Original articles
Vol. 117: Issue 4 - August 2025
Public health impact of a diagnostic improvement intervention supported by Rapid On-Site Evaluation (ROSE) in thoracic CT-guided biopsies: a pre-post study
Summary
Background. Lung cancer is the leading cause of cancer death worldwide and was the most commonly diagnosed cancer in 2022. The Rapid On-Site Evaluation (ROSE) technique allows immediate evaluation of samples collected during needle aspiration and needle biopsy procedures, improving diagnostic accuracy and reducing the need for repeated procedures.
Study Design. A pre-post study evaluated the health benefits for patients and improved healthcare costs with ROSE diagnostic support from a public health perspective.
Methods. We compared two groups of patients who underwent TC-guided transthoracic needle aspiration/biopsy from March 2017 to March 2022. In the first group (pre-ROSE) the procedures were performed without the support of ROSE, while in the second group (post-ROSE) the pathologist assisted the radiologist in all cases. The diagnostic advantages, the economic-organizational impact of the procedure, and the related benefits for patients were analyzed.
Results. The pre-ROSE group comprised 97 patients, and the post-ROSE group comprised 67. In the group receiving ROSE diagnostic support, the rate of inadequate diagnostic tests requiring repetition decreased from 29.9% to 9.0% (p = 0.001). This saved time for the radiologist, pathologist, nurse, radiology technician, laboratory technician, and support staff, freeing up diagnostic slots that could be used to reduce waiting lists and improve the quality of patient service.
Conclusions. ROSE support has improved diagnostic efficacy and sample quality, reducing repeat testing and associated costs. This leads to better management of healthcare resources, reduced waiting times, and more accurate diagnoses, improving the quality of patient care and bringing public health benefits.
Introduction
Lung cancer is the leading cause of cancer-related death globally 1 and, in 2022, was the most frequently diagnosed cancer, with nearly 2.5 million new cases 2. The diagnosis is mainly based on specific diagnostic tests on small cyto-histological samples, and molecular characterization is crucial, as it allows the identification of possible therapeutic targets through the analysis of recurrent genetic alterations 3. The cyto-histological and molecular characterization of tumors is an increasingly relevant field in pathology, and, regarding lung cancer, the search for new methods for early and accurate diagnosis is essential for its effective treatment 4.
Rapid On-Site Evaluation (ROSE) can be used in the cytological diagnosis of pulmonary and mediastinal diseases 5,6, allowing an immediate evaluation of the suitability and adequacy of the sample collected during invasive procedures 7. The advantage offered by ROSE may be that the affected lesion is directly studied within the procedure setting, allowing for adequate evaluation of the samples and minimizing the need to repeat procedures for additional desired tests (e.g., molecular studies). Some studies have shown that ROSE does not negatively impact the number of aspirations, total procedure time, or post-procedure complication rate. On the contrary, it can provide a preliminary diagnosis that can reduce additional invasive procedures 8. In addition, the implementation of ROSE in case of endosonography-derived samples decreases the number of sites to be sampled, the times of the procedure and allows thorough molecular profiling in most patients 9. The pathologist’s support with ROSE examination improves patient care significantly. However, the ROSE technique also has disadvantages, such as the need for an experienced and trained pathologist on site, the occurrence of unreimbursed costs, and the fact that it is time-consuming in routine activities.
The study focused on three main areas of interest: i. diagnostic improvement, ii. organizational benefits (economic and time-saving), and iii. improvement of the health service offered to the patient.
The study aims to demonstrate how improving diagnostic procedures can significantly impact public health. Specifically, the outcomes of patients undergoing transthoracic needle aspiration (TTNA) or transthoracic needle biopsy (TTNB) were evaluated with and without ROSE support; the two groups were compared to evaluate the improvement of the diagnostic yield for lung and mediastinal tumors vs. to methods that do not use it. The aim is to avoid re-interventions and to obtain a complete cyto-histological and molecular characterization with a diagnostic procedure. Subsequently, the economic impact of implementing these diagnostic methods in patient management and cost savings is considered from a hospital and healthcare management perspective. This evaluation aims to demonstrate if this can avoid unnecessary repeated tests, improve the quality of care provided to the patient, and lead to a diagnostic advantage in terms of timing, generating a benefit for the entire public health service.
