Patient Outcomes Research Teams (PORTS) Managing Conflict of Interest (1991) / Chapter Skim
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Appendix D Background Papers and Presentations
Appendix D Background Papers and Presentations
Pages 125-170
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From page 125... ...
But when researchers receive support from the companies that produce the products or seIvices they are investigating, when they enter into consulting arrangements with them, or when they share in the ownership of these products, their commitment to upholding professional norms may be or appear compromised. Such personal economic interests increase the likelihood that researchers will lose their Dr.
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From page 126... ...
under their Medical Treatment Effectiveness Program. Research is conducted by multidisciplinary Patient Outcomes Research Teams (PORTs)
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From page 127... ...
The hope is that medical practices will evolve in the right direction with this kind of cher~y-picking. These natural evolutionary forces may substitute for the expensive, time consuming, and cumbersome randomized clinical trials that have been the traditional way to evaluate alternative treatment strategies.~9 Each PORT focuses on a specific clinical problem, for example benign prostatic hyperplasia or gallstones, with the aim of evaluating the medical alternatives to this problem and identifying those that best achieve desired patient goals.
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From page 128... ...
Conflicts of Interest in Patient Outcomes Research Teams Like the outcome research supported by PORTs, randomized clinical trials also are designed to compare and evaluate treatment alternatives
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From page 129... ...
PORTs also are vulnerable to infecting their methods, consciously or not, with interests that conflict with professional research goals. Some might argue that compared with investigators involved in randomized clinical trials, PORTs are less vulnerable because they rely so heavily on secondary data sources that are, by and large, out of their control.
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From page 130... ...
When primary data must be collected about functional status, for example to assess outcomes with greater resolution than mortality or reoperation rates, biases and subjectivity can as easily be introduced as in any other primary research. The development of practice guidelines, although based on the initial subtasks of outcome research, is highly subject to personal interpretation.
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From page 131... ...
Spinoff Ventures and Intellectual Property Rights Although PORTs focus on existing medical practices, there are nevertheless opportunities for entrepreneurialism that may conflict with the goals of academic research or may represent the diversion of federal funds for private gain. One not so surprising finding of the PORT investigating benign prostatic hyperplasia, for example, is that the subjective importance of various symptoms and outcomes varies greatly among patients with prostatism.22 If patients knew more about these outcomes and the probabilities of achieving them, they would be better equipped to make informed choices to reflect their personal preferences and goals.
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From page 132... ...
The fundamental justification for the PORT methodologies is to hasten and improve the evaluation of medical practices. Practitioners heavily invested in existing technologies may feel vulnerable when those practices come under evaluation.23 PORTs rely on such practitioners in their primary data collection about preferences for risks and outcomes.
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From page 133... ...
It is not only individual physicians who may introduce these conflicts. While investigators in more traditional clinical trials may develop conflicts through the participation of industry collaborators, PORTs may develop conflicts because of the participation of professional societies.
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From page 134... ...
The products of outcome research are of concern to more interest groups than are the products of more traditional clinical research. But is outcome research sufficiently different that separate guidelines need to be constructed to prevent the socially undesirable consequences of industry links?
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From page 135... ...
Sola L, Schori A, Jaffe R Use of claims data systems to evaluate health care outcomes: mortalilv and reoDeration following nro.ct~rt~mv lAMA 1987;257:933-6.
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From page 136... ...
Introduction I was asked by the staff at the Institute of Medicine to write a paper on the impact of PORTs on health services research, technology innovation and on payment policy. They asked that the paper be a provocative and forward looking document rather than a scholarly one.
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From page 137... ...
I expect that we will make significant advances in the analyses of claims data. We will develop better methods of linking files to produce information on episodes of illness as well as in assessing the effect of treatment by determining surrogate health status measures from the procedure and diagnostic information contained in such files.
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From page 138... ...
Structure The structure of the funded POARPs and PORTs is modeled after the study on prostatism that was pioneered by Wennberg. Briefly, large interdisciplinary teams will conduct meta-analyses of the condition of interest, examine claims data files, undertake some prospective clinical studies, develop models of care, inform practicing physicians about their findings, implement educational programs to change physician practice patterns, and evaluate the success of these educational interventions.
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From page 139... ...
We have come a long way in making use of claims data, and no doubt we will move much further along as a result of the PORT initiative. However, claims data do not contain clinical information nor do they contain much information on specific treatment technologies.
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From page 140... ...
This prospective component is a major strength of the project. (The alternative strategy is to conduct large multi-site clinical trials.)
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From page 141... ...
If somebody submits a proposal to examine knee surgery; will the Knee jerk" response be that "Indiana is taking care of that? " Along the same lines, how will ROls by members of the PORT teams to study additional questions related to the PORT be received?
