Value of rapid on-site evaluation combined with interventional pulmonology techniques in the diagnosis of pulmonary cryptococcosis.

OBJECTIVES: The aim of this study is to evaluate the diagnostic value of rapid on-site evaluation (ROSE) combined with computed tomography-guided percutaneous needle biopsy (CT-PNB) or radial endobronchial ultrasound-guided transbronchial lung biopsy (EBUS-TBLB) for pulmonary cryptococcosis (PC). METHODS: Clinical data of 33 patients diagnosed with PC at the Third Affiliated Hospital of Soochow University between February 2018 and June 2023 were retrospectively analysed. Patients were divided into the CT-PNB and EBUS-TBLB groups based on the intervention method, and the diagnostic positivity rate and incidence of complications were compared between the two groups. RESULTS: Compared with the final diagnosis, the positive diagnostic rates of ROSE, histopathology and serum CrAg of all patients were 81.8% (27/33), 72.7% (24/33) and 63.6% (21/33), respectively. The average turnaround times of the three methods were 0.1 (0.1-0.2) h, 96.0 (48.0-120.0) h and 7.8 (4.5-13.6) h, respectively (P < 0.001). The coincidence rate between histopathology and ROSE was 84.8% with a kappa value of 0.574. The positive diagnostic rate for PC was significantly higher in the CT-PNB group than in the EBUS-TBLB group (92.9% vs. 57.9%), and the difference was statistically significant (P < 0.05). Combined with the ROSE results, the positive diagnostic rate in the EBUS-TBLB group increased to 84.2% (16/19). CONCLUSION: ROSE has commendable accuracy and timeliness, and CT-PNB offers further advantages in this regard. ROSE enhances the diagnostic efficiency of EBUS-TBLB for PC and is safe and effective.

Microbiological Rapid On-Site Evaluation for Pulmonary Infectious Diseases.

The prompt initiation of empirical anti-infective therapy is crucial in patients presenting with unexplained pulmonary infection. Although imaging acquisition is relatively straightforward in clinical practice, its lack of specificity often necessitates additional time-consuming tests such as sputum culture, bronchoalveolar-lavage fluid culture, or genetic sequencing to identify the underlying etiology of the disease accurately. Moreover, the limited efficacy of empirical anti-infective treatment may contribute to antibiotic misuse. Recent advancements in interpreting microbial background on rapid on-site evaluation (ROSE) slides have enabled clinicians to promptly obtain samples through bronchoscopy (e.g., alveolar lavage, mucosal brushing, tissue clamp), facilitating bedside staining and interpretation that provides essential microbial background information. Consequently, this establishes a foundation for developing targeted anti-infection treatment and individualized drug therapy plans. With a better understanding of which pathogens are causing infections in real-time, physicians can avoid unnecessary broad-spectrum antibiotics contributing to antibiotic resistance. Establishing a rapid and standardized M-ROSE workflow within respiratory medicine departments or intensive care units will greatly assist physicians in formulating accurate treatment strategies for patients, which holds significant clinical implications.

[Role of General Anesthesia and Rapid On-site Evaluation 
in the Diagnosis of Lung Cancer with EBUS-TBNA].

BACKGROUND: Lung cancer is a common malignant tumor of respiratory system. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a valuable tool for the diagnosis and staging of lung cancer. EBUS-TBNA is predominantly performed under local anesthesia or conscious sedation. However, the diagnostic performance of EBUS-TBNA under general anesthesia and in conjunction with rapid on-site evaluation (ROSE) remains uncertain. This study aims to investigate the value of general anesthesia and ROSE in the diagnosis of lung cancer with EBUS-TBNA. METHODS: A retrospective analysis was conducted on 164 patients treated in the Department of Respiratory and Critical Care Medicine of The Affiliated Hospital of Southwest Medical University from January 2018 to December 2022. All patients were preoperatively suspected of lung cancer and underwent EBUS-TBNA. Based on whether they received general anesthesia and ROSE, the patients were divided into three groups: local anesthesia group (LA group)(n=54), general anesthesia group (GA group)(n=67) and general anesthesia with ROSE group (GA-ROSE group)(n=43). The puncture characteristics and diagnostic differences were analyzed among the groups. RESULTS: The number of lymph node puncture needles in the LA group was higher than in GA-ROSE group (P<0.01). The overall diagnostic rates of EBUS-TBNA for the three groups were 87.04%, 89.55% and 90.70%, respectively, with malignant tumor diagnostic rates of 88.24%, 88.89% and 94.74%. No statistically significant differences were observed among the three groups (P>0.05). There were no instances of severe complications or adverse anesthesia reactions in any of the groups. CONCLUSIONS: Compared to the combination of local anesthesia with intravenous analgesia and sedation, the implementation of EBUS-TBNA under general anesthesia, with or without ROSE, achieves equally accurate results, and general anesthesia combined with ROSE can reduce in the number of lymph node puncture needles.

