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Jason Karlawish - One of the best experts on this subject based on the ideXlab platform.
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alzheimer s prevention initiative generation program development of an apoe genetic counseling and Disclosure Process in the context of clinical trials
Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2019Co-Authors: Carolyn Langlois, Angela R Bradbury, Elisabeth M Wood, Scott J Roberts, Scott Y H Kim, Marieemmanuelle Riviere, Fonda Liu, Eric M Reiman, Pierre N Tariot, Jason KarlawishAbstract:Abstract Introduction As the number of Alzheimer's disease (AD) prevention studies grows, many individuals will need to learn their genetic and/or biomarker risk for the disease to determine trial eligibility. An alternative to traditional models of genetic counseling and Disclosure is needed to provide comprehensive standardized counseling and Disclosure of apolipoprotein E (APOE) results efficiently, safely, and effectively in the context of AD prevention trials. Methods A multidisciplinary Genetic Testing, Counseling, and Disclosure Committee was established and charged with operationalizing the Alzheimer's Prevention Initiative (API) Genetic Counseling and Disclosure Process for use in the API Generation Program trials. The objective was to provide consistent information to research participants before and during the APOE counseling and Disclosure session using standardized educational and session materials. Results The Genetic Testing, Counseling, and Disclosure Committee created a Process consisting of eight components: requirements of APOE testing and reports, psychological readiness assessment, determination of AD risk estimates, guidance for identifying providers of Disclosure, preDisclosure education, APOE counseling and Disclosure session materials, APOE counseling and Disclosure session flow, and assessing APOE Disclosure impact. Discussion The API Genetic Counseling and Disclosure Process provides a framework for large-scale Disclosure of APOE genotype results to study participants and serves as a model for Disclosure of biomarker results. The Process provides education to participants about the meaning and implication(s) of their APOE results while also incorporating a comprehensive assessment of Disclosure impact. Data assessing participant safety and psychological well-being before and after APOE Disclosure are still being collected and will be presented in a future publication.
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apoe related risk of mild cognitive impairment and dementia for prevention trials an analysis of four cohorts
PLOS Medicine, 2017Co-Authors: Jing Qian, Eric M Reiman, Jason Karlawish, Frank J Wolters, Alexa Beiser, Mary N Haan, Arfan M Ikram, Jessica B Langbaum, John Neuhaus, Scott J RobertsAbstract:Author(s): Qian, Jing; Wolters, Frank J; Beiser, Alexa; Haan, Mary; Ikram, M Arfan; Karlawish, Jason; Langbaum, Jessica B; Neuhaus, John M; Reiman, Eric M; Roberts, J Scott; Seshadri, Sudha; Tariot, Pierre N; Woods, Beth McCarty; Betensky, Rebecca A; Blacker, Deborah | Abstract: BACKGROUND:With the onset of prevention trials for individuals at high risk for Alzheimer disease, there is increasing need for accurate risk prediction to inform study design and enrollment, but available risk estimates are limited. We developed risk estimates for the incidence of mild cognitive impairment (MCI) or dementia among cognitively unimpaired individuals by APOE-e4 dose for the genetic Disclosure Process of the Alzheimer's Prevention Initiative Generation Study, a prevention trial in cognitively unimpaired APOE-e4/e4 homozygote individuals. METHODS AND FINDINGS:We included cognitively unimpaired individuals aged 60-75 y, consistent with Generation Study eligibility criteria, from the National Alzheimer's Coordinating Center (NACC) (n = 5,073, 158 APOE-e4/e4), the Rotterdam Study (n = 6,399, 156 APOE-e4/e4), the Framingham Heart Study (n = 4,078, 67 APOE-e4/e4), and the Sacramento Area Latino Study on Aging (SALSA) (n = 1,294, 11 APOE-e4/e4). We computed stratified cumulative incidence curves by age (60-64, 65-69, 70-75 y) and APOE-e4 dose, adjusting for the competing risk of mortality, and determined risk of MCI and/or dementia by genotype and baseline age. We also used subdistribution hazard regression to model relative hazard based on age, APOE genotype, sex, education, family history of dementia, vascular risk, subjective memory concerns, and baseline cognitive performance. The four cohorts varied considerably in age, education, ethnicity/race, and APOE-e4 allele frequency. Overall, cumulative incidence was uniformly higher in NACC than in the population-based cohorts. Among APOE-e4/e4 individuals, 5-y cumulative incidence was as follows: in the 60-64-y age stratum, it ranged from 0% to 5.88% in the three population-based cohorts versus 23.06% in NACC; in the 65-69-y age stratum, from 9.42% to 10.39% versus 34.62%; and in the 70-75-y age stratum, from 18.64% to 33.33% versus 38.34%. Five-year incidence of dementia was negligible except for APOE-e4/e4 individuals and those over 70 y. Lifetime incidence (to age 80-85 y) of MCI or dementia for the APOE-e4/e4 individuals in the long-term Framingham and Rotterdam cohorts was 34.69%-38.45% at age 60-64 y, 30.76%-40.26% at 65-69 y, and 33.3%-35.17% at 70-75 y. Confidence limits for these estimates are often wide, particularly for APOE-e4/e4 individuals and for the dementia outcome at 5 y. In regression