Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jul 1;10(7):ofad336.
doi: 10.1093/ofid/ofad336. eCollection 2023 Jul.

An Adjudication Protocol for Severe Pneumonia

Chiagozie I Pickens  1 , Catherine A Gao  1 , Justin Bodner  1 , James M Walter  1 , Jacqueline M Kruser  1   2 , Helen K Donnelly  1 , Alvaro Donayre  1 , Katie Clepp  1 , Nicole Borkowski  1 , Richard G Wunderink  1 , Benjamin D Singer  1 ; NU SCRIPT Study Investigators
Affiliations

An Adjudication Protocol for Severe Pneumonia

Chiagozie I Pickens et al. Open Forum Infect Dis. .

Abstract

Background: Clinical end points that constitute successful treatment in severe pneumonia are difficult to ascertain and vulnerable to bias. The utility of a protocolized adjudication procedure to determine meaningful end points in severe pneumonia has not been well described.

Methods: This was a single-center prospective cohort study of patients with severe pneumonia admitted to the medical intensive care unit. The objective was to develop an adjudication protocol for severe bacterial and/or viral pneumonia. Each episode of pneumonia was independently reviewed by 2 pulmonary and critical care physicians. If a discrepancy occurred between the 2 adjudicators, a third adjudicator reviewed the case. If a discrepancy remained after all 3 adjudications, consensus was achieved through committee review.

Results: Evaluation of 784 pneumonia episodes during 593 hospitalizations achieved only 48.1% interobserver agreement between the first 2 adjudicators and 78.8% when agreement was defined as concordance between 2 of 3 adjudicators. Multiple episodes of pneumonia and presence of bacterial/viral coinfection in the initial pneumonia episode were associated with lower interobserver agreement. For an initial episode of bacterial pneumonia, patients with an adjudicated day 7-8 clinical impression of cure (compared with alternative impressions) were more likely to be discharged alive (odds ratio, 6.3; 95% CI, 3.5-11.6).

Conclusions: A comprehensive adjudication protocol to identify clinical end points in severe pneumonia resulted in only moderate interobserver agreement. An adjudicated end point of clinical cure by day 7-8 was associated with more favorable hospital discharge dispositions, suggesting that clinical cure by day 7-8 may be a valid end point to use in adjudication protocols.

Keywords: adjudication; clinical; end point; pneumonia; severe.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest. B.D.S. holds US patent 10,905,706, “Compositions and methods to accelerate resolution of acute lung inflammation,” and serves on the Scientific Advisory Board of Zoe Biosciences, for which he holds stock options. C.I.P., C.A.G., J.B., J.M.W., J.M.K., H.K.D., A.D., K.C., N.B., and R.G.W. declare no conflicts of interest. All other authors report no potential conflicts.

Figures

Figure 1.
Figure 1.
Diagram illustrating the adjudication process. Out of 593 hospitalizations, 55 had only 1 adjudicator (A1), 259 cases had 2 adjudicators (A2), and 279 cases required a third adjudicator (A3). A small subset went directly to committee review after A1 and A2.
Figure 2.
Figure 2.
Crude rates of interobserver agreement by year. When interobserver agreement was defined as consensus between 2 of 2 adjudicators, the crude rates of interobserver agreement did not exceed 0.6. Interobserver agreement, defined as agreement between 2 of 3 adjudicators, increased the rate of agreement.
Figure 3.
Figure 3.
The association between day 7–8 clinical end points (cure, indeterminate, persistent, or superinfection) for the initial episode of bacterial or bacterial–viral coinfection pneumonia and discharge disposition at the end of the hospitalization. Favorable discharge dispositions are home, AIR, LTACH, and SNF. Unfavorable discharge dispositions are hospice or deceased. aDeceased includes patients who underwent lung transplantation for refractory respiratory failure during their hospitalization. Abbreviations: AIR, acute inpatient rehabilitation; LTACH, long-term acute care hospital; P and S, persistence and superinfection; SNF, skilled nursing facility.
See this image and copyright information in PMC

References

    1. US Food and Drug Administration . Guidance for Industry: Community Acquired Bacterial Pneumonia: Developing Drugs for Treatment. US Food and Drug Administration; 2014. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati.... Accessed April 26, 2023.
    1. Meduri GU, Mauldin GL, Wunderink RG, et al. . Causes of fever and pulmonary densities in patients with clinical manifestations of ventilator-associated pneumonia. Chest 1994; 106:221–35. - PubMed
    1. Fagon JY, Chastre J, Wolff M, et al. . Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med 2000; 132:621–30. - PubMed
    1. Pickens CO, Gao CA, Cuttica MJ, et al. . Bacterial superinfection pneumonia in patients mechanically ventilated for COVID-19 pneumonia. Am J Respir Crit Care Med 2021; 204:921–32. - PMC - PubMed
    1. Ioanas M, Ferrer M, Cavalcanti M, et al. . Causes and predictors of nonresponse to treatment of intensive care unit-acquired pneumonia. Crit Care Med 2004; 32:938–45. - PubMed