Methods
A pre-post study 10 was conducted from March 2017 to March 2022 at the Maggiore Hospital in Bologna (Italy), a hub of the Local Health Authority of Bologna, to evaluate the success rate of transthoracic needle aspiration/biopsy (TTNA/B), guided by computed tomography (CT) and ultrasound (US) methods using ROSE. For this purpose, two groups of patients undergoing TTNA/B for thoracic lesions were compared with pulmonary and mediastinal origin lesions.
The first group of patients (pre-ROSE group) did not benefit from the ROSE support technique at the time of diagnosis. In contrast, the second group (post-ROSE group) benefited from a systematic use of ROSE during radiological procedures.
ROSE was performed on liquid and biopsy materials. Glass slides for liquid materials were first labelled and then the material smeared and air dried. Tissue biopsies were instead touch imprinted on the glass slide and let the imprint air-dry. The Diff-Quik staining method was utilized for all the ROSE slides. Briefly, slides were sequentially immersed in ethanol 95° for 30’’, then in eosin G for 30’’, then in Thiazine for 30’’, both diluted in phosphate buffer. Slides were then rinsed three times to remove excess dye and read promptly under the microscope without mounting. The entire procedure lasted 5 to 10 minutes according to the operator.
For each of the areas of interest, the following evaluation methods were used:
The diagnostic improvement was calculated as the decrease in repeated exams due to inadequate material after the implementation of the ROSE. Material inadequacy was considered when both cyto-histological and molecular diagnostics were not possible. Cases that were diagnostic at cytology or histology but not sufficient for molecular diagnostic were still considered adequate.
As for organizational benefits, time-saving was calculated considering the operators involved (radiologist, pathologist, nurse, radiologist technician, laboratory technician, and support staff) and the improperly occupied diagnostic slots (CT and US). A further economic evaluation was quantified by estimating the cost of the material used (needles used for TTNA and TTNB). The research was conducted using data extracted from software used within the registries of radiology units and materials purchased from the hospital pharmacy. This led to accurately determining the costs of needles used in TTNA and TTNB procedures and evaluating the cost of performing diagnostic CT- and US-guided biopsies.
The last area, difficult to quantify economically but significant, is related to avoiding unnecessary radiological risk for patients with increased quality of health services. The patient’s benefit is substantial, associated with lower diagnostic delay, lower radiological risk, and the lack of repetition of unnecessary healthcare tests.
Continuous variables were summarized as mean and standard deviation and categorical variables as absolute and relative frequencies. A chi-squared test was conducted to compare the proportions of inadequate diagnoses between the two groups. Statistical significance was set at p < 0.05.
The present study has been approved by Comitato Etico Emilia Romagna AVEC - AnaPat ROSE CE 23004; CE AVEC n° 161-2023 -OSS-AUSLBO. All data were collected in compliance with privacy regulations.
Patient risk, cost, and time savings were estimated as reported in Table I.
Results
DESCRIPTIVE ANALYSIS
The study retrospectively analyzed two patient groups: the first did not use ROSE support for diagnosis (pre-ROSE group), and the second used ROSE support (post-ROSE group).
The pre-ROSE group included 97 patients, of whom 57 were males and 40 were females. In contrast, the post-ROSE group included 67 patients, 38 males and 29 females (Tab. II).
The mean age of patients in the pre-ROSE group was 67.8±13.0 years, while 70.8±12.1 years for the post-ROSE group.
In the pre-ROSE group, 89.7% of cases involved lung cancer, while 10.3% were related to the mediastinum. In comparison, 88.1% of cases in the post-ROSE group were in the lungs and 11.9% in the mediastinum. In the pre-ROSE group 50 patients (51.5%) underwent CT-guided TTNA or TTNB. In the post-ROSE group, the number of CT-guided TTNA or TTNB raised up to 45 out of 67 total procedures (67.2%).
Only 25.8% of patients in the pre-ROSE group received a transthoracic needle biopsy (TTNB); however, in the post-ROSE group, the rate of TTNB performed increased to 94.0%. Moreover, in 68.7% of cases, a single TTNB pass was sufficient to diagnose the patient and perform cyto-histological and molecular characterization of the sample (Tab. III).
Accordingly, characterization by Next-Generation Sequencing (NGS) 11,12 was possible in 45.4% of cases in the pre-ROSE group, compared to 62.7%in the post-ROSE group.
DIAGNOSTIC IMPROVEMENT
The number of inadequate procedures, or those that had to be repeated a second time, statistically significantly (p = 0.001) reduced from 29.9% in the pre-ROSE group to 9.0% in the post-ROSE group (Tab. IV).