models, APOE-e4 dose and age both consistently increased risk, as did lower education, subjective memory concerns, poorer baseline cognitive performance, and family history of dementia. We discuss several limitations of the study, including the small numbers of APOE-e4/e4 individuals, missing data and differential dropout, limited ethnic and racial diversity, and differences in definitions of exposure and outcome variables. CONCLUSIONS:Estimates of the absolute risk of MCI or dementia, particularly over short time intervals, are sensitive to sampling and a variety of methodological factors. Nonetheless, such estimates were fairly consistent across the population-based cohorts, and lower than those from a convenience cohort and those estimated in prior studies-with implications for informed consent and design for clinical trials targeting high-risk individuals.
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development of a Process to disclose amyloid imaging results to cognitively normal older adult research participants
Alzheimer's Research & Therapy, 2015Co-Authors: Kristin Harkins, Robert C Green, Pamela Sankar, Reisa A Sperling, Joshua D Grill, Keith A Johnson, Megan Healy, Jason KarlawishAbstract:Introduction: The objective of this study was to develop a Process to maximize the safety and effectiveness of disclosing Positron Emission Tomography (PET) amyloid imaging results to cognitively normal older adults participating in Alzheimer’s disease secondary prevention studies such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4) Study. Methods: Using a modified Delphi Method to develop consensus on best practices, we gathered and analyzed data over three rounds from experts in two relevant fields: informed consent for genetic testing or human amyloid imaging. Results: Experts reached consensus on (1) text for a brochure that describes amyloid imaging to a person who is considering whether to undergo such imaging in the context of a clinical trial, and (2) a Process for amyloid PET result Disclosure within such trials. Recommendations included: During consent, potential participants should complete an educational session, where they receive verbal and written information covering what is known and unknown about amyloid imaging, including possible results and their meaning, implications of results for risk of future cognitive decline, and information about Alzheimer’s and risk factors. Participants should be screened for anxiety and depression to determine suitability to receive amyloid imaging information. The person conducting the sessions should check comprehension and be skilled in communication and recognizing distress. Imaging should occur on a separate day from consent, and Disclosure on a separate day from imaging. Disclosure should occur in person, with time for questions. At Disclosure, investigators should assess mood and willingness to receive results, and provide a written results report. Telephone follow-up within a few days should assess the impact of Disclosure, and periodic scheduled assessments of depression and anxiety, with additional monitoring and follow-up for participants showing distress, should be performed. Conclusions: We developed a document for use with potential study participants to describe the Process of amyloid imaging and the implications of amyloid imaging results; and a Disclosure Process with attention to ongoing monitoring of both mood and safety to receive this information. This document and Process will be used in the A4 Study and can be adapted for other research settings.
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using ad biomarker research results for clinical care a survey of adni investigators
Neurology, 2013Co-Authors: Melanie B Shulman, Kristin Harkins, Robert C Green, Jason KarlawishAbstract:Objective: To inform whether the Alzheimer9s Disease Neuroimaging Initiative (ADNI) should change its policy of not returning research results to ADNI participants, we surveyed investigators and research staff about disclosing ADNI biomarker information to research participants, with particular emphasis on amyloid imaging results. Methods: In April 2012, just before Food and Drug Administration approval of the amyloid-binding radiotracer, florbetapir, all ADNI investigators and personnel were recruited to complete an anonymous online survey that contained fixed choice and free-text questions. Results: Although ADNI participants often requested amyloid imaging results (the proportions of investigators who reported requests from more than half of their participants with normal cognition or mild cognitive impairment were 20% and 22%, respectively), across all diagnostic groups, the majority of ADNI investigators (approximately 90%) did not return amyloid imaging results to ADNI participants. However, the majority of investigators reported that, if the Food and Drug Administration approved florbetapir, they would support the return of amyloid imaging results to participants with mild cognitive impairment and normal cognition, but they emphasized the need for guidance on how to provide these results to participants and for research to assess the value of returning results as well as how returning results will affect study validity and participant well-being. Conclusions: A majority of ADNI investigators support returning amyloid imaging results to ADNI participants. The findings that they want guidance on how to do this and research on the impact of Disclosure suggest how to develop and monitor a Disclosure Process.
