Browsing by Subject "Program Development"

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Open Access
Application of the Intervention Mapping protocol to develop Keys, a family child care home intervention to prevent early childhood obesity.
(BMC Public Health, 2015-12-10) Mann, Courtney M; Ward, Dianne S; Vaughn, Amber; Benjamin Neelon, Sara E; Long Vidal, Lenita J; Omar, Sakinah; Namenek Brouwer, Rebecca J; Østbye, Truls
BACKGROUND: Many families rely on child care outside the home, making these settings important influences on child development. Nearly 1.5 million children in the U.S. spend time in family child care homes (FCCHs), where providers care for children in their own residences. There is some evidence that children in FCCHs are heavier than those cared for in centers. However, few interventions have targeted FCCHs for obesity prevention. This paper will describe the application of the Intervention Mapping (IM) framework to the development of a childhood obesity prevention intervention for FCCHs METHODS: Following the IM protocol, six steps were completed in the planning and development of an intervention targeting FCCHs: needs assessment, formulation of change objectives matrices, selection of theory-based methods and strategies, creation of intervention components and materials, adoption and implementation planning, and evaluation planning RESULTS: Application of the IM process resulted in the creation of the Keys to Healthy Family Child Care Homes program (Keys), which includes three modules: Healthy You, Healthy Home, and Healthy Business. Delivery of each module includes a workshop, educational binder and tool-kit resources, and four coaching contacts. Social Cognitive Theory and Self-Determination Theory helped guide development of change objective matrices, selection of behavior change strategies, and identification of outcome measures. The Keys program is currently being evaluated through a cluster-randomized controlled trial CONCLUSIONS: The IM process, while time-consuming, enabled rigorous and systematic development of intervention components that are directly tied to behavior change theory and may increase the potential for behavior change within the FCCHs.
Open Access
Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.
(Translational behavioral medicine, 2018-03) Zullig, Leah L; McCant, Felicia; Silberberg, Mina; Johnson, Fred; Granger, Bradi B; Bosworth, Hayden B
Relatively few successful medication adherence interventions are translated into real-world clinical settings. The Prevention of Cardiovascular Outcomes in African Americans with Diabetes (CHANGE) intervention was originally conceived as a randomized controlled trial to improve cardiovascular disease-related medication adherence and health outcomes. The purpose of the study was to describe the translation of the CHANGE trial into two community-based clinical programs. CHANGE 2 was available to Medicaid patients with diabetes and hypertension whose primary care homes were part of a care management network in the Northern Piedmont region of North Carolina. CHANGE 3 was available to low-income patients receiving care in three geographical areas with multiple chronic conditions at low or moderate risk for developing cardiovascular disease. Adaptations were made to ensure fit with available organizational resources and the patient population's health needs. Data available for evaluation are presented. For CHANGE 2, we evaluated improvement in A1c control using paired t test. For both studies, we describe feasibility measured by percentage of patients who completed the curriculum. CHANGE 2 involved 125 participants. CHANGE 3 had 127 participants. In CHANGE 2, 69 participants had A1c measurements at baseline and 12-month follow-up; A1c improved from 8.4 to 7.8 (p = .008). In CHANGE 3, interventionists completed 47% (n = 45) of calls to enroll participants at the 4-month encounter, and among those eligible for a 12-month call (n = 52), 21% of 12-month calls were completed with participants. In CHANGE 2, 40% of participants (n = 50) completed all 12 encounters. Thoughtful adaptation is critical to translate clinical trials into community-based clinic settings. Successful implementation of adapted evidence-based interventions may be feasible and can positively affect patients' disease control.
Open Access
Developing drugs for developing countries.
(Health Aff (Millwood), 2006-03) Ridley, David; Moe, Jeffrey
Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a "priority review voucher." The voucher could save an average of one year of U.S. Food and Drug Administration (FDA) review and be sold by the developer to the manufacturer of a blockbuster drug. In a well-functioning market, the voucher would speed access to highly valued treatments. Thus, the voucher could benefit consumers in both developing and developed countries at relatively low cost to the taxpayer.
Open Access
Development and implementation of a proficiency testing program for Luminex bead-based cytokine assays.
