Nancy Reame

Using Information Technology and Social Networking for Recruitment of Research Participants: Experience From an Exploratory Study of Pediatric Klinefelter Syndrome

Background Recruiting pediatric samples for research may be challenging due to parental mistrust of the research process, privacy concerns, and family time constraints. Recruitment of children with chronic and genetic conditions may further complicate the enrollment process. Objective In this paper, we describe the methodological challenges of recruiting children for research and provide an exemplar of how the use of information technology (IT) strategies with social networking may improve access to difficult-to-reach pediatric research participants. Methods We conducted a cross-sectional descriptive study of boys between the ages of 8 and 18 years with Klinefelter syndrome. This study presented unique challenges for recruitment of pediatric participants. These challenges are illustrated by the report of recruitment activities developed for the study. We reviewed the literature to explore the issues of recruiting children for research using conventional and IT approaches. Success rates of conventional recruitment approaches, such as brochures, flyers in medical offices, and physician referrals, are compared with IT-based outreach. The IT approaches included teleconferencing via a Klinefelter syndrome support group, services of a Web-based commercial recruitment-matching company, and the development of a university-affiliated research recruitment website with the use of paid advertising on a social networking website (Facebook). Results Over a 3-month period, dissemination of over 150 recruitment brochures and flyers placed in a large urban hospital and hospital-affiliated clinical offices, with 850 letters to physicians and patients were not successful. Within the same period, face-to-face recruitment in the clinical setting yielded 4 (9%) participants. Using Web-based and social networking approaches, 39 (91%) agreed to participate in the study. With these approaches, 5 (12%) were recruited from the national Klinefelter syndrome advocacy group, 8 (19%) from local and teleconference support groups, 10 (23%) from a Web-based research recruitment program, and 16 (37%) from the university-affiliated recruitment website. For the initial 6 months, the university website was viewed approximately 2 to 3 times per day on average. An advertisement placed on a social networking site for 1 week increased website viewing to approximately 63 visits per day. Out of 112 families approached using all of these methods, 43 (38%) agreed to participate. Families who declined cited either travel distance to the study site (15, 22%) or unwillingness to disclose the Klinefelter syndrome diagnosis to their sons (54, 78%) as the reasons for nonparticipation. Conclusions Use of Web-based technologies enhances the recruitment of difficult-to-reach populations. Of the many approaches employed in this study, the university-affiliated recruitment website supported by a Facebook advertisement appeared to be the most successful. Research grant budgets should include expenses for website registration and maintenance fees as well as online advertisements on social networking websites. Tracking of recruitment referral sources may be helpful in planning future recruitment campaigns.

Early menopausal hormone use influences brain regions used for visual working memory.

Objective:The cognitive benefit of postmenopausal hormone use is controversial; however, timing of treatment close to menopause may increase the likelihood of preserving cognitive function. We examined the effects of early-initiation hormone use on visual working memory, hypothesizing that long-term hormone use is associated with greater brain activation during visual working memory. Methods:This was a cross-sectional comparison of long-term early hormone users-current (n = 13) and past (n = 24; 2.1 ± 1.0 years off hormones)-with never users (n = 18), using a visual memory task and functional magnetic resonance imaging (MRI). We evaluated 55 women older than 60 years at the University of Michigans General Clinical Research Center. Hormone users had completed at least 10 continuous years of conjugated equine estrogens with or without medroxyprogesterone acetate, begun within 2 years of menopause. Women were excluded for illness, medication, intermittent estrogen use, phytoestrogen use, recent smoking, and MRI contraindications. The primary outcome was functional MRI-detected brain activity during the visual memory task. Results:Compared with never users, both groups of hormone users had increased activation in the frontal and parietal cortices, insula, hippocampus, and cingulate; combined hormone users also had increased activation in the putamen and raphe (corrected P < 0.05 or uncorrected P < 0.001 with a priori hypothesis). Across the entire sample, the medial temporal cortex (P < 0.0001 right; P < 0.018 left) and right hippocampus (P < 0.0001) positively correlated with task performance. Conclusions:Hormone use was associated with increased brain activation during the visual memory task, in regions used for visual working memory. A positive correlation between activation and task performance suggests that early-initiation, long-term postmenopausal hormone use may benefit visual working memory.

