New models for large prospective studies: is there a risk of throwing out the baby with the bathwater?

Manolio et al. (Am J Epidemiol. 2012;175:859-866) proposed that large cohort studies adopt novel models using "temporary assessment centers" to enroll up to a million participants to answer research questions about rare diseases and "harmonize" clinical endpoints collected from administrative records. Extreme selection bias, we are told, will not harm internal validity, and "process expertise to maximize efficiency of high-throughput operations is as important as scientific rigor" (p. 861). In this article, we describe serious deficiencies in this model as applied to the United States. Key points include: 1) the need for more, not less, specification of disease endpoints; 2) the limited utility of data collected from existing administrative and clinical databases; and 3) the value of university-based centers in providing scientific expertise and achieving high recruitment and retention rates through community and healthcare provider engagement. Careful definition of sampling frames and high response rates are crucial to avoid bias and ensure inclusion of important subpopulations, especially the medically underserved. Prospective hypotheses are essential to refine study design, determine sample size, develop pertinent data collection protocols, and achieve alliances with participants and communities. It is premature to reject the strengths of large national cohort studies in favor of a new model for which evidence of efficiency is insufficient.

Addressing the information gap: developing and implementing a cervical cancer prevention education campaign grounded in principles of community-based participatory action.

Despite significant advances in prevention, Mexican American women continue to experience disparities related to cervical cancer and access to current and relevant health information. To address this disparity a community-campus partnership initiated an outreach program to Latinas in Arizona as one part of an integrated approach. Promotoras (community health workers) provided the leadership in the development of a curriculum to (a) train promotoras on cervical cancer, (b) meet informational needs of community members, (c) address relevant social determinants of heath, and (d) promote access to health care. The purpose of this article is to describe the community-based participatory approach used in the development of the curriculum. Specifically, the article describes the leadership of promotoras, the curriculum development, and the use of continual feedback to inform the quality control. To address cervical cancer disparities for Mexican American women, the Pima County Cervical Cancer Prevention Partnership used principles of community-based participatory action.

Adolescent emotional distress: the role of family obligations and school connectedness.

The current study draws upon ecodevelopmental theory to identify protective and risk factors that may influence emotional distress during adolescence. Hierarchical regression analyses were used to examine the relationship among family obligations, school connectedness and emotional distress of 4,198 (51% female) middle and high school students who were primarily (59%) European American. The overall model explained 21.1% of the variance in student emotional distress. A significant interaction effect was found indicating that school connectedness moderated the relationship between family obligations and emotional distress. Specifically, for students with low to moderate levels of family obligations, a stronger sense of school connectedness was associated with lower emotional distress. The buffering effect of school connectedness was weakened as the level of family obligations increased and completely disappeared for students who experienced high levels of family obligations. The creation of a program that takes a holistic approach, in order to curtail the levels of highly emotionally distressed adolescents, must continue to address the ever changing demands that adolescents encounter and prepare youth to deal with functioning within multiple contexts and do so while maintaining emotional well-being.

The National Children's Study: Recruitment Outcomes Using an Enhanced Household-Based Approach.

OBJECTIVES: Ten National Children's Study (NCS) study locations with diverse demographic characteristics used an enhanced household-based recruitment (EHBR) approach to enroll preconceptional and pregnant women. Study centers used different types and dosages of community outreach and engagement (COE) activities and supplemental strategies. The goal of the study was to determine whether variability in enumeration and recruitment outcomes correlated with study location characteristics or types and dosages of COE activities (number of COE events, number of advance household mailings, total media expenditures, and total COE expenditures). METHODS: Each of the sites provided data on COE activities, protocol implementation, supplemental recruitment activities, location demographic characteristics, and enumeration/recruitment outcomes. RESULTS: COE activities varied across sites in breadth and scope. Numerous strategies were used, including media advertising, social media, participation in community-wide events, presentations to stakeholders, and creation of advisory boards. Some sites included supplemental recruitment efforts. EHBR sites enrolled 1404 women at the initial pregnancy screening. No significant relationships were found between study location demographic characteristics or between the types and dosages of COE activities and recruitment outcomes. CONCLUSIONS: Probability sampling for a long-term study requires a positive image with stakeholders and within communities; this requirement may be especially true for door-to-door recruitment. EHBR sites successfully recruited a representative sample of preconceptional and pregnant women. Sites reported implementing similar COE activities but with varying dosage and cost; however, analyses did not support a benefit of COE strategies on study recruitment.

Optimal health and well-being for women: definitions and strategies derived from focus groups of women.

Women participating in focus groups were asked how they define health and well-being, and what strategies they would suggest for health optimization. Women defined health and well-being largely in terms of relationships. Their strategies for improving health involved enhancement of the quality of relationships with families, partners, and community. These proposed strategies included: creating a context for resilience; valuing and nurturing children, parents, and families; promoting interpersonal connections and community; realizing equality for women; and cultivating relational values. These perspectives can inform clinicians and health policy.

Smoking susceptibility among students followed from grade six to eight.

