David Faraggi

University of Utah, Salt Lake City, Utah, United States

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Publications (89)293.72 Total impact

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    ABSTRACT: STUDY QUESTION What is the association between daily preconception-initiated low-dose aspirin (LDA) treatment and very early pregnancy losses or euploid (chromosomally normal) losses among women with one to two prior losses?
    No preview · Article · Jan 2016 · Human Reproduction

  • No preview · Article · Sep 2015 · Obstetric Anesthesia Digest
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    ABSTRACT: Several lines of evidence suggest that male embryos may have greater vulnerability than female embryos to disordered inflammation; therefore, antiinflammatory drugs, such as low-dose aspirin (LDA), may alter the sex ratio. Here, we assessed the effect of LDA on male live birth and male offspring, incorporating pregnancy losses (n = 56) via genetic assessment, as part of a parallel-design, block-randomized, placebo-controlled trial of preconception LDA. Participants (615 treated with LDA, 613 treated with placebo) ranged in age from 18 to 40 years of age, with 1 to 2 prior pregnancy losses. We estimated the intention-to-treat (ITT) risk ratio (RR) and 95% CI and assessed interaction with baseline high-sensitivity C-reactive protein (hsCRP) serum concentration - a marker of systemic inflammation. Among the 1,078 women who completed follow-up (535 treated with LDA, 543 treated with placebo), the male live birth ITT RR equaled 1.31 (95% CI: 1.07-1.59). With increasing tertile of hsCRP, the proportion of males at birth decreased in the placebo group, and the effect of LDA on male live birth increased (first tertile: 48% male in LDA vs. 52% in placebo, ITT RR = 0.97, 95% CI: 0.70-1.35; second tertile: 57% male in LDA vs. 43% in placebo, ITT RR = 1.36, 95% CI: 0.98-1.90; third tertile: 53% male in LDA vs. 35% in placebo, ITT RR = 1.70, 95% CI: 1.13-2.57; P interaction = 0.03). Analysis of pregnancy with male offspring yielded similar results. Initiation of LDA prior to conception restored numbers of male live births and pregnancy with male offspring among women with 1 to 2 prior pregnancy losses. Moreover, our data suggest that LDA modulates inflammation that would otherwise reduce the conception or survival of male embryos. ClinicalTrials.gov NCT00467363. Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health.
    Full-text · Article · Aug 2015 · The Journal of clinical investigation
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    ABSTRACT: To evaluate the association between low-dose aspirin initiated before conception and the risk of preterm birth. This was a secondary analysis of the Effects of Aspirin in Gestation and Reproduction trial. Women with a history of pregnancy loss (original stratum: one loss less than 20 weeks of gestation during the previous year; expanded stratum: one or two losses with no restrictions on timing or gestational age of the losses) were randomized to either daily low-dose aspirin (81 mg, n=615) and folic acid or folic acid alone (placebo; n=613). Preterm birth was compared between groups using intent-to-treat analysis. Preterm birth rates were 4.1% (22/535 low-dose aspirin) and 5.7% (31/543 placebo) (relative risk [RR] 0.72, 95% confidence interval [CI] 0.42-1.23); spontaneous preterm birth rates were 1.1% (6/535 low-dose aspirin) and 2.2% (12/543 placebo) (RR 0.51, 95% CI 0.19-1.34); medically indicated preterm birth rates were 2.6% (14/535 low-dose aspirin) and 2.9% (16/543 placebo) (RR 0.89, 95% CI 0.44-1.80). After restriction to confirmed pregnancies using inverse probability weighting, preterm birth rates were 5.7% and 9.0% (RR 0.63, 95% CI 0.37-1.09) and spontaneous preterm birth rates were 1.4% and 3.2% (RR 0.44, 95% CI 0.17-1.18). In confirmed pregnancies in the original stratum, preterm birth occurred in 3.8% and 9.7% of the low-dose aspirin and placebo groups, respectively (RR 0.39, 95% CI 0.16-0.94). Preconception low-dose aspirin was not significantly associated with the overall rate of preterm birth. Although the study was underpowered for this secondary analysis, numeric trends in favor of benefit, particularly in the women with a recent, single early pregnancy loss, warrant further investigation. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00467363. LEVEL OF EVIDENCE:: I.
    No preview · Article · Mar 2015 · Obstetrics and Gynecology
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    ABSTRACT: Objective: To determine the effect of preconception-initiated daily low-dose aspirin (LDA; 81 mg/day) treatment on time to pregnancy in women with a history of pregnancy loss. Design: Multi-center, block-randomized, double-blind, placebo-controlled trial. Participants were block-randomized by center and eligibility stratum. Setting: Four U.S.A. medical centers (2007-2012). Participants: Women aged 18-40 years actively attempting pregnancy, stratified by eligibility criteria-the "original" stratum, women with one loss <20 weeks' gestation during the previous year; and the "expanded" stratum, women with one or two previous losses of any gestational age regardless of time since loss. Intervention: Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy. Main outcome measure: Time to hCG detected pregnancy and clinically confirmed pregnancy, analyzed by intention-to-treat. Results: Of the 1228 women randomly assigned to LDA (n=615) or placebo (n=613), 410 (67%) women receiving LDA achieved pregnancy compared to 382 (63%) receiving placebo, corresponding to a fecundability odds ratio (FOR) of 1.14 (95% CI: 0.97, 1.33). Among women in the original stratum (n=541), LDA was associated with increased fecundability compared to placebo (FOR: 1.28; 95%CI: 1.02, 1.62). Conclusions: Preconception-initiated LDA treatment resulted in a nonsignificant increase in fecundability of 14% in women with a history of 1-2 pregnancy losses, and a significant increase of 28% in women with a history of only one pregnancy loss of <20 weeks' gestation in the preceding year. Preconception-initiated LDA may increase fecundability in certain women with a recent early pregnancy loss.
    Full-text · Article · Feb 2015 · Journal of Clinical Endocrinology & Metabolism
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    ABSTRACT: Objective: We sought to assess the relationship between a short interpregnancy interval (IPI) following a pregnancy loss and subsequent live birth and pregnancy outcomes. Study design: A secondary analysis of women enrolled in the Effects of Aspirin in Gestation and Reproduction trial with a human chorionic gonadotropin-positive pregnancy test and whose last reproductive outcome was a loss were included in this analysis (n = 677). IPI was defined as the time between last pregnancy loss and last menstrual period of the current pregnancy and categorized by 3-month intervals. Pregnancy outcomes include live birth, pregnancy loss, and any pregnancy complications. These were compared between IPI groups using multivariate relative risk estimation by Poisson regression. Results: Demographic characteristics were similar between IPI groups. The mean gestational age of prior pregnancy loss was 8.6 ± 2.8 weeks. The overall live birth rate was 76.5%, with similar live birth rates between those with IPI ≤3 months as compared to IPI >3 months (adjusted relative risk [aRR], 1.07; 95% confidence interval [CI], 0.98-1.16). Rates were also similar for periimplantation loss (aRR, 0.95; 95% CI, 0.51-1.80), clinically confirmed loss (aRR, 0.75; 95% CI, 0.51-1.10), and any pregnancy complication (aRR, 0.88; 95% CI, 0.71-1.09) for those with IPI ≤3 months as compared to IPI >3 months. Conclusion: Live birth rates and adverse pregnancy outcomes, including pregnancy loss, were not associated with a very short IPI after a prior pregnancy loss. The traditional recommendation to wait at least 3 months after a pregnancy loss before attempting a new pregnancy may not be warranted.
    Full-text · Article · Sep 2014 · American Journal of Obstetrics and Gynecology