(Journal of Immunological Methods, 2014-07) Lynch, Heather E; Sanchez, Ana M; D'Souza, M Patricia; Rountree, Wes; Denny, Thomas N; Kalos, Michael; Sempowski, Gregory D
Luminex bead array assays are widely used for rapid biomarker quantification due to the ability to measure up to 100 unique analytes in a single well of a 96-well plate. There has been, however, no comprehensive analysis of variables impacting assay performance, nor development of a standardized proficiency testing program for laboratories performing these assays. To meet this need, the NIH/NIAID and the Cancer Immunotherapy Consortium of the Cancer Research Institute collaborated to develop and implement a Luminex assay proficiency testing program as part of the NIH/NIAID-sponsored External Quality Assurance Program Oversight Laboratory (EQAPOL) at Duke University. The program currently monitors 25 domestic and international sites with two external proficiency panels per year. Each panel includes a de-identified commercial Luminex assay kit with standards to quantify human IFNγ, TNFα, IL-6, IL-10 and IL-2, and a series of recombinant cytokine-spiked human serum samples. All aspects of panel development, testing and shipping are performed under GCLP by EQAPOL support teams. Following development testing, a comprehensive site proficiency scoring system comprised of timeliness, protocol adherence, accuracy and precision was implemented. The overall mean proficiency score across three rounds of testing has remained stable (EP3: 76%, EP4: 75%, EP5: 77%); however, a more detailed analysis of site reported results indicates a significant improvement of intra- (within) and inter- (between) site variation, suggesting that training and remediation for poor performing sites may be having a positive impact on proficiency. Through continued proficiency testing, identification of variables affecting Luminex assay outcomes will strengthen efforts to bring standardization to the field.
Open Access
Development of a contemporary globally diverse HIV viral panel by the EQAPOL program.
(J Immunol Methods, 2014-07) Sanchez, Ana M; DeMarco, C Todd; Hora, Bhavna; Keinonen, Sarah; Chen, Yue; Brinkley, Christie; Stone, Mars; Tobler, Leslie; Keating, Sheila; Schito, Marco; Busch, Michael P; Gao, Feng; Denny, Thomas N
The significant diversity among HIV-1 variants poses serious challenges for vaccine development and for developing sensitive assays for screening, surveillance, diagnosis, and clinical management. Recognizing a need to develop a panel of HIV representing the current genetic and geographic diversity NIH/NIAID contracted the External Quality Assurance Program Oversight Laboratory (EQAPOL) to isolate, characterize and establish panels of HIV-1 strains representing global diverse subtypes and circulating recombinant forms (CRFs), and to make them available to the research community. HIV-positive plasma specimens and previously established isolates were collected through a variety of collaborations with a preference for samples from acutely/recently infected persons. Source specimens were cultured to high-titer/high-volume using well-characterized cryopreserved PBMCs from National y donors. Panel samples were stored as neat culture supernatant or diluted into defibrinated plasma. Characterization for the final expanded virus stocks included viral load, p24 antigen, infectivity (TCID), sterility, coreceptor usage, and near full-length genome sequencing. Viruses are made available to approved, interested laboratories using an online ordering application. The current EQAPOL Viral Diversity panel includes 100 viral specimens representing 6 subtypes (A, B, C, D, F, and G), 2 sub-subtypes (F1 and F2), 7 CRFs (01, 02, 04, 14, 22, 24, and 47), 19 URFs and 3 group O viruses from 22 countries. The EQAPOL Viral Diversity panel is an invaluable collection of well-characterized reagents that are available to the scientific community, including researchers, epidemiologists, and commercial manufacturers of diagnostics and pharmaceuticals to support HIV research, as well as diagnostic and vaccine development.
Open Access
Effectiveness of mentoring programs for youth: a meta-analytic review.
(Am J Community Psychol, 2002-04) DuBois, David L; Holloway, Bruce E; Valentine, Jeffrey C; Cooper, Harris
We used meta-analysis to review 55 evaluations of the effects of mentoring programs on youth. Overall, findings provide evidence of only a modest or small benefit of program participation for the average youth. Program effects are enhanced significantly, however, when greater numbers of both theory-based and empirically based "best practices" are utilized and when strong relationships are formed between mentors and youth. Youth from backgrounds of environmental risk and disadvantage appear most likely to benefit from participation in mentoring programs. Outcomes for youth at-risk due to personal vulnerabilities have varied substantially in relation to program characteristics, with a noteworthy potential evident for poorly implemented programs to actually have an adverse effect on such youth. Recommendations include greater adherence to guidelines for the design and implementation of effective mentoring programs as well as more in-depth assessment of relationship and contextual factors in the evaluation of programs.