ORGANIZATIONAL BENEFITS AND IMPROVEMENT OF THE HEALTH SERVICE OFFERED TO THE PATIENT
In the previous paragraph, the main result of our study was shown, that is, how the use of ROSE diagnostic support reduced the repetition rate of inappropriate diagnostic tests by almost two-thirds. Thanks to this result, it is possible to quantify the main costs and performances associated with the diagnostic procedures, as shown in Table V.
In Table VI, we can observe the differences in costs and risks between the two types of intervention. When using the ROSE diagnostic support, the procedure time can increase by up to 10 minutes, and the needle mainly used can cost more. However, this is still a relatively small increase (5.95 euros/needle versus 20.01 euros/needle). Furthermore, it must be considered that the healthcare personnel involved include a Pathologist on site, thus increasing the total staff by one doctor. This results in a slightly lower diagnostic cost without ROSE diagnostic support for the single service.
Net of a slightly higher pathologist’s cost, the ROSE technique, reducing the test repetition rate by 20.9%, generates savings in the terms shown in Table VI. It generates savings for the patient (less diagnostic delay, less radiation exposure, and less exposure to unnecessary invasive tests) and savings for the health service (better use of diagnostic slots, the efficiency of use for health personnel, and higher quality of cyto-histological samples collected). It also creates a knowledge advantage thanks to the knowledge shared between professional figures specialized in different fields.
Discussion
The diagnostic efficiency of ROSE was known in the scientific literature 13. The data of our study show that the ROSE procedure improved the efficiency of TTNA/B examinations and the quality of the samples, allowing more accurate and in-depth characterization of lung and mediastinal tumors, especially as support of endobronchial ultrasound (EBUS) 14. The consistent execution of ROSE during TTNA/B reduced the number of inadequate samples and increased the diagnostic yield. Furthermore, it allowed the collection of qualitatively valid tissue for further cyto-histological and molecular diagnostic analyses in a single procedure.
Our analysis provides a basis for considering implementing diagnostic strategies that improve the accuracy and completeness of initial tests. As reported in other studies, these strategies could significantly reduce the need for repeat tests, leading to a more efficient use of healthcare resources 15,16.
If diagnostic improvement results align with what was already explored in the scientific literature, this study introduced the most novelties: the organizational and economic advantages and patient benefits. These topics could provide public health decision-makers with even more decision-making tools.
From the analysis of the study results, it emerges that the diagnostic procedure supported by ROSE, despite a very slight increase in unit costs of the service compared to a diagnosis without ROSE support, due to the longer duration of the intervention (up to 10 minutes more) and the use of a more expensive biopsy needle (20.01 euros vs 5.95 euros), generates a number of tests to be repeated because they are not conclusive that is significantly lower from 29.9% to 9.0%. This means that the number of tests to be repeated has dcreased by almost two-thirds thanks to ROSE support. In this way, having to repeat fewer tests, the material used will be less, the working time of the operators to reach the single diagnosis will be less, the diagnostic slots used to get the correct diagnosis will be fewer, and the impact on the patient (diagnostic delay, radiological risk and undergoing unnecessary invasive tests) and caregivers will be less.
The diagnostic improvement was, therefore, 20.9%. The organizational benefits were also manifested with the lower use of diagnostic slots for CT and US (-20.9%) that could be used for new diagnoses and, therefore, helping to reduce waiting lists. Furthermore, by decreasing the rate of repeated tests, the material (e.g., biopsy needles) misused will also be lower. The same percentage of the lower rate of repetition of tests is the same that generates savings in the working time of healthcare personnel who, at this point, can be diverted to new diagnoses rather than repeating inconclusive tests already performed. The difference between personnel involved in the technique with ROSE support is similar to the diagnosis without ROSE. What changes most, as shown in the results, is that with ROSE support, the Pathologist is present on-site at the time of the exam and subsequently sends the sample to the Pathological Anatomy laboratories to be processed by a Laboratory Technician and analyzed by a Pathologist. Without ROSE support, the sample goes directly to the laboratory, where the personnel involved are the Laboratory Technician and the Pathologist. The substantial advantage of the ROSE technique, having the Pathologist also on site, is that it can immediately direct towards a correct diagnosis and, thanks to the on-site evaluation, reduces by 20.9% the tests that must be repeated twice, saving working time for all the other operators involved. This is also thanks to the collaboration between Radiologists and Pathologists, which focuses on an important area to investigate as such close contact work could bring mutual benefits. Other studies 17 indicate that these specialists could improve their knowledge by working closely and sharing insights.
