Prediction of stillbirth from placental growth factor at 19-24 weeks

Objectives: To investigate whether measurement of maternal serum placental growth factor (PLGF) at 19-24 weeks’ gestation improves the performance of screening for stillbirths that is achieved by a combination of maternal factors, fetal biometry and uterine artery pulsatility index (UT-PI) and evaluate the performance of screening of this model for all stillbirths and those due to impaired placentation and unexplained or other causes. Methods: This was a prospective screening study of 70,003 singleton pregnancies including 268 stillbirths, carried out in two phases. The first phase, which included prospective measurements of UT-PI and fetal biometry were available in all cases. The second phase included prospective measurements of maternal serum PLGF which were available for 9,870 live births and 86 antepartum stillbirths. The values of PLGF obtained from this screening study were simulated in the remaining cases based on bivariate Gaussian distributions, defined by the mean and standard deviations. Multivariate logistic regression analysis was used to determine whether the addition of maternal serum PLGF improved the performance of screening that was achieved by a combination of maternal factors, fetal biometry and UT-PI. Results: Significant contribution to the prediction of stillbirths was provided by maternal factor derived a priori risk, MoM values of PLGF, UT-PI and fetal biometry Z-scores. A model combining these variables predicted 58% of all stillbirths and 84% of those due to impaired placentation, at false positive rate of 10%; within the impaired placentation group the detection rate of stillbirth at 37 weeks (97% vs 61%; p<0.01). Conclusions: A high proportion of stillbirths due to impaired placentation can be effectively identified in the second trimester of pregnancy

Framing Hospital Engagement for the Recruitment of a Birth Cohort for the NCS: Lessons Learned for Ensuring Collaboration in Worcester County

In 2011, three designated NCS Study Centers began preparatory work for field implementation of a planned recruitment strategy called Provider Based Sampling (PBS). In each PBS primary sampling unit, three hospitals were selected to test the feasibility of recruiting a cohort of 125 women and their babies around delivery time. The selected hospitals for Worcester account for nearly 80% of County births and can be categorized into three distinct facility types and patient catchment areas: an academic medical center; a university-affiliated but independent community hospital; and a private for-profit community hospital with market share competitor of the academic medical center. Methods: We used tailored negotiations and engagement strategies to gain the cooperation and engagement of targeted hospitals/birthing centers. Preliminary Conclusions: The lessons learned from this exercise are:• Time to gain hospital engagement and clearance to initiate study activities ranges anywhere from 2 weeks to 2 months and depends largely upon the type of the institution, the profile of the Negotiator, and the nature of the scope of work.• A greater likelihood of hospital engagement in the NCS seems to be associated with the depth of existing relationships between the Study Center and targeted hospitals.• Thoughtful interactions and timely discussions with the key institutional stakeholders (either individually or in groups) are important to achieve collaboration and engagement.• Balancing sensitivity to clinical cultures and settings while preserving research integrity is essential for study implementation in busy hospital/clinical environments.• Planning for site compensation and/or the ability to support local clerical staff to help with study activities must be considered as a means to facilitate negotiations and site engagement.• Adequate resources must be planned for successful implementation and execution of research activities in settings (e.g community hospitals) unfamiliar with research activities.• Involvement of nursing personnel is crucial for successful implementation of any protocol

A Comparison of Recruitment Strategies for a Long-Term Study at Two Maternal Stages: Effectiveness of Recruitment During Pregnancy vs. After Childbirth

Introduction. National Children’s Study (NCS) Provider Based Sampling (PBS) aims to conduct a pilot study to test cost, acceptability and feasibility of recruiting a representative sample of women/children using two recruitment strategies: through prenatal providers and hospitals. Methods. A sampling frame consisting of all providers of prenatal and delivery care within and 10-miles outside Worcester County, 16 provider and 3 hospital locations were selected as point of entry for study recruitment. During 1st prenatal care visits or post-delivery at these locations, face-to-face contact was utilized to: a) identify study eligibility and b) assess study recruitment. Preliminary Results. Certified Data Collectors made contact with prescreened women. Consent rates of women at prenatal provider locations were lower than the consent rates in hospital locations. On average, results have shown twice as many consents could be obtained per day at hospital locations than at provider locations. Preliminary Conclusions. Although both strategies utilized direct rapport, the two recruitment methods were associated with different consent rates. Consideration of preliminary results may lead one to consider recruitment after childbirth for several reasons: 1) greater likelihood of having opportunity to discuss study with the woman and partner from outset; 2) opportunity to check back with undecided women easily 3) longer periods to answer questions and conduct screening and consent; 4) support of nursing staff to foster participation; 5) daily presence of NCS staff; and 6) reality of infant’s birth to spur mother to consent. Recruitment during pregnancy visits may yield lower rates; further examination may be necessary to overcome challenges such as: 1) burden of adding recruitment session to often long and anxiety-laden1st prenatal visit; 2) need to develop rapport quickly during brief time periods; 3) making contact with potential participants outside of provider office when recruitment is not completed

Assessment of Parental Mental Disorders in the National Children’s Study (NCS)

