Evidence map›Paper›PMID 42339770›Full record

Trial reportOpen forum infectious diseases2026

Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections.

Jessica Howard-Anderson, Toshimitsu Hamasaki, Lizhao Ge, Deborah Collyar, Sara E Cosgrove, Sarah B Doernberg, Holly Geres, Ramya Gopinath, Thomas L Holland, Heather A King and 6 more

Abstract readClinical Trial
In one paragraph

Trial report in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Interagency Collaboration for Patient-Centered Antibacterial Drug Development.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Jessica Howard-AndersonDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.ORCID 0000-0001-9924-0458
Toshimitsu HamasakiThe Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, D.C., USA.
Lizhao GeThe Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, D.C., USA.
Deborah CollyarPatient Advocates in Research, Danville, California, USA.ORCID 0000-0003-0886-0964
Sara E CosgroveDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-9458-4331
Sarah B DoernbergDivision of Infectious Diseases, Department of Medicine, University of California School of Medicine, SanFrancisco, California, USA.
Holly GeresDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Ramya GopinathCenter for Drug Evaluation and Research, United States Food and Drug Administration, Washington, D.C., USA.
Thomas L HollandDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Heather A KingDivision of Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Sumathi NambiarJohnson & Johnson, Raritan, New Jersey, USA.
Daniel RubinCenter for Drug Evaluation and Research, United States Food and Drug Administration, Washington, D.C., USA.
Henry F ChambersDivision of Infectious Diseases, Department of Medicine, University of California School of Medicine, SanFrancisco, California, USA.ORCID 0000-0001-5317-4491
Vance G FowlerDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Scott R EvansThe Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, D.C., USA.ORCID 0000-0003-3186-172X
Helen W BoucherTufts University School of Medicine and Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, Massachusetts, USA.

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

Background: Desirability of outcome ranking (DOOR), a paradigm for the design, analysis, and interpretation of clinical trials based on patient-centered benefit-risk evaluation, could help inform drug development for acute bacterial skin and skin structure infections (ABSSSIs). Method: A multidisciplinary committee created an infectious diseases DOOR endpoint, incorporating clinical response, infectious complications, serious adverse events, and mortality, and adapted this for ABSSSI. We retrospectively applied DOOR to 2 previous ABSSSI randomized controlled registrational trials (OASIS-1 and OASIS-2), both comparing omadacycline with linezolid. We evaluated the DOOR distribution and estimated the probability of having a more desirable outcome with omadacycline compared with linezolid. For OASIS-2, we used the 36-Item Short Form Health Survey Version 2 (SF-36v2) scores as a "tiebreaker" for participants who would otherwise have the same DOOR outcome. We performed DOOR component, partial credit, and subgroup analyses. Results: The ABSSSI DOOR demonstrated similar overall clinical outcomes between treatment arms for OASIS-1 and OASIS-2. The probability of a more desirable outcome for a participant treated with omadacycline, compared with linezolid, was 50.6% (95% confidence interval [CI], 47.4%-53.7%) and 52.1% (95% CI, 49.2%-55.0%) in OASIS-1 and OASIS-2, respectively. In OASIS-2, applying a health-related quality-of-life score as a tiebreaker did not significantly change the DOOR probability. Partial credit and subgroup analyses demonstrated similar overall results. Conclusions: DOOR may provide additional perspective on benefit versus risk in individual patients in ABSSSI trials. Future trials using DOOR prospectively will continue inform how to incorporate patient-centered outcomes in ABSSSI trials.

Indexed as

acute bacterial skin and skin structure infectionclinical trialsdesirability of outcome rankingdrug developmentpatient-centered endpoint

Identifiers

PMID42339770
PMCPMC13284871

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.