background: Despite efforts to increase diversity in clinical trials, racial/ethnic minority grou... more Background: Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. Methods: The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan.
Background: Few research studies with non-English-Speaking audiences have been conducted to explo... more Background: Few research studies with non-English-Speaking audiences have been conducted to explore community members’ views on biospecimen donation and banking, and no validated Spanish-language multi-scale instruments exist to measure community perspectives on biobanking. This study describes the development and psychometric properties of the Biobanking Attitudes aNd Knowledge Survey-Spanish (BANKS-SP). Methods: The BANKS was translated into Spanish using the Brislin method of translation. Draft BANKS-SP items were refined through cognitive interviews, and psychometric properties were assessed in a sample of 85 Spanish-speaking individuals recruited at various community events in a three county area in Central West Florida, USA. Results: The final BANKS-SP includes 3 scales: Attitudes, Knowledge, and Self-Efficacy; as well as 3 single items, which evaluated receptivity and intention to donate a biospecimen for research. The final Cronbach’s alpha coefficients for the two scales that use Likert response format indicated adequate internal consistency (Attitudes: α=.79; Self-Efficacy: α=.91). Intention to donate blood and intention to donate urine were positively correlated with attitudes, self-efficacy, and receptivity to learning more about biobanking (all p’s <.001). BANKS-SP-Knowledge was not statistically significantly correlated with other BANKS-SP scales or single items measuring intention to donate a biospecimen for research and receptivity for learning more about biospecimen research. Conclusions: The BANKS-SP Attitudes and Self-Efficacy scales show evidence of satisfactory reliability and validity. Additional research should be conducted with larger samples to assess the BANKS-SP instrument’s reliability and validity. A valid and reliable Spanish-language instrument measuring Spanish-speaking community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation among this population.
Journal of Empirical Research on Human Research Ethics, 2016
This study developed and validated the Biomedical Research Trust Scale (BRTS), a 10-item measure ... more This study developed and validated the Biomedical Research Trust Scale (BRTS), a 10-item measure of global trust in biomedical research, in English and Spanish (BRTS-SP). Eighty-five English- and 85 Spanish-speaking participants completed the BRTS or BRTS-SP, as well as measures of biobanking attitudes, self-efficacy, receptivity, and intentions to donate blood or urine. Results indicated the BRTS and BRTS-SP showed adequate internal consistency in both English and Spanish. Additionally, greater levels of trust in biomedical research were significantly associated with greater self-efficacy, receptivity, attitudes, and intentions to donate blood and urine in English-speaking participants, and self-efficacy and intention to donate urine in Spanish-speaking participants. These results support the use of the BRTS and BRTS-SP among English- and Spanish-speaking community members.
Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; h... more Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128) stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1) knowledge and understanding of clinical trials, 2) fears and concerns about participating, 3) perceived benefits of participating, and 4) incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.
Background: This article describes community-engaged processes employed by two Community Network ... more Background: This article describes community-engaged processes employed by two Community Network Program Center (CNPC) sites located in Tampa, Florida, and Buffalo, New York, toward the development of Spanish/English educational products about biobanking and biospecimen research.
Methods: Each CNPC carried out a community-based participatory research (CBPR) approach that underscored six essential components that moved concepts to a final educational product in a highly participatory fashion. The similar CBPR processes at the two locations focused on the same topic, resulted in different engagement approaches and tools for their respective communities: 1) DVD and brochure toolkit and 2) PowerPoint, group program with audience response system (ARS).
Results: We detail a comparison of methods and applications for using these tools among diverse community groups to advance understandings about genetic and biomedical research technologies.
Conclusion: Ultimately, these tools and associated educational efforts emphasize the critical value of co-learning among academic and community members in biobanking and biospecimen research.
This paper recounts experiences, challenges, and lessons learned when implementing a lay patient ... more This paper recounts experiences, challenges, and lessons learned when implementing a lay patient navigator program to improve cancer care among medically underserved patients who presented in a primary care clinic with a breast or colorectal cancer abnormality. The program employed five lay navigators to navigate 588 patients. Central programmatic elements were the following: (1) use of bilingual lay navigators with familiarity of communities they served; (2) provision of training, education, and supportive activities; (3) multidisciplinary clinical oversight that factored in caseload intensity; and (4) well-developed partnerships with community clinics and social service entities. Deconstruction of healthcare system information was fundamental to navigation processes. We conclude that a lay model of navigation is well suited to assist patients through complex healthcare systems; however, a stepped care model that includes both lay and professional navigation may be optimal to help patients across the entire continuum.
