- Email: [email protected]
154. Adults' Perceptions About Adolescent Health Education Research Participation
S94
Poster Abstracts / 52 (2013) S21–S113
Purpose: Institutional Review Boards (IRBs) are expected to conduct an objective and informed ethics review of research protocols. However, the review of protocols involving vulnerable populations, such as adolescents, is frequently shaped by reviewer experiences and background. Our purpose was to examine how experience, training and self-efficacy influenced the research community’s assessment of how the IRB reviews adolescent protocols. Methods: As part of IRB quality improvement in a large public university, IRB members, investigators with protocols involving 11-17 year olds, and IRB staff participated in a web-based anonymous survey (response rate 51%). Predictor measures included demographics, religiosity, professional and personal experiences relevant to adolescents, ethics training, and self-efficacy related to the review of adolescent protocols. Professional experiences included IRB membership, clinical care of adolescent patients, and research with adolescents. Personal experience included parenting an adolescent. Ethics training was divided into basic (required CITI modules) and advanced levels (coursework or ethics degree). A self-efficacy scale measured respondent’s confidence in their knowledge of guidelines (3 items, ? ⫽ 0.76), and a single item measured how challenging it felt to assess risks and benefits in behavioral research with adolescents. Outcome measures were adapted from a published IRB quality tool. The four quality measures included 1) procedural justice (3 items, ? ⫽ 0.86); 2) reviewer knowledge (2 items); 3) IRB competency (4 items, ? ⫽ 0.86); and 4) absence of bias (3 items, ? ⫽ 0.87). A series of 4 multivariate linear regressions examined the influence of experiences, training, and selfefficacy on each of the IRB competency scales. Results: Participants included 80 IRB members, 15 IRB staff, and 107 investigators (202 total). Experiences, training, and self-efficacy influenced ratings of IRB quality. Across all 4 quality measures, IRB members rated quality higher than non-members, and parents of adolescents rated the IRB higher than non-parents. Participants with the most clinical experience with adolescents rated the IRB higher in procedural justice, expert knowledge and competency, but lower in absence of bias than those with less experience. Participants with no adolescent research experience rated the IRB more favorably in all measures than those with adolescent research experience. Participants with more advanced ethics training rated the IRB lower in all quality measures. For self-efficacy, as participants’ confidence in their knowledge of guidelines increased, their assessment of IRB quality increased. In contrast, the more challenging the participants found the assessment of risks and benefits, the lower they rated IRB quality. Conclusions: Experiences with adolescents, level of ethics training, and self-efficacy all influence the research community’s perception of IRB quality. These findings are important, but perceptions drive the professional culture at an institution and can impact an institution’s research mission. Understanding factors influencing members’, investigators’ and staffs’ experiences of IRB quality can inform training and quality improvement in the ethics review of adolescent research. Sources of Support: Indiana University Health Values Fund for the Integration of Spiritual and Religious Dimensions in Health Care. 153.
Methods: Data for this present study was originally collected in Project Iowa SCY (Strengthening Communities for Youth) which compared the effectiveness of family and group treatment for adolescent substance abuse (Smith, Hall, Williams, An & Gotman, 2006). For Project Iowa SCY, adolescents were screened to determine if substance abuse treatment was needed and, if outpatient treatment was recommended for the adolescent, both the adolescent and his/ her parent/guardian were given the opportunity to participate in the SCY randomized longitudinal research. Depending on their decision, each adolescent and his/her parent/guardian were asked to complete either the Reasons for Participating (RFP) or Reasons for Declining (RFD) questionnaire which were developed for the original SCY study (Williams, Smith & Hall, 2006). Of those given the opportunity to participate, (31) adolescents and (32) parents decided to participate in the SCY research, compared to (27) adolescents and (27) parents who declined to participate in research. Results: A great deal of confusion exists within the research community regarding the ethics of using incentives to recruit research participants. Although much of the literature focuses on the use of monetary incentives as the main ethical concern, some research indicates that a reward (or incentive) may mean less if the potential participant feels positively associated with the intent of the study (i.e., altruism). Thus, an individual’s decision to participate in research could be impacted more by positive feelings associated with “helping” than by a monetary incentive. Literature on research study participation has generally focused on adults as the primary