Background. In discussions of recruitment, the question was raised as to whether returning research results to subjects would help recruitment.
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1 Alzheimer s Disease Neuroimaging Initiative Return of Research Results Working Group
2 The REVEAL Study NHGRI/NIA Funded d
3 Background In discussions of recruitment, the question was raised as to whether returning research results to subjects would help recruitment. The FDA was considering (and has now approved) the clinical use of florbetapir (Avid/Lilly) for imaging amyloid. The A4 Trial will face the question of recruiting based upon amyloid imaging results (and hence disclosure). Return of Research Results (RORR) Working Group formed to develop recommendations on return of research results to ADNI subjects, starting with amyloid imaging.
4 Alzheimer s Disease Neuroimaging Initiative Return of Research Results Working Group Robert C. Green (co-chair) chair) Jason Karlawish (co-chair) chair) Emily Borgelt Lars Bertram Tatiana Foroud Matt Huentelman Judy Illes Jennifer Lingler Steven Potkin Allyson Rosen Andy Saykin Reisa Sperling Mike Weiner
5 RORR Workgroup Process Developed framework and initial recommendations based on scientific, clinical, ethical and logistical considerations (entire committee). Conducted a structured review of consent forms from ADNI-1, ADNI-GO and ADNI-2 (Emily Borgelt, Judy Illes, Robert Green). Conducted a survey of ADNI investigators (Jason Karlowish, Melanie Shulman, Kristen Harkins, Robert Green). Finalized recommendations and presented them to ADNI Executive Committee (entire committee).
6 Review of Most Recent Consent Forms
7 RORR Statements by Study and Sites RORR Statement Present RORR Statement Not Present Total ADNI ADNI-GO ADNI Total (%)
8 RORR Statement Locations in Consent Forms ADNI ADNI-GO ADNI-2 PET-PIB Total n= 58 n = 55 n = 56 n = 15 n = 184 Access to research records Benefits Confidentiality Procedures Risks Sample storage and future use Incidental findings Use of results in clinical care What else do you need to know?
9 Type of RORR Statement Referenced ADNI-1 No Type of data referenced Routinely Not If clinically statement Total in RORR statement returned returned significant ifi present Biomarker Genetic Imaging, MRI Imaging, PET Imaging, Florbetapir Imaging, Nonspecific Lab tests Lumbar puncture Neuropsychological Nonspecific statement Total
10 Type of RORR Statement Referenced ADNI-GO Type of data referenced Routinely Not If clinically in RORR statement returned returned significant No statement present Total Biomarker Genetic * - 55 Imaging, MRI Imaging, PET Imaging, Florbetapir Imaging, Nonspecific Lab tests Lumbar puncture Neuropsychological Nonspecific statement Total *In addition to statement of non-return, additional statement indicates potential return of future results.
11 Type of RORR Statement Referenced ADNI-2 Type of data referenced Routinely Not If clinically in RORR statement returned returned significant No statement present Total Biomarker Genetic Imaging, MRI Imaging, PET Imaging, Florbetapir Imaging, Nonspecific Lab tests Lumbar puncture Neuropsychological Nonspecific statement Total
12 PET-PIB RORR Statements Routinely returned Not returned If clinically significant No statement present Total PET-PIB
13 Survey of ADNI Investigators
14 Response Rate Role Total Total Response Rate Contacted Completed Principal Investigators (30%) 64% Study Physicians (14%) 53% Other Clinicians (14%) 49% Study Coordinators (42%) 37% Total * 52% * Total 159 surveys complete, n = 2 missing response
15 Participant Characteristics What degrees do you hold? N (%) (select all that apply) MD/DO 69 (45%) PhD 24 (16%) RN/CRNP/PA 21 (14%) MSW 0 (0%) MPH 6 (4%) Master s s 32 (21%) BA/BS 46 (30%) TOTAL 152* * Total 159 surveys complete, n = 7 missing response
16 Return of Amyloid Imaging Results Dementia Return to dementia participants N, % Always 2 ( 1%) Sometimes 11 ( 8%) Never 126 (91%) TOTAL 139 (100%) When you returned an amyloid imaging result to a participant with dementia, was it: (select all that apply) Total Responses (N=13) To provide risk assessment 5 (38%) To clarify a diagnosis 10 (77%) To guide therapy 4 (31%) Other (please specify) 2 (15%) the volunteer asked for information because they specifically asked
17 Return of Amyloid Imaging Results MCI Return to MCI participants N, % Always 2 (1%) Sometimes 12 (9%) Never 125 (90%) TOTAL 139 (100%) When you returned an amyloid imaging result to a participant with MCI, was it: (select all that apply) Total Responses (N=14) To provide risk assessment 6 (43%) To clarify a diagnosis 8 (57%) To guide therapy 6 (43%) Other (please specify) 2 (14%) the participant asked for information they specifically asked
18 Return of Amyloid Imaging Results Cognitively Normal Return to participants with normal cognition N, % Always 2 (1%) Sometimes 7 (5%) Never 130 (94%) TOTAL 139 (100%) When you returned an amyloid imaging result to a participant with normal cognition, was it: (select all that apply) TOTAL Responses (N=9) To provide risk assessment 6, 67% To clarify a diagnosis 4, 44% To guide therapy 0, 0% Other (please specify) 1, 11% the participant asked for information
