Dataset Information

Design, methods, and population for a study of PFOA health effects among highly exposed mid-Ohio valley community residents and workers.

ABSTRACT:

Background

A cohort of community residents and workers is the basis for a series of epidemiologic studies of a Mid-Ohio Valley population with substantial perfluorooctanoic acid (PFOA) exposure due to releases from a chemical plant.

Objectives

We describe study design, methods, and study participants for a longitudinal cohort study of associations between PFOA exposure and adult chronic diseases.

Methods

Two cohorts were formed, one recruited from community residents who participated in a previous community-wide survey, and one from plant workers. Study participants were interviewed during 2008-2011 regarding demographics, health-related behaviors, and personal history of chronic diseases. Reported diseases were validated through medical records review and registry matching. Here we describe cohort characteristics, compare survey respondents and nonrespondents, provide data on the number of diseases reported and validated, and describe historical estimates of serum PFOA concentrations over time.

Results

The final combined cohort included 32,254 participants (28,541 community; 3,713 worker). Participation rates were high (community, 81.5%; worker, 72.9% of target population). The final population from each cohort was representative of the target population in terms of demographic characteristics and measured serum PFOA concentrations in 2005-2006. The study had a wide exposure range and the number of reported cases of chronic diseases was high, resulting in greater power to detect associations than has been the case for many previous studies.

Conclusions

This is the largest study to date of the health effects of PFOA. The information from this cohort is being used to examine associations between PFOA exposure and multiple adult chronic diseases.

SUBMITTER: Winquist A

PROVIDER: S-EPMC3734501 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Publications

Design, methods, and population for a study of PFOA health effects among highly exposed mid-Ohio valley community residents and workers.

Winquist Andrea A Lally Cathy C Shin Hyeong-Moo HM Steenland Kyle K

Environmental health perspectives 20130604 8

<h4>Background</h4>A cohort of community residents and workers is the basis for a series of epidemiologic studies of a Mid-Ohio Valley population with substantial perfluorooctanoic acid (PFOA) exposure due to releases from a chemical plant.<h4>Objectives</h4>We describe study design, methods, and study participants for a longitudinal cohort study of associations between PFOA exposure and adult chronic diseases.<h4>Methods</h4>Two cohorts were formed, one recruited from community residents who pa ...[more]

PMID: 23735518

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Project description:BackgroundPerfluorooctanoic acid (PFOA or C8) has hepatotoxic effects in animals. Cross-sectional epidemiologic studies suggest PFOA is associated with liver injury biomarkers.ObjectivesWe estimated associations between modeled historical PFOA exposures and liver injury biomarkers and medically validated liver disease.MethodsParticipants completed surveys during 2008-2011 reporting demographic, medical, and residential history information. Self-reported liver disease, including hepatitis, fatty liver, enlarged liver and cirrhosis, was validated with healthcare providers. Alanine aminotransferase (ALT), ?-glutamyltransferase (GGT) and direct bilirubin, markers of liver toxicity, were obtained from blood samples collected in the C8 Health Project (2005-2006). Historically modeled PFOA exposure, estimated using environmental fate and transport models and participant residential histories, was analyzed in relation to liver biomarkers (n = 30,723, including 1,892 workers) and liver disease (n = 32,254, including 3,713 workers).ResultsModeled cumulative serum PFOA was positively associated with ALT levels (p for trend < 0.0001), indicating possible liver toxicity. An increase from the first to the fifth quintile of cumulative PFOA exposure was associated with a 6% increase in ALT levels (95% CI: 4, 8%) and a 16% increased odds of having above-normal ALT (95% CI: odds ratio: 1.02, 1.33%). There was no indication of association with either elevated direct bilirubin or GGT; however, PFOA was associated with decreased direct bilirubin. We observed no evidence of an effect of cumulative exposure (with or without a 10-year lag) on all liver disease (n = 647 cases), nor on enlarged liver, fatty liver, and cirrhosis only (n = 427 cases).ConclusionResults are consistent with previous cross-sectional studies showing association between PFOA and ALT, a marker of hepatocellular damage. We did not observe evidence that PFOA increases the risk of clinically diagnosed liver disease.CitationDarrow LA, Groth AC, Winquist A, Shin HM, Bartell SM, Steenland K. 2016. Modeled perfluorooctanoic acid (PFOA) exposure and liver function in a Mid-Ohio Valley community. Environ Health Perspect 124:1227-1233;?http://dx.doi.org/10.1289/ehp.1510391.

Project description:Industrial discharges of perfluorooctanoic acid (PFOA) to the Ohio River, contaminating water systems near Parkersburg, WV, were previously associated with nearby residents' serum PFOA concentrations above US general population medians. Ohio River PFOA concentrations downstream are elevated, suggesting Mid-Ohio River Valley residents are exposed through drinking water.Quantify PFOA and 10 other per- and polyfluoroalkyl substances (PFAS) in Mid-Ohio River Valley resident sera collected between 1991 and 2013 and determine whether the Ohio River and Ohio River Aquifer are exposure sources.We measured eleven PFAS in 1608 sera from 931 participants. Serum PFOA concentration and water source associations were assessed using linear mixed-effects models. We estimated between-sample serum PFOA using one-compartment pharmacokinetics for participants with multiple samples.In serum samples collected as early as 1991, PFOA (median = 7.6 ng/mL) was detected in 99.9% of sera; 47% had concentrations greater than US population 95th percentiles. Five other PFAS were detected in greater than 82% of samples; median other PFAS concentrations were similar to the US general population. Serum PFOA was significantly associated with water source, sampling year, age at sampling, tap water consumption, pregnancy, gravidity and breastfeeding. Serum PFOA was 40-60% lower with granular activated carbon (GAC) use. Repeated measurements and pharmacokinetics suggest serum PFOA peaked 2000-2006 for participants using water without GAC treatment; where GAC was used, serum PFOA concentrations decreased from 1991 to 2012.Mid-Ohio River Valley residents appear to have PFOA, but not other PFAS, serum concentrations above US population levels. Drinking water from the Ohio River and Ohio River Aquifer, primarily contaminated by industrial discharges 209-666 km upstream, is likely the primary exposure source. GAC treatment of drinking water mitigates, but does not eliminate, PFOA exposure.

Project description:The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach.To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation.The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network.The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization.Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability.Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

Dataset Information

Design, methods, and population for a study of PFOA health effects among highly exposed mid-Ohio valley community residents and workers.

Background

Objectives

Methods

Results

Conclusions

Publications

Design, methods, and population for a study of PFOA health effects among highly exposed mid-Ohio valley community residents and workers.

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