  • No preview · Article · Sep 2014 · Fertility and Sterility
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    ABSTRACT: Preconception-initiated low-dose aspirin might positively affect pregnancy outcomes, but this possibility has not been adequately assessed. Our aim was to investigate whether low-dose aspirin improved livebirth rates in women with one to two previous pregnancy losses. In this multicentre, block-randomised, double-blind, placebo-controlled trial, women aged 18-40 years who were attempting to become pregnant were recruited from four medical centres in the USA. Participants were stratified by eligibility criteria-the original stratum was restricted to women with one loss at less than 20 weeks' gestation during the previous year, whereas the expanded stratum included women with one to two previous losses, with no restrictions on gestational age or time of loss. Women were block-randomised by centre and eligibility stratum in a 1:1 ratio. Preconception-initiated daily low-dose aspirin (81 mg per day) plus folic acid was compared with placebo plus folic acid for up to six menstrual cycles; for women who conceived, study treatment continued until 36 weeks' gestation. Participants, trial staff, and investigators were masked to the assigned treatment. The primary outcome was livebirth rate, which was analysed by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00467363. Overall, 1228 women were recruited and randomly assigned between June 15, 2007, and July 15, 2011, 1078 of whom completed the trial and were included in the analysis (535 in the low-dose aspirin group and 543 in the placebo group). 309 (58%) women in the low-dose aspirin group had livebirths, compared with 286 (53%) in the placebo group (p=0·0984; absolute difference in livebirth rate 5·09% [95% CI -0·84 to 11·02]). Pregnancy loss occurred in 68 (13%) women in the low-dose aspirin group, compared with 65 (12%) women in the placebo group (p=0·7812). In the original stratum, 151 (62%) of 242 women in the low-dose aspirin group had livebirths, compared with 133 (53%) of 250 in the placebo group (p=0·0446; absolute difference in livebirth rate 9·20% [0·51 to 17·89]). In the expanded stratum, 158 (54%) of 293 women in the low-dose aspirin group and 153 (52%) of 293 in the placebo group had livebirths (p=0·7406; absolute difference in livebirth rate 1·71% [-6·37 to 9·79]). Major adverse events were similar between treatment groups. Low-dose aspirin was associated with increased vaginal bleeding, but this adverse event was not associated with pregnancy loss. Preconception-initiated low-dose aspirin was not significantly associated with livebirth or pregnancy loss in women with one to two previous losses. However, higher livebirth rates were seen in women with a single documented loss at less than 20 weeks' gestation during the previous year. Low-dose aspirin is not recommended for the prevention of pregnancy loss. Eunice Kennedy Shriver National Institute of Child Health and Human Development (US National Institutes of Health).
    No preview · Article · Apr 2014 · The Lancet