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From page 142... ...
Although PORT teams have received significant levels of funding from the new agency, the size of this funding fades into insignificance given the amount of funding other researchers have received from NIH.
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From page 143... ...
The practice patterns examined by PORTS were established practices, and it is difficult to see how studies of this sort would have much of an impact on technology innovation. However, it would be naive to assume that PORTs should or will continue to have such a benign role.
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From page 144... ...
However, I think that we can be sure that the ultimate effect of all of this evaluation will be that technology innovation and diffusion will be different than it would have been in the absence of such activity. Payment Policy The research conducted by PORTS will generate much needed information about the effectiveness of certain treatments.
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From page 145... ...
These organizations will have much better information against which to assess the practice patterns of physicians who manage the kinds of conditions that are the focus of specific PORTs. Payment Guidelines.
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From page 146... ...
However, it is not clear that if one carefully examined the practice patterns of individual physicians in Boston that they would be found to be any more "inappropriate~ than the practices of individual physicians in New Haven, although they would be found to be different. We do not know how to use payment policy to make providers in Boston practice medicine in the same way as they do in New Haven.
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From page 147... ...
However, many of these changes will be quite subtle, and it may be difficult to measure them. There is some likelihood that PORTS will be evaluated on the basis of their impact on the overall level of health care costs in the United States.
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From page 148... ...
. Recent developments in regard to self-regulation by investigators in clinical trials also suggest the wisdom of a self-denying rule whereby all key scientific participants in PORTs would forego financial ties to interested 1Dr.
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From page 149... ...
At the height of federal support for academic research in the mid-1960's some agencies, notably the Atomic Energy Commission, sought to deter conflicts arising from undisclosed financial interests in connection with research paid for by the government, e.g., the purchase of equipment from, or the orientation of research to benefit, a private firm in which the faculty member had an interest. At that time, stringent government-wide regulation was forestalled when research institutions through their consortia (the American Association of University Professors and the American Council on Education)
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From page 150... ...
Some, such as Yale, commenced institution-initiated disclosure in the form of an annual report of the level of commitment and the organizations involved in all non-university professional work, including consulting, equity, board memberships and managerial positions.9 Others, such as Harvard, retained faculty-initiated mechanisms, but sought to refine and improve policies regulating university-industry sponsored research agreements and concomitant bilateral agreements between such companies and faculty.~° Such policies were intended to insure: (1) the priority of the institution's commitment to education and training and to the development of basic knowledge in preference to commercial applications; (2)
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From page 151... ...
Certainly a state university or hospital employee must carefully consider any applicable state statute in planning outside relationships. It should also be noted that since the mid-1980's some federal agencies have prohibited ~organizational" (as opposed to "personals)
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From page 152... ...
Rep. Weiss held hearings in September 1988 at which witnesses testified that some investigators in Phase II clinical trials of anti-blood clot medications (the TIMI or "Thrombolysis in Myocardia Infarctions" trials)
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From page 153... ...
In the wake of the Tseng case, a further step followed in January 1989, when an amendment to the NIH Guide to Grants and Contract stated the agency's "expectations that participating investigators "will not have financial interests in organizations that produce drugs, devices, or other interventions studied in a controlled clinical trial.n2t In June, NIH jointly sponsored with the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) a two-day meeting on conflict of interest including representatives of academe, industry, independent research institutions and government.22 This was followed in September by the publication for comment in the NIH Guide of a far-reaching but highly ambiguous document entitled "Proposed Guidelines for Policies on Conflict of Interest." (nProposed NIH Guidelinesn)
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From page 154... ...
Secretary Louis Sullivan to withdraw the draft guidelines on December 29, 1989.24 Secretary Sullivan has promised a new proposal but indicates that it will be published in the Federal Register for notice and comment, rather than in the more informal and legally dubious format of the NIH Guide. Representative Weiss has publicly warned DHHS not to be deterred by criticism from the research community25 and has threatened to add conflict of interest standards to the NIH authorization bill this year.26 Recent Self-Regulation in Clinical Studies Public discussion of this topic has led to two notable instances of selfregulation in connection with clinical trials and to calls from within the biomedical community for more of the same.
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From page 155... ...
Arthur Caplan, director of the Center for Biomedical Ethics at the University of Minnesota, has also called for a flat ban on financial stakes of any kind in clinical trials: "These people should divest their awnings or disqualify themselves if they have a stake in the outcome.... The standards for human research have to be higher than those of other studies.n30 Recent Moves by Consortia and Individual Institutions Under the impetus of these suggestions and with a determination to insure continued public confidence in the integrity of the biomedical research enterprise, the major professional consortia have reviewed the subject and promulgated new recommendations to their memberships, and
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From page 156... ...