Influence of depressed mood and psychological stress symptoms on perceived oral contraceptive side effects and discontinuation in young minority women

BACKGROUND We examined the influence of depressed mood and psychological stress on oral contraceptive (OC) side effects and discontinuation. STUDY DESIGN We administered standard psychological instruments to 354 young women (13-24 years old) beginning a 6-month OC continuation intervention trial and questions on OC side effects and use at 6 months. Logisitic regression determined the relationships between psychological conditions, perceived OC side effects and continuation rates. RESULTS Baseline depressed mood (21%) and stress (19%) and 6-month mood (25%) and weight changes (57%) were relatively common. Only 38% continued OCs at 6 months. Depressed mood [odds ratio (OR) 2.27, confidence interval (CI) 1.25-4.15, p=.007] and stress (OR 2.07, CI 1.12-3.82, p=.02) were associated with perceived OC-related moodiness; depressed mood was associated with perceived weight loss (OR 1.89, CI 1.01-3.55, p=.05). Depressed mood (OR 0.54, CI 0.29-0.99, p=.04), stress (OR 0.48, CI 0.25-0.91, p=.03) and perceived weight change (OR 0.60, CI 0.38-0.94, p=.03) all reduced the likelihood of OC continuation. CONCLUSION Young women with adverse psychological symptoms are at risk for perceived OC side effects and discontinuation.

Postmenopausal hormone use impact on emotion processing circuitry

Despite considerable evidence for potential effects of estrogen on emotional processing, several studies of postmenopausal women who began hormone therapy (HT) remote from menopause report no effects of HT on emotional measures. As early HT initiation may preserve brain mechanisms, we examined effects of HT on emotional processing in postmenopausal women who started HT early after menopause. We performed a cross-sectional comparison of 52 postmenopausal women 66±5 years old, including 15 users of conjugated equine estrogen, 20 users of conjugated equine estrogen plus medroxyprogesterone acetate, and 17 who never used hormones (NT). All hormone users started therapy within two years of menopause, and received at least 10 years of continuous therapy. Outcomes were fMRI-detected brain activity and behavioral measures during an emotional processing picture rating task. During processing of positive pictures, NT women had greater activation than estrogen treated women in medial prefrontal cortex extending to the anterior cingulate, and more activation than estrogen plus progestin treated women in the insula. During processing of negative pictures, estrogen treated women had higher activation than NT women in the entorhinal cortex. Current compared to past HT users showed greater activation in the hippocampus and higher emotion recognition accuracy of neutral stimuli. Estrogen plus progestin treated women had slower response time than NT women when rating all pictures. In conclusion, hormone use was associated with differences in brain functional responses during emotional processing. These fMRI effects were more prominent than those observed for behavioral measures and involved brain regions implicated in cognitive-emotional integration.

Early Initiation of Hormone Therapy in Menopausal Women Is Associated with Increased Hippocampal and Posterior Cingulate Cholinergic Activity