Rapid on-site evaluation of touch imprint cytology in navigation bronchoscopy for small peripheral pulmonary nodules.

BACKGROUND: Rapid on-site evaluation (ROSE) of cytopathology plays an important role in determining whether representative samples have been taken during navigation bronchoscopy. With touch imprint cytology (TIC), histologic samples can be assessed using ROSE. Although advised by guidelines, there have been almost no studies on the performance of TIC during navigation bronchoscopy. The objective of this study was to evaluate the value of TIC-ROSE (forceps/cryobiopsy) in combination with conventional ROSE (cytology needle/brush). METHODS: In this single-center, prospective cohort study, patients who had pulmonary nodules with an indication for navigation bronchoscopy were consecutively included. The primary outcome of the study was the concordance of ROSE and the procedural outcome. The concordance rates of TIC-ROSE and the combination of TIC-ROSE plus conventional ROSE were compared. RESULTS: Fifty-eight patients with 66 nodules were included. Conventional ROSE and TIC-ROSE were assessable in 61 nodules (90.9%) each. By combining both ROSE techniques, all sampled lesions were assessable. Combining conventional ROSE with TIC-ROSE showed concordant results in 51 of 66 cases (77.3%) versus 44 of 66 (66.7%) and 48 of 66 (72.8%) concordant results for conventional ROSE and TIC-ROSE alone, respectively, compared with the procedural outcome. There was no indication of tissue depletion as a result of TIC. The combined ROSE approach had a statistically significant higher concordance rate compared with conventional ROSE alone. CONCLUSIONS: TIC-ROSE is a cheap, easily implementable technique that can result in higher concordant ROSE outcomes. This could lead to more efficient procedures and possibly higher diagnostic results. In a monomodality sampling setting with only histologic samples, TIC can provide ROSE.

Telecytology - remote rapid on-site evaluation for ultrasound-guided head and neck fine needle aspiration utilising a clinical imaging assistant with an extended practice role.

OBJECTIVE: Rapid On-Site Evaluation (ROSE) of fine needle aspirations (FNA) is widely accepted as best practice, resulting in better outcomes and delivery of care for patients. However, it is not always practical for cytology laboratories to release staff. To increase the availability of ROSE, this study aimed to robustly test the effectiveness of Telecytology ROSE (TCROSE) utilising a clinical imaging assistant (CIA) to prepare the samples and operate the microscope. METHODS: The study was divided into 3 phases. Phase 1, equipment testing, validation and in-house training for the CIA and the Consultant Biomedical Scientist (CBMS) performing TCROSE. Phase 2, Verifying TCROSE on the same site as the cytology laboratory and phase 3, TCROSE utilising a clinic at a peripheral site away from the cytology laboratory. RESULTS: 78/80 (97% sensitivity, 95% accuracy) of TCROSE cases matched the final report for assessment of adequacy and sufficient sampling, demonstrating 94% reliability with a 95% confidence value. An appropriately trained CIA effectively prepared the samples and operated the microscope for remote interpretation. The samples were triaged effectively, and biopsy requests were appropriate to reduce the need for repeat procedures and delays in treatment. This approach received positive feedback from patients. CONCLUSION: TCROSE utilising a CIA provides a highly effective alternative to conventional ROSE, minimising the resources required from cytopathology services and improving patient care and access to best practice. This study supports the validity of trained CIAs for a more involved role in the ultrasound-guided FNA service.

World Health Organization reporting system for lung cytopathology-A brief correspondence.