Furthermore, the Rapid On-Site Evaluation could improve telecytology by facilitating the adoption of new technologies that can positively impact the health service 18.
Another fundamental aspect to consider is that improving the success of an invasive test by 20.9% brings enormous benefits to the patient. In fact, in two-thirds of cases, the patient will not have to undergo a subsequent examination, avoiding an invasive procedure, a further radiological risk, and decreasing the waiting time to have the most accurate diagnosis possible. This substantially impacts the life of the patient and caregivers.
Among the study limitations is the retrospective design used. This study describes an improvement thanks to the introduction of ROSE support. However, the heterogeneity of the groups (different proportions of TTNA and TTNB and different size of the lesions), the different gauge of needles used for TTNA and TTNB, and the different moments in which the intervention was evaluated did not allow us to draw causal solid links as would have been possible with other study designs.
A further limitation is that the study was conducted within the Italian National Health Service, where the costs are standardized and regulated by a national collective agreement. This only allows a partial economic comparison with other international realities. For this reason, the analysis focused mainly on evaluating staff time-savings rather than economic savings, which are more relevant in a different healthcare context.
In conclusion, focusing on diagnostic accuracy from the first examination can lead to a more efficient use of resources and significantly improve healthcare quality. Encouraging further investigations into implementing these strategies in the health sector can provide policy and health decision-makers with a greater awareness of how specific interventions can impact multiple aspects of public health and improve the performance of health services, which can benefit citizens.
ACKNOWLEDGEMENTS
We are grateful to Andrea Velotti Fino for data retrieval.
FUNDING
This study received no funding.
CONFLICT OF INTEREST STATEMENT
The authors declare no conflict of interest
ETHICAL CONSIDERATION
The present study has been approved by Comitato Etico Emilia Romagna AVEC - AnaPat ROSE CE 23004; CE AVEC n° 161-2023 -OSS-AUSLBO. All data were collected in compliance with privacy regulations.
AUTHORS CONTRIBUTION
FA: histo-cytopathological analyses and manuscritp preparation. MR: Cost analyses and manuscript preparation. NN: histo-cytopathological analyses. JB: Cost analyses. SG: Cost analyses, study design. EM: radiology procedures Michele Imbriani: study design.
CL: study supervision. MF: study supervision, manuscript preparation.
History
Received: December 1, 2024
Accepted: January 7, 2025
Figures and tables
| Risks to the patient, healthcare personnel and material involved | Risk/Cost |
|---|---|
| Patient | diagnostic delay; radiological risk; repetition of unnecessary healthcare test |
| Medical Doctor – Radiologist | working-time |
| Medical Doctor – Pathologist | working-time |
| Nurse | working-time |
| Radiology Technician | working-time |
| Laboratory Technician | working-time |
| Support Staff | working-time |
| TTNA Biopsy Needle 25G x 100 mm | unit cost |
| TTNB Biopsy Needle 18G x 100 mm | unit cost |
| CT service | diagnostic slot usage |
| US service | diagnostic slot usage |
| Notes: TTNA = Transthoracic Needle Aspiration; TTNB = Transthoracic Needle Biopsy; CT = Computed Tomography; US = Ultrasound. | |
| pre-ROSE Group | post-ROSE Group | |
|---|---|---|
| ROSE support | No | Yes |
| Total (n, %) | 97 (100.0%) | 67 (100.0%) |
| Male | 57 (58.8%) | 38 (56.7%) |
| Female | 40 (41.2%) | 29 (43.3%) |
| Mean Age (years±SD) | 67.8±13.0 | 70.8±12.1 |
| Male | 69.5±12.4 | 73.2±8.7 |
| Female | 65.5±13.5 | 67.6±15.1 |
| Cancer Site (n, %) | ||