actors in the decision making process. The present study adds in an extra dimension to assess adolescents’ motivations for participating or declining to participate in research, as well as including their parents/ guardians. A comparative analysis between parents and adolescents shows that adolescents decisions were similarly unaffected in RFD, with the largest factor in RFD for both parents and adolescents being a lack of time (parents X ⫽ 3.37, adolescents X ⫽ 3.44). Conclusions: Through better understanding of motivations and mitigating factors to research participation, researchers may be able to identify key factors that will aid in subject recruitment in future research studies. Results from this study showed that money is not the best motivator to participate in research, but it has a higher level of impact on adolescents than parents. When recruiting research study participants it is important for research staff to highlight the importance of the research study, find a means to directly relate the study to participants’ ability to contribute to finding solutions to the identified problem, and illustrate how their participation could help others. A greater focus on these substantive areas may have the potential to yield higher participation rates during screening. Sources of Support: HRSA/MCHB R40MC08721; HRSA/MCHB T71 MC000008; SAMHSA U79 TI-13354. 154. ADULTS’ PERCEPTIONS ABOUT ADOLESCENT HEALTH EDUCATION RESEARCH PARTICIPATION Veronte T. Stubbs, MPH1, Mousumi Banikya-Leaseburg, MBBS2, Janie M. Leary, PhD2, Pamela J. Murray, MD, MPH2. 1
WHY DO ADOLESCENTS AND PARENTS PARTICIPATE IN RESEARCH? Kyle A. McGregor, MSW, James A. Hall, PhD. Indiana University School of Medicine Purpose: The purpose of this study was to evaluate potential factors that affected the decision to participate or to decline to participate in research by adolescents and their parents.
N/A; 2West Virginia University
Purpose: This study examines adults’ perceptions about adolescents’ participation in health education research (H.E.R.) with and without parental consent. Methods: Recruitment occurred in a university-based pediatric clinic waiting room in a rural state. Participants completed a 10minute, self-report survey indicating their perception of importance of and agreement with adolescents’ participation in H.E.R. by age and
Poster Abstracts / 52 (2013) S21–S113
S95
topic, with and without parental consent. Respondents answered questions about a research study scenario where parental consent was not required for adolescent participation. Data analyzed in SPSS, version 19.0. Results: Respondents (n ⫽ 153) were predominately female (73.2%), white (87.6%), and had a mean age of 39.4 years (SD ⫽ 10.4). Most respondents were married or living with a partner (68.0%) and had some college (54.3%). Most respondents had at least one 13-17 year old living with them (58.2%). Most respondents reported it was important for adolescents to participate in H.E.R. about driving (84.7%), birth control (84.9%), STIs (88.9%), and sex education (90.2%). Respondents reported whether 14, 15, 16, and 17 year olds should be allowed to participate in H.E.R., with and without parental consent, for driving behavior, preventing teen pregnancy, and preventing sexually transmitted infections (STIs). Topics were grouped by age for analysis. Responses were scored from zero (indicating no participation should be allowed) to three (indicating adolescents should be allowed to participate in H.E.R. on all three topics). A significant mean difference in rank was found indicating that as adolescents aged, respondents increasingly agreed that teens should be allowed to participant in H.E.R with parental consent (x2 (3) ⫽ 28.7, p ⬍ .001) with mean rank increases from 2.37 at age 14 to 2.60 at age 17. Additionally, a significant mean difference in rank was found indicating that as adolescents aged, respondents increasingly agreed that teens should be allowed to participant in H.E.R without parental consent (x2 (3) ⫽ 131.5, p ⬍ .001) with mean rank increases from 2.02 at age 14 to 2.93 at age 17. Respondents were then given a description of a research study where teen women could participate in an internet-based intervention without parental consent. Given a list of options, respondents wanted to know who would have access to their daughter’s information (75.2%), study conclusions (70.6%), to view the videos (69.9%), and to view the survey questions (65.4%) with the greatest frequency. They least frequently wanted to know reimbursement for participation (28.1%). Conclusions: Responses to perception questions did not significantly vary by respondent demographics. An open ended question about theoretical study participation elicited a range of supportive and unsupportive comments. For adolescents as young as 14; adults support adolescent participation in H.E.R. with and without parental consent. Support increases with older adolescents. Given options, adult respondents express concerns about privacy of information; have an interest in study outcomes and study content; and are least concerned about reimbursement for participation. Sources of Support: Subcontract through Carnegie Mellon University with DHHR Office of Adolescent Health (5 TP1AH000040-03-00).
