==== Front Alzheimers Dement (Amst)Alzheimers Dement (Amst)Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring2352-8729Elsevier S2352-8729(18)30028-910.1016/j.dadm.2018.05.003Diagnostic Assessment & PrognosisAmyloid positron emission tomography candidates may focus more on benefits than risks of results disclosure Lingler Jennifer H. linglerj@pitt.eduab∗Roberts J. Scott cKim Hyejin aMorris Jonna L. aHu Lu dMattos Meghan eMcDade Eric fLopez Oscar L. bga Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, PA, USAb Alzheimer Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USAc Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USAd Department of Population Health, New York University School of Medicine, New York, NY, USAe Department of Acute & Specialty Care, School of Nursing, University of Virginia, Charlottesville, VA, USAf Department of Neurology, School of Medicine, Washington University, St. Louis, MI, USAg Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA∗ Corresponding author. Tel.: 412-383-5214; Fax: 412-383-7293. linglerj@pitt.edu30 5 2018 2018 30 5 2018 10 413 420 © 2018 The Authors2018This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Introduction Given mounting calls to disclose biomarker test results to research participants, we explored factors underlying decisions by patients with mild cognitive impairment to receive amyloid imaging results. Methods Prospective, qualitative interviews were conducted with 59 participants (30 = mild cognitive impairment patients, 29 = care partners) from the scan arm of a randomized controlled trial on the effects of amyloid PET results disclosure in an Alzheimer Disease Research Center setting. Results Sixty-three percent of the participants were female, with an average age of 72.9 years, and most had greater than a high school level of education (80%). Primary motivations included: (1) better understanding one's mild cognitive impairment etiology and prognosis to plan ahead, and (2) learning one's brain amyloid status for knowledge's sake, regardless of whether the information is actionable. Most participants demonstrated an adequate understanding of the scan's limitations, yet instances of characterizing amyloid PET as a definitive test for Alzheimer's disease occurred. Mention of potential drawbacks, such as negative psychological outcomes, was minimal, even among care partners. Discussion Findings demonstrate a risk of disproportionate focus on possible benefits of testing among amyloid scan candidates and suggest a need to clearly emphasize the limitations of amyloid PET when counseling cognitively impaired patients and their families before testing. Future research should examine whether minimizing drawbacks at the pre-imaging stage has adverse consequences on results disclosure. Keywords EthicsMild cognitive impairmentAlzheimer's diseaseAmyloid PETDecision-making ==== Body 1 Introduction Despite the rapid proliferation of imaging-based and other biomarkers for Alzheimer's disease (AD) in research and practice, investigations into how patients and families view undergoing predictive or diagnostic testing for AD are limited. Understanding the motivations for, and perceived drawbacks of, pursuing such testing will be critical to developing best practices for providing information and support to candidates for AD biomarker testing. The need for such data is underscored, on the one hand, by advocates for early detection of AD who are working to minimize barriers to diagnostic testing [1], and on the other hand, by commentators who caution against indiscriminately screening for AD pathology in the absence of a preventative or curative intervention for those who test positive [2], [3]. Regarding positron emission tomography (PET) amyloid imaging, there is growing consensus that patients and research participants who will receive their scan results should be adequately counseled before imaging [4], [5], [6], [7]. Efforts to develop such pretest counseling (PTC) protocols have focused on considerations unique to cognitively healthy individuals [8] and those with mild cognitive impairment (MCI) [7]. Early evaluations of protocols to inform MCI patients of the benefits, risks, and limitations of amyloid PET have shown PTC to be well received and comprehensible to patients [7]. Yet, prospective studies of factors influencing real-time decisions to pursue amyloid imaging are limited. One recent study documented that the ability to better understand one's brain heath and make future decisions to be the main reasons MCI research participants seek amyloid PET results [9]. Extending this line of inquiry, we examined factors influencing decisions to pursue amyloid PET among both scan candidates with MCI and their family members, focusing on a critical 2-week window following PTC, but before scheduling a scan. 2 Methods 2.1 Study design, sample, and setting We conducted a prospective, interview-based qualitative study as part of a larger, ongoing investigation of how amyloid PET disclosure impacts the understanding of and ability to cope with a diagnosis of MCI. Patients with MCI and their care partners (typically family members) were recruited into the ongoing parent study from the University of Pittsburgh Alzheimer Disease Research Center (ADRC; NIA grant P50 AG005133) beginning in October of 2015. Of the 113 ADRC participants invited by the ADRC staff, 75 (66%) agreed to be referred to the parent study; to date, 72 of those have enrolled. Primary reasons for declining to participate in the parent study included health problems on the part of either the patient or the care partner and concerns that the study was very time consuming. Inclusion criteria for the parent study were as follows: (1) a current ADRC consensus diagnosis of MCI (isolated impairment in memory, isolated deficit in non-memory domain, or mild deficits in multiple cognitive domains) [10]; (2) the capacity to provide informed consent as verified by the University of San Diego Brief Assessment of Capacity to Consent [11], [12]; (3) residence within 100 miles from the university (to facilitate home study visits); and (4) having a care partner who also consented to participate. Exclusion criteria were as follows: (1) familial AD genetic mutation carriers (this group already has biomarker-based AD risk information); and (2) active, untreated mood, or anxiety disorders defined as a Hamilton Depression Rating Scale [13] score of >17 or a Spielberger State Anxiety [14] score of >40. Care partner participants had to be 18 years of age or older. The sample for the sub study reported herein consists of the first 30 dyads (participant + care partner) to undergo a qualitative interview as described below. 