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Institute of Medicine (US) Committee to Review the Federal Response to the Health Effects Associated with the Gulf of Mexico Oil Spill; Goldman L, Mitchell A, Patlak M, editors. Review of the Proposal for the Gulf Long-Term Follow-Up Study: Highlights from the September 2010 Workshop. Washington (DC): National Academies Press (US); 2010.

Cover of Review of the Proposal for the Gulf Long-Term Follow-Up Study

Review of the Proposal for the Gulf Long-Term Follow-Up Study: Highlights from the September 2010 Workshop.

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GuLF Study Design

Dale Sandler, principal investigator of the GuLF study, gave a basic description of the study, noting that its primary objectives are to assess the short- and long-term health effects associated with the oil spill cleanup and to create a resource for future collaborative research on more focused hypotheses and specific subgroups. More detailed information about the GuLF study can be found on the NIEHS website.3

The study’s main broad hypothesis is that exposure to the oil, dispersants, or combustibles given off by the burning of the oil, as well as disaster-related stress and working under excessive heat conditions, places workers at greater risk for developing mental or physical health problems. The study is open-ended, in that it is not assessing specific health outcomes, although investigations will be guided to some degree by the health complaints of others with similar exposures, such as those involved with previous oil spills.

The study population is proposed to consist of two groups:

  • Exposed adults 18 years of age or older who worked for pay or on a volunteer basis for one or more days in any cleanup task and
  • Unexposed adults who completed safety training but who did not perform cleanup work, and other community members, such as friends and relatives of the workers, if needed.

The study will have a nested design, such that a large anticipated cohort of workers (55,000, if the response rate is 70 percent) will receive a baseline phone questionnaire and will then be passively followed by linking them to cancer registries and vital statistics databases. A smaller subset of these workers will be actively studied by following up with detailed questionnaires and by collection of biological specimens and environmental samples and of physiological and anthropometric measures. A subset of these active participants will undergo biomedical surveillance done in collaboration with researchers in the Gulf area. Although the exact nature of the biomedical surveillance component of the study is still being worked out, these investigators will probably conduct comprehensive pulmonary function analyses, neurological and neurobehavioral testing, reproductive function evaluation, and mental health screening.

The GuLF study will have a community advisory board. GuLF study investigators have already implemented some initial outreach activities to a number of communities in the affected states. The investigators plan to engage the community refining the design and protocols and to work with the community to explain the rationale for collecting data. Community stakeholders will be involved at key study points, according to Dr. Sandler, who hopes to facilitate community involvement and ownership to foster trust and mutual understanding. The GuLF study team also hopes to create opportunities for community-directed research either by answering questions of concern or by fostering add-on or companion studies.

The GuLF study may be subject to numerous limitations that Dr. Sandler pointed out, including

  • Limited availability of preexposure biological samples or health assessments,
  • Limited availability of quantitative exposure measures,
  • Likely low individual exposures, and
  • For some cohort members, petrochemical and other exposures not due to their oil spill cleanup activities.

Dr. Sandler said that the study processes in the GuLF study, including data gathering, will be transparent and shared according to National Institutes of Health (NIH) guidelines. Sharing of individual-level data will be through a controlled-access process. Francis Collins, director of the NIH, suggested using the genome-wide association studies (GWAS) as a model for the GuLF study data access policies. He noted that GWAS data were stripped of all individual identifiers and that data access for GWAS was two tiered, such that the public had access to the study protocol and descriptive information, whereas investigators approved by a data access committee had controlled access to more detailed data.

Harvey Fineberg, president of the Institute of Medicine, noted the pathbreaking nature of the GuLF study. A study of this type has never been assembled in such a short time frame before, he said. Although it is uncertain whether the study will ultimately discover disease and health consequences, “what can be certain is that from methodology, the processes, and the manner in which you conduct this study, you have the opportunity to set new standards. You have an opportunity to engage with a community in a way that has never been quite accomplished.”

A number of themes for improving the GuLF study emerged from the workshop discussions, although they do not reflect consensus among the workshop participants, as the workshop did not have the goal of reaching a consensus. The list of themes follows and each theme is expanded upon below.

  • Making greater use of resources and expertise available both at the federal level and locally, including adding investigators from federal agencies other than NIH to the core research team;
  • Providing more details in the protocol concerning the administration and coordination of the various components of the study and a plan for ensuring data sharing and quality;
  • Validating exposure assumptions and assessments and collecting data on likely confounders;
  • Choosing appropriate controls;
  • Providing more specific, focused outcomes or concrete hypotheses that can be used to guide decisions about the data to be collected;
  • Planning for enrollment lower than that predicted in the protocol and giving careful consideration of how to maximize the enrollment and retention of study participants;
  • Fostering more collaboration with the community, with communications with all members of the community needing to be culturally sensitive and taking health literacy into account;
  • Planning to ensure that the health referrals likely to be needed for the participants with immediate health concerns are adequate;
  • Planning for the legal issues related to confidentiality likely to arise and the potential impact on participant enrollment; and
  • Including more health outcomes such as additional psychosocial measurements and gathering of data from pregnant women affected by the oil spill.
Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK50903

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