| Lung (right and left) | 87 (89.7%) | 59 (88.1%) |
| Mediastinum | 10 (10.3%) | 8 (11.9%) |
| Notes: ROSE = Rapid On-Site Evaluation; n = number; y.o. = years old; SD = Standard deviation. | ||
| pre-ROSE Group | post-ROSE Group | |
|---|---|---|
| ROSE support | No | Yes |
| Procedure (n, %) | ||
| TTNA | 72 (74.2%) | 4 (6.0%) |
| TTNB | 25 (25.8%) | 63 (94.0%) |
| Preliminar Diagnosis (n, %) | ||
| Total | - | 61 (91.0%) |
| Single Pass | - | 46 (68.7%) |
| Diagnosis (n, %) | ||
| NSCLC/ADK | 34 (35.1%) | 27 (40.3%) |
| NSCLC/SCC | 4 (4.1%) | 7 (10.4%) |
| NSCLC/NOS | 6 (6.2%) | 8 (11.9%) |
| NSCLC/LCNEC | 3 (3.1%) | 4 (6.0%) |
| Others | 21 (21.6%) | 15 (22.4%) |
| Molecular Analysis NGS (n, %) | ||
| Total | 44 (45.4%) | 42 (62.7%) |
| Of which cytology | 27 (61.4%) | 28 (66.7%) |
| Of which histology | 17 (38.6%) | 14 (33.3%) |
| Notes: ROSE = Rapid On-Site Evaluation; n = number; TTNA = Transthoracic Needle Aspiration; TTNB = Transthoracic Needle Biopsy; NSCLC/ADK = Non-Small Cell Lung Cancer/Adenocarcinoma; NSCLC/SCC = Non-Small Cell Lung Cancer/Squamous Cell Carcinoma; NSCLC/NOS = Non-Small Cell Lung Cancer/Not Otherwise Specified; NSCLC/LCNEC = Non-Small Cell Lung Cancer/Large Cell Neuroendocrine Carcinoma; NGS = Next-Generation Sequencing. | ||
| pre-ROSE Group | post-ROSE Group | p-value | |
|---|---|---|---|
| Inadequate Diagnosis (n, %) | 29 (29.9%) | 6 (9.0%) | p = 0.001 |
| Notes: ROSE = Rapid On-Site Evaluation; n = number. | |||
| Type of Performance or Material | Unit cost |
|---|---|
| Total duration of the service without ROSE support | 35 minutes for diagnosis + 30 minutes post-test waiting time. |
| Total duration of the service with ROSE support | 45 minutes for diagnosis + 30 minutes post-test waiting time |
| TTNA Biopsy Needle 25G x 100 mm | 5.95 euros/needle |
| TTNB Biopsy Needle 18G x 100 mm | 20.01 euros/needle |
| Saving working-time for Medical Radiologist | 35 minutes |
| Saving working-time for Medical Pathologist | 35 minutes |
| Saving working-time for Nurse/Radiology Technician/Laboratory Technician | 35 minutes |
| Saving working-time for Support Staff | 35 minutes |
| CT service cost | a missed diagnostic slot |
| Ultrasound service cost | a missed diagnostic slot |
| Patient risks | delayed diagnosis; radiation exposure; second exposure to invasive testing |
| Notes: ROSE = Rapid On-Site Evaluation; TTNA = Transthoracic Needle Aspiration; TTNB = Transthoracic Needle Biopsy; CT = Computed Tomography. | |
| pre-ROSE Group | post-ROSE Group | |
|---|---|---|
| Total Duration of the Service | 35 minutes for diagnosis + 30 minutes post-test waiting time. | 45 minutes for diagnosis + 30 minutes post-test waiting time |
| Biopsy Needle | Mainly TTNA Biopsy Needle 25G x 100 mm (5.95 euros/needle) | Mainly TTNB Biopsy Needle 18G x 100 mm (20.01 euros/needle) |
| Healthcare Personnel Involved | On Site: Radiologist, Nurse, Radiology Technician, Support Staff.In the Laboratory: Pathologist. Laboratory Technician. | On Site: Pathologist, Radiologist, Nurse, Radiology Technician, Support Staff.In the Laboratory: Pathologist. Laboratory Technician. |
| Advantages and savings of the procedure | For the patient:time-saving of just a few minutes (max 10 minutes). For the healthcare service: lowest unit cost for each test | For the patient: reduced diagnostic delay, lower radiological risk, and fewer unnecessary test repetitions. For the healthcare service: minimize missed diagnostic slots and operators’ working time required for test repetitions (-20.9% of test repetitions). Improvement of the collected cyto-histological sample. Collaboration among various professionals to share and implement collective knowledge. |
| Notes: ROSE = Rapid On-Site Evaluation; TTNA = Transthoracic Needle Aspiration; TTNB = Transthoracic Needle Biopsy | ||
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