2.2 Procedures This research was approved by the University of Pittsburgh Institutional Review Board. All patients with MCI and their care partners provided informed consent, but one care partner later declined the qualitative interview. Baseline interviews for the parent study included a 10-point self-rating of interest in pursuing amyloid PET and receiving the scan results. Higher ratings indicated greater interest in obtaining a scan. Participants completed this scale at baseline and following the qualitative interview that is the focus of this report. After baseline data collection, all parent study participants were randomized to a scan group with results disclosure or to a comparison group with an MCI education session. All participants were informed of their group assignment at the completion of the baseline visit. An exception was made for individuals who had previously undergone a research PET amyloid scan under a protocol that precluded results disclosure. The randomization process was overridden in these cases, and these individuals were placed in the scan group, with the opportunity to undergo a new amyloid PET scan and results disclosure. Scan group participants underwent formal PTC. Based on a protocol described previously, PTC sessions were conducted by master's prepared clinicians and included an overview of MCI and AD, followed by a presentation of the purpose of amyloid imaging and its potential pros, cons, and limitations in the context of MCI [7]. At the end of PTC, dyads were encouraged to carefully consider whether or not they wanted to pursue amyloid imaging. During a 2-week interim between PTC and the scheduling of the scan (if decided upon), a qualitative interview was conducted to capture participants' perspectives on the decision-making process in real time. The interview guide contained five semi-structured questions (e.g., “Tell me about your experience with deciding whether or not to get the scan.”) and 15 follow-up probes (e.g., “What kinds of factors did you consider when making your decision?”). Questions were open-ended and neutrally worded (See Table 1). Interviewers were trained in qualitative data collection and instructed to probe for clarification when ambiguous or conflicting statements were made. Interviews were completed in participants' homes by two study staff members, one who interviewed the patient and another who simultaneously interviewed the care partner. Interviews were audio-recorded and transcribed verbatim.Table 1 Semi-structured interview guide with probes Introduction The purpose of this interview is to learn about your experiences with deciding whether or not to undergo [or have your family member undergo] a special type of brain scan (amyloid scan) with the option of getting the results of that scan afterward. It is important that you express yourself openly. There are no right or wrong answers. We want to know what you think. 1. Tell me about your (or your family member's) decision to participate in an amyloid brain scan research study in the first place. Probes: Why did you (or is your family member) participate in the research study? What motivated you (or your family member) to volunteer for a brain scan study? 2. What were your first thoughts when you were asked if you wanted to be in a study where you could receive your (or your family member's) research scan results? 3. Tell me about your experience with deciding whether or not to get the scan and receive its results. Probes: What kinds of factors did you consider when making your decision? Did you feel like you had all of the information that you needed in making your decision? If not, what other information would have been helpful? Who, if anyone, did you discuss your decision with? What was that discussion like? How was your decision influenced by the fact that the scan was part of a research study, as opposed to something that your regular physician ordered? How do you think the process of making this decision was different from other medical decisions you've made in the past? 4. At this point, have you (or has your family member) made a final decision or are you still thinking about whether or not to do the next scan and receive your results? If a decision has been made: How do you feel about your decision? What, if anything, if your biggest concern about your decision at this point in time? Would you say that the information session influenced this decision? If so, how? Were you leaning one way or another when you enrolled in the study? 5. How would you describe the type and amount of support that you have received during the decision-making process? NOTE. Interview conducted within 2 weeks of formal pretest counseling session for amyloid imaging. 2.3 Data analysis The current report describes findings from qualitative analysis of the first 30 dyads in the scan group to undergo a qualitative interview after PTC. Descriptive analysis of this subsample was conducted using IBM SPSS Statistics for Windows, version 24.0. Interview data were managed in ATLAS.ti 7.0 and analyzed using the qualitative method of constant comparison [15]. This method centers the analysis on comparing and contrasting data between and within interview transcripts to determine whether incidents fit or do not fit within emerging categories and the properties that define them. Although each member of the dyad was interviewed separately to ensure adequate opportunity for the expression of individual thoughts and feelings, their data were analyzed together to form a complete representation of factors influencing the decision to be scanned. Line-by-line coding of transcripts was performed by three coders, categories were generated to label codes as similarities emerged, and themes were developed as a result of the constant comparison analysis. 3 Results 3.1 Sample characteristics As Table 2 indicates, 63% of patient participants were female and 87% Caucasian, with an average age of 73 years. Care partners were also primarily female (83%) and Caucasian (86%), but slightly younger, with an average age of 68 years. Both patients and care partners reported relatively high levels of educational attainment, with 80% of the total sample having more than a high school level of education. Most participants had expressed a high level of interest in undergoing amyloid imaging on enrollment into the parent study (Table 2). At the time of the qualitative interview, 24 of the 30 patients with MCI had made a decision to proceed with the scan; the remaining individuals were either still deciding (n = 4) or had decided against it (n = 2). Analysis of the decision-making interviews revealed rich information concerning participants' motivations for, and perceived drawbacks of, pursuing amyloid imaging. Key features of the decision-making dynamic within this highly motivated group were also identified.Table 2 Sample characteristics Variable Patient (N = 30) Family member (N = 29) Mean age in years (SD) 72.9 (8.94) 68.2 (9.67) Education, n (%)