CONTEXT The role of ovarian hormones in maintaining neuronal integrity and cognitive function is still debated. This study was undertaken to clarify the potential relationship between postmenopausal hormone use and the cholinergic system. OBJECTIVE We hypothesized that early initiated hormone therapy (HT) preserves the cholinergic system and that estrogen therapy (ET) would be associated with higher levels of acetylcholinesterase activity in the posterior cingulate cortex and hippocampus compared to estrogen plus progestin therapy (EPT) or no HT. DESIGN AND SETTING We conducted a cross-sectional study at a university teaching hospital. PATIENTS Fifty postmenopausal women (age, 65.2 ± 0.7 yr) with early long-term HT (n = 34; 13 ET and 21 EPT) or no HT (n = 16) participated in the study. INTERVENTIONS There were no interventions. MAIN OUTCOME MEASURE We measured cholinergic activity (acetylcholinesterase) in the hippocampus and posterior cingulate brain regions as measured by N-[(11)C]methylpiperidin-4-yl propionate and positron emission tomography as a marker of cholinergic function. RESULTS Significant effects of treatment on cholinergic activity measures were obtained in the left hippocampus (F = 3.56; P = 0.04), right hippocampus (F = 3.42; P = 0.04), and posterior cingulate (F = 3.76; P = 0.03). No significant effects were observed in a cortical control region. Post hoc testing identified greater cholinergic activity in the EPT group compared to the no-HT group in the left hippocampus (P = 0.048) and posterior cingulate (P = 0.045), with a nonstatistically significant trend in the right hippocampus (P = 0.073). CONCLUSIONS A differential effect of postmenopausal ET and EPT on cholinergic neuronal integrity was identified in postmenopausal women. The findings are consistent with a preservation of cholinergic neuronal integrity in the EPT group.

Phenotype and Adverse Quality of Life in Boys with Klinefelter Syndrome

OBJECTIVES To characterize associations among psychosocial well-being, physical phenotype, and sex hormones in a sample of youth with Klinefelter syndrome (KS). We hypothesized that KS physical traits (phenotype) are associated with adverse psychosocial health measures and that testosterone levels are associated with adverse psychosocial health. STUDY DESIGN Forty-three boys with KS (ages 8-18 years) participated in a cross-sectional study. Participants underwent physical examination, hormone analyses, and psychosocial health questionnaires. RESULTS Using an investigator-developed Klinefelter Phenotype Index Scale, the number of KS physical traits ranged from 1-13 (mean 5.1 ± 1.9). Pubertal boys presented with more KS traits compared with prepubertal boys (5.6 vs 4.2, P = .01). Boys diagnosed prenatally had a milder phenotype compared with those diagnosed postnatally. Gonadotropins were elevated without androgen deficiency in 45%. Psychosocial health scores indicated adverse quality of life (QOL) (67%), low self-esteem (38%), poor self-concept (26%), and risk for depression (16%) without a difference between pubertal groups. Linear regression showed that 22% of the variance in QOL (P = .0001) was explained by phenotype. Testosterone level was not associated with psychosocial health measures. CONCLUSIONS Depending on the degree of phenotypic abnormality, boys with KS may be at risk for impaired QOL. Testosterone levels were not shown to influence psychosocial health. The Klinefelter Phenotype Index Scale may be a useful tool to characterize KS features in boys.

Using social network analysis to examine collaborative relationships among PhD and DNP students and faculty in a research-intensive university school of nursing.

The nursing profession has seen a dramatic rise in the number of schools offering both DNP and PhD nursing programs. Information is limited on the impact of this parallel approach in doctoral education on the quality and scope of scholarly interactions or institutional culture.The authors studied collaboration characteristics across the DNP and PhD programs of a research-intensive university school of nursing, before and after programmatic enhancements. An IRB-approved online survey was delivered to faculty and students of both programs at baseline and one year after curricular changes. Response rates were 70% and 74%, respectively. The responses were analyzed by using social network analysis and descriptive statistics to characterize the number and strength of connections between and within student groups, and between students and faculty. At baseline, the flow of communication was centralized primarily through faculty. At Time 2, density of links between students increased and network centralization decreased, suggesting more distributed communication. This nonlinear quantitative approach may be a useful addition to the evaluation strategies for doctoral education initiatives.

An exploratory analysis of associations between eating disordered symptoms, perceived weight changes, and oral contraceptive discontinuation among young minority women.