Open Access
Establishing a regional, multisite database for quality improvement and service planning in community-based palliative care and hospice.
(J Palliat Med, 2010-08) Bull, Janet; Zafar, S Yousuf; Wheeler, Jane L; Harker, Matthew; Gblokpor, Agbessi; Hanson, Laura; Hulihan, Deirdre; Nugent, Rikki; Morris, John; Abernethy, Amy P
BACKGROUND: Outpatient palliative care, an evolving delivery model, seeks to improve continuity of care across settings and to increase access to services in hospice and palliative medicine (HPM). It can provide a critical bridge between inpatient palliative care and hospice, filling the gap in community-based supportive care for patients with advanced life-limiting illness. Low capacities for data collection and quantitative research in HPM have impeded assessment of the impact of outpatient palliative care. APPROACH: In North Carolina, a regional database for community-based palliative care has been created through a unique partnership between a HPM organization and academic medical center. This database flexibly uses information technology to collect patient data, entered at the point of care (e.g., home, inpatient hospice, assisted living facility, nursing home). HPM physicians and nurse practitioners collect data; data are transferred to an academic site that assists with analyses and data management. Reports to community-based sites, based on data they provide, create a better understanding of local care quality. CURRENT STATUS: The data system was developed and implemented over a 2-year period, starting with one community-based HPM site and expanding to four. Data collection methods were collaboratively created and refined. The database continues to grow. Analyses presented herein examine data from one site and encompass 2572 visits from 970 new patients, characterizing the population, symptom profiles, and change in symptoms after intervention. CONCLUSION: A collaborative regional approach to HPM data can support evaluation and improvement of palliative care quality at the local, aggregated, and statewide levels.
Open Access
Evolution of the World Health Organization's programmatic actions to control diarrheal diseases.
(Journal of global health, 2019-12) Wolfheim, Cathy; Fontaine, Olivier; Merson, Michael
The Program for the Control of Diarrheal Diseases (CDD) of the World Health Organization (WHO) was created in 1978, the year the Health for All Strategy was launched at the Alma Ata International Conference on Primary Health Care. CDD quickly became one of the pillars of this strategy, with its primary goal of reducing diarrhea-associated mortality among infants and young children in developing countries. WHO expanded the previous cholera-focused unit into one that addressed all diarrheal diseases, and uniquely combined support to research and to national CDD Programs. We describe the history of the Program, summarize the results of the research it supported, and illustrate the outcome of the Program's control efforts at country and global levels. We then relate the subsequent evolution of the Program to an approach that was more technically broad and programmatically narrow and describe how this affected diarrheal diseases-related activities globally and in countries.
Open Access
Fostering Radiation Oncology Physician Scientist Trainees Within a Diverse Workforce: The Radiation Oncology Research Scholar Track.
(International journal of radiation oncology, biology, physics, 2021-06) Salama, Joseph K; Floyd, Scott R; Willett, Christopher G; Kirsch, David G
There is a need to foster future generations of radiation oncology physician scientists, but the number of radiation oncologists with sufficient education, training, and funding to make transformative discoveries is relatively small. A large number of MD/PhD graduates have entered he field of radiation oncology over the past 2 decades, but this has not led to a significant cohort of externally funded physician scientists. Because radiation oncologists leading independent research labs have the potential to make transformative discoveries that advance our field and positively affect patients with cancer, we created the Duke Radiation Oncology Research Scholar (RORS) Program. In crafting this program, we sought to eliminate barriers preventing radiation oncology trainees from becoming independent physician scientists. The RORS program integrates the existing American Board of Radiology Holman Pathway with a 2-year post-graduate medical education instructor position with 80% research effort at the same institution. We use a separate match for RORS and traditional residency pathways, which we hope will increase the diversity of our residency program. Since the inception of the RORS program, we have matched 2 trainees into our program. We encourage other radiation oncology residency programs at peer institutions to consider this training pathway as a means to foster the development of independent physician scientists and a diverse workforce in radiation oncology.
