ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Exploration of a Potential Desirability of Outcome Ranking Endpoint for Complicated Intra-Abdominal Infections Using 9 Registrational Trials for Antibacterial Drugs.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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.
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.
Who cites it
16 citing papers in PubMed, 19 citations in OpenAlex.
- Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections.Open forum infectious diseases · 2026Trial
- Consequences of Delaying Surgical Intervention in Patients With Native Joint Septic Arthritis.Open forum infectious diseases · 2025Trial
- Evaluating Desirability of Outcome Ranking (DOOR) and Win Ratio for Hierarchical Composite Endpoints in Cryptococcal Meningitis Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- What's Behind DOOR Number 2? Recent Applications From Post-Hoc Analyses of Infectious Diseases Randomized Clinical Trials.Open forum infectious diseases · 2026Article
- Patient-Centric Pragmatic Clinical Trials: Opening the DOOR.Statistics in medicine · 2026Article
- A patient-centric paradigm and tool for clinical research: the DOOR is open.Antimicrobial agents and chemotherapy · 2026Article
- Making Sense of Hierarchical Composite End Points in Randomized Clinical Trials-A Primer for Infectious Diseases Clinicians and Researchers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- Beyond Accuracy: Methodological Advances for Assessing the Clinical Impact of Infectious Disease Diagnostics.Open forum infectious diseases · 2025Article
- Interagency Collaboration for Patient-Centered Antibacterial Drug Development.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Moving Beyond Mortality: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Application of desirability of outcome ranking to the milking in non-vigorous infants trial.Early human development · 2024Article
- The Antibacterial Resistance Leadership Group: Scientific Advancements and Future Directions.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- The Future Ain't What It Used to Be…Out With the Old…In With the Better: Antibacterial Resistance Leadership Group Innovations.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- The Next Generation: Mentoring and Diversity in the Antibacterial Resistance Leadership Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Under the Hood: The Scientific Leadership, Clinical Operations, Statistical and Data Management, and Laboratory Centers of the Antibacterial Resistance Leadership Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundDesirability of outcome ranking (DOOR) is a novel approach to clinical trial design that incorporates safety and efficacy assessments into an ordinal ranking system to evaluate overall outcomes of clinical trial participants. Here, we derived and applied a disease-specific DOOR endpoint to registrational trials for complicated intra-abdominal infection (cIAI).
methodsInitially, we applied an a priori DOOR prototype to electronic patient-level data from 9 phase 3 noninferiority trials for cIAI submitted to the US Food and Drug Administration between 2005 and 2019. We derived a cIAI-specific DOOR endpoint based on clinically meaningful events that trial participants experienced. Next, we applied the cIAI-specific DOOR endpoint to the same datasets and, for each trial, estimated the probability that a participant assigned to the study treatment would have a more desirable DOOR or component outcome than if assigned to the comparator.
resultsThree key findings informed the cIAI-specific DOOR endpoint: (1) a significant proportion of participants underwent additional surgical procedures related to their baseline infection; (2) infectious complications of cIAI were diverse; and (3) participants with worse outcomes experienced more infectious complications, more serious adverse events, and underwent more procedures. DOOR distributions between treatment arms were similar in all trials. DOOR probability estimates ranged from 47.4% to 50.3% and were not significantly different. Component analyses depicted risk-benefit assessments of study treatment versus comparator.
conclusionsWe designed and evaluated a potential DOOR endpoint for cIAI trials to further characterize overall clinical experiences of participants. Similar data-driven approaches can be utilized to create other infectious disease-specific DOOR endpoints.
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What OpenQuestion holds
Registered trials
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.