Introduction: Parental mental disorders are powerful risk factors for children’s behavioral and mental disorders, making it critical to obtain estimates of parental mental disorders in NCS baseline assessments. These disorders are usually clinically assessed and diagnosed using lengthy interview instruments. This study will validate a brief set of mental health screens against the gold-standard Composite International Diagnostic Interview (CIDI). Methods: Sample: Up to 1200 English-speaking pregnant women and their male partners, aged \u3e17 with over-sampling of racial and ethnic minorities. Instruments: A brief 25-minute set of REDCap based screening scales will be administered. Probability sub-samples of 450-600 respondents with or without DSM-IV diagnoses will be selected for clinical reappraisal using the CIDI. Patients without DSM-IV diagnoses but with subsyndromal disorders will be used to optimize the sensitivity and specificity of screening scales. Diagnostic Assessment: Major depression, bipolar spectrum disorders, generalized anxiety, panic, post-traumatic stress, and substance abuse will be assessed. Analytic Methods: Kappa statistics, Receiver Operating Curve and regression methods will be used to evaluate concordance between diagnoses from screening scales and the CIDI at the aggregate and individual levels. Sensitivity and specificity will be reported for the cohort and separately for mothers and fathers as well as racial and ethnic minorities. Significance: This is the largest investigation of the epidemiology of mental disorders in a representative sample of community based pregnant mothers and their male partners. Information will be used to study the importance of parental psychopathology in the emergence of mental disorders in children over 21 years of follow-up of the parents and their children

Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads

OBJECTIVE: In 2010, the National Children\u27s Study launched 3 alternative recruitment methods to test possible improvements in efficiency compared with traditional household-based recruitment and participant enrollment. In 2012, a fourth method, provider-based sampling (PBS), tested a probability-based sampling of prenatal provider locations supplemented by a second cohort of neonates born at a convenience sample of maternity hospitals. METHODS: From a sampling frame of 472 prenatal care provider locations and 59 maternity hospitals, 49 provider and 7 hospital locations within or just outside 3 counties participated in study recruitment. During first prenatal care visits or immediately postdelivery at these locations, face-to-face contact was used to screen and recruit eligible women. RESULTS: Of 1450 screened women, 1270 were eligible. Consent rates at prenatal provider locations (62%-74% by county) were similar to those at birth locations (64%-77% by county). During 6 field months, 3 study centers enrolled a total prenatal cohort of 530 women (the majority in the first trimester) and during 2 months enrolled a birth cohort of an additional 320 mother-newborn dyads. As personnel became experienced in the field, the time required to enroll a woman in the prenatal cohort declined from up to 200 hours to 50 to 100 hours per woman recruited. CONCLUSIONS: We demonstrated that PBS was feasible and operationally efficient in recruiting a representative cohort of newborns from 3 diverse US counties. Our findings suggest that PBS is a practical approach to recruit large pregnancy and birth cohorts across the United States

The effect of a telephone counseling intervention on self-rated health of cardiac patients

OBJECTIVE: The objective of this study was to evaluate the effectiveness of a telephone-based intervention on psychological distress among patients with cardiac illness. METHODS: We recruited hospitalized patients surviving an acute coronary syndrome with scores on the Hospital and Anxiety Depression Scale (HADS) indicating mild to severe depression and/or anxiety at 1 month postdischarge. Recruited patients were randomized into either an intervention or control group. Intervention patients received up to six 30-minute telephone-counseling sessions focused on identifying cardiac-related fears. Control patients received usual care. For both groups, we collected patients\u27 responses to the HADS and to the Global Improvement (CGI-I) subscale of the Clinical Global Impressions (CGI) Scale at baseline and at 2, 3, and 6 months postbaseline using Interactive Voice Recognition (IVR) technologies. We used mixed-effects analysis to estimate patients\u27 changes in CGI-I measures over the three time points of data collection postbaseline. RESULTS: We enrolled 100 patients, and complete CGI-I measures were collected for 79 study patients. The mean age was 60 years (standard deviation = 10), and 67% of the patients were male. A mixed-effects analysis confirmed that patients in the intervention group had significantly greater improvements in self-rated health (SRH) between baseline and month 3 than the control group (p = .01). Between month 3 and month 6, no significant differences in SRH improvements were observed between the control and intervention groups. CONCLUSIONS: Study patients reported greater SRH improvement resulting from the telephone-based intervention compared with control subjects. Future research should include additional outcome measures to determine the effect of changes in SRH on patients with comorbid physical and emotional disorders

Improving Psychologic Adjustment to Chronic Illness in Cardiac Patients: The Role of Depression and Anxiety

BACKGROUND: Poor mood adjustment to chronic medical illness is often accompanied by decrements in function. OBJECTIVE: To evaluate the effectiveness of a telephone-based intervention for psychologic distress and functional impairment in cardiac illness. DESIGN: Randomized, controlled trial. METHODS: We recruited survivors of acute coronary syndromes using the Hospital and Anxiety Depression Scale (HADS) with scores indicative of mood disturbances at 1-month postdischarge. Recruited patients were randomized to experimental or control status. Intervention patients received 6 30-minute telephone counseling sessions to identify and address illness-related fears and concerns. Control patients received usual care. Patients' responses to the HADS and the Workplace Social Adjustment Scale (WSAS) were collected at baseline, 2, 3, and 6 months using interactive voice recognition technology. At baseline, the PRIME-MD was used to establish diagnosis of depression. We used mixed effects regression to study changes in outcomes. RESULTS: We enrolled 100 patients. Mean age was 60; 67% of the patients were male. Findings confirmed that the intervention group had a 27% improvement in depression symptoms (P=.05), 27% in anxiety (P=.02), and a 38% improvement in home limitations (P=.04) compared with controls. Symptom improvement tracked those for WSAS measures of home function (P=.04) but not workplace function. CONCLUSIONS: The intervention had a moderate effect on patient's emotional and functional outcomes that were observed during a critical period in patients' lives. Patient convenience, ease of delivery, and the effectiveness of the intervention suggest that the counseling can help patients adjust to chronic illness