Biostatistics Commons^™

Can Changes In Angiogenic Biomarkers Between The First And Second Trimesters Of Pregnancy Predict Development Of Pre-Eclampsia In A Low-Risk Nulliparous Patient Population?, Leslie Myatt, Rebecca G. Clifton, J. M. Roberts, Catherine Y. Spong, Ronald J. Wapner, +10 Additional Authors

GW Biostatistics Center

OBJECTIVE:

To determine if change in maternal angiogenic biomarkers between the first and second trimesters predicts pre-eclampsia in low-risk nulliparous women.

DESIGN:

A nested case-control study of change in maternal plasma soluble Flt-1 (sFlt-1), soluble endoglin (sEng) and placenta growth factor (PlGF). We studied 158 pregnancies complicated by pre-eclampsia and 468 normotensive nonproteinuric controls.

SETTING:

A multicentre study in 16 academic medical centres in the USA.

POPULATION:

Low-risk nulliparous women.

METHODS:

Luminex assays for PlGF, sFlt-1 and sEng performed on maternal EDTA plasma collected at 9-12, 15-18 and 23-26 weeks of gestation. Rate of change of analyte between first and …

Modeling The Impact And Costs Of Semiannual Mass Drug Administration For Accelerated Elimination Of Lymphatic Filariasis, Wilma A. Stolk, Quirine A. Ten Bosch, Sake J. De Vlas, Peter U. Fischer, Gary J. Weil, Ann S. Goldman

Epidemiology Faculty Publications

The Global Program to Eliminate Lymphatic Filariasis (LF) has a target date of 2020. This program is progressing well in many countries. However, progress has been slow in some countries, and others have not yet started their mass drug administration (MDA) programs. Acceleration is needed. We studied how increasing MDA frequency from once to twice per year would affect program duration and costs by using computer simulation modeling and cost projections. We used the LYMFASIM simulation model to estimate how many annual or semiannual MDA rounds would be required to eliminate LF for Indian and West African scenarios with varied …

Environmental Exposure To Pyrethroids And Sperm Sex Chromosome Disomy: A Cross-Sectional Study, Heather A. Young, John D. Meeker, Sheena E. Martenies, Zaida I. Figueroa, Dana Boyd Barr, Melissa J. Perry

Epidemiology Faculty Publications

Background

The role of environmental pesticide exposures, such as pyrethroids, and their relationship to sperm abnormalities are not well understood. This study investigated whether environmental exposure to pyrethroids was associated with altered frequency of sperm sex chromosome disomy in adult men.

Methods

A sample of 75 subjects recruited through a Massachusetts infertility clinic provided urine and semen samples. Individual exposures were measured as urinary concentrations of three pyrethroid metabolites ((3-phenoxybenzoic acid (3PBA), cis- and trans- 3-(2,2-Dichlorovinyl)-1-methylcyclopropane-1,2-dicarboxylic acid (CDCCA and TDCCA)). Multiprobe fluorescence in situ hybridization for chromosomes X, Y, and 18 was used to determine XX, YY, XY, 1818, and …

Information And Communication Technology To Link Criminal Justice Reentrants To Hiv Care In The Community, Ann Kurth, Irene Kuo, James Peterson, Nkiru Azikiwe, Lauri Bazerman, Alice Cates, Curt G. Beckwith

Epidemiology Faculty Publications

The United States has the world’s highest prison population, and an estimated one in seven HIV-positive persons in the USA passes through a correctional facility annually. Given this, it is critical to develop innovative and effective approaches to support HIV treatment and retention in care among HIV-positive individuals involved in the criminal justice (CJ) system. Information and communication technologies (ICTs), including mobile health (mHealth) interventions, may offer one component of a successful strategy for linkage/retention in care. We describe CARE+ Corrections, a randomized controlled trial (RCT) study now underway in Washington, that will evaluate the combined effect of computerized motivational …

Determinants Of Negative Pathways To Care And Their Impact On Service Disengagement In First-Episode Psychosis., Kelly K. Anderson, Rebecca Fuhrer, Norbert Schmitz, Ashok K Malla

Epidemiology and Biostatistics Publications

PURPOSE: Although there have been numerous studies on pathways to care in first-episode psychosis (FEP), few have examined the determinants of the pathway to care and its impact on subsequent engagement with mental health services.

