“Most guidelines used today suffer from shortcomings in development,” according to the IOM report, published in 2011. “Guideline development groups optimally comprise members without conflict of interest.”
Of course it's not always possible, or even necessarily desirable, to exclude anyone who has financial conflicts with industry from working on guidelines committees, many say. The government can't afford to fund all studies on the effectiveness of best practices or new products, and sometimes those closest to industry are among the best- informed people in a field.
Effective management of conflicts is key, experts say. That includes asking members of studies and guideline committees to fill out detailed assessments of potential conflicts, and asking anyone with financial entanglements on particular issues to limit their participation when discussing or voting on those issues.
Moreover, “chairs or co-chairs of such committees should definitely not have conflicts of interest,” said Dr. Daniel Carlat, director of the Pew Charitable Trusts' Prescription Project, which seeks greater transparency in physician-industry relationships. “We want our committees to make decisions based on the medical evidence.”
Although the issue of guidelines-development hasn't gotten much attention outside of the IOM report, Carlat said it can be a critically important issue because the standards are explicitly intended to influence patient care nationally. “The composition of such committees should be looked at very carefully,” he said.
Officials at the NQF were quick to point out last week that their vetting process, even if it is flawed, did prevent the publication of the industry-tainted guideline after enough concerns were raised by observers to trigger an “ad hoc review” of the draft.
“We can look backward and say that the way we managed the process in those days wasn't as strong as it should have been,” said Dr. Christine Cassel, who took over as president and CEO of the NQF last summer. “In fact, the process worked. It ended with someone pointing the finger and saying there is not enough evidence.”
The NQF's new policies greatly limit the influence of grant-funders and beef up the conflict-disclosure process—changes that followed the Aug. 19, 2009 meeting where Denham was asked and failed to reveal the $11.6 million in payments from CareFusion to his for-profit company, Health Care Concepts, meeting minutes showed.
Johns Hopkins' Pronovost served on the same committee as Denham in 2009 and 2010, as did University of California at Davis professor Dr. Patrick Romano. In interviews with Modern Healthcare, both said they were uncomfortable with how the committee reached its decisions on what best practice to add or update in the 2010 report.
“Peter and I both had the view that the process seemed to be rushed and there were inadequate NQF resources in the process, and too much of the work was being done by Denham's own staff,” Romano said.
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