19 Participant request for amyloid imaging results MCI % MCI who request N (%) results % 25 (18%) 51-75% 6 (4%) 26-50% 16 (11%) 1-25% 37 (26%) 0% 55 (40%) Total Responses 139 (100%)
20 Participant request for amyloid imaging results Normal Cognition % normal who N (%) request results % 23 (16%) 51-75% 5 (4%) 26-50% 14 (10%) 1-25% 35 (25%) 0% 62 (45%) Total Responses 139 (100%)
21 ADNI researchers endorsing a policy of disclosure of amyloid-imaging information to participants with mild cognitive impairment ADNI researchers overall (N=159) 73% support (definitely or probably) 14% unsure 13% do not support (probably or definitely) ADNI physician-researchers (N=68) 84% support (definite or probable) 3% unsure 13% do not support (probably or definitely)
22 ADNI researchers endorsing a policy of disclosure of amyloid-imaging information to participants with normal cognition ADNI researchers overall (N=159) 58% support (definitely or probably) 23% unsure 19% do not support (probably or definitely) ADNI physician-researchers (N=68) 56% support (definite or probable) 18% unsure 26 % do not support (probably or definitely)
23 Your Comments In Favor Once approved, subjects benefit from having had the test and are entitled to the results, assuming the processing procedures are standard. In the past, the only reason we have not reported these results is because they are not provided d to the site. I believe the ADNI participants have a right to know their amyloid imaging results. I also believe that we have an ethical obligation to inform the participants about APOE4 status
24 Your Comments - Against we still do not have enough information relating to the implications of amyloid positivity in MCI and especially in normal cognition may bias cognitive performance - ie. perform worse than they normally would if they are not aware of any underlying disease process - all cognitive data will have to be analyzed separately for those who are unaware of their diagnosis vs. those who are. h i t d d ill f d li i l lt changing study procedures will confound clinical results and outcomes with partial knowledge of biomarkers.
25 Your Comments - Thoughtful In general, I agree with returning results. The concern is that it is not clear what the results mean and there is always the risk that subjects will interpret t results incorrectly, regardless of how much we explain that we are still in the early stages of trying to determine the meaningfulness of these results. At the end of the day though, h they are adults capable of making their own decisions in the MCI and normal cohort, and in large part in the AD cohort too.
26 Your Comments - Thoughtful We are not the participant's physician. Results such as this should come from someone who has an ongoing role and will be able to deal with the participants p emotional and medical needs if they were PET PIB positive.
27 Your Comments Would only support if disclosure was done as part of the research study -with ih outcome measurements about the knowledge as may affect the subject's wellbeing and the integrity of the ADNI data
28 Summary The vast majority of ADNI investigators do not currently return amyloid imaging results to ADNI participants (~90% across all diagnostic groups). Requests for amyloid imaging results from ADNI participants are not uncommon -- 20% of ADNI investigators report requests from more than half of participants i t with normal cognition, and 22% report requests from more than half of participants with MCI. The majority of ADNI investigators would support the return of amyloid The majority of ADNI investigators would support the return of amyloid imaging results to participants with MCI and normal cognition, given FDA approval of Florbetapir.
29 Current Recommendations of the RORR Working Group
30 Framework for Recommendations
31 Summary of RORR Recommendations 1. Amyloid imaging results should not be returned to cognitively normal or MCI ADNI participants. i t 1. Amyloid imaging results may be returned to ADNI participants with dementia. 1. Amyloid imaging results should only be returned when requested. 1. Amyloid imaging interpretation should only be performed by qualified individuals.
32 Summary of RORR Recommendations 5. Amyloid imaging results should ideally be returned by non-adni clinicians. 5. Investigators should document the return of all amyloid imaging results. 5. ADNI investigators and staff should not use amyloid imaging to aid in diagnostic determination for ADNI.
33 Working Group on Return of Research Results
Indiana University School of Medicine, Indianapolis, IN USA 1
GWAS and Candidate Studies of MRI and Amyloid PET Phenotypes for Alzheimer's Disease Andrew J. Saykin Depts. of Radiology & Imaging Sciences and Medical & Molecular Genetics, Neurology & Psychiatry; Indiana
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