METHODS: Using a sample of 324 FEP patients from a catchment area-based early intervention (EI) program in Montréal, we estimated the association of several socio-demographic, clinical, and service-level factors with negative pathways to care and treatment delay. We also assessed the impact of the pathway to care on time to disengagement from EI services.

RESULTS: Few socio-demographic or clinical factors were predictive of negative pathways …

Obesity And Preference-Weighted Quality Of Life Of Ethnically Diverse Middle School Children: The Healthy Study, Roberto P. Trevino, Trang H. Pham, Sharon Edelstein

GW Biostatistics Center

No abstract provided.

Transmission Potential Of Influenza A/H7n9, February To May 2013, China, Gerardo Chowell, Lone Simonsen, Sherry Towers, Mark A. Miller, Cecile G. Viboud

Epidemiology Faculty Publications

Background

On 31 March 2013, the first human infections with the novel influenza A/H7N9 virus were reported in Eastern China. The outbreak expanded rapidly in geographic scope and size, with a total of 132 laboratory-confirmed cases reported by 3 June 2013, in 10 Chinese provinces and Taiwan. The incidence of A/H7N9 cases has stalled in recent weeks, presumably as a consequence of live bird market closures in the most heavily affected areas. Here we compare the transmission potential of influenza A/H7N9 with that of other emerging pathogens and evaluate the impact of intervention measures in an effort to guide pandemic …

A Case–Control Study Of Incident Rheumatological Conditions Following Acute Gastroenteritis During Military Deployment, Kathryn Deyoung, Mark A. Riddle, Larissa S. May, Chad K. Porter

Epidemiology Faculty Publications

Objectives The aim of this study was to assess the risk of incident rheumatological diagnoses (RD) associated with self-reported diarrhoea and vomiting during a first-time deployment to Iraq or Afghanistan. Such an association would provide evidence that RD in this population may include individuals with reactive arthritis (ReA) from deployment-related infectious gastroenteritis.

Design This case–control epidemiological study used univariate and multivariate logistic regression to compare the odds of self-reported diarrhoea/vomiting among deployed US military personnel with incident RD to the odds of diarrhoea/vomiting among a control population.

Setting We analysed health records of personnel deployed to Iraq or Afghanistan, including …

Augmenting Program Data With Secondary Data Sources To Improve The Quality Of Existing Statistics : Four Examples From The New York State Department Of Health Hospital-Acquired Infection Reporting Program, Valerie Benson Haley

Legacy Theses & Dissertations (2009 - 2024)

The objective of this dissertation is to illustrate the novel application of methods that can be used to improve the accuracy of hospital-acquired infection (HAI) rates. Public reporting of HAI rates is relatively new. New York was one of the first states to mandate reporting in acute care hospitals (2007), followed by national pay-for-reporting in 2011, and national value-based purchasing in 2013. Given the financial ramifications of public reporting, it is critical that the data are validated and adjusted for differences in underlying risk among patient populations so that hospital performance can be fairly compared. However, limited information on the …

Data Mining And Pattern Discovery Using Exploratory And Visualization Methods For Large Multidimensional Datasets, Hsin-Fang Li

Theses and Dissertations--Epidemiology and Biostatistics

Oral health problems have been a major public health concern profoundly affecting people’s general health and quality of life. Given that oral health data is composed of several measurable dimensions including clinical measurements, socio-behavioral factors, genetic predispositions, self-reported assessments, and quality of life measures, strategies for analyzing multidimensional data are neither computationally straightforward nor efficient. Researchers face major challenges to identify tools that circumvent the processes of manually probing the data.

The purpose of this dissertation is to provide applications of the proposed methodology on oral health-related data that go beyond identifying risk factors from a single dimension, and to …

Screening For Elder Mistreatment Among Older Adults Seeking Legal Assistance Services, Sheryl M. Strasser, Megan Smith, Scott Weaver, Shimin Zheng, Yan Cao

ETSU Faculty Works

Introduction: The aging population is a rapidly growing demographic in the United States. Isolation, limited autonomy, and declining physical and mental health render many older adults vulnerable to elder mistreatment (EM). The purpose of this study was to assess the prevalence and correlates of EM among a sample of older adults using legal assistance services in Atlanta, Georgia.