The WHO lung cytopathology reporting system has been published recently and is now a five-tier category system without any subcategorization. WHO reporting system also encourages the application of ancillary diagnostic tests like cell block preparation, immunocytochemistry, and rapid on-site evaluation for better categorization of specimens and further management. This correspondence aims to provide a brief outline of the lung reporting system. Lung cytopathology reporting system use standardized nomenclature and usage of the terminologies harmonizing with the WHO Blue Book, and table and flow diagram may be helpful for the readers.

American Society of Cytopathology Telecytology validation recommendations for rapid on-site evaluation (ROSE).

Telecytology has multiple applications, including rapid onsite evaluation (ROSE) of fine-needle aspiration (FNA) specimens. It can enhance cytopathology practice by increasing productivity, reducing costs, and providing subspecialty expertise in areas with limited access to a cytopathologist. However, there are currently no specific validation guidelines to ensure safe practice and compliance with regulations. This initiative, promoted by the American Society of Cytopathology (ASC), intends to propose recommendations for telecytology implementation. These recommendations propose that the validation process should include testing of all hardware and software, both separately and as a whole; training of all individuals who will participate in telecytology with regular competency evaluations; a structured approach using retrospective slides with defined diagnoses for validation and prospective cases for verification and quality assurance. Telecytology processes must be integrated into the laboratory's quality management system and benchmarks for discrepancy rates between preliminary and final diagnoses should be established and monitored. Special attention should be paid to minimize discrepancies that downgrade malignant cases to benign (false positive on telecytology). Currently, billing and reimbursement codes for telecytology are not yet available. Once, they are, recommendation of the appropriate usage of these codes would be a part of the recommendations. These proposed guidelines are intended to be a resource for laboratories that are considering implementing telecytology. These recommendations can help to ensure the safe and effective use of telecytology and maximize its benefits for patients.

Rapid on-site evaluation improves diagnostic performance of fine-needle aspiration cytology for salivary lesions: Comparison of data from two cancer centers in southern China.

OBJECTIVES: To evaluate the diagnostic performance of Milan system for reporting salivary gland cytopathology (MSRSGC) in two southern China tertiary cancer centers and investigate the impact of rapid on-site evaluation (ROSE) on FNAC performance. MATERIALS AND METHODS: Five hundred and forty-nine patients who underwent FNAC for salivary lesions with surgical follow-up from two centers were enrolled in this retrospective cohort study. All slides were recategorized using MSRSGC after consensus on diagnostic criteria for each category. The diagnostic performance of FNAC for salivary lesions was evaluated and compared and the impact of ROSE on FNAC performance was analyzed. RESULTS: The distribution of cases per category based on the MSRSGC criteria in the whole series was as followed: ND 49 (8.9%), NN 76 (14.4%), BN 262 (47.7%), AUS 20 (3.6%), SUMP 43 (7.8%), SM 21 (3.8%), M 78 (14.2%). The SUMC series had significantly more ND distributions than JXCH did (16.2% vs. 0, p = .000). Risk of malignancy for each category in the total series was as followed: 42.9% for ND, 9.2% for NN, 3.8% for BN, 30.0% for AUS, 23.3% for SUMP, 81.0% for SM, and 94.9% for M. When ND and AUS/SUMP were excluded, the sensitivity, specificity, PPV, NPV, and accuracy were 84.0%, 97.1%, 89.9%, 95.1%, and 94.0%, respectively; sensitivity, specificity, PPV, NPV, and accuracy were comparable between the two centers. CONCLUSIONS: FNAC using MSRSGC provides a good tool in preoperative evaluation for salivary lesions in southern China. ROSE improves its diagnostic performance by reducing the ratio of the ND category.

[Cytology Smears of Rapid On-site Evaluation as Supplemental Material 
for Molecular Testing of Non-small Cell Lung Cancer].