BACKGROUND: Smoking is a leading risk factor for heart disease and cancer. By identifying factors associated with smoking onset, more effective prevention programs can be developed. Research questions are (1) does smoking susceptibility status change from grade six to eight, (2) are indicators of risk (perceived harm, smoking susceptibility status, positive peers, and resilience) measured in sixth grade associated with smoking susceptibility status in eighth grade and, (3) are there differences by gender in either research question? METHODS: The current study is a secondary analysis of data collected during the evaluation of a Safe Schools Healthy Students Project. Students were followed from grade six to grade eight, with survey data collected in each grade from August 2006 to December 2008. Participants (n=577) were in grade six at baseline, 52% were girls and 57% identified as White, non-Hispanic. RESULTS: From grade six to grade eight the number of students in the high smoking susceptibility status doubled (5% to 17%). More boys than girls moved into the high susceptibility group over time. By eighth grade, boys were twice as likely to belong to the high smoking susceptibility group compared to girls (p=0.01). Multiple logistic regression models showed that the positive peers' variable in grade six was protective for girls in their reported smoking susceptibility in grade eight. In contrast, higher resilience scores in grade six were protective for boys' reported smoking susceptibility in grade eight. CONCLUSIONS: Smoking susceptibility rose over time for all adolescents, but boys had notably sharper increases. Positive peers and having resources important to resilience may be beneficial in preventing the attitudes that support smoking initiation. Based on these results, we recommend gender-tailored, school-based smoking prevention programs that begin in grade six.

A comparison of maternal sensitivity and verbal stimulation as unique predictors of infant social-emotional and cognitive development.

UNLABELLED: Although maternal sensitivity has been shown to influence social-emotional development, the role of verbal stimulation on infant developmental outcomes has received less exploration. Recent research has focused on intentional behaviors within the context of a mother-infant interaction as a critical influence and as distinct from sensitivity. In this investigation 6377 mother-infant dyads participated in a teaching task as part of the sample from the Early Childhood Longitudinal Study Birth Cohort (ECLS-B). Analyses focused in deciphering the role of maternal sensitivity and verbal stimulation as contributors to the infant's social-emotional (S-E) and cognitive (Cog) development. We further hypothesized that inclusion of infant age as a moderator of maternal behaviors would illuminate any differences between younger and older infants. RESULTS: For the infant's S-E development, our hypothesis that maternal sensitivity would be a stronger predictor than verbal stimulation was not supported; nor did we find support for our hypothesis that the association would be moderated by age. For Cog development, only verbal stimulation had a direct positive effect on the infant's cognitive ability; our findings for moderation showed that mothers spoke more to older infants than younger infants. CONCLUSION: Identification of specific maternal behaviors associated with infant outcomes informs the child development field, and also provides strategies for early intervention to assist mothers with developing or maintaining a consistent relationship that includes sensitivity and verbal stimulation.

Mutuality's prospective beneficial effects on inflammation in female patients with rheumatoid arthritis.

OBJECTIVE: Supportive close relationships are important for health. Mutuality, the reciprocal sharing of thoughts and feelings in close relationships, is linked with better outcomes for patients with rheumatoid arthritis (RA) in cross-sectional data. Hypothesizing that mutuality has a beneficial impact on inflammation, we tested potentially causal relations of couple mutuality with erythrocyte sedimentation rate (ESR) in prospective data. METHODS: Female patients with RA (n = 70; mean age 57 years, mean RA disease duration 5 years) completed questionnaires at baseline, 6 months, and 12 months, including measures of mutuality, RA flares, and negative affect. ESR laboratory values available near questionnaire dates were collected from medical charts. Using regression, we examined cross-lagged effects of mutuality and ESR over the two 6-month time spans (baseline to 6 months, 6 months to 12 months). We anticipated that mutuality would exert lagged inverse effects on subsequent ESR levels, and that ESR would have no effect on subsequent mutuality levels. RESULTS: After controlling for lagged effects of earlier inflammation, disease-modifying antirheumatic drugs, antiinflammatory drugs, RA flares, and negative affect, mutuality's lagged inverse effects over both time spans accounted for unique variance in subsequent levels of ESR, explaining 9% at 6 months and 12.5% at 12 months. Concomitantly, earlier ESR had no effect on subsequent mutuality. CONCLUSION: Patients with RA reporting more mutuality had less inflammation at subsequent time points, but inflammation had no effect on subsequent reports of mutuality. This suggests that mutuality exerts a beneficial effect on inflammation. Clinical implications and potential applications are discussed.

Rheumatoid arthritis patients' perceptions of mutuality in conversations with spouses/partners and their links with psychological and physical health.

OBJECTIVE: Mutuality, measured as subjects' perceptions of responsiveness in conversations with their spouse/partners, is linked with women's psychological health. Our objectives were to examine physical and psychological health outcomes of married/partnered patients with rheumatoid arthritis (RA) in relation to their perceptions of their own responsiveness (self-mutuality), their partner's responsiveness (partner-mutuality), and combined responsiveness (overall mutuality), and to examine potential sex differences in the links between mutuality and depressive symptoms. METHODS: Symptoms of depression and anxiety, physical disability, and arthritis impact reported by RA patients were examined in correlation matrices with their perceptions of overall mutuality, partner-mutuality, and self-mutuality in conversations with spouses/partners in the whole sample (n = 148) and separately for men (n = 34) and women (n = 114). Sex moderation of the links between mutuality and depression was tested in hierarchical regressions. RESULTS: In the whole sample and among women, all mutuality measures had significant inverse correlations with all health outcomes. In men, physical disability was unrelated to mutuality measures, but otherwise correlations approximated those in the whole sample and for women. Sex (being female) interacted with self-mutuality, but not overall or partner-mutuality, in predicting fewer depressive symptoms. CONCLUSION: RA patients' perceptions of mutuality in conversations with spouses/partners predicted better health across a spectrum of outcomes. Overall mutuality and partner-mutuality predicted fewer depressive symptoms for both men and women, but self-mutuality appeared more important for women than for men. The clinical relevance of findings and their implications for behavioral interventions with RA patients are discussed.