Publications

BACKGROUND

Analyses from double-blind randomized trials have reported lower mortality among participants who were more adherent to placebo compared with those who were less adherent. We explored this phenomenon by analyzing data from the placebo arm of the Heart and Estrogen/Progestin Replacement Study (HERS), a randomized, double-blind, placebo-controlled trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Our primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the HERS. Secondary aims included assessment of the association between placebo adherence and cause-specific morbidity and mortality.

METHODS

Participants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication during each individual's participation in the study, whereas those with "lower placebo adherence" took less than 75%. The primary outcome was in-study all-cause mortality.

RESULTS

More adherent participants had significantly lower total mortality compared with less adherent participants (hazard ratio, 0.52; 95% confidence interval, 0.29-0.93). Adjusting for available confounders did not change the magnitude or significance of the estimates. Analyses revealed that the association of higher adherence and mortality might be explained, in part, by time-dependent confounding.

CONCLUSIONS

Analyses of the HERS data support a strong association between adherence to placebo study medication and mortality. Although probably not due to simple confounding by healthy lifestyle factors, the underlying mechanism for the association remains unclear. Further analyses of this association are necessary to explain this observation.

This pilot study examined the effects of a teacher-taught, locomotor skill (LMS)-based physical activity (PA) program on the LMS and PA levels of minority preschooler-aged children. Eight low-socioeconomic status preschool classrooms were randomized into LMS-PA (LMS-oriented lesson plans) or control group (supervised free playtime). Interventions were delivered for 30 min/day, five days/week for six months. Changes in PA (accelerometer) and LMS variables were assessed with MANCOVA. LMS-PA group exhibited a significant reduction in during-preschool (F (1,16) = 6.34, p = .02, d = 0.02) and total daily (F (1,16) = 9.78, p = .01, d = 0.30) percent time spent in sedentary activity. LMS-PA group also exhibited significant improvement in leaping skills, F (1, 51) = 7.18, p = .01, d = 0.80). No other, significant changes were observed. The implementation of a teacher-taught, LMS-based PA program could potentially improve LMS and reduce sedentary time of minority preschoolers.

BACKGROUND

Most preschool centers provide two 30-min sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 min. This paper describes the design and baseline participant characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. The STEP study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity (SBS-PA) implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity (PA) in preschoolers.

METHODS/DESIGN

Ten preschool centers serving low-income families were randomized into SBS-PA versus unstructured PA (UPA). SBS-PA schools were asked to implement age-appropriate 10 min structured PA routines within the classroom setting, twice daily, followed by 20 min of usual unstructured playtime. UPA intervention consisted of 30 min of supervised unstructured free playtime twice daily. Interventions were implemented during the morning and afternoon designated gross-motor playtime for 30 min/session, five days/week for six months. Outcome measures were between group difference in during-preschool PA (accelerometers and direct observation) over six-months. Ten preschool centers, representing 34 classrooms and 315 children, enrolled in the study. The average age and BMI percentile for the participants was 4.1 ± 0.8 years and 69th percentile, respectively. Participants spent 74% and 6% of their preschool day engaged in sedentary and MVPA, respectively.

DISCUSSION

Results from the STEP intervention could provide evidence that a PA policy that exposes preschoolers to shorter bouts of structured PA throughout the preschool day could potentially increase preschoolers' PA levels.

BACKGROUND

New patient-centered models of ambulatory care aim to substitute better primary care for preventable acute care within existing primary care practices. This study aims to identify whether mental illness and other characteristics of primary care patients are related to risk for an acute event for an ambulatory care-sensitive condition (ACSC).

METHODS

We conducted a 2-year, longitudinal analysis comparing ambulatory care-sensitive admissions and emergency department (ED) visits for a cohort of 18,526 primary care patients followed in 5 veterans affairs (VA) primary care sites. We compared rates, risks, and costs of ACSC-related acute events during a follow-up year for patients with and without mental illness seen during the previous year in primary care.

RESULTS

The 12-month rate of ACSC admissions was 31.7 admissions per 1000 patients with mental health diagnoses compared with 21.0 admissions per 1000 patients without (P=0.0009). The ACSC-associated ED visit rate was also significantly higher (P<0.0001). In adjusted analyses controlling for demographics, chronic disease, illness severity, and prior ambulatory care, those with depression or drug use disorders had higher odds of receiving ACSC-related acute care (odds ratio=1.10, 95% confidence interval: 1.03, 1.17 for depression; odds ratio=1.48, 95% confidence interval: 1.05, 1.99 for drug use disorders). Costs per admission and ED visit were similar across patient groups. Higher medication use and lower medication regimen complexity were significantly associated with decreased risk for ACSC events.

CONCLUSIONS

Prior mental health diagnoses and medication use were independent risk factors for ACSC-related acute care. These risk factors require focused attention if the full benefits of new primary care models are to be achieved.