Michael E Lamb - One of the best experts on this subject based on the ideXlab platform.
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exploring the Disclosure of child sexual abuse with alleged victims and their parents
Child Abuse & Neglect, 2007Co-Authors: Irit Hershkowitz, Omer Lanes, Michael E LambAbstract:Abstract Objective The goal of the present study was to examine how children disclosed sexual abuse by alleged perpetrators who were not family members. Methodology Thirty alleged victims of sexual abuse and their parents were interviewed. The children were interviewed using the NICHD Investigative Interview Protocol by six experienced youth investigators. The same principles were followed when the parents were asked to describe in detail what had happened since the abusive incidents. The statements made by the children and parents were then content analyzed. Major characteristics of the children's and parents’ reported behaviors were identified by two independent raters. Findings More than half (53%) of the children delayed Disclosure for between 1 week and 2 years, fewer than half first disclosed to their parents, and over 40% did not disclose spontaneously but did so only after they were prompted; 50% of the children reported feeling afraid or ashamed of their parents’ responses, and their parents indeed tended to blame the children or act angrily. The Disclosure Process varied depending on the children's ages, the severity and frequency of abuse, the parents’ expected reactions, the suspects’ identities, and the strategies they had used to foster secrecy. Conclusions The children's willingness to disclose abuse to their parents promptly and spontaneously decreased when they expected negative reactions, especially when the abuse was more serious. A strong correlation between predicted and actual parental reactions suggested that the children anticipated their parents’ likely reactions very well.
David J Hansen - One of the best experts on this subject based on the ideXlab platform.
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factors influencing children to self disclose sexual abuse
Clinical Psychology Review, 2002Co-Authors: Mary L Paine, David J HansenAbstract:Self-Disclosure by victims of child sexual abuse (CSA) is critical to initiate legal and therapeutic intervention. Unfortunately, research indicates that lengthy delays in Disclosure and even nonDisclosure are common. A comprehensive review of the clinical and research literature on CSA and an overview of related bodies of literature was conducted. Areas addressed include the context of sexual abuse as it relates to Disclosure, the context and elements of children's Disclosures, motivational factors inhibiting Disclosure, and models of the Disclosure Process. Ancillary and analogue research on secrecy and Disclosure are also reviewed. Implications for future research and practice are discussed.
Sarah Scollon - One of the best experts on this subject based on the ideXlab platform.
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clinical providers experiences with returning results from genomic sequencing an interview study
BMC Medical Genomics, 2018Co-Authors: Julia Wynn, Katie L Lewis, Laura M Amendola, Barbara A Bernhardt, Sawona Biswas, Manasi Joshi, Carmit K Mcmullen, Sarah ScollonAbstract:Current medical practice includes the application of genomic sequencing (GS) in clinical and research settings. Despite expanded use of this technology, the Process of Disclosure of genomic results to patients and research participants has not been thoroughly examined and there are no established best practices. We conducted semi-structured interviews with 21 genetic and non-genetic clinicians returning results of GS as part of the NIH funded Clinical Sequencing Exploratory Research (CSER) Consortium projects. Interviews focused on the logistics of sessions, participant/patient reactions and factors influencing them, how the sessions changed with experience, and resources and training recommended to return genomic results. The length of preparation and Disclosure sessions varied depending on the type and number of results and their implications. Internal and external databases, online resources and result review meetings were used to prepare. Respondents reported that participants’ reactions were variable and ranged from enthusiasm and relief to confusion and disappointment. Factors influencing reactions were types of results, expectations and health status. A recurrent challenge was managing inflated expectations about GS. Other challenges included returning multiple, unanticipated and/or uncertain results and navigating a rare diagnosis. Methods to address these challenges included traditional genetic counseling techniques and modifying practice over time in order to provide anticipatory guidance and modulate expectations. Respondents made recommendations to improve access to genomic resources and genetic referrals to prepare future providers as the uptake of GS increases in both genetic and non-genetic settings. These findings indicate that returning genomic results is similar to return of results in traditional genetic testing but is magnified by the additional complexity and potential uncertainty of the results. Managing patient expectations, initially identified in studies of informed consent, remains an ongoing challenge and highlights the need to address this issue throughout the testing Process. The results of this study will help to guide future providers in the Disclosure of genomic results and highlight educational needs and resources necessary to prepare providers. Future research on the patient experience, understanding and follow-up of recommendations is needed to more fully understand the Disclosure Process.
