Table 1 Overview of studies presenting empirical evidence
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 |