Methods: Researchers administered surveys to consenting older adults (aged 60þ) in 5 metro Atlanta community centers that hosted legal assistance information sessions as part of the Elderly Legal Assistance Program. The surveys screened for risk factors and prevalence of EM risk using …

Uncontrolled Hypertension And Associated Factors In Hypertensive Patients At The Primary Healthcare Center Luis H. Moreno, Panama: A Feasibility Study, Roderick Ramon Chen Camano

USF Tampa Graduate Theses and Dissertations

Background: According to the World Health Organization (WHO), hypertension is a major risk factor for cardiovascular disease (CVD), renal impairment, peripheral vascular disease, and blindness. In Panama, a recent study estimated the prevalence of hypertension at 38.5% in the two main provinces of the country, with a rate of uncontrolled hypertension of 47.2%.

Objectives: The aims of this study were to assess the feasibility of the study design and to describe the characteristics of the hypertensive population and the physician's adherence to Panamanian antihypertensive protocols and their relationship with uncontrolled hypertension.

Methods: This is a cross-sectional study of adult hypertensive …

A Monte Carlo Approach To Change Point Detection In A Liver Transplant, Alexia Melissa Makris

USF Tampa Graduate Theses and Dissertations

Patient survival post liver transplant (LT) is important to both the patient and the center's accreditation, but over the years physicians have noticed that distant patients struggle with post LT care. I hypothesized that patient's distance from the transplant center had a detrimental effect on post LT survival. I suspected Hepatitis C (HCV) and Hepatocellular Carcinoma (HCC) patients would deteriorate due to their recurrent disease and there is a need for close monitoring post LT. From the current literature it was not clear if patients' distance from a transplant center affects outcomes post LT. Firozvi et al. (Firozvi AA, 2008) …

Evaluation Of The Survival Effect For Various Treatment Modalities Among Stage Ii And Iii Rectal Cancer Patients In California, 1994-2009, Myung Mi Cho

Loma Linda University Electronic Theses, Dissertations & Projects

Background: European trials evaluating the effect of preoperative (PreOP) versus postoperative chemoradiotherapy (PostOP CRT) found no survival benefit. However, the effect of a change from PostOP to PreOP CRT has not been evaluated in a population-based setting. We sought to evaluate multimodal treatment changes and overall survival for perioperative (PeriOP) CRT versus surgery alone and for PreOP versus PostOP CRT from 1994 through 2009 among patients receiving radical surgery for stage II and III rectal cancer (RC).

Patients and Methods: We conducted a nonconcurrent cohort study evaluating demographic predictors of multimodal therapy for stage II and III RC using …

The Morbidity & Mortality Of Prevalent Heart Failure, Jennifer Kwon

Loma Linda University Electronic Theses, Dissertations & Projects

The first study population included 292 unselected consecutive patients from the LLUMC heart failure clinic who were enrolled in the study from January to July 2006 and were followed up through the end of December 2010. The treatment policy at the clinic was to uptitrate dosages of beta-adrenergic blockade (β-blockers), angiotensin-converting-enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) to the most tolerable levels in order to reach target dosages, as recommended by the Heart Failure Society of America (HFSA). Patients were classified into systolic heart failure (ejection fraction (EF) < 40%) or diastolic heart failure (EF≥40%). All dosages of β-blockers, ACEi and ARB were extracted through chart reviews and were used as the main predictors of the patients' survival. Results from analyses showed that reaching target dosages of β-blockers and ACEi/ARB may increase survival when compared to not reaching target among the systolic HF population (HR_{β_biockers}= 0.64, 95% CI 0.26-1.56 and HR_ACEi/ARB=0.50, …

Effects Of Genetic Variants Previously Associated With Fasting Glucose And Insulin In The Diabetes Prevention Program, Jose C. Florez, Kathleen A. Jablonski, Jarred B. Mcateer, Paul W. Franks, Clinton C. Mason, Kieren J. Mather, Edward Horton, Ronald Goldberg, Dana Dabelea, Steven E. Kahn, Richard F. Arakaki, Alan R. Shuldiner, William C. Knowler