Open Access
Guidelines for international service learning programs.
(Dev World Bioeth, 2011-12) Crump, John A; Sugarman, Jeremy
Open Access
Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting.
(Am J Public Health, 2014-02) Dodge, KA; Goodman, WB; Murphy, RA; O’Donnell, K; Sato, J; Guptill, S
OBJECTIVES: We evaluated whether a brief, universal, postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity, prevent emergency health care services, and promote positive parenting by infant age 6 months. METHODS: Durham Connects is a manualized 4- to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being. All 4777 resident births in Durham, North Carolina, between July 1, 2009, and December 31, 2010, were randomly assigned to intervention and control conditions. A random, representative subset of 549 families received blinded interviews for impact evaluation. RESULTS: Of all families, 80% initiated participation; adherence was 84%. Hospital records indicated that Durham Connects infants had 59% fewer infant emergency medical care episodes than did control infants. Durham Connects mothers reported fewer infant emergency care episodes and more community connections, more positive parenting behaviors, participation in higher quality out-of-home child care, and lower rates of anxiety than control mothers. Blinded observers reported higher quality home environments for Durham Connects than for control families. CONCLUSIONS: A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes.
Open Access
Implementation of a Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections on a College Campus - Duke University, Durham, North Carolina, August 2-October 11, 2020.
(MMWR. Morbidity and mortality weekly report, 2020-11-20) Denny, Thomas N; Andrews, Laura; Bonsignori, Mattia; Cavanaugh, Kyle; Datto, Michael B; Deckard, Anastasia; DeMarco, C Todd; DeNaeyer, Nicole; Epling, Carol A; Gurley, Thaddeus; Haase, Steven B; Hallberg, Chloe; Harer, John; Kneifel, Charles L; Lee, Mark J; Louzao, Raul; Moody, M Anthony; Moore, Zack; Polage, Christopher R; Puglin, Jamie; Spotts, P Hunter; Vaughn, John A; Wolfe, Cameron R
On university campuses and in similar congregate environments, surveillance testing of asymptomatic persons is a critical strategy (1,2) for preventing transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). All students at Duke University, a private research university in Durham, North Carolina, signed the Duke Compact (3), agreeing to observe mandatory masking, social distancing, and participation in entry and surveillance testing. The university implemented a five-to-one pooled testing program for SARS-CoV-2 using a quantitative, in-house, laboratory-developed, real-time reverse transcription-polymerase chain reaction (RT-PCR) test (4,5). Pooling of specimens to enable large-scale testing while minimizing use of reagents was pioneered during the human immunodeficiency virus pandemic (6). A similar methodology was adapted for Duke University's asymptomatic testing program. The baseline SARS-CoV-2 testing plan was to distribute tests geospatially and temporally across on- and off-campus student populations. By September 20, 2020, asymptomatic testing was scaled up to testing targets, which include testing for residential undergraduates twice weekly, off-campus undergraduates one to two times per week, and graduate students approximately once weekly. In addition, in response to newly identified positive test results, testing was focused in locations or within cohorts where data suggested an increased risk for transmission. Scale-up over 4 weeks entailed redeploying staff members to prepare 15 campus testing sites for specimen collection, developing information management tools, and repurposing laboratory automation to establish an asymptomatic surveillance system. During August 2-October 11, 68,913 specimens from 10,265 graduate and undergraduate students were tested. Eighty-four specimens were positive for SARS-CoV-2, and 51% were among persons with no symptoms. Testing as a result of contact tracing identified 27.4% of infections. A combination of risk-reduction strategies and frequent surveillance testing likely contributed to a prolonged period of low transmission on campus. These findings highlight the importance of combined testing and contact tracing strategies beyond symptomatic testing, in association with other preventive measures. Pooled testing balances resource availability with supply-chain disruptions, high throughput with high sensitivity, and rapid turnaround with an acceptable workload.
Open Access
Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.
(J Immunol Methods, 2014-07) Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice
This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing.
Open Access
Is implementation fidelity associated with improved access to care in a school-based Child and Family Team model?