PURPOSE To explore associations between eating-disordered (ED) symptoms, perceived oral contraceptive (OC)-related weight changes, and OC discontinuation among young minority women. METHODS We conducted a prospective substudy of a randomized controlled trial evaluating the impact of a pill pack supply (3 vs. 7 months) on OC continuation among young urban women presenting to a university-affiliated community-based family planning clinic for OC management. Participants (n = 354) were adolescent (n = 173) and young adult (n = 181) women aged 13-24 years, predominantly underinsured and largely Hispanic (92%). We conducted a structured baseline interview that included an ED screening instrument. At the 6-month follow-up, we conducted a telephone interview to determine OC continuation and dimensions of perceived OC-related weight changes during the study period. RESULTS At baseline, 24% of the subjects fulfilled the moderate/severe ED symptom screen criteria (n = 60). By 6 months, 57% of the subjects (n = 200) reported weight changes and 62% (n = 218) had discontinued OC use. Unadjusted discontinuation rates were similar across age- and ED symptom groups. In multivariate analysis, both ED symptoms (odds ratio = .49, 95% confidence interval = .25-.96, p = .04) and perceived weight changes (odds ratio = .60, 95% confidence interval = .38-.94, p = .03) were negatively associated with OC continuation. CONCLUSIONS ED symptoms and perceived weight changes were associated with an increased likelihood of OC discontinuation among these young women. Reproductive health practitioners should consider psychological symptoms when managing OC.

Fat, fit, or famished? No clear answers from the Women's Health Initiative about diet and dieting for longstanding hot flashes.

We’ve learned a lot in the last decade about hot flashes thanks to a number of national and international longitudinal studies across the perimenopause transition. Specifically, results from SWAN, the study of women across the nation (SWAN;1), the Melbourne studies (2), the PENN Aging study (3) and the Seattle Midlife Women’s Health study (4) have all contributed to a better understanding of the etiology, risk factors, onset and duration of these bothersome but normal changes that accompany the final menstrual period around age 51 and the natural transition to post-reproductive life. In the US, women who smoke, are obese, stressed, have less than college education and difficulty paying the bills, or African-American are at highest risk for debilitating vasomotor symptoms (VMS: hot flashes and night sweats). The continuing analysis of these longitudinal data by members of the committee for Staging Reproductive Phases in Women (STRAW+10) has revealed that VMS peak in frequency relatively late in the transition during the two years after menses has ceased (approximately age 53), now referred to as the early postmenopause phase. (5)

Prenatal Toxicology Screening for Substance Abuse in Research: Codes and Consequences

Prenatal substance abuse has long been identified as a risk factor for the developing fetus, and implicated in pediatric cognitive, neuropsychological and physiologic problems. Conservative estimates suggest that prenatal substance abuse affects hundreds of thousands of pregnancies annually and is associated with developmental delays, learning disabilities, social disturbances and lifelong health issues for the child. Prenatally substance-exposed children experience higher levels of child abuse and neglect, are more likely to need foster parenting, and have higher rates of subsequent substance abuse than non-exposed children (1, 2). The scientific necessity to screen for substance abuse in research participants raises ethical issues when illicit drug use is uncovered. The impact of legislative policies restricting maternal rights in the setting of substance abuse needs to be considered by researchers as potentially intruding into confidential relationships between research participants and investigators. Moreover, the legal implications for substance-abusing pregnant research subjects may not surprisingly act as a deterrent to their participation in research studies altogether. By its nature, research with pregnant women involves the protection of two research participants. Even observational studies in pregnancy require extra scrutiny by the IRB, with adherence to special requirements mandated for vulnerable populations. Complicated by ongoing contentious debate over maternal and fetal rights, the resolution of research dilemmas in pregnancy is often not ideal. It is important for those involved in perinatal research to be familiar not only with current controversies about the consequences of perinatal substance abuse for both mother and child, but also with policies guiding ethical obligation of the provider under these circumstances, and pertinent legislation directing provider action in certain cases.