Patient Outcomes Research Teams (PORTS) Managing Conflict of Interest (1991) / Chapter Skim
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4 Sources of Special Concern about Conflicts of Interest in PORTS
4 Sources of Special Concern about Conflicts of Interest in PORTS
Pages 47-60
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From page 47... ...
ELEVEN ISSUES OF SPECIAL CONCERN PORTs as Hybrid Entities: Research and Quasi-Regulatory Functions PORTs as a Public finest for Development of Scientific Knowledge PORTs are highly visible examples of academic science and technology; as such, they are part of a sizable public investment in academic medical research that is intended to improve health. Such government-supported basic and applied biomedical research has over the decades resulted in major advances in scientific knowledge (Hamburg and Nightingale, 1984; Colloton, 1989; Schroeder et al., 1989~.
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From page 48... ...
PORT investigation, a young and rapidly evolving science, consists of methods for evaluating and improving medical practice by considering the effectiveness of care through outcomes research. It is thus at the heart what has been termed "the new technology assessment" (Fuchs and Garber, 1990~.
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From page 49... ...
Protecting PORT Credibility PORT findings are likely to be controversial from the viewpoint of clinicians, manufacturers, and other interested parties; whether they are "positive" or "negative," they may not be accepted without struggle. That struggle will probably involve examining all potential sources of bias, possibly with the intent of damaging the credibility of the PORT findings.
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From page 50... ...
Concentration of Expertise Many participants in the IOM workshop were concerned about the implications of the concentration of expertise that will occur in the multidisciplinary PORTs (a problem not unique to PORT research)
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From page 51... ...
Some published studies and most unpublished studies may be excluded because they fail to meet the inclusion criteria established by PORT investigators. Another possible source of bias is the selection of methods to conduct the necessary "cleanings and transforming of insurance claims data tapes; yet, these methods generally are not described in detail.
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From page 52... ...
PORT researchers must rely on the active participation of individual practitioners and professional societies to enroll patients in their studies and to conduct some primary data collection about patient preferences regarding risks and outcomes. For example, the outcome assessment team at the University of Washington is investigating low back pain, a problem that is the second leading reason for all physician visits and the leading reason for visits to orthopedic surgeons and neurosurgeons.
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From page 53... ...
The same general points probably apply as well to insurance data purchased from private carriers or obtained from state data consortia. General access to these valuable data bases can be facilitated or restricted by AHCPR (through grant and contract specifications)
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From page 54... ...
Several participants at the IOM workshop and other health services researchers who have PORT subcontracts noted, however, that they are unaware of their own institution's policies on conflicts of interest or that those policies have not been revised for many years and may no longer suffice in the PORT environment. Further, awareness and acceptance by PORT members of a lead institution's policies represent only the first step towards avoiding conflict of interest.
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From page 55... ...
Aspects of controlled trials thus may come to be incorporated in PORT design, and private funding of many kinds may be grafted onto core PORT funding. These factors, as well as the more usual questions related to equity interests in products under evaluation, raise special issues regarding conflict of interest, and are described in the remainder of the chapter.
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From page 56... ...
For example, a nonscientific conflict of interest might occur if an investigator whose continued secondary funding depends on enrolling a sufficient number of cases recruits patients preferentially to the secondary protocol. A scientific conflict of interest might occur if systematic recruitment weakens the power of the PORT study, (i.e., the ability of the investigators to find statistically significant differences or to draw strong and proper inferences from their data)
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From page 57... ...
This might, for instance, involve special software for claims data analysis, survey tools to assess outcomes, approaches for assessing utilities or patient preferences, and educational programs describing alternative treatments. Primary data collection on patient preferences for various outcomes could be seen as extensive pilot testing (Asch, 1990~.
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From page 58... ...
To the extent that voluntary or involuntary restrictions on free discussion inhibit PORT evaluations, they represent a conflict of interest for PORT researchers (Eisenberg, 1988~. In particular, when agreements are made between manufacturers and biomedical researchers, they commonly include so-called secrecy and exclusivity clauses temporarily restricting the investigator from interactions that might compromise the patentability or competitive advantage of the product at issue.
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From page 59... ...
PORT use of qualitative, subjective, and patient-reported qualitative judgments in outcome assessments; (5) the potential for biases arising from professional and collegial ties to the nonPORT practitioners; (6)
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From page 60... ...
9. PORT members are lil;ely to enter financial arrangements related to spin - ff ventures using intellectual property rights as a result of their PORT research.
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