BACKGROUND: The thoracic small biopsy sampling procedure including transbronchial forceps lung biopsy (TBLB) and endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) can be accompanied by rapid on-site evaluation (ROSE) of sample material to provide immediate feedback for the proceduralist. The present study aims to investigate the supplemental effect of ROSE smear samples for lung cancer molecular test. METHODS: In a retrospective study, 308 patients admitted to our hospital from August 2020 to December 2022 undergoing diagnostic TBLB and EBUS-TBNA with ROSE and subsequently diagnosed as non-small cell lung cancer (NSCLC) were analyzed. The matched formalin-fixed paraffin-embedding (FFPE) tissue section and ROSE smears for tumor cellularity were compared. DNA yields of smears were determined. Real-time polymerase chain reaction (PCR) and next-generation sequencing (NGS) were performed on adequate smear samples. RESULTS: ROSE smear samples were enriched in tumor cells. Among 308 biopsy samples, 78 cases (25.3%) exhibited inadequate FFPE tissue sections, whereas 44 cases (14.3%) yielded adequate smear samples. Somatic mutations detected in the FFPE tissue section samples were also detected in the matching adequate smear sample. CONCLUSIONS: ROSE smear samples of the thoracic small biopsies are beneficial supplemental materials for ancillary testing of lung cancer. Combined use of cytology smear samples with traditional FFPE section samples can enhance the detection rate of informative mutations in patients with advanced NSCLC. We recommend that the laboratory could further evaluate the ROSE cell smears of the patient when FFPE tissue sections are inadequate, and that adequate cell smears can be used as a supplemental source for the molecular testing of NSCLC.

Application of rapid on-site evaluation combined with flexible bronchoscopy in the diagnosis of lung lesions.

BACKGROUND: Pathology is considered the gold standard for the diagnosis of lung lesions, but the pathological result is relatively lagging and cannot provide real-time guidance for the biopsy procedure. OBJECTIVE: To investigate the potential application of rapid on-site evaluation (ROSE) during flexible bronchoscopy (FB) in the evaluation and diagnosis of lung lesions. PATIENTS AND METHODS: Consecutive patients who underwent FB for the diagnosis of lung lesions between August 2022 and February 2023 were included in this retrospective study. 294 patients underwent FB with ROSE, while 304 patients underwent FB without ROSE. The final pathological results and the number of patients undergoing repeat biopsies were recorded in both groups. Specifically, we conducted separate statistical analysis for patients undergoing different biopsy methods, including the endobronchial biopsy (EBB), radial probe endobronchial ultrasound transbronchial lung biopsy with guide sheath (r-EBUS-GS-TBLB), and the endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) to study the detailed roles that ROSE plays under different biopsy methods. RESULTS: The adequacy rate of biopsy specimens from the non-ROSE group was significantly lower than that of the ROSE group (259/281 = 92.17 % vs. 263/268 = 98.13 %, p = 0.001). Meanwhile, fewer patients underwent repeat biopsies in the ROSE group compared to the non-ROSE group (2/294 = 0.68 % vs. 10/304 = 3.29 %, p = 0.023). For the ROSE group, the consistency between ROSE diagnoses and final pathological diagnoses was 94.40 % (κ = 0.886), with 95.58 % for benign diseases and 93.55 % for malignant diseases. CONCLUSION: The utility of ROSE during FB increases the adequacy rate of biopsy specimens and thus decreases the need for repeat biopsies in patients with lung lesions to get a definite diagnosis. Moreover, the high consistency between ROSE diagnoses and final pathological diagnoses suggests that ROSE is a reliable tool for optimizing the diagnosis of lung lesions.

SI-ViT: Shuffle instance-based Vision Transformer for pancreatic cancer ROSE image classification.

BACKGROUND AND OBJECTIVE: The rapid on-site evaluation (ROSE) technique improves pancreatic cancer diagnosis by enabling immediate analysis of fast-stained cytopathological images. Automating ROSE classification could not only reduce the burden on pathologists but also broaden the application of this increasingly popular technique. However, this approach faces substantial challenges due to complex perturbations in color distribution, brightness, and contrast, which are influenced by various staining environments and devices. Additionally, the pronounced variability in cancerous patterns across samples further complicates classification, underscoring the difficulty in precisely identifying local cells and establishing their global relationships. METHODS: To address these challenges, we propose an instance-aware approach that enhances the Vision Transformer with a novel shuffle instance strategy (SI-ViT). Our approach presents a shuffle step to generate bags of shuffled instances and corresponding bag-level soft-labels, allowing the model to understand relationships and distributions beyond the limited original distributions. Simultaneously, combined with an un-shuffle step, the traditional ViT can model the relationships corresponding to the sample labels. This dual-step approach helps the model to focus on inner-sample and cross-sample instance relationships, making it potent in extracting diverse image patterns and reducing complicated perturbations. RESULTS: Compared to state-of-the-art methods, significant improvements in ROSE classification have been achieved. Aiming for interpretability, equipped with instance shuffling, SI-ViT yields precise attention regions that identifying cancer and normal cells in various scenarios. Additionally, the approach shows excellent potential in pathological image analysis through generalization validation on other datasets. CONCLUSIONS: By proposing instance relationship modeling through shuffling, we introduce a new insight in pathological image analysis. The significant improvements in ROSE classification leads to protential AI-on-site applications in pancreatic cancer diagnosis. The code and results are publicly available at https://github.com/sagizty/MIL-SI.