Epidemiology Faculty Publications

Common genetic variants have been recently associated with fasting glucose and insulin levels in white populations. Whether these associations replicate in pre-diabetes is not known. We extended these findings to the Diabetes Prevention Program, a clinical trial in which participants at high risk for diabetes were randomized to placebo, lifestyle modification or metformin for diabetes prevention. We genotyped previously reported polymorphisms (or their proxies) in/near G6PC2, MTNR1B, GCK, DGKB, GCKR, ADCY5, MADD, CRY2, ADRA2A,FADS1, PROX1, SLC2A2, GLIS3, C2CD4B, IGF1, and IRS1 in 3,548 Diabetes …

Measuring Infertility In Populations: Constructing A Standard Definition For Use With Demographic And Reproductive Health Surveys, Maya N. Mascarenhas, Hoiwan Cheung, Colin D. Mathers, Gretchen A. Stevens

Dartmouth Scholarship

Background: Infertility is a significant disability, yet there are no reliable estimates of its global prevalence. Studies on infertility prevalence define the condition inconsistently, rendering the comparison of studies or quantitative summaries of the literature difficult. This study analyzed key components of infertility to develop a definition that can be consistently applied to globally available household survey data.

Methods: We proposed a standard definition of infertility and used it to generate prevalence estimates using 53 Demographic and Health Surveys (DHS). The analysis was restricted to the subset of DHS that contained detailed fertility information collected through the reproductive health calendar. …

Genetic Modulation Of Lipid Profiles Following Lifestyle Modification Or Metformin Treatment: The Diabetes Prevention Program, Toni I. Pollin, Tamara Isakova, Kathleen A. Jablonski, Paul I.W. De Bakker, Andrew Taylor, Jarred B. Mcateer, Qing Pan, Edward Horton, Linda M. Delahanty, David Altshuler, Alan R. Shuldiner, Ronald Goldberg, Jose C. Florez, George A. Bray

Epidemiology Faculty Publications

Weight-loss interventions generally improve lipid profiles and reduce cardiovascular disease risk, but effects are variable and may depend on genetic factors. We performed a genetic association analysis of data from 2,993 participants in the Diabetes Prevention Program to test the hypotheses that a genetic risk score (GRS) based on deleterious alleles at 32 lipid-associated single-nucleotide polymorphisms modifies the effects of lifestyle and/or metformin interventions on lipid levels and nuclear magnetic resonance (NMR) lipoprotein subfraction size and number. Twenty-three loci previously associated with fasting LDL-C, HDL-C, or triglycerides replicated (P = 0.04–1×10−17). Except for total HDL particles (r = −0.03, …

Fall In C-Peptide During First 2 Years From Diagnosis: Evidence Of At Least Two Distinct Phases From Composite Type 1 Diabetes Trialnet Data., Carla J. Greenbaum, Craig A. Beam, David Boulware, Stephen E. Gitelman, Peter A. Gottlieb, Kevan C. Herold, John M. Lachin, Paula L. Mcgee, Jerry P. Palmer, Mark D. Pescovitz, Heidi Krause-Steinrauf, Jay S. Skyler, Jay M. Sosenko

Epidemiology Faculty Publications

Interpretation of clinical trials to alter the decline in β-cell function after diagnosis of type 1 diabetes depends on a robust understanding of the natural history of disease. Combining data from the Type 1 Diabetes TrialNet studies, we describe the natural history of β-cell function from shortly after diagnosis through 2 years post study randomization, assess the degree of variability between patients, and investigate factors that may be related to C-peptide preservation or loss. We found that 93% of individuals have detectable C-peptide 2 years from diagnosis. In 11% of subjects, there was no significant fall from baseline by 2 …

Selective Impact Of Hiv Disease Progression On The Innate Immune System In The Human Female Reproductive Tract., Timothy Lahey, Mimi Ghosh, John V. Fahey, Zheng Sheng, Lucy R. Mukura, Yan Song, Susan Cu-Uvin, Kenneth H. Mayer, Peter F. Wright, John C. Kappes, Christina Ochsenbauer, Charles R. Wira

Epidemiology Faculty Publications

Background

We have previously demonstrated intrinsic anti-HIV activity in cervicovaginal lavage (CVL) from HIV-infected women with high CD4 counts and not on antiretroviral therapy. However, the impact of HIV disease progression on CVL innate immune responses has not been delineated.