\ The AAHC similarly endorses regular disclosure by faculty, researchers, staff and students for themselves and their immediate family members of "significant financial, personal or professional relationships that raise a potential conflict of interest between their academic role and outside interests.~32 With respect to sponsored research, the report also calls for disclosure of "significant financial, persona, or professional relationships that raise a potential conflict of interest.... in all speeches, writings, advertising, public communications, or collegial discussions" relating to the research.3 At the institutional level, Johns Hopkins last November joined a number of schools in intensifying disclosure requirements and instituted a flat ban on the ownership by investigators of shares in companies sponsoring their work.34 According to Science, however, Stanford University School of Medicine has so far resisted per se prohibitions but has begun "spot auditing" of its annual disclosure forms and has added questions on an investigator's financial ties to its human subject review protocol.35 Existing rules have also been extensively revamped at Harvard Medical School, where the Faculty Council and the thirteen-institution consortium of affiliated teaching hospitals recently approved a new policy.
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From page 157... ...
iden~if~no the marl common sensitive situations.36 , , ~ _ What is new in the Harvard policy is a category of outside activities to be subject to maximum scrutiny, focusing upon faculty who conduct clinical research and those who own stock in companies sponsoring their work. The policy mandates intensive review by a standing faculty committee on conflict of interest for every case in which a faculty member proposes to participate in any way in clinical research (including FDA or other committees reviewing such research)
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From page 158... ...
, a trend in clinical trials towards a selfdenying rule whereby key scientific participants agree to forgo financial ties to interested businesses during such studies. Conflict of interest guidelines for PORTs investigators should also take into account several specific features of these studies.
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From page 159... ...
"Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research," adopted by the Executive Council of the Association of American Medical Colleges, February 22, 1990, p.
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From page 160... ...
4. "On Preventing Conflicts of Interest In Government-Sponsored Research at Universities: A Joint Statement of The Council of the American Association of University Professors and The American Council on Education," American Council on Education, December 1964.
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From page 161... ...
See B Healey, et al., "Conflict-Of-Interest Guidelines for A Multicenter Clinical Trial of Treatment After Coronary-Artery Bypass-Graft Surgery," The New England Journal of Medicine, Vol.
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From page 162... ...
APPENDIX D4. THE STRUCTURE AND METHODS OF PORTS: SOURCES OF BL\S John Wennberg, M.D.1 I want to thank the Institute of Medicine for hosting this Workshop on Potential Conflicts of Interest in Patient Outcomes Research Teams.
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From page 163... ...
(For example, they may include improved coronary artery blood flow or improvement in the flow of urine, but not changes in symptoms, the occurrence of side effects or changes in functional status.) The failure to systematically evaluate all treatment theories relevant to a particular condition, to use outcome measures that capture the events that are relevant to patients and to make the results of assessments available to physicians and patients in ways useful in choosing treatment options results in systematic flaws in the scientific and ethical basis for clinical decisionmaking.
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From page 164... ...
Ultimately, they must set the rules that cause ideas to be evaluated. I use the phrase "set the rules in the sense of pointing to the examples for good research based on appropriate methods, identifying the relevant outcomes, establishing processes for evaluating and synthesizing research and reaching conclusions on the status of specific treatment theories.
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From page 165... ...
Putting together information from the medical literature, claims data analysis, interview studies, and decision analysis, we could show that the preventive theory was in error. Using a wide range of possible assumptions, we could find no evidence that people would live longer if patients with BPH were operated upon to prevent subsequent development of bladder or kidney obstruction.
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From page 166... ...
. We have been at work now for a year with the AUA, helping in the design of a large scale randomized clinical trial to test the hypothesis of excessive mortality following TURP.
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From page 167... ...
The latter's judgments concerning the relative advantages and disadvantages of a specific stake holders particular treatment theories have obvious economic consequences. PORT teams can expect active interest from industry in their activities and numerous opportunities for consulting fees and honoraria.
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From page 168... ...
However, such direct financial dealings between manufacturers and PORTs or its collaborators raises red flags and should be avoided. If we can learn to harness the energies of industry, to help them in their need to have their products developed, the outcomes research agenda can be accelerated.
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From page 169... ...
A good deal of the needed protection may rest in the commitment of the federal government to ongoing funding in the area of the evaluative sciences. This, in turn, works to advance the evaluative sciences into the tenured faculty ranks, to make them and the ethics of evaluation central to the mission of the academic medical center.
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From page 170... ...
I anticipate that other PORTs, as a result of their assessments, will come to similar conclusions concerning clinical practice: for many (probably most) medial conditions, there is no single "correct" or "appropriate~ treatment; what is right for one patient—the treatment that best fits his or her preferences for outcomes and risks—is not the same treatment that is right for another patient faced with a similar situation.
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