  • No preview · Article · Jan 2014 · American Journal of Obstetrics and Gynecology

  • No preview · Article · Jan 2014 · American Journal of Obstetrics and Gynecology
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    ABSTRACT: Low-dose aspirin (LDA) has been proposed to improve pregnancy outcomes in couples experiencing recurrent pregnancy loss. However, results from studies of LDA on pregnancy outcomes have been inconsistent, perhaps because most studies evaluated LDA-initiated post-conception. The purpose of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was to determine whether preconception-initiated LDA improves livebirth rates in women with one to two prior losses. We performed a multicentre, block randomised, double-blind, placebo-controlled trial. Study participants were recruited using community-based advertisements and physician referral to four university medical centres in the US (2006-12). Eligible women were aged 18-40 years actively trying to conceive, with one to two prior losses. Participants were randomised to receive daily LDA (81 mg/day) or a matching placebo, and all were provided with daily 400-mcg folic acid. Follow-up continued for ≤6 menstrual cycles while attempting to conceive. For those who conceived, treatment was continued until 36 weeks gestation. The primary outcome was the cumulative livebirth rate over the trial period. There were 1228 women randomised (615 LDA, 613 placebo). Participants had a mean age of 28.7, were mostly white (95%), well educated (86% more than high school education), and employed (75%) with a household income >$100 000 annually (40%). The characteristics of those in the treatment and placebo arms were well balanced. We describe the study design, recruitment, data collection, and baseline characteristics of participants enrolled in EAGeR, which aimed to determine the effect of LDA on livebirth and other pregnancy outcomes in these women.
    No preview · Article · Oct 2013 · Paediatric and Perinatal Epidemiology

