Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling.

Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Although lifestyle treatments produce weight reductions of sufficient magnitude to improve health, the existing research is limited with respect to the long-term maintenance of treatment effects and the dissemination of services to underserved populations. Recent studies have demonstrated the feasibility of delivering lifestyle programs through the infrastructure of the U.S. Cooperative Extension Service (CES), which has >2900 offices nationwide and whose mission includes nutrition education and health promotion. In addition, several randomized trials have shown that supplementing lifestyle treatment with extended-care programs consisting of either face-to-face sessions or individual telephone counseling can improve the maintenance of weight loss. However, both options entail relatively high costs that inhibit adoption in rural communities. The delivery of extended care via group-based telephone intervention may represent a promising, cost-effective alternative that is well suited to rural residents who tend to be isolated, have heightened concerns about privacy, and report lower quality of life. The Rural Lifestyle Eating and Activity Program (Rural LEAP) is a randomized trial, conducted via CES offices in rural communities, targeted to adults with obesity (n = 528), and designed to evaluate the effectiveness and cost-effectiveness of extended-care programs delivered via group or individual telephone counseling compared to an education control condition on long-term changes in body weight.

Venous thromboembolism incidence, recurrence, and mortality based on Women's Health Initiative data and Medicare claims.

INTRODUCTION: Our objective was to compare Medicare claims to physician review and adjudication of medical records for identifying venous thromboembolism (VTE), and to assess VTE incidence, recurrence, and mortality in a large national cohort of post-menopausal women followed up to 19years. MATERIALS AND METHODS: We used detailed clinical data from the Women's Health Initiative (WHI) linked to Medicare claims. Agreement between data sources was evaluated among 16,003 women during 1993-2010. A claims-based definition was selected to analyze VTE occurrence and impact among 71,267 women during 1993-2012. RESULTS: Our VTE definition had 83% sensitivity. Positive predictive value was 69% when all records were included, and 94% after limiting Medicare records to those with a WHI hospitalization adjudicated. Annualized VTE incidence was 4.06/1000person-years (PY), recurrence was 5.30/100PY, and both rates varied by race/ethnicity. Post-VTE mortality within 1year was 22.49% from all causes, including 1.01% from pulmonary embolism, 10.40% from cancer, and 11.08% from other causes. Cancer-related VTE compared to non-cancer VTE had significantly (p<0.001) higher recurrence (9.86/100PY vs. 4.43/100PY) and mortality from all causes (45.89% vs. 12.28%), but not from pulmonary embolism (0.40% vs. 1.27%). CONCLUSIONS: Medicare claims compared reasonably well to physician adjudication. The combined data sources provided new insights about VTE burden and prognosis in older women.

Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial.

OBJECTIVE: To evaluate the effects and costs of three doses of behavioral weight-loss treatment delivered via Cooperative Extension Offices in rural communities. METHODS: Obese adults (N = 612) were randomly assigned to low, moderate, or high doses of behavioral treatment (i.e., 16, 32, or 48 sessions over two years) or to a control condition that received nutrition education without instruction in behavior modification strategies. RESULTS: Two-year mean reductions in initial body weight were 2.9% (95% Credible Interval = 1.7-4.3), 3.5% (2.0-4.8), 6.7% (5.3-7.9), and 6.8% (5.5-8.1) for the control, low-, moderate-, and high-dose conditions, respectively. The moderate-dose treatment produced weight losses similar to the high-dose condition and significantly larger than the low-dose and control conditions (posterior probability > 0.996). The percentages of participants who achieved weight reductions ≥ 5% at two years were significantly higher in the moderate-dose (58%) and high-dose (58%) conditions compared with low-dose (43%) and control (40%) conditions (posterior probability > 0.996). Cost-effectiveness analyses favored the moderate-dose treatment over all other conditions. CONCLUSIONS: A moderate dose of behavioral treatment produced two-year weight reductions comparable to high-dose treatment but at a lower cost. These findings have important policy implications for the dissemination of weight-loss interventions into communities with limited resources.

Comparison of Medicare claims versus physician adjudication for identifying stroke outcomes in the Women's Health Initiative.

