Skip to main content

Table 1 Overview of studies presenting empirical evidence

From: Disclosure of amyloid positron emission tomography results to individuals without dementia: a systematic review

Author (year) Objective Setting Design Population (n) Determinant Assessment time points Outcome measures Results Conclusion
Research context
 Researchers attitudes towards disclosure
  Shulman et al. (2013) [37] To evaluate nondisclosure policy Research Survey 159 ADNI investigators and research staff n.a. n.a. Practices and attitudes about returning amyloid imaging results Small minority of CN (45%) and MCI (40%) participants do not request PET results. Most ADNI investigators did not return amyloid results to CN (94%) and MCI (90%). Majority would support disclosure to CN (58%) and MCI (73%) if FDA approval. Emphasized need for guidance on disclosure strategy In view of FDA approval of amyloid imaging, disclosure to both CN and MCI is supported, and there is a need for 1) disclosure protocols and 2) knowledge on effect on participants
 Cognitively normal study participants attitudes towards disclosure
  Ott et al. (2016) [36] To assess the interest in knowledge of amyloid PET status Research Survey 164 CN n.a. n.a. Wishes to learn amyloid PET status and, if so, reasons for wanting to know 81% desired to know amyloid status, motivated by desire to participate in AD research (73%), and to prepare family for illness (60%). Main reason for not desiring amyloid status was due to depressed feelings (40%). 12% indicated to use information for making plans on ending their life when memory loss becomes imminent Stakeholders in AD prevention research generally wish to know information about their risk for developing AD to assist future planning.
  Gooblar et al. (2015) [32] To assess effect of education on disclosure attitude Research RCT 219 CN Education intervention (education: n = 119, placebo: n = 110) Pre- and postintervention Interest in disclosurea High preintervention interest (mean: 4.0 ± 1.1) in receiving amyloid imaging results, which significantly decreased after education versus placebo (OR 2.8, 95% CI 1.6–5.1) when controlled for preintervention level of interest Learning about limitations of disclosure somewhat tempers interest
  Grill et al. (2016) [33] To assess the impact of amyloid disclosure on trial participation willingness Research RCT 132 self-reported CN older adults Hypothetical ICF (transparent: n = 66, and blinded enrolment: n = 66) Postintervention Likelihood of enrollmentb No significant difference in willingness to participate between transparent (70%) and blinded (61%) group. Requirement of amyloid disclosure may not slow recruitment to preclinical AD trials
 Impact of disclosure
  Burns et al. (2017) [31] To assess effect of amyloid disclosure Research Prospective cohort study 97 CN older adults Amyloid status (amyloid positive: n = 27, amyloid negative: n = 70) Before and at disclosure, and 6 weeks and 6 months post-disclosure Depression (CES-D), anxiety (BAI), and test-related distress (IGT-AD) No difference in depressive symptoms, slight increase in test-related distress, and group by time interaction in anxiety, without significant group differences Disclosure has low risk of psychological harm
  Lim et al. (2016) [35] To assess impact of amyloid disclosure Research Prospective cohort study 11 CN older adults Psychoeducational program (amyloid positive: n = 3, amyloid negative: n = 8) Baseline, 9 and 18 months follow-up Subjective complaints (MAC-Q), depression (DASS-D), anxiety (DASS-A), stress symptoms (DASS-S), and impact of events scale (IES-R) Insufficient numbers for formal comparisons. Little change in psychological factors. Psychoeducational brochure rated as very useful. Disclosure of amyloid positivity motivated lifestyle changes Disclosing amyloid status to CN older adults, who requested the information, seems safe
  Vanderschaeghe et al. (2017) [42] To assess how patients perceive and experience disclosure Research Semi-structured interviews 38 amnestic MCI patients n.a. 2 weeks and 6 months post-disclosure Fixed set of interview elements 2/8 PET-positive patients experienced emotional difficulties. 3/30 PET-negative patients doubted whether they received the correct result Experienced advantages and disadvantages depended on outcome of PET result
  Grill et al. (2017) [43] To assess how patients perceive and experience disclosure Clinic Semi-structured telephone interview 26 patient-caregiver dyads, mostly with dementia, some MCI n.a. Post-disclosure (unspecified) Fixed set of interview elements Most patients would undergo amyloid PET again. Regardless of outcome, patients and caregivers commonly expressed relief on learning their results Amyloid PET may provide information that patients and families find useful
 Development of approach for amyloid disclosure
  Lingler et al. (2016) [30] Development of amyloid disclosure protocol Research RCT and focus group 10 MCI care dyads Mock disclosure (amyloid positive: n = 4, amyloid negative: n = 4, inconclusive: n = 2) Postintervention Satisfaction surveys, comprehension assessments, and focus groups Recommendations included pretest counseling, screening for anxiety and depression, separate days for consent procedure, imaging, and disclosure, and follow-up to monitor the impact of disclosure, anxiety, and depression MCI care dyads comprehended the information and were highly satisfied
  Harkins et al. (2015) [29] Development of amyloid disclosure protocol Research Modified Delphi method Experts n.a. n.a. n.a. Recommendations included pretest counseling, the use of participants’ own brain images during disclosure, take-home materials, and follow-up to address emerging questions Documents and process will be used in the A4 study
Clinical context
 Dementia specialists attitudes towards disclosure
  Klein and Kaye (2013) [34] To assess attitudes of neurologists specializing in dementia towards the use of amyloid imaging Clinic Survey 135 neurologists specializing in dementia n.a. n.a. Intention to use amyloid imaging in diagnosing AD and, if so, how they plan to use it 84% affirmed intention to use amyloid PET in practice. 24% intended to use PET for screening asymptomatic individuals. Patients should be counseled (92%) Specialists generally support disclosure, but recognize complexity of scan interpretation, and need for patient counseling
  1. A4 Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease, AD Alzheimer’s disease, ADNI Alzheimer’s Disease Neuroimaging Initiative, BAI Beck Anxiety Inventory, CES-D Center for Epidemiological Studies of Depression Scale, CI confidence interval, CN cognitively normal, DASS-A depression, anxiety, and stress scale, anxiety subscale, DASS-D depression, anxiety, and stress scale, depression subscale, DASS-S depression, anxiety, and stress scale, stress subscale, FDA Food and Drug Administration, ICF informed consent form, IES-R impact of events scale, revised edition, IGT-AD Impact of Genetic Testing for Alzheimer’s Disease, MAC-Q Memory Complaints Questionnaire, MCI mild cognitive impairment, n.a. non-applicable, OR odds ratio, PET positron emission tomography, RCT randomized controlled trial
  2. aFive-point Likert scale
  3. bSix-point Likert scale