Roman Jaeschke, MD
St. Joseph’s Hospital
McMaster University
Hamilton, Ontario, Canada

Phillip Dellinger, MD, FCCM
University of Medicine and Dentistryof New Jersey
Cooper University Hospital
Camden, New Jersey, USA


Revising the Surviving Sepsis Campaign Guidelines: A Closer Look

References

As guideline revisions reach the final stages, the Surviving Sepsis Campaign gives insight into the methods used to update recommendations.

In 2003, critical care and infectious disease experts rep¬resenting 11 international organizations developed the Surviving Sepsis Campaign (SSC) guidelines for the management of severe sepsis.1 The effort was funded by unrestricted industry grants and administered through the Society of Critical Care Medicine (SCCM), the European Society of Intensive Care Medicine (ESICM) and the International Sepsis Forum. The campaign aimed to increase awareness and improve outcomes in severe sepsis. Hundreds of institutions have implemented the campaign, and these guidelines clearly have served the critical care community well. With the assistance of other professional groups, the Society is in the final stages of revising the guidelines and wishes to keep the critical care community informed of the rigorous process involved in developing and maintaining best practices.

The original guidelines process included a modified Delphi method, a consensus conference, several subsequent smaller meetings of subgroups and key individuals, teleconferences and electronically based discussions among sub¬ groups and members of the entire committee. Sponsoring organizations included the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American College of Emergency Physicians, the American Thoracic Society, the Australian and New Zealand Intensive Care Society, the European Society of Clinical Microbiology and Infectious Diseases, the European Respiratory Society and the Surgical Infection Society.

Taking the Lead
In 2005, SCCM began to revise the guidelines, but unlike the first effort, no industry funding was needed for this process. The Society provided primary support for the process with assistance from ESICM, and other sponsoring organizations helped by funding travel to the consensus meeting. Several subgroups were formed, each charged with developing recommendations in specific areas, including glucocorticosteroids, blood products, activated protein C, renal replacement therapy, antibiotics, source control and glucose control. Subgroups agreed on draft proposals and then brought them to all members for general discussion. In January 2006, the entire group met during the 35th Critical Care Congress in San Francisco, California, USA. The results of that discussion were incorporated into the next version of recommendations and again discussed using electronic mail. Final recommendations have been submitted for editorial style formatting and form unification.

At the start of the revision process, the Surviving Sepsis Campaign Steering Committee col¬laborated with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group, using the group’s structured process for generating clinical practice guidelines.2 This international collaboration of guideline developers advocates a system that classifies quality of evidence as high (grade A), moderate (grade B), low (grade C) or very low (grade D). Grade levels are determined according to the study method, the consistency and precision of the results of different studies, the directness of the evi¬dence (in terms of population studied, interventions used and outcomes mea¬sured, and how they relate to the question of interest) and other factors. The quality of evidence based on the results of observational studies may be upgraded on the basis of large or very large effect size. This resulting quality of evidence reflects confidence in research estimates of the true effects of an intervention. The GRADE system then classifies recommendations as strong (grade 1) or weak (grade 2).

Weighing the Outcomes
The group is charged with assessing whether the desirable effects of adherence will outweigh the undesirable effects, and the strength of a recommendation reflects the group’s degree of confidence in that goal. In a strong recommen¬dation, the authors are confident that the desirable effects of adherence to a recommendation will outweigh the undesirable effects. A weak recommendation indicates the authors concluded that the desirable effects of adherence to a recommendation probably will outweigh the undesirable effects, but the panel is not confident about these tradeoffs. Desirable effects include beneficial health outcomes, less burden on patients and staff and savings. Undesirable effects include harms, more burden on patients and staff and costs.

Reasons for not being confident include:
• Absence of high-quality evidence
• Presence of imprecise estimates of benefits or harms
• Uncertainty or variation in how different individuals value the outcomes
• Small benefits
• Benefits that may not be worth the costs (including the costs of implementing the recommendation)

While the degree of confidence is a continuum and there is a lack of a precise threshold between a strong and a weak recommendation, the presence of important concerns about one or more of the above factors makes a weak recommendation more likely.

In case of disagreements or controversies concern¬ing application of the GRADE system, an 80% majority was required to accept the wording of a recommendation while developing the SSC guidelines.
This procedure was necessary for the recommendations dealing with the use of glucocorticosteroids, activated protein C and degree of glucose control.

The SSC expects to publish the guideline revisions in late 2006. The guidelines serve as the source document for the SSC sepsis change bundle performance improvement program and the associated software. This program, developed in collaboration with the Institute of Healthcare Improvement, is used by hundreds of hospital systems and individual hospitals in more than 20 countries throughout the world. The guideline revisions are not expected to have any immediate effect on the bundle quality indicators. The timing for any revision of the bundle indicators will be based primarily on analysis of ongoing data collection, process change and clinical outcome change.

The Society would like to acknowledge others who contrib¬uted to this process, including Gordon Guyatt, MD, Deborah Cook, MD, Maureen Meade, MD, Holger Schünemann, MD, and Yngve Falck-Ytter, MD.