Author: Ong, Charlene Zhi Lin ; Ho, Gideon ; Kleiner, David E ; Sanyal, Arun J ; Chin, Chih-Liang ; Saigal, Ashmita ; Hendra, Christopher ; Chng, Elaine ; Kendall, Timothy J ; Raji, Annaswamy ; Forest, Thomas ; Lek, Serene ; Abdurrachim, Desiree ; Talukdar, Saswata ; Soon, Gwyneth ; Zhou, Yongqi ; Wong, Chun Kit ; Krishnan, Radha ; Ali, Asad Abu Bakar ; Wee, Aileen ; Engel, Samuel S ; Tai, Dean ; Idowu, Michael O ; Baumgartner, Richard

BACKGROUND & AIMSIntra and inter-pathologist variability poses a significant challenge in metabolic dysfunction-associated steatohepatitis (MASH) biopsy evaluation, leading to suboptimal selection of patients and confounded assessment of histological response in clinical trials. We evaluated the utility of an artificial intelligence (AI) digital pathology (DP) platform to help pathologists improve the reliability of fibrosis staging.METHODSA total of 120 digitized histology slides from two trials (NCT03517540, NCT03912532) were analyzed by four expert hepatopathologists, with and without AI assistance in a randomized, crossover design. We utilized an AI DP platform consisting of unstained second harmonic generation/two photon excitation fluorescence (SHG/TPEF) images and AI quantitative fibrosis (qFibrosis) values.RESULTSAI assistance significantly improved inter-pathologist kappa for fibrosis staging, particularly for early fibrosis (F0-F2), with reduced variance around the median reads. Intra-pathologist kappa was unchanged. AI assistance increased pathologist concordance for identifying clinical trial inclusion cases (F2-F3) from 45% to 71%, exclusion cases (F0/F1/F4) from 38% to 55%, and evaluation of fibrosis response to treatment from 49% to 61%. SHG/TPEF images, qFibrosis continuous values, and qFibrosis stage were considered useful by at least three out of four pathologists in 83%, 55%, and 38% of cases, respectively. In the context of a clinical trial, the increase in inter-pathologist concordance was modeled to result in a ∼25% reduction in the potential need for adjudication as well as a ∼45% increase in the study power for a kappa improvement from ∼0.4 to ∼0.7.CONCLUSIONSThe use of AI DP enhances inter-rater reliability of fibrosis staging for MASH. This indicates that the SHG/TPEF-based AI DP tool is useful for assisting pathologists in assessing fibrosis, thereby enhancing clinical trial efficiency and reliability of fibrosis readouts in response to treatments.IMPACT AND IMPLICATIONSImplementing an AI DP platform as a tool for pathologists significantly improved inter-pathologist agreement on fibrosis staging, particularly for early-stage fibrosis (F0-F2), which is critical for clinical trial eligibility. The second harmonic generation imaging technology used in conjunction with AI quantitative scores provided enhanced visualization of fibrosis with an indication of severity along the disease continuum. This led to increased pathologist confidence in fibrosis staging and, therefore, increased pathologist concordance for the classification of clinical trial inclusion/exclusion and evaluation of treatment, compared to a standard scoring method based on traditional stains without AI assistance. Improved pathologist concordance with AI assistance could streamline clinical trial processes, reducing the need for adjudication and enhancing study power, potentially decreasing required sample sizes. Continued exploration of the utility of AI assistance across a broader range of pathologists and in prospective clinical trials will be essential for validating the effectiveness of AI assistance.

01 Apr 2025·Diagnostic Microbiology and Infectious Disease

A real-world investigation into prescribing patterns and effectiveness of ceftolozane/tazobactam among critically ill patients from SPECTRA

Article

Author: Thalhalmmer, Florian ; Obi, Engels N ; Viale, Pierluigi ; Kaul, Sundeep ; Watanabe, Alexandre H ; Yücel, Emre ; Allen, Mike ; Wirbel, Stephanie ; Kluge, Stefan ; Soriano, Alex ; Akrich, Brune ; Paterson, David L

BACKGROUNDCeftolozane/tazobactam (C/T) real-world use was examined in a global population of critical care patients treated in intensive care unit settings.METHODSThe Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam Real-world Analysis (SPECTRA) is a multinational, retrospective observational study of 617 adults treated with C/T conducted between 2016 and 2020. Population-associated clinical, treatment-related, and microbiologic characteristics, resource utilization, and clinical outcomes were assessed in critical care patients.RESULTSIn this SPECTRA critical care cohort (n=298), 81.5% had ≥1 comorbidity. Common infection sites were respiratory (50.0%), skin/wound/tissue (21.1%), blood (13.7%), and urine (10.3%); common pathogens were Pseudomonas aeruginosa (89.7%; 66.7% multidrug resistant), Klebsiella spp. (6.9%), and Escherichia coli (6.4%); 51.7% received C/T as third-line/salvage therapy. Thirty-day readmission rates were 3.4% (all cause) and 1.7% (infection related). Overall clinical success was 53.4% (95% confidence interval: 47.5% to 59.1%) and was greater with first-line C/T (62.2%) versus third line (45.5%). All-cause in-hospital mortality was 35.6%; infection-related mortality was 13.8%.CONCLUSIONSIn this multinational, high-risk cohort, most patients had beneficial outcomes despite their clinical complexity and late intervention with C/T. These results support C/T use against a wide range of Gram-negative pathogens in critical care settings.TRIAL REGISTRATIONNot applicable due to retrospective design.

01 Mar 2025·Journal of Global Antimicrobial Resistance

Unveiling results and insights from multinational, multicenter Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam Real-world Analysis (SPECTRA)

Article

Author: Watanabe, Alexandre H ; Kaul, Sundeep ; Viale, Pierluigi ; Wirbel, Stephanie ; Allen, Mike ; Thalhammer, Florian ; Soriano, Alex ; Kluge, Stefan ; Akrich, Brune ; Paterson, David L ; Yücel, Emre ; Obi, Engels N

OBJECTIVESAntibacterial-resistant gram-negative hospital-acquired infections result in significant morbidity and mortality. In clinical trials, ceftolozane/tazobactam (C/T) has been effective against these infections; however, real-world findings are limited.METHODSSPECTRA was a global, retrospective, observational inpatient study of adults treated with C/T for ≥48 h, conducted between 2016 and 2020. The primary objective was to describe real-world utilisation of C/T: socio-demographic, clinical characteristics, prescribing patterns, clinical outcomes, and healthcare resource utilisation in hospitalised patients treated with C/T.RESULTSIn total, 617 patients from 7 countries met inclusion criteria. Most (82.7%) had ≥1 comorbidity. The most common medical conditions where C/T was used were pneumonia (29.5%), sepsis (20.4%), complicated intra-abdominal infection (15.1%), and complicated urinary tract infection (14.4%). The most common pathogens were Pseudomonas aeruginosa (87.4%) and Escherichia coli (8.2%). Median C/T treatment duration was 11 days. Clinical success occurred in 67.3% of patients (including those with 'unknown' status in the denominator). In a separate analysis that excluded those with 'unknown' status, clinical success ranged from 94.1% in patients with bacteraemia to 58.9% with sepsis. Overall, 18.8% of patients had documented microbiologic response. All-cause in-hospital mortality was 21.2%; infection-related mortality was 7.6%. Median hospital length of stay was 42 days (30 days for those who received early C/T therapy [before pathogen identification] vs. 48 days for definitive therapy [after identification]).CONCLUSIONSThese data elucidate real-world utilisation and prescribing patterns of C/T in a diverse patient population with complex medical conditions and various profiles of pathogen resistance between 2016 and 2020.

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