Background: No validated multiscale instruments exist that measure community members’ views on bi... more Background: No validated multiscale instruments exist that measure community members’ views on biobanking and biospecimen donation. This study describes the development and psychometric properties of the English-language BANKS (Biobanking Attitudes and Knowledge Survey).
Methods: The BANKS was created by item generation through review of scientific literature, focus groups with community members, and input from a community advisory board. Items were refined through cognitive interviews. Content validity was assessed through an expert panel review. Psychometric properties of the BANKS were assessed in a sample of 85 community members.
Results: The final BANKS includes three scales: attitudes, knowledge, and self-efficacy; as well as three single items, which evaluated receptivity and intention to donate a biospecimen for research. Cronbach a coefficients for two scales that use Likert response format indicated high internal consistency (attitudes: a, 0.88; self-efficacy: a, 0.95). Content validity indices were moderate, ranging from 0.69 to 0.89. Intention to donate blood and intention to donate urine were positively correlated with attitudes, knowledge, self-efficacy, and receptivity to learning more about biobanking (P values range from 0.029 to <0.001).
Conclusions: The final BANKS shows evidence of satisfactory reliability and validity, is easy to administer, and is a promising tool to inform biospecimen research. Additional studies should be conducted with larger samples considering biospecimen donation to further assess the reliability and validity of the instrument.
Impact: A valid and reliable instrument measuring community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation. A Spanish-language BANKS is under development.
Preparing healthy community members with timely communications prior to engaging them in a reques... more Preparing healthy community members with timely communications prior to engaging them in a request to donate biospecimens promises to improve the experience of biobanking participation. To this end, a qualitative study was conducted to assess community member knowledge, attitudes, beliefs, and informational needs about cancer-related biospecimen collection in a large metropolitan area in southwest Florida. The study utilized purposive sampling techniques to recruit a total of 95 participants to participate in 12 focus groups, segmented by race/ethnicity and language preference (mixed race, African American only, and Spanish speaking) and age (18–29, 30–54, and 55 and older). Focus group interviews were analyzed using content analysis to identify emergent themes. Overall, participants in the 30 years and older groups were favorable toward participating in biobanking if their concerns were addressed, such as confidentiality and consent issues, in contrast to participants aged 18–29 who were more skeptical. For all participants, the desire to participate in research that seeks new cancer treatments outweighed mistrust. Moreover, many cited the potential scientific benefit for future generations as a primary motivator. Finally, in some groups a therapeutic misconception was expressed, where participants expressed a willingness to forego confidentiality of their health status in exchange for therapeutic benefit. This study contributes to the literature on community perceptions of the benefits and barriers of biobanking and adds to the development of meaningful education communication priming tools to advance understandings about biobanking.
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Papers by Mariana Arevalo
Methods: The BANKS was translated into Spanish using the Brislin method of translation. Draft BANKS-SP items were refined through cognitive interviews, and psychometric properties were assessed in a sample of 85 Spanish-speaking individuals recruited at various community events in a three county area in Central West Florida, USA.
Results: The final BANKS-SP includes 3 scales: Attitudes, Knowledge, and Self-Efficacy; as well as 3 single items, which evaluated receptivity and intention to donate a biospecimen for research. The final Cronbach’s alpha coefficients for the two scales that use Likert response format indicated adequate internal consistency (Attitudes: α=.79; Self-Efficacy: α=.91). Intention to donate blood and intention to donate urine were positively correlated with attitudes, self-efficacy, and receptivity to learning more about biobanking (all p’s <.001). BANKS-SP-Knowledge was not statistically significantly correlated with other BANKS-SP scales or single items measuring intention to donate a biospecimen for research and receptivity for learning more about biospecimen research.
Conclusions: The BANKS-SP Attitudes and Self-Efficacy scales show evidence of satisfactory reliability and validity. Additional research should be conducted with larger samples to assess the BANKS-SP instrument’s reliability and validity. A valid and reliable Spanish-language instrument measuring Spanish-speaking community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation among this population.
Methods: Each CNPC carried out a community-based participatory research (CBPR) approach that underscored six essential components that moved concepts to a final educational product in a highly participatory fashion. The similar CBPR processes at the two locations focused on the same topic, resulted in different engagement approaches and tools for their respective communities: 1) DVD and brochure toolkit and 2) PowerPoint, group program with audience response system (ARS).