Rapid on-site evaluation (ROSE) of image-guided FNA specimens improves subsequent core biopsy adequacy in clinical trial patients: The impact of preanalytical factors and its correlation with survival.

BACKGROUND: Sufficient tumor collection has become of utmost importance in therapeutic experimental protocols. Rapid on-site evaluation (ROSE) ensures adequate sampling for quantification of biomarkers, molecular analyses, and other ancillary studies. The objectives of this study were to evaluate the role of ROSE in trial-associated fine-needle aspiration (FNA) and to analyze predictors of adequacy and cumulative survival from in-house FNA cases used in clinical trials. METHODS: Clinical trial FNA biopsies performed at a large academic institution were analyzed over 10 months using a comprehensive chart review of the electronic medical records. SPSS version 28 was used for statistical analysis. RESULTS: Three hundred twenty-five FNAs were collected for 57 clinical trials. In total, 225 individual patients had an average of 1.4 FNA procedures each as a result of a multidepartmental collaborative effort. ROSE was performed for all patients, and adequacy was evaluated by cytotechnologists. Seventy-eight percent of samples were considered adequate, 14% were considered less than optimal, and 8% were considered inadequate, with the latter two categories designated together as less than adequate. The imaging modalities were mainly ultrasound-guided (n = 267; 82%) and computed tomography-guided (n = 58; 18%). There was a statistically significant association between adequate sampling and ultrasound-guided biopsies (83%) compared with computed tomography-guided biopsies (59%; p < .01). The effect of body mass index (BMI) on mortality was also a significant finding. The authors observed a survival benefit in patients who had elevated BMIs (range, 25.0-34.9 kg/m2 ) compared with those who were underweight (BMI, <18.5 kg/m2 ) or class III obese (BMI, >35.0 kg/m2 ; p < .01). Therefore, the best predictors of adequacy and mortality were imaging modality and BMI, respectively. CONCLUSIONS: Ultrasound-guided modalities are recommended for obtaining adequate FNA sampling for clinical trials. In addition, patients with cancer who had slightly elevated BMIs (25.0-34.0 kg/m2 ) had increased overall survival in this cohort.

Impact of rapid on-site evaluation in expediting the fast investigative lung cancer pathway.

OBJECTIVE: EBUS-TBNA is a method of acquiring tissue samples from intrathoracic lymph nodes and central intrathoracic tumours in patients suspected of having lung cancer. Rapid on-site evaluation (ROSE) denotes assessing tissue samples during EBUS (or bronchoscopy), providing instant feedback on sample adequacy and provisional cytomorphological diagnosis. Sector multidisciplinary team (MDT) discussion can then make informed treatment decisions, with confirmatory immunohistochemistry being finalised before provision of final treatment. Currently, impact of ROSE on length of time patients spend on the lung cancer diagnostic pathway remains unclear. METHODS: We retrospectively evaluated the impact of ROSE on the length of time between patients' EBUS/bronchoscopy procedures and discussion at sector MDT, referred to as time to treatment decision (TTD), at our institution. Additionally, we assessed impact of ROSE on number of passes (number of times nodes/masses were sampled) per procedure. RESULTS: The mean TTD was 77.9% shorter (p = 0.001) with ROSE present than when absent. Patients who received ROSE spend 34.3% less time (p = 0.028) on lung cancer diagnostic pathway overall. There was a significant reduction in number of passes in non-malignant nodes with ROSE present (2.23) than when absent (3.14) (p < 0.001). With ROSE present there was a significantly greater number of passes at malignant sites (5.07) than non-malignant sites (2.23) (p < 0.001). CONCLUSIONS: These findings support conclusions made in our institution's previous study, that utilisation of ROSE reduces TTD. ROSE also allows safe advancement through nodes with low suspicion of malignant involvement, focusing time on sampling nodes/masses of greater suspicion.

