Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience.

BACKGROUND: Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. PURPOSE: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. METHODS: Women from three geographic areas with a weekly average of ≥14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. RESULTS: Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2% CONCLUSIONS: Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.

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.

Psychological and social characteristics associated with religiosity in Women's Health Initiative participants.

Measures of religiosity are linked to health outcomes, possibly indicating mediating effects of associated psychological and social factors. We examined cross-sectional data from 92,539 postmenopausal participants of the Women's Health Initiative Observational Study who responded to questions on religious service attendance, psychological characteristics, and social support domains. We present odds ratios from multiple logistic regressions controlling for covariates. Women attending services weekly during the past month, compared with those not attending at all in the past month, were less likely to be depressed [OR = 0.78; CI = 0.74-0.83] or characterized by cynical hostility [OR = 0.94; CI = 0.90-0.98], and more likely to be optimistic [OR = 1.22; CI = 1.17-1.26]. They were also more likely to report overall positive social support [OR = 1.28; CI = 1.24-1.33], as well as social support of four subtypes (emotional/informational support, affection support, tangible support, and positive social interaction), and were less likely to report social strain [OR = 0.91; CI = 0.88-0.94]. However, those attending more or less than weekly were not less likely to be characterized by cynical hostility, nor were they less likely to report social strain, compared to those not attending during the past month.

Recruiting patients with breast cancer and their families to behavioral research in the post-HIPAA period.

PURPOSE/OBJECTIVES: To describe a process for, response rates of, and indicated interest in recruiting patients with breast cancer and their spouses and family members from a clinical setting into behavioral and psychiatric research studies since the Health Insurance Portability and Accountability Act (HIPAA) regulations have taken effect. DATA SOURCES: Published articles, books and book chapters, MEDLINE, government agency information and HIPAA regulatory Web sites, and survey data. DATA SYNTHESIS: Response rates among the three target groups--patients, spouses and partners, and female first-degree relatives--were 77%, 95%, and 88%, respectively. Interest was high in the three target groups, with 77%, 87%, and 65% of responding patients, spouses and partners, and female first-degree relatives, respectively. CONCLUSIONS: Taken together, these data indicate that high participation rates can be expected from patients with breast cancer and their families in clinical settings. IMPLICATIONS FOR NURSING: Regulations pose barriers to patient and family recruitment, but thoughtful systems actually can improve rates of recruitment.