of this research was to craft a set of legal, practical and ethical recommendations for confidential provision of care to minors in the era of EMRs. Methods: Information for the recommendations were collected from three sources: an extensive literature review of existing policy papers and research studies was undertaken along with a review of current federal and state statutes regarding confidential care of minors; health care providers, policy analysts and legal experts in this field were also interviewed for their insight and recommendations; and a case study was used in discussion to review the ethical and practical considerations of these recommendations. Results: Health care providers working with adolescents acknowledge that protecting adolescent privacy in the era of EMRs is a priority concern. A set of recommendations acknowledges that the current legal precedents and legislation lag behind the new technological innovation and its applications. Providers need to be involved in designing ways to refine and improve EMR templates designed with adolescent care and confidentiality in mind. A default setting for age-based control policies in EMRs should be available for use with patients who are minors. It is clear that parents will need to consent for this proxy access. This makes it important that providers continue to foster improved communication with parents and patients about sensitive issues and to expand parents’ knowledge of the importance of confidentiality in the care of their child’s health. Conclusions: It is clear that EMRs have expanded the challenge of providing confidential health care to adolescents. The increased use of EMRs as a standard of care however, requires that health care providers serve as advocates, educators and facilitators of the application of confidentiality within this new technology. Advisory councils and works groups are needed to address the adolescent issues and concerns raised within the use of the EMRs. Specific legal recommendations may take longer to develop but will eventually be needed to help guide how EMRs are used with adolescent patients. Sources of Support: Research Grant: Institute for Practical Ethics and Public Life.
155.
Purpose: A critical portion of the adolescent preventive health visit is the provision of confidential care. To ensure this, health care providers should explicitly assure confidentiality and spend time alone with the adolescent. Previous studies have found that this does not occur frequently enough; only 30-60% of visits are explicitly confidential, and time alone occurs in only 50% of visits. These studies were based on patient or physician self-report; none on objective audio recorded encounters. This study sought to describe objectively the proportion of visits including explicit confidentiality assurances and the proportion of encounters where physicians spent time alone with adolescents during routine primary care visits. Methods: As part of an intervention designed to enhance physician communication skills with overweight and obese adolescents, we audio recorded 166 comprehensive annual examinations between 49 primary care physicians (40 pediatricians and 9 family practitioners) and their adolescent overweight and obese patients. We coded encounters for explicit assurances of confidentiality, time physicians
IMPACT OF ELECTRONIC MEDICAL RECORDS ON THE PROVISION OF CONFIDENTIAL REPRODUCTIVE CARE TO MINORS: LEGAL, PRACTICAL AND ETHICAL CONSIDERATIONS Laura Hansen, MPH, Nancy M. Mclaren, MD. Teen Health Center, University of Virginia Purpose: The advent of Electronic Medical Record systems (EMRs) heralds in a new era of medical care. Their implementation offers increased efficiency, cost saving and improved communication with patients and providers and between providers. However they also challenge the ability of providers of care to adolescents to maintain confidentiality and avoid inadvertent disclosures of sensitive health information. Health care providers and health systems need to devise a way to utilize EMR technology and to continue to assure privacy and provide necessary confidential care to adolescent patients. The purpose
156. PRIMARY CARE PHYSICIANS’ ASSURANCES OF CONFIDENTIALITY AND TIME SPENT ALONE WITH ADOLESCENTS DURING ROUTINE HEALTH CARE VISITS Terrill Bravender, MD, MPH1, Pauline Lyna, MPH2, James Tulsky, MD2, Truls Ostbye, MD, PhD2, Rowena Dolor, MD2, Cynthia Coffman, PhD2, Alicia Bilheimer, MPH2, Pao-Hwa Lin, PhD2, Kathryn Pollak, PhD2. 1
Nationwide Children’s Hospital; 2Duke University Medical Center
Poster Abstracts / 52 (2013) S21–S113
