ISHLT special report
Report of the ISHLT Working Group on Primary Lung Graft Dysfunction Part II: Definition. A Consensus Statement of the International Society for Heart and Lung Transplantation

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Goals

The goals of this consensus group center on standardizing taxonomy as well as specifying schema that capture the spectrum of the syndrome and are appropriate for many clinical research uses, including clinical trials and translational mechanistic studies (Table 1). The process for achieving these goals has been outlined in the accompanying study, “Report of the ISHLT Working Group on Primary Lung Graft Dysfunction Part I: Introduction and Methods.”

Clinical Epidemiology Principles for Definition of Clinical Syndromes

To be consistently useful, a definition needs to be valid and reliable. The validity (or accuracy) of an operational syndrome definition is the ability of a definition to distinguish between those people who have the syndrome and those who do not.9, 10 Validity essentially asks the question: “Is the operational definition capturing the true clinical syndrome?” There are many components that contribute to the concept of a valid definition.11 When defining a syndrome such as PGD, measures of

Definitions-a review of the lung transplant literature

Although there have been many terms used to describe PGD in the literature (Table 3), most studies have employed variations of the ARDS classification schemes to define PGD in their own patient populations (Table 4). Specifically, classification schemes have used oxygenation characteristics, defined as a ratio of the partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2). Generally, when this ratio (the P/F ratio) is <200, investigators have concluded that a

Potential difficulties with the defining criteria for PGD

The criteria used to define PGD may be problematic to employ. The inter-observer reliability of chest radiographs for ARDS is inconsistent, even when simply assessing for presence or absence of diffuse bilateral infiltrates. However, inconsistency may be improved by training sessions.12 Variations between observers in ARDS raise concerns over use of X-ray grading systems and point scores in PGD. In addition, gas-exchange impairment has been assessed by using the P/F ratio. Although this is a

Recommendations of the working group on primary graft dysfunction

The following recommendations represent the results of months of process, as described in the introductory report in this series. They contain changes recommended at the 2004 ISHLT Conference following the Satellite Symposium and the meetings that followed.

Summary and conclusions

The working group recognizes that the syndrome of PGD represents a spectrum of disease and that the proposed PGD definitions should be a starting point for further discussion. The group has attempted to incorporate the best features of previous single-center studies, recognizing that different studies have been associated with different definition schemes. Given that our understanding of the clinical course of PGD is evolving, the group concludes that there should be a separation of the time

Future directions and suggestions for research

The working group particularly encourages several types of research in future studies refining the definitions of PGD. If conducted carefully, these types of studies may lead to future refinements of the definition, which will be the cornerstone to more complete study of PGD. Specific recommendations for future research on the risk factors, outcomes, and therapy of PGD are covered in subsequent manuscripts from the ISHLT PGD working group. Specific recommendations regarding future research on

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