Review of the Proposal for the Gulf Long-Term Follow-Up Study Highlights from the September 2010 Workshop: Workshop Report (2010) / Chapter Skim
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GULF STUDY DESIGN
GULF STUDY DESIGN
Pages 2-16
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From page 2... ...
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.
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From page 3... ...
• 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.
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From page 4... ...
not only has thousands of water, sediment, and air samples collected from the oil spill site but also has unique exposure reconstruction tools that it is willing to share, according to Michele Colon from EPA. She indicated that the agency is eager to be involved in the GuLF study because it views worker health as an important sentinel for assessing environmental health consequences of the oil spill.
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From page 5... ...
Maureen Lichtveld of Tulane University added that ongoing studies of a unique cohort of Vietnamese participants performed before and after Hurricane Katrina may be able to provide some useful data or resources. Several participants stressed using community connections already established by health care workers and academic researchers in the affected areas.
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From page 6... ...
Roberta Ness,5 a member of the IOM committee, noted that virtually no one listed on the current team of investigators is a local academic or linked in some way to the local community, which is needed to build buy in and future capacity. Those involved in designing the GuLF study noted that they have planned to partner with consortia of local academic researchers and community groups to address health issues that are not the focus of the GuLF study.
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From page 7... ...
Bernard Goldstein added that biological markers of exposure could be helpful after oil spills but that most do not persist long enough to be of value to the GuLF study at this late date. David Cohen, a member of the IOM committee, suggested that key to assessing exposure accurately will be determinations of whether workers used the personal protective equipment that was given to them and whether they had additional personal hygiene habits that might have further limited their exposure.
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From page 8... ...
Sandler said. She acknowledged that "this is tricky to do." David Tollerud expressed concern that regarding the number of controls, "there's just not enough to do what you need to do." Maureen Lichtveld agreed that exposure reconstruction "will make or break" the study, as a true baseline is no longer available; the study participants were exposed to multiple contaminants and had multiple exposure routes and exposure opportunities; and the exposure duration to each contaminant could have been brief, intermittent, or continual.
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From page 9... ...
PLANNING FOR LOWER ENROLLMENT Many participants questioned the 70 percent enrollment figure given for the GuLF study, which they viewed as being overly optimistic, given that enrollment in the World Trade Center Registry was less than half that. In addition, many Gulf of Mexico oil spill cleanup workers have already moved to other areas and will be difficult to locate.
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From page 10... ...
As Roxane Cohen Silver noted, researchers can acknowledge to the study participants the presence of ambiguity and uncertainty, as long as they do so honestly and believably. Several workshop participants suggested ensuring that the communication materials used in the study pass low-literacy requirements; be sensitive to cultural differences, such as how health concerns are viewed and reported; and be appropriately translated into Vietnamese and the other languages that the study participants speak and ensuring that those communication materials are pretested in focus groups.
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From page 11... ...
Dale Sandler and Francis Collins noted that it is hard to assess which community representatives are the most appropriate ones to seek input from, as several often exist for specific communities in the Gulf. Howard Osofsky noted that after the Hurricane Katrina disaster, community members were somewhat disappointed with community representatives because they did not adequately advocate the needs of the community.
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From page 12... ...
Nancy Kass suggested including funds for bolstering local health clinics as part of the study budget, including donating more mobile clinics to local public health facilities and funding a few more health care staff for them. She noted that being able to tell participants that services are in place to address some of the concerns that they articulate will have enormous value in terms of trust and study retention.
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From page 13... ...
Bernard Goldstein noted that long-term follow-up of individuals in communities affected by the Exxon Valdez oil spill was hampered by the actions of a federal judge who required the release of the information gathered from those individuals, despite a promise of confidentiality from the investigators. Lynn Goldman added that those data used in the reconstruction of exposure, such as height, weight, and when the person was working at a specific location, may enable an employer or others to identify a participant.
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From page 14... ...
Dale Sandler added that the gathering of information on reproductive health is an opportunity for creating partnerships. Maureen Lichtveld suggested that more psychosocial measures be collected from the study participants and that mental health be more explicitly listed as a potential health risk, especially because studies of other disasters have shown mental and behavioral health issues to be major outcomes.
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From page 15... ...
Quoting a letter that Abigail Adams wrote to her son John Quincy Adams in 1780, Francis Collins noted, "It is not in the still calm of life, or in the repose of a pacific station, that great characters are formed. The habits of a vigorous mind are formed in contending with difficulties."
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