A Cohort Study to Determine the Epidemiology of Estuary-Associated Syndrome

From the Introduction: Estuary-Associated Syndrome (EAS) is the name given to a potential illness characterized primarily by changes in an individual\u27s cognitive abilities, including acute onset of memory loss or the sudden inability to solve simple problems. Other possible signs of illness include respiratory symptoms, skin rash, or gastrointestinal distress. This illness appears to arise following exposure to toxin produced by Pfiesteria piscicida, or other toxic dinoflagellates, that resides in estuary waters. …. In order to learn more about this possible syndrome and to determine if a causal relationship exists between association to waters containing Pfiesteria or other toxic PLOs and illness, cohort studies in Maryland, North Carolina and Virginia were funded by the Centers for Disease Control and Prevention (CDC). In Virginia, CDC funding through VDH supports the study being done by the Survey and Evaluation Research Laboratory (SERL) at Virginia Commonwealth University with assistance from researchers at the Medical College of Virginia/Virginia Commonwealth University, Eastern Virginia Medical School and the University of Virginia. This study is being conducted in collaboration with researchers at Old Dominion University (ODU), the Virginia Institute of Marine Science (VIMS) and the Department of Environmental Quality (DEQ) who are gathering information on the environmental aspects of Virginia\u27s waters. The objectives of the study include: 1. Determine the association between exposure to estuary waters containing PLOs and possible EAS. 2. Characterize the clinical signs and symptoms of EAS. 3. Determine the incidence and prevalence of EAS. 4. Identify risk factors and exposure conditions required for illness

Cohort Studies of Health Effects among People Exposed to Estuarine Waters: North Carolina, Virginia, and Maryland

A variety of human symptoms have been associated with exposure to the dinoflagellate Pfiesteria and have been grouped together into a syndrome termed "possible estuary-associated syndrome." Prospective cohort studies of health effects associated with exposure to estuarine waters that may contain Pfiesteria spp. and related organisms are in progress in North Carolina, Virginia, and Maryland. The three studies recruited cohorts of 118-238 subjects who work or engaged in recreation in estuary waters. Baseline health and neuropsychological evaluations are conducted, and study subjects are followed prospectively for 2-5 years with periodic assessments of health and performance on a battery of neuropsychological tests. Health symptoms and estuary water exposure are recorded by telephone interviews or diaries every 1-2 weeks. Water quality information, including measurements of Pfiesteria spp., is collected in the areas where the subjects are working. Because it is not possible to measure individual exposure to Pfiesteria or a toxin produced by this organism, these studies examine surrogate exposure measures (e.g., time spent in estuary waters, in a fish kill area, or in waters where Pfiesteria DNA was detected by molecular amplification). Preliminary analyses of the first 2 years (1998-2000) of data indicate that none of the three ongoing cohorts have detected adverse health effects. However, there have not been any reported fish kills associated with Pfiesteria since the studies began, so it is possible that none of the study subjects have been exposed to toxin-producing Pfiesteria spp

A Method for Reducing Misclassification in the Extended Glasgow Outcome Score

The eight-point extended Glasgow Outcome Scale (GOSE) is commonly used as the primary outcome measure in traumatic brain injury (TBI) clinical trials. The outcome is conventionally collected through a structured interview with the patient alone or together with a caretaker. Despite the fact that using the structured interview questionnaires helps reach agreement in GOSE assessment between raters, significant variation remains among different raters. We introduce an alternate GOSE rating system as an aid in determining GOSE scores, with the objective of reducing inter-rater variation in the primary outcome assessment in TBI trials. Forty-five trauma centers were randomly assigned to three groups to assess GOSE scores on sample cases, using the alternative GOSE rating system coupled with central quality control (Group 1), the alternative system alone (Group 2), or conventional structured interviews (Group 3). The inter-rater variation between an expert and untrained raters was assessed for each group and reported through raw agreement and with weighted kappa (κ) statistics. Groups 2 and 3 without central review yielded inter-rater agreements of 83% (weighted κ = 0.81; 95% CI 0.69, 0.92) and 83% (weighted κ = 0.76, 95% CI 0.63, 0.89), respectively, in GOS scores. In GOSE, the groups had an agreement of 76% (weighted κ = 0.79; 95% CI 0.69, 0.89), and 63% (weighted κ = 0.70; 95% CI 0.60, 0.81), respectively. The group using the alternative rating system coupled with central monitoring yielded the highest inter-rater agreement among the three groups in rating GOS (97%; weighted κ = 0.95; 95% CI 0.89, 1.00), and GOSE (97%; weighted κ = 0.97; 95% CI 0.91, 1.00). The alternate system is an improved GOSE rating method that reduces inter-rater variations and provides for the first time, source documentation and structured narratives that allow a thorough central review of information. The data suggest that a collective effort can be made to minimize inter-rater variation

A Method for Reducing Misclassification in the Extended Glasgow Outcome Score

The eight-point extended Glasgow Outcome Scale (GOSE) is commonly used as the primary outcome measure in traumatic brain injury (TBI) clinical trials. The outcome is conventionally collected through a structured interview with the patient alone or together with a caretaker. Despite the fact that using the structured interview questionnaires helps reach agreement in GOSE assessment between raters, significant variation remains among different raters. We introduce an alternate GOSE rating system as an aid in determining GOSE scores, with the objective of reducing inter-rater variation in the primary outcome assessment in TBI trials. Forty-five trauma centers were randomly assigned to three groups to assess GOSE scores on sample cases, using the alternative GOSE rating system coupled with central quality control (Group 1), the alternative system alone (Group 2), or conventional structured interviews (Group 3). The inter-rater variation between an expert and untrained raters was assessed for each group and reported through raw agreement and with weighted kappa (κ) statistics. Groups 2 and 3 without central review yielded inter-rater agreements of 83% (weighted κ = 0.81; 95% CI 0.69, 0.92) and 83% (weighted κ = 0.76, 95% CI 0.63, 0.89), respectively, in GOS scores. In GOSE, the groups had an agreement of 76% (weighted κ = 0.79; 95% CI 0.69, 0.89), and 63% (weighted κ = 0.70; 95% CI 0.60, 0.81), respectively. The group using the alternative rating system coupled with central monitoring yielded the highest inter-rater agreement among the three groups in rating GOS (97%; weighted κ = 0.95; 95% CI 0.89, 1.00), and GOSE (97%; weighted κ = 0.97; 95% CI 0.91, 1.00). The alternate system is an improved GOSE rating method that reduces inter-rater variations and provides for the first time, source documentation and structured narratives that allow a thorough central review of information. The data suggest that a collective effort can be made to minimize inter-rater variation