Importance Clinical guidelines currently recommend against amyloid imaging for cognitively unimpaired persons. The goal of Alzheimer's disease (AD) prevention, together with advances in understanding the pathophysiology of AD, however, has led to trials testing drugs in cognitively unimpaired persons who show evidence of AD biomarkers. Assuming the eventual success of such trials, millions of patients will be affected. There is a need to understand the effects of biomarker disclosure on those individuals. Design The Study of Knowledge and Reactions to Amyloid Testing (SOKRATES) involved 2 semistructured telephone interviews with individuals who received amyloid PET scan results as part of screening for research participation. Post-disclosure interviews were conducted at 4 to 12 weeks and again 1 year later. Data were collected from November 5, 2014 to November 30, 2016. Interviews were transcribed and coded in NVivo 12.0. Participants 80 adults aged 65 and older: 50 who received "elevated" and 30 who received "not-elevated" amyloid PET scan results. Main outcomes Interviews examined four domains: (1) comprehension of the amyloid PET scan result; (2) implications of the result for sense of self, memory, and future; (3) sharing of results with others; and (4) AD risk-reduction behaviors.
IMPORTANCEThe goal of Alzheimer disease (AD) prevention together with advances in understanding the pathophysiology of AD have led to clinical trials testing drugs in cognitively unimpaired persons who show evidence of AD biomarkers. Data are needed to inform the processes of describing AD biomarkers to cognitively normal adults and assessing their understanding of this knowledge.OBJECTIVE To determine the comprehension of an elevated amyloid positron emission tomographic (PET) biomarker result by cognitively unimpaired adults. DESIGN, SETTING, AND PARTICIPANTSThe Study of Knowledge and Reactions to Amyloid Testing, a substudy of an AD prevention trial, involved 2 semistructured telephone interviews with 80 participants recruited from 9 study sites: 50 received elevated and 30 received not elevated amyloid PET scan results. Interviews were conducted 4 to 12 weeks after result disclosure and again 1 year later. Data presented here were collected from November 5, 2014, through December 10, 2015. The 50 participants included in this study were cognitively normal, aged 65 to 85 years, evenly distributed by gender, and had elevated amyloid PET results. Subsequent reports will examine persons with "not elevated" results and compare the influence of the different results. MAIN OUTCOMES AND MEASURES Participant comprehension of an elevated amyloid resultwas assessed by analyzing their responses to the following questions: "What was the result of your amyloid PET scan?" (followed by "Can you tell me in your own words what that means?" or "How would you explain it to a friend?"), "Was it the result you expected?" and "Did the result teach you anything or clarify anything for you?" RESULTS Of the 50 participants aged 65 to 85 years, 49 (98%) were white, 40 (80%) reported a family history of AD, and 30 (60%) had a postgraduate educational level. Most participants (31 [62%]) understood that elevated amyloid conferred an increased but uncertain risk of developing AD. Some desired understanding of the term elevated other than its being a categorical result enabling trial entry eligibility; they wanted information regarding how elevated their amyloid was, how close to the study threshold they were, or percentages, numbers, or a scale to help them make sense of the result.CONCLUSIONS AND RELEVANCE Including an explanation of how and why a dimensional biomarker is converted to a categorical classification would enhance future AD biomarker clinical trials and educational materials.
INTRODUCTION: One of the early physiologic changes in pre-eclampsia (PE) is increased vascular permeability that can cause hemoconcentration. We hypothesized higher hemoglobin (Hgb) may be an early marker for development of PE. METHODS: During a 3 year period, records of women without known renal disease and a gestational age at delivery (GAD) >24 weeks were evaluated. PE was defined as elevated blood pressure (>140/90) and increased protein: creatinine ratio (PCR>0.29). The Hgb obtained between GA 22-32 weeks were reviewed. In addition to GAD, maternal age (MA) and body mass index (BMI) was recorded. Odds ratios (OR, 95% CI) were determined for the development of PE in women with Hgb >12.9 and >13.9 grams. RESULTS: Of the 10,418 deliveries, 901 (8.6%) were diagnosed with PE. Women with PE delivered earlier (37.2 ± 2.8 vs 38.6 ± 2.1 wks, P<.001) and had higher BMI (35.2 ± 7.1 vs 32.6 ± 6.2 Kg/M2, P<.001). Of the 396 women with a Hgb >12.9, 74 developed PE (OR 2.5, 1.8-3.1, P<.001). Other than GAD (34.4±5.5 vs 37.2±3.6 wks, P<.001), PE with Hgb>12.9 did not differ in MA or BMI. Of 44 women who had Hgb>13.9, 14 developed PE (OR 4.7, 2.5-8.9, P<.001). PE with Hgb>13.9 did not differ in GAD, MA or BMI, however sample size was limited. CONCLUSION: In this retrospective case control study, elevated Hgb was associated with PE. Most pregnant women have Hgb between 24 to 30 weeks. This inexpensive, ubiquitous test may provide an additional warning sign for the development of PE.
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