(Eval Program Plann, 2015-04) Gifford, Elizabeth J; Wells, Rebecca S; Bai, Yu; Malone, Patrick S
Effective child and family centered service planning is crucial to addressing vulnerable children's needs. However, there is limited evidence about what facets of these processes improve service use and outcomes. The current study used a Poisson random effects hazard model to test correlations between fidelity to NC's Child and Family Support Team model and time to service receipt, using case management data for 3396 children served by that program during the 2008-2009 school year. Students were more likely to receive recommended services more quickly when caregivers and the students attended planning meetings, when their plans included services for caregivers, and when child and family team leaders followed up after meetings to verify service receipt. Contrary to the Child and Family Support Team theory of change, match between student needs and the lead agency of the meeting was not associated with the odds of quicker service receipt, nor was attendance by natural supports. Findings from this study demonstrate the potential effectiveness of using case management systems to measure service planning process fidelity, as well as how results thereof can both inform process improvement and potential refinements to models' theories of change.
Open Access
Providing successful faculty development to graduate medical education program directors.
(International journal of medical education, 2017-09-11) Nagler, Alisa; Andolsek, Kathryn M; Rudd, Mariah; Kuhn, Catherine M
Open Access
Setting objective thresholds for rare event detection in flow cytometry.
(J Immunol Methods, 2014-07) Richards, Adam J; Staats, Janet; Enzor, Jennifer; McKinnon, Katherine; Frelinger, Jacob; Denny, Thomas N; Weinhold, Kent J; Chan, Cliburn
The accurate identification of rare antigen-specific cytokine positive cells from peripheral blood mononuclear cells (PBMC) after antigenic stimulation in an intracellular staining (ICS) flow cytometry assay is challenging, as cytokine positive events may be fairly diffusely distributed and lack an obvious separation from the negative population. Traditionally, the approach by flow operators has been to manually set a positivity threshold to partition events into cytokine-positive and cytokine-negative. This approach suffers from subjectivity and inconsistency across different flow operators. The use of statistical clustering methods does not remove the need to find an objective threshold between between positive and negative events since consistent identification of rare event subsets is highly challenging for automated algorithms, especially when there is distributional overlap between the positive and negative events ("smear"). We present a new approach, based on the Fβ measure, that is similar to manual thresholding in providing a hard cutoff, but has the advantage of being determined objectively. The performance of this algorithm is compared with results obtained by expert visual gating. Several ICS data sets from the External Quality Assurance Program Oversight Laboratory (EQAPOL) proficiency program were used to make the comparisons. We first show that visually determined thresholds are difficult to reproduce and pose a problem when comparing results across operators or laboratories, as well as problems that occur with the use of commonly employed clustering algorithms. In contrast, a single parameterization for the Fβ method performs consistently across different centers, samples, and instruments because it optimizes the precision/recall tradeoff by using both negative and positive controls.
Open Access
Statistical methods for the assessment of EQAPOL proficiency testing: ELISpot, Luminex, and Flow Cytometry.
(Journal of Immunological Methods, 2014-07) Rountree, Wes; Vandergrift, Nathan; Bainbridge, John; Sanchez, Ana M; Denny, Thomas N
In September 2011 Duke University was awarded a contract to develop the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) External Quality Assurance Program Oversight Laboratory (EQAPOL). Through EQAPOL, proficiency testing programs are administered for Interferon-γ (IFN-γ) Enzyme-linked immunosorbent spot (ELISpot), Intracellular Cytokine Staining Flow Cytometry (ICS) and Luminex-based cytokine assays. One of the charges of the EQAPOL program was to apply statistical methods to determine overall site performance. We utilized various statistical methods for each program to find the most appropriate for assessing laboratory performance using the consensus average as the target value. Accuracy ranges were calculated based on Wald-type confidence intervals, exact Poisson confidence intervals, or via simulations. Given the nature of proficiency testing data, which has repeated measures within donor/sample made across several laboratories; the use of mixed effects models with alpha adjustments for multiple comparisons was also explored. Mixed effects models were found to be the most useful method to assess laboratory performance with respect to accuracy to the consensus. Model based approaches to the proficiency testing data in EQAPOL will continue to be utilized. Mixed effects models also provided a means of performing more complex analyses that would address secondary research questions regarding within and between laboratory variability as well as longitudinal analyses.
Open Access
Teaching neuraxial anesthesia techniques for obstetric care in a Ghanaian referral hospital: achievements and obstacles.