[Diagnostic yield of bronchoscopic rapid on-site evaluation in severe invasive bronchopulmonary aspergillosis].

OBJECTIVE: To explore the diagnostic yield of bronchoscopic rapid on-site evaluation (B-ROSE) in patients with severe invasive bronchopulmonary aspergillosis (IBPA) and provide evidence for starting antifungal treatment before microbiological results were available. METHODS: A prospective cohort study was conducted to select patients with severe pneumonia suspected of IBPA admitted to the respiratory intensive care unit (RICU) in the First Affiliated Hospital of Xinjiang Medical University from June 2014 to June 2022, and those who were primarily infected with other pathogens (such as bacteria, Mycobacterium tuberculosis) at admission were excluded. Whether the antifungal treatment was initiated or not on the basis of the bedside B-ROSE, the B-ROSE was administered as soon as possible within 24 hours after admission to RICU. The current international definition of invasive aspergillosis was used as the gold diagnostic standard, the diagnostic accordance rate, the sensitivity and specificity of B-ROSE were calculated respectively, and the receiver operator characteristic curve (ROC curve) was also plotted, to evaluate the predictive value in diagnosing IBPA. RESULTS: A total of 176 patients with severe pneumonia suspected of IBPA were included in the study. According to international diagnostic standards, there were 81 cases of IBPA and 95 cases of non-IBPA. According to the early diagnosis of B-ROSE, there were 89 cases of IBPA and 87 cases of non-IBPA. The diagnostic accordance rate of B-ROSE was 84.09% (148/176), the area under the ROC curve for B-ROSE in diagnosing severe IBPA was 0.844, the 95% confidence interval (95%CI) was 0.782-0.905, the sensitivity was 87.65%, the specificity was 81.05%, the positive predictive value was 79.78%, the negative predictive value was 88.51%, the rate of underdiagnosis was 12.35% (10/81), and the rate of misdiagnosis was 18.95% (18/95). Compared with the true negative group, the proportion of long-term (≥ 14 days) use of glucocorticoid [70.0% (7/10) vs. 9.1% (7/77), P < 0.01] and the proportion of cases with diabetes [40.0% (4/10) vs. 10.4% (8/77), P < 0.05] were significantly higher in the false negative group (underdiagnosis group). However, B-ROSE of both groups showed mucosal bleeding, congestion and edema [100.0% (10/10) vs. 94.8% (73/77), P > 0.05], indicating that acute mucosal inflammation was non-characteristic. Compared with the true positive group, the proportion of long-term (≥ 14 days) use of glucocorticoid in the false positive group (misdiagnosis group) was significantly reduced [33.3% (6/18) vs. 60.6% (43/71), P < 0.05]. The B-ROSE results showed the proportion of cases with mucosal white spots, black plaques and pseudomembrane was significantly reduced [16.7% (3/18) vs. 52.1% (37/71), P < 0.01] in the misdiagnosed group, which suggest that cases of long-term use of glucocorticoid and cases with B-ROSE showing mucosal white spots, black plaques and pseudomembrane were less likely to be misdiagnosed. The main diseases that were easily misdiagnosed as IBPA included pulmonary tuberculosis (38.9%, 7/18), inflammatory lung adenocarcinoma (27.8%, 5/18) and pulmonary vasculitis (16.7%, 3/18). CONCLUSIONS: Before obtaining microbiological evidence, B-ROSE can assist in decision-making of early anti-aspergillus treatment for severe IBPA. This method is prompt, simple, and has high accuracy and reliability. If B-ROSE lacks characteristic manifestations, especially for severe pneumonia in patients with long-term use of glucocorticoid or diabetes, attention should be paid to the underdiagnosis of IBPA. Diseases such as lung tuberculosis, inflammatory lung adenocarcinoma and lung vasculitis should be vigilant against misdiagnosis as IBPA.

[Application of Rapid HE Staining in Cytological Rapid On-site Evaluation of 
Peripheral Lung Cancer Needle Biopsy].