Methods

CVL from 57 HIV-infected women not on antiretroviral therapy were collected by washing the cervicovaginal area with 10 ml of sterile normal saline. We characterized subject HIV disease progression by CD4 count strata: >500 cells/µl, 200–500 cells/µl, or <200 cells/µl of blood. To assess CVL anti-HIV activity, we incubated TZM-bl cells with HIV plus or minus CVL. Antimicrobials, cytokines, chemokines and anti-gp160 HIV IgG antibodies were measured by ELISA and Luminex.

Results

CVL exhibited broad anti-HIV activity against multiple laboratory-adapted and transmitted/founder (T/F) viruses, with anti-HIV activity ranging from 0 to 100% …

Change-Point Analysis Of Paired Allele-Specific Copy Number Variation Data, Yinglei Lai

GW Biostatistics Center

The recent genome-wide allele-specific copy number variation data enable us to explore two types of genomic information including chromosomal genotype variations as well as DNA copy number variations. For a cancer study, it is common to collect data for paired normal and tumor samples. Then, two types of paired data can be obtained to study a disease subject. However, there is a lack of methods for a simultaneous analysis of these four sequences of data. In this study, we propose a statistical framework based on the change-point analysis approach. The validity and usefulness of our proposed statistical framework are demonstrated …

Characteristics Of Children With Type 1 Diabetes And Persistent Suboptimal Glycemic Control., Hyuntae Kim, Angelo Elmi, Celia L. Henderson, Fran R. Cogen, Paul B. Kaplowitz

Epidemiology Faculty Publications

Objective: This study aims to determine the relationship between the duration of persistent poor glycemic control in type 1 diabetes mellitus (T1DM) children and the likelihood of subsequent improvement.

Methods: A retrospective cohort study was conducted on T1DM patients aged 6-18 years, followed for at least six visits at Children’s National Medical Center (Washington, DC) with at least one hemoglobin A1c (HbA1c) ≥10% after the first year since the initial visit (n=151). Medical records of patients with subsequently improved glycemic control were reviewed (n=39).

Results: Patients aged 12-18 years, females, and Medicaid patients were twice as likely to be in …

Dna Methylation Arrays As Surrogate Measures Of Cell Mixture Distribution, Eugene Houseman, William P. Accomando, Devin C. Koestler, Brock C. Christensen, Carmen J. Marsit

Dartmouth Scholarship

There has been a long-standing need in biomedical research for a method that quantifies the normally mixed composition of leukocytes beyond what is possible by simple histological or flow cytometric assessments. The latter is restricted by the labile nature of protein epitopes, requirements for cell processing, and timely cell analysis. In a diverse array of diseases and following numerous immune-toxic exposures, leukocyte composition will critically inform the underlying immuno-biology to most chronic medical conditions. Emerging research demonstrates that DNA methylation is responsible for cellular differentiation, and when measured in whole peripheral blood, serves to distinguish cancer cases from controls.

Perbandingan Tingkat Kepuasan Kerja Perawat Dan Kepuasan Pasien, Jamilla Upik Noras, Ratu Ayu Dewi Sartika

Kesmas

Perawat adalah ujung tombak pemberi pelayanan langsung pada pasien selama 24 jam. Tujuan penelitian adalah untuk membandingkan tingkat kepuasan kerja perawat dengan kepuasan pasien terhadap pelayanan keperawatan kelas 3 di Rumah Sakit Umum Pusat (RSUP) X Jakarta. Penelitian ini bersifat deskriptif dengan desain studi cross sectional, pendekatan kuantitatif dan kualitatif. Populasi adalah seluruh perawat yang bertugas sebagai pelaksana keperawatan kelas 3 sebanyak 40 orang ser- ta pasien yang dirawat di ruang rawat inap kelas 3 sebanyak 120 orang. Pengambilan sampel dilakukan secara purposive sampling sesuai dengan kriteria inklusi dan ekslusi. Hasil pengukuran kuantitatif menunjukkan bah- wa tingkat kepuasan kerja perawat …

Demographics And Survival Of Aids Cases With Cancer, Washington, Dc, 1996-2006, Heather A. Young, Eric Engels, Anne-Marie Sufian-Kargbo, Alicia Vargas, Kathleen Rogers, Tiffany West, Amanda D. Castel

Epidemiology Faculty Publications

Background

Washington, DC (DC) has one of the highest HIV/AIDS rates in the U.S and cancer is the second leading cause of death among DC residents. This study sought to examine the demographic characteristics and survival of persons with AIDS defining cancers (ADCs) compared to those with non-AIDS defining cancers (NADCs) between the early HAART era (1996-2001) and the late HAART era (2002-2006) in DC.