  • No preview · Article · Jan 2013 · American Journal of Obstetrics and Gynecology
  • Ronen Fluss · Benjamin Reiser · David Faraggi
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    ABSTRACT: The ROC (receiver operating characteristic) curve is frequently used for describing effectiveness of a diagnostic marker or test. Classical estimation of the ROC curve uses independent identically distributed samples taken randomly from the healthy and diseased populations. Frequently not all subjects undergo a definitive gold standard assessment of disease status (verification). Estimation of the ROC curve based on data only from subjects with verified disease status may be badly biased (verification bias). In this work we investigate the properties of the doubly robust (DR) method for estimating the ROC curve adjusted for covariates (ROC regression) under verification bias. We develop the estimator's asymptotic distribution and examine its finite sample size properties via a simulation study. We apply this procedure to fingerstick postprandial blood glucose measurement data adjusting for age.
    No preview · Article · Jan 2012 · Journal of Statistical Planning and Inference
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    Full-text · Article · Aug 2009 · European Journal of Epidemiology
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    ABSTRACT: The efficacy of self-hypnosis (SH), masking (MA) and attentiveness to the patient's complaints (AT) in the alleviation of tinnitus was evaluated. Forty-five male patients close in age with chronic tinnitus related to acoustic trauma were assigned to three matched subgroups: SH, AT or MA. The therapeutic stimuli in the SH and MA sessions, recorded on audio cassettes, were given to the patients for use when needed. SH significantly reduced the tinnitus severity; AT partially relieved the tinnitus; MA did not have any significant effect.
    No preview · Article · Jul 2009 · Audiology: official organ of the International Society of Audiology
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    ABSTRACT: The ROC (receiver operating characteristic) curve is the most commonly used statistical tool for describing the discriminatory accuracy of a diagnostic test. Classical estimation of the ROC curve relies on data from a simple random sample from the target population. In practice, estimation is often complicated due to not all subjects undergoing a definitive assessment of disease status (verification). Estimation of the ROC curve based on data only from subjects with verified disease status may be badly biased. In this work we investigate the properties of the doubly robust (DR) method for estimating the ROC curve under verification bias originally developed by Rotnitzky, Faraggi and Schisterman (2006) for estimating the area under the ROC curve. The DR method can be applied for continuous scaled tests and allows for a non-ignorable process of selection to verification. We develop the estimator's asymptotic distribution and examine its finite sample properties via a simulation study. We exemplify the DR procedure for estimation of ROC curves with data collected on patients undergoing electron beam computer tomography, a diagnostic test for calcification of the arteries.
    Full-text · Article · Jul 2009 · Biometrical Journal
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    ABSTRACT: The Youden Index is often used as a summary measure of the receiver operating characteristic curve. It measures the effectiveness of a diagnostic marker and permits the selection of an optimal threshold value or cutoff point for the biomarker of interest. Some markers, while basically continuous and positive, have a spike or positive mass of probability at the value zero. We provide a flexible modeling approach for estimating the Youden Index and its associated cutoff point for such spiked data and compare it with the standard empirical approach. We show how this modeling approach can be adjusted to take covariate information into account. This approach is applied to data on the Coronary Calcium Score, a marker for atherosclerosis.
    Full-text · Article · Jan 2008 · Statistics in Medicine
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    ABSTRACT: Previous studies have suggested that diabetes and metabolic syndrome are significant risk factors for coronary artery disease (CAD). However, in women, their relative importance remains controversial. To evaluate risk factors for CAD in women and their association with the severity and extent of coronary angiographic findings. We clinically evaluated 243 consecutive female patients with chest pain who underwent coronary angiography. The location and extent of coronary artery occlusions were assessed using the modified Gensini index. Compared with women with normal coronary arteries (n = 90), those with CAD (n = 153) reported less physical activity (p = 0.001), and had higher prevalences of diabetes (p = 0.046), hypertension (p = 0.002), and the metabolic syndrome (p = 0.001). They also had lower HDL cholesterol levels (p = 0.017), higher levels of triglycerides (p = 0.005), and higher fasting plasma glucose (FPG) (p < 0.001). Physical activity, FPG, serum triglycerides and HDL-cholesterol, but not the metabolic syndrome, were independent predictors of CAD. A score combining the extent and severity of angiographic findings was significantly higher in women with diabetes (p = 0.007), hypertension (p = 0.010) and FPG >or=100 mg/dl (p = 0.031), but showed no association with the metabolic syndrome. In a multivariate linear regression analysis, diabetes was an independent predictor of the extent and severity of angiographic score (p = 0.013). Diabetes, fasting plasma glucose and hypertension, but not the metabolic syndrome, were associated with severity of coronary angiographic findings in these women.
    Full-text · Article · Sep 2007 · QJM: monthly journal of the Association of Physicians
  • Katy Molodianovitch · David Faraggi · Benjamin Reiser
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    ABSTRACT: In order to compare the discriminatory effectiveness of two diagnostic markers the equality of the areas under the respective Receiver Operating Characteristic Curves is commonly tested. A non-parametric test based on the Mann-Whitney statistic is generally used. Weiand et al. (1989) present a parametric test based on normal distributional assumptions. We extend this test using the Box-Cox power family of transformations to non-normal situations. These three test procedures are compared in terms of significance level and power by means of a large simulation study. Overall we find that transforming to normality is to be preferred. An example of two pancreatic cancer serum biomarkers is used to illustrate the methodology.
    No preview · Article · Oct 2006 · Biometrical Journal
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    ABSTRACT: The receiver operating characteristic (ROC) curve and in particular the area under the curve (AUC) is commonly used to examine the discriminatory ability of diagnostic markers. Certain markers while basically continuous and non-negative have a positive probability mass (spike) at the value zero. We discuss a flexible modelling approach to such data and contrast it with the standard non-parametric approach. We show how the modelling approach can be extended to take account of the effect of explanatory variables. We motivate this problem and illustrate the modelling approach using data on the coronary calcium score, measured by electron beam tomography, which is a marker for atherosclerosis.
    Preview · Article · Feb 2006 · Statistics in Medicine

Publication Stats

2k Citations
293.72 Total Impact Points

Institutions

  • 2015
    • University of Utah
      Salt Lake City, Utah, United States
  • 1990-2015
    • University of Haifa
      • Department of Statistics
      H̱efa, Haifa, Israel
  • 2006-2009
    • Universidad Torcuato di Tella
      • Departamento de Economía
      Buenos Aires, Buenos Aires F.D., Argentina
  • 1992-1999
    • Technion - Israel Institute of Technology
      • Rambam Medical Center
      H̱efa, Haifa District, Israel
  • 1994-1998
    • National Cancer Institute (USA)
      • Biometrics Research Branch
      베서스다, Maryland, United States
  • 1991
    • Barzilai Medical Center Ashkelon
      Majdal, Southern District, Israel
    • Mid-Columbia Medical Center
      DLS, Oregon, United States