Purpose: Institutional Review Boards (IRBs) are expected to conduct an objective and informed ethics review of research protocols. However, the review of protocols involving vulnerable populations, such as adolescents, is frequently shaped by reviewer experiences and background. Our purpose was to examine how experience, training and self-efficacy influenced the research community’s assessment of how the IRB reviews adolescent protocols. Methods: As part of IRB quality improvement in a large public university, IRB members, investigators with protocols involving 11-17 year olds, and IRB staff participated in a web-based anonymous survey (response rate 51%). Predictor measures included demographics, religiosity, professional and personal experiences relevant to adolescents, ethics training, and self-efficacy related to the review of adolescent protocols. Professional experiences included IRB membership, clinical care of adolescent patients, and research with adolescents. Personal experience included parenting an adolescent. Ethics training was divided into basic (required CITI modules) and advanced levels (coursework or ethics degree). A self-efficacy scale measured respondent’s confidence in their knowledge of guidelines (3 items, ? ⫽ 0.76), and a single item measured how challenging it felt to assess risks and benefits in behavioral research with adolescents. Outcome measures were adapted from a published IRB quality tool. The four quality measures included 1) procedural justice (3 items, ? ⫽ 0.86); 2) reviewer knowledge (2 items); 3) IRB competency (4 items, ? ⫽ 0.86); and 4) absence of bias (3 items, ? ⫽ 0.87). A series of 4 multivariate linear regressions examined the influence of experiences, training, and selfefficacy on each of the IRB competency scales. Results: Participants included 80 IRB members, 15 IRB staff, and 107 investigators (202 total). Experiences, training, and self-efficacy influenced ratings of IRB quality. Across all 4 quality measures, IRB members rated quality higher than non-members, and parents of adolescents rated the IRB higher than non-parents. Participants with the most clinical experience with adolescents rated the IRB higher in procedural justice, expert knowledge and competency, but lower in absence of bias than those with less experience. Participants with no adolescent research experience rated the IRB more favorably in all measures than those with adolescent research experience. Participants with more advanced ethics training rated the IRB lower in all quality measures. For self-efficacy, as participants’ confidence in their knowledge of guidelines increased, their assessment of IRB quality increased. In contrast, the more challenging the participants found the assessment of risks and benefits, the lower they rated IRB quality. Conclusions: Experiences with adolescents, level of ethics training, and self-efficacy all influence the research community’s perception of IRB quality. These findings are important, but perceptions drive the professional culture at an institution and can impact an institution’s research mission. Understanding factors influencing members’, investigators’ and staffs’ experiences of IRB quality can inform training and quality improvement in the ethics review of adolescent research. Sources of Support: Indiana University Health Values Fund for the Integration of Spiritual and Religious Dimensions in Health Care. 153.
Methods: Data for this present study was originally collected in Project Iowa SCY (Strengthening Communities for Youth) which compared the effectiveness of family and group treatment for adolescent substance abuse (Smith, Hall, Williams, An & Gotman, 2006). For Project Iowa SCY, adolescents were screened to determine if substance abuse treatment was needed and, if outpatient treatment was recommended for the adolescent, both the adolescent and his/ her parent/guardian were given the opportunity to participate in the SCY randomized longitudinal research. Depending on their decision, each adolescent and his/her parent/guardian were asked to complete either the Reasons for Participating (RFP) or Reasons for Declining (RFD) questionnaire which were developed for the original SCY study (Williams, Smith & Hall, 2006). Of those given the opportunity to participate, (31) adolescents and (32) parents decided to participate in the SCY research, compared to (27) adolescents and (27) parents who declined to participate in research. Results: A great deal of confusion exists within the research community regarding the ethics of using incentives to recruit research participants. Although much of the literature focuses on the use of monetary incentives as the main ethical concern, some research indicates that a reward (or incentive) may mean less if the potential participant feels positively associated with the intent of the study (i.e., altruism). Thus, an individual’s decision to participate in research could be impacted more by positive feelings associated with “helping” than by a monetary incentive. Literature on research study participation has generally focused on adults as the primary actors in the decision making process. The present study adds in an extra dimension to assess adolescents’ motivations for participating or declining to participate in research, as well as including their parents/ guardians. A comparative analysis between parents and