BACKGROUND AND PURPOSE: Many studies use medical record review for ascertaining outcomes. One large, longitudinal study, the Women's Health Initiative (WHI), ascertains strokes using participant self-report and subsequent physician review of medical records. This is resource-intensive. Herein, we assess whether Medicare data can reliably assess stroke events in the WHI. METHODS: Subjects were WHI participants with fee-for-service Medicare. Four stroke definitions were created for Medicare data using discharge diagnoses in hospitalization claims: definition 1, stroke codes in any position; definition 2, primary position stroke codes; and definitions 3 and 4, hemorrhagic and ischemic stroke codes, respectively. WHI data were randomly split into training (50%) and test sets. A concordance matrix was used to examine the agreement between WHI and Medicare stroke diagnosis. A WHI stroke and a Medicare stroke were considered a match if they occurred within ±7 days of each other. Refined analyses excluded Medicare events when medical records were unavailable for comparison. RESULTS: Training data consisted of 24 428 randomly selected participants. There were 577 WHI strokes and 557 Medicare strokes using definition 1. Of these, 478 were a match. With regard to algorithm performance, specificity was 99.7%, negative predictive value was 99.7%, sensitivity was 82.8%, positive predictive value was 85.8%, and κ=0.84. Performance was similar for test data. Whereas specificity and negative predictive value exceeded 99%, sensitivity ranged from 75% to 88% and positive predictive value ranged from 80% to 90% across stroke definitions. CONCLUSIONS: Medicare data seem useful for population-based stroke research; however, performance characteristics depend on the definition selected.

Demographic and health factors associated with enrollment in posttrial studies: the Women's Health Initiative Hormone Therapy Trials.

BACKGROUND: After clinical trials end, continued follow-up of the assembled cohort often is desirable for additional research. Factors influencing participants' decisions to consent to additional follow-up and how these shape posttrial cohorts have not been broadly studied. PURPOSE: We examined how two re-enrollment campaigns and the passage of time altered features of the posttrial cohorts compared with the original Women's Health Initiative (WHI) Hormone Therapy clinical trials. METHODS: We examined associations that markers of sociodemography, health, lifestyle, and on-trial experiences had with re-enrollment and contrasted the characteristics of successive posttrial cohorts with those of the original enrollees. RESULTS: The posttrial enrollment campaigns re-enrolled 81.1% and 82.5% of available women, respectively. Women who re-enrolled tended to have better health characteristics than those not re-enrolled. Compared to women of comparable age in the original cohort, women retained for the second posttrial follow-up less often had a history of cardiovascular disease (odds ratio (OR) = 0.36), hypertension (OR = 0.57), diabetes (OR = 0.59), or measured cognitive deficit (OR = 0.40). These women more often had graduated from high school (OR = 1.72) and had participated in other WHI trials (OR = 1.76). LIMITATIONS: We have examined experience with creating follow-up cohorts from participants in a single study. Thus, our findings may not apply to other cohorts and protocols. CONCLUSIONS: Posttrial enrollment in follow-up studies can be successful; however, the characteristics of the resulting cohort may differ substantially from the originally assembled group of trial participants. Collection during the original trial of potential predictors of differential re-enrollment may strengthen interpretation of findings.

Comparing Costs of Telephone vs Face-to-Face Extended-Care Programs for the Management of Obesity in Rural Settings.

BACKGROUND: A major challenge after successful weight loss is continuing the behaviors required for long-term weight maintenance. This challenge can be exacerbated in rural areas with limited local support resources. OBJECTIVE: This study describes and compares program costs and cost effectiveness for 12-month extended-care lifestyle maintenance programs after an initial 6-month weight-loss program. DESIGN: We conducted a 1-year prospective randomized controlled clinical trial. PARTICIPANTS/SETTING: The study included 215 female participants age 50 years or older from rural areas who completed an initial 6-month lifestyle program for weight loss. The study was conducted from June 1, 2003 to May 31, 2007. INTERVENTION: The intervention was delivered through local Cooperative Extension Service offices in rural Florida. Participants were randomly assigned to a 12-month extended-care program using either individual telephone counseling (n=67), group face-to-face counseling (n=74), or a mail/control group (n=74). MAIN OUTCOME MEASURES: Program delivery costs, weight loss, and self-reported health status were directly assessed through questionnaires and program activity logs. Costs were estimated across a range of enrollment sizes to allow inferences beyond the study sample. STATISTICAL ANALYSES PERFORMED: Nonparametric and parametric tests of differences across groups for program outcomes were combined with direct program cost estimates and expected value calculations to determine which scales of operation favored alternative formats for lifestyle maintenance. RESULTS: Median weight regain during the intervention year was 1.7 kg for participants in the face-to-face format, 2.1 kg for the telephone format, and 3.1 kg for the mail/control format. For a typical group size of 13 participants, the face-to-face format had higher fixed costs, which translated into higher overall program costs ($420 per participant) when compared with individual telephone counseling ($268 per participant) and control ($226 per participant) programs. Although the net weight lost after the 12-month maintenance program was higher for the face-to-face and telephone programs compared with the control group, the average cost per expected kilogram of weight lost was higher for the face-to-face program ($47/kg) compared with the other two programs (approximately $33/kg for telephone and control). CONCLUSIONS: Both the scale of operations and local demand for programs are important considerations in selecting a delivery format for lifestyle maintenance. In this study, the telephone format had a lower cost but similar outcomes compared with the face-to-face format.