(Anesth Analg, 2015-06) Olufolabi, Adeyemi J; Atito-Narh, Evans; Eshun, Millicent; Ross, Vernon H; Muir, Holly A; Owen, Medge D
Anesthesia providers in low-income countries may infrequently provide regional anesthesia techniques for obstetrics due to insufficient training and supplies, limited manpower, and a lack of perceived need. In 2007, Kybele, Inc. began a 5-year collaboration in Ghana to improve obstetric anesthesia services. A program was designed to teach spinal anesthesia for cesarean delivery and spinal labor analgesia at Ridge Regional Hospital, Accra, the second largest obstetric unit in Ghana. The use of spinal anesthesia for cesarean delivery increased significantly from 6% in 2006 to 89% in 2009. By 2012, >90% of cesarean deliveries were conducted with spinal anesthesia, despite a doubling of the number performed. A trial of spinal labor analgesia was assessed in a small cohort of parturients with minimal complications; however, protocol deviations were observed. Although subsequent efforts to provide spinal analgesia in the labor ward were hampered by anesthesia provider shortages, spinal anesthesia for cesarean delivery proved to be practical and sustainable.
Open Access
The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells.
(J Immunol Methods, 2014-07) Sarzotti-Kelsoe, Marcella; Needham, Leila K; Rountree, Wes; Bainbridge, John; Gray, Clive M; Fiscus, Susan A; Ferrari, Guido; Stevens, Wendy S; Stager, Susan L; Binz, Whitney; Louzao, Raul; Long, Kristy O; Mokgotho, Pauline; Moodley, Niranjini; Mackay, Melanie; Kerkau, Melissa; McMillion, Takesha; Kirchherr, Jennifer; Soderberg, Kelly A; Haynes, Barton F; Denny, Thomas N
The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV protective vaccine. Studies to meet this goal required the use of cryopreserved Peripheral Blood Mononuclear Cell (PBMC) specimens, and therefore it was imperative that a quality assurance (QA) oversight program be developed to monitor PBMC samples obtained from study participants at multiple international sites. Nine site-affiliated laboratories in Africa and the USA collected and processed PBMCs, and cryopreserved PBMC were shipped to CHAVI repositories in Africa and the USA for long-term storage. A three-stage program was designed, based on Good Clinical Laboratory Practices (GCLP), to monitor PBMC integrity at each step of this process. The first stage evaluated the integrity of fresh PBMCs for initial viability, overall yield, and processing time at the site-affiliated laboratories (Stage 1); for the second stage, the repositories determined post-thaw viability and cell recovery of cryopreserved PBMC, received from the site-affiliated laboratories (Stage 2); the third stage assessed the long-term specimen storage at each repository (Stage 3). Overall, the CHAVI PBMC QA oversight program results highlight the relative importance of each of these stages to the ultimate goal of preserving specimen integrity from peripheral blood collection to long-term repository storage.
Open Access
The effect of the WIC program on the health of newborns.
(Health Serv Res, 2010-08) Foster, EM; Jiang, M; Gibson Davis, CM
OBJECTIVE: To determine the effect of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on birth outcomes. DATA SOURCE: The Child Development Supplement (CDS) of the Panel Study of Income Dynamics (PSID). The PSID provides extensive data on the income and well-being of a representative sample of U.S. families from 1968 to present. The CDS collects information on the children in PSID families ranging from cognitive, behavioral, and health status to their family and neighborhood environment. The first two waves of the CDS were conducted in 1997 and 2002, respectively. We use information on 3,181 children and their mothers. STUDY DESIGN: We use propensity score matching with multiple imputations to examine whether WIC program influences birth outcomes: birth weight, prematurity, maternal report of the infant's health, small for gestational age, and placement in the neonatal intensive care unit. Furthermore, we use a fixed-effects model to examine the above outcomes controlling for mother-specific unobservables. PRINCIPAL FINDINGS: After using propensity scores to adjust for confounding factors, WIC shows no statistically significant effects for any of six outcomes. Fixed-effects models, however, reveal some effects that are statistically significant and fairly substantial in size. These involve preterm birth and birth weight. CONCLUSIONS: Overall, the WIC program had moderate effects, but findings were sensitive to the estimation method used.

Browsing by Subject "Program Development"

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