Participants randomized to intensive SBP control had greater risk of hypotension and possibly syncope, but not falls. The greater risk of developing these events associated with intensive treatment did not vary according to age.

Rationale and Objectives-The rates of enrollment of volunteers for brain magnetic resonance imaging (MRI) studies vary by demographic and clinical characteristics. We use data from a large MRI study to identify factors associated with differential enrollment and to examine potential biases this may produce in study results.Materials and Methods-Results from recruitment of 1,431 women into the MRI substudy of the Women's Health Initiative Memory Study (WHIMS-MRI) are described. A sensitivity analysis was conducted to estimate the degree of bias associated with missing data on estimates of risk factor relationships.Results-Of 2,345 women contacted from an established cohort of women older than 70 years of age, 72% consented to undergo screening for WHIMS-MRI. Scanning was ultimately completed on 61%. Completion rates varied according to a range of sociodemographic, lifestyle, and clinical characteristics that may be related to study outcomes. Plausible levels of selective enrollment in magnetic resonance imaging studies may produce moderate biases (< ±20%) in characterizations of risk factor relationships. Adverse events, such as claustrophobia, occurred during 1.7% of the attempted scans and, in 0.8% of instances, led to lost data.Conclusions-Enrollment of older women into brain imaging studies is feasible, although selection biases may limit how well study cohorts reflect more general populations.

Objective: To examine the performance of the Telephone Interview for Cognitive Status (TICS) for identifying participants appropriate for trials of physical activity and cognitive training interventions. Methods: Volunteers (N = 343), ages 70–85 years, who were being recruited for a pilot clinical trial on approaches to prevent cognitive decline, were administered TICS and required to score ≥31 prior to an invitation to attend clinic-based assessments. The frequencies of contraindications for physical activity and cognitive training interventions were tallied for individuals grouped by TICS scores. Relationships between TICS scores and other measures of cognitive function were described by scatterplots and correlation coefficients. Results: Eligibility criteria to identify candidates who were appropriate candidates for the trial interventions excluded 51.7% of the volunteers with TICS<31. TICS scores above this range were not strongly related to cognition or attendance at screening visits, however overall enrollment yields were approximately half for participants with TICS = 31 versus TICS = 41, and increased in a graded fashion throughout the range of scores. Conclusions: Use of TICS to define eligibility criteria in trials of physical activity and cognitive training interventions may not be worthwhile in that many individuals with low scores would already be eliminated by intervention-specific criteria and the relationship of TICS with clinic-based tests of cognitive function among appropriate candidates for these interventions may be weak. TICS may be most useful in these trials to identify candidates for oversampling in order to obtain a balanced cohort of participants at risk for cognitive decline.

Background US POINTER is a multisite randomized clinical trial funded by the Alzheimer's Association. It is designed to evaluate whether different lifestyle interventions (exercise, nutrition, and cognitive and social stimulation) protect cognitive function over a 2‐year period in approximately 2000 older adults. Method We have designed a web‐based safety tracking system (STS) that meets the complexity of this trial that involves oversight of participants as they carry out the interventions by community partners at 5 trial sites. Result In US POINTER, participants interact with community interventionists as well as research clinic staff and clinicians. All personnel are charged with documenting potential safety events. We designed the STS to allow timely and accurate collection of safety data by study personnel regardless of their role in the study or the location of their contact with the participant. This ensures that safety data are complete. Health events entered by interventionists and clinical trial staff are reviewed by local site clinicians to determine if the event meets criteria for an adverse event (AE). If so, the clinician then determines the expectedness, relatedness, and risk of harm of the AE. These determinations are captured on the STS. Safety reporting is then reviewed and adjudicated by the central Safety Manager and the trial Safety Officer and, if needed, by the Safety Committee. The STS facilitates these processes and ensures the accuracy and consistency of safety data reporting throughout the trial. Importantly, the trial design requires that study personnel, Safety Manager, Safety Officer, and the Data Coordinating Center remain masked or unmasked as to study interventions and outcomes. The STS was designed so that access to the STS is restricted by study role in order to maintain the intervention assignment mask. These attributes of the STS help to maintain the rigor and integrity of the trial. Conclusion The innovation of the POINTER STS is that it allows for reporting of AEs obtained during any point of contact between the participant, community partners and study personnel, and allows for a multi‐level review of safety events in a centralized, efficient and timely manner thus ensuring participant’s ongoing safety throughout the trial.