Rosaleen Mcelvaney - One of the best experts on this subject based on the ideXlab platform.
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Disclosure of child sexual abuse delays non Disclosure and partial Disclosure what the research tells us and implications for practice
Child Abuse Review, 2015Co-Authors: Rosaleen McelvaneyAbstract:This paper reviews the research on Disclosure of child sexual abuse with specific reference to delays in disclosing, non-Disclosure and partial Disclosure of experiences of child sexual abuse. Findings from large-scale national probability studies highlight the prevalence of both non-Disclosure and delays in Disclosure, while findings from small-scale qualitative studies portray the complexity, diversity and individuality of experiences. The possible explanations regarding why children are reluctant to disclose such experiences have significant implications for addressing the issue of child sexual abuse from the perspectives of child protection, legal and therapeutic professionals. The importance of understanding the dynamics of Disclosure, in particular the needs of young people to maintain control over the Disclosure Process, the important role that peers play in this Process, the responses of adults in both informal and formal networks, and the opportunities to tell, is key to helping young people speak more promptly about their experiences of sexual abuse. Copyright © 2013 John Wiley & Sons, Ltd. ‘The importance of understanding the dynamics of Disclosure’ Key Practitioner Messages Children typically delay disclosing experiences of abuse. Asking children questions about their wellbeing gives them the opportunity to tell when they are ready. The challenge is to find the right questions at the right time. Peers can be the right people to ask these questions. Adolescents need to know about how to ask and what to do if someone tells. Adolescents need to know about how to ask and what to do if someone tells.
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to tell or not to tell factors influencing young people s informal Disclosures of child sexual abuse
Journal of Interpersonal Violence, 2014Co-Authors: Rosaleen Mcelvaney, Sheila Greene, Diane HoganAbstract:The aim was to understand the factors influencing informal Disclosure of child sexual abuse experiences, taking account of dynamics operating prior to, during, and following Disclosure. In-depth semi-structured interviews were conducted with 22 young people who experienced child sexual abuse and 14 parents. Grounded theory methodology informed the study. The key factors identified as influencing the Disclosure Process included being believed, being asked, shame/self-blame, concern for self and others, and peer influence. Many young people both wanted to tell and did not want to tell. Fear of not being believed; being asked questions about their well-being; feeling ashamed of what happened and blaming themselves for the abuse, for not telling, and for the consequences of Disclosure; concern for how both Disclosure and nonDisclosure would impact on themselves and others; and being supported by and yet pressurized by peers to tell an adult, all illustrate the complex intrapersonal and interpersonal dynamics reflecting the conflict inherent in the Disclosure Process. These findings build on previous studies that emphasize the dialogic and interpersonal dynamics in the Disclosure Process. Both intrapersonal and interpersonal influencing factors need to be taken account of in designing interventions aimed at helping children tell. The importance of asking young people about their psychological well-being and the role of peer relationships are highlighted as key to how we can help young people tell.
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to tell or not to tell factors influencing young people s informal Disclosures of child sexual abuse
Journal of Interpersonal Violence, 2014Co-Authors: Rosaleen Mcelvaney, Sheila Greene, Diane HoganAbstract:The aim was to understand the factors influencing informal Disclosure of child sexual abuse experiences, taking account of dynamics operating prior to, during, and following Disclosure. In-depth semi-structured interviews were conducted with 22 young people who experienced child sexual abuse and 14 parents. Grounded theory methodology informed the study. The key factors identified as influencing the Disclosure Process included being believed, being asked, shame/self-blame, concern for self and others, and peer influence. Many young people both wanted to tell and did not want to tell. Fear of not being believed; being asked questions about their well-being; feeling ashamed of what happened and blaming themselves for the abuse, for not telling, and for the consequences of Disclosure; concern for how both Disclosure and nonDisclosure would impact on themselves and others; and being supported by and yet pressurized by peers to tell an adult, all illustrate the complex intrapersonal and interpersonal dynamics ...