adolescents shows that adolescents decisions were similarly unaffected in RFD, with the largest factor in RFD for both parents and adolescents being a lack of time (parents X ⫽ 3.37, adolescents X ⫽ 3.44). Conclusions: Through better understanding of motivations and mitigating factors to research participation, researchers may be able to identify key factors that will aid in subject recruitment in future research studies. Results from this study showed that money is not the best motivator to participate in research, but it has a higher level of impact on adolescents than parents. When recruiting research study participants it is important for research staff to highlight the importance of the research study, find a means to directly relate the study to participants’ ability to contribute to finding solutions to the identified problem, and illustrate how their participation could help others. A greater focus on these substantive areas may have the potential to yield higher participation rates during screening. Sources of Support: HRSA/MCHB R40MC08721; HRSA/MCHB T71 MC000008; SAMHSA U79 TI-13354. 154. ADULTS’ PERCEPTIONS ABOUT ADOLESCENT HEALTH EDUCATION RESEARCH PARTICIPATION Veronte T. Stubbs, MPH1, Mousumi Banikya-Leaseburg, MBBS2, Janie M. Leary, PhD2, Pamela J. Murray, MD, MPH2. 1
WHY DO ADOLESCENTS AND PARENTS PARTICIPATE IN RESEARCH? Kyle A. McGregor, MSW, James A. Hall, PhD. Indiana University School of Medicine Purpose: The purpose of this study was to evaluate potential factors that affected the decision to participate or to decline to participate in research by adolescents and their parents.
N/A; 2West Virginia University
Purpose: This study examines adults’ perceptions about adolescents’ participation in health education research (H.E.R.) with and without parental consent. Methods: Recruitment occurred in a university-based pediatric clinic waiting room in a rural state. Participants completed a 10minute, self-report survey indicating their perception of importance of and agreement with adolescents’ participation in H.E.R. by age and
Poster Abstracts / 52 (2013) S21–S113
S95
topic, with and without parental consent. Respondents answered questions about a research study scenario where parental consent was not required for adolescent participation. Data analyzed in SPSS, version 19.0. Results: Respondents (n ⫽ 153) were predominately female (73.2%), white (87.6%), and had a mean age of 39.4 years (SD ⫽ 10.4). Most respondents were married or living with a partner (68.0%) and had some college (54.3%). Most respondents had at least one 13-17 year old living with them (58.2%). Most respondents reported it was important for adolescents to participate in H.E.R. about driving (84.7%), birth control (84.9%), STIs (88.9%), and sex education (90.2%). Respondents reported whether 14, 15, 16, and 17 year olds should be allowed to participate in H.E.R., with and without parental consent, for driving behavior, preventing teen pregnancy, and preventing sexually transmitted infections (STIs). Topics were grouped by age for analysis. Responses were scored from zero (indicating no participation should be allowed) to three (indicating adolescents should be allowed to participate in H.E.R. on all three topics). A significant mean difference in rank was found indicating that as adolescents aged, respondents increasingly agreed that teens should be allowed to participant in H.E.R with parental consent (x2 (3) ⫽ 28.7, p ⬍ .001) with mean rank increases from 2.37 at age 14 to 2.60 at age 17. Additionally, a significant mean difference in rank was found indicating that as adolescents aged, respondents increasingly agreed that teens should be allowed to participant in H.E.R without parental consent (x2 (3) ⫽ 131.5, p ⬍ .001) with mean rank increases from 2.02 at age 14 to 2.93 at age 17. Respondents were then given a description of a research study where teen women could participate in an internet-based intervention without parental consent. Given a list of options, respondents wanted to know who would have access to their daughter’s information (75.2%), study conclusions (70.6%), to view the videos (69.9%), and to view the survey questions (65.4%) with the greatest frequency. They least frequently wanted to know reimbursement for participation (28.1%). Conclusions: Responses to perception questions did not significantly vary by respondent demographics. An open ended question about theoretical study participation elicited a range of supportive and unsupportive comments. For adolescents as young as 14; adults support adolescent participation in H.E.R. with and without parental consent. Support increases with older adolescents. Given options, adult respondents express concerns about privacy of information; have an interest in study outcomes and study content; and are least concerned about reimbursement for participation. Sources of Support: Subcontract through Carnegie Mellon University with DHHR Office of Adolescent Health (5 TP1AH000040-03-00).