Results: We detail a comparison of methods and applications for using these tools among diverse community groups to advance understandings about genetic and biomedical research technologies.
Conclusion: Ultimately, these tools and associated educational efforts emphasize the critical value of co-learning among academic and community members in biobanking and biospecimen research.
Methods: The BANKS was created by item generation through review of scientific literature, focus groups with community members, and input from a community advisory board. Items were refined through cognitive interviews. Content validity was assessed through an expert panel review. Psychometric properties of the BANKS were assessed in a sample of 85 community members.
Results: The final BANKS includes three scales: attitudes, knowledge, and self-efficacy; as well as three single items, which evaluated receptivity and intention to donate a biospecimen for research. Cronbach a coefficients for two scales that use Likert response format indicated high internal consistency (attitudes: a, 0.88; self-efficacy: a, 0.95). Content validity indices were moderate, ranging from 0.69 to 0.89. Intention to donate blood and intention to donate urine were positively correlated with attitudes, knowledge, self-efficacy, and receptivity to learning more about biobanking (P values range from 0.029 to <0.001).
Conclusions: The final BANKS shows evidence of satisfactory reliability and validity, is easy to administer, and is a promising tool to inform biospecimen research. Additional studies should be conducted with larger samples considering biospecimen donation to further assess the reliability and validity of the instrument.
Impact: A valid and reliable instrument measuring community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation. A Spanish-language BANKS is under development.
Methods: The BANKS was translated into Spanish using the Brislin method of translation. Draft BANKS-SP items were refined through cognitive interviews, and psychometric properties were assessed in a sample of 85 Spanish-speaking individuals recruited at various community events in a three county area in Central West Florida, USA.
Results: The final BANKS-SP includes 3 scales: Attitudes, Knowledge, and Self-Efficacy; as well as 3 single items, which evaluated receptivity and intention to donate a biospecimen for research. The final Cronbach’s alpha coefficients for the two scales that use Likert response format indicated adequate internal consistency (Attitudes: α=.79; Self-Efficacy: α=.91). Intention to donate blood and intention to donate urine were positively correlated with attitudes, self-efficacy, and receptivity to learning more about biobanking (all p’s <.001). BANKS-SP-Knowledge was not statistically significantly correlated with other BANKS-SP scales or single items measuring intention to donate a biospecimen for research and receptivity for learning more about biospecimen research.
Conclusions: The BANKS-SP Attitudes and Self-Efficacy scales show evidence of satisfactory reliability and validity. Additional research should be conducted with larger samples to assess the BANKS-SP instrument’s reliability and validity. A valid and reliable Spanish-language instrument measuring Spanish-speaking community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation among this population.
Methods: Each CNPC carried out a community-based participatory research (CBPR) approach that underscored six essential components that moved concepts to a final educational product in a highly participatory fashion. The similar CBPR processes at the two locations focused on the same topic, resulted in different engagement approaches and tools for their respective communities: 1) DVD and brochure toolkit and 2) PowerPoint, group program with audience response system (ARS).
Results: We detail a comparison of methods and applications for using these tools among diverse community groups to advance understandings about genetic and biomedical research technologies.
Conclusion: Ultimately, these tools and associated educational efforts emphasize the critical value of co-learning among academic and community members in biobanking and biospecimen research.
Methods: The BANKS was created by item generation through review of scientific literature, focus groups with community members, and input from a community advisory board. Items were refined through cognitive interviews. Content validity was assessed through an expert panel review. Psychometric properties of the BANKS were assessed in a sample of 85 community members.
Results: The final BANKS includes three scales: attitudes, knowledge, and self-efficacy; as well as three single items, which evaluated receptivity and intention to donate a biospecimen for research. Cronbach a coefficients for two scales that use Likert response format indicated high internal consistency (attitudes: a, 0.88; self-efficacy: a, 0.95). Content validity indices were moderate, ranging from 0.69 to 0.89. Intention to donate blood and intention to donate urine were positively correlated with attitudes, knowledge, self-efficacy, and receptivity to learning more about biobanking (P values range from 0.029 to <0.001).
Conclusions: The final BANKS shows evidence of satisfactory reliability and validity, is easy to administer, and is a promising tool to inform biospecimen research. Additional studies should be conducted with larger samples considering biospecimen donation to further assess the reliability and validity of the instrument.
Impact: A valid and reliable instrument measuring community members’ views about biobanking may help researchers evaluate relevant communication interventions to enhance understanding, intention, and actual biospecimen donation. A Spanish-language BANKS is under development.