Lessons Learned from (COVID-19) Diagnostics: Perspectives from the Infectious Diseases Society of America (IDSA) COVID-19 Diagnostics Guideline Panel

Article type
Authors
Mustafa R1, Mustafa R2, El Mikati I3, Altayar O4, El Alayli A5, Mansour R6, Patel P7, Alabed F8, nazzal J9, Iqneibi S10, Englund J11, Loeb M12, Patel R13, Bhimraj A14, Morgan D15, Lee F16, Heald J17, Caliendo A18, Hanson K19, Hayden M20
1Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, United States
2Department of Health Research Methods, Evidence, and Impact, McMaster UniversityHamilton, Ontario, Canada
3Department of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
4Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, United States
5Department of Internal medicine, Saint Louis University, St. Louis, Missouri, United States
6Department of Internal medicine, University of Kansas Medical Center, Kansas City, Kansas, United States
7Department of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Emory University, Atlanta, Georgia, United States
8University of Kansas Medical Center Medical School, Kansas City, Kansas
9Outcomes and Implementation Research Unit, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, United States
10Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia, United States
11Department of Pediatrics, University of Washington, Seattle Children’s Research Institute, Seattle, Washington, United States
12Division of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada
13Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology and Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota, United States
14Department of Infectious Diseases, Cleveland Clinic, Cleveland, Ohio, United States
15Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, United States
16Departments of Pathology and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, United States
17Infectious Diseases Society of America, Darien, Illinois, United States
18Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States
19Divisions of Infectious Diseases and Clinical Microbiology, Department of Internal Medicine and Pathology, University of Utah, Salt Lake City, Utah, United States
20Division of Infectious Diseases, Department of Medicine, Rush University Medical Center, Chicago, Illinois; Department of Pathology, Rush University Medical Center, Chicago, Illinois, United States
Abstract
Background:


The Infectious Diseases Society of America (IDSA) COVID-19 Diagnosis Panel published living and rapid guidelines during the pandemic. In this article, we provide a summary of barriers to developing those guidelines and the lessons learned (Table 1).


Methods:


The methods team drafted an initial list of barriers and suggested solutions. Through an iterative process of semi-structured discussion and written communication, the clinical experts contributed, and the methods team made appropriate edits to reflect the group’s consensus.


Results:


- Single vs multiple recommendations update:

Recognizing a change in a single diagnostic approach could directly impact the next step in testing or management; the guideline development group opted to release updated recommendations simultaneously rather than single recommendations. This allowed for the creation of visual decision trees/algorithms that were useful for clinicians and decision-makers.

-Reference standard modifications:

With COVID-19, the accepted reference standard was established to be the nucleic acid amplification tests. The literature, however, included a variety of reference standards with most of them falling out of favor as the pandemic progressed. For groups planning to develop diagnostic guidelines, it would be important to discuss the optimal reference standard.

- patients vs public perspective:

Because of the highly communicable nature of the disease, the recommendations for testing related not just to the patient, but to the community. Thus, groups planning to develop recommendations around communicable diseases should consider what perspective the recommendations will use and how that would align with the goals of the end user.

- Context for implementation considerations:

variations in the incidence and the pretest probability were common early in the pandemic and frequently changed during outbreaks. Additionally, the pretest probability varied across symptomatic and asymptomatic individuals, those with known exposure, and vaccination status. To address these issues, we considered multiple prevalence values and pre-test probabilities for each recommendation.


Conclusions:


The conduct of diagnostic guidelines within the setting of a pandemic was a challenge that left us with many lessons. Those lessons are relevant for groups developing guidelines, those interested in the rapid and living guidelines approach, or decision-makers interested in building on this experience for other contexts.