BACKGROUND: Rapid on-site evaluation (ROSE) is a technique used for simultaneous evaluation of biopsy specimens through rapid cytology staining. Diff-Quik (DQ) staining is the most commonly employed method for cytological rapid on-site evaluation (C-ROSE). However, the utilization of DQ staining for on-site cytological interpretation remains uncommon among pathologists in China, posing challenges to the implementation of C-ROSE. This study aims to assess the application of rapid hematoxylin-eosin (HE) staining and DQ staining for C-ROSE during percutaneous needle biopsy of peripheral lung cancer and evaluate the value of rapid HE staining in C-ROSE. METHODS: Computed tomography (CT)-guided lung biopsies were conducted on 300 patients diagnosed with peripheral lung cancer. The patients were randomly assigned to two groups for C-ROSE using either rapid HE staining or DQ staining, and subsequently the two methods were compared and evaluated. RESULTS: The concordance rate between C-ROSE and histopathological diagnosis was 96.7%. The median staining time for rapid HE staining was 160 s, while that for DQ staining was 120 s, representing a significant difference between the two groups (P<0.001). However, there were no significant differences observed in terms of total biopsy time, concordance rate with histopathology, cytology specimen peeling rate, and incidence of serious adverse reactions between the two groups (P>0.05). CONCLUSIONS: Both staining methods comply with C-ROSE criteria in the biopsy setting of peripheral lung cancer. Rapid HE staining is more aligned with domestic clinical requirements and holds potential for further promotion and adoption in C-ROSE.

Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia.

INTRODUCTION: The mortality rate of hospitalized patients with severe hospital-acquired pneumonia (SHAP) remains high. Empirical broad-spectrum antibiotic coverage and the misuse of high-grade antibiotics could lead to the emergence of multi-drug and even pandrug-resistant bacteria. In addition to metagenomic next-generation sequencing (mNGS), microbiological rapid on-site evaluation (M-ROSE) might be a useful technique to identify the pathogens in the early stage; however, the effect of M-ROSE guiding anti-infection treatment on prognostic outcomes of SHAP patients is still unclear. METHODS/DESIGN: This is a multicenter, single-blind, prospective, randomized controlled trial to evaluate the effect of M-ROSE guiding anti-infection treatment in SHAP patients, which will provide new strategies for the prevention and control of clinical multi-drug resistance bacteria. A total of 166 patients with SHAP, aged 18 years and over, will be recruited from seven centers in Beijing and randomly assigned to the intervention group (M-ROSE combined with mNGS) or the control group (mNGS only) in a 1:1 ratio using the central randomization system. Patients in the intervention group will accept M-ROSE and mNGS analysis, and the control group will accept mNGS analysis. Individualized anti-infective treatment and routine treatment will be selected according to the analysis results. The primary outcome is the ICU outcome (mortality). The safety of the intervention measures will be evaluated during the entire trial period. This trial will be the first randomized controlled trial to evaluate the effect of M-ROSE guiding treatment on mortality in patients with SHAP and may change the prevalence of multi-drug resistant bacteria. ETHICS AND DISSEMINATION: This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Chinese PLA General Hospital (Approval Number: 20220322001). TRIAL REGISTRATION: ClinicalTrials.gov NCT05300776. Registered on 25 March 2022.

The value of microbiology rapid on-site evaluation of sepsis caused by pulmonary infection.

OBJECTIVE: This study aims to evaluate the value of microbial rapid on-site evaluation (M-ROSE) of sepsis, and septic shock caused by pulmonary infection. PATIENTS AND METHODS: Thirty-six patients with sepsis and septic shock due to hospital-acquired pneumonia were analyzed. Accuracy and time were compared with M-ROSE, traditional culture, and next-generation sequencing (NGS). RESULTS: A total of 48 strains of bacteria and 8 strains of fungi were detected by bronchoscopy in 36 patients. The accuracy rate of bacteria and fungi was 95.8% and 100%, respectively. M-ROSE took an average of 0.34±0.01 hours, much faster than NGS (22h±0.01 h, p<0.0001) and traditional culture time (67.50±0.91 h, p<0.0001). CONCLUSIONS: M-ROSE may quickly identify common bacteria and fungi, so it may be a useful method for the etiological diagnosis of sepsis and septic shock caused by pulmonary infection.

Rapid On-Site Evaluation (ROSE): A Microfluidic Approach.

