Validation of Eligibility to Participate
In order to be eligible to participate in the C8 Health Project and receive payment, all members of The Class had to provide Brookmar, Inc. with the required documentation supporting both identity and use of drinking water for at least a 1 year period (between 1950 and December 3, 2004) in one of the six affected water districts (see the Eligibility section of this website). Brookmar, Inc. retained a copy of all supporting documentation supplied by participants, and the validity and accuracy of all documents were independently verified by a member of the Brookmar, Inc. staff. Where validity of documents could not be confirmed, or exposure to the specified drinking water for at least one year could not be verified, participants were excluded from the C8 Health Project, and payment was withheld.
Verification of Responses to Health Questionnaire
As part of the data collection process, participants were required to complete the Health Questionnaire (see the Data Collection section of this website). It was requested that participants complete this questionnaire before making an appointment (at which time documentation (above) was collected and blood was drawn). At the time of this appointment, a member of the Brookmar, Inc. staff verified all Health Questionnaire responses with the participant. It is important to note that while all responses were verified (i.e., each response was confirmed to be that which the participant intended), each response was not independently validated.
Integrated Information Technology Quality Assurance
The information systems used by Brookmar, Inc. to manage and house the data collected as part of the C8 Health Project incorporated multiple layers designed to improve and enhance data quality. Extensive programming was used to require that Health Questionnaire responses were both within the expected range and logically consistent. Further, a direct programming interface was developed in order to electronically transfer results from clinical laboratory testing from the LabCorp, Inc. information system.
"Data Cleaning" Activities
In addition to the integrated information technology processes (described above), additional data cleaning activities were performed by the WVU team. The dataset was examined for extreme or unexpected values, or responses that were logically inconsistent.
Validation of Medical Diagnoses
As part of the Health Questionnaire, participants provided information about their own medical conditions (see the Data Collection part of this website). A series of medical diagnoses were selected to be independently validated (see the Data Collection part of this website for a list of these diagnoses). For any participant self-reporting one of these diagnoses, Brookmar, Inc. requested that participants sign a release permitting Brookmar, Inc. personnel to contact hospitals and / or private physicians to retrieve medical records to validate these diagnoses. Brookmar, Inc. personnel requested only the minimum portion of participants' medical records that addressed the diagnosis as self-reported by the participant. As needed, Brookmar, Inc. staff reviewed records maintained by physicians, hospitals, diagnostic services, and / or physicians' offices where participants had received the care that validated the self-reported diagnosis. Resources were provided to caregivers in order to assist Brookmar, Inc. in obtaining the requested minimum medical records.
All of values of the perfluorochemicals (C5-12, including C8 and several salts) were determined by the Exygen Corporation. Brookmar, Inc. sent a substantial number of "split" serum samples for a second, independent determination to another laboratory, Axys. After testing was done, all of the remaining serum samples were sent to West Virginia University's tissue bank for storage.
Brookmar, Inc. put an extensive quality-assurance mechanism into place for PFC serum concentrations and for certain important survey data of concern, such as cancer outcomes. When the PFC data are complete, WVU intends to submit a peer-review report concerning quality-assurance methods and findings.