Methods

Cases reported from 1996-2006 to the DC Cancer Registry and the AIDS Surveillance Registry were linked using a probabilistic matching algorithm. Cases were included if the cancer occurred from 4 months to 60 months …

High And Persistent Hiv Seroincidence In Men Who Have Sex With Men Across 47 U.S. Cities, Marta-Louise Ackers, Alan E. Greenberg, Carol Y. Lin, Bradford N. Bartholow, Adrian Hirsch Goodman, Michael Longhi, Marc Gurwith

Epidemiology Faculty Publications

Objective

To provide HIV seroincidence data among men who have sex with men (MSM) in the United States and to identify predictive factors for seroconversion.

Methods

From 1998–2002, 4684 high-risk MSM, age 18–60 years, participated in a randomized, placebo-controlled HIV vaccine efficacy trial at 56 U.S. clinical trial sites. Demographics, behavioral data, and HIV status were assessed at baseline and 6 month intervals. Since no overall vaccine efficacy was detected, data were combined from both trial arms to calculate HIV incidence based on person-years (py) of follow-up. Predictors of seroconversion, adjusted hazards ratio (aHR), were evaluated using a Cox proportional …

Progestogens To Prevent Preterm Birth In Twin Pregnancies: An Individual Participant Data Meta-Analysis Of Randomized Trials., Ewoud Schuit, Sarah Stock, Rolf H.H. Groenwold, Kimberly Maurel, C. Andrew Combs, Thomas Garite, Catherine Y. Spong, Elizabeth A. Thom, Dwight J. Rouse, Steve N. Caritis, George Saade, Julia M. Zachary, Jane E. Norman, Line Rode, Katharina Klein, Ann Tabor, Elcin Cetingoz, John C. Morrison, Everett F. Magann, Christian M. Briery, Vicente Serra, Alfredo Perales, Juan Meseguer, Anwar Nassar, Arianne C. Lim, Karel G.M. Moons, Anneke Kwee, Ben W.J. Mol

Epidemiology Faculty Publications

Background

Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix) or to determine adverse effects for rare outcomes such as intrauterine death.

Methods/design

We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The …

Does Secondary Inflammatory Breast Cancer Represent Post-Surgical Metastatic Disease?, Salman Hashmi, Ladan Zolfaghari, Paul H. Levine

Epidemiology Faculty Publications

The phenomenon of accelerated tumor growth following surgery has been observed repeatedly and merits further study. Inflammatory breast carcinoma (IBC) is widely recognized as an extremely aggressive malignancy characterized by micrometastasis at the time of diagnosis, with one interesting subgroup defined as secondary IBC where pathologically identifiable IBC appears after surgical treatment of a primary non-inflammatory breast cancer. One possible mechanism can be related to the stimulation of dormant micrometastasis through local angiogenesis occurring as part of posttraumatic healing. In this report, we review cases of secondary IBC and others where localized trauma was followed by the appearance of IBC …

Effect Of Nutrition Changes On Foods Selected By Students In A Middle School-Based Diabetes Prevention Intervention Program: The Healthy Experience, Connie Mobley, Diane D. Stadler, Myrlene A. Staten, Laure El Ghormli, Bonnie Gillis, Jill Hartstein, Anna Maria Siega-Riz, Amy Virus, Healthy Study Group

GW Biostatistics Center

No abstract provided.

Repeat Prenatal Corticosteroid Prior To Preterm Birth: A Systematic Review And Individual Participant Data Meta-Analysis For The Precise Study Group (Prenatal Repeat Corticosteroid International Ipd Study Group: Assessing The Effects Using The Best Level Of Evidence) - Study Protocol, Caroline A. Crowther, Fariba Aghajafari, Lisa M. Askie, Elizabeth V. Asztalos, Peter Brocklehurst, Elizabeth A. Thom, +22 Additional Authors

GW Biostatistics Center

Background

The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.

Methods/Design

The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants …