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

Existing capacity to manage pharmaceuticals and related commodities in East Africa: an assessment with specific reference to antiretroviral therapy

BACKGROUND: East African countries have in the recent past experienced a tremendous increase in the volume of antiretroviral drugs. Capacity to manage these medicines in the region remains limited. Makerere University, with technical assistance from the USAID supported Rational Pharmaceutical Management Plus (RPM Plus) Program of Management Sciences for Health (MSH) established a network of academic institutions to build capacity for pharmaceutical management in the East African region. The initiative includes institutions from Uganda, Tanzania, Kenya and Rwanda and aims to improve access to safe, effective and quality-assured medicines for the treatment of HIV/AIDS, TB and Malaria through spearheading in-country capacity. The initiative conducted a regional assessment to determine the existing capacity for the management of antiretroviral drugs and related commodities. METHODS: Heads and implementing workers of fifty HIV/AIDS programs and institutions accredited to offer antiretroviral services in Uganda, Kenya, Tanzania and Rwanda were key informants in face-to-face interviews guided by structured questionnaires. The assessment explored categories of health workers involved in the management of ARVs, their knowledge and practices in selection, quantification, distribution and use of ARVs, nature of existing training programs, training preferences and resources for capacity building. RESULTS: Inadequate human resource capacity including, inability to select, quantify and distribute ARVs and related commodities, and irrational prescribing and dispensing were some of the problems identified. A competence gap existed in all the four countries with a variety of healthcare professionals involved in the supply and distribution of ARVs. Training opportunities and resources for capacity development were limited particularly for workers in remote facilities. On-the-job training and short courses were the preferred modes of training. CONCLUSION: There is inadequate capacity for managing medicines and related commodities in East Africa. There is an urgent need for training in aspects of pharmaceutical management to different categories of health workers. Skills building activities that do not take healthcare workers from their places of work are preferred

Vulnerability-Based Spatial Sampling Stratification for the National Children\u27s Study, Worcester County, Massachusetts: Capturing Health-Relevant Environmental and Sociodemographic Variability

Background: The National Children\u27s Study is the most ambitious study ever attempted in the United States to assess how environmental factors impact child health and development. It aims to follow 100,000 children from gestation until 21 years of age. Success requires breaking new interdisciplinary ground, starting with how to select the sample of \u3e 1,000 children in each of 105 study sites; no standardized protocol exists for stratification of the target population by factoring in the diverse environments it inhabits. Worcester County, Massachusetts, like other sites, stratifies according to local conditions and local knowledge, subject to probability sampling rules.Objectives: We answer the following questions: How do we divide Worcester County into viable strata that represent its health-relevant environmental and sociodemographic heterogeneity, subject to sampling rules? What potential does our approach have to inform stratification at other sites?Results: We developed a multivariable, vulnerability-based method for spatial sampling consisting of two descriptive indices: a hazards/stressors exposure index (comprising three proxy variables), and an adaptive capacity/sociodemographic character index (five variables). Multivariable, health-relevant stratification at the start of the study may improve detection power for environment-child health associations down the line. Eighteen strata capture countywide heterogeneity in the indices and have optimal relative homogeneity within each. They achieve comparable expected birth counts and conform to local concepts of space. Conclusion: The approach offers moderate to high potential to inform other sites, limited by intersite differences in data availability, geodemographics, and technical capacity. Energetic community engagement from the start promotes local stratification coherence, plus vital researcher-community trust and co-ownership for sustainability

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

Vulnerability-based spatial sampling stratification for the National Children\u27s Study, Worcester County, Massachusetts: capturing health-relevant environmental and sociodemographic variability

BACKGROUND: The National Children\u27s Study is the most ambitious study ever attempted in the United States to assess how environmental factors impact child health and development. It aims to follow 100,000 children from gestation until 21 years of age. Success requires breaking new interdisciplinary ground, starting with how to select the sample of \u3e 1,000 children in each of 105 study sites; no standardized protocol exists for stratification of the target population by factoring in the diverse environments it inhabits. Worcester County, Massachusetts, like other sites, stratifies according to local conditions and local knowledge, subject to probability sampling rules. OBJECTIVES: We answer the following questions: How do we divide Worcester County into viable strata that represent its health-relevant environmental and sociodemographic heterogeneity, subject to sampling rules? What potential does our approach have to inform stratification at other sites? RESULTS: We developed a multivariable, vulnerability-based method for spatial sampling consisting of two descriptive indices: a hazards/stressors exposure index (comprising three proxy variables), and an adaptive capacity/sociodemographic character index (five variables). Multivariable, health-relevant stratification at the start of the study may improve detection power for environment-child health associations down the line. Eighteen strata capture countywide heterogeneity in the indices and have optimal relative homogeneity within each. They achieve comparable expected birth counts and conform to local concepts of space. CONCLUSION: The approach offers moderate to high potential to inform other sites, limited by intersite differences in data availability, geodemographics, and technical capacity. Energetic community engagement from the start promotes local stratification coherence, plus vital researcher-community trust and co-ownership for sustainability

Identifying symptom profiles of depression and anxiety in patients with an acute coronary syndrome using latent class and latent transition analysis

OBJECTIVE: To identify symptom profiles of depression and anxiety in patients with an acute coronary syndrome (ACS), to examine changes in symptom profiles over time, and finally, to examine the effects of age and sex on patients\u27 symptom profiles. METHODS: One hundred ACS patients with mild to severe symptoms of depression and/or anxiety at 1 month post-hospital discharge were enrolled in a randomized trial of cognitive behavioral therapy. Latent class and latent transition analyses were used to identify symptom profiles and describe change over the time in profile membership. RESULTS: A two-class solution was selected to describe depression and anxiety symptom profiles. Class I (76% of patients at baseline) was labeled depression and some anxiety symptoms. Class II (24% of patients at baseline) was labeled anxiety and some depression symptoms. Approximately 25% of patients in the treatment condition transitioned from the depression and some anxiety symptoms class to the anxiety and some depression symptoms class at follow-up compared to 10% of patients in the control condition at follow-up; nearly 50% of patients in the control condition showed worsening of symptoms as compared to 28% in the treatment condition. Results suggested age differences in the probabilities of transitioning between the classes; older patients were more likely to continue having depression and some anxiety symptoms at the time of follow-up. CONCLUSIONS: Identifying symptom profiles of depression and anxiety in patients with an ACS may improve diagnostic practices and help to design tailored interventions

Classes of depression, anxiety, and functioning in acute coronary syndrome patients

OBJECTIVES: To describe change in subgroups characterized by patterns of depression, anxiety, and functional impairment; examine treatment effects on subgroup membership; examine effects of sex and age on subgroup membership. METHODS: Latent class models were used to meet the first 2 objectives using 79 patients with depression/anxiety. Generalized estimating equations were used to meet the third objective. RESULTS: Three subgroups characterized by different combinations of psychiatric disorders and functioning were identified. Patients who received treatment were more likely to transition to a less impaired subgroup. CONCLUSIONS: Unique information about holistic treatment effects can be gained when multiple outcomes are considered simultaneously