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T he mortality of severe sepsis on a modified Delphi methodology, and associated rationale were discussed
(infection-induced organ dys- with categorization as previously de- and critiqued. When strong trial evi-
function or hypoperfusion ab- scribed (Table 2; adapted from refer- dence existed for outcome benefit in
normalities) and septic shock ence 3). The methods for this document critically ill populations known to con-
(hypotension not reversed with fluid re- build on a 2001 publication sponsored tain a larger number of sepsis patients,
suscitation and associated with organ by the International Sepsis Forum and these trials were considered in determi-
dysfunction or hypoperfusion abnormali- use the same method of grading recom- nation of recommendation grading. A
ties) in most centers remains unaccept- mendations (4). The 2001 publication, strict evidence-based methodology with
ably high (1, 2). Similar to an acute myo- which was used as a starting point for a scoring system was not used. Each
cardial ischemic attack and an acute the current process, included a MED- participant completed a conflict of in-
brain attack, the speed and appropriate- LINE search for clinical trials in the terest form, and individuals were not
ness of therapy administered in the initial preceding 10 yrs, supplemented by a assigned to a subgroup topic if they had
hours after the syndrome develops likely manual search of other relevant jour- a potential conflict of interest. Follow-
influence the outcome. In June 2003, a nals. Subtopics for each recommenda- ing the meeting, the process continued
group of international critical care and tion were cross-referenced to sepsis, se- with further refinement of recommen-
infectious disease experts in the diagnosis vere sepsis, septic shock, sepsis dations through electronic communi-
and management of infection and sepsis, syndrome, and infection. The SSC cation among committee members. A
representing 11 organizations (Table 1), guidelines considered the evidence in second meeting of core members of the
gathered to develop guidelines that the the 2001 publication (through 1999) committee occurred in early October
bedside clinician could use to improve and repeated the process for 2000 2003. The executive summary of the
outcome in severe sepsis and septic through 2003. The consensus commit- guidelines process with key recommen-
shock. Lead authors on recent positive tee met in June 2003 with the first dations was finalized and approved by
clinical trials were excluded from the pro- presentations of data and recommenda- the consensus committee and by spon-
cess to limit potential bias. This process tions. At that time, recommendations soring organizations in December
represented Phase II of the Surviving
Sepsis Campaign (SSC), an international
effort to increase awareness and to im- Table 1. Eleven participating organizations
prove outcome in severe sepsis. (Phase I
of the SSC was initiated in October 2002 1. American Association of Critical-Care Nurses
with the Barcelona Declaration to im- 2. American College of Chest Physicians
prove survival in severe sepsis, and Phase 3. American College of Emergency Physicians
4. American Thoracic Society
III is dedicated to the use of the manage- 5. Australian New Zealand Intensive Care Society
ment guidelines to evaluate the impact 6. European Respiratory Society
on clinical outcome; see concluding arti- 7. European Society of Clinical Microbiology and Infectious Diseases
cle in this supplement.) The meeting was 8. European Society of Intensive Care Medicine
partially funded by unrestricted industry 9. International Sepsis Forum
10. Society of Critical Care Medicine
grants. There were no industry members 11. Surgical Infection Society
on the committee. There was no industry
input into guidelines development and no
industry presence at any of the meetings.
Industry awareness or comment on the Table 2. Grading system
recommendations was not allowed. The Grading of recommendations
sponsors of the educational grants did A. Supported by at least two level I investigations
not see the recommendations until the B. Supported by one level I investigation
manuscript was peer reviewed and ac- C. Supported by level II investigations only
cepted for publication in final form. D. Supported by at least one level III investigation
E. Supported by level IV or V evidence
The recommendations from the con- Grading of evidence:
sensus conference were graded based I. Large, randomized trials with clearcut results; low risk of false-positive (alpha) error or false-
negative (beta) error
II. Small, randomized trials with uncertain results; moderate-to-high risk of false-positive
(alpha) and/or false-negative (beta) error
Copyright 2004 by the Society of Critical Care III. Nonrandomized, contemporaneous controls
Medicine and Lippincott Williams & Wilkins IV. Nonrandomized, historical controls and expert opinion
V. Case series, uncontrolled studies, and expert opinion
DOI: 10.1097/01.CCM.0000147015.53607.1F