of this research was to craft a set of legal, practical and ethical recommendations for confidential provision of care to minors in the era of EMRs. Methods: Information for the recommendations were collected from three sources: an extensive literature review of existing policy papers and research studies was undertaken along with a review of current federal and state statutes regarding confidential care of minors; health care providers, policy analysts and legal experts in this field were also interviewed for their insight and recommendations; and a case study was used in discussion to review the ethical and practical considerations of these recommendations. Results: Health care providers working with adolescents acknowledge that protecting adolescent privacy in the era of EMRs is a priority concern. A set of recommendations acknowledges that the current legal precedents and legislation lag behind the new technological innovation and its applications. Providers need to be involved in designing ways to refine and improve EMR templates designed with adolescent care and confidentiality in mind. A default setting for age-based control policies in EMRs should be available for use with patients who are minors. It is clear that parents will need to consent for this proxy access. This makes it important that providers continue to foster improved communication with parents and patients about sensitive issues and to expand parents’ knowledge of the importance of confidentiality in the care of their child’s health. Conclusions: It is clear that EMRs have expanded the challenge of providing confidential health care to adolescents. The increased use of EMRs as a standard of care however, requires that health care providers serve as advocates, educators and facilitators of the application of confidentiality within this new technology. Advisory councils and works groups are needed to address the adolescent issues and concerns raised within the use of the EMRs. Specific legal recommendations may take longer to develop but will eventually be needed to help guide how EMRs are used with adolescent patients. Sources of Support: Research Grant: Institute for Practical Ethics and Public Life.
155.
Purpose: A critical portion of the adolescent preventive health visit is the provision of confidential care. To ensure this, health care providers should explicitly assure confidentiality and spend time alone with the adolescent. Previous studies have found that this does not occur frequently enough; only 30-60% of visits are explicitly confidential, and time alone occurs in only 50% of visits. These studies were based on patient or physician self-report; none on objective audio recorded encounters. This study sought to describe objectively the proportion of visits including explicit confidentiality assurances and the proportion of encounters where physicians spent time alone with adolescents during routine primary care visits. Methods: As part of an intervention designed to enhance physician communication skills with overweight and obese adolescents, we audio recorded 166 comprehensive annual examinations between 49 primary care physicians (40 pediatricians and 9 family practitioners) and their adolescent overweight and obese patients. We coded encounters for explicit assurances of confidentiality, time physicians
IMPACT OF ELECTRONIC MEDICAL RECORDS ON THE PROVISION OF CONFIDENTIAL REPRODUCTIVE CARE TO MINORS: LEGAL, PRACTICAL AND ETHICAL CONSIDERATIONS Laura Hansen, MPH, Nancy M. Mclaren, MD. Teen Health Center, University of Virginia Purpose: The advent of Electronic Medical Record systems (EMRs) heralds in a new era of medical care. Their implementation offers increased efficiency, cost saving and improved communication with patients and providers and between providers. However they also challenge the ability of providers of care to adolescents to maintain confidentiality and avoid inadvertent disclosures of sensitive health information. Health care providers and health systems need to devise a way to utilize EMR technology and to continue to assure privacy and provide necessary confidential care to adolescent patients. The purpose
156. PRIMARY CARE PHYSICIANS’ ASSURANCES OF CONFIDENTIALITY AND TIME SPENT ALONE WITH ADOLESCENTS DURING ROUTINE HEALTH CARE VISITS Terrill Bravender, MD, MPH1, Pauline Lyna, MPH2, James Tulsky, MD2, Truls Ostbye, MD, PhD2, Rowena Dolor, MD2, Cynthia Coffman, PhD2, Alicia Bilheimer, MPH2, Pao-Hwa Lin, PhD2, Kathryn Pollak, PhD2. 1
Nationwide Children’s Hospital; 2Duke University Medical Center