June 2002
Volume 66 |
Number 6
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ADMINISTRATIVE UPDATE
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| Streamlining the
Approval of Clinical Publications |
Eugene P. Sinclair, M.D., Speaker of the House of Delegates
Clinically useful publications are approved for distribution
to members in various ways. This article explains the process
used to develop and approve practice parameters and committee
booklets.
In March 1991, the Task Force on Practice Parameters submitted
report 428-1 to the Board of Directors. The report recommended
1) that the task force become a standing committee, 2) the topics
for the first two practice parameters and 3) a process for approving
practice parameters.
The task force recommended that practice parameters not require
approval by the House of Delegates. It recommended that the review
process originate with the panel of experts who developed the
parameter. Next, the Committee on Practice Parameters was to review
the document before sending it to the Administrative Council for
final approval. As a precedent for this recommendation, the task
force cited the mechanisms that other specialty societies used
to approve similar publications. The Board amended this proposed
approval process to require final approval by the House of Delegates,
which would retain only veto authority. The House approved the
Board's changes.
Until 1997, each year in which practice parameters were submitted
to the House, the speaker explained that by prior action of the
House, practice parameters could not be amended but could be fully
debated, approved, rejected or referred. In 1997, the House added
this provision to its Rules of Order.
In recent years, the development process for practice parameters
has been expanded to include presentation for comment in appropriate
forums before the committee submits them to the House.
Booklets that committees develop for general distribution are
approved in a different manner. This Section on Clinical Care
submitted report 610.1 to the 1997 House of Delegates. The report
observed that there seemed to be inconsistent review processes
for various publications with varying outcomes. A committee publication
up to that time would be submitted to the Board and the House
where each body would fully consider, amend appropriately, then
approve, reject or refer it.
The section report noted that the work products of committees
may be controversial but are authoritative and contain valuable,
timely information that is requested by members in order for them
to practice according to current guidelines for good medical practice.
To make this information available to members on a more timely
basis, the report suggested development of a final review mechanism
that is not as costly or lengthy as the process for developing
a practice guideline.
In response to this suggestion, the House authorized the President
to oversee the development of a mechanism for expedient review
of committee work products intended for general distribution to
the membership. The review process was to occur before publication
and emphasize the impact that a publication might have on clinical
practice.
In December 1997, the Administrative Council approved the mechanism
by which some committee publications have subsequently been authorized
for distribution without final approval by the House of Delegates.
The process requires that the section chair, vice-chair and chair
of the relevant board committee approve the committee publication
prior to distribution. Each individual in the approval chain reviews
the document and indicates approval, disapproval or approval with
noted revisions. After determining that the document is consistent
with ASA policies and that appropriate processes were utilized
in its development, a disclaimer statement that was approved by
the 1997 House of Delegates is appended to the publication. It
reads:
"This document has been developed by the [committee name]
but has not been reviewed or approved as a practice parameter
or policy statement by the ASA House of Delegates. Variances from
recommendations contained in this document may be acceptable based
on the judgment of the responsible anesthesiologist. The recommendations
are designed to encourage quality patient care and safety in the
workplace but cannot guarantee a specific outcome. They are subject
to revision from time to time as warranted by the evolution of
technology and practice."
In summary, the diverse approval mechanisms for clinical publications
retain the scientific integrity of the final products and are
characterized by development through open dialogue between the
House and the originating task force or committee.
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