Rapid on-site evaluation (ROSE) increases the diagnostic accuracy of fine-needle aspiration (FNA) samples from cysts, a sack-like fluid-containing tissue that sometimes can be precancerous, but is highly dependent on the skills and availability of cytopathologists. We present a semiautomated sample preparation device for ROSE. The device consists of a smearing tool and a capillary-driven chamber that allow smearing and staining of an FNA sample in a single platform. Here, we show the capability of the device to prepare samples for ROSE, using a human pancreatic cancer cell line (PANC-1) and liver, lymph node, and thyroid FNA model samples. Using microfluidics, the device reduces the equipment needed in an operating room for FNA sample preparation, which may lead to a wider implementation of ROSE in healthcare centers.

Rapid on-site evaluation improves the sensitivity of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for solid pancreatic lesions irrespective of technique: A single-centre experience.

OBJECTIVE: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the first-line technique for the sampling of pancreatic lesions. Many factors can influence the diagnostic performance of this procedure, including the use of rapid on-site evaluation (ROSE). The primary aim of this study was to compare the adequacy, diagnostic yield, accuracy, sensitivity and specificity of EUS-FNA for solid pancreatic lesions before and after the introduction of ROSE. METHODS: This retrospective single-centre study evaluated all consecutive patients who underwent EUS-FNA for suspicious, solid pancreatic masses from April 2012 to March 2015. We compared the findings of EUS-FNA procedures performed during the first and second years following the adoption of ROSE ("ROSE1" and "ROSE2", respectively) to those performed the year before ROSE introduction (the "pre-ROSE" group). RESULTS: Ninety-one consecutive patients with a total of 93 pancreatic lesions were enrolled. For the pre-ROSE, ROSE1 and ROSE2 groups, the adequacy rates were 96.2%, 96.6% and 100%, the diagnostic yield values were 76.9%, 89.7% and 92.1% and accuracy values were 69.2%, 86.2% and 89.5% (p = NS). Sensitivity for malignancy improved from 63.7% in the pre-ROSE group to 91.7% and 91.2% in the post-ROSE groups (p < 0.05). Specificity for malignancy was 100% in all groups. CONCLUSIONS: ROSE can improve the diagnostic performance of EUS-FNA for solid pancreatic lesions, although only sensitivity reached statistical significance.

Endoscopic ultrasound-guided tissue acquisition with or without rapid on-site evaluation for solid pancreatic lesions: five years of experience from a single center.

BACKGROUND: Endoscopic ultrasound (EUS)-guided tissue acquisition (TA) by EUS-guided fine needle aspiration (FNA) or fine needle biopsy (FNB) is a standard diagnostic procedure for solid pancreatic lesions. Whether rapid on-site evaluation (ROSE) should be used to support EUS-TA remains controversial. Here we assessed the diagnostic performance of EUS-TA with or without self-ROSE for solid pancreatic masses. METHODS: Three hundred and seventy EUS-TA cases with self-ROSE and 244 cases without ROSE were retrospectively enrolled between August 2018 and June 2022. All procedures including ROSE were performed by the attending endoscopist. Clinical data, EUS characteristics, and diagnostic performance for distinguishing benign from malignant solid pancreatic masses including accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were compared between groups. RESULTS: Self-ROSE improved the diagnostic accuracy of solid pancreatic lesions by 16.7% in the EUS-TA group (p < 0.001) and by 18.9% in the EUS-FNA alone group (p < 0.001). Self-ROSE also improved the diagnostic sensitivity by 18.6% in the EUS-TA group (p < 0.001) and by 21.2% in the EUS-FNA alone group (p < 0.001). Improvements in the diagnostic accuracy by self-ROSE in the EUS-FNB group were not significant. 2.2 ± 0.7, 2.4 ± 0.9, 2.3 ± 0.7, 2.5 ± 0.9, 2.1 ± 0.6, and 2.1 ± 0.7 needle passes were required in the EUS-TA, EUS-FNA, and EUS-FNB with or without self-ROSE groups, respectively. CONCLUSIONS: Self-ROSE significantly improved the accuracy and sensitivity of EUS-FNA alone and EUS-TA diagnosis of solid pancreatic lesions and helped to reduce needle passes during the procedure. Whether self-ROSE benefits EUS-FNB and whether EUS-FNB alone is